Health Care Complaints Commission v Serafin

Outline of Complaint

1. Throughout these proceedings, the Commission has made a series of amendments to the original complaint filed with NCAT in November 2019. In these reasons we refer to the most recent version, tendered 17 December 2020, as "the Complaint".
2. 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.
3. Complaints 1 to 5 are based on numerous particulars. Dr Serafin denies most of those particulars. In addition, he disputes that any admitted particulars amount to unsatisfactory professional conduct or professional misconduct.
4. In Complaint 1, the Commission alleges, among other things, that Dr Serafin inappropriately compounded and dispensed Myer's Cocktail and glutathione which were administered at two "wellness clinics" 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.
5. In Complaint 2, the Commission alleges, among other things, that Dr Serafin inappropriately compounded and dispensed and/or failed to ensure that the pharmacists in his employ appropriately compounded and dispensed peptides and other substances in circumstances where he failed to ensure that the supply of the medications to the individual patients was in a quantity, or for a purpose, that accorded with the "recognised therapeutic standards of what was appropriate in the circumstances".
6. In Complaint 3, the Commission alleges, among other things, that between July 2014 and October 2014, Dr Serafin inappropriately compounded and supplied and/or failed to ensure that the pharmacists in his employ appropriately compounded and supplied, peptides CJC and Growth Hormone Releasing Peptides-6 (GHRP-6) for Dr Dusan Sajdak at the Melbourne Sports Clinic in circumstances where he failed to identify the individual patients for whom the supply was being made.
7. In Complaint 4, the Commission alleges that Dr Serafin inappropriately compounded and dispensed ketamine and/or failed to ensure that the pharmacists in his employ appropriately compounded and dispensed prescriptions for ketamine to five patients in circumstances where, among other things, contrary to cl 79 of the Poisons and Therapeutic Goods Regulation 2008 (NSW) (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.
8. In Complaint 5, the Commission alleges that Dr Serafin inappropriately compounded and dispensed and/or failed to ensure that the pharmacists in his employ appropriately compounded and dispensed, Human Growth Hormone (HGH), a prescribed restricted substance, 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 and, where several prescriptions were out of date.
9. In Complaint 6, the Commission alleges that Dr Serafin is guilty of professional misconduct.

Onus and standard of proof

1. The Commission bears the burden of proving, on the balance of probabilities, the matters particularised in the Complaint: Gautam v Health Care Complaints Commission [2021] NSWCA 85 at [3] (Leeming JA).
2. The Tribunal is not bound by the rules of evidence and, strictly speaking, "neither Briginshaw nor s 140 of the Evidence Act [1995 (NSW)] applies directly in decision-making by NCAT": Bronze Wing International Pty Ltd v SafeWork NSW [2017] NSWCA 41 at [127], (Leeming JA, Gleeson JA agreeing); Ng v Health Care Complaints Commission [2017] NSWSC 53 at [56], (cf Gautam v Health Care Complaints Commission at [89] (Payne JA, Leeming JA and Simpson AJA agreeing)). Nonetheless, given the gravity of the allegations made against Dr Serafin, in deciding whether the particulars alleged are proven we have adopted the approach set out in Briginshaw v Briginshaw (1938) 60 CLR 336; [1938] HCA 34. See Health Care Complaints Commission v Morsingh [2021] NSWCATOD 13 at [3].
3. Dixon J explained in Briginshaw (at 361) that when the law requires proof of any fact, "the tribunal must feel an actual persuasion of its occurrence or existence before it can be found" and the more serious the consequences, the more they will affect the consideration. But, as has been repeatedly emphasised, the standard of proof remains the balance of probabilities, not a standard between the criminal standard of proof, beyond reasonable doubt, and proof on the balance of probabilities.
4. The authorities have cautioned against the use of the term "comfortably satisfied" (a phrase adopted from Rich J in Briginshaw at 350) to imply that proof to a higher standard than the balance of probabilities is required: Forster v Hunter New England Area Health Service (2010) 77 NSWLR 495; [2010] NSWCA 106 at [22]; Neat Holdings Pty Ltd v Karajan Holdings Pty Ltd [1992] HCA 66; (1992) 67 ALJR 170; (1992) 110 ALR 449 at [1].

Complaint 1

1. Complaint 1 consists of 12 particulars. Each relates to Dr Serafin's actions in compounding, dispensing and supplying parenteral substances (substances administered other than by mouth, usually intravenously) to the (then) provisionally registered pharmacist, Ms Shadi Kazeme. Ms Kazeme owned and operated two clinics, called "iv.me Hydration Clinic", which were marketed as "wellness clinics". One clinic was based in a medical practice in Melbourne, the OGAM Medical Centre (OGAM); the other clinic was located in a medical practice in Sydney, Holdsworth House.
2. Between September 2015 and August 2016, at the request of Ms Kazeme, Dr Serafin compounded and dispensed 59 prescriptions (issued to 17 people, including Ms Kazeme) for parenteral products, including: 1. 387 doses of Myer's Cocktail (a combination of vitamins and minerals); 2. 129 x 10ml vials of the prescribed restricted substance, glutathione); 3. 5 x various quantities of Methyl cobalamin (vitamin B12).
3. On 13 February 2016, after receiving an injection at Holdsworth House, Patient A1 was admitted to hospital with suspected endotoxaemia. That admission triggered an investigation by the PRU into the clinic at Holdsworth House and later, the Pharmacy.
4. The PRU found that the substances supplied to Ms Kazeme by the Pharmacy, listed in Schedule 1A to the Complaint, were not being administered to the people to whom they were prescribed. Dr Serafin claimed that it was not until he read media reports about Patient A1's admission to hospital that he became aware that the clinics with which Ms Kazeme was involved were called "iv.me Hydration Clinic" and that the substance the Pharmacy supplied to those clinics were being administered to people other than to whom they were prescribed.
5. Of the 69 supplies made to Ms Kazeme, all but two pre-dated Patient A1's admission to hospital. On 19 May 2016 and 8 August 2016, the Pharmacy supplied Ms Kazeme with Human chorionic gonadotropin (HCG). Dr Serafin stated he was unaware of and played no role in dispensing those substances to Ms Kazeme and it was the result of a mistake made by a staff member.

Particulars 1 and 2

1. Dr Serafin denies Particulars 1 and 2 which state: "1. Between September 2015 and August 2016, the practitioner inappropriately compounded and dispensed a total of 59 prescriptions for parenteral products, including Schedule 4 prescription products, to 17 patients in accordance with Schedule A1 hereto, to be administered by the Clinics with the knowledge in circumstances where he knew or ought to have known exercising responsible professional judgment that after he supplied these products, they would be administered to persons other than to whom they were prescribed. 2. From September 2015 to August 2016, the practitioner inappropriately continued to compound and dispense products for the Clinics in accordance with Schedule A1 hereto, despite his concerns that the products he was compounding and dispensing were not being administered to only the patients in whose names the prescriptions were written and without contacting the prescribers to ensure the validity of the prescriptions."

Dr Serafin's account

1. According to Dr Serafin, Ms Kazeme first contacted him in September 2015 and asked whether the Pharmacy could supply Myer's Cocktails and other drugs. He claims that Ms Kazeme told him: 1. she was a pharmacist; 2. she was working in Melbourne at OGAM, under the supervision of Dr O'Gorman, and was responsible for managing IV [intravenous] patients, booking appointments and ordering stock; 3. that the ordered substances would be administered under the supervision of a doctor; 4. that the patients for whom the substances were prescribed were being treated for chronic illnesses, such as chronic fatigue and fibromyalgia. According to Dr Serafin, he was aware that Myer's Cocktail was used in the treatment of those types of conditions; 5. in January 2016, that she would be working between OGAM and Holdsworth House, Sydney where she would be assisting Dr Dick Quan in much the same way as she had been assisting Dr O'Gorman.
2. According to Dr Serafin: 1. under the arrangement with Ms Kazeme, upon receipt of prescriptions issued by Dr O'Gorman and Dr Quan, the Pharmacy compounded and dispensed the substances and sent them by courier to either OGAM or Holdsworth House, addressed to Ms Kazeme; 2. neither he nor any member of staff had any contact with Dr O'Gorman or Dr Quan. All contact was with Ms Kazeme; 3. a couple of days before Patient A1's admission to hospital, he said to a member of his staff that "something did not feel right" and he had decided to "cut off supply" to Ms Kazeme.

Email exchange between Ms Kazeme and Dr Serafin

1. In an email sent to Dr Serafin on 16 December 2015, Ms Kazeme wrote: "I am writing to touch base regarding the products we order from you. In January 2016, we are expanding our business to Sydney, and will thus be ordering more product from you- essentially double what we already doing, if not more. I want to write to make sure that your lab can keep up with the orders? Are you able to offer a further discount to the products as we will only be ordering more as time goes on and our expansion increases. Furthermore, the TOLL service that you use to courier the products to us have failed on the last 4 attempts to deliver in a timely manner. …. Other than this issue, I am happy with the quality of your products and would like to lock in business with you for 2016 and going forward."
2. On 17 December 2015, Dr Serafin replied: "Hi Shadi Thanks for your email and feedback. I do appreciate your business over 2015 and look forward to 2016. Moving forward we both need to clear up a few matters to make sure we are both doing everything correctly, especially if you intend to expand thus bringing yourself further under the investigation spotlight. The bigger you get the more you get noticed and more chance of being investigated so you need to dot your I's and cross your T's. Firstly is there a doctor present at all times in the premises where these injections are being used? No doctor has made contact with me in regards to these injections for your clinic which is unusual as they are ultimately legally responsible for them as they are writing the scripts. There also appears to be an issue/delay getting scripts at times which has led me to think maybe there is no doctor on site? Can you give me a bit of background on the clinic please. Moving forward we can certainly handle double the work load - no problem there. I could also possibly suggest other IV nutrients to expand your practice if your interested. The next issue that needs to be addressed are prescriptions. Dispensing multiple vials to a single patient within a short time frame which would exceed the expected use for that patient is not allowed and not only myself but also the prescribing doctor can get into serious trouble if I am inspected and cannot justify why a patient was prescribed and receives excessive amounts of injections. Realistically a single patient would receive no more than 3 injections per week. At this dose rate that patient cannot order any more than 36 lots of Myers Cocktail (36 x Vial A + 36 x Vial B) within a 3 month period. If you intend to expand then you'll need to make sure you have scripts to cover each order and not exceed this supply per patient. We need to make sure we are both doing everything correctly in case we are inspected. If a patient is having daily injections and thus requires larger quantities please have a doctor indicate on the script the dose is daily to help justify larger supplies. Price wise as the orders increase I can reassess the prices for you - no problem. …" (Emphasis added)
3. On 17 December 2015, Ms Kazeme responded: "I have answered your queries below: 1. Yes, there is a doctor present at all times in the premises. We work out of medical practices. OGAM Medical Clinic is a general practice cosmetic clinic. The same situation is being in Sydney where the clinic is Holdsworth House Medical Practice- and as time goes on the other states will be the same. I am fully aware of the importance of this. 2. With regards to the prescriptions- I am roughly going through 60 vials of Myers Cocktail a fortnight… Can you tell me how many name of scripts you will need per month to arrange this in a way that is expected for your records. I can ask the Doctor to write the script that is no issue. How many names per month do you need of how many quantity of vials for about 120 - 150 vials per clinic per month. 3. Please do reassess the prices, we are spending a lot, also do you guys have accounts? It might be easier to pay our account at the end of each month. … Look forward to expansion and further business together in the new year." (Emphasis added)
4. Later that day, Dr Serafin replied: "Thanks for letting me know the setup. Now I understand the situation which is all good. For 120 vials per month ideally we would require 10 scripts for 10 separate patients for 12 bottles each as it is reasonable that one patient would use 12 vials per month. The script should be written as: Myers Cocktail 10ml x 12, Repeat 6 Dose: 20ml three times a week Therefore we can dispense 12 bottles each month per script. Ideally we also need a few days notice for each order as they take a lot of time to make up and we need to work it in with our other customers and then allowing time to be delivered. We can set up an account - fill in the account application attached and return to us. I will look at the prices. …." (Emphasis added)
5. On 24 December 2015, Ms Kazeme replied to Dr Serafin: "I will let the doc know that scripts are to be written like this now for the Myers. What other nutrients can you offer IV and or IM?" (Emphasis added)
6. In an email to Ms Kazeme sent on 4 January 2016, Dr Serafin responded: "I have attached our price list. They Myers we sell for $55 for the two vials - you have been getting it for $50 on discount already so the lowest I can go is $45 when ordering at a time. See other attachment for a list of other injections available."
7. In these proceedings, Dr Serafin denied that the reason he wrote "dot your Is and cross your Ts" in the email sent to Ms Kazeme on 17 December 2015 was because he was concerned that the clinics were "non-compliant". Rather, he said he wanted to make sure that everything was done correctly: "I understand these treatments are considered unconventional and under the spotlight and knew that there at some stage … would be an investigation. We got organisations like Friends of Health in Medicine - Friends of Science in Medicine, sorry, who constantly put in complaints about anything that's outside of the norm, so I knew that there was a potential for an investigation and I basically wanted Shadi to make sure she was doing everything correctly." (Tcpt, 17 December 2020 p 60 (25-30))

Supply of methyl cobalamin

1. On 18 January 2016, following receipt of a prescription from Ms Kazeme, the Pharmacy compounded and dispensed 90 doses of methyl cobalamin. The prescription named Ms Kazeme as the patient. According to Dr Serafin, at that time he was under a great deal of stress, he was the only pharmacist working at the Pharmacy, mistakes were being made by new members of staff, he had infant children and was sleep deprived. He said when presented with the order for 90 doses of methyl cobalamin, which he agreed was "a little excessive", he was told by a member of staff that Ms Kazeme was yelling down the phone, demanding that the order be filled. He said he made an "instant decision" and "allowed [the order] to go" (Tcpt, 14 December 2020, p 30(44)).
2. In response to questions from the Commission, provided under s 40 of the Health Care Complaints Act 1993 (NSW) (the section 40 response), Dr Serafin said that the prescription dispensed on 18 January 2016 for methyl cobalamin was the only prescription received from Ms Kazeme which caused him concern.
3. In oral evidence, Dr Serafin said that on 8 February 2016, when the Pharmacy received an order from OGAM, he was concerned that there were a few repeat scripts where the repeat intervals "were kind of short" (Tcpt, 14 December 2020, p 31 (18-19)). He claimed that on a previous occasion he had asked to speak to the prescribing doctor, Dr O'Gorman, and was told by Ms Kazeme that he was with a patient and would call Dr Serafin back. When he did not hear from Dr O'Gorman he started to get "a bad feel[ing] basically that something wasn't right". Dr Serafin said at about this time staff reported that Ms Kazeme was being demanding. He said to one of the dispensing technicians, Ms Rebecca Dunsome that the next time Ms Kazeme rings, "I'm going to can it".
4. In an undated statement, Ms Dunsome stated that she recalled a conversation with Dr Serafin in early February 2016 in which he said he was becoming uncomfortable about his dealings with Ms Kazeme, and that the next time she called he intended to tell her that he had decided to cease supply. Ms Dunsome stated that Dr Serafin did not tell Ms Kazeme that he had decided to cease supply because a week or so after that conversation, Dr Serafin was notified by NSW Health about Patient A1's "reaction to the injectables".
5. After dispensing 90 doses of methyl cobalamin on 18 January 2016, the Pharmacy dispensed the following prescriptions received from Ms Kazeme: 1. on 27 January 2016, for a prescription issued to Ms Kazeme for human chorionic gonadotropin (10 ml); 2. on 1 February 2016, for a prescription issued to Patient Q1 for Myer's Cocktail (6 vials); 3. on 8 February 2016, for three prescriptions issued to Patients JI, K1 and M1 respectively for Glutathione (3 vials each); 4. on 8 February 2016, for a prescription issued to Patient K1 for Myer's Cocktail (6 vials); 5. on 10 February 2016, for prescriptions issued to Patients E1, F1, G1, H1 and L1 for Myer's Cocktail (4 x 12 vials; 1 x 6 vials; 1 x 3 vials); 6. on 15 February 2016, for a prescription issued to Ms Kazeme for Glutathione (9 vials); 7. on 18 February 2016, for prescriptions issued to Patients B1, C1 and D1 for Myer's Cocktail; 8. on 18 February 2016, for prescriptions issued to Ms Kazeme for Myer's Cocktail, Glutathione and methyl cobalamin; 9. on 19 May 2016, for a prescription issued to Ms Kazeme for human chorionic gonadotropin (20 ml); 10. on 8 August 2016, for a prescription issued to Ms Kazeme for human chorionic gonadotropin (20 ml).

Submissions

1. Dr Serafin submits that his claim that he was unaware that the substances ordered by Ms Kazeme were being administered to people other than to whom they were prescribed should be accepted, for the following reasons: 1. Ms Kazeme had been convicted of theft and appears to have been a persuasive liar (Health Care Complaints Commission v Kazeme [2020] NSWCATOD 25). Therefore, it is entirely plausible that she was capable of deceiving Dr Serafin. 2. When he was first approached by Ms Kazeme, Dr O'Gorman and Dr Quan were reputable medical practitioners, working in established medical practices. Until becoming involved with Ms Kazeme in January 2016, Dr Quan had enjoyed a 30-year unblemished record as a general practitioner: Health Care Complaints Commission v Quan [2018] NSWCATOD 111 at [1]. 3. Ms Kazeme's claim that Dr O'Gorman and Dr Quan were prescribing Myer's Cocktail for chronic illness, such as chronic fatigue and fibromyalgia, was consistent with his understanding about the type of conditions those products were used to treat. 4. Consistent with the Pharmacy's long-standing practice, all substances supplied to Ms Kazeme were supplied upon receipt of a prescription, including those that could be legally supplied without a prescription. 5. It was unremarkable that he had no direct dealings with Dr O'Gorman and Dr Quan. Dr Serafin claims that it is common for a pharmacist, seeking further information about a prescription, to be unable to speak to the prescribing practitioner and to instead speak with a nurse practitioner or practice manager. 6. Apart from two supplies of methyl cobalamin, the amount and frequency of drugs supplied could not be described as excessive. Dr Serafin asserts that each of the drugs supplied had a low risk profile.
2. The Commission submits that it is implausible that Dr Serafin was unaware that the substances supplied were being administered to persons other than to whom they were prescribed for the following reasons: 1. the volume and frequency of drugs supplied by the Pharmacy to Ms Kazeme; 2. the email exchange between Dr Serafin and Ms Kazeme; 3. the circumstances surrounding the supplies.
3. Dr Serafin disputes the Commission's contention, that his email exchange with Ms Kazeme, set out above, supports the inference being drawn that he was aware that the substances were not being administered to the persons to whom they were administered. He contends that this exchange should be read in context and care taken not to draw inferences from single comments which the Commission seeks to highlight.

Knew or ought to have known: Particular 1

1. To find Particular 1 proven we must be satisfied that Dr Serafin knew or ought to have known, exercising responsible professional judgement, that the substances compounded and dispensed by the Pharmacy listed in Schedule A1 would be administered to persons other than to whom they were prescribed.
2. There is no direct evidence that, before learning of Patient A1's admission to hospital, Dr Serafin was aware that the substances dispensed to Ms Kazeme were administered to patients other than to whom the prescriptions were issued. Nor, in our view, does the evidence support that inference being drawn, at least in relation to the first three months the Pharmacy was supplying substances to Ms Kazeme.
3. However, for the following reasons, we find that from 17 December 2015, exercising responsible professional judgement, Dr Serafin ought to have known that the substances supplied would be administered to persons other than to whom they were prescribed.
4. First, the frequency and quantity of the substances dispensed. By 17 December 2015, on multiple occasions the Pharmacy had dispensed amounts of Myer's Cocktail purportedly to individual patients in amounts considerably in excess of those likely to be administered to an individual patient. For example, the Pharmacy dispensed: 1. on 30 November 2015 and 14 December 2015, 15 vials (10ml each) of Myer's Cocktail, purportedly to Patient 8; 2. on 21 October 2015 and 2 November 2015, 15 vials and on 23 November 2015, 6 vials of Myer's Cocktail, purportedly to Patient 9; 3. on 16 November 2015 and 30 November 2015, 15 vials of Myer's Cocktail, purportedly to Patient 10; 4. on a fortnightly basis between 16 September 2015 and 9 November 2015, 15 vials of Myer's Cocktail purportedly to Patient 11.
5. Had Patients 8, 9, 10 and 11 used the above quantities of Myer's Cocktail, each would have required daily injections. In his initial response to the Council, dated 15 March 2016, Dr Serafin made no mention of "daily dosing" and stated that two to three injections of Myer's Cocktail per week was used to treat chronic medical conditions. He made no mention of daily dosing until his second response to the Council on 31 May 2016. His email to Ms Kazeme, sent on 17 December 2015, reveals that at that time, in Dr Serafin's view, 20ml three times a week was a "reasonable dose". However, each patient was supplied more than 10 times that amount, about 750ml per week. That Myer's Cocktail is a relatively benign substance and poses little risk of over-dosing, is not to the point. Exercising responsible professional judgement, the volume and frequency of Myer's Cocktail supplied to Patients 8, 9, 10 and 11 should have alerted Dr Serafin to the real possibility that, in addition to the patients to whom it was prescribed, it was being used by other people.
6. Second, as the exchange of emails set out above reveals, by 17 December 2015, Dr Serafin was raising concerns with Ms Kazeme about the arrangements surrounding the administration of the injections. For example, he asked whether a doctor was involved, pointing out that he had not been contacted by a doctor, which he described as "unusual as they are ultimately legally responsible for them as they are writing the scripts". In addition, he pointed to the delay in receiving prescriptions after Ms Kazeme had placed orders. Dr Serafin claims that his concerns were addressed by Ms Kazeme's answers to his questions. In our view, had he been exercising responsible professional judgement, his concerns would not have been so readily assuaged, especially given that Ms Kazeme's claims about the way the clinics operated were entirely unsupported.
7. Third, and very tellingly in the email sent at 11:59 am on 17 December 2015, Ms Kazeme squarely asked Dr Serafin for advice about how many prescriptions she would be required to provide to "obtain 120-150 vials per clinic per month". Dr Serafin replied: "Ideally, we would require ten scripts for ten separate patients for 12 bottles each." As Dr Serafin concedes, the more appropriate response would have been that he could not possibly give any advice as to how many patients or how many scripts would be required because it would depend on the number of actual patients there were. (Tcpt, 29 February 2021, p 62 (30-49)). Ms Kazeme's email was highly suspicious because she was reversing the usual order of treating patients with prescribed substances. It is obvious from the email that she wanted a specific quantity of the substances and would supply the appropriate number of scripts to ensure that her records and Dr Serafin's would withstand uncritical investigation. Such an email would, in our view, have raised the suspicions of any moderately intelligent and competent pharmacist. The irresistible inference to be drawn from that email is that the substances supplied were not being used for the exclusive use of the individual patients for whom those substances were supplied. That Dr Serafin did not challenge Ms Kazeme on this point and did not demand further particulars from her, Dr O'Gorman or Dr Quan was not satisfactorily explained by Dr Serafin.
8. Fourth, in an earlier email exchange, Ms Kazeme requested the Pharmacy to post HCG to a patient in Western Australia. When informed by the Pharmacy that a prescription issued in the name of that patient was required before the requested HCG could be sent, Ms Kazeme responded "send it to me". Ms Kazeme was then apparently based in Melbourne. This, in itself, should have raised concerns on Dr Serafin's part about Ms Kazeme's bona fides.
9. Fifth, the circumstances surrounding the supply to the clinics, which included order forms with notes "Always confirm with Shadi on doses", the practice of patient names being crossed off orders forms and replaced with other names and the omission of the name of patients from the labels affixed to the vials of the substances supplied is also very troubling.
10. Sixth, on his account, Dr Serafin had no previous dealings with Ms Kazeme, Dr O'Gorman or Dr Quan. He was entirely reliant on Ms Kazeme for information about how the clinics supplying significant amounts of substances operated. Nonetheless, he failed to make any enquiries. A search of the Australian Health Practitioner Regulation Agency (AHPRA) register would have revealed that, since January 2014, Ms Kazeme's registration was subject to a condition that she could only practise under supervision. Dr Serafin's claim that he attempted to speak to Dr O'Gorman on one occasion only may or may not be true. But, given that he was being requested by Ms Kazeme to supply unusual quantities of substances, and given that he had been quizzed by Ms Kazeme on how many scripts he needed to justify the supply of the quantity she requested, his lack of determination in obtaining confirmation of the scripts from Dr O'Gorman or Dr Quan suggests, at least, wilful blindness on his part. Whether he had actual knowledge, however, we are unable to say.
11. Finally, Dr Serafin claimed in these proceedings that his dealings with Ms Kazeme demonstrated that he was vulnerable and gullible. (Tcpt, 29 February 2021, p 68 (27-29)). Our impression, however, having observed Dr Serafin give evidence is he is highly intelligent and self-confident and unlikely to be fooled for long by a schemer who was prepared to ask him how to carry out her scheme by inquiring how many scripts she needed to produce to him.
12. Had Dr Serafin been exercising responsible professional judgement, the pattern of dispensing after 17 December 2015 ought to have reinforced concerns that the substances dispensed by the Pharmacy listed in Schedule A1 were being administered to persons other than to whom they were prescribed. The dispensing to Ms Kazeme on 18 January 2016 of 90ml of methyl cobalamin (10ml x 9 vials) is of particular significance. In answer to a question from the Tribunal, Dr Serafin agreed that the amount dispensed would have been sufficient for 900 doses or about 900 days of supply. In re-examination Dr Serafin sought to qualify that concession. Nonetheless, as Dr Serafin conceded, the amount dispensed was plainly excessive. Despite his claim that this supply factored large in his decision to cease supplying to Ms Kazeme, the Pharmacy continued to supply Ms Kazeme up until he learned of Patient A1's admission to hospital.
13. We find that, had he been exercising responsible professional judgement, Dr Serafin ought to have known that from 17 December 2015 the substances dispensed by the Pharmacy listed in Schedule A1 would be administered to persons other than to whom they were prescribed. While it is possible, we are not satisfied that Dr Serafin in fact knew that those substances would be administered to persons other than to whom they were prescribed.
14. Particular 1 is proven in part, that is, for the period from 17 December 2015.

Inappropriately continued to compound and dispense: Particular 2

1. Dr Serafin denies Particular 2 which states: "2. From September 2015 to August 2016, the practitioner inappropriately continued to compound and dispense products for the Clinics in accordance with Schedule A1 hereto, despite his concerns that the products he was compounding and dispensing were not being administered to only the patients in whose names the prescriptions were written and without contacting the prescribers to ensure the validity of the prescriptions."
2. Dr Serafin claims that, consistent with his letter to the Council dated 15 March 2016, he only became suspicious that the substances supplied to Ms Kazeme were being administered to people other than to whom they were prescribed, "towards the end of the supply to Holdsworth House" and "a couple of days before" the incident with Patient A1 [13 February 2016]. He argues that this is consistent with his conversation with Ms Dunsome. As noted above, Ms Dunsome recalled that that conversation took place "a week or two" before being notified by NSW Health that "someone had a reaction to an infusion and that he needed to stop supplying these injections".
3. For largely the same reasons given in relation to Particular 1, we find it more likely than not that, by 17 December 2015, Dr Serafin had concerns that the substances being supplied to Ms Kazeme were being administered to people other than to whom they were prescribed. It follows that it was inappropriate for Dr Serafin to compound and dispense those substances.
4. Particular 2 is proven in part.

Unsatisfactory professional conduct

1. In evaluating whether the conduct the subject of Particulars 1 and 2 amounts to unsatisfactory professional conduct within the meaning of s 139B(1)(a) of the National Law, we must: 1. identify the standard "reasonably expected" of a pharmacist of an equivalent level of training or experience to Dr Serafin (the relevant standard), and 2. evaluate whether the admitted or proven conduct demonstrates that the "knowledge, skill or judgment possessed", or "care exercised", by Dr Serafin in the practice of his profession fell "significantly below" the relevant standard.
2. As the Tribunal explained in Health Care Complaints Commission v Amalakumar [2019] NSWCATOD 173 at [25]: "Determining whether the "knowledge, skill or judgment" possessed by a practitioner, or the "care exercised" by a practitioner is significantly below the standard reasonably expected, in order for the elements of s 139B(1)(a) to be established, requires the undertaking of an evaluative process. A benchmark standard which is expected of practitioners in the relevant field must be ascertained, and then the conduct which has been proven against the practitioner the subject of the disciplinary action, must be assessed against that standard. If the conduct is considered to be below the standard arrived at, then a further evaluation must be made as to whether the conduct is significantly below that standard."
3. By 2015, Dr Serafin had been practising as a pharmacist for about 20 years. He was not only very experienced but a highly trained pharmacist holding a Bachelor of Pharmacy (first class honours) from the University of Sydney and a PhD in pharmaceutical chemistry. Therefore, the relevant standard is that reasonably expected of a very experienced and highly qualified pharmacist.
4. In our view, Dr Serafin's actions in continuing to compound and dispense parenteral products after 17 December 2015 in circumstances where he ought to have known exercising responsible professional judgement that they would be administered to persons other than to whom they were prescribed, demonstrates that the judgement he possessed, and care exercised, fell significantly below the relevant standard. For the same reasons, his decision to continue to compound and dispense after 17 December 2015, despite his concerns, demonstrates that the judgement he possessed, and care exercised, fell significantly below the relevant standard.

