Health Care Complaints Commission v Salloum [2025] NSWCATOD 16 | Case summary

Health Care Complaints Commission v Salloum [2025] NSWCATOD 16 | Case summary | Zoe

Introduction and overview

This matter concerns an application by the Health Care Complaints Commission (the Commission) under the Health Practitioner Regulation National Law (NSW) (the National Law) for disciplinary findings and orders with respect to a complaint (the Complaint) against the respondent Amine Abi Salloum, a registered pharmacist (the practitioner).
The Commission determined to prosecute the Complaint pursuant to s 90B(1) of the Health Care Complaints Act 1993 (NSW) (the HCC Act), alleging that: 1. the practitioner is guilty of unsatisfactory professional conduct within the meaning of s 139B(1)(a) of the National Law (conduct significantly below reasonable standard) with respect to the dispensing of medications concerning nine patients, with particularised grounds for each patient (Complaint One); and 2. the practitioner is guilty of professional misconduct within the meaning of s 139E of the National Law (Complaint Two).
The Complaint alleged that the practitioner, in his capacity as a pharmacist or as the proprietor of a pharmacy in Newtown (the Pharmacy), dispensed drugs listed in Schedule 8 (Schedule 8 drugs) of the Poisons and Therapeutic Goods Regulation 2008 (NSW) (the PTGR) and drugs listed in Schedule 4D (Schedule 4D drugs) of the PTGR to various patients on the dates and in the quantities set out in Schedule B to the Complaint. It was alleged that the dispensing of these drugs in the period from 16 April 2020 to 11 April 2022 was contrary to cl 109 of the PTGR in that the drugs were supplied in quantities and/or at intervals that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Further allegations included that: 1. in circumstances where certain prescriptions were defaced and/or appeared to be forged or fraudulently obtained, and contained matters that should make a pharmacist suspicious (referred to as "red flags"), the practitioner failed to contact the purported prescriber to confirm the legitimacy of the prescriptions before dispensing; 2. the practitioner, in his role as proprietor, failed to implement measures such as having policies and procedures in place to reduce the risk of dispensing forged and fraudulent prescriptions; 3. the practitioner, in his role as proprietor, failed to conduct stock checks of buprenorphine and methadone and this was contrary to cl 118(2)(a) of the PTGR, failed to ensure that the Drug Register at the Pharmacy was kept in accordance with the PTGR to detect discrepancies for certain drugs including buprenorphine and methadone, and failed to ensure that the registers did not fall into a negative balance; and 4. the practitioner, in his role as proprietor, failed to report the loss of methadone to the Pharmaceutical Regulatory Unit for 10 entries relating to "spillage", and this was contrary to cl 124 of the PTGR.
The Commission relied upon the opinion of an expert Consultant Pharmacist whose credentials and comprehensive report were not challenged by the practitioner, and sought orders to have the practitioner's registration cancelled, with a non-review period of two years.
The Commission initially also sought an order prohibiting the practitioner from providing health services for a period of two years but subsequently withdrew that proposed order. The Commission also sought an order for costs.
The practitioner filed a Reply to the Commission's Complaint admitting that he is guilty of unsatisfactory professional conduct pursuant to s 139B(1)(a) of the National Law in respect of the particulars to Complaint One (with two exceptions), thereby admitting that his conduct fell significantly below that expected of a practitioner of equivalent training or experience.
He also admitted that, when considered together, the allegations in relation to Complaint One are sufficient to constitute professional misconduct pursuant to s 139E of the National Law, for the purpose of Complaint Two.
The practitioner's position was that the Tribunal should find each of the allegations proven and that the proven conduct amounted to unsatisfactory professional conduct and professional misconduct. However, the practitioner argued that any protective orders should not include cancellation of his registration, and proposed that a number of conditions be imposed upon his registration.
After hearing and considering all the relevant evidence, we find the subject matter of Complaints One and Two to have been proven.
We are satisfied that the practitioner's practice of pharmacy fell significantly below the standard reasonably expected under s 139B(1)(a) of the National Law, and that his conduct demonstrably reached the threshold of professional misconduct under s 139E of the National Law.
We are also satisfied that his conduct was very serious over an extended period of time and, apart from the practitioner's own assertions that he will not repeat the conduct, there is no independent corroborative evidence to persuade the Tribunal that he is reformed in character and behaviour. Accordingly, for the protection of the public, and for the purpose of deterring other practitioners from engaging in such conduct and thus maintaining public confidence in the profession, anything less than cancellation of his registration would be inadequate.
However, acknowledging the practitioner's frank appraisal of his conduct and efforts to educate himself and correct the identified deficiencies in his practice, we consider that a non-review period of two years goes beyond what is reasonably necessary to promote the protective purpose of the National Law. We are of the view that one year is appropriate.
This will allow the practitioner the opportunity to further reflect upon his personal circumstances and, in particular, the aspects of his character and behaviour that caused him to fail to exercise his own independent decision-making. In particular, he failed to exercise professional autonomy when assessing and verifying prescriptions for their legitimacy and assessing whether the requested medications accord with the recognised therapeutic standard of what is appropriate in the circumstances.
We do not propose to order the practitioner to undergo formal psychological counselling or therapy. However, we strongly recommend that he seeks professional assistance to gain insight into his personal circumstances and develop strategies to put in place as protective factors against lapsing into his previous conduct and behaviour.
The non-review period of one year will enable the practitioner to continue with his Continuing Professional Development (CPD) and further consolidate his knowledge of the National Law and the PTGR, his understanding of opioid dependency and misuse, and the risks associated with diversion of dangerous drugs into the black market.
At the end of the non-review period, the practitioner will be eligible to seek to be reinstated to practice in the profession, demonstrating his avowed passion to pursue that career path.
We also order the practitioner to pay the applicant's costs of these proceedings.

[9]

Family, education and employment history

The practitioner is currently 40 years of age, and is married with four children. He came to Australia from Lebanon when he was a child of 2 years of age, and then returned to Lebanon with his family when he was around 8 years old and completed his secondary schooling in Lebanon. He returned to Australia when he was around 17 years of age and decided to embark on a career in pharmacy.
After gaining admission at the University of Western Sydney to study Medical Science, he met the woman who was to later become his wife. He was then accepted into University of Sydney to study pharmacy but decided to study at the University of Newcastle, along with his wife who pursued a Bachelor of Public Health and a group of friends. Throughout his university study, the practitioner returned to Sydney on weekends to work part-time.
He obtained a Master of Pharmacy in 2010 and relocated to Sydney with his then fiancée to get married. He took on a full-time pharmacy assistant role at a pharmacy in Condell Park and, according to his statement, he enjoyed the pharmacy setting because of the professional relationship with direct customers.
After obtaining provisional registration as a pharmacist, the practitioner completed his internship year at the Condell Park pharmacy and became a registered pharmacist on 24 January 2013.
He then moved to another pharmacy in Revesby owned by the same proprietor of the Condell Park pharmacy, and was promoted to Pharmacy Manager. He worked between both the Condell Park and Revesby pharmacies, as required.
The practitioner and his wife welcomed their first baby in late 2015, a second baby in April 2017, a third in September 2018 and then a fourth child in June 2020.
In April 2016, he commenced discussions with the proprietor of the Pharmacy (in Newtown) and settled on his purchase of the business in December 2016.
The practitioner's registration as a pharmacist was suspended by the Pharmacy Council of NSW (the Council) on 10 June 2022 (discussed below).
The practitioner subsequently sold the Pharmacy in October 2023 and no longer holds any financial interest in any pharmacy business.

[10]

Background to the Complaint

As part of the audit program conducted by the Ministry of Health NSW on pharmacies and methadone clinics that deliver Opioid Treatment Program (OTP) services, the Pharmacy (in Newtown) where the practitioner was both the pharmacist in charge and proprietor, was inspected by the Pharmaceutical Regulatory Unit (PRU) on 11 April 2022. According to the Ministry's database, the Pharmacy was an active dosing point for 46 patients, 10 of whom were on buprenorphine and 36 on methadone.
According to reports obtained from SafeScript NSW, large quantities of oxycodone 80 mg tablets and Fentanyl 100 mcg transdermal patches had been supplied by the Pharmacy.
The PRU inspection identified that large numbers of forged prescriptions for Schedule 8 drugs had been dispensed and that there were many examples where large quantities of Schedule 8 opioids and psychostimulants had been supplied in large quantities in single transactions. The inspection also observed the non-compliant storage of drugs of addiction.
During the inspection, the practitioner advised that the Pharmacy had only recently experienced an influx of around 15-18 OTP patients and that the Pharmacy was at capacity, unable to take on any new patients for the program. On the day of the inspection, the practitioner was working in the Pharmacy, with an additional pharmacist on duty.
When the inspectors arrived at the Pharmacy, they observed that the drug safe was unlocked, with the key left on the door of the safe. The safe was not bolted to the floor. They learned that the key to the drug safe was kept "hidden" in the Pharmacy after hours. They also observed that Schedule 8 drugs of addiction including methadone, buprenorphine, fentanyl and oxycodone were stored in a metal filing cabinet instead of the drug safe. At the time of the inspection, drugs of addiction had been left on the floor in the dispensary and methadone was left on the dispensary bench when not in immediate use.
The inspectors seized duplicate Schedule 8 prescriptions and accessed the drug register and dispensing records.

