Health Care Complaints Commission v Abrams

Complaint The Health Care Complaints Commission of Level 13, 323 Castlereagh Street, Sydney NSW, having consulted with the Pharmacy Council of New South Wales ("the Council") in accordance with sections 39(2) and 90B(3) of the Health Care Complaints Act 1993 and section 145A of the Health Practitioner Regulation National Law (NSW) ("the National Law") HEREBY COMPLAINS THAT Mr Ian Saville Abrams ("the practitioner") of Unit 29/24-26 Ralph Street, Alexandria NSW 2015, being a pharmacist registered under the National Law, BACKGROUND TO COMPLAINT The practitioner was first registered as a pharmacist in Australia on 11 March 1998. He was previously registered and worked as a pharmacist in South Africa from 1985. In 1998 the pharmacist commenced working as an employed pharmacist at Maroubra Pharmacy ('the Pharmacy'). Around 21 July 2000 he entered into a partnership with Pharmacist A and became a co-proprietor of Maroubra Pharmacy. Both the pharmacist and Pharmacist A divested ownership of the Pharmacy around 11 May 2016. Maroubra Pharmacy was a retail pharmacy which had a significant compounding component. The pharmacist established Sydney Sterile Compounding ('SSC') around 13 May 2015. SSC operated purely as a compounding pharmacy and did not have a retail shopfront. Around 20 September 2013 the pharmacist and Doctor A incorporated and became director and shareholders of Peptide Clinics Pty Limited ('Peptide Clinics'). Doctor A divested himself of ownership of Peptide Clinics in September 2016. Peptide Clinics maintained a website which allowed patients to request prescriptions for peptides and other compounded drugs which would then be reviewed and issued by a doctor and forwarded to SSC to be compounded and dispensed. Following a series of inspections of the SSC premises in December 2015, the Pharmaceutical Regulatory Unit prepared a stock check report which revealed that the following drugs could not be accounted for • 47 packs of 25 oxazepam 30mg tablets (Alepam® and Serepax® brands); • 92 packs of 25 temazepam 10mg tablets (Normison®, Temaze® and Temtabs® brands); • 89 packs of 50 diazepam 5mg tablets (Valium® and Valpam® brands); • 25 packs of 30 anastrozole 1mg tablets (Anastrozole AN®, Anastrozole RBX® and Anastrozole SNZ® brands); • 2 packs of 30 tamoxifen 20mg tablets (Nolvadex-D® brand); • 2 packs of 10 clomiphene 50mg tablets (Clomid® brand); • 3 packs of 60 isotretinoin 10mg capsules (Oratane® brand); • 48 packs of 60 modafinil 100mg tablets (Modafin® and Modafinil SNZ® brands); • 550 packs of 14 zolpidem 10mg tablets (Zolpidem Synthon® and Zolpidem AN® brands); • 112 packs of 20 paracetamol/codeine 500m0/30mg tablets (Prodeine Forte® brand). COMPLAINT ONE is guilty of unsatisfactory professional conduct under section 1398(1)(a) and/or (I) of the National Law in that the practitioner has: i. engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or ii engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy. PARTICULARS OF COMPLAINT ONE MAROUBRA PHARMACY 1. Between 22 January 2013 and 1 February 2013, the practitioner inappropriately dispensed, or permitted to be dispensed, on prescriptions from Doctor A, drugs listed in Schedule 4 and 4D of the Poisons and Therapeutic Goods Regulation 2008 NSW ("the PTGR"), on the dates and in the quantities set out in Schedule 1 to this Complaint, in circumstances where; a) the prescriptions were not endorsed, contrary to Clause 41(1) of the PTGR; b) the drugs were supplied to patients without adequate directions for use; c) the prescriptions did not contain the prescriber's handwritten signature, contrary to clause 35(2) of the PTGR and the NSW Health Guideline TG184/8, Criteria for Issuing Non-Handwritten (Computer Generated) Prescriptions. 2. Between 6 August 2015 and 13 August 2015, the practitioner inappropriately dispensed, or permitted to be dispensed, Schedule 4 and 4D drugs on prescriptions from Doctor B, on the dates and in the quantities set out in Schedule 2 to this Complaint in circumstances where; a) the prescriptions were not endorsed, contrary to Clause 41(1) of the PTGR; b) the drugs were supplied to patients without adequate directions for use; c) the prescriptions did not contain the prescriber's handwritten signature, contrary to clause 35(2) of the PTGR and the NSW Health Guideline TG184/8, Criteria for Issuing Non-Handwritten (Computer Generated) Prescriptions. 3A. Around 24 June 2015 (as amended from 2016) the practitioner inappropriately dispensed an excessive quantity of the schedule 4D drug Dehydroepiandrosterone ('DHEA') to Patient A, in circumstances where: a) he dispensed 100 15mg capsules contrary to the prescription which specified the quantity as 50 capsules, as set out in Annexure 1 to this Complaint; b) he failed to ensure that the quantity of supply was appropriate, contrary to clause 54 of the PTGR. 3B. In the alternative to particular 3A, the practitioner failed to discharge his obligations as the proprietor of the Pharmacy when he permitted an excess quantity of DHEA to be dispensed by another pharmacist at the pharmacy, and in doing so: a) failed to maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted; b) failed to intervene when necessary; c) failed to maintain accurate dispensing records. 4A. Around 22 October 2015, the practitioner inappropriately dispensed DHEA to Patient B, in circumstances where: a) the prescription was dated more than 6 months before the date on which the supply was requested, contrary to clause 40(g) of the PTGR; b) the prescription did not specify an interval for repeated supply, contrary to clause 39 of the PTGR. 4B. In the alternative to particular 4A, the practitioner failed to discharge his obligations as the proprietor of the Pharmacy when he permitted the dispensing by another pharmacist at the Pharmacy, and in doing so: a) failed to maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted; b) failed to intervene when necessary; c) failed to ensure the Pharmacy had protocols in place to identify expired prescriptions. 5. Between 2 September 2015 and 16 December 2015, the practitioner inappropriately dispensed compounded phentermine, a schedule 4D drug, on the dates and in the quantities set out in Schedule 3 to this Complaint, in circumstances where: a) an appropriate commercial product was available, contrary to the Pharmacy Board of Australia, Guidelines on Compounding of Medicines, March 2015 ('the Compounding Guidelines'); b) without confirming with the prescriber that there was a therapeutic purpose for the dispensing; c) without confirming with the prescriber that there were no contraindications for dispensing. 6. Between 2 September 2015 and 16 December 2015, the practitioner failed to discharge his obligations as the proprietor of the Pharmacy when he permitted the dispensing of phentermine by other pharmacists at the Pharmacy, on the dates and in the quantities set out in Schedule 3 to this Complaint, and in doing so: a) failed to maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted; b) failed to intervene when necessary; c) failed to maintain accurate dispensing records. 7. Between 2 September 2015 and 19 October 2015, the practitioner dispensed phentermine in excess of the quantity specified on the prescription on the dates and in the quantities set out in Schedule 3 to this Complaint. 8. Between 2 September 2015 and 19 October 2015, the practitioner failed to discharge his obligations as the proprietor of the Pharmacy when he permitted the dispensing of excess phentermine by other pharmacists at the Pharmacy, on the dates and in the quantities set out in Schedule 3 to this Complaint, and in doing so: a) failed to maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted; b) failed to intervene when necessary; c) failed to maintain accurate dispensing records. 9. Between 6 January 2015 and 11 November 2015, the practitioner inappropriately dispensed the schedule 4D peptides Ipamorelin, CJC‑1295, CJC‑1295/GHRP‑2, CJC-1295/Ipamorelin, GHRP-6 and the Selective Androgen Modulator Receptor ('SARM') SARM S22 on the dates and in the quantities set out in Schedule 4 to this Complaint, in circumstances where: a) the peptides were unregistered products and the prescribing was therefore off-label; b) he failed to verify that there was an individual therapeutic purpose for the dispensing to each patient; c) he failed to document any discussions with Doctor B about the intended use and evidence of efficacy and safety of the peptides; d) as a result of his failures in sub-particulars a) to c), he failed to ensure that the purpose of supply was in accordance with the recognised therapeutic standard, subject to clause 54 of the PTGR. 10. Between 6 January 2015 and 11 November 2015, the practitioner failed to discharge his obligations as the proprietor of the Pharmacy when permitted the peptides Ipamorelin, CJC‑1295, CJC‑1295/GHRP‑2, CJC‑1295/Ipamorelin, GHRP‑6 and the Selective Androgen Modulator Receptor ('SARM') SARM S22 to be dispensed by other Pharmacy employees, on the dates and in the quantities set out in Schedule 4, in circumstances where: a) the peptides were unregistered products and the prescribing was therefore off-label; b) he failed to verify that there was an individual therapeutic purpose for the dispensing to each patient; c) he failed to document any discussions with Doctor B about the intended use and evidence of efficacy and safety of the peptides; d) as a result of his failures in sub-particulars a) to c), he failed to ensure that the purpose of supply was in accordance with the recognised therapeutic standard, subject to clause 54 of the PTGR. 11. Between around 2 June 2015 and 2 November 2015, the practitioner inappropriately compounded and dispensed 200IU troches of the schedule 4 drug Oxytocin on the dates and in the quantities set out in Schedule 5 to this Complaint, in circumstances where: a) Oxytocin is registered for use in managing labour in women and therefore the prescribing was off-label; b) he failed to verify that there was an individual therapeutic purpose for the dispensing to each patient; c) he failed to document any discussions with Doctor B about the intended use and evidence of efficacy and safety of using Oxycotin for its intended off-label purpose; d) as a result of his failures in sub-particulars a) to c), he failed to ensure that the purpose of supply was in accordance with the recognised therapeutic standard, subject to clause 54 of the PTGR. 12. Between 2 June 2015 and 2 November 2015, the practitioner failed to discharge his obligations as the proprietor of the Pharmacy when he permitted Oxytocin 200IU troches to be dispensed by other Pharmacy employees on the dates and in the quantities set out in Schedule 5, in circumstances where: a) Oxytocin is registered for use in managing labour in women; b) the dispensing was the for purposes of enhancing social confidence and/or sexual function; c) he failed to ensure the Pharmacy had adequate protocols in place in relation to the dispensing of compounded products for off-label prescribing including the need to call the prescriber; d) as a result of his failures in sub-particulars a) to c), he failed to ensure that the purpose of supply was in accordance with the recognised therapeutic standard, subject to clause 54 of the PTGR. 13. On 6 July 2015 and 12 August 2015 the practitioner inappropriately dispensed the schedule 4D drug, NutropinAq to Patient C in the quantities set out in Schedule 6 to this Complaint, in circumstances where: a) NutropinAq is registered for use in adults with growth hormone deficiency; b) the dispensing was for the purpose of promoting injury repair; c) he failed to document any discussions with the prescriber about the intended use and evidence of efficacy and safety of using NurtopinAq for its intended off-label purpose; e) as a result of his failures in sub-particulars