Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Health Care Complaints Commission v Knowles [2022] NSWCATOD 37 Hearing dates: 6, 7 and 8 December 2021 Date of orders: 31 March 2022 Decision date: 31 March 2022 Jurisdiction: Occupational Division Before: R C Titterton OAM, Senior Member D North OAM, Senior Member R Jaja, Senior Member Dr C Berglund, General Member Decision: 1. Each of Complaints Two and Four to Seventeen is established (save for particulars (1)(g) and (3) to Complaint Eleven). 2. If the respondent was still registered as a pharmacist, the Tribunal would have cancelled his registration. 3. The respondent is disqualified from being registered in the pharmacy profession for a period of three years from the date of these orders. 4. The Pharmacy Board of Australia is required to record the fact that the Tribunal would have cancelled the respondent's registration in the National Register kept by the Board. 5. The respondent is to pay the applicant's costs of the proceedings. Catchwords: PROFESSIONS AND TRADES – health care professional – pharmacy – where practitioner admits he is guilty of unsatisfactory professional conduct and professional misconduct – appropriate protective orders Legislation Cited: Civil and Administrative Tribunal Act 2013 (NSW) s 64(1) Health Practitioner Regulation National Law No 86a of 2009 (NSW) – ss 3, 3A, 5, 139B, 139E, 149C Pharmacy Act 1964 (NSW) (repealed) – ss 19A, 25 Cases Cited: Health Care Complaints Commission v Do [2014] NSWCA 307 Health Care Complaints Commission v Philipiah [2013] NSWCA 342 Health Care Complaints Commission v Varma [2022] NSWCATOD 4 New South Bar Association v Meakes [2006] NSWCA 340 Prakash v Health Care Complaints Commission [2006] NSWCA 153 Qasim v Health Care Complaints Commission [2015] NSWCA 282 Sabag v Health Care Complaints Commission [2001] NSWCA 411 Category: Principal judgment Parties: Health Care Complaints Commission (Applicant) Darryl Knowles (Respondent) Representation: Counsel: S Maybury (Applicant) Solicitors: Health Care Complaints Commission (Applicant) Respondent: self-represented File Number(s): 2019/00401053 Publication restriction: The Tribunal made an order pursuant to s 64(1) of the Civil and Administrative Tribunal Act 2013 (NSW), prohibiting the disclosure to any person or entity of the names, addresses or any other identifying information of any person referred to as a patient or staff member of the respondent in the evidence in the proceedings. REASONS FOR DECISION Introduction 1. The Health Care Complaints Commission (Commission), pursuant to s 149C of the Health Practitioner Regulation National Law No 86a of 2009 (NSW) (National Law), seeks protective orders from the Tribunal in respect of the conduct of the respondent Mr Daryll Knowles (practitioner). 2. The practitioner admitted each of the complaints pursued at the hearing. Independently of those admissions, we found each complaint established. Had the practitioner been registered we would have ordered that his registration as a pharmacist be cancelled. 3. At the request of the parties we made a non-publication order in respect of the identification of any staff member or patient of the practitioner. 4. Following concessions and admissions made by the practitioner on the first day of the hearing, the proceedings were conducted as a combined Stage 1 and Stage 2 hearing. Amended Complaint 1. The Commission brought 17 Complaints to the Tribunal. However, on the first day of the hearing, Complaints One and Three were withdrawn along with particulars (1)(g) and (3) to Complaint Eleven. Each of the remaining complaints, which are set out in Annexure A, were admitted by the practitioner. 2. For convenience, we will refer to the Complaints by their original numbering. 3. Each of Complaints Two and Four to Fifteen was a complaint that the practitioner is guilty of unsatisfactory professional conduct under s 139B(1)(a) and/or (l) of the National Law in that the practitioner had: 1. 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; and/or 2. engaged in improper or unethical conduct relating to the practice of pharmacy. 1. Complaint Sixteen was a complaint that the practitioner was guilty of professional misconduct under s 139E of the National Law in that the practitioner has: 1. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or 2. 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 suspension or cancellation of the practitioner's registration. 1. The Background to Complaints Two and Four to Sixteen was stated as follows: The practitioner was first registered as a pharmacist on 11 March 1982. Australian Custom Pharmaceuticals (ACP) is a large compounding pharmacy. ACP compounds substances on prescriptions from doctors all over Australia, and dispenses those substances to patients all over Australia. The practitioner was the sole proprietor of ACP at the time of the compounding and dispensing which is the subject of this Complaint. Amongst other drugs, ACP compounded peptides, selective androgen receptor modulators (SARMs) and a collection of other drugs which are often associated with illicit or off-label use for performance and image enhancement. The Australian Register of Therapeutic Goods ('the ARTG') is a database of all therapeutic goods that can be marketed and supplied in Australia. Access to non-approved goods ('non-ARTG drugs') is limited to certain authorised prescribers, special access schemes or clinical trials. Pyridoxine, ketamine, hCG, testosterone, anastrozole, hyaluronidase, progesterone and phentermine ('the ARTG drugs') are all currently or have previously been listed on the ARTG. CJC-1295, Ipamorelin, IGF-LR3, LGD-4033, Bremelanotide, Follistatin 315, Melanotan II, AOD9604, Cerebrolysin, GHRP-6, GHRP-2, IGF-1LR, Mechano Growth Factor, SARMs -22, DHEA and thymosin beta 4 are all non-approved drugs which have never been registered on the ARTG. 1. Complaint Seventeen was a complaint that the practitioner was guilty of professional misconduct in that the practitioner entered into an arrangement which contravened s 25 of the Pharmacy Act 1964 (NSW) (now repealed) during a period when to do so was professional misconduct pursuant to s 19A of the Pharmacy Act 1964 (NSW) (now repealed). 2. The Background to Complaint Seventeen was stated as: In around February 2002 the practitioner entered into an arrangement with Mr Brian Sher whereby companies controlled by Mr Sher, Redwood Anti-Ageing Pty Ltd and Redwood Nutraceuticals Pty Ltd (the Redwood entities) referred prescriptions for compounded pharmaceutical products to the practitioner (or a pharmacist nominated by him) and the profits generated from dispensing those prescriptions were paid to the Redwood entities (the arrangement). The arrangement continued until around October 2006. From around February 2002 until around April 2002 and from around April 2003 until around October 2006, the practitioner dispensed products pursuant to the arrangement from a compounding pharmacy, with respect to which he was the licensed pharmacist. Between around April 2002 and around April 2003, the practitioner did not control any licensed compounding pharmacy but arranged for other licensed pharmacists to dispense compounded pharmaceutical products pursuant to the arrangement. Throughout the period from around February 2002 to around October 2006, the practitioner knew, or was reckless as to whether, the arrangement was contrary to section 25 of the Pharmacy Act 1964 (now repealed). 