Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Health Care Complaints Commission v Ashour [2021] NSWCATOD 165 Hearing dates: 26 – 28 April 2021 Date of orders: 20 October 2021 Decision date: 20 October 2021 Jurisdiction: Occupational Division Before: A Britton, Deputy President B Radojkovic, Senior Member M Steffensen, Senior Member J Barker, General Member Decision: (1) Mr Ashour's registration is suspended for a period of six months. (2) After the period of suspension, the following conditions are imposed on the practitioner's registration: Restrictions on supply, dispense or compound (a) Must not supply, dispense or compound or allow the supply, dispensing or compounding of any pharmaceutical products containing any of the following at any pharmacy in which the practitioner has a financial interest: (i) Somatropin (ii) Testosterone (iii) Mesterolone (iv) Anastrozole except for an approved indication as specified for that product on the Australian Register of Therapeutic Goods. (b) Must not compound or allow the compounding of a medicine (whether prescribed or not) at any pharmacy in which the practitioner has a financial interest that would be a close formulation to an available and suitable commercial product where it is unlikely to produce a different therapeutic outcome to the commercial product. (c) Mr Ashour is to accept an auditor appointed by the Pharmacy Council of NSW (the Auditor) with the first audit or risk assessment to occur within 6 months and thereafter annually for a further 2 years. (d) The Auditor is to conduct his or her audits into the supply, dispensing or compounding of Schedule 4B drugs, somatropin and anastrozole. (e) The audits are to be provided to the Council. (f) Mr Ashour is to meet the costs of the audits. Mentoring (g) Mr Ashour is to undergo mentoring by an experienced pharmacist approved by the Council for a period of 12 months or for any further period as determined by Council and at the frequency and terms determined by Council. (i) Mr Ashour is to provide to the mentor approved by Council a copy of the Tribunal's decision and reasons of the proceedings. (ii) Mr Ashour is to provide a mentoring plan to the Council for approval. (iii) At each meeting Mr Ashour is to review and discuss his practice with his approved mentor with a particular focus on: (A) Management of his pharmacy practice (B) Duties and responsibilities as a proprietor pharmacist (C) Supervision of pharmacy staff (D) Legal requirements regarding compounding (E) Adequacies of policies and procedures (F) Compliance with his obligations under the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW) (iv) Mr Ashour is to authorise the mentor to provide reports at the frequency determined by Council and at the conclusion of the mentoring period to Council about his professional conduct. (v) Mr Ashour is to meet all costs associated with the mentoring conditions. Education (h) Mr Ashour is required to complete a course focusing on "complex compounding" as defined by the Australian Pharmaceutical Formulary Handbook 25, as approved by the Council: (i) Within 4 weeks of completing the course the practitioner is to provide documentary evidence of completion of the course to the Council. Attendance at pharmacies (i) Mr Ashour is to physically attend each pharmacy at which he is the sole proprietor pharmacist on average once a week for 48 weeks of the calendar year. (j) Mr Ashour is to supply documentary evidence to the Council of the attendances upon request. Review of pharmacies (k) Mr Ashour is to accept the appointment of a person approved by the Council (the Reviewer) to conduct a review of the current policies of each pharmacy in which he is a proprietor pharmacist within 3 months. (l) Mr Ashour is to implement any proposed changes suggested by Reviewer. Catchwords: HEALTH – professional registration and discipline – professional misconduct – appropriate protective orders Legislation Cited: Health Practitioner Regulation National Law (NSW) Poisons and Therapeutic Goods Act 1966 (NSW) Poisons and Therapeutic Goods Regulation 2008 (NSW) Therapeutic Goods Act 1989 (Cth) Cases Cited: Briginshaw v Briginshaw (1938) 60 CLR 336; [1938] HCA 34 Bronze Wing International Pty Ltd v SafeWork NSW [2017] NSWCA 41 Chen v Health Care Complaints Commission [2017] NSWCA 186 Director-General, Department of Ageing, Disability and Home Care v Lambert (2009) 74 NSWLR 523; [2009] NSWCA 102 Gautam v Health Care Complaints Commission [2021] NSWCA 85 Health Care Complaints Commission v Do [2014] NSWCA 307 Health Care Complaints Commission v Elias [2019] NSWCATOD 19 Health Care Complaints Commission v Karalasingham [2007] NSWCA 267 Health Care Complaints Commission v Kennedy [2017] NSWCATOD 72 Health Care Complaints Commission v Litchfield [1997] NSWSC 297; (1997) 41 NSWLR 630 Health Care Complaints Commission v Morsingh [2021] NSWCATOD 13 Health Care Complaints Commission v Saab [2020] NSWCATOD 145 Health Care Complaints Commission v Tamer [2021] NSWCATOD 164 Health Care Complaints Commission v Visvis [2020] NSWCATOD 87 Lee v Health Care Complaints Commission [2012] NSWCA 80 Ng v Health Care Complaints Commission [2017] NSWSC 53 Prakash v Health Care Complaints Commission [2006] NSWCA 153 Texts Cited: NSW Health, Approved systems for recording the supply of substances on prescription generally or in an emergency to health professionals (document TG50/6, November 2015) Pharmacy Board of Australia, Code of Conduct for Pharmacists (March 2014) Pharmacy Board of Australia, Guidelines for dispensing of medicines (August 2010) Pharmacy Board of Australia, Guidelines for dispensing of medicines (December 2015) Pharmacy Board of Australia, Guidelines for proprietor pharmacists (September 2015) Pharmacy Board of Australia, Guidelines on Compounding of Medicines (March 2015) Pharmacy Board of Australia, Guidelines on responsibilities of pharmacists when practising as proprietors (December 2010) Category: Principal judgment Parties: Health Care Complaints Commission (Applicant) Samer Ashour (Respondent) Representation: Counsel: D Fuller (Applicant) DA Lloyd SC (Respondent) Solicitors: Health Care Complaints Commission (Applicant) Clyde & Co (Respondent) File Number(s): 2020/00057394 Publication restriction: Pursuant to section 64(1)(a) of the Civil and Administrative Tribunal Act 2013, the publication, broadcast or disclosure of the name of any patient referred to in these proceedings, including but not limited to those listed in the Schedules to the Complaint, is prohibited. REASONS FOR DECISION 1. Registered pharmacist, Mr Samer Ashour, has been the sole proprietor of the Kingswood Compounding Pharmacy (the Pharmacy) since 2005. He holds financial interests in six other pharmacies, four as a sole proprietor. 2. These reasons concern a complaint about Mr Ashour (the Complaint), referred by the Health Care Complaints Commission (the Commission) to the New South Wales Civil and Administrative Tribunal (NCAT). 3. In broad terms, the Complaint relates to deficiencies in the record-keeping practices of pharmacists employed at the Pharmacy in relation to the dispensing and compounding of Schedule 4 and Schedule 8 drugs. Mr Ashour accepts most of the factual allegations contained in the Complaint. In addition, he accepts that throughout the period covered by the Complaint, August 2015 to July 2017, the policies and procedures in place at the Pharmacy were inadequate to ensure adherence to relevant legislative requirements and guidelines and to enable breaches of those requirements to be detected. He concedes that he failed to fully comply with his obligations as a proprietor pharmacist. 4. The Complaint was heard concurrently with a complaint referred by the Commission to NCAT in relation to Mr Nabil Tamer, the pharmacist-in-charge of the Pharmacy between September 2014 and July 2017 (the Tamer Complaint). Parts of these reasons are identical to those in Health Care Complaints Commission v Tamer [2021] NSWCATOD 164. 5. The central issues in dispute concern whether Mr Ashour's conduct, if found or admitted to be, "unsatisfactory professional conduct" (s 139B(1)(a) of the Health Practitioner Regulation National Law (NSW) (the National Law)), justifies a finding of "professional misconduct" (s 139E of the National Law), and, if so, whether the appropriate protective order is to suspend Mr Ashour's registration. 6. For the reasons that follow, we have found Mr Ashour guilty of professional misconduct. We have decided to suspend Mr Ashour's registration for a period of six months and to impose several conditions on his registration. 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 [which sets the standard of proof in civil proceedings] applies directly in decision-making by NCAT": Bronze Wing International Pty Ltd v SafeWork NSW [2017] NSWCA 41 at [127] (Leeming JA, Gleeson JA agreeing); Ng v Health Care Complaints Commission [2017] NSWSC 53 at [56]. (cf Gautam v Health Care Complaints Commission at [89] (Payne JA, Leeming JA and Simpson AJA agreeing)). Nonetheless, in deciding whether the disputed 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. In Briginshaw, Dixon J, in considering what proof is required to meet the civil standard, said at 361-362: The truth is that, when the law requires the proof of any fact, the tribunal must feel an actual persuasion of its occurrence or existence before it can be found… Reasonable persuasion is not a state of mind that is attained or established independently of the nature and consequence of the fact or facts to be proved. The seriousness of the allegation made, the inherent likelihood of an occurrence of a given description, or the gravity of the consequences of flowing from a particular findings are considerations which must affect the answer to the question whether the issue has been proved to the reasonable satisfaction of the tribunal. 1. The allegations in this case are serious as are the consequences of an adverse finding for Mr Ashour. In making our findings, we have been conscious of those factors. The regulatory framework PTGA and PTGR 1. In Australia, a national classification scheme, "scheduling", operates to control how medicines and poisons are made available to the public. Under that schedule, medicines and poisons are classified into one of nine schedules according to the level of regulatory control over their availability that is assessed as being required to protect public health and safety. The schedules are published in the Poisons Standard, a legislative instrument made under s 52D(2)(b) of the Therapeutic Goods Act 1989 (Cth). In NSW, the Poisons Standard is given effect by s 8 of the Poisons and Therapeutic Goods Act 1966 (NSW) (PTGA). [1] 2. The substances the subject of the Complaint are either "restricted substances" or "drugs of addiction": 1. listed in Schedule 4 of the Poisons Standard, restricted substances are commonly referred to as "Schedule 4 substances". Restricted substances are further classified within Schedule 4 as "special restricted substances" (Appendix B to Schedule 4 (Schedule 4B drugs)) and "prescribed restricted substances" (Appendix D to Schedule 4 (Schedule 4D drugs)). 