Solicitors:
Health Care Complaints Commission (Applicant)
Remington & Co (Respondent)
File Number(s): 2019/00155306
Publication restriction: An order is made pursuant to s 64 of the Civil and Administrative Tribunal Act 2013 prohibiting the disclosure of the names, addresses or any other identifying information of any patient referred to in the evidence in the proceedings.
[2]
REASONS FOR DECISION
Introduction
Background
Pharmacists as Proprietors of Pharmacies
Tribunal proceedings
Standard of proof
The Complaint
Mr Saab's reply to the Complaint
Complaint 1
Particulars 1- 4: Overview
Particulars 1- 4: Methadone drug register, biannual stock checks and equipment
Particular 5: Schedule 4 Appendix B prescriptions
Particulars 6 and 7: Mr Saab's initials in the Dispensing System
Complaint 2 and 3: Overview
The Poisons and Therapeutic Goods Regulation 2008 (PTGR)
Dispensing Guidelines
Complaint 2: Patients A - Y and Patient Z
Patients A - Y: Overview Particulars 1 to 115
Complaint 2: The Particulars
Patient A and Schedule A: Particulars 1 - 4
Patient B and Schedule B: Particulars 5 - 11
Patient C and Schedule C: Particulars 12 - 16
Patient D and Schedule D: Particulars 17 - 20
Patient E and Schedule E: Particulars 21- 25
Patient F and Schedule F: Particulars 26 - 31
Patient G and Schedule G: Particulars 32 - 35
Patient H and Schedule H: Particulars 36 - 40
Patient I and Schedule I: Particulars 41 - 44
Patient J and Schedule J: Particulars 45 - 47
Patient K and Schedule K: Particulars 48 - 53
Patient L and Schedule L: Particulars 54 - 58
Patient M and Schedule M: Particulars 59 - 63
Patient N and Schedule N: Particulars 64 - 66
Patient O and Schedule O: Particulars 67 - 71
Patient P and Schedule P: Particulars 72 - 74
Patient Q and Schedule Q: Particulars 75 - 79
Patient R and Schedule R: Particulars 80 - 85
Patient S and Schedule S: Particulars 86 - 90
Patient T and Schedule T: Particulars 91 - 95
Patient U and Schedule U: Particulars 96 - 99
Patient V and Schedule V: Particulars 100 - 104
Patient W and Schedule W: Particulars 105 - 109
Patient X and Schedule X: Particulars 110 - 112
Patient Y and Schedule Y: Particulars 113 - 115
Mr Saab's evidence in response to Complaint 2: Patients A - Y
Patient Z and Schedule Z: Particulars 116 - 117
Complaint 3: Patients A1 - L1
Particulars 1 - 12: Overview
Patients A1 to L1: The medications and prescriptions
Patient A1:
Patient B1:
Patient C1:
Patient D1:
Patient E1:
Patient F1:
Patient G1:
Patient H1:
Patient I1:
Patient J1:
Patient K1:
Patient L1:
The Pharmacy Board of Australia Guidelines for Proprietor Pharmacists
The Pharmaceutical Society of Australia Code of Ethics for Pharmacists
Expert Reports
Ms Croker
Mr Mahony
The Credit of Mr Saab
FINDINGS
Complaint 1
Particulars 1 and 2: Methadone Registers
Particular 3: Biannual stock checks
Particular 4: Methadone Pump
Particular 5: Separation of Schedule 4B prescriptions
Particular 6: Removal of initials from the dispensing system
Particular 7: Initials
Complaint 2
Dispensing Schedule 8 drugs of addiction to patients outside the Pharmacy's local area
Prescriptions and Supply: Clauses 79, 80, 86 and 87 PTGR
Private Prescriptions
Supply Generally: Clause 109 PTGR Quantity and Purpose of Supply to be appropriate
Patient Z
Complaint 3
Conclusions
Complaints One, Two and Three: Unsatisfactory Professional Conduct sections 139B(1)(a) and (l)
Professional Misconduct
Complaint Four: Professional Misconduct section 139E of the National Law
Stage 2 Proceedings
Orders
ANNEXURE A
ANNEXURE B
[3]
Introduction
The Health Care Complaints Commission (the Commission) seeks disciplinary findings and orders under the Health Practitioner Regulation National Law (NSW) (the National Law) against Tony Saab, a registered Pharmacist.
In its amended Complaint attached to the Application, the Commission brings four individual complaints in relation to the conduct of Mr Saab.
The first three complaints allege unsatisfactory professional conduct under s 139B(1)(a)) and/or s 139B(1)(l) of the National Law.
The Commission alleges that Mr Saab's conduct demonstrates that the judgement possessed, or care exercised, by him in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience (s 139B(1)(a)); and/or his conduct was improper or unethical (s 139B(1)(l)).
The fourth complaint alleges that the unsatisfactory professional conduct detailed in the first three complaints amounts to professional misconduct under s 139E of the National Law.
Central to the Complaint is Mr Saab's conduct at a pharmacy in Granville of which he was the sole proprietor. The conduct relates to the period January 2015 to March 2017.
A substantial but not the sole element of the Complaint, relates to 38 separate patients, and whether the dispensing of Schedule 8 drugs of addiction and Schedule 4B and D prescribed restricted substances to these patients by Mr Saab's Pharmacy was appropriate.
Of these 38 patients, 25 patients were dispensed drugs of addiction under prescriptions from three different Doctors where those prescriptions came from prescription pads that had been stolen. These prescriptions were subsequently identified as being fraudulent.
The remaining 13 patients were dispensed special prescribed restricted substances.
Other aspects of the Complaint alleged failing to maintain proper and accurate records for methadone, a Schedule 8 drug, failing to notify the NSW Ministry of Health of losses in methadone, failing to undertake biannual stocktakes for methadone and the removal by Mr Saab of his name and initials from the Pharmacy dispensing system.
The Complaint includes Patient Schedules in the form of tables for each patient referred to in the Complaint. The Schedules set out the prescription number, dispensing date, medication dispensed including strength, the quantity of medication dispensed, the number of repeats, the prescriber and the price.
The particulars which underpin the factual matrix to the individual complaints were amended further throughout the course of the proceedings to correct typographical errors. It is the further amended notice of complaint filed on 8 September 2020 which is the subject of this decision. The further amended notice of complaint without the patient schedules is annexed to these reasons and marked A.
[4]
Background
Mr Saab became a registered Pharmacist on 4 January 2008. After working in a number of suburban pharmacies, including as a pharmacist in charge, Mr Saab purchased and became the sole proprietor of Pharma Save in Granville (the Pharmacy) on 18 July 2014.
Mr Saab worked in the Pharmacy along with two full time employed pharmacists and a locum pharmacist.
On 9 March 2017, 19 April 2017 and 24 April 2017 the NSW Ministry of Health Pharmaceutical Regulatory Unit (PRU) inspected the Pharmacy.
In a subsequent report dated 5 June 2017 completed by a senior pharmaceutical officer with the PRU, reference is made to the Pharmacy being chosen for inspection following an assessment of wholesaler records provided to the PRU which indicated that the Pharmacy "purchased amongst the highest quantities of high strength Fentanyl patches and high strength oxycodone tablets of any pharmacy in NSW".
Fentanyl is a highly potent synthetic opioid. One Fentanyl 100mcg/hour patch applied every 3 days is the equivalent of 360mg of morphine orally daily. Fentanyl can be extracted from patches and misused. Oxycodone is available in different dosages and forms such as tablets, capsules and liquid. It is a narcotic like morphine and heroin. Both are part of a group of drugs known as opioids. Both are listed as Schedule 8 drugs under the Poisons and Therapeutic Goods Regulation 2008 (PTGR). This reflects their significance as drugs of addiction. Fentanyl is the generic name for brand names such as Durogesic. Oxycodone is known by brand names such as Oxycontin.
The PTGR sets out stringent statutory requirements in relation to the storage, handling and record keeping for drugs of addiction. These Regulations exist to manage and address the risks to patients and the public more broadly in dispensing drugs of addiction.
Schedule 4 (Restricted Substances) are substances which in the public interest should be supplied only by, or upon the written prescription of, an authorised practitioner.
Appendix D of the PTGR lists Schedule 4 substances (prescription-only medicines) that have common therapeutic uses, but are also liable to abuse, misuse and diversion, warranting more stringent controls on possession and supply. These substances are referred to under the PTGR as prescribed restricted substances, and are also more commonly referred to as Schedule 4 Appendix D (S4D) medicines.
Appendix B of the PTGR lists Schedule 4 substances (prescription-only medicines) that have more stringent controls on possession and supply because they are liable to abuse, misuse and diversion. These substances are referred to under the PTGR as special restricted substances, and are more commonly referred to as Schedule 4 Appendix B (S4B) medicines. Anabolic steroids are special restricted substances.
S4B medicines are a subset of medicines listed in Appendix D of the Regulation (S4D medicines) and have more stringent dispensing requirements than other S4D medicines.
Schedule 8 (Drugs of Addiction) are substances which are addiction producing or potentially addiction producing. Possession, supply, prescribing and use are strictly limited: see Guide to Poisons and Therapeutic Goods Legislation for Pharmacists, issue date June 2015 produced by Pharmaceutical Services Unit, Legal and Regulatory Services Branch, NSW Ministry of Health.
After the PRU's initial inspection of the Pharmacy on 9 March 2017 the Director of the PRU, Bruce Battye, decided to take action under the provisions of Clause 175 (1) of the PTGR and Section 18AA of the Poisons and Therapeutic Goods Act 1966 to withdraw Mr Saab's authority to possess any drugs of addiction (Schedule 8 drugs), prescribed restricted substances (Schedule 4, Appendix D drugs) and a number of other specified restricted substances.
Under cover of letter addressed to Mr Saab dated 17 March 2017, Mr Battye advised Mr Saab that he had made an order under Clause 175 (1) of the PTGR prohibiting him from supplying or having possession of, or manufacturing any preparation, admixture or extract of a drug of addiction. On the same date this letter was delivered by officers of the PRU to the Pharmacy.
By letter dated 20 March 2017 Mr Battye informed The Pharmacy Council of New South Wales (the Council) of his decision to withdraw Mr Saab's authority.
The Council decided to convene proceedings to determine whether any action should be taken against Mr Saab under section 150 of the National Law by either suspending or imposing conditions on his registration.
Section 150 proceedings occur in the context of the Council's obligation under the National Law to take action at any time if it is satisfied it is appropriate to do so for the protection of the health and safety of the public or for reasons otherwise in the public interest.
A hearing under s.150 was conducted by the Council with Mr Saab on 30 March 2017. As a consequence of that hearing, the Council imposed various conditions on Mr Saab's registration as a Pharmacist including that he "Must not practice as a pharmacist". This condition remains in place.
At the time of the condition to practice being imposed on Mr Saab's registration as a pharmacist he had been practicing for some nine years.
Mr Saab sold the Pharmacy on 20 December 2017.
[5]
Pharmacists as Proprietors of Pharmacies
In this case we look at Mr Saab's conduct as a pharmacist and; because he owned the Pharmacy, his conduct as a proprietor pharmacist.
Under the National Law (NSW), a person cannot carry on a pharmacy business in NSW unless the premises have a current approval and all the holders of the financial interest in the pharmacy business are registered in the National Register of Pharmacists, maintained by the Australian Health Practitioner Regulation Agency (AHPRA): see Clauses 3 and 5 of Schedule 5F of the National Law.
This means that only a registered pharmacist can own a Pharmacy.
Unauthorised possession of a drug of addiction is illegal. A pharmacist engaged in the retail practice of pharmacy is authorised to have possession of a drug of addiction for the purpose of their particular profession unless in any particular case that authority has been withdrawn: see Guide to Poisons and Therapeutic Goods Legislation for Pharmacists, issue date June 2015 produced by Pharmaceutical Services Unit.
Guidelines for Proprietor Pharmacists issued by the Pharmacy Board of Australia (December 2010 and reissued in more detail in September 2015) focus on the professional responsibilities of proprietor pharmacists that impact on the safe, effective delivery of services to the public to ensure that the Pharmacy business is conducted properly. The Board's guidelines exist to provide guidance to pharmacy proprietors not specifically set out in legislation.
A central theme to both iterations of the Guidelines is that if the owner of a pharmacy is not the pharmacist usually in charge of that pharmacy, he or she must determine regularly how the practice of pharmacy is being conducted to be satisfied it is in accordance with any applicable State, Territory or Commonwealth law applicable to the practice of pharmacy, with any relevant Pharmacy Board of Australia policies, codes, guidelines, and with good pharmacy practice. If the proprietor finds otherwise, he or she must intervene to ensure that the pharmacy business is conducted properly.
In relation to the obligations of a proprietor pharmacist there is a variation between the 2010 and 2015 guidelines. The 2010 version states that "A proprietor/owner cannot abdicate his or her professional obligations", the 2015 version replaces the word "abdicate" with "delegate".
[6]
Tribunal proceedings
This matter has come before the Tribunal in the midst of COVID-19 pandemic restrictions. To reflect the public health measures deployed in response to the pandemic the matter was heard via audio visual link with parties and witnesses participating from different locations. In addition Mr Saab was provided with closed captioning so that he could read what was said in the proceedings.
Mr Saab and Raja Morris, a pharmacist and former employee of Mr Saab, gave oral evidence. Two experts provided written reports and gave oral evidence; Nerida Croker on behalf of the Commission and Patrick Mahony on behalf of Mr Saab. Two pharmaceutical officers who had conducted "the PRU" inspections of the Pharmacy, Aleksandar Gavrilovic and Paul Smith, also gave oral evidence.
At the commencement of the proceedings, Mr Saab sought that the proceedings be conducted by way of a two stage hearing. The Commission did not seek to be heard against such an approach. As the hearing progressed and the evidence came out, it became clear that it was appropriate for the matter to be conducted in two stages.
In this first stage we examine the Complaint and the evidence relevant to it. This is stage one of the proceedings.
These reasons only deal with whether the Complaint is established. Because the Complaint has been substantiated, we will deal with the question of the making of appropriate protective orders in a second stage of the proceedings.
[7]
Standard of proof
Unlike professional disciplinary proceedings under the Legal Profession Uniform Law, in disciplinary proceedings under the Health Practitioner Regulation National Law the Tribunal is not bound by rules in respect of admissibility of evidence: Section 38(2) of the Civil and Administrative Tribunal Act 2013 and Clause 2 of Schedule 5D of the National Law.
In Mr Saab's submissions, reference is made to the applicable standard of proof being consistent with the civil standard as enunciated in Briginshaw v Briginshaw (1938) 30 NSWLR 699.
The Briginshaw test is a reference to a principle applied by courts dealing with civil litigation in applying a standard of proof on the balance of probabilities, as described in section 140 of the Evidence Act 1995 (NSW): Bronze Wing International Pty Ltd v SafeWork NSW [2017] NSWCA 41 at [15].
As submitted by the HCCC, whilst neither the Briginshaw civil standard nor section 140 of the Evidence Act 1995 directly applies to the Tribunal's decision making, the principles remain relevant, and the Tribunal should be informed by matters including the seriousness of an allegation and the gravity of the consequences of making the finding: Bronze Wing International Pty Ltd v SafeWork NSW [at [127]; Health Care Complaints Commission v Meneghetti [2020] NSWCATOD 39 at [14].
As Fullerton J observed in Donnelly v Health Care Complaints Commission (NSW) [2011] NSWSC 705 at [18]:
"...because of the seriousness of the allegations and their consequences [the Tribunal] had to be reasonably satisfied that the particulars of the complaints had been established by evidence of sufficient quality and weight before considering whether those particulars constituted unsatisfactory professional conduct or professional misconduct or both."
[8]
The Complaint
The Complaint sets out four individual complaints against Mr Saab under the National Law.
Complaints 1, 2 and 3 allege unsatisfactory professional conduct. Complaint 4 alleges professional misconduct.
Each individual complaint is supported by particulars. Complaint 1 comprises 7 particulars, Complaint 2 comprises 117 particulars and Complaint 3 comprises 12 particulars. The Complaint runs to some 30 pages and consists of a total of 136 pleaded particulars with some particulars containing sub-particulars. The Complaint together with the patient schedules comprises 74 pages.
[9]
Mr Saab's reply to the Complaint
A reply dated 6 March 2020 was filed in response to the Complaint. Apart from some limited factual concessions, the reply disputed every particular pleaded in the Complaint.
There was no statement of agreed facts between the parties.
Although the reply was amended during the course of the hearing, this did not materially affect Mr Saab's denial of the particulars or the Complaint. The amended reply is annexed to these reasons and marked B.
Consistent with Mr Saab's written reply during the course of his oral evidence he conceded some aspects of various factual matters. However, with the exception of potentially one particular, Mr Saab did not concede any of the particulars relied upon by the Commission. Apart from this one particular it was said was conceded, Mr Saab, denied unsatisfactory professional conduct and professional misconduct.
At the beginning of the hearing Counsel for Mr Saab made an opening statement. He indicated that the Commission had brought a particular case against Mr Saab with particular allegations. He intended to hold the Commission to that complaint. He indicated that in closing submissions his intention was to address the material relied upon by the Commission to show the case was not established and was misconceived as a matter of the proper interpretation of a pharmacist's obligations.
We are conscious of the commentary made by the Supreme Court of NSW in various cases on the form of pleadings that have been adopted by the Commission in the past where complaints of unsatisfactory professional conduct and professional misconduct have been laid in reliance on the same set of particulars: see for example Lucire v Health Care Complaints Commission [2011] NSWCA 99.
This commentary was a matter that Counsel for Mr Saab addressed at length in written and oral submissions to target what was said to be deficiencies in the case as pleaded by the Commission. Amongst other cases reference was made to Health Care Complaints Commission v Karalasingham [2007] NSWCA 267 at [30] and Health Care Complaints Commission v Wingate [2007] NSWCA 326 at [13] per Basten JA (McColl JA relevantly agreeing and Harrison J agreeing).
For example, reference was made to Mr Saab's obligations as a pharmacist proprietor on the basis that such allegations were not specifically pleaded. It was said that statutory provisions in the PTGR relied upon to establish a breach must be precisely stated, pleadings should be construed strictly, all alleged breaches including those based on Professional Guidelines should be pleaded, what the standard applicable to a particular professional is ultimately a question of law and, where misconduct is alleged, pleadings ought to state the allegation with the same precision as a criminal indictment.
These matters were expanded upon in written and oral submissions on the last day of hearing by Mr Saab's counsel with a particular focus on the specific statutory provisions of the PTGR that were raised by the Complaint.
Whilst we have attempted to deal with the detail of Mr Saab's submissions in our findings which appear later in this decision, we would make some general observations about the submissions, and specifically our rejection of the suggestion that pleadings must be construed strictly.
In broad terms Mr Saab's submissions as to statutory construction did not come to terms in any meaningful way with the need for us to have regard to the nature of our jurisdiction and the purposes of the National Law. Nor did the submissions come to terms in a material way with the content of the Guidelines and standards of professional practice that were referred to in the evidence before us.
The objective and guiding principle in the exercise of our functions under the National Law is that the protection of the health and safety of the public must be the paramount consideration.
The use of registration standards, codes or guidelines in disciplinary proceedings is specifically identified in the National Law. An approved registration standard for a health profession, or a code or guideline approved by a National Board, is admissible in proceedings against a health practitioner as evidence of what constitutes appropriate professional conduct or practice: see section 41 National Law.
The PTGR sets out statutory requirements in relation to the storage, handling and record keeping for drugs of addiction. Various Guidelines for Pharmacists issued by the Pharmacy Board of Australia exist to provide guidance to pharmacists not specifically set out in legislation.
Therefore there is coherence to the protective objects of the National Law, individual statutory requirements that might apply under the PTGR legislation and guidelines as they relate to the standards expected of pharmacists including the standards of oversight expected to be given to the pharmacies in which they hold a pecuniary interest.
Some of the criticisms made of the pleadings fail to come to grips with the wrongdoing which is alleged in the Complaint. That is; that Mr Saab, inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction and Schedule 4B and D prescribed restricted substances.
The provisions of the PTGR that are identified in the Complaint serve to add context and meaning. As we will detail later in this decision, pharmacists have legislative and professional responsibilities to assess whether it is safe, appropriate and lawful to dispense a prescription. They should not merely assume that when a prescription is presented that all is well.
In Sabag v Health Care Complaints Commission [2001] NSWCA 411, Sperling J, referred to particulars at [83]:
The primary function of particulars is to apprise the opposite party of the case to be met. There is a special need for particulars in disciplinary proceedings ... because of the elements of degree and judgement involved in a finding of professional offence ... The particulars of the complaint must specify the conduct relied upon sufficiently to apprise the person not only of the bare facts relied upon but also of those aspects of the conduct relied upon as satisfying the elements of degree and judgment which are involved.
It is this evaluative process which is overlooked in the submissions made on behalf of Mr Saab. Professional disciplinary proceedings involve an evaluative process. A benchmark standard which is expected of practitioners in the relevant field must be ascertained, and then the conduct which has been proven against the practitioner the subject of the disciplinary action, must be assessed against that standard: see Health Care Complaints Commission v Amalakumar [2019] NSWCATOD 173 at [25].
As to the strictness of pleadings the following observations by Wilson J in Shuquan Liu v Health Care Complaints Commission [2018] NSWSC 315 at [32]-[33] ("Shuquan") are instructive:
Given that a complaint may be made by anyone, it is clear that the complaint need not be drafted by a person with legal training or one who plays a formal legal role in the proceedings initiated by the complaint. Whilst that is what in fact happened in this case, it is not a statutory requirement. Necessarily, there is no requirement for the complaint to be drafted in the same restrictive form and with the same care as an indictment, information, or pleading.
The complaint "initiates the chain of inquiry which may bring matters before the Tribunal": King v Health Care Complaints Commission [2011] NSWCA 353, at [5] per McColl JA, who was in agreement on this and other points with Handley AJA; Macfarlan J dissenting). Handley AJA said on that point that a complaint functions as a "summary or distillation of the complaints, formulated as an aide memoire for the benefit of the [person the subject of the complaint] and the Tribunal" (at [171]). Its purpose is to inform the proceedings, not to confine them.
Further, in Shuquan at [27], Her Honour also observed the importance of bearing in mind that, when hearing and determining a complaint of the nature of that made by the Commission, the Tribunal is not exercising the powers of a criminal court hearing a criminal charge, and it is not obliged to meet the same procedural or evidentiary standards. Its function is quite different.
Further the Tribunal is not a court presided over by a judge; it is constituted by a combination of lawyers, relevant health professionals, and lay persons, as required by s 165B of the National Law. Its particular expertise is in providing a mechanism for dealing expeditiously and practically with problems that arise in medical practice, always with the aim of protecting the public. See Shuquan at [29].
That being said, because of the way the case was prosecuted and more specifically the way it was responded to, it is necessary to set out the particulars in full which underpin the Complaint and which are relied upon by the Commission in support of the individual complaints laid against Mr Saab.
[10]
Particulars 1- 4: Overview
Complaint 1, particulars 1 to 4 relate to the dispensing, stock checks and record keeping for methadone at the Pharmacy.
The Pharmacy had approximately 40 methadone patients. Requirements in relation to the storage, handling, dispensing and record keeping of drugs of addiction such as methadone are set out in the PTGR.
Part 4 Division 5 Subdivision 3 Clause 118 of the PTGR states that a periodical inventory of stock of drugs of addiction such as methadone must be conducted in March and September each year.
Part 4 Division 7 Clause 124 of the PTGR provides that a person who is authorised to be in possession of drugs of addiction must immediately notify the Director-General if the person loses a drug of addiction or if a drug of addiction is stolen from the person.
Dispensing equipment, such as a methadone pump, is not specifically referred to in the PTGR.
[11]
Particulars 1- 4: Methadone drug register, biannual stock checks and equipment
Particular 1
1. On 7 November 2015, the practitioner failed to immediately notify the Director-General of the NSW Ministry of Health when a pharmacist in his employ recorded a loss of 869 millilitres of Methadone in the Drugs Register at the Pharmacy, contrary to Clause 124 of the Poisons and Therapeutic Goods Regulation 2008 ("the PTGR").
Particular 1 alleges that on 7 November 2015 Mr Saab failed to notify the NSW Ministry of Health of the loss of 869 millilitres of Methadone 5mg.
Mr Morris was a pharmacist employed by Mr Saab. He worked at the Pharmacy between July 2014 and December 2016. On 7 November 2015 he conducted a stock check of Methadone 5mg/ml.
The drug register for Methadone 5mg/ml shows a balance of 4369 millilitres as at 7 November 2015. The stock check done by Mr Morris on that same day recorded an amount of 3500 millilitres on hand. Mr Morris entered that amount into the drug register.
Accordingly the stock check indicates that on 7 November 2015 the Pharmacy held 869 millilitres of Methadone less on hand to that recorded in the running balance in the drug register.
Mr Morris gave evidence about this issue as follows:
Q. What did you do when you made that entry of the 3,500?
A. As I recall, I told Mr Saab about this, even earlier during the year when I've noticed this discrepancy in the volume of methadone, and he said that he's going to check the pump.
Q. Did he check the pump, that you know of?
A. No, I wasn't aware that the pump has been checked.
Q. If I can then - just in relation to that page, are you familiar with Mr Saab's handwriting?
A. Yes, I can see his - that's his initials "TS". That's how he signs.
Q. And is that his handwriting?
A. Yes.
We note that a number of entries on the same page of the Methadone drug register are made by Mr Saab. One entry is made on 10 November 2015, some three days after the stock check was done by Mr Morris.
In relation to the loss of 869 millilitres of Methadone recorded in the Register on 7 November 2015, under cross-examination Mr Saab gave evidence as follows:
he was aware of the loss of 869 millilitres at the time that Mr Morris made this entry in the Pharmacy's Controlled Drug Register;
he conceded that the did not notify the Ministry of Health about the missing Methadone on 7 November 2015 or shortly thereafter;
he conceded that he knew that he was required to notify the Ministry of Health;
he conceded that there had been no attempt to try and reconcile what was the cause of the differential of 869 millilitres in the Controlled Drug Register.
Particular 2
2. On 29 January 2017, the practitioner failed to immediately notify the Director-General of the NSW Ministry of Health when the practitioner recorded a loss of 2,579 millilitres of Methadone in the Drugs Register at the Pharmacy, contrary to Clause 124 of the PTGR.
Particular 2 alleges that on 29 January 2017 Mr Saab failed to notify the Ministry of Health of the loss of 2,579 millilitres of Methadone 5mg.
The drug register for Methadone 5mg shows that on 29 January 2017 a stock check was conducted. The stock check recorded that the Pharmacy held 2,579 millilitres of Methadone less on hand to that recorded in the running balance in the drug register. This stock check was performed by Mr Saab as is evidenced by his initials in the Drug Register.
Under cross-examination, Mr Saab gave evidence as follows:
that he was working 2 days a week in January and February 2017;
he did not report the missing Methadone to the Ministry of Health;
he attempted to find out the cause of the discrepancy and concluded that the Methadone pump was the cause of the discrepancy.
Mr Saab gave evidence during the hearing that the two instances of a loss of methadone related to a minor discrepancy in the pump resulting in a loss of less than 1% over time. This was a position that Mr Saab had similarly adopted in the s.150 proceedings.
As we understood Mr Saab's evidence he believed that as a proportion across the cohort of methadone patients and over time the variances in doses to individual patients would have been less than 0.1%.
Evidence was put before the Tribunal by Mr Saab as to the Calibrex banded pump he was using at the time and its accepted accuracy range of 0.5 - 1.5%.
Particular 3
3. The practitioner failed to undertake accurate stock checks as required by Clause 118 of the PTGR for methadone at the Pharmacy as follows:
a) in March 2015;
b) in September 2015;
c) in March 2016; and
d) in September 2016.
Particular 3 alleges that Mr Saab failed to undertake accurate bi-annual stock checks for Methadone in March and September of 2015 and in March and September of 2016 as required by Clause 118 of the PTGR.
The evidence in support of this allegation can be found in the PRU's preliminary report dated 27 March 2017, which has copies of the Methadone Controlled Drug Register pages for the relevant period. This indicates that stock checks were completed in 2015 but not during the prescribed periods of March and September.
For example, a stock check was performed by Mr Morris on 2 January 2015. In this stock check Mr Morris recorded a surplus of Methadone of 149 millilitres in the drug register, and the stock check in November 2015 also done by Mr Morris which recorded a loss of 869 millilitres.
Mr Morris made a witness statement in the proceedings dated 3 October 2017. He relevantly stated as follows:
During 2015, I would do the bi-annual stocktake. On more than one occasion I noticed a discrepancy in the volume of Methadone and I immediately reported to Mr Saab. Every time his response was that he will do something about it and that he will check the pump. As far as I know I do not recall Mr Saab calling any professional to recalibrate the dispensing pump, as he informed me that he wanted to fix it himself.
After 2015, I stopped doing the bi-annual stocktake as I was uncomfortable that the discrepancy with the pump was not fixed.
When the PRU came in March 2017 to the Pharmacy, they checked the Methadone Register and calculated a variance of 2 L. Then the PRU forced for Mr Saab to order a new pump, which we received in April 2017. The new pump solved this issue and reduced the variance which was about 20-25 ml weekly in the Methadone volume to negligible.
I recall that at some time after the PRU came to the Pharmacy, Mr Saab showed me the Drug Register, which showed that the stock count regularly showed a deficiency of 20-25 ml. Mr Saab explained that the small issue with the pump could cause a cumulative loss of 20-25 ml per week.
Under cross examination Mr Morris agreed that Mr Saab had tasked him with undertaking the stock checks for methadone. Mr Morris could not recall if he told Mr Saab that he was no longer doing the stock take.
[12]
Particular 5: Schedule 4 Appendix B prescriptions
Particular 5
5. Between 9 March 2015 and 9 March 2017, the practitioner failed to keep Schedule 4 Appendix B prescriptions separate to all other prescriptions at the Pharmacy, contrary to Clause 42(2) of the PTGR.
Particular 5 relates to the storage of Schedule 4B prescriptions. In the initial complaint this particular erroneously referred to Schedule 4D prescriptions.
The PRU inspection report dated 5 June 2017 indicates that at the inspection undertaken at the Pharmacy on 9 March 2017 Mr Saab was asked to provide the Schedule 4 Appendix B prescriptions that had been dispensed during the preceding two year period. Although Mr Saab was able to provide some current Schedule 4 Appendix B prescriptions, it was noted in the report that the prescriptions for the preceding two year period were not provided. Indeed Mr Saab is recorded as stating that the prescriptions were not kept separate and were amongst a large volume of prescriptions that he kept in storage.
Under cross examination Mr Saab gave the following evidence that Schedule 4B prescriptions were kept separate and such prescriptions were provided to the PRU:
Q. And that did not happen, did it?
A. It did happen. Prescriptions that were presented, S4B prescriptions that were presented at the pharmacy, any patient that presented an S4B prescription at the pharmacy, we took steps to ensure that these prescriptions were stored separately…. [8]
Mr Saab was then directed to the relevant portion of the PRU inspection report dated 5 June 2017 which recorded that "in failing to provide an Inspector with prescriptions for a drug of addiction (S8) or a special restricted substance (S4B) which had been requested for the preceding 2 year period, and failing to store such prescription separate from other prescriptions, Mr Saab has breached … clause 42(2) of the Poisons and Therapeutic Goods Regulation 2008".
Q Just have a read of that to yourself. Nowhere in your evidence subsequent to this report of the PRU do you refer to having rectified that issue at that paragraph and having contacted the PRU and provided them with all of the relevant prescriptions, do you?
A. The PRU made requests for these documents and they were provided to them.
Q. Yes, but at the time of the PRU inspection the schedule 4B prescriptions were not being kept separately as required at your pharmacy?
A. Yes, they were, it's in my evidence. [9]
Apart from this assertion we have been unable to identify any part of Mr Saab's evidence which objectively supports this contention.
[13]
Particulars 6 and 7: Mr Saab's initials in the Dispensing System
Particular 6 and Particular 7
6. Between 9 March 2017 and 19 April 2017, the practitioner inappropriately removed his name and initials from the dispensing system at the Pharmacy contrary to Clause 55 of the PTGR.
7. Between 18 July 2014 and 9 March 2017, the practitioner failed to ensure that prescriptions dispensed at the Pharmacy identified the pharmacist who had dispensed the actual prescription and permitted other pharmacists in his employ to use his name and initials when dispensing prescriptions contrary to Clause 55 of the PTGR.
Particulars 6 and 7 relate to the removal of Mr Saab's initials from the dispensary system and a failure to ensure that prescriptions dispensed at the Pharmacy identified the pharmacist who had dispensed them.
Clause 55(1)(d) of the PTGR relevantly provides:
"(1) A pharmacist who supplies a restricted substance on prescription must record the following details in a manner approved by the Director-General -
(d) the name of the person by whom the substance was supplied."
During Ms Croker's evidence in chief, she gave the following evidence in relation to pharmacist's initials:
Q. Can you explain to the tribunal the importance of pharmacists identifying themselves through their initials when dispensing medications at the pharmacy?