1. The practitioner admitted each of the 15 Complaints maintained by the Commission. Relevant Law 1. It is appropriate to set out the relevant provisions of the National Law. These are as follows. 2. Section 3, which provides: 3 Objectives and guiding principles (1) The object of this Law is to establish a national registration and accreditation scheme for-- (a) the regulation of health practitioners; and (b) the registration of students undertaking-- (i) programs of study that provide a qualification for registration in a health profession; (ii) clinical training in a health profession. (2) The objectives of the national registration and accreditation scheme are- (a) to provide for the protection 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; and (b) to facilitate workforce mobility across Australia by reducing the administrative burden for health practitioners wishing to move between participating jurisdictions or to practise in more than one participating jurisdiction; and (c) to facilitate the provision of high quality education and training of health practitioners; and (d) to facilitate the rigorous and responsive assessment of overseas-trained health practitioners; and (e) to facilitate access to services provided by health practitioners in accordance with the public interest; and (f) to enable the continuous development of a flexible, responsive and sustainable Australian health workforce and to enable innovation in the education of, and service delivery by, health practitioners. (3) The guiding principles of the national registration and accreditation scheme are as follows-- (a) the scheme is to operate in a transparent, accountable, efficient, effective and fair way; (b) fees required to be paid under the scheme are to be reasonable having regard to the efficient and effective operation of the scheme; (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. 1. Section 3A of the National Law, which is an additional provision for NSW, provides, in terms: 3A Objective and guiding principle [NSW] In the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration. 1. A "NSW provision" is defined in s 5 of the National Law as: (a) a provision that forms part of this Law because of a modification made by the Health Practitioner Regulation (Adoption of National Law) Act 2009; or (b) a NSW regulation. Note — This definition is an additional New South Wales provision. 1. Section 139B of the National Law (which is also an additional provision for NSW), which relevantly provides: 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. … (l) Other improper or unethical conduct Any other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession. 1. Section 139E of the National Law (again, an additional provision for NSW), provides: 139E Meaning of "professional misconduct" [NSW] For the purposes of this Law, professional misconduct of a registered health practitioner means— (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. Consideration of Complaint Two 1. By way of general summary, as submitted by the Commission, this complaint alleges that 312 ketamine prescriptions were compounded and dispensed with directions 'for intramuscular injection' where there were no directions for use on the prescription. 2. The conduct the subject of this complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. In particular we note, as submitted by the Commission, one of the practitioner's employed pharmacists stated that instructions were never included for those prescriptions and he based his directions on the dispensed medications on a discussion with Prof Barrett held prior to the prescribing commencing, and notwithstanding that Prof Barrett did not write each of the prescriptions. Consideration of Complaint Four 1. By way of general summary, as submitted by the Commission, this complaint also relates to compounding and dispensing ketamine and alleges the dispensing was for an off label use, not for a clinical trial and there was not sufficient evidence to support the dispensing. It also alleges no consumer medicine information disclosures were made, which is important for any medication let alone a compounded one. 2. The conduct the subject of this complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. Consideration of Complaint Five 1. By way of general summary, as submitted by the Commission, this complaint relates to providing substances to Patient B. 2. The conduct the subject of this complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. In particular we note, as submitted by the Commission, the evidence of the practitioner referred to his lack of knowledge of Patient B's medical conditions and what the substances were for. Prof Handelsman explains there is no therapeutic use for most of the substances in his report and that Patient B was warned about the risks of the drugs and the large quantity and variety of the drugs. This creates at least an inference they were not all for Patient B's own use. Consideration of Complaint Six 1. By way of general summary, as submitted by the Commission, this complaint relates to the practitioner providing Patient B with three substances without a prescription. At the time Melanotan required a prescription but the other two substances strictly did not. 2. The conduct the subject of this complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. In particular we note, as submitted by the Commission, it was inappropriate for the practitioner to provide a prescription substance to a patient for testing without a prescription. The substance obviously could have been provided to the laboratory in various other ways. We accept that this shows a substantial lack of care and judgment. Consideration of Complaint Seven 1. By way of general summary, as submitted by the Commission, this complaint relates to compounding and dispensing human chorionic gonadotrophin (HCG) for a non-therapeutic use. 2. The conduct the subject of this Complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. In particular we note, as submitted by the Commission, the practitioner acknowledges it was provided as part of an "HCG diet" for weight loss, which is not a recognised or proven use. Consideration of Complaint Eight 1. By way of general summary, as submitted by the Commission, this complaint relates to compounding and dispensing peptides. 2. The conduct the subject of this complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. Consideration of Complaint Nine 1. By way of general summary, as submitted by the Commission, this complaint relates to nearly 8,000 occasions of dispensing peptides. 