2. listed in Schedule 8 of the Poisons Standard, drugs of addiction are commonly referred to as "Schedule 8 drugs". 1. In NSW, the PTGA and the Poisons and Therapeutic Goods Regulation 2008 (NSW) (PTGR) regulate the packaging, labelling, possession, storage, prescription and supply of Schedule 4 and Schedule 8 drugs. The PTGA and PTGR restrict the possession and supply of Schedule 4 substances and Schedule 8 drugs and impose record-keeping requirements on pharmacists. 2. The following provisions of the PTGA and PTGR are relevant to the Complaint. 3. Sections 10(3) and (4) of the PTGA make it an offence for a person to supply a Schedule 4 substance (other than by wholesale) unless they fall into specified categories. One of those categories is a pharmacist who supplies the substance in accordance with the prescription of a medical practitioner. 4. Similarly, Part 4, Division 4 of the PTGR restricts those who may supply Schedule 8 drugs. A pharmacist is permitted to supply such drugs on prescription (provided that the prescription is in the required form), or in certain circumstances in an emergency: cll 85, 96 of the PTGR. 5. In addition, the PTGR requires pharmacists who supply Schedule 4 substances and Schedule 8 drugs to: 1. not supply the substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances: cl 54 (Schedule 4 substances), cl 109 (Schedule 8 drugs); and 2. record certain details in relation to the supply of the substance, including the name of the person by whom the substance was supplied, in the "approved manner": cl 55(1)(d) (Schedule 4 substances), cl 113(1)(d) (Schedule 8 drugs). 1. The "approved manner" of recording the details required to be recorded by cll 55(1)(d) and 113(1)(d) of the PTGR is set out in a memorandum issued by NSW Health, in November 2015, "Approved systems for recording the supply of substances on prescription generally or in an emergency to health professionals" (document TG50/6). 2. In addition to those set out above, further restrictions apply to the possession and supply of Schedule 4B and Schedule 4D substances: s 16 PTGA; cll 35(1)(f), 38(1)(e), 39(2)(b), 41(2)(b), 42 of the PTGR. Pharmacy Board of Australia Guidelines 1. Relevant to the Complaint is the Code of Conduct for Pharmacists (the Code of Conduct) and various guidelines relating to the dispensing and compounding of medicines. Each was developed under s 39 of the National Law by the Pharmacy Board of Australia (the Pharmacy Board) and are therefore admissible in these proceedings as evidence of what constitutes appropriate professional conduct or practice for pharmacists: s 41 of the National Law. Code of Conduct 1. The Code of Conduct provides, among other things, that: 1. pharmacists have a duty to make the care of patients or clients their first concern and to practise safely and effectively (cll 1.2, 2.1); 2. pharmacists must, themselves, assess the patient or client taking into account an appropriate history, their views and an appropriate physical examination where relevant (cl 2.1(a)); 3. pharmacists must recognise the limits of their own competence (cll 2.1(d), 2.2(a)); and 4. pharmacists must maintain clear and accurate health records, including recording 'relevant details of clinical history, clinical findings, investigations, information given to patients or clients, medication and other management in a form that can be understood by other health practitioners' (cl 8.4). Dispensing Guidelines 1. In August 2010, the Pharmacy Board issued "Guidelines for dispensing of medicines" (2010 Dispensing Guidelines). In September 2015, the Pharmacy Board issued replacement guidelines which came into effect on 7 December 2015 (2015 Dispensing Guidelines). These guidelines (collectively the "Dispensing Guidelines") require pharmacists to: 1. exercise independent judgment to ensure that a medicine they are proposing to dispense is safe and clinically appropriate for the patient; 2. document their clinical decision-making in the dispensing record and where possible in the patient's health record, including any circumstances of the patient that were taken into account; 3. dispense multiple repeats only where there are exceptional circumstances, and make an appropriate notation of that decision on the prescription in the dispensing record and where possible in the patient's health record; and 4. take responsibility for dispensing decisions by recording their name as the dispensing pharmacist. Compounding Guidelines 1. In March 2015, the Pharmacy Board issued "Guidelines on compounding of medicines", which came into effect on 28 April 2015 (Compounding Guidelines). Those guidelines state that there are only three circumstances in which it is appropriate for a pharmacist to prepare a compounded medicine: 1. an appropriate commercial product is unavailable; 2. a commercial product is unsuitable (for example, if a patient experienced an allergy to an excipient in the commercial product); or 3. when undertaking research sanctioned by a recognised human research ethics committee. Proprietor Guidelines 1. On 8 December 2010, the Pharmacy Board issued "Guidelines on responsibilities of pharmacists when practising as proprietors" (2010 Proprietor Guidelines). In September 2015, the Pharmacy Board issued revised guidelines with effect from 7 December 2015 (2015 Proprietor Guidelines). These guidelines (collectively the "Proprietor Guidelines") apply to any pharmacist who has a legal or financial interest in a pharmacy. 2. The 2015 Proprietor Guidelines state that if the proprietor is not the pharmacist usually in charge of the pharmacy, they must "vigilantly maintain an active interest in how the practice of pharmacy is being conducted ... to ensure that the pharmacy operation is in accordance with: * any applicable state, territory or Commonwealth law; * relevant Pharmacy Board of Australia policies, codes and guidelines; * applicable professional practice and quality assurance standards and guidelines, and * good pharmacy practice." 1. The 2010 Proprietor Guidelines are to similar effect and state that if the proprietor is not the pharmacist usually in charge of the pharmacy they "must determine regularly how the practice of pharmacy is being conducted to be satisfied it is in accordance with any applicable state, territory or Commonwealth law applicable to the practice of pharmacy, with any relevant Pharmacy Board of Australia policies, codes, guidelines, and with good pharmacy practice". Those Guidelines go on to state that if the proprietor finds otherwise, they "must intervene to ensure that the pharmacy business is conducted properly". 2. In addition, the Proprietor Guidelines require the proprietor to: 1. intervene if they find the practice of pharmacy does not operate in accordance with these matters to ensure that the pharmacy business is conducted properly; 2. ensure that appropriate policies and procedures are in place and are being followed, including in relation to risk management; 3. maintain oversight of services being offered and goods being sold, especially those known to be subject to misuse or abuse; 4. ensure that the pharmacy is suitably resourced by suitably trained and supervised staff; and 5. not delegate (2015 Proprietor Guidelines) / not abdicate (2010 Proprietor Guidelines) their professional obligations. Background to the Complaint 1. The trigger for the separate complaints referred to NCAT concerning Messrs Tamer and Ashour was the discovery made in 2017 by the Pharmaceutical Regulatory Unit (PRU) that the Pharmacy had been purchasing large quantities of somatropin and testosterone, drugs known to be abused and misused. 2. In a report dated 29 June 2017, prepared following its investigation of the Pharmacy, the PRU stated that between July 2015 and May 2017, Mr Tamer and other pharmacists employed by the Pharmacy had inappropriately dispensed and compounded several drugs, including Somatropin and testosterone. In addition, the PRU identified several deficiencies relating to record-keeping in relation to the supply of Schedule 4 and 8 drugs and the oversight of the Pharmacy. 3. On 4 August 2017, following receipt of the PRU's report, the Pharmacy Council of New South Wales (the Council) convened proceedings under s 150 of the National Law in relation to Mr Ashour. In its reasons for decision the Council found that: 1. Mr Tamer supplied two patients with large quantities of Somatropin in quantities or for a purpose not in accordance with recognised therapeutic standards. The Council noted that Somatropin is known to be misused to induce anabolic effects, reduce muscle breakdown and reduce body fat; 2. Mr Tamer supplied a patient with large quantities of Primoteston Depot (testosterone) and Proviron (mesterolone) in quantities or for a purpose not in accordance with recognised therapeutic standards. The Council noted that both drugs are known to be the subject of abuse and misuse; 3. in breach of the 2015 Compounding Guidelines, the Pharmacy had compounded and supplied capsules of Tadalafil to about 50 patients, in circumstances where a commercially available product, Cialis, was available; 4. in breach of the 2015 Compounding Guidelines, the Pharmacy had compounded and supplied products for the treatment of Hepatitis C where a commercially available product was available. 1. In its reasons for decision, dated 1 September 2017, the Council concluded that Mr Tamer had breached applicable laws and guidelines. At [41], the Council criticised Mr Ashour's oversight and management of the Pharmacy. 2. The Council imposed the following conditions on Mr Ashour's registration: 1. Must not supply, dispense or compound or allow the supply, dispensing or compounding of any pharmaceutical products containing any of the following at any pharmacy in which the practitioner has a financial interest: 1. Somatropin 2. Testosterone 3. Mesterolone 4. Anastrozole; except for an approved indication as specified for that product on the Australian Register of Therapeutic Goods. 1. Must not compound or allow the compounding of any pharmaceutical products containing any of the following at any pharmacy in which the practitioner has a financial interest: 1. Tadalafil 2. Phentermine 3. Sofosbuvir 4. Ledipasvir 5. Daclatasvir 6. Ribavirin. 1. Must not compound or allow the compounding of a medicine (whether prescribed or not) that would be a close formulation to an available and suitable commercial product where it is unlikely to produce a different therapeutic outcome to the commercial product. 2. Must conduct monthly audits of all Schedule 4B medicines at any pharmacy in which the practitioner has a financial interest. 1. Must deliver to the Council by the fifth day of each month, from September 2017: 1. monthly dispensing records of all Schedule 4B medicines for the previous calendar month for any pharmacy in which the practitioner has a financial interest. The monthly dispensing record is to include: * patient name * dosing instructions * date of dispensing * quantity supplied. 1. a written report on the practitioner's analysis of the monthly dispensing records mentioned in condition 4a(i). The report should highlight any anomalies identified and state the course of action taken to address the anomalies. 