Particular 3

1. Dr Serafin denies Particular 3 which states: "3. Between September 2015 and August 2016, the practitioner inappropriately compounded and dispensed products for the Clinics in accordance with Schedule A1 hereto as follows: i. based on orders and prescriptions from Ms Kazeme in circumstances where the practitioner had no contact with either the prescribers or the patients; ii. the volumes of compounded products were inappropriate; iii. repeats were compounded in inappropriate timeframes; iv. the supply of Glutathione, a Schedule 4 prescribed medication, by the practitioner 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 Clause 54 of the Poisons and Therapeutic Goods Regulation 2008 ("the PTGR"); and v. the practitioner dispensed products for the Clinics in Ms Kazeme's name as a means for her to provide medication to other patients."
2. Having regard to the text and context, sub-particular (v) requires a finding that Dr Serafin knew that the products dispensed in Ms Kazeme's name were dispensed as "a means for her to provide medication to other patients". While it is possible, especially following the supply of methyl cobalamin on 18 January 2016, we are not persuaded on the balance of probabilities that Dr Serafin knew that on each occasion he supplied substances to Ms Kazeme dispensed in her name, this was a means for her to provide medication to other patients.
3. Particular 3 is not established.

Particular 4

1. Particular 4 is denied by Dr Serafin and states: "4. The practitioner inappropriately compounded and dispensed a prescription dated 14 January 2016 in Ms Kazeme's name, where the typed patient's name "Patient Test" had been crossed out and replaced with Ms Kazeme's name in handwriting on the prescription, in breach of Clause 40(1)(d) of the PTGR."
2. A pharmacist must not supply a restricted substance on prescription if the prescription is illegible or defaced: cl 40(1)(d) of the PTGR.
3. Dated 14 January 2016, the prescription the subject of Particular 4 was issued by Dr Quan for Myer's Cocktail 20ml x 12 (6 repeats), glutathione 200mg/ml x 9 (6 repeats) and methyl cobalamin B-12 10mg/ml 10ml x 9 (6 repeats).
4. The prescription was computer-generated. The patient's name and address had been crossed out by hand and replaced with the name "Shadi Kazeme" written by hand. The words "Patient Test" can be seen under "Shadi Kazeme". The prescription did not contain the address of the patient, as required by cl 35(1)(b) of the PTGR.
5. Dr Serafin contends that the prescription was not rendered "illegible" or "defaced" because of the patient's name and address being crossed out.
6. The words "illegible" and "defaced" are not defined by the PTGR. They are ordinary English words and should be given their ordinary meanings.
7. The online versions of the Macquarie Dictionary and the Oxford Dictionary give similar definitions of each word: "Macquarie Dictionary illegible: not legible; impossible or hard to read or decipher: this letter is completely illegible. deface: 1. to mar the face or appearance of; disfigure. 2. to blot out; obliterate; efface." "Oxford Dictionary illegible: Not legible, that cannot be read; esp. of written characters; Undecipherable. unreadable, because of language or matter. deface: To mar the face, features, or appearance of; to spoil or ruin the figure, form, or beauty of; to disfigure; To blot out, obliterate, efface (writing, marks)."
8. While it is permissible to consult dictionaries to determine the ordinary meaning of a word, ultimately it is a matter for the Tribunal to determine the meaning having regard to the context in which it is appears. In TAL Life Ltd v Shuetrim; MetLife Insurance Ltd v Shuetrim (2016) 91 NSWLR 439; [2016] NSWCA 68, Leeming JA at [80] stated: "Dictionary definitions may assist in identifying the range of possible meanings a word may bear in various contexts, but will not assist in ascertaining the precise meaning the word bears in a particular context."
9. Because it is possible to read the patient name "Shadi Kazeme", the crossing out of the words "Patient Test" did not render the prescription illegible. However, did it render the prescription "defaced"?
10. The use of the word "or" indicates that the words "deface" and "illegible" as used in cl 40(1)(d) of the PTGR carry different meanings. For that reason, we have taken the word deface, to mean "to mar the face or appearance of; disfigure" (Macquarie); "to mar the ... appearance of; to disfigure" (Oxford Dictionary).
11. We find the crossing out of the words "patient test" and the insertion of, the words "Shami Kazeme" marred the appearance of or disfigured the prescription. It follows that by supplying glutathione, Dr Serafin contravened cl 40(1)(d) of the PTGR.

Unsatisfactory professional conduct

1. In support of the contention that Dr Serafin's actions in supplying glutathione on a defaced prescription demonstrated that the judgement he possessed, and care exercised, fell significantly below the relevant standard, the Commission relied on the opinion of pharmacist, Mr Mark Feldschuh, who prepared reports for these proceedings and gave oral evidence. Mr Feldschuh considered it significant that Dr Serafin had supplied glutathione, a prescribed restricted substance, on a defaced prescription in circumstances where he had not contacted the prescribing doctor.
2. Dr Serafin disagreed and points to the opinion provided by pharmacist, Mr Bruce Chilton, who prepared a report for these proceedings and gave oral evidence. Mr Chilton was of the view that the subject prescription could not be described as either defaced or illegible. Mr Chilton was not critical of Dr Serafin's conduct, stating that "prescriptions are changed by hand by the prescriber every day of the week and pharmacists familiar with the prescribers' handwriting dispense these prescriptions".
3. We prefer Mr Feldschuh's opinion that, in circumstances where he did not contact the prescriber, Dr Serafin's action in supplying a prescribed restricted substance on production of a defaced prescription demonstrates that the judgement he possessed, and care exercised, fell significantly below the relevant standard. Even if Mr Chilton's view were accepted (and it is not), it would, in our view, nevertheless be a troubling lapse of judgement for a prescription of this kind to be dispensed without direct, recorded confirmation by the prescribing medical practitioner and a replacement script being forwarded.
4. Particular 4 is established.

Particular 6

1. Dr Serafin denies Particular 6, which states: "6. Between September 2015 and August 2016, the practitioner inappropriately compounded and dispensed Glutathione, a Schedule 4 prescribed medication, as follows: i. for Patients N1, O1 and P1 in volumes (10ml vials x 3, 6, 9 and 12) that differed to the amounts that were prescribed (60ml vials x 6 with 6 repeats); and ii. for Patient M1, the prescriber stipulated an order for 250mls and contrary to that order, on 3 occasions the practitioner dispensed 10ml vials - 6, 12 and 3 vials respectively."

Patients N1, O1 and P1

1. Dr Serafin agrees that he dispensed glutathione to Patients N1, O1 and P1 in amounts different to that prescribed but claims he supplied "well below the quantity prescribed". He explained that the reason he dispensed amounts of glutathione different to those prescribed was "to supply the clinic what was required, based on what I would have assumed was the patient's up and coming appointment schedule with the respective clinics". Dr Serafin agrees that he did not contact the prescribing doctor before dispensing and that the order was "placed on verbal by Shadi".
2. The prescription issued for each patient was for glutathione 200mg/ml with 5 repeats. The Pharmacy dispensed to: 1. Patient N1: on 10 February 2016, 3 vials of glutathione 200mg/ml; 2. Patient O1: on 14 December 2015, 6 vials; on 5 January 2016, 12 vials; on 20 January 2016, 12 vials; and on 8 February 2016, 3 vials of glutathione 200mg/ml; 3. Patient P1: on 7 December 2015, 9 vials; on 20 January 2016, 6 vials; and on 8 February 2016, 3 vials of glutathione 200mg/ml injections 10ml.
3. Mr Feldschuh considered that Dr Serafin's actions in dispensing amounts of glutathione different to that prescribed fell significantly below the relevant standard. Mr Chilton disagreed. He stated that, given Dr Serafin's explanation, together "with the mathematics", he was not critical of Dr Serafin's actions.
4. While the total amount of glutathione dispensed to each patient was significantly less than the total amount prescribed, on two occasions the amounts dispensed to Patient O1 exceeded the amount prescribed. On one occasion the amount dispensed to Patient P1 exceeded the amount prescribed.
5. Arguably, Dr Serafin's actions in dispensing to Patient N1, on a single occasion, an amount less than that prescribed fell below, but not significantly below, the relevant standard. However, in our view, dispensing to Patients O1 and P1 amounts which exceeded the single or per dispense amount, in circumstances where the subject drug was a prescribed restricted substance and Dr Serafin had failed to contact the prescribing doctor, evidences that the judgement he possessed, and care exercised, fell significantly below the relevant standard.

Patient M1

1. Dr Serafin disputes the factual premise on which sub-particular (ii) is based: that he dispensed glutathione for Patient M1 on three occasions. He claimed that he dispensed glutathione on two occasions.
2. The Commission contends that the Pharmacy's dispensing records reveal that glutathione was dispensed to Patient M1: 1. on 21 September 2015: Glutathione 200mg/ml 60ml; 2. on 21 January 2016: Glutathione 200mg/ml 120ml; 3. on 8 February 2016: Glutathione 200mg/ml 30ml.
3. Dr Serafin claims that, while he received a prescription for glutathione dated 8 February 2016, he did not dispense that prescription. In support, he points to the order form received from OGAM in which Patient M1's name is deleted.
4. There are conflicting records in relation to the claimed dispensing of glutathione on 8 February 2016. Dr Serafin has given a plausible explanation for his claim that the prescription dated 8 February 2016 was not dispensed. The Commission has failed to establish that Dr Serafin dispensed glutathione to Patient M1 on 8 February 2016.
5. Sub-particular 6(ii) is not proven. Particular 6(i) is established.

Particular 7

1. Particular 7 states: "7: Between January 2016 and February 2016, the practitioner inappropriately compounded and dispensed Myer's Cocktail Part A for the Clinics in accordance with Schedule A1 hereto as follows: i. labelling the medication with a shelf life of 6 months, when the practitioner had already determined that the appropriate shelf life was 3 months; and ii. using one of the raw ingredients, robiflavin-5-phosphate, which had an expiry date of February 2016."
2. Dr Serafin admits the facts of Particular 7. However, he submits that that conduct does not amount to unsatisfactory professional conduct. According to Dr Serafin: 1. for several years before supplying Ms Kazeme, he assigned Myer's Cocktail a six-month expiry (use by) date; 2. when he commenced supplying Myer's Cocktail to Ms Kazeme, he reviewed the literature which revealed that Vitamin B12 can deteriorate in the presence of Vitamin C. Both are ingredients of Myer's Cocktail; 3. after reviewing that literature he decided a three-month expiry date was more appropriate; 4. of the other ingredients in Part A [1] of Myer's Cocktail, each is chemically stable in solution at room temperature. The least stable ingredient is thiamine which, in the presence of niacinamide (an ingredient in Myer's Cocktail), has a shelf life of 12 months at room temperature; 5. in addition to assigning a three-month expiry date, Dr Serafin stipulated that all orders of Myer's Cocktail be stored in a refrigerator for "extra precaution", reasoning that the lower temperature would slow down reaction rates and further increase its stability.
3. According to Dr Serafin, the decision to reduce the expiry date from six to three months was implemented by changing the "master formula" (the recipe) of Myer's Cocktail used by the dispensing technicians and by amending the label required to be affixed to the vials containing Myer's Cocktail. However, without informing him, thinking that the three-month expiry date was a mistake, a staff member reinstated the original six-month expiry date on both the master formula and the labels.
4. Dr Serafin admits that one of the ingredients, robiflavin-5-phosphate, contained in the Myer's Cocktail dispensed in January 2016 and February 2016, had an expiry date of February 2016. He said the error occurred because of an oversight by the dispensing technicians and himself.

Unsatisfactory professional conduct

1. Dr Serafin contends that, taken together, the following factors support a conclusion that the conduct the subject of Particular 7 does not amount to unsatisfactory professional conduct: 1. the dispensing errors occurred during a period where he was stressed and overworked, he had difficulty finding and retaining suitably qualified staff, he was working long hours, he had a young family and was sleep deprived, and he was constantly being interrupted in his work by enquiries from patients and doctors; 2. there is no suggestion those errors resulted in patient harm; 3. new procedures have been implemented to avoid those errors being repeated; 4. the errors occurred in what was otherwise a well-run pharmacy.
2. The dispute between the experts surrounding the appropriateness of assigning a three-month expiry date, which we address below, is irrelevant to the question of whether dispensing vials of Myer's Cocktail carrying labels with a six-month expiry date demonstrated that the care exercised by Dr Serafin fell significantly below the relevant standard. The issue raised is whether, having made the decision to change the expiry date from six to three months, continuing to dispense Myer's Cocktail carrying labels with a six-month expiry date demonstrated that the care exercised by Dr Serafin fell significantly below the relevant standard. Had there been one or two instances where Myer's Cocktail was dispensed with the incorrect label, arguably the conduct might be described as falling below but not significantly below the relevant standard. However, the error went undetected for a significant period. Throughout that period, Dr Serafin failed to detect that the master formula had been altered or that the labels carried an expiry date different to that he had assigned.
3. That conduct demonstrated that the care he exercised fell significantly below the relevant standard.

Using robiflavin-5-phosphate, which had expired, or was about to expire

1. Mr Chilton stated that in compounding Myer's Cocktail it would have been "prudent" not to have used an ingredient, robiflavin-5-phosphate, which had expired or was about to expire. However, in Mr Chilton's view, that error was of no great significance: "[G]iven that this is a, is a vitamin or a vitamin type preparation, as I said, expiry dates to my way of thinking do not expire - it's not like a light being switched on or off. On that particular date that has been assigned that has been given around about two years of, of, of life. That two years of life means that it's come from X per cent down to X minus something per cent. Now, it might be a hundred, it might be 95, it depends on what the - what is the specification for assay, 73 to 79, and it came - the result was 74. So my way of thinking is yes it is past the expiry date but to me that will not constitute any danger to the patient. It would not put the patient's health at risk." (Tcpt, 16 December 2021,p 56 (2-10))
2. We do not share Mr Chilton's relaxed attitude about the use of ingredients that have expired, or are about to expire, in compounded products for parenteral use. Dr Serafin's conduct in dispensing Myer's Cocktail containing an ingredient, which had or was about to expire, demonstrates that the care exercised by Dr Serafin fell significantly below the relevant standard.
3. That Dr Serafin subsequently put in place measures designed to prevent the errors the subject of Particular 7 being repeated, while relevant to the form of disciplinary orders, is irrelevant to the question posed by s 139B(1)(a) of the National Law: whether the proven or admitted conduct demonstrates that the knowledge, skill or judgement possessed, or care exercised, by Dr Serafin in the practice of his profession, fell "significantly below" the relevant standard.
4. Particular 7 is established.

Particular 10

1. Dr Serafin denies Particular 10 which states: "10. Between September 2015 and August 2016, the practitioner assigned inappropriate expiration dates for Myer's Cocktail and Glutathione, a Schedule 4 prescribed medication, for parental use, for the Clinics in accordance with Schedule A1 hereto."
2. As discussed above, Dr Serafin decided to assign a three-month expiry date to the Myer's Cocktail and glutathione supplied to Ms Kazeme but, because of a series of dispensing errors, a six-month expiry date was assigned. We proceed on the basis that three months is the "inappropriate expiration dates" referred to in Particular 10.
3. Each expert gave an opinion about whether assigning a three-month expiry date to Myer's Cocktail was appropriate. Mr Feldschuh considered a one-month expiry date to be appropriate. Mr Chilton considered a six-month expiry date to be appropriate.
4. In his report dated 11 February 2017, Mr Feldschuh stated: "[T]he APF 23 [the Pharmaceutical Society of Australia, Australian Pharmaceutical Formulary Handbook 23] states that any compounded product must be assigned and labelled with an expiry date. This should be 28 days or less, unless otherwise specified. Assigning an expiry date longer than 28 days should be based on reliable literature. The SHPA Guidelines 2010 state "due to the risk of microbial contamination, the default expiry date for aseptic products without sterility tests should be 24 hours, which may be extended to 7 days provided" certain processes are undertaken (my words). To re-inforce this the PBA has issued Compounding Guidelines in 2016. The expiry dates for these sorts of medicines was to be 1 day. These expiry dates have not been implemented because of on-going consultation. However, it would be hard to claim or justify that any shelf-life (expiry dates) determined for compounding of a sterile product in a pharmacy should be more than 28 days." (Emphasis added)
5. At p 28, the Pharmaceutical Society of Australia, Australian Pharmaceutical Formulary Handbook (23rd ed, 2015) (APF 23) states: "All compounded products must be assigned and labelled with an expiry date. This should be 28 days or less unless otherwise specified. Assigning an expiry date longer than 28 days should be based on reliable literature but under no circumstances should an expiry date of longer than 6 months be assigned for compounded products."
6. In cross-examination, Mr Feldschuh did not agree with the proposition that APF 23 permits an expiry date of up to six months: "A. Thank you, I'm glad you asked me that question. The - after - we found that there was problems with interpretation of that in the APF23 and there was a committee set up for practice standards for compounding in 2017 which I chaired and this was the particular item that really worried us, and in fact at that committee hospital pharmacists wanted an expiry date of one day and subsequently it was improved. There was never any understanding that a sterile product would go to six months. It was just at that stage it was very unexpected that anyone would try - would put an expiry date of up to six months for sterile prescriptions. Q. I take it that the whole reason for convening the committee in 2017 was to clarify that for pharmacists who might've been confused about the issue? A. No I wouldn't go that far, it was to make sure that no-one could come up with any other explanation than what's written in the new standards. Q. Because you had information that people might think that where it says not to - I'll read you it directly, where it says an expiry date of longer than six months can't be assigned people would reasonably assume that six months could be assigned? A. No, no, no way. That's, that's incorrect too. It's just - it might be pushed to as much as six months. Q. I suggest to you that it's an entirely reasonable reading of the English language in that APF23 that where it says assigning an expiry date of longer than six months is not allowed, it's entirely reasonable that you would assume that an expiry date of six months may be allowed, or it was allowed? A. No because there's a risk assessment one has to undertake at the same time. It's part of a whole process. Q. Did the language get clarified after 2017? A. I don't know the language but probably but it, it certainly - this particular - it was maybe clarified is the right word but I, I can't - I certainly was - the committee was aware that we had to have boundaries on that, on that expiry type of issue. Q. Did the committee clarify the boundaries after that meeting in 2017? A. It wasn't - no it, not it didn't clarify but there was a lot of discussion on it. Six months - a six months expiry on a sterile now would be seen as totally inappropriate but at the time as it - as happens here maybe was pushed, but six months is just - for this product this is still too long, in my opinion." (Tcpt 16 December 2020, p 28(36) - p 29(25))
7. Mr Feldschuh's view that APF 23 prohibits pharmacists from assigning an expiry date of more than 28 days for compounded products is inconsistent with the plain language of that document. APF 23 permits a pharmacist to assign an expiry date of more than 28 days (but less than six months) for compounded products, provided that decision is "based on reliable literature". Dr Serafin has given an apparently cogent explanation for his decision to assign a three-month expiry date to Myer's Cocktail and glutathione. Mr Feldschuh did not address the explanation given by Dr Serafin for assigning a three-month expiry date to Myer's Cocktail and glutathione. On the other hand, Mr Chilton stated that in his opinion, the explanation given by Dr Serafin justified assigning a three-month expiry date.
8. The Commission has failed to adduce evidence to support the proposition that Dr Serafin's analysis was not based on reliable literature as required by APF 23.
9. Particular 10 is not proven.

Particular 8

1. Particular 8 states: "8. Between September 2015 and August 2016, the practitioner failed to print storage information on the labels of Glutathione, a Schedule 4 prescribed medication and Myer's Cocktail Part A, which both required refrigeration, for the Clinics in accordance with Schedule A1 hereto."
2. In final submissions, Dr Serafin denied this particular. In contrast, in his statement dated 29 June 2020, Dr Serafin admitted the facts but did not concede that this amounted to unsatisfactory professional conduct.
3. While it is unclear, we proceed on the basis that Dr Serafin now disputes the factual premise on which Particular 8 is based, that is, that the labels of glutathione and Myer's Cocktail Part A did not carry storage instructions, specifically that the substances must be refrigerated.
4. In his statement dated 29 June 2020, Dr Serafin stated: "I accept that no storage instructions were on the label and ideally should be. As we had only ever supplied these injections to medical centres who are well-informed of the storage conditions, it had never been an issue. In addition, we send the vials via courier in an esky packed with ice so it is obvious how they should be stored. All products we supply to patients directly have storage instructions. "
5. In his letter to the Council, 30 May 2016, Dr Serafin stated: "Often multiple vials of a particular product were ordered for an individual patient. Each vial was individually labelled with a general label with the name, strength and dose instructions for the contents of the vials. The label also contained use by date, special storage instruction (if appropriate) and our pharmacy name. The appropriate amount of these labelled vials were then packed into a zip locked bag which was then labelled with the official pharmacy dispensing label. This label contains all the appropriate information in regards to the patient's name., prescribing doctor's name, the name, strength and dose of the medication, expiry date etc all in accordance with the regulations."
6. In evidence in these proceedings, Dr Serafin said that the Pharmacy's practice was to "label individual vials according to the regulations … there were storage instructions". In support, he pointed to photographs taken by PRU investigators of vials apparently seized during their investigation of Holdsworth House on 17 February 2016, which included photographs of: 1. multiple labelled vials, contained in zip lock plastic bags. Because of the size of the photograph, it is not possible to read what is contained on the label; 2. labelled vials of carnitine (a substance purportedly used for weight loss). The labels on those vials contain instructions to store in the refrigerator; 3. labelled vials of methyl cobalamin. While difficult to read, those labels appear to contain instructions to discard after being exposed to light.
7. In support of this Particular, the Commission relied on a statement prepared by Ms Kim Dolan, Principal Pharmaceutical Officer, PRU, dated 17 February 2016. Ms Dolan stated that during the PRU's inspection of Holdsworth House on 17 February 2016 she discovered unlabelled ampoules in a small refrigerator. Ms Dolan noted that some of the zip lock bags (apparently a reference to the photograph at annexure F to her statement) were labelled with patient names.

Consideration

1. It falls to the Commission to establish that Dr Serafin failed to print storage information on the labels of the glutathione and Myer's Cocktail Part A supplied to the Clinics between September 2015 and August 2016. It is agreed that Dr Serafin was required to affix, to each vial, labels stating that the substances must be refrigerated.
2. In the statement dated 29 June 2020, Dr Serafin conceded that there were "no storage instructions on the label and ideally should be" on the glutathione and Myer's Cocktail Part A that was supplied to the OGAM and Holdsworth House between September 2015 and August 2016. Dr Serafin repeated that concession in his letter to the Commission dated 7 April 2017. He explained that those injectables were supplied to medical clinics who "are well-informed of the storage conditions". In addition, he pointed out that the practice of the Pharmacy was to send the vials in an esky packed with ice and reasoned "it is obvious how they should be stored".
3. There is no photographic evidence to support the factual premise on which Particular 8 is based, and Ms Dolan did not expressly refer to the absence of storage instructions. However, together with Dr Serafin's failure to explain why those admissions were abandoned in final submissions, we find it more probable than not that the Pharmacy dispensed glutathione and Myer's Cocktail Part A to the clinics without labels containing storage information.

Unsatisfactory professional conduct

1. Mr Chilton apparently accepts that glutathione and Myer's Cocktail Part A required refrigeration. However, in his opinion, the failure to include storage information on the labels was regrettable but did not fall significantly below the standard reasonably expected of a practitioner of Dr Serafin's level of training and experience. He considered it was relevant that there had been no report of a person having suffered harm.
2. Mr Feldschuh disagrees and considered Dr Serafin's failure to print storage information to be "significantly below the standard reasonably expected".
3. That there was no report of anyone being harmed as a result of the failure to include storage information on the labels of the subject substances is not to the point. If Mr Chilton is suggesting that the standard reasonably expected of a practitioner is measured by reference to whether a person did or did not suffer harm as a result of the pharmacist's act or omission, we cannot agree. In our view, the standard reasonably expected of a pharmacist of Dr Serafin's level of training and experience, in supplying substances requiring refrigeration, is to ensure that that requirement was stated on the labels affixed to those substances. This was not an occasional failure to properly label substances requiring refrigeration, but one repeated on multiple occasions over a period of 12 months. Dr Serafin had no way of knowing whether the clinics' employees assumed, from the fact that the substances were packed in ice when delivered, that those substances must be refrigerated until administered.
4. Dr Serafin's failure to include storage information on the labels of the subject substances demonstrated that the care he exercised fell significantly below the relevant standard.
5. Particular 8 is established.

Particular 9

1. Dr Serafin denies Particular 9 which states: "9. Between September 2015 and August 2016, the practitioner inappropriately labelled the vials and bags containing the vials of the compounded and dispensed medications for the Clinics in accordance with Schedule A1 hereto."
2. The parties agree that: 1. the substances listed in Schedule A1 were sent to the clinics in vials contained in plastic zip lock bags; 2. each bag contained multiple vials; 3. the vials and the bags in which they were contained were labelled; 4. the labels on the vials included the drug name, strength, quantity, and name of the manufacturer but not the name of the patient or the prescribing practitioner; 5. the labels affixed to each bag was a "Pharmacy Dispense label", and contained the drug name, strength, quantity and the name of the patient.
3. The basis for the Commission's contention that Dr Serafin inappropriately labelled the vials, is that the labels affixed to the vials did not contain the names of the patient, or the prescribing doctor, and that information was required to be included, notwithstanding that it was contained in the labels affixed to the bags.
4. Dr Serafin rejects that contention. He contends that the practice of not including the name of the patient and the prescriber on the labels of the vials complied with the requirements of the Poisons Standard 2016. [2] Dr Serafin points out that by the operation of s 1.5.2 of that standard, injection vials were exempt from the labelling requirements contained in s 1.3.
5. In his report dated 30 July 2020, Mr Chilton stated that providing the individual vials were contained in a zip lock bag which carried a Pharmacy Dispense label containing all the information required to be included by s 1.3 of the Poisons Standard, it could not be said that either the bags or vials were inappropriately labelled.
6. In contrast, Mr Feldschuh stated in his report dated 11 January 2017: "Dr Serafin should have labelled and packed all the items for each patient in their individual bags. This would have reduced the chances of any mistakes both at the pharmacy level and at the clinic level. It makes no sense to me why, if each patient has products individually prescribed and dispensed for them that any other system is contemplated."

Consideration

1. A pharmacist who supplies a poison [3] must ensure that the poison is packaged and labelled in accordance with the relevant provisions of the current Poisons Standard: cl 7(1) of the PTGR. Clause 7 does not apply to the labelling of a substance that is supplied by a pharmacist providing that the substance is supplied in a package that is labelled in accordance with the requirements of Appendix A to the PTGR. Appendix A requires that the label on a container of a therapeutic substance must contain, among other things, the name of the person, if the substance is intended for the treatment of a person: cl 1(g) of Appendix A to the PTGR.
2. As Dr Serafin correctly points out the requirements contained in s 1.3 of the Poison Standard do not to apply to a "selected container", which is defined to include an injection vial having a nominal capacity of ten millilitres or less: ss 1.5.2(1), 1.5.1(1) of the Standard.
3. However, s 1.3 of the Poison Standard largely deals with cautionary warnings, such as "keep out of reach of children", which must be included on the labels of poisons. It does not state that the name of the patient must be included on the label. That requirement is found in Appendix A to the PTGR. Section 1.5.2 does not operate to permit the name of the patient to be omitted from the label of an injection vial.
4. While not raised by either party we note that the Pharmacy Board of Australia, "Guidelines for dispensing of medicines" (August 2010) (the 2010 Dispensing Guidelines) at par 7.2 states that a dispensing label must contain among other things, the name of the patient. At par 7.1, those guidelines state: "The dispensing label is to be firmly attached to the immediate container (including each component of multiple-therapy packs) unless the immediate container is so small or is so constructed that the label would compromise the patient's ability to use the medicine (e.g. metered aerosols and some eye drops). In such instances, the label should be attached to the primary pack or alternatively, purpose-designed labelling tags or 'winged' labels may be used."
5. The Pharmacy Board of Australia, "Guidelines for dispensing of medicines" (December 2015) (the 2015 Dispensing Guidelines) are to similar effect.
6. In our view it could not be said that the subject vials were "so small or so constructed" that attaching a dispensing label would "compromise the patient's ability to use the medicine".
7. The Commission has failed to identify the basis for its contention that Dr Serafin was required to include the name of the prescriber on the labels affixed to the vials.
8. We find that by failing to include the name of the patient on the labels affixed to the vials Dr Serafin inappropriately labelled the vials of the substances listed in Schedule A1 to the Complaint.
9. In addition, we find Dr Serafin's failure to include storage information on the labels of the subject substances demonstrated that the care he exercised fell significantly below the relevant standard.
10. Particular 9 is established.

