Health Care Complaints Commission v Salloum [2025] NSWCATOD 16
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Civil and Administrative Tribunal
New South Wales
Medium Neutral Citation: Health Care Complaints Commission v Salloum [2025] NSWCATOD 16
Hearing dates: 28 – 29 October 2024
Date of orders: 18 February 2025
Decision date: 18 February 2025
Jurisdiction: Occupational Division
Before: A Starke, Senior Member
A Lee, Professional Member
K Carter, Professional Member
M Maher, General Member
Decision: (1) Pursuant to s 149C(1)(b) of the Health Practitioner Regulation National Law (NSW), the respondent's registration as a health practitioner is cancelled, with a non-review period of one year.
(2) Pursuant to clause 13 of Schedule 5D of the Health Practitioner Regulation National Law (NSW), the respondent is to pay the Commission's costs as agreed or assessed in accordance with the applicable costs legislation.
Catchwords: OCCUPATION – Pharmacy – Application for disciplinary findings and orders where practitioner found guilty of unsatisfactory professional conduct within the meaning of s 139B(1)(a) of the Health Practitioner Regulation National Law (NSW) in that the practitioner's practice fell significantly below the standard expected of a practitioner of an equivalent level of training or experience – practitioner found guilty of professional misconduct under s 139E of the Health Practitioner Regulation National Law (NSW) in that the practitioner engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration and engaged in more than one instance of unsatisfactory professional conduct of a sufficiently serious nature to justify cancellation of the practitioner's registration.
Legislation Cited: Civil and Administrative Tribunal Act 2013 (NSW)
Evidence Act 1995 (NSW)
Health Care Complaints Act 1993 (NSW)
Health Practitioner Regulation National Law (NSW)
Poisons and Therapeutic Goods Regulation 2008 (NSW)
Cases Cited: Briginshaw v Briginshaw [1938] HCA 34; 60 CLR 336
Bronze Wing International Pty Ltd v SafeWork NSW [2017] NSWCA 41
Chen v Health Care Complaints Commission [2017] NSWCA 186
Clyne v NSW Bar Association (1960) 104 CLR 186
Director General, Department of Ageing, Disability and Home Care v Lambert [2009] NSWCA 102
Ex parte Tziniolis; Re Medical Practitioners Act (1966) 67 SR (NSW) 448
Gad v Health Care Complaints Commission [2002] NSWCA 411
Gautam v Health Care Complaints Commission [2021] NSWCA 85
HCCC v Brush (No. 2) [2015] NSWCATOD 154
HCCC v CSM [2016] NSWCATOD 125
Health Care Complaints Commission v Ahmad [2015] NSWCATOD 103
Health Care Complaints Commission v Do [2014] NSWCA 307
Health Care Complaints Commission v Elliott [2018] NSWCATOD 47
Health Care Complaints Commission v Elshaimy [2019] NSWCATOD 17
Health Care Complaints Commission v Fearon [2018] NSWCATOD 26
Health Care Complaints Commission v Litchfield [1997] 41 NSWLR 630
Health Care Complaints Commission v Liu [2016] NSWCATOD 133
Health Care Complaints Commission v Meneghetti [2020] NSWCATOD 39
Health Care Complaints Commission v Sadek [2017] NSWCATOD 181
Health Care Complaints Commission v Sadek (No 2) [2018] NSWCATOD 90
Lee v Health Care Complaints Commission [2012] NSWCA 80
Oshlack v Richmond River Council [1998] HCA 11; 193 CLR 72
Prakash v Health Care Complaints Commission [2006] NSWCA 153
Shelley v Nurses & Midwives Tribunal of NSW & Anor [2007] NSWSC 1240
Texts Cited: Pharmacy Board of Australia, Guidelines for dispensing of medicines (issued September 2015).
Pharmacy Board of Australia, Guidelines for proprietor pharmacists (issued September 2015).
NSW Department of Health, Guide to Poisons and Therapeutic Goods Legislation for Pharmacists (TG79/32) (issued June 2015).
Category: Principal judgment
Parties: Health Care Complaints Commission (Applicant)
Amine Abi Salloum (Respondent)
Representation: Counsel:
E Bayley (Health Care Complaints Commission) (Applicant)
S Maybury (Respondent)
Solicitors:
Health Care Complaints Commission (Applicant)
Hall and Wilcox (Respondent)
File Number(s): 2024/00170796
Publication restriction: Pursuant to an order made on 23 May 2024, the disclosure of persons named in Schedule A to the Complaint is prohibited under s 64(1) of the Civil and Administrative Tribunal Act 2013 (NSW).
Note: a reference to the name of a person includes a reference to any information, picture or other material that identifies the person or is likely to lead to the identification of the person.
REASONS FOR DECISION
Introduction and overview
1. This matter concerns an application by the Health Care Complaints Commission (the Commission) under the Health Practitioner Regulation National Law (NSW) (the National Law) for disciplinary findings and orders with respect to a complaint (the Complaint) against the respondent Amine Abi Salloum, a registered pharmacist (the practitioner).
2. The Commission determined to prosecute the Complaint pursuant to s 90B(1) of the Health Care Complaints Act 1993 (NSW) (the HCC Act), alleging that:
1. the practitioner is guilty of unsatisfactory professional conduct within the meaning of s 139B(1)(a) of the National Law (conduct significantly below reasonable standard) with respect to the dispensing of medications concerning nine patients, with particularised grounds for each patient (Complaint One); and
2. the practitioner is guilty of professional misconduct within the meaning of s 139E of the National Law (Complaint Two).
1. The Complaint alleged that the practitioner, in his capacity as a pharmacist or as the proprietor of a pharmacy in Newtown (the Pharmacy), dispensed drugs listed in Schedule 8 (Schedule 8 drugs) of the Poisons and Therapeutic Goods Regulation 2008 (NSW) (the PTGR) and drugs listed in Schedule 4D (Schedule 4D drugs) of the PTGR to various patients on the dates and in the quantities set out in Schedule B to the Complaint. It was alleged that the dispensing of these drugs in the period from 16 April 2020 to 11 April 2022 was contrary to cl 109 of the PTGR in that the drugs were supplied in quantities and/or at intervals that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
2. Further allegations included that:
1. in circumstances where certain prescriptions were defaced and/or appeared to be forged or fraudulently obtained, and contained matters that should make a pharmacist suspicious (referred to as "red flags"), the practitioner failed to contact the purported prescriber to confirm the legitimacy of the prescriptions before dispensing;
2. the practitioner, in his role as proprietor, failed to implement measures such as having policies and procedures in place to reduce the risk of dispensing forged and fraudulent prescriptions;
3. the practitioner, in his role as proprietor, failed to conduct stock checks of buprenorphine and methadone and this was contrary to cl 118(2)(a) of the PTGR, failed to ensure that the Drug Register at the Pharmacy was kept in accordance with the PTGR to detect discrepancies for certain drugs including buprenorphine and methadone, and failed to ensure that the registers did not fall into a negative balance; and
4. the practitioner, in his role as proprietor, failed to report the loss of methadone to the Pharmaceutical Regulatory Unit for 10 entries relating to "spillage", and this was contrary to cl 124 of the PTGR.
1. The Commission relied upon the opinion of an expert Consultant Pharmacist whose credentials and comprehensive report were not challenged by the practitioner, and sought orders to have the practitioner's registration cancelled, with a non-review period of two years.
2. The Commission initially also sought an order prohibiting the practitioner from providing health services for a period of two years but subsequently withdrew that proposed order. The Commission also sought an order for costs.
3. The practitioner filed a Reply to the Commission's Complaint admitting that he is guilty of unsatisfactory professional conduct pursuant to s 139B(1)(a) of the National Law in respect of the particulars to Complaint One (with two exceptions), thereby admitting that his conduct fell significantly below that expected of a practitioner of equivalent training or experience.
4. He also admitted that, when considered together, the allegations in relation to Complaint One are sufficient to constitute professional misconduct pursuant to s 139E of the National Law, for the purpose of Complaint Two.
5. The practitioner's position was that the Tribunal should find each of the allegations proven and that the proven conduct amounted to unsatisfactory professional conduct and professional misconduct. However, the practitioner argued that any protective orders should not include cancellation of his registration, and proposed that a number of conditions be imposed upon his registration.
6. After hearing and considering all the relevant evidence, we find the subject matter of Complaints One and Two to have been proven.
7. We are satisfied that the practitioner's practice of pharmacy fell significantly below the standard reasonably expected under s 139B(1)(a) of the National Law, and that his conduct demonstrably reached the threshold of professional misconduct under s 139E of the National Law.
8. We are also satisfied that his conduct was very serious over an extended period of time and, apart from the practitioner's own assertions that he will not repeat the conduct, there is no independent corroborative evidence to persuade the Tribunal that he is reformed in character and behaviour. Accordingly, for the protection of the public, and for the purpose of deterring other practitioners from engaging in such conduct and thus maintaining public confidence in the profession, anything less than cancellation of his registration would be inadequate.
9. However, acknowledging the practitioner's frank appraisal of his conduct and efforts to educate himself and correct the identified deficiencies in his practice, we consider that a non-review period of two years goes beyond what is reasonably necessary to promote the protective purpose of the National Law. We are of the view that one year is appropriate.
10. This will allow the practitioner the opportunity to further reflect upon his personal circumstances and, in particular, the aspects of his character and behaviour that caused him to fail to exercise his own independent decision-making. In particular, he failed to exercise professional autonomy when assessing and verifying prescriptions for their legitimacy and assessing whether the requested medications accord with the recognised therapeutic standard of what is appropriate in the circumstances.
11. We do not propose to order the practitioner to undergo formal psychological counselling or therapy. However, we strongly recommend that he seeks professional assistance to gain insight into his personal circumstances and develop strategies to put in place as protective factors against lapsing into his previous conduct and behaviour.
12. The non-review period of one year will enable the practitioner to continue with his Continuing Professional Development (CPD) and further consolidate his knowledge of the National Law and the PTGR, his understanding of opioid dependency and misuse, and the risks associated with diversion of dangerous drugs into the black market.
13. At the end of the non-review period, the practitioner will be eligible to seek to be reinstated to practice in the profession, demonstrating his avowed passion to pursue that career path.
14. We also order the practitioner to pay the applicant's costs of these proceedings.
Non-disclosure order
1. The Tribunal made an order on 23 May 2024 under s 64(1) of the Civil and Administrative Act 2013 (NSW) prohibiting the disclosure of the names of any person listed in Schedule A to the Complaint. Accordingly, in these Reasons, the persons named in Schedule A to the Complaint are referred to as 'Patient A', 'Patient B', 'Patient C', 'Patient D', 'Patient E', 'Patient F', 'Patient G', 'Patient H' and 'Patient I'.
Material filed in these proceedings
Filed on behalf of the Commission
1. In support of its application for disciplinary findings and orders filed on 8 May 2024, the Commission relied on the following documents:
1. a bundle of documents filed on 20 August 2024 in two volumes (marked for identification in the Registry file as "Exhibit A1 Volume 1" and "Exhibit A1 Volume 2");
2. a further bundle of documents filed on 18 October 2024 (marked for identification as "Exhibit A2");
3. Amended Complaint filed on 24 October 2024 (marked for identification as "Exhibit A3");
4. Chronology, filed as an aide memoire document on 25 October 2024 (marked for identification as "Exhibit A4");
5. Consolidated dispensing table, also filed as an aide memoire document on 25 October 2024 (marked for identification a "Exhibit A5");
6. Email correspondence on 14 and 15 October 2024 between the Commission and Ms Helen Benson, Consultant Pharmacist, who provided an expert report dated 21 August 2023 which is contained within Exhibit A1 Volume 1 (this later email correspondence was marked for identification as "Exhibit A6");
7. Compliance Policy – Supervision published by the Pharmacy Council of New South Wales (updated November 2017) (marked for identification as "Exhibit A7"); and
8. written submissions dated 29 October 2024 (not marked).