A. So any prescription that's dispensed needs to be, it needs to be clear which pharmacist dispensed or checked it and the reason being that if there is some issue with the prescription, if there's an error or any issue that may pop up, it does need to be able to be clearly - it needs to be clear which pharmacist dispensed the medication so that, I guess, you know, if necessary, if there was an error made, it can be sort of assigned to the certain pharmacist, but also it's just a legislative requirement, a pharmacist must check every prescription that leaves the pharmacy and you need to know who has done that to make sure it's been, you've met your legislative requirements. [10]
Mr Saab stated in his affidavit dated 5 March 2020 that after the inspection by the PRU on 9 March 2017 it was apparent that there was a problem with his initials being used by other pharmacists or pharmacy assistants. To correct that issue he removed his initials from the system on days he was not working so they could not be misused. He did not permit other pharmacists to use his name and initials, and he was not aware of this occurring until the investigation into his Pharmacy commenced.
Under cross-examination Mr Saab gave evidence that he removed his initials from the Pharmacy's dispensing system between 9 March 2017 and 19 April 2017 but he could not recall when.
Relevantly, Mr Saab's evidence was as follows:
Q. Why do you say you removed your initials from the pharmacy dispensing system?
A. Under consultation with the PRU, the PRU representatives, they informed me that they would prefer that no one else be able to use my initials if I were not in the pharmacy.
Q. Between 9 March of 2017 and 31 March 2017 were you working in the pharmacy?
A. Yes.
Q. Your initials had been removed, hadn't they, during that period from the dispensing system?
A. I'm not exactly sure when they were removed. They weren't removed as they were suspended, the account for my log in was suspended. So for me to, or for anyone to use my initials I would have to reactivate the account.
Q. It was important though for your initials to be in the dispensing system during times that you were working?
A. Yes.
…
Q: Mr Saab, you were suspended from practice, there was no need to remove your initials from the dispensing program as you yourself were unable to practice?
A. The PRU suggested that I remove my initials or suspend my initials from the dispensing program, not to allow anyone else to use them.
Q. But Mr Saab can I take you to, back-to-back to tab 7, p 79. ..(not transcribable)., line 42 to 44. Was it your view at the time the section 150 hearing that your pharmacists were not responsible for the conduct?
A. I did not form a point of view at this time, no.
Q. No. And you haven't had a basis for forming that view subsequent, have you?
A. It was not up to me to decide, it was up to the PRU and the Pharmacy Board and the HCCC.
Q. Mr Saab, you had a responsibility as proprietor to work out if you deny having dispensed these prescriptions to these--
A. I lost that privilege when I was suspended and not allowed back into my own pharmacy.
Q. You still had means by which you could make that enquiry, Mr Saab?
A. I was not allowed back into my pharmacy. [11]
…
Q: Mr Saab, you did not have any discussions with the PRU where they advised you to remove your initials from your dispensary system?
A. It was in those conversations with the PRU that it was suggested that I remove my initials from the dispensing system. [12]
…
Q: Mr Saab, you did not tell the PRU that you had removed your initials from the dispensing system prior to their inspection on 19 April 2017?
A. I was under the instruction of the PRU to remove my initials from the dispensing system.
Q. When do you say that you had those discussions?
A. Somewhere between the first inspection and when I was suspended. [13]
…
Q: I'm putting to you, Mr Saab, that Mr Smith never advised you to remove your initials?
A. I'm not sure who advised me, whether it was Mr Smith or Mr Gavrilovic, but the decision I decided to remove my initials, which the only thing that would stop is anyone using my initials to dispense medication in the future, the only reason why I did that was under the advice of the PRU and it makes sense. If I have an issue or if an issue has been raised that there may have been the misuse of my initials in the pharmacy, then what you would want to do is not let that be an option for people in the pharmacy to do, to use your initials. So it sounds like, it sounds like a good result or solution to the problem. [14]
In the PRU report of 5 June 2017 Mr Smith refers to his attendance at the Pharmacy in the company of another Senior Pharmaceutical officer, Ms Wei, on 19 April 2017. The purpose of this attendance was to obtain dispensing records. Mr Saab was not at the Pharmacy at this time.
Mr Smith records in his report that whilst preparing the reports on the Pharmacy's dispensing program (Z software) he noted that Mr Saab's name and dispensing initials had been removed from the dispensing system.
Mr Morris was present during the PRU inspection on 19 April 2017. He was questioned by Mr Smith about the removal of the initials "TS" from the dispensing programme. Mr Morris said that he was aware that Mr Saab's initials had been removed, but he did not know exactly when or how this had occurred.
Mr Smith in his witness statement to the Tribunal dated 20 July 2020 gave evidence at as follows:
To the best of my knowledge, I have never instructed any pharmacist including but not limited to Mr Saab to remove their initials or name from a dispensing program, or to alter any historic health record.
In oral evidence Mr Smith stated that the first time he was aware that Mr Saab's initials had been removed was when he attended the Pharmacy on 19 April 2017. He did not recall Mr Saab ever raising concerns with him that other pharmacists were using his initials.
Mr Gavrilovic gave evidence under examination in chief as follows:
Q. To the best of your recollection did you ever have a conversation with Mr Saab about his initials in the dispensing--
A. About his initials?
Q. Yes, in the dispensing system?
A. No. No, I did not. [15]
There was no evidence of any conversations between Mr Saab and the PRU about the removal of his initials from the dispensing system, other than what Mr Saab said.
In response to questions from Professional Member Preswick as to what steps Mr Saab could have taken to address concerns that someone was using his initials apart from removing his initials from the dispensing system, the following evidence was given by Mr Saab:
Q…could you have simply just called a staff meeting and said, 'Guys, someone's being using my initials, can you stop it'?
A. We didn't have a staff meeting per se, but I did have individual conversations with the staff members informing them that that issue had arisen and was to stop.
Q. So why would you find it necessary if you had spoken to them, why would you find it necessary to remove them?
A. They knew this the first time they worked in the pharmacy, so obviously there's been some sort of a breakdown. It's just to prevent the unlikely scenario that it was accidentally used. So there's no, there's no possible way that the initials could have been used, even if it was by accident.
Q. Right. But couldn't you have just, the first day after your day off, just clicked a button and seen if TS was used on your day off, just as easily than removing and adding back your initials?
A. No, I don't think that's being proactive in preventing a problem.
There was no direct evidence before us that others in the Pharmacy were using Mr Saab's initials. Nor is there any direct evidence that Mr Saab permitted others to use his initials.
In response to a request made by the Commission Mr Morris gave evidence through his solicitors, Meridian Lawyers, on 9 April 2018 about this issue as follows:-
He does not recall dispensing Schedules 4D or Schedules 8 under another pharmacist's initials.
He does not recall seeing the situation occur [the use of another pharmacist's initials].
Particular 7 appears to be based on assertions Mr Saab made about others using his initials which he had made at various points in the process prior to the Complaint being filed.
For example two earlier submissions which had been made on behalf of Mr Saab by Sparke Helmore Lawyers referred to the Pharmacy's dispensing system.
Both submissions bear the same date 29 March 2017 and both were addressed to the Council. Both appeared to have been prepared for the purposes of the s 150 proceedings which were to take place the next day. In each of these submissions there is a reference to Mr Saab being unable to recall dispensing particular prescriptions which had been put to him for comment and his belief that he was not working on the days in question. Each submission raises the possibility that another unidentified pharmacist dispensed the prescriptions using Mr Saab's initials: see Commissions Documents Exhibit A1, Tab 10 paragraph 25 and Exhibit A1 Tab 12 paragraph 13.
The use of Mr Saab's initials by others was discussed at the s.150 proceedings. During the course of these proceedings Mr Saab was questioned about a number of prescriptions dispensed by his Pharmacy. Consistent with his earlier claims that he could not recall dispensing the particular prescriptions, reference was made to other pharmacists potentially using his initials. At one point Mr Saab suggested that a pharmacy assistant could have used his initials.
We note that at none of these points either in the written submissions for the s 150 proceedings or orally at the s 150 proceedings did Mr Saab suggest that he had actually removed his initials from the dispensing system or that he was advised to do so by the PRU.
[14]
Complaint 2 and 3: Overview
Complaint 2 and 3 deal with the dispensing of prescriptions to 38 patients for Schedule 8 (drugs of addiction) and Schedule 4D (special restricted substances) by Mr Saab and his employed pharmacists.
It is helpful to set out in detail the specific clauses in the PTGR raised by the particulars of Complaint 2 and 3. It is also useful to set out dispensing guidelines produced by the Pharmacy Board of Australia before we set out the lengthy and detailed particulars in respect of each patient which comprise Complaints 2 and 3.
[15]
The Poisons and Therapeutic Goods Regulation 2008 (PTGR)
Part 3 Restricted Substances (S4)
Division 3 Prescriptions
34 Quantity and purpose of prescriptions to be appropriate
An authorised practitioner must not issue a prescription for a restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
35 Form of prescription
(1) A prescription for a restricted substance must include the following details -
(a) the date on which it is issued,
(b) if the treatment is for -
(i) a patient - the name and address of the patient, or
(ii) an animal - the species of animal and the name and address of the animal's owner, or
(iii) a patient's partner and the prescription is for azithromycin for the treatment of chlamydia - the name and email address or mobile phone number of the partner,
(c) the name, strength (if not readily apparent) and quantity of the substance to be supplied,
(c1) the route of administration (if not readily apparent) of the substance to be supplied,
(d) adequate directions for use,
(e) the maximum number of times the substance may be supplied on the prescription,
(f) in the case of a prescription for a special restricted substance, the intervals at which the substance may be supplied on the prescription,
(g) if the prescription is issued at a hospital, the name and designation of the person by whom it is issued and the name, address and telephone number of the hospital,
(h) if the prescription is issued elsewhere than at a hospital, the name and designation of the person by whom it is issued and the address and telephone number of the premises at which it is issued.
(1A) As an alternative to complying with subclause (1), a medication chart prescription authorising the supply of a substance that is not a special restricted substance or a substance listed in clause 37 must include the following details -
(a) the date on which it is issued,
(b) the name and address of the patient,
(c) the name and form (if not readily apparent) of the substance to be supplied,
(d) the strength (if not readily apparent) of the substance to be supplied,
(e) the route of administration (if not readily apparent) of the substance to be supplied,
(f) adequate directions for use,
(g) the frequency or times at which the substance is to be administered or used,
(h) the period during which the substance is to be used or administered (being a period that ends on a date that is no more than 4 months from the date of first use of the relevant chart for the resident),
(i) the name and designation of the person by whom it is issued,
(j) the name, address and telephone number of the relevant residential care facility.
(2) The details referred to in subclause (1A)(b) and (j) can be made out by any person.
(2A) The details referred to in subclause (1) or (1A)(a) or (c)-(i) must be made out -
(a) in the handwriting of the person by whom the prescription is issued, or
(b) in such other manner as may be approved for the time being by the Director-General.
(2B) A prescription must be signed by the person by whom it is issued (whether it complies with subclause (1) or (1A)).
(3) The person by whom the prescription is issued must confirm any dose that could be regarded as being dangerous or unusual by underlining the part of the prescription that specifies the intended dose and by initialing the prescription in the margin.
(4) A person who issues a prescription for a restricted substance must ensure that the prescription complies with the requirements of this clause.
(5) The Director-General may, by order in writing, exempt any person or restricted substance, or any class of persons or restricted substances, from any or all of the requirements of this clause.
(6) Such an exemption may be given unconditionally or subject to conditions.
(7) In this clause -
partner of a patient includes any of the following -
(a) the patient's spouse,
(b) the patient's de facto partner,
(c) a person with whom the patient is or was in a sexual relationship.
Division 4 Supply
Subdivision 1 Supply on Prescription
40 Certain prescriptions not to be filled
(1) A pharmacist must not supply a restricted substance on prescription -
(a) if the prescription is marked "CANCELLED", or
(b) if the substance has already been supplied on the prescription the maximum number of times indicated by the prescription, or
(c) if the interval of time that has elapsed since the substance was last supplied on the prescription is less than that indicated by the prescription as the minimum interval that must elapse between successive supplies of the substance, or
(d) if the prescription is illegible or defaced, or
(e) if the prescription appears to have been forged or fraudulently obtained, or
(f) if the prescription appears to have been altered otherwise than by the authorised practitioner by whom it was issued, or
(g) if the prescription is dated -
(i) in the case of a medication chart prescription - more than 4 months before the date on which the supply is requested, or
(ii) in the case of a prescription, other than a medication chart prescription, for a prescribed restricted substance - more than 6 months before the date on which the supply is requested, or
(iii) in any other case - more than 12 months before the date on which the supply is requested, or
(h) in the case of a medication chart prescription - where it appears to the pharmacist that a sufficient quantity of the substance has already been supplied to the resident for the period indicated on the prescription.
(2) Immediately on being requested to supply a prescribed restricted substance in either of the circumstances referred to in subclause (1)(e) or (f), a pharmacist must retain the prescription and cause notice of the request to be given to a police officer
42 Prescriptions for certain substances to be kept
(1) A pharmacist who supplies a special restricted substance on prescription must keep the prescription, whether or not the prescription authorises more than one supply of the substance.
(2) A pharmacist must keep prescriptions for special restricted substances separate from other prescriptions (other than prescriptions for drugs of addiction).
Subdivision 4 Supply Generally
52 Authority required to supply certain restricted substances
(1) This clause applies to the following substances -
…
clomiphene
…
(2) A person must not supply a substance to which this clause applies unless the person holds an authority under Part 8 to supply the substance.
(3) This clause does not apply to the supply of a substance -
(a) by wholesale, or
(b) by a veterinary practitioner, or
(c) by a pharmacist on the prescription of -
(i) a medical practitioner holding an authority under Part 8 to prescribe the substance, or
(ii) a veterinary practitioner, or
(d) by a person who is authorised by the Permanent Head of the Commonwealth Department of Health to supply the substance.
54 Quantity and purpose of supply to be appropriate
An authorised practitioner or pharmacist must not supply any restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances
Division 5 Records of Supply
55 Supply on prescription to be recorded
(1) A pharmacist who supplies a restricted substance on prescription must record the following details in a manner approved by the Director-General -
(a) the details required by clause 35(1) to be included in the prescription,
(b) a unique reference number for the prescription,
(c) the date on which the substance was supplied,
(d) the name of the person by whom the substance was supplied.
(2) A prescription for the supply of a restricted substance in a hospital need not be recorded so long as the chief pharmacist of the hospital keeps the prescription or a copy of the prescription.
(3) The Director-General may, by order in writing, exempt any person or restricted substance, or any class of persons or restricted substances, from the requirements of this clause.
(4) Such an exemption may be given unconditionally or subject to conditions.
Part 4 Drugs of Addiction (S8)
Division 3 Prescriptions
79 Quantity and purpose of prescriptions to be appropriate
An authorised practitioner must not issue a prescription for a drug of addiction in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
80 Form of prescription
(1) A person who issues a prescription for a drug of addiction must ensure that the prescription includes the following details -
(a) the date on which it is issued,
(b) the name and address of the patient or (if the treatment is for an animal) the species of animal and the name and address of the animal's owner,
(c) the name, strength and quantity (expressed in both words and figures) of the drug to be supplied,
(d) adequate directions for use,
(e) the maximum number of times the drug may be supplied on the prescription,
(f) the intervals at which the drug may be supplied on the prescription,
(g) if the prescription is issued at a hospital, the name and designation of the person by whom it is issued and the name, address and telephone number of the hospital,
(h) if the prescription is issued elsewhere than at a hospital, the name and designation of the person by whom it is issued and the address and telephone number of the premises at which it is issued,
(i) if the drug of addiction is a type A drug of addiction and the person holds an authority to issue the prescription under section 29 of the Act or Part 8 of this Regulation, the reference number of the authority.
(2) The details referred to in subclause (1)(a)-(f) must be made out -
(a) in the handwriting of the person by whom the prescription is issued, or
(b) in such other manner as may be approved for the time being by the Director-General,
and the prescription must be signed by the person by whom it is issued.
(3) The person by whom the prescription is issued must confirm any dose that could be regarded as being dangerous or unusual by underlining the part of the prescription that specifies the intended dose and by initialling the prescription in the margin.
(4) A person must not issue a prescription that includes -
(a) more than one preparation containing a drug of addiction, or
(b) both a preparation containing a drug of addiction and another preparation.
(5) The Director-General may, by order in writing, exempt any person or drug of addiction, or any class of persons or drugs of addiction, from any or all of the requirements of this clause.
(6) Such an exemption may be given unconditionally or subject to conditions.
Division 4 Supply
Subdivision 1 Supply on Prescription
86 Certain prescriptions not to be filled
(1) A pharmacist must not supply a drug of addiction on prescription -
(a) if the prescription is marked "CANCELLED", or
(b) if the drug has already been supplied on the prescription the maximum number of times indicated by the prescription, or
(c) if the interval of time that has elapsed since the drug was last supplied on the prescription is less than that indicated by the prescription as the minimum interval that must elapse between successive supplies of the drug, or
(d) if the prescription is illegible or defaced, or
(e) if the prescription is dated more than 6 months before the date on which the supply is being requested, or
(f) if the prescription appears to have been forged or fraudulently obtained, or
(g) if the prescription appears to have been altered otherwise than by the authorised practitioner by whom it was issued, or
(h) if notice of an order prohibiting the person by whom the prescription was issued from issuing such a prescription has been published in the Gazette, unless the prescription contains a direction for the supply of the drug more than once and it appears that the drug has been supplied on the basis of the prescription at least once before the notice was published.
(2) Immediately on being requested to supply a drug of addiction in any of the circumstances referred to in subclause (1)(f), (g) or (h), a pharmacist must retain the prescription and cause notice of the request to be given to a police officer.
(3) A pharmacist must not supply a drug of addiction on a prescription that includes -
(a) more than one preparation containing a drug of addiction, or
(b) both a preparation containing a drug of addiction and another preparation.
87 Prescriptions require verification
(1) A pharmacist must not supply a drug of addiction on prescription unless he or she -
(a) is familiar with the handwriting of the person who issued the prescription, or
(b) knows the person for whom the drug is prescribed, or
(c) has verified that the person who is purported to have issued the prescription has actually issued the prescription.
(2) This clause does not prevent a pharmacist who is otherwise authorised to supply drugs of addiction from supplying a drug of addiction on prescription in a quantity sufficient for no more than 2 days' treatment
Subdivision 4
Manufacture, possession and Supply Generally
109 Quantity and purpose of supply to be appropriate
An authorised practitioner or pharmacist must not supply any drug of addiction in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances
Division 5 Records of Supply
Subdivision 3 Records generally
118 Periodical inventory of stock of drugs of addiction
(1) The person responsible for maintaining a drug register at any place -
(a) must, during the prescribed periods, make an accurate inventory of all drugs of addiction at that place, and
(b) must endorse the relevant drug register, immediately under the last entry for each drug of addiction, with the quantity of each drug of addiction actually held and the date on which the inventory was made, and
(c) must sign each entry.
(2) The prescribed periods for the purposes of subclause (1)(a) are -
(a) March and September each year, or
(b) if the Director-General determines some other periods, either generally or in specified circumstances, the periods so determined.
(3) A person who assumes control for a period of one month or more over any place at which drugs of addiction are held must, immediately on assuming control, make an inventory and endorse the drug register as if the inventory were an inventory made under this clause.
Division 7 Miscellaneous
124 Loss or theft of drugs of addiction
A person who is authorised to be in possession of drugs of addiction must immediately notify the Director-General if the person loses a drug of addiction or if a drug of addiction is stolen from the person.
[16]
Dispensing Guidelines
Under s. 39 of the National Law the Pharmacy Board of Australia has developed Guidelines for Dispensing of Medicines. The Guidelines were issued on 2 September 2015 with effect from 7 December 2015. The Guidelines provide guidance to pharmacists in relation to the dispensing of medicines, not set out in the legislation or a registration standard. The Guidelines set out the steps involved in the review of a prescription. The following are relevant extracts from the Guidelines:
1. The dispensing process
For the purpose of these guidelines, the Board defines dispensing as:
The review of a prescription and the preparation, packaging, labelling, record keeping and transfer of the prescribed medicine including counselling to a patient, their agent, or another person who is responsible for the administration of the medicine to that patient.
Guideline
The pharmacist should ensure that the prescription is valid, that the medicine is clinically appropriate for the patient, and that information is provided to ensure safe and appropriate use of the medicine.
The process of dispensing includes:
a. receiving a prescription
b. ascertaining the authority of the prescriber to prescribe
c. obtaining any supplementary information to enable:
i. the patient to be properly identified so the medicine is dispensed to the person for whom it is intended, and
ii. the medicine to be dispensed safely
d. determining the prescriber's intentions as to the patient's medicine, including the dosing instructions
e. reviewing the medication history and other relevant patient information, to ensure that the medicine is safe and proper for the patient to use and that where possible, all other relevant considerations of the patient's health, including the use of any other prescription and non-prescription medicine such as complementary and alternative medicine, are taken into account….
2. Dispensing precaution - safety of prescriptions
A pharmacist must take reasonable steps during the dispensing process (detailed in Guideline 1 The dispensing process) to ensure that the dispensing of a medicine in accordance with a prescription or order is consistent with the safety of the person named in that prescription or order.
Guideline
In dispensing a prescription, a pharmacist has to exercise an independent judgement to ensure the medicine is safe and appropriate for the patient, as well as that it conforms to the prescriber's intentions. Where clarification is required, the patient or their agent should be consulted and if necessary, the prescriber contacted. …
At all times the dispensing of a prescription or any other action taken by the pharmacist, must be consistent with the safety of the patient…
In conforming to this principle, dose, frequency and route of administration, duration of treatment, the presence or absence of other medicines, the patient's illness, medication history, allergies, and other relevant circumstances need to be taken into account. When this information is collected by the pharmacist, relevant details should be recorded in the dispensing record, and where possible in the patient's health record, so that the safety of any future medicines that are prescribed and/or dispensed for that patient can also be assured.
3. Dispensing multiple repeat prescriptions at one time
Dispensing multiple quantities of particular medicines (whether or not directed by the prescriber) may not be consistent with the safety of the patient (refer to Guideline 2 Dispensing precaution - safety of prescriptions).
The supply of multiple repeats at the one time is permitted under Regulation 49 of the National Health (Pharmaceutical Benefits) Regulations 2017 (previously Regulation 24 of the National Health (Pharmaceutical Benefits) Regulations 1960). [16] An authorised prescriber must endorse each prescription for multiple supplies if satisfied that the patient's circumstances meet the criteria outlined in the regulations. In the case of non-Pharmaceutical Benefits Scheme (non-PBS) medicines, prescribers may specify quantities that suit the patient's circumstances.
When not directed by the prescriber, the simultaneous supply of multiple quantities of a particular medicine (i.e. the supply of multiple repeats at once) may be contrary to the Quality Use of Medicines principles outlined in the National Medicines Policy. It does not promote regular review of therapy and effective provision of medicine information by pharmacists, which may assist in minimising medication misadventure. It may also be contrary to state or territory legislation.
Guideline
Dispensing multiple quantities of any prescription should only occur at the specific direction of the prescriber on each occasion, unless exceptional circumstances exist to the satisfaction of the pharmacist. An appropriate notation should be made to that effect on the prescription, in the dispensing record and where possible, in the patient's health record. Examples of exceptional circumstances may include a patient going away for an extended period of time, or a patient who cannot easily attend the pharmacy because of disability and/or a mobility issue. State and territory legislation must be complied with.
[17]
Complaint 2: Patients A - Y and Patient Z
The stated background to this complaint is that Mr Saab inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed prescriptions for Patients A to Z for Schedule 8 drugs of addiction and Schedule 4 Appendix B and D prescribed restricted substances at the Pharmacy.
Further, that Mr Saab inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed prescriptions for Patients A to Z from Dr Jit Seng Ng, Dr Ashraf Thabit Selim, and Dr Shamila Sadhu for forged Schedule 8 drugs of addiction at the Pharmacy.
[18]
Patients A - Y: Overview Particulars 1 to 115
Particulars 1 to 115 relate to the dispensing of Schedule 8 prescriptions to 25 patients at the Pharmacy including on forged prescriptions from Dr Ng, Dr Selim and Dr Sadhu.
All of the forged prescriptions from Dr Ng, Dr Selim and Dr Sadhu were for Oxycodone 80mg, Fentanyl 100mcg and Alprazolam 2mg and dispensed by the Pharmacy as Non-PBS.
There are 94 prescriptions dispensed at the Pharmacy on forged prescriptions from Dr Ng and all of these prescriptions have the initials "TS" on them being Mr Saab's initials. These prescriptions were dispensed to Patients A to Y inclusive.
Dr Ng is a General Practitioner and the forged prescriptions were handwritten on a prescription pad for a practice at Haymarket, some 20 kilometres away from the Pharmacy.
Dr Ng provided a witness statement stating that:
1. the prescriptions the subject of Complaint 2 dispensed by the Pharmacy were forged;
2. he closed his medical practice at Haymarket in January 2017;
3. a prescription pad was stolen from his medical practice at Haymarket;
4. he reviewed his medical records and found no entries that he had prescribed drugs of addiction to any of the patients whose names were on the forged prescriptions;
5. he could not recall receiving a telephone call from a pharmacist at the Pharmacy.
Looking at the prescriptions purportedly issued by Dr Ng it is apparent to us that the handwriting for the patients' addresses is different to the handwriting on the remainder of the prescriptions.
Under cross examination about the prescriptions purported to be from Dr Ng, Mr Saab gave evidence as follows:
Q. And it's fair to say, isn't it, that you were not familiar with Dr Ng as a prescriber?
A. No, I'd say that based on the quantity of prescriptions we were getting from him that there was some familiarity in his handwriting, or the handwriting on the prescriptions.
Q. You didn't know Dr Ng?
A. No.
Q. You can't recall ever speaking to him?
A. No. [17]
…
Q. And you were not familiar with Dr Ng's handwriting?
A. For the first one that would have been presented, no, but with the handwriting being similar in all the prescriptions, unfortunately it was probably incorrect to assume that they were all written by the same person.
Q. Rather than being incorrect, it was a significant breach of your obligations as a pharmacist not making the enquiry with the prescriber when you first received that prescription, wasn't it, Mr Saab?
A. No, that's not correct because if we go through the clause that we were seeking about yesterday at tab 87, the prescriptions that required verification, one of the ways of requiring verification is if the person for whom the drug is prescribed is known. [18]
…
Q. Mr Saab, with multiple pharmacists each pharmacist has to familiarise themselves with the handwriting, don't they?
A. Yes.
Q. You cannot rely upon another pharmacist in doing so?
A. No, but one way of checking to see if the prescription, the writing looks familiar is by checking against previous prescriptions that have been dispensed by the pharmacy from that doctor.
Q. Mr Saab, that is not acceptable practice amongst pharmacists, do you agree?
A. It's a hard one to answer, that question, because I believe that it was an acceptable practice. If the doctor could not be reached, if the doctor was not in a surgery or it was after hours and the patient needed their medicine, if you confirm the writing of the doctor compared to other prescriptions that have been presented, then I believe that does show that the, it does show some familiarity in the writing. It's a practice that could be adopted.
Q. Mr Saab, that is lazy and sloppy practices as a pharmacist?
A. We need to take steps to ensure that these prescriptions are being written by the doctor and unfortunately one of the ways is familiarising yourself with the doctor's writing and comparing prescriptions is not an unreasonable thing to do. [19]
There are 5 prescriptions dispensed at the Pharmacy on forged prescriptions from Dr Selim and all of such prescriptions have the initials "TS" on them. These prescriptions were dispensed to Patients B, C, E, T and W.
Dr Selim is a General Practitioner and the forged prescriptions were handwritten on a prescription pad for a practice at Punchbowl, over 17 kilometres away from the Pharmacy. The patient addresses were missing from the prescriptions.
In a witness statement Dr Selim stated that:
1. each of the prescriptions the subject of Complaint 2 were forged; and
2. the prescriptions were written on stationery which had been stolen from his Punchbowl Medical and Dental Centre practice at Punchbowl.
There are 15 prescriptions dispensed at the Pharmacy on forged prescriptions from Dr Sadhu and 14 of those prescriptions have the initials "TS" on them. These prescriptions were dispensed to Patients B, E, F, G, H, K, L, M, O, Q, R, S, V and W. One of the prescriptions has Mr Morris' initials on it.
Dr Sadhu is a General Practitioner and the forged prescriptions were handwritten on a prescription pad for a practice at Mt Druitt, over 20 kilometres away from the Pharmacy. The patient addresses were missing on all of the prescriptions.
In a witness statement, Dr Sadhu stated that:
1. all of the prescriptions were forged;
2. she had reviewed her clinical records and found no entries to suggest that she had ever prescribed a drug of addiction to any of the patients whose names appear on the prescriptions;
3. as far as she could recall she had never received a telephone call from a pharmacist at the Pharmacy.
Mr Saab concedes that he did not make any contact with Dr Ng, Dr Selim or Dr Sadhu to enquire as to the provenance of the prescriptions purported to be from them and presented to the Pharmacy.
The patient histories contained in the corresponding Schedules attached to the Complaint for Patients A to Y show the patients received Oxycodone 80mg, Fentanyl (Durogesic) 100mcg and Alprazolam 2mg on Non-PBS prescriptions from multiple prescribers and at varying intervals.
Alprazolam belongs to a class of medications called benzodiazepines. It is commonly known by its brand name Kalma. It is also a Schedule 8 drug.
Ms Croker gave oral evidence about these medications and in what circumstances it would be appropriate for a pharmacist to dispense that medication for an appropriate therapeutic purpose. Ms Croker stated as follows:
OxyContin 80milligrams:
…OxyContin 80 milligrams is very strong opioid medication. It is not a medication that you use for an acute issue. So by that I mean if you fell and broke your arm or something like that and had acute pain you would not be prescribed that strength purely because it is a high dose and you could not be opioid naive to be able to take that medication. If you had never taken opioids before you would be more likely to start on perhaps Oxycodone 5 milligrams, maybe 10 milligrams. So you would expect Oxycodone 80 milligrams to be used for a therapeutic use would be only for long-term pain, and even then there are concerns about those strengths and, for example, in the Australian Medicines Handbook it does actually say that if you get over 30 milligrams twice a day and it's still not providing benefit that there should be a reassessment of the pain issues. So Oxycontin at 80 milligrams as a regular dose, it's a high dose of opioids and it would be usually presumed to be under the care of a specialist.
Durogesic 100:
Similarly, so Durogesic fentanyl is the ingredient in a Durogesic patch, it is a very potent opioid. The Durogesic 100 patch, if you were to, when you're sort of comparing opioids you use a comparison called oral morphine equivalent dose. So that particular patch is equivalent to 360 milligrams of morphine daily, which again is a large dose and is not a dose that you would ever see somebody start on. Actually again it's a clear warning in all of the literature that you never start anyone on a fentanyl patch, even the smallest dose, which is 12, you never start them on that patch if they've never had opioids before. So these doses are high doses. They may be appropriate in chronic pain and certainly in cancer pain they are used, but for a person that was not being treated for cancer pain these levels, even just by itself Durogesic 100 would be a high dose and would be probably expected to be under care of a specialist or having some specialist input in it as well.
Alprazolam 2 milligrams:
So alprazolam or Kalma, but alprazolam is a benzodiazepine. It is used for anxiety or panic attacks potentially. The therapeutic dose for this may vary, but again the usual therapeutic dose is lower. The proprietary preparation is available in a 0.25 milligram, a 0.5 milligram a 1 milligram or a 2 milligram. More generally you would see the lower doses of 0.25 or maybe 0.5, once, twice, three times a day. It does vary for that one I guess depending on what mental health condition the practitioner is treating. However regardless of that 2 milligrams three times a day would be considered a high dose, and again similar to the S8 medication that we were just discussing, you wouldn't start somebody on a 2 milligram dose. They would only start on a much lower dose, the 0.25 and then potentially increase if they were still experiencing anxiety symptoms. But again for a therapeutic use for 2 milligrams three times a day it would be concerning and I believe they should be also under the care of perhaps a psychiatrist or specialist because that is quite a high dose for someone.
During questioning by Professional Member Preswick, Ms Croker gave evidence in relation to Oxycodone 80mg, Fentanyl 100mcg and Alprazolam 2mg as follows:
Q: What about the sudden cessation of all these, which we've got no evidence there is, but if-
The sudden cessation of any of these, so with opioid, even a single one of these high dose opioids, so even if someone was just on Durogesic or just on OxyContin, if they were to cease them suddenly at these doses you would expect to see quite significant withdrawal effects, which would include things like agitation, diarrhoea, vomiting, nausea, I guess issues with cognitive confusion. And again potentially I would expect at these high levels of opioid if they were to be ceased or suddenly withdrawn, there could be risks of even, again, death. When you combine all of them together - and Alprazolam also has quite significant withdrawal effects if people stop them suddenly, agitation, sweating, insomnia, all sorts of unpleasant effects and, yeah, certainly if you're thinking about all of those medications which have been, assuming they're being taken at, taken concurrently, if they were to be ceased suddenly that would be quite dangerous for the patient
All of the prescriptions which are the subject of particulars 1 -115 in Complaint 2 were available to us and formed part of the evidence relied upon by the Commission. Almost all of the prescriptions were dispensed as non PBS.