1. Must nominate a risk assessor, to be approved by the Council, to conduct a risk assessment of compounding practice at each pharmacy in which the practitioner has a financial interest that offers compounding services. 1. Must provide the following to the Council for its approval by 9am on 16 August 2017: 1. the name of the nominated risk assessor 2. a timeline for the conduct of risk assessment at each pharmacy that offers compounding services. 1. Within two (2) weeks of receipt of the risk assessment report/s from the risk assessor, the practitioner must provide the Council with: 1. a copy of the risk assessment report/s 2. a written summary of his understanding of any concerns raised in the risk assessment report/s and the course of action taken or to be taken to address the concerns. 1. Those conditions apply to this day. 2016 conditions 1. In April 2014 following a report from the NSW Police, the PRU investigated the Pharmacy and identified numerous breaches of regulations relating to the storage, labelling and record keeping for Schedule 4 and Schedule 8 drugs. In addition, the PRU found significant quantities of Diamond-branded Stanozolol products which are prohibited for use in Australia. 2. In May 2014, the Pharmacy Council imposed conditions on the registration of the then pharmacist in charge, Mr Adam Kennedy, which included that he not work as pharmacist in charge; not enter any pharmacy in which he is employed unless another pharmacist is present; not possess or dispense Schedule 8 or Schedule 4D drugs. Messrs Kennedy and Ashour are brothers. In 2017, following disciplinary proceedings commenced by the Commission, NCAT found Mr Kennedy guilty of professional misconduct and imposed several additional conditions on his registration: Health Care Complaints Commission v Kennedy [2017] NSWCATOD 72. One of those conditions was that he submit to an audit of his practice. Those conditions remain in place. Mr Kennedy continues to work at the Pharmacy subject to those conditions. 3. In early 2016, the Pharmacy Council held an inquiry into Mr Ashour and found him guilty of unsatisfactory professional conduct. The Council cautioned Mr Ashour and imposed the following conditions on his registration effective 22 January 2016: 1. The Practitioner is to accept counselling by a Panel appointed by the Council with the first counselling session to occur by 30 March 2016; and further sessions to occur at a frequency to be determined by the Council. The focus of counselling is to be his pharmacy processes and procedures. 2. The Practitioner is to accept an Auditor, appointed by the Pharmacy Council of NSW, to conduct an audit of his pharmacy processes and procedures, with the first audit to occur by 30 September 2016; and further audits to occur at a frequency to be determined by the Council. 1. In April 2016, a pharmacist appointed by the Pharmacy Council conducted an audit of the Pharmacy. On 13 July 2016, the Pharmacy Council removed all conditions on Mr Ashour's registration having found that he complied with those conditions. The Complaint 1. Set out at Annexure A to these reasons, the Complaint consists of four individual complaints. The Commission contends that the conduct the subject of Complaints 1, 2, and 3 amounts to unsatisfactory professional conduct within the meaning s 139B(1)(a) of the National Law: "Unsatisfactory professional conduct" of a registered health practitioner includes each of the following-- Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. Complaint 1 1. Complaint 1 broadly corresponds with Complaint 1 of the Tamer Complaint and consists of four particulars: 1. Particulars 1 and 2 state that between 14 August 2015 and 15 May 2017 Mr Ashour failed to ensure that the Pharmacy's dispensing records for the supply of restricted substances Phentermine (7), Anastrazole (1), Somatropin (6) and Testosterone (53), recorded the details of the dispensing pharmacist as required by cl 55(1)(d) of the PTGR and the 2010 and 2015 Dispensing Guidelines; 2. Particular 3 states that between 16 September 2015 and 26 May 2017 Mr Ashour failed to ensure that the Pharmacy's dispensing records for the supply of the Schedule 8 drugs Ketamine (3), Dexamphetamine (1), Fentanyl (1) and Alprazolam (2), recorded the details of the dispensing pharmacist as required by the Dispensing Guidelines. Particulars 1, 2 and 3 1. Mr Ashour accepts the facts of Particulars 1, 2 and 3, that is, that the subject dispensing records contained the initials of the dispensing technician and not the name of the dispensing pharmacist, as required by the PTGR and the Dispensing Guidelines. 2. However, he argues that the Proprietor Guidelines cannot be read as imposing an obligation on proprietors to ensure that each pharmacist in their employ complies in real time with their statutory and professional obligations. He points out that the PTGR and the Dispensing Guidelines require the dispensing pharmacist to record their details in the Pharmacy's dispensing records. Mr Ashour contends that Particulars 1, 2 and 3 are misconceived. 3. The Commission urges the Tribunal to reject that analysis and argues: 1. First, a proprietor cannot escape responsibility for misconduct by saying that they took steps to try to prevent that misconduct. The Commission points out that in Health Care Complaints Commission v Saab [2020] NSWCATOD 145 (Saab) at [420]-[426], the Tribunal held that it was ultimately the proprietor's responsibility to ensure that regulatory obligations were complied with, which followed from the proprietor's obligation not to delegate his or her professional obligations: Saab at [426], [656]-[657]. (Similar reasoning was adopted by the Tribunal in Health Care Complaints Commission v Visvis [2020] NSWCATOD 87 at [44].) 2. Second, the policies, procedures and oversight employed by the Pharmacy to ensure compliance with the Dispensing Guidelines and the PTGR were deficient as evidenced by: 1. the protracted period over which the failures in this case went undetected by Mr Ashour; 2. the fact that they occurred despite Mr Ashour auditing the Pharmacy's dispensing records – an audit that did not include looking at the recorded initials of the dispenser or the patient's name, matters that might be thought essential to conducting a proper evaluation of whether dispensing was occurring correctly; 3. Mr Ashour's infrequent attendance at the Pharmacy from 2016, which he accepted in cross-examination was inadequate to discharge his responsibility to maintain an active interest in the Pharmacy; and 4. a review of the policies and procedures that Mr Ashour says were in place at the relevant times shows that they gave inadequate direction about all matters which are the subject of the complaints, and, in any event, Mr Tamer's oral evidence was that he was not shown or given copies of any policy or procedure documents. Consideration Are Particulars 1, 2 and 3 misconceived? 1. As formulated, Particulars 1, 2 and 3 require the Commission to establish that Mr Ashour "failed to ensure that the Pharmacy dispensing records for the supply of [the subject drugs]" complied with the requirements imposed by the Dispensing Guidelines and, in respect of restricted substances, cl 55(1)(d) of the PTGR, that the name of the person who supplied the subject drugs be recorded in the Pharmacy's dispensing records. 2. The PTGR requires the person who supplies a restricted substance on prescription to record their name in the pharmacy's dispensing records: "A pharmacist who supplies a restricted substance on prescription must record … the name of the person by whom the substance was supplied": cl 55(1)(d) of the PTGR. Clause 113(1)(d) of the PTGR, which governs the supply of Schedule 8 drugs, is to the same effect. Neither the 2010 nor the 2015 Dispensing Guidelines expressly refer to the requirement to record the name of the dispensing pharmacist in the dispensing records. We understand that the Commission, in support of Particulars 2 and 3, relies on the general instruction contained in each: Pharmacists must comply with all legislation relevant to the practice of pharmacy in the jurisdiction where the dispensing occurs. 1. We accept that the Proprietor Guidelines cannot be construed as meaning that in every case where a pharmacist fails to comply with their obligations under the PTGR or relevant guidelines, that it can be said that the proprietor "failed to ensure" compliance. The Proprietor Guidelines cannot be read as imposing an obligation on proprietors to supervise their employed pharmacists. Whether a proprietor "failed to ensure" that a pharmacist in their employ complied with a requirement of the PTGR or the relevant guidelines, depends on the facts of the particular case. 2. Had this been a case of a single instance of a dispensing pharmacist failing to record their name in the dispensing records, the argument made by Mr Ashour would have greater force. However, here, on 74 occasions over an 18-month period, pharmacists employed by Mr Ashour failed to record their names in the dispensing records when supplying Schedule 4 substances or Schedule 8 drugs. 3. We reject the contention that the Proprietor Guidelines should be read as meaning that a proprietor's obligation to "ensure that the pharmacy operation is in accordance with: any applicable state, territory or Commonwealth law, [and] relevant Pharmacy Board of Australia policies" is only enlivened where a proprietor becomes aware of the non-compliance and fails to "intervene". To accept that proposition would reward indolence or negligence on the part of a proprietor. It would be an invitation to lower rather than maintain standards. 4. This is a regulatory scheme intended to maintain high standards of practice and patient safety. In our view, the concepts of strict or absolute liability in the criminal law are, by analogy, relevant here. An onus is placed on proprietors to comply with the scheme. The question is not one of intentional wrongdoing or negligent omission. The question is whether relevant standards were adhered to. Extending the analogy of strict liability, the facts do not and could not give rise to a defence of honest and reasonable mistake of fact. Mr Ashour did not make any reasonable effort to ascertain the facts. This is clear from the evidence that he failed to detect 74 instances of pharmacists not recording their names in the dispensing records. Particular 4 1. Particular 4 states that the conduct as set out in Particulars 1, 2 and 3 demonstrates a failure by Mr Ashour "to maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted with respect to the Pharmacy's dispensing records and a failure to intervene, when necessary, contrary to the [Proprietor Guidelines]". Mr Ashour admits this particular. Unsatisfactory professional conduct 1. While Mr Ashour accepts that his failures the subject of Particular 4 fell below the relevant standard, he argues that it did not fall significantly below that standard because: 1. the proportion of the subject supplies where the dispensing pharmacist failed to record their name in the dispensing records was very small. In the period covered by Complaint 1, August 2015 to April 2017, the Pharmacy dispensed about 120,000 prescriptions (about 200 per day). Mr Ashour points out that the Commission has failed to lead evidence that this level of non-compliance falls significantly below the compliance levels of comparable pharmacies. 