Filed on behalf of the practitioner
1. The following documents were filed on behalf of the practitioner:
1. Reply to the Commission's Complaint, filed on 29 July 2024 (marked for identification as "Exhibit R1");
2. Statement of Amine Abi Salloum dated 29 July 2024 together with a document referred to as 'Annexure A' in the statement, both of which were filed on 23 August 2024 (marked for identification as "Exhibit R2");
3. Schedule of conditions proposed by the applicant to be imposed on his registration subject to the Tribunal's determination of disciplinary orders (marked for identification as "Exhibit R3"); and
4. written outline of submissions dated 29 October 2024 (not marked).
The Complaint
1. The Complaint against the practitioner (comprising Complaint One and Complaint Two) is particularised and is set out in the Schedule to these Reasons.
2. The Complaint attached:
1. a schedule (Schedule A) listing the names of nine patients who have been de-identified and are referred to as Patient A through to and including Patient I;
2. a schedule (Schedule B) setting out the dates on which medications were dispensed, the names of the patients, the name and strength of the medication dispensed, and the quantity dispensed, against the initials of the pharmacist who dispensed the medication; and
3. a schedule (Schedule C) identifying matters considered to be red flags on various prescriptions dispensed in the Pharmacy.
1. The details contained in Schedules B and C to the Complaint are variously referred to in our Reasons.
Issues for the Tribunal to consider and determine
1. Pursuant to s 149 of the National Law, the Tribunal may exercise disciplinary power if it finds the subject matter of the Complaint against the practitioner to have been proved, or he admits to it in writing to the Tribunal.
2. Notwithstanding the practitioner's admissions, the issues for the Tribunal to determine are:
1. whether the conduct as pleaded in Complaint One is proven or admitted in whole or in part;
2. if the conduct in Complaint One is proven or admitted, whether for the purpose of Complaint One, the conduct constitutes "unsatisfactory professional conduct" under s 139B(1)(a) of the National Law;
3. if the conduct in Complaint One is found to constitute "unsatisfactory professional conduct", whether the proven conduct is of a sufficiently serious nature to constitute "professional misconduct", or whether in circumstances where more than one instance of proven unsatisfactory professional conduct, considered together with other instances, amounts to "professional misconduct", under s 139E of the National Law, for the purpose of Complaint Two;
4. whether, and if so in what manner, the Tribunal should exercise its disciplinary powers under Subdivision 6 of the National Law, including:
1. whether to suspend (for a specified period) or cancel the practitioner's registration under s 149C(1)(b),
2. whether to impose a non-review period under s 149C(7) with respect to an order cancelling the practitioner's registration;
1. whether to order the practitioner to pay the Commission's costs of these proceedings.
Background to the proceedings
Family, education and employment history
1. The practitioner is currently 40 years of age, and is married with four children. He came to Australia from Lebanon when he was a child of 2 years of age, and then returned to Lebanon with his family when he was around 8 years old and completed his secondary schooling in Lebanon. He returned to Australia when he was around 17 years of age and decided to embark on a career in pharmacy.
2. After gaining admission at the University of Western Sydney to study Medical Science, he met the woman who was to later become his wife. He was then accepted into University of Sydney to study pharmacy but decided to study at the University of Newcastle, along with his wife who pursued a Bachelor of Public Health and a group of friends. Throughout his university study, the practitioner returned to Sydney on weekends to work part-time.
3. He obtained a Master of Pharmacy in 2010 and relocated to Sydney with his then fiancée to get married. He took on a full-time pharmacy assistant role at a pharmacy in Condell Park and, according to his statement, he enjoyed the pharmacy setting because of the professional relationship with direct customers.
4. After obtaining provisional registration as a pharmacist, the practitioner completed his internship year at the Condell Park pharmacy and became a registered pharmacist on 24 January 2013.
5. He then moved to another pharmacy in Revesby owned by the same proprietor of the Condell Park pharmacy, and was promoted to Pharmacy Manager. He worked between both the Condell Park and Revesby pharmacies, as required.
6. The practitioner and his wife welcomed their first baby in late 2015, a second baby in April 2017, a third in September 2018 and then a fourth child in June 2020.
7. In April 2016, he commenced discussions with the proprietor of the Pharmacy (in Newtown) and settled on his purchase of the business in December 2016.
8. The practitioner's registration as a pharmacist was suspended by the Pharmacy Council of NSW (the Council) on 10 June 2022 (discussed below).
9. The practitioner subsequently sold the Pharmacy in October 2023 and no longer holds any financial interest in any pharmacy business.
Background to the Complaint
1. As part of the audit program conducted by the Ministry of Health NSW on pharmacies and methadone clinics that deliver Opioid Treatment Program (OTP) services, the Pharmacy (in Newtown) where the practitioner was both the pharmacist in charge and proprietor, was inspected by the Pharmaceutical Regulatory Unit (PRU) on 11 April 2022. According to the Ministry's database, the Pharmacy was an active dosing point for 46 patients, 10 of whom were on buprenorphine and 36 on methadone.
2. According to reports obtained from SafeScript NSW, large quantities of oxycodone 80 mg tablets and Fentanyl 100 mcg transdermal patches had been supplied by the Pharmacy.
3. The PRU inspection identified that large numbers of forged prescriptions for Schedule 8 drugs had been dispensed and that there were many examples where large quantities of Schedule 8 opioids and psychostimulants had been supplied in large quantities in single transactions. The inspection also observed the non-compliant storage of drugs of addiction.
4. During the inspection, the practitioner advised that the Pharmacy had only recently experienced an influx of around 15-18 OTP patients and that the Pharmacy was at capacity, unable to take on any new patients for the program. On the day of the inspection, the practitioner was working in the Pharmacy, with an additional pharmacist on duty.
5. When the inspectors arrived at the Pharmacy, they observed that the drug safe was unlocked, with the key left on the door of the safe. The safe was not bolted to the floor. They learned that the key to the drug safe was kept "hidden" in the Pharmacy after hours. They also observed that Schedule 8 drugs of addiction including methadone, buprenorphine, fentanyl and oxycodone were stored in a metal filing cabinet instead of the drug safe. At the time of the inspection, drugs of addiction had been left on the floor in the dispensary and methadone was left on the dispensary bench when not in immediate use.
6. The inspectors seized duplicate Schedule 8 prescriptions and accessed the drug register and dispensing records.
Withdrawal of Schedule 8 Authority
1. The PRU Interim Inspection Report made a number of key findings which were identified to the practitioner in a notification under s 175(1) of the PTGR withdrawing his Schedule 8 drug authority effective from 29 April 2022.
2. The PRU advised the practitioner that under cl 175(1) of the PTGR he was prohibited as a pharmacist from supplying or having possession of, or manufacturing any preparation, admixture, or extract of a drug of addiction as authorised by cll 85, 99, 99A, 101(1) and 102 of the PTGR. The PRU concluded that it was necessary for the purpose of protecting the life, or the physical or mental health, of the practitioner or any other person (whether or not any other such person is identifiable) to withdraw his Schedule 8 drug authority. The Order under cl 175(1) was to remain in force until it was revoked or amended. It is an offence to contravene an Order in force under cl 175(1) of the PTGR.
3. The PRU advised the practitioner of his avenues of appeal, by way of an internal review or application to the Supreme Court of New South Wales. The PRU also advised the practitioner that the Pharmacy Council of NSW (the Council) would be notified of the action taken.
4. We understand that the practitioner did not seek an internal review of the PRU decision and did not apply to the Supreme Court for a review of the withdrawal of his Schedule 8 drug authority.
Council's suspension of registration under s 150 of the National Law
1. On 2 June 2022, the PRU wrote to the Council with the full investigation report of their findings. The report alleged that "Mr Salloum has systematically ignored the regulatory framework in which a pharmacist is expected to operate, including serious non-compliance with the PTGR and expected compliance with professional standards, with the effect that his ongoing poor practice has provided unacceptable risks to the patients concerned and the general community."
2. Under s 150 of the National Law, the Council must, if at any time it is satisfied it is appropriate to do so for the protection of the health or safety of any person or persons, or if satisfied the action is otherwise in the public interest, suspend a health practitioner's registration or impose conditions on the practitioner's registration. Action taken under s 150 is interim in nature pending further review.
3. The Council convened an urgent hearing on 9 June 2022 to consider whether it was appropriate to take action under s 150 of the National Law in respect of the practitioner for the protection of the safety or health of the public or otherwise in the public interest.
4. The practitioner attended the s 150 hearing, with support from his legal representative. He provided a letter dated 8 June 2022 (Submission to the Council), addressing a number of issues identified by the PRU and setting out the remedial action he had taken. Overall, the practitioner acknowledged that his practice as a pharmacist and proprietor of the Pharmacy was deficient and that he had not exercised thorough diligence in dispensing drugs of addiction. He said that he was extremely upset and "in awe" as to how far his practice had fallen short of acceptable standards.
5. During the s 150 hearing, the practitioner acknowledged that, with hindsight, he had not been sufficiently aware of his responsibilities as a pharmacist. With respect to his dispensing of a very large amount of opiates (amounting to an Oral Morphine Equivalent Dose (OMEDD) of 1643 milligrams daily) to Patient A, the practitioner conceded that he was too quick to believe and trust the patient and the doctor.
6. With respect to the dispensing of two and a half years' worth of testosterone in one day to the same patient, the practitioner said he relied on the doctor monitoring the patient who practised body building as a sport. The practitioner said that the illegality of dispensing hormones for body building was not particularly addressed during his university education, and that although he had questioned the prescriptions, he didn't scrutinise them enough and was easily swayed by the pressure from doctors.
7. The Council questioned the practitioner about his knowledge of the abuse of opiates on prescription and the contribution by pharmacists to the illicit drug market. The practitioner's response was that he was not sufficiently aware of the worldwide problem with prescription opiates. He also said that he understood the purpose of the OTP Program but that he didn't know until recently that he should dispense other central nervous system medications along with OTP.
8. The Council was very concerned that it appeared the practitioner had not considered diversion of drugs into the illicit drug market when the "man in the street" would realise that the level of dosing being dispensed in single transactions in this case was well beyond the level of appropriateness.
9. Another matter of concern was that the practitioner admitted that he did not know until shortly before the s 150 hearing that OTP patients were not permitted to be prescribed Schedule 8 or Schedule 4D medications without the knowledge and approval of the authorised OTP prescriber. Due to his lack of knowledge about this restriction, the practitioner had dispensed benzodiazepines and opioids to multiple OTP patients on multiple occasions. This was done in breach of the NSW Opioid Treatment Program Community Pharmacy Dosing Point Protocol.
10. The Council expressed its concern in its written reasons at paragraph 23, that the practitioner's dispensing of other Schedule 8 medications to patients on the OTP program in fact contradicted and worked against the purpose of the program:
"It is extremely concerning to us that Mr Salloum stated that he understands the purpose of the OTP program, which is intended to help people overcome or at the very least manage their dependence, yet he did not realise that taking such medications in addition to their buprenorphine or methadone was completely defeating the purpose."
1. The Council expressed the view that the practitioner's attention was focused on the business aspects of the Pharmacy without consideration of the health and safety of his patients or diversion to the general public via the black market:
"Again, we formed the view that Mr Salloum's [sic] has focused his attention to the business aspects of his pharmacy without any consideration of the health and safety of his patients or indeed the general public who may have gained their supplies of illicit substances from his patients."
1. The practitioner's lack of knowledge of the regulations which are basic to the practice of pharmacy was expressly noted, particularly since many of the regulations he had breached were considered to be matters that were known by the average person on the street:
"We are most concerned that he stated throughout that he didn't know the regulations which are basic to the practice of pharmacy. A newly registered pharmacist is expected to know them and he, as a graduate of 12 years standing, should have been practising in accordance with them, so they are second nature to him."
