Health Care Complaints Commission v Serafin - [2021] NSWCATOD 11 - NSWCATOD 2020 case summary — Zoe

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Health Care Complaints Commission v Serafin

[2021] NSWCATOD 11

NCAT Occupational|2020-12-18

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Source facts

Court

NCAT Occupational

Decision date

2020-12-18

Source

Original judgment source is linked above.

Judgment (17 paragraphs)

[1]

REASONS FOR DECISION

In October 2019, the Health Care Complaints Commission (the Commission) referred a complaint (the Complaint) about pharmacist, Dr Michael Serafin, to the New South Wales Civil and Administrative Tribunal (NCAT).
The proceedings are part-heard by the Tribunal. A five-day hearing was held in December 2020. A further two days of hearing are listed for late March 2021.
At the conclusion of the hearing in December 2020, the Commission applied for orders under s 165L(1) of the Health Practitioner Regulation National Law (NSW) (the National Law) to prohibit Dr Serafin supplying, dispensing or compounding any of the following products at any pharmacy in which he has a financial interest: 1. Any peptide including: 1. BPC-157 2. CJC-1295 3. Ipamorelin 1. Human Growth Hormone (HGH) 2. Growth Hormone Secretagogues (GHS)
The Commission contends that, in circumstances where it is unlikely that a final decision will be made by the Tribunal within the next six months, where Dr Serafin admits to continuing to compound and dispense HGH, GHS and peptides containing BPC-157, CJC-1295 and Ipamorelin, (the subject drugs), and where there is expert evidence that the safety and efficacy of those drugs is not properly established, it is appropriate and necessary that the Tribunal exercise the discretion to make the order it seeks.
Dr Serafin undertakes to fully comply with any order made by the Tribunal. He asserts that, contrary to Professor Carter's opinion, there is a significant body of expert opinion which demonstrates the safety and efficacy for human use of each of the subject drugs. He contends that many of the concerns raised by the Commission about his compounding and dispensing practices have been addressed by a series of reforms made to the practices and procedures employed by the Practice, progressively introduced since mid-2016. Finally, he emphasises that it is not illegal to prescribe or dispense any of the subject drugs.
For the reasons that follow, we have decided to exercise the discretion to make the order sought by the Commission (the proposed order).

[2]