Particular 11

1. Dr Serafin denies Particular 11 which states: "11. Between September 2015 and August 2016, the practitioner maintained inadequate records at the Pharmacy for the compounded and dispensed medications for the Clinics in accordance with Schedule A1 hereto."
2. In support of the contention that Dr Serafin maintained inadequate records at the Pharmacy for the substances listed in Schedule A1, the Commission points to, among other things: 1. the subject compounding worksheets (the worksheets) did not contained a pharmacist's signature; 2. the worksheets for Myer's Cocktail and glutathione do not refer to the subject prescriptions; 3. the numerous discrepancies between the worksheets and the order forms for Myer's Cocktail and glutathione, as detailed in par 319 of the Commission's submissions dated 1 April 2021; 4. the fact that where there was a discrepancy between the amount compounded and dispensed and the amount prescribed, that discrepancy was not recorded; 5. the fact that the dispensing histories for the patients the subject of Complaint 1 did not contain the prescriber's details, dosage directions, the number of individual doses compounded on each occasion, the actual quantities, the date of the prescriptions or the repeats issued; 6. the fact that the dispensing histories for the patients the subject of Complaint 1 contain only the total quantity of substances compounded and dispensed at any one time, not the volume of the amount dispensed.
3. Mr Feldschuh considered it significant that the worksheets were not signed by a pharmacist and did not record that the ingredients used in the compounding by the dispensing technician had been checked by a pharmacist.
4. Dr Serafin claims that at all relevant times he was aware of, and the Pharmacy's dispensing records met, the requirements of cl 55 of the PTGR: 55 Supply on prescription to be recorded (1) A pharmacist who supplies a restricted substance on prescription must record the following details in a manner approved by the Secretary-- (a) the details required by clause 35(1) to be included in the prescription, (b) a unique reference number for the prescription, (c) the date on which the substance was supplied, (d) the name of the person by whom the substance was supplied.
5. The basis for Dr Serafin's denial of this particular appears to be the contention that cl 55 of the PTGR was the only relevant record-keeping requirement and he met that requirement. We disagree.
6. In addition to those contained in cl 55 of the PTGR, there are several requirements relating to dispensing and compounding records. For example, APF 23 requires that detailed information be contained in "extemporaneous dispensing forms", including the batch number, expiry dates of ingredients. In addition, APF 23 requires that the dispensing form records the name of any supervised staff and be signed by the supervising pharmacist. The examples listed above provided by the Commission demonstrate that Dr Serafin failed to meet the requirements for record keeping.
7. We find that Dr Serafin failed to maintain adequate records at the Pharmacy for the compounded and dispensed medications for the Clinics. That conduct demonstrated that the care exercised by Dr Serafin fell significantly below the relevant standard.
8. Particular 11 is established.

Particular 13 and 14

1. Particulars 13 and 14 state: "13. Between September 2015 and August 2016, the practitioner inappropriately compounded and dispensed Myer's Cocktail for the Clinics in accordance with Schedule A1 hereto as follows: i. For Patients I1, K1 and Q1 where the prescriber had ordered 5 repeats, the prescriptions recorded did not contain a strength and did not list how many millilitres were to be dispensed other than "Quantity: 15x55", the practitioner dispensed the prescriptions in two parts - 10mls of Part A and 10mls of Part B as follows: a. For Patient I1, the practitioner compounded and dispensed 30 x vials each of Part A and Part B on three occasions; b. For Patient K1, the practitioner compounded and dispensed 15 x vials each of Part A and Part B on two occasions and 6 x vials each of Part A and Part B on one occasion; c. For Patient Q1, the practitioner compounded and dispensed 15 x vials each of Part A and Part B on two occasions, 30 x vials each of Part A and Part B on one occasion and 6 x vials each of Part A and Part B on one occasion; ii. The practitioner failed to contact the prescriber and confirm the validity of the prescriptions for Myer's Cocktail for Patients I1, K1 and Q1; iii. The practitioner failed to contact the prescriber and seek further details for the prescriptions for Myer's Cocktail for Patients I1, K1 and Q1; and iv. The practitioner failed to contact the prescriber and request that the prescriptions for Myer's Cocktail for Patients I1, K1 and Q1 be rewritten. 14. Between September 2015 and August 2016, the practitioner inappropriately compounded and dispensed Myer's Cocktail to Patient L1 in accordance with Schedule A1 hereto in a volume that differed to the amount prescribed as follows: i. the prescription was for 12 x 20mls of Myer's Cocktail (presumably 10mls of each part) with 6 repeats; ii. the prescription gave dosage instructions of "20mls three times per week"; and iii. the practitioner compounded and dispensed the prescription for Patient L1 on one occasion and for six vials of each."
2. The central allegation underlying each particular is that Dr Serafin dispensed, to each patient, quantities of Myer's Cocktail different to the quantities prescribed and that was inappropriate in circumstances where he had not discussed this change with Dr O'Gorman.

Patients I1, K1 and Q1

1. On the prescriptions issued for Patients I1, K1 and Q1, Dr O'Gorman wrote: "Myer's Cocktail Vial Myer's cocktail For doctor's use Quantity 15* 55 with 5 repeats"
2. The Commission alleges that Dr Serafin dispensed to: 1. Patient I1: 30 vials on 3 occasions; 2. Patient K1: 15 x 10ml vials on 16 November 2015 and 30 November 2015 and 6 x 10ml on 8 February 2016; 3. Patient Q1: 15 x 10ml vials on 16 September 2015, 30 September 2015, 13 October 2015, 27 October 2015, 9 November 2015, 5 January 2016, 1 February 2016.
3. According to Dr Serafin: 1. it was not necessary that the prescription for Myer's Cocktail stipulate the strength of that substance because "it is a standard strength mixture in the same way as many standardised products"; 2. he was taught and always understood "15*55" to mean "15 x 55ml"; 3. on each occasion the amount dispensed was less than the total amount prescribed, that is 825ml (15 x 55ml = 825 ml); 4. when she placed these orders, Ms Kazeme confirmed the quantity required; 5. being a "non-prescription vitamin supplement", he did not consider it necessary to contact the doctor before dispensing Myer's Cocktail in a volume different from that prescribed.
4. In cross-examination, Dr Serafin agreed that on each occasion he compounded and dispensed Myer's Cocktail to Patients I1, K1, it was dispensed in 10ml vials and that the amount dispensed differed from the amount prescribed. He explained that the reason for the difference between the volume prescribed and the volume dispensed was because of the size of the available vials: "Yes. The 15 or the 55 ml, the problem with 55 mls is that you either have to use 100 ml vial to put 55 mls - there's no - basically the vial size goes from 2, 5, 10, 50 and 100, and also, I believe that if you're adding two vials, so if you got part A and part B is 55 mls each, you're going to be adding 110 mls into an infusion bag. An infusion bag normally only holds a litre so you're adding an extra 10% of fluid into that. I think best practice is to try to have the medication in as small a volume as possible, hence why we made them in 10 ml vials, and Shadi was instructed from that. Again, I agree the doctor should've been informed, but Shadi was well aware that they came in 10 ml vials, and therefore in the case of Myers' cocktail she would withdraw the full 10 mls out of vial A and the full 10 mls out of vial B and would've injected those into the infusion bag." (Tcpt 17 December 2020, p 80(18-31)))
5. Messrs Chilton and Feldschuh disagree about whether: 1. in the context of a prescription, the use of an asterisk should be taken to mean "multiplied by", and 2. in circumstances where the volume dispensed was less than the amount prescribed, the dispense should not occur without contacting the prescribing doctor.
6. Mr Feldschuh does not agree with the proposition that it was "convention" that "15 x 55" meant "15 x 55 ml". Mr Chilton disagreed asserting that "any competent practising pharmacist" would understand that to be the case.
7. Mr Chilton was not critical of Dr Serafin's failure to contact the prescriber. In his report dated 30 July 2020, he stated: "[T]here is no legislated requirement for the pharmacist to contact any prescriber for this preparation, and using his (Dr Serafin a competent and experienced practising pharmacist) professional judgement and integrity, Dr Serafin is not required to confirm the validity of the prescription, does not have to contact the prescriber to seek further details or request that the prescriber rewrite the prescriptions."
8. Mr Feldschuh disagreed. In his opinion, in the circumstances it was inappropriate for Dr Serafin to have proceeded to dispense without first speaking with the prescriber.

Consideration

1. Like Mr Feldschuh, the professional members of this Tribunal are unaware of the convention that an asterisk written on a prescription is accepted as meaning multiplied. The meaning of the entry "15*55" is ambiguous and begs several questions, including 15 of what? Dr Serafin has, in effect, guessed what he thought Dr O'Gorman meant by that entry.
2. But even if that entry had stated "15 x 55ml", in circumstances where Dr Serafin had no contact with Dr O'Gorman, his actions in compounding and dispensing Myer's Cocktail in different, albeit lesser, quantities than prescribed was inappropriate. As Dr Serafin explained, vials do not generally come in sizes of 55ml. Of itself, this should have prompted Dr Serafin to clarify with Dr O'Gorman, with whom he had never had any direct contact, the volume prescribed. As Mr Feldschuh pointed out, Dr Serafin had no way of knowing what Dr O'Gorman knew about and the extent to which he was familiar with Myer's Cocktail. It is no answer that Dr Serafin had "verbal approval" from Ms Kazeme, especially given the number of supplies and the significant variation between the amount prescribed and supplied.
3. Particular 13 is proven.
4. While Particular 14 involved a single supply, in circumstances where there was a material difference between the amount compounded and dispensed and the amount prescribed, and Dr Serafin failed to contact Dr O'Gorman, we find this particular proven.
5. The standard reasonably expected of a senior and experienced pharmacist who is unable to dispense the exact amount of a substance prescribed because of logistical reasons (here, the size of the available vials) would be to contact the prescriber before dispensing that substance. If Dr Serafin is suggesting that because Myer's Cocktail can be supplied without a prescription, a lesser standard of care and judgement applied, we disagree. Dr Serafin was supplying significant quantities of substances which were to be injected.
6. We find that the conduct of each Particular demonstrated that the judgement possessed, and care exercised, by Dr Serafin fell significantly below the relevant standard.

Summary

1. Particulars 3, 6(ii) and 10 are not proven. The balance of Complaint 1 is proven in whole or part. That conduct amounts to unsatisfactory professional conduct.

Complaint 2

1. Complaint 2 concerns the compounding and dispensing of peptides and anabolic steroids, prescribed to 12 patients by several GPs located throughout Australia.
2. Of the 18 particulars of Complaint 2, 12 allege that Dr Serafin inappropriately compounded and dispensed substances, and, among other things, failed to ensure the supply of substances was "in a quantity, or for a purpose, that accorded with the recognised therapeutic standards of what was appropriate in the circumstances". [4] Dr Serafin admits most of the remaining particulars, which in the main allege that Dr Serafin failed to comply with various requirements relating to the dispensing of substances contained in the PTGR. However, he does not concede that that conduct amounts to unsatisfactory professional conduct.
3. It is agreed that the substances the subject of Complaint 2 (the subject substances): 1. in the main, are novel medications and are not commonly used in Australia in what Dr Serafin described as "mainstream medicine"; 2. with the exception of testosterone and nandrolone, are not entered on the ARTG; 3. are scheduled as either S 4D or S 4B. None are scheduled as S 9 substances. As we explain below, it is generally unlawful to supply or prescribe S 9 substances; 4. are widely known to be liable for abuse and misuse, in particular for body building, sports performance and image-enhancement.

Regulatory framework

1. The Therapeutic Goods Administration (TGA) is responsible for ensuring that therapeutic goods available for supply in Australia are safe and fit for their intended purpose. In most cases, therapeutic goods must be entered into the ARTG, or be specifically exempted, before they can be lawfully sold or advertised in Australia.
2. Where a drug is listed on the ARTG, the TGA lists its "clinical indication" or therapeutic use. The ARTG carries Consumer Medicines Information (CMI) for most of the listed drugs. CMIs are prepared by the pharmaceutical company (sponsor) of the drug and contain, among other things, the names of the active and inactive ingredients of the drug, the dosage, what the drug is used for and how it works.
3. A national classification system, "scheduling", operates throughout Australia and controls how medicines and poisons are made available to the public. Medicines and poisons are classified into one of nine schedules according to the level of regulatory control, assessed as being required to protect public health and safety. Those schedules are published in the Poisons Standard, a legislative instrument made under s 52D(2)(b) of the Therapeutic Goods Act 1989 (Cth) and, in NSW, given effect by s 8 of the PTGA.
4. In this Complaint, three schedules are of particular relevance: 1. Schedule 8, which lists substances which "are addiction producing or potentially addiction producing"; 2. Schedule 4, which lists "restricted substances", prescription only medicine. Restricted substances are further classified as: 1. "prescribed restricted substances" (Appendix D to Schedule 4 (S 4D)), and 2. "special restricted substances" (Appendix B to Schedule 4 (S 4B)), a sub-set of S 4D substances. S 4B substances are subject to more stringent regulations than S 4D substances. 1. Schedule 9, which lists "Prohibited Substance": "Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State or Territory Health Authorities".
5. The subject substances are classified as either S 4D or S 4B: 1. S 4D: AOD-9604, CJC-1295, GHRP, GHRP-2, GHRP-6; Growth hormone secretagogues, Insulin-like growth factors, ipamorelin, selective androgen receptor modulators (SARMs) (since 1 June 2015) and somatropin (since 1 May 2013); 2. S 4B: anabolic and androgenic steroidal agents, nandrolone and testosterone.

Classification of performance and image enhancing drugs

1. 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 substances from the Advisory Committee on Medicines Scheduling (ACMS), a committee established under s 52B(1) of the Therapeutic Goods Act.
2. 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.
3. In reasons for that decision, the Secretary explained: "[GHRPs] are 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)
4. The Secretary stated that the ACMS recommended that these substances be included under S 4D 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."

Regulations relating to the prescribing and dispensing of Schedule 4 drugs

1. Clause 34 of the PTGR provides that an authorised practitioner must not issue a prescription for a restricted substance "in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances". An authorised practitioner is defined to mean a medical practitioner: cl 3 of the PTGR.
2. Clause 54 prohibits a pharmacist from supplying 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".

Recognised therapeutic standard

1. Central to each particular is the contention that Dr Serafin failed to ensure that the supply of the subject substances was in a quantity, or for a purpose, that accorded with the "recognised therapeutic standards of what was appropriate in the circumstances".
2. Neither the PTGR nor the PTGA define the term "recognised therapeutic standard". Its meaning was considered in Health Care Complaints Commission v Epstein [2015] NSWCATOD 21 (Epstein) at [133], [134]: "133 … On a strict reading of the regulation it is hard to argue with that proposition, as the MIMS criteria are the therapeutic standard recognised Australia wide. The regulation does not refer to "a" recognised therapeutic standard or standards. But we do not think the words "the recognised therapeutic standard" can be read in isolation from what follows, namely "of what is considered appropriate in the circumstance". 134 There can be no doubt that the MIMS criteria do set out the recognised therapeutic standard for each of the relevant drugs prescribed "on-label" (that is, for their approved use by the TGA). But many drugs, including many prescribed for paediatric use, are prescribed "off-label", to a standard recognised generally as appropriate by the profession. So too we accept, in appropriate clinical circumstances and with proper examination and investigation, off-label prescribing may be appropriate if an informed and trained minority cohort of practitioners support the practice for a particular condition or a particular set of conditions. In this regard we are guided by the discussion by Kirby P (as his Honour then was) in Don Nai Hsi Huang v Walton (Court of Appeal (NSW), 30 April 1993, unrep). His Honour said: The conduct of a medical practitioner does not, within s27(1)(a) of the Act, demonstrate a lack of adequate knowledge, experience, skill, judgment or care in the practice of medicine, simply because a course of therapy is embarked upon which does not conform to a given professional norm. So long as the practitioner is acting lawfully and conscientiously and is pursuing, in the treatment of his or her patient, a "respectable, though minority, view" in such treatment, no misconduct exists as will attract discipline under the law [citations omitted] In Childs v Walton, as the Tribunal itself noted, Samuels JA said at 10): A departure from a generally accepted procedure does not necessarily constitute professional misconduct. There may be different schools of medicine and disputes between them. Adherence to the practice of a minority group does not alone entail professional misconduct 'Every innovation has to be performed for a first time. That something has not been done is not proof that it ought not to be done' (per Hutley in Qidwai at 1010)." (Emphasis added)
3. Pointing out that most of the subject substances are novel and not listed on the ARTG, the Commission contends that their efficacy and/or safety for human use have not been properly established. In support, the Commission relies on the opinion of endocrinologist, Professor John Carter. At the request of the Commission, Professor Carter prepared reports dated 30 September 2019 and 14 September 2020 and gave oral evidence.
4. Dr Serafin disagrees. He contends that the safety and efficacy of each subject substance has been established. In support he cites numerous studies and articles (Exh A1, tabs 122, 123, 191-207; Exh R1, vol 2).
5. Dr Serafin claims that: 1. before supplying any of the subject substances he read widely to satisfy himself of their safety and efficacy; 2. his research included an online presentation given by Dr Edwin Lee (director, Institute for Hormonal Balance, Florida, USA) about his experience using peptides together with research conducted by Dr Hertoghe (President of the International Hormone Society), Dr William Seeds (chairman of the International Peptide Society and orthopaedic surgeon); 3. he has spoken with a couple of Australian medical practitioners, who have been prescribing peptides for some time, the main practitioner being Dr Carol Pearce. (In September 2018, the State Administrative Tribunal (WA) found Dr Pearce guilty of professional misconduct, suspended her registration for four months and imposed a series of conditions on her registration, which include that she not prescribe many of the subject substances: Medical Board of Australia and Pearce [2018] VR 53).
6. Dr Serafin points out that none of the subject substances are classified as S 9, and therefore there is no prohibition on prescribing, compounding, or supplying those substances.
7. Dr Serafin submits that little weight should be given to the opinion expressed by Professor Carter about the subject substances. He points out that Professor Carter has little practical experience with most of the subject substances and no experience in pharmacology or setting standards for pharmacology.
8. In addition, Dr Serafin contends that Professor Carter lacked objectivity. Dr Serafin asserts that Professor Carter failed to give proper consideration and in some cases had not even read, the many studies and articles he (Dr Serafin) tendered in these proceedings in support of his contention that the safety and efficiency of the subject substances has been established. Dr Serafin argues that Professor Carter's "scornful assessment" of the opinion expressed by Dr Lee, the author of one of those studies, and according to Dr Serafin, "at the forefront of peptide research in the USA", because he had not trained as an endocrinologist, underscores the danger of placing any significant weight on the opinion expressed by Professor Carter.
9. Dr Serafin argues that Professor Carter's statement "SARMs have not been approved for human use in any country of the world (Tcpt, 15 December 2020, p 50(3))", demonstrates Professor Carter's lack of objectivity given that, in Australia, SARMS can legally be supplied on prescription.
10. Dr Serafin points out that, throughout the period of the Complaint and to this day, there is no requirement that the subject substances be prescribed by a medical specialist. In oral evidence he disagreed with the proposition that, given that the subject substances are novel and not listed on the ARTG, they should have been prescribed by an endocrinologist: "A. To be brutally honest, no. The reason for that is most endocrinologists - and I don't mean to be disrespectful here; I know they do great work and I'm not diminishing them by any means - but the bread and butter of an endocrinologist is diabetes. They may dabble in a little bit of thyroid and they may dabble in a tiny little bit of testosterone replacement but even the responses yesterday that Professor Carter gave clearly indicated to me he doesn't have much experience with TRT at all. So no, I don't feel that they are properly equipped to be dealing with a lot of these. There are certain integrative medical doctors who do a lot of research in this area … … I've had multiple conversations with endocrinologists over the last 20 years and again, I don't mean to be disrespectful but I believe their knowledge base in certain hormone areas is - is not adequate." (Tcpt, 17 December 2020, p 93 (6-30))
11. Citing Epstein at [134], Dr Serafin submits that it is well accepted that prescribing off-label substances is both lawful and necessary for the effective treatment of some patients who do not respond to recognised, regular therapy.
12. Dr Serafin acknowledges that many people in the medical profession, such as Professor Carter, do not share his opinion about the subject substances. However, he submits that, in determining whether he failed to ensure that those substances were supplied "in accordance with the recognised therapeutic standards of what is appropriate in the circumstances", it must be borne in mind that reasonable minds can and do differ, which is not surprising given that the science of medicine is not static. He contends that, in circumstances where he held a genuine belief that the subject substances were being prescribed for a proper therapeutic purpose, where that belief is supported by a considerable body of scientific literature, together with the opinion expressed by Mr Chilton, the contention that the subject substances were supplied in a quantity and/or for a purpose that did not accord with the recognised therapeutic standard is not established.

Particulars 1, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13

1. In each particular, the Commission alleges that Dr Serafin inappropriately compounded and dispensed and/or failed to ensure that the pharmacists in his employ appropriately compounded and dispensed the particular subject substances to the individual patient. In the main, each particular consists of six identical sub-particulars: 1. Dr Serafin failed to ensure that the supply of the subject substances to the individual patient was in a quantity, or for a purpose, that accorded with the recognised therapeutic standards of what was appropriate under the circumstances; 2. Dr Serafin was aware that the subject medications were liable to abuse and failed to take adequate steps to ensure that the individual patient was not abusing those medications; 3. Dr Serafin failed to have proper regard to the individual patient's dispensing history in assessing the appropriateness of the prescribed medications and the associated risks to that patient's health and safety; [5] 4. there were insufficient precedents available at the relevant time to support Dr Serafin's decisions to compound the medications for the individual patient including in combination with other scheduled medications of a similar nature; 5. Dr Serafin failed to keep contemporaneous notes of any conversations with the individual patient and the prescriber of their medications, including the medical reasons for the prescribing, the nature of any ongoing testing of the subject patient to ensure no adverse side effects, the frequency and timing of dosing including in combination with other medications, any ethics committee approval or drug trial approval for the prescribing of the medications and patient counselling in general; and 6. Dr Serafin failed to ensure that there were adequate dispensing procedures, systems and protocols in place for dispensary technicians and pharmacists, including himself, at the Pharmacy for the compounding of medications for the individual patient.
2. We consider each particular in turn. Because the issues raised in sub-particulars (iv) and (vi) are common to all particulars, we consider them together.

Particular 1

1. Between March 2015 and August 2015, Dr Serafin compounded and dispensed and/or failed to ensure that the pharmacists in his employ appropriately compounded and dispensed testosterone/progesterone/ Dehydroepiandrosterone (DHEA) cream, AOD-9606 and Selective Androgen Receptor Modulators (SARMs) for Patient A on the following dates and in the following quantities: 1. on 11 March 2015, 100g of Testosterone (30%), Progesterone (2%) and DHEA (5%) cream; 2. on 26 May 2015 50mL of AOD 9604 300mcg/ml cream; 3. on 26 May 2015 100mL of SARMS 200mcg/ml cream; 4. on 23 June 2015 100g of Testosterone (30%), Progesterone (2%) and DHEA (5%) cream; 5. on 11 August 2015 50mL of AOD 9604 300mcg/ml cream; and 6. on 11 August 2015 100mL of SARMS 200mcg/ml cream.
2. Dr Serafin denies that he failed to ensure that the substances listed above were supplied in a quantity, or for a purpose, that accorded with the recognised therapeutic standards of what was appropriate in the circumstances. Dr Serafin claims that he was very familiar with Patient A and understood that Patient A: 1. had been diagnosed with low testosterone confirmed by blood tests, and for that reason had been prescribed testosterone cream; 2. suffered from sciatica and muscle wastage in his right leg, and for that reason had been prescribed peptides; 3. suffered from osteoarthritis, and for that reason had been prescribed AOD 9604, for cartilage loss.

Professor Carter's opinion about the substances supplied to Patient A

1. According to Professor Carter, the supply of these substances to Patient A did not accord with recognised therapeutic standards. Professor Carter stated:

Testosterone/Progesterone/DHEA cream 1. the safety, quality, and efficacy of testosterone cream has been established, but only in people who are testosterone deficient; 2. there are no clinical indications for prescribing progesterone cream in adult males; 3. the clinical indications for prescribing DHEA cream are controversial. He is unaware of any clinical trials showing any benefits relating to transdermal administration of DHEA; 4. the safety, quality, and efficacy of testosterone/progesterone/DHEA cream, has not been established.

AOD 906

1. Professor Carter described the peptide AOD-906 as a "synthetic fragment of human growth hormone" developed primarily to assist fat and weight loss. According to Professor Carter: 1. he is unaware of any clinical studies, which have indicated clinical benefits for fat/weight loss. Clinical trials for weight loss were ceased in February 2017 because of lack of efficacy; 2. while there are numerous studies about AOD-906 in the main they have been published in relatively obscure journals. Those studies were sponsored by the peptide manufacturer and the reports of those studies were written by people who appeared to have a financial interest in the drug and thus a conflict of interest; 3. due to lack of clinical data, it is not possible to comment definitively on the safety of AOD-906; 4. the clinical use of AOD-906 is not evidence-based.

SARMS

1. Professor Carter described SARMs as "selective androgen receptor modulators, which bind to androgen receptors throughout the body resulting in stimulation or inhibition of androgen (e.g. testosterone) production". According to Professor Carter: 1. there are limited data that indicate SARMs can be used to increase muscle protein synthesis and to decrease muscle atrophy; 2. many of the published studies on SARMs are small and have been performed by the manufacturer (raising the question of conflict of interest); 3. there are insufficient data to comment on the safety, quality, and efficacy of SARMs in clinical situations, particularly in "normal" adults; 4. in 2017 the US Food and Drug Administration (FDA) warned that the use of SARMs was linked to liver failure and increased risk of heart attack or stroke. The TGA's website stated (26 March 2019), "No SARM has been fully researched or approved for human use".

Risks or contraindications

1. According to Professor Carter: 1. SARMS: Because SARMS selectively activate the androgen receptor, there is a risk of precipitation or exacerbation of cardiovascular disease, citing in support S.Y. Loo et al., "Cardiovascular and Cerebrovascular Safety of Testosterone Replacement Therapy Among Aging Men with Low Testosterone Levels: a Cohort Study" (2019) 132 American Journal of Medicine 1069; 2. AOD-906: it is not possible to identify definite contraindications due to lack of clinical data; 3. Progesterone and DHEA creams: there does not appear to be any significant risk or contraindication although there would not appear to be any clinical indication for prescribing these drugs for an adult male; 4. Testosterone cream: the risks predominantly relate to cardiovascular disease. There are no data or studies relating to the combined use of the above substances.

Dr Serafin's opinion about the substances supplied to Patient A

1. Dr Serafin rejects the contention that the substances supplied to Patient A were in a quantity and for a purpose that did not accord with "recognised therapeutic standards". He acknowledges that AOD-906, SARMS and testosterone combination creams are not registered on the ARTG, and therefore there is no approved product information or published recognised therapeutic standards for those substances. He submits that, in those circumstances, he was entitled to rely on research from reputable sources.
2. Responding to Professor Carter's opinion about the safety and efficacy of the subject substances, Dr Serafin stated: 1. DHEA: contrary to Professor Carter's view, the safety and efficacy of DHEA has been studied, citing in support, "DHEA monograph" (2001) 6(3) Alternative Medicine Review 314 and E Olech, J Merrill, "DHEA supplementation: the claims in perspective" (2005) 72(11) Cleveland Journal of Medicine 965. Dr Serafin asserts that, in the USA and several other countries DHEA is available as an "over-the-counter supplement". In addition, he asserts that it is "well established and any textbook from any integrative hormone specialist would agree" that DHEA can be used to treat patients with chronic fatigue and fibromyalgia who often have "adrenal insufficiency" which DHEA can restore (Tcpt, 17 December 2020, p 96 (25)); 2. Progesterone: its safety is well-established in women; progesterone capsules are commercially available in Australia; 3. AOD-906: while, as Professor Carter points out, its efficacy for weight loss has not been established, it was not supplied to Patient A for that purpose. Rather, it was supplied for injury repair and collagen production. Studies evidencing that AOD-906 is safe for human use include, H. Stier, E. Vos, D. Kenley, "Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans" (2013) 3(1-2) Journal of Endocrinology and Metabolism 7; 4. SARMS: the safety of SARMS 22 is "well-established", citing in support J Dalton et al, "The selective androgen receptor modulator GTx-024 (enobosarm) improves lean body mass and physical function in healthy elderly men and postmenopausal women: results of a double-blind, placebo-controlled phase II trial" (2011) 2 J Cachexia Sarcopenia Muscle 153; (see also papers at Exhibit R1, Vol 2, Tabs 16, 17); 5. Testosterone: Professor Carter's opinion that there is evidence of a link between testosterone use and cardiovascular disease is "outdated", citing in support the following studies: 1. A. Traish, G. Hackett, M. Miner, A. Morgentaler, "Cardiovascular and Cerebrovascular Safety of Testosterone Therapy: Letter to the Editor" (2019) American Journal of Medicine 1 2. A. Elagizi, T. Kohler, C. Lavie, "Testosterone and Cardiovascular Health" (2017) Mayo Clinic Proceedings 1 3. A. Tambo, M. Roshan, N. Pace, "Testosterone and Cardiovascular Disease" (2016) 10 Open Cardiovascular Medicine Journal 1 4. E. Rhoden, A. Morgentaler, "Risks of Testosterone-Replacement Therapy and Recommendations for Monitoring" (2004) 350(5) New England Journal of Medicine 482 5. A Morgentaler et al, "Testosterone Therapy and Cardiovascular Risk: Advances and Controversies" (2015) 90(2) Mayo Clinic Proceedings 224.
3. Dr Serafin submitted that little weight should be given to Professor Carter's opinion because as evidenced in cross-examination: 1. when taken to the 2011 article, referred to at 208, Professor Carter agreed that that trial was a double-blind placebo-controlled Phase II trial. (Tcpt, 15 December 2020, p 63(42)). Nonetheless, Professor Carter sought to detract from that article by pointing out that it was written by employees of the sponsor pharmaceutical company, notwithstanding that they had declared their interest in the trial (Tcpt, 15 December 2020, p 64 (15-18)); 2. when taken to the article, S. Bhasin, R. Jasuja, "Selective Androgen Receptor Modulators (SARMs) as Function Promoting Therapies" (2009) 12(3) Current Opinion in Clinical Nutrition & Metabolic Care 232, Professor Carter agreed that the authors concluded that SARMS "holds promise". However, he sought to detract from that study by pointing out that it was based on a Phase 1 trial; 3. Professor Carter was argumentative and demonstrated a lack of appreciation of the literature tendered by Dr Serafin in these proceedings.
4. In cross-examination Dr Serafin agreed with the following propositions: 1. there are no therapeutic guidelines for peptides; 2. there are contraindications to the use of certain peptides, some of which are unknown; 3. there are no long-term studies on the safety and effectiveness of the subject peptides.