1. The Council formed the view that the practitioner's actions were considered and deliberate.
2. In explaining his degree of inattention over a period of two years, the practitioner noted that the Pharmacy had been handed over to him in unusual circumstances where the previous proprietor was terminally ill and passed away, and another pharmacist who was supposed to help with the handover process failed to provide even one hour of familiarisation with the Pharmacy. The practitioner said he felt he had been "left in the dark". Further, he noted the impact of the COVID pandemic, as having created a sense of havoc amongst communities, and how doctors were overwhelmed in the circumstances. The practitioner also acknowledged a lack of self-confidence on his part, that he had prematurely trusted a prescriber's authority. He stated that he would address that aspect via his perseverance to want to self-educate and improve by undertaking further learning in pharmacy practices and ethics.
3. The Council decided that the practitioner did not have the required standard of knowledge of pharmacy practice and had not exercised any clinical judgment or shown concern for his patients' health and safety such that he posed a risk to the health and safety of the public. The Council formed the view that the practitioner had, by his conduct, aided and abetted the release of dangerous medications onto the illicit drug market.
4. Further, the Council considered whether suitable conditions could be imposed on the practitioner's registration that might protect the health and safety of the public. However, the Council formed the view that either the practitioner's knowledge of the law was seriously deficient or he had deliberately chosen to ignore it, and thus the imposition of conditions would be insufficient to protect the public. Further, the Council was mindful of the harm that may have been caused to his patients if they were taking medications in the quantities dispensed, or to the general public at large.
5. The Council considered that the egregious nature of the practitioner's behaviour justified the suspension of his registration. Accordingly, under s 150(1)(a) of the National Law, the Council suspended his registration with effect from 10 June 2022.
6. After suspending the practitioner's registration, the Council referred the matter to the Commission for investigation pursuant to s 150D of the National Law.
Commission's investigation and application for disciplinary findings and orders
1. On 3 August 2022, the Commission advised the practitioner that the PRU complaint was to be investigated.
2. In a letter dated 24 August 2022 to the Commission, the practitioner provided his written response to the matters contained in the PRU Final Inspection Report. Again, the practitioner set out the circumstances under which he had acquired the Pharmacy, noting that he felt he had been left "in the deep end from the outset" since the previous proprietor passed away and the primary pharmacist failed to offer even one hour of familiarisation with the Pharmacy, its procedures and customers. The practitioner acknowledged that he had failed to discharge his duty of care to his patients and public health and that he had breached guidelines and regulations. He accepted his suspension as a reflection of serious failings and stated that he intended to reflect and improve on his pharmacy practices.
3. In connection with its investigation, the Commission sought an expert report from Dr Helen Benson who was asked to provide her opinion on the adequacy and appropriateness of the practitioner's oversight as the proprietor of the Pharmacy. Dr Benson was also asked to provide her opinion on the adequacy or appropriateness of the practitioner's supply (as dispensing pharmacist) and/or as proprietor of various Schedule 8, Schedule 4B, Schedule 4D and other drugs to Patients A, B, C, D, E, F, G, H and I. Dr Benson provided her report dated 21 August 2023.
4. On 5 September 2023, the Commission provided a copy of the expert's report to the practitioner and advised that the matter was to be referred to the Director of Proceedings for determination of whether to prosecute a complaint before a professional disciplinary body. The Commission invited the practitioner to make submissions and to comment upon the expert's report.
5. The practitioner provided a written submission dated 3 October 2023.
6. On 8 May 2024 the Commission filed its application for disciplinary findings and orders in the Tribunal with respect to the Complaint.
Relevant statutory provisions and legal principles
Guiding principle and paramount consideration
1. In all matters before it under the National Law, the Tribunal is guided by s 3A which states:
The main guiding principle of the national registration and accreditation scheme is that the protection of the health and safety of the public must be the paramount consideration.
1. Accordingly, when assessing whether it is appropriate to make disciplinary orders against a practitioner, the fundamental and paramount consideration for the Tribunal is the protection of the health and safety of the public.
Orders are intended to be protective and not punitive
1. Orders are made under the National Law for the protection of the public and not for the purpose of punishing the practitioner, as pointed out by the High Court of Australia in the context of the disbarment of a legal practitioner in Clyne v NSW Bar Association (1960) 104 CLR 186 ("Clyne") at 201-202:
"Although it is sometimes referred to as the 'penalty of disbarment' it must be emphasized that a disbarring order is in no sense punitive in character. When such an order is made, it is made, from the public point of view, for the protection of those who require protection, and from the professional point of view, in order that abuse of privilege may not lead to loss of privilege."
1. The decision in Clyne has been adopted in a number of Tribunal decisions including Health Care Complaints Commission v Liu [2016] NSWCATOD 133 ("Liu") at [42] and Health Care Complaints Commission v Meneghetti [2020] NSWCATOD 39 ("Meneghetti") at [97].
2. Although the specific purpose for which orders are made is to be protective of the health and safety of the public, it is acknowledged that such orders may be punitive in their effect, and that punitive effect may be relevant in formulating a protective order: Meneghetti at [98]; Lee v Health Care Complaints Commission [2012] NSWCA 80 ("Lee") at [20] citing Director General, Department of Ageing, Disability and Home Care v Lambert [2009] NSWCA 102; (2009) 74 NSWLR 523 at [83].
3. Indeed, under s 2(c) of s 3A of the National Law, no order should be made which has more serious consequences for the practitioner than is reasonably necessary to promote the protective purpose:
3A Guiding principles [NSW]
…
(2) …
(c) restrictions on the practice of a health profession are to be imposed under the scheme only if it is necessary to ensure health services are provided safely and are of an appropriate quality.
1. As correctly submitted on behalf of the practitioner, protection of the health and safety of the public is not confined to preventing repeat behaviour by the practitioner. Indeed, the protection sought applies more broadly, to protect against similar conduct or incompetence of other practitioners, and to uphold public confidence in the standards of the profession. Meagher JA, with whom Basten and Emmett JJA agreed, discussed these matters in Health Care Complaints Commission v Do [2014] NSWCA 307 at [35]:
"The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar conduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise."
Maintaining ethical and professional standards
1. Protective orders arising from disciplinary proceedings against members of a profession are intended to maintain proper ethical and professional standards, primarily for the protection of the public but also for the protection of the profession: Meneghetti at [98] citing Health Care Complaints Commission v Litchfield [1997] NSWSC 297; (1997) 41 NSWLR 630 ("Litchfield") at 637.
Maintaining public confidence in high standards of a profession
1. Protective orders serve to maintain public confidence in the high standards of the medical profession: Meneghetti at [98] citing Prakash v Health Care Complaints Commission [2006] NSWCA 153 ("Prakash") at [91].
Effect of deterrence
1. Protective orders also involve an element of deterrence, encouraging other practitioners to recognise the importance of complying with professional standards and the risks of failing to do so: Meneghetti at [97] citing Prakash at [91].
Grounds for complaint against registered health practitioners
1. Section 144 of the National Law sets out the grounds on which complaints may be made about a registered health practitioner. Relevantly, for the purpose of this proceeding, it includes "unsatisfactory professional conduct" and "professional misconduct":
(b) Unsatisfactory professional conduct or professional misconduct
A complaint the practitioner has been guilty of unsatisfactory professional conduct or professional misconduct.
Meaning of "unsatisfactory professional conduct"
1. Section 139B(1) of the National Law sets out the meaning of "unsatisfactory professional conduct" of registered health practitioners. It includes a range of conduct and, relevantly for this proceeding, includes in paragraph 139B(1)(a) conduct that is significantly below the reasonable standard:
Conduct significantly below reasonable standard
Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience.
Meaning of "professional misconduct"
1. Under s 139E of the National Law, "professional misconduct" of a registered health practitioner means, for the purpose of this Law:
(a) unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or
(b) more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration.
1. In Chen v Health Care Complaints Commission [2017] NSWCA 186 ("Chen") at [19], the Court of Appeal per Basten JA regarded professional misconduct as merely a category of unsatisfactory professional conduct which is sufficiently serious to justify suspension or cancellation.
Measuring the conduct of the practitioner against reasonable standard
1. The conduct of the practitioner must be measured against what is reasonably expected of a practitioner of an equivalent level of training and experience and by the standard of the profession.
2. In Litchfield, the Court made the following comment at 638:
"The gravity of professional misconduct is not to be measured by reference to the worst cases, but by the extent to which it departs from proper standards. If this is not done there is a risk that the conduct of the delinquents in a profession will indirectly establish the standards applied by the Tribunal."
Powers of the Tribunal if a complaint is proved or admitted
1. If a complaint is proved or admitted, the Tribunal may exercise its disciplinary powers as set out in s 149 of the National Law:
The Tribunal may exercise any power conferred on it by this Subdivision in relation to a registered health practitioner or student if—
(a) it finds the subject-matter of a complaint against the practitioner or student to have been proved; or
(b) the practitioner or student admits to it in writing to the Tribunal.
1. The Tribunal's general powers to suspend or cancel a practitioner's registration are found in s 149C(1) of the National Law as set out below:
(1) The Tribunal may suspend a registered health practitioner's registration for a specified period or cancel the registered health practitioner's registration if the Tribunal is satisfied—
(a) the practitioner is not competent to practise the practitioner's profession; or
(b) the practitioner is guilty of professional misconduct; or
(c) the practitioner has been convicted of or made the subject of a criminal finding for an offence, either in or outside this jurisdiction, and the circumstances of the offence render the practitioner unfit in the public interest to practise the practitioner's profession; or
(d) the practitioner is not a suitable person for registration in the practitioner's profession.
Evaluative process to determine the outcome of each case
1. A number of comparable cases may be said to have achieved outcomes that assist the Tribunal in deciding what protective orders are appropriate. However, when determining the outcome for a health practitioner, each case before the Tribunal must be considered on its own merits and this involves an evaluative judgment to be made having regard to the nature and seriousness of the conduct. This was confirmed by the Court of Appeal in Chen per Basten JA at [20] (with whom Leeming JA agreed):
"There is no category of unsatisfactory professional conduct which is not capable, depending on the circumstances, of giving rise to professional misconduct and hence engaging the power of either suspension or cancellation of registration. The only requirement is that it be 'sufficiently serious' to justify such an order, a characterisation which must depend upon an evaluative judgment made by the Tribunal. Some, perhaps all, categories include conduct which may reveal a defect of character as to which the Tribunal may conclude that the person should not be allowed to practise his or her profession unless at some future date the practitioner is able to satisfy the Tribunal that the defect has been overcome. Incompetence or inadequate care may in some circumstances be remediable by specific steps; in other circumstances the Tribunal may be concerned that the carelessness, for example, is such as to cast doubt on the suitability of the person to practise medicine. Each of the criteria for cancellation or suspension may be analysed in this way. Each case will depend upon an evaluative judgment to be made by the Tribunal as to the nature and seriousness of the conduct."
1. In determining what protective orders are appropriate in each case, the Court of Appeal in Lee set out some of the applicable principles per Barrett JA (with whom Barrett JA agreed) at [34]:
"In cases of the present kind, therefore, this court should proceed on the basis that:
(a) comparison with the outcomes in earlier cases may be useful if those earlier cases show some discernible range or pattern;
(b) such a range or pattern, even when discernible, cannot be regarded as a precedent indicating what is 'correct';
(c) the range or pattern is, at best, a reflection of the accumulated experience and wisdom of decision-makers;
(d) the range or pattern will potentially be of value only if it is possible to gather from it an appreciation of some unifying principle;
(e) since the predominant consideration is the protection of the public, a decision can only be made by reference to the facts of the particular case and by considering what measures are needed to ensure that the future behaviour of the particular practitioner is shaped in a way that is consistent with that protection; and
(f) the Medical Tribunal, as a specialist tribunal, brings special skill and experience to the task of formulating protective orders."