[12]

Council's suspension of registration under s 150 of the National Law

On 2 June 2022, the PRU wrote to the Council with the full investigation report of their findings. The report alleged that "Mr Salloum has systematically ignored the regulatory framework in which a pharmacist is expected to operate, including serious non-compliance with the PTGR and expected compliance with professional standards, with the effect that his ongoing poor practice has provided unacceptable risks to the patients concerned and the general community."
Under s 150 of the National Law, the Council must, if at any time it is satisfied it is appropriate to do so for the protection of the health or safety of any person or persons, or if satisfied the action is otherwise in the public interest, suspend a health practitioner's registration or impose conditions on the practitioner's registration. Action taken under s 150 is interim in nature pending further review.
The Council convened an urgent hearing on 9 June 2022 to consider whether it was appropriate to take action under s 150 of the National Law in respect of the practitioner for the protection of the safety or health of the public or otherwise in the public interest.
The practitioner attended the s 150 hearing, with support from his legal representative. He provided a letter dated 8 June 2022 (Submission to the Council), addressing a number of issues identified by the PRU and setting out the remedial action he had taken. Overall, the practitioner acknowledged that his practice as a pharmacist and proprietor of the Pharmacy was deficient and that he had not exercised thorough diligence in dispensing drugs of addiction. He said that he was extremely upset and "in awe" as to how far his practice had fallen short of acceptable standards.
During the s 150 hearing, the practitioner acknowledged that, with hindsight, he had not been sufficiently aware of his responsibilities as a pharmacist. With respect to his dispensing of a very large amount of opiates (amounting to an Oral Morphine Equivalent Dose (OMEDD) of 1643 milligrams daily) to Patient A, the practitioner conceded that he was too quick to believe and trust the patient and the doctor.
With respect to the dispensing of two and a half years' worth of testosterone in one day to the same patient, the practitioner said he relied on the doctor monitoring the patient who practised body building as a sport. The practitioner said that the illegality of dispensing hormones for body building was not particularly addressed during his university education, and that although he had questioned the prescriptions, he didn't scrutinise them enough and was easily swayed by the pressure from doctors.
The Council questioned the practitioner about his knowledge of the abuse of opiates on prescription and the contribution by pharmacists to the illicit drug market. The practitioner's response was that he was not sufficiently aware of the worldwide problem with prescription opiates. He also said that he understood the purpose of the OTP Program but that he didn't know until recently that he should dispense other central nervous system medications along with OTP.
The Council was very concerned that it appeared the practitioner had not considered diversion of drugs into the illicit drug market when the "man in the street" would realise that the level of dosing being dispensed in single transactions in this case was well beyond the level of appropriateness.
Another matter of concern was that the practitioner admitted that he did not know until shortly before the s 150 hearing that OTP patients were not permitted to be prescribed Schedule 8 or Schedule 4D medications without the knowledge and approval of the authorised OTP prescriber. Due to his lack of knowledge about this restriction, the practitioner had dispensed benzodiazepines and opioids to multiple OTP patients on multiple occasions. This was done in breach of the NSW Opioid Treatment Program Community Pharmacy Dosing Point Protocol.
The Council expressed its concern in its written reasons at paragraph 23, that the practitioner's dispensing of other Schedule 8 medications to patients on the OTP program in fact contradicted and worked against the purpose of the program: "It is extremely concerning to us that Mr Salloum stated that he understands the purpose of the OTP program, which is intended to help people overcome or at the very least manage their dependence, yet he did not realise that taking such medications in addition to their buprenorphine or methadone was completely defeating the purpose."
The Council expressed the view that the practitioner's attention was focused on the business aspects of the Pharmacy without consideration of the health and safety of his patients or diversion to the general public via the black market: "Again, we formed the view that Mr Salloum's [sic] has focused his attention to the business aspects of his pharmacy without any consideration of the health and safety of his patients or indeed the general public who may have gained their supplies of illicit substances from his patients."
The practitioner's lack of knowledge of the regulations which are basic to the practice of pharmacy was expressly noted, particularly since many of the regulations he had breached were considered to be matters that were known by the average person on the street: "We are most concerned that he stated throughout that he didn't know the regulations which are basic to the practice of pharmacy. A newly registered pharmacist is expected to know them and he, as a graduate of 12 years standing, should have been practising in accordance with them, so they are second nature to him."
The Council formed the view that the practitioner's actions were considered and deliberate.
In explaining his degree of inattention over a period of two years, the practitioner noted that the Pharmacy had been handed over to him in unusual circumstances where the previous proprietor was terminally ill and passed away, and another pharmacist who was supposed to help with the handover process failed to provide even one hour of familiarisation with the Pharmacy. The practitioner said he felt he had been "left in the dark". Further, he noted the impact of the COVID pandemic, as having created a sense of havoc amongst communities, and how doctors were overwhelmed in the circumstances. The practitioner also acknowledged a lack of self-confidence on his part, that he had prematurely trusted a prescriber's authority. He stated that he would address that aspect via his perseverance to want to self-educate and improve by undertaking further learning in pharmacy practices and ethics.
The Council decided that the practitioner did not have the required standard of knowledge of pharmacy practice and had not exercised any clinical judgment or shown concern for his patients' health and safety such that he posed a risk to the health and safety of the public. The Council formed the view that the practitioner had, by his conduct, aided and abetted the release of dangerous medications onto the illicit drug market.
Further, the Council considered whether suitable conditions could be imposed on the practitioner's registration that might protect the health and safety of the public. However, the Council formed the view that either the practitioner's knowledge of the law was seriously deficient or he had deliberately chosen to ignore it, and thus the imposition of conditions would be insufficient to protect the public. Further, the Council was mindful of the harm that may have been caused to his patients if they were taking medications in the quantities dispensed, or to the general public at large.
The Council considered that the egregious nature of the practitioner's behaviour justified the suspension of his registration. Accordingly, under s 150(1)(a) of the National Law, the Council suspended his registration with effect from 10 June 2022.
After suspending the practitioner's registration, the Council referred the matter to the Commission for investigation pursuant to s 150D of the National Law.

[13]

Commission's investigation and application for disciplinary findings and orders

On 3 August 2022, the Commission advised the practitioner that the PRU complaint was to be investigated.
In a letter dated 24 August 2022 to the Commission, the practitioner provided his written response to the matters contained in the PRU Final Inspection Report. Again, the practitioner set out the circumstances under which he had acquired the Pharmacy, noting that he felt he had been left "in the deep end from the outset" since the previous proprietor passed away and the primary pharmacist failed to offer even one hour of familiarisation with the Pharmacy, its procedures and customers. The practitioner acknowledged that he had failed to discharge his duty of care to his patients and public health and that he had breached guidelines and regulations. He accepted his suspension as a reflection of serious failings and stated that he intended to reflect and improve on his pharmacy practices.
In connection with its investigation, the Commission sought an expert report from Dr Helen Benson who was asked to provide her opinion on the adequacy and appropriateness of the practitioner's oversight as the proprietor of the Pharmacy. Dr Benson was also asked to provide her opinion on the adequacy or appropriateness of the practitioner's supply (as dispensing pharmacist) and/or as proprietor of various Schedule 8, Schedule 4B, Schedule 4D and other drugs to Patients A, B, C, D, E, F, G, H and I. Dr Benson provided her report dated 21 August 2023.
On 5 September 2023, the Commission provided a copy of the expert's report to the practitioner and advised that the matter was to be referred to the Director of Proceedings for determination of whether to prosecute a complaint before a professional disciplinary body. The Commission invited the practitioner to make submissions and to comment upon the expert's report.
The practitioner provided a written submission dated 3 October 2023.
On 8 May 2024 the Commission filed its application for disciplinary findings and orders in the Tribunal with respect to the Complaint.

[15]

Orders are intended to be protective and not punitive

Orders are made under the National Law for the protection of the public and not for the purpose of punishing the practitioner, as pointed out by the High Court of Australia in the context of the disbarment of a legal practitioner in Clyne v NSW Bar Association (1960) 104 CLR 186 ("Clyne") at 201-202: "Although it is sometimes referred to as the 'penalty of disbarment' it must be emphasized that a disbarring order is in no sense punitive in character. When such an order is made, it is made, from the public point of view, for the protection of those who require protection, and from the professional point of view, in order that abuse of privilege may not lead to loss of privilege."
The decision in Clyne has been adopted in a number of Tribunal decisions including Health Care Complaints Commission v Liu [2016] NSWCATOD 133 ("Liu") at [42] and Health Care Complaints Commission v Meneghetti [2020] NSWCATOD 39 ("Meneghetti") at [97].
Although the specific purpose for which orders are made is to be protective of the health and safety of the public, it is acknowledged that such orders may be punitive in their effect, and that punitive effect may be relevant in formulating a protective order: Meneghetti at [98]; Lee v Health Care Complaints Commission [2012] NSWCA 80 ("Lee") at [20] citing Director General, Department of Ageing, Disability and Home Care v Lambert [2009] NSWCA 102; (2009) 74 NSWLR 523 at [83].
Indeed, under s 2(c) of s 3A of the National Law, no order should be made which has more serious consequences for the practitioner than is reasonably necessary to promote the protective purpose: 3A Guiding principles [NSW] … (2) … (c) restrictions on the practice of a health profession are to be imposed under the scheme only if it is necessary to ensure health services are provided safely and are of an appropriate quality.
As correctly submitted on behalf of the practitioner, protection of the health and safety of the public is not confined to preventing repeat behaviour by the practitioner. Indeed, the protection sought applies more broadly, to protect against similar conduct or incompetence of other practitioners, and to uphold public confidence in the standards of the profession. Meagher JA, with whom Basten and Emmett JJA agreed, discussed these matters in Health Care Complaints Commission v Do [2014] NSWCA 307 at [35]: "The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar conduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise."