2. The conduct the subject of this complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. Consideration of Complaint Ten 1. By way of general summary, as submitted by the Commission, this complaint relates to combinations of peptides prescribed to four patients with inappropriate directions for use and without a belief they were being provided for a legitimate purpose. 2. The conduct the subject of this complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. Consideration of Complaint Eleven 1. By way of general summary, as submitted by the Commission, this complaint relates to compounding and dispensing Phentermine when there was a commercially available product. 2. The conduct the subject of this complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. Consideration of Complaint Twelve 1. By way of general summary, as submitted by the Commission, this complaint relates to compounding and dispensing testosterone cream with chrysin when there was a commercially available Australian Register of Therapeutic Goods (ARTG) approved testosterone product available. 2. The conduct the subject of this complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. In particular, we note that the evidence that Androforte was relevantly available and that Chrysin would not be absorbed through the skin. Consideration of Complaint Thirteen 1. By way of general summary, as submitted by the Commission, this complaint relates to compounding and dispensing testosterone cream with zinc. 2. The conduct the subject of this complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. Consideration of Complaint Fourteen 1. By way of general summary, as submitted by the Commission, this complaint relates to compounding and dispensing testosterone cream with SARMS-22. 2. The conduct the subject of this complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. In particular, we note the evidence of Prof Handelsman that SARMS-22 has no therapeutic use, and accept the Commission's submission that there was no reason to compound testosterone cream with SARMS-22, and that it was inappropriate to do so. Consideration of Complaint Fifteen 1. By way of general summary, as submitted by the Commission, this complaint relates to compounding and dispensing testosterone cream with zinc. 2. The conduct the subject of this complaint and the particulars set out in Attachment A has been admitted by the practitioner. 3. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission, references to which appear in the Commission's submissions. Conclusions re Complaints Two and Four to Fifteen 1. As noted, these complaints are that the practitioner is guilty of unsatisfactory professional conduct under s 139B(1)(a) and/or (l) of the National Law. Conduct significantly below the reasonable standard 1. Section 139B(1)(a) is set out above. 2. The expert evidence relied on by the Commission was that of Prof Handelsman, and Mr Cotterell and Mr Bruce Chilton and Dr Betty Chaar. 3. Prof Handelsman's conclusions were, in summary, that: 15.1. There appears to be no valid therapeutic purpose for any of the compounding of peptides and SARMs considered in this matter. None have ever been approved for any human therapeutic use and this includes GHRP-2 which was approved in Japan only for diagnostic (single dose) use, usually in a medical facility, but not for therapeutic use. 15.2. For safety reasons, sourcing of peptides for sterile injection into humans should only use peptide raw materials manufactured in a properly certified GMP production facility to assure the patients, in particular, and the public, in general, of the authenticity of the product, its purity from adulteration, sterility and non-pyrogenicity over the designated full shelf-life. 15.3. The reasonable scientific basis of the designated shelf-life should be subject to some regulation stipulating how such designation is established and what steps are to be taken to verify the potency and sterility of the product over the full shelf-life. 15.4. Repeated use of non-approved peptides that are growth factors warrants long-term follow-up for additional risks entailed in prolonged treatment including risks from cumulative toxic effects of unknown adulterants, of infections from non-sterile formulations, teratogenicity and carcinogenicity. 1. As to the reports of Mr Cotterell and Mr Chilton, they generally provide some, but not complete, support for claims that the conduct of the practitioner was below standard and if so, whether the departure from the standard was "significantly below" the standard or otherwise and if so, whether the departure from the standard invites the expert's "strong criticism". 2. Nevertheless, the practitioner withdrew his criticism of these three experts and "mostly agreed" with what he described as their "objective and well researched opinions". 3. As to Dr Chaar, the practitioner asked that the Tribunal disregard her evidence in its entirety, on the basis that it is: "aggressive, subjective[ly] biased and she offers opinions on area she is clearly not an expert but unlike the other 3 experts does not recuse herself on the basis of being unqualified and inexperienced to comment. In this vitriolic rant which flys in the face of the other experts she uses no less than 35 derogatory words to describe myself personally, my actions the staff and ACP. … The main reason I ask the Tribunal to throw out her report is that she breached [the] NCAT Expert Witness Code of Conduct by using confidential and sensitive information surrounding this matter to promote her own opinions and career by publishing an opinion piece in the AJP. 1. The overall impression of Dr Chaar's report is that she held opinions which were stronger, and in some cases significantly stronger, than those of Mr Cotterell and Mr Chilton. For instance, in response to the question: Please provide any other comment about Mr Knowles' overall conduct in the context of his oversight and approval of ACP's dispensing of peptides, selective androgen receptor modulators, bio-identical hormones and aromatase inhibitors. Mr Chilton stated: So long as any prescription complies with the requirements of both the NSW Poison & Therapeutic Goods Act 1966, and NSW Poisons & Therapeutic Goods Regulations 2008, and is a valid prescription, Mr Knowles is able to approve the dispensing of the medicines as requested by the authorised practitioner. 1. However, Dr Charr stated: The impression one has of Mr Knowles is he is more the entrepreneur than he is a pharmacist. He defends and describes new unfounded claims about products not in the mainstream with much confidence and perhaps slightly brazen attitude. For him not to have protocols in place at ACP for when off-label compounding is requested – is irresponsible and lack professionalism. 