Deciding any non-review period if registration is cancelled
1. When a finding of professional misconduct is made, the Tribunal has discretion to cancel a practitioner's registration and decide the length of any non-review period.
2. It is not necessary to make a finding that the practitioner is probably permanently unfit to practise before registration can be cancelled: Chen per Payne JA at [67]-[69].
3. The Supreme Court in Shelley v Nurses & Midwives Tribunal of NSW & Anor [2007] NSWSC 1240 at [37]-[38] found that in cases where a medical practitioner's registration is cancelled, the non-review period is not determined via an arithmetical process, but through a process of instinctive synthesis using the specialist experience and knowledge of the Tribunal:
"The determination of the period before which the plaintiff will be permitted to reapply for registration involved the weighing by the Tribunal not only of the plaintiff's situation but the obligations to protect the safety of the public, to prevent the recurrence of professional misconduct, to act as a deterrent to other members of the profession and to maintain the profession's standards and public confidence therein. In determining this matter, the Tribunal had the advantage of observing the plaintiff and forming an opinion as to her attitude and demeanour.
The Tribunal's ultimate conclusion is the product of the weighing by it, as a specialist tribunal, of the various factors identified by it in its written reasons. The nature of the weighing process does not lend itself to an arithmetical process. Rather, the process is one of instinctive synthesis in which relevant factors are identified and then weighed as a whole using the specialist experience and knowledge of the Tribunal."
Reformation of character and of behaviour
1. It may be relevant for the Tribunal to consider whether an applicant whose standard of practice has been found to be significantly below the standard reasonably expected, has undergone a reformation of character and behaviour, in order to safely predict that his or her conduct will not be repeated.
2. In Litchfield at 637, the Court of Appeal considered the importance of the medical practitioner in that instance having become a reformed person, making the following observations:
"In cases such as this, the Tribunal and this Court should not assume that the
doctor has become a reformed person. As Walsh JA said in Ex parte Tziniolis;
Re Medical Practitioners Act (1966) 67 SR (NSW) 448 at 461; 84 WN (NSW)
(Pt 2) 275 at 286:
'… Reformations of character and of behaviour can doubtless occur but their occurrence is not the usual but the exceptional thing. One cannot assume that a change has occurred mrely because some years have gone by and it is not proved that anything of a discreditable kind has occurred. If a man has exhibited serious deficiencies in his standards of conduct and his attitudes it must require clear proof to show that some years later he has established himself as a different man."'
Burden of proof and standard of proof
1. The burden of proof rests with the Commission: Gautam v Health Care Complaints Commission [2021] NSWCA 85 at [3].
2. The standard of proof required to establish a complaint is the civil standard, that is, on the balance of probabilities: Liu at [40]. Because of the seriousness of the allegations and the gravity of their consequences, the Tribunal must have "a reasonable satisfaction" that the particulars of a complaint have been proved, as per Dixon J in Briginshaw v Briginshaw [1938] HCA 34; (1938) 60 CLR 336 ("Briginshaw") at 362:
"The seriousness of an allegation made, the inherent unlikelihood of an occurrence of a given description, or the gravity of the consequences flowing from a particular finding are considerations which must affect the answer to the question whether the issue has been proved to the reasonable satisfaction of the tribunal."
1. Section 140 of the Evidence Act 1995 (NSW) provides that matters including the gravity of the matters alleged may be taken into account when making findings of fact. However, under s 38(2) of the Civil and Administrative Tribunal Act 2013 (NSW), the Tribunal is not bound by the rules of evidence. Therefore, strictly speaking, neither the Briginshaw civil standard (having the particulars of a complaint proved to the reasonable satisfaction of the Tribunal) nor s 140 of the Evidence Act 1995 applies directly in decision-making by the Tribunal: Bronze Wing International Pty Ltd v SafeWork NSW [2017] NSWCA 41 at [127].
2. However, as noted in Meneghetti at [13]-[14], the general accepted approach is that when deciding whether the evidence is sufficient to meet the civil standard of proof, the Tribunal will be informed by matters including the seriousness of an allegation and the gravity of the consequences of making the finding.
Relevant provisions under the Poisons and Therapeutic Goods Regulation 2008
Prohibition on supply of a restricted substance
1. Section 54 in the PTGR prohibits the supply of a restricted substance unless it is in accordance with the recognised therapeutic standard of what is appropriate under the circumstances:
54 Quantity and purpose of supply to be appropriate
An authorised practitioner or pharmacist must not supply any restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Maximum penalty—20 penalty units or imprisonment for 6 months, or both.
Prohibition on supply of a drug of addiction
1. Likewise, section 109 in the PTGR prohibits the supply of a drug of addiction unless it is in accordance with the recognised therapeutic standard of what is appropriate under the circumstances:
109 Quantity and purpose of supply to be appropriate
An authorised practitioner or pharmacist must not supply any drug of addiction in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Maximum penalty—20 penalty units or imprisonment for 6 months, or both.
Matters to be included in a prescription for drugs of addiction
1. Section 80 of the PTGR sets out the matters to be included in a prescription for a drug of addiction, as set out below:
80 Form of prescription
(1) A person who issues a prescription for a drug of addiction must ensure that the prescription includes the following details—
(a) the date on which it is issued,
(b) the name, date of birth and address of the patient or (if the treatment is for an animal) the species of animal and the name and address of the animal's owner,
(c) the name, strength and quantity (expressed in both words and figures) of the drug to be supplied,
(d) adequate directions for use,
(e) the maximum number of times the drug may be supplied on the prescription,
(f) the intervals at which the drug may be supplied on the prescription,
(g) if the prescription is issued at a hospital, the name and designation of the person by whom it is issued and the name, address and telephone number of the hospital,
(h) if the prescription is issued elsewhere than at a hospital, the name and designation of the person by whom it is issued and the address and telephone number of the premises at which it is issued,
(i) if the drug of addiction is a type A drug of addiction and the person holds an authority to issue the prescription under section 29 of the Act or Part 8 of this Regulation, the reference number of the authority.
(2) The details referred to in subclause (1)(a)–(f) must be made out—
(a) in the handwriting of the person by whom the prescription is issued, or
(b) in such other manner as may be approved for the time being by the Secretary,
and the prescription must be signed by the person by whom it is issued.
(3) The person by whom the prescription is issued must confirm any dose that could be regarded as being dangerous or unusual by underlining the part of the prescription that specifies the intended dose and by initialling the prescription in the margin.
(4) A person must not issue a prescription that includes—
(a) more than one preparation containing a drug of addiction, or
(b) both a preparation containing a drug of addiction and another preparation.
…
Maximum penalty—20 penalty units.
1. Section 85 permits a pharmacist to supply a drug of addition on prescription if the prescription is in the form required under cl 80, and is set out below:
85 Pharmacists may supply drugs of addiction on prescription
(1) A pharmacist may supply a drug of addiction on prescription if the prescription is in the form required by Division 3.
(2) This clause does not prevent a pharmacist from supplying a drug of addiction on prescription merely because—
(a) the prescription fails to specify the maximum number of times the drug may be supplied, or
(b) the prescription fails to specify the intervals at which the drug may be supplied, or
(c) the prescription fails to specify the patient's date of birth.
(3) A pharmacist must not supply a drug of addiction on a prescription referred to in subclause (2)(a) or (b) if it appears to the pharmacist that the drug has previously been supplied on the prescription, regardless of how many times the prescription purports to authorise the supply of the drug.
(4) The Secretary may, by order in writing, exempt any person or drug, or any class of persons or drugs, from any or all of the requirements of this clause.
(5) Such an exemption may be given unconditionally or subject to conditions.
Maximum penalty—20 penalty units.
Matters to be verified before supplying a drug of addiction
1. Section 87 of the PTGR sets out the matters that a pharmacist must verify with respect to a prescription before supplying a drug of addiction, except where the pharmacist is otherwise authorised to supply in a quantity sufficient for no more than 2 days' treatment:
87 Prescriptions require verification
(1) A pharmacist must not supply a drug of addiction on prescription unless he or she—
(a) is familiar with the handwriting of the person who issued the prescription, or
(b) knows the person for whom the drug is prescribed, or
(c) has verified that the person who is purported to have issued the prescription has actually issued the prescription.
(2) This clause does not prevent a pharmacist who is otherwise authorised to supply drugs of addiction from supplying a drug of addiction on prescription in a quantity sufficient for no more than 2 days' treatment.
Maximum penalty—20 penalty units.
Prohibition on supply if prescription illegible or defaced or appears to be forged or fraudulently obtained or appears to have been altered
1. Sections 40(1)(d), (e) and (f) of the PTGR provide that pharmacists must not supply Schedule 4D drugs if the prescription is illegible or defaced, or the prescription appears to be forged or fraudulently obtained, or the prescription appears to have been altered otherwise than by the authorised prescriber:
40 Certain prescriptions not to be filled
(1) A pharmacist must not supply a restricted substance on prescription—
(a) …
(b) …
(c) …
(d) if the prescription is illegible or defaced, or
(e) if the prescription appears to have been forged or fraudulently obtained, or
(f) if the prescription appears to have been altered otherwise than by the authorised practitioner by whom it was issued, or …
Notifying police of forged, fraudulently obtained or altered prescriptions
1. Section 40(2) of the PTGR provides that a pharmacist who is asked to supply a restricted substance on a prescription which appears to be forged or fraudulently obtained, or appears to have been altered by a person other than the prescriber must retain the prescription and notify the police of the matter:
(2) Immediately on being requested to supply a prescribed restricted substance in either of the circumstances referred to in subclause (1)(e) or (f), a pharmacist must retain the prescription and cause notice of the request to be given to a police officer.
Maximum penalty—15 penalty units.
Compulsory stock checks of drugs of addiction
1. The relevant provisions in the PTGR mandating that stock checks of drugs of addiction are to be undertaken in March and September of each year are set out below:
118 Periodical inventory of stock of drugs of addiction
(1) The person responsible for maintaining a drug register at any place—
(a) must, during the prescribed periods, make an accurate inventory of all drugs of addiction at that place, and
(b) must endorse the relevant drug register, immediately under the last entry for each drug of addiction, with the quantity of each drug of addiction actually held and the date on which the inventory was made, and
(c) must sign each entry.
(2) The prescribed periods for the purposes of subclause (1)(a) are—
(a) March and September each year, or
(b) if the Secretary determines some other periods, either generally or in specified circumstances, the periods so determined.
Immediate notification if drugs of addiction lost or stolen
1. Section 124 of the PTGR requires the loss or theft of a drug of addiction to be immediately notified to the Secretary of NSW Health:
124 Loss or theft of drugs of addiction
A person who is authorised to be in possession of drugs of addiction must immediately notify the Secretary if the person loses a drug of addiction or if a drug of addiction is stolen from the person.
Maximum penalty—20 penalty units.
Use of approved standards, codes or guidelines in disciplinary proceedings
1. Under s 41 of the National Law, an approved code or guideline approved by a National Board is admissible in disciplinary proceedings.
2. There are a number of relevant guidelines that apply to the practice of pharmacy, including:
1. Guidelines for Dispensing of Medicines developed by the Pharmacy Board of Australia, issued in September 2015 (Dispensing Guidelines);
2. Guidelines for Proprietor Pharmacists also developed by the Pharmacy Board of Australia, issued in September 2015 (Proprietor Pharmacist Guidelines);
3. Guide to Poisons and Therapeutic Goods Legislation for Pharmacists (Ref TG79/32), issued by the NSW Department of Health in June 2015 (PTGR Guide).
1. The Dispensing Guidelines were developed by the Pharmacy Board of Australia under s 39 of the National Law, to provide guidance to pharmacists in relation to the dispensing of medicines, not set out in the legislation or a registration standard. The Guidelines specifically state that they can be used in disciplinary proceedings under the National Law as evidence of what constitutes appropriate professional conduct or practice for pharmacists. The dispensing process is comprehensively dealt with in Guideline 1 as set out below:
"The pharmacist should ensure that the prescription is valid, that the medicine is clinically appropriate for the patient, and that information is provided to ensure safe and appropriate use of the medicine.