[24]

Evaluative process to determine the outcome of each case

A number of comparable cases may be said to have achieved outcomes that assist the Tribunal in deciding what protective orders are appropriate. However, when determining the outcome for a health practitioner, each case before the Tribunal must be considered on its own merits and this involves an evaluative judgment to be made having regard to the nature and seriousness of the conduct. This was confirmed by the Court of Appeal in Chen per Basten JA at [20] (with whom Leeming JA agreed): "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. 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."
In determining what protective orders are appropriate in each case, the Court of Appeal in Lee set out some of the applicable principles per Barrett JA (with whom Barrett JA agreed) at [34]: "In cases of the present kind, therefore, this court should proceed on the basis that: (a) comparison with the outcomes in earlier cases may be useful if those earlier cases show some discernible range or pattern; (b) such a range or pattern, even when discernible, cannot be regarded as a precedent indicating what is 'correct'; (c) the range or pattern is, at best, a reflection of the accumulated experience and wisdom of decision-makers; (d) the range or pattern will potentially be of value only if it is possible to gather from it an appreciation of some unifying principle; (e) since the predominant consideration is the protection of the public, a decision can only be made by reference to the facts of the particular case and by considering what measures are needed to ensure that the future behaviour of the particular practitioner is shaped in a way that is consistent with that protection; and (f) the Medical Tribunal, as a specialist tribunal, brings special skill and experience to the task of formulating protective orders."

[31]

Matters to be included in a prescription for drugs of addiction

Section 80 of the PTGR sets out the matters to be included in a prescription for a drug of addiction, as set out below: 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, date of birth 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 Secretary, 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. … Maximum penalty - 20 penalty units.
Section 85 permits a pharmacist to supply a drug of addition on prescription if the prescription is in the form required under cl 80, and is set out below: 85 Pharmacists may supply drugs of addiction on prescription (1) A pharmacist may supply a drug of addiction on prescription if the prescription is in the form required by Division 3. (2) This clause does not prevent a pharmacist from supplying a drug of addiction on prescription merely because - (a) the prescription fails to specify the maximum number of times the drug may be supplied, or (b) the prescription fails to specify the intervals at which the drug may be supplied, or (c) the prescription fails to specify the patient's date of birth. (3) A pharmacist must not supply a drug of addiction on a prescription referred to in subclause (2)(a) or (b) if it appears to the pharmacist that the drug has previously been supplied on the prescription, regardless of how many times the prescription purports to authorise the supply of the drug. (4) The Secretary may, by order in writing, exempt any person or drug, or any class of persons or drugs, from any or all of the requirements of this clause. (5) Such an exemption may be given unconditionally or subject to conditions. Maximum penalty - 20 penalty units.

[37]

Use of approved standards, codes or guidelines in disciplinary proceedings

Under s 41 of the National Law, an approved code or guideline approved by a National Board is admissible in disciplinary proceedings.
There are a number of relevant guidelines that apply to the practice of pharmacy, including: 1. Guidelines for Dispensing of Medicines developed by the Pharmacy Board of Australia, issued in September 2015 (Dispensing Guidelines); 2. Guidelines for Proprietor Pharmacists also developed by the Pharmacy Board of Australia, issued in September 2015 (Proprietor Pharmacist Guidelines); 3. Guide to Poisons and Therapeutic Goods Legislation for Pharmacists (Ref TG79/32), issued by the NSW Department of Health in June 2015 (PTGR Guide).
The Dispensing Guidelines were developed by the Pharmacy Board of Australia under s 39 of the National Law, to provide guidance to pharmacists in relation to the dispensing of medicines, not set out in the legislation or a registration standard. The Guidelines specifically state that they can be used in disciplinary proceedings under the National Law as evidence of what constitutes appropriate professional conduct or practice for pharmacists. The dispensing process is comprehensively dealt with in Guideline 1 as set out below: "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 f) entering the prescription details on the pharmacy computer and recording any other aspect of the dispensing according to the requirements of the law … k) Carefully checking and re-checking all dispensing for accuracy and completeness l) Counselling the patient, or the patient's agent, sufficiently to allow a proper understanding of all the information required by the patient to use the medicine safely and effectively and to motivate the patient to comply with that advice (which may include provision of printed supplementary information when required), and to allow for a final check of the dispensed medicine m) Ensuring that the entire dispensing process has been carried out according to good pharmacy practice, and accepting that responsibility by placing his or her initials or signature in the prescription records of the pharmacy and any other place according to relevant legislation."
Guideline 2 of the Dispensing Guidelines refers to the pharmacist's obligation to exercise independent judgment to ensure the prescribed medicine is safe and appropriate for the patient, as set out below (emphasis added): 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. Good practice involves seeking consent from patients before disclosing information, where practicable … If the prescriber cannot be contacted, or if on consultation with the prescriber there is a difference in opinion regarding the safety of the prescription, professional judgment must be exercised by the pharmacist in deciding appropriate action to take. 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 the above 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 an/or dispensed for that patient can also be assessed.
The Proprietor Pharmacist Guidelines provide guidance to pharmacists in relation to the professional responsibilities of pharmacy proprietors, not set out in the legislation or a registration standard. These Guidelines focus on the professional responsibilities of proprietor pharmacists that impact on the safe, effective delivery of services to the public. In essence, there are three key guidelines: 1. Proprietors are to vigilantly maintain an active interest in how the pharmacy business is conducted, to ensure the pharmacy operation is in accordance with: 1. any applicable state, territory or Commonwealth law; 2. relevant Pharmacy Board of Australia policies, codes and guidelines; 3. applicable professional practice and quality-assurance standards and guidelines; and 4. good pharmacy practice. 1. Proprietor pharmacists cannot delegate their professional obligations; 2. Responsibilities of proprietor pharmacists include: 1. ensuring the pharmacy business is conducted properly and includes ensuring appropriate risk management procedures are in place for the operation of the pharmacy, including all types of services delivered at that pharmacy; 2. ensuring that their employed pharmacists have ready access to the list of essential references specified by the Board; 3. ensuring compliance with any state or territory legislation regarding facilities and equipment required for the types of services delivered at the pharmacy; 4. 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 or the pharmacy premises registering authorities; 5. ensuring that business procedures, policies and protocols are developed, implemented and routinely followed for all services developed at the pharmacy.
The Proprietor Pharmacist Guidelines specifically refer to the vigilance required of proprietor pharmacists to be on-site and attend staff meetings: "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."
The PTGR Guide provides specific guidance on a diverse range of issues for pharmacists including, relevantly for this case, the matters that must be included in prescriptions (including for restricted substances, drugs of addiction and anabolic steroids): 1. The matters that must be included in prescriptions (unless it is computer generated in which case it only requires the signature to be in the prescriber's handwriting) such as: 1. the date on which it is issued; 2. the patient's name and address; 3. the name, strength and quantity of the restricted substance; 4. the number of repeats (noting that some prescriptions require repeat intervals); 5. adequate directions for use.

[40]

Schedule 8 medications

With respect to Schedule 8 medications, these must be written on a separate prescription form and no other preparation may be written on the same form. Further requirements are set out in cl 8.8, which states that a prescription must include in ink in the prescriber's legible handwriting: 1. date on which it is issued; 2. name and address; 3. name and strength of the drug of addiction; 4. quantity of the drug of addiction in words and figures; 5. maximum number of times the prescription may be dispensed; 6. interval for repeat where repeats are ordered; 7. adequate directions for use; and 8. prescriber's signature.
Clause 8.9 sets out the circumstances when drugs of addiction must not be dispensed: A prescription for a drug of addiction may not be dispensed: a) if it is not correctly written as indicated [in clause 8.8]; b) if it is more than six months old; c) if, where repeats are ordered, the specified interval of time has not elapsed; d) if it is marked "Cancelled" or all the repeats are used up; e) if it is illegible or defaced; f) if it is, or appears to be, forged, altered (otherwise than by the prescriber) or fraudulently obtained; g) if it was written by a person whose authority to prescribe has been withdrawn and it had not been dispensed at least once prior to the date on which the authority was withdrawn Where a prescription bears no repeat instructions or does not clearly indicate the number of repeats ordered and interval for repeat, it may be dispensed once only, then cancelled and retained.
We note, in particular, where a prescription as described in (f) (appears to be forged or altered or fraudulently obtained) or (g) is presented "it must be retained and the police notified" (emphasised in cl 8.9 itself).
Clause 8.9 contains further caution about dispensing drugs of addiction, requiring pharmacists to be familiar with the prescriber's handwriting or that they know the person for whom the drug has been prescribed, or has verified with the purported prescriber that the prescription was written by them. Importantly, telephone numbers must be verified as being the legitimate contact details of the purported prescriber: A prescription for a drug of addiction that meets all of the above requirements may still not be dispensed unless the pharmacist dispensing it: a) Is familiar with the prescriber's handwriting, or b) Knows the person for whom the drug has been prescribed, or c) Has verified with the purported prescriber that the prescription was written by them (care must be taken to ensure that telephone numbers shown on prescriptions are the legitimate contact details of the purported prescriber) (our emphasis).

