Health Care Complaints Commission v Tamer

Solicitors: Health Care Complaints Commission (Applicant) Meridian Lawyers (Respondent) File Number(s): 2020/00057399 Publication restriction: Pursuant to section 64(1)(a) of the Civil and Administrative Tribunal Act 2013, the publication, broadcast or disclosure of the name of any patient referred to in these proceedings, including but not limited to those listed in the Schedules to the Complaint, is prohibited.

REASONS FOR DECISION

1. Between September 2014 and July 2017, Mr Nabil Tamer worked as the pharmacist-in-charge at the Kingswood Compounding Pharmacy (the Pharmacy). He was first registered as a pharmacist in May 2010.
2. In 2017, the Pharmaceutical Regulatory Unit (PRU) discovered that the Pharmacy had been purchasing large quantities of Somatropin and Testosterone, drugs known to be abused by body builders. Two years earlier the PRU had investigated the Pharmacy and found significant quantities of Diamond-branded Stanozolol products, which are prohibited for use in Australia. [1]
3. In a report dated 29 June 2017, prepared following its investigation of the Pharmacy, the PRU recorded its findings that between July 2015 and May 2017, Mr Tamer and other pharmacists employed by the Pharmacy had inappropriately dispensed and compounded several drugs, including Somatropin and Testosterone. In addition, the PRU identified several deficiencies relating to records and oversight of the Pharmacy.
4. On 24 July 2017, following receipt of the PRU's report, the Pharmacy Council of New South Wales (the Council) convened proceedings under s 150 of the Health Practitioner Regulation National Law (NSW) (the National Law). The Council imposed conditions on Mr Tamer's registration, including that he must not work as a pharmacist in charge or as a sole pharmacist and must not compound or manufacture Somatropin and Testosterone. Those conditions remain in place to this day.
5. In February 2020, the Health Care Complaints Commission (the Commission) referred a complaint (the Complaint) about Mr Tamer to the New South Wales Civil and Administrative Tribunal (NCAT). Mr Tamer admits most of the particulars of the Complaint. In addition, he agrees that most of the admitted conduct amounts to "unsatisfactory professional conduct" (s 139B(1) of the National Law) but denies "professional misconduct" (s 139E of the National Law).
6. Mr Sam Ashour is the sole proprietor and operator of the Pharmacy. He is the subject of a separate complaint referred by the Commission to NCAT. Given the overlap in the subject matter of the two complaints, they were heard concurrently. Parts of these reasons are identical to those in Health Care Complaints Commission v Ashour [2021] NSWCATOD 165.
7. In August 2017, Mr Tamer commenced employment at Pharmacy4Less Caringbah as a "supporting pharmacist" where he remains working.
8. For the reasons that follow, we find Mr Tamer guilty of unsatisfactory professional conduct and professional misconduct. We have issued Mr Tamer with a reprimand and have imposed several conditions on his registration.

Standard and onus of proof

1. The Commission bears the burden of proving, on the balance of probabilities, the matters particularised in the Complaint.
2. Pursuant to s 38(2) of the Civil and Administrative Tribunal Act 2013 (NSW), NCAT is not bound by the rules of evidence and, strictly speaking, "neither Briginshaw nor s 140 of the Evidence Act [which sets the standard of proof in civil proceedings] applies directly in decision-making by NCAT": Bronze Wing International Pty Ltd v SafeWork NSW [2017] NSWCA 41 at [127] (Leeming JA, Gleeson JA agreeing); Ng v Health Care Complaints Commission [2017] NSWSC 53 at [56]. (cf Gautam v Health Care Complaints Commission [2021] NSWCA 85 at [89] (Payne JA, Leeming JA and Simpson AJA agreeing)). Nonetheless, given the gravity of the allegations made against Mr Tamer, in deciding whether the particulars alleged are proven we have adopted the approach set out in Briginshaw v Briginshaw (1938) 60 CLR 336; [1938] HCA 34.
3. In that case, Dixon J, in considering the question of the proof required to meet the civil standard, said at 361-362: The truth is that, when the law requires the proof of any fact, the tribunal must feel an actual persuasion of its occurrence or existence before it can be found… Reasonable persuasion is not a state of mind that is attained or established independently of the nature and consequence of the fact or facts to be proved. The seriousness of the allegation made, the inherent likelihood of an occurrence of a given description, or the gravity of the consequences of flowing from a particular findings are considerations which must affect the answer to the question whether the issue has been proved to the reasonable satisfaction of the tribunal.
4. The allegations in this case are serious as are the consequences of an adverse finding for Mr Tamar. In making our findings, we have been conscious of those factors.