Ms Croker gave evidence about the medications that were dispensed as non-PBS in this case. After explaining the kind of circumstances where a pharmacist would receive a prescription for a non-PBS medication included where a doctor might prescribe a medication for what is known as an "off label indication" being used for an indication that was not covered by the PBS, or it may be that the quantity that is ordered is greater than the normal PBS quantity she made the following observations about the interplay between Schedule 8 medications and the PBS:
..In terms of the S8 prescriptions, so the Durogesic patches, the OxyContin tablets, both of those medications are generally available on PBS in smaller quantities, although in the case of the Durogesic five patches is available on a PBS prescription. OxyContin tablets, generally it's 28 tablets at a time on a PBS prescription. The fact that most of them, or all of them I believe, were given as non-PBS and also most of them were given in larger quantities, that is concerning. It is a potential red flag. They're very expensive medications and most people, if they need this for a therapeutic reason, it would be assumed that their GP could write a prescription that was on PBS and it would be more cost effective for them. If you have a pension or concession card, it would only be - at that time it would have been probably $6 per prescription. Even if you do not have a pension card it still would have been around $36, $38 rather than much more expensive, which I believe they were, which of course is likely to be an issue for many people to pay a large amount of money for their medication. And again, the fact that they're all for big quantities and all non-PBS it does flag in your mind that it may not be for a therapeutic use, that there may be an issue potentially with this prescription.
Ms Croker gave evidence about the differences for the records maintained for PBS and non PBS prescriptions as follows:
…The potential difference I suppose in terms of the information or how records of the PBS or non-PBS or private prescriptions happen is that if it is what is a PBS prescription, that information goes to Medicare, it goes to a patient's - now it goes to their My Health record, potentially on a - I'm not sure what it goes on to but there's government records, I suppose, so that there is a record of who is being dispensed what medication and that is like an online kind of record. A private prescription, the only place that that is kept is within the pharmacy that dispensed it, their dispensed history. It doesn't go to Medicare. There's no government involvement, I guess. So there's not a record of that in the PBS. I don't know where they keep their information, in the Cloud or wherever, so there's not a record there. There wasn't now, right now, but this is obviously current, but now that information may go to a person's My Health record, but previously there was no other place that a non-PBS prescription might go to. [20]
…
[19]
Patient A and Schedule A: Particulars 1 - 4
Particulars 1 - 4:
1. On 14 July 2016, 31 July 2016, 25 August 2016 and 1 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient A on the dates and in the quantities as outlined in the Schedule attached and marked "A" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
2. On 14 July 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Oxycontin 80mg (56 tablets), a Schedule 8 drug of addiction, to Patient A when presented with a prescription allegedly from Dr Jit Seng Ng dated 13 July 2017 as outlined in Schedule A hereto, contrary to Clause 86 of the PTGR.
3. Between 2 July 2015 and 1 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient A on the dates and in the quantities as outlined in Schedule A hereto as private prescriptions when the Pharmaceutical Benefits Scheme ("PBS") was available.
4. Between 2 July 2015 and 1 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient A on the dates and in the quantities as outlined in Schedule A hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 2 July 2015 and 1 September 2016 the Pharmacy dispensed Schedule 8 medications to Patient A, namely, Durogesic 100, Oxycodone Sandoz 80mg, Oxycontin CR 80mg and Kalma 2mg on private prescriptions from 11 prescribers including Dr Ng and Dr Sadu, including for quantities of 10 Durogesic 100 and 56 Oxycodone 80mg and 100 Kalma tablets in single dispensings.
On 14 July 2016, 25 August 2016 and 1 September 2016 Patient A was dispensed Oxycodone Sandoz 80mg 56 tablets, and on 31 July 2016 Durogesic 100 5 patches on forged prescriptions from Dr Ng.
The dispensing of Oxycodone Sandoz to Patient A on 14 July 2016 was done under a prescription that bore a date a year in advance. The prescription that was presented was dated 13 July 2017.
Prior to Patient A being dispensed Schedule 8 prescriptions on forged prescriptions from Dr Ng, Patient A had been dispensed Schedule 8 prescriptions at the Pharmacy from 10 other prescribers.
Ms Croker made the following observations about Patient A's medication history and the number of different prescribers:
I believe it is a concern to have a number of different GP, or prescribers. If a patient is given these medications regularly as for therapeutic use you would expect them to have chronic pain issues, these are strong pain medications, and my experience is that most people with significant health issues have a single prescriber, but perhaps they would have a second prescriber within the same practice, but it would not usually be that they would have ten different prescribers over the period of time and only really, yeah, a bit over a year, so that's quite a short period of time to see ten different doctors. The other thing that I noted, it seems a little unusual in that it would be the same doctor for, well, depending on the doctor but, you know, two or three or four prescriptions and then it would switch to another doctor and be the same doctor for a number of prescriptions. The pattern of prescribing seemed quite unusual from my point of view, but certainly the number of prescribers is concerning. You would more expect to see the same prescriber or like I said, perhaps two, or perhaps a specialist and a GP but not that number of prescribers.
[20]
Patient B and Schedule B: Particulars 5 - 11
Particulars 5 - 11:
5. On 14 July 2016, 31 July 2016, 4 August 2016, 16 August 2016, 25 August 2016 and 8 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient B on the dates and in the quantities as outlined in the Schedule attached and marked "B" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
6. On 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Kalma 2mg (100 tablets), a Schedule 8 drug of addiction, to Patient B when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule B hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
7. On 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Kalma 2mg (100 tablets), a Schedule 8 drug of addiction, to Patient B when presented with a prescription allegedly from Dr Ashraf Thabit Selim as outlined in Schedule B hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
8. Between 21 February 2015 and 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient B on the dates and in the quantities as outlined in Schedule B hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
9. Between 21 February 2015 and 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient B on the dates and in the quantities as outlined in Schedule B hereto in circumstances where Patient B:
a) Had an address in Mackay, Queensland; outside of the Pharmacy's local area; and
b) Was previously on the NSW Opioid Treatment Program up until 31 July 2016.
10. Between 21 May 2015 and 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient B on the dates and in the quantities as outlined in Schedule B hereto as private prescriptions when the PBS was available.
11. Between 21 February 2015 and 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient B on the dates and in the quantities as outlined in Schedule B hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 21 February 2015 and 1 December 2016 Patient B was dispensed Durogesic 100, Oxycodone Sandoz 80mg and Kalma 2mg from 15 prescribers on private prescriptions other than on 21 February 2015 for Durogesic 100 and 11 July 2015 for Oxycodone Sandoz 80mg, when these two prescriptions were dispensed on the PBS using a concession card.
On 14 July 2016, 31 July 2016 and 25 August 2016 Patient B was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng. On 4 August 2016 Patient B was dispensed Oxycodone Sandoz 80mg and on 16 August 2016 and 8 September 2016 Kalma 2mg 100 tablets on forged prescriptions from Dr Ng.
On 22 November 2016 Patient B was dispensed Kalma 2mg 100 tablets on a forged prescription from Dr Sadhu.
On 1 December 2016 Patient B was dispensed Kalma 2mg 100 tablets on a forged prescription from Dr Selim.
The address indicated on the prescriptions for Patient B was Mackay, Queensland.
Mr Saab's evidence was to the effect that at the time the Schedule 8 medications were dispensed by the Pharmacy to Patient B, he did not know Patient B was on the NSW Opioid Treatment Programme.
In closing submissions, the Commission acknowledged that particulars 8 and 11 were the same and duplicated one another. Accordingly, particular 8 was withdrawn.
[21]
Patient C and Schedule C: Particulars 12 - 16
Particulars 12 - 16:
12. On 19 July 2016, 31 July 2016, 16 August 2016 and 8 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient C on the dates and in the quantities as outlined in the Schedule attached and marked "C" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
13. On 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100mcg (5 patches), a Schedule 8 drug of addiction, to Patient C when presented with a prescription allegedly from Dr Ashraf Thabit Selim as outlined in Schedule C hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
14. Between 16 October 2015 and 28 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient C on the dates and in the quantities as outlined in Schedule C hereto in circumstances where Patient C had an address in Merrylands, NSW; outside of the Pharmacy's local area.
15. Between 16 October 2015 and 28 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient C on the dates and in the quantities as outlined in Schedule C hereto as private prescriptions when the PBS was available.
16. Between 16 October 2015 and 28 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient C on the dates and in the quantities as outlined in Schedule C hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 16 October 2015 and 28 December 2016, Patient C was dispensed Tramal SR 200mg, Tramal SR 100mg, Durogesic 100 and Kalma 2mg on prescriptions at the Pharmacy from 10 prescribers.
Tramal is a brand name for Tramadol. It is a Schedule 4D drug.
On 19 July 2016, 16 August 2016 and 8 September 2016, Patient C was dispensed Durogesic 100 at the Pharmacy on forged prescriptions from Dr Ng. On 31 July 2016 Patient C was dispensed Kalma 2mg 100 tablets on a forged prescription from Dr Ng.
On 1 December 2016 Patient C was dispensed Durogesic 100 5 patches on a forged prescription from Dr Selim.
All of the prescriptions for Patient C were dispensed as non-PBS.
The address for Patient C was Merrylands about 2 kilometres away from the Pharmacy.
[22]
Patient D and Schedule D: Particulars 17 - 20
Particulars 17 - 20:
17. On 14 July 2016 and 28 July 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient D on the dates and in the quantities as outlined in the Schedule attached and marked "D" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
18. Between 16 March 2015 and 28 July 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient D on the dates and in the quantities as outlined in Schedule D hereto in circumstances where Patient D had an address in Belfield, NSW; outside of the Pharmacy's local area.
19. Between 16 March 2015 and 28 July 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient D on the dates and in the quantities as outlined in Schedule D hereto as private prescriptions when the PBS was available.
20. Between 16 March 2015 and 28 July 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient D on the dates and in the quantities as outlined in Schedule D hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 16 March 2015 and 28 July 2016 the Pharmacy dispensed for Patient D Durogesic 100, Kalma 2mg and Oxycodone Sandoz 80mg on prescriptions from 11 prescribers as non-PBS.
On 14 July 2016 and 28 July 2016 Patient D was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng.
Patient D had an address in Belfield, about 14 kilometres away from the Pharmacy.
[23]
Patient E and Schedule E: Particulars 21- 25
Particulars 21 - 25:
21. On 19 July 2016, 31 July 2016, 11 August 2016, 16 August 2016 and 1 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient E on the dates and in the quantities as outlined in the Schedule attached and marked "E" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
22. On 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100mcg (5 patches), a Schedule 8 drug of addiction, to Patient E when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule E hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
23. On 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100mcg (10 patches), a Schedule 8 drug of addiction, to Patient E when presented with a prescription allegedly from Dr Ashraf Thabit Selim as outlined in Schedule E hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
24. Between 28 April 2015 and 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient E on the dates and in the quantities as outlined in Schedule E hereto as private prescriptions when the PBS was available.
25. Between 28 April 2015 and 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient E on the dates and in the quantities as outlined in Schedule E hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 28 April 2015 and 1 December 2016, Patient E was dispensed Durogesic 100, Tramal SR 200mg and Kalma 2mg from 18 prescribers.
On 3 June 2015 and 18 July 2015, Patient E was dispensed Durogesic 100 on the PBS using a concession card. All of the other prescriptions were dispensed as non-PBS.
On 19 July 2016 and 11 August 2016 Patient E was dispensed Kalma 2mg 100 tablets on forged prescriptions from Dr Ng. On 31 July 2016, 16 August 2016 and 1 September 2016, Patient E was dispensed Durogesic 100 on forged prescriptions from Dr Ng.
On 22 November 2016, Patient E was dispensed Durogesic 100 5 patches on a forged prescription from Dr Sadhu.
On 1 December 2016, Patient E was dispensed Durogesic 100 10 patches on a forged prescription from Dr Selim.
[24]
Patient F and Schedule F: Particulars 26 - 31
Particulars 26 - 31:
26. On 19 July 2016, 4 August 2016, 18 August 2016 and 8 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient F on the dates and in the quantities as outlined in the Schedule attached and marked "F" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
27. On 4 August 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100mcg (5 patches), a Schedule 8 drug of addiction, to Patient F when presented with a prescription allegedly from Dr Jit Seng Ng dated 2 August 2017 as outlined in Schedule F hereto, contrary to Clause 86 of the PTGR.
28. On 24 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100mcg (10 patches), a Schedule 8 drug of addiction, to Patient F when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule F hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
29. Between 6 July 2015 and 24 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient F on the dates and in the quantities as outlined in Schedule F hereto in circumstances where Patient F had an address in Merrylands, NSW; outside of the Pharmacy's local area.
30. Between 6 July 2015 and 24 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient F on the dates and in the quantities as outlined in Schedule F hereto as private prescriptions when the PBS was available.
31. Between 6 July 2015 and 24 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient F on the dates and in the quantities as outlined in Schedule F hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 6 July 2015 and 24 November 2016, Patient F was dispensed Durogesic 100, Oxycodone Sandoz 80mg and Kalma 2mg at the Pharmacy from 10 prescribers.
On 19 July 2016, 4 August 2016, 18 August 2016 and 8 September 2016 Patient F was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng.
Particular 27 relates specifically to the prescription dispensed on 4 August 2016 for Durogesic 100 5 patches on a forged prescription from Dr Ng.
Exhibit A1 Tab 18, at page 20, evidences the prescription which had a date of 2 August 2016 that was changed from 2 August 2017 before it was dispensed on 4 August 2016. It is apparent that the handwriting changing the date from 2017 to 2016 is different, as is evidenced by the 2016 date on the other prescription also found at Tab 18, page 20.
On 24 November 2016 Patient F was dispensed Durogesic 100 10 patches on a forged prescription from Dr Sadhu.
The address for Patient F was Merrylands.
[25]
Patient G and Schedule G: Particulars 32 - 35
Particulars 32 - 35:
32. On 21 July 2016, 24 July 2016, 28 July 2016 and 11 August 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient G on the dates and in the quantities as outlined in the Schedule attached and marked "G" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
33. On 27 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100mcg (5 patches), a Schedule 8 drug of addiction, to Patient G when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule G hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
34. Between 30 August 2015 and 10 February 2017, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient G on the dates and in the quantities as outlined in Schedule G hereto as private prescriptions when the PBS was available.
35. Between 30 August 2015 and 10 February 2017, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient G on the dates and in the quantities as outlined in Schedule G hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 30 August 2015 and 10 February 2017 Patient G was dispensed Durogesic 100, Kalma 2mg and Oxycodone Sandoz 80mg from 16 prescribers. All of the prescriptions were private, other than on 14 January 2017 and 10 February 2017, when Durogesic 100 5 patches were dispensed on the PBS.
On 21 July 2016 Patient G was dispensed Kalma 2mg on a forged prescription from Dr Ng. On 24 July 2016, 28 July 2016 and 11 August 2016 Patient G was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng.
On 27 November 2016 Patient G was dispensed Durogesic 100 5 patches on a forged prescription from Dr Sadhu.
[26]
Patient H and Schedule H: Particulars 36 - 40
Particulars 36 - 40:
36. On 19 July 2016, 31 July 2016, 18 August 2016 and 1 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient H on the dates and in the quantities as outlined in the Schedule attached and marked "H" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
37. On 27 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100mcg (10 patches), a Schedule 8 drug of addiction, to Patient H when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule H hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
38. Between 7 July 2015 and 27 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient H on the dates and in the quantities as outlined in Schedule H hereto in circumstances where Patient H had an address in Merrylands, NSW; outside of the Pharmacy's local area.
39. Between 7 July 2015 and 27 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient H on the dates and in the quantities as outlined in Schedule H hereto as private prescriptions when the PBS was available.
40. Between 7 July 2015 and 27 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient H on the dates and in the quantities as outlined in Schedule H hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 7 July 2015 and 27 November 2016 Patient H was dispensed Durogesic 100 on private prescriptions from 9 prescribers.
On 19 July 2016, 31 July 2016, 18 August 2016 and 1 September 2016 Patient H was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng.
On 27 November 2016 Patient H was dispensed Durogesic 100 10 patches on a forged prescription from Dr Sadhu.
The address for Patient H was Merrylands.
[27]
Patient I and Schedule I: Particulars 41 - 44
Particulars 41 - 44:
41. On 24 July 2016, 4 August 2016, 11 August 2016 and 25 August 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient I on the dates and in the quantities as outlined in the Schedule attached and marked "I" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
42. Between 2 July 2015 and 24 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient I on the dates and in the quantities as outlined in Schedule I hereto in circumstances where Patient I had an address in Prestons, NSW; outside of the Pharmacy's local area.
43. Between 2 July 2015 and 24 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient I on the dates and in the quantities as outlined in Schedule I hereto as private prescriptions when the PBS was available.
44. Between 2 July 2015 and 24 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient I on the dates and in the quantities as outlined in Schedule I hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 2 July 2015 and 24 November 2016, Patient I was dispensed Durogesic 100 and Kalma 2mg on private prescriptions from 10 prescribers, including Dr Sadhu and Dr Ng.
On 24 July 2016, 11 August 2016 and 25 August 2016, Patient I was dispensed Durogesic 100 5 patches and on 4 August 2016, Patient I was dispensed Kalma 2mg 100 tablets on forged prescribes from Dr Ng.
Patient I had an address in Prestons, about 30 kilometres away from the Pharmacy.
[28]
Patient J and Schedule J: Particulars 45 - 47
Particulars 45 - 47:
45. On 24 July 2016, 4 August 2016, 11 August 2016 and 25 August 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient J on the dates and in the quantities as outlined in the Schedule attached and marked "J" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
46. Between 2 July 2015 and 24 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient J on the dates and in the quantities as outlined in Schedule J hereto as private prescriptions when the PBS was available.
47. Between 2 July 2015 and 24 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient J on the dates and in the quantities as outlined in Schedule J hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 2 July 2015 and 24 November 2016, Patient J was dispensed Durogesic 100 and Kalma 2mg at the Pharmacy on private prescriptions from 10 prescribers, including Dr Sadhu and Dr Ng.
On 24 July 2016, 11 August 2016 and 25 August 2016 Patient J was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng and on 4 August 2016, Patient J was dispensed Kalma 2mg 100 tablets on a forged prescription from Dr Ng.
[29]
Patient K and Schedule K: Particulars 48 - 53
Particulars 48 - 53:
48. On 24 July 2016, 6 August 2016 and 1 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient K on the dates and in the quantities as outlined in the Schedule attached and marked "K" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
49. [Deleted]
50. On 24 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Kalma 2mg (100 tablets), a Schedule 8 drug of addiction, to Patient K when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule K hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
51. Between 20 December 2015 and 6 April 2017, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient K on the dates and in the quantities as outlined in Schedule K hereto in circumstances where Patient K had an address in North Sydney, NSW; outside of the Pharmacy's local area.
52. Between 20 December 2015 and 6 April 2017, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient K on the dates and in the quantities as outlined in Schedule K hereto as private prescriptions when the PBS was available.
53. Between 20 December 2015 and 6 April 2017, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient K on the dates and in the quantities as outlined in Schedule K hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 20 December 2015 and 6 April 2017, Patient K was dispensed Durogesic 100, Kalma 2mg and Oxycodone Sandoz 80mg from 14 prescribers. All of the prescriptions were on private prescriptions other than on 26 May 2016 and 6 April 2017, when Durogesic 100 and Durogesic 75 were dispensed on the PBS using a concession card.
On 24 July 2016 and 6 August 2016, Patient K was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng and on 1 September 2016 Patient K was dispensed Kalma 2mg 100 tablets on a forged prescription from Dr Ng.
On 24 November 2016, Patient K was dispensed Kalma 2mg 100 tablets on a forged prescription from Dr Sadhu.
Patient K had an address in North Sydney about 25 kilometres away from the Pharmacy.
[30]
Patient L and Schedule L: Particulars 54 - 58
Particulars 54 - 58:
54. On 21 July 2016, 4 August 2016, 18 August 2016 and 1 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient L on the dates and in the quantities as outlined in the Schedule attached and marked "L" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
55. On 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100mcg (5 patches), a Schedule 8 drug of addiction, to Patient L when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule L hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
56. Between 9 June 2015 and 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient L on the dates and in the quantities as outlined in Schedule L hereto in circumstances where Patient L had an address in Guildford, NSW; outside of the Pharmacy's local area.
57. Between 9 June 2015 and 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient L on the dates and in the quantities as outlined in Schedule L hereto as private prescriptions when the PBS was available.
58. Between 9 June 2015 and 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient L on the dates and in the quantities as outlined in Schedule L hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 9 June 2015 and 22 November 2016 Patient L was dispensed Durogesic 100, Oxycodone Sandoz 80mg and Kalma 2mg on private prescriptions at the Pharmacy from 10 prescribers, including Dr Sadhu and Dr Ng.
On 21 July 2016, 4 August 2016, 18 August 2016 and 1 September 2016 Patient L was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng.
On 22 November 2016 Patient L was dispensed Durogesic 100 5 patches on a forged prescription from Dr Sadhu.
Patient L had an address in Guildford about 3 kilometres away from the Pharmacy.
[31]
Patient M and Schedule M: Particulars 59 - 63
Particulars 59 - 63:
59. On 24 July 2016, 31 July 2016, 6 August 2016 and 1 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient M on the dates and in the quantities as outlined in the Schedule attached and marked "M" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
60. On 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Kalma 2mg (100 tablets), a Schedule 8 drug of addiction, to Patient M when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule M hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
61. Between 7 April 2015 and 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient M on the dates and in the quantities as outlined in Schedule M hereto in circumstances where Patient M had an address in Ryde, NSW; outside of the Pharmacy's local area.
62. Between 7 April 2015 and 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient M on the dates and in the quantities as outlined in Schedule M hereto as private prescriptions when the PBS was available.
63. Between 7 April 2015 and 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient M on the dates and in the quantities as outlined in Schedule M hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 7 April 2015 and 22 November 2016, Patient M was dispensed Durogesic 100, Tramal SR 200mg, Kalma 2mg, Oxycodone Sandoz 80mg, Endone 5mg and Durogesic 75, on private prescriptions, including from Dr Ng and Dr Sadhu.
On 24 July 2016 and 6 August 2016, Patient M was dispensed Durogesic 100 5 patches, on 31 July 2016 Oxycodone Sandoz 80mg 56 Tablets, and on 1 September 2016 Kalma 2mg 100 tablets on forged prescriptions from Dr Ng.
On 22 November 2016, Patient M was dispensed Kalma 2mg 100 tablets on a forged prescription from Dr Sadhu.
Patient M had an address in Ryde about 13 kilometres from the Pharmacy.
[32]
Patient N and Schedule N: Particulars 64 - 66
Particulars 64 - 66:
64. On 21 July 2016 and 11 August 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient N on the dates and in the quantities as outlined in the Schedule attached and marked "N" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
65. Between 6 January 2015 and 29 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient N on the dates and in the quantities as outlined in Schedule N hereto as private prescriptions when the PBS was available.
66. Between 6 January 2015 and 29 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient N on the dates and in the quantities as outlined in Schedule N hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 6 January 2015 and 29 November 2016, Patient N was dispensed Durogesic 100, Oxycodone Sandoz 80mg, Kalma 2mg and Temaze 10mg on private prescriptions, other than on 19 February 2015 and 7 April 2015 when prescriptions were dispensed on the PBS using a concession card.
Between 6 January 2015 and 29 November 2016, Patient N was dispensed prescriptions at the Pharmacy from approximately 20 prescribers.
On 21 July 2016 and 11 August 2016, Patient N was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng.
Of note is that on 23 July 2016, Patient N was dispensed Durogesic 100 5 patches on a prescription on the PBS between the two prescriptions from Dr Ng.
[33]
Patient O and Schedule O: Particulars 67 - 71
Particulars 67 - 71:
67. On 21 July 2016, 16 August 2016, 25 August 2016 and 1 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient O on the dates and in the quantities as outlined in the Schedule attached and marked "O" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
68. On 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100 mcg (5 patches), a Schedule 8 drug of addiction, to Patient O when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule O hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
69. Between 4 January 2015 and 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient O on the dates and in the quantities as outlined in Schedule O hereto in circumstances where Patient O had an address in Stanhope Gardens, NSW; outside of the Pharmacy's local area.
70. Between 4 January 2015 and 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient O on the dates and in the quantities as outlined in Schedule O hereto as private prescriptions when the PBS was available.
71. Between 4 January 2015 and 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient O on the dates and in the quantities as outlined in Schedule O hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 4 January 2015 and 22 November 2016, Patient O was dispensed Durogesic 100, Oxycodone Sandoz 80mg, Kalma 2mg and Tramal SR 200mg on private prescriptions at the Pharmacy from approximately 22 prescribers.
In relation to Patient O's patient history at the Pharmacy, Patient O was dispensed antibiotics, asthma inhalers and Panafcortelone 25mg on the PBS using a concession card. Patient O was also dispensed Durogesic 100 5 patches on 30 April 2015 on the PBS using a concession card.
On 21 July 2016, 16 August 2016 and 1 September 2016, Patient O was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng and on 25 August 2016 was dispensed Kalma 2mg 100 tablets on a forged prescription from Dr Ng.
On 22 November 2016, Patient O was dispensed Durogesic 100 5 patches on a forged prescription from Dr Sadhu.
Patient O had an address in Stanhope Gardens some 30 kilometres away from the Pharmacy.
[34]
Patient P and Schedule P: Particulars 72 - 74
Particulars 72 - 74:
72. On 21 July 2016 and 4 August 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient P on the dates and in the quantities as outlined in the Schedule attached and marked "P" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
73. Between 24 May 2015 and 24 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient P on the dates and in the quantities as outlined in Schedule P hereto as private prescriptions when the PBS was available.
74. Between 24 May 2015 and 24 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient P on the dates and in the quantities as outlined in Schedule P hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 24 May 2015 and 24 November 2016, Patient P was dispensed Durogesic 100, Kalma 2mg, Oxycodone Sandoz 80mg and Oxycontin CR 80mg at the Pharmacy on private prescriptions from 12 prescribers, including Dr Ng and Dr Sadhu.
On 21 July 2016 and 4 August 2016, Patient P was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng.
[35]
Patient Q and Schedule Q: Particulars 75 - 79
Particulars 75 - 79:
75. On 21 July 2016, 6 August 2016 and 1 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient Q on the dates and in the quantities as outlined in the Schedule attached and marked "Q" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
76. On 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100 mcg (5 patches), a Schedule 8 drug of addiction, to Patient Q when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule Q hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
77. Between 2 July 2015 and 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient Q on the dates and in the quantities as outlined in Schedule Q hereto in circumstances where Patient Q had an address in Cabramatta, NSW; outside of the Pharmacy's local area.
78. Between 2 July 2015 and 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient Q on the dates and in the quantities as outlined in Schedule Q hereto as private prescriptions when the PBS was available.
79. Between 2 July 2015 and 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient Q on the dates and in the quantities as outlined in Schedule Q hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 2 July 2015 and 22 November 2016, Patient Q was dispensed Durogesic 100 on private prescriptions from 9 prescribers, including Dr Sadhu and Dr Ng.
On 21 July 2016, 6 August 2016 and 1 September 2016, Patient Q was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng.
On 22 November 2016, Patient Q was dispensed Durogesic 100 5 patches on a forged prescription from Dr Sadhu.
Patient Q had an address in Cabramatta about 10 kilometres away from the Pharmacy.
[36]
Patient R and Schedule R: Particulars 80 - 85
Particulars 80 - 85:
80. On 21 July 2016, twice on 4 August 2016, 18 August 2016 and 1 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient R on the dates and in the quantities as outlined in the Schedule attached and marked "R" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
81. On 21 July 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100mcg (5 patches), a Schedule 8 drug of addiction, to Patient R when presented with a prescription allegedly from Dr Jit Seng Ng dated 21 July 2017 as outlined in Schedule R hereto, contrary to Clause 86 of the PTGR.
82. On 27 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100 mcg (5 patches), a Schedule 8 drug of addiction, to Patient R when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule R hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
83. Between 28 May 2015 and 27 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient R on the dates and in the quantities as outlined in Schedule R hereto in circumstances where Patient R had an address in Pennant Hills, NSW; outside of the Pharmacy's local area.
84. Between 28 May 2015 and 27 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient R on the dates and in the quantities as outlined in Schedule R hereto as private prescriptions when the PBS was available.
85. Between 28 May 2015 and 27 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient R on the dates and in the quantities as outlined in Schedule R hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 28 May 2015 and 27 November 2016, Patient R was dispensed Durogesic 100 and Kalma 2mg at the Pharmacy on private prescriptions from 12 prescribers, including Dr Sadhu and Dr Ng.
On 21 July 2016, 4 August 2016, 18 August 2016 and 1 September 2016, Patient R was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng and on 4 August 2016 was dispensed Kalma 2mg 100 tablets on a forged prescription from Dr Ng.
On 27 November 2016, Patient R was dispensed Durogesic 100 5 patches on a forged prescription from Dr Sadhu.
Patient R had an address in Pennant Hills about 15 kilometres away from the Pharmacy.
[37]
Patient S and Schedule S: Particulars 86 - 90
Particulars 86 - 90:
86. On 21 July 2016, 31 July 2016, 11 August 2016, 18 August 2016 and 1 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient S on the dates and in the quantities as outlined in the Schedule attached and marked "S" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
87. On 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100 mcg (5 patches), a Schedule 8 drug of addiction, to Patient S when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule S hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
88. Between 13 June 2015 and 13 January 2017, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient S on the dates and in the quantities as outlined in Schedule S hereto in circumstances where Patient S had an address in Baulkham Hills, NSW; outside of the Pharmacy's local area.
89. Between 13 June 2015 and 13 January 2017, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient S on the dates and in the quantities as outlined in Schedule S hereto as private prescriptions when the PBS was available.
90. Between 13 June 2015 and 13 January 2017, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient S on the dates and in the quantities as outlined in Schedule S hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 13 June 2015 and 13 January 2017, Patient S was dispensed Durogesic 100, Durogesic 50 and Kalma 2mg on private prescriptions from 16 prescribers.
On 21 July 2016 and 18 August 2016, Patient S was dispensed Kalma 2mg 100 tablets on forged prescriptions from Dr Ng and on 31 July 2016, 11 August 2016 and 1 September 2016, Patient S was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng.
On 22 November 2016, Patient S was dispensed Durogesic 100 5 patches on a forged prescription from Dr Sadhu.
Patient S had an address in Baulkham Hills about 10 kilometres away from the Pharmacy.
[38]
Patient T and Schedule T: Particulars 91 - 95
Particulars 91 - 95:
91. On 26 July 2016 and 25 August 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient T on the dates and in the quantities as outlined in the Schedule attached and marked "T" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
92. On 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100mcg (5 patches), a Schedule 8 drug of addiction, to Patient T when presented with a prescription allegedly from Dr Ashraf Thabit Selim as outlined in Schedule T hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
93. Between 7 July 2015 and 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient T on the dates and in the quantities as outlined in Schedule T hereto in circumstances where Patient T had an address in Merrylands, NSW; outside of the Pharmacy's local area.
94. Between 7 July 2015 and 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient T on the dates and in the quantities as outlined in Schedule T hereto as private prescriptions when the PBS was available.
95. Between 7 July 2015 and 1 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient T on the dates and in the quantities as outlined in Schedule T hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 7 July 2015 and 1 December 2016, Patient T was dispensed Durogesic 100 on private prescriptions from 11 prescribers, including Dr Sadhu, Dr Ng and Dr Selim.
On 26 July 2016 and 25 August 2016, Patient T was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng.
On 1 December 2016, Patient T was dispensed Durogesic 100 5 patches on a forged prescription from Dr Selim.
The address for Patient T was in Merrylands.
[39]
Patient U and Schedule U: Particulars 96 - 99
Particulars 96 - 99:
96. On 26 July 2016, 6 August 2016, 18 August 2016, 1 September 2016 and 8 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient U on the dates and in the quantities as outlined in the Schedule attached and marked "U" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
97. Between 5 January 2016 and 8 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient U on the dates and in the quantities as outlined in Schedule U hereto in circumstances where Patient U had an address in Cranebrook, NSW; outside of the Pharmacy's local area.
98. Between 5 January 2016 and 8 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient U on the dates and in the quantities as outlined in Schedule U hereto as private prescriptions when the PBS was available.
99. Between 5 January 2016 and 8 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient U on the dates and in the quantities as outlined in Schedule U hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 5 January 2016 and 8 September 2016, Patient U was dispensed Oxycodone Sandoz 80mg, Oxycontin CR 80mg and Kalma 2mg on private prescriptions at the Pharmacy from 6 prescribers, including Dr Sadhu and Dr Ng.
On 26 July 2016, 6 August 2016, 18 August 2016 and 1 September 2016, Patient U was dispensed Oxycodone 80mg on forged prescriptions from Dr Ng and on 8 September 2016 Patient U was dispensed Kalma 2mg 100 tablets on a forged prescription from Dr Ng.
Patient U had an address in Cranbrook about 30 kilometres away from the Pharmacy.