Background to the Complaint

Since 2001, Dr Serafin has owned and operated Complementary Compounding Services, Ballina (the Pharmacy). Dr Serafin holds a PhD in Pharmaceutical Chemistry.
The trigger for the Complaint was the admission to St Vincent's Hospital, Sydney of a patient with suspected endotoxaemia in February 2016. The patient had attended the "Sydney Clinic" and received a vitamin infusion of "Myer's Cocktail" and a Glutathione injection, which had been compounded and dispensed by Dr Serafin. (There is no suggestion that Dr Serafin was responsible for the condition which led to the patient's admission). The patient's admission led the Pharmaceutical Regulatory Unit (PRU) to investigate the Sydney Clinic, and, in turn, several NSW-based compounding pharmacies, including the pharmacy operated by Dr Serafin.
In March 2017, PRU Director, Mr Bruce Battye, gave the Commission a copy of the report into its investigation of Dr Serafin. In the covering letter to that report, Mr Bruce Battye stated: (a) "The CCS pharmacy dispensed at least 1,432 prescriptions for the following peptides, none being approved for human therapeutic use, either in isolation or in combination, during the period 1 June 2014 to 20 May 2016: SARM - S22; AOD9604; LGD-4033; CJC-1295; Ipamorelin; GHRP-6; GHRP-2; IGF-1 LR3. (b) It is unclear what recognised science-based evidence supported Dr Serafin's professional judgement to compound and dispense the above peptides in accord with recognised therapeutic standards of what is appropriate in the circumstances, contrary to clause 54 of the Poisons and Therapeutic Goods Regulation 2008, and contrary to the Pharmacy Board of Australia's Guidelines on compounding of medicines, Guideline 6, where appropriate. (c) On numerous occasions, Dr Serafin, through the operation of his Complementary Compounding Services pharmacy has prepared and supplied compounded peptide preparations, when the safety and efficacy of such products for human therapeutic use has not been established, including the long-term safety of such substances. (d) Dispensed a large number of invalid prescriptions for human growth hormone, peptides, anabolic steroids and ketamine, contrary to clauses 39, 40, 85 and 86 of the Poisons and Therapeutic Goods Regulation 2008. (e) Failed to ensure that a periodical inventory of Schedule 8 drugs was undertaken as required, contrary to clause 118 of the Poisons and Therapeutic Goods Regulation 2008. (f) Obtained peptide raw materials, not approved for human therapeutic use, sourced from overseas, without the necessary evidence to demonstrate that the substances complied with the requirements of pharmacopoeial standards, contrary to Guideline 10 of the Pharmacy Board of Australia's Guidelines on compounding of medicines. (g) Compounded human growth hormone and anabolic steroids when appropriate commercial products, registered on the Australian Register of Therapeutic Goods, where the quality, safety and efficacy of such products had been assessed by the Therapeutic Goods Administration and manufactured by licensed manufacturers to ensure quality standards of the commercial products were readily available. (h) Supplied greatly excessive quantities of peptide preparations to Dr Sadjak and the Melbourne Sports Medicine Clinic, excessive quantities of anabolic steroids and peptides to David Newlands, Queensland and excessive quantities of compounded ketamine to Dr Peter O'Brien (who after the intervention of PRU had his name removed from the AHPRA register of practitioners)."
Mr Battye recommended that the Commission refer the matter for "immediate consideration" to the Pharmacy Council of NSW (the Council).
Following receipt of the PRU's March 2017 report, the Council imposed conditions on Dr Serafin's registration, which prohibited him from: (1) dispensing, supplying or compounding any products containing ketamine. (2) allowing the supply, dispensing or compounding of any products containing ketamine in any pharmacy in which he has a financial interest.
Ketamine is a "drug of addiction" listed on the Poisons List proclaimed under s 8 of the Poisons and Therapeutic Goods Act 1966 (NSW) (the PTGA). Dr Serafin voluntarily ceased dispensing ketamine in May 2015.
Previously, in April 2016, the Council had imposed conditions on Dr Serafin's registration prohibiting him from allowing the compounding of any of the following pharmaceutical products for parenteral use, at any pharmacy in which he has a pecuniary interest: (1) products containing glutathione, and (2) Nutrient 'Myer's Cocktail' mixtures.

[3]