2. Mr Ashour gave a plausible explanation for the reason the initials of the dispensing technicians were entered in the dispensing records. 1. In submissions provided to the Pharmacy dated 23 July 2017, Mr Ashour stated that he was unaware that it was "not best practice" for dispensing technicians to record their names in the dispensing records when supplying Schedule 4 and Schedule 8 drugs: "28. In relation to the recording of the initials of a person other than the pharmacist who supplied the restricted substance in our system, at the outset I want to make it clear this practice should not have occurred and I have taken steps to ensure that it does not occur in the future. Dispensing technicians have previously had their initials in the system and I was not previously aware that this was not best practice. Following the investigation, I have ensured all initials, other than those of dispensing pharmacists, have been deleted from our system, such that it is now not possible for anyone other than the dispensing pharmacist to form part of the record. 29. By reason of explanation at the time, we were trying to measure the "scan rates" of our staff to ensure all molecules dispensed were scanned, which is why the initials of all staff could be entered into the records. I did not think it would be an issue because the roster could be used to confirm which pharmacist was working at the time and therefore it would be that pharmacist who dispensed the medication. 30. I understand that this is not best practice and, additionally, was in contravention of the Regulation which I now accept." 1. In these proceedings, Mr Ashour stated that until the PRU brought it to his attention he was not aware that dispensary technicians were entering their initials in the dispensing records. He admitted that with better policies, procedures and oversight, that practice could have been detected and remedied. 2. In support of the contention that the failures the subject of Complaint 1 amounted to unsatisfactory professional conduct, the Commission relies on the opinion of pharmacist, Mr Bruce Chilton. Commenting on the explanation given by Mr Ashour to the Pharmacy Council, Mr Chilton stated that it indicated that Mr Ashour was ignorant of, or did not understand, the requirements of the PTGR. At the request of the Commission, Mr Chilton prepared a report and gave oral evidence commenting on the conduct the subject of the Complaint. Consideration 1. In evaluating whether the conduct the subject of Particular 4, Complaint 1 amounts to unsatisfactory professional conduct within the meaning of s 139B(1)(a) of the National Law it is necessary to: 1. identify the standard "reasonably expected" of a proprietor pharmacist of an equivalent level of training or experience to Mr Ashour (the relevant standard), and 2. evaluate whether the admitted conduct demonstrates that the knowledge, skill or judgment possessed, or care exercised, by Mr Ashour in the practice of his profession, fell "significantly below" the relevant standard. 1. Mr Ashour was first registered as a pharmacist in 2002. He purchased the Pharmacy in 2005. At the commencement of the period of the Complaint he owned seven pharmacies. It follows that the relevant standard is that of an experienced pharmacist and proprietor. 2. As set out above, there is conflicting evidence about whether Mr Ashour was aware of the practice of dispensing technicians entering their initials in the dispensing records recorded. Whichever explanation is accepted, the conduct the subject of each particular of the Complaint amounts to unsatisfactory professional conduct. 3. If the reason dispensing technicians recorded their name in the dispensing records when supplying Schedule 4 and Schedule 8 drugs was because Mr Ashour was ignorant of the requirement of the PTGR and the Dispensing Guidelines, it demonstrates that the knowledge he possessed fell significantly below the relevant standard. The standard reasonably expected of an experienced proprietor is to have a thorough working knowledge of the regulations and guidelines governing the practice of pharmacy in NSW, especially those which have regular application, such as cl 55 of the PTGR. 4. Alternatively, if the reason for the practice was because Mr Ashour failed to detect that the dispensing technicians were entering their initials in the dispensing records, it demonstrates that the care he exercised fell significantly below the relevant standard. That only a small proportion of the dispensing records contained the initials of dispensing pharmacists does not assist Mr Ashour because, as he admitted, when he audited those records he did not examine the name of the dispenser. 5. Complaint 1 is proven. Complaint 2 Complaint 2, Particulars 1 - 12 1. The conduct which underlies these Particulars relates to Mr Tamer's failure to document the reasons he supplied, the therapeutic basis for supplying, and/or his contact with the prescriber about their decision to prescribe Schedule 4 drugs on the dates and in the quantities particularised to Patients A, B and C. 2. Particulars 1 to 12 allege that Mr Ashour failed: 1. to ensure that Mr Tamer: 1. documented his contact with the prescriber in circumstances where the prescription was for an off-label purpose/ the prescriber's directions for use were inconsistent to those given by the manufacturer/ the amount dispensed did not accord with recognised therapeutic standards; 2. documented the reason for supplying the subject drugs; and 3. documented the therapeutic basis for the supply, quantity or interval of dispensing; 1. to develop and implement policies and protocols at the Pharmacy to support safe and appropriate dispensing and recording practices; 2. to monitor his employed pharmacists in their adherence to policies and procedures; and 3. to exercise appropriate oversight of the employed pharmacists as the proprietor pharmacist. Particulars 1, 4 and 10 1. These Particulars are formulated as a failure "to ensure that Mr Tamer documented …" the reasons for supplying, the therapeutic basis for supplying, and/or his contact with the prescriber. Mr Ashour repeats the argument advanced in respect of Complaint 1, that is, the Proprietor Guidelines do not operate to require proprietors to ensure that individual pharmacists comply with their professional obligations and therefore the Particulars are misconceived. 2. For the reasons given in relation to Complaint 1, we reject that argument. The conduct the subject of each Particular related to multiple instances over some months where Mr Tamer failed to comply with the requirements of the PTGR and the Dispensing Guidelines, in relation to documenting the supply of Schedule 4 substances. 3. Particulars 1, 4 and 10 are therefore proven. 4. We find the conduct of each Particular demonstrates that the care exercised by Mr Ashour fell significantly below the relevant standard. Particulars 2, 3, 5, 6, 7, 8, 9, 11 and 12 1. Mr Ashour admits each Particular. In addition, he admits that the admitted conduct amounts to unsatisfactory professional conduct. 2. Mr Ashour states that he made genuine attempts to comply with his obligations under the Proprietor Guidelines by having policies and procedures in place and by routinely attending the Pharmacy, speaking to the dispensing pharmacists and inspecting the dispensing records. However, he admits the policies and procedures, supervision, inspection and oversight of the employed pharmacists were inadequate to detect the particularised failures to document. In addition, he admits that with better policies, procedures and system of supervision, inspection and oversight those failures could have been detected. Particulars 13, 14, 15 and 16 1. These Particulars relate to the supply of Somatropin to Patients D and E. Both are children. 2. In contrast to Particulars 1 to 12, the Commission does not allege that the dispensing pharmacist failed to document the reasons for supplying, the therapeutic basis for supplying, and/or his contact with the prescriber about their decision to prescribe the subject drugs. Nor does the Commission allege any other failure in relation to the subject supply/dispense of those drugs. Nor does the Commission allege that the subject prescriptions were deficient in some way, or that the drugs prescribed, or the quantities or dosage, did not accord with a proper therapeutic purpose. 3. Rather, the Commission alleges that in the period covered by these Particulars Mr Ashour failed to comply with his general obligations as proprietor to: 1. develop and implement policies and protocols at the Pharmacy to support safe and appropriate dispensing and recording practices; monitor his employed pharmacists in their adherence to policies and procedures; exercise appropriate oversight of the employed pharmacists as the proprietor pharmacist (particulars 13 and 15); 2. maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted with respect to appropriately documenting the rationale for dispensing, and failed to intervene when necessary, contrary to the Proprietor Guidelines (particulars 14 and 16). 1. There is no apparent relationship between the subject supply/dispense of Somatropin to Patients D and E and Mr Ashour's alleged failure to comply with his obligations as a proprietor to develop and implement policies, and to maintain oversight of the Pharmacy etc. 2. As the Commission points out, the fact that Mr Tamer complied with the requirements of the PTGR and the Dispensing Guidelines in each of the subject supplies of Somatropin to Patients D and E does not establish Mr Ashour had put in place adequate policies and procedures to ensure and monitor compliance. However, that does not answer the question of the proper construction of these Particulars. The interpretation the Commission urges us to adopt requires that these particulars be read as a series of general allegations, concerning policies and system failures unrelated to each of the subject supplies. That interpretation requires us to ignore that part of each particular which details the subject supplies. 3. We agree with Mr Ashour that these particulars are misconceived. Conclusion 1. Particulars 13, 14, 15 and 16 are not established. The balance of Complaint 2 is established. Complaint 3 1. At the request of the Tribunal, on the final day of hearing Mr Ashour handed up a further amended reply to the Complaint, parts of which were handwritten. After the hearing, again at the request of the Tribunal, Mr Ashour filed a typed version of that document. With respect to Complaint 3, there are several material differences between the two documents. For example, in the former, Particulars 2 and 4 are admitted; in the latter, Particular 2 and sub-Particular 4(a) are denied. 