[40]
Patient V and Schedule V: Particulars 100 - 104
Particulars 100 - 104:
100. On 28 July 2016, 18 August 2016 and 8 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient V on the dates and in the quantities as outlined in the Schedule attached and marked "V" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
101. On 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100 mcg (5 patches), a Schedule 8 drug of addiction, to Patient V when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule V hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
102. Between 9 June 2015 and 6 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient V on the dates and in the quantities as outlined in Schedule V hereto in circumstances where Patient V had an address in Telopea, NSW; outside of the Pharmacy's local area.
103. Between 9 June 2015 and 6 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient V on the dates and in the quantities as outlined in Schedule V hereto as private prescriptions when the PBS was available.
104. Between 9 June 2015 and 6 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient V on the dates and in the quantities as outlined in Schedule V hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 9 June 2015 and 6 December 2016, Patient V was dispensed Durogesic 100, Oxycodone Sandoz 80mg and Kalma 2mg, on private prescriptions from 11 prescribers, including Dr Ng, Dr Sadhu and Dr Selim.
On 28 July 2016, Patient V was dispensed Oxycodone Sandoz 80mg 56 tablets on a forged prescription from Dr Ng and on 18 August 2016 and 8 September 2016, Patient V was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng.
On 22 November 2016, Patient V was dispensed Durogesic 100 5 patches on a forged prescription from Dr Sadhu.
Patient V had an address in Telopea about 8 kilometres away from the Pharmacy.
[41]
Patient W and Schedule W: Particulars 105 - 109
Particulars 105 - 109:
105. On 26 July 2016, 11 August 2016 and 25 August 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient W on the dates and in the quantities as outlined in the Schedule attached and marked "W" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
106. On 6 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100mcg (10 patches), a Schedule 8 drug of addiction, to Patient W when presented with a prescription allegedly from Dr Ashraf Thabit Selim as outlined in Schedule W hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
107. On 22 November 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Durogesic 100 mcg (5 patches), a Schedule 8 drug of addiction, to Patient W when presented with a prescription allegedly from Dr Sadhu as outlined in Schedule W hereto, contrary to Clauses 80, 86 and 87 of the PTGR.
108. Between 10 January 2016 and 6 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient W on the dates and in the quantities as outlined in Schedule W hereto as private prescriptions when the PBS was available.
109. Between 10 January 2016 and 6 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient V on the dates and in the quantities as outlined in Schedule V hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 10 January 2016 and 6 December 2016, Patient W was dispensed Durogesic 100 and Kalma 2mg on private prescriptions at the Pharmacy from 7 prescribers, including Dr Sadhu, Dr Ng and Dr Selim.
On 26 July 2016, 11 August 2016 and 25 August 2016, Patient W was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng.
On 6 December 2016, Patient W was dispensed Durogesic 100 10 patches on a forged prescription from Dr Selim.
On 22 November 2016, Patient W was dispensed Durogesic 100 5 patches on a forged prescription from Dr Sadhu.
[42]
Patient X and Schedule X: Particulars 110 - 112
Particulars 110 - 112:
110. On 28 July 2016, 4 August 2016, 6 August 2016 and 8 September 2016 the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient X on the dates and in the quantities as outlined in the Schedule attached and marked "X" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
111. Between 30 June 2015 and 6 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient X on the dates and in the quantities as outlined in Schedule X hereto as private prescriptions when the PBS was available.
112. Between 30 June 2015 and 6 December 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient X on the dates and in the quantities as outlined in Schedule X hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 5 February 2015 and 6 December 2016, Patient X was dispensed Durogesic 100, Oxycodone Sandoz 80mg, Kalma 2mg, Oxycontin CR 80mg and Tramal SR 200 mg on mostly private prescriptions, other than 4 prescriptions which were dispensed on the PBS using a concession card, from 15 prescribers, including Dr Ng and Dr Sadhu.
On 28 July 2016 and 8 September 2016, Patient X was dispensed Durogesic 100 5 patches, on 4 August 2016 Patient X was dispensed Oxycodone Sandoz 80mg 56 tablets and on 6 August 2016, Patient X was dispensed Kalma 2mg 100 tablets on forged prescriptions from Dr Ng.
[43]
Patient Y and Schedule Y: Particulars 113 - 115
Particulars 113 - 115:
113. On 28 July 2016, 11 August 2016 and 8 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient Y on the dates and in the quantities as outlined in the Schedule attached and marked "Y" when presented with prescriptions allegedly from Dr Jit Seng Ng contrary to Clauses 79, 80, 86 and 87 of the PTGR.
114. Between 6 June 2015 and 8 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient Y on the dates and in the quantities as outlined in Schedule Y hereto as private prescriptions when the PBS was available.
115. Between 6 June 2015 and 8 September 2016, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patient Y on the dates and in the quantities as outlined in Schedule Y hereto in a quantity and/ or for a purpose contrary to Clause 109 of the PTGR.
Between 6 June 2015 and 8 September 2016, Patient Y was dispensed Durogesic 100, Kalma 2mg, Oxycodone Sandoz 80mg, on private prescriptions from 12 prescribers, including Dr Sadhu and Dr Ng.
On 28 July 2016 and 8 September 2016, Patient Y was dispensed Durogesic 100 5 patches on forged prescriptions from Dr Ng and on 11 August 2016 Patient Y was dispensed Oxycodone Sandoz 80mg 56 tablets on a forged prescription from Dr Ng.
[44]
Mr Saab's evidence in response to Complaint 2: Patients A - Y
Mr Saab gave evidence that the Pharmacy had lots of patients who came from out of the area. It was not unusual and it did not raise concerns for him. He added that the patients had a regular history with the Pharmacy.
Mr Saab "could not recall" contacting Drs Ng, Selim or Sadhu to verify the prescriptions presented at the Pharmacy. In relation to verifying the prescriptions, Mr Saab relied on the fact that the patients were known to the Pharmacy. The medication in the prescriptions had previously been dispensed and used by the patients and so the medications prescribed in his view was their therapeutic dose. Mr Saab was confident that the medicines that were dispensed were taken correctly and were appropriate therapeutic dosages.
In relation to multiple prescribers, Mr Saab gave evidence that this was not uncommon because sometimes a person's regular Doctor was not available.
[45]
Patient Z and Schedule Z: Particulars 116 - 117
Particulars 116 - 117:
116. The practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed the following prescribed restricted substances, contrary to Clauses 34 and 54 of the PTGR on the dates and in the quantities as outlined below:
6 October 2016 - Proviron (1,000 tablets);
6 October 2016 - Arimidex (300 tablets);
6 October 2016 - Valium 5mg (1,000 tablets);
6 October 2016 - Primoteston Depot 250mg/1ml syringes (60 syringes);
8 November 2016 - Primoteston Depot 250mg/1ml syringes (30 syringes);
10 November 2016 - Primoteston Depot 250mg/1ml syringes (15 syringes);
15 November 2016 - Primoteston Depot 250mg/1ml syringes (30 syringes);
22 November 2016 - Primoteston Depot 250mg/1ml syringes (30 syringes);
29 November 2016 - Primoteston Depot 250mg/1ml syringes (30 syringes);
7 January 2017 - Valium 5mg (1,000 tablets);
7 January 2017 -Tramal SR 200mg (400 tablets);
9 January 2017 - Antenex tablets (1,000 tablets);
10 January 2017 - Primoteston Depot 250mg/1ml syringes (30 syringes);
10 January 2017 - Nolvadex-D (1,200 tablets);
12 January 2017 - Primoteston Depot 250mg/1ml syringes (15 syringes);
12 January 2017 - Nolvadex-D (600 tablets);
15 January 2017 - Proviron (1,000 tablets);
15 January 2017 - Pregnyl 1500 iu Ampoules (10 ampoules);
15 January 2017 - Aromasin (600 tablets)
17 January 2017 - Pregnyl 1500 iu Ampoules (10 ampoules);
17 January 2017 - Primoteston Depot 250mg/1ml syringes (30 syringes);
16 February 2017 - Genotropin GoQuick Injection 12mg (6 syringes); and
7 March 2017 - Clomid 50mg (30 tablets).
117. On 7 March 2017, the practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed the prescribed restricted substance Clomid 50mg (30 tablets) contrary to Clause 52 of the PTGR.
Particular 116 relates to the dispensing to Patient Z of anabolic steroids (Proviron, Primoteston), benzodiazepines (Valium, Antenex), oestrogen suppression drugs ordinarily used for breast cancer (Arimidex, Nolvadex, Aromasin), fertility drugs (Pregnyl), human growth hormone (Genotrophin) and Tramadol for pain relief.
Patient Z's patient history at the Pharmacy was obtained by the PRU. Patient Z was male.
All of the prescriptions for Patient Z were dispensed as private prescriptions. The patient history indicates that significant sums of money were being spent in the name of Patient Z. For example, the three medications dispensed on 15 January 2017 Aromasin, Pregynl and Proviron cost a total of $5350 whilst the Genotropin dispensed on 16 February 2017 cost $3960.
None of the prescriptions for Patient Z were actually located by the PRU nor were any produced by Mr Saab. Because none of the prescriptions were located, we do not have the source material from which to discern the dispensing pharmacist.
In the patient history records seized by the PRU, the prescriptions dispensed by the Pharmacy on 7 January 2017, 9 January 2017, 10 January 2017, 12 January 2017, 15 January 2017 and 17 January 2017 were all dispensed as "hospital" with no reference to a particular doctor and, accordingly, not from a valid prescriber.
In cross examination (7 August 2020) Mr Saab gave evidence about this issue as follows:
Q. And the hospital prescriber, with no reference to a particular doctor, is highly inappropriate, isn't it?
A. That's the way the dispensing system works. It should have been taken to enter the doctor's details but it's acceptable that prescriptions are dispensed in hospital if it comes as that.
Q. That is not true, is it, Mr Saab?
A. No, I think that's what it represents.
Q. Mr Saab, pharmacists are required to enter into their dispensing systems the doctor and the doctor's prescribing number for any prescription, aren't they?
A. The issue with hospital prescriptions is sometimes the prescriber doesn't put down their prescriber number. They only have a, like a pager number or a beeper number and the authority itself - not the authority but the prescription itself has the details of the hospital on it, so that's what the system would reflect.
Q. Mr Saab, it would never be appropriate to accept a prescription from a hospital for these drugs, would it?
A. No, I don't think so.
Q. And nor would it be appropriate to accept a prescription at the pharmacy for this combination of drugs from a hospital?
A. We've accepted them before for other patients from different prescribers.
Q. It's not appropriate, Mr Saab, is it?
A. Like I said, we have accepted prescriptions before for other patients for these sort of combinations.
Q. That doesn't make it right though, does it, Mr Saab?
A. It doesn't make it wrong either based just on the prescriber
Mr Saab's evidence about to what extent he knew Patient Z and whether he dispensed any medications to Patient Z is not entirely clear.
In broad terms in the s. 150 proceedings, Mr Saab said that he had no recollection of dispensing the prescriptions. In Mr Saab's affidavit dated 5 March 2020 and lodged in these proceedings, he did not recall the prescriptions in question and denied dispensing the medications to Patient Z.
Under cross examination on 7 August 2020 Mr Saab said he did not know Patient Z, could not recall if he directly dispensed but it was likely he did provide some of the medications. He also agreed that he was present in the Pharmacy on most of the days that Patient Z received medication.
In subsequent cross examination on 20 August 2020, Mr Saab stated that it was "possible" that he dispensed prescriptions to Patient Z.
At another point in cross examination on 20 August 2020, Mr Saab gave evidence as follows:
A. I can't recall every time I was in the pharmacy and these medicines were dispensed, but I said it was more likely than not that I didn't dispense some.
Q. Sorry, it dropped out. It's more likely than not that you did or didn't dispense them
A. That I didn't dispense them.
Q. What do you base that on, Mr Saab?
A. Just on my dispensing habits. [21]
The Controlled Drugs Register for Methadone evidences that the initials "TS" signed off on the Methadone Controlled Drugs Register on all of the days that Patient Z was dispensed medications at the Pharmacy other than 9 January 2017, 30 December 2016, 3 December 2016, 30 November 2016, 27 October 2016, 19 September 2016, 14 June 2016 and 24 August 2015.
Under cross examination, Mr Saab was taken to Patient Z's history. He conceded that looking at Patient Z's history as a whole that the quantities were excessive. He did not, however, accept that the combination was suggestive that the medication was not for a therapeutic purpose. He gave evidence as follows:
Q. Mr Saab, tell me, what medical conditions would a patient have to be using multiple different steroids, being testosterone based, an oestrogen blocker, a fertility stimulant at the same time?
A. It's normally used in patients that are recovering from any sort of injury, mainly sports injuries. So for people that have injured themselves playing sport, so knee or shoulder or hip injuries, torn muscles, that sort of things. These medications are being used for that. (Transcript 7 August 2020 pg 319)
….
You could not have been satisfied that Patient Z was using Pregnyl for an appropriate therapeutic purpose when the medication was dispensed by your pharmacy?
A. The medication that was prescribed to the patient, just like the majority of the medications that were prescribed to this patient, were prescribed for an off-label use, mainly, so I think in regards to sports injuries and the like, and this sort of medication is used to prevent side effects from the other medications they were taking. This one is a stimulating hormone. It's there to, I guess you could say to restart certain processes in the body as a result of them being, them being blocked by other medications they were taking.
Q. Mr Saab, earlier, before the lunchtime adjournment, you gave evidence that you could not recall meeting patient Z and you could not recall patient Z coming into the pharmacy. How is it now that you can tell this Tribunal in no uncertain terms what patient Z was using these medications for?
A. I'm just going off the types of patients that came in for these medications. Patient Z was not the only patient that came in for these times of medications. We had a number of other patients presenting prescriptions from Regenacell and they were using it in the same way [22]
In questions posed to Mr Saab by Professional Member Preswick about the medication dispensed to Patient Z and whether its use for sports injuries was recognised and accepted, Mr Saab was unable to identify any published research or textbook to support his contention: see Transcript 27 August pg 513.
Questions were also posed to Mr Saab by Professional Member Carter about Patient Z. After establishing that for some patients the pharmacy secured copies of passport and licences, however there was no similar identification held for Patient Z, the following evidence was given:
Q. Raja Morris doesn't know Patient Z. Patient Z came into the pharmacy quite frequently, I would almost call him a frequent flier because of how often he was dispensed medications. Do you think it's odd that Raja Morris didn't know who patient Z was?
A. If he's saying he doesn't know him then that's what he's saying.
Q. Presiding Member McIllhatton: I think the question, Mr Saab, though was did you think that was odd?
A. I don't think so, no.
Q. Member Preswick spoke to you about quantities of Nolvadex and there was a manual order, and if I'm reading it correctly, the 9th of the 1st 2017, which is the first entry on the top of the page, for 40 boxes of Nolvadex 20 milligram?
A. Yes.
Q. …on the 10th of the 1st 2017 patient Z was dispensed 1200 tablets, which is 40 boxes of 30?
A. Yes.
Q. So someone must have known that there was going to be a prescription come in for Nolvadex 1200 tablets, do you agree?
A. I'm unsure.
Q. ... back at the Sigma records, the next entry is for 20 boxes on the 10th of the 1st 2017, and patient Z was dispensed 600 tablets on the 12th of the 1st 17. So with that sort of quantity it is actually a special order, isn't it?
A. It may have been, yes.
Q. But someone must have known that that quantity was going to be dispensed to order that in?
A. Possibly, yes.
Q. For what purpose would a patient require 1200 tablets on the 10th of the 1st 17 and then 600 tablets on the 12th of the 1st 17?
A. No, there wouldn't be any purpose. There wouldn't be any purpose.
Q. Have you ever seen a prescription written with this quantity?
A. No.
Q. So would someone have just made up this prescription by entering it in the system as there was no record of prescriptions for patient Z, so do you think someone has just made up a prescription with this quantity?
A. I don't believe so, no.
Q. At the point of sale system, patient Z's prescriptions were taken out at no charge. Why was this?
A. I'm not sure.
Q. Did patient Z actually exist?
A. I believe he did, yes.
Q. So why would we want to give 1800 tablets of Nolvadex to a person in two days?
A. Shouldn't be.
Q. …it says that you were not rostered on the 8th and 15th and 29th of November 16 and the 7th, 9th and 15th of January 2017. However, when I've cross-referenced the DD book for Alprazolam, your initials TS were in the register on the 15th and 29th of November 16 and the 7th and 15th of January 17. Can you comment?
A. I think it's just saying that I wasn't rostered to work as a pharmacist on those days but I may have been in the pharmacy [23]
Ms Croker gave the following evidence in relation to the medications dispensed by the Pharmacy to Patient Z:
Q. Patient Z, I think it's not controversial in these proceedings, he was a male patient. In what circumstances would you expect to see Pregnyl 1500 units prescribed to a male?
A. Pregnyl is a fertility medication I believe. Sorry, I'm just going to - so, yeah, it would not, I don't know of any therapeutic reason that you would provide Pregnyl to a male patient. It's generally used for - no, sorry, I take it back, sorry, I was confused. I just looked this up in the MIM's, that's what I have there, because I'm not very familiar with Pregnyl itself, I don't dispense it very often or really ever. Sorry, it's for delayed puberty or reduced hormone, it could be used in males for that reason. It's also used for fertility for women to increase ovulation, that was what I was thinking, but yes, for males it could be used for, yeah, specific cases of reduced hormone levels.
Q. What about in this, for patient Z, looking at his patient history, what do you make of the dispensing of Pregnyl to him?
A. I would expect that it was being used as an anabolic steroid, or as a steroid possibly for body-building. Men who wish to increase muscle mass do or can use medications like Pregnyl and some of the other medications which are listed there, like Primoteston and the Genotropin, which is a growth hormone, they have been known to be used by body-builders increasing muscle mass.
Q. Assuming patient Z was using it for those purposes was it appropriate for a pharmacist to dispense it to him?
A. No.
Q. In what circumstances would you expect to see Genotropin prescribed?
A. Again, it's a human growth hormone medication and so it can be used in, again, quite specific situations, often in children who have growth disorders or who have chronic renal problems which has led to hormone reduction and reduced growth hormone for them or specific disorders of the pituitary and so on. The indications are around short stature and certain syndromes, so for a male adult it would probably be unlikely but it could be possible to be treated for hormonal disorders. [24]
…
Q. What about Reandron, when would a pharmacist normally dispense a prescription for that?
A. So Reandron is a type of testosterone and again similarly to what I've also mentioned earlier, if it was for a therapeutic use it would need to be for specific cases of reduced hormone levels for a male. But again if it was therapeutic I would expect it to be managed by a specialist in that area. [25]
…
Q. What about Arimidex?
A. Similar to Nolvadex, Arimidex is a medication which is generally used for women, it's a hormone blocker, an oestrogen blocker, and it's generally prescribed for women who are either, often it's for women who have had breast cancer and it's a maintenance therapy.
Q. When would a pharmacist dispense Arimidex and Nolvadex to a male patient?
A. It possibly could be used if a male - for a therapeutic use the only reason I can think of is if a male person had breast cancer, which could happen, but it is also known to be used by body-builders to manage side effects from the steroid medication. So the steroid medications and the testosterone type medications they will lead to an increased amount of oestrogen and sometimes they can grow breasts, for example. So these medications which block oestrogens are to manage side effects that you might get from using the testosterone and steroids for body-building.
Q. What is the usual dose for Arimidex, 1 milligram?
A. One milligram per day, yes.
Q. What about the fact on 6 October 2016, 300 tablets were dispensed in one day?
A. Again, I mean if it was being used for a therapeutic purpose, which does not appear likely particularly given the other history involved there, that would be nearly a year's supply at one time, which is not, there's no clear reason why you would need such a large supply. [26]
…
Q. What is the usual dose for Arimidex, 1 milligram?
A. One milligram per day, yes.
Q. What about the fact on 6 October 2016, 300 tablets were dispensed in one day?
A. Again, I mean if it was being used for a therapeutic purpose, which does not appear likely particularly given the other history involved there, that would be nearly a year's supply at one time, which is not, there's no clear reason why you would need such a large supply.
Q. If you look at valium on 6 October 2016, there were 1000 tablets of valium dispensed?
A. Again, valium is Diazepam which is a type of benzodiazepines. Therapeutically it may be used for anxiety, insomnia. It has a potential to misused and abused. It also has a potential if you take a large dose of valium could can lead to respiratory suppression, you could pass away. It's quite potentially a dangerous issue to have that many tablets out. One pack of those is usually 50 tablets I believe but, yeah, to have 1000 valium tablets dispensed to one person on one day is - I cannot think of a single reason that someone would need that many tablets.
Q. Let's take-have a look at 6 October 2016 for patient Z. He has been dispensed at the pharmacy 500 tablets of Tertroxin, 300 tablets of Arimidex, 1000 tablets of valium, 600 tablets of Nolvadex-D and 60 Pregnyl injections, plus also Primoteston, 60 injections. Firstly, can you comment in relation to the combination of those drugs being dispensed for a patient on the same day?
A. So that - purely on the type, talking about the types of medication, even giving someone Arimidex and Nolvadex, if you believed it was for a therapeutic use they would not be taking both. They both do very similar things. If someone had breast cancer they usually would take one or the other, not both of those medications. Then to add on top of that two different types of hormonal agents, it seems unusual if it was, again if you were considering it to be a therapeutic use, if somebody had breast cancer there is no real reason they would need to have those other hormonal injection medications, and then adding on top just the quantities we're talking about there, there's no -I don't believe there's any therapeutic, you cannot say that there would be any therapeutic reason that people would need that quantity of any of those medications. The Nolvadex, yeah, that would be approximately almost a year's worth of supply if it was to be used therapeutically, which is usually one tablet twice a day. The injections, again, the quantities given would be far greater than what you would expect to see as therapeutic. The Tertroxin is a thyroid medication which is not all that commonly used. And the other question I suppose is just those quantities of medications would have had to be available, like someone would have had to order them in previously. There's no pharmacy that I'm aware of would keep that kind of quantity, particularly of the Pregnyl and Primoteston, which are not commonly prescribed medications. So yeah, the quantities and the types of medications there are very concerning. [27]
…
Particular 117 relates to the dispensing of Clomid which is a trade name for Clomiphene. Clomiphene is a fertility drug. It is a restricted substance. Clause 52 of the PTGR is to the effect that a pharmacist must not supply Clomiphene unless the medical practitioner who prescribes it holds an authority to prescribe it.
On 7 March 2017, and under prescriptions from a Dr W Ng, Clomid 50mg 30 tablets was dispensed to Patient Z, together with the following:
1. Andriol Testocaps capsules 40mg 120;
2. Proviron tablets 25mg 250;
3. Primoteston Depot syringe 250mg/1ml 15; and
4. Nolvadex-D tablets 20mg 300;
Mr Saab conceded in cross examination that he did not think that Dr Ng had authority to prescribe clomiphene.
Mr Croker's evidence in relation to Clomid was as follows:
Q. On 7 March 2017, Clomid 50 milligrams was dispensed. Who can prescribe Clomid?
A. The only people who can prescribe Clomid is a (not transcribable).. specialist or a specially registered gynaecologist specialists. [28]
…
Q: Can a general practitioner like Dr Ng prescribe Clomid?
A. No.
Q. Under what therapeutic purposes would it be appropriate for a male patient to receive Clomid?
A. Again, I'm not familiar with the therapeutic purpose for a male. It is the only reason I have ever known it to be prescribed is to, the support or produce ovulation in a female being treated for fertility issues.
Q. Can it be abused by patients?
A. Because of its effect on hormone levels and the kind of feedback mechanisms, from what I understand it can be used by body-builders as well to manage some of the side effects that they have from the use of testosterone or other steroids. [29]
…
Mr Croker gave evidence about the therapeutic outcome if Patient Z used all of the medications that were dispensed to him for his own personal use as follows:
Q. Taking a step back and looking at patient Z's patient history as a whole at the pharmacy between August 2015 and 7 March 2017, let's assume that patient Z used all of the medications that were dispensed to him for his own personal use, what would you expect to be the therapeutic outcome had he done so?
A. I don't think I could say. I can't imagine that someone could use all of those for themselves, not in the quantities - when we're talking about the hormonal agents and the steroids, there's multiple different types of hormone, like testosterone type or androgen type medications, there's multiple different times of oestrogen blockers to try and manage side effects, and the quantities involved in most of them are quite large. I don't, I honestly don't believe some one single person could take all of those and I don't know, I couldn't say what the result would be, I don't think he would be well if he did take them all, he would have serious hormonal issues. And even talking about the things like the multiple dispensing of Diazepam of 1000 tablets at a time, because there's more than one of those, and in I think, I'm just looking at it now, within two days in January 2017 he was given 1000 tablets each time, so 2000 Diazepam. If one person took that quantity of tablets, again I believe they would die if they took all of that medication. It would be too much of a risk of, like I said before, respiratory suppression, yeah, drowsiness. The quantities involved are just too great [30] .
Q. What, if anything, do you say about the prices that were charged by the pharmacy for these medications for non-PBS?
A. In terms of some of the medications like Primoteston and even Arimidex, they are quite expensive wholesale medications, so the price reflects that. However, again the quantities we're talking about, the prices that were paid, it was into the thousands of dollars each time, and similarly with the Diazepam with the Antronex and the valium tablets, I think there was $300 or $400 each time, which is a very expensive way to buy medications. If there was a therapeutic use, if he needed Diazepam on a prescription, if you have a pension you can get it for $6 for around 50 tablets. Or if you don't, you probably would only pay about $20 for that prescription. So to get those kind of quantities at that price again would flag there's something, some issue going on. And like I said, the quantities we're talking about and that date that you mentioned, the October date we went through just before, all of those different medications, the money spent on that single day must have been well into the thousands of dollars, and it is a red flag if a patient comes into a pharmacy and wants to buy any medications but, you know, can spend that kind of money on medications, I think there are serious concerns [31] .
Q. Are the medications that were dispensed to patient Z at the pharmacy liable to abuse?
A. Yes….
…given the quantities and the combinations, but I think you would have to expect they're being used for body-building, that they're not being used for a therapeutic use. Diazepam definitely is also liable to misuse or abuse, aside from body-building, anybody may misuse that. And there's, it's concerning definitely that those kinds of quantities of medications, which are more than likely being used in an inappropriate manner, were being given out [32] .
In relation to questions about the amount of money spent by Patient Z overall and for individual items at the Pharmacy, Mr Saab responded that the Pharmacy had patients that spent more.
Mr Morris gave evidence that he did not recall ever meeting Patient Z.
[46]
Complaint 3: Patients A1 - L1
The stated background to this complaint is that Mr Saab inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed prescriptions for Patients A1 to L1 from Dr Kanthan for prescribed restricted substances at the Pharmacy.
[47]
Particulars 1 - 12: Overview
Complaint 3 relates to the dispensing of anabolic androgenic steroids and peptides to 12 patients under prescriptions issued by Dr Kanthan. Each patient is the subject of a particular with various sub-particulars.
The prescriptions which are the subject of Complaint 3 bore the name "Regenacell". Dr Kanthan worked for the Regenacell Clinic around late November and early December 2016 and the prescriptions were issued during this time.
The 12 particulars assert that on specified dates, Mr Saab inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed prescriptions for Patient A1 through to L1 from Dr Kanthan for prescribed restricted substances.
The individual medications or combination of medications detailed in the particulars are not exactly the same for every patient.
However, most patients were dispensed Primoteston 250mg/ml and Proviron 25mg (200 tablets). With the exception of Patients E 1, F1, G1, I1 medications who were also dispensed Human Growth Hormone 12mg/ml (12ml), and Patient H1 who was dispensed Primobolan 100mg/ml (10ml).
The sub-particulars are not exactly the same for every patient but in broad terms the inappropriate dispensing was said to be because:
1. adequate directions for use were not specified contrary to Clause 35 of the PTGR;
2. the prescriptions did not possess a unique prescription number on each form as required for all computer-generated prescriptions; (although this did not apply to Patient I1 and K1) and
3. the prescriptions appeared to be forged or fraudulently obtained contrary to Clause 40 of the PTGR.
In addition there was a further sub-particular alleged for Patient D1 as the prescription was unsigned contrary to Clause 35 of the PTGR.
Kim Dolan, Principal Pharmaceutical Officer, PRU, spoke to Dr Kanthan on 12 December 2016. Dr Kanthan explained he worked for Regenacell for 6 days. He had resigned several days before the phone conversation with Ms Dolan. In a record of conversation made by Ms Dolan on 12 December 2016 the following matters were recorded:
1. Dr Kanthan had been working for a locum agency which had been asked to provide a medical practitioner to Regenacell.
2. He was told that the company was new and had protocols written by a sports medicine biochemist.
3. When he finally met the biochemist he became uncomfortable about what he was being asked to prescribe.
4. He said the "penny dropped" and realised that the biochemist was Stephen Dank.
5. He worked a total of 6 days. He gave his notice last week.
6. In total he saw and prescribed for 23 patients. He refused to prescribe for 2 patients.
The Regenacell Clinic was operated by Stephen Dank, a Biochemist, who has been the subject of extensive media coverage in the sporting industry, including the AFL and NRL, with him receiving a lifetime ban imposed by the Australian Sports Anti-Doping Authority. We note that shown on a prescription for Patient F1 under the "Patient Details" section is the email address "Stevedank…@…".
Clause 5(1) Schedule 5D of the National Law provides that subject to relevance, the Tribunal may receive and admit on production evidence of other proceedings including a judgment, findings, verdict, certificate, decision, or determination. Under Clause 5(1)(d) specifies a finding, decision or determination of a Professional Standards Committee.
A Professional Standards Committee decision was made in relation to Dr Kanthan on 29 April 2020. This decision was in evidence before us.
In this decision, Dr Kanthan described how the patient arrived for the consultation after already being assessed by Mr Dank. The patient presented a prescription form with the drugs and dosages already listed. Dr Kanthan saw his role as little more than checking that the dosage was "safe." By safe Dr Kanthan meant that the "bloods" that he was provided with did not show any contraindications and that he dosages were within the ranges specified on product information sheets (if available) or from MIMMS. Dr Kanthan had not ordered the blood tests, nor had he specified what tests might be needed. He was presented with no more than the information that came from Mr Dank and the patient.
Dr Kanthan knew that he was prescribing "off label" and not for the purposes for which the drugs were ordinarily to be used. He assumed that the range of dosages specified for the usual purpose would also be a safe dose for the off label purpose. He made no other inquiry and checked no other source. He did not consider whether the dose was safe or appropriate for the particular patient.
The Professional Standards Committee found relevantly as follows:
It is our view that in prescribing as he did Dr Kanthan engaged in unsatisfactory professional conduct in that his conduct demonstrated that he did not have the knowledge or judgement, and exercised poor care in issuing his prescriptions, such that his conduct was significantly below the standard reasonably expected of a practitioner of his level of training or experience. We have also come to the conclusion that in working as he did at RegenaCell and under the effective direction of Mr Dank, Dr Kanthan's conduct was unethical: he allowed his naïve enthusiasm for some of Mr Dank's ideas to displace his professional obligation to provide good patient care.
The second component of the Complaint is that Dr Kanthan issued the prescriptions without sufficient clinical indication or consideration of the therapeutic purpose. This led him to prescribe excessive dosages and quantities and on occasion to inappropriately prescribe medications in combination. Given that most of the drugs were Schedule 4D drugs, Dr Kanthan should have been especially careful. He should have made, or at least considered making appropriate specialist referrals, such as to an endocrinologist. He should not have prescribed in the absence of correspondence with the patient's existing treating general practitioners. We conclude that Dr Kanthan's conduct was significantly below the standard reasonably expected of him. [33]
This decision and the extract set out above illustrates the importance of a pharmacist not merely relying on a Doctor's prescription and the necessity for them to bring their own independent and evaluative judgement to bear before dispensing a prescription for a restricted substance.
Indeed the decision reveals that it was a pharmacist who was called upon to fill a prescription issued by Dr Kanthan who made a report to the PRU which then undertook an investigation. This is the context for Ms Dolan's contact with Dr Kanthan on 12 December 2016.
[48]
Patients A1 to L1: The medications and prescriptions
All of the prescriptions were printed on printer generated A4 pieces of paper and not on prescription pads or computer generated prescriptions.
The prescriptions for Patients A1, B1, C1, D1, E1, F1, G1, H1, J1 and L1 do not contain prescription numbers.
The medications dispensed to Patients A1 to L1 were as follows:
[49]
Patient A1 [34] :
1. Primoteston 250mg per milligram was prescribed for 3 months, being 1ml weekly, Proviron 25mg was prescribed two tablets daily Monday to Friday 30 minutes after waking and Primobolan 100mg/ml was prescribed 1ml weekly.
2. Primoteston and Proviron were dispensed by the Pharmacy under the initials "TS" and 3 repeats for each were provided, notwithstanding that the prescriptions did not expressly state any repeats. They were also dispensed as non-PBS.