The process of dispensing includes:
a) receiving a prescription
b) ascertaining the authority of the prescriber to prescribe
c) obtaining any supplementary information to enable:
i. the patient to be properly identified so the medicine is dispensed to the person for whom it is intended, and
ii. the medicine to be dispensed safely
d) determining the prescriber's intentions as to the patient's medicine, including the dosing instructions
e) reviewing the medication history and other relevant patient information, to ensure that the medicine is safe and proper for the patient to use and that where possible, all other relevant considerations of the patient's health, including the use of any other prescription and non-prescription medicine such as complementary and alternative medicine are taken into account
f) entering the prescription details on the pharmacy computer and recording any other aspect of the dispensing according to the requirements of the law
…
k) Carefully checking and re-checking all dispensing for accuracy and completeness
l) Counselling the patient, or the patient's agent, sufficiently to allow a proper understanding of all the information required by the patient to use the medicine safely and effectively and to motivate the patient to comply with that advice (which may include provision of printed supplementary information when required), and to allow for a final check of the dispensed medicine
m) Ensuring that the entire dispensing process has been carried out according to good pharmacy practice, and accepting that responsibility by placing his or her initials or signature in the prescription records of the pharmacy and any other place according to relevant legislation."
1. Guideline 2 of the Dispensing Guidelines refers to the pharmacist's obligation to exercise independent judgment to ensure the prescribed medicine is safe and appropriate for the patient, as set out below (emphasis added):
In dispensing a prescription, a pharmacist has to exercise an independent judgement to ensure the medicine is safe and appropriate for the patient, as well as that it conforms to the prescriber's intentions. Where clarification is required, the patient or their agent should be consulted and if necessary, the prescriber contacted.
Good practice involves seeking consent from patients before disclosing information, where practicable … If the prescriber cannot be contacted, or if on consultation with the prescriber there is a difference in opinion regarding the safety of the prescription, professional judgment must be exercised by the pharmacist in deciding appropriate action to take.
At all times the dispensing of a prescription or any other action taken by the pharmacist, must be consistent with the safety of the patient …
In conforming to the above principle, dose, frequency and route of administration, duration of treatment, the presence or absence of other medicines, the patient's illness, medication history, allergies, and other relevant circumstances need to be taken into account. When this information is collected by the pharmacist, relevant details should be recorded in the dispensing record, and where possible in the patient's health record, so that the safety of any future medicines that are prescribed an/or dispensed for that patient can also be assessed.
1. The Proprietor Pharmacist Guidelines provide guidance to pharmacists in relation to the professional responsibilities of pharmacy proprietors, not set out in the legislation or a registration standard. These Guidelines focus on the professional responsibilities of proprietor pharmacists that impact on the safe, effective delivery of services to the public. In essence, there are three key guidelines:
1. Proprietors are to vigilantly maintain an active interest in how the pharmacy business is conducted, to ensure the pharmacy operation is in accordance with:
1. any applicable state, territory or Commonwealth law;
2. relevant Pharmacy Board of Australia policies, codes and guidelines;
3. applicable professional practice and quality-assurance standards and guidelines; and
4. good pharmacy practice.
1. Proprietor pharmacists cannot delegate their professional obligations;
2. Responsibilities of proprietor pharmacists include:
1. ensuring the pharmacy business is conducted properly and includes ensuring appropriate risk management procedures are in place for the operation of the pharmacy, including all types of services delivered at that pharmacy;
2. ensuring that their employed pharmacists have ready access to the list of essential references specified by the Board;
3. ensuring compliance with any state or territory legislation regarding facilities and equipment required for the types of services delivered at the pharmacy;
4. maintaining an awareness of and responsibility for the services being provided including unregulated services, and goods being sold, particularly those known to be subject to abuse or misuse and those not regulated through the Therapeutic Goods Administration or the pharmacy premises registering authorities;
5. ensuring that business procedures, policies and protocols are developed, implemented and routinely followed for all services developed at the pharmacy.
1. The Proprietor Pharmacist Guidelines specifically refer to the vigilance required of proprietor pharmacists to be on-site and attend staff meetings:
"The vigilance of the practice described in these guidelines includes on-site visits and attendance at staff meetings at a frequency that ensures that the proprietor is able to fulfill the above responsibilities at all times."
1. The PTGR Guide provides specific guidance on a diverse range of issues for pharmacists including, relevantly for this case, the matters that must be included in prescriptions (including for restricted substances, drugs of addiction and anabolic steroids):
1. The matters that must be included in prescriptions (unless it is computer generated in which case it only requires the signature to be in the prescriber's handwriting) such as:
1. the date on which it is issued;
2. the patient's name and address;
3. the name, strength and quantity of the restricted substance;
4. the number of repeats (noting that some prescriptions require repeat intervals);
5. adequate directions for use.
Anabolic steroids
1. Where anabolic steroids are prescribed, the prescription must also include the name of the prescriber (as registered to practice in Australia) and designation; the address and telephone number of the premises at which the prescription is issued.
Restricted substances
1. With respect to restricted substances, cl 4.4 of the PTGR Guide provides (emphasis added):
A prescription for a restricted substance may NOT be dispensed if:
a) it is not correctly written as indicated in clause 4.3;
b) it is more than 12 months old (6 months if the drug is listed in Appendix D to the Regulation)
c) it is marked "cancelled" or all of the repeats have been dispensed;
d) where an interval for repeat is shown, the prescription is presented for dispensing at a shorter interval. Where a prescription bears no repeat instructions or does not clearly indicate the number of repeats ordered, it may be dispensed once only, then cancelled.
e) it is illegible or defaced (our emphasis);
f) it appears to have been altered otherwise than by the prescriber (our emphasis);
g) it appears to have been forged or fraudulently obtained (our emphasis).
1. Also with respect to restricted substances, the pharmacist has obligations to properly record the dispensing:
The person dispensing a prescription for a restricted substance must:
a) make a full record of the prescription in an approved recording system…, and give it a prescription number;
b) stamp or write on the prescription the pharmacy name and address, the prescription record number and the date dispensed;
c) cancel the prescription on last dispensing;
d) retain the record specified in (a) for not less than two years.
Schedule 8 medications
1. With respect to Schedule 8 medications, these must be written on a separate prescription form and no other preparation may be written on the same form. Further requirements are set out in cl 8.8, which states that a prescription must include in ink in the prescriber's legible handwriting:
1. date on which it is issued;
2. name and address;
3. name and strength of the drug of addiction;
4. quantity of the drug of addiction in words and figures;
5. maximum number of times the prescription may be dispensed;
6. interval for repeat where repeats are ordered;
7. adequate directions for use; and
8. prescriber's signature.
1. Clause 8.9 sets out the circumstances when drugs of addiction must not be dispensed:
A prescription for a drug of addiction may not be dispensed:
a) if it is not correctly written as indicated [in clause 8.8];
b) if it is more than six months old;
c) if, where repeats are ordered, the specified interval of time has not elapsed;
d) if it is marked "Cancelled" or all the repeats are used up;
e) if it is illegible or defaced;
f) if it is, or appears to be, forged, altered (otherwise than by the prescriber) or fraudulently obtained;
g) if it was written by a person whose authority to prescribe has been withdrawn and it had not been dispensed at least once prior to the date on which the authority was withdrawn
Where a prescription bears no repeat instructions or does not clearly indicate the number of repeats ordered and interval for repeat, it may be dispensed once only, then cancelled and retained.
1. We note, in particular, where a prescription as described in (f) (appears to be forged or altered or fraudulently obtained) or (g) is presented "it must be retained and the police notified" (emphasised in cl 8.9 itself).
2. Clause 8.9 contains further caution about dispensing drugs of addiction, requiring pharmacists to be familiar with the prescriber's handwriting or that they know the person for whom the drug has been prescribed, or has verified with the purported prescriber that the prescription was written by them. Importantly, telephone numbers must be verified as being the legitimate contact details of the purported prescriber:
A prescription for a drug of addiction that meets all of the above requirements may still not be dispensed unless the pharmacist dispensing it:
a) Is familiar with the prescriber's handwriting, or
b) Knows the person for whom the drug has been prescribed, or
c) Has verified with the purported prescriber that the prescription was written by them (care must be taken to ensure that telephone numbers shown on prescriptions are the legitimate contact details of the purported prescriber) (our emphasis).
Storage of drugs of addiction
1. The PTGR Guide also contains guidance on the storage of drugs of addiction, the maintenance of a drug register and stock-checks.
8.4 Storage
A pharmacist must keep all drugs of addiction separate from other goods (other than cash or documents) in a steel safe meeting the specified requirements and fixed to the building. The safe must be kept securely locked when the drugs are not in immediate use and the key kept on the pharmacist's person and not left on the premises overnight.
8.5 Drug Register
All persons engaged in the manufacture, distribution, sale or supply of drugs of addiction must keep a drug register.
…
Records of all transactions must be entered in the register on the day of the transaction It is an offence for a person to make an entry in the register that the person knows to be false or misleading.
Alterations, obliterations or cancellation of entries must not be made in the register. Any mistake may be corrected by a marginal or footnote, initialled and dated.
A separate page of the register must be used for each brand name and each strength of a drug of addiction.
The register must be kept on the premises where the drugs are stored.
The register must be maintained for two years from the date of the last entry and made available for inspection if required…
8.6 Stock-checks
Twice a year, during March and September, every person who is required to keep a drug register must carry out a full stock-check of all drugs of addiction in their possession. Immediately under the last entry on the relevant page they must write the date on which the check was made, the words "Balance on hand", the quantity actually held and must sign the entry. Any person who assumes control of a practice for one month or more must perform a similar stock-check irrespective of the time of the year.
NSW Opioid Treatment Program Community Pharmacy Dosing Point Protocol
1. For completeness, we note that the NSW Health Department prepared a document titled NSW Opioid Treatment Program Community Pharmacy Dosing Point Protocol (Ref TG 201/5) issued in October 2020 for community pharmacists to follow when supplying methadone and buprenorphine preparations under the OTP. Compliance with the protocol is mandatory for all pharmacies participating as a dosing point for the OTP, as was the case for the Pharmacy in which the practitioner was the proprietor and pharmacist in charge.
2. In essence, the legislative requirements for the receipt, storage and supply of methadone and buprenorphine under the OTP are the same as for any other drug of addiction. However, the monitoring and supervisory requirements of the OTP imposes additional obligations. Importantly, the document states that "compliance with the protocol provides proper accountability, minimises the risks associated with the program, and protects the health and safety of patients."
3. In accordance with cl 92 of the PTGR, the maximum number of patients in supervised OTP dosing at any one community pharmacy is 65 (although patients assessed to be stable and are supplied takeaway doses weekly, fortnightly or monthly are not counted toward this limit of 65). The protocol explains that the limit aims to minimise the potential for patients congregating in the vicinity of community pharmacies and contribution to local amenity concerns. Clause 92 of the PTGR is set out below:
92 Supply by pharmacists of liquid methadone or buprenorphine
(1A) Despite clause 85, a pharmacist must not supply methadone in oral liquid form or buprenorphine on prescription for the treatment of drug dependence unless—
(a) the methadone or buprenorphine is supplied at the premises of, and in the course of carrying on the business of, a retail pharmacy, and
(b) the retail pharmacy is located on premises at which a pharmacist is approved to supply pharmaceutical benefits under section 90 of the National Health Act 1953 of the Commonwealth.
Maximum penalty—20 penalty units.
(1) A pharmacist at a retail pharmacy must not, on any particular day, supply any person with methadone in oral liquid form or buprenorphine on a prescription for the treatment of drug dependence if that supply would result in more than 65 persons having been supplied with methadone in oral liquid form or buprenorphine on prescription at that pharmacy on that day.