PTGA and PTGR

1. In Australia, a national classification scheme, "scheduling", operates to control how medicines and poisons are made available to the public. Under that schedule, medicines and poisons are classified into one of ten schedules according to the level of regulatory control over their availability that has been assessed as being required to protect public health and safety. The schedules are published in the Poisons Standard, a legislative instrument made under s 52D(2)(b) of the Therapeutic Goods Act 1989 (Cth). In NSW, the Poisons Standard is given effect by s 8 of the Poisons and Therapeutic Goods Act 1966 (NSW) (PTGA). [2]
2. The substances the subject of the Complaint are either "restricted substances" or "drugs of addiction": 1. Listed in Schedule 4 of the Poisons Standard, restricted substances are commonly referred to as "Schedule 4 substances". Restricted substances are further classified within Schedule 4 as "special restricted substances" (Appendix B to Schedule 4 (Schedule 4B drugs)) and "prescribed restricted substances" (Appendix D to Schedule 4 (Schedule 4D drugs)). 2. Listed in Schedule 8 of the Poisons Standard, drugs of addiction are commonly referred to as "Schedule 8 drugs".
3. In NSW the PTGA and the Poisons and Therapeutic Goods Regulation 2008 (NSW) (PTGR) regulate the packaging, labelling, possession, storage, prescription and supply of Schedule 4 and Schedule 8 drugs. The PTGA and PTGR restrict the possession and supply of Schedule 4 substances and Schedule 8 drugs, and impose record-keeping requirements on pharmacists.
4. The following provisions of the PTGA and PTGR are relevant to the Complaint.
5. Section 10(3) and (4) of the PTGA, makes it an offence for a person to supply a Schedule 4 substance (other than by wholesale) unless the person falls into specified categories. One of those categories is a pharmacist who supplies in accordance with the prescription of a medical practitioner: s 10(4)(b) of the PTGA.
6. Similarly, Part 4, Division 4 of the PTGR restricts those who may supply Schedule 8 drugs. A pharmacist is permitted to supply such drugs on prescription (provided that the prescription is in the required form) or in certain circumstances in an emergency: cll 85, 96 of the PTGR.
7. In addition, the PTGR requires pharmacists who supply Schedule 4 substances and Schedule 8 drugs to: 1. not supply the substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances: cl 54 (Schedule 4 substances), cl 109 (Schedule 8 drugs); and 2. record certain details in relation to the supply of the substance, including the name of the person who supplied the substance in the "approved manner": cl 55(1)(d) (Schedule 4 substances), cl 113(1)(d) (Schedule 8 drugs).
8. The "approved manner" of recording the details is set out in cll 55(1)(d) and 113(1)(d) of the PTGR and in a memorandum issued by NSW Health: Approved systems for recording the supply of substances on prescription generally or in an emergency to health professionals (document TG50/6, November 2015).
9. In addition, further restrictions apply to the possession and supply of Schedule 4B and Schedule 4D substances: s 16 of the PTGA; cll 35(1)(f), 38(1)(e), 39(2)(b), 41(2)(b), 42 of the PTGR.

Relevant guidelines

1. Relevant to the Complaint is the Pharmacy Board of Australia, Code of Conduct for Pharmacists (March 2014) (the Code of Conduct) and various guidelines relating to the dispensing and compounding of medicines. These were developed under s 39 of the National Law by the Pharmacy Board of Australia (the Pharmacy Board) and are therefore admissible in proceedings under the National Law as evidence of what constitutes appropriate professional conduct or practice for pharmacists: s 41 of the National Law.

Code of Conduct

1. The Code of Conduct provides, among other things, that pharmacists: 1. have a duty to make the care of patients or clients their first concern and to practise safely and effectively (cll 1.2, 2.1); 2. must, themselves, assess the patient or client taking into account an appropriate history, their views and an appropriate physical examination where relevant (cl 2.1(a)); 3. must recognise the limits of their own competence (cll 2.1(d), 2.2(a)); and 4. must maintain clear and accurate health records, including recording relevant details of clinical history, clinical findings, investigations, information given to patients or clients, medication and other management in a form that can be understood by other health practitioners (cl 8.4).

Dispensing Guidelines

1. In August 2010, the Pharmacy Board issued "Guidelines for dispensing of medicines" (2010 Dispensing Guidelines). In September 2015, the Pharmacy Board issued replacement guidelines which came into effect on 7 December 2015 (2015 Dispensing Guidelines). Those Guidelines require pharmacists to: 1. exercise independent judgment to ensure that a medicine they are proposing to dispense is safe and clinically appropriate for the patient; 2. document their clinical decision-making in the dispensing record and where possible in the patient's health record, including any circumstances of the patient that were taken into account; 3. dispense multiple repeats only where there are exceptional circumstances, and make an appropriate notation of that decision on the prescription, in the dispensing record and where possible in the patient's health record; and 4. take responsibility for dispensing decisions by recording their name as the dispensing pharmacist.

Compounding Guidelines

1. In March 2015, the Pharmacy Board issued "Guidelines on compounding of medicines", which came into effect on 28 April 2015 (Compounding Guidelines). Those guidelines state that there are only three circumstances in which it is appropriate for a pharmacist to prepare a compounded medicine: 1. an appropriate commercial product is unavailable; 2. a commercial product is unsuitable (for example, if a patient experienced an allergy to an excipient in the commercial product); or 3. when undertaking research sanctioned by a recognised human research ethics committee.