1. We can understand why comments like this may have upset the practitioner. That said, on many occasions Dr Charr was entirely in agreement with for instance Mr Chilton. For instance, in relation to the question Please provide your opinion on Mr Knowles risk management of ACP's dispensing of peptides, selective androgen receptor modulators, bio-identical hormones and aromatase inhibitors assuming he was aware that those medicines were associated with body building and other performance enhancing purposes. Mr Chilton's response was: It is my opinion that a person with the knowledge, training and experience of Mr Knowles was fully aware of the potential misuse of medications, with respect to non-therapeutic indications. On all his literature and website advertisements Mr Knowles refers himself as an experienced compounder with extra skills in antiaging, metabolic and appearance medications. This alone lends me to believe he was aware of the misuse. In my opinion Mr Knowles' behaviour was significantly below the standard expected and invites my strong criticism. 1. On the other hand, Dr Chaar's response was: Mr Knowles hardly had any risk management protocols in place, no patient interaction, no counselling. He knew most of the products he produced were for body building and should have made himself aware of the possible side effects associated with such practices. Yet no effort was made to set up protocols that ensured safe use and understanding of the products compounded in ACP. In the overseeing of operations at ACP, I consider Mr Knowles' conduct negligent of his key role as a pharmacist and significantly below the standard of a practitioner of his level of training and experience and invites strong criticism. 1. While the language of Dr Chaar's reports is perhaps more provocatively expressed than is usually the case, given the practitioner's admissions, Dr Chaar was never cross-examined so we are not in a position to draw any conclusions about allegations of bias, aggression or unethical behaviour. 2. We consider that the combination the practitioner's admissions and the opinions of the other experts sufficient for us to find that the conduct the subject of Complaints Two to Fifteen was Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession was significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. Other improper or unethical conduct 1. Section 139B(1)(l) is set out above. 2. The meaning of the expression "improper or unethical conduct" in s 139B(1)(l) of the National Law was considered by the Tribunal in Health Care Complaints Commission v Kesserwani [2020] NSWCATOD 65. At [21] and following the Tribunal stated: 21. The words "improper" and "unethical" are not defined by the National Law. There is nothing in the language, the statutory context, or the scheme of the National Law which suggests that either word has any technical meaning, nor is a term of art. Both are ordinary English words. Giving a word its ordinary meaning does not, however, preclude the word deriving shades of meaning from its context and the syntax of the sentence in ways which are significant for the case in hand: Duffy v Da Rin [2014] NSWCA 270 at [30]. 22. The Macquarie Dictionary offers several definitions of both words which include: Improper 2. not in accordance with propriety of behaviour, manners, etc: improper conduct. Unethical 1. contrary to moral precept; immoral. 2. in contravention of some code of professional conduct. 23. The meaning of the words "improper" and "unethical" were considered in a different statutory context in Office of Local Government v Toma [2015] NSWCATOD 21. After quoting from the discussion of the term "impropriety" by the High Court in R v Byrnes and Hopwood (1995) 183 CLR 501; [1995] HCA 1, the Tribunal wrote: Applying these authorities, I do not need to state an exhaustive definition of improper or unethical conduct. Rather it is enough to here note that the expression encompasses conduct which, viewed objectively, would be regarded by reasonable persons as falling below the standards of conduct to be expected of Councillors, in that it has a tendency to bring into disrepute the civic office held by Councillors, or the Council, or both. 24. That interpretation was adopted by the Tribunal in relation to the meaning of those words in s 139B(1)(l) of the National Law in Health Care Complaints Commission v Liu [2016] NSWCATOD 133 at [53]. 25. The use of the word "or" in s 139(1)(l) suggests that the words unethical and improper should be read disjunctively and do not carry the same meaning. However, their meanings may overlap. While not necessary to reach a concluded view arguably a broader class of conduct is caught by the term improper conduct, than unethical conduct. 26. In our view, the test of "unethical conduct" has both objective and subjective elements. The word "unethical" connotes moral opprobrium. The term "unethical conduct" implies that the conduct concerned not only objectively falls short of a certain professional standard but that the person involved has performed subjectively in a way that is morally dubious or unprincipled and is therefore reprehensible on that ground. It is unnecessary here to provide exhaustive categories of conduct that may be unethical. Conduct may be unethical if it is constituted by a deliberate flouting of significant professional standards. Reckless disregard of, or wilful blindness to, significant ethical standards or principles may also constitute unethical conduct. All will depend on the relevant circumstances. 1. Whether conduct is improper or unethical is an objective test: Health Care Complaints Commission v Liu [2016] NSWCATOD 133 at [51]-[60]. 2. We are satisfied that the established particulars of Complaint Two and Four to Fifteen, including the conduct admitted by the practitioner, was unethical and that he is therefore guilty of unsatisfactory professional misconduct as defined in s 139B(1)(l) of the National Law. Consideration of Complaint Sixteen 1. Complaint Sixteen was that the practitioner is guilty of professional misconduct under s 139E of the National Law in that the practitioner had: 1. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or 2. 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 suspension or cancellation of the practitioner's registration. 1. In support of this Complaint, the following particulars were relied upon individually: * Complaint Four, particulars 1(a) to 1(c) inclusive, 2 and 3; * Complaint Eight, particulars 1(a) and (b) and 2; * Complaint Nine, particulars 1(a) and (b) and 2; * Complaint Eleven, particulars 1(a) and 5; * Complaint Twelve, particulars 1(a) to (c) inclusive and 2; * Complaint Thirteen, particular 1(a) and 2; * Complaint Fourteen, particular 1(a) and 2; * Complaint Fifteen, particular 1(a) and 2. 1. In addition, Complaints Two and Four to Fifteen inclusive and the particulars thereto were relied upon cumulatively, or in any combination. 2. The definition of professional misconduct in s 139E is set out above. 