[42]

NSW Opioid Treatment Program Community Pharmacy Dosing Point Protocol

For completeness, we note that the NSW Health Department prepared a document titled NSW Opioid Treatment Program Community Pharmacy Dosing Point Protocol (Ref TG 201/5) issued in October 2020 for community pharmacists to follow when supplying methadone and buprenorphine preparations under the OTP. Compliance with the protocol is mandatory for all pharmacies participating as a dosing point for the OTP, as was the case for the Pharmacy in which the practitioner was the proprietor and pharmacist in charge.
In essence, the legislative requirements for the receipt, storage and supply of methadone and buprenorphine under the OTP are the same as for any other drug of addiction. However, the monitoring and supervisory requirements of the OTP imposes additional obligations. Importantly, the document states that "compliance with the protocol provides proper accountability, minimises the risks associated with the program, and protects the health and safety of patients."
In accordance with cl 92 of the PTGR, the maximum number of patients in supervised OTP dosing at any one community pharmacy is 65 (although patients assessed to be stable and are supplied takeaway doses weekly, fortnightly or monthly are not counted toward this limit of 65). The protocol explains that the limit aims to minimise the potential for patients congregating in the vicinity of community pharmacies and contribution to local amenity concerns. Clause 92 of the PTGR is set out below: 92 Supply by pharmacists of liquid methadone or buprenorphine (1A) Despite clause 85, a pharmacist must not supply methadone in oral liquid form or buprenorphine on prescription for the treatment of drug dependence unless - (a) the methadone or buprenorphine is supplied at the premises of, and in the course of carrying on the business of, a retail pharmacy, and (b) the retail pharmacy is located on premises at which a pharmacist is approved to supply pharmaceutical benefits under section 90 of the National Health Act 1953 of the Commonwealth. Maximum penalty - 20 penalty units. (1) A pharmacist at a retail pharmacy must not, on any particular day, supply any person with methadone in oral liquid form or buprenorphine on a prescription for the treatment of drug dependence if that supply would result in more than 65 persons having been supplied with methadone in oral liquid form or buprenorphine on prescription at that pharmacy on that day. Maximum penalty - 20 penalty units. (2) For the purposes of subclause (1), if an amount of methadone in oral liquid form or buprenorphine is supplied for consumption on a day other than the day on which it is supplied, the supply of that amount is taken to have occurred on the day on which the amount is to be consumed. (3) A person is not to be counted for the purposes of subclause (1) if the person is supplied with an amount of methadone in oral liquid form or buprenorphine that is intended to last the person for at least one week and the person is supplied at that pharmacy with either of those drugs no more than once in any 7 day period. (4) Subclause (1) does not apply to the supply of methadone in oral liquid form or buprenorphine at a pharmacy in accordance with - (a) an exemption granted under clause 93, or (b) a licence issued under Division 3 of Part 8.

[45]

Practitioner's level of training & experience

At the time of the PRU audit, the practitioner had been a registered pharmacist for more than 7 years and had been the proprietor of the Pharmacy for just over 3 years.
As the proprietor and pharmacist in charge, the practitioner had access to the dispensing records showing prescriptions previously dispensed by himself and his staff.
In written submissions (which were not challenged), the Commission noted that, as a member of the Pharmaceutical Society of Australia ("PSA") and the Pharmacy Guild, the practitioner had access to resources including: • the dispensing records showing prescriptions previously dispensed by himself or his staff; • Pharmacy Board of Australia resources including the Dispensing Guidelines and the Proprietor Pharmacist Guidelines; • the legislation applicable to pharmacists, including the PTGR; • NSW Health resources, including the PTGR Guide, the NSW Opioid Treatment Program Community Pharmacy Dosing Point Protocol; • Current medication information (through MIMS) and the Australian Medicines Handbook; • Various alerts, notifications and newsletter emails from professional organisations including NSW Health, the PBA, the Pharmacy Council, the Pharmacy Guild, the PRU, the PSA and Pharmacy Defence Limited; • the "Prescriptions reported lost, stolen or forged" table on the PRU website; • advice from other pharmacists.
Under cross-examination, the practitioner acknowledged that he had access to the above resources. He also said that although he thought he was ready to become a proprietor of a pharmacy business, he probably did not do enough reading on a proprietor's obligations beforehand. He knew he was required to have resources available and accessible at the Pharmacy, but conceded that instead of doing an independent assessment, he depended on the previous owner to have put the necessary resources in place.
When questioned specifically about some of the resources, the practitioner had no recollection of reading emails from the PRU until the time of the audit in April 2020. Further, he conceded that he was not even sure where the resources (including the PTGR) were located, although he acknowledged that he had access to MIMS, the Australian Medicines Handbook and therapeutic guidelines.
His evidence was that his time was consumed by undertaking administrative procedures to make sure the business was being run appropriately. As a result, he conceded that many alerts and emails, including those concerning the abuse of opioids, were not accessed and remained unread.
The practitioner's oral evidence was that in 2020 he knew about the clinical side effects of Schedule 8 medications such as oxycodone, alprazolam and fentanyl and the risks of dependency, addiction, overdose or death. However, he said that he was not so aware of the black market for fentanyl.
He also said that he knew the risks associated with testosterone, and that it was used recreationally for body building, as an acceptable off-label use under a doctor's management.

[62]

Tribunal findings

Whilst we accept the practitioner gave his evidence without reservation, and apparently held the belief that "off-label" use of testosterone and other steroids was common practice and safe in body building provided patients were being monitored, we find his views to be naive, particularly in circumstances where he had been a practising pharmacist for seven years and the average "man on the street" would have been cautious in light of general public discussion on anabolic steroids.
It is well known by the general population that the use of anabolic steroids for body building is illegal. One does not need to be a pharmacist to be privy to that information. Yet the practitioner's explanation to the Council during the s 150 hearing was that he had not realised that supplying testosterone was against the law and he had been reassured by doctors that the patient was under surveillance and being monitored.
We wrestled with whether the practitioner was genuinely ignorant about the law or had been insincere about his knowledge on the illegality of using anabolic steroids for body building. Further, we held concerns that his focus on the business value of some transactions may have overwhelmed his professional judgment. We were troubled by an inconsistency in the practitioner's statements about his understanding of the illegality of supplying steroids for body building and the existence of a black market for such products. In the s 150 hearing, he said that the use of steroids was not brought up in his university study and that he had not realised that supplying them for a body building cause was against the law. However, when asked whether he had considered his duty of care to the health of the patient using steroids at that extraordinarily high rate, his answer demonstrates that he knew there was, indeed, a black market for such products: "I knew at the time that he was using them to body build that quantity I knew would have lasted him a lot less than the two years… And also, that he [referring to the prescribing doctor] probably thought it would be a better idea for him to be supplied with those resources from a pharmacy rather than from a black market."
On balance, we are inclined to conclude that the practitioner was indeed more aware of the black market than he has acknowledged, and that he supplied the testosterone as a commercial decision, without properly considering the safety of the patient as his primary obligation.
We find his conduct in dispensing excessive amounts of testosterone fell well below the required standard.

[86]

Practitioner's evidence

In his filed Reply, the practitioner admitted paragraph 10 without qualification.
In his statement to the Tribunal, the practitioner gave context to his dispensing of fentanyl patches (relevant to both Patient D and Patient E). He asserted that, at the time, he did not have a proper understanding of the therapeutic indication and contra-indications for Durogesic patches. He also asserted that he did not realise how heavily fentanyl patches were abused and that he did not realise how profitable it was on the black market. We note, below, his comments that he believed his complacency and over-reliance on prescribers were driven by his personal circumstances: "I also did not realise just how heavily abused it is and how profitable it is on the black market. I treated it more or less as I would any other painkiller, albeit a potent one. That knowledge gap was a huge problem for me and was acceptable. If I had maintained appropriate understanding and knowledge of therapeutic guidelines in relation to fentanyl patches, and if I had applied Oral Morphine Equivalent Daily Dose (OMEDD) I would have been equipped to realise the dosage levels and intervals being prescribed were clearly inappropriate. My lack of understanding and knowledge, along with my complacency as a result of my personal circumstances led to me placing over-reliance on prescribers. If they said a dose was appropriate, I was very unlikely to disagree with them because I just did not have the time or energy to do so and had begun cutting corners by that point as a result. It got to the point where I stopped contacting prescribers if the same (inappropriate) dosage was consistent with an earlier prescription, as I just relied on the prescriber to have exercised clinical judgment."
In his s 40 Submissions, the practitioner admitted that he failed to identify the pattern of dispensing to Patient D, which posed a risk of harm to the patient and potentially to the wider public.
When giving his oral evidence, the practitioner acknowledged that he realised that fentanyl 100 mcg patches were a high strength medication and that the patches were to be replaced every 3 days. His evidence was that he was rushing and not paying attention to how long a box of patches would last. He said that he had missed notifications from NSW Health about fentanyl. He also said that he did not recognise that when fentanyl 100 mcg was prescribed on a private script it was a "red flag". His evidence was that, at the time, he had not appreciated the difference between a PBS (Pharmaceutical Benefits Scheme) script and a private script, and that he now understands the difference in regulation between the two systems, with PBS scripts reported to Medicare (subsidised by the Australian Government).