The Complaint

1. Set out at Annexure A to these reasons, the Complaint (as amended) consists of five individual complaints. The Commission contends that the conduct the subject of Complaints 1, 2, 3 and 4 amounts to unsatisfactory professional conduct within the meaning s 139B(1)(a) of the National Law: 139B Meaning of "unsatisfactory professional conduct" of registered health practitioner generally [NSW] (1) "Unsatisfactory professional conduct" of a registered health practitioner includes each of the following - (a) Conduct significantly below reasonable standard Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience
2. Unless otherwise stated, Mr Tamer admits each particular and agrees that it amounts to unsatisfactory professional conduct within the meaning s 139B(1)(a) of the National Law. 1. Complaint 1 consists of three particulars: 1. Particulars 1 and 2 relate to Mr Tamer's failure to ensure that the Pharmacy's dispensing records for the supply of restricted substances, Phentermine, Anastrazole, Somatropin and Testosterone, recorded the details of the dispensing pharmacist as required by cl 55(1)(d) of the PTGR, and the 2010 and 2015 Dispensing Guidelines; 2. Particular 3 relates to Mr Tamer's actions in permitting dispensing technicians to record the name of a non-pharmacist on the supply of the Schedule 8 drugs, Ketamine, Dexamphetamine, Fentanyl and Alprazolam, in breach of the 2010 and 2015 Dispensing Guidelines. 1. Complaint 2, consists of two particulars: 1. Particular 1 relates to Mr Tamer's actions in dispensing to Patient A, Testosterone, a Schedule 4 substance on six occasions between 7 October 2016 and 24 January 2017, in circumstances where, among other things, the dose prescribed and the prescribing doctor's directions for use were inconsistent with the manufacturer's directions for use; and, contrary to cl 54 of the PTGR, the dispensing did not accord with the recognised therapeutic standard for Testosterone; 2. Particular 2 relates to Mr Tamer's actions in dispensing to Patient B, Somatropin (Human Growth Hormone), a Schedule 4 substance on two occasions between 28 April 2016 and 27 June 2016, in circumstances where contrary to cl 54 of the PTGR, the dispensing did not accord with the recognised therapeutic standard. 1. Complaint 3 consists of three particulars: 1. Particular 1 relates to Mr Tamer's actions in dispensing to multiple patients, Tadafil (erectile dysfunction medication), a Schedule 4 drug in circumstances where he failed to contact the prescriber to discuss the clinical indications for compounding when Cialis, an Australian Register of Therapeutic Goods-listed product (ARTG-listed product), was commercially available; 2. Particular 2 relates to Mr Tamer's actions in compounding and dispensing Hepatitis C anti-viral drugs on 223 occasions to multiple patients in circumstances where three ARTG-listed products were commercially available and the basis for compounding those was to provide those drugs to patients at a lesser cost than the commercially available equivalent. Mr Tamer admits the facts of this particular but does not agree that it amounts to unsatisfactory professional conduct; 3. Particular 3 relates to Mr Tamer's actions in compounding raw materials purporting to be Hepatitis C anti-viral drugs, brought in by customers, in circumstances where he did not test those materials prior to compounding. Mr Tamer admits that he did not test the raw materials prior to compounding but contends that that conduct does not amount to unsatisfactory professional conduct. 1. Complaint 4 relates to Mr Tamer's failure to adequately document contact with the prescriber on multiple occasions with respect to prescriptions presented by Patients A, B and C, contrary to Guideline 2 of the 2015 Dispensing Guidelines. 2. Complaint 5 states that each particular of Complaints 1, 2 and 3, or in the alternative, when taken together Complaints 1, 2, 3 and 4 justify a finding of professional misconduct. Mr Tamer does not admit professional misconduct.
3. In addition, Mr Tamer admits that the admitted conduct amounts to unsatisfactory professional conduct under s 139B(1)(a) of the National Law.

Particular 2, Complaint 3

1. Mr Tamer admits the facts of Particular 2, Complaint 3 but does not admit that the admitted conduct amounts to unsatisfactory professional conduct. In addition, he does not admit Particular 3, Complaint 3.
2. According to Mr Tamer, in early 2015 the Pharmacy began receiving requests from customers to encapsulate raw material they had imported from overseas for self-treatment of Hepatitis C. He claimed that on each occasion the customer presented a "certificate of analysis". According to Mr Tamer, the Pharmacy acceded to those requests on a handful of occasions. However, because of concerns about the risk of using substances purchased from unknown overseas sources, in September 2015 the Pharmacy began sourcing those materials from a local supplier, Astral Scientific Pty Ltd.
3. Mr Tamer claimed that in September 2015, the Pharmacy was inundated with orders for compounded Hepatitis C medication. Demand dropped off in or about March 2016, when ARTG-listed products Sofosbuvir, Ribavirin and Daclatasvir became commercially available. (Sofosbuvir, Ribavirin and Daclatasvir were listed on the ARTG on 30 June 2014, 15 March 2015 and 25 June 2015 respectively.)
4. Mr Tamer claims that the Pharmacy continued to compound Hepatitis C medication as it was substantially cheaper for those customers who did not have access to Pharmaceutical Benefits Scheme-subsidised (PBS-subsidised) treatment because, for example, they did not have a Medicare card. He claims that without the PBS-subsidy, the price of a 12-week course of the commercially available drugs was between $30,000 and $60,000. In contrast, the price of the compounded equivalent was between $1,600 and $2,300.
5. Mr Tamer stated that throughout the period the Pharmacy compounded Hepatitis C medication, he was aware that the Compounding Guidelines prohibited pharmacists from compounding medicine where an appropriate commercial product was available. However, he stated that he read the Guidelines as permitting the supply of a compounded product where a customer could not afford the commercially available equivalent. He said he thought he had a duty of care to those patients who could not afford this "life-saving treatment". In these proceedings, he said he now appreciates that his understanding of the application of the Guidelines was flawed.

Unsatisfactory professional conduct

1. Particular 2 states: 2. "Between 1 January 2016 and 11 May 2017, the practitioner compounded and dispensed Hepatitis C anti-viral drugs on 223 occasions as set out in Tab 3 of the additional documents upon which the Commission relies in circumstances where: a. the compounded Australian Register of Therapeutic Goods listed product Sofosbuvir, Ribarvin, and Daclatasvir were commercially available; b. the basis for compounding was to reduce the costs to the patients of the medications by comparison to the cost of the commercially available medication, in breach of Guideline 2 of the Pharmaceutical Board of Australia's 'Guidelines on Compounding Medicines'."
2. In evaluating whether the conduct the subject of Particular 2, Complaint 3 amounts to unsatisfactory professional conduct within the meaning of s 139B(1)(a) of the National Law, it is necessary to: 1. identify the standard "reasonably expected" of a pharmacist of an equivalent level of training or experience to Mr Tamer (the relevant standard), and 2. evaluate whether the admitted conduct demonstrates that the knowledge, skill or judgment possessed, or care exercised, by Mr Tamer in the practice of his profession, fell "significantly below" the relevant standard.
3. By January 2016, Mr Tamer had been working as a pharmacist for about six years and as a pharmacist-in-charge for about four years.
4. Mr Tamer contends that while regrettable, his conduct did not fall significantly below the relevant standard because, first, he was motivated by genuine concern for his patients. Second, as observed by Mr Bruce Chilton, an experienced pharmacist who, at the request of the Commission, prepared a report for these proceedings and gave oral evidence, the Compounding Guidelines are "soft law" and allow for professional judgment to be exercised by the dispensing pharmacist.