2. The reason Mr Ashour was given leave to file a typed version of the Reply after the hearing was so the Tribunal would have the benefit of a legible version of that document. Mr Ashour did not seek and was not given leave to further amend the Reply. It may be that the reason for the discrepancy between the two versions of the Reply was the result of an administrative error. Whatever the explanation, we have not had regard to the typed version of the Reply, and proceed on the basis that the version handed up on the final day of hearing constitutes Mr Ashour's formal response to the Complaint. Particulars 1 and 2 1. The conduct underlying Particular 1 corresponds to Particular 1, Complaint 3 of the Tamer Complaint which was admitted by Mr Tamer. It relates to Mr Tamer's actions in supplying and dispensing the schedule 4 restricted substance Tadalafil (erectile dysfunction medication) on 238 occasions to multiple patients between January 2016 and May 2017 in circumstances where he failed to: 1. contact the prescriber to discuss the clinical indications for compounding when Cialis, an ARTG-listed product (Australian Register of Therapeutic Goods), was commercially available; 2. document the clinical indication or reason for justifying the compounding of this drug which was commercially available. 1. Mr Ashour does not formally admit the facts on which Particular 1 is based. However, he properly acknowledges that in circumstances where Mr Tamer has admitted those facts and he cannot point to any conflicting evidence, he is not in a position to deny those facts. We are satisfied those facts are established. 2. In respect of Particular 1, Mr Ashour repeats the argument he made in response to Particulars 1, 2 and 3 of Complaint 1 and Particulars 1, 4 and 10 of Complaint 2, that is, the Proprietor Guidelines do not impose an obligation on proprietors to ensure that their employed pharmacists comply with the requirements of PTGR and relevant guidelines. For the reasons given above, we reject that argument, noting that the conduct the subject of Particular 1 was repeated and occurred over a protracted period 3. Mr Ashour admits Particular 2, which states that with respect to the dispensing of Tadalafil, the subject of Particular 1, he failed to ensure: 1. adequate systems were in place to guide and monitor the compliance of his employed pharmacists when compounding; 2. his employed pharmacists completed an adequate risk assessment and evaluation when compounding and dispensing prescriptions, including contacting the prescriber and documenting the discussions; and 3. the dispensing and compounding was not in breach of Code 2 of the Compounding Guidelines. 1. We find each Particular proven. In addition, we find that Mr Ashour's failure, the subject of Particulars 1 and 2, demonstrates that the care he exercised in meeting his obligations as proprietor fell significantly below the relevant standard. Particular 3 1. This Particular relates to the dispensing and compounding of Phentermine on 10 occasions over six months, in circumstances where Mr Ashour failed to ensure: 1. That adequate systems were in place to guide and monitor the compliance of his employed pharmacists when compounding; and 2. That his employed pharmacists completed an adequate risk assessment and evaluation when compounding and dispensing prescriptions, including contacting the prescriber and documenting the discussions. 1. Mr Ashour accepts that there were not adequate systems in place as alleged by Particular 3. As he did in relation to Particular 1, he does not formally admit the particularised conduct, that is, that the Pharmacy dispensed and compounded Phentermine on 10 occasions but acknowledges that he cannot point to evidence to disprove that allegation. 2. It falls to the Commission to prove, not to Mr Ashour to disprove the alleged conduct. The Commission tendered in these proceedings the dispensing records for Phentermine which underpins this particular. No evidence was led which cast doubt on the reliability of that record. We find this particular proven. In addition, we find that Mr Ashour's failure to maintain adequate systems as alleged by Particular 3 demonstrates care which falls significantly below the relevant standard. Particular 4 1. Mr Ashour admits Particular 4 and accepts that it amounts to unsatisfactory professional conduct. That concession is consistent with the evidence and is properly made. Conclusion 1. Complaint 3 is established. Complaint 4 1. Complaint 4 states that each particular of Complaints 1, 2 and 3, and, in the alternative, two or more of the particulars of those Complaints amounts to professional misconduct. Mr Ashour 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. 1. 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] 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). 2. 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. 3. 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] NSWSC 297; (1997) 41 NSWLR 630 at 638. Submissions 1. Mr Ashour argues there is no basis in the evidence to make a finding that his admitted failures were of a sufficiently serious nature to justify the suspension or cancellation of his registration for the following reasons. 2. First, while Mr Ashour accepts that the policies and systems he developed to ensure his employed pharmacists complied with the PTGR and relevant guidelines were inadequate to both achieve compliance and to detect non-compliance, he argues that he made genuine efforts to ensure that his employed pharmacists were given guidance about their obligations under the PTGR and relevant guidelines. In support, he points to the policies and procedures in place during the period of the Complaint and his routine attendance at the Pharmacy throughout that period. 3. Second, citing Health Care Complaints Commission v Elias [2019] NSWCATOD 19 at [55], Mr Ashour argues that relevant to an evaluation of the seriousness of the conduct is the potential for harm of that conduct. He points out that the conduct the subject of the Complaint relates largely to failures by the dispensing pharmacists to maintain a proper record of dispensing. Mr Ashour accepts the importance of pharmacists maintaining proper documentary records and that a failure to do so has the potential to cause harm to patients. However, he argues that those failures are less likely to cause harm to patients than other types of conduct such as dispensing drugs without a prescription or dispensing the wrong dose of medication. 4. Third, he contends that the Commission failed to adduce any probative evidence to support its contention that the impugned conduct was of a sufficiently serious nature to justify suspension or cancellation. He argues that, given Mr Chilton has not reviewed the current policies and practices in place at the Pharmacy, little weight should be given to his opinion about the extent to which Mr Ashour's conduct departed from proper professional standards. Consideration 1. While the impugned conduct could not be characterised as being conduct of the most serious nature, in our view it was nonetheless very serious. 2. For over 18 months, Mr Ashour failed to develop and implement adequate policies and procedures in the Pharmacy to support and guide his employed pharmacists to comply with their obligations to document their interactions with prescribers and/or their rationale for supplying drugs, such as Schedule 4 drugs the subject of Complaint 2, known to be subject to abuse and misuse. 3. In addition, Mr Ashour failed to put in place adequate policies and procedures to support and guide his employed pharmacists in compounding and supplying drugs, including Schedule 4 drugs. 4. Further, as evidenced by the volume of contraventions the subject of Complaints 1, 2 and 3 and the protracted period over which they occurred, Mr Ashour's monitoring and oversight of the Pharmacy was grossly inadequate and fell well short of the obligation imposed by the Proprietor Guidelines to "vigilantly maintain an active interest" in the practice of pharmacy. 5. The drugs being dispensed were capable, if misused, of causing serious harm to patients or users of them. Apart from that, it is well-known that there is a black market in scheduled drugs. In the light of those two basic facts, the necessity for, and value of, keeping scrupulous records in relation to scheduled substances are self-evident. Pharmacists are given a commercial monopoly to supply these drugs because they have the training and expertise to ensure that they are dispensed safely. With that monopoly comes responsibility. 6. The impugned conduct was objectively serious because it paid insufficient attention to the seriousness of pharmacists' responsibilities to maintain the security and integrity of the system designed to ensure safe, honest dispensing of these powerful drugs. Submissions to the effect that no harm was done miss this important point. In aggregate, the impugned conduct was sufficiently serious to justify suspension, if not cancellation, of Mr Ashour's registration. Oversight and auditing of the Pharmacy Oversight of the Pharmacy 1. When appointed to their respective roles as pharmacist in charge of the Pharmacy, Messrs Kennedy and Tamer were young and inexperienced. 2. Mr Kennedy was 26 years of age and had been registered for 12 months. In the NCAT disciplinary proceedings, Mr Kennedy said that he was ill-equipped to take on the role of pharmacist in charge and was provided with insufficient support. Mr Ashour agreed that he failed to provide an adequate level of support to Mr Kennedy: Health Care Complaints Commission v Kennedy at [164]. 3. When he took over the role from Mr Ashour, Mr Tamer was in his early thirties and had been registered for about four and a half years. His experience of working as a pharmacist in charge was limited to occasional work after the pharmacist in charge left for the day, while working as a pharmacist at Chemist Warehouse Liverpool between May 2010 and November 2011. Mr Tamer had no experience in compounding, which continues to represent about a third of the Pharmacy's dispensing work. 4. In addition to his responsibilities as pharmacist in charge, Mr Tamer was required to ensure that Mr Kennedy worked within the conditions of his registration. Mr Ashour had emphasised to Mr Tamer the importance of ensuring that Mr Kennedy working within those conditions. 5. According to Mr Ashour, when Mr Tamer was first appointed, he visited the Pharmacy on a weekly basis. However, by 2016 he had reduced his visits to every two or so weeks because he was confident in Mr Tamer's ability to manage the pharmacy and also by that time his other professional commitments and personal obligations, including building a new house and the birth of his first child, were absorbing much of his time. He acknowledges that it was a serious error on his part to reduce the oversight of the Pharmacy, especially given its history. 6. Mr Ashour acknowledged in these proceedings that the policies and procedures in place throughout the period of the Complaint, and the steps he took to monitor compliance, were inadequate. A review of those documents reveals that they were deficient in several material respects. Most relate to procedures for dispensing morphine and buprenorphine. None expressly refer to either the Dispensing or the Compounding Guidelines, in particular the requirements in each which gave rise to the conduct the subject of Complaints 2 and 3. For example, none give instructions about how to assess whether the drug prescribed, or the amount or dosage prescribed, accords with a proper therapeutic purpose. In addition, none contain check lists or other types of monitoring mechanism. 