Outline of Complaint

The Commission has made a series of amendments to the original Complaint, since filing it with NCAT in November 2019. For convenience, we refer to its most recent version as "the Complaint".
The Complaint consists of six individual complaints. Complaints 1 to 5 allege that Dr Serafin engaged in unsatisfactory professional conduct under ss 139B(1)(a) and 139B(1)(l) of the National Law. Complaint 6 alleges Dr Serafin is guilty of professional misconduct under s 139E of the National Law.
Complaints 1 to 5 are based on numerous particulars, only some of which are referred to in this outline. Complaints 2, 3 and 5, in part, relate to Dr Serafin's actions in compounding and dispensing some of the subject drugs.
Dr Serafin denies most of the particulars of Complaints 1 to 5. In addition, he admits certain particularised conduct but denies that it constitutes unsatisfactory professional conduct or professional misconduct.
In Complaint 1, the Commission alleges that Dr Serafin inappropriately compounded and dispensed "Myer's Cocktail" and glutathione medication, which were administered at two "wellness clinics" operated by the (then) provisionally registered pharmacist, Ms Shadi Kazeme. The Commission alleges, among other things, that between September 2015 and August 2016, Dr Serafin inappropriately compounded and dispensed: 1. 59 prescriptions for parenteral products to 17 patients in circumstances where he knew or ought to have known exercising responsible professional judgement that after he supplied these products, they would be administered to persons other than the person to whom they were prescribed. 2. 37 prescriptions based on orders and prescriptions from Ms Kazeme in circumstances where: 1. he had no contact with either the prescribers or the patients; 2. the volume of the compounded products was inappropriate; 3. the supply of glutathione, a Schedule 4 prescribed medication, was not in a quantity, or for a purpose, that accorded with the recognised therapeutic standard of what was appropriate in the circumstances, contrary to cl 54 of the Poisons and Therapeutic Goods Regulation 2008 (NSW) ("the PTGR").
In Complaint 2, the Commission alleges that Dr Serafin inappropriately compounded and dispensed, among other things, HGH and peptides, including CJC-1296, in circumstances where Dr Serafin: 1. failed to ensure that the supply of the medications to the subject patient was in a quantity, or for a purpose, that accorded with the "recognised therapeutic standards of what was appropriate in the circumstances". 2. was aware that the medications compounded and dispensed for the subject patient were liable to abuse and failing to take adequate steps to ensure that the subject patient was not abusing those medications; 3. failed to have proper regard to the subject patient's dispensing history in assessing the appropriateness of the prescribed medications and the associated risks to their health and safety; 4. failed to keep contemporaneous notes of any conversations with the subject patient and the prescriber of their medications, including in relation to the medical reasons for the medication being prescribed.
In Complaint 3 the Commission alleges that between July 2014 and October 2014, Dr Serafin inappropriately compounded and dispensed peptides, CJC and Growth Hormone Releasing Peptides-6 (GHRP-6) for Dr Dusan Sajdak at the Melbourne Sports Clinic, in circumstances where: 1. Dr Serafin failed to identify the individual patients for whom the supply was being made. 2. Dr Serafin failed to identify the particular indication for the supply for each individual patient. 3. Dr Serafin failed to verify the directions for use and ensure the appropriateness of the therapeutic purpose and directions for use for the supply to each individual patient; and 4. Dr Serafin's only understanding in relation to the supply was that it was for anti-aging therapy.
In Complaint 4, the Commission alleges that Dr Serafin inappropriately compounded and dispensed ketamine to four patients in circumstances where, among other things, contrary to cl 79 of the PTGR, the prescriptions were in a quantity, or for a purpose, that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances.
In Complaint 5, the Commission alleges that Dr Serafin inappropriately compounded and dispensed HGH, a schedule 4D prescribed restricted substance: 1. to Patient S in circumstances where the subject prescription failed to specify the name, strength and quantity of the substance to be dispensed and provide direction for its use, contrary to cl 35 of the PTGR; 2. to Patients T, U, V and W in circumstances where the issued prescriptions were out of date, contrary to cl 40 of the PTGR.

[5]

Classification of performance and image enhancing drugs (PIEDS)

The task of classifying substances under the Poisons Standard is undertaken by the Secretary of the Commonwealth Department of Health (the Secretary) or their delegate. The Secretary receives advice on the classification of poisons from the Advisory Committee on Medicines Scheduling (ACMS), a committee established under s 52B(1) of the Therapeutic Goods Act.
On 1 June 2015, acting on the recommendation of the ACMS, the Secretary included the following Performance and Image Enhancing Drugs (PIEDS) in Schedule 4, Appendix D to the Poisons Standard: Growth Hormone Releasing Hormones and Analogues (GHRHs), Growth Hormone Secretagogues (GHSs), Growth Hormone Releasing Peptides (GHRPs) and Growth Hormone Variants, as well as new individual substance entries for CJC-1295, ipamorelin, GHPR-2, GHPR-6, hexarelin and AOD-9604.
In reasons for that decision, the Secretary explained that Growth Hormone Releasing Peptides (GHRP): [A]re a class of compounds, which stimulate the release of growth hormone. GHRP variants include GHRP-2, GHRP-6, hexarelin, ipamorelin and agents with similar actions including CJC-1295. These agents are considered peptide hormones. GHRPs are thought to act by stimulating the release of endogenous human growth hormone leading to pharmacological effects such as increased bone mineral density, increased lean muscle mass, modest improvements in strength and improved recovery from injuries such as fractures. (References omitted)
The delegate went on to note that the ACMS recommended that these substances be included under Schedule 4, Appendix D to the Poisons Standard for the following reasons: There is limited information on the risks and benefits of the substances as there has been minimal use under appropriate medical supervision. Risks from misuse are considered to be similar to those associated with the misuse of growth hormone. There is increasing evidence that the PIEDs are being advertised to attract a number of user markets including: Strength enhancement/muscle enhancement Anti-ageing Fat loss Injury rehabilitation Libido enhancement Growth hormone deficiency There is the potential for the side effects associated with use of growth hormone when growth hormone secretagogues are used, particularly if the use is not under medical supervision. There are limited data on the safety of intravenous and subcutaneous use of AOD-9604 and on the long-term oral use of AOD-9604 in doses in excess of those used in clinical trials. Many of the substances are injected. This carries additional risks compared with other routes of administration. Injections need to be administered by persons who use appropriate infection control procedures. There is misuse of the substances in sport and by body builders. There is evidence of involvement of organised crime in supply of the substances. The substances are offered for sale via the internet. Many of the substances are promoted as safe alternatives to traditional performance enhancing substances such as the anabolic steroids. Suppliers are making unproven assertions about the efficacy and safety of the substances.