a) to c), he failed to ensure that the purpose of supply was in accordance with the recognised therapeutic standard, subject to clause 54 of the PTGR. 14. On 30 August 2015, 9 October 2015 and 11 November 2015, the practitioner inappropriately dispensed NutropinAq to Patient D in the quantities set out in Schedule 6, in circumstances where: a) NutropinAq is registered for use in adults with growth hormone deficiency; b) the dispensing was for the purpose of promoting injury repair; c) he failed to document any discussions with the prescriber about the intended use and evidence of efficacy and safety of using NurtopinAq for its intended off-label purpose; d) as a result of his failures in sub-particulars a) to c), he failed to ensure that the purpose of supply was in accordance with the recognised therapeutic standard, subject to clause 54 of the PTGR. 15. On 3 June 2015, the practitioner inappropriately dispensed the schedule 4D compounded drug Testosterone 50mg/ DHEA 30mg/ Mesterelone 40mg to Patient E in the quantities set out in Schedule 6, in circumstances where: a) he failed to document any discussions with the prescriber about the intended use and evidence of efficacy and safety of Testosterone 50mg/ DHEA 30mg/ MestereIone 40mg; b) as a result of his failures in sub-particulars a), he failed to ensure that the purpose of supply was in accordance with the recognised therapeutic standard, subject to clause 54 of the PTGR. 16. On 3 June 2015 and 1 July 2015, the practitioner inappropriately dispensed the schedule 4 drug Sildenafil 100g/ Apomorphine 3mg and the schedule 4D drugs CJC-12951/Ipamorelin 200mcg/mL and SARMS S22 to Patient F in the quantities set out in Schedule 6, in circumstances where: a) the approved use of Apomorphine is for the treatment of Parkinson's Disease, however, the dispensing of Sildenafil 100g/Apomorphine 3mg was for erectile dysfunction; b) CJC-1295/ Ipamorelin 200mcg/mL is not a registered product and the dispensing of CJC-1295/ Ipamorelin 200mcg/mL was for stimulating growth hormone levels, muscle growth and fat/weight loss; c) SARMS S22 is not a registered product and the dispensing of SARMS S22 was for improved lean body mass and increased strength and bone density; d) he failed to document any discussions with the prescriber about the intended use and evidence of efficacy and safety of the off-label prescribing of those drugs; e) he failed to document any discussions with the prescriber about the evidence of efficacy and safety of using that combination of drugs; f) as a result of his failures in sub-particulars a) to e), he failed to ensure that the purpose of supply was in accordance with the recognised therapeutic standard, subject to clause 54 of the PTGR. 17. Between 5 February 2014 and 5 August 2015 the practitioner inappropriately dispensed schedule 4 drugs on prescriptions issued by Doctor A to seven patients for various compounds made up of DHEA, Pregnenolone and Tadalafil, on the dates and in the quantities set out in Schedule 7, in circumstances where: a) he failed to document any discussions with the prescriber about the intended use and evidence of efficacy and safety of for each of the patients for whom those drugs had been prescribed; b) he failed to verify whether the patients had been advised about the cardiovascular risks associated with those drugs; c) the frequency of dispensing exceeded the directions for use; d) he failed to discuss with the patients how many capsules they were consuming per day; e) as a proprietor of the Pharmacy, he failed to ensure that protocols were in place to ensure the dispensing was in accordance with the directions for use, quantity and dose listed on the prescriptions. 18. The practitioner maintained an inappropriate business relationship with Doctor C to dispense medicines on prescriptions for his patients in circumstances where the financial gain from that relationship caused a potential conflict of interest with obligations towards those patients, contrary to the Pharmacy Board of Australia's Professional Practice Profile for Pharmacists Undertaking Complex Compounding, March 2015 ('the Complex Compounding Guidelines). COMPLAINT TWO is guilty of unsatisfactory professional conduct under section 139B(1)(a) and/or (I) of the National Law in that the practitioner has: i. engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or ii. engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy. PARTICULARS OF COMPLAINT TWO SSC 1. The practitioner engaged in bulk manufacturing and dispensing of drugs which were not for a particular person, contrary to the compounding exemption in Item 6, Schedule 5 of the Therapeutic Goods Regulations 1990 (Cth) and section 19D of the Therapeutic Goods Act 1989 (Cth). 2. Between 16 November 2014 and 13 June 2016, the practitioner inappropriately dispensed Schedule 4D drugs on prescriptions from Doctor B, on the dates and in the quantities as set out in Annexure 4 to this Complaint, in circumstances where: a) he failed to ensure that the patients were provided with adequate directions for use; and b) the prescriptions were for off-label use and therefore needed to be handled with more caution and patient care; c) the prescriptions were not endorsed, contrary to Clause 41(1) of the PTGR. 3. Between 1 September 2015 and 28 February 2017, the practitioner failed to maintain accurate dispensing records contrary to clause 176(2) of the PTGR. COMPLAINT THREE is guilty of unsatisfactory professional conduct under section 139B(1)(I) of the National Law in that the practitioner has engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy. PARTICULARS OF COMPLAINT THREE 1. Throughout the period July 2016 to August 2018, the practitioner supplied to himself for personal use, the schedule 4 drugs Prodeine Forte and Modafinil and the schedule 4D drugs, Temazepam and Serepax, from the stocks of SSC; a) without a prescription; b) without making records of the supply; c) contrary to s10(3) and s10(4)(b) of the Poisons and Therapeutic Good Act 1966 NSW ('PTG Act'). 2. Throughout the period July 2016 to August 2018, the practitioner supplied to Employee A, schedule 4 antibiotics and the drug Zolpidem, and the schedule 4D drugs Diazepam, Temazepam and Oxazepam from the stocks of SSC without a valid prescription, and in circumstances where; a) he failed to record the supply; b) he did not have the qualifications, knowledge and authority of an authorised prescriber and therefore placed the health and safety of Employee A at risk; c) contrary to s10(3) and s10(4)(b) of the PTG Act and Part 2, Division 4 of the PTGR. 3. Throughout the period July 2016 to August 2018, the practitioner supplied to Employee B, the schedule 4 drugs Zolpidem, Prodeine forte and Modafinil and the schedule 4D drugs, Diazepam, Temazepam arid Oxazepam from the stocks of SSC without a valid prescription, and in circumstances where; a) he failed to record the supply; b) he did not have the qualifications, knowledge and authority of an authorised prescriber and therefore placed the health and safety of Employee B at risk; c) contrary to s10(3) and s10(4)(h) of the PTG Act and Part 2, Division 4 of the PTGR. 4. Throughout the period July 2016 to August 2018, the practitioner supplied to Employee C, the schedule 4 drugs Zolpidem, Prodeine Forte and Modafinil and the schedule 4D drugs, Diazepam, Temazepam and Oxazepam from the stocks of SSC without a valid prescription, and in circumstances where; a) he failed to record the supply; b) he did not have the qualifications, knowledge and authority of an authorised prescriber and therefore placed the health and safety of Employee C at risk; c) contrary to s10(3) and s10(4)(b) of the PTG Act and Part 2, Division 4 of the PTGR. 5. Throughout the period July 2016 to August 2018, the practitioner supplied to Employee D, the schedule 4 drugs Zolpidem, Keflex, Amoxil and Augmentin, Prodeine Forte, and Modafinil and the schedule 4D drugs, Diazepam, Temazepam and Oxazepam from the stocks of SSC without a valid prescription, and in circumstances where; a) he failed to record the supply; b) he did not have the qualifications, knowledge and authority of an authorised prescriber and therefore placed the health and safety of Employee D at risk; c) contrary to s10(3) and s10(4)(b) of the PTG Act and Part 2, Division 4 of the PTGR. 6. Throughout the period July 2016 to August 2018, the practitioner supplied to Employee E, the schedule 4 drugs Zolpidem, Prodeine Forte and Modafinil and the schedule 4D drugs, Diazepam, Temazepam and Oxazepam from the stocks of SSC without a valid prescription, and in circumstances where; a) he failed to record the supply; b) he did not have the qualifications, knowledge and authority of an authorised prescriber and therefore placed the health and safety of Employee E at risk; c) contrary to s10(3) and s10(4)(b) of the PTG Act and Part 2, Division 4 of the PTGR. 7. Throughout the period July 2016 to August 2018, the practitioner supplied to Employee F, the schedule 4 antibiotics and the drugs zolpidem and Modafinil and the schedule 4D drugs, Diazepam, Temazepam and Oxazepam from the stocks of SSC without a valid prescription, and in circumstances where; a) he failed to record the supply; b) he did not have the qualifications, knowledge and authority of an authorised prescriber and therefore placed the health and safety of Employee F at risk; c) contrary to s10(3) and s10(4)(b) of the PTG Act and Part 2, Division 4 of the PTGR. 8. Throughout the period July 2016 to August 2018, the practitioner supplied to Employee G, the schedule 4 drugs Zolpidem, Anastrozole, Prodeine Forte and the schedule 4D drugs, Diazepam, Temazepam and Oxazepam from the stocks of SSC without a valid prescription, and in circumstances where; a) he failed to record the supply; b) he did not have the qualifications, knowledge and authority of an authorised prescriber and therefore placed the health and safety of Employee G at risk; c) contrary to s10(3) and s10(4)(b) of the PTG Act and Part 2, Division 4 of the PTGR. 9. Throughout the period July 2016 to August 2018, the practitioner supplied to Employee H, the schedule 4 drugs Zolpidem, Augmentin and Codeine Forte and the schedule 4D drugs, Diazepam, Temazepam and Oxazepam from the stocks of SSC without a valid prescription, and in circumstances where; a) he failed to record the supply; b) he did not have the qualifications, knowledge and authority of an authorised prescriber and therefore placed the health and safety of Employee H at risk; c) contrary to s10(3) and s10(4)(b) of the PTG Act and Part 2, Division 4 of the PTGR. 10. Throughout the period July 2016 to August 2018, the practitioner supplied to Employee I, the schedule 4 drug Avantan cream, from the stocks of SSC without a valid prescription, and in circumstances where; a) he failed to record the supply; b) contrary to s10(3) and 610(4)(b) of the PTG Act and Part 2, Division 4 of the PTGR. 11. Throughout the period July 2016 to August 2018, the practitioner supplied to Person A, up to 450 boxes of the schedule 4 drug Zolpidem from the stocks of SSC without a valid prescription, and in circumstances where; a) he failed to record the supply; b) he knew that Person A was a drug dependent person; c) he did not have the qualifications, knowledge and authority of an authorised prescriber and therefore placed the health and safety of Person A at risk; d) contrary to s10(3) and s10(4)(b) of the PTG Act and Part 2, Division 4 of the PTGR. COMPLAINT FOUR is guilty of professional misconduct under section 139E of the National Law in that the practitioner has: i. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration, or ii. engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioner's registration. PARTICULARS OF COMPLAINT FOUR 1. Complaints One, Two and Three and the particulars thereof are repeated and relied upon both individually and cumulatively.