3. We find that the 13 admitted instances of unsatisfactory professional conduct the admitted particulars set out above when considered together amount to conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration. In our view, the extent of the individual instances of unsatisfactory professional conduct represents a very serious departure from the standards expected of a registered pharmacist of equivalent training and experience. In addition, the very serious departures from the expected standards can be characterised as unethical. The lack of appropriate risk management protocols for off-label prescribing was practised on a high volume commercial basis over a long period of time and without due regard to the regulatory requirements that should have been applied in that timeframe. This amounted to a pattern of unacceptable practice which has posed considerable risk to the health and safety of patients and the public. Consideration of Complaint Seventeen 1. Complaint Seventeen is that the practitioner was guilty of professional misconduct in that he entered into an arrangement which contravened s 25 of the Pharmacy Act 1964 (NSW) (now repealed) during a period when to do so was professional misconduct pursuant to s 19A of the Pharmacy Act 1964 (now repealed). 2. The background to this Complaint is set out above. 3. Complaint Seventeen was admitted and therefore we find it established. 4. Independently of this admission, we find the facts underlying this Complaint proved by the evidence relied on by the Commission. What is the appropriate protective order? 1. The Commission submitted that the only appropriate protective order was cancellation of registration if the practitioner was still registered together with an order that he not be permitted to apply for registration for a period of three years. 2. The practitioner indicated that he would never seek reregistration. He sent some written submissions in which he submitted there was no evidence before the Tribunal of any actual or probable theoretical harm to any patient. 3. In relation to what he described as the "best public interest", the practitioner submitted: There is no legal definition of best public interest as every case may have a different definition. This is clearly where the [Commission] and its handlers differ in opinion from myself. Regulators make judgment calls based on their own personal experience and opinions as to [best public interest]. … My opinion of what is best public interest above all the multitudinous minutia of this case is the ultimate level of best public interest in a democracy like Australia that is a patients right to an informed decision regarding their medication. This is the crux of this matter - My opinion on what is in the best interest for the patients of ACP is different from the opinions of Mr Battye, his PRU team and his appointees on the PCNSW. Did they speak to one of the over 10,000 patients to enquire if they were given the resources to make an informed decision? No not once. This is a battle I cannot win despite the fact that I have never in the pursuit of my definition of best public interest ever harmed and reduced the quality of life of any of the over 1,000,000 patients I have provided pharmacy service to. In admitting to the allegations I have admitted that at the time of the allegations a young compounding industry and ACP was still finding its feet in the quagmire of regulation. For the first 27 years of my compounding career there were no compounding guidelines for the first 22 years no proprietor guidelines. We were all high jumpers with out a bar. This complaint is stale. Most of the conduct is between 6 and 10 years old with one issue over 19 years old. So when considering the environment at the time in 2015 and the decisions I made back over the 13 year period from 2002 until 2015 then I have to admit they were deficient at times. And I admit that. But since the introduction of the Compounding Guidelines in 2015 (Sterile 2018) and Review of the Proprietor Guidelines I have made it my mission to remediate both myself and my business to increase patient safety of all types. 1. The practitioner then continues and asks the Tribunal to consider his contribution to the profession, including his academic and teaching contributions, his peer recognition and his pro bono work for the profession. 2. In conclusion, he asks the Tribunal to consider that: The stale nature of these allegations. My understanding and admission of the deficiencies in my conduct during the period of the complaint. The intensity [sic – intense] remediation of my Pharmacy practice and intensive training and contributions to the industry. But most of all the INTENT of my actions. My intent was never criminal or purposefully illegal. My conduct over the previous three decades fell short of the 2015 Regulations. My crime which lead to my admission in this matter was I didn't act quickly enough to modify my behaviour and the systems of ACP. My highest regard was always given to patient safety and their individual best interest and right to make a decision. Finally to address the need for a public deterrent effect. I submit that by disregarding all of the practice improvement and remediation I and ACP have undergone to create a state of the art compounding and training facility to condemn the historic conduct with punitive actions will cause more harm than benefit. Since the news of further attacks on myself professionally and ACP not one more pharmacy has undergone independent ISO or PCAB accreditation in Australia. The message is what's the point. Consideration Relevant principles 1. As the Tribunal stated in Health Care Complaints Commission v Varma [2022] NSWCATOD 4 at [131], the relevant principles in determining a protective order have been stated on many occasions and include the following: 1. the protection of public safety and health is paramount; National Law, s 3A; 2. public protection is achieved by ensuring that only health practitioners who are suitably trained and qualified to practice in a competent and ethical manner are registered; National Law, s 3(2)(a); 3. the Tribunal must consider the maintenance of standards of the profession, preservation of public confidence in the profession and, more broadly, the protection of the community: Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91]; 4. protective orders also involve an element of deterrence or, to put it more positively, encouragement to other practitioners to recognise the importance of complying with professional standards and the risks of failing to do so: Prakash at [91]; 5. the indirect but important effects of a protective order which must be considered when determining the appropriate protective order. These include general deterrence to the profession and a public statement of the unacceptability of the conduct: see Health Care Complaints Commission v Do [2014] NSWCA 307 and New South Bar Association v Meakes [2006] NSWCA 340. 6. whether seriousness of the conduct is sufficient to warrant suspension or deregistration is a matter of degree and judgement: Sabag v Health Care Complaints Commission [2001] NSWCA 411 at [82]. Commission's submissions 1. The Commission, accepting that the practitioner was deregistered, submitted that the appropriate order was if the practitioner was still registered, the Tribunal should cancel his registration. The Commission also submitted that the practitioner not be permitted to reapply for registration for three years. 2. For his part, the practitioner indicated that he would never practise again, and wanted his name removed from the register. However, he said that if he did seek reregistration, he would give whatever undertakings were appropriate and necessary. Conclusion 1. We have found that each of Complaints Two and Four to Seventeen established (save for particulars (1)(g) and (3) to Complaint Eleven). 