[7]

Pharmacy Board of Australia: Guidelines on Compounding of Medicines

In addition to the PTGA and PTGR, several codes and guidelines regulate the practice of pharmacy in NSW. These include the "Guidelines on Compounding of Medicines", issued in March 2015 by the Pharmacy Board of Australia under s 39 of the National Law. The Guidelines state: 6. Formulation considerations When compounding medicines, pharmacists must ensure that there is good clinical and pharmaceutical evidence to support the quality, stability (including appropriate expiry periods), safety, efficacy and rationality of any extemporaneous formulation. This may involve collaboration with the prescriber, so an agreement on the suitability of the product for the intended patient is able to be achieved. At all times the pharmacist must be satisfied that the dispensing and supply of a compounded medicine is consistent with the safety of the patient (refer to Guideline 1 Dispensing precaution - safety of prescriptions of the Board's Guidelines for dispensing of medicines). This includes off-licence use of medicines which are to be compounded into a product. Consideration should also be given to whether a compounded medicine is appropriate for use, for example a sports supplement (refer to the section Drugs in sport in the current edition of the Australian Pharmaceutical Formulary and Handbook). Evidence to support a decision to compound a medicine must be obtained from reputable references (refer to the reference texts for compounding pharmacists listed in these guidelines), international pharmacopoeial standards, or peer reviewed journals, and must not be based on testimonials and impressions. For guidance on assigning an appropriate expiry date to a compounded medicine, pharmacists should refer to the section Extemporaneous dispensing in the current edition of the Australian Pharmaceutical Formulary and Handbook. … 6.1 Formulations for which precedents do not exist A pharmacist is required to use sound judgement based on current clinical and pharmaceutical knowledge and risk assessment, before deciding whether to prepare a formulation for which there is no precedent in a reputable reference. If a medicine is compounded under these circumstances, the evidence supporting the decision should be documented. The pharmacist must also ensure that the patient has been advised that the compounding has taken place under these circumstances. Particular care should be exercised by pharmacists who are requested to compound medicines for which there are no precedents in the reputable references, and for which there is inadequate published safety, efficacy, pharmacokinetic and clinical data on the intended formulation. Examples of such products could include (but are not limited to): preparations containing hormones. substances not approved in Australia for therapeutic use preparations compounded for topical use that contain drugs for which only oral use is well established. modified release medicine in the absence of good pharmacokinetic and clinical data on the precise formulation intended for use, or parenteral medicines containing combinations of ingredients where there is no compatibility data. The compounding of such products must be justified through the pharmacist obtaining additional data and/ or evidence. If deciding to compound such products, a pharmacist should document: evidence of appropriateness of the intended formulation which is accessible for all future compounding of this formulation, which includes: evidence of the efficacy, pharmacokinetic and clinical data, and the basis for the assigned expiry date of the intended formulation the process to maintain the safety of the pharmacy staff where the compounding is taking place any other steps in relation to ensuring that the dispensing and supply of the compounded medicine is consistent with the safety of the individual patient.