Nature of the jurisdiction

1. The nature of the jurisdiction of the Tribunal is not to punish the Respondent but to protect the public and to maintain proper standards in the profession of pharmacy.
2. In Clyne v NSW Bar Association (1960) 104 CLR 186 at 201 202, [1960] HCA 40 the High Court said: "Although it is sometimes referred to as "the penalty of disbarment" it must be emphasised that a disbarring order is in no sense punitive in character. When such an order is made, it is made from the public point of view for the protection of those who require protection and from the professional point of view in order that abuse of privilege may not lead to loss of privilege."
3. Section 3A of the Health Practitioner Regulation National Law (NSW) ("the National Law"), provides that "in the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration". The interests of the public includes patients or potential patients of the Practitioner concerned.
4. As observed by Beston JA in Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91]: "The purpose of any order consequent upon a finding that a complaint has been proved is said to be protected [sic] of the interests of the public at large but more particularly patients or potential patients of the Practitioner concerned. However, the public interests include indirectly the standing of the medical profession and the maintenance of public confidence in the high standards … of Practitioners. There is also an element of deterrence or, to put it more positively, encouragement to other Practitioners to recognise the importance of complying with professional standards and the risks of failing to do so. The powers of a Tribunal having two members of the medical profession should, at least in relation to professional standards, be accorded a degree of flexibility which might not necessarily be accorded to a Tribunal differently constituted. In determining the appropriate orders to be made, the paramount consideration for the Tribunal is the protection of the health and safety of the public pursuant to s3A of the National Law."

The issues

1. On commencement of the hearing, the Respondent advised the Tribunal that he accepted and admitted allegations in complaints One to Four and the particulars of each of those Complaints, save that he denied the allegations made at Complaint One, particulars 3A, 4A, 5A, 6A, 13 and 14 of Complaint One, and particulars 1 and 3 of Complaint Two.
2. At the Hearing, the Applicant advised the Tribunal that it would not be calling witnesses and that it would rely on three bundles of documents consisting of 65 tabs and tendered as Exhibit 1. The Applicant indicated to the Tribunal that under s 165(h) of the National Law with the admissions that had been made the Applicant proposed to move directly to a Stage 2 Hearing. However, in light of the denials raised by the Respondent to particulars 3A and 4A of Complaint One, it was necessary for the Hearing to proceed on the basis of Stage 1 and Stage 2.
3. Accordingly, it is necessary for the Tribunal to determine whether around 24 June 2015, the practitioner inappropriately dispensed an excessive amount of the schedule 4D drug Dehydroepiandrosterone ("DHEA") to Patient A in circumstances where he dispensed 100 15mg capsules contrary to the prescription which specified the quantity as 50 capsules and failed to ensure that the quantity of supply was appropriate contrary to clause 54 of the PTGR. In addition, the Tribunal will need to decide whether around 22 October 2015, the practitioner inappropriately dispensed Dehydroepiandrosterone to Patient B in circumstances where the prescription was dated more than six months before the date on which the supply was requested, contrary to clause 40(g) of the PTGR and did not specify an interval for repeated supply contrary to clause 39 of the PTGR.