2. Given this conclusion, under ss 149C(1) and (4)(a) of the Health Practitioner Regulation National Law (NSW), if the respondent was still registered as a pharmacist practitioner, we consider that the Tribunal would have cancelled his registration. That order is warranted by the extent, length and nature of the admitted conduct. 3. In addition to seeking that order, the Commission submitted that, under s 149C(4)(b) of the National Law, the respondent should disqualified from being registered in the pharmacy profession for a period of three years from the date of our orders. 4. That order was not, in terms, opposed by the practitioner, as he said he did not propose to practise again. In the circumstances, we consider that order an appropriate one to make. Costs 1. As the Commission has been successful, we propose to make an order that the practitioner pay the Commission's costs as agreed or assessed. This is a costs jurisdiction, and costs usually follow the event: Health Care Complaints Commission v Philipiah [2013] NSWCA 342; Qasim v Health Care Complaints Commission [2015] NSWCA 282. 2. If the practitioner seeks some other order, he should provide submissions (of no more than five pages) to the Commission, and to the Tribunal, within 14 days of receiving these reasons. The Commission may respond within a further 14 days. 3. We propose that any decision as to costs should be made "on the papers" and without a hearing. If either party thinks otherwise, it should address that issue in their submissions. Orders 1. It is sufficient to conclude and to order that: 1. each of Complaints Two and Four to Seventeen is established (save for particulars (1)(g) and (3) to Complaint Eleven); 2. if the respondent was still registered as a pharmacist, the Tribunal would have cancelled his registration; 3. the respondent is disqualified from being registered in the pharmacy profession for a period of three years from the date of these orders; 4. the Pharmacy Board of Australia is required to record the fact that the Tribunal would have cancelled the respondent's registration in the National Register kept by the Board; 5. the respondent is to pay the applicant's costs of the proceedings. ********** ATTACHMENT A AMENDED COMPLAINT BACKGROUND TO COMPLAINTS ONE TO SIXTEEN The practitioner was first registered as a pharmacist on 11 March 1982. Australian Custom Pharmaceuticals (ACP) is a large compounding pharmacy. ACP compounds substances on prescriptions from doctors all over Australia, and dispenses those substances to patients all over Australia. The practitioner was the sole proprietor of ACP at the time of the compounding and dispensing which is the subject of this Complaint. Amongst other drugs, ACP compounded peptides, selective androgen receptor modulators (SARMs) and a collection of other drugs which are often associated with illicit or off-label use for performance and image enhancement. The Australian Register of Therapeutic Goods (ARTG) is a database of all therapeutic goods that can be marketed and supplied in Australia. Access to non-approved goods (non-ARTG drugs) is limited to certain authorised prescribers, special access schemes or clinical trials. Pyridoxine, ketamine, hCG, testosterone, anastrozole, hyaluronidase, progesterone and phentermine (ARTG drugs) are all currently or have previously been listed on the ARTG. CJC-1295, Ipamorelin, IGF-LR3, LGD-4033, Bremelanotide, Follistatin 315, Melanotan II, AOD9604, cerebrolysin, GHRP-6, GHRP-2, IGF-1LR, mechano growth factor, SARMs -22, DHEA and thymosin beta 4 are all non-approved drugs which have never been registered on the ARTG. COMPLAINT ONE [Withdrawn] COMPLAINT TWO is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy. PARTICULARS OF COMPLAINT TWO 1. Between 20 August 2014 and 6 May 2015 the practitioner (as sole proprietor of ACP) permitted Ketamine in injectable form to be dispensed in approximately 312 prescriptions on the basis of prescription orders which contained inadequate directions for use, being prescription orders worded either as: (a) Ketamine HCL 200mg/mL x 5. Pls compound into 24 vials of Ketamine 40mg/mL in a volume of saline mL; or (b) Ketamine HCL 200mg/2mLO (five ampoules) please compound into 24 (twenty-four) syringes of Ketamine 40mb/1mL in a volume of 1mL of saline 2. Between 20 August 2014 and 6 May 2015 the practitioner (as sole proprietor of ACP) permitted approximately 312 Ketamine prescriptions with directions of 'for intramuscular injection' to be dispensed despite there being no such direction on the prescription. 3. In allowing the conduct described in particulars 1 and 2 the Practitioner failed to exercise proper oversight of the dispensing practice at ACP. COMPLAINT THREE [Withdrawn] COMPLAINT FOUR is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice of pharmacy. PARTICULARS OF COMPLAINT FOUR 1. Between 15 September 2014 and 15 May 2015, on approximately 312 occasions, the practitioner (as sole proprietor of ACP) permitted Ketamine to be compounded and dispensed for treatment resistant depression in circumstances where: (a) Neither depression generally nor treatment resistant depression specifically is an approved therapeutic use of Ketamine, such that the prescriptions were for off label use; (b) The compounding and dispensing was not for use in a clinical trial approved by the Therapeutic Goods Administration; (c) There was, at the time of compounding and dispensing, not sufficient high quality evidence supporting the use of Ketamine in the manner intended to warrant it being compounded and dispensed for off label use to treat depression or treatment resistant depression. 2. Between 15 September 2014 and 15 May 2015 on approximately 312 occasions, the practitioner (as sole proprietor of ACP) permitted Ketamine to be compounded and dispensed without Consumer Medicines Information (CMI) disclosures. 3. In allowing the conduct described in particulars 1 and 2 the Practitioner failed to exercise proper oversight of the dispensing practice at ACP. COMPLAINT FIVE is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice of pharmacy. PARTICULARS OF COMPLAINT FIVE 1. Between 30 September 2013 and 28 October 2014 the practitioner (as sole proprietor of ACP) permitted hormones and peptides to be dispensed to Patient B, in circumstances where: (a) The practitioner did not know what, if any, medical conditions Patient B suffered for which the peptides were being prescribed; (b) The practitioner did not have any reasonable basis for believing the peptides were prescribed for an appropriate therapeutic purpose; (c) The prescriptions were in a quantity and combination that was unlikely to be all for Patient B's own personal use; (d) For the peptides Follistatin 344, CJC1295, Ipamorelin 2000mcg/mL, IGF1-LR3 1000mcg/mL, AOD 9604, GHRP-6, Cerebrolysin, Mechano Growth Factor, Melatotan II, SARMS-22, Thymosin beta 4, there was no appropriate therapeutic purpose for its use in humans except in potential lifesaving conditions under approval of the TGA Special Access Scheme; (e) For HCG, the only indication for its use in men is gonadotrophin deficiency which there was no indication Patient B suffered; (f) Without warning the patient of the risks of using the drugs. 