Mr Chilton

1. In his report dated 20 July 2020, Mr Chilton stated that in his view, if a medical practitioner made a decision based on the patient's symptoms, it is reasonable for any competent pharmacist "after appropriate consideration" to dispense the prescribed medication.
2. In his view, no criticism should be made of Dr Serafin's decision to dispense the substances the subject of Particular 1: "I agree with Dr Serafin that SARM S22 and testosterone are obvious choices for muscle wasting syndromes due to their anabolic effects while AOD was being used for repair of cartilage as Patient A had Osteoarthritis."

Particular 1(i): recognised therapeutic standards

1. It falls to the Commission to establish that Dr Serafin failed to ensure that the supply of the subject substances to Patient A was in a quantity, or for a purpose, that accorded with the recognised therapeutic standards of what was appropriate in the circumstances.
2. As the Tribunal acknowledged in Epstein, it does not follow that, because a particular substance is not entered on the ARTG or listed in MIMS (Monthly Index of Medical Specialities), the use for which it is prescribed does not accord with "the recognised therapeutic standards of what was appropriate in the circumstances". In NSW, prescribing off-label (that is, prescribing a substance that is not entered on the ARTG, or is not approved by the TGA for the indication, route or administration or patient group for which the drug is prescribed) is commonplace and itself does not evidence that the substance has been supplied in a quantity or for a purpose that did not accord with the recognised therapeutic standards of what was appropriate in the circumstances.
3. Determining whether a particular substance was supplied to a patient in a quantity or for a purpose that did or did not accord with the recognised therapeutic standards of what was appropriate in the circumstances requires an evaluative judgement taking into account several considerations, including: 1. the nature of the subject substance; 2. the patient's medical history; 3. the nature of the condition for which the substance was prescribed to treat; 4. the dosage and quantity prescribed and the duration for which the substance is prescribed; 5. any available material about the safety, efficacy and quality of the subject substance, and the reliability of that material; and 6. where the patient is taking other substances, the existence of any scientific material about the interaction between those substances with the prescribed substances.
4. That task is especially difficult where, as here, the subject substance is not entered on the ARTG and therefore there is no approved product information available and no published, recognised therapeutic standard(s).
5. In deciding whether, as the Commission contends, Dr Serafin failed to ensure that the supply of the subject substances was in a quantity, or for a purpose, that did not accord with the recognised therapeutic standards of what was appropriate in the circumstances we have adopted the approach taken by the Tribunal in Epstein at [134], and ask whether "an informed and trained minority cohort of practitioners" support the use of the subject substances for the particular condition or particular set of conditions for which the subject patients have been diagnosed.
6. It follows therefore that, while relevant, Professor Carter's opinion about whether the subject substances were supplied in a quantity, or for a purpose, that accorded with the recognised therapeutic standards, is not determinative.
7. Similarly, Dr Serafin's subjective belief about the safety and efficacy of the subject substances is not determinative. We disagree with the argument made by Dr Serafin that providing he held the honest belief that the subject substances were safe and efficacious for the use for which they were prescribed, and that there was material to support that belief, it cannot be said that he failed to ensure that those substances were supplied in a quantity or for a purpose that did not accord with recognised therapeutic standards. Rather, consistent with the approach in Epstein, it is necessary to decide whether an informed and trained minority cohort of practitioners is of the opinion that the quantity and purpose for which the subject substances were supplied accorded with a recognised therapeutic standard for the particular condition or particular set of conditions for which the subject patients have purportedly been diagnosed. In answering that question, it will be necessary to evaluate the quality of the information on which those opinions are based, and the experience and training of the practitioners who espouse those opinions.
8. The studies and articles on which Dr Serafin relies are generally favourable to the subject substances. However, as Professor Carter points out, Dr Serafin in the main they are not peer-reviewed from clinical studies published in reputable journals to substantiate his opinions regarding indication for use, optimal dosage and the safety profile of the subject substances. Having read each of those articles, in our view it cannot be said that individually, or in combination, they establish that the subject substances are safe for human use, are effective for the purported use for which they prescribed and that there is a recognised therapeutic standard for those substances. For example:

AOD 9604

1. According to Dr Serafin, Patient A suffered osteoarthritis and was prescribed AOD 9604 for cartilage loss. In support of the proposition that this substance was safe and effective for the treatment of cartilage loss, Dr Serafin relied on the following: 1. H. Stier, E. Vos, D. Kenley: "Safety and Tolerability of the Hexadecapeptide AOD9604 in Humans" (2013) 3(1-2) Journal of Endocrinology and Metabolism 7. Based on six randomized, double-blind, placebo-controlled trials the authors concluded that "AOD 9604 displayed a very good safety and tolerability profile indistinguishable from placebo". The study did not examine the efficacy of AOD 9604. 2. Patent application made to the World International Property Organisation; citing several experiments and studies on animals and humans, the application asserts that AOD 9604 may be efficacious for cartilage repair.

DHEA cream

1. According to Dr Serafin, Patient A was prescribed DHEA cream for low testosterone. In support of the proposition that DHEA cream was safe and effective, Dr Serafin relied on the following: 1. "DHEA monograph" (2001) 6(3) Alternative Medicine Review 314. The authors wrote: 1. the clinical evidence supporting the use of DHEA as an anti-aging hormone is inconclusive; 2. one double-blind, cross-over study of 30 subjects shows "a remarkable increase in physical and psychological well-being" and "no side effects"; 3. DHEA appears to be relatively safe if given in normal physiological doses; 4. as its long-term effects are not known, DHEA should be used with caution. 1. E. Olech, J.TMerrill, "DHEA supplementation: the claims in perspective" (2005) 72(11) Cleveland Clinic Journal of Medicine 965. The authors state that DHEA may be a promising treatment for common disorders arising in the context of chronic illnesses and shows some promise in "observational clinical trials". The authors conclude: "DHEA shows some promise in observational clinical studies and laboratory experiments, but we still need large-scale human studies to answer key questions. For now, we do not have enough evidence to recommend routine treatment with DHEA. As with other supplements, quality control is always a concern, and different brands may contain different amounts of active ingredient." (emphasis added)
2. In addition to the submitted studies, Dr Serafin relies upon the opinion of Dr Pearce and a "couple of Australian practitioners". The only documentary material about the views of these practitioners is a one-page undated letter to Dr Serafin, in which Dr Pearce sets out her opinion about and experience in prescribing several peptides. For example, , Dr Pearce stated that AOD-9604 can be used for the treatment of osteoarthritis and in "my experience gives pain relief and improved mobility within days". Dr Pearce attached to that letter a list of articles and studies but does not explain their relevance to the opinion(s) stated in her letter.
3. Leaving to one side the fact that in 2020 Dr Pearce's registration as a medical practitioner was suspended, and her registration is now subject to conditions, including that she not prescribe many of the subject substances, her letter to Dr Serafin could not be said to establish that the peptides to which she referred are safe and efficacious for human use, that her opinion is informed, or, that "an informed and trained minority cohort of practitioners" share her opinion.

Mr Chilton's opinion

1. In his report dated 30 July 2020, Mr Chilton stated "one cannot be judged about a standard that does not exist". By that statement we understand Mr Chilton to mean that where, as here, a pharmacist supplies a substance "off-label", it cannot be said that it does not accord with the recognised therapeutic standards because there are no recognised therapeutic standards for that substance.
2. We reject that view. As discussed above, the task of determining whether a particular drug was prescribed or supplied to a patient in a quantity, or for a purpose, that did or did not accord with the recognised therapeutic standards does not start and end with consideration of whether it is listed on the PTGR, or there exist a published therapeutic standard. It requires an evaluative judgement to be made having regard to several factors.
3. In addition, for the reasons that follow, we place little weight on Mr Chilton's opinion about whether the supply of the subject substances was in a quantity, or for a purpose, that accorded with the recognised therapeutic standards of those substances.
4. First, Mr Chilton failed to set out the assumptions on which many of his stated opinions about the subject substances were based. For example, in relation to the substances supplied to Patient A, he stated: "SARM S22 and Testosterone are obvious choices for muscle wasting syndromes while AOD was being used for repair of cartilage." "There is considerable international experience in support of the use of testosterone/progesterone/dehydroepiandrosterone combinations, AOD-906 and selective androgen receptors modulators."
5. Mr Chilton did not explain the basis for his opinion that SARMs and testosterone were "obvious choices". Nor did he identify the international experience which he asserts supports their use. We were left with the impression that, at best, Mr Chilton had a superficial understanding of the literature and studies about the subject substances. In several instances he appeared to be merely repeating the opinions expressed by Dr Serafin about the safety and efficacy of those substances.
6. Second, Mr Chilton failed to give a cogent explanation for his opinion that peptides are safe for human use in circumstances where there are no long-term clinical studies to support that view.
7. Professor Carter, on the other hand, impressed us as having a more sophisticated understanding of each of the subject substances, how they worked, their safety and efficacy and the aetiology of the conditions they were purportedly being used to treat.
8. We reject the submission made by Dr Serafin that little weight should be given to Professor Carter's opinion because of his limited direct experience with most of the subject substances. We are unable to agree with the proposition implicit in that criticism that only practitioners who prescribe or supply those substances are qualified to express an opinion about their safety and efficacy.
9. In addition, we reject Dr Serafin's submission that the oral evidence given by Professor Carter demonstrated that he lacked objectivity. Dr Serafin is probably correct that Professor Carter was somewhat sceptical of many of the studies on which he (Dr Serafin) relied, and the credentials of their authors. Professor Carter's opinion which is consistent with that expressed by reputable bodies such as the National Health and Medical Research Council, is that not all studies are of equal value and the reliability of a particular study is dependent on several factors, including the methodology employed, the length of the study and the sample size. [6]
10. Nonetheless, as explained above, Professor Carter's opinion, while relevant, is not determinative of the question of whether the subject substances were not supplied in a quantity, or for a purpose, that accorded with the recognised therapeutic standards of what was appropriate in the circumstances. Unsurprisingly, there is often a range of opinion in medicine about the safety and efficacy of drugs, especially where, as here, they are novel and prescribed off-label.

Consideration

1. For the following reasons we conclude that Dr Serafin failed to ensure that the substances supplied to Patient A were for a purpose that accorded with the recognised therapeutic standards of what was appropriate in the circumstances: 1. The weight of evidence is that the safety and efficacy of testosterone/ progesterone/DHEA combination creams, AOD-906 and SARMS is not established. As conceded by Dr Serafin, there have been no clinical trials in Australia and no long-term studies into the safety and efficacy of the subject peptides. 2. As discussed above, in our view, the material on which Dr Serafin relies falls a long way short of establishing that an informed and trained minority cohort of practitioners is of the view that the subject substances have been demonstrated as being both safe and efficacious for the purpose they were purportedly prescribed to Patient A. 3. While the prescribing practitioner and the couple of Australian medical practitioners with whom Dr Serafin has spoken may share Dr Serafin's opinion about the safety and efficacy of the substances prescribed for Patient A, that does not establish that an informed and trained minority cohort of practitioners shares that view. 4. In reaching that conclusion we have taken into account that Professor Carter was the only expert to have expressed the view Dr Serafin failed to ensure that the subject substances were supplied in a quantity and for a purpose that accorded with a recognised therapeutic purpose. Mr Cotterell's only criticism of Dr Serafin's supply to Patient A was that the original supply appeared to predate the prescription. In our view, it was apparent that Mr Cotterell, like Mr Chilton, had limited knowledge of the available scientific literature about the subject substances. 5. Particular 1(i) is established.

Particular 1(ii): failing to take adequate steps to ensure that Patient A was not abusing the subject substances

1. Dr Serafin acknowledges that the subject substances are liable to abuse, and he was aware of that fact when he supplied them to Patient A. However, he contends that he took reasonable steps to ensure Patient A was not abusing the supplied substances. He claimed that he spoke with Patient A to ensure that his use was legitimate. In support, he points to a single, undated note on Patient A's "patient profile": "Spoke with [Patient A] using Testo for muscle wasting in right leg. Tested low for testo in blood tests."
2. According to Dr Serafin, Patient A could barely walk and was in no condition to train at the gym. Based on that conversation he concluded that there was a low risk of Patient A abusing the product for body building or sports purposes.
3. In these proceedings, Dr Serafin did not claim that he spoke with the prescribing practitioner about the reasons he had prescribed the subject substances or raised with the prescriber whether, in their opinion, there was a risk that Patient A was abusing those substances. Indeed, in his section 40 response dated 20 September 2018, Dr Serafin stated with respect to several patients, of which Patient A was one, that he "either spoke with the patient and/or their doctor prior to supply to ascertain the reason why they were being prescribed".

Consideration

1. The issue raised by sub-particular (ii) is whether Dr Serafin failed to take adequate steps to ensure that Patient A was not abusing the subject substances. We note that there is no evidence, and nor does the Commission suggest, that Patient A was abusing those substances.
2. In circumstances where the subject substances were known to be liable to abuse, in our view a single conversation with a patient does not constitute adequate steps to ensure that the substances were not being abused.
3. Sub-particular 1(ii) is established.

Sub-particular 1(iii): failing to have regard to patient's dispensing history

1. In his statement dated 30 June 2020, Dr Serafin claimed that he took into account Patient A's dispensing history in assessing the appropriateness and associated risks of the subject substances.
2. That unsupported claim is at odds with the account given by Dr Serafin of the practice within the Pharmacy throughout the period mid-2014 to early 2016. Dr Serafin stated that throughout that period the practice within the Pharmacy was that, before commencing to fill a prescription, the dispensing technician would hand him the prescription for approval. Dr Serafin said that, before giving approval for a prescription to be filled, it was not his practice to check the patient's dispensing history, the patient's "full hard file" (Tcpt, 17 December 2020, p 102 (17-40)). Dr Serafin said that he had assumed that as "per Pharmacy protocols" the dispensing technician had reviewed the patient's dispensing history before giving him the prescription for approval. However, he accepted that this did not always occur.
3. We find it more likely than not that between mid-2014 and early 2016, it was not Dr Serafin's practice to review a patient's dispensing history before approving a prescription to be filled. It follows that Dr Serafin could not be said to have had "proper regard to Patient A's dispensing history in assessing the appropriateness of the prescribed medications and the associated risks to Patient A's health and safety". Whether, in retrospect, Dr Serafin held the view that, given the patient's dispensing history, the subject supply was appropriate and did not pose a risk to Patient A's health and safety, is not to the point. The issue raised by sub-particular (iii) is whether at the time of the second and subsequent dispenses Dr Serafin had proper regard to Patient A's dispensing history. We find he did not.
4. Sub-particular 1(iii) is established.

Sub-particular 1(v): failed to keep contemporaneous notes of conversations with patient

1. As formulated, sub-particular (v) requires the Commission to establish that Dr Serafin failed to keep contemporaneous notes of any conversations with Patient A and/or the prescriber about, among other things, the medical reasons for prescribing to Patient A, the frequency and timing of dosing etc. In circumstances where Dr Serafin did not speak with the prescriber and he made a note of his only conversation with Patient A, sub-particular (v) must fail.

Particular 3

1. Dr Serafin admits para (iii) (failing to have proper regard to patient's dispensing history) but otherwise denies Particular 3, which states: "3. Between 9 August 2016 and 22 August 2016, Dr Serafin and/or pharmacists in his employ compounded and dispensed Insulin-Like Growth Factor 1 ("IGF-1"), CJC-1295, Testosterone and Nandrolone injections for Patient B on the following dates and in the following quantities: 1. 10mL of IGF-1 LR3 1000mcg/ml INJ on 9 August 2016; 2. 10mL of Testosterone Cypionate 200mg/ml on 9 August 2016; 3. 10mL of Nandrolone Decanoate 200mg/ml IM INJ on 9 August 2016; and 4. 10mL of CJC-1295 2000mcg/ml GHRP2 2000mcg/ml INJ on 22 August 2016."
2. GP Dr Alice Meneghetti prescribed the substances supplied to Patient B. In April 2020, NCAT cancelled Dr Meneghetti's registration as a medical practitioner after finding her guilty of professional misconduct: Health Care Complaints Commission v Meneghetti [2020] NSWCATOD 39. The Tribunal found that Dr Meneghetti inappropriately prescribed peptides and hormones "at Mr Dank's behest" to Mr Dank and 8 other patients. In June 2015, the Australian Sports Anti-Doping Authority imposed a lifetime ban on Mr Dank for possession, trafficking and prescription of PIEDs.
3. For about two and a half months, Dr Serafin supplied substances to two of Dr Meneghetti's patients, Patient B and Patient K. He claimed that when he learned, through a patient, of Dr Meneghetti's association with Mr Dank, he immediately ceased supplying to her patients.
4. It does not form part of Complaint 2, and nor do we understand the Commission to contend, that throughout the period the Pharmacy supplied substances to Dr Meneghetti's patients, Dr Serafin was aware, or ought to have been aware, of the association between Dr Meneghetti and Mr Dank.

Recognised therapeutic standards: IGF-1, CJC-1295, and Testosterone and Nandrolone injections

1. In his report dated 29 October 2019, Professor Carter commented on the safety and efficacy of the substances supplied to Patient B:

IGF-1

1. Professor Carter explained that IGF-1 is "a hormone produced predominantly in the liver following stimulation by GH. Almost all of the biologic effects of GH are mediated by the stimulation of IGF-1 production. The prescribed IGF-1 peptide is produced by a recombinant DNA technique and when used in appropriate doses would appear to be safe". Professor Carter stated: 1. the quality of IGF-1 is high; 2. the efficacy of IGF-1 has been proven when used as therapy for IGF-1 deficient patients, but not for adults with normal IGF-1 levels; 3. he is unaware of any clinical trials establishing the safety and efficacy of IGF-1 for human use, except in people who are IGF-1 deficient; 4. he is aware that some patients with muscle tendon injury or muscle injuries are being prescribed IGF-1. To his knowledge, definitive evidence of benefit has not been shown in clinical studies; 5. given the lack of clinical trials indicating consistent benefit, there are no accepted therapeutic standards in terms of dosage or duration of prescribing IGF-1 to promote muscle tissue growth and/or repair.

CJC-1295

1. Professor Carter described CJC-1295 as: "a synthetic analogue of growth hormone releasing hormone (GHRH). It acts on the GHRH receptors on the pituitary gland to stimulate endogenous GH synthesis and secretion."
2. Professor Carter stated: 1. there are limited published clinical trials relating to CJC-1295. The findings of those studies are variable with some reports indicating an increase in muscle strength in "normal" adults with other studies showing no effect; 2. there are insufficient clinical studies to comment on the safety of CJC-1295 but, as the mechanism of action is via an increase in GH secretion, the known side effects of GH injections (which include oedema, carpal tunnel syndrome, abnormalities in glucose metabolism, arthralgias and gynaecomastia) need to be considered; 3. the safety, quality and efficacy of CJC-1295 has not been established.

Nandrolone

1. Professor Carter explained that nandrolone is "an anabolic steroid which is an analogue of testosterone". He stated that: 1. when used in an appropriate and approved dose, nandrolone would appear to be safe; 2. the quality of the preparation is high; 3. the only proven clinical indication of nandrolone is for the treatment of anaemia with renal insufficiency; 4. the risks regarding nandrolone therapy relate to men with carcinoma of the breast or known or suspected carcinoma of the prostate, while liver disease and cardiovascular disease are also risks and thus relative contraindications; 5. he is unaware of clinical trials regarding the safety and efficacy of nandrolone except with respect to the treatment of anaemia with renal insufficiency; 6. he understands that the non-therapeutic indications for nandrolone (and testosterone) predominantly centre around either performance enhancement or muscle development (image enhancement).

Recognised therapeutic purpose

1. In Professor Carter's opinion (on the assumption that Dr Serafin did not know the individual indications for which he was supplying the subject substances to Patient B): "In view of the lack of evidence of clinical benefit with IGF-1 and CJC-1295 in adults with normal GH/IGF-1 levels, I believe that Dr Serafin's oversight and approval of the supply of these drugs did not accord with his responsibility to ensure the medicines were supplied for a recognised therapeutic purpose. However, I do not believe it was Dr Serafin's responsibility to determine that the testosterone was supplied for a recognised therapeutic purpose as prescribing of this more commonly used drug should be the responsibility of the doctor writing the prescription. With respect to Nandrolone, I do not believe that Dr Serafin's oversight and approval was in accord with his responsibility."

Dr Serafin

1. Dr Serafin disagreed with Professor Carter's opinion that the safety and efficacy of CJC and IGF-1 have not been properly established. Dr Serafin stated: 1. the mechanism of action to boost endogenous HGH secretion is well defined, and therefore it is logical to use CJC to boost HGH levels when they were tested and found to be low, accompanied by relevant symptoms; 2. CJC is very similar in composition to sermorelin and tesamorelin which have been approved for use in the USA. Dr Serafin reasoned that therefore it is logical to expect that CJC will have the same effect as it has similar safety profiles to those substances; 3. IGF-1 is commercially available in the USA and is considered safe. Dosing protocols have been developed based on this data and are used by many anti-aging doctors around the world.
2. With respect to nandrolone, Dr Serafin acknowledges that there are no long-term, double-blind placebo-controlled studies. However, he argues that the following articles demonstrate the safety and efficacy of nandrolone: 1. A. Tatem, L. Holland, J. Kovac, J. Beilan and .L Lipshultz, "Nandrolone decanoate relieves joint pain in hypogonadal men: a novel prospective pilot study and review of the literature" (2019) Translational Andrology and Urology 1. The authors stated that in a small study (48 men who had been diagnosed with hypogonadism and reported joint pain) 18 participants reported a decrease in joint pain. No adverse effects were noted; 2. M. Pan and J. Kovac, "Beyond testosterone cypionate: evidence behind the use of nandrolone in male health and wellness" (2016) 5(2) Transl Androl Urol 213: a 2016 literature review written by one of the authors of the 2019 study (above), which explored a potential role for Nandrolone in joint healing and muscle growth. The authors conclude: "Minimal literature exists regarding the use of nandrolone and, as such, further human studies are required".
3. In addition, Dr Serafin pointed to the Consumer Medicine Information (CMI) for nandrolone, published in October 2013, which he asserts shows "there's a whole list of approved therapeutic purposes". The CMI stated that nandrolone is used to treat osteoporosis (loss of bone tissue), certain types of anaemia, breast cancer (in women) and patients on long term corticosteroids.
4. Dr Serafin claimed that, before supplying prescriptions issued by Dr Meneghetti, he spoke with Dr Meneghetti to ensure that she was "prescribing for therapeutic purposes and not for sports or bodybuilding". She assured him that they were prescribed for therapeutic purposes, specifically to increase hormone levels. In addition, he claimed that he told Dr Meneghetti that those substances should only be prescribed when test results indicated that the patient's hormone levels were low.

Conclusion

1. Dr Serafin conceded that he was unaware of the reason Dr Meneghetti had prescribed testosterone and nandrolone to Patient B. While Dr Serafin said that he was assured from his discussions with Dr Meneghetti that she was not prescribing for the purposes of bodybuilding or body enhancement, we find it more likely than not he was also unaware of the precise reason Dr Meneghetti had prescribed IGF-1, CJC-1295 to Patient B.
2. In circumstances where Dr Serafin was not aware of the condition(s) Patient B suffered, and for which the supplied substances were prescribed, an assurance of a general nature given by the prescriber that those substances were not being prescribed for the purpose of body building etc, cannot be said to amount to ensuring that those substances were for a purpose that accorded with recognised therapeutic standards.
3. But even if it is assumed that Dr Serafin understood that Patient B suffered from one of the conditions which, in his view the subject substances were appropriate to treat - weight loss, injury repair, osteoporosis, and fatigue (CJC and IGF-1), low testosterone levels (nandrolone) - the weight of evidence is that the efficacy of those substances to treat those conditions is not established.
4. Further, having reviewed the material on which Dr Serafin relies, we are not persuaded that it supports the proposition that "an informed and trained minority cohort of practitioners" share Dr Serafin's view that CJC and IGF-1 are safe and efficacious to use to treat those conditions, either at large, or in the case of Patient B. At best, they show that there are some studies which suggest that those substances show promise, warranting further studies about their efficacy and safety.
5. With respect to the dispensing of nandrolone and testosterone on 9 August 2016, Dr Serafin conceded in cross-examination that the dispensing of those substances together indicated "a potential for abuse". (Tcpt, 17 December 2020, p 101 (8-9)). He said that he would not have dispensed two types of testosterone products together and points out that they had been dispensed by dispensing pharmacist, Mr Jason Revell. In cross-examination Dr Serafin said that Mr Revell "was very aware that we needed to be very prudent about supply of those compounds to anyone". He said, as a proprietor, he could not be expected to be "looking over [Mr Revell's] shoulder".
6. Dr Serafin suggested in cross-examination that a possible reason for Mr Revell's decision to dispense nandrolone and testosterone together is because nandrolone is known to suppress endogenous testosterone production, and for that reason doctors prefer to add testosterone to maintain healthy levels.
7. The Pharmacy Board of Australia, "Guidelines on responsibilities of pharmacists when practising as proprietors" (December 2015) (the 2015 Proprietor Guidelines) and its predecessor, required Dr Serafin among other things to "maintain oversight of services being offered and goods being sold, especially those known to be subject to misuse or abuse". Dr Serafin is correct that his obligations under those guidelines did not extend to "standing over the shoulder" of an employed pharmacist each time they dispensed a drug. Nonetheless, the fact that Dr Serafin was unaware that Mr Revell had dispensed nandrolone and testosterone to Patient B on the same day until sometime later when he was notified of the Complaint evidenced that he failed to maintain adequate oversight of the dispensing of substances known to be liable for abuse.
8. We find that that Dr Serafin failed to ensure that the substances dispensed to Patient B were for a purpose that accorded with the recognised therapeutic standards of what was appropriate in the circumstances.

Sub-particular 3(ii): failing to take adequate steps to ensure that the patient was not abusing the subject substances

1. Dr Serafin acknowledges that he was aware that the subject substances were liable to abuse. However, he denies that he failed to take reasonable steps to ensure that those substances were not being abused by Patient B. In support he points to his claimed conversation with Dr Meneghetti in which she assured him that she was not prescribing those substances for body building or other non-therapeutic purposes.
2. In circumstances where each of the supplied substances was known to be liable to abuse, where Dr Serafin had not counselled Patient B, where he had no previous dealings with Dr Meneghetti, an assurance that she was not prescribing for non-therapeutic purposes could not be said to amount to adequate steps to ensure that Patient B was not abusing the subject substances.
3. Sub-particular 3(ii) is proven.

Sub-particular 3(iii): failing to have proper regard to patient's dispensing history

1. As noted, Dr Serafin admits this sub-particular.

Sub-particular 3(v): failing to keep contemporaneous notes of conversations with the patient and the prescriber

1. In circumstances where there is no evidence that Dr Serafin spoke with Patient B, or with Dr Meneghetti about Patient B, the allegation that Dr Serafin failed to keep contemporaneous notes of those conversations must fail.