Applicant's evidence

1. The documents provided to the Tribunal included an expert report analysing each of the allegations contained in the complaint against the Respondent. In summary the expert advised that each and every particular of claim if proven was below the standard expected of a practitioner with the experience of the Respondent. That behaviour was either below the standard or significantly below the standard. As the Respondent has admitted, each and every one of the particulars of the Complaint save for the particulars contained in paragraphs 3A and 4A of Complaint One, it is unnecessary for the Tribunal to record in its decision each and every comment. In respect of the particulars at 3A and 4A of Complaint One, it is necessary for the Tribunal to decide whether it accepts the denial of those allegations by the Respondent or whether it believes that there is sufficient evidence to show that the Respondent is in fact guilty in respect of those allegations.
2. The Tribunal had available to it a letter from Mills Oakley who at the time were representing the Respondent in which they sought to call into question the veracity of the expert report provided to the Applicant. The essence of the comments regarding the expert report is that the expert was asked by the Applicant to make certain assumptions and express an opinion thereon. This is not an unusual manner of dealing with an expert analysis and the Tribunal is well able to determine whether the assumption called for is proven and, if so, whether the relevant comment by the expert is of value to the Tribunal in its deliberations. Prior to the closing of the Respondent's case and in light of the information provided to the Tribunal the Respondent denied that he had personally dispensed the drugs referred to in particular 3A and 4A of Complaint One. He explained that the fact that it had his initials was a computer quirk which meant that he might have dispensed a prescription prior to the dispensing of those drugs and then the next person had not changed the initials to indicate who had dispensed the next description.
3. The Applicant tendered a statement from one Paul Frosdick, the Chief Executive Officer of the software company that provided the software to the pharmacy, in which he stated the following: 1. This statement made by me accurately sets out the evidence which I would be prepared, if necessary, to give before a Tribunal or Professional Standards Committee as a witness. The statement is true to the best of my knowledge and belief and I make it knowing that, if it is tendered in evidence, I shall be liable to prosecution if I have wilfully stated in it anything which I know to be false or do not believe to be true. 2. I am 57 years of age 3. I am employed as Chief Executive Office by MediSecure Ltd, sole owners of Simple Retail Pty Ltd. I have been employed with that firm since October 2019. Based on my enquiries I can confirm that my understanding is as follows. 4. Simple Retail produces a dispensing system for use by pharmacists called "Aquarius". This is the only dispensing system produced by Simple Retail for this purpose. 5. When Aquarius starts, the pharmacist must enter their identity (initials) and password. The software has required a password to operate it since 2000. If the identity and password are recorded in the system, a user session is generated. 6. The pharmacist's initials associated with that identity are required to be re‑entered as part of the data recorded for every prescription dispensed during that session 7. The Aquarius software has an "auto clear" feature which was introduced as an upgrade some time in 2006. By this feature, if the pharmacist leaves the screen idle, it will auto clear and the user session ended. The pharmacist's initials and password must be re-entered for them to continue to use the system, creating a new user session. The auto-clear time is configurable by the system manager to be between one and ten minutes. 8. I am aware that the software has been improved to support more complex passwords since its introduction in 2000. However, regardless of password strength it remains possible for someone other than the password holder to dispense medications using the holder's credentials if they have been shared or discovered.
4. The Respondent offered no objection to the tender of that statement and did not require the witness to be called to give evidence and be cross‑examined.
5. The Applicant then closed its case.

Respondent's evidence

1. The Respondent advised the Tribunal that he was happy to give sworn evidence and to be cross‑examined on the evidence which he presented. Essentially, all of his relevant evidence related to the question of the dispensing system whereby according to his evidence the system operated in a manner in which the first person of the day would operate on the system and insert their initials when dispensing a prescription. If that person failed to then delete their initials, the system would reflect on any future dispensing that initial person as the dispensing pharmacist. In essence, the Respondent advised the Tribunal that the fact that those drugs referred to in particular 3A and 4A were not dispensed by him and the fact that they bore his initial simply relates to the quirk in the system.
2. The Respondent stated in evidence as an example that in respect of the dispensing on 24 June 2015 when the system indicates him as the dispensing pharmacist, he could not have dispensed that drug as it was his wife's birthday and he was not working on that day.
3. In support of that contention he tendered a statutory declaration by one Joe Jovic in which Mr Jovic stated that he has worked with Mr Abrams for the entire time that he had Maroubra Pharmacy, that he never worked on a Tuesday or on his wife's birthday. He did state that he would, however, come and open the pharmacy if the locum pharmacist was delayed. He also tendered a letter written by one Monica Kilias in which she stated that there was an issue with the Aquarius Dispensing Software System ("Aquarius"). She stated that when dispensing a prescription in Aquarius, the pharmacist's initials were auto‑populated from the previous user. If a pharmacist continued to press enter and not change the initials, a prescription could have been inadvertently dispensed under the previous user's initials. She stated that she recalled having discussions with the Respondent in regard to this and indicated that she was aware that it is an issue with multiple dispensing software systems and it was an issue with Aquarius at that point in time. There was no objection to the tender of either of those statements and there was no requirement for the parties to be produced for cross‑examination.
4. In cross‑examination of the Respondent, there was a concentration on the issue of the software system used in the pharmacy and the difficulty of the allocation of the dispensing to the appropriate pharmacist. The Respondent indicated that there were three dispensing terminals. Two separated by a metre and a half and one at the rear of the pharmacy. He indicated that the initial that appears on the first prescription is the initial of the person that worked the day before. In essence, that should then be deleted and the dispensing pharmacist's initials should be added. If that is not done then his initial, if from the previous day, would keep perpetuating. It is for that reason that he states that he is comfortable to say that in respect of particular 3A he is not at fault but as the proprietor, as an owner, he is responsible for the allegations in particular 3B. He indicated that in an attempt to address that issue he had all of his staff together in regular staff meetings and indicated that they needed to be more efficient in making sure that these errors were not perpetuated.
5. He was asked whether he and his partner were meticulous in changing the allocated pharmacist every morning when they worked there to which he responded that he was not. It was put to him that it was therefore inconsequential to him as to whether the records recorded the correct pharmacist that was dispensing. He denied that it was inconsequential and stated that it does not follow and that there could be human error.
6. He was asked whether he had ever discussed this computer quirk with the software company. He did state that he had spoken to them but the issue was certainly not addressed. Their retort to him was to make sure that the pharmacist is aware that he is required to change the initials but that makes it prone to human error. He did state that as the proprietor, if it is prone to human error, then he has an obligation to minimise that human error and ensure the accuracy of the prescriptions. He accepted that he had that responsibility and that he erred in that regard. The same line of questioning followed in respect of particular 4A.
7. At the conclusion of the cross‑examination by the Applicant, the Respondent was asked various questions by the Members of the Tribunal, most of which addressed the same issue and the correctness of the computer reflecting prescriptions dispensed by him which he denies that he dispensed.
8. That concluded the evidence and the Respondent closed its case.