3. Primoteston was dispensed on 2 further occasions.
[50]
Patient B1 [35] :
1. was prescribed Primoteston 250 per ml being 1ml per week, and Saxenda, a weight loss drug, to be administered daily and the dose to be increased by 0.6mg per week;
2. 3 repeats were issued for Primoteston notwithstanding the prescription not expressly stating repeats;
3. the prescriptions were dispensed as non-PBS despite not stating non-PBS;
4. the prescription was dispensed under the initials "TS".
[51]
Patient C1 [36] :
1. Primoteston 250mg/ml 1ml weekly and Proviron 25mg 2 tablets daily Monday to Friday 30 minutes after waking were prescribed;
2. the prescription was dispensed under the initials "TS";
3. 3 repeats were issued notwithstanding the prescription not expressly stating repeats;
4. the prescriptions were dispensed as non-PBS despite not stating non-PBS.
[52]
Patient D1 [37] :
1. Primoteston 250mg/ml 2ml weekly and Proviron 25mg 2 tablets daily Monday to Friday 30 minutes after waking was prescribed;
2. the prescriptions were dispensed under the initials "TS";
3. 3 repeats were issued notwithstanding the prescription not expressly stating repeats;
4. there was no doctor's signature on the prescription (Complaint 3, particular 4(c));
5. the prescriptions were dispensed as non-PBS despite not stating non-PBS.
[53]
Patient E1 [38] :
1. human growth hormone 12mg/ml 0.2mls Monday to Friday 30 minutes after waking, Primoteston 250mg/ml 2mls weekly and Proviron 25mg 2 daily Monday to Friday 30 minutes after waking was prescribed;
2. the prescriptions were dispensed under the initials "TS";
3. 3 repeats were issued for each item notwithstanding no repeats being expressly stated;
4. the prescriptions were dispensed as non-PBS despite not stating non-PBS.
[54]
Patient F1 [39] :
1. Primoteston 250mg/ml 1ml weekly, Proviron 25mg 2 daily Monday to Friday 30 minutes after waking and human growth hormone 0.2 mls Monday to Friday 30 minutes after waking was prescribed;
2. the prescriptions were dispensed under the initials "TS";
3. 3 repeats were issued for each notwithstanding no repeats being expressly stated;
4. the prescriptions were dispensed as non-PBS despite not stating non-PBS;
5. an email address for Stephen Dank was also on the prescription;
6. a copy of Patient F1's Australian Passport was obtained by the PRU during one of the Pharmacy's inspections.
[55]
Patient G1 [40] :
1. human growth hormone 12mg/ml 0.2ml Monday to Friday 30 minutes after waking, Primoteston 250mg/ml 1ml weekly and Proviron 25mg 2 per day Monday to Friday 30 minutes after waking was prescribed;
2. the prescriptions were dispensed under the initials "TS";
3. 3 repeats were issued notwithstanding no repeats being expressly stated on the prescriptions;
4. the prescriptions were dispensed as non-PBS despite not stating non-PBS;
5. a copy of Patient G1's Queensland Driver's Licence and Medicare Card was obtained by the PRU during one of its inspections at the Pharmacy.
[56]
Patient H1 [41] :
1. Primoteston 250mg/ml 1ml weekly, Proviron 25mg 2 daily Monday to Friday 30 minutes after waking and Primobolan 100mg/ml 1ml weekly were prescribed;
2. the prescriptions were dispensed under the initials "TS";
3. the prescriptions were dispensed as non-PBS despite not stating non-PBS.
[57]
Patient I1 [42] :
1. Primoteston 250mg/ml 1ml weekly and human growth hormone 12mg/ml 0.3ml Monday to Friday 30 minutes after waking was prescribed;
2. the prescriptions were dispensed under the initials "TS";
3. for Primoteston 3 repeats were provided and for Genotropin (human growth hormone) 17 repeats were provided notwithstanding that no repeats were provided for on the prescription;
4. the prescriptions were dispensed as non-PBS despite not stating non-PBS;
5. the prescription had a prescription identification number unlike many of the other prescriptions.
[58]
Patient J1 [43] :
1. Primoteston 250mg/ml 1ml weekly was prescribed;
2. the prescription was dispensed under initials "RM" used by Mr Morris;
3. 3 repeats were provided notwithstanding the prescription not expressly stating repeats;
4. the prescription was dispensed as non-PBS despite not stating non-PBS.
[59]
Patient K1 [44] :
1. Primoteston 250mg/ml 1ml weekly and Proviron 25mg 2 daily Monday to Friday 30 minutes after waking was prescribed;
2. the prescriptions were dispensed using the Respondent's initials "TS";
3. 3 repeats were provided on both prescriptions notwithstanding the prescriptions not expressly stating repeats;
4. the prescription had a prescription identification number unlike many of the other prescriptions;
5. the prescription was dispensed as non-PBS despite not stating non-PBS.
[60]
Patient L1 [45] :
1. Primoteston 250mg/ml 1ml weekly was prescribed;
2. the prescription was dispensed under the initials "TS";
3. 3 repeats were provided notwithstanding the prescription not expressly stating the number of repeats; and
4. the prescription was dispensed as non-PBS despite not stating non-PBS.
None of the prescriptions the subject of Complaint 3 expressly state repeats on them. Notwithstanding this, the Pharmacy dispensed the medication again relying on the intervals written on the prescriptions.
Mr Saab gave evidence that it is appropriate for pharmacists to determine the number of repeats based on the intervals, absence any express number of repeats being written by the prescriber for Schedule 4B medications. [46]
In response to a question from the Tribunal, Ms Croker gave evidence in relation to this issue as follows:
Q: Is there any problem with that?
A. Well, yes, as I said, you know, if you're going to pretty much change quantities, I suppose, you can't, you can't change quantities and add repeats in this situation where it is like a legislative requirement if there were to be repeats that the prescriber puts them and puts in intervals. It is a problem, you need to dispense the quantity that is prescribed. That's assuming -1 guess the other issue is, of course, talking about clause 109, which is, is this for therapeutic use, is this a therapeutic quantity, all of those issues, but purely on the repeats, if there were to be repeats they need to be written by the prescriber with an interval specified. [47]
…
Q. If there's to be repeats for a prescription, I think you mentioned the legislation requires that that actually be written by the prescriber. I've understood that correctly?
A. That's right. I'm speaking particularly for S4B, or what is known as an S4B medication, I think it's a special or restricted prescription and the annex is B in the legislation, so that's why it's S4B. And Primateston falls into that category, so these specific medications have that requirement for their repeats and the intervals.
Q. I guess what's a little confusing about this particular prescription is that it suggests the repeats are being given but the script itself has not been marked with repeats, but as you pointed out when you look at the total amount, it's still the same amount?
A. Yes.
Q. It looks odd to me. Is that a fair summary?
A. Yes. I think it is a fair summary. Ultimately I suppose you could say that the quantity which was prescribed is what is given, however, it's not the pharmacist's - the pharmacist does not have that discretion, for these medications we don't have any discretion to change what the prescriber has written. If in the unlikely event that you did, you would have to have contacted the prescriber and made certain notes, but I don't believe that is allowed for in legislation anyway. [48]
Mr Saab's evidence was to the effect that the patients who presented with Regenacell prescriptions were taking the medication for sports injuries. He was steadfast in his evidence that taking human growth hormones for sports injuries was an appropriate and recognised therapeutic purpose.
Of the Regenacell prescriptions, Mr Saab stated in his oral evidence as follows:
…The patient would have presented with the prescription for a specific injury and the medicine was to be used for that. The thing with these Regenacell prescriptions is we were in contact with the office when we immediately first got their prescriptions, to inquire as to the use of them, as well as to make inquiries with the patient and to make sure they were being used for the correct reasons and most of these prescriptions, if not all the prescriptions from Regenacell, were presented by patients that were using it for some sort of injury or another (Transcript 7 August 2020 pp 347-348).
In continued cross examination of Mr Saab on 20 August 2020, he was asked about the specific prescriptions dispensed to Patient A1 (Primoteston, Proviron and Primobolan):
Q. In relation to those prescriptions, it is not usual, is it, for a pharmacy to receive prescriptions on printed pieces of paper, is it?
A. It is not unusual - it's not usual. I'd say it's not usual, no.
Q. And that in and of itself should raise alarm bells for you as a pharmacist that the prescriptions are potentially forged or fraudulently obtained?
A. They were confirmed with the doctor that prescribed them. (Transcript 20 August 2020 at p.372)
Mr Saab's oral evidence was also to the effect that he had no objective evidence to support his contention that he contacted Dr Kanthan to verify the prescriptions. For example, he had no file notes or other records.
In continued cross examination of Mr Saab on 20 August 2020 the following proposition was put to him:
Mr Saab, a thing that I'm going to say to this Tribunal in closing submissions is that these prescriptions for patient A1 appear to be fraudulent or forged on the basis that they do not appear on proper prescription forms, they do not have prescription numbers, they do not specify repeats, their directions for use are unclear and the combination of drugs in and of itself should raise alarm bells for a pharmacist that they are being abused and not being used for an appropriate therapeutic purpose. What do you say about that?
A. I say all the information was confirmed with the doctor.
Q. Mr Saab, you cannot say that to this Tribunal on the evidence before it confidently, can you?
A. Yes, I do say it confidently.
Q. Mr Saab, you cannot recall a specific conversation with Dr Kanthan about patient A1?
A. I know we definitely had a couple of conversations with the prescriber and these prescriptions.
Q. Not for this specific patient though, Mr Saab?
A. I can't recall if it was for this specific patient or another patient [49] .
We note that in Mr Saab's affidavit in support of his reply to the Complaint, he stated that in or around December 2016 he telephoned Dr Kanthan to confirm a prescription he had received. He could not recall the details of the prescription but believed looking at the prescriptions which were in produced by the Commission it may have been either Primoteston and/or human growth hormone. He explained that he called Dr Kanthan because it was unusual to get prescriptions for these types of drugs. He stated that Dr Kanthan confirmed the prescription and the directions. Dr Kanthan asked whether the Pharmacy had the quantities of the medicine in stock and, if so, he would send further patients to the Pharmacy. Mr Saab recalled having a second call with Dr Kanthan at the time of dispensing a further prescription. Again he could not recall the details of the prescription but believed looking at the prescriptions which were in produced by the Commission he believed it may have been either Primoteston and/or human growth hormone.
Later in cross examination on 20 August 2020, Mr Saab gave evidence that he spoke to Dr Kanthan on at least two occasions [50] .
In response to this evidence Mr Saab was taken his statement dated 15 March 2018 which was provided to the Commission on his behalf by Sparke Helmore Lawyers. The relevant part of the statement is as follows:
I believe I spoke to Dr Kanthan in November or December 2016. I cannot recall the precise terms of any conversation I had with Dr Kanthan and cannot say whether or not the conversations related specifically to the patients referred to in the Notice. I believe that the conversations related to confirmation of patients details, the medications to be dispensed and the strength of doses to be dispensed.
It was put to Mr Saab that there was no reference to two conversations with Dr Kanthan, as opposed to referring to conversations in general. The following exchange took place:
Q. Mr Saab, if you had a clear recollection at the time that this response was prepared by you on 15 March 2018, you would have said that there were two conversations with Dr Kanthan, as opposed to referring to conversations in general?
A. I know there was multiple conversations but that's all I can recall.
Q. Multiple or two, Mr Saab, there is a big difference?
A. Two is a multiple of one, so more than one conversation.
Q. Mr Saab, is your evidence that there were two conversations or more than two conversations?
A. Two or more conversations.
Q. But you can't remember, can you, Mr Saab?
A. I can't remember the exact amount, no.
Q. And you can't remember which patients you spoke to Dr Kanthan about?
A. No. [51]
Ms Croker gave evidence about the medications the subject of this complaint as follows:
…The other medications again, particularly the steroid medications, the Primoteston, which is testosterone, the growth hormones, as far as I understand it they are only available on an authority prescription for very specific reasons, which is the therapeutic indication for things like androgen deficiency or human growth hormone deficiency and they would more than likely be under the care of a specialist. So again, the fact that they were not prescribed as authorities potentially points to the fact that they may not be being used for that therapeutic indication and that it might be being used for some other reason, it doesn't give an indication for an authority, and again would be likely to be of concern.
During the hearing the Commission tendered the Guidelines for Non-handwritten Computer Generated Prescriptions produced by the NSW Department of Health which sets out the requirements for prescription numbers at page 2, paragraph 2(e) as follows:
A number which uniquely identifies the prescription OR which uniquely identifies each prescribed medication's details (the name, strength, route for administration, if not apparent, and quantity of the medication) to be printed on the prescription and which can be related to the clinical or prescription record on the patient or animal.
Ms Croker examined the prescriptions for Patients A1 to L1 in particulars 1-12 for the purposes of her written report. She stated that the standard to be expected of a practitioner of an equivalent level of training and experience would be to ensure that all legislative requirements for prescriptions were followed. In the case of prescription generated prescriptions, this included that they are printed with a unique prescription number. In Ms Croker's view, dispensing a prescription from Regenacell which did not have a unique prescription number fell significantly below the standard expected.
Further the fact that the medications dispensed were steroids, which may be open to abuse and misuse, led her to say that she was strongly critical of this conduct.
In other respects, Ms Croker considered that the prescriptions from Regenacell contained adequate directions.
[61]
The Pharmacy Board of Australia Guidelines for Proprietor Pharmacists
At the time that the conduct arose in relation to this matter, the Pharmacy Board of Australia had Guidelines in place as follows:
from 8 December 2010 to 6 December 2015 in relation to the responsibilities of proprietors of pharmacies, namely, "Guidelines on Responsibilities of Pharmacists when Practicing as Proprietors" ("the 2015 Guidelines"); and
from 7 December 2015 onwards, namely "Guidelines for Proprietor Pharmacists" ("the current Guidelines").
Of relevance in the 2015 Guidelines is the following:
If the proprietor/owner of a partner-in-ownership pharmacist is not the pharmacist usually in charge of that pharmacy, he or she must determine regularly how the practice of pharmacy is being conducted to be satisfied it is in accordance with any applicable State, Territory or Commonwealth law applicable to the practice of pharmacy, with any relevant Pharmacy Board of Australia policies, codes, guidelines, and with good pharmacy practice. If the proprietor finds otherwise, he or she must intervene to ensure that the pharmacy business is conducted properly.
For the purpose of this guideline, determining how the pharmacy business is conducted includes:
Ensuring appropriate risk management procedures are in place …
Understanding the liability associated with the sale of goods and the provision of services …
Ensuring business procedures and policies established by the proprietor/s are being followed.
The current Guidelines relevantly provide as follows:
1. Proprietors to maintain an active interest in how the pharmacy business is conducted
If the proprietor/owner or partner-in-ownership pharmacist is not the pharmacist usually in charge of that pharmacy, he or she must vigilantly maintain an active interest in how the practice of pharmacy is being conducted. This is to ensure that the pharmacy operation is in accordance with:
any applicable state, territory or Commonwealth law
relevant Pharmacy Board of Australia policies, codes and guidelines
applicable professional practice and quality-assurance standards and guidelines, and
good pharmacy practice.
If the proprietor finds that the practice of pharmacy does not operate in accordance with these, he or she must intervene to ensure that the pharmacy business is conducted properly.
2. Proprietor pharmacists cannot delegate their professional obligations
A proprietor/owner or partner-in-ownership of a pharmacy cannot delegate his or her professional obligations, even if that partner is not regularly present at the pharmacy. This applies to pharmacists who own a pharmacy, or pharmacies, in all forms of business structures.
3. Responsibilities of proprietor pharmacists
For the purposes of these guidelines, ensuring the pharmacy business is conducted properly includes:
assuring themselves that the pharmacists they employ are complying with and adhering to the Board's registration standards and guidelines, and where applicable, make any necessary arrangements that facilitate the pharmacists meeting these requirements, for example:
proprietors who arrange professional indemnity insurance (PII) cover for an employed pharmacist should ensure that sufficient evidence of currency of PII cover is available to the employed pharmacist
ensuring that their employed pharmacists have ready access to the list of essential references specified by the Board in Guideline 1 of its Guidelines on practice-specific issues
ensuring compliance with any state or territory legislation regarding facilities and equipment required for the types of services delivered at the pharmacy
ensuring that confidential patient information is appropriately stored and accessed
ensuring that the pharmacy is suitably resourced, and that staff members are suitably trained and appropriately supervised to provide services in accordance with their position descriptions
maintaining an awareness of and responsibility for the services being provided including unregulated services, and goods being sold, particularly those known to be subject to abuse or misuse and those not regulated through the Therapeutic Goods Administration (TGA) or the pharmacy premises registering authorities
The vigilance of the practice described in these guidelines includes on-site visits and attendance at staff meetings at a frequency that ensures that the proprietor is able to fulfill the above responsibilities at all times.
[62]
The Pharmaceutical Society of Australia Code of Ethics for Pharmacists
The Pharmaceutical Society of Australia Code of Ethics for Pharmacists (2011) was in force at the time of the conduct identified in the Complaint. It provides as follows:
Professional judgement must be exercised to prevent the supply of products likely to constitute an unacceptable hazard to health or the supply of unnecessary and/or excessive quantities of medicines or products, particularly those which had a potential for abuse or dependency.
[63]
Ms Croker
Ms Croker prepared an Expert Report which examined Mr Saab's conduct. The report is dated 5 August 2018. Ms Croker has been a registered pharmacist for some 20 years. Her professional experience includes over 15 years in community pharmacy, including managing and acting as a locum pharmacist in charge at various suburban and city pharmacies. Currently she holds a range of positions. These include roles as a clinical consultant pharmacist in the Aged Care Sector providing medication reviews and medication management services to around 400 aged care homes and a quality improvement officer in digital health. Since early 2016 she has been a casual University academic teaching pharmacy post graduate students in professional services subjects including legislative and ethical requirements for pharmacists.
Ms Croker's report referred to various Guidelines including those issued by the Pharmacy Board of Australia such as Guidelines for Dispensing of Medicines and Proprietor Pharmacists. Ms Croker's report also referred extensively to specific provisions of the PTGR.
In broad terms Ms Croker's evidence was to the effect that the standard expected for a practitioner of equivalent training and experience would be to ensure that all legislative requirements for prescriptions were followed. For Schedule 8 medications it would be expected that extra care and scrutiny be given to a prescription as the medications may be open to abuse and misuse.
Ms Croker examined all of the prescriptions the subject of Complaint 2. Her report sets out her reasoning as to why the dispensing of all these prescriptions fell significantly below the standard expected.
Ms Croker also examined the Regenacell prescriptions the subject of Complaint 3. She identified that the standard expected for a practitioner of equivalent training and experience would be to ensure that a computer generated prescription contained a unique prescription number as well as adequate directions for use. In her view dispensing a prescription which did not contain a unique prescription number fell significantly below the standard expected. However, she did consider that all the prescriptions which she examined contained adequate directions for use.
Some additional matters addressed in Ms Croker's report but not detailed elsewhere in this decision include her view that there was clear pattern of patients presenting at the Pharmacy with prescriptions from a certain provider for a period and then the provider would change. The quantities of high dose Schedule 8 medications, they were nearly always for Oxycontin 80 mg and Durogesic 100mcg patches rather than other strengths, and the ability for the patients to pay private prescriptions should have all raised red flags with Mr Saab regarding the use of the medications being dispensed.
Ms Croker was strongly critical of Mr Saab's conduct in providing large quantities of medications which included steroid drugs, hormonal agents benzodiazepines and pain killers such that it would be unlikely to believe that they were for a therapeutic or personal use purpose. She added that, as a proprietor, Mr Saab should have followed the guidelines for proprietor pharmacists and vigilantly maintained an active interest in how the practice of pharmacy was being conducted and intervened to ensure that the pharmacy business was conducted properly.
Other areas in which Ms Croker examined standards in her report included following all legislation regarding the periodical inventory of stock of drugs of addiction, the management of drugs of addiction and to maintain accurate and correct records at all times. She identified that a failure to comply with legislation to keep Schedule 4B prescriptions separate and a failure to report the loss in Methadone fell significantly below the standard.
[64]
Mr Mahony
Attached to Mr Saab's reply was an Expert Report prepared by Patrick Mahony, pharmacist, dated 28 February 2020.
Mr Mahony has been a pharmacist for some 50 years. He has extensive experience in community pharmacy and in partnership currently owns two pharmacies in Tamworth and Moree.
Amongst other matters, Mr Mahony expressed the view in his written report that Mr Saab had been "sucked in" to dispense the prescriptions the subject of Complaints 2 and 3. He also made somewhat qualified observations around the prescriptions not necessarily being deemed as being fraudulent on their appearance and referred to Mr Saab knowing the patients.
Mr Mahoney's written report made no reference to specific provisions in the PTGR and made little reference to standards or guidelines issued by the Pharmacy Board of Australia.
On day nine of the hearing (28 August 2020) and arising from the direct and targeted questioning by Counsel for the Commission, it became apparent that Mr Mahony had not been properly briefed with all of the Complaint.
Mr Mahony was not provided with Complaint 4 alleging professional misconduct. However and more significantly, Mr Mahony did not have the Patient Schedules containing the patient histories and medications that had been attached to and formed part of the Complaint.
There was also other evidence relied upon by the Commission that Mr Mahony did not have. This consisted of the statements from Dr Ng, Dr Selim and Dr Sadhu indicating that the prescriptions the subject of Complaint 2 were forged, and the Regenacell prescriptions which underpinned Complaint 3.
The Commission called for the briefing material that had been provided to Mr Mahony. This document was made available, was tendered by the Commission, and it became an exhibit in the proceedings.
We interpolate here to note it were not for the diligence of Counsel for the Commission the Tribunal would have been under the erroneous belief that when Mr Saab's expert, Mr Mahony, completed his report, he had the Complaint in its entirety, had considered all the evidence relied upon by the Commission relevant to what he was being asked to give an opinion about, and his report was based on the same source material comprising the prescriptions and patient histories as upon that which Ms Croker had prepared her report.
We also note that prior to the Commission's cross examination of Mr Mahony, Counsel for Mr Saab objected to a course proposed by Counsel for the Commission that Mr Mahony read Ms Croker's report, which comprised some 89 pages, with a view to identifying for the benefit of the Tribunal what in that report he agreed with and what he did not.
Under cross examination by the Commission, Mr Mahony conceded that he had not been asked by Mr Saab to expressly deal with Ms Croker's report and his report had been limited to five specific questions.
Other areas where Mr Mahony had not been properly informed prior to the preparation of his report concerned the period that Mr Saab had been practicing as a pharmacist prior to purchasing the Pharmacy. Mr Mahony was of the understanding that Mr Saab had been practicing since September 2011, when he had in fact been practicing since January 2008. Mr Mahony was also not informed of the fact that the Pharmacy was QCPP accredited and had written procedures in place for the dispensing of prescriptions.
In light of the fact that Mr Mahony was not properly briefed and did not have sufficient time to consider the material provided to him, the Commission submits, and we accept, that where the evidence of Mr Mahony and Ms Croker differs, we prefer the evidence of Ms Croker.
That being said, there were a number of areas in Mr Mahony's oral evidence where his opinions aligned with Ms Croker.
For example, and significantly in our view, when Mr Mahony was given the opportunity to review the patient histories contained in the Schedules for Patients A through to Y he gave the following evidence in cross examination:
Q. You've had a look at all the schedules for patients A through to Y, and those schedules relate to the forged prescriptions from Dr Ng, Dr Selim and Dr Sadhu, and the prescribing of OxyContin 80 milligrams and Fentanyl 100s and Kalma 2 milligrams?
A. Yes.
Q. In relation to all of those patients, their histories are for private prescriptions for those drugs of abuse generally in the majority of cases?
A. Yeah, well for those ones they were and some of them had other medication, like antibiotics at different times that I could see. Particularly patient Z I could see he had other medications early on which the process - but most of them are, as you said, and others, patient U had an antibiotic as well in January 16. But the rest of them were those medications that we discussed, yes.
Q. And all of them were receiving the highest dosage of Durogesic, OxyContin and ..(not transcribable)..?
A. I agree, yes.
Q. And all of them were receiving these medications from multiple prescribers?
A. Again, yes. It's not - indisputable.
Q. It was not appropriate for Mr Saab and his pharmacy to dispense ..(not transcribable).. given the histories and the circumstances of the prescriptions that I've previously taken you to?
A. No, I would accept a small number but as soon as that pattern was addressed in most of those cases they should have stopped.
Q. That pattern of all of those patients should have also raised alarm bells?
A. Yes, once - a single patient doing this sort of thing occasionally, that could have generated a bit of a concern, but once you had multiple patients with the same class of medication, or group of medications, I think the concerns should have increased dramatically.
Mr Mahony also drew our attention to a recent warning issued to pharmacists by the NSW Ministry of Health Pharmaceutical Services in relation to the misuse of Fentanyl patches. This document became Exhibit A 11.
The key messages from this warning are that Fentanyl is a highly potent synthetic opioid which can be extracted from patches and misused. The risk of drug dependence on Fentanyl patches is high. Fentanyl patches have a high illicit value and are subject to trafficking. In Australia the main source of Fentanyl patches used illicitly is from those obtained on prescription. Pharmacists were advised that careful scrutiny of prescriptions for Fentanyl patches was required. Specifically Pharmacists should check the validity of any Fentanyl prescriptions presented for dispensing especially if on private prescriptions or for multiple packs.
It is the experience of the professional members of this panel that the potential for misuse of Fentanyl patches has been an issue well known in the profession for some time.
[65]
The Credit of Mr Saab
We found Mr Saab to be an unreliable witness.
Mr Saab seemed unable or unwilling to face up to the gravamen of the complaint against him. He was equally unable to accept the significance of his conduct both as the pharmacist responsible for dispensing individual prescriptions and as the owner responsible for the operations of the Pharmacy.
We found it difficult to tell what Mr Saab holds to be true. He gave evasive and inconsistent evidence. He was prepared to assert the improbable and to deny the obvious.
There are many examples.
The most obvious was his assertion, made for the first time in cross examination, that officers of the PRU advised him to delete his name and initials from the dispensing system at the Pharmacy.
At times Mr Saab was evasive. An early example occurred on the first day of his cross examination. Mr Saab was taken to the Pharmacy methadone register for 2014/15. He was asked whether where the initials "TS" appeared in the register represented where he had signed off on the register. The following exchange took place:
Q. That is your handwriting?
A. They are my initials.
…
Q. Where the initials TS appear on that page, you have signed off on the methadone register?
A. TS indicates my initials.
Q. Yes, and that is your handwriting, Mr Saab?
A. I would assume so.
Q. You know your own handwriting, don't you?
…
A: What I've written in the book, I don't know, the numbers and the initials TS. I would assume that that would be my handwriting [52] .
An example of Mr Saab's unwillingness or inability to acknowledge the significance of his conduct, both as the pharmacist responsible for dispensing individual prescriptions and as the owner responsible for the operations of the Pharmacy, arose in cross examination when he was questioned about the drug register for Oxycodene 80 mg for the period December 2015/January 2016 as follows:
Q. Mr Saab, I'm talking about your responsibilities as a proprietor and as a pharmacist, I'm not talking about the statutory required six monthly stock checks. I'm talking about an ongoing obligation that you had as proprietor and as pharmacist to review your records for drugs of addiction and ensure that they were being properly dispensed?
A. Where does it say that I need to do that?
Q. In the proprietor guidelines?
A. The guidelines? We are ensuring that we meet all requirements, so we would have been keeping an eye on our stock levels, yes, but as far as ascertaining whether or not prescriptions were being - or fraudulent prescriptions were being dispensed, you can't really tell that from an ordering perspective, no.
Q. Mr Saab, this page in front of you shows significant quantities of Oxycodone 80 milligrams being dispensed from your pharmacy in a short period of seven and a half weeks, doesn't it?
A. And it's all been done correctly.
Q. It has not, has it, Mr Saab?
A. No, it's been done correctly. There is no issue with these prescriptions that were dispensed at that time.
Q. Mr Saab, in relation to this page, did you review it at the time and think to yourself as a proprietor and pharmacist that this was a significant quantity being ordered by your pharmacy?
…
Q. At the time of the entries of 8 December 2015 to 30 January 2016?
A. What could I have possibly been looking for at the time of filling these entries into the register? [53]
We note that the relevant page of the register shows that in this period alone more than 1500 Oxycodone tablets were received into the Pharmacy through ordering and 1540 were dispensed. Most of the dispensing was done by Mr Saab. It beggars belief that Mr Saab could not have been aware of the significant quantities of Oxycodone passing through his pharmacy, or for the potential for abuse or profitable diversion.
An insight into Mr Saab's preparedness to be evasive and embroider his evidence as he went along arose during cross examination about the methadone pump.
In both his s.150 hearing and his affidavit dated 5 March 2020, Mr Saab stated that he was told by an officer of the PRU to continue using the pump.
In in his cross examination Mr Saab again restated the position that he continued to use the methadone pump under instructions from the PRU.
However at varying points in cross examination conducted on 26 June 2020, Mr Saab took this line further to suggest that this was a collaborative exercise with the PRU. He stated that he "worked together with the PRU to come up with a reasonable or acceptable way to deal with the problem" and at the time of the PRU investigation he made sure he "took steps in collaboration with the PRU to ensure that the problem would be solved which included ordering a new pump". At another point he stated of the PRU "we worked together to come up with a solution that wouldn't interfere with providing medicines to our patients" and, "I took steps together with the PRU to ensure that this problem would be solved".
The following exchanges took place with Mr Saab about his continuing to use the same pump about which he had concerns
Q. You see what I'm trying to say to you, Mr Saab, is that at the time of the PRU inspection on 9 March 2017 you had concerns about the accuracy of the methadone pump and yet at the time of the section 150 hearing on 30 March 2017 that pump had not been recalibrated during that period, nor had it been replaced?
A. At the time of the inspection by the PRU on 9 March 2017 the PRU representative raised an issue with the inconsistencies in the methadone register and came to the conclusion that the - that these concerns arose from the accuracy of the methadone pump and together we took steps to address that issue [54] .
…
Q. … you did not take any steps between the PRU inspection on 9 March 2017 and the section 150 hearing on 30 March 2017 to fix or replace - the pump had not been fixed or replaced?
A. Under the instructions of the PRU we took steps to resolve the issue, which included ordering a new pump one week before the section 150 hearing [55] .
It strains credulity to think that an officer of the PRU, charged with regulatory responsibilities, in the course of an investigation into the Pharmacy for the purposes of assessing compliance with the PTGR legislation, would instruct a pharmacist to continue to use an inaccurate pump for a potent drug.
We have set out later in this decision at paragraphs [434] to [437] our assessment of the evidence given by Mr Gavrilovic and Mr Saab about this issue. On Mr Saab's account he continued to use the pump because he was acting on instructions from the PRU. However Mr Gavrilovic was clear in his evidence that equipment such as a methadone pump is not within the remit of the PRU. In our view there would be no rationale for an officer of the PRU to come to a view about the accuracy of a methadone pump or make any suggestion about its replacement.
In cross examination, Mr Saab sought to enhance the significance of his contact with the PRU and portray himself as working with the PRU. In our view, this was done to overcome the difficulty as he perceived it that he had continued to use a methadone pump which on his own account was not accurate.
Other evidence that Mr Saab gave which persuaded us that he was an extremely unreliable witness was the evidence he gave about the medication dispensed to Patient Z and, his preparedness to refute the logical implication that medication was being abused or misappropriated.
In our view, the forensic evidence in relation to inappropriate dispensing to Patient Z was overwhelming. No prescriptions for Patient Z were ever located. The quantities and multiple nature of the hormonal agents and steroids dispensed to Patient Z could not have been used by one person. Yet Mr Saab was steadfast in his evidence under cross examination that the dispensed medication was for an appropriate therapeutic purpose. He was prepared to deny the obvious implication that the medication was being abused or misappropriated. The most he was prepared to concede was that some of the dispensed quantities were excessive.
Similarly Mr Saab was reluctant to concede the obvious in relation to the dispensing of 1000 tablets of Valium to Patient Z on 6 October 2016. In cross examination the following exchange took place:
Q… On 6 October 2016 there's five separate entries for Valium at 200 tablets a go. That's another 1,000 tablets?
A. Yes.
Q. Mr Saab, if this patient was to take that type of quantity that would kill him, wouldn't it?
A. Just because the patient has access to all the medications that were provided to him on prescription, does not necessarily mean that the patient's looking to overdose on the medication.
Q. Yes, the patient could be trying to misappropriate it, couldn't he?
A. They could, yeah. Any patient with any quantity could misappropriate the medication. Even with the quantity of 50 you could argue that any patient has the ability to misappropriate it [56] .
Mr Saab gave oral evidence that he experienced mental health issues following the PRU's investigation. He also gave evidence that these mental health issues dated back with periodic intermissions to 2009. It was submitted on his behalf that to the extent that certain earlier statements are relied upon, many of those statements were either made through lawyers and were made at a time when Mr Saab was experiencing mental health issues that followed the PRU's investigation. Reference was also made in Mr Saab's oral evidence as to the impact of his prior mental health issues on his ability to clearly recollect events that occurred during the period of the Amended Complaint.
We reject these submissions. The issues we have identified with Mr Saab's credit are not confined to lapses in memory or an inability to recall events. This is about the evidence Mr Saab gave explaining his conduct as a pharmacist and proprietor and the judgement he exercised in the handling and supply of Schedule 8 and 4B and D drugs.