Consideration

1. We accept that Mr Tamer read the Compounding Guidelines to permit medicine to be compounded and dispensed medicine in circumstances where there was a significant price differential between the ARTG-listed product and the compounded equivalent and the patient could not afford the ARTG-listed product. In addition, we accept that Mr Tamer's actions were motivated by concern for his patients.
2. However, this does not dispose of the question of whether Mr Tamer's conduct in dispensing and compounding Hepatitis C medication demonstrated knowledge and judgment that fell significantly below the relevant standard. We find it did so for these reasons.
3. First, as Mr Tamer concedes, his conduct contravened Guideline 2 of the Compounding Guidelines.
4. Second, while, as Mr Chilton points out, the Compounding Guidelines allow for the exercise of professional judgment in some areas, such as compounding and dispensing medication where an ARTG-listed product is available, the Guidelines are stated to be prescriptive.
5. Third, the standard reasonably expected of a pharmacist of Mr Tamer's level of experience is to be familiar with and to have a proper understanding of the Compounding Guidelines, especially where, as in this case, the pharmacist was working in a pharmacy with a significant compounding practice.
6. Fourth, the conduct was not a one-off breach which might be attributable to work pressure or oversight. On 223 occasions over a period of 15 months, Mr Tamer dispensed and compounded Hepatitis C medication. In that period, he had ample opportunity to review the Guidelines and seek advice about the proper interpretation of Guideline 2.
7. Mr Tamer's conduct the subject of Particular 2, Complaint 3 amounts to unsatisfactory professional conduct as defined by s 139B(1)(a) of the National Law.

Particular 3, Complaint 3

1. Particular 3, Complaint 3 reads: 3. During 2015, the practitioner inappropriately compounded medications using unknown raw materials purporting to be Hepatitis C anti-viral drugs which were brought in by customers and labelled the compounded medications as requested by the customer in circumstances where: a. there was no Certificate of Analysis; b. the materials were not tested prior to compounding.
2. Mr Tamer admits compounding and dispensing the raw materials without testing those materials. However, he insists that on each occasion he received a Certificate of Analysis with those materials. In closing submissions, the Commission did not press the allegation that the raw materials were not accompanied by a Certificate of Analysis.
3. It follows that the question of the proper interpretation of Particular 3 arises, namely whether as Mr Tamer contends that, as formulated, Particular 3 requires the Commission to establish both paragraph (a) and paragraph (b). The Commission disagrees.
4. The central allegation made by Particular 3 is that Mr Tamer inappropriately compounded medications using unknown raw materials purporting to be Hepatitis C anti-viral drugs which were brought in by customers (raw materials). Arguably it is capable of being read in two ways. That the facts alleged in each paragraph, or only one paragraph, must be established. While the conjunction "and" is not used to join paragraphs (a) and (b), in our view Particular 3 reads as though there is a silent "and" because the paragraphs appear to read in a cumulative fashion.
5. It follows that Particular 3 is not established.

Complaint 4

1. As noted, Complaint 4 concerns Mr Tamer's failure to adequately document contact with the prescriber on multiple occasions with respect to prescriptions presented by Patients A, B and C, contrary to Guideline 2 of the 2015 Dispensing Guidelines.
2. Mr Tamer admits all the facts of Complaint 4. In addition, he admits that the facts alleged in relation to Patient A (Particular 2) and Patient B (Particular 3) amount to unsatisfactory professional conduct. However, he disputes that the facts alleged in relation to Patient C (Particular 1) amount to unsatisfactory professional conduct.
3. Guideline 2 of the 2015 Dispensing Guidelines states that, in dispensing a prescription, a pharmacist must exercise independent judgment to ensure the medicine is safe and appropriate for the patient, and conforms to the prescriber's intentions. The Guidelines state that where clarification is required, the patient or, if necessary, the prescriber, should be contacted. In addition, the Guidelines state that when dispensing a prescription, the pharmacist must take into account the dose, frequency and route of administration among other things, and record that information in the dispensing record, and where possible the patient's health record: "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 and/or dispensed for that patient can also be assured."

Particular 1

1. On 6 July 2015, Mr Tamer dispensed the restricted substance Scitropin (20 x 3 mg) to Patient C. The subject prescription was issued by Dr Ian Mitchell for 100 mls with 5 repeats. In a diary note, adjacent to the dispensing label, Mr Tamer wrote: "contacted [prescribing practitioner, Dr Ian Mitchell] and confirmed Rpts [repeats] reduced to 20 boxes per supply"
2. In a statement provided to the Council dated 18 July 2017, Mr Tamer wrote that he contacted Dr Mitchell to confirm the validity of the prescription presented by Patient C and to seek clarification about the quantity, strength, indication and dosage. According to Mr Tamer, Dr Mitchell explained that Patient C had been taking Scitropin for some time because of ongoing injuries and that the quantity prescribed was high because of Patient C's weight, 140kg. Mr Tamer states that because he had come across examples where up to 11 boxes of Scitropin with repeats had been prescribed for paediatric patients, he did not question Dr Mitchell further.
3. Mr Tamer recommended reducing the quantity prescribed from 66 to 20 boxes per supply. Dr Mitchell agreed.
4. Mr Tamer agrees that the file note he made of his conversation with Dr Mitchell did not adequately document the details of that conversation, in particular, Dr Mitchell's explanation for prescribing an exceedingly high dose of Scitropin. He admits that, in contravention of the Guidelines, he failed to adequately document his conversation with Dr Mitchell, specifically the "relevant details" (dose, frequency and route of administration, duration of treatment, the presence or absence of other medicines, the patient's illness, medication history, allergies etc). In addition, Mr Tamer concedes that he failed, as required by Guideline 2, to record those details in the dispensing record and Patient C's patient file.
5. However, while Mr Tamer agrees that these failures demonstrate that the judgment he possessed and care exercised fell below the relevant standard, he submits that it did not fall significantly below that standard, citing in support the opinion expressed by Mr Chilton. According to Mr Chilton, the "few notes in the diary" made by Mr Tamer about his discussion with Dr Mitchell were insufficient. While critical of the lack of detail contained in that note and Mr Tamer's failure to record it in the dispensing records, Mr Chilton was not strongly critical of those failures.