Applicant's submissions

1. The Tribunal had available to it submissions made by the Applicant at the commencement of the hearing and an outline of further submissions provided to the Tribunal at the conclusion of the Hearing. Set out below are the detailed submissions made by the Applicant both in the submissions prior to the Hearing and the additional further submissions at the conclusion. COMPLAINANT'S OUTLINE OF SUBMISSIONS 1. The complainant filed a Complaint in October 2019 alleging four complaints against the respondent, Ian Saville Abrams. Statutory framework 2. Section 149C(1)(c) of the National Law empowers the Tribunal to suspend or cancel a health practitioner's registration where the practitioner has been found to have engaged in professional misconduct. 3. Section 3 of the National Law sets out the objectives and guiding principles of the law, as those objectives and principles apply to the national registration scheme. The relevant parts of s 3, for the purposes of this hearing, are as follows: 3. The guiding principles of the national registration and accreditation scheme are as follows- (2) The objectives of the national registration and accreditation scheme are- (a) to provide for the protection of the public by ensuring that only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered; and (3)(a) the scheme is to operate in a transparent, accountable, efficient, effective and fair way; … (c) restrictions on the practice of a health profession are to be imposed under the scheme only if it is necessary to ensure health services are provided safely and are of an appropriate quality. 4. Section 3A of the National Law sets out the objective and guiding principle to be applied by a Tribunal in New South Wales conducting an inquiry into a complaint and, if appropriate to do so, when making protective orders. Section 3A provides as follows: 3A. In the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration. 5. Orders are not intended to punish the practitioner, but to protect the public (see Clyne v NSW Bar Association [1960] HCA 40; (1980) 104 CLR 186; HCCC v Litchfield [1997] NSWSC 297; (1997) 41 NSWLR 630; and HCCC v Gillett [2007] NSWNMT). 6. In Chen v Health Care Complaints Commission [2017] NSWCA 186 Basten JA in the Court of Appeal said the following: [20] There is no category of unsatisfactory professional conduct which is not capable, depending on the circumstances, of giving rise to professional misconduct and hence engaging the power of either suspension or cancellation of registration. The only requirement is that it be "sufficiently serious" to justify such an order, a characterisation which must depend upon an evaluative judgment made by the Tribunal. Some, perhaps all, categories include conduct which may reveal a defect of character as to which the Tribunal may conclude that the person should not be allowed to practise his or her profession unless at some future date the practitioner is able to satisfy the Tribunal that the defect has been overcome. Incompetence or inadequate care may in some circumstances be remediable by specific steps; in other circumstances the Tribunal may be concerned that the carelessness, for example, is such as to cast doubt on the suitability of the person to practise medicine. Each of the criteria for cancellation or suspension may be analysed in this way. Each case will depend upon an evaluative judgment to be made by the Tribunal as to the nature and seriousness of the conduct. It follows that the legislative scheme is inconsistent with the implication of the abstract condition sought to be imposed by the practitioner on the language of s 149C(1). [22] The fixing of a period within which re-registration may not be sought may be seen to have a twofold operation. On the one hand, it indicates the minimum period within which the Tribunal considers the person should not be able to practise his or her profession; on the other hand, it holds open the possibility that an application for re-registration thereafter will at least be considered. It is entirely proper for the Tribunal to consider all aspects of the possible orders available to it in determining what order to make. The suggestion that there must be a two-stage process in undertaking that function was misguided. 7. Payne JA found in Chen that: [88] The Tribunal was permitted by s 149C(7) to identify a period of a time during which a registration application could not be made. Doing so indicated the seriousness, from the Tribunal's perspective, of the conduct. A practitioner wishing to challenge that period may do so by way of appeal. Contrary to the appellant's submission, a time fixed under s 149C(7) does not necessarily mean that the Tribunal has formed a view that things will have changed by the end of the period which has been fixed. The Tribunal is permitted by s 149C(7) to make clear in its orders the seriousness with which it views the conduct of the practitioner reflected in the complaints which have been proven. Such an order plays a part in the general deterrence reflected by the order. 8. The jurisdiction of the Tribunal is protective rather than punitive. The nuances of the Tribunal's protective role in making orders have been considered extensively in the case law. In HCCC v Do [2014] NSWCA 307 the Court of Appeal opined: "The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It included protecting the public from the similar misconduct or incompetence of other practitioner and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining the standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operated both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise." (at [35]). 9. The applicable principles are usefully distilled in Health Care Complaints Commission v Dr Della Bruna [2014] NSWCATOD 31: Applicable Principles 88. In determining the appropriate protective orders that it should make in this matter, the Tribunal is guided by the following considerations: (1) In the exercise of its functions under Subdivision 6 of Division 3 of Part 8 of the National Law, the protection of the health and safety of the public must be the Tribunal's paramount consideration - s 3A of the National Law. (2) Disciplinary proceedings against members of a profession are intended to maintain proper ethical and professional standards, primarily for the protection of the public but also for the protection of the profession - Health Care Complaints Commission v Litchfield [1997] NSWSC 297; (1997) 41 NSWLR 630 at 637, (3) The public interests served by protective orders include, indirectly, the standing of the medical profession and the maintenance of public confidence in the high standards of medical practitioners - Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91]. (4) Protective orders also involve an element of deterrence or, to put it more positively, encouragement to other practitioners to recognise the importance of complying with professional standards and the risks of failing to do so - Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91]. (5) Although the specific purpose for which the Tribunal makes orders is protective of the public interest and not punitive with respect to the practitioner, that is not to deny that such orders may be punitive in effect and that punitive effect may be relevant in formulating a protective order - Lee v Health Care Complaints Commission [2012] NSWCA 80 at [20] citing Director General, Department of Ageing, Disability and Home Care v Lambert [2009] NSWCA 102; (2009) 74 NSWLR 523 at [83]. Nature of the Wrongdoing 10. The respondent's wrongdoing occurred over several years and involved different kinds of transgressions. At Maroubra Pharmacy, of which he was a co-owner and to which Complaint One refers, Mr Abrams: a. Inappropriately dispensed drugs b. As proprietor, permitted inappropriate dispensing to occur c. Inappropriately compounded drugs d. Maintained a relationship with Doctor C giving rise to a conflict of interest (Particular 18). 11. The inappropriate dispensing included: a. Dispensing schedule 4 and schedule 4D drugs where the prescriptions were not endorsed and did not contain the prescribers handwritten signature, and without adequate directions (Particular 1 and 2) b. Dispensing excessive quantities of a schedule 4D drug (Particular 3A) c. Dispensing drugs where the prescription was out of date and did not specify repeats (Particular 4A) d. Dispensing schedule 4D drug phentermine where a commercial alternative was available and no appropriate exception applied (Particular 5) e. Dispensing phentermine in excess of the quantity specified in the prescriptions f. Dispensing Schedule 4D drugs (Peptides, growth hormone deficiency drugs, and hormones) that were off-label and without required precautions and thus failing to ensure that the prescribing was appropriate (Particulars 9, 13, 14, 15 and 16) g. Dispensing schedule 4 drugs without addressing risks with the patients, and other omissions- Particular 17. 12. The failures as a proprietor included: a. Permitting phentermine to be dispensed, including in excess of the amount specified on the prescription (Particular 6, 8) b. Permitting peptides to be dispensed (Particular 10) c. Permitting oxytocin to be dispensed (Particular 12). d. The compounding failure related to compounding and dispensing of oxytocin - Particular 11. 13. The failures extended over more than two years and involved significant statutory breaches, and a failure to adhere to the Professional Practice Profile for Pharmacists Undertaking Compounding (March 2015) (Tab 42). On any view of it, the breaches at Maroubra Pharmacy alone are serious. 14. However, from 2016 Mr Abrams then operated Sydney Sterile Compounding. As set out in the PRU Report behind Tab 47: "Sydney Sterile Compounding Pharmacy was investigated during 2016, when it was found that pharmacist/owner Ian Abrams supplied peptides, sometimes multiple different peptides, through a 'closed loop' arrangement between himself (Sydney Sterile Compounding Pharmacy), Peptide Clinics Australia [of which Mr Abrams is a director - see Tab 24 p.2], and a prescribing doctor, Doctor B. The advertising of peptides by Peptides Clinics Australia encouraged the purchasing of large and varied quantities of injectable peptides in order to receive financial discounts or rewards points as part of an apparent inventive scheme. The online business model enabled individuals, from all parts of Australia and overseas, to purchase peptides where little, if any, clinical intervention by either the prescriber of the pharmacist occurred and where there is no face-to-face interaction between the patient, the prescriber or the pharmacist." (page 1 of 57) 15. Complaint Two describes prescribing over a period between June 2016 and February 2017 during which time Mr Abrams a. Was engaged in bulk manufacturing and distribution of drugs b. Dispensed schedule 4D drugs without ensuring that patients had adequate directions for their use c. Did not address requirement that arose due to the drugs being off-label; and d. Did not have endorsed prescriptions e. Did not maintain records. 16. The risk to the public from these practices, again, is patent. 17. Finally, as set out in Complaint Three, over a period of more than two years the respondent demonstrated contumelious disregard for his obligations as a professional pharmacist by supplying schedule 4 and schedule 4D drugs to himself and to eight employees a. Without a prescription b. Without recording the supply; and c. Contrary to the Poisons and Therapeutic Goods Act (NSW) 1966, and the PTGR. 18. The drugs supplied included Zolpidem, or Stilnox. In 2008 the Therapeutic Goods Administration mandated a boxed warning of Zolpidem as follows: "Zolpidem may be associated with potentially dangerous complex sleep-related behaviours which may include sleep walking, sleep driving and other bizarre behaviours. Zolpidem is not to be taken with alcohol. Caution is needed with other CNS depressant drugs. Limit use to four weeks maximum under close medical supervision." 19. For some employees Mr Abrams supplied both Zolpidem and multiple benzodiazepines (Particulars 2, 3, 4, 5, 6, 8, 9). Quite apart from the dangers to the employees, unrecorded supplies of this kind lead to untraced and untraceable prescription drugs being released into the Australian community outside of the regulatory framework designed to allow review and tracing of supplies, and identify inappropriate prescribing. 20. The respondent's defaults have been persistent and serious, and continued after the PRU first investigated the respondent. Appropriate Orders 21. In Health Care Complaints Commission v Do [2014] NSWCA 307 the Court of Appeal discussed the objects of protecting the health and safety of the public in the context of proceedings in which protective orders are sought: 34. The National Law establishes a registration and accreditation scheme. That scheme, by Div 3 of Pt 8, includes provisions for the making of complaints about registered health practitioners and the determination of those complaints, including in relation to serious complaints, by the Tribunal. The objectives of that scheme, as described in s 3(2), include to "provide for the protection of the public by ensuring that only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered" and to "facilitate access to services provided by health practitioners in accordance with the public interest". The provisions in Pt 8 concerning the making and dealing with of complaints are provisions substituted in the National Law by the Health Practitioner Regulation (Adoption of National Law) Act 2009 (NSW). Section 3A of the Law provides that in the exercise of those functions "the protection of the health and safety of the public must be the paramount consideration". Section 4, which applies to the National Law as in force in New South Wales, also requires that an entity having functions under it "is to exercise its functions having regard to the objectives and guiding principles" set out in s 3. 