No independent evidence was put before us as to whether Mr Saab's mental health issues could affect his understanding or recollection of events. Equally there was no objective evidence as to the extent to which his mental health issues could affect his understanding, perception or recollection or in what specific ways it might do so.
Whatever mental health issues Mr Saab may have experienced we are not satisfied that this impacted on his ability or deprived him of the opportunity to be candid and forthright in his evidence to us.
It was also submitted on behalf of Mr Saab that in the circumstances, and given the importance of these proceedings his career and reputation, it is perhaps unsurprising that Mr Saab occasionally expressed some frustration in the course of giving his evidence. Mr Saab was cross examined over a number of days. Cross-examination was complicated by the complexity of proceedings, the necessary repetition inherent in cross-examination and the technological difficulties involved in a hearing by audio-visual link. Making matters more difficult, it was said the days Mr Saab spent under cross-examination were not sequential, but were interrupted by periods of days and even weeks.
In our view, none of these matters detract from or answer the difficulties we have identified with the substance of Mr Saab's evidence.
Overall we cannot accept Mr Saab as a witness of truth. He exhibited a tendency to eschew responsibility for his own actions and the dispensing practices in his Pharmacy. In our opinion he was prepared to assert, in sworn evidence, whatever he thought was necessary to repel the express or implicit burdens, as he perceived them of questions put to him in cross examination or other difficulties he perceived to be facing him.
[66]
Particulars 1 and 2: Methadone Registers
The difference of 869 millilitres of Methadone on 7 November 2015 was recorded by Mr Morris in the Pharmacy's Controlled Drug Register. The difference of 2,579 millilitres of Methadone on 29 January 2017 was recorded by Mr Saab in the Pharmacy's Controlled Drug Register.
In Mr Saab's amended reply it was admitted that Mr Saab did not notify the Ministry of Health of a "discrepancy" in Methadone in drugs register on 7 November 2015 and 29 January 2017, but otherwise particulars 1 and 2 were denied.
As we understood Mr Saab's evidence and the submissions made on his behalf, Mr Saab was using the methadone pump within its accepted accuracy range and there was no real "loss" of methadone because particular patients were given fractionally greater amounts of methadone than was intended. Therefore the cause of the loss was not theft or something similar but rather a dispensing error the cause of which could be traced back to the calibration issue.
It was also argued, referencing sections of the PTG Act s. 24(2) and the PTGR that, a retail pharmacist is authorised to be in possession of drugs of addiction, and a retail pharmacist means a pharmacist employed in a retail pharmacy: see PTGR Definitions reg 3(1). As Mr Saab was not an employee the obligation arising under clause 124 of the PTGR did not apply to him. It was submitted that the Tribunal was required to construe the pleadings strictly and as the obligation under clause 124 did not apply to Mr Saab the complaint must be dismissed.
The Commission pointed to dictionary definitions of employ for example the Macquarie Dictionary defines employ as to "use the services of (a person), have or keep in one's service"; "to occupy or devote (time, energies"). It submitted that a strict interpretation of the word employ was not appropriate given the protective nature of the jurisdiction. It also argued that the there was a circularity to the argument in that if Mr Saab was not an employed pharmacist pursuant to the definition of a retail pharmacist he would not have been authorised to possess and supply drugs of addiction.
We do not accept the submissions made on behalf of Mr Saab for a number of reasons.
First being "employed" and being "an employee" are not necessarily the same thing. As the Commission pointed out, one can be self-employed.
The dictionary definitions of "employ" submitted and relied upon by the Commission are broad. As cautioned by Basten JA in Cooper v The Owners - Strata Plan No 58068 [2020] NSWCA 250 at [22], the purpose of a dictionary is to supply a range of synonyms. It is rarely of assistance in identifying how a term is used in a particular statutory context. Indeed, to focus on the possible meanings of individual words to the exclusion of contextual considerations is apt to lead to error.
Holding that caution to mind, an assessment of connected circumstances by reference to the values and norms recognised by the text, structure and context of the PTGR legislation and the National Law leads to the conclusion as only a registered pharmacist can own a retail pharmacy, the intention must be that the owner is subject the same legislative obligations under the PTGR as any pharmacist who is employed by them. To conclude otherwise would undermine a purpose of the PTGR which is to manage and address the risks to patients and the public more broadly in dispensing drugs of addiction.
Further it would be nonsensical if an employee pharmacist was subject to the requirements of the PTGR but the pharmacy owner was not. It would mean that a pharmacy owner could always argue that the PTGR did not apply them and would never be required to comply. That position simply cannot co-exist in a protective structure to which the PTGR and the National Law are directed.
The Guide to Poisons and Therapeutic Goods Legislation for Pharmacists, issue date June 2015 produced by Pharmaceutical Services Unit specifically indicates that a pharmacist "engaged" in the retail practice of Pharmacy is authorised to have possession of a drug of addiction for the purpose of their particular profession unless in any particular case that authority has been withdrawn. It makes no distinctions around employees or employers or owners.
But most significantly, Counsel's submission for Mr Saab fails to come to terms with the fact that Mr Saab was authorised to possess drugs of addiction. It was this authority that Mr Battye withdrew when he made the relevant order under the PTGR.
Mr Saab believed that the amount of methadone held in the safe at the Pharmacy did not match the dangerous drug register because of a faulty methadone pump. He estimated an error of around 1% in dispensing across the cohort of methadone patients.
In our view this was an assumption made by Mr Saab. The evidence before us as to the accuracy range of Socorex Calibrex methadone pump used by the Pharmacy does not of itself mean that this was the reason for the drug register not balancing on 7 November 2015 and 29 January 2017.
This is because Mr Saab cannot identify a point in time where the divergence between the amount of methadone held on hand to that contained in the written record commenced. He does not know what the level of accuracy or inaccuracy of the pump was each time it was used to dispense methadone.
After a stock check recorded a difference in the methadone held on hand to that recorded in the drug register Mr Saab did not, nor did any of his employed pharmacists, conduct a reconciliation in an attempt to explain the discrepancy. For example where a patient may have received Methadone but it had not been recorded in the register.
There were two stock checks done in 2015. One was done on 2 January 2015, which showed an excess of 149ml of methadone on hand; and a second on 7 November 2015, which showed a deficiency of 869ml, the subject of the current complaint. No stock checks were done at all in 2016 for methadone. The next stock check that was done was on 29 January 2017 which showed a deficiency of 2,579 ml, also the subject of the current complaint.
Without stock checks conducted at regular intervals and a process of reconciliation there is no objective evidence to demonstrate that the deficiency in methadone was in fact proportional and occurred over time across the cohort of methadone patients as Mr Saab suggests.
For all intents and purposes as at 7 November 2015 and 29 January 2017 the amount of methadone held in the safe at the Pharmacy did not match the dangerous drug register.
We do not accept the submissions made on behalf of Mr Saab that there was no loss but merely a dispensing error. The deficiency amounted to a loss at that time which Mr Saab or his employed pharmacist was unable to objectively explain.
Similarly we do not accept the attempt made by Counsel for Mr Saab to distinguish the case by drawing a distinction between the use of the word "loss" in the PTGR and the use of the word "discrepancy".
As submitted by the Commission the legislative requirements for pharmacists are very clear in relation to Schedule 8 medications, and that is; if the Controlled Drugs Register does not balance, and an immediate reconciliation cannot explain why it does not balance it must be immediately reported. It is not appropriate for a pharmacist to take the position they have no requirement to report that fact to the Ministry of Health as in their view it is due to an ongoing calibration issue with the methadone pump.
In our view as a proprietor and pharmacist Mr Saab ought to have been aware that the stock check done by Mr Morris on 7 November 2015 showed a loss of 869ml of methadone. He made entries in the register several days later. Mr Saab undertook the stock check on 29 January 2017. That showed a loss of 2,579 ml of methadone.
We find that these losses should have been reported by Mr Saab. We find that particulars 1 and 2 are proved.
[67]
Particular 3: Biannual stock checks
A periodical inventory of stock of drugs of addiction is required to be done under Clause 118 of the PTGR. The inventory must be done during the prescribed periods of March and September of each year.
The Controlled Drugs Register for the Pharmacy for Methadone found in the preliminary PRU report evidences that stock checks were not conducted for Methadone at the Pharmacy in March 2015, September 2015, March 2016 and September 2016.
On behalf of Mr Saab it was submitted that it was Mr Raja Morris and not Mr Saab who was the "person responsible for maintaining the drug register" for the purposes of the obligation under cl 118(1) of the PTGR. Accordingly, Mr Saab was not in breach of cl 118(1).
In support of this reliance was placed on Ms Croker's evidence as contained in her written report that the obligation under s 118 may be carried out by:
"[a]ny pharmacist employed in the pharmacy" and that a pharmacist proprietor would comply with their obligations if they "instruct their staff members to undertake this inventory": [5]
It was submitted that consistent with this obligation, Mr Saab had instructed Mr Morris to undertake the stock checks.
In our view this is not a fair representation of the totality of Ms Croker's evidence. In the very next paragraph of the report, Ms Croker deals with the standard required of a proprietor in relation to the keeping of a drug register. Ms Croker observed that the standard required is to ensure that all appropriate legislation is met in keeping a drug register. The drug register must be an accurate count of drugs of addiction kept on the premises. It is the proprietor's responsibility to ensure that the legislation is followed, and that the drug register is maintained appropriately: [6].
In our view Ms Croker's report cannot be seen supporting the proposition that Counsel for Mr Saab appears to be suggesting that where a proprietor instructs an employee to perform a stock check and it is not done, that provided the proprietor instructed that the stock check be performed, there is no further obligation. A proposition of this nature was not put to Ms Croker and in fairness it is simply not what she says.
Further, it would undermine the protective architecture of the PTGR if a pharmacy owner could simply say in response to any failure or omission by an employee to comply with the legislation that it was not their responsibility because the employee had been instructed to comply.
Counsel for Mr Saab placed reliance on Mr Morris' inability to recall ever telling Mr Saab that he was no longer doing the bi-annual stock take for methadone. Accordingly, Mr Saab's instruction to Mr Morris that he conduct the stocktakes remained current and operative throughout the period relied upon by the Commission even though Mr Morris ceased conducting those stock checks. It was submitted that if anyone, it was Mr Morris, not Mr Saab, who is in breach of his obligations under s 118 of the PTGR.
We do not accept this submission. Employee pharmacists may be autonomous and have obligations under the legislation but that says nothing about, nor does it detract from, the independent responsibilities that a proprietor has within their own pharmacy. The Guidelines for Proprietor Pharmacists make it clear that a proprietor cannot delegate his or her professional obligations to their employed pharmacists. Ultimately it was Mr Saab's responsibility as a proprietor to ensure that Clause 118 was complied with and that stock checks were conducted either by himself or an employed pharmacist in March and September of each year.
Counsel for Mr Saab further submitted that the evidence does not establish any relevant breach in relation to the stock checks conducted by Raja Morris in 2015 or if so; is only the most technical of breaches. In particular:
1. The March 2015 stock check was performed by Mr Morris (albeit completed early, in January 2015) and was accurate.
2. The September 2015 stock check was performed by Mr Morris (albeit completed late) in November 2015 and was accurate. The fact that a discrepancy was identified by Mr Morris does not mean the stock-check was not accurate.
As we understood this submission biannual stock checks were conducted albeit not in the correct months and so it was a technical breach which would not sound in any disciplinary proceedings.
We reject this submission. As submitted by Counsel for the Commission a reliance on stock checks that were conducted outside of March and September is a distraction and does little to address the actual particular of what is required for pharmacists under clause 118 of the PTGR.
We find that particular 3 is proved.
[68]
Particular 4: Methadone Pump
This particular is framed in alternate terms, that Mr Saab neglected to replace or, recalibrate the methadone pump at the Pharmacy in circumstances where he was aware that the pump required recalibration.
Part of Mr Saab's response to this particular is that he was advised by officers of the PRU to continue to use the pump after he had raised concerns about its accuracy.
The evidence given by Mr Gavrilovic and Mr Smith is irreconcilable with Mr Saab's evidence that he was told to continue using a faulty pump.
Submissions made on behalf of Mr Saab addressed conversations between Mr Saab and the PRU. It was submitted that nowhere do any of the officers of the PRU give any evidence that disputes Mr Saab's evidence that he raised a concern about the pump given the recent recalibration; or that they told Mr Saab to replace the pump in those circumstances.
Reference was made to Mr Saab's evidence that he understood that he was to continue operating the pump until he was later told to replace the pump. It was submitted that the same message was given to Mr Morris by Mr Gavrilovic. As soon as Mr Saab was told to replace the pump, he did so. Had the PRU considered the public was in any way at risk, then that was something they would have told him on the date of the very first inspection.
We do not accept these submissions. In our view it is apparent from the evidence of both Mr Gavrilovic and Mr Smith, and Mr Gavrilovic's file note of 22 March 2017, that at no stage did either of them advise Mr Saab to continue using a faulty Methadone pump at the Pharmacy subsequent to the first PRU inspection. Mr Gavrilovic's file note was clear, he advised Mr Saab to replace the pump if he believed it to be faulty.
The confidence and clarity with which Mr Gavrilovic and Mr Smith gave their evidence and the detail they were able to recall persuades us that they are witnesses of truth whose evidence we can with confidence accept.
The evidence of Mr Gavrilovic about the scope of the advice that officers of the PRU may give to pharmacists from time to time was clear. To provide general advice and instructions to comply with the law.
Mr Gavrilovic's evidence was that a methadone pump or any measuring device is not stipulated in the PTG legislation and therefore is not within the remit of the PRU. It is not something that the PRU would be involved with other than offering general advice to any pharmacist offering OTP's that they must ensure they deliver that accurately and using appropriate equipment. We accept that evidence and note it is consistent with the experience of the professional members of the panel.
We do not accept Mr Saab's evidence that he was instructed by the PRU to continue to use the pump. We find that Mr Saab was not instructed by any officer of the PRU to continue to use a faulty pump or one that was not working accurately.
Other submissions made by Counsel for Mr Saab were to the effect that the Commission could not establish this particular for several reasons. It was submitted it could not prove that recalibrating would have had any effect in correcting the issue with the pump, and the Commission had not pleaded a case of failing to replace the pump.
It was also submitted the Commission could not establish that the methadone pump was not in fact working within a tolerable range of accuracy or that there is any "standard" that Mr Saab breached by continuing to operate the pump. Reference was made to Ms Croker's oral evidence that the Socorex branded dispenser is suggested for use by the Pharmacy Guild of Australia.
It was submitted that Mr Saab was using a Calibrex branded pump 10mL pump that had an accepted accuracy range of 0.5 - 1.5%. Mr Saab's evidence is that the discrepancy in the methadone pump was less than 1% of the methadone dispensed by the Pharmacy. Therefore it was argued that at all material times, Mr Saab was operating the pump within the manufacturer's tolerated range of accuracy.
The balance of the submissions by Counsel for Mr Saab made criticisms of Ms Croker's evidence. It was said Ms Croker's evidence did not properly or clearly address the manufacturer's range of accuracy in respect of the pump. It was also argued if Ms Croker's opinion were to be accepted it would mean that a pharmacist would be breaching their obligations simply by using the suggested Calibrex pump. Amongst other matters Ms Croker's level of experience in dispensing methadone was also criticised. For example it was submitted that Mr Saab had significantly more experience in dispensing methadone than Ms Croker. Looking at Ms Croker's experience and evidence as a whole, in our view these criticisms were without any foundation.
We found the totality of the submissions made on behalf of Mr Saab confusing and not helpful in answering the case in respect of this particular as we understood it was put by the Commission.
As we have indicated above in paragraph [408], the evidence before us is not clear or direct enough to prove that the shortfall in methadone that existed in 2015 and 2017 was as a result of calibration issues as Mr Saab suggests. Mr Saab appears to have simply looked at the shortfall and averaged it out over a period and assumed that the cause was because the pump needed calibrating. The stock checks that were required to be done in March and September in 2015 and 2016 were not done; and reconciliations of the Pharmacy's records for the relevant periods were never conducted.
But more significantly as we understand this particular, it is directed towards Mr Saab's own evidence which initially emerges in the submissions made by Sparke Helmore Lawyers dated 29 March 2017 and expanded upon in greater detail by Mr Saab during the course of his s.150 hearing that the methadone pump was faulty or it required re-calibration.
Looking at Mr Saab's affidavit dated 5 March 2020 he deposed that on 9 March 2017 when the PRU first inspected the Pharmacy he conducted a stock check on the "methadone pump" and found the records not accurate. He had a discussion with Mr Gavrilovic about his recent attempt to calibrate the pump and expressed the view that rather than calibration there must be an issue with the pump itself. He decided to order a new pump. In the meantime he continued to use the same pump until he was suspended on 30 March 2017.
The particular relied upon by the Commission is that between this period of 9 March 2017 to 30 March 2017, Mr Saab failed, refused or otherwise neglected to replace or recalibrate the methadone pump at the Pharmacy in circumstances where he was aware that the methadone pump required recalibration.
As it is framed the particular arises out of Mr Saab's own evidence that he believed there was a calibration issue with the methadone pump or it was faulty. The particular relates to a very discrete period in time and in our view it is Mr Saab's own evidence which supports the particular.
Further evidence that Mr Saab believed that the pump either required re-calibration or was faulty during the time frame to which the particular is directed can be found in the file note of Mr Gavrilovic of the phone conversation he had with Mr Saab on 22 March 2017.
We find that particular 4 is proved.
[69]
Particular 5: Separation of Schedule 4B prescriptions
Clause 42(2) of the PTGR requires as follows:
A pharmacist must keep prescriptions for special restricted substances separate from other prescriptions (other than prescriptions for drugs of addiction).
We note that the original complaint referred to Schedule 4 Appendix D prescriptions in error. The complaint was subsequently amended to correct the reference to Schedule 4 Appendix B.
On the basis of the pleading as it appeared in the original complaint, Mr Saab's reply accepted that he did not keep the prescriptions separate, but denied that it constituted a breach as alleged. Mr Saab's submissions referenced that this was in circumstances where the complaint was misguided because Schedule 4, Appendix D prescriptions are not "special restricted substances" within the meaning of s 42(2) of the PTGR.
However, in light of the amended complaint, it was said Mr Saab admitted that he did not keep Schedule 4 Appendix B prescriptions separate and that the conduct constitutes unsatisfactory professional conduct. This was the only particular that Counsel for Mr Saab told us was conceded.
We found this concession somewhat confusing given that this was not what we understood Mr Saab's oral evidence to have been under cross examination even allowing for the erroneous reference to Schedule 4 Appendix D.
The PRU inspection report dated 5 June 2017 records that on 9 March 2017 when Mr Saab was asked to provide the Schedule 4 Appendix B prescriptions that had been dispensed during the preceding two year period, he stated that the 4B prescriptions had not been kept separate from other prescriptions and they were amongst a large volume of prescriptions he kept in storage.
The Commission submits that Mr Saab did not produce any evidence that he had in fact provided the Schedule 4 Appendix B prescriptions to the PRU. Detailed submissions were made by the Commission about Mr Saab's credibility. It was submitted that during the course of his oral evidence Mr Saab was at times evasive and argumentative. In support of this numerous areas within the transcript were identified. The areas identified by the Commission are in the main in addition to those which have been referenced in this decision.
In this light the Commission argued by that we should approach Mr Saab's evidence with caution and prefer the evidence of the PRU. It was submitted that where there is a difference between his evidence and that of the PRU, we should prefer the PRU's evidence. We accept those submissions.
For the reasons set out above we did not find Mr Saab to be a reliable witness. We do not accept his unsupported contention that he kept Schedule 4 Appendix B prescriptions separate.
We find that particular 5 is proved.
[70]
Particular 6: Removal of initials from the dispensing system
Clause 55 of the PTGR relevantly provides:
Supply on prescription to be recorded
(1) A pharmacist who supplies a restricted substance on prescription must record the following details in a manner approved by the Director-General -
(a) the details required by clause 35(1) to be included in the prescription,
(b) a unique reference number for the prescription,
(c) the date on which the substance was supplied,
(d) the name of the person by whom the substance was supplied.
Apart from Mr Saab's contention there is no evidence of any conversations between Mr Saab and officers of the PRU about the removal of his initials from the dispensing system.
In our view the totality of the evidence from officers of the PRU indicates that they were unaware that Mr Saab's initials had been removed from the dispensing system until the inspection on 19 April 2017, when Mr Smith asked Mr Morris about this issue.
The Commission submits that, in the absence of evidence to support Mr Saab's assertion that the conversations occurred and given the issues raised in relation to Mr Saab's credit, we should reject Mr Saab's evidence that he was advised by the PRU to remove his initials.
We do not accept Mr Saab's assertions made for the first time at the hearing, that he was advised to remove his initials from the dispensing system by officers of the PRU. In our view in light of the significance he attached to this explanation at the hearing if this had occurred it would have been squarely raised in the written submissions made on his behalf for the s.150 hearing or orally by him at the s 150 proceedings or in his affidavit in support of his reply in these proceedings.
Both Mr Smith and Mr Gavrolivic had no recollection of any conversation with Mr Saab about the removal of his initials. Mr Smith specifically refuted advising Mr Saab to remove his initials. We have already indicated that we found both Mr Smith and Mr Gavrolivic to be reliable and convincing witnesses.
Further as submitted by the Commission and in our view correctly, there was no need for Mr Saab to remove his initials from the Pharmacy's dispensing system in circumstances where on 17 March 2017 an order had been made which prohibited him from supplying and possessing any Schedule 8 drugs of addiction, any Schedule 4 Appendix D drugs and a number of other prescribed medications. Further, on 30 March 2017 the Pharmacy Council imposed a "not to practice as a pharmacist" condition on his registration.
Mr Saab claimed others were using his initials in the dispensing programme. However, he did not take any steps to identify any details around who was potentially using his initials, including reviewing dates and times and proof of who was working. In our view these were obvious and logical things that he could have done to address the issue without the need to remove his initials from the system.
We find that Mr Saab removed his initials of his own accord. However on the evidence before us we are unable to determine when this occurred. On Mr Saab's evidence it occurred sometime between the PRU inspection on 9 March 2017 and 19 April 2017. Certainly at the time of the s.150 hearing on 30 March 2017 Mr Saab did not indicate to the Council that he had removed his initials.
The Commission submits that removing the initials was in breach of clause 55 of the PTGR.
On behalf of Mr Saab it is submitted that provided a pharmacist records at the time of dispensation that they are the person supplying the substance, there is no other obligation either on that pharmacist or anyone else. Clause 55(1) does not prohibit a pharmacist from removing their initials from a dispensing system. Further, Mr Saab acted entirely responsibly. He was not aware that other pharmacists were using his initials and, upon learning that this was occurring in March 2017 when the PRU attended his Pharmacy, deactivated his initials from the system on the days he was not working. Further there was no improper motive established in Mr Saab de-activating his initials on the days he was not working.
We do not accept that such a strict statutory interpretation ought to apply to this particular as urged upon us by Counsel for Mr Saab.
The PTGR does not deal with how a pharmacist uses software within their pharmacy as it relates to initials. But it does require that the name of the person who dispenses a prescription must be recorded. Just because the PTGR does not expressly prevent a pharmacist from removing their initials from the dispensing system does not necessarily mean it cannot be a pivot for the conduct that is the subject of disciplinary proceedings. As submitted by the Commission is not appropriate and is contrary to the protective nature of this jurisdiction to require such a strict statutory interpretation.
The evidence from Ms Croker, as well as from the PRU, indicates the rationale for why pharmacists should have their initials in the dispensing system. This includes being able to identify and track which pharmacist had dispensed medication in the event of an error. Equally it appears to us that this rationale is one of a number of aspects which underpin the details that are to be recorded when a pharmacist supplies a restricted substance on prescription as reflected in Clause 55.
The real issue raised by this particular is whether it was inappropriate for Mr Saab to remove his initials from the dispensing system. It is this conduct to which the particular is directed. Although Clause 55 may not specifically refer to the removal of initials in a dispensing system, by removing his initials Mr Saab did not act in a way which was consistent with or aligned to Clause 55.
In our view it was inappropriate for Mr Saab to remove his initials.
We find that particular 6 is proved.
[71]
Particular 7: Initials
As it is framed, particular 7 appears to reflect Mr Saab's belief that others within the Pharmacy were using his initials. It is sourced from information Mr Saab gave for the purposes of the s 150 proceedings which have been set out above at paragraphs [141] to [143].
The particular is directed to the period between 18 July 2014 and 9 March 2017 and Mr Saab's conduct in overseeing pharmacists in his employ to ensure that the pharmacist who actually dispensed the prescription was identified. It is also alleged that Mr Saab permitted other employed pharmacists to use his name and initials when dispensing prescriptions.
The Commission submits Mr Saab's failure to take proper steps in this regard as a proprietor and his continuing belief that others had been using his initials at the Pharmacy to dispense, even after the first PRU inspection on 9 March 2017, evidences that he failed to ensure that prescriptions dispensed at the Pharmacy identified the pharmacist who had dispensed the actual prescriptions and permitted other pharmacists in his employ to use his initials.
There was no direct evidence before us that others in the Pharmacy were using Mr Saab's initials. All we have is Mr Saab's belief that it was so. Nor is there any direct evidence that Mr Saab actually permitted others to use his initials.
Mr Morris did not recall dispensing under another pharmacists initials and he did not recall seeing that occur. Although he was aware that Mr Saab's initials had been removed, he did not know when or how this occurred.
We are not persuaded that Mr Saab removed his initials from the dispensing system for the reasons he has suggested. As we have indicated above at paragraph [468] if Mr Saab held concerns that others were using his initials there were other simpler and more obvious steps he could have taken. Further our conclusions about Mr Saab's credibility make us reluctant to accept, in the absence of some objectively established facts, his explanation that he removed his initials because others were using them.
That being said we are not satisfied that the evidence before us is of sufficient quality or clear enough to make a finding that Mr Saab failed to ensure that the prescriptions dispensed at the Pharmacy identified the pharmacist who had dispensed the actual prescription. Nor is the evidence clear or persuasive enough to find that Mr Saab permitted other pharmacists in his employ to use his name and initials when dispensing prescriptions.
We find that particular 7 is not proved.
[72]
Complaint 2
Our findings in relation to Complaint 2 may be conveniently addressed on the basis of why the Commission alleges Mr Saab inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed prescriptions for Patients A to Z for Schedule 8 drugs of addiction and Schedule 4 Appendix B and D prescribed restricted substances at the Pharmacy rather than on the basis of each patient.
This is because the particulars are extensive and although similar, they are not identical across the patient cohort.
[73]
Dispensing Schedule 8 drugs of addiction to patients outside the Pharmacy's local area
Particulars 9a), 14, 18, 29, 38, 42, 51, 56, 61, 69, 77, 83, 88, 93, 97 and 102 relate to Patients B, C, D, F, H, I, K, L, M, O, Q, R, S, T, U and V and the dispensing of Schedule 8 drugs of addiction to patients whose addresses were outside of the Pharmacy's local area at Granville.
It is not inconceivable that a person might travel to a suburb different to where they live for a particular reason and whilst there get a prescription filled. But when we look at the totality of the patients that travelled to the Pharmacy who did not live in Granville, who presented a prescription from a Doctor that was out of the area, and the types and quantities of drugs dispensed, that the issue of the patient being out of area becomes telling.
The Commission submits, and we accept that the patients living outside of the Pharmacy's local area in and of itself should have been a red flag to Mr Saab in both his capacity as proprietor and as Pharmacist working at the Pharmacy that the Schedule 8 drugs of addiction dispensed at the Pharmacy to those patients were not for an appropriate therapeutic dose and purpose and, in the case of prescriptions from Dr Ng, Dr Selim and Dr Sadhu, those prescriptions were forged.
The forged prescriptions obtained by those patients who were out of area came from prescribers who were out of area relative to where the patients themselves actually lived, being from Dr Ng at Haymarket, Dr Selim at Punchbowl and Dr Sadhu at Mt Druitt. Almost all were on private prescription.
This cohort of patients was receiving high strength Oxycodone 80mg, Fentanyl 100mcg and Alprazolam 2mg. This should have raised a red flag for Mr Saab in both is capacity as proprietor and as Pharmacist working in the Pharmacy as to the appropriateness of the dispensing of the Schedule 8 medications.
In relation to Patients C, F, H, T and L, whilst these patients lived in neighbouring suburbs to the Pharmacy (Merrylands and Guildford), the very nature of the prescriptions themselves being high strength Schedule 8 medications should have prompted further enquiries by Mr Saab. As both the proprietor and the pharmacist dispensing he should have contacted the prescribing Doctors. If he had it would have identified that the prescriptions were in fact forged.
As submitted by the Commission, correctly in our view, the fact that the same prescriber was prescribing high strength Oxycodone, Fentanyl and Alprazolam to multiple patients from different areas in Sydney, that the prescriptions were being presented to the same pharmacy and in a similar time frame should also have prompted further enquiries by Mr Saab in both his capacity as proprietor and the dispensing pharmacist to ensure that the prescriptions were valid and being used for an appropriate therapeutic purpose and in an appropriate quantity.
The patient histories for all these patients also show that they were receiving similar Schedule 8 medications from multiple prescribers at the Pharmacy prior to being dispensed Schedule 8 medications on forged prescriptions from Dr Ng, Dr Selim and Dr Sadhu. Again this should also have prompted further enquiry as to the validity of the prescriptions by Mr Saab in both his capacity as proprietor and the dispensing pharmacist.
Consistent with the experience of the professional members of this Tribunal panel, pharmacists recognise that red flags for identifying the validity of Schedule 8 prescriptions include the presentation of prescriptions from patients out of area, the prescribing from a General Practitioner who is out of area, multiple prescribers suggestive of doctor shopping and the capacity of the patient to fund the prescriptions privately when they are entitled to the PBS.
We find that, with one exception that is dealt with below, particulars 9, 14, 18, 29, 38, 42, 51, 56, 61, 69, 77, 83, 88, 93, 97 and 102 are proved.
Patient B had an address in Mackay, Queensland, outside of the Pharmacy's local area and was previously on the NSW Opioid Treatment Programme until 31 July 2016.
In relation to Particular 9(b), Mr Saab's evidence was that he did not know that Patient B was on the NSW Opioid Treatment Programme at the time that the Schedule 8 medications were dispensed by the Pharmacy to her.
The Commission submits that arguably, had Mr Saab made proper enquiries with Patient B's prescribers of the Schedule 8 medications, he may have been informed of this by a prescriber who had past dealings with this patient on such a Program.
In our view whilst Mr Saab ought to have made enquiries with Patient B's prescribers of the Schedule 8 medications given her patient history for the reasons set out above, we are not able to find that even if he had made those enquiries that this would have revealed that Patient B was on the OTP program. This is because her prescribers may have been unwilling to reveal this information. Accordingly we are not satisfied that particular 9(b) is established.
[74]
Prescriptions and Supply: Clauses 79, 80, 86 and 87 PTGR
In respect of Patients A - Y the Commission's case is that Mr Saab inappropriately dispensed and or failed to ensure that the pharmacists in his employ, appropriately dispensed prescriptions for Schedule 8 drugs of addiction when presented with prescriptions contrary to Clauses 79, 80, 86 and 87 of the PTGR. All these clauses deal with drugs of addiction.
Clause 79 and 80 relate to prescriptions. Clause 86 and 87 relate to supply on prescription.
Clause 79 deals with quantity and purpose. Clause 80 deals with the form of a prescription.
Particulars 1, 5, 12, 17, 21, 26, 32, 36, 41, 45, 48, 54, 59, 64, 67, 72, 75, 80, 86, 91, 96, 100, 105, 110 and 113 allege breaches of Clause 79 of the PTGR. They concern Patients A through to Y and the forged prescriptions from Dr Ng dispensed by the Pharmacy to these patients.
Clause 79 provides that an authorised practitioner must not issue a prescription for a drug of addiction in a quantity or for a purpose that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Particulars 1, 5, 6, 7, 12, 13, 17, 21, 22, 23, 26, 28, 32, 33, 36, 37, 41, 45, 48, 50, 54, 55, 59, 60, 64, 67, 68, 72, 75, 76, 80, 82, 86, 87, 91, 92, 96, 100, 101, 105, 106, 107, 110 and 113 allege breaches of Clause 80 of the PTGR for Patients A to Y for forged prescriptions dispensed by the Pharmacy from Dr Ng, Dr Selim and Dr Sadhu.
Clause 80 provides that a person who issues a prescription must ensure that certain details be included in the prescription. This includes the name and address of the patient, and adequate directions for use.
None of the forged prescriptions from Dr Selim and Dr Sadhu had the patients' addresses on them contrary to Clause 80(1)(b) of the PTGR.
The prescription from Dr Selim for Kalma 2mg 100 tablets for Patient B had no directions on it [57] , contrary to Clause 80(1)(d) of the PTGR.
The forged prescriptions from Dr Sadhu for Kalma 2mg 100 tablets for Patient K [58] , Patient B [59] and Patient M [60] had no directions for use on them contrary to clause 80(1)(d) of the PTGR.
The forged prescriptions from Dr Ng had the patients' addresses on them but were in a different handwriting to the remainder of the prescriptions.