[107]

Expert evidence

The expert evidence is that the oxycodone prescription (purportedly written by Dr Naseem) has a number of red flags, is clearly a non-compliant prescription, and should have been suspected as a forgery. The red flags include the fact that it was prescribed as a private item by the National Home Doctors Service, the patient details are barely legible, the patient's name address and Medicare number are missing, and the amount being supplied is a high quantity. Additionally, the expert noted that if this was a national home doctor service script it would be for a quantity that allowed the patient after hours treatment prior to seeing their regular doctor and therefore, a full month of a high dose opioid is therapeutically inappropriate in that context. The expert noted that no evidence was provided that the appropriateness of the prescriptions was questioned prior to supply. Dr Benson concluded that the practitioner's failure to contact the prescriber prior to dispensing and record that contact demonstrates conduct that falls significantly below the standard required of practising pharmacists and pharmacist proprietors.
Additionally, the expert evidence is that each of the supplies of Oxycontin between 8 July 2021 and 24 March 2022 on prescriptions attributed to Dr Victor Tadros was of a strength and quantity to raise concerns and should have resulted in a phone call to the prescriber for confirmation of the appropriateness of dispensing. Dr Benson found that the practitioner's failure to contact the prescriber prior to dispensing and record that contact demonstrates conduct that falls significantly below the required standard of practising pharmacists and pharmacist proprietors.
Further, the prescription dated 29 October 2020 for oxycodone issued by Dr Harry Johnson contained a handwritten alteration to the medication strength from 40 mg to 80 mg in two places on the face of the prescription. The PRU obtained a copy of Dr Johnson's prescribing records which indicated that 40 mg was prescribed on the day. The prescription was dispensed on 30 October 2020 and the back of the prescription contained a handwritten note by the practitioner stating that the doctor had confirmed the numeric strength mistake and authorised a change on the phone. The note also stated that an updated script had been requested. However, the PRU found no evidence of the authorised increase in strength in the doctor's prescribing records and no replacement prescription was received by the Pharmacy. As the new prescription for the correct strength of Oxycontin had not been received within 7 days, the practitioner was under a professional obligation to report this to NSW Health, in compliance with s 96(2)(b) of the PTGR. The expert found that, in failing to report the matter, the practitioner's conduct fell below the standard reasonably expected of a practitioner.

[109]

Tribunal finding

There is no evidence that the practitioner contacted Dr Naseem. Likewise, there is no evidence that he contacted Dr Tadros.
With respect to the practitioner's dispensing on 22 May 2020 of Oxycontin 80 mg (240 tablets) and Endone 5 mg (200 tablets) for Patient F, the Pharmacy's prescribing record simply noted "Called Dr Johnson". Immediately above that entry, the words "Called Dr confirmed increased qtty" appear, but without an identifying date. Another note in the record on 3 April 2020 related to a prescription for 140 Suboxone films (4 films per day), stating "Liaised with Dr Johnson - spoke with dr on his personal mobile phone, confirmed his willingness to prescribe Suboxone along with other strong pain killers at given doses - dr Johnson said he is closely monitoring patient and he knows better her requirements and her tolerance he has apparently been their family Dr for a while". We note that on the previous day (2 April 2020) a prescription for 140 Oxycontin 80 mg tablets was dispensed for Patient F. It would appear that the practitioner had some alertness regarding the combined medication of Suboxone and Oxycontin for this patient. This, we consider, indicates that the practitioner certainly knew enough about the combination of Suboxone and Oxycontin to cause him to call the prescriber. We are inclined to the view that he has downplayed the level of his knowledge about opiate medications at that time in his career, and that he dispensed medications knowing the risk involved based on assurances given to him by prescribers. In doing so, he failed to exercise his own independent judgment.
With respect to his asserted conversation with Dr Johnson on 30 October 2020, the practitioner's handwritten note said "confirmed numeric strength mistake change on phone requested updated rx".We note that Dr Johnson's prescribing records do not provide evidence of an authorised increase in strength of the prescription, and no replacement script was received in the Pharmacy. The practitioner failed to follow up with Dr Johnson regarding an updated prescription and failed to notify NSW Health within 7 days that he had not received the prescription authorising the increased dose. He could have refused supply until he had received the updated script. The litany of failures paints a picture of a pharmacist who repeatedly took risks, and failed to maintain records of integrity. It certainly does not reflect the approach of a pharmacist who asserted to the Tribunal that he was passionate about learning how medications interacted with the human body and passionate about helping people.
We note the expert's additional comment about the impact of the practitioner's conduct upon setting the culture and standard of practice. Dr Benson stated: "By dispensing high quantities of high strength opioids to the same patient in an ongoing manner Mr Salloum was setting an example of practice that was below the standard required and this may have been seen as tacit approval of said practice by the other pharmacists employed at the pharmacy. In failing to provide sufficient education and training to pharmacy staff in relation to S4D, S4B and S8 medications, and by setting a poor example of professional conduct Mr Salloum's conduct falls below that required of pharmacist proprietors."
We accept the expert's opinion. We find the practitioner's conduct to be egregious, and it falls significantly below the standard required.

[132]

Practitioner's evidence

In his filed Reply, the practitioner admitted with respect to paragraph 21(a) that he did not conduct a stock check of buprenorphine and methadone in September 2021, and that he had conducted the stock check in July 2021.
With respect to paragraph 21(c) and (d), the practitioner said in his filed Reply that the entries in the Drug Register were accurate and were an accurate reflection of the level of medication held by the Pharmacy. He admitted there were numerous other issues with the Drug Register, including that entries were not always maintained in chronological order, resulting in the Drug Register being difficult to interpret and, at times, showing a negative balance. He admitted that he failed to identify or detect the discrepancies in the Drug Register.
In his response dated 24 August 2022 to the Commission, the practitioner noted the following with respect to his alleged non-compliant storage of Schedule 8 drugs during the PRU inspection: "(a) Drugs of addiction including methadone, buprenorphine, fentanyl transdermal patches and oxycodone tablets were stored in a meta filing cabinet on 11 April 2022. I had previously been told by a Guild Inspector that this practice was appropriate. However, I acknowledge that I should have been cognisant of Clause 76 of the PTG Regulations, and it is my responsibility as a proprietor and pharmacist to ensure drugs are stored correctly. (b) A box of drugs of addiction delivered on 9 April 2022 which contain Durogesic 100 transdermal patches, Subutex 8 mg tablets and Aspen methadone syrup were left on the floor in the dispensary and had still not been stored correctly by 11 April 2022. The Pharmacy was very busy on the day of delivery and I had not been able to put them away. I recognise that this practice is incorrect. As outlined in the updated procedures and protocols, drugs of addiction must be immediately secured in the locked DD safe upon receipt and must be kept in the safe unless in immediate use, and I have endeavoured to purchase a much larger safe than the one we had in order to facilitate the quick storage of Schedule 8 products upon receipt. (c) the drug safe was not bolted to the brick, concrete floor or timber framed wall and the key was left in the door of the drug safe. A new large safe with a digital lock has been professionally supplied and installed, in compliance with legislative requirements… (d) Methadone was left on the dispensary bench when not in immediate use. I recognise this is improper practice and should not have occurred. As stated above the Pharmacy's procedures and protocols have been updated to ensure that methadone which is not in immediate use is stored in the safe."
The practitioner said in his response to the Commission that the inappropriate storage of drugs of addiction had been an "honest mistake" which had occurred for the very first time due to the unexpected extreme surge in OTP clients at the time which created an "unexpected transient state of overload (and almost havoc)" in the Pharmacy. He added that it was one of the busiest and most overwhelming times, which is why he had an additional pharmacist on duty on the day of the PRU inspection.

[140]

Consideration of appropriate protective orders consequent upon finding "professional misconduct"