Maximum penalty—20 penalty units.
(2) For the purposes of subclause (1), if an amount of methadone in oral liquid form or buprenorphine is supplied for consumption on a day other than the day on which it is supplied, the supply of that amount is taken to have occurred on the day on which the amount is to be consumed.
(3) A person is not to be counted for the purposes of subclause (1) if the person is supplied with an amount of methadone in oral liquid form or buprenorphine that is intended to last the person for at least one week and the person is supplied at that pharmacy with either of those drugs no more than once in any 7 day period.
(4) Subclause (1) does not apply to the supply of methadone in oral liquid form or buprenorphine at a pharmacy in accordance with—
(a) an exemption granted under clause 93, or
(b) a licence issued under Division 3 of Part 8.
Consideration
1. Notwithstanding the frank submission made on behalf of the practitioner that the Tribunal should find each of the allegations proven and that the proven conduct amounts to unsatisfactory conduct and professional misconduct, the Tribunal is obliged to make its own findings, and does so.
2. In considering the application, and any protective orders that may be required, our paramount consideration is the protection of the health and safety of the public.
3. In order to assess whether the practitioner's conduct, in the practice of his profession, was significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience, the Tribunal had the benefit of an expert opinion from Ms Nina Benson, an experienced accredited community pharmacist, currently a senior lecturer in pharmacy practice at the University of Technology, Sydney. Ms Benson's report dated 21 August 2023 found that, across a range of allegations, the practitioner's conduct fell below the standard of practising pharmacists and pharmacist proprietors and in most instances, fell significantly below the required standard.
4. The Tribunal accepted Ms Benson as being well qualified to provide her opinion, and the practitioner did not challenge her credentials or the factual basis for her opinion.
5. The expert report was admitted into evidence without objection. The practitioner elected to not require the expert for cross-examination and did not serve any opposing expert evidence.
6. After examining all the relevant evidence, we make the following findings with respect to Complaints 1 and 2.
Complaint One
1. Complaint One is that the practitioner is guilty of unsatisfactory professional conduct under s 139B(1)(a) of the National Law in that he has 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.
2. In summary, Complaint One particularises the allegation of unsatisfactory professional conduct with respect to the dispensing of various medications to Patient A, Patient B, Patient C, Patient D, Patient E, Patient F, Patient G, Patient H and Patient I. Complaint One then particularises the practitioner's conduct with respect to other matters, including the failure to implement appropriate measures to reduce the risk of dispensing forged and fraudulent prescriptions, the failure to ensure that the Drug Register at the Pharmacy was kept in accordance with the PTGR and the failure to ensure the loss of methadone was reported to the PRU.
Practitioner's level of training & experience
1. At the time of the PRU audit, the practitioner had been a registered pharmacist for more than 7 years and had been the proprietor of the Pharmacy for just over 3 years.
2. As the proprietor and pharmacist in charge, the practitioner had access to the dispensing records showing prescriptions previously dispensed by himself and his staff.
3. In written submissions (which were not challenged), the Commission noted that, as a member of the Pharmaceutical Society of Australia ("PSA") and the Pharmacy Guild, the practitioner had access to resources including:
• the dispensing records showing prescriptions previously dispensed by himself or his staff;
• Pharmacy Board of Australia resources including the Dispensing Guidelines and the Proprietor Pharmacist Guidelines;
• the legislation applicable to pharmacists, including the PTGR;
• NSW Health resources, including the PTGR Guide, the NSW Opioid Treatment Program Community Pharmacy Dosing Point Protocol;
• Current medication information (through MIMS) and the Australian Medicines Handbook;
• Various alerts, notifications and newsletter emails from professional organisations including NSW Health, the PBA, the Pharmacy Council, the Pharmacy Guild, the PRU, the PSA and Pharmacy Defence Limited;
• the "Prescriptions reported lost, stolen or forged" table on the PRU website;
• advice from other pharmacists.
1. Under cross-examination, the practitioner acknowledged that he had access to the above resources. He also said that although he thought he was ready to become a proprietor of a pharmacy business, he probably did not do enough reading on a proprietor's obligations beforehand. He knew he was required to have resources available and accessible at the Pharmacy, but conceded that instead of doing an independent assessment, he depended on the previous owner to have put the necessary resources in place.
2. When questioned specifically about some of the resources, the practitioner had no recollection of reading emails from the PRU until the time of the audit in April 2020. Further, he conceded that he was not even sure where the resources (including the PTGR) were located, although he acknowledged that he had access to MIMS, the Australian Medicines Handbook and therapeutic guidelines.
3. His evidence was that his time was consumed by undertaking administrative procedures to make sure the business was being run appropriately. As a result, he conceded that many alerts and emails, including those concerning the abuse of opioids, were not accessed and remained unread.
4. The practitioner's oral evidence was that in 2020 he knew about the clinical side effects of Schedule 8 medications such as oxycodone, alprazolam and fentanyl and the risks of dependency, addiction, overdose or death. However, he said that he was not so aware of the black market for fentanyl.
5. He also said that he knew the risks associated with testosterone, and that it was used recreationally for body building, as an acceptable off-label use under a doctor's management.
Patient A
Practitioner's admissions
1. With respect to Patient A, in his filed Reply to the Complaint, the practitioner admitted paragraphs 1, 2, 3, 4 and 5 of the Particulars. Notwithstanding those admissions, we consider each allegation and make our findings.
Paragraph 1 of Particulars
1. Between 16 April 2020 and 20 October 2021, a period of 18 months, the practitioner dispensed Schedule 8 drugs on 32 occasions and, as proprietor, permitted Schedule 8 drugs to be dispensed on 8 occasions to Patient A in extremely large quantities contrary to cl 109 of the PTGR. The drugs were also dispensed at close intervals contrary to the recognised therapeutic standard (no more than 30 mg of oxycodone per day without specialist support). For example, on 12 November 2020, the practitioner dispensed opioid medication in the form of 520 tablets (280 Oxycontin and 240 oxycodone) to Patient A. Then, 22 days later, on 4 December 2020, the same amount of Oxycontin and oxycodone was dispensed to Patient A again.
Expert opinion
1. In the opinion of Dr Benson, the supply of 2100 Oxycontin 80 mg tablets to Patient A from 16 April 2020 to 4 December 2020 was equivalent to 9 tablets of 720 mg of Oxycontin per day. This was equivalent to 1080 mg of oral morphine per day. Dr Benson found the practitioner's conduct to be significantly below the standard required:
"The supply of 280 Oxycontin 80 mg (10 boxes) and 240 (12 boxes) Endone on the 12 November 2022 is particularly concerning due to the clear risk of patient harm, diversion, and potential harm to the public posed by dispensing such an excessive quantity in a single transaction.
Dispensing this quantity and combination of drugs of addiction to a patient is significantly below the standard required of a practicing pharmacist and is of real concern."
Practitioner's evidence
1. In his submission dated 3 October 2023 to the Commission (s 40 Submissions), the practitioner stated as a general comment:
"I accept that I failed to exercise appropriate independent clinical judgment in relation to the quantity and interval of supply of certain medications supplied to patients identified by the PRU. I similarly accept that my oversight at the Pharmacy failed to identify those same issues in relation to the dispensing of my staff."
1. In the same submission, specifically with respect to Patient A, the practitioner acknowledged that the quantities and combination of drugs of addiction dispensed to Patient A were contrary to cl 109 of the PTGR.
2. In his defence, the practitioner claimed that he had spoken to Patient A's prescribing doctor (Dr Johnson) on several occasions confirming his belief that Patient A did require and could safely tolerate such quantities of medication, and was reassured by Dr Johnson that he was closely monitoring Patient A's health and wellbeing.
3. The practitioner, with the benefit of hindsight, acknowledged in his submission that he had been "too trusting and easily swayed by Dr Johnson's reassurances. I should have exercised my own independent judgment and refused supply".
4. We note that the dates on which the practitioner asserted he had contacted Dr Johnson were not identified in the dispensing notes and, under cross-examination, the practitioner conceded that it was possible he had stopped calling the doctor.
Tribunal findings
1. It is, as submitted by the Commission, inconceivable to this Tribunal that any pharmacist, of equivalent expertise to the practitioner, would consider that dispensing 520 tablets of Oxycontin and oxycodone to one patient on a single day, let alone on the two dates identified, would be in accordance with acceptable therapeutic standards. It defies plausibility that a pharmacist of 7 years' experience, would accept reassurance from a doctor that such a high volume of Schedule 8 medication was within safe clinical practice, given the risk of addiction and overdose.
2. It is also inconceivable, when one considers that Patient A was also being supplied with medication (Suboxone) used to treat opioid addiction, that the practitioner did not turn his mind to the possibility that Patient A may have been heavily addicted to Schedule 8 medications. It is possible that the practitioner was so focussed on the monetary value of transactions that any consideration of the therapeutic guidelines simply fell away or was expunged from the practitioner's consciousness once he relied upon the purported prescriber's reassurances.
3. We find the practitioner failed to exercise his own independent judgment, regardless of whether he had any discussion with the purported prescriber.
4. We find the practitioner's dispensing was unsafe and thereby placed Patient A at risk of overdose or death, as well as members of the general public if, indeed, the Schedule 8 medication was being diverted onto the black market. We find the practitioner's conduct fell significantly below the standard required.
Paragraph 2 of Particulars
1. On the dates and in the quantities set out in Schedule B, between 16 April 2020 and 4 December 2020, the practitioner inappropriately concurrently dispensed to Patient A the medication Suboxone as well as other Schedule 8 drugs in circumstances where the patient was not then registered on the OTP and/or where it would have been reasonable to assume that Patient A was drug dependent.
Expert opinion
1. In Dr Benson's opinion, from the multiple high doses of Schedule 8 drugs and multiple prescribers involved, it would be reasonable to assume that Patient A may have been drug dependent. Patient A was receiving both alprazolam and buprenorphine for longer than eight weeks without confirmation that the prescriber had a NSW Ministry of Health authority. Dr Benson found that the practitioner's conduct in dispensing without requesting proof of the authority to prescribe fell significantly below that required of a practising pharmacist.
Practitioner's evidence
1. The practitioner's evidence was that, at the time, he understood that Suboxone could be prescribed in conjunction with opioid medication if the doctor was in the process of seeking to wean the patient from opioids.
Tribunal findings
1. We find the practitioner had a deficiency in his knowledge and placed too much reliance on the prescribing doctor. The practitioner deferred too easily to the prescriber without consulting with the relevant therapeutic guidelines, and failed to exercise his independent judgment.
2. It would have been reasonable to assume that Patient A, requiring Suboxone medication for the treatment of opioid addiction, was indeed opioid dependant. Whilst the truthfulness of the practitioner's evidence was not challenged, there is a fundamental inconsistency between his statement dated 29 July 2024 to the Tribunal and his acknowledged deficiency in knowledge which is difficult to reconcile. In particular, the practitioner stated in paragraph 5 of his statement that he was "passionate about learning how medications interacted with the human body", yet his lack of knowledge on the effect of opioids, especially when combined with other medications to treat opioid dependency, and his failure to question the prescriptions, struck the panel as a glaring contradiction.
3. We find the practitioner's conduct fell significantly below the required standard.
Paragraph 3 of Particulars
1. On 20 October 2021, the practitioner inappropriately dispensed 28 Oxycontin tablets (80 mg) to Patient A, in circumstances where the patient had been registered on the OTP since 22 June 2021, and had received doses of Suboxone from the Pharmacy on the 10 dates and in the quantities set out in Schedule B to the Complaint. On six of the dates identified, the practitioner had dispensed Suboxone and on the other four dates another staff pharmacist in the employ of the practitioner dispensed the drug.