Particulars 2 and 3

1. In contrast, Mr Chilton was strongly critical of Mr Tamer's failure to adequately record his contact with Dr Alicia Meneghetti, who had prescribed Proviron to Patient A (Particular 2) and Somatropin to Patient B (Particular 3).
2. Mr Tamer made no record of any discussion with Dr Meneghetti before dispensing to Patient A large amounts of Proviron, an anabolic steroid, on four occasions between 7 October 2016 and 24 January 2017.
3. The only record of Mr Tamer's contact with Dr Meneghetti in relation to the prescription issued for Somatropin to Patient B is a diary note made by him on 28 April 2016, adjacent to the dispensing label: "Dr contacted and verified Rx. RX → mitte 11& Repeat 1"
4. Mr Chilton explained that he viewed the conduct the subject of Particular 1 to be less concerning than the conduct the subject of Particulars 2 and 3 because in the latter cases the disparity between the amount and dose prescribed and the "standard dosage" was greater, making it more important that the explanation given by the prescriber for issuing the prescription to be documented. In addition, he noted that Mr Tamer made no record of his discussion with Dr Meneghetti about the explanation she gave for prescribing to Patient A large amounts of Proviron.

Unsatisfactory professional conduct

1. We find that the failures particularised in relation to Particulars 2 and 3 demonstrate that the care exercised by Mr Tamer fell significantly below the relevant standard. In addition to the considerations identified by Mr Chilton, we consider it relevant that each of the drugs prescribed were Schedule 4B drugs, which were known to be liable to abuse, and the dosage prescribed was unusually high. A further concern with respect to Particular 2 is that Proviron was being dispensed in combination with an androgen, Primoteston.
2. While less serious than the conduct the subject of Particulars 2 and 3, we reject Mr Chilton's opinion that the conduct the subject of Particular 1 did not demonstrate that the care exercised by Mr Tamer fell significantly below the relevant standard. In reaching that conclusion we have taken into account that while Mr Tamer recorded having queried Dr Mitchell about his decision to prescribe large amounts of Scitropin, missing from the note made of that discussion is the explanation given by Dr Mitchell. Given the amount prescribed, in our view, the standard reasonably expected of a practitioner of an equivalent level of experience and training to Mr Tamer would be to record that explanation. His failure to do so evidences conduct that fell significantly below that standard.
3. Complaint 4 is proven.

Does the proven or admitted conduct amount to professional misconduct?

1. Complaint 5 states that each particular of Complaints 1 to 3, and, in the alternative, two or more of the particulars of Complaints 1 to 4 amount to professional misconduct. Mr Tamer does not admit professional misconduct.
2. Section 139E of the National Law states that a practitioner is guilty of professional misconduct if they engage in: 139E Meaning of "professional misconduct" [NSW] … (a) unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or (b) more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration.
3. We must decide whether the proven or admitted conduct (the impugned conduct) amounts to unsatisfactory professional conduct that is of a "sufficiently serious nature" to justify an order for suspension or cancellation. This requires that we make an evaluative judgement: Chen v Health Care Complaints Commission (2017) NSWLR 334; [2017] NSWCA 186 at [20]. The definition of professional misconduct is focused on the nature of the conduct, not whether an order for suspension or cancellation should be made: Health Care Complaints Commission v Karalasingham [2007] NSWCA 267 at [67] (Basten JA).
4. In evaluating whether the impugned conduct is of a sufficiently serious nature to justify suspension or cancellation, circumstances that bear on the objective assessment of that conduct must be taken into account. These include the nature and duration of the conduct, any mitigating factors, and an assessment of where the offending conduct falls on the spectrum of unsatisfactory professional conduct.
5. The impugned conduct is to be measured by the extent to which it departs from proper standards and not by reference to the worst cases. To do the latter would risk the misconduct of some practitioners indirectly setting the standards to be applied by NCAT: Health Care Complaints Commission v Litchfield (1997) 41 NSWLR 630 at 638; [1997] NSWSC 297.
6. Mr Tamer argues that in assessing whether the impugned conduct is of a sufficiently serious nature to justify suspension or cancellation, the following factors are relevant: 1. there was nothing suspicious about his conduct or intentions; 2. the conduct of Mr Tamer was neither careless nor negligent. Rather, the mistakes he made were innocent errors, made by a well-intentioned pharmacist, who was working extraordinary hours and doing his best to comply with onerous work obligations; and 3. as Mr Ashour attested, throughout the period of working at the Pharmacy, Mr Tamer has been diligent about paperwork, particularly the drug register for Schedule 8 drugs (cl 111 of the PTGR).
7. Mr Tamer argues that the following factors mitigate against a finding that the impugned conduct is of a sufficiently serious nature to justify suspension or cancellation: 1. his relative youth and inexperience; 2. his long hours of work, averaging 60 hours per week; 3. the onerous nature of his role, being the pharmacist in charge of a large and busy pharmacy with a significant compounding practice together with his responsibility to ensure that pharmacist, Adam Kennedy, who was subject to significant conditions, worked within those conditions; and 4. his demonstrated commitment to address any shortcomings in his practice and to learn from his mistakes.
8. The Commission argues that Mr Tamer's overall lack of knowledge and judgment justifies a finding of professional misconduct. The Commission argues that the impugned conduct demonstrates that Mr Tamer was out of his depth and either ignorant of his legislative and regulatory obligations or lacked the confidence or strength of character to question practices that did not conform with those obligations. In relation to dispensing, his inquiries of prescribers were not sufficiently informed by the exercise of independent clinical judgment and not properly documented. In relation to compounding, his decisions were misguided by a focus on financial considerations in priority to patient safety.