Consequent upon our finding of professional misconduct, we now consider what protective orders are appropriate - whether the practitioner's registration should be suspended for a specified period, or cancelled, or whether he should be permitted to practice under conditions as proposed in submissions made on his behalf.
In determining what protective orders are appropriate, the paramount consideration is the protection of the health and safety of the public.
The national scheme provides for the protection of the health and safety of the public by ensuring that "only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered": s 3(2)(a) of the National Law.
When making protective orders, we note that no order should be made which has more serious consequences for the practitioner than is reasonably necessary. We also have regard to the following recognised principles: 1. maintaining the standards of the profession, to preserve public confidence in the integrity of the profession and thereby protect the community: Prakash at [91]; 2. protecting the health and safety of the public is not confined to protecting current or potential patients but includes protecting the public from similar misconduct of others and upholding public confidence in the standards of the profession: Health Care Complaints Commission v Do [2014] NSWCA 307 at [35]; 3. deterring both the practitioner and others from engaging in similar conduct, to maintain professional standards and thereby ensure public safety and faith in the profession: Litchfield at 637; 4. whilst the Tribunal's jurisdiction is primarily protective and not punitive, it is unavoidable that protective orders may be incidentally punitive: Clyne at [201]-[202]; Litchfield at 637; Liu at [42] and Meneghetti at [97]; Lee at [20] and [31] and Meneghetti at [98].
The Commission argued that cancellation of the practitioner's registration is needed in order to: 1. denounce his serious misconduct; 2. deter him from similar misconduct; 3. deter other practitioners from similar misconduct; 4. uphold high professional standards of the pharmacy profession.
It was submitted on behalf of the practitioner, that his misconduct (though acknowledged on his behalf to have been "terrible") did not warrant cancellation of his registration, and that the imposition of conditions on his registration was an appropriate protective remedy. A Schedule of Conditions proposed to be imposed for a period of two years was put forward on behalf of the practitioner as offering protection for the health and safety of the general public. The Schedule of Conditions included conditions that the practitioner not hold a financial interest in any pharmacy business or practise as the pharmacist in charge for two years. They also included conditions that the practitioner practise under Category C supervision for one year, and engage in mentoring for a period of six months.
The practitioner argued that the whole of his conduct should be considered, consistent with the Court of Appeal's decision in Gad v Health Care Complaints Commission [2002] NSWCA 411 ("Gad") at [54]. Reference was then made to the Tribunal's decision in Health Care Complaints Commission v Fearon [2018] NSWCATOD 26 ("Fearon") to cancel Mr Fearon's registration as a pharmacist with a non-review period of 12 months. In that case, the pharmacist had been found to not be a suitable person to hold registration. On multiple occasions, Mr Fearon had supplied patients with Schedule 8 and Schedule 4 drugs without a prescription. He was not considered to be a credible witness in relation to a number of patient records where a hospital was recorded as the prescriber. In an interview with police, Mr Fearon knowingly provided false and/or misleading information in relation to one patient.
Reference was also made to the Tribunal's decision in Health Care Commission v Ahmad [2015] NSWCATOD 103 ("Ahmad") to cancel the pharmacist's registration, with a non-review period of 24 months. In that case, the practitioner had dispensed Schedule 8 medication in excessive quantities, without prescriptions, and received cash in return. The practitioner was found to have given untruthful evidence and to have no genuine insight into his obligations or failures.
In another case, Health Care Complaints Commission v Sadek [2017] NSWCATOD 181 ("Sadek 1"), the pharmacist's conduct on multiple occasions was found to amount to professional misconduct. In Health Care Complaints Commission v Sadek [2018] NSWCATOD 90 ("Sadek 2"), the practitioner's registration was cancelled, with a non-review period of two years. The practitioner was found to have engaged in professional misconduct by dispensing very large quantities of high strength Oxycontin in highly irregular and inappropriate circumstances in multiple instances. The Tribunal found that more than mere incompetence was involved, and that Mr Sadek's conduct was improper and unethical since he had actual or constructive knowledge that the drugs were very likely being misused. Further, the Tribunal made a finding that Mr Sadek was prepared to tailor and falsify his evidence under oath. The Tribunal concluded that, in light of the severity of the conduct and the practitioner's lack of insight and remorse, the only appropriate outcome was cancellation, accompanied by a non-review period of 2 years.
It was submitted that, unlike the practitioners in Fearon, Ahmad and Sadek, the practitioner had been honest and had not given false information, but had provided multiple detailed submissions which contained acceptance of his misconduct, explanations as to his lack of knowledge and poor standards of practice and some contextual information as to how and why the misconduct had occurred. It was further submitted that the practitioner had done his best to give clear and cogent evidence, and at no point was it suggested that he was not telling the truth.
It was argued that the practitioner's explanations and contextual evidence, whilst far from excusing his conduct, should be accepted as his honest beliefs at the time of dispensing. With respect to Patient A, eight of the forty Schedule 8 scripts were dispensed by another pharmacist. Whilst acknowledging that the practitioner had not exercised sufficient oversight, it was argued that the fact that eight of the forty scripts were dispensed by another pharmacist in the Pharmacy, was relevant to severity and context. We do not accept this argument having regard to his responsibilities as proprietor and managing pharmacist to exercise appropriate oversight over his employed pharmacists, and in light of the many other occasions on which the practitioner dispensed medications in breach of regulations. We have no confidence that the practitioner would have acted differently with respect to those eight scripts in light of the number of occasions on which he deferred to prescribers (or the alleged prescribers), despite the red flags.
On behalf of the practitioner, reference was also made to the Tribunal's decision in Health Care Complaints Commission v Elliott [2018] NSWCATOD 47 ("Elliott"). In that case, the pharmacist in charge dispensed Schedule 8 drugs to 11 patients who were on the OTP in circumstances where the prescribing doctor lacked the authority to prescribe such drugs. Mr Elliott had also dispensed excessive doses of drugs of addiction to three other patients. The practitioner admitted that his conduct amounted to unsatisfactory professional conduct, but argued that his conduct did not amount to professional misconduct since there was no "moral turpitude" on his part, he genuinely believed he was adhering to his legal obligations, he made regular contact with prescribing doctors, the patients presented as suffering chronic pain and were not "doctor shopping", and one of the patients was being treated by a doctor who Mr Elliott believed to be a pain specialist. It was also argued that Elliott should be distinguished from other cases in which it was demonstrated there was a profit motive for improperly dispensing drugs, and in other cases the oversupply of drugs had been accompanied by multiple other departures from proper standards such as failures to maintain records or store dangerous drugs appropriately. The Tribunal decided that Mr Elliott should be reprimanded and that an order for suspension or cancellation was not appropriate.
We agree that the practitioner's whole conduct should be taken into account when deciding what protective orders are appropriate (in line with the reasoning in Gad). In that respect, we acknowledge that the practitioner has been cooperative and forthcoming with his explanation of matters raised and in providing context for his conduct during all stages of the Commission's investigation following the PRU audit. Whilst his truthfulness as a witness was not put into question, the evidence was at times inconsistent with respect to whether he had contacted a number of prescribers. We held reservations about the level of his knowledge of the illicit black market for fentanyl and anabolic steroids.
We find comparison with the cases cited on behalf of the practitioner (Fearon, Ahmad, Sadek 2 and Elliott) to be of some, though limited, value. Those cases offer no unifying principle (as referred to in the Court of Appeal's decision in Lee) such that a precedent is discernible for application to the case before us. We therefore make an evaluative judgment (consistent with the rationale in Chen), having regard to the nature and seriousness of the matters which we have found to be proven.

[142]

What corrective action has the practitioner undertaken?