2. In allowing the conduct described in particular 1 the Practitioner failed to exercise proper oversight of the dispensing practice at ACP. COMPLAINT SIX is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice of pharmacy. PARTICULARS OF COMPLAINT SIX 1. Shortly prior to October 2014 the practitioner (as sole proprietor of ACP) supplied, or permitted ACP to supply Patient B with 2 vials of Melanotan, 1 vial of AOD 9604 and 2 vials of Thymosin beta 4 in circumstances where Patient B did not have a prescription for those drugs. COMPLAINT SEVEN is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice of pharmacy. PARTICULARS OF COMPLAINT SEVEN 1. Between 12 October 2010 and 21 July 2014 the practitioner (as sole proprietor of ACP) permitted 12 prescriptions for HCG to be compounded and dispensed on prescriptions from Dr Willcourt, Dr Bosnich and Dr Yen said to be for weight loss in circumstances where: (a) The only approved indication for its use in men is gonadotrophin deficiency and in women is to trigger ovulation in conjunction with fertility treatments; (b) The HCG was not supplied for a recognised therapeutic purpose; (c) There was, at the time of compounding and dispensing, not sufficient high quality evidence supporting the use of HCG in the manner intended to warrant it being compounded and dispensed for off label use for weight loss. 2. In allowing the conduct described in particular 1 the Practitioner failed to exercise proper oversight of the dispensing practice at ACP. COMPLAINT EIGHT is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice of pharmacy. PARTICULARS OF COMPLAINT EIGHT 1. Between 22 January 2014 and 17 September 2014 the practitioner (as sole proprietor of ACP) permitted peptides to be dispensed on approximately 168 occasions, sometimes in combination with other peptides, in circumstances where: (a) The practitioner did not know what, if any, medical conditions the patients suffered for which the peptides were being prescribed; (b) The practitioner did not have any reasonable basis for believing the peptides were prescribed for an appropriate therapeutic purpose; (c) A large number of the directions for use included references to training, weight loss or body building, which are not appropriate therapeutic purposes; (d) There was no appropriate therapeutic purpose for their use in humans except in potential life saving conditions under approval of the TGA Special Access Scheme. 2. In allowing the conduct described in particular 1 the Practitioner failed to exercise proper oversight of the dispensing practice at ACP. COMPLAINT NINE is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice of pharmacy. PARTICULARS OF COMPLAINT NINE 1. Between 1 June 2014 and 12 May 2016 the practitioner (as sole proprietor of ACP) permitted 7,951 prescriptions for peptides to patients, which included SARMS, AOD9604, LGD-4033, CJC-1295, Ipamorelin, GHRP-6, GHRP-2 and IGF-1LR3ACP to be compounded and dispensed in circumstances where: (a) The practitioner did not know what, if any, medical conditions the patients suffered for which the peptides were being prescribed; (b) The practitioner did not have any reasonable basis for believing the peptides were prescribed for an appropriate therapeutic purpose; (c) Some of the directions for use included references to weight loss, toning/lean muscle building and body building, which are not appropriate therapeutic purposes; (d) There was no appropriate therapeutic purpose for their use in humans except in potential life saving conditions under approval of the TGA Special Access Scheme. 2. In allowing the conduct described in particular 1 the Practitioner failed to exercise proper oversight of the dispensing practice at ACP. COMPLAINT TEN is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice of pharmacy. PARTICULARS OF COMPLAINT TEN 1. Between 16 June 2014 and 2 December 2014 the practitioner (as sole proprietor of ACP) permitted different peptides to be dispensed in combinations to four patients, in circumstances where: (a) The directions on the prescriptions were vague and insufficiently clear; (b) The practitioner did not know what, if any, medical conditions the patients suffered for which the peptides were being prescribed; (c) The practitioner did not have any reasonable basis for believing the peptides were prescribed for an appropriate therapeutic purpose; (d) There was no appropriate therapeutic purpose for their use individually and/or in combination in humans except in potential life saving conditions under approval of the TGA Special Access Scheme. 2. In allowing the conduct described in particular 1 the Practitioner failed to exercise proper oversight of the dispensing practice at ACP. COMPLAINT ELEVEN is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice of pharmacy. PARTICULARS OF COMPLAINT ELEVEN 1. Between 3 December 2015 and 15 February 2016 the practitioner (as sole proprietor of ACP) permitted Phentermine 30mg to be compounded and supplied to 184 patients in circumstances where: (a) There were commercially available ARTG approved products that were equivalents, being Metermine and Duromine; (b) Metermine and Duromine were available in 30mg capsules which included 30mg of the active ingredient Phentermine; (c) There was no reasonable need to compound the medications; (d) Compounding the medications was in breach of Guideline 2 of the PBA Guidelines to the Compounding of Medicines; (e) There is insufficient high level evidence to support the additions that ACP made to the formulation materially altering the effects from the commercially available approved products Metermine and Duromine; (f) Chromium Picolinate and/or 5HTP which were used in the formulation of the Phentermine could have been taken by the patients separately as supplements if that was required; (g) [Withdrawn] (h) The practitioner did not provide any information or warning to the patients receiving the drugs about the fact they had been compounded and any increased risks they may pose. 2. Between 3 December 2015 and 15 February 2016 the practitioner (as sole proprietor of ACP) permitted Phentermine 30mg to be compounded and supplied Phentermine 30mg to 184 patients in circumstances where: (a) The practitioner did not provide a Consumer Medicines Information statement with the drugs setting out relevant information about the compounded drugs; (b) The practitioner supplied the Consumer Medicines Information statement for Duromine with the drugs which may have misled consumers into thinking the drug was the ARTG approved Duromine. 3. [Withdrawn] 4. Between 3 December 2015 and 15 February 2016 the practitioner (as sole proprietor of ACP) permitted Phentermine 30mg to be compounded and supplied to 184 patients in circumstances where it took no reasonable steps to establish that the medication was suitable for the patients supplied. 