Particular 4

1. Dr Serafin compounded and dispensed to Patient C: 1. on 10 June 2015, 10mL of CJC-1295 1mg/ml injection; and 2. on 27 October 2015, 10mL of Testosterone Cypionate 200mg/ml injection.
2. The prescriber in each case was GP Dr Bruce Heineman who also prescribed to Patient F and Patient H. Dr Serafin claims he knew Dr Heineman well and that Dr Heineman has an interest in musculoskeletal disorders and musculoskeletal patients (Tcpt, 15 December 2020, p 31 (14, 26)).
3. According to Dr Serafin: "[Dr Heineman] indicated that he would use testosterone in testosterone replacement therapy when men were tested and found to have low levels of testosterone and had associated symptoms. And he would use CJC, again, obviously to boost growth hormone levels in conditions when growth hormone was low or there was a condition that indicated the need for it like injury repair, that kind of thing." (Tcpt 18 December 2020, p 18(7)).
4. Dr Serafin admitted that he did not speak to Dr Heineman about Patient C and was unaware of the condition for which Patient C had been prescribed CJC-1295 and testosterone. He said he had assumed that it was to boost Patient C's testosterone and growth hormone levels. Dr Serafin said he genuinely and reasonably believed that the prescriptions were for a legitimate purpose.
5. As stated, Professor Carter is of the opinion that the safety and efficacy of CJC-1295 has not been established. In addition, in his opinion there is no evidence of clinical benefit of testosterone except for people who are testosterone deficient. In his opinion, the supply of CJC-1295 and testosterone to Patient C was not for proper therapeutic purpose.

Consideration

1. Given that CJC-1295 and testosterone were known to be liable for abuse, Dr Serafin did not know the condition(s) for which Dr Heineman had prescribed those substances, we find that Dr Serafin failed to ensure that the supply of the medications to Patient C was for a purpose, that accorded with the recognised therapeutic standards of what was appropriate in the circumstances.
2. Particular 4(i) is proven.
3. For largely the same reasons Particular 4(ii) (failing to take adequate steps to ensure that the patient was not abusing the subject substances) is also established.
4. We find that in dispensing Testosterone on 27 October 2015, Dr Serafin failed to have proper regard to Patient C's dispensing history in assessing the appropriateness of that medication and its associated risks. Particular 4(iii) is established.
5. For the reasons given in respect of Particular 3(v), Particular 4 (v) is not established.

Particular 5

1. Between 8 August 2016 and 3 May 2017, Dr Serafin compounded and dispensed IGF-1, Nandrolone, IGF-1 LR3 and CJC-1295 injections for Patient D 1. on 8 August 2016, 5mL of IGF-1 LR3 1000mcg/ml INJ; 2. on 8 August 2016, 10mL of Nandrolone Decanoate 200mg/ml IM INJ; 3. on 7 October 2016, 10mL of Nandrolone Decanoate 200mg/ml IM INJ; 4. on 11 October 2016, 5mL of IGF-1 LR3 1000mcg/ml INJ; 5. on 7 November 2016, 10mL of CJC-1295 2000mcg/ml, GHRP2 2000mcg/ml INJ; 6. on 19 April 2017, 10mL of Nandrolone Decanoate 200mg/ml IM INJ; and 7. on 3 May 2017, 10mL of CJC-1295 2000mcg/ml GHRP2 2000mcg/ml INJ.

Recognised therapeutic purpose

1. According to Dr Serafin, Patient D: 1. was diagnosed with a pituitary disorder at 30 years of age; 2. produces very little growth hormone (HGH) and testosterone; 3. over the years has tried IGF-1 as a substitute for HGH, as well as CJC, in an attempt to stimulate HGH production; 4. has tried various forms of testosterone and prefers nandrolone (due to experiencing less androgenic side effects) as a testosterone replacement in an attempt to function normally.
2. In Dr Serafin's opinion there is no sign that Patient D's condition will reverse and he will be on the subject substances "long term".
3. Dr Serafin said that that he was not concerned that the subject substances were not prescribed by a specialist. In his view, it is not difficult to manage a person with the types of disorders he understood Patient D to suffer "all you need to do is to get a blood test" to measure hormone and testosterone levels.
4. Dr Serafin asserts that the safety and efficacy of CJC, GHRP-6 and IGF-1 are well established.

Professor Carter

1. Professor Carter explained that IGF-1 LR3 " is a synthetic analogue of IGF-1", which differs from "native IGF-1" in several respects and as a consequence, it "retains the pharmacological activity of IGF-1 while it has approximately three times greater potency associated with a significantly longer half-life".
2. In Professor Carter's opinion, like IGF-1, the efficacy of IGF-1 LR3 has not been established for treatment, except for of IGF-1 deficient patients. With respect to the safety and efficacy of IGF-1 LR3, Professor Carter said that the opinions he expressed in relation to IGF-1 apply equally.

Consideration

1. We accept Professor Carter's opinion that the efficacy of IGF-1, IGF-1 LR3 and CJC-1295 for the treatment of pituitary disorders is not established. In addition, we accept his opinion that the efficacy of nandrolone has only been established with respect to the treatment of anaemia with renal insufficiency.
2. For the reasons given above, we do not accept that the material on which Dr Serafin relies supports the proposition that an informed and trained minority cohort of practitioners share Dr Serafin's view that IGF-1, IGF-1 LR3 and CJC-1295 are safe and efficacious to use to treat pituitary disorders, and that nandrolone is safe and efficacious to treat "low testosterone levels", either at large, or in the case of Patient D. At best, the available material reveals that those substances show promise, warranting further studies about their efficacy and safety.
3. Sub-particular 5(i) is established.

Sub-particular 5(ii): failing to take adequate steps to ensure that the patient was not abusing the subject substances

1. There is no evidence, and nor is it suggested, that Dr Serafin discussed with the prescriber the reason for prescribing the subject substances to Patient D. In circumstances where the subject substances were known to be liable to abuse, reliance on a patient's self-report that they were not interested in body building or "obsessive about the gym" cannot be said to represent adequate steps to ensure that the patient was not abusing the subject substances.
2. Sub-particular 5(ii) is proven.

Sub-particular 5(iii): failing to have regard to patient's dispensing history

1. For the reasons given in relation to sub-particular 1(iii), this sub-particular is established.

Sub-particular 5(v): failing to keep contemporaneous notes of discussions with Patient D

1. Dr Serafin does not claim that he spoke with the prescriber about Patient D. He claims that he "regularly spoke" with Patient D. Dr Serafin made a note of a single conversation with Patient D: "Spoke with [Patient D] 8/8/16-has pituitary issues so produces little HGH and Testo. Lots of symptoms so supplements."
2. As formulated, this sub-particular requires the Commission to establish that Dr Serafin failed to keep contemporaneous notes of any conversation with Patient D. While self-evidently Dr Serafin failed to keep notes of each claimed conversation with Patient D, it cannot be said that he failed to keep contemporaneous notes of any conversation with Patient D. This sub-particular must fail.

Particular 6

1. Between June 2015 and June 2016, Dr Serafin compounded and dispensed to Patient E: (i) on 22 March 2016, 10mL of Nandrolone Decanoate 200mg/ml IM INJ; (ii) on 22 March 2016, 5mL CJC-1295 2mg/ml Ipamorelin 2mg/ml INJ; (iii) on 20 April 2016, 15mL CJC-1295 2mg/ml Ipamorelin 2mg/ml INJ; and (iv) on 22 June 2016, 10mL CJC-1295 2mg/ml Ipamorelin 2mg/ml INJ.
2. The prescriptions dispensed on 22 March 2016 were issued by Dr Cameron Day; those dispensed in April and June 2016 were issued by Dr Stephen Hadges.
3. In February 2018 the Health Practitioners Tribunal of South Australia suspended Dr Hadges' registration for a period of 8 months: Medical Board of Australia v Stephen Hadges [2018] SAHPT. The Tribunal found among other things that Dr Hadges had prescribed anabolic androgenic steroids and human growth hormones without clinical justification.
4. According to Dr Serafin, Patient E told Pharmacy staff that he was had a "severe injury" and for that reason was using nandrolone and CJC.
5. We accept the opinion expressed by Professor Carter that the efficacy of nandrolone, CJC to treat "severe injury" is not established. In addition, we accept his opinion as expressed in relation to Patient B that the safety and quality of CJC is not established.
6. We are not persuaded that an informed and trained minority cohort of practitioners supports either Nandrolone and CJC to treat "severe injury" at large or in the case Patient E.
7. 307308 Sub-particular 6(i) is established

Sub-particular 6(ii): failing to take adequate steps to ensure that the patient was not abusing the subject substances

1. According to Dr Serafin during phone conversations with Patient E he detected no signs that he was abusing the subject substances. He stated that Patient E told him that that he was not a body builder or a "motivated athlete".
2. Where, as here, the subject substances are known to be subject to abuse, a single discussion with a patient cannot be said to constitute adequate steps to ensure that the patient was not abusing those substances.
3. Sub-particular 6(ii) is established.

Sub-particular 6(iii): failing to have regard to Patient E's dispensing history

1. For the reasons given in relation to sub-particular 1(iii), this sub-particular is established.

Sub-particular 6(v): failing to keep contemporaneous notes of discussions with Patient E

1. According to Dr Serafin he spoke with Patient E and made the following note in his file: "23/3/16 spoke with [Patient E] - severe injury using peptides and Testo to aid recovery"
2. Dr Serafin does not claim to have spoken with either prescriber about Patient E. For the reasons given in relation to sub-particular 1(v), this sub-particular must fail.

Particular 7

1. On 10 June 2015 Dr Serafin compounded and dispensed to Patient F: 1. 20mL of nandrolone decanoate 200mg/ml IM INJ; 2. 10mL of GHRP-6 2mg/ml; and 3. 10mL of CJC-1295 1mg/ml.
2. As noted above according to Dr Serafin he knew the prescriber, Dr Bruce Heineman, well. Dr Heineman had assured him he was not prescribing for sports or body building but rather for therapeutic purposes. In a statement dated 26 June 2020, Dr Serafin said that he discussed "these products" (presumably nandrolone decanoate, GHRP-6 and CJC-1295) with Dr Heineman and informed Dr Heineman that they should only be prescribed when the patient's hormone levels were low.
3. In Dr Serafin's opinion: "As Nandrolone binds to testosterone receptors and CJC/GHRP-6 regulate HGH production it is clear they have different physiological functions, and if doses are considered safe, no expected problems are anticipated for these combinations as their endogenous counterparts occur together and maintain healthy physiological function without any issues. Clinical experience supports this. In addition, CJC/GHRP-6 ideally should be used in combination to mimic endogenous Growth Hormone Releasing Hormone (CJC 12195) and endogenous Growth Hormone Release Peptide (GHRP-6) which both work synergistically to regulate HGH production, so are prescribed in combination for circumstances where HGH would be prescribed. Studies are available for both peptides indicating their safety."
4. With respect to GHRP-6 Professor Carter states that: 1. The safety, quality, and efficacy of GHRP-6 has not been established. This peptide stimulates endogenous GH secretion with the aim of inducing protein anabolism and lipolysis. It has also been used in an attempt to enhance muscle injury repair and also as an anti-ageing agent. Although GH injections have proven benefits in GH deficient individuals, no significant beneficial effects have been documented when used in adults with normal GH levels. 2. There are no clinical indications for prescribing GHRP-6 in normal individuals. 3. There are no accepted therapeutic standards with respect to dosage and duration. 4. There is a paucity of clinical data relating to risks from prescribing GHRP-6. In view of the mode of action, which is via increasing endogenous GH secretion, an increase in the development of glucose intolerance in addition to the possibility of peripheral oedema, arthralgias, carpal tunnel syndrome, and gynaecomastia may be expected. Glucose intolerance or diabetes would be a relative contraindication as would underlying peripheral oedema along with carpal tunnel syndrome. 5. He is unaware of any clinical trials establishing the safety and efficacy of GHRP-6.

Consideration

1. Dr Serafin admits that he did not discuss with Dr Heineman the reason he had prescribed nandrolone decanoate, GHRP-6 and CJC-1295 to Patient F. For the reasons given in relation to Patient B, in circumstances where Dr Serafin was not aware of the condition(s) Patient F suffered, and the purpose for which each of the substances was prescribed, an assurance given by Dr Heineman that he was not prescribing those substances for body building etc, does not amount to ensuring that those substances were in a quantity or for a purpose that accorded with the recognised therapeutic standards.
2. Sub-particular 7(i) is established.
3. Given that Dr Serafin did not speak with Patient F or discuss with Dr Heineman the reason he had prescribed the subject substances to Patient F, we find that Dr Serafin failed to take adequate steps to ensure that Patient F was not abusing the subject substances. Sub-particular 7(ii) is established.

Sub-particular 7(iv): failing to keep contemporaneous notes of discussions with Patient F

1. Sub-particular 7(iv) rests on the premise that Dr Serafin had discussions with Patient F and/or Dr Heineman about the medical reasons etc for prescribing the subject substances etc. That premise is not established. It follows that sub-particular 7(iv) is not proven.

Particular 8

1. Between October 2015 and June 2017, Dr Serafin and/or pharmacists in his employ compounded and dispensed nandrolone, CJC-1295 and SARMs injections for Patient G as follows: 1. 10mL of Nandrolone Decanoate 200mg/ml IM INJ on 23 October 2015; 2. 10mL of Nandrolone Decanoate 200mg/ml IM INJ on 10 June 2016; 3. 10mL of Nandrolone Decanoate 200mg/ml IM INJ on 8 February 2017; 4. 10 mL of CJC-1295 2000mcg/ml GHRP2 2000mcg/ml INJ 14 June 2017; 5. 20mL of SARMS 3000mcg/ml INJ on 14 June 2017; and 6. 10mL of Nandrolone Decanoate 200mg/ml IM INJ on 14 June 2017.
2. According to Dr Serafin he knew the prescriber Dr Bellich well and they spoke "fairly often". He claimed that they discussed these products (by which we understand Dr Serafin to mean CJC-1295 and SARMs) and he told Dr Bellich that they should only be prescribed where the patients' hormone levels were low and required appropriate therapy to bring them up to normal levels. With respect to nandrolone, Dr Serafin claimed that he accepted Dr Bellich's assurance that he would only prescribe nandrolone where a MRI confirmed that the patient had tissue damage.
3. For the reasons given in relation to Patient B, in circumstances where Dr Serafin was not aware of the condition(s) Patient G suffered, and the purpose for which each of the substances was prescribed, an assurance of a general nature given by Dr Bellich that he was not prescribing those substances for body building etc, does not amount to ensuring that those substances were in a quantity or for a purpose that accorded with the recognised therapeutic standards. Sub-particular 8(i) is established.
4. There is no evidence that Dr Serafin spoke to Patient G or spoke to Dr Bellich about the reason he was prescribing nandrolone, CJC-1295 and SARMs to patient G. It follows that Dr Serafin failed to take adequate steps to ensure that Patient G was not abusing those substances. Sub-particular 8(ii) is established.

Sub-particular 8(iii): failing to have regard to Patient G's dispensing history

1. In cross-examination Dr Serafin conceded that the dispensing of nandrolone and SARM S-22 by Mr Revell on the same day was a cause for concern and something he would not have permitted.
2. We find that, in concurrently dispensing nandrolone and SARM S-22, Mr Revell failed to have proper regard to Patient G's dispensing history, in particular the risk associated with concurrent use of nandrolone and SARM S-22. For the reasons given in relation to Particular 3, we find that Dr Serafin failed to maintain adequate oversight of the dispensing of substances known to be liable for abuse as required by the Proprietor Guidelines. Sub-particular 8(iii) is established.

Sub-particular 8(v): failing to keep contemporaneous notes of discussions with Patient G

1. As with sub-particular 1(v), this sub-particular rests on the premise that Dr Serafin had discussions with Patient G and/or Dr Bellich about the medical reasons etc for prescribing the subject substances etc. That premise is not established. Sub-particular 8(iv) must fail.

Particular 9

1. Between 10 June 2015 and 27 October 2015, Dr Serafin compounded and dispensed CJC-1295, GHRP-6 and testosterone injections for Patient H as follows: 1. 10mL of CJC-1295 1mg/ml injection on 10 June 2015; 2. 10mL of GHRP-6 2mg/ml injection on 10 June 2015, and 3. 10mL of Testosterone Cypionate 200mg/ml on 27 October 2015.
2. Dr Serafin admits not knowing the reasons Dr Heineman had prescribed CJC-1295, GHRP-6 and Testosterone Cypionate to Patient H. As with Particular 7, Dr Serafin claims that he was confident that Dr Heineman was prescribing these substances for a proper therapeutic purpose but did not discuss the reason he had prescribed these substances to Patient H.
3. The reasons we gave in relation to Particular 7 apply equally to this particular. Sub-particulars 9(i) and 9(ii) are proven. Sub-particular 9(v) is not proven.

Sub-particular 9(iii): failing to have regard to Patient H's dispensing history

1. While Dr Serafin contends that the decision to supply Patient H was reasonable, he does not claim he took into account Patient H's dispensing history before approving that dispensing. For the reasons given in relation to sub-particular 1(iii), this particular is established.

Particular 10

1. Between 23 February 2015 and 12 January 2017, Dr Serafin compounded and dispensed nandrolone and CJC-1295 for Patient I as follows: 1. 10mL of Nandrolone Decanoate 200mg/ml IM INJ on 23 February 2015; 2. 10mL of Nandrolone Decanoate 200mg/ml IM INJ on 28 May 2015; 3. 10mL of Nandrolone Decanoate 200mg/ml IM INJ on 28 September 2015, and 4. 10mL of Nandrolone Decanoate 200mg/ml IM INJ on 6 January 2016; 5. 10mL of CJC-1295 2000mcg/ml GHRP6 2000mcg/ml injection on 24 March 2016; 6. 10mL of Nandrolone Decanoate 200mg/ml IM INJ on 18 July 2016, and 7. 10mL of Nandrolone Decanoate 200mg/ml IM INJ on 12 January 2017.
2. Dr Serafin admitted that he did not speak to the prescriber, Dr Bellich about the reason he had prescribed nandrolone decanoate, CJC-1295 and GHRP6 to Patient I. Nor is there any evidence that Dr Serafin spoke with Patient I.
3. Given those circumstances, for the reasons given in relation to Particular 3 (Patient B), sub-particulars 10(i) and (ii) are established.
4. For the reasons given in relation to sub-particular 9(iii), sub-particular 10(iii) is established.
5. As there is no evidence that Dr Serafin spoke with Patient I or with Dr Bellich about Patient I, sub-particular 10(v) must fail.

Particular 11

1. Between 3 December 2014 and 30 January 2017, Dr Serafin compounded and dispensed, and/or failed to ensure that the pharmacists in his employ appropriately compounded and dispensed, CJC-1295, GHRP-6, testosterone and SARMs for Patient J as follows: 1. 10mL of CJC-1295 2mg/ml injection on 3 December 2014; 2. 10mL of GHRP-6 2mg/ml injection on 3 December 2014; 3. 10mL of CJC-1295 2mg/ml injection on 4 February 2015; 4. 10mL of GHRP-6 2mg/ml injection on 4 February 2015; 5. 10mL of Testosterone Cypionate 200mg/ml on 4 February 2015; 6. 10mL of GHRP-6 2mg/ml injection on 5 February 2015; 7. 10mL of CJC-1295 2mg/ml injection on 29 September 2015; 8. 20mL of GHRP-6 2mg/ml injection on 29 September 2015; 9. 50mL of CJC-1295 GHRP-6 400mcg/ml cream on 26 November 2015; 10. 50mL of CJC-1295 GHRP-6 400mcg/ml cream on 26 February 2016; 11. 50mL of CJC-1295 400mcg/ml and GHRP6 400mcg/ml cream on 27 September 2016; 12. 20mL of SARMS 3000mcg/ml injection on 17 January 2017; 13. 50mL of CJC-1295 400mcg/ml and GHRP6 400mcg/ml cream on 30 January 2017.
2. Dr Serafin claims that Patient J told him that he had a pituitary disorder. In the patient profile, Dr Serafin wrote: "Spoke with [Patient J] 4/12/14-has pituitary issues so suffers low HGH and testo. Bad symptoms so supplements".
3. Dr Serafin claims that he spoke a couple of times with the prescribing doctor, Dr Anthony Nigro, and was confident of his ability to "prescribe responsibly". In a statement dated 29 June 2020, Dr Serafin stated "I had not had an in-depth discussion with the prescriber". That statement is consistent with the statement made by Dr Serafin in his section 40 response, dated 20 September 2018, in which referring to a group of patients of which Patient J was one, he wrote "I either spoke with the patient and/or their doctor prior to supply to ascertain the reason why they were being prescribed". At best, it appears that Dr Serafin had a conversation of a general nature with Dr Nigro about prescribing the subject substances. Dr Serafin does not claim that he spoke with Dr Akram Bangash, the prescriber of the substances dispensed on 17 January 2017 and 30 January 2017.
4. We find that Dr Serafin failed to ensure that the supply of CJC-1295, GHRP-6, testosterone and SARMs for Patient J was in a quantity, or for a purpose, that accorded with the recognised therapeutic standards of what was appropriate in the circumstances for these reasons: 1. As noted by Professor Carter, Dr Serafin's understanding that Patient J had a "pituitary disorder" was neither confirmed by the prescribing practitioner(s) nor supported by any documentary evidence. In Professor Carter's opinion, before considering prescribing any GH releasing drugs or testosterone, it should be mandatory to document a testosterone and GH deficiency. 2. We accept Professor Carter's opinion that the safety and efficacy of CJC-1295, GHRP-6 and SARMs is not established. 3. The material on which Dr Serafin relies does not, in our view, support the conclusion that an informed and trained minority cohort of practitioners are of the opinion that the CJC-1295, GHRP-6, testosterone and SARMs in the quantities and, in the combination to which they were supplied to Patient J, were both safe and effective to treat a "pituitary disorder". Notably, as acknowledged by Dr Serafin, the long-term effects of using CJC-1295, GHRP-6, testosterone and SARMs are unknown. In cross-examination, Dr Serafin said on reflection that Patient J's long-term use of CJC-1295 and GHRP-6 was a "cause of concern". (Tcpt, 18 December 2020, p 34 (22-23)).
5. Sub-particular 11(i) is proven.

Sub-particular 11(ii): failing to take adequate steps to ensure that Patient H was not abusing the subject substances

1. Dr Serafin acknowledges that he was aware that the subject substances were liable to abuse. He said he was confident, after a discussion with Patient J, that the patient was not a "gym junkie". In oral evidence Dr Serafin claimed to have had "several conversations" with Patient J. The only record made by Dr Serafin of those conversations is that set out above. It is said to have occurred on 4 December 2014, the day after the first dispense of CJC-1295 and GHRP-6.
2. In circumstances where the subject substances were known to be liable to abuse, where they were supplied to Patient J over an extended period, where there was no documentary evidence to support the proposition that Patient J had a pituitary disorder, where Dr Serafin did not discuss with the prescribing practitioners the reason for prescribing the subject substances, a discussion with Patient J and a self report that he was not a gym junkie could not be said to amount to adequate steps to ensure that Patient J was not abusing those substances.

Sub-particular 11(iii): failing to have regard to Patient H's dispensing history

1. For the reasons given in relation to sub-particular 1(iii), sub-particular 11 (iii) is established.

Sub-particular 11(iv): failing to keep contemporaneous notes of discussions with Patient H, Dr Nigro and or Dr Bangash

1. Dr Serafin does not claim to have discussed Patient J with either prescriber. While he did not record each of the claimed conversations with Patient J, it cannot be said that Dr Serafin failed to keep contemporaneous notes of any conversations with Patient J.
2. Sub-particular 11(iv) must fail.

Particular 12

1. On 8 August 2016, Dr Serafin compounded and dispensed to Patient K: 1. 20mL of CJC-1295 2000 mcg/ml Ipamorelin injection; 2. 10mL of IGF-1 LR3 1000 mcg/ml injection; and 3. 10mL of Testosterone Cypionate 200 mg/ml injection.
2. Dr Meneghetti prescribed the above substances to Patient K. As with Particular 2, Dr Serafin does not claim that he spoke with Patient K or with Dr Meneghetti about Patient K.
3. For the reasons given in relation to Particular 3, sub-particulars 12(i) and 12(ii) are established. Sub-particular 12(iv) fails.

Particular 13

1. In final submissions, Dr Serafin stated that he admitted the facts of Particular 13. It appears that Dr Serafin admits sub-particular (i) (failing to ensure that the supply of the medications to Patient L accorded with the recognised therapeutic standards), sub-particular (ii) (failing to take adequate steps to ensure that Patient L was not abusing those medications), sub-particular (iii) (failing to have proper regard to Patient l's dispensing history), and sub-particular (iv) (failing to keep contemporaneous notes of any conversations with Patient L and the prescriber). We do not understand Dr Serafin to admit the balance of the sub-particulars.
2. Dr Serafin compounded and dispensed the following prescriptions to Patient L: 1. between 6 July 2015 and 9 November 2015 10mL vials of CJC-1295 2000mcg/ml GHRP-6 2000mcg/ml for injection on 5 occasions; 2. between 26 May 2015 and 15 February 2016 10mL vials of GHRP-6 2mg/ml for injection on 10 occasions; 3. between 15 May 2015 and 9 November 2015 3 x 10mL vials and 7 x 5mL vials of Melatonin II 2000mcg/ml for injection; 4. between 13 April 2015 and 1 September 2015 1 x 10mL and 2 x 20mL vials of Nandrolone Deaconate 200mg/ml for injection on 3 occasions; 5. between 26 May 2015 and 23 September 2015 2 x 10mL and 2 x 20mL vials of SARMs 300mcg/ml for injection; 6. between 16 February 2015 and 12 November 2015 3mL vials of Somatropin (Growth Hormone) 30IU for injection on 9 occasions for a total of 35 x 3mL vials; 7. between 9 November 2015 and 19 January 2016 1 x 30mL Testosterone for injection and 2 x 40mL Testosterone for injection.
3. Dr Serafin claimed that he contacted the prescribing practitioner, Dr Robert Mackay, to verify the legitimacy and quantity of the first prescription issued, a prescription for somatropin. According to Dr Serafin, Dr Mackay said he had prescribed somatropin because Patient L had low HGH and testosterone levels, and as a result, he would not recover from an injury and its associated symptoms. In addition, Dr Serafin claimed that he was informed by Dr Mackay that Patient L had a "pituitary issue".
4. Dr Serafin claimed throughout the 12 months the Pharmacy supplied substances to Patient L Dr Mackay experimented with HGH and various HGH secretagogues such as CJC and GHRP-6 in an attempt to raise Patient L's HGH levels.
5. Dr Serafin claimed that the reason Patient L switched from HGH to GHRP-6 in May 2015 was because the introduction of new compounding guidelines prevented the Pharmacy compounding HGH and the commercially available product was too expensive.
6. Dr Serafin claimed that, in mid-February 2016, he reviewed Patient L's history and noticed the large number of PAHs (peptides and hormones) supplied to Patient L over the past year, and that several repeat intervals of supply were a "little short". He said that it was only at that point that he became aware of the frequency and the volume of the supply, which in his view was inappropriate. It was, according to Dr Serafin, then that he informed Patient L that the Pharmacy would no longer supply him. Dr Serafin concedes that Patient L "fell through the cracks" and this had occurred because dispensing staff had failed to pick up on Patient L's "history and supply". He said he had failed to detect that the protocols he had put in place for dispensing staff were not being followed. He claimed that this was a result of a heavy workload and personal pressures.
7. Dr Serafin properly concedes that the quantities of substances supplied to Patient L were excessive. Given the nature, quantity, frequency and combination of the substances prescribed, we find that Dr Serafin failed to ensure that the supply to Patient L was in a quantity, and for a purpose, that accorded with the recognised therapeutic standards of what was appropriate in the circumstances.
8. Sub-particular (i) is established.
9. As noted, Dr Serafin admits sub-particulars (ii), (iii) and (iv).

Sub-particular 1(iv): insufficient precedents

1. Sub-particular (iv), which is denied by Dr Serafin, is common to each particular and alleges that: "there were insufficient precedents available at the relevant time to support the practitioner's decisions to compound the medications for [the subject patient] including in combination with other scheduled medications of a similar nature."
2. The Pharmacy Board of Australia, "Guidelines on Compounding of Medicines" (March 2015) (2015 Compounding Guidelines) states: "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 2 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 … 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. … Formulations for which Precedents do not Exist … 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 … 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. In the absence of such documented evidence, a pharmacist must not compound such products.
3. Dr Serafin agrees that at the time he supplied the subject substances there were no applicable pharmacopoeia standards or precedents. Pharmacopoeias provide standards for pharmaceutical substances. In Australia, the recognised pharmacopoeias include the British Pharmacopoeia, the European Pharmacopoeia, the United States Pharmacopeia-National Formulary. (See s 10 of the TGA Act).
4. However, Dr Serafin contends that, notwithstanding the absence of any pharmacopoeia precedents for the subject peptides, there was a reasonable basis for his belief that the available precedents supported his decision to compound them, including in combination with other subject substances. He pointed out that the subject substances were used by practitioners in Australia and overseas. In addition, he asserted that "dosage protocols" had been developed in accordance with the "published studies" and had a safe track record.
5. Commenting on the operation of the 2015 Compounding Guidelines, in circumstances where there are no pharmacopoeia precedents, Dr Serafin said: "[T]he compounding guidelines submitted in 2015 do refer to the fact that we can - at least my interpretation of any other pharmacist's interpretation, we can supply medications when there is no precedent as long as we have got - we document safety data and obviously there's a prescription involved so the doctor has looked at it and obviously agreed or they have evaluated it and thought that this was a potentially useful treatment." (Tcpt, 17 December 2020, p 91 (9-15))
6. Dr Serafin said he had taken into account the dosage protocols used by Dr Pearce which he stated accorded with "most of the doctors from overseas like Thierry Hertoghe and Dr Seed."