Expert opinion
1. Dr Benson advised that once Patient A was registered on the OTP, it was not appropriate for the practitioner to concurrently supply Suboxone and other Schedule 8 drugs to the patient. Dr Benson also noted that the supply of Oxycontin 80 mg on 20 October 2021 was dispensed under a separate prescriber to the registered OTP prescriber and there was no evidence provided that each of the prescribers knew of the other prescriber's prescribing activity. This poses a real risk of patient harm and possible diversion of medication. In her opinion, the practitioner's conduct in dispensing Oxycontin to Patient A while registered under the OTP fell significantly below the standard required.
Practitioner's evidence
1. The practitioner acknowledged that it was inappropriate to supply Suboxone to Patient A on 20 October 2021. He asserted that, similar to his lack of knowledge which led him to dispense Suboxone while Patient A was not registered on the OTP, he thought it was ok to dispense that drug with the knowledge of the OTP prescriber. The practitioner acknowledged on 15 May 2023 in a statement to the Commission that he was unable to locate any dispensing notes about any discussions with Patient A's prescribers.
Tribunal findings
1. While the practitioner has conceded his lack of knowledge on the OTP, it is inconceivable that a pharmacist of 7 years' experience with approximately 38 – 40 patients on the OTP, would not know that Suboxone was used to help patients who are dependent on drugs of addiction and that there was a risk that taking Suboxone plus opioid medication was risky.
2. We find the practitioner's conduct in supplying Oxycontin to Patient A, known to the practitioner to be taking Suboxone under the OTP fell significantly below the required standard.
Paragraph 4 of Particulars
1. Between 24 June 2020 and 8 July 2021, the practitioner dispensed to Patient A, drugs listed in Schedule 4D of the PTGR on the dates and quantities set out in Schedule B to the Complaint, contrary to cl 54 of the PTGR, in that the drugs were supplied in a quantity and/or at an interval that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Expert evidence
1. Dr Benson noted that the practitioner dispensed the following quantities of testosterone injections:
1. 135 Sustanon ampoule 250 mg/1mL (in 3 lots, on 4 February, 25 March and 25 November 2021);
2. 117 Primoteston depot solution for injection 250 mg/1mL (on 3 occasions in 2020, on 24 June, 8 September and 17 September 2020; and then on 25 November 2021);
3. 1 Reandron ampoule 1000 mg (on 24 November 2020).
1. Dr Benson opined that if the Primoteston was being supplied in accordance with the recognised therapeutic standard, each ampoule would last the patient between two to three weeks. The single supply of 45 ampoules on 24 June 2020 would last the patient more than 18 months, yet 9 further ampoules were dispensed again in less than 3 months. The supply of 108 ampoules would last the patient four and a half years. Similarly, the supply of 135 Sustenon ampoules, administered once every 2-3 weeks, equated to 5 years' supply. In Dr Benson's opinion, there is no therapeutic reason for a patient to be using both Sustanon and Primoteston at the same time yet high quantities of both were dispensed by the practitioner on 25 November 2021.
2. Supplying these medications in the quantities recorded puts both the patient at significant risk, as well as the general public as a result of diversion.
3. In Dr Benson's opinion, the practitioner's dispensing of these drugs was in "extreme excess" of the recognised therapeutic standard and his conduct fell significantly below the standard required.
Practitioner's evidence
1. The practitioner gave evidence that, to his knowledge and understanding at the time, the use of testosterone and other steroid type products was common in body building and was an acceptable off-label use under a prescriber's management. He also said that he didn't realise at the time that testosterone was being abused by body builders.
2. His evidence was that body builders used much higher doses than the therapeutic use would warrant, and so long as the prescriber was monitoring the patient, it was ok.
3. He acknowledged that it was unusual for a patient who is prescribed opioid medication for pain to also be practising body building.
4. His further evidence was that he had spoken with Patient A's prescriber but didn't think he had to record the conversation at the time. He said he understood the patient was exercising his preference for the sport of body building and that the prescriber was monitoring the patient's physical and mental health.
Tribunal findings
1. Whilst we accept the practitioner gave his evidence without reservation, and apparently held the belief that "off-label" use of testosterone and other steroids was common practice and safe in body building provided patients were being monitored, we find his views to be naive, particularly in circumstances where he had been a practising pharmacist for seven years and the average "man on the street" would have been cautious in light of general public discussion on anabolic steroids.
2. It is well known by the general population that the use of anabolic steroids for body building is illegal. One does not need to be a pharmacist to be privy to that information. Yet the practitioner's explanation to the Council during the s 150 hearing was that he had not realised that supplying testosterone was against the law and he had been reassured by doctors that the patient was under surveillance and being monitored.
3. We wrestled with whether the practitioner was genuinely ignorant about the law or had been insincere about his knowledge on the illegality of using anabolic steroids for body building. Further, we held concerns that his focus on the business value of some transactions may have overwhelmed his professional judgment. We were troubled by an inconsistency in the practitioner's statements about his understanding of the illegality of supplying steroids for body building and the existence of a black market for such products. In the s 150 hearing, he said that the use of steroids was not brought up in his university study and that he had not realised that supplying them for a body building cause was against the law. However, when asked whether he had considered his duty of care to the health of the patient using steroids at that extraordinarily high rate, his answer demonstrates that he knew there was, indeed, a black market for such products:
"I knew at the time that he was using them to body build that quantity I knew would have lasted him a lot less than the two years…
And also, that he [referring to the prescribing doctor] probably thought it would be a better idea for him to be supplied with those resources from a pharmacy rather than from a black market."
1. On balance, we are inclined to conclude that the practitioner was indeed more aware of the black market than he has acknowledged, and that he supplied the testosterone as a commercial decision, without properly considering the safety of the patient as his primary obligation.
2. We find his conduct in dispensing excessive amounts of testosterone fell well below the required standard.
Paragraph 5 of Particulars
1. On 8 July 2021, the practitioner dispensed 2 injections (12 mg) of Genotropin GoQuick (Somatropin, Schedule 4D drug), contrary to cl 40(1)(e) of the PTGR, in that the prescription appeared to be forged or fraudulently obtained, in circumstances where:
1. the prescription contained red flags outlined in Schedule C to the Complaint;
2. the practitioner failed to contact the purported prescriber to confirm the legitimacy of the prescription or confirm the indication was appropriate prior to dispensing.
Expert evidence
1. The drug is indicated for patients with human growth hormone deficiency, and prescribers require special authority approval to prescribe it.
2. Dr Benson noted that the red flags would lead a pharmacist to suspect a potential forgery. Since the prescription was a non-PBS prescription, a red flag should have been raised that the supply was potentially not in accordance with the approved indication.
3. The private prescription had insufficient patient details, no Medicare number, no patient address, insufficient instructions on use, and a signature that does not appear to correspond with the prescriber's details as noted on the prescription.
4. Dr Benson's report stated that the practitioner should have contacted the prescriber to confirm the legitimacy of the prescription and to confirm the indication was appropriate. Failure to contact the prescriber prior to dispensing demonstrates conduct that falls significantly below the standard required.
Practitioner's evidence
1. The practitioner's written statement to the Tribunal did not specifically address his dispensing of Genotropin GoQuick. However, as a general statement about his dispensing of scripts that contained red flags, and his failure to contact the purported prescribers, he acknowledged the red flags were, for the most part obvious and should have been noticed by him immediately. He said that he failed to properly scrutinise the prescriptions and was not vigilant enough. He referenced his difficult personal circumstances. He stated that he was distressed and deeply regretted that his actions placed the public at risk.
Tribunal finding
1. We accept the expert's opinion and find that the practitioner's conduct in failing to recognise the red flags and failure to contact purported prescribers before dispensing fell significantly below the standard required.
Patient B
Paragraph 6 of Particulars
1. Between 20 August 2020 and 11 April 2022, the practitioner dispensed, or permitted to be dispensed, to Patient B, Schedule 8 drugs (oxycodone), on the dates and in the quantities set out in Schedule B to the Complaint, contrary to cl 109 of the PTGR, in that the drugs were supplied in a quantity and/or at an interval that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Expert evidence
1. Dr Benson's report noted that, for patients with chronic non-cancer pain, the therapeutic guidelines recommend doses of no more than 30 mg of oxycodone per day without specialist support. The number of tablets supplied to Patient B from 20 August 2020 to 11 April 2022 was almost nine times the recommended dose, equivalent to 360 mg of morphine per day.
2. The expert opined that the fact that the prescriptions were all private should have raised a concern that the patient was potentially drug dependant and was being prescribed high dose opioid medication without NSW Ministry of Health approval. There is no evidence that this was ever queried by the practitioner.
Practitioner's evidence
1. In his filed Reply to the Complaint, the practitioner admitted paragraphs 6 and 7 of the Particulars.
2. In his letter dated 24 August 2022 to the Commission responding to the PRU's Final Inspection Report, the practitioner stated he had contacted the prescriber (on a mobile phone number) and dispensed the medication in light of the patient's history with the Pharmacy.
3. His oral evidence was that contact with the prescriber (Dr Wong) was on a mobile phone and potentially on the patient's mobile phone. His dispensing note suggested he had spoken to an (unnamed) doctor on a mobile number (unspecified) outside working hours. He said he placed too much trust in the patient he knew, and relied on the prescriber's assurance that the medication and the prescribed quantity was therapeutically safe, rather than exercise his own judgment.
PRU investigation report
1. The PRU found that the prescriptions were forgeries since Dr Victor Wong had never prescribed medication to Patient B.
Tribunal finding
1. We find that the practitioner's conduct in dispensing such a high amount of oxycodone to Patient B contrary to the therapeutic guidelines (at a rate far exceeding the maximum for non-cancer patients) and failing to exercise his own professional judgment fell well below the standard required of a pharmacist of equivalent training or experience.
Paragraph 7 of Particulars
1. Between 20 August 2020 and 11 April 2022, the practitioner dispensed, or as proprietor permitted to be dispensed, to Patient B, Schedule 8 drugs (oxycodone), on the dates (20 occasions) and in the quantities (total 2108) set out in Schedule C to the Complaint, contrary to cll 40(1)(d) and/or (e) of the PTGR, in that the prescriptions were defaced and/or appeared to be forged or fraudulently obtained, in circumstances where:
1. the prescription contained red flags outlined in Schedule C to the Complaint (including private prescriptions, Prescriber details include "Diabetes Service"/"National Home Doctor Service", insufficient patient details, incomplete patient name, no Medicare number, the signature did not accord with the prescriber details, no patient address, handwritten alterations to the prescriber details, patient address 400 km from the Pharmacy);
2. the practitioner failed to contact the purported prescriber to confirm the legitimacy of the prescriptions before dispensing.
Expert evidence
1. Dr Benson observed that several obvious red flags of potential forgery were either not detected or ignored by the practitioner. The red flags included that the purported prescriber was a diabetes specialist not in the same area as the pharmacy, and several of the patient details were not clear or missing, and the patient's address was several hundred kilometres from the Pharmacy.
2. The expert found that the practitioner's conduct fell significantly below the standard required.
Practitioner's evidence
1. The practitioner claimed that he unintentionally missed the red flags as a result of his reliance on the prescriber, and he had relied on the previous dispensing record.
Tribunal finding
1. In light of our finding with respect to particular 6, and the expert's opinion on the prevalence of red flags which were obvious and should have caused the practitioner to suspect the prescriptions were forgeries, we find the practitioner's conduct fell significantly below the standard required of a pharmacist of equivalent training or experience.
Patient C
Paragraph 8 of Particulars
1. Between 8 May 2020 and 30 October 2020 (5 months), the practitioner dispensed Schedule 8 drugs (fentanyl, methylphenidate and oxycodone) to Patient C, on the six dates and in the quantities set out in Schedule B to the Complaint, contrary to cl 109 of the PTGR, in that the drugs were supplied in a quantity and/or at an interval that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Expert evidence
1. Dr Benson's evidence is that supplying 800 methylphenidate tablets on a single date was not in accordance with the recognised therapeutic standard, and posed a risk to the patient due to possible dependence and overdose. It also posed a risk to the public of diversion and/or misadventure.