Consideration

1. Of the impugned conduct we find the conduct the subject of Particular 1, Complaint 2 to be the most serious. It involved the dispensing of Primoteston Depot on multiple occasions over a three-month period in circumstances where the dose prescribed significantly exceeded the recognised therapeutic standard. It demonstrated that Mr Tamer had not turned his mind to the possibility that the drugs prescribed were being misused or abused. In addition, it demonstrated that Mr Tamer lacked the necessary knowledge and/or confidence to challenge Dr Meneghetti's decision to prescribe excessive quantities of that drug.
2. Mr Tamer's actions were the result of a combination of ignorance, inexperience and undue deference to the prescribing practitioners. There is no evidence, and nor is it suggested, that Mr Tamer was motivated by personal gain or that he deliberately disregarded his professional obligations. Nonetheless, we find that the conduct the subject of Particular 1, Complaint 2 to be sufficiently serious to justify suspension of Mr Tamer's registration.
3. While the conduct the subject of the remaining particulars are not individually sufficiently serious to justify suspension of Mr Tamer's registration, in our view, when weighed together, the cumulative effect of a range of unprofessional practices over a reasonably extended period amounts to professional misconduct.
4. Complaint 5 is therefore proven.

What, if any, disciplinary powers should be exercised?

1. Where a complaint made under the National Law is admitted or proven, NCAT may exercise any of the powers in Subdiv 6, Div 3 of Pt 8 of the National Law. They include the powers to caution, reprimand and to impose conditions on a practitioner's registration. Where, as here, the Tribunal is satisfied that a practitioner is guilty of professional misconduct, it may suspend or cancel the practitioner's registration: s 149C(1)(b) of the National Law.
2. In exercising the power to make disciplinary orders, the paramount consideration is the protection of the health and safety of the public: s 3A of the National Law.
3. In Prakash v Health Care Complaints Commission [2006] NSWCA 153, Basten JA commented at [101] that: "[T]he adverse consequences for a practitioner may require that no more restrictive an order should be made than is necessary for the proper protection of the community and the other proper purposes of such an order".
4. In Lee v Health Care Complaints Commission [2012] NSWCA 80, Barrett JA observed at [20]-[21] that, in making protective orders, the task of the decision-maker centres not on punishment but on the protection of the public and the maintenance of proper professional standards, citing with approval the comments made by Basten JA in Director-General, Department of Ageing, Disability and Home Care v Lambert (2009) 74 NSWLR 523; [2009] NSWCA 102 at [83].
5. The Commission urges the Tribunal to reprimand Mr Tamer and to impose several conditions on his registration, including that: 1. for a period of 12 months, Mr Tamer must not work as a pharmacist in charge; 2. for a period of 12 months, Mr Tamer must not work as a sole pharmacist; 3. Mr Tamer must not compound or manufacture ten listed drugs including those the subject of the Complaint; 4. Mr Tamer may only supply, dispense or administer any of the 10 listed drugs for an approved indication as specified for that product in the ARTG; and 5. for a period of 12 months, Mr Tamer accept a mentor approved by the Council.
6. In broad terms the proposed conditions reflect the conditions that have been imposed on Mr Tamer's registration since July 2017. However, in contrast to the current conditions, the prohibition on Mr Tamer working as a pharmacist in charge and as a sole pharmacist is limited to 12 months.
7. While Mr Tamer does not oppose a reprimand being issued and undertakes to comply with any conditions the Tribunal decides to impose, he argues that the continuation of conditions is neither necessary nor appropriate. He points out that he has fully complied with all conditions of his registrations. He argues that the continuation of the prohibition on him working as a pharmacist in charge or a sole pharmacist will further delay the progression of his career, which has effectively been on hold for the past four years.

Character references

1. In August 2017, Mr Tamer commenced employment at Pharmacy4Less Caringbah as a "supporting pharmacist". Mr Tamer tendered in these proceedings references prepared by the managing pharmacist and the owner of that pharmacy.
2. The managing pharmacist, Mr Steven Gindy, stated that he has a high opinion of Mr Tamer's work as a pharmacist. He stated that Mr Tamer has demonstrated "impressive attention to detail … taking the extra step to ensure accuracy and adherence to the conditions". He stated that Mr Tamer follows relevant legislation "to the letter, even if it means missing out on sales". He wrote that Mr Tamer is respected by patients for his "professional, thoroughness and high moral standards".
3. The owner, Mr Salim Ghostin, shares Mr Gindy's high opinion of Mr Tamer, his work ethic and adherence to professional standards.
4. Each stated that Mr Tamer made full disclosure of, and at all times, adhered to the conditions on his registration.

Conclusions

1. We accept Mr Tamer's claim that he is genuinely remorseful for his conduct and has made real efforts to improve his knowledge of the rules and guidelines which govern the practice of pharmacy in NSW. In addition, we find that he has demonstrated insight into his misconduct and a genuine desire to improve his practice.
2. Nonetheless, we have decided that it is appropriate to extend the prohibition on Mr Tamer working as pharmacist in charge or sole pharmacist for a further six months. In that period Mr Tamer will be required to work with a mentor. This will give him the opportunity to build on the improvements he has made to his practice and ability to navigate the complex regulatory framework which governs the practice of pharmacy in NSW.
3. In addition, we have decided to include a condition prohibiting Mr Tamer from undertaking "complex compounding" until such time as he has undertaken a course of education or professional development in relation to complex compounding as approved by the Council. As a consequence of the current conditions on his registration, Mr Tamer has not worked in complex compounding for over four years. For that reason, we considered it appropriate that he undertake further education before recommencing this area of work.