Consideration

1. Where, as here, a pharmacist is requested to compound substances for which there are no pharmacopoeia precedents, the 2015 Compounding Guidelines instruct that "particular care" must be exercised and the compounding of such products must be justified by the pharmacist "obtaining additional data and/or evidence".
2. The issue raised by sub-particular (iv) is whether there were sufficient precedents available to support Dr Serafin's decisions to compound the subject substances prescribed for Patient A. While the Commission bears the evidentiary burden, in circumstances where the issue has been squarely raised, where there were no pharmacopoeia precedents for the subject substances, where Dr Serafin has failed to provide evidence to support the claim that the precedents he used were sufficient to support his decision to compound the subject substances alone, or in combination with the other substances supplied to the individual patients, we find this sub-particular proven.

Sub-particular (v) or (vi): adequate dispensing procedures etc

1. The following sub-particular is common to each particular and alleges that Dr Serafin: "Failed to ensure that there were adequate dispensing procedures, systems and protocols in place for dispensary technicians and pharmacists, including himself, at the Pharmacy for the compounding of medications for [the subject patient]."
2. Dr Serafin denies this sub-particular and states that throughout the period covered by these particulars there was: 1. a procedure manual kept in reception for dispensing technicians to follow; 2. Standard Operating Procedures made available for the compounding technicians; 3. a checking procedure for the pharmacists.
3. In responding to Particular 13, Dr Serafin acknowledged that, between mid-2014 and early 2016 several dispensing procedures were not being followed. Specifically, checking patients' dispensing history before a prescription was handed to the pharmacist for approval to fill.
4. In addition, the evidence reveals that throughout the period covered by these particulars, numerous dispensing errors were made including issuing out-of-date prescriptions. When interviewed by PRU inspectors on 3 February 2017 about whether the Pharmacy's dispensing system flagged out-of-date prescriptions, Dr Serafin responded, "No. I'm actually in the process of getting a new system because ours is an American-based compounding system and it's pretty basic in its reporting and what not, so I'm trying to update to get something to flag stuff like that". In addition, Dr Serafin admitted that the dispensing system failed as required to identify and record the name of the dispenser.
5. According to Dr Serafin, in 2016 he introduced several new practices and procedures to address these shortcomings, including procedures for checking work sheets and conducting final checks before dispensing a product.

Consideration

1. Dr Serafin's denial of this particular is at odds with his acknowledgement of the identified problems in the Pharmacy's dispensing systems. Over an extended period, among other things, Pharmacy staff repeatedly failed to follow the procedures Dr Serafin put in place to ensure that prescriptions were not dispensed without the patient's dispensing history being reviewed. Dr Serafin failed to detect that those procedures were not being followed. This systemic non-compliance reveals that the procedures, systems and protocols in place were demonstrably inadequate.
2. Sub-particular (vi) of Particulars 1, 3, 4, 5, 6, 8, 9, 10, 11 and 13 and sub-particular (v) of Particulars 7 and 12 is proven.

Summary

1. Sub-particular (v) of Particulars 1, 3, 4, 5, 6, 8, 9, 10, 11, and 13 and sub particulars (iv) of 7 and 12 are not proven. The balance of each of these particular is proven. The premise central to each particular is established: that, because of the proven conduct (as identified in the sub-particulars) Dr Serafin inappropriately compounded and dispensed and/or failed to ensure that the pharmacists in his employ appropriately compounded and dispensed the subject substances.

Unsatisfactory professional conduct

1. The standard reasonably expected of all pharmacists is to ensure that any restricted substance supplied is supplied in a quantity, or for a purpose, that accords with the recognised therapeutic standards of what is appropriate in the circumstances. That standard is reflected in cl 54 of the PTGR. Clause 34 of the PTGR imposes a corresponding obligation on medical practitioners and makes it an offence to issue a prescription for a restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
2. As explained above, we found that Dr Serafin failed to ensure that the substances supplied to the patients the subject of these particulars was in a quantity, or for a purpose, that accords with the recognised therapeutic standards.
3. As Dr Serafin correctly points out, neither the PTGR nor the PTGA prohibit GPs from prescribing any of the subject substances. In addition, by 1 May 2015, each of those substances were scheduled as either S 4B or S 4B, none as S 9.
4. That there was no prohibition on supplying (or prescribing) any of the subject substances did not absolve Dr Serafin (or the prescriber) from the obligation to ensure that they were supplied (or prescribed) in a quantity, or for a purpose, that accorded with the recognised therapeutic standard of what is appropriate in the circumstances. Nor does the fact that the substances had been prescribed by a GP absolve Dr Serafin from that obligation.
5. We acknowledge that where, as here, a substance is prescribed off-label, the task of determining whether it is being supplied in a quantity and for a purpose that accords with the recognised therapeutic standards of what is appropriate in the circumstances is especially difficult. Unlike the prescribing practitioner, a dispensing pharmacist generally does not have the detailed information about a patient's condition and medical history. Nonetheless, that does not excuse a pharmacist from the obligation to ensure that restricted substances supplied to patient are in a quantity and for a purpose that accords with the recognised therapeutic standards. Nor does it permit a pharmacist to defend the supply by pointing out that the substance was prescribed by a medical practitioner. In our view, Dr Serafin's actions in supplying the subject substances, in circumstances where he failed to ensure that their supply accorded with those standards, demonstrates that the judgement he possessed, and care exercised, fell significantly below the relevant standard.
6. In addition, we find that the following are standards reasonably expected of an experienced and highly trained pharmacist: 1. to take adequate steps to ensure that a patient was not abusing supplied substances known to be liable to abuse; 2. to have proper regard to a patient's dispensing history, especially where, as here, supplied substances were, in the main, novel and known to be liable to abuse; 3. to only compound substances where there are sufficient precedents available to support a decision to compound those substances; 4. in the case of proprietor pharmacists, to ensure that there were adequate dispensing procedures, systems and protocols in place to ensure that substances were not compounded and dispensed without review of the patient dispensing history.
7. The proven conduct the subject of each particular demonstrated that the care exercised, and judgement possessed by Dr Serafin fell significantly below each of these standards.

Particular 2

1. Dr Serafin admits Particular 2 which states: "The practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed a prescription dated 25 May 2015 for Patient A for Testosterone/ Progesterone/ DHEA cream, with 2 repeats contrary to Clause 39(2)(b) of the PTGR as no interval for repeats was specified."
2. A prescription for a special restricted substance must include the details of intervals at which the substance may be supplied on the prescription: cl 35(1)(f) of the PTGR. The Pharmacy dispensed repeat supplies of testosterone/progesterone/DHEA cream on the basis of a prescription for Patient A dated 25 May 2015, which failed to stipulate repeat intervals.
3. Dr Serafin stated that the dispensing of testosterone/progesterone/DHEA cream on a prescription which failed to stipulate repeat intervals was an oversight and the result of a heavy workload and family commitments throughout the period, mid-2014 to early 2016.

Unsatisfactory professional conduct

1. Mr Chilton characterised Dr Serafin's action in dispensing the subject prescription in circumstances where it did not stipulate repeat intervals as a "procedural oversight".
2. Dr Serafin's actions in dispensing testosterone/progesterone/DHEA cream in circumstances where the prescription did not contain repeat intervals undoubtedly fell below the relevant standard. While close to the line, as a one-off instance we are not persuaded that it demonstrates that the care exercised by Dr Serafin fell significantly below the relevant standard.
3. Particular 2 is not established.

Particulars 14, 15, 16 and 17

1. Each particular relates to the dispensing of substances to Patient L (the subject of Particular 13) in circumstances where the subject prescription is alleged not to comply with one or more of the requirements imposed by the PTGR.

Particular 14

1. Dr Serafin denies Particular 14 which states: "On 13 April 2015, 18 August 2015 and 1 September 2015, the practitioner inappropriately dispensed Nandrolone, a Schedule 4D prescribed restricted substance, to Patient L as follows: i. The prescriptions listed the drug as "Mamdrolome"; ii. The prescription was for 30 repeats with no repeat intervals specified; iii. Contrary to Clause 34 of the PTGR as the prescription was in a quantity, or for a purpose, that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances; iv. Contrary to Clause 35 of the PTGR as the prescription failed to specify the name, strength and quantity of the substance to be supplied, adequate directions for use and the intervals at which the substance may be supplied on the prescription; and v. Contrary to Clause 39(2)(b) of the PTGR as no interval for repeats was specified.
2. Dr Serafin denies: 1. that he dispensed nandrolone to Patient L on 13 April 2015, 18 August 2015 and 1 September 2015 on the basis of the prescription dated 9 April 2015 (Exhibit A1, Tab 90) (the subject prescription); 2. that it was inappropriate to dispense nandrolone to Patient L in circumstances where the subject prescription, which listed the drug prescribed as "Mamdrolome", was for 30 repeats, did not specify repeat intervals, and did not contain directions for use; 3. that the subject prescription failed to specify the name, strength and quantity of the substance to be supplied; 4. that the subject prescription was in a quantity, or for a purpose, that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances.

Dispensing on the basis of the subject prescription

1. In his statement dated 29 June 2020, Dr Serafin admitted Particular 14 but denied that the admitted conduct amounted to unsatisfactory professional conduct. In final submissions he denied Particular 14.
2. Dr Serafin does not dispute that the Pharmacy dispensed nandrolone to Patient L on 13 April 2015, 18 August 2015 and 1 September 2015. However, in cross-examination, apparently for the first time, Dr Serafin claimed that the nandrolone was not dispensed on the basis of the subject prescription. Rather, it was dispensed on the basis of some other prescription: "We had other prescriptions for nandrolone that we dispensed from". (Tcpt, 18 December 2020, p 50(32)). When asked why he had failed to produce those prescriptions in these proceedings, Dr Serafin said the Commission had not requested him to do so (Tcpt 18 December 2020, p 50(32)). Dr Serafin pointed out that the subject prescription did not carry a dispense sticker which he asserts indicated that it had been rejected by the Pharmacy.
3. For the following reasons, we reject Dr Serafin's claim that the nandrolone dispensed to Patient L was not dispensed on the basis of the subject prescription: 1. Dr Serafin has consistently claimed that he was aware of, and raised with Patient L, the misdescription of nandrolone on the subject prescription. For example, in final submissions dated 6 May 2021, Dr Serafin stated "it was confirmed with Patient [L] that he required Nandrolone and not Mandrolone". Self-evidently, the reason Dr Serafin sought clarification from Patient L was because of the misdescription of nandrolone on the subject prescription. 2. Dr Serafin has been on notice for over three years that the Commission alleges that the nandrolone dispensed to Patient L on 13 April 2015, 18 August 2015 and 1 September 2015 was dispensed on the basis of the subject prescription. In those circumstances, Dr Serafin has failed to satisfactorily explain the reason for failing to produce the actual prescription.

Dispensing Nandrolone in circumstances where the prescription listed the drug as "Mamdrolome"

1. Dr Serafin argued that, while it was not "best practice", it was appropriate to dispense Nandrolone on the basis of the subject prescription because: 1. he was aware from discussions with Patient L and "background conversations" with the prescriber that Patient L suffered from testosterone deficiency; 2. the quantity and dosage prescribed was consistent with his understanding of what is commonly prescribed to patients with a testosterone deficiency.
2. The spelling of "Mamdrolome" and "Nandrolone" are materially different. In his supplementary statement dated 5 November 2018, Mr Cotterell stated: "I acknowledge that handwritten prescriptions pose a difficult challenge and a lot of interpretation can be implied. I also understand that prescribers may not know how to correctly spell the medication, however this is usually a slight misspell and generally the prescriber "smudges or slurs" the letters to hide the misspell. When a prescriber does this for a medication that they may never have prescribed before, or for a medication that has a high risk for misuse alarm bells begin to sound. A simple phone call to the prescriber to confirm what is being written, as well as clarifying the prescriber's intentions allow for the opportunity to confirm the dosage, the intended use and a treatment guide. The pharmacist would then annotate the prescription as to the outcome of the call AND REQUEST A CORRECTED PRESCRIPTION BE WRITEN AND SENT. " (Emphasis in the original)
3. On the other hand, Mr Chilton stated that any competent pharmacist would realise that "Mamdrolone" was meant to be "nandrolone".

Repeat intervals and number of repeats

1. Dr Serafin accepts that the subject prescription provided for 30 repeats and did not stipulate repeat intervals. He appears to argue that it was nonetheless appropriate to dispense the subject prescription because: 1. it was valid for only six months, and therefore Patient L "would not have used all the scripts up"; 2. the prescriber was based in Queensland. In contrast to NSW, in Queensland there is no requirement that prescribers stipulate repeat intervals on prescriptions. Dr Serafin claims that he was told by the PRU that if the script is valid in the state in which it was written, it could be honoured in NSW.

Recognised therapeutic standards

1. Dr Serafin asserted that nandrolone was appropriate for use for testosterone replacement and injury repair. He argued that, as he had been informed by Patient L and his doctor of Patient L's low testosterone levels and ongoing injury, using nandrolone therefore appeared to be appropriate.
2. For the reasons discussed above in relation to Particular 13, we reject the assertion that the use of nandrolone to treat Patient L's reported low testosterone levels and ongoing injury was in accordance with the recognised therapeutic standards of what was appropriate in the circumstances.

Consideration

1. Sub-particulars (i), (ii), (iii) and (v) are established. Sub-particular (iv) is established in part: the prescription did not contain the (correct) name of the drug prescribed or directions for its use. In addition, it did not specify the intervals between supplies. However, as Dr Serafin points out, the prescription did contain the strength and quantity of the substance to be supplied.
2. The question raised by Particular 14 is whether, in those circumstances, it was inappropriate for Dr Serafin to dispense nandrolone to Patient L.
3. This was not a case of a minor difference between the name of the drug written on the prescription and the name of the actual drug dispensed. In addition, that discrepancy was but one of several procedural defects contained in the subject prescription. In those circumstances it was inappropriate for Dr Serafin to dispense the prescription.

Unsatisfactory professional conduct

1. We reject Dr Chilton's opinion that Dr Serafin's actions in dispensing nandrolone on three separate occasions on the basis of the subject prescription does not amount to unsatisfactory professional conduct. Even if Dr Serafin's unsupported claim of being informed by the PRU that a NSW-based pharmacist could lawfully dispense a prescription issued in Queensland that did not comply with the requirements of the PTGR but otherwise complied with Queensland regulations is accepted, the failure to specify repeat intervals was but one of several defects in the subject prescription.
2. We find that Dr Serafin's actions in dispensing the subject prescription demonstrated that the care he exercised, and judgement possessed, fell significantly below the relevant standard.
3. Particular 14 is established.

Particular 15

1. Particular 15 states: "The practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed a prescription dated 5 June 9 November 2015 for Patient L for Testosterone Propionate, a Schedule 4D prescribed restricted substance, with 10 repeats contrary to Clause 39(2)(b) of the PTGR as no interval for repeats was specified."
2. In his amended reply, Dr Serafin denied Particular 15. In final submissions, Dr Serafin "accepted" Particular 15 and stated that the subject prescription should not have been dispensed because, as he discovered in these proceeding, it had already been dispensed by another pharmacy.
3. The conduct the subject of Particular 15 is not that the prescription was dispensed in circumstances where it had already been dispensed by another pharmacy but rather that it had been dispensed in circumstances where, contrary to cl 39(2)(b) of the PTGR, the prescription did not specify the intervals at which the drug, testosterone propionate, could be supplied.
4. In our view, it was inappropriate for the Pharmacy to dispense testosterone propionate in circumstances where the prescription specified 10 repeats but did not specify repeat intervals.

Unsatisfactory professional conduct

1. Dr Serafin repeated the argument he made in respect of Particular 14, that is, he was entitled to rely on the advice given by the PRU about dispensing a prescription which complied with Queensland regulations. For those reasons, Mr Chilton is not critical of Dr Serafin's actions in dispensing the subject prescription.
2. Dr Serafin makes two apparently inconsistent claims. On several occasions prior to these proceedings, he defended his actions in dispensing prescriptions issued by Queensland prescribers which did not stipulate repeat intervals, on the basis that to refuse to do so would have resulted in the prescribers becoming frustrated and their patients becoming abusive. (See for example, Exhibit A1 Tab 128, p 8 and Tab 116, p 3). In these proceedings he defended his actions on the basis that he had relied on advice given by the PRU that it was permissible to dispense a prescription issued by a Queensland prescriber that complied with Queensland, but not NSW rules.
3. Even if it is accepted that Dr Serafin received verbal advice from the PRU that there was no bar to dispensing prescriptions issued in Queensland that did not comply with the PTGR but did comply with the PTGR's Queensland equivalent, a practitioner of Dr Serafin's experience ought to have known that this was not a correct statement of the law. Dr Serafin's actions in dispensing the prescription in those circumstances demonstrated that the knowledge he possessed fell significantly below the relevant standard. In addition, it demonstrated that the care exercised, and judgement he possessed, fell significantly below that standard.
4. Particular 15 is established.

Particular 16

1. Particular 16 states: "16. On 13 April 2015, 28 April 2015, 15 October 2015 and 12 November 2015 the practitioner inappropriately dispensed Somatropin (human growth hormone), a Schedule 4D prescribed restricted substance, to Patient L on a prescription dated 9 April 2015 as follows: i. The prescription was for 80 repeats with no repeat intervals specified; ii. Contrary to Clause 34 of the PTGR as the prescription was in a quantity, or for a purpose, that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances; iii. Contrary to Clause 35 of the PTGR as the prescription failed to specify the name, strength and quantity of the substance to be supplied, adequate directions for use and the intervals at which the substance may be supplied on the prescription; and iv. Contrary to Clause 40 of the PTGR when the prescription was dispensed on 15 October 2015 and 12 November 2015, as more than 6 months had elapsed since the prescription was written."
2. Dr Serafin admits sub-particulars (iv) and part of sub-particular (i) (that the prescription was for 80 repeats) and sub-particular (iii) (that the prescription did not specify directions for use) but denies the balance of Particular 16.
3. With respect to sub-particular (i), as Dr Serafin points out, the PTGR requires a prescription for a special restricted substance (S 4B) to contain details of the intervals at which the substance may be supplied on the prescription: cl 35(1)(f). That requirement does not apply to somatropin which is a prescribed restricted substance (s 4D).
4. We accept, as claimed, that on 13 April 2015 Dr Serafin contacted the prescriber Dr Mackay "in regards to the number of repeats (80) on a new script for HGH presented by [Patient L]" and that Dr Mackay "confirmed the intended use of the medication and to limit [Patient L's] supply now to 8 vials a month - still within the usual dose range".
5. Nonetheless, for the reasons given in relation to Particular 13, we find that the somatropin supplied to Patient L was in a quantity, and for a purpose, that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances. That Dr Mackay told Dr Serafin that, in his opinion, the prescribing was appropriate does not alter our view. As explained above, the opinion of the prescribing practitioner, while relevant, is not determinative of the question of whether the substance prescribed is in a quantity, or for a purpose, that accords with the recognised therapeutic standard of what was appropriate in the circumstances.
6. We find that the dispensing of somatropin on 13 April 2015, 28 April 2015, 15 October 2015 and 12 November 2015 was inappropriate because the subject prescription was for 80 repeats, did not contain directions for use, and was in a quantity, or for a purpose, that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances. In addition, as conceded by Dr Serafin, the dispensing on 15 October 2015 and 12 November 2015 was contrary to cl 40 of the PTGR which instructs that a pharmacist must not supply a prescribed restrictive substance if the date of the subject prescription is six months older than the supply.

Unsatisfactory professional conduct

1. Mr Chilton and Mr Cotterell agree that Dr Serafin's actions in dispensing somatropin on 15 October 2015 and 12 November 2015, in circumstances where the subject prescription was out of date, fell below the relevant standard. Mr Cotterell was of the opinion that it fell significantly below. Mr Chilton disagreed.
2. As Mr Cotterell explained, supplying a substance on the basis of an out-of-date prescription carries the risk that the patient's condition may have changed and that the prescribed substance is no longer appropriate.
3. As conceded by Dr Serafin, this was not the only occasion that the Pharmacy dispensed an out-of-date prescription.
4. In our view, Dr Serafin's actions in dispensing somatropin on two occasions where the prescription was out of date demonstrated that the care he exercised fell significantly below the relevant standard.
5. In addition, we find that Dr Serafin's actions in inappropriately dispensing somatropin on five occasions demonstrated that the judgement possessed, and care exercised, by Dr Serafin fell significantly below the relevant standard.
6. Particular 16 is established.

Particular 17

1. Dr Serafin admits the facts of Particular 17 but does not agree that that conduct amounts to unsatisfactory professional conduct. Particular 17 states: 17: On a prescription dated 15 May 2015, the practitioner inappropriately compounded and supplied Melanotan Melatonin II 2,000mcg/mL for Patient L when the prescription specified Melatonin 2,000mcg/1mL on 6 July 2015, 12 August 2015 and 28 September 2015.
2. Dr Serafin repeats the arguments he made in respect of Particular 14, that is, that it is commonplace for medical practitioners to misspell the names of the drug prescribed, and, of itself, this does not require the pharmacist refuse to dispense a prescription. Dr Serafin asserts that it was "pretty obvious" that the prescriber meant to write "Melanotan II 200 mcg/ml" and that the error was "two letters back to front". In addition, he asserts that the strength and dose written on the prescription was the "usual" supplied for melanotan.
3. Neither Mr Cotterell nor Mr Chilton were of the view that the conduct the subject of Particular 17 fell significantly below the relevant standard. Mr Cotterell considered it significant that melanotan did not have a "high-risk profile" and that Dr Serafin had apparently checked with Patient L his understanding of the nature of the drug prescribed.
4. The difference between the words "Melanotan" and "Melatonin" is not as stark as that between "Mamdrolome" and "Nandrolone". Undoubtedly, Dr Serafin's actions in compounding and supplying melanotan on three occasions in circumstances where the prescriber had written Melatonin on the subject prescription demonstrates that the care exercised, and judgement possessed by Dr Serafin fell below the relevant standard. However, considered in isolation, we are not persuaded that it demonstrates that the care exercised, and judgement possessed, by Dr Serafin fell significantly below that standard.
5. Particular 17 is not established

Particular 18

1. Dr Serafin admits the facts of Particular 18 but does not agree that that conduct amounts to unsatisfactory professional conduct. Particular 18 states that, between March 2010 and September 2017, Dr Serafin failed to undertake an accurate inventory of all drugs of addiction at the Pharmacy in March and September of each year, as required by cl 118 of the PTGR.
2. Dr Serafin conceded that in contravention of cl 118 he failed to undertake biannual inventories of ketamine. He claimed that that stock levels were checked each occasion a new order of "raw material" arrived. He pointed out that he ceased supplying ketamine in May 2015. In cross-examination, Dr Serafin conceded that, other S 8 drugs were held by the Pharmacy and that he failed to undertake biannual inventories of those drugs after May 2015.
3. In oral evidence, Mr Chilton and Mr Cotterell agreed that Dr Serafin's failure to undertake biannual inventory of s 8 drugs is "below the standard required".
4. Dr Serafin's repeated failure over some seven years to comply with the requirement imposed by cl 118 of the PTGR demonstrates, in our view, an appalling lack of care. We find that the care he exercised fell significantly below the relevant standard.

Summary

1. Particulars 2, 10 and 17 are not proven. The balance of Complaint 2 is proven in whole or part. That conduct amounts to unsatisfactory professional conduct.

Complaint 3

1. Complaint 3 consists of three particulars and concerns Dr Serafin's actions in compounding and dispensing peptides, CJC and Growth Hormone Releasing Peptides-6 (GHRP-6) at the request of Dr Dusan Sajdak at the "Melbourne Sports Clinic". Between 7 July 2014 and 21 October 2014, Dr Serafin compounded and supplied 355 ampoules of the peptides GHRP-6 2mg/ml CJC 0.5mg/ml to Dr Sajdak.
2. Throughout the period covered by Complaint 3, the peptides GHRP-6 and CJC were unscheduled. On 1 June 2015 they were scheduled as S 4D.
3. Dr Serafin claims that notwithstanding that, before une 2015, these peptides were readily available throughout Australia without a prescription he only supplied them on prescription. He claims he did so to ensure that a doctor was involved and to avoid patients self-prescribing without being monitored.

Particular 1

1. Particular 1 states: "Between 7 July 2014 and 21 October 2014, the practitioner inappropriately compounded and supplied and/or failed to ensure that the pharmacists in his employ appropriately compounded and supplied 355 ampoules of the peptides GHRP-6 2mg/ml CJC 0.5mg/ml in accordance with Schedule M hereto to Dr Sajdak in the following circumstances: i. The practitioner failed to identify the individual patients for whom the supply was being made; ii. The practitioner failed to identify the particular indication for the supply for each individual patient; iii. The practitioner failed to verify the directions for use and ensure the appropriateness of the therapeutic purpose and such directions for use for the supply to each individual patient; and iv. The practitioner's only understanding in relation to the supply was that it was for anti-aging therapy.
2. With the exception of sub-particular (iv), Dr Serafin admits the facts of Particular 1. Dr Serafin claims that he understood that, in addition to anti-aging, Dr Sajdak was using the peptides to promote weight loss and to treat chronic fatigue.
3. The key issue raised by Particular 1 is whether Dr Serafin's conduct in supplying peptides, in circumstances where the prescription did not contain the name of the patient and Dr Serafin failed to identify the particular indication for which the peptide was prescribed, amounted to unsatisfactory professional conduct.
4. In a report dated 7 August 2018, Mr Cotterell stated that the supply was "legal" and that the "guidelines surrounding complex compounding [Pharmacy Board of Australia, "Guidelines on Compounding of Medicines" (March 2015)] had not been actioned". He reasoned that therefore Dr Serafin's actions in supplying the peptides were "of a suitable standard".
5. In a supplementary report dated 5 November 2018 after the Commission had brought to Mr Cotterell's attention that the Pharmacy Board of Australia, "Guidelines for dispensing of medicines" (March 2010, retired 28 April 2015), were in force at the time of the subject dispensing, Mr Cotterell revised his original opinion: "[The March 2010 Guideline] states that extemporaneous preparations or compounded products were only exempt of the GMP and TGA registered product regulation, if the product is for a specific person, for a specific purpose for a specific period of time. The preparation for the purpose of a Dr's bag type arrangement does not meet this test and as such the preparation."
6. In cross-examination Mr Cotterell appeared to have overlooked his revised opinion, repeating the view stated in his original report which was to the effect that in 2014 when Dr Serafin supplied GHRP-6 to Dr Sajdak without a prescription issued in the name of the individual patient, this was not prohibited by a Pharmacy Board of Australia Guideline: "A. The guidelines came in force in 2015 however I'm pretty sure that they 30 were discussed quite significantly with pharmacists. It was definitely discussed across the professional practice in notifications. I'm happy to say at that time I wasn't a significant compounder in terms of quantity but I managed to have access to those guidelines or ideas of what was happening and it had previously been discussed of cases in America of supplying products to 35 a facility leading to issues rather than individual patients, so I think that it does fall - I believe it falls below the standard of a person with the qualifications of Dr Serafin and by reflection myself to supply quantities to a practice for admission outside of my control. Q. Even a year before the official guidelines come into place? A. Yeah, the guidelines were written in response to a couple of cases in America that led to some significant adverse outcomes and it was discussed earlier than 2014 in wide media about these issues, so I believe that yes you should have better practice than that. 45 Q. So your opinion is it falls below? A. My opinion is that it falls below. Q. But not significantly below? A. I don't believe significant, that's a challenging one. Significant is hard. I definitely believe it falls below." (Tcpt, 15 December 2021, p 16 (30) - p17 (2))
7. Later, when asked to assume that the supply was for a "doctor's bag", Mr Cotterell stated that in his opinion the practice was "not below standard": "Even though it wasn't a scheduled product at the time, I personally believe that still falls under the professional guidelines of a pharmacist. … If Dr Serafin was under the belief that he states that he was supplying it to the practice for the doctor to administer or use like a Doctor's Bag, then his practice was not below standard because his - the doctor's usage of the product under that protocol of Doctor's Bag is for the doctor to administer as opposed for the doctor to supply." (Emphasis added) (Tcpt, 15 December 2021, p 17 (41-47)

Consideration

1. Neither expert stated in oral evidence that in their opinion Dr Serafin's conduct in supplying the then unscheduled peptide, GHRP-6 in circumstances where the subject prescriptions failed to state the name of the patient and the particular indication for which the peptides had been prescribed, fell significantly below the relevant standard.
2. As demonstrated by his conflicting opinions, Mr Cotterell was somewhat uncertain about the rules which governed the supply of unscheduled substances in 2014. Neither expert appeared to be familiar with the relevant rules, the effect of which (as conceded by Dr Serafin) was that it was impermissible for a pharmacist to compound and supply unscheduled substances without a prescription issued in the name of the individual patient.
3. In circumstances where two experienced pharmacists had a poor understanding of the relevant rules, without some evidence that in 2014 those rules were understood and applied by pharmacists of Dr Serafin's experience and training, we could not be reasonably satisfied that Dr Serafin's conduct demonstrated that the knowledge and judgement he possessed, and/or or care he exercised, fell significantly below the relevant standard.
4. Particular 1 is not established.