The forged prescriptions from Dr Ng for Oxycodone 80mg for Patients A [61] , B [62] , M [63] , U [64] , V [65] , X [66] and Y [67] has no directions for use contrary to clause 80(1)(d) of the PTGR.
The forged prescriptions from Dr Ng for Kalma 2mg for Patients B [68] , C [69] , E [70] , G [71] , I [72] , K [73] , M [74] , O [75] , R [76] , S [77] , U [78] and X [79] had no directions for use on them contrary to clause 80(1)(d) of the PTGR.
Counsel for Mr Saab submitted that the Commission had not established its pleaded case in respect of clause 79 or clause 80. It was argued that there had been no breach of either clause in circumstances where Mr Saab was not an "authorised practitioner" who issues prescriptions. Mr Saab dispensed drugs pursuant to a prescription issued by an authorised or purportedly authorised by a practitioner. It was submitted that the obligations on a prescriber were not to be conflated with the obligations on a pharmacist. The regulations are very specific as to what obligations apply to pharmacists.
Further it was submitted that dispensing a prescription in circumstances where an address is missing or where there are not adequate directions for use is at most a technical breach in circumstances where the patient is known to the pharmacist and has a consistent and longstanding use of that particular medication.
We do not accept the submissions made on behalf of Mr Saab which in effect amount to a strict statutory interpretation of Clauses 79 and 80 without regard to context. Just because Mr Saab is not the authorised practitioner who issued the prescriptions, he still had a responsibility as a proprietor and a pharmacist to ensure that the prescriptions were compliant with the legislation, safe and appropriate.
Regulations and Guidelines exist so that the very real risks of dispensing drugs of addiction can be managed and mitigated. Prescribers and pharmacists share a responsibility to exercise their individual clinical judgement to ensure that patients and the public more generally are protected.
Whilst under Clause 79 a prescriber has a responsibility to ensure that the prescription is for an appropriate therapeutic purpose and quantity, a pharmacist has that same responsibility to assess that prescription in that context prior to dispensing it. If that were not the case then there would be no need for pharmacists and no need for their skill and judgment.
We agree with the submission of the Commission that Pharmacists have a responsibility to ensure that the prescriptions they dispense for Schedule 8 drugs of addiction are valid. A pharmacist cannot seek to absolve their responsibilities for dispensing an invalid prescription on the basis that the prescriber is at fault. Pharmacists play an important gatekeeper role in ensuring that prescriptions are valid and are required to take steps in the event that invalid prescriptions are presented, including steps to rectify the prescriptions with the prescriber and refusing to dispense them.
On being presented with a prescription a Pharmacist has to exercise an independent judgement to ensure the medicine is safe and appropriate for the patient. It is not the role of a pharmacist to dispense anything and everything merely because a prescription is presented.
Particulars 1, 2, 5, 6, 7, 12, 13, 17, 21, 22, 23, 26, 27, 28, 32, 33, 36, 37, 41, 45, 48, 50, 54, 55, 59, 60, 64, 67, 68, 72, 75, 76, 80, 81, 82, 86, 87, 91, 92, 96, 100, 101, 105, 106, 107, 110 and 113 allege breaches of Clause 86 of the PTGR for Patients A to Y for forged prescriptions dispensed by the Pharmacy from Dr Ng, Dr Selim and Dr Sadhu.
Clause 86 relates to certain prescriptions that are not to be filled. These include if the prescription appears to have been forged or fraudulently obtained or if the prescription appears to have been altered otherwise than by the practitioner by whom it was issued.
All of the addresses on the prescriptions purported to be from Dr Ng, had been added in handwriting different to that of the remainder of the prescription contrary to clause 86(1)(g) of the PTGR. None of the prescriptions purported to be from Dr Selim and Dr Sadhu had a patient address.
In respect of the prescription for Oxycontin 56 tablets purported to be from Dr Ng dispensed to Patient A on 14 July 2016 (particular 2), the prescription was dated the following year. The prescription for Durogesic 100 mg 5 patches purported to be from Dr Ng dispensed to Patient F on 4 August 2016 (particular 27) contains an obvious alteration to the date from 2017 to 2016 in different handwriting. The prescription for Durogesic 100 mg 5 patches purported to be from Dr Ng dispensed to Patient R on 21 July 2016 (Particular 81) also contains an alteration to the date from 2017 to 2016.
Counsel for Mr Saab submitted that there was no breach of clause 86. It was argued that attention be given to how the prescription "appears" at the time it is presented to the pharmacist. It is irrelevant if, in hindsight, the prescription is in fact forged. The question is about what its appearance was at the time it was presented.
Further it was argued clause 86(1)(g) requires more than a mere "suspicion" that the prescription "might be" forged or fraudulently obtained; the clause requires that the prescription "appears to have been forged or fraudulently obtained". The seriousness of that obligation is apparent when it is seen that, where a prescription so appears, the pharmacist must immediately notify the police: clause 86(2). A suspicion must almost always be present if a pharmacist is performing their role diligently and cognizant of the nature of the medications and the risk that they may be abused. At the same time, a pharmacist cannot be referring patients to the police simply based on a mere suspicion.
Continuing on this theme it was argued that over-readily refusing to dispense important medications to patients would not only be disadvantageous to patients who need their medications but could expose pharmacists to legal action. Clause 86(1)(g) requires that the prescriptions appear "forged or fraudulently obtained", namely, that a crime has been committed to obtain the prescription. The clause it was argued is not concerned with any risk that a patient may be, for instance, misusing their medication.
Finally it was submitted that clause 86(1)(g) should be construed in a manner that is harmonious with the construction of clauses 85 and 35. In short, such a construction must dictate that a prescription will not appear forged or fraudulently obtained merely because the form of a prescription does not comply with clauses 85 and 35 of the PTGR (e.g. because it is missing an address or did not contain adequate directions for use). Were that the case, cl 86(1)(g) would serve no relevant purpose in the regulatory scheme. Clause 86(1)(g) requires that attention be given to whether there is something in particular about the prescription that makes it appear forged or fraudulently obtained.
We do not accept these submissions.
As submitted by the Commission, and in our view correctly, looking at the totality of the prescriptions they all appear to have been forged or fraudulently obtained for the following reasons:
1. Most of the patients were out of area;
2. the prescribers were out of area;
3. all of the prescriptions were for similar high strength Oxycodone 80mg, Durogesic 100 and Kalma 2mg;
4. many of the prescriptions did not have any or any adequate directions for use;
5. the patients had previously received similar high dose Schedule 8 drugs of addiction from multiple prescribers;
6. the patients' histories did not show consistent dosing with high strength drugs of addiction where patients taking such medications may experience dependency and withdrawal symptoms;
7. all of the prescriptions were for non-PBS, despite many if not all of the patients being entitled to the PBS;
8. multiple prescriptions for multiple patients for the same high dose Oxycodone 80mg, Kalma 2mg and Durogesic 100 were received in a short space of time from the same prescriber.
Particulars 1, 5, 6, 7, 12, 13, 17, 21, 22, 23, 26, 28, 32, 33, 36, 37, 41, 45, 48, 50, 54, 55, 59, 60, 64, 67, 68, 72, 75, 76, 80, 82, 86, 87, 91, 92, 96, 100, 101, 105, 106, 107, 110 and 113 allege breaches of Clause 87 of the PTGR for Patients A to Y for forged prescriptions dispensed by the Pharmacy from Dr Ng, Dr Selim and Dr Sadhu.
Clause 87 relates to prescriptions requiring verification. It provides at 87(1) that a pharmacist must not supply a drug of addiction unless he or she -
1. is familiar with the handwriting of the person who issued the prescription or
2. knows the person for whom the drug is prescribed or
3. has verified that the person who is purported to have issued the prescription has actually issued it.
Mr Saab gave evidence under cross-examination by the Commission that he gained a familiarity for Dr Ng's handwriting from previous prescriptions and conceded that no enquiry had been made in relation to the first prescription.
Mr Saab did not verify any of the forged prescriptions with Dr Ng, Dr Selim and Dr Sadhu.
Notwithstanding any familiarity Mr Saab claimed he had with the patients in our view as both proprietor and dispensing Pharmacist he should have enquired as to the validity of the prescriptions, particularly given the patients' dispensing histories at the Pharmacy which show the supply of high strength drugs of addiction from multiple prescribers prior to the dispensing on forged prescriptions.
Mr Saab's evidence was to the effect that he verified the prescriptions because he knew the patients. In our view this was not enough given the nature and extent of the prescriptions.
Clause 87 is a protective provision which ensures that pharmacists satisfy themselves as to the validity of prescription for Schedule 8 drugs of addiction. In our view Mr Saab did not take steps to ensure the validity or provenance of the prescriptions with which he was presented.
We do not accept the submissions made by Counsel for Mr Saab that a breach of clause 87 cannot be established because the options in clause 87(1) are alternatives. It was submitted that because the patients were known to Mr Saab's Pharmacy and there was familiarity with the handwriting of the prescriber Mr Saab was not required to verify the prescription with the prescriber.
The submissions made by Counsel for Mr Saab seek to confine the Tribunal's jurisdiction to a strict legislative interpretation of the clauses pleaded of the PTGR. As we have indicated this is contrary to the protective nature of the jurisdiction.
It is not simply a case of a pharmacist identifying in isolation what is needed under Clause 87 as to whether it is appropriate or not to dispense a drug of addiction prescription. Clause 87 serves to add context and meaning to Clause 86 which precedes it. Clause 86 deals with the kind of prescriptions which should not be filled. It includes if the prescription appears to have been forged or fraudulently obtained or appears to be altered by someone other than the prescriber.
It is a legislative and professional requirement for pharmacists to ensure that prescriptions are appropriate and that they have not been forged or fraudulently obtained.
In the present case it was obvious on the face of the prescriptions that they were potentially forged or fraudulently obtained.
Further, Mr Saab's own evidence was to the effect that the first prescription would have been dispensed without having regard to contacting the prescriber.
Particulars 1, 2, 5, 6, 7, 12, 13, 17, 21, 22, 23, 26, 27, 28, 32, 33, 36, 37, 41, 45, 48, 50, 54, 55, 59, 60, 64, 67, 68, 72, 75, 76, 80, 81, 82, 86, 87, 91, 92, 96, 100, 101, 105, 106, 107, 110 and 113 all deal with Clauses 80, 86 and 87 of the PTGR.
Of these particulars the forged prescriptions from Dr Ng dispensed by the Pharmacy to Patients A through to Y also deal with Clause 79 of the PTGR. These are Particulars 1, 5, 12, 17, 21, 26, 32, 36, 41, 45, 48, 54, 59, 64, 67, 72, 75, 80, 86, 91, 96, 100, 105, 110 and 113.
Mr Saab had direct knowledge of the high strength and volumes of Schedule 8 medications being dispensed by his Pharmacy under the prescriptions purported to be issued by Dr Ng. He was responsible for being attentive to the obvious risks of dispensing those Schedule 8 drugs. He was required to bring his professional judgement to bear to prevent the supply of unnecessary and/or excessive quantities of medicines particularly those which have a potential for abuse or dependency.
All this is amplified by the fact that Dr Ng was out area. In the main the patients were out of area. The prescriptions purported to be from Dr Ng contained entirely different handwriting in the address field.
In our view all these matters should have led Mr Saab to have had serious doubts about the provenance of the prescriptions purported to be from Dr Ng. He made no inquiry of Dr Ng. His evidence did not persuade us that he independently satisfied himself that the prescriptions he was presented with were issued in a quantity or for a purpose that accorded with the recognised therapeutic standard of what is appropriate in the circumstances.
For the reasons set out above we find that all the particulars which reference Clauses 79, 80, 86 and 87 of the PTGR are established.
Particulars 3, 10, 15, 19, 24, 30, 34, 39, 43, 46, 52, 57, 62, 65, 70, 73, 78, 84, 89, 94, 98, 103, 108, 111 and 114 relate to the dispensing of the Schedule 8 drugs of addiction to Patients A to Y as private prescriptions and not under the PBS.
The dispensing histories for Patients B, E, G, K, N, O and X demonstrate that those patients were entitled to the PBS.
There is no evidence that the other patients were not entitled to the PBS.
All of the medications dispensed at the Pharmacy to Patients A - Y were available on the PBS.
Further, for Fentanyl (Durogesic 100) 5 patches and Oxycodone 80mg 28 tablets, these are available on the PBS without the need for an authority.
Patients B, E, K, N, O and X all held concession cards, which entitled them to prescriptions on a concessional PBS rate. As a matter of practical reality an available inference is that a patient who has a concession card may not be able to afford to pay for medications privately.
Ms Croker gave evidence that private prescriptions dispensed at a pharmacy do not form part of a patient's Medicare history and My Health Record.
Mr Saab was unable to provide any explanation, other than compliance with the prescriptions themselves as to why the prescriptions for Patients A - Y that were dispensed by the Pharmacy were dispensed as private prescriptions.
With few exceptions Patients A - Y all received high strength opioids as private prescriptions.
The Commission submits that it is inappropriate for a pharmacy to dispense prescriptions as non-PBS when the patients were otherwise entitled to the PBS. Further, the fact that the prescriptions were Non-PBS for Schedule 8 drugs of addiction liable to abuse, should have caused Mr Saab in both his capacity as proprietor and pharmacist to enquire as to their validity with the prescribers.
In view of the sheer scale and number of prescriptions that were dispensed as private prescriptions and the fact that they were for Schedule 8 drugs of addiction liable to abuse we agree with the submissions of the Commission.
Supply Generally: Clause 109 PTGR Quantity and Purpose of Supply to be appropriate
Particulars 4, 8, 11, 16, 20, 25, 31, 35, 40, 44, 47, 53, 58, 63, 66, 71, 74, 79, 85, 90, 95, 99, 104, 109, 112 and 115 allege breaches of Clause 109 of the PTGR for Patients A to Y for their entire patient dispensing histories at the Pharmacy.
Clause 109 of the PTGR relevantly provides that a pharmacist must not supply any drug of addiction in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
In our view looking at the dispensing histories for Patients A to Y contained in the corresponding Schedules indicates that they were being dispensed high strength Schedule 8 drugs of addiction not in a quantity or for a purpose that accorded with recognised therapeutic standards of what was appropriate in the circumstances for the following reasons:
1. all of the prescriptions were for similar high strength Oxycodone 80mg, Durogesic 100 and Kalma 2mg;
2. the patients received similar high dose Schedule 8 drugs of addiction from multiple prescribers;
3. the patients' histories did not show consistent dosing with high strength drugs of addiction where patients taking such medications may experience dependency and withdrawal symptoms;
4. the patients did not appear to be under the care of a pain specialist and/or psychiatrist in the case of Alprazolam;
5. the combination of high dose Schedule 8 drugs of addiction, namely Oxycodone 80mg, Durogesic 100mcg and Alprazolam 2mg should have led to the exercise of great caution in dispensing;
6. the prescribers were out of area and most patients were out of area.
The oral evidence of Ms Croker is to the effect there was a pattern of patients presenting with prescriptions from a certain provider for a period, and then the provider would change. The quantities of high dose Schedule 8 medications (e.g. they were nearly always for Oxycontin 80mg and Durogesic 100mcg patches, rather than any other strengths) and the ability for patients to pay private prescription prices should have all raised red flags with Mr Saab regarding the use of medications being dispensed.
The evidence of Mr Mahony was to the effect that the pattern of Patients A - Y should have also raised alarm bells for Mr Saab. Whilst a single patient doing "this sort of thing occasionally", could have generated a bit of a concern, but once you had multiple patients with the same class of medication, or group of medications, he believed that the concerns should have increased dramatically.
Mr Mahony acknowledged in his oral evidence that the PTGR sets out stringent requirements for dispensing of drugs that are liable to abuse. He stated that a high standard is required for all schedule 4D and 8 drugs.
In broad terms the totality of Mr Mahony's evidence was to the effect when dispensing there are a number of potential alarm bells for pharmacists. These included patients being out of area, prescribers being out of area, private prescriptions, multiple providers and strength and quantity of drugs.
The patient histories contained in the schedules attached to the Complaint for patients A to Y show the patients receiving Oxycodone 80mg, Fentanyl 100mcg and Alprazolam 2mg on Non-PBS prescriptions from multiple prescribers and at varying intervals not necessarily consistent with the dosage and quantity dispensed, including longer and shorter periods than required for continuous dosing.
Submissions made by Counsel for Mr Saab were that the Commission could not establish a breach of Clause 109 because it had led no evidence as to the circumstances in which the prescriptions were dispensed. This it was said included details of the patient, the way in which the patient presented to the Pharmacy, the representations made by the patient to the pharmacist in question about the reasons for the prescription and other circumstances such as the time of day the person presented themselves and the way in which the person was introduced to the Pharmacy.
Further it was submitted that the Commission did not lead any evidence as to the doctors who prescribed the medications other than the few doctors said to have been the subject of fraudulent scripts. The balance of the doctors can be inferred to have been properly prescribing the medication in appropriate doses and appropriate intervals for the patient.
Finally it was submitted that the Commission had not pointed to any regulation, standard or guideline that would establish that the drugs particularised could never have been dispensed regardless of the particular circumstances. Every dispensation must depend on the particular circumstances of the individual case.
We reject these submissions. It is not necessary for us to have evidence as to the circumstances in which the prescriptions were dispensed. The dispensing histories contained in Schedules A - Y provide substantial and sufficient forensic material to enable us to form a view about the supply of drugs of addiction by the Pharmacy. Nor is it open to us on the evidence to infer that the non-fraudulent prescriptions for drugs of addiction were properly prescribed, in appropriate doses and at appropriate intervals for the patients.
As a proprietor and pharmacist Mr Saab was responsible for adherence to the PTGR concerning dispensing Schedule 8 medications. As a pharmacist it his knowledge of the obvious risks of dispensing Schedule 8 drugs and the bringing of his professional judgement to bear to prevent the supply of unnecessary and/or excessive quantities of medicines which have a potential for abuse or dependency.
As indicated above whilst a prescriber has a responsibility to ensure that the prescription is for an appropriate therapeutic purpose and quantity, a pharmacist has that same responsibility to assess that prescription in that context prior to dispensing it.
In this case the responsibility is amplified because there were multiple prescribers. The doses were high. The quantities were high. Many patients were out of area. Almost all of the prescriptions were dispensed as non-PBS. The prescribers of the forged prescriptions which form part of the subject of this Complaint were out of area. There were irregularities in the form of the forged prescriptions relating to addresses, and some prescriptions contained obvious alterations.
We have no difficulty in finding that Mr Saab inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Schedule 8 drugs of addiction to Patients A - Y on the dates and in the quantities as outlined in the corresponding Schedules in a quantity or for a purpose contrary to Clause 109 of the PTGR.
Particular 116 relates to Clauses 34 and 54 of the PTGR.
Clause 34 of the PTGR provides as follows:
An authorised practitioner must not issue a prescription for a restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Clause 54 of the PTGR provides as follows:
An authorised practitioner or pharmacist must not supply any restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Submissions made on behalf of Mr Saab were to the effect that there had been no breach of "clause 79" of the PTGR as Mr Saab was not an "authorised practitioner". We note that the reference to Clause 79 is incorrect and we understood the submission to mean Clause 34.
Second, reference was made to Mr Saab's affidavit attached to his reply that he denied having dispensed the medicines to Patient Z, did not recall the prescriptions in question and would not have dispensed the alleged medicines. On this basis it was argued that there had been no other breach alleged. Reference was also made to the Commission's case not rising above "inexact proofs" and incapable of satisfying the Tribunal to any Briginshaw standard. It was argued that this was because the Commission called no evidence from the prescribing doctors, no evidence from Patient Z and no evidence from any pharmacists in Mr Saab's Pharmacy other than Mr Morris.
We do not accept these submissions for a number of reasons.
As we have already indicated Mr Saab as a pharmacist and proprietor had a legislative and professional responsibility to assess whether it was lawful, safe and appropriate to dispense a prescription.
Second we found the totality of Mr Saab's evidence as to whether he did or did not dispense medication to Patient Z only served to obfuscate his role in the dispensing of medication to Patient Z.
Mr Saab's affidavit dated 5 March 2020 is to the effect that he did not recall the prescriptions in question and denied dispensing the medications to Patient Z. Under cross examination on 7 August 2020 he said he did not know Patient Z, could not recall if he directly dispensed but it was likely he did provide some of the medications. He also agreed that he was present in the Pharmacy on most of the days that Patient Z received medication.
In subsequent cross examination on 20 August 2020 he stated that it was "possible" that he dispensed prescriptions to Patient Z. At another point in cross examination on the same day he gave evidence that he could not recall every time that he was in the Pharmacy when the medicines were dispensed, but said "it was more likely than not that he didn't dispense some".
Mr Saab gave evidence that he attended the Pharmacy on days when he was not rostered. There is evidence in the form of entries in the drug registers that he was present in the Pharmacy on days when Patient Z was dispensed medication.
Given the difficulties we have identified with Mr Saab's credit we do not believe he has been candid with us in his role in dispensing medications to Patient Z. Nor do we believe that he has been candid as to the true extent of his knowledge about Patient Z.
Many of the medications Patient Z was dispensed were unorthodox. They were not the kind of medications that a pharmacy would have on hand and the evidence suggested that they would need to be specially ordered. Significant sums of money were spent by Patient Z. Mr Saab showed no concern for the therapeutic outcome if Patient Z used all of the medications that were dispensed to him.
Third the patient history for Patient Z shows numerous prescriptions were dispensed at "hospital" with no identified prescriber and no prescriptions were found in relation to Patient Z. Mr Smith said that the absence of prescriptions was unusual. There is no evidence that any other pharmacists ever saw Patient Z.
Fourth, and as the Commission submits, Mr Saab in both his capacity as proprietor and as Pharmacist working at the Pharmacy had a responsibility to ensure that all prescriptions dispensed by the Pharmacy to Patient Z were in a quantity or for a purpose that accorded with the recognised therapeutic standard of what was appropriate in the circumstances.
Patient Z was dispensed with anabolic steroids, benzodiazepines, oestrogen suppression drugs ordinarily used for breast cancer, fertility drugs, human growth hormone and Tramadol for pain relief.
In our view the combination of drugs is indicative that they were being abused, potentially for body building purposes. This is consistent with the views expressed by Ms Croker. The quantities are also in excess of what would ordinarily be prescribed for an appropriate therapeutic purpose and in an appropriate therapeutic quantity.
In our view it was obvious on the face of Patient Z's patient history that the quantity and the purpose of medications dispensed by the Pharmacy to him were not for a recognised therapeutic standard of what was appropriate in the circumstances.
We have no difficulty in concluding that the combination of drugs dispensed to Patient Z by the Pharmacy, including in the quantities dispensed, suggests that the medication was being abused.
We find that particular 116 is proved.
Particular 117 relates to the dispensing of Clomiphene (Clomid). This is a medication which is ordinarily used by women struggling to conceive and is a fertility drug. Along with a number of other medications, Clause 52 of the PTGR applies to Clomiphene.
Clause 52 of the PTGR relevantly provides
Authority required to supply certain restricted substances
(1) This clause applies to the following substances -
…
Clomiphene
…
(2) A person must not supply a substance to which this clause applies unless the person holds an authority under Part 8 to supply the substance.
(3) This clause does not apply to the supply of a substance -
(a) by wholesale, or
(b) by a veterinary practitioner, or
(c) by a pharmacist on the prescription of -
(i) a medical practitioner holding an authority under Part 8 to prescribe the substance, or…
Ms Croker gave evidence that a GP such as the listed prescriber in Schedule Z (Patient Z), Dr W Ng, could not prescribe Clomiphene. Mr Saab gave evidence that he did not think Dr Ng was able to prescribe Clomiphene.
The Dispensing Guidelines set out in this decision indicate that the process of dispensing includes ascertaining the authority of the prescriber to prescribe. Mr Saab did not do this.
We find that particular 117 is proved.
[78]
Complaint 3
Complaint 3 relates to the prescriptions dispensed to Patients A1 - L1 and Clauses 35 and 40 of the PTGR. The prescriptions related to Schedule 4B special restricted substances.
The Commission submits that the prescriptions from Dr Kanthan did not possess adequate directions for use including directions for use consistent with a quantity or purpose that accorded with recognised therapeutic standards.
In addition the prescriptions did not possess a unique prescription number on each form as required for computer generated prescriptions.
As we understood the submission these two matters and the combination of drugs prescribed should have led Mr Saab not to dispense the prescriptions because they appeared to be fraudulently obtained.
The initials "TS" appear on all but one of the prescriptions the subject of Complaint 3. We have no difficulty in finding Mr Saab dispensed these prescriptions.
Mr Saab adopted the same position that he had held in relation to Patient Z, which was that the steroid medications dispensed to Patients A1 to L1 were for a recognised therapeutic purpose namely sports injuries. On the information before us we reject that position. There is no credible or authoritative research that we are aware of which supports that position and nor was Mr Saab able to point to any.
We further find that the specific medication prescribed in the Regenacell prescriptions for Patients A1 to L1 is liable to abuse including by body builders.
Mr Saab contends he spoke to Dr Kanthan about the prescriptions.
As we have indicated we did not find Mr Saab to be a reliable witness, and there is no objective evidence to support his contention that he spoke Dr Kanthan about individual patients and their individual prescriptions.
Equally we found Mr Saab's evidence about his conversations with Dr Kanthan to be unconvincing.
In a statement made on 15 March 2018 Mr Saab stated that he could not recall the precise terms of any conversation he had with Dr Kanthan and could not say whether or not the conversations related specifically to the patients. He believed that the conversations related to confirmation of patients details, the medications to be dispensed and the strength of doses to be dispensed.
Mr Saab's affidavit dated 5 March 2020 referred to two telephone calls. He could not recall the details of which prescription it was but believed it may have been a prescription for Primoteston and/or human growth hormone. This does not really advance matters much given that all the prescriptions for Patients A1 to L1 referenced these medications.
In cross examination Mr Saab was asked about the specific prescriptions dispensed to Patient A1 and B1. In response he said they were confirmed with the doctor that prescribed them. When pressed about this in cross examination he conceded he could not recall if it was for these specific patients or not.
When Mr Saab was again pressed about the two specific conversations with Dr Kanthan to which he had referred as opposed to referring to conversations in general, he said that there had been multiple conversations.
Whatever the true nature of the conversation Mr Saab had with Dr Kanthan we are not satisfied from the evidence that he spoke to Dr Kanthan about individual prescriptions or individual patients or about any aspect of the validity of the prescriptions.
All of the prescriptions were printed on printer generated A4 pieces of paper and not on prescription pads or computer generated prescriptions. The Commission submits and we accept that in and of itself that should have prompted Mr Saab in his capacity as Pharmacist and as proprietor to make further enquires in relation to the appropriateness and validity of those prescriptions, particularly when the prescriptions were for Schedule 4B special restricted substances that are liable to abuse.
Mr Saab gave evidence that it is appropriate for pharmacists to determine the number of repeats based on the duration of treatment, absence any express number of repeats being written by the prescriber for Schedule 4B special restricted substances. [80] This is what was done in relation to a number of the prescriptions.
In relation to the lack of expressly stated repeats Ms Croker gave evidence that repeats for 4B special restricted substances need to be written by the prescriber on the prescription with an interval specified. Although it could be said in this case that the quantity which was prescribed was what was dispensed, a pharmacist does not have that discretion. She was firm in her evidence that for these medications a pharmacist does not have any discretion to change what the prescriber has written. The Pharmacy Board's Guidelines for dispensing repeat prescriptions at one time set outs that this should only occur at the specific direction of the prescriber unless exceptional circumstances exist. There was no evidence that this was the case here.
The Commission submits and we accept that it was inappropriate for Mr Saab to determine the number of repeats based on the dosage frequency, in the absence of any express number of repeats being written by the prescriber. We also accept as submitted by the Commission that this demonstrates a lack of understanding by Mr Saab of his responsibilities as a Pharmacist dispensing Schedule 4B special restricted substances.
The prescriptions with the exception of Patients I 1 and K1 did not have a unique prescription number which could link them directly to the clinical or prescription record of the patient which is required under the Guidelines for Non-handwritten Computer Generated Prescriptions produced by the NSW Department of Health at page 2, paragraph 2(e).
Submissions were made on behalf of Mr Saab that the criteria for computer-generated prescriptions were satisfied because the numbers next to the prescriptions and the corresponding details next to those medications clearly uniquely identify those prescriptions, albeit not with a unique identification number.
In our view this submission is misconceived.
The submission overlooks that if there is not a unique prescription number, then under 2(e) there needs to be a number which uniquely identifies each prescribed medication's details to be printed on the prescription and which can be related to the clinical or prescription record of the patient.
As submitted by Counsel for the Commission the numbers Mr Saab's counsel referred to are consecutive numbering or item numbers that appear on the prescription such as 1, 2 and in some cases 3. Using these numbers would not lead to a particular patient and a particular prescription item in the Regenacell Clinic's records and that's not what is intended by 2(e).
What is intended by 2(e) is a direct reference to the actual patient and the record of the patient. It is a number printed on the prescription which uniquely identifies each prescribed medication's details and, which can be related to the clinical or prescription record of the patient.
The medications in the prescriptions were unusual. They were dispensed in a short time frame. In our view these matters and the combination of anabolic steroids and human growth hormone and the dosages should have caused Mr Saab to be suspicious about the prescriptions and to make further specific enquiries about those prescriptions. In our view he ought to have been concerned about the risk of diversion and he should have raised these concerns for example with the PRU or other regulator.
That said however there are difficulties with how the Commission has framed the particulars for Complaint 3 as it relates to clauses 35 and 40 of the PTGR.
Specifically the Commission pleaded its first sub particular for Patients A1 through to L1 inclusive on the basis that adequate directions for use were not specified in the prescriptions contrary to clause 35 of the PTGR.
Ms Croker's evidence is to the effect that the directions for use were adequate. Mr Saab submits that whilst the directions could have been clearer they were adequate. In our view the sub particular the allegation that adequate directions for use for use were not specified on each of the prescriptions dispensed to Patients A1 to L1 is not supported by the evidence before us and cannot be established.
A further sub particular pleaded for Patients A1 through to L1 is that the relevant prescription appeared to be forged or fraudulently obtained contrary to clause 40 of the PTGR.
The difficulty with this sub particular is that there is no evidence that the prescriptions appeared to be forged or fraudulently obtained. The prescriptions were from a medical practitioner, Dr Kanthan. The evidence indicates that Dr Kanthan intended to issue the prescriptions and did so. Although the Professional Standards Committee found that Dr Kanthan's conduct in prescribing the drugs amounted to unsatisfactory professional conduct, on their face apart from 10 prescriptions not possessing a unique prescription number there was nothing about the form of the prescription which indicated that it they were or appeared to be forged or fraudulent.
The nature and combination of the medications, their potential for abuse should have led Mr Saab to bring his own evaluation to bear on the provenance of the prescription and led him make further enquiries. However that does not rise to evidence establishing that the prescriptions appeared to be forged or fraudulently obtained. In our view this sub-particular is not supported by the evidence before us and cannot be established.
Accordingly we find that particulars, 1a) and c); 2a) and c); 3a) and c); 4a) and d); 5a) and c); 6a) and c); 7 a) and c); 8a) and c); 9a) and c); 10a) and c); 11a) and c); 12a) and c) are not proved.
Particulars 9 and 11, which related to Patients I1 and K1 respectively, fail in their entirety. This is because the prescriptions the subject of these particulars possessed a unique prescription number. As these particulars relied solely on a contravention of clauses 35 and 40 of the PTGR and because we have found these contraventions are not proved, particulars 9 and 11 fail.
We find that for those prescriptions which did not possess a unique prescription number this aspect of the Complaint is established.
Accordingly we find that the following particulars are proved; 1b); 2b); 3b); 4b); 5b); 6b); 7b); 8b); 10b); and 12b). In addition particular 4c) is proved because the prescription was unsigned contrary to Clause 35 of the PTGR.
As a pharmacist and proprietor Mr Saab had a professional responsibility to assess whether it was appropriate to dispense the prescriptions issued by Dr Kanthan.
We find that Mr Saab inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed prescriptions for Patients A1, B1, C1, D1, E,1, F1, G1, H1, J1, and L1 from Dr Kanthan for prescribed restricted substances at the Pharmacy because those prescriptions did not contain unique prescription numbers.
[79]
Complaints One, Two and Three: Unsatisfactory Professional Conduct sections 139B(1)(a) and (l)
The three complaints against Mr Saab are that of unsatisfactory professional conduct. The two avenues identified by the Complaint are sections 139B(1)(a) and/or (l) of the National Law.
The first avenue alleges that Mr Saab's conduct demonstrates that the judgment possessed, or care exercised, by him in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience: see section 139B(1)(a) of the National Law.
The second avenue alleges that Mr Saab engaged in improper or unethical conduct relating to the practice of his profession: see section 139B(1)(l)
In Health Care Complaints Commission v Amalakumar [2019] NSWCATOD 173 the Tribunal referenced the evaluation, assessment or characterisation required of the conduct alleged in order to be established as unsatisfactory professional conduct. It stated at [25] -[26] as follows:
Determining whether the "knowledge, skill or judgment" possessed by a practitioner, or the "care exercised" by a practitioner is significantly below the standard reasonably expected, in order for the elements of s 139B(1)(a) to be established, requires the undertaking of an evaluative process. A benchmark standard which is expected of practitioners in the relevant field must be ascertained, and then the conduct which has been proven against the practitioner the subject of the disciplinary action, must be assessed against that standard. If the conduct is considered to be below the standard arrived at, then a further evaluation must be made as to whether the conduct is significantly below that standard. If that conduct is assessed to be significantly below the standard reasonably expected, then there is no discretion as to whether that conduct is characterised as unsatisfactory professional conduct. The section designates it as such.