35. The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise. 36. In Law Society of New South Wales v Foreman Mahoney JA described (at 441) the scope of the objective of protecting the public interest in the context of disciplinary proceedings against a solicitor as follows: "The protection of the public has been described as, for example, the primary purpose or primary object of such proceedings: ... In the relevant sense, the protection of the public is in my opinion not confined to the protection of the public against further default by the solicitor in question. It extends also to the protection of the public against similar defaults by other solicitors and has, in this sense, the purpose of publicly marking the seriousness of what the instant solicitor has done. But, in my opinion, it would be wrong to confine the objects of disciplinary proceedings and the purposes to be achieved by the orders made in them strictly to matters of this kind. Those purposes and objectives have traditionally been seen as having a wider operation. In the end, the question to be determined is whether the solicitor is a fit and proper person to be a solicitor of the Court and the orders to be made are to be directed to ensuring that, to the extent she is not, her practice is restricted." 37. In Herron v McGregor (1986) 6 NSWLR 246 McHugh JA referred more briefly to the same consideration (at 258): "It is, of course, of fundamental importance to bear in mind the public interest in disciplining doctors who are guilty of professional misconduct. In many cases the protection of the public and the maintenance of professional standards requires that the names of doctors be removed from the register. However, it is present fitness to practise which is the principal and ultimate issue of public interest." 22. Health Care Complaints Commission v Mayr [2017] NSWCATOD 52 is also useful as well as Lee v Health Care Complaints Commission [2012] NSWCA 80. 23. In determining the appropriate protective orders, the Tribunal should have regard to: a. The gravity of the misconduct; b. How long ago the misconduct occurred; c. What has occurred in relation to the practitioner since the misconduct occurred; d. The practitioner's level of remorse and degree of insight, if any, into his misconduct e. What (if any) steps have been taken by the practitioner by way of rehabilitation. f. General encouragement of higher standards g. Specific consideration of what is required to ensure that the practitioner does not pose similar risks in the future. 24. In relation to these matters the complainant submits as follows: 25. The Tribunal would be satisfied that the respondent's misconduct falls at the high end of the range of seriousness. 26. The misconduct occurred over approximately a five year period until conditions were placed on Mr Abrams in 2018. 27. Mr Abrams has provided very little evidence before this Tribunal. From the letter dated March 2020 addressed to the Pharmacy Council (the only documentary evidence supplied from Mr Abrams directly) Mr Abrams describes shutting down SCC and attending an ethics course. He has not disclosed whether he has been employed or engaged in other work since a not‑to‑practice condition was imposed on him. In short, the Tribunal has been little assisted by Mr Abrams in assessing his conduct since 2018. His expressions of remorse are limited, and there is very little on which the Tribunal could proceed to be satisfied that Mr Abrams has any significant insight into his extensive wrongdoing. 28. The role of pharmacists in an effective health system is essential. High standards of behaviour are not only expected, they are necessary to secure the safety of patients and the broader community from the effect of prescription drugs. The responsibility of pharmacists in relation to compounding is equally significant. 29. Mr Abrams was a proprietor of a pharmacy and then a co-owner of a business dispensing drugs to people who relied on him for their safety. His breach of trust, and the damage to the reputation of pharmacists who work within the laws, rules and guidelines, is liable to cause significant damage to the standing of the profession. 30. This Tribunal has significant responsibility in imposing orders specifically targeted at Mr Abrams to prevent him engaging in such harmful conduct in the future. Proposed Orders 31. The Tribunal will find that the practitioner engaged in professional misconduct. The respondent seeks the following orders: a. An order pursuant to s 149C(1)(b) of the National Law cancelling the registration of Ian Saville Abrams (registration number [PHA0001406090]) with a non review period of between 4-5 years with immediate effect. b. An order pursuant to s 149C(7) that Mr Abrams not make an application for review under Division 8 of Part 8 of the National Law for a period of at least three years from the date of these orders. c. An order that Mr Abrams will from the date of this decision be subject to a prohibition order as follows: (a) Mr Ian Abrams (the practitioner) is not work in any health service as defined pursuant to s 4 of the Health Care Complaints Act 1993 (NSW), including online health services. (b) The practitioner is not to compound or manufacture nor to hold a financial interest in a pharmacy that compounds or manufactures products containing any of the following: (i) A Schedule 4 drug listed in Appendix D to the Poisons and Therapeutic Goods Regulation 2008 (NSW) or any substance in an equivalent List in any other Australian state or territory (ii) anastrozole, tamoxifen, clomiphene, zolpidem, modafinil, isotretinoin, paracetamol in combination with codeine (iii) nicotine, except in circumstances when dispensed in accordance with the agreed protocol of a registered clinical trial as listed in the Australian New Zealand Clinical Trial Register (ANZCTR) which has ethics approval for conduct within Australia (A) Within 7 days of receiving written ethics approval to participate in a registered Australian clinical trial and before compounding any product containing nicotine under that clinical trial, must provide the Pharmacy Council with a copy of the ethics approval including the approved protocol and the ANZCTR reference. (iv) finasteride, minoxidil, latanoprost, dutasteride or melatonin for the indication of hair loss, except in circumstances when dispensed in accordance with the agreed protocol of a registered clinical trial as listed in the Australian New Zealand Clinical Trial Register (ANZCTR) which has ethics approval for conduct within Australia (A) Within 7 days of receiving written ethics approval to participate in a registered Australian clinical trial and before compounding any product containing finasteride, minoxidil, latanoprost, dutasteride or melatonin under that clinical trial, provide the Pharmacy Council with a copy of the ethics approval including the approved protocol and the ANZCTR reference. d. An order that Mr Abrams pay the complainant's costs as agreed or, if not agreed, then the amount of costs be assessed by a costs assessor under the legal costs legislation (as defined in section 3A of the Local Profession Uniform Law Application Act 2014). COMPLAINANT'S OUTLINE OF FURTHER SUBMISSIONS 32. Mr Abrams denies particulars 3A, 4A and 5 on the basis that the pharmacy computer system defaulted to the previous prescriber. He says he was aware of this software deficiency and told staff to be aware of the issue and to change the prescriber. He claims that his partner at the time established and operated the phentermine prescribing business. However Mr Abrams has not called his previous partner to corroborate his contention, and his story regarding the computer software is entirely self-interested. Mr Abrams has not called any of the employees of his pharmacy to corroborate his version, and the statements from employees included in the complainant's evidence do not refer to any issue with the software. The primary evidence of the prescriptions themselves - which show Mr Abrams as the dispensing pharmacist - should be accepted at face value and the particulars denied by Mr Abrams should be found to be made out to the requisite standard. 33. In the alternative, if the Tribunal only finds Particulars 3B, 4B and 5 made out, the particulars should be viewed as most serious in circumstances where Mr Abrams knew that the software system allowed dispensing to occur under the wrong pharmacists' name, but did nothing beyond holding staff meetings to address the issue. 34. In relation to Complaint 2 and stage 2 issues, Mr Abrams gave evidence to the following effect: Q Are you saying now that you wouldn't use that drug because you would fall foul of the authorities? A.I am saying that I would err on the side of caution Q. You mean off label? A. Yes Q. And the reason is that you would fall foul of the regulatory authorities? A. Correct 35. This suggests that Mr Abrams is more aware of the risks of being caught prescribing drugs for non-standard purposes, but demonstrates little if any insight into the regulatory parameters that surround prescribing drugs for an off-label purpose. 36. The Tribunal has completed stage one proceedings involving one of the doctors for whom Mr Abrams prescribed drugs for off-label purposes - see Health Care Complaints Commission v Hart [2021] NSWCATOD 36. In cross‑examination Mr Abrams acknowledged that he was aware of the purpose for which most of the drugs listed in the Complaint are meant to be prescribed. It follows that he was fully aware that he was choosing to ignore the regulatory control of TGA approvals and to issue drugs outside the parameters of the scheme. The scheme is designed to, and does, protect consumers. Mr Abrams' flagrant disregard of the limits applying to off-label prescribing are clear examples of professional misconduct. 37. In relation to bulk-manufacturing, although Mr Abrams in oral evidence claimed that there were customers for every batch he compounded, when pressed it became apparent that he claimed to have estimated the quantity of drugs required by reference to repeat prescriptions in existence. As there was no way of knowing whether customers with repeats would have them filled, his method of manufacture - even on his own version - demonstrates bulk manufacturing. 38. Mr Abrams' assessment of the s.150 proceedings did not reflect the issues identified by the members of the s.150 panel. Although no direct action was taken at the time, the s.150 written reasons clearly highlights issues that required further investigation. Appropriately, those issues were referred to the complainant, in a process that Mr Abrams described (twice) as "passing the buck". This comment highlights Mr Abrams' lack of knowledge of/ wilful ignorance of/ disdain for the regulatory processes. The fact that he continued to compound and dispense drugs through SSC, when he was aware that his peers at the s.150 proceedings had significant disquiet about matters related to the SSC business, further emphasises the respondent's lack of genuine insight. 39. In relation to supply to his employees, Mr Abrams' evidence as to whether or not he turned his mind to the possibility that the drugs were being on-sold or abused by his employees was nothing short of startling. The Tribunal is invited to reject Mr Abrams' attempt to dress up his actions as having some moral basis - protecting his employees from being "exploited" on the "dark web" - in circumstances where he exercised no control over the ordering of drugs by his employees, and where those employees accessed significant quantities of restricted drugs. 40. Taken together, Mr Abram's admitted conduct - and, if found proven consistent with the complainant's submissions, the further particulars that he denies demonstrate significant and persistent failures by Mr Abrams in discharging his responsibilities as a pharmacist. 41. Mr Abrams' evidence is focussed on the impact on him of his wrongdoing; there is little evidence of genuine insight into, or contrition for, his wrongdoing. Even in these proceedings he described the Department of Health as undertaking a "witch-hunt", notwithstanding that he admitted engaging in conduct that was significantly deficient and posed actual risk to the health and safety of the public. 42. The complainant presses for an order cancelling Mr Abrams registration and excluding him from making a reinstatement application for a minimum of four years from the date of the order.
2. In oral submissions, the Applicant referred to the statements tendered by the Applicant from Mr Joe Jovic and Ms Monica Kilias and pointed out that they are directed to whether or not the Tribunal accepts the Respondent's denial that he dispensed those prescriptions which had his initials. The Applicant stated that the Respondent gave evidence of his wife's birthday and that he was not working on that day. In the statement of Mr Jovic he said that the Respondent never worked on a Tuesday or his wife's birthday. They submitted that they had reviewed all of the dispensing and that none of the other dispensing items were on a Tuesday. They further submitted that reference must be had to the statement of Mr Frosdick who stated that since 2006 the initials would be automatically deleted after 10 minutes and the next dispenser would have to insert their own initials. In addition, they submitted that in respect of the letter from Ms Kilias, she simply stated that they were aware that it could happen. The Applicant submitted that there was nothing to prevent a pharmacist from deleting the initials of the previous pharmacist and inserting their own.
3. The Applicant submitted that ultimately the additional documents provided by the Respondent do not take the matter any further and it is up to the Tribunal to determine who they believe.
4. Finally, the Applicant stated that they rely on their original submissions and they require cancellation and seek a prohibition order.
5. The Respondent then made submissions to the Tribunal.