7. In cross examination, Mr Ashour admitted that during the period the subject of the Complaint, he had "dropped the ball" but said that since that time he has run a "tight ship" across his seven pharmacies. 8. According to Mr Ashour, in 2017 after being alerted to the problems at the Pharmacy by the PRU investigation, he reviewed the policies and procedures then in place, revised them and introduced additional policies. He said that in about September 2020 he introduced a further 18 policies. According to Mr Ashour, the same policies and procedures apply across all his pharmacies. 9. In these proceedings, Mr Ashour tendered copies of the current policies and procedures used in his pharmacies. They are undated and cover over 30 policies and procedures and run to some 130 pages. [2] 10. In evidence, Mr Ashour said he was confident that the policies and procedures now in place provide adequate guidance to dispensing staff. However, he acknowledged in cross examination that there was room for improvement. For example, the policy on dispensing procedures, which at [3] states that after "checking the dose, quantity, drug interaction/s", the pharmacist is to "consult with the doctor where appropriate", does not provide guidance on when the pharmacist should consult the prescribing doctor. 11. When asked about whether his approach to the development of policies and procedures had mostly been reactive to issues that have been identified, Mr Ashour disagreed, although he acknowledged that many of the policies that he developed were reactive to Mr Tamer's conditions. He asserted that the policies he introduced in September 2020 were proactive. 12. In cross-examination, when questioned about how the policies and procedures are actually implemented, Mr Ashour stated that he did so by "regular [weekly] store visits, by observation, by monitoring, by being present, by just watching and observing everyone". He said that while he had no formal process for receiving feedback from staff, he is "a very approachable person" and he continuously tries to make improvements if needed and to work with his pharmacists to "try to create [the] best and easiest practice possible". 13. Later he was questioned about whether he had developed a management plan for the pharmacies [3] : Q. Do you have any kind of management plan for any of your pharmacies? A. What do you mean by "management plan", a business plan? Q. A business plan? A. There's management plans in the store. Yes. Q. That is not something you have provided in this proceeding, is that right? A. No. Q. Is there a reason for that? A. When you say, "management plan" what do you mean by as in business management plan cause I thought this hearing is more of, you know, regulatory compliances and making sure that. Q. I will put it to you this way: do you remember seeing in the expert's report that he made some comments about there being a lack of an overall management plan? A. Management. In terms of management, no, there's very strong management in place because I'm continuously there overseeing the management of the store but I'm also continuously following up, so if I delegate something I'm always following up. If I find something I'm always following up, so to be honest I don't actually agree with the expert being in terms of lack of management. If I couldn't manage the stores that I have then I wouldn't last if they were poorly managed. 1. In cross-examination, Mr Ashour said he is continuously looking at the policies and procedures that apply to his pharmacies but had not undertaken a systemic or overall review of them. Nor had he engaged an external person to review the policies and procedures he had developed. He said he was confident he "had it under control". Auditing of the Pharmacy 1. Since August 2017, Mr Ashour's registration has been subject to a condition that he must conduct monthly audits of all Schedule 4B drugs in all his pharmacies. In addition, he is required to give to the Council the monthly dispensing records for those drugs together with a report which analyses those records and identifies any anomalies. Mr Ashour has fully complied with that requirement. The Council has not raised any issues of concern. 2. Pursuant to the conditions of his registration in November 2017, a risk assessor approved by the Council, Ms Kerry Davison, conducts a risk assessment of the compounding practice at four of the pharmacies, including the Pharmacy. In a report dated 1 November 2017, Ms Davison identified several issues of concern. 3. In a report of a follow-up audit conducted in March 2018, Ms Davison wrote that she was satisfied that each of the four pharmacies had "made significant improvements and have taken on board all recommendations". 4. Pursuant to conditions imposed by NCAT, Mr Kennedy has been subject to audit conditions since May 2017. Neither party filed any documents about that audit. The Tribunal understand that the auditor has not reported any issues of concern. Character evidence 1. Mr Ashour tendered in these proceedings character references prepared by pharmacists, Messrs Feras Karem and Jason Liu. Each state they have read the Complaint. 2. Vice President of the Pharmacy Guild of NSW and CEO of franchise Pharmacy4Less, Mr Karem has known Mr Ashour for over a decade in a professional capacity. In his opinion, Mr Ashour is a dedicated and hard-working pharmacist and a person of good character. 3. Mr Liu is the director of pharmacy software company, Z Software. He and Mr Ashour attended university together in the later 1990s and have remained in regular contact. In Mr Liu's opinion, Mr Ashour is a good pharmacist and proprietor, honest, reliable and hardworking. What, if any, protective order 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. Where, as here, the Tribunal is satisfied that a practitioner is guilty of professional misconduct, it may suspend or cancel the practitioner's registration: s 149C(1) of the National Law. 2. In exercising the power to make disciplinary orders, the paramount consideration is the protection of the health and safety of the public: s 3A of the National Law. 3. In Prakash v Health Care Complaints Commission [2006] NSWCA 153, Basten JA commented at [101] that "[t]he adverse consequences for a practitioner may require that no more restrictive an order should be made than is necessary for the proper protection of the community and the other proper purposes of such an order." 4. In Lee v Health Care Complaints Commission [2012] NSWCA 80, Barrett JA observed at [20] 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 parties agree that it is necessary and appropriate that conditions be imposed on Mr Ashour's registration. There is broad agreement about the form of conditions. However, they disagree on the question of suspension. 2. The Commission contends that it is appropriate that Mr Ashour's registration be suspended. The Commission argues that suspension will give Mr Ashour the opportunity to reflect on his conduct and will have an individual and general deterrent effect. It points out the practical effect of a suspension for a period not exceeding six months is that Mr Ashour will not be required to divest his interests in those pharmacies of which he is a proprietor: cl 5(2)(c) of Schedule 5F to the National Law. 3. Mr Ashour submits that no proper purpose would be served by suspending his registration for the following reasons: 1. The suite of conditions he proposes is sufficient to address the concerns raised by the Commission and to protect the public interest. Mr Ashour contends that the proposed conditions are more onerous than those proposed by the Commission, and require, among other things, that he attend each pharmacy of which he is a sole proprietor on an average of once a week and accept the appointment of a person approved by the Council to review the current policies of each pharmacy and to implement any proposed changes. 2. In the last four years there has not been a single reported failure or complaint about any of the pharmacies of which he is the proprietor. Throughout that period each pharmacy has been subject to extensive internal and external analysis. 3. The Pharmacy is the only pharmacy of which he is the proprietor which has been the subject of a complaint or an identified failure or breach of any regulation or guideline. 4. The Commission failed to adduce any expert evidence addressing the adequacy of the steps Mr Ashour has taken to rectify the policy and system failures the subject of the Complaint. Conclusion 1. 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 cautioned in Prakash, given the adverse consequences for a practitioner, "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". 2. Applying those principles, we have decided that it is necessary and appropriate that an order suspending Mr Ashour's registration for six months be made for the following reasons. 3. First, for the reasons given above, the conduct the subject of the Complaint was of a serious nature and extended over 18 months. Significantly, this was the second time problems with the oversight and management of the Pharmacy had been identified. Having been alerted to the problem of providing inadequate support and supervision to the young and inexperienced Mr Kennedy, Mr Ashour went on and did much the same thing to Mr Tamer. In those circumstances, we agree with the submission made by the Commission that Mr Ashour's misconduct be denounced to underscore to him, the profession and the public of the standards expected of proprietor pharmacists: Health Care Complaints Commission v Do [2014] NSWCA 307 at [35]. 4. Second, while the policies and procedures now in place are a significant improvement on their predecessors, in our view there remains room for improvement. Of particular concern is the lack of an adequate mechanism to ensure that policies and procedures developed are consistently implemented across all of Mr Ashour's pharmacies. While personal observations of, and discussions with, staff might be adequate if Mr Ashour was the proprietor of one or two pharmacies, in our view they are inadequate to ensure implementation across all pharmacies over the long term. No mention was made by Mr Ashour of training in the actual application of the recently developed policies or how he would ensure they were implemented in practice on a daily basis. 5. Third, a six-month suspension gives Mr Ashour the opportunity to address the deficiencies in his knowledge of the regulations which govern compounding. In NSW the regulatory framework governing the practice of pharmacy is complex, that governing compounding even more so. The answers given by Mr Ashour to questions by the Tribunal [4] reveal that his knowledge of the rules relating to the regulation of compounding was deficient in several material respects. To his credit, Mr Ashour acknowledges that fact and has undertaken to complete further study. Self-evidently, a proprietor's ability to develop and implement appropriate policies and to provide effective and adequate guidance and support to employees requires a thorough working knowledge of the regulations governing pharmacy. 