We recognise the corrective action taken by the practitioner to rectify the issues identified by the PRU. We also acknowledge the efforts made by him to undertake continuing professional development (CPD) in the areas where his knowledge was deficient and to engage in five mentoring sessions with Mr Albert Regoli. The reports from Albert Regoli detail the topics covered in the mentoring sessions and offer some confirmation of the practitioner's positive progress in educating himself on his obligations both as a pharmacist and proprietor.
As helpfully noted in the Chronology provided by the Commission, the practitioner has attended to a number of matters to address areas of risk and self-educate as summarised below: Date Practitioner's Activity/Education/Mentoring 27 April 2022 Practitioner purchased a new drug safe 12 June 2022 Practitioner started conducting regular pharmacist staff meetings and started systems to regularly review/audit the prescriptions dispensed by pharmacist staff to identify any issues 26-27 June 2022 Practitioner completed SafeScript training modules 28 June 2022 Practitioner emailed to his staff pharmacists the PRU letter to review links to the PTGR and included links to the PGTR, resources and OTP protocol. 28 June 2022 Practitioner emailed his letter to the PRU, including a new Schedule 8 checklist so that pharmacists were required, as a new accountability, to independently verify the prescription with the prescriber as well as cross-reference contact details on the prescription against a reputable resource such as the AHPRA health practitioner's register, and advising of new procedures so that alert emails in the pharmacy email inbox were to be checked daily by pharmacists on duty and later covered in meetings. 5 July 2022 Practitioner emailed the PRU attaching requested photographs, further information and further updated policies. 12 July 2022 Practitioner emailed to the PRU his notification forms regarding lost methadone. 13-18 August 2022 Practitioner completed training modules about opioid use disorder, opioid harm and fentanyl. Practitioner attended his first mentoring session with Albert Regoli. The areas of focus and matters discussed included: • Diversion of fentanyl patches and fentanyl availability on darknet markets • Opioid-use Disorder • Opioid harm in Australia • Oversight of the Pharmacy - use of checklist to develop a structured approach to his oversight and creating documentation to evidence his oversight • Review of the s 150 reasons for suspending the practitioner's registration • Practitioner's acknowledgment of PRU's concern that a large number of forged prescriptions for S8 drugs had been dispensed and that some supplies were dispensed in a single transaction 17 August 2022 • Practitioner's lack of knowledge on prescribing requirements for psychostimulant drugs • Difference between a PBS approval and a NSW Health approval • red flags with respect to private prescriptions • Verification of S8 prescriptions if the pharmacist does not know the patient and prescriber • Identifying patients seeking supplies on fraudulent prescriptions - obtain treatment plan from the prescriber • Patients' dispense files should be used for clinical notes, and not for primarily recording overdue accounts • How to apply OMEDD (oral morphine equivalent daily dose) calculations in practice • Practitioner's over-reliance on a prescriber's competency to make decisions as he was not inclined to question their judgment • Gap in practitioner's knowledge regarding the use of anabolic steroids for bodybuilding - discussion of "off-label" prescribing Practitioner attended his second mentoring session with Albert Regoli. Matters discussed included: • Prepared list of issues identified in the s 150 hearing and proposed actions to address those issues • Large number of forged scripts and large quantity of S8 (including psychostimulants) dispensed, sometimes in a single transaction - Practitioner suggested he develop S8 checklist for his staff pharmacists to use prior to dispensing including matters to evaluate if script is forged • Compliance with PTGR and professional standards • Inadequate levels of knowledge, judgment, skills & care in dispensing S8 and S4B (such as testosterone) • Vigilance in calling prescribers and confirming legitimacy of S8 prescriptions • OTP patients being prescribed drugs of addiction from non-OTP prescribers • Dispensing S4D prescriptions that have been altered 22 August 2022 • Vigilance in confirming appropriate therapeutic quantities • OTP knowledge to be improved • Non-compliant S8 safe and storage of S8 drugs • Understanding and utilising OMEDD calculations in prescription procedure • Considering potential for diversion of drugs to illicit drug market • Autonomy in decision-making and practice choices • Improve understanding of testosterone • Recognising red flags • Off-label prescribing "legal" vs "illegal" 22 August 2022 Practitioner submitted PSA Ethics in Dispensing module (Part 4) 24 August 2022 Practitioner response to the Commission, attaching a number of documents including his new Schedule 8 checklist to ensure the practices of his employed pharmacists dispensing Schedule 8 medications adhere to the legislative requirements, meeting records, CPD and Learning Plan 14 January 2024 to 11 July 2024 Practitioner accessed CPD resources including about opioids, risk and "the importance of saying no". Practitioner attended his third mentoring session with Albert Regoli Practitioner. Matters discussed included: • Review of CPD records and review of Pharmacy Board Guidelines on CPD • Review of Pharmacy Board Guidelines on Dispensing • Review of Pharmacy Board Guidelines on Practice Specific issues • Review Professional Practice Standards • Review Pharmacy Council newsletter for May 2022 (particularly concerns on high dose fentanyl and forged prescriptions and red flags), practitioner noted requirement to retain and report suspected forged prescriptions to police and NSW Health 20 May 2024 • Review Pharmacy Council newsletter for December 2022, supporting resources for managing S8, S4B and S4D medicines • "Emergency supply" provisions within PTGR and "continued dispensing" • Pharmacist's autonomy and need to arrive at an independent decision and that the prescription should reflect an acceptable therapeutic standard as well as being valid • Criteria for issuing a printed computer-generated S8 prescription in NSW, noting the required hand-written elements • Exemptions to S8 prescriptions supplied under the OTP • Discussed patients categorised as "drug dependent" treated differently from other patients • Value of Pharmacy Board guidelines that apply to pharmacy practice and Pharmacy Council newsletters to inform pharmacists of more recent developments and issues relating to high risk medicines. Practitioner attended his fourth mentoring session with Albert Regoli. Matters discussed: • CPD planning for current year • Electronic system (MethDA) superior to paper-based systems 10 June 2024 • Mandatory stock checks of Schedule 8 drugs • OMEDD • Use and misuse of opioids - multiple references reviewed - risks associated with poor management of opioid dispensing • Illicit markets in opioids • Schedule 4b and Schedule 4d categories in the PGTR Practitioner attended his fifth mentoring session with Albert Regoli. Relevantly, the following matters were discussed: • PGTR (monitored medicines, special restricted substances, prescribed restricted substances, persons authorised to possess and use substances) • Electronic DD Book and MethDA software • Prescriptions that require verification 24 June 2024 • Pharmacy Council newsletters • Discussions on e-scripts • Discussions on "off-label" use - risks and pitfalls • Staged supply of medicines • Recent changes to the prescribing of psychostimulants and the use of class authorities

[144]

Has the practitioner shown remorse, demonstrated insight into the gravity of his conduct and accepted full responsibility for his conduct?

We observed the practitioner when giving his oral evidence to be a quietly spoken man who appeared to be tentative, struggling with the embarrassment and humiliation over his misconduct. At times he appeared to not understand the questions asked of him. This may have been due to his general unease and anxiety when being cross-examined over matters that he has conceded many times in writing made him feel extremely upset. Overall, he appeared to be very remorseful, and quite sad that his practice of pharmacy had fallen short of acceptable standards.
We do not discount the sincerity of the practitioner's apology for creating a risk to the safety of the public and wider community as set out in paragraph 74 of this statement: "My dispensing and my lack of oversight created a risk to the safety of the public and the wider community, for which I apologise. I should have done better and provided an effective safeguard to those medications entering the community."
Further, in paragraph 97, the practitioner acknowledged the role of pharmacists as gatekeepers and that he had been unaware of just how significant the risks to the public were from high risk medications: "I have previously provided comments in relation to the identified dispensing on prescriptions which contained red flags, particularly in relation to high risk medications. Pharmacists occupy a key role in the health industry and are the final line of defence against medication inappropriately entering the community and being subjected to issue. I was unaware at the time of just how significant the risk to the public were from those medications. I am distressed by and deeply regret that my actions placed the public at risk."
The Commission acknowledged the practitioner's admissions (almost all of which were unqualified) but submitted that there were concerns that the practitioner had not fully accepted accountability for his misconduct and had not demonstrated full insight into the magnitude of his actions.
In a number of his submissions and his statement to the Tribunal, the practitioner deflected some of the responsibility onto the previous proprietor of the Pharmacy and had found fault with the pharmacist who had not provided a handover of the business and its patient information. However, we note that the practitioner first purchased the Pharmacy in December 2016 and had a period of three and a half years before the inspection in April 2022 to become fully acquainted with details concerning his patients, including those being treated under the OTP.
The practitioner had also pointed to the impact of the COVID pandemic, as a mitigating factor. We fail to see how the COVID pandemic environment exerted pressures on the practitioner such that he or his employed pharmacists would succumb to ignoring obvious red flags on prescriptions, and breach regulations.
The practitioner's personal reflections in the fourth mentoring report are eloquent, and identify a number of contributory factors to the opioid misuse problem in Australia. However, his reflections appear to be expressed from a theoretical perspective and from the general perspective of the pharmacy profession as a whole. He refers to "our" responsibility, as opposed to his own personal responsibility as a pharmacist. In our view, the practitioner's reflections offer only limited insight into his own contribution to the harm (or potential harm) caused by dispensing Schedule 8 and Schedule 4 drugs in excessively large quantities to vulnerable patients who need to be protected from their addiction. His reflections do not acknowledge the potential diversion of opioids into the illicit black market and his contribution to that diversion by his past offending conduct.
We are of the view that the practitioner has genuinely reflected on the gravity of his failure to practice pharmacy to the expected standard. However, in light of the matters he attempted to explain in mitigation of his conduct, we are uncertain as to whether the practitioner has accepted full responsibility for his conduct. In seeking to deflect some blame onto others, and to excuse his conduct through the COVID pandemic, he has not demonstrated that he accepts that he is fully responsible for his own failures.

[145]

The practitioner's contention that his personal circumstances were a significant cause for his conduct