Respondent's submissions

1. The Respondent commenced his submissions offering sincere appreciation to the Tribunal and the Applicant's counsel for indulging him. He submitted that if one has regard to the HCCC's further submissions in regard to the computer software, he needs to add some comments. He addressed the submission by the Applicant that he did not call his former partner to support his evidence that his partner was responsible for the dispensing of the drugs the subject of particulars 3A and 4A of Complaint One. He advised the Tribunal that he did not call his former partner because of the acrimonious relationship which ended the partnership and that he saw no value in calling a person with whom he had such an acrimonious relationship.
2. In regard to the initials, he submitted that his partner was never in on a Friday so he could not have dispensed any medication on a Friday and by implication, therefore, that there were dispensing records on a Friday bearing the initials of his partner. No reference was made to those particular instances.
3. In addition, he submitted that initials of a prior dispenser would only disappear after 10 minutes and accordingly, therefore, if a future dispenser dispensed within 10 minutes and did not delete the initials of the previous dispenser, the previous dispenser's initials would continue for as long as that process proceeded.
4. He submitted that a lot of the prescriptions came from out of state which supports the fact that his partner set up a separate PO Box and lends credibility to the fact that he dispensed them.
5. He submitted that he was mistaken in believing that by telling the staff to avoid the problem, that it would work. In hindsight it did not and he should have been more rigid. He posed the question as to how the Tribunal would view his not resolving the problem more effectively. He does accept that it must be regarded as important.
6. In relation to the submissions by the Applicant that he had a flagrant disregard for off‑label dispensing, the Respondent knew the patients and the doctors and realises now that he should not have done what he did and would not do that again.
7. In respect of the bulk manufacturing which the Applicant alleges against him, he submits that this needs to be contextualised in order to understand that it was done not to breach the law but to improve the efficacy and supply of the products. The vials produced in respect of which there is the complaint were two milligram vials which cannot really be sterilised properly and the TGA has certain quality requirements. In addition, two milligrams is almost impossible to weigh. He had prescriptions for more than two milligrams and, therefore, made larger quantities for sterilising. He was trying to mitigate the quality and sterilisation etc. and what he did was, therefore, reasonable.
8. Regarding the submission by the Applicant that his assessment of the s 150 proceedings did not reflect the issues identified by the Members of the Panel, he submitted that there was no need to do anything to him at that stage. But when the ruling came out six weeks later, they were scathing of the use of those products. He stated that he did attempt to contact the pharmacy inspector and NSW Health but the contact was not very promising.
9. In reference to the supply of the drugs to his employees, he submitted that he recognises that this was a grave error of judgment and that it would not happen again.
10. In general principle, he submitted that he is seeking psychological help to try and deal with what he did wrong. He also submitted that he has kept up professional development and it seems incongruous with the Applicant's view which it has expressed in its submission.
11. He states that he takes full responsibility for his error and that it has consequences but he did make some attempts to settle with the Applicant which were not accepted.
12. He rejects the suggestion by the Applicant that he does not demonstrate contrition. He states that he has understood the error of his ways and that he has embarrassed his colleagues, his friends and his family.
13. That ended the submissions by the Respondent.
14. The Tribunal Members addressed various questions to the Respondent in respect of his submissions. In particular, he was asked what he had done about his CPD points. He stated that he had certainly read a lot but does not have a record of what he has actually done.
15. He was asked regarding the use of initials to identify the person dispensing a prescription and whether he could explain to the Tribunal why that is done. He stated that it looks at who dispensed and that enables the tracking of the original of that prescription. For example, he stated that if you assume that a wrong product is dispensed, then the responsible person should be identifiable. So it helps with the identification. Similarly, if the date of the prescription is incorrect, the same would apply.
16. He was asked about bulk manufacturing and in response he stated that when manufacturing there has to be sufficient product for the weighing of the product and, therefore, it would not be possible to weigh two milligrams without consolidating it with other manufacturing to reach an acceptable level for weighing and sterilisation. He submitted in response that one needs to look at the TGA guidelines for sterility testing where it states that if you make 100 milligrams you have to test at least 10%. He suggested that pharmaceutical compounding requirements allow for self‑auditing although he had not looked at the compounding requirements for at least three years. He stated that there was no malice aforethought and when he did send away the quantities for sterilisation they were found to be OK.
17. He was asked whether he could advise the Tribunal as to why he believes that prescriptions are an absolute requirement for the dispensing of any drugs. He confirmed to the Tribunal that the purpose of prescriptions was for control, to prevent problems of addiction and prevent gross misuse.
18. The Respondent sought to rely on Item 6 of Schedule 5 of the Pharmacy Board of Australia Guidelines on Compounding of Medicine 2015 and the Tribunal sought to have evidence of the basis of which he believed that he was entitled to bulk manufacture in the way that he did.
19. The Tribunal afforded him time to do that investigation and on resumption he indicated that the Guidelines on Compounding Medication of August 2017 allow for compounding a batch for individual patients.
20. That concluded the Respondent's submissions.

Applicant's submissions in reply

1. In submissions in reply the Applicant addressed the issue of the Respondent not calling his partner. Despite the given reasons, the Applicant does not change their view that he should have been called to give evidence on the dispensing.
2. In respect of his submissions relating to the bulk manufacture the Applicant submitted that while the Respondent claimed that something so small could not be done other than in bulk, they submitted that the Tribunal should reject that because it does not answer the problem. The exception allows only compounding for an individual patient. The example given by the Respondent ignores that it has to be an individual patient and he has not given a valid answer to relying on the exception because it does not allow bulk manufacture for more than one individual.
3. That concluded the matter and the decision was reserved.