6. Fourth, the evidence of compliance across Mr Ashour's seven pharmacies since August 2017 is powerful evidence supporting Mr Ashour's claim that since that time he has made genuine efforts to maintain an active interest in the Pharmacy. However, in our view more needs to be done, including an external review of the implementation of the policies and procedures and continual quality control in each of his pharmacies. 7. In addition, we have decided that it is necessary and appropriate that Mr Ashour's registration be subject to several conditions, including: 1. that Mr Ashour not supply, dispense, compound or allow the supply, dispensing or compounding of any pharmaceutical products containing Somatropin, Testosterone, Mesterolone or Anastrozole, except for an "approved indication". Mr Ashour proposes as an alternative that an auditor be appointed by the Council to audit the supply, dispensing or compounding of these drugs. We agree that an audit requirement is necessary. However, in our view it is appropriate that the restriction on supplying etc of these drugs except for an "approved indication" be continued; 2. that Mr Ashour submit to a regular audit of all Schedule 4B drugs and Somatropin and Anastrozole; 3. that Mr Ashour undergo mentoring by an experienced pharmacist for a period of 12 months; 4. that Mr Ashour physically attend each pharmacy of which he is a sole proprietor on a weekly basis; 5. that Mr Ashour submit all policies of his pharmacies to external review by a person approved by the Council, and adopt any recommended changes; 6. that Mr Ashour complete a course on "complex compounding". Orders 1. Mr Ashour's registration is suspended for a period of six months. 2. After the period of suspension, the following conditions are imposed on the practitioner's registration: Restrictions on supply, dispense or compound 1. Must not supply, dispense or compound or allow the supply, dispensing or compounding of any pharmaceutical products containing any of the following at any pharmacy in which the practitioner has a financial interest: 1. Somatropin 2. Testosterone 3. Mesterolone 4. Anastrozole except for an approved indication as specified for that product on the Australian Register of Therapeutic Goods. 1. Must not compound or allow the compounding of a medicine (whether prescribed or not) at any pharmacy in which the practitioner has a financial interest that would be a close formulation to an available and suitable commercial product where it is unlikely to produce a different therapeutic outcome to the commercial product. 2. Mr Ashour is to accept an auditor appointed by the Pharmacy Council of NSW (the Auditor) with the first audit or risk assessment to occur within 6 months and thereafter annually for a further 2 years. 3. The Auditor is to conduct his or her audits into the supply, dispensing or compounding of Schedule 4B drugs, somatropin and anastrozole. 4. The audits are to be provided to the Council. 5. Mr Ashour is to meet the costs of the audits. Mentoring 1. Mr Ashour is to undergo mentoring by an experienced pharmacist approved by the Council for a period of 12 months or for any further period as determined by Council and at the frequency and terms determined by Council. 1. Mr Ashour is to provide to the mentor approved by Council a copy of the Tribunal's decision and reasons of the proceedings. 2. Mr Ashour is to provide a mentoring plan to the Council for approval. 3. At each meeting Mr Ashour is to review and discuss his practice with his approved mentor with a particular focus on: 1. Management of his pharmacy practice 2. Duties and responsibilities as a proprietor pharmacist 3. Supervision of pharmacy staff 4. Legal requirements regarding compounding 5. Adequacies of policies and procedures 6. Compliance with his obligations under the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW) 1. Mr Ashour is to authorise the mentor to provide reports at the frequency determined by Council and at the conclusion of the mentoring period to Council about his professional conduct. 2. Mr Ashour is to meet all costs associated with the mentoring conditions. Education 1. Mr Ashour is required to complete a course focusing on "complex compounding" as defined by the Australian Pharmaceutical Formulary Handbook 25, as approved by the Council: 1. Within 4 weeks of completing the course the practitioner is to provide documentary evidence of completion of the course to the Council. Attendance at pharmacies 1. Mr Ashour is to physically attend each pharmacy at which he is the sole proprietor pharmacist on average once a week for 48 weeks of the calendar year. 2. Mr Ashour is to supply documentary evidence to the Council of the attendances upon request. Review of pharmacies 1. Mr Ashour is to accept the appointment of a person approved by the Council (the Reviewer) to conduct a review of the current policies of each pharmacy in which he is a proprietor pharmacist within 3 months. 2. Mr Ashour is to implement any proposed changes suggested by Reviewer. Annexure A IN THE CIVIL AND ADMINISTRATIVE TRIBUNAL OF NSW OCCUPATIONAL DIVISION HEALTH PRACTITIONER DIVISION LIST NO. Of In the matter of Mr Samer Ashour, a person registered under the Health Practitioner Regulation National Law (NSW) FURTHER AMENDED COMPLAINT The Health Care Complaints Commission of Level 12, 323 Castlereagh Street, Sydney New South Wales, having consulted with the Pharmacy Council of New South Wales 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 Samer Ashour ("the practitioner") of [address omitted], being a pharmacist registered under the National Law, BACKGROUND TO ALL COMPLAINTS The practitioner graduated with a Bachelor of Pharmacy from Charles Sturt University in 2002. The practitioner was first registered as a pharmacist in New South Wales in 2002. The practitioner is the sole proprietor of Kingswood Compounding Pharmacy ("the Pharmacy") since June 2005. The practitioner was the proprietor of four other pharmacies in New South Wales being: • Pharmacy4Less in Blacksmith, from July 2007. • Mediadvice Pharmacy in Georgetown, from December 2007. • Woodrising Compounding Pharmacy in Woodrising, from July 2011. • Ryde Compounding Pharmacy in Ryde, from August 2012. COMPLAINT ONE The practitioner is guilty of unsatisfactory professional conduct under section 139B(1)(a) of the National Law in that the practitioner has: i. engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. PARTICULARS OF COMPLAINT ONE 1. Between 14 August 2015 and 15 May 2017, the practitioner failed to ensure that the Pharmacy dispensing records for the supply of Schedule 4 restricted substances complied with clause 55(1)(d) of the Poisons and Therapeutic Goods Regulation (PTGR), as outlined in the table below, in that the Pharmacy's dispensing records did not record the details of the dispensing pharmacist. DATE QUANTITY DRUG 3 November 2016 – 15 May 2017 7 Phentermine 14 August 2015 1 Anastrazole (to a male) 27 May 2016 – 27 April 2017 6 Somatropin (Human Growth Hormone) 15 September 2015 – 21 April 2017 53 Testosterone 2. Between 14 August 2015 and 15 May 2017, the practitioner failed to ensure that the Pharmacy dispensing records for the supply of Schedule 4 restricted substances complied with the Pharmacy Board of Australia 'Guidelines for dispensing medicine' (2015) and the Pharmacy Board of Australia 'Guidelines for Dispensing Medicines (2010)', in relation to the period before 7 December 2015, as outlined in the table above at particular 1, in that the Pharmacy's dispensing records did not record the details of the dispensing pharmacist. 3. Between 16 September 2015 and 26 May 2017, the practitioner failed to ensure that the Pharmacy dispensing records for the supply of Schedule 8 drugs of addiction complied with the Pharmacy Board of Australia 'Guidelines for dispensing medicine' (2015) and the Pharmacy Board of Australia 'Guidelines for Dispensing Medicines (2010)', in relation to the period before 7 December 2015 as outlined in the table below, in that the Pharmacy's dispensing records did not record the details of the dispensing pharmacist. DATE QUANTITY DRUG 16 September 2015 – 22 May 2017 3 Ketamine 26 May 2017 1 Dexamphetamine 1 March 2017 1 Fentanyl 1 March 2017 and 28 April 2017 2 Alprazolam 4. The conduct as set out in particulars 1, 2 and 3 above demonstrates a failure of the practitioner to maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted with respect to the Pharmacy's dispensing records and a failure to intervene when necessary, contrary to the Australian Guidelines for Proprietor Pharmacists. COMPLAINT TWO The practitioner is guilty of unsatisfactory professional conduct under section 139B(1)(a) of the National Law in that the practitioner has: i. engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. PARTICULARS OF COMPLAINT TWO Patient A 1. Between 3 February 2016 and 24 July 2017, the practitioner failed to ensure that his employed pharmacists at the Pharmacy undertook the following tasks when dispensing the Schedule 4 restricted substance Somatropin (Human Growth Hormone) to Patient A on the dates and in the quantities as set out in Schedule A: a. document their contact with the prescriber for the prescription for an off-label purpose for an interstate patient; b. document their reason for supplying this medication to an adult patient; c. document the therapeutic basis for the supply, quantity or interval of dispensing. 2. Between 3 February 2016 and 24 July 2017, with respect to the dispensing of Somatropin (Human Growth Hormone) to Patient A on the dates and in the quantities as set out in Schedule A, the practitioner failed to: a. develop and implement policies and protocols at the Pharmacy to support safe and appropriate dispensing and recording practices; b. monitor his employed pharmacists in their adherence to policies and procedures; c. exercise appropriate oversight of the employed pharmacists as the proprietor pharmacist. 3. Between 3 February 2016 and 24 July 2017, with respect to the dispensing of Somatropin (Human Growth Hormone) to Patient A on the dates and in the quantities as set out in Schedule A, the practitioner failed to discharge his obligations as the proprietor of the Pharmacy by failing to maintain an awareness of the manner in which the Pharmacy's dispensing practice was being conducted with respect to not appropriately documenting the rationale for dispensing, and failed to intervene when necessary, contrary to the Australian Guidelines for Proprietor Pharmacists. Patient B 4. Between 7 October 2016 and 24 January 2017, the practitioner failed to ensure that his employed pharmacists at the Pharmacy undertook the following tasks when dispensing the Schedule 4 restricted substance Primoteston Depot (Testosterone) to Patient B in on the dates and in the quantities as set out in Schedule B: a. document the reason for dispensing medication when the prescribing doctors' directions for use and dose (one vial per week) were inconsistent with the manufacturer's directions for use (one vial per 3 – 4 weeks); b. document the reason for the dispensing of multiple repeats; c. document their contact with the prescribing doctor regarding the safety of the prescribed dosage. 