5. In allowing the conduct described in particulars 1, 2, 3, and 4 the Practitioner failed to exercise proper oversight of the dispensing practice at ACP. COMPLAINT TWELVE is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice of pharmacy PARTICULARS OF COMPLAINT TWELVE 1. Between 28 September 2015 and 4 October 2016 the practitioner (as sole proprietor of ACP) permitted testosterone with Chrysin to be compounded and dispensed to patients on approximately 418 occasions in circumstances where: (a) The practitioner had not done any clinical trials to satisfy himself as to the safety of the formulation; (b) The practitioner had not done any clinical trials to satisfy himself of the efficacy of the formulation; (c) There was a commercially available ARTG approved product, Androforte, which was not materially different to the product compounded by ACP; (d) Compounding and dispensing the testosterone cream was contrary to Guideline 2 of the PBA Guidelines on Compounding of Medicine. (e) There was insufficient information about the topical exposure of Chrysin to be satisfied about its safety. 2. In allowing the conduct described in particular 1 the Practitioner failed to exercise proper oversight of the dispensing practice at ACP. COMPLAINT THIRTEEN is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice of pharmacy. PARTICULARS OF COMPLAINT THIRTEEN 1. Between 28 September 2015 and 4 October 2016 the practitioner (as sole proprietor of ACP) permitted testosterone with zinc to be compounded and dispensed to patients on approximately 418 occasions in circumstances where: (a) There was a commercially available ARTG approved product, Androforte, which was not materially different to the product compounded by ACP; (b) Compounding and dispensing the testosterone cream was contrary to Guideline 2 of the PBA Guidelines on Compounding of Medicine; (c) The practitioner had no reasonable basis to believe the addition of zinc had any material effect on the therapeutic purpose of the product. 2. In allowing the conduct described in particular 1 the Practitioner failed to exercise proper oversight of the dispensing practice at ACP. COMPLAINT FOURTEEN is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice of pharmacy. PARTICULARS OF COMPLAINT FOURTEEN 1. Between 14 July 2015 and 12 April 2016 the practitioner (as sole proprietor of ACP) permitted a topical preparation containing testosterone with SARMS 22 to be compounded and dispensed to 7 male patients in circumstances where: (a) There was a commercially available ARTG approved product, Androforte, which was not materially different to the product compounded by ACP; (b) Compounding and dispensing the topical preparation was contrary to Guideline 2 of the PBA Guidelines on Compounding of Medicine; (c) The practitioner had no reasonable basis to believe the addition of SARMS 22 had any material effect on the therapeutic purpose of the product; (d) There was no appropriate therapeutic purpose for the use of SARMS 22 in humans except in potential life saving conditions under approval of the TGA Special Access Scheme. 2. In allowing the conduct described in particular 1 the Practitioner failed to exercise proper oversight of the dispensing practice at ACP. COMPLAINT FIFTEEN is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) 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; and/or (ii) engaged in improper or unethical conduct relating to the practice of pharmacy. PARTICULARS OF COMPLAINT FIFTEEN 1. Between 3 July 2014 and 9 November 2016 the practitioner (as sole proprietor of ACP) permitted a topical preparation including testosterone and DHEA to be compounded and dispensed patients in circumstances where: (a) There was a commercially available ARTG approved product, Androforte, which was not materially different to the product compounded by ACP; (b) Compounding and dispensing the topical preparation was contrary to Guideline 2 of the PBA Guidelines on Compounding of Medicine; (c) The practitioner had no reasonable basis to believe the addition of DHEA had any material effect on the therapeutic purpose of the product; (d) There was no appropriate therapeutic purpose for the use of DHEA in humans except in potential life saving conditions under approval of the TGA Special Access Scheme. 2. In allowing the conduct described in particular 1 the Practitioner failed to exercise proper oversight of the dispensing practice at ACP. COMPLAINT SIXTEEN 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; 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 suspension or cancellation of the practitioner's registration. PARTICULARS OF COMPLAINT SIXTEEN 1. The following particulars are relied upon individually: (a) Complaint Four, particulars 1(a) to 1(c) inclusive, 2 and 3; (b) Complaint Eight, particulars 1(a) and (b) and 2; (c) Complaint Nine, particulars 1(a) and (b) and 2; (d) Complaint Eleven, particulars 1(a) and 5; (e) Complaint Twelve, particulars 1(a) to (c) inclusive and 2; (f) Complaint Thirteen, particular 1(a) and 2; (g) Complaint Fourteen, particular 1(a) and 2; (h) Complaint Fifteen, particular 1(a) and 2. 2. Complaints One to Fifteen inclusive and the particulars thereof are relied upon cumulatively, or in any combination. COMPLAINT SEVENTEEN is guilty of professional misconduct in that the practitioner entered into an arrangement which contravened section 25 of the Pharmacy Act 1964 (now repealed) during a period when to do so was professional misconduct pursuant to section 19A of the Pharmacy Act 1964 (now repealed). BACKGROUND TO COMPLAINT SEVENTEEN In around February 2002 the practitioner entered into an arrangement with Mr Brian Sher whereby companies controlled by Mr Sher, Redwood Anti-Ageing Pty Ltd and Redwood Nutraceuticals Pty Ltd (the Redwood entities) referred prescriptions for compounded pharmaceutical products to the practitioner (or a pharmacist nominated by him) and the profits generated from dispensing those prescriptions were paid to the Redwood entities (the arrangement). The arrangement continued until around October 2006. From around February 2002 until around April 2002 and from around April 2003 until around October 2006, the practitioner dispensed products pursuant to the arrangement from a compounding pharmacy, with respect to which he was the licensed pharmacist. Between around April 2002 and around April 2003, the practitioner did not control any licensed compounding pharmacy but arranged for other licensed pharmacists to dispense compounded pharmaceutical products pursuant to the arrangement. Throughout the period from around February 2002 to around October 2006, the practitioner knew, or was reckless as to whether, the arrangement was contrary to section 25 of the Pharmacy Act 1964 (now repealed). PARTICULARS OF COMPLAINT SEVENTEEN 1. From around February 2002 until around October 2006 the practitioner entered into an arrangement to conduct a pharmacy business with a non-pharmacist in contravention of section 25 of the Pharmacy Act 1964 (now repealed). ** END ** 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: 06 April 2022