The practitioner emphasised in his written statement to the Tribunal and in various submissions made to the PRU, the Council, the Commission that he was under extreme pressure in his personal life generally. This is a matter that we have considered carefully, since he linked the extent of his deficiency in practice, and his complacency, to the personal stress he was suffering.
In his statement to the Tribunal, there are multiple references to his personal circumstances. In particular, in paragraph 71, he drew linkages between his lack of knowledge, complacency, and over-reliance on prescribers to his personal circumstances (including issues at home which left him short on time and energy such that he began to cut corners): "My lack of understanding and knowledge, along with my complacency as a result of my personal circumstances led to me placing over-reliance on prescribers. If they said a dose was appropriate, I was very unlikely to disagree with them because I just did not have the time or energy to do so and had begun cutting corners by that point as result. It got to the point where I stopped contacting prescribers if the same (inappropriate) dosage was consistent with an earlier prescription, as I just relied on the prescriber to have exercised clinical judgment. That is not appropriate in any circumstance for a pharmacist, let alone in relation to high risk medication such as fentanyl patches. While I accept exercising independent judgment without appropriate therapeutic knowledge may not have changed much, it would certainly have resulted in some of the prescriptions not being dispensed."
In paragraph 73 of his statement, the practitioner also acknowledged that due to his personal circumstances he failed as proprietor of the Pharmacy to provide proper oversight of the dispensing practices by his staff pharmacists: "My lack of understanding and knowledge, along with my complacency as a result of my personal circumstances, caused my failure to provide proper oversight of the dispensing of my staff pharmacists I didn't know what should be done, and so I couldn't properly educate or supervise or identify issues with the dispensing activity of my staff. My role as a proprietor was not only to provide effective oversight of the Pharmacy's operations, but also to be a leader and mentor to my staff. My lack of knowledge meant I could not effectively do that."
In paragraph 66 of this statement, the practitioner explained that the sudden influx of methadone clients shortly before the PRU audit caused further stress to him as he was unable to properly support his wife and assist with the care of his children, and things were "just so crazy" that although he had hired some new staff, he did not properly onboard them. Indeed, we obtain a sense of his feeling of intense personal stress in his expression that there was "overall sense of mayhem at the Pharmacy".
In terms of failing to exercise his own independent judgment on the appropriateness of dispensing drugs of addiction in high quantities and at intervals that did not accord with s 109 of the PTGR, the practitioner candidly acknowledged in paragraph 78 of his statement that his family issues caused him to be inattentive and complacent: "I took the view that if a prescriber had prescribed that medication, then they must have exercised professional judgment after undertaking a risk assessment, and I failed to exercise my own professional judgment. That corner cutting is not acceptable. As I have set out above, I was struggling to juggle four children, sick parents, my wife's health issues and a business with high staff turnover and very little time off. That caused me to become inattentive and complacent in my practice. That is of course, not an excuse for my conduct."
In his letter dated 24 August 2022 to the Commission (responding to the PRU Final Report in the context of commenting upon his dispensing of large quantities of Suboxone films and Oxycontin 80 mg tablets on the same day to Patient A), the practitioner referred to his lack of self-confidence at the time: "My trust in the prescriber's reassurance, I now realise, is indicative of some lack of self-confidence in my practice at the time, easily swayed and prematurely trusting in a prescriber's authority."
Whilst we acknowledge that these admissions are frank and demonstrate the practitioner has reflected upon the reasons why his practice lapsed so significantly below the expected standard, we are concerned that the misconduct complained of extended beyond the period specified in the Complaint, from the time when he first commenced operations in the Pharmacy.
On the subject of the practitioner missing or ignoring red flags on prescriptions, he conceded his failures were particularly concerning however he again linked these failings to his personal circumstances (in paragraphs 98 and 99): "98. There are a large number of red flags on the prescriptions identified in the NCAT Complaint. Some were missing patient addresses or other key patient details. Others had insufficient patient instructions, spelling mistakes, handwritten amendments or had particularly unclear handwriting. Many had signatures which would not ordinarily correspond with the name of the prescriber. 99. While some of the red flags could potentially be explained (for example, spelling mistakes or messy handwriting), the number of red flags on each of the identified prescriptions in question should have led me, at the very least, to contact the prescriber, if not decline supply altogether. The red flags for the most part were obvious and should have been noticed immediately. I failed to properly scrutinise the prescriptions in question and was just not vigilant enough in the circumstances. I have explained my difficult personal circumstances already, but again, that is no excuse for my failures which are particularly concerning in relation to high risk medications."
The level of the practitioner's personal and marital distress (to the extent that his marriage became strained and was on the brink of collapse on several occasions) apparently caused him to seek professional treatment from a clinical psychologist, for anxiety and depression.
The practitioner has not provided any report from the clinical psychologist with whom he consulted. In his own assessment, his difficult personal circumstances were a large part of the cause for his failings in pharmacy practice, exacerbated by his conceded knowledge gaps with respect to drugs of addiction, the OTP, the use and misuse of opioids, the operation of the illicit black market regarding fentanyl, and the obligations of a pharmacist and of a proprietor. For the reasons explained above, we are of the view that it is possible that these failings accompanied the practitioner's practice of pharmacy from the outset, and he was not equipped to properly acquire the Pharmacy and discharge his obligations.
This, in turn, leads us to consider whether his failings had become entrenched conduct.
We retain some discomfort with the possibility that his practice of pharmacy for a number of years early in his career was deficient, with corners being cut when he was feeling under personal and family pressures. On an application for reinstatement, a Tribunal would need to be confident that the practitioner's past behaviour had not become so entrenched that he would relapse when under pressure. A Tribunal would need to be confident that the practitioner has achieved some stability in his personal circumstances such that he is not impeded in the execution of his professional responsibilities.

[147]

Decision to cancel the practitioner's registration

In Chen, the Court of Appeal at [38] noted that the Tribunal's decision below had recognised the treatment of the cohort of patients who are prescribed drugs of addiction as a serious matter, with significant responsibilities attaching to the prescribing doctor. We consider that the Court of Appeal's comments apply equally to pharmacists, in their role as 'gatekeepers' of drugs of addiction: "The appellant's actions in improperly prescribing and managing patients who are administered drugs of addiction was a 'serious matter': [137]… Medical practitioners are in a unique position in enabling members of the public to have access to drugs of addiction and the community is entitled to rely on the integrity and professional expertise of medical practitioners to avoid creating drug addicts and to avoid feeding the habits of drug addicts. This is not necessarily an easy task, but there are well-recognised protocols for the administration of drugs of addiction and well-recognised resources to assist medical practitioners in treating their patients."
We consider the practitioner's misconduct to be very serious, on multiple occasions over an extended period of time, with significant risk posed to his patients and potentially the general public if dangerous drugs were being diverted into the illicit black market, that continued suspension of his registration would be inadequate.
His misconduct was all the more egregious in a number of circumstances where red flags were plainly evident that some prescriptions were forged and/or fraudulent. Rather than exercise independent professional judgment and refuse to supply, the practitioner dispensed addictive medication in dangerously large amounts.
In all the circumstances, we conclude that the professional misconduct which we have found, and which we have described, is sufficiently serious to warrant the cancellation of the practitioner's registration. This decision does not suggest or imply that the practitioner is permanently unfit for registration (applying the rationale in Chen that it is not necessary to find that a practitioner is probably permanently unfit to practise before registration can be cancelled). Against that, we have balanced the consideration as to whether the practitioner has become a reformed person (applying the rationale in Litchfield) in the sense that we could be confident that in future he will execute his professional autonomous decision-making responsibilities. Whilst we do not doubt the sincerity of his personal warranty about his future conduct, there is no independent evidence to support such an assurance.

[148]

Consideration of non-review period

The Tribunal has the power and discretion to set a non-review period with respect to an order cancelling a practitioner's registration. The effect of setting a non-review period is that a practitioner may not make an application for review of the cancellation order during the non-review period: s 163A(3) of the National Law.
At the end of the non-review period, the practitioner is entitled to make an application to the Tribunal for reinstatement: s 163A(1) of the National Law.
We note that, after all that the practitioner has experienced and learned as a result of the Complaint, despite having his registration suspended, he has said that he would "cherish" the chance to return to pharmacy practice in the future.
The paramount consideration when determining the length of a non-review period is the protection of the health and safety of the public. The duration of the non-review period indicates the minimum period within which the Tribunal considers the practitioner should not be able to practise his profession by sending a clear message of denouncement of the offending conduct to the practitioner, the pharmacy profession and the public about professional standards to be maintained.
The general public needs to be confident that they are protected from this practitioner and to be confident that the conduct is strongly denounced. In this case, where concern for the susceptibility to addiction by vulnerable patients receiving Schedule 8 medications weighs heavily, the practitioner's conduct is particularly offensive.
We are of the view that a non-review period is needed in the circumstances of this case. Whilst we do not make light of the mental, emotional and financial stresses the practitioner has experienced and continues to experience, a non-review period will allow him further time to demonstrate whether: 1. he has accepted full responsibility for the gravity of his conduct without seeking to deflect blame onto the previous proprietor of the Pharmacy or the impact of the COVID epidemic; 2. he has completed meaningful further education, to ensure that his technical knowledge continues to be up to date and particularly to address the exercise of his professional judgment and ethical pharmacy practice; 3. his character and behaviour are truly reformed such that he can demonstrate his acceptance of his professional responsibilities to scrutinise prescriptions in appropriate circumstances, and can be relied upon to practice pharmacy to the expected standards in the future.
The decision on the period of time during which a practitioner may not apply for review, is dependant on the facts and circumstances of each case. As already noted, the predominant consideration is the protection of the public: Lee at [23]-[24]. The non-review periods imposed in previous Tribunal decisions do not, however, set a benchmark for subsequent cases: Health Care Complaints Commission v Elshaimy [2019] NSWCATOD 17 ("Elshaimy") at [47]. The gravity of the misconduct is not to be measured by reference to the worst cases: Litchfield at 638.
The Commission argued that cancellation with non-review period of two years was appropriate.
On balance, for the reasons set out above, we consider that a non-review period of one year is appropriate in the circumstances of this case. In our opinion, this order serves a number of purposes: 1. It protects the public from the risk that the offending conduct might be repeated if the practitioner lacks the confidence to exercise his independent professional judgment and refuse to supply Schedule 8 or Schedule 4 drugs contrary to regulations in the face of a prescriber's reassurance that a patient is being monitored. This requires strength of character, recognition of the pharmacist's duty of care as "gatekeeper" of dangerous drugs toward patients, appropriate assessment of the risk in each circumstance and independent decision-making. 2. It provides the practitioner with an opportunity to firmly consolidate his newly acquired technical knowledge through CPD and be in a position to apply that knowledge upon seeking to be registered. 3. It unequivocally denounces the conduct, sending a clear message to the profession of the responsibilities of pharmacists as "gatekeepers" and the grave consequences of failing to comply with the required professional standards. 4. It acts as a deterrent to both the practitioner and other members of the profession. 5. It maintains the high standard of the profession. 6. It allows the practitioner to engage in such remedial or counselling processes as he may determine before applying for re-registration, if he desires to do so.
Whilst we do not propose to order the practitioner to undergo psychological counselling, we urge him to explore that course of action in anticipation of an application to seek to be re-registered at the end of the non-review period. This would assist him to explore his past reticence to challenge prescribers in circumstances warranting further scrutiny, and to assist him in putting strategies in place to act as protective measures against feeling he was "easy" to be "taken advantage of" as expressed in his statement to the Tribunal. This may assist him in providing independent probative material to persuade the Tribunal that he has the personal confidence to exercise his own independent judgment in the future, and to grant him reinstatement as a registered pharmacist upon application once the period of non-review has expired.

Health Care Complaints Commission v Salloum

At a glance

Court

Decision date

Source

Judgment (151 paragraphs)

Parties

Legislation Cited (5)

Cases Cited (26)