5. Between 7 October 2016 and 24 January 2017, with respect to the dispensing of Primoteston Depot (Testosterone) to Patient B on the dates and in the quantities as set out in Schedule B, the practitioner failed to: a. develop and implement policies and protocols at the Pharmacy to support safe and appropriate dispensing and recording practices; b. monitor his employed pharmacists in their adherence to policies and procedures; c. exercise appropriate oversight of the employed pharmacists as the proprietor pharmacist. 6. Between 7 October 2016 and 24 January 2017, with respect to the dispensing of Primoteston Depot (Testosterone) to Patient B on the dates and in the quantities as set out in Schedule B, the practitioner failed to discharge his obligations as the proprietor of the Pharmacy by failing to maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted with respect to not documenting the rationale for dispensing, and failed to intervene when necessary, contrary to the Australian Guidelines for Proprietor Pharmacists. 7. Between 7 October 2016 and 24 January 2017, the practitioner failed to ensure that his employed pharmacists at the Pharmacy undertook the following tasks when dispensing the Schedule 4 restricted substance Proviron (Mesterolone) (androgen and anabolic steroid) to Patient B on the dates and in the quantities as set out in Schedule C: a. document the contact made with the prescribing doctor regarding the safety of the prescribed dosage. 8. Between 7 October 2016 and 24 January 2017, with respect to the dispensing of Proviron (Mesterolone) (androgen and anabolic steroid) to Patient B on the dates and in the quantities as set out in Schedule C, the practitioner failed to: a. develop and implement policies and protocols at the Pharmacy to support safe and appropriate dispensing and recording practices; b. monitor his employed pharmacists in their adherence to policies and procedures; c. exercise appropriate oversight of the employed pharmacists as the proprietor pharmacist. 9. Between 7 October 2016 and 24 January 2017, with respect to the dispensing of Proviron (Mesterolone) (androgen and anabolic steroid) to Patient B on the dates and in the quantities as set out in Schedule C, the practitioner failed to discharge his obligations as the proprietor of the Pharmacy by failing to maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted with respect to appropriately documenting the rationale for dispensing, and failed to intervene when necessary, contrary to the Australian Guidelines for Proprietor Pharmacists. Patient C 10. On 28 April 2016 and 27 June 2016, the practitioner failed to ensure that his employed pharmacists undertook the following tasks when dispensing the Schedule 4 restricted substance Somatropin (Human Growth Hormone) to Patient C on the dates and in the quantities as set out in Schedule A: a. document the reason why the amount dispensed (eleven vials for each two month period) does not accord with recognised therapeutic standards of what is appropriate in breach of cl 54 of the PTGR. 11. On 28 April 2016 and 27 June 2016, with respect to the dispensing of Somatropin (Human Growth Hormone) to Patient C on the dates and in the quantities as set out in Schedule A the practitioner failed to: a. develop and implement policies and protocols at the Pharmacy to support safe and appropriate dispensing and recording practices; b. monitor his employed pharmacists in their adherence to policies and procedures; c. exercise appropriate oversight of the employed pharmacists as the proprietor pharmacist. 12. On 28 April 2016 and 27 June 2016, with respect to the dispensing of Somatropin (Human Growth Hormone) to Patient C on the dates and in the quantities as set out in Schedule A, the practitioner failed to discharge his obligations as the proprietor of the Pharmacy by failing to maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted with respect to appropriately documenting the rationale for dispensing, and failed to intervene when necessary, contrary to the Australian Guidelines for Proprietor Pharmacists. Patient D 13. On 16 August 2016, 24 November 2016 and 29 December 2016, with respect to the dispensing of the Schedule 4 restricted substance Norditropin Flexpro (Somatropin) (Human Growth Hormone) to Patient D on the dates and in the quantities as set out in Schedule A the practitioner failed to: a. develop and implement policies and protocols at the Pharmacy to support safe and appropriate dispensing and recording practices; b. monitor his employed pharmacists in their adherence to policies and procedures; c. exercise appropriate oversight of the employed pharmacists as the proprietor pharmacist. 14. On 16 August 2016, 24 November 2016 and 29 December 2016, with respect to the dispensing of the Schedule 4 restricted substance Norditropin Flexpro (Somatropin) (Human Growth Hormone) to Patient D on the dates and in the quantities as set out in Schedule A, the practitioner failed to discharge his obligations as the proprietor of the Pharmacy by failing to maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted with respect to appropriately documenting the rationale for dispensing, and failed to intervene when necessary, contrary to the Australian Guidelines for Proprietor Pharmacists. Patient E 15. On 27 May 2016, 12 October 2016 and 31 January 2017, with respect to the dispensing of the Schedule 4 restricted substance Genotropin GoQuick (Somatropin) (Human Growth Hormone) to Patient E on the dates and in the quantities as set out in Schedule A, the practitioner failed to: a. develop and implement policies and protocols at the Pharmacy to support safe and appropriate dispensing and recording practices; b. monitor his employed pharmacists in their adherence to policies and procedures; c. exercise appropriate oversight of the employed pharmacists as the proprietor pharmacist. 16. On 27 May 2016, 12 October 2016 and 31 January 2017, with respect to the dispensing of the Schedule 4 restricted substance Genotropin GoQuick (Somatropin) (Human Growth Hormone) to Patient E on the dates and in the quantities as set out in Schedule A, the practitioner failed to discharge his obligations as the proprietor of the Pharmacy by failing to maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted with respect to appropriately documenting the rationale for dispensing, and failed to intervene when necessary, contrary to the Australian Guidelines for Proprietor Pharmacists. When two or more of the particulars of Complaint Two are taken together they amount to unsatisfactory professional conduct. COMPLAINT THREE The practitioner is guilty of unsatisfactory professional conduct under section 139B(1)(a) of the National Law in that the practitioner has: i. engaged in conduct that demonstrates the knowledge or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. PARTICULARS OF COMPLAINT THREE 1. Between 1 January 2016 and 11 May 2017, the practitioner failed to ensure that his employed pharmacists at the Pharmacy undertook the following tasks when dispensing the Schedule 4 restricted substance Tadalafil (erectile dysfunction medication) on 238 occasions to multiple patients as set out in Tab 79 of the documents upon which the Commission relies: a. contact the prescriber to discuss the clinical indications for compounding when the Australian Register of Therapeutic Goods listed product (Cialis) was commercially available; b. document the clinical indication or reason for justifying the compounding of this drug which was commercially available. 2. Between 1 January 2016 and 11 May 2017, with respect to the dispensing of Tadalafil (erectile dysfunction medication) at the Pharmacy on 238 occasions to multiple patients as set out in Tab 79 of the documents upon which the Commission relies the practitioner failed to ensure that: a. adequate systems were in place to guide and monitor the compliance of his employed pharmacists when compounding; b. his employed pharmacists completed an adequate risk assessment and evaluation when compounding and dispensing prescriptions, including contacting the prescriber and documenting the discussions; c. the dispensing and compounding was not in breach of Code 2 of the Pharmaceutical Board of Australia's 'Guidelines on Compounding Medicines'. 3. Between 31 October 2016 and 15 May 2017, with respect to the dispensing and compounding of Phentermine at the Pharmacy on 9 10 occasions on the dates and in the quantities as set out in Schedule D the practitioner failed to ensure that: a. adequate systems were in place to guide and monitor the compliance of his employed pharmacists when compounding; b. his employed pharmacists completed an adequate risk assessment and evaluation when compounding and dispensing prescriptions, including contacting the prescriber and documenting the discussions. Compounding and dispensing Hepatitis C anti-viral drugs 4. Between 1 January 2016 and 11 May 2017, with respect to the dispensing and compounding of Hepatitis C anti-viral drugs Harvoni (Sofosbuvir 400mg/Ledipasvir 90mg), Sovaldi 400mg (Sofosbuvir) lbavyne 200mg (Ribavirin) and Daklinza 60mg (Daclatasvir) at the Pharmacy on 223 occasions as set out in Tab 71 of the documents upon which the Commission relies the practitioner failed to ensure that: a. adequate systems were in place to guide and monitor the compliance of his employed pharmacists when compounding; b. his employed pharmacists completed an adequate risk assessment and evaluation when compounding and dispensing prescriptions, including contacting the prescriber and documenting the discussions. COMPLAINT FOUR The practitioner is guilty of professional misconduct under section 139E of the National Law in that the practitioner has: i. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration, and/or ii. engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioner's registration. PARTICULARS OF COMPLAINT FOUR 1. Each particular of Complaint 1 to 3 justifies a finding of professional misconduct. 2. In the alternative, when two or more of the particulars of Complaint 1 - 3 are taken together, a finding of professional [The annexures to the Complaint are omitted because they identify the patients the subject of the Complaint] ********** Endnotes 1. Since 1 July 2016, the proclamation of the Poisons List has been by reference to the Commonwealth Poisons Standard as in force from time to time. Before that time, a Poisons List was separately proclaimed in NSW, but advice from the NSW Health Pharmaceutical Regulatory Unit is that at least from 17 August 2015, it relevantly reflected the Commonwealth Poisons Standard. 2. Affidavit, Samer Ashour, 12 December 2020, Annexure D. 3. Transcript of Proceedings, p 170(5-30). 4. Transcript of Proceedings, 28 April 2021, pp 184(25) – 197(5). I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales. Registrar DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 20 October 2021