[8]

Safety and efficacy of peptides, HGH and GHS

An issue in dispute in these proceedings is whether the safety, quality and efficacy of some of the drugs the subject of the Complaint, including those the subject of the proposed interlocutory order, has been properly established. At the request of the Commission, endocrinologist Professor John Carter provided two reports and gave oral evidence in these proceedings. In his opinion, the safety, quality and efficacy of peptides has not been properly established.
According to Professor Carter, there are limited published clinical trials relating to CJC-1295, describing the findings of the available studies as "variable". Some indicate an increase in muscle strength in "normal" adults; others show no effect. In Professor Carter's opinion, there are insufficient clinical studies to draw any reliable conclusion on the safety of this peptide. However, given that the mechanism of action of CJC-1295 is via an increase in growth hormone secretion, the known side effects of growth hormone injections (which include oedema, carpal tunnel syndrome, abnormalities in glucose metabolism, arthralgia and gynaecomastia) must be considered.
In Professor Carter's view, given the lack of clinical data, there are no clinical indications or accepted therapeutic standards for prescribing CJC-1295 for "normal adults".
Applying that analysis, in Professor Carter's view, by dispensing CJC-1295 to nine of the patients the subject of Complaint 2, Dr Serafin failed to comply with the obligation not to supply "any restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances": cl 54 of the PTGR.
Nor, in Professor Carter's opinion, is the safety, quality and efficacy of GHRP-6 (growth hormone releasing peptide 6) properly established. GHRP-6 is sometimes used to enhance muscle repair and as an anti-aging therapy. While Professor Carter accepts that Growth Hormone injections have proven benefits in "Growth Hormone deficient individuals", he states there are no clinical indications for prescribing GHRP-6 to normal individuals. In his opinion, in dispensing GHRP-6 to the patients the subject of Complaint 2, Dr Serafin failed to comply with the requirement imposed by cl 54 of the PTGR.
In a detailed written response to Professor Carter's report, Dr Serafin: 1. pointed out that in June 2015 the TGA entered CJC, Ipamorelin, GHRP-6 in the ARTG; 2. asserted that there is no approved product information or published recognised therapeutic standard for these drugs and, as a consequence, it could not be argued, as the Commission contends, that he dispensed those drugs in a quantity or for a purpose that does not accord with the "recognised therapeutic standard". 3. asserted that his decision to compound peptides, including CJC, was based on clinical data which indicated that peptides are safe and effective for human use, citing in support a number of published scientific studies which he tendered in these proceedings. 4. disagreed with Professor Carter's opinion that the studies cited by him were questionable because they had not been peer-reviewed or published in reputable medical journals and the credentials of their authors were not established. 5. stated that, among other things, HGH helps to maintain, build and repair healthy tissue in the brain and other organs, can speed up healing after injury and repair muscle tissue after exercise.

[15]

Conclusion

While the Tribunal has the power to make the orders sought by the Commission, in our view, a cautious approach should be taken to the exercise of that power in circumstances where, as here, the Tribunal is yet to determine whether the Complaint is proven.
Dr Serafin mounts a powerful argument that his actions in compounding and dispensing the subject drugs are not unlawful, and all but BPC 157 have been classified under Schedule 4D in the Poisons Standard. In our view, the fact that Dr Serafin has and continues to compound and dispense the subject drugs, of itself, would not be a sufficient justification to exercise the discretion to impose a condition on his registration prohibiting him from doing so before the Complaint is determined. However, the absence of a statutory prohibition on the supply of the subject drugs does not dispose of the issue of risk to the health and safety of the public. There is evidence which, if accepted, supports a finding that on occasion Dr Serafin has supplied some of the subject drugs "in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances", contrary to cl 54 of the PTGR. While there is also evidence which, if accepted, supports a finding that Dr Serafin has taken steps to address some of the concerns raised by the Commission, it does not entirely address the issue of whether there is a risk that he may be continuing to contravene cl 54 of the PTGR.
If, before the determination of the Complaint Dr Serafin supplies the subject drugs, either alone or in combination with other drugs, "in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances", the health and safety of the public may be at risk. We put it no higher than that. If Professor Carter's opinion is accepted, that risk may be unacceptable. Given that there is at least a possibility of risk, and given that the effect of the orders is unlikely to materially prejudice Dr Serafin, we have decided to exercise the discretion to make those orders.

Health Care Complaints Commission v Serafin

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