In disciplinary proceedings in relation to s 139B(1)(l) of the National Law, the determination of the question as to whether "any other improper or unethical conduct relating to the practice … of the practitioner's profession" has occurred requires the making of findings of fact as to whether the alleged conduct has occurred, and then the characterisation of that conduct as improper or unethical (or otherwise). If the conduct has occurred, and if that conduct is determined to be improper or unethical, then that conduct is inevitably characterised as unsatisfactory conduct by s 139B(1)(l) of the National Law. There is no discretion to be exercised between the finding that the determination that conduct has occurred which is improper or unethical and the characterisation of that conduct as unsatisfactory conduct.
A number of authorities were referred to by the Commission in relation to the obligations of proprietor pharmacists.
In Khodary [2003] NSWPB 4, the Pharmacy Board of New South Wales observed as follows:
It is the view of the Board of Inquiry that an owner can allocate tasks to staff but cannot devolve the owner of the ultimate responsibility for all the activities which are carried on within the pharmacy.
The Act provides for a pharmacist only to own a pharmacy. This ensures that the person directing the business has the knowledge and understanding of legal and ethical requirements relating to the practice of pharmacy and of the profession generally. It also ensures that the owner is directly accountable through their own registration for all activities carried on within the pharmacy.
This view, with which the Board of Inquiry agrees, was encapsulated by the Professional Standards Committee in the case of Walton v Vivienne Lois Beck [1998] NSWPB 8 (9 December 1998):
The ownership of a pharmacy by a pharmacist is a privileged position. The legislation has accepted that this form of exclusive right is granted so as to provide the maximum possible protection to the public. The responsibility of ownership extends to ensure that at all relevant times, suitable procedures, protocols and validation are in place to eliminate professional misconduct in the pharmacy.
In Pharmacy Board of Australia v Tavakol [2014] QCAT 112, in considering a proprietor of a pharmacy's responsibilities for the conduct of employed pharmacists, the Queensland Civil and Administrative Tribunal at paragraph [33] referenced David Loewy and Sandra Loewy v Pharmacy Board of Victoria [1992] VSC 630 (7 December 1992) as follows:
In my view such a responsibility is not capable of being discharged by holding personal belief in the integrity and professionalism of one's employee or partner. It requires supervision and acquaintance with what is occurring at the pharmacy when the relevant person is not present …
In Health Care Complaints Commission v Visvis [2020] NSWCATOD 87 the Tribunal considered the responsibilities of a proprietor pharmacist to ensure compliance with the regulations governing the dispensing and supply of Schedule 8 and Schedule 4D medications and concluded at paragraphs [44] and [46] as follows:
As proprietor Pharmacist Mr Visvis was responsible for the adherence to Regulations concerning the dispensing of Sch 8 and 4D medications. Mr Visvis had direct knowledge of the high strength and increasing volume of Sch 8 medication being dispensed by the pharmacy at the relevant time. The practitioner's failure to ensure that the dispensing of every Sch 8 script was in adherence to the requirement that the dispenser be familiar with the doctor or patient, both in his own dispensing and that of his employees, was very serious…
…the practitioner was not alert, and did not ensure that his employees were alert, to risk factors for opioid misuse and fraud such as: private scripts for PBS medications, high volume and high strength opioids, and inappropriately short intervals between supply.
We are satisfied that the Complaints of unsatisfactory professional conduct are made out for the following reasons.
As a proprietor and pharmacist Mr Saab was responsible for adherence to the PTGR concerning biannual stock checks, the reporting of any losses in drugs of addiction, keeping Schedule 4B prescriptions separate, and the identification of dispensing pharmacists.
The evidence referred to in this decision, including that of Ms Croker indicates that in all these areas the standard expected for a practitioner of equivalent training and experience would be to ensure that all legislative requirements were followed. Mr Saab did not do this. We are satisfied that in all these areas Mr Saab's conduct was significantly below the standard reasonably expected.
The use of a methadone pump by Mr Saab which on his account he believed to be inaccurate is conduct which is also significantly below the standard reasonably expected. The risks to patient safety and health of using equipment which is not accurate in delivering a dose for a potent drug is obvious.
Mr Saab's conduct as particularised in Complaint 1 also amounts to unethical and improper conduct.
Mr Saab failed to report the losses of methadone. This appeared to be explained by him on the basis that it was a calibration issue and he was not required to report it to the Ministry of Health. In our view this is unethical and improper. It reflects a seriously deficient understanding of his legislative responsibilities as a pharmacist.
Mr Saab's failure to ensure that the PTGR mandated biannual stock checks were done appeared to be explained on the fact that he had tasked others to undertake this work. As the proprietor Mr Saab was responsible for ensuring that the practice of pharmacy in his Pharmacy was being conducted properly and that his Pharmacy's operation was in accordance with the PTGR. He should have intervened. It was improper for him not to do so.
Mr Saab's use of a methadone pump for a number of weeks which on his account he believed to be faulty put the safety of patients at risk. It was improper and unethical because he placed his own interests above good patient care.
The separation of Schedule 4B prescriptions should be seen in the context of Patient Z. No prescriptions for the anabolic steroids dispensed to Patient Z were ever located. The legislative requirement is that prescriptions of this nature are to be kept separately for a period of two years. Seen in this light Mr Saab's conduct was also improper and unethical.
Whatever the true reason was for Mr Saab to remove his initials from the dispensing system, it was a decision he was responsible for taking. It was done in his own interests and, in the event that there was an issue with a prescription, without regard to patient safety. It was improper and unethical.
In our view every individual particular which we have found proven in Complaint 1 individually reflects conduct by and of itself which amounts to unsatisfactory professional conduct under both s. 139B(1)(a) and (l) of the National Law.
Turning to Complaint 2, the Dispensing Guidelines produced by the Pharmacy Board of Australia indicate that in dispensing, pharmacists must ensure that prescriptions are valid and that medicines are clinically appropriate for the patient. Mr Saab had an obligation to ensure that the prescriptions dispensed by him and his Pharmacy were valid. He did not do this.
As a proprietor and pharmacist Mr Saab was responsible for adherence to the PTGR concerning dispensing Schedule 8 medications and prescribed restricted substances. He was responsible for being attentive to the obvious risks of dispensing these medications. He was required to bring his professional judgement to bear to prevent the supply of unnecessary and/or excessive quantities of medicines particularly those which have a potential for abuse or dependency. He did not do this.
Ms Croker's evidence was to the effect that the standard expected for a practitioner of equivalent training and experience would be to ensure that all legislative requirements for prescriptions were followed. For Schedule 8 medications it would be expected that extra care and scrutiny be given to a prescription as the medications may be open to abuse and misuse. Mr Saab did not do this.
A pharmacist has a role as a caretaker of prescription medications in the community and should possess the judgment and skill to question where prescribing patterns raise suspicions and to seek further advice or counsel. If there was no role for the pharmacist in this regard, then doctors would be dispensers as well as prescribers. They are not.
A pharmacist should be vigilant in looking out for scams. They should examine all prescriptions critically. They should be especially alert to drugs of addiction because they are subject to abuse and profitable diversion. A pharmacist should attempt to determine why a prescription is atypical. By being watchful for prescription falsification, alterations or irregularities pharmacists can serve in the first line of defence in recognising problematic patterns in prescription drug use. Mr Saab did not do this.
We are satisfied that Mr Saab's conduct in dispensing and failing to ensure that the pharmacists in his employ appropriately dispensed prescriptions for Patients A to Z the subject of Complaint 2 falls significantly below the standard expected. Complaint 2 of unsatisfactory professional conduct under s. 139B(1)(a) of the National Law is established. Indeed in our view the evidence in relation to Patient Z alone establishes unsatisfactory professional conduct under s. 139B(1)(a) of the National Law.
By not bringing professional judgement to bear Mr Saab did not behave ethically to prevent the supply of unnecessary and/or excessive quantities of medicines or products which had a potential for abuse or dependency. He showed no regard for their potential for diversion. He did not act in a way that is consistent with the Pharmaceutical Society of Australia Code of Ethics for Pharmacists (2011). Accordingly Mr Saab's conduct also amounts unsatisfactory professional conduct under s. 139B(1)(l) of the National Law.
Turning to Complaint 3 not all the particulars alleged about the Regenacell prescriptions were proved. However we are satisfied that the complaint of unsatisfactory conduct is still established as it relates to the particulars which were proved.
Prescriptions were dispensed although they did not have a unique prescription number. Ms Croker identified that the standard expected for a practitioner of equivalent training and experience would be to ensure that a computer generated prescription contained a unique prescription number. In her view dispensing a prescription which did not contain a unique prescription number fell significantly below the standard expected. We agree with that view.
We are satisfied that Mr Saab's conduct in dispensing and failing to ensure that the pharmacists in his employ appropriately dispensed prescriptions for Patients A1 to L1 (excluding Patients I1 and K1) falls significantly below the standard expected. Complaint 3 of unsatisfactory professional conduct under s. 139B(1)(a) of the National Law is established.
Mr Saab's conduct was also unethical. All of the prescriptions concerned special restricted substances and which were known for potential abuse. Mr Saab insisted that a legitimate use of the medication was for treating sports injuries although there is no research or published literature to support this. We found this explanation demonstrated that he was more interested in pursuing his own beliefs than providing good patient care. Further he displayed that he had no regard or care for where the special restricted substances his Pharmacy dispensed could potentially land.
We are satisfied that Mr Saab's conduct which we have found proven in Complaint 3 amounts to unsatisfactory professional conduct under both s. 139B(1)(a) and (l) of the National Law.
We find that the three complaints brought against Mr Saab of unsatisfactory professional conduct under both s 139B(1)(a) and (l) are established.
[80]
Complaint Four: Professional Misconduct section 139E of the National Law
Mr Saab denies professional misconduct.
There is no comprehensive exploration in the case law as to when unsatisfactory professional conduct will amount to professional misconduct. The concept as contained in s 139E should be given a purposive interpretation. The Tribunal is required to not only consider the object of the protection of the public but to recognise that object also includes deterring the practitioner, and other practitioners from repeating the same misconduct: see Health Care Complaints Commission v Saedlounia [2013] NSWMT 13 at paragraphs [43] - [50] and Health Care Complaints Commission v Do [2014] NSWCA 307 at paragraph [35].
As explained by Basten JA in Chen v Health Care Complaints Commission [2017] NSWCA 186 the term "professional misconduct" does not have a specific meaning; it is merely a category of "unsatisfactory professional conduct" which is sufficiently serious to justify suspension or cancellation: see paragraph [19]. There is no category of unsatisfactory professional conduct which is not capable, depending on the circumstances, of giving rise to professional misconduct and hence engaging the power of either suspension or cancellation of registration. The only requirement is that it be "sufficiently serious" to justify such an order, a characterisation which must depend upon an evaluative judgment made by the Tribunal: [20].
At [20] his Honour continued:
…Some, perhaps all, categories include conduct which may reveal a defect of character as to which the Tribunal may conclude that the person should not be allowed to practise his or her profession unless at some future date the practitioner is able to satisfy the Tribunal that the defect has been overcome. Incompetence or inadequate care may in some circumstances be remediable by specific steps; in other circumstances the Tribunal may be concerned that the carelessness, for example, is such as to cast doubt on the suitability of the person to practise medicine. Each of the criteria for cancellation or suspension may be analysed in this way. Each case will depend upon an evaluative judgment to be made by the Tribunal as to the nature and seriousness of the conduct….
It is the seriousness of the nature of the conduct which is found to have been established which is relevant to professional misconduct.
Mr Saab's unsatisfactory professional conduct is of a sufficiently serious nature to fall within the definition of "professional misconduct" pursuant to s 139E of the National Law for the following reasons.
Mr Saab chose to deny any responsibility and he has maintained that position. On occasions he blamed others including other pharmacists and pharmacy assistants. We found the forensic evidence against him to be compelling.
Mr Saab's conduct encompassed significant and ongoing breaches of his obligations as both a proprietor and as a Pharmacist in relation to the PTGR. Such breaches included the dispensing of Schedule 4B and D and Schedule 8 medications and permitting high quantities of opioids including high strength Oxycodone, high strength Fentanyl and benzodiazepines, such as Diazepam in high quantities and high strength Alprazolam, to be dispensed on forged prescriptions, in excessive quantities and as private prescriptions to numerous patients over a period in excess of two years.
Mr Saab failed to report losses in methadone. He failed to undertake accurate stock checks for methadone. He continued to use a methadone pump which on his account he did not believe was accurate. He put the safety of patients at risk by not receiving the correct dose.
The PTGR sets out stringent statutory requirements in relation to the storage, handling and record keeping for drugs of addiction. It sets out what is required when dispensing prescriptions. These requirements include the content or the kind of information which a prescription must include, its form, provisions as to supply on prescription, and that quantity and purpose on supply to be appropriate. These Regulations exist to manage and address the very real risks to patients and the public more broadly in dispensing drugs of addiction.
The Guidelines for Proprietor Pharmacists issued by the Pharmacy Board of Australia (December 2010 and reissued in more detail in September 2015) focus on the professional responsibilities of proprietor pharmacists that impact on the safe, effective delivery of services to the public to ensure that the pharmacy business is conducted properly.
A pharmacist who is a proprietor must maintain and be able to demonstrate an awareness of the manner in which their pharmacy business is being conducted and, where necessary, intervene to ensure that the practice of pharmacy is conducted in accordance with applicable laws, standards and guidelines. A failure to be attentive as to whether statutory requirements, standards and guidelines are being adhered to diminishes this protective structure.
Pharmacists act as our caretakers in the community in the responsible and lawful dispensing of Schedule 8 medications and drugs of addiction and special prescribed restricted substances. It is their compliance with the protective architecture to which the Regulations and Guidelines are directed which ensure the safe benefits of such medications to individual patients and the community as a whole. As a proprietor and pharmacist Mr Saab failed to ensure that these requirements were met.
Through his Pharmacy Mr Saab dispensed substantial quantities of prescription opioids and anabolic steroids that were not for a therapeutic purpose. The gravity and repetition of his conduct for some 38 patients and over a prolonged period from January 2015 to March 2017 is conduct of a nature which strikes at the heart of public confidence in the pharmacy profession as caretakers of prescription opioids and special prescribed restricted substances.
In our view without clinical justification and contrary to the interests of patients Mr Saab's conduct put the welfare of patients at risk and, because arguably the drugs have been made available in the community, to the public in general. There was no exercise of judgement or ethics by Mr Saab to protect patients and the public from the risk of oversupplied or misappropriated opioids and special restricted substances.
In our view the conduct which we have found proven in Complaints One, Two and Three is individually so serious that each complaint in and of itself amounts to professional misconduct.
We have no difficulty in being satisfied that the complaint of professional misconduct which forms Complaint Four is proved.
[81]
Stage 2 Proceedings
As indicated in paragraph [43] of this decision, these reasons only deal with stage one of the process. An order will be made listing the matter for directions with a view to fixing a date for the hearing of stage 2, at which point a consideration of the appropriate protective orders will be undertaken.
[82]
Orders
1. The complaints of unsatisfactory professional conduct and professional misconduct are proved.
2. The proceedings are listed for directions on 18 December 2020 at 9.00am.
[83]
I hereby certify that this is a true and accurate record of the reasons for decision of the New South Wales Civil and Administrative Tribunal.
Registrar
[84]
Endnotes
Transcript 26.06.2020 p175 lines 19-26
Transcript 26.06.2020 p176 lines 3 to 7
Transcript 26.06.2020 p177 lines 33 to 46
Transcript 26.06.2020 p181 lines 1 to 18
Transcript 26.06.2020 p132 lines 14 to 31
Transcript 26.06.2020 p133 lines 14 to 22
Transcript 26.06.2020 p138 lines 21 to 29
Transcript 26.06.2020 p181 lines 27 to 32
Transcript 26.06.2020 p182 lines 26 to 35.
Transcript 25.06.2020 p78 lines 18 to 27
Transcript 26.06.2020 p185 lines 16 to 38
Transcript 26.06.2020 p192 lines 8 to 11
Transcript 26.06.2020 p192 lines 28 to 34
Transcript 26.06.2020 p232 lines 42 to 50 & p233 line 1
Transcript 28.08.2020 p651 lines 4 to 9
Amended on 2 June 2017 to reflect 2017 regulations.
Transcript 20.08.2020 p417 lines 45 to 50 & p418 lines 1 to 16
Transcript 26.06.2020 p143 lines 11 to 23
Transcript 20 August page 407, lines 1- 9
Transcript 7 August pages 329 - 330.
Transcript 27 August pages 535-536
Transcript 25.06.2020 p69 lines 44 to 48 & p70 lines 1 to 26
Transcript 25.06.2020 p70 lines 35 to 41
Transcript 25.06.2020 p70 lines 35 to 41
Transcript 25.06.2020 p71 lines 11 to 41 & p 72 lines 1 to 25
Transcript 25.06.2020 p72 line 46 & p73 lines 1 to 3
Transcript 25.06.2020 p72 lines 11 to 23
Transcript 25.06.2020 p73 lines 32 to 50
Transcript 25.06.2020 p74 lines 1 to 19
Transcript 25.06.2020 p74 lines 21 to 32
Exhibit A9, page 3
Exhibit A1 Tab 51, pages 17 and 18
Exhibit A1 Tab 51, pages 19 and 20 and Tab 9, page 37 were a more legible copy can be found
Exhibit A1 Tab 51, page 21
Exhibit A1 Tab 51, page 22
Exhibit A1 Tab 51, page 24 and a duplicate at page 25
Exhibit A1 Tab 51, page 32 and Tab 9, page 23
Exhibit A1 Tab 51, page 38 and Tab 9, page 18
Exhibit A1 Tab 51, pages 26 and 27
Exhibit A1 Tab 51, page 37
Exhibit A1 Tab 51, page 29
Exhibit A1 Tab 51, page 33
Exhibit A1 Tab 51, page 31
Transcript 20.08.2020 p 382 lines 3 to 31.
Transcript 26.06.2020 p147 lines 6 to 14
Transcript 26.06.2020 p147 lines 20 to 39
Transcript 20 August 2020 at pages 379 -380 lines 41 - 50 and lines 1-10
Transcript 20 August 2020 page 383 line 10.
Transcript 20 August 2020 pages 383-4 lines 35 -50 and lines 1-2
Transcript 26 June 2020 pp170-171 lines 36 to 50; lines 1 to 17
Transcript 7 August 2020 p290 lines 18 to 48
Transcript 26.06.2020 p 179 lines 49 to 50 and p.180 lines 1 to 8
Transcript 26.06.2020 p 180 lines 14 to 18
Transcript 7 August 2020 pp 337-338 lines 42 to 50 and 1 to 5;
Exhibit 1A Tab 20 p1
Tab 21, page 120
Tab 21, page 117
Tab 21, page 116
Tab 18, page 1, Tab 18, page 36, Tab 18, page 40
Tab 18, page 22
Tab 18, page 17
Tab 18, page 11, Tab 18, page 23, Tab 18, page 43
Tab 18, page 12
Tab 18, page 19
Tab 18, page 26
Tab 18, page 30, Tab 18, page 44
Tab 18, page 18
Tab 18, page 3, Tab 18, page 26
Tab 18, page 4, Tab 18, page 34
Tab 18, page 18
Tab 18, page 42
Tab 18, page 39
Tab 18, page 35
Tab 18, page 21
Tab 18, page 10, Tab 18, page 33
Tab 18, page 47
Tab 18, page 22
20.08.2020 p 382 lines 3 to 31.
I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales.
Registrar
DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated.
Decision last updated: 11 December 2020
Mr Morris was challenged in cross examination that the only time he raised a discrepancy with Mr Saab was in November 2015. Mr Morris's evidence was to the effect that it could have been on more than one occasion but he could clearly recall the time in November.
No stock checks were done at all in any month in 2016. The next stock check that was done occurred on 29 January 2017 which was done by Mr Saab. This recorded a loss of 2,579 millilitres and is the subject of particular 2 above.
Mr Saab's evidence contained in his affidavit was to the effect that Mr Morris was in charge of ordering and maintaining an accurate inventory of methadone. He denied that Mr Morris raised the issue of methadone on more than one occasion. On the one occasion Mr Morris did raise it, which in context appears to be November 2015 Mr Saab stated he took steps to calibrate the pump. He stated Mr Morris did not inform him and he was unaware, that he had stopped doing the bi-annual stocktake.
Particular 4
4. Between 9 March 2017 and 30 March 2017, the practitioner failed, refused or otherwise neglected to replace or recalibrate the methadone pump at the Pharmacy in circumstances where he was aware that the methadone pump required recalibration.
Particular 4, alleges Mr Saab failed to replace or recalibrate the Methadone pump at the Pharmacy between the period of the first PRU inspection on 9 March 2017 and the s.150 hearing held with the Pharmacy Council on 30 March 2017.
The background to this particular is that when the loss of methadone was raised with Mr Saab by the PRU in the course of their inspection on 9 March 2017, he responded that he believed that the Methadone pump required recalibration.
When the issue of the accuracy of the Methadone pump was discussed at the s.150 proceedings, Mr Saab revealed that he had continued to use the same pump. He had ordered a new pump at the end of the week prior to the s.150 hearing but it had not yet arrived
Mr Saab explained his continued use of the pump to the Council on the basis that this was what he was instructed to do by an officer of the PRU.
Mr Saab held to this explanation as to why he continued to use a pump which he believed was faulty. It became a significant point of controversy before us.
During the s150 hearing, Mr Saab gave evidence in relation to the Methadone pump and the advice given to him by the PRU as follows:
Mr Saab: Yes. We've ordered a new one but under instructions from Mr Gavrilovic at the time - because I said to him, "I think it's the pump," and now you - sorry, he said, "continue using it until you receive further information from us." So I was assuming maybe he wanted to see how we went for the next couple of weeks or so, to see if these discrepancies continued.
…
Mr Sinclair: I don't think that's quite what he meant. Do you think he would potentially put people at risk by using a poorly or non-calibrated pump to see if in a month's time there was ---
Mr Saab: And I asked him repeatedly, I said to him, "Are you sure?" and he said to me, "Just continue doing what you're doing and we will be in contact." Now, I don't know if he meant that in the sense that, "I'll let you know by the end of today or tomorrow or" ---
Mr Sinclair: Did that cause any concerns for you, given that you'd said to him, "I think the pump's not right"?
Mr Saab: Yeah, but that's the reason why we've had a number of conversations since.
Mr Saab's affidavit dated 5 March 2020 lodged in these proceedings relevantly stated as follows:
On 9 March 2017, officers from the PRU inspected the pharmacy. I conducted a stock check on the methadone pump and found the records were not accurate. I had a discussion with Aleksander Gavrilovic about my recent attempt to calibrate the pump and expressed the view that, rather than calibration, there must be an issue with the pump itself. Given the issues with the pump were persisting I decided to order a new pump. Gavrilovic told me to continue to use the pump in the meantime. Accordingly I did so until I was suspended on 30 March 2017.
During the Commission's cross examination, Mr Saab gave oral evidence about the recalibration and replacement of the methadone pump between the first PRU inspection of the Pharmacy on 9 March 2017 and the s150 hearing on 30 March 2017 as follows:
Q. Mr Saab, did you have concerns about the calibration of the methadone pump at the time of the PRU inspection?
A. At the time of the PRU inspection the representatives from the PRU did a stock check on the methadone and found a discrepancy and after they found the discrepancy I had concerns about the calibration of the methadone pump.
Q. And yet your pharmacy continued to use that pump?
A. Under the instructions of the PRU [1] .
…
Q. Mr Saab, regardless of what the PRU told you, you yourself as proprietor of the pharmacy had a responsibility at the time of the PRU inspection to ensure that the methadone pump was accurate?
A. I worked together with the PRU to come up with a reasonable or acceptable way to deal with the problem [2] .
…
Q. And you were concerned at the time of the PRU investigation at your pharmacy about the accuracy of your methadone pump being used?
A. When I was made aware of the discrepancy in the methadone.
Q. Yes?
A. At the time of the PRU investigation I made sure that we took steps in collaboration with the PRU to ensure that the problem would be solved, which included ordering a new pump [3] .
…
Q. Using the same pump that you had concerns about while you were waiting for the new pump?
A. Yes.
Q. That was not appropriate, was it, Mr Saab?
A. Following instructions from the PRU is not appropriate?
Q. Mr Saab, it was your responsibility?
A. I was under instructions from the PRU.
Q. Mr Saab, you yourself had a responsibility to ensure that the methadone pump was accurate at the time of the PRU inspection in March of 2017?
A. Like I said, after they found the discrepancy in the methadone we worked together to come up with a solution which wouldn't interfere with providing medicines to our patients that required their daily medication dose of methadone, but to also ensure that these discrepancies would not happen in the future, which included the purchase of a new pump.
Q. But, Mr Saab, do you agree that it was your responsibility as pharmacist and proprietor to ensure at the time of the PRU inspection and afterwards that the pump was accurate for the methadone?
A. As I have previously stated, at the time that the methadone was found to be inaccurate, we took steps together, I took steps together with the PRU to ensure that this problem would be solved. I was under the instructions of the PRU.
…
Q. And the pharmacy continued during that period to use a pump that was not accurate?
A. Under the instructions of the PRU we were required to continue to use that pump
Q. Mr Saab, you placed the health and safety of your methadone patients at risk by continuing to use at the pharmacy a pump that in your mind was not accurate?
A. I don't agree with that.
Q. You were sufficiently concerned during the section 150 hearing to acknowledge some of those concerns about the accuracy of the methadone pump at that time, that's right, isn't it, Mr Saab?
A. At the time of the section 150 hearing we were still taking steps to resolve the issue in regards to the methadone pump.
Q. Because it had not been resolved?
A. I was working together with the PRU to resolve the issue.
Q. But it had not been resolved, Mr Saab, had it?
A. At the time of the section 150 hearing, no. [4]
Prior to the listing of the matter for hearing Mr Saab had not indicated in any directions hearing, in any correspondence to the Tribunal or to the Commission that the officer from the PRU whom he claimed had instructed him to continue to use the pump, whom in context appeared to be Mr Gavrilovic, was required for cross examination.
A significant amount of hearing time was taken up in relation to the issue of the advice Mr Saab says he was provided by officers of the PRU. Indeed Mr Saab advanced claims for the first time at the hearing that officers of the PRU had also told him to remove his initials in the Pharmacy dispensing system. The removal of Mr Saab's initials from the dispensing system forms particulars 6 and 7 and is dealt with in detail below at paragraphs [124] to [144].
In this context, during the course of the hearing and over objections, the Commission was granted leave to obtain witness statements from Mr Gavrilovic and Mr Smith, who were employed by the PRU at the time of the Pharmacy's inspections. Both were required for cross-examination by Mr Saab. Their statements became exhibits in the proceedings. A Summons during the hearing was also issued by Mr Saab for the PRU's documents in relation to the inspection of the Pharmacy.
Both Mr Gavrilovic and Mr Smith denied advising Mr Saab to continue to use a faulty pump.
Pursuant to the Summons issued by Mr Saab to the PRU documents were tendered which included a file note from Mr Gavrilovic dated 22 March 2017 in relation to a conversation that he had with Mr Saab that same day. It recorded:
"Mr Saab tried, at length, to justify the "missing" Methadone in his Drug Register, blaming a faulty pump on the issue. I advised him to check the pump, calibrate it and clean it regularly and to replace the pump if he believes it to be faulty, otherwise his patients will be being overdosed."
In oral evidence, Mr Gavrilovic responded to the suggestion that he had instructed Mr Saab to continue to use the methadone pump and that Mr Saab was working with the PRU to address the problem cause by the pump:
…no instructions were given to him at any of those meetings or conversations about him using or not using a pump. You asked the question of Mr Saab, 'Regardless of what the PRU told you, you yourself as proprietor of the pharmacy had a responsibility at the time of the PRU inspection to ensure that the methadone pump was accurate?' The response from Mr Saab was, 'I worked together with the PRU to come up with a reasonable or acceptable way to deal with the problem'. I don't understand the answer to that because that's not true, we have not worked together with Mr Saab. I don't understand what he means by that. I'm not a partner in his business and I can only offer him general advice and instructions to comply with the law. I can't solve his professional issues such as choosing to use a pump. … His answer was he looked to the PRU to come up with away to resolve the issue and I can again deny that we have ever offered to work with anybody to come up with a way to resolve the issue. The issue in question for the PRU was that there was an apparent discrepancy in the balance of methadone found at the pharmacy and our expectation was that Mr Saab will reconcile the potential loss of nearly 3 litres of methadone. It wasn't, we did not offer to try and solve any pump issues. Further down, Mr Saab again elected that at the time of the PRU investigation, he says, 'I made sure that we took steps in collaboration with the PRU to ensure that the problem would be solved, which included ordering a new pump' and this was in reference to stock checks that were found in November 2015 and also January 2017 where there were discrepancies noted in the PRU report. And I guess my statement there is if he knew in 2015 and 2017 that he needed to take steps to have the pump cleaned and recalibrated to ensure that discrepancies wouldn't occur again, why did he suddenly need the PRU to tell him how to fix the problem in 2017 when we revisited him? He cleaned and calibrated the pumps then and we told him nothing different in 2017. Again, a number of times it was said he was acting under instructions of the PRU. This is not true, we did not instruct him about using the pump.
…
Yes, I think I have one more comment. I think it's a question by Ms Petrie which says, 'Between 9 March when the PRU inspection and 30 March 2017 in the section 150 hearing the only steps that you have taken in relation to the methadone pump was to order a new one. That was yet to be delivered', and the answer from Mr Saab was, 'I went through a number of ways to resolve the issue with the PRU and then neither of them worked. We decided on purchasing a new pump'. I don't understand what these ways of resolving the issue were and why they didn't work, because again I state we offered him no solution to what he would do with his pump. I take the other opportunity to say that the use of a pump or any measuring device is not stipulated in the Poisons and Therapeutic Goods legislation and therefore is not in our remit. That is specified under the National Law and the equipment that he uses can be found in the various regulations under the National Law. It is not something that Pharmaceutical Regulatory Unit would be involved with other than offering general advice to any pharmacist offering OTP's that they must ensure they deliver that accurately and using appropriate equipment.
Mr Smith also gave evidence in his statement and orally that he had not instructed Mr Saab to use a pump which was believed to be faulty.
As previously indicated Mr Saab gave evidence during the hearing that the loss of methadone related to a minor discrepancy in the pump resulting in a loss less than 1% and the Pharmacy had approximately 40 methadone patients.
The Commission's expert Ms Croker gave evidence under cross examination in relation to this issue as follows:
Q. I want you to assume that the inaccuracy of that pump is between 0.6 per cent and 1.5 per cent?
A. Okay.
Q. The manufacturer's stated accuracy of the pump, okay. In those circumstances would you accept that operating a pump within that manufacturer's range would be entirely acceptable?
A. I accept there may be some margin of error when you're dispensing methadone, however I - regardless of the percentages and when the -1 know that there was a reference to less than 1 per cent of the entire doses of methadone. The volume overall, though, was still very large, 869 mis and then I think a further 2500 something, 79, something like that, which is a very large amount of methadone which was missing. And whether it was to do with the pump or not, that should have been picked up. You need to do six monthly, at a minimum six monthly checks. When you're dispensing a lot of methadone the Guild recommendation is at least monthly checks for this exact reason, so you can see at an early date if there is any discrepancy between the methadone - if the pump is, for whatever reason, not 100 per cent accurate and you can act on that immediately. To be getting those sort of volumes as a discrepancy is concerning because it would - you would expect that means those checks were not done very frequently, that the balance checks were not being undertaken frequently for that kind of volume to be eventually noticed as missing. [5]
…
Q. I'm not suggesting you're saying this, I'm just asking whether you're saying this. Are you saying that if a pharmacist operates a pump, a methadone pump, with a degree of accuracy that is within the accepted manufacturer's range, that by operating that pump the pharmacist is falling or acting in a manner that is significantly below the standard expected of that pharmacist?
A. I am saying that they might be depending on other factors, including in legislation around stock checks and in the guides as well, how frequently are the stock checks. Unfortunately the legislation does not have any margin of error. There is no allowance for one per cent or any other per cent of S8 medication to be missing. It states in the legislation that you must report any discrepancy. [6]
Under re-examination by the Commission, Ms Croker went on to give evidence about the quantities provided by manufacturers for methadone as follows:
Q. When methadone is supplied by a manufacturer to a pharmacy, is the quantity written on the bottle of methadone accurate?
A. My understanding is that most bottles of any liquid, but of methadone, would have a slight overage, so if there was - to allow for perhaps one small drip or a few very small. I don't an exact, I don't think it's a standard quantity as such but it would be accurate or potentially slightly more than what was in the volume written on the bottle. It would not be less. [7]