Orders 1. Mr Tamer is reprimanded. 2. The following conditions are imposed on Mr Tamer's registration: 1. Must not work as the pharmacist in charge and must not seek a review of this condition for 6 months. 2. Must not work as a sole pharmacist and must not seek a review of this condition for 6 months. 3. Must not compound or manufacture, or be involved in any step in connection with "complex compounding" as defined by the Australian Pharmaceutical Formulary Handbook 25, unless and until he: 1. Undertakes a course of education or professional development in relation to complex compounding as approved by the Pharmacy Council of NSW; 2. Notifies the Pharmacy Council of NSW of his successful completion of that course. 1. May only supply, dispense, administer, or participate in any step in connection with the supplying, dispensing or administering of, any pharmaceutical products containing any of the following: 1. Somatropin 2. Testosterone 3. Mesterolone 4. Anastrozol 5. Tadalafil 6. Phentermine 7. Sofosbuvir 8. Ledipasvir 9. Daclatasvir 10. Ribavirin for an approved indication as specified for that product on the Australian Register of Therapeutic Goods. 1. Must nominate or accept a mentor approved by the Pharmacy Council of NSW, to advise and assist the practitioner in the management of his pharmacy practice, focusing on legislative compliance with obligations pursuant to the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW). 2. Must provide the mentor with a copy of the decision made by the New South Wales Civil and Administrative Tribunal which imposed these conditions (the NCAT Decision) and the mentor must provide a signed copy of the decision to the Council within four weeks of being appointed as a mentor. 3. Must nominate or accept a mentor within four weeks of the NCAT Decision. Such mentoring is to continue for a period of 12 months from the date of the Council's appointment or approval. The mentor shall report to the Council as and when required by it during the term or his or her appointment. 4. Must notify his employer(s) and the pharmacist in charge at any pharmacy at which he is employed of the conditions imposed. Within five days of commencing new employment Mr Tamer must provide to the Council a statement signed by his current employer, which states that that they been provided with a copy of the conditions. 1. The Pharmacy Council of New South Wales is the appropriate review body for the purposes of Part 8, Division 8 of the Health Practitioner Regulation National Law (NSW).

Annexure A IN THE CIVIL AND ADMINISTRATIVE TRIBUNAL OF NSW OCCUPATIONAL DIVISION HEALTH PRACTITIONER DIVISION LIST NO. Of In the matter of Nabil Tamer, a person registered under the Health Practitioner Regulation National Law (NSW) FURTHER AMENDED COMPLAINT The Health Care Complaints Commission of Level 12, 323 Castlereagh Street, Sydney NSW, having consulted with the Pharmacy Council of NSW in accordance with sections 39(2) and 90B(3) of the Health Care Complaints Act 1993 and section 145A of the Health Practitioner Regulation National Law (NSW) ("the National Law") HEREBY COMPLAINS THAT Mr Nabil Tamer ("the practitioner") of [address omitted], being a pharmacist registered under the National Law, BACKGROUND TO ALL COMPLAINTS The practitioner was the pharmacist-in-charge and sole pharmacist at the Kingswood Compounding Pharmacy ("the Pharmacy") from September 2014 - July 2017. The practitioner graduated with a Bachelor of Science in 2005. The practitioner graduated from the University of Canberra with a Masters of Pharmacy in 2009. The practitioner was first registered in New South Wales in May 2010. COMPLAINT ONE The practitioner is guilty of unsatisfactory professional conduct under section 139B(1)(a) of the National Law in that the practitioner has: i. engaged in conduct that demonstrates the knowledge or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience PARTICULARS OF COMPLAINT ONE 1. Between 14 August 2015 and 15 26 May 2017, the practitioner failed to ensure that the pharmacy dispensing records for the supply of Schedule 4 restricted substances complied with clause 55(1)(d) of the Poisons and Therapeutic Goods Regulation (PTGR), as outlined in the table below, in that the pharmacy's dispensing records did not record the details of the dispensing pharmacist. DATE QUANTITY DRUG 3 November 2016 - 15 May 2017 7 Phentermine 14 August 2015 1 Anastrazole 27 May 2016 - 27 April 2017 6 Somatropin (Human Growth Hormone) 15 September 2015 - 21 April 2017 53 Testosterone

2. Between 14 August 2015 and 15 May 2017, the practitioner failed to ensure that the pharmacy dispensing records for the supply of Schedule 4 restricted substances complied with the Pharmacy Board of Australia 'Guidelines for dispensing medicine' (2015) and the Pharmacy Board of Australia 'Guidelines for Dispensing Medicines' (2010) in relation to the period before 7 December 2015, as outlined in the table above at particular 1, in that the pharmacy's dispensing records did not record the details of the dispensing pharmacist. 3. Between 16 September 2015 and 26 May 2017, the practitioner inappropriately allowed the dispensing technicians to record the name of a non-pharmacist on the supply of Schedule 8 drugs of addiction as outlined in the table below, which was a breach of the Pharmacy Board of Australia, 'Guidelines for dispensing medicine' (2015) and the Pharmacy Board of Australia 'Guidelines for Dispensing Medicines' (2010) in relation to the period before 7 December 2015. DATE QUANTITY DRUG 16 September 2015 - 22 May 2017 3 Ketamine 26 May 2017 1 Dexamphetamine 1 March 2017 1 Fentanyl 1 March 2017 and 28 April 2017 2 Alprazolam