Decision and Reasons

1. The Tribunal having read the evidence contained in all of the exhibits provided to the Tribunal, having heard the evidence presented by the Applicant and the evidence given by the Respondent, having reviewed the various additional documents which were tendered and having considered the submissions made by the Applicant and the Respondent, the Tribunal is satisfied that the complaint made by the Applicant against the Respondent as set out in Complaints 1, 2, 3 and 4 is proven and that the Respondent is guilty of unsatisfactory professional conduct and professional misconduct.
2. The basis on which the Tribunal has come to that conclusion is that all but the allegations contained in particulars 3A and 4A were admitted by the Respondent and the Tribunal finds no reason to reject those admissions.
3. In relation to particulars 3A and 4A of the Complaint, the Tribunal has significant concerns regarding the evidence given by the Respondent as to how it came about that his initials appear on those prescriptions and relied on the fact that he was not working on the days on which those prescriptions were dispensed. The Tribunal did have regard to the statutory declaration of Mr Jovic and the letter of Ms Kilias both of which seek to confirm the nature of the system quirk and to thereby excuse that fact. The concern of the Tribunal centred around the fact that the Tribunal was presented with an enormous number of prescriptions dispensed under the initial "IA" and the fact that the Respondent was able to identify the very two which were of significance to the Complaint made by the Applicant. While the Tribunal is not able to be comfortably satisfied whether or not the Respondent did in fact dispense those two prescriptions, the Tribunal believes that it is not relevant to the decision which it makes in this matter as it regards the behaviour of the Respondent as an extremely serious breach of the obligations of a pharmacist with the background and experience of the Respondent. In that regard, the Tribunal has looked at each and every alleged breach by the pharmacist.
4. In respect of Complaint One the Tribunal believes the dispensing of drugs referred to in paragraphs 1 and 2 of the Particulars of Complaint One are significant and a serious breach.
5. In respect of the dispensing of the drugs in paragraphs 3A, 3B, 4A and 4B, whether or not the Respondent dispensed those drugs personally he certainly has admitted and the Tribunal is satisfied that he failed in his obligations as the owner and proprietor of the pharmacy to ensure that such dispensing did not take place. He had that obligation and he failed to fulfil that obligation.
6. In respect of dispensing compounded phentermine, a schedule 4D drug on the dates and in the quantities set out in Schedule 3 to the Complaint, we are aware that there was an appropriate commercial product available which makes the compounding contrary to the Pharmacy Board of Australia Guidelines on Compounding of Medicines without confirming with the prescriber that there was a therapeutic purpose for the dispensing and without confirming that there were not contrary indications for dispensing.
7. In addition, the Respondent failed to discharge his obligations as the proprietor of the pharmacy when he permitted the dispensing of compounded phentermine by other pharmacists on the dates and in the quantities set out in the Schedule to the Complaint.
8. His dispensing between 2 September 2015 and 19 October 2015 when the Respondent dispensed phentermine in excess of the quantities specified on the prescription dates is a further serious transgression and in allowing this to happen through other pharmacists is, in addition, a serious transgression.
9. Between 6 January 2015 and 11 November 2015 the Respondent inappropriately dispensed schedule 4D peptides which were unregistered products and the prescribing was therefore off‑label. He failed to verify that there was an individual therapeutical purpose for the dispensing to each patient, that he failed to document any discussions with Dr B about the intended use and evidence of efficacy and safety of the peptides. As a result, he failed to ensure that the purpose of supply was in accordance with the recognised therapeutic standard subject to clause 54 of the PTGR. Similarly, in that period as a proprietor he failed to ensure that other pharmacists in his employ did not dispense the same peptides.
10. In respect of the allegation that between 2 June 2015 and 2 November 2015, the practitioner inappropriately compounded and dispensed troches of the schedule 4 Oxytocin which is registered for use in managing labour in women and, therefore, the prescribing was off‑label. He failed to verify that there was an individual therapeutic purpose for the dispensing to each patient, failed to document any discussions with Dr B about the intended use and evidence of efficacy and safety of using Oxytocin for the intended off‑label purpose; and, therefore, failed to ensure that the purpose of supply was in accordance with a recognised therapeutic standard subject to clause 54 of the PTGR.
11. Similarly, between those dates as a proprietor he failed to ensure that other members of his staff did not do so.
12. In respect of the dispensing of the schedule 4D NutropinAq on 6 July 2015 and 12 August 2015, the same failure on the part of the Respondent is a serious breach of his obligations.
13. The same applies in respect of the dispensing of NutropinAq on 30 August, 9 October and 11 November in 2015.
14. The Tribunal had regard to particulars 15, 16 and 17 of Complaint One and is comfortably satisfied that each of these is a serious breach of the Respondent's obligations. In respect of the allegation that the practitioner maintained an inappropriate relationship with Dr C to dispense medicines on prescriptions for his patients in circumstances where the financial gain from that relationship caused a potential conflict of interest with obligations towards those patients contrary to the Pharmacy Board of Australia's Professional Practice Profile for Pharmacists Undertaking Complex Compounding of March 2015, the Tribunal regards this as extremely serious and has regard to that in its deliberations.
15. In respect of the particulars of Complaint Two that the Respondent engaged in bulk manufacturing and dispensing of drugs which were not for a particular person contrary to the compounding exemption in Item 6 Schedule 5 of Therapeutic Goods Regulations 1990 (Cth) and s 19D of the Therapeutic Goods Act 1989 (Cth), the Tribunal had regard to the submissions made by the Respondent that it was not possible for him not to bulk manufacture for a prescription for two milligrams of product and that therefore he was entitled to consolidate multiple prescriptions for multiple individuals in order to be able to fill those prescriptions.
16. The Tribunal rejects this proposition as the wording of the Guidelines on Compounding of Medicine is clear and states as follows. A pharmacist may be required to compound multiple units of issue of a particular product (i.e. a batch) for individual named patients, for example, certain circumstances. Looking at the named circumstances none of those apply. In addition, it is clear that the manufacture of a compounded product has to be for a named individual against a prescription in the name of that individual and accordingly the Tribunal is comfortably satisfied that the Respondent breached his obligations in that respect.
17. In Complaint Three it is alleged and admitted that the Respondent supplied to himself various schedule 4 drugs including Prodeine Forte and Modafinil, Temazepam and Serepax without a prescription, without making records of the supply and contrary to s 10(3) and s 10(4)(b) of the Poisons and Therapeutic Goods Act 1966 (NSW) ("PTG Act").
18. Throughout the period July 2016 to August 2018, the Respondent supplied to employees various schedule 4 antibiotics and the drugs Zolpidem, Diazepam, Temazepam and Oxazepam, Prodeine Forte and Modafinil, Keflex, Amoxil and Augmentin and Anastrozole, Avantan Cream, without a prescription, failed to record the supply, did not have the qualifications, knowledge and authority of an authorised prescriber and, therefore, placed the health and safety of employees at risk contrary to s 10(3) and s 10(4)(b) of the PTG Act and Part 2 of Division 4 of the PTGR.
19. In addition to providing those drugs personally, the evidence as admitted by the Respondent is to the effect that on occasions his staff members self‑ordered quantities of those drugs and without recording them in the records of the pharmacy and removing them from the pharmacy for their own purposes.
20. The Respondent was questioned on his transgression in this regard to which he responded that it was an error of judgment on his part, that it should never have happened and that it would not happen again.
21. The Tribunal is unable to accept that this was an error of judgment, as it was not a one‑off situation but it was a consistent and ongoing breach of the obligations of a pharmacist and a serious risk to the public.
22. In coming to its conclusion, the Tribunal is fully aware and agrees with the submissions of the Applicant as to the purpose and role of the Tribunal in complaints of this nature against a practitioner and is aware that its obligation is to ensure the safety of the public while at the same time also protecting the good name of the profession.
23. In addition, the Tribunal has regard to the fact that its role is protective and not punitive, but should also operate as a deterrent for other members of the profession.
24. In this respect, the Tribunal considered the various cases referred to by the Applicant which deal with these issues and was comfortably satisfied that an order for cancellation of the registration of the Respondent is appropriate. In considering the question of registration, it is important to note that in the view of the Tribunal each of the alleged breaches by the Respondent in Complaints One to Four and the particulars thereof, would be sufficient for the Respondent's registration to be cancelled. Taken together, the Tribunal believes that the Respondent is guilty of unsatisfactory professional conduct and professional misconduct. The Tribunal is of the view that the breaches are extremely significant and that the only explanation for the conduct of the practitioner, a practitioner of some 30 years at the time of the breaches, constitutes a flagrant disregard for the obligations of the Respondent and a serious risk to the public.
25. While the Respondent has sought to explain his behaviour as errors of judgment and while he has sought to express contrition and regret for what he has done, the Tribunal does not believe that the Respondent demonstrates sufficient insight into his behaviour to allow an element of leniency in dealing with this matter. The Tribunal is of the view that the Respondent requires a considerable amount of time to reflect on his transgressions and develop insight into his behaviour.
26. In the circumstances, the Tribunal makes the following orders.

Orders 1. The registration of the Respondent is cancelled with effect from the date of this decision. 2. The Respondent is not permitted to seek a review of the cancellation for a period of four years from the date of this decision. 3. The Respondent will from the date of this decision be subject to a prohibition order as follows: 1. Mr Ian Abrams (the practitioner) is not to work in any health service as defined pursuant to s 4 of the Health Care Complaints Act 1993 (NSW), including online health services. 2. The practitioner is not to compound any scheduled or unscheduled medication whether the medication is intended to be used by a medical practitioner, allied health or alternative health practitioner or administered solely by the patient, or where the compound is part of a clinical trial. 1. The Respondent is ordered to pay the costs of the Applicant as assessed or agreed.

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

Amendments 30 November 2021 - Publication Restriction text amended. [6] Text amended. 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: 30 November 2021