Particular 2

1. Particular 2 states: "2. Between 7 July 2014 and 21 October 2014, the practitioner inappropriately compounded and supplied and/or failed to ensure that the pharmacists in his employ appropriately compounded and supplied 355 ampoules of the peptides GHRP-6 2mg/ml CJC 0.5mg/ml in accordance with Schedule M hereto to Dr Sajdak contrary to the Pharmaceutical Society of Australia Guidelines "Guidelines for Dispensing Medicines" (2010).
2. Dr Serafin admits to breaching the Pharmaceutical Society of Australia (PSA) Compounding Guidelines, but not the PSA Dispensing Guidelines, by failing to keep a record for each individual supplied with compounded medicines, including non-prescription medicines. Dr Serafin claimed that once he became aware of the issue, it was immediately corrected.
3. In our view, that conduct fell below but not significantly below the relevant standard. Particular 2 is not established.

Particular 3

1. Dr Serafin denies Particular 3 which states: "3. Between 7 July 2014 and 21 October 2014, the practitioner inappropriately compounded and supplied and/or failed to ensure that the pharmacists in his employ appropriately compounded and supplied 355 ampoules of the peptides GHRP-6 2mg/ml CJC 0.5mg/ml in accordance with Schedule M hereto to Dr Sajdak by batch manufacturing for non-specific supply, contrary to the Good Manufacturing Practice ("GMP") and Therapeutic Goods Administration ("TGA") guidelines."
2. Dr Serafin denies that his conduct in supplying peptides to Dr Sajdak can be described as "batch manufacturing". He asserts that batch manufacturing means manufacturing substances in advance of a sale. He stated that it was the practice of the Pharmacy to only compound and supply peptides to Dr Sajdak on receipt of an order and not in anticipation of a sale.
3. In his supplementary report dated 5 November 2018, when asked to identify "the risks, if any, for medicines to be compounded and supplied, for example to a doctor, in bulk without a patient's name being assigned to each medicine" Mr Cotterell stated: "The risk is very real. Whilst the doctor may have knowledge in the use of a product the pharmacist is the expert in that area. Incorrect dosing, preparation or incorrect use of a dosage form, stability and storage requirements are all considered by the compounding pharmacist. When a product is taken from BULK or Impress stock, (not individually prescribed) the risk of selecting an incorrect product not appropriate for that patient is increased. Most importantly the products that are compounded are not MANUFACTURED and as such whilst safety concerns and specific knowledge are used by the compounding pharmacist the Good Manufacturing Practice (GMP) and TGA guidelines are not enforced in supplying single purpose compounding however must be followed in the case of BULK non-specific supply. Risk for patient safety in the stated question are very real and prominent." "The difference between compounding and manufacturing is the quantity produced and the purpose of production. Individual usage for a specific purpose, a specific patient at a specific time is considered compounding and is outside the regulations of manufacturing. Batch production and non-specific supply is manufacturing and the GMP and TGA regulations must be followed for patient safety." As stated the regulations were written to cease this type of practice [batch manufacturing] due to inherent risk of storage, stability and potential of misuse. The difference between compounding and manufacturing is the quantity produced and the purpose of production. Individual usage for a specific purpose, a specific patient at a specific time is considered compounding and is outside the regulations of manufacturing. Batch production and non-specific supply is manufacturing and the GMP and TGA regulations must be followed for patient safety. It is my opinion that the oversight and approval by Dr Serafin was below standard."
4. In contrast Mr Chilton was not critical of Dr Serafin's action, endorsing Dr Serafin's definition of the term "batch manufacturing".
5. In oral evidence, Mr Chilton agreed with the proposition that in 2014, it was standard practice for pharmacists not to batch-compound, and to only compound for individual patients. When taken to his report, he retreated from that opinion and said that he understood that "schedule - like schedule products" could not be batch-manufactured but that "it's probably okay to" bulk compound non-scheduled products: Tcpt, 16 December 2020, p 73(20-24).

Consideration

1. Particular 3 refers to "batch manufacturing for non-specific supply". The expression "batch manufacturing" is qualified by the words "for non-specific supply". In our view, read in context, the phrase "batch manufacturing for non-specific supply" should be read to mean "manufacturing or compound[ing] units of issue of a particular product (i.e. a batch) in circumstances where it is to be administered to unspecified person(s)". That is consistent with the use of the term "batch preparation" used in the 2015 Compounding Guidelines.
2. While we disagree with the definition adopted by Dr Serafin, nonetheless the Commission has failed to establish the premise on which this particular rests, namely, that at the relevant time the Good Manufacturing Practice guidelines applied to compounding (as opposed to manufacturing). A further difficulty is that the Commission has failed to identify which requirement of those guidelines Dr Serafin is said to have breached. Further, the Commission has failed to identify which "Therapeutic Goods Administration guideline" Dr Serafin is alleged to have contravened.
3. Particular 3 is not established.

Complaint 4

1. Complaint 4 consists of 15 particulars and concerns Dr Serafin's actions in compounding and dispensing a S 8 drug, oral ketamine. Particulars 1 to 5 allege that Dr Serafin compounded and dispensed oral ketamine for five patients in quantities or for a purpose that did not accord with the "recognised therapeutic standard of what is appropriate in the circumstances". Particulars 6 to 15 allege that Dr Serafin inappropriately dispensed prescriptions, mainly for ketamine, that were defective in form.
2. In May 2015, Dr Serafin decided to stop supplying ketamine. In these proceedings he explained that he made that decision because he did "not want another target on my back with the authorities" (Tcpt, 14 December 2020, p 55 (21)). In addition, he claimed that he had become concerned about the length of the period ketamine was being dispensed to four of the patients the subject of Complaint 4.
3. Each particular is formulated in the alternative, alleging that Dr Serafin did, or failed to ensure that the pharmacists in his employ did not do, the subject conduct. Dr Serafin accepts in each instance he was responsible for the alleged conduct. Therefore, for convenience we will refer to Dr Serafin, and not his employed pharmacists.

Recognised therapeutic standard: oral ketamine

1. Central to Particulars 1, 2, 3, 4 and 5 is the contention that the oral ketamine compounded and dispensed was "in a quantity, or for a purpose, that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances".
2. Clause 79 of the PTGR states that an "authorised practitioner" must not issue a prescription for a drug of addiction in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances. An "authorised practitioner" is defined to include a medical practitioner: cl 3 of the PTGR. Clause 109 of the PTGR states that an authorised practitioner or pharmacist must not supply a S 8 drug in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
3. Ketamine can be administered orally and parenterally (by injection). Complaint 4 largely involves the compounding and dispensing of ketamine in troches (lozenges and wafers). Throughout the period of that complaint, October 2013 to May 2015, ketamine solution for injection but not oral ketamine was entered on the ATGR. Ketamine solution for injection was listed for anaesthetic use. The use of ketamine for any other purpose, including pain relief, was "off label".

Background

1. Throughout the period of Complaint 4, a GP, Patient M, prescribed ketamine to Patient N (with whom he was living) and Patients O and P, who were living together. Patient M had a social relationship with Patients O and P. Throughout that period, Patient M was also using oral ketamine.
2. Dr Serafin was in regular contact with and was friendly with Patient M, a local GP.
3. The Pharmacy's records reveal that Dr Serafin was supplying ketamine to Patients M, N, O and P in December 2011.
4. Dr Serafin claims that: 1. Patient M told him, and he accepted, that he suffered from neuropathic pain and was using ketamine for pain relief; 2. sometime before December 2013, he became uncomfortable with the fact that Patient M was self-prescribing and told him he required an authority. A GP, Dr David Miller, then started prescribing ketamine to Patient M; 3. eventually he decided he "had enough" and told Patient M he could not continue to supply. He made up a story "as a way to politely get rid of him without offending [Patient M]".

Particulars 1, 2, 3, 4 and 5

1. The Commission contends that Dr Serafin inappropriately compounded and dispensed ketamine 200mg troches to Patient M (Particular 1), Patient N (Particular 2), Patient O (Particular 3), Patient P (Particular 4) and Patient R (Particular 5). Dr Serafin admits the facts of each particular but not the central premise on which each particular is based: that the subject 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.

Particulars 1 and 2

1. Between 6 December 2013 and 4 May 2015, Dr Serafin compounded and dispensed on prescription 1,500 ketamine 200mg troches to Patient M, as follows: 1. 150 x ketamine 200mg Troche on 6 December 2013; 2. 150 x ketamine 200mg Troche on 15 January 2014; 3. 150 x ketamine 200mg Troche on 3 March 2014; 4. 300 x ketamine 200mg Troche on 22 September 2014; 5. 300 x ketamine 200mg Troche on 17 March 2015; 6. 300 x ketamine 200mg Troche on 4 May 2015; 7. 150 x ketamine 200mg Troche on an unknown date (prescription dated 24 January 2014 for 2 repeats).
2. Between 1 November 2013 and 31 March 2015, Dr Serafin compounded and dispensed on prescription 2,400 ketamine 200mg troches to Patient N, as follows: 1. 150 x ketamine 200mg Troche on 1 November 2013; 2. 150 x ketamine 200mg Troche on 6 December 2013; 3. 150 x ketamine 200mg Troche on 15 January 2014; 4. 150 x ketamine 200mg Troche on 13 March 2014; 5. 300 x ketamine 200mg Troche on 16 July 2014 (prescription dated 15 July 2014 of 2 repeats with no repeat intervals identified); 6. 300 x ketamine 200mg Troche on 24 October 2014 (first repeat of prescription dated 15 July 2014 of 2 repeats with no repeat intervals identified); 7. 300 x ketamine 200mg Troche on 8 December 2014 (prescription dated 24 January 2014 of 21 repeats with no repeat intervals identified); 8. 300 x ketamine 200mg Troche on 9 December 2014 (second and final repeat of prescription dated 15 July 2014 of 2 repeats with no repeat intervals identified); 9. 300 x ketamine 200mg Troche on 2 February 2015; and 10. 300 x ketamine 200mg Troche on 31 March 2015.
3. Dr Serafin does not accept that the quantity of ketamine supplied to Patient M and N was excessive, or that it was prescribed for a purpose that did not accord with the recognised therapeutic standard.
4. According to Dr Serafin, the accepted dose range for oral ketamine varies from between "25 to 50 mg per day to 1 gram", citing in support M Blonk et al, "Use of oral ketamine in chronic pain management: A review" (2009) 14(5) European Journal of Pain 466.
5. Dr Serafin acknowledged that the amount of ketamine prescribed to Patients M and N, 800mg a day, could be described as being "on the high side". However, he argued that that amount "fell within the reported limits".
6. Dr Serafin asserted that the therapeutic standard varies according to the route of the administration of the substance. In the case of oral ketamine, he asserts that its bioavailability is substantially less (29%) than that of ketamine in liquid form and therefore different therapeutic standards apply.
7. According to Dr Serafin, there are "hundreds of studies" on the benefits of ketamine for neuropathic pain. He contends that proof of its therapeutic legitimacy is evidenced by the fact that the PRU continues to issue authorities for prescriptions for ketamine written by pain specialists for patients with neuropathic pain.
8. Dr Serafin stated: 1. in most instances he supplied Patient M and Patient N with 150 lozenges, which "equates to a 38-day supply on this dose" and a dosage of 200mg four times per day; 2. the Pharmacy's dispensing records indicate the repeat intervals are reasonably consistent with that use, indicating there was no oversupply; 3. on the odd occasion, he supplied 300 lozenges to Patient M because he was planning to travel overseas; 4. Patient M and N had fibromyalgia and suffered from chronic neuropathic pain; 5. each told him that ketamine relieved their pain; 6. despite his encouragement, neither Patient M nor N had consulted a pain specialist; 7. he understood that: 1. after he ceased supplying ketamine to Patient M and N, each continued to use ketamine; 2. Patient N was being prescribed ketamine by a pain specialist; 3. before moving to Queensland, Patient M was also being prescribed ketamine by a pain specialist who over three years reduced Patient M's daily dose to 400 mg.
9. Dr Serafin said that in supplying ketamine to Patients M and N it did not cause him concern: 1. that their respective diagnosis of neuropathic pain had been made by a GP not a specialist; 2. that they had been prescribed a S 8 drug by a GP not a specialist "GPs prescribe S 8s every day" (Tcpt, 29 March 2021, p 25 (29)); 3. that they had been prescribed a drug which was not listed on the ARTG by a GP: "anyone can read the research and determine what the research shows" (Tcpt, 29 March 2021, p 25 (39)); 4. that neither were under the care of a pain specialist.
10. In addition, Dr Serafin said that it had not caused him concern that Patient M had diagnosed Patient N with fibromyalgia and had prescribed her with ketamine. He said he was aware they were living together and understood it to be a "new age" type relationship, "free and loose". In these proceedings he said: "I recognise it's not best practice and I would not do it again, given there is a risk that a doctor with a close relationship would lose objectivity. However, I consider that it is acceptable, since I knew both parties suffered severe pain and it was a legitimate therapeutic purpose for prescribing."

Consideration

1. Central to Particulars 1 and 2 is the question of whether the oral ketamine prescribed to Patients M and N was in a quantity, or for a purpose, that did not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
2. The article, "Use of oral ketamine in chronic pain management" in the European Pain Journal, on which Dr Serafin relies does not support his view about the safety and efficacy of the long-term use of ketamine in treating chronic pain. The authors point out that the evidence on the use of oral ketamine in treating chronic pain is "limited and the quality of the studies not very high". In addition, they point out that ketamine is increasingly being used as a "street drug because of its psychotomimetic effects" and irrespective of which oral formulation is used, the question of "potential abuse remains important, especially in patients with a history of drug abuse".
3. The authors conclude at par 4.4: "Efficacy and long-term adverse effects are insufficiently studied to promote the routine use of oral ketamine in chronic pain management. Some of the studies on oral ketamine show a disappointing success rate, either due to treatment failure or appearance of adverse effects. Wide clinical use of ketamine is limited due to psychotomimetic and other adverse effects. On the other hand, ketamine as an analgesic has proven to be of effect in patients with severe pain who have failed to respond to routine pharmacotherapy. In these patients with intractable pain the use of oral ketamine can be beneficial. From that perspective, oral ketamine may have a limited place as add-on therapy in complex chronic pain patients when other therapeutic options have failed."
4. We find that the subject prescriptions issued for ketamine for Patients M and N were in a quantity, and for a use, that did not accord with the recognised therapeutic standard of what is appropriate in the circumstances. Those circumstances include: 1. oral ketamine is and is known to be a drug of addiction; 2. as pointed out by the authors of the above study, the efficacy and long-term adverse effects are insufficiently studied to promote the routine use of oral ketamine in chronic pain management; 3. the duration of use. The Pharmacy had been supplying Patients M and N since 2011. It is unknown whether they had been using ketamine before 2011. As Dr Serafin concedes, the duration of supply was a key reason in his decision to discontinue supply; 4. the dosage prescribed. As Dr Serafin concedes, the dosage was on the "high side", albeit under what he considered to be the maximum permissible dosage; 5. the fact that Patient N was being prescribed ketamine by Patient M with whom she was living and who was also using ketamine.

Unsatisfactory professional conduct

1. The Commission contends that the conduct the subject of Particulars 1 and 2 amounts to unsatisfactory professional conduct within the meaning of s 139B(1)(a). Dr Serafin disagrees.
2. Pointing out that ketamine is as drug of addiction and not a "first line treatment option", Mr Cotterell stated that it is "the duty of a pharmacist to obtain as much information as possible about the patient's intended use, length of use, previous use of ketamine". He considered Dr Serafin's actions in supplying ketamine to Patients M and N, given the nature of that drug, the quantity supplied and the duration of the supply, fell significantly below the standard.
3. Mr Cotterell described as "alarming" Dr Serafin's actions in supplying ketamine to Patient N, in circumstances where she lived with the prescriber who himself was being supplied ketamine by Dr Serafin.
4. On the other hand, Mr Chilton was not critical of Dr Serafin's actions in supplying ketamine to either Patient M or Patient N. In his report dated 30 July 2020, Mr Chilton stated that Dr Serafin knew that "Patient M had a legitimate medical issue and that the quantity of ketamine was not excessive given the severity of his pain". He wrote that it is the responsibility of the authorised prescriber to decide the quantity, purpose and the recognised therapeutic standard of what is appropriate. Referring to the fact that there is no published recognised therapeutic standard for oral ketamine, he stated "one cannot be judged against a standard that does not exist".
5. In contrast to Mr Cotterell, Mr Chilton was not critical of Dr Serafin's actions in supplying ketamine to Patient N in circumstances where she was being prescribed ketamine by Patient M who himself was being supplied ketamine by Dr Serafin, reasoning: "There is no legislation in respect of medicines and medicine supply that dictates who can live with who. I agree with Dr Serafin that it is not illegal for a pharmacist to dispense an S8 prescribed by someone who is their flat mate. Dr Serafin had no basis for thinking that the drugs were being misused, given the legitimate need of this patient for pain relief."

Consideration

1. We agree with the opinion expressed by Mr Cotterell. In addition to the considerations referred to above relevant to our assessment of the appropriateness of Dr Serafin compounding and dispensing ketamine to Patients M and N, the following considerations support the conclusion that Dr Serafin's actions demonstrate that the judgement he possessed, and the care he exercised, fell significantly below the relevant standard: 1. In each case the drugs were prescribed by a GP. While Dr Serafin is correct that it is unremarkable for a GP to prescribe S 8 drugs, here the prescribing was for significant quantities over a prolonged period. It should have been apparent to a pharmacist of Dr Serafin's experience and training that a further opinion was warranted, most likely from pain specialist. 2. That according to Dr Serafin, Patients M and N later came under the care of pain specialists who continued to prescribe them ketamine, proves little. Throughout the period they were supplied by the Pharmacy, neither was under the care of a pain specialist. Throughout that period there was no proper basis for Dr Serafin's stated belief that the use of large amounts of oral ketamine was effectively the only available option to manage their reported pain. According to Dr Serafin, the pain specialist who had the care of Patient M, over time, significantly reduced the amount prescribed to Patient M. which suggests suggesting that they had concerns about the amount prescribed or had trialled other methods of pain relief. 3. Dr Serafin was aware that Patient M was living with Patient N. Whether their relationship was or was not a "new age" relationship is not the point. The fact that they were living together ought to have alerted Dr Serafin to the real possibility that Patient M may have lacked objectivity, especially given that he himself was using ketamine. As Dr Serafin agrees, supplying a S 8 drug to a person living with the prescriber is not best practice and he would not do it again.
2. Particulars 1 and 2 are established.

Particulars 3 and 4

1. Between 30 October 2013 and 20 April 2015, Dr Serafin compounded and dispensed 480 Ketamine 200mg troches to Patient O, on prescriptions from Patient M as follows: 1. 60 x ketamine 200mg Troche on 30 October 2013; 2. 60 x ketamine 200mg Troche on 18 February 2014; 3. 60 x ketamine 200mg Troche on 20 May 2014 (prescription dated 10 February 2014 for 2 repeats with no repeat intervals identified); 4. 60 x ketamine 200mg Troche on 10 August 2014 (prescription dated 13 August 2014 for 1 repeat with no repeat intervals identified); 5. 60 x ketamine 200mg Troche on 19 August 2014; 6. 60 x ketamine 200mg Troche on 4 November 2014; 7. 60 x ketamine 200mg Troche on 12 February 2015; and 8. 60 x ketamine 200mg Troche on 20 April 2015 (prescription dated 9 January 2015 for 2 repeats with no repeat intervals identified).
2. Over the same period, Dr Serafin compounded and dispensed 420 Ketamine 200mg troches to Patient P on prescriptions from Patient M, in the same volume, and on the same dates (except for 10 August 2014), as dispensed to Patient O.
3. Dr Serafin stated: 1. he understood that Patient M had diagnosed Patients P and O as having fibromyalgia; 2. each reported that they experienced neuropathic pain and ketamine gave them great relief; 3. he observed no signs that either was misusing ketamine; 4. throughout the period they were supplied ketamine, he understood Patients P and O were in a domestic relationship with each other and in a social relationship with Patient M; 5. Patients P and O were on a lower dosage than Patients M and N and ordered within expected time fames based on their respective prescribed doses; 6. he could not recall whether he had spoken to Patients M and N about consulting a pain specialist.
4. In his supplementary report dated 5 November 2018, Mr Cotterell stated that the supply of ketamine to Patients O and P seemed appropriate (except the supplies to Patient O on 10 August 2014 and 19 August 2014). He stated that the treatment regime "may have merit, however the nature of the medication and the quantity of the supply, length of treatment leads to potential misuse". He stated that as an isolated case he saw no issue with the oversight/approval of Dr Serafin in relation to either patient.
5. In his report dated 30 July 2020, Mr Chilton stated that the fact that Patients O and P were living together was "irrelevant" and further that "many people who live together take the same medicine, irrespective of who prescribed the medicine and whether the prescriber was prescribed the same medicine". He stated that Dr Serafin was obliged to "turn his mind to whether there was any suspicion of abuse of the drug". However, he asserted that Dr Serafin had done so, and was satisfied that the patient had a legitimate need for the Ketamine at the prescribed amount.
6. Mr Chilton concluded that in those circumstances, Dr Serafin's actions could not be said to be "below the standard expected".

Consideration

1. Neither Mr Cotterell nor Mr Chilton were critical of Dr Serafin's actions in supplying ketamine to Patients O and P. The basis for the different opinion expressed by Mr Cotterell about the appropriateness of the supply to Patients M and N appears to be that Patients O and P were supplied about a third of the amount supplied to Patients M and N over roughly the same period.
2. As discussed above, the available material raised doubts about the safety and efficacy of the long-term use of oral ketamine to treat chronic pain, even where, as here, the dosage prescribed was low (at least as compared to that prescribed to Patient M and N).
3. The Commission bears the evidentiary onus. While arguable, the premise on which Particulars 3 and 4 are based is not established.

Particular 5

1. Particular 5 relates to Dr Serafin's actions in supplying Patient R with 1100 ketamine 50mg capsules between 28 October 2013 and 10 March 2015 as follows: 1. 100 x ketamine 50mg CAPS on 28 October 2013; 2. 100 x ketamine 50mg capsules on 25 November 2013; 3. 100 x ketamine 50mg capsules on 11 December 2013; 4. 100 x ketamine 50mg capsules on 8 January 2014; 5. 100 x ketamine 50mg capsules on 6 February 2014; 6. 100 x ketamine 50mg capsules on 17 March 2014; 7. 100 x ketamine 50mg capsules on 23 April 2014; 8. 100 x ketamine 50mg capsules on 23 April 2014; 9. 100 x ketamine 50mg capsules on 3 October 2014; 10. 100 x ketamine 50mg capsules on 11 December 2014, and 11. 100 x ketamine 50mg capsules on 10 March 2015.
2. Particular 5 rests on the same premise as Particulars 1 to 4, that "contrary to clause 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".
3. As was the case with Patients O and P, neither Mr Cotterell nor Mr Chilton were critical of Dr Serafin's action in supplying ketamine to Patient R.
4. For the reasons given in relation to Particulars 3 and 4, Particular 5 is not proven.

Particulars 6 to 15

1. Each particular relates to Dr Serafin's actions in dispensing prescriptions for ketamine (and testosterone (Particular 6)), in circumstances where it is alleged that the subject prescription(s) failed to comply with the requirements of the PTGR.
2. Dr Serafin admits Particulars 6, 7, 8, 10, 13 and 15 and partially admits Particular 9, 11, 12 and 14.

Particular 9

1. Particular 9 states: "The practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed a prescription dated 8 December 2014 for Patient N prescribed by Patient M for Ketamine 200mg troches, a Schedule 8 drug of addiction, with 21 repeats contrary to Clause 80 of the PTGR as the prescription failed to specify the strength and quantity (in both words and figures) of the substance to be supplied, adequate directions for use and the intervals at which the substance maybe supplied on the prescription." (Emphasis added)
2. A person who issues a prescription for a S 8 drug is required to ensure that the prescription includes details of the strength and quantity (expressed in both words and figures) of the drug to be supplied, adequate directions for use, and the intervals at which the drug may be supplied: cll 80(1)(c),(d),(f) of the PTGR.
3. The subject prescription was dated 8 December 2014 and dispensed on 31 March 2015. It was written by hand. Having examined that prescription, we agree with Dr Serafin that the number of repeats should be read as being 2 not 21.
4. Dr Serafin concedes that the strength and quantity of ketamine was not specified in both words and figures and that no repeat intervals were specified, contrary to the requirements of cl 80(1) of the PTGR.
5. With respect to the allegation that the prescription did not contain adequate directions for use ─ " i TDS PRN" ─ we accept, as contended by the Commission, that that expression would be understood by a pharmacist to mean "one four times a day when required". As the Commission points out, given that the prescription was for 300 x 200 mg troches of ketamine, if those directions for use were followed, this represents a 75 days' supply. While this indicates an oversupply, it does not follow as alleged that the directions are "inadequate" contrary to the requirement in cl 80(1)(d) of the PTGR.
6. Particular 9 is proven in part.

Particular 12

1. Particular 12 states: "12. The practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed a prescription dated 9 January 2015 for Patient O prescribed by Patient M for Ketamine 200mg troches, a Schedule 8 drug of addiction, with 2 repeats contrary to Clause 80 of the PTGR as the prescription failed to specify the strength and quantity (in both words and figures) of the substance to be supplied, adequate directions for use and the intervals at which the substance maybe supplied on the prescription."
2. Dr Serafin denies that the prescription did not contain adequate directions for use but otherwise admits this particular.
3. The directions for use contained on the prescription state: "i TDS PRN". A practicing pharmacist is likely to understand that to mean "one three times per day when required". Although it would be best practice to specify the indication, that is "when required for pain", in our view the directions for use are adequate.
4. Particular 12 is proven in part.

Particulars 11 and 14

1. Particulars 11 and 14 state: "11. The practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed a prescription dated 13 August 2014 for Patient O prescribed by Patient M for Ketamine 200mg troches, a Schedule 8 drug of addiction, with 1 repeat contrary to Clause 80 of the PTGR as the prescription failed to specify the strength and quantity (in both words and figures) of the substance to be supplied, adequate directions for use and the intervals at which the substance maybe supplied on the prescription. … 14. The practitioner inappropriately dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed a prescription dated 13 August 2014 for Patient P prescribed by Patient M for Ketamine 200mg troches, a Schedule 8 drug of addiction, with 1 repeat contrary to Clause 80 of the PTGR as the prescription failed to specify the strength and quantity (in both words and figures) of the substance to be supplied, adequate directions for use and the intervals at which the substance maybe supplied on the prescription."
2. Dr Serafin admits that the prescriptions the subject of Particulars 11 and 14 did not comply with the requirements of cl 80 of the PTGR because the strength and quantity of ketamine were not specified in words and the repeat intervals were not specified. However, he disputes that the directions for use, in each case ─ "1 3 times a day when required", was inadequate.
3. The basis for the Commission's contention that the directions for use on the prescriptions the subject of Particulars 11 and 14 is inadequate is unclear. Neither Mr Chilton nor Mr Cotterell addressed the issue.
4. The contention that the directions for use contained on the subject prescriptions are inadequate is not established. The balance of Particulars 11 and 14 are proven.

Unsatisfactory professional conduct

1. None of the prescriptions the subject of Particulars 6 to 15 fully complied with the requirements of cll 80 and/or 40 of the PTGR.
2. Mr Chilton characterised these failures as "procedural errors", asserting that no harm was done. He stated that they did not evidence conduct that fell "significantly below standard". In cross-examination, he agreed with the proposition that the subject prescriptions did not comply with the requirements of cl 80 and therefore Dr Serafin should not have dispensed them without first contacting the prescriber.
3. Mr Cotterell explained that where a prescription contains repeats, and the repeat interval is not specified, the prescription is valid for only one supply and then must be cancelled and a copy retained by the pharmacist.
4. In NSW, a pharmacist dispensing prescriptions must comply with the requirements of the PTGR. It goes without saying that particular care must be taken when dispensing S 8 drugs. The difficulty of determining whether the prescription dated 8 December 2014 for ketamine (Particular 9) was for two or 21 repeats highlights the need for strict compliance with the requirements as to the form of the prescriptions contained in the PTGR. While those requirements are arguably "merely procedural", as characterised by Mr Chilton, they are nonetheless critical to the safe practice of pharmacy.
5. We find Dr Serafin's actions in dispensing the subject prescriptions in circumstances where he failed to comply with each of the requirements of cll 80 and/or 40 of the PTGR demonstrated that the care he exercised fell significantly below the relevant standard.

Summary

1. Particulars 3, 4, and 5 are not proven. The balance of Complaint 4 is proven in whole or part. That conduct amounts to unsatisfactory professional conduct.