COMPLAINT TWO The practitioner is guilty of unsatisfactory professional conduct under section 139B(1)(a) of the National Law in that the practitioner has: i. engaged in conduct that demonstrates the knowledge or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience PARTICULARS OF COMPLAINT TWO Patient A 1. Between 7 October 2016 and 24 January 2017, the practitioner dispensed the Schedule 4 restricted substance Primoteston Depot (Testosterone) to Patient A in on the dates and in the quantities as set out in Schedule A in circumstances where: a. the prescribing doctors' directions for use and dose were inconsistent with the manufacturer's directions for use but the practitioner dispensed the medication; b. the practitioner dispensed multiple repeats on several occasions; c. the practitioner failed to adequately document the contact with the prescriber; d. the dispensing does not accord with recognised therapeutic standards of what is appropriate contrary to cl 54 of the Poisons and Therapeutic Goods Regulation (PTGR). e. the practitioner breached Guideline 2 of the Pharmacy Board of Australia, 'Guidelines for dispensing medicine' (2015). Patient B 2. On 28 April 2016 and 27 June 2016, the practitioner dispensed the Schedule 4 restricted substance Somatropin (Human Growth Hormone) to Patient B on the dates and in the quantities as set out in Schedule B in circumstances where the dispensing did not accord with the recognised therapeutic standard contrary to cl 54 of the PTGR. COMPLAINT THREE The practitioner is guilty of unsatisfactory professional conduct under section 139B(1)(a) of the National Law in that the practitioner has: i. engaged in conduct that demonstrates the knowledge or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience PARTICULARS OF COMPLAINT THREE 1. Between 1 January 2016 and 11 May 2017, the practitioner dispensed the Schedule 4 restricted substance Tadafil (erectile dysfunction medication) on 238 occasions to multiple patients as set out in Tab 16 of the documents upon which the Commission relies: in circumstances where: a. the practitioner failed to contact the prescriber to discuss the clinical indications for compounding when the Australian Register of Therapeutic Goods listed product (Cialis) was commercially available; a. there was no clearly documented clinical indication or reason for justifying the compounding of this drug which was commercially available; b. the dispensing and compounding was contrary to Code 2 of the Pharmaceutical Board of Australia's 'Guidelines on Compounding Medicines'. 2. Between 1 January 2016 and 11 May 2017, the practitioner compounded and dispensed Hepatitis C anti-viral drugs on 223 occasions as set out in Tab 3 of the additional documents upon which the Commission relies in circumstances where: a. the compounded Australian Register of Therapeutic Goods listed product Sofosbuvir, Ribarvin, and Daclatasvir were commercially available; b. the basis for compounding was to reduce the costs to the patients of the medications by comparison to the cost of the commercially available medication, in breach of Guideline 2 of the Pharmaceutical Board of Australia's 'Guidelines on Compounding Medicines'. 3. During 2015, the practitioner inappropriately compounded medications using unknown raw materials purporting to be Hepatitis C anti-viral drugs which were brought in by customers and labelled the compounded medications as requested by the customer in circumstances where: a. there was no Certificate of Analysis; b. the materials were not tested prior to compounding. COMPLAINT FOUR The practitioner is guilty of unsatisfactory professional conduct under section 139B(1)(a) of the National Law in that the practitioner has: i. engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience PARTICULARS OF COMPLAINT FOUR The conduct in Particulars 1, 2 and 3 of Complaint Four are repeated and relied upon in combination as a course of conduct involving a failure to document contact with the prescriber on multiple occasions for multiple for Patient A, B and C amounting to unsatisfactory professional conduct. Patient C 1. Between 3 February 2016 and 11 July 2016, the practitioner dispensed the Schedule 4 restricted substance Scitropin A (Human Growth Hormone) to Patient C on the dates and in the quantities as set out in Schedule C: a. without adequately documenting the contact with the prescriber; b. contrary to Guideline 2 of the Pharmacy Board of Australia, 'Guidelines for dispensing medicine' (2015). Patient A 1. Between 7 October 2016 and 24 January 2017, the practitioner dispensed the Schedule 4 restricted substance Proviron (Mesterolone) (androgen and anabolic steroid) to Patient A on the dates and in the quantities as set out in Schedule A: a. without adequately documenting the contact with the prescriber; b. contrary to Guideline 2 of the Pharmacy Board of Australia, 'Guidelines for dispensing medicine' (2015). Patient B 1. During the period 26 April 2016 to 27 June 2016, the practitioner dispensed the Schedule 4 restricted substance Somatropin (Human Growth Hormone) to Patient B: a. without adequately documenting the contact with the prescriber; b. contrary to Guideline 2 of the Pharmacy Board of Australia, 'Guidelines for dispensing medicine' (2015). COMPLAINT FIVE The practitioner is guilty of professional misconduct under section 139E of the National Law in that the practitioner has: i. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration, and/or ii. engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioner's registration PARTICULARS OF COMPLAINT FIVE 1. Each particular of Complaints 1 - 3 justifies a finding of professional misconduct. 2. In the alternative, when two or more (or all) of the particulars of Complaints 1 - 4 3 are taken together, a finding of professional misconduct is justified. 3. When all of the particulars of Complaint 4 are taken together, a finding of professional misconduct is justified. [The annexures to the Complaint are omitted because they identify the patients the subject of the Complaint]

Endnotes

1. As a consequence of the PRU's investigation, disciplinary proceedings were commenced in NCAT in relation to the then pharmacist in charge, Adam Kennedy. NCAT found Mr Kennedy guilty of professional misconduct and imposed several conditions on his registration: Health Care Complaints Commission v Kennedy [2017] NSWCATOD 72. Throughout the period Mr Tamer worked at the Pharmacy, Mr Kennedy remained working at the Pharmacy. Mr Tamer was responsible for ensuring that Mr Kennedy complied with the conditions of his registration.
2. Since 1 July 2016, the proclamation of the Poisons List has been by reference to the Commonwealth Poisons Standard as in force from time to time. Before that time, a Poisons List was separately proclaimed in NSW, but advice from the NSW Health Pharmaceutical Regulatory Unit is that at least from 17 August 2015, it relevantly reflected the Commonwealth Poisons Standard. I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales. Registrar DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 20 October 2021