Complaint 5

1. Complaint 5 concerns Dr Serafin's actions in compounding and dispensing HGH, a prescribed restricted substance, prescribed to five patients by Dr Jerzy Cywinski. The Commission alleges that Dr Serafin inappropriately compounded and dispensed HGH: 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 subject prescriptions were out of date, contrary to cl 40 of the PTGR.

Particular 1

1. Particular 1 states: "1. Between August 2014 and January 2016, the practitioner inappropriately compounded and dispensed and/or failed to ensure that the pharmacists in his employ appropriately dispensed Human Growth Hormone ("HGH"), a Schedule 4D prescribed restricted substance, to Patient S prescribed by Dr Jerzy Cywinski ("Dr Cywinski") as follows: i. Dr Cywinski wrote five prescriptions for Patient S for five ampoules of HGH with five repeats for a total of 125 ampoules; ii. Each of the handwritten prescriptions stated: "Saizen 8mg 5 x 5 x 5" with no directions for use; iii. Contrary to Clause 35 of the PTGR as the prescription failed to specify the address of the patient, name, strength and quantity of the substance to be supplied, adequate directions for use and the intervals at which the substance maybe supplied on the prescription; iv. Patient S received compounded HGH from the Pharmacy despite the prescriptions specifying Saizen, contrary to Dr Cywinski's instructions on the prescriptions and in circumstances where a commercial product was available; and v. Patient S continued to receive HGH from the Pharmacy in the absence of the Pharmacy obtaining prescriptions for Patient S from Dr Cywinski in compliance with Clause 35 and for the correct prescribed restricted substance that was being dispensed."
2. While Dr Serafin admits the facts of each sub-particular, we understand that he does not concede the premise on which Particular 1 is based, namely, that given those facts, it was inappropriate to have compounded and dispensed HGH to Patient S.
3. The following considerations lead us to conclude that Dr Serafin's actions in compounding and dispensing HGH to Patient S were inappropriate.
4. First, compounding HGH contravened guidelines issued by the Pharmacy Board of Australia. At the time of the supply, Saizen, an equivalent proprietary product to HGH (the substance the subject of Complaint 5) was commercially available. The 2010 Dispensing Guidelines stated that a pharmacist should not compound a substance where there is a "close formulation to an available suitable commercial product and would not be likely to produce a different therapeutic outcome to the commercial product".
5. Dr Serafin states that he first became aware of that rule in March 2015, when the Pharmacy Board of Australia issued revised guidelines, the 2015 Compounding Guidelines. Those guidelines incorporated the rule contained in the 2010 Dispensing Guidelines about the compounding of substances where a suitable commercial product is available. Dr Serafin stated that he ceased compounding commercially available substances when he became aware of the revised guidelines.
6. Second, the description on the subject prescription of the quantity and dose of the drug prescribed, "8 mg 5 x 5 x 5" is at best unclear.
7. Third, the substance compounded and dispensed, HGH "30 IU INJ" did not correspond with what was written on the prescription "Saizen … 8 mg 5 x 5 x 5". Dr Serafin acknowledges this and in his statement dated 29 June 2020 stated that, after being contacted by a dispensing technician to "decipher what the script meant", he rang Dr Cywinski and was told: "[H]e would prescribe compounded HGH for only 2-3 patients as a trial and that he was only familiar with Saizen 8mg brand, but it was too expensive so wanted to try the compounded version and see how these patients responded. He asked that the Pharmacy adjust the scripts accordingly to reflect the compounded HGH version, which the Pharmacy supplied. Dr Cywinski confirmed the script, the dose and the monthly supply. A note was made in the file of Patient S to record this."
8. In circumstances where the quantity and dose prescribed was unclear and where the prescriber advised that they were seeking the compounded equivalent of the drug prescribed, it was inappropriate for Dr Serafin to proceed to supply HGH to Patient S based upon Dr Cywinski's verbal advice. Not to require Dr Cywinski to issue a new prescription demonstrated poor judgement and a lack of care. Of particular concern is that this was not a single prescription which needed to be "deciphered". Dr Serafin proceeded to compound and dispense a further four prescriptions which contained the same defects as contained in the original prescription.
9. Finally, each of the five prescriptions failed to meet the requirements of cl 35 of the PTGR in several respects, in that they did not specify the address of the patient or contain adequate directions for use.

Unsatisfactory professional conduct

1. The standard reasonably expected of a senior and experienced pharmacist is to be familiar with the key rules and requirements which govern the practice of pharmacy. One such rule is contained in the 2010 Dispensing Guidelines about compounding where a suitable commercial product is available. Self-evidently that rule takes on particular significance when the pharmacist works exclusively in the area of compounding. We find that Dr Serafin's ignorance of that rule demonstrated that his knowledge fell significantly below the relevant standard.
2. In addition, for the reasons given for our conclusion that it was inappropriate for Dr Serafin to compound and dispense HGH to Patient S, we find that the conduct described in Particular 1 demonstrates that the judgement possessed, and care exercised by, Dr Serafin fell significantly below the relevant standard.
3. Particular 1 is established.

Particulars 2, 3, 4 and 5

1. Each particular concerns Dr Serafin's actions in supplying prescribed restricted substances to four different patients on the basis of out-of-date prescriptions. A pharmacist must not supply a restricted substance on prescription if the prescription is dated more than six months before the date on which the supply is requested: cl 40(1)(g)(ii) of the PTGR.
2. Dr Serafin admits the facts of each particular. However, he disagrees that that conduct amounts to unsatisfactory professional conduct. Mr Chilton agrees. In his opinion, supplying a S 4D substance on the basis of an out-of-date prescription constitutes a "procedural compliance error" and, while it falls below, it does not fall significantly below the relevant standard.
3. Reflecting the position he took in relation to Complaint 2 Particular 16, Mr Cotterell takes a less forgiving view. He considers relevant the potential risks to the patient in supplying a S 4D substance on the basis of an out-of-date prescription.
4. Each prescription was out-of-date for a significant period, ranging from about five weeks (Particular 4) to 11 weeks (Particular 3). Taken together with the potential risks of supplying s 4D substances on the basis of out-of-date prescriptions, we find that the conduct described in Particulars 2, 3, 4 and 5 demonstrated that the care exercised by Dr Serafin fell significantly below the relevant standard.

Summary

1. Complaint 5 is proven in whole or part. That conduct amounts to unsatisfactory professional conduct.

Complaint 6: Misconduct

1. Complaint 6 alleges that Dr Serafin is guilty of professional misconduct under section 139E of the National Law. Dr Serafin does not admit professional misconduct.
2. Section 139E of the National Law states that a practitioner is guilty of professional misconduct if they: (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 the suspension or cancellation of the practitioner's registration.
3. We must decide whether the conduct, found or admitted to, amount to unsatisfactory professional conduct (the impugned conduct), is of a "sufficiently serious nature" to justify an order for suspension or cancellation. This requires that we make an evaluative judgement: Chen v Health Care Complaints Commission (2017) 95 NSWLR 334; [2017] NSWCA 186 at [20]. The definition of professional misconduct is focused on the nature of the conduct, not whether an order for suspension or cancellation should be made: Health Care Complaints Commission v Karalasingham [2007] NSWCA 267 at [67] (Basten JA). In evaluating whether the impugned conduct is of a sufficiently serious nature to justify suspension or cancellation, circumstances that bear on the objective assessment of that conduct must be taken into account. These include the nature and duration of the conduct, any mitigating factors, and an assessment of where the offending conduct falls on the spectrum of unsatisfactory professional conduct.
4. The impugned conduct is to be measured by the extent to which it departs from proper standards and not by reference to the worst cases. To do the latter would risk the misconduct of some practitioners indirectly setting the standards to be applied by the Tribunal: Health Care Complaints Commission v Litchfield (1997) 41 NSWLR 630 at 638; [1997] NSWSC 297.

Submissions

1. Dr Serafin submits that the impugned conduct is not of a sufficiently serious nature to justify the suspension or cancellation of his registration as he contends that there was no deliberate departure from, or indifference to accepted standards. The Commission disagrees.

Consideration

1. The impugned conduct occurred falls broadly into several categories: 1. Repeated failures to comply with the requirements of the PTGR in compounding and dispensing prescribed restricted substances and drugs of addiction. (Particulars 4, 6, 7, 8, 9and 13 of Complaint 1; Particulars 14, 15, 16 and 17 of Complaint 2; Particulars 6 to 14 of Complaint 2; Particulars 1 to 5 of Complaint 5 (the Dispensing complaints); 2. Compounding and dispensing ketamine an S 8 drug in quantities and for a purpose which did not accord with the recognised therapeutic standards of what was appropriate under the circumstances (Particulars 1 and 2 of Complaint 4) (the ketamine complaints); 3. Inappropriately compounding and dispensing prescribed restricted substances, in the main PIEDs, in circumstances where among other things, he failed to ensure that they were in quantities and for a purpose which accords with the recognised therapeutic standards of what was appropriate under the circumstances (Particulars 1, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 of Complaint 2) (the PIEDS complaints); 4. Compounding and dispensing Myers's Cocktail and other substances for parenteral use in circumstances where he ought to have known exercising responsible professional judgement that they would be administered to people other than to whom they were prescribed (Particulars 1 and 2 of Complaint 1) (the Kazeme complaints); 5. Over a period of seven years, failing to conduct biannual audits of S 8 drugs as required by the PTGR (Particular 18 of Complaint 2) (the audit complaint).
2. A notable feature of the Complaint is the range of the impugned conduct and the extended period over which it occurred, 2013 to June 2017.
3. As evidenced by the volume of contraventions the subject of the Dispensing and audit complaints, the practices in place within the Pharmacy to ensure compliance with the requirements of the PTGR were grossly inadequate. As explained above we reject the contention that those failures can be characterised as "procedural non-compliance" and not especially serious.
4. Further the conduct the subject of the PIEDs, Kazeme and ketamine complaints are objectively serious and, in terms of seriousness, fall at the high end of unsatisfactory professional conduct.
5. Taken together we find the impugned conduct is sufficiently serious to justify cancellation of Dr Serafin's registration.
6. Complaint 6 is established.

What, if any, protective orders should be made?

1. Where a complaint made under the National Law is admitted or proven, the Tribunal may exercise any of the powers in Subdiv 6, Div 3 of Pt 8 of the National Law. They include the powers to caution, reprimand and to impose conditions on a practitioner's registration: s 149A(1) of the National Law. Where, as here, the Tribunal finds that a practitioner is guilty of professional misconduct, the power to suspend or cancel the practitioner's registration may be exercised: s 149C(1)(b) of the National Law.
2. In exercising the power to make protective orders, the paramount consideration is the protection of the health and safety of the public: s 3A of the National Law.
3. In Lee v Health Care Complaints Commission [2012] NSWCA 80, Barrett JA observed at [20] that, in making protective orders, the task of the decision-maker centres not on punishment but on the protection of the public and the maintenance of proper professional standards, citing with approval the comments made by Basten JA in Director-General, Department of Ageing, Disability and Home Care v Lambert (2009) 74 NSWLR 523; [2009] NSWCA 102 at [83].

Submissions

1. The Commission submits that given the gravity of the impugned conduct and Dr Serafin's alleged failure to address the issues the subject of these proceedings, it is appropriate that Dr Serafin's registration be cancelled for a period of three to four years. The Commission contends that Dr Serafin has demonstrated an inability or unwillingness to recognise the significant impact the novel substances the subject of these proceedings may have on the health and safety of his patients, particularly in the long term. His conduct, argues the Commission, evidences disregard, indifference and carelessness towards the need to ensure that substances supplied are in an appropriate therapeutic quantity and for an appropriate therapeutic purpose.
2. In addition, the Commission seeks a prohibition order under s 149C of the National Law.
3. Dr Serafin disagrees. For the following reasons he submits that the appropriate protective orders are a reprimand and conditions, if considered appropriate by the Tribunal.
4. First, Dr Serafin contends that the Commission's position effectively seeks to punish him and destroy his livelihood for conduct which, when committed, was legal. Dr Serafin contends that it would be one thing for the Commission to now seek to impose conditions preventing him from compounding certain substances but another to call for the cancellation of his registration. He argues that that approach offends fundamental notions of justice and fairness and runs counter to the rule of legality embedded in our legal system, that laws, and (even more fundamentally) sanctions, should not operate retrospectively. In support, Dr Serafin cites the following passage from the decision of the High Court in Australian Education Union v General Manager of Fair Work Australia (2012) 246 CLR 117; [2012] HCA 19 at [30]: "In a representative democracy governed by the rule of law, it can be assumed that clear language will be used by the Parliament in enacting a statute which falsifies, retroactively, existing legal rules upon which people have ordered their affairs, exercised their rights and incurred liabilities and obligations. That assumption can be viewed as an aspect of the principle of legality, which also applies the constructional assumption that Parliament will use clear language if it intends to overthrow fundamental principles, infringe rights, or depart from the general system of law."
5. Dr Serafin points out that throughout the period of the Complaint and currently, the subject substances were legally available in Australia and could be legally prescribed, compounded and supplied. In addition, he points out that had the TGA held concerns about the safety of any of the subject substances, it could have decided to classify them as S 9. Not only did the TGA not do so, it decided to classify most of the subject substances as S 4D, not S 4B, which would have ensured that they were subjected to more stringent regulation.
6. Based on the TGA's scheduling, Dr Serafin assumed that it was (and is) acceptable to supply, based on a legal prescription (Tcpt, 15 December 2020, p 33 (8, 9)). He argues that in circumstances where he had researched the substances, had a reasonable basis for his belief that they were being prescribed for a proper therapeutic purpose and sought to satisfy himself of the bona fides of the prescribers, cancellation is not an appropriate order.
7. Second, the significant delay by the Commission in prosecuting the Complaint runs contrary to the contention the Commission now urges the Tribunal to adopt that he poses a risk the health and safety of the public. It is contrary to the expectations of the public that the Commission would see no urgency in progressing the matter to the Tribunal, during which time Dr Serafin practised with minimal conditions, and at the same time, urge the Tribunal to cancel his registration.
8. Third, the conduct to which he has admitted was largely the result of shortcomings in the Pharmacy's practices and procedures and his failure to properly oversee the work of the Pharmacy because of lack of time and sleep. He has now put in place numerous procedures and protocols to address those shortcomings. In addition, he has made changes to his work and personal life to ensure that he has adequate time and emotional reserves to devote to managing the Pharmacy.
9. Fourth, Dr Serafin is recognised as being an extremely gifted pharmacist. He was able to demonstrate good clinical knowledge of the products compounded at the Ballina Pharmacy. Those clinical skills make him well placed to continue in the industry.
10. Fifth, there is evidence that peptides and growth hormones are available from a number of compounding pharmacies throughout Australia and also via the internet, not just on the black market. There is significant demand for those products. If reputable suppliers, such as Dr Serafin, are shut down, patients will be forced to rely on operators who do not have the laboratory standards or strict controls of a skilled pharmacist like Dr Serafin.
11. Sixth, throughout his work, Dr Serafin has attempted to introduce and encourage standards in the compounding industry, an industry that values good practice and effective guidelines and regulations. He has demonstrated that, as long as those guidelines and regulations are clear, he is willing to follow them.
12. Seventh, Dr Serafin has practised with conditions since 2016 and at all times abided by those conditions. The Tribunal could be confident that if it decided to impose conditions, Dr Serafin would fully comply with them.
13. Eighth, the Tribunal would be satisfied that Dr Serafin is a man of integrity, as reflected by the character references submitted on his behalf. None of his character referees were required for cross-examination by the Commission.
14. Ninth, in written and oral evidence, Dr Serafin has indicated his willingness to embrace any suggestions for his practice. For example, in his statement dated 26 November 2020, he wrote at par 148: "I am always willing to learn about any errors made and strive for best practice, and I will take on board any further suggestions made as a result of this review. I regard being a Pharmacist as a privilege and will continue to strive for excellence."
15. Tenth, Dr Serafin enjoys an excellent reputation amongst his staff and colleagues, whose evidence is not challenged by the Commission. Pharmacist Mr Scott Wratten has known Dr Serafin for three years as an employer and a friend. He stated that Dr Serafin has "proven to be an honest, trustworthy, caring and dependable person. As a pharmacist he has the highest levels of integrity and professionalism". Pharmacist Mr David Bittar has known Dr Serafin as a friend and colleague for 30 years. He describes Dr Serafin as a "professional with many years of excellence and experience" who has "displayed warmth, compassion and loyalty a guardian of his friends and colleagues". He stated that he has "always found [Dr Serafin] to conduct himself with the utmost integrity".
16. Finally, a reprimand is an appropriate form of disciplinary order because it will act as a determent to both Dr Serafin and other members of the pharmacy profession (NSW Bar Association v Meakes [2006] NSWCA 340 (Meakes)) and further will uphold and reinforce the standards of the profession. The cancellation of Dr Serafin's registration will undoubtedly have dire consequences for himself resulting in the loss of his livelihood and business and also for the many people he employs. While the protection of the public is paramount, nonetheless, consistent with the observations made by Basten JA in Meakes at [113], [114], the Tribunal should endeavour to impose the least restrictive order necessary in execution of the protective purpose. Such approach has been adopted by Courts and tribunals exercising the power to make disciplinary orders under the National Law. See, for example Vito Zepinic v Health Care Complaints Commission [2020] NSWSC 13.

Conclusion

1. Before addressing the question of what, if any, protective orders should be made, we address the retrospectivity argument made by Dr Serafin. The argument that an order for cancellation would in effect punish Dr Serafin for conduct that was "legal" at the time it was committed fails to acknowledge that the statutory framework which governs the practice of pharmacy, does not start and end with whether or not a substance is classified as S 9, whether the substance was entered on the ARTG, or whether the substance has been prescribed by a medical practitioner. Throughout the period of the Complaint and to this day, the PTGR makes it an offence for a pharmacist to supply any restricted substance, or drug of addiction in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
2. The National Law directs that, in exercising the power to make protective orders, the health and safety of the public is the paramount consideration. The jurisdiction exercised is protective not punitive. As Basten JA explained in Prakash v Health Care Complaints Commission [2006] NSWCA 153, at [101] "[t]he adverse consequences for a practitioner may require that no more restrictive an order should be made than is necessary for the proper protection of the community and the other proper purposes of such an order."
3. Applying those principles, we have decided nonetheless that it is appropriate and necessary for the proper protection of the public that Dr Serafin's registration be cancelled for the following reasons.
4. First, the conduct the subject of the Complaint was of a very serious nature, encompassed many aspects of pharmacy practice and extended over several years. In those circumstances, we agree with the submission made by the Commission that Dr Serafin's misconduct be denounced to underscore to him, the profession and the public of the standards expected of pharmacists: Health Care Complaints Commission v Do [2014] NSWCA 307 at [35].
5. Second, we accept that the series of reforms Dr Serafin put in place at the Pharmacy are likely to prevent a repeat of the conduct the subject of the Dispensing complaints (see for example, the reforms described by Dr Serafin in Exh R2). However, those reforms are unlikely to prevent a reoccurrence of the conduct the subject of the PIEDS and ketamine complaints, which demonstrated the exercise of poor judgement by Dr Serafin. As the Commission points out throughout these proceedings, Dr Serafin refused to acknowledge that, in circumstances where there were no published standards and limited evidence about the subject substances, his opinion about those substances may be at odds with what constitutes recognised therapeutic standards. As was evident throughout these proceedings, Dr Serafin holds a high opinion about his ability to assess scientific and medical evidence. Throughout these proceedings he was somewhat dismissive of those who held opinions which differed from his. For example, Dr Serafin: 1. expressed a low opinion of the ability of endocrinologists to evaluate the safety and efficacy of peptides and considered that he was better placed than Professor Carter to assess their appropriate therapeutic use (Tcpt, 17 December 2020, p 93 (6-10); p 93 (48)-94(5)); 2. was dismissive of the suggestion that a decision to prescribe oral ketamine for long term use may require specialist input, "GPs prescribe S 8s every day" (Tcpt, 29 March 2021, p 25(29)); 3. was not concerned that a GP had prescribed oral ketamine for pain relief, in circumstances where it was not listed on the ARTG for that purpose or the subject of a recognised therapeutic standard: "anyone can read the research and determine what the research shows" (Tcpt, 29 March 2021, p 25 (39)).
6. Dr Serafin is evidently intelligent and highly educated in the field of pharmacy. It is not incompatible with the proper discharge of the obligations of the profession for a pharmacist to be confident about their intellect and professional ability. However, we were left with the impression that Dr Serafin's confidence may have clouded his ability to objectively scrutinise the quality of the information on which he relied and to assess whether the quantity and purpose for which subject substances were supplied accorded with a proper therapeutic purpose.
7. Third, we formed the view that Dr Serafin lacked insight into the gravity of his conduct and the extent to which it deviated from professional standards. Throughout the proceedings he repeatedly accused the Commission and/or the PRU of making "false allegations", subjecting him to a "witch hunt" and seeking to "tarnish his reputation". For example: "I feel the corruption that occurs within all levels of the investigation, making up false allegations - I don't know when this is ever going to stop. I speak to fellow compounders virtually every day, and, again, they are experiencing exactly the same. There's so much uncertainty in the industry, especially in New South Wales, that most of us go to work on a daily basis in a constant state of anxiety because we don't know what we can and can't do because we interpret the guideline in one way, and some other spark will come in and interpret it completely different, and we have got no clear guidance, and at the moment, there is a witch hunt on compounding." (Tcpt, 29 March 2021, p 36(41-50))
8. A practitioner who is the subject of disciplinary proceedings and faces the prospect of losing their livelihood will invariably be experiencing stress and anxiety. Colourful comments made in the course of proceedings about the "accuser" must be seen in that light. Nonetheless, the repeated nature of the comments made by Dr Serafin leads us to conclude that Dr Serafin lacks insight into the gravity of his conduct, even to that conduct to which he admits.
9. Fourth, we are not confident that at this stage Dr Serafin will bring to the many difficult decisions that pharmacists are called on to make in the course of practice, especially those working in the complex area of compounding pharmacy, the necessary judgement to make sound evidence-based decisions and to have proper regard to the health and safety of patients. Many of the decisions that need to be made by pharmacists cannot be simply answered by asking whether "it is legal" and require the exercise of sound judgement.
10. In reaching that conclusion we note for example that to this day, Dr Serafin strenuously defends his decision in supplying oral ketamine, a highly addictive substance that was prescribed off-label to Patient M and N, notwithstanding that Patient M had initially self-prescribed, they were living together, and neither had consulted with, less still were monitored by, a pain specialist. Similarly, it was apparent that Dr Serafin saw no apparent need for the patients to whom he supplied PIEDs to be reviewed by a specialist, notwithstanding their novel nature, their reputation for abuse and misuse, the lack of any recognised therapeutic standards, together with the fact that in many cases, they were being supplied in combination with other novel substances. The Kazeme complaints provide yet another example of poor judgement. As found by us, Dr Serafin continued to supply parenteral substances to Ms Kazeme in circumstances where, had he been exercising responsible professional judgement, he ought to have known that those substances would be administered to persons other than to whom they were prescribed.
11. Fifth, the conditions proposed by Dr Serafin in our view are not adequate for the proper protection of the public. The proposed conditions include that Dr Serafin: 1. not compound or manufacture any substance containing HGH, and HGH secretagogue, any novel peptide of SARM with no long terms safety data, 2. and work with a mentor approved by the Pharmacy Council.
12. While the proposed conditions go some way to addressing our concerns, in our view, there is a real and material risk that in the future if Dr Serafin is requested to supply novel substances that fall outside those the scope of the conditions of his registration, he will fail to exercise sound judgement in deciding whether the purpose, and the quantity, for which they were prescribed accords with recognised therapeutic standards. If that were to occur, this potentially puts the health and safety of the public at risk.
13. While not raised by either party we have also considered whether suspension is an appropriate order. We decided it was not, primarily because, in our view, unless and until Dr Serafin develops insight into his conduct, there is a real risk that the impugned conduct will be repeated. It may be that after a period of reflection Dr Serafin develops insight, reviews his practices and as a consequence, no longer poses a relevant risk. However, until Dr Serafin has undergone a period of reflection, it is not possible to say whether that will be the case. Therefore, the automatic reinstatement of his registration after a period of suspension is not sufficiently protective of the public.
14. Finally, we have taken into account that a decision to cancel Dr Serafin's registration will have a devastating effect on Dr Serafin, both personally and professionally. Among other things, it will require that he dispose of his interest in the Pharmacy. Undoubtedly, it will also severely impact on the employees of the Pharmacy and those who use its services. In addition, we have taken into account that several pharmacists of good repute hold Dr Serafin in high regard. While these are powerful considerations which favour a less restrictive form of order, they are outweighed by the consideration of the proper protection of the public.

Non-review period

1. At this stage it is not possible to say whether Dr Serafin will be able and willing to address the concerns raised by us about his insight and judgement so that he no longer poses a risk to patient health and safety. We think it unlikely that these concerns can be addressed in less than 18 months.
2. However, if, after 18 months, Dr Serafin can demonstrate that he has addressed those concerns in our view he should not be deprived of the opportunity to apply for review of the cancellation order.
3. We have therefore decided to order that Dr Serafin not be permitted to seek review of the cancellation order for 18 months.

Date of effect of decision

1. We have decided to exercise the discretion conferred by s 61 of the Civil and Administrative Tribunal Act 2013 (NSW) to order that our decision will not come into effect until 60 days after publication of our reasons for decision. This will enable Dr Serafin to put in place necessary arrangements relating to the management of the Pharmacy. In the intervening period, the current conditions imposed on Dr Serafin's registration will continue to apply.

Should a prohibition order be made?

1. The Commission seeks a prohibition order under s 149C(5) of the National Law preventing Dr Serafin from "providing any health service, as defined in s4 of the Health Care Complaints Act 1993, whether on a public, private or volunteer basis including community health services, and pharmaceutical services" and "working as a pharmacy assistant".
2. The power to make a prohibition order can only be exercised if we are satisfied that Dr Serafin poses a "substantial risk to the health of members of the public" (emphasis added): Health Care Complaints Commission v Menz (No. 2) [2017] NSWCATOD 172 at [18]; Health Care Complaints Commission v Grygiel [2021] NSWCATOD 28 at [437].
3. The form of order sought by the Commission is extremely wide and would operate to prevent Dr Serafin from providing "any health service". The Commission has failed to articulate the nature of the risk posed by Dr Serafin if he were to provide any health services. Nor has the Commission advanced any argument to support the contention that it is appropriate to exercise the discretion to make an order of such breadth. We are left with the impression that the application for a prohibition order is something of an afterthought.
4. In circumstances where the apprehended risk has not been clearly identified, Dr Serafin is unable to meaningfully respond to that allegation.
5. As the Commission has failed to establish Dr Serafin poses a "substantial risk to the health of members of the public", if he were to provide any health service, the power to make a prohibition order cannot be exercised.

Costs

1. The Commission seeks the opportunity to respond to Dr Serafin's submissions that if we make a finding of professional misconduct, he should be ordered to pay no more than 80% of the Commission's costs. We direct that the parties use their best endeavours to reach agreement on costs. If agreement is not reached, any party applying for costs must provide submissions in support in accordance with the timetable set out in the orders below.

Orders 1. Pursuant to s 149C(1) of the Health Practitioner Regulation National Law (NSW) Dr Serafin's registration as a pharmacist is cancelled. 2. Pursuant to s 149C(7) of the Health Practitioner Regulation National Law (NSW) Dr Serafin may not apply for review of the cancellation order for a period of 18 months. 3. Pursuant to s 61 of the Civil and Administrative Tribunal Act 2013 (NSW) orders 1 and 2 take effect 60 days from the date of this Decision. 4. Within 14 days of this Decision, any party seeking costs must file and serve short submissions in support of their application. 5. Within 10 days of receipt of those submissions, the other party must file and serve any submissions in reply. 6. Within 21 days of the date of this Decision, each party must notify the Tribunal and each other in writing whether in their opinion the issue of costs can be adequately determined on the basis of written submissions and without holding a further hearing as permitted by s 50(2) of the Civil and Administrative Tribunal Act 2013 (NSW).

            I hereby certify that this is a true and accurate record of the reasons for decision of the New South Wales Civil and Administrative Tribunal.

Registrar

Endnotes

1. Myer's Cocktail consists of two parts. Part A includes combination of various B vitamins, calcium and magnesium. Part B consists of sodium ascorbate (vitamin C).
2. The relevant standard was in fact the Poisons Standard 2015, which came into effect on 5 February 2015 and was in force for most of the period the subject of Complaint 1. Nothing turns on this.
3. The Poison Standard defines "poison" to mean "any substance or preparation included in a Schedule to this Standard". In the PTGR expressions that are defined in the current Poisons Standard have the meanings given to them by that Standard: cl 3(2)(a) of the PTGR.
4. Particulars 1, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13.
5. This sub-particular does not apply to Particulars 7 and 12, where there was a single dispense.
6. The National Health and Medical Research Council has ascribed a hierarchy of levels of evidence. At the top of that hierarchy, are systematic reviews of two or more randomised controlled trials through to case series, with either post-test or pre-test-post-test outcomes. (see, Exh A 5, Tab 4, APF 23, Evidence based medicine). 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: 01 February 2022