2. Dr Benson also said that supplying 60 high strength (100 mcg/hr) fentanyl patches between 8 May 2020 and 9 July 2020 (62 days) was three times the maximum dose and would be potentially fatal. In the expert's opinion, the practitioner's statement that the patient had a broken leg did not justify the quantity and strength of the opioid prescribed, or the length of treatment.
3. The expert found that the practitioner's conduct in supplying the high amounts of methylphenidate and fentanyl fell significantly below the standard required of a practising pharmacist.
Practitioner's evidence
1. In his filed Reply to the Tribunal, the practitioner admitted paragraph 8 of the particulars.
2. In his evidence before the Pharmacy Council, the practitioner claimed that he was under the impression that Patient C needed methylphenidate (Ritalin) as he was going on a 4-month holiday, and he needed fentanyl due to a broken leg.
3. In his statement to the Tribunal, the practitioner acknowledged that his dispensing of 800 tablets on 16 July 2020 was a significant amount, particularly at the maximum recommended dosage of 60 mg per day. He said it should have lasted the patient 133 days (4-5 months). A note appearing in the dispensing record said: "Large quantity given at once to cover holiday requirements – do not dispense again for at least 3-4 months". The practitioner said that if he had been more aware of Ritalin's popularity on the black market and risk of addiction and overdose, he would have been more vigilant in his dispensing of the medication. He acknowledged that he should have asked to see travel documents, and he should have declined supply.
Tribunal finding
1. We have no reason to disagree with the expert's opinion and find that the practitioner's conduct fell significantly below the standard required.
Paragraph 9 of Particulars
1. Between 8 May 2020 and 30 October 2020, the practitioner dispensed Schedule 8 drugs (fentanyl, methylphenidate and oxycodone) to Patient C, on the dates and in the quantities set out in Schedule C to the Complaint, contrary to cl 40(1)(e) of the PTGR, in that the prescriptions appeared to be forged or fraudulently obtained, in circumstances where:
1. the prescriptions contained red flags outlined in Schedule C to the Complaint;
2. the practitioner failed to contact the purported prescribers (Dr Wong and Dr Naseem) to confirm the legitimacy of the prescriptions before dispensing.
Expert evidence
1. As noted by the expert, pharmacists are not able to supply methylphenidate unless the prescription bears an authority number issued by the NSW Ministry of Health, and the usual prescribers of this medication are specialist psychiatrists, neurologists and sleep specialists.
2. The red alerts on the prescriptions were numerous – it was a private prescription, there was no evidence of authority from the NSW Ministry of Health, the prescriber was a diabetes specialist, there were incomplete patient details, and the amount prescribed was excessive.
3. In the expert's opinion, by supplying the 800 methylphenidate tablets in a single transaction on a potentially forged prescription, the practitioner's conduct fell significantly below the standard required of a practising pharmacist.
Practitioner's evidence
1. In his filed Reply, the practitioner claimed that he had contacted the prescriber for Ritalin on 16 July 2020 however the dispensing note on that date makes no mention of any contact with the prescriber, and contradicts the practitioner's response (24 August 2022 to the Commission) that he should have contacted Dr Wong.
2. The practitioner claimed that he missed obvious red flags and trusted the validity of the prescription because there were previous dispensing notes.
3. A dispensing note on 2 April 2020 read "dr on mobile confirmed quantity to last at least 3 months due to patient's trouble with mobility – broken leg".
Tribunal finding
1. The prescriptions were plainly forgeries, and we find the practitioner's conduct in dispensing the medications fell significantly below the standard required.
Patient D
Paragraph 10 of Particulars
1. Between 11 April 2020 and 22 March 2022, the practitioner dispensed, or as proprietor permitted to be dispensed, to Patient D, Durogesic Patches (fentanyl, Schedule 8 drug), on the dates and in the quantities set out in Schedule B to the Complaint, contrary to cl 109 of the PTGR, in that the drugs were supplied in a quantity and/or at an interval that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Expert evidence
1. The expert opined that the supply of 415 fentanyl patches (100 mcg/hr) in a 710-day period was 1.75 times the maximum dose and would be potentially fatal to the patient. The practitioner was not the only pharmacist who dispensed fentanyl for this patient but as the proprietor of the Pharmacy it was his responsibility to recognise the risk to the patient and the public posed by this pattern of dispensing.
2. In the expert's view, in failing to address the high strength, quantity and duration of treatment with fentanyl, the practitioner's conduct falls significantly below the standard required of practising pharmacists and pharmacist proprietors.
Practitioner's evidence
1. In his filed Reply, the practitioner admitted paragraph 10 without qualification.
2. In his statement to the Tribunal, the practitioner gave context to his dispensing of fentanyl patches (relevant to both Patient D and Patient E). He asserted that, at the time, he did not have a proper understanding of the therapeutic indication and contra-indications for Durogesic patches. He also asserted that he did not realise how heavily fentanyl patches were abused and that he did not realise how profitable it was on the black market. We note, below, his comments that he believed his complacency and over-reliance on prescribers were driven by his personal circumstances:
"I also did not realise just how heavily abused it is and how profitable it is on the black market. I treated it more or less as I would any other painkiller, albeit a potent one. That knowledge gap was a huge problem for me and was acceptable.
If I had maintained appropriate understanding and knowledge of therapeutic guidelines in relation to fentanyl patches, and if I had applied Oral Morphine Equivalent Daily Dose (OMEDD) I would have been equipped to realise the dosage levels and intervals being prescribed were clearly inappropriate.
My lack of understanding and knowledge, along with my complacency as a result of my personal circumstances led to me placing over-reliance on prescribers. If they said a dose was appropriate, I was very unlikely to disagree with them because I just did not have the time or energy to do so and had begun cutting corners by that point as a result. It got to the point where I stopped contacting prescribers if the same (inappropriate) dosage was consistent with an earlier prescription, as I just relied on the prescriber to have exercised clinical judgment."
1. In his s 40 Submissions, the practitioner admitted that he failed to identify the pattern of dispensing to Patient D, which posed a risk of harm to the patient and potentially to the wider public.
2. When giving his oral evidence, the practitioner acknowledged that he realised that fentanyl 100 mcg patches were a high strength medication and that the patches were to be replaced every 3 days. His evidence was that he was rushing and not paying attention to how long a box of patches would last. He said that he had missed notifications from NSW Health about fentanyl. He also said that he did not recognise that when fentanyl 100 mcg was prescribed on a private script it was a "red flag". His evidence was that, at the time, he had not appreciated the difference between a PBS (Pharmaceutical Benefits Scheme) script and a private script, and that he now understands the difference in regulation between the two systems, with PBS scripts reported to Medicare (subsidised by the Australian Government).
Tribunal finding
1. At the time of dispensing, the practitioner had been practising for almost 7 years. He knew fentanyl was a strong painkiller. He knew that 100 mcg was the highest strength available.
2. It defies plausibility that a practitioner of 7 years' standing did not have a clear understanding of the difference between PBS and private scripts. Indeed, given the practitioner's focus on the business aspects of the Pharmacy, this must have been a matter that occupied his mind and ought to have raised his suspicions that private scripts for large amounts of Schedule 8 drugs were red flags, and likely to be forgeries.
3. The practitioner dispensed fentanyl to Patient D on multiple dates himself. He had access to the dispensing history and could therefore see when the medication had been dispensed by his staff pharmacists. Even without doing the OMEDD calculation, a simple maths calculation would have alerted the practitioner to the excessive quantity of patches being dispensed to this patient.
4. In the circumstances, we find his complacency to be staggering. We find his conduct put the patient and the general public (due to the possibility of diversion) at risk, and his conduct fell significantly below the required standard.
Paragraph 11 of Particulars
1. Between 17 July 2020 and 22 March 2022, the practitioner dispensed, or as proprietor permitted to be dispensed, to Patient D, Durogesic Patches, on the dates and in the quantities set out in Schedule C to the Complaint, contrary to cl 40(1)(e) of the PTGR, in that the prescriptions appeared to be forged or fraudulently obtained, in circumstances where:
1. the prescriptions contained red flags outlined in Schedule C to the Complaint;
2. the practitioner failed to contact the purported prescriber to confirm the legitimacy of the prescriptions before dispensing.
Expert evidence
1. The expert said that the presence of the many red flags on the prescriptions for fentanyl to Patient D would have prompted her to investigate the legitimacy of the prescriptions. The red flags included that all the prescriptions were private, the prescriber is not located close to the Pharmacy, and the patient's home address in the Eastern Suburbs is not close to the Pharmacy.
2. No evidence was provided that the appropriateness of the prescriptions was questioned before supply. The expert concluded that failure to contact the prescriber prior to dispensing and record the contact demonstrates conduct that falls significantly below the standard required.
3. As a pharmacist proprietor, the practitioner had responsibility to ensure that all staff were aware of medications that are likely to be diverted and abused. The practitioner should have had policies and procedures in place to regularly review Schedule 8 and Schedule 4 prescriptions at the Pharmacy to ensure compliance with appropriate standards. Conducting those reviews would have highlighted the large number of prescriptions red flags.
4. The expert found that in failing to provide sufficient education and training to his staff, and failing to implement appropriate measures to reduce the risk of dispensing forged and fraudulent prescriptions, the practitioner's conduct falls below that required of pharmacist proprietors.
PRU Report
1. The PRU confirmed (in an interim report) that the practitioner had supplied Patient D with 165 fentanyl 100 mcg/hr transdermal patches and that the prescriptions (purportedly provided by Dr Tabba) were forgeries. The PRU investigators found that Dr Tabba had never worked at the medical centre identified on the prescriptions (Macquarie Street, Sydney), and there was no record of Patient D at that medical centre.
Practitioner's evidence
1. In his filed Reply, the practitioner admitted paragraph 11 without qualification.
2. In his submission dated 8 June 2022 to the Pharmacy Council, the practitioner said that the prescriber (Dr Tabba) had been called (in relation to Patient D, Patient E and Patient F) upon first introduction to the Pharmacy to "ensure that the prescribed medication was appropriate in the circumstances." The practitioner said, further:
"On each occasion, the prescriber confirmed the prescription and I was satisfied that it was appropriate to dispense. Upon review, I accept the fact that this given type of medication does require further diligence and care in dispensing and supplying than was given at the time, also making sure that I not only rely on the prescriber contact details provided on the script, but that I also cross-reference those details with prescriber practice details found on credible government websites …".
Tribunal finding
1. The Pharmacy dispensing record contains no evidence that the practitioner ever contacted Dr Tabba. In his statement to the Tribunal, the practitioner acknowledged that he had started cutting corners and stopped contacting prescribers if the same dosage was consistent with previous prescriptions. In those circumstances, the practitioner simply relied upon the prescriber having exercised clinical judgment. When cross-examined on whether he had, in fact, contacted Dr Tabba, the practitioner conceded that he may have dispensed the medication to Patient D if the patient was known to the Pharmacy and the dispensing history showed that the medication had been dispensed previously.
2. We are not convinced that the practitioner contacted the purported prescriber upon first introduction of the prescriptions for Patient D. If he did contact the prescriber, he failed to record the contact in the dispensing record and, in any event, he did not contact the prescriber on successive productions of prescriptions despite the obvious red flags.
3. We find that the practitioner failed to exercise diligence when considering the legitimacy of prescriptions for high dose opioid medications. He appears to have attempted to delegate his own independent professional judgment to purported prescribers, relying entirely on those prescribers' clinical judgment.
4. We agree with the expert's findings and find that the practitioner's conduct fell significantly below that required of a practising pharmacist and pharmacist proprietors.
Patient E
Paragraph 12 of Particulars
1. Between 24 April 2020 and 8 April 2022, the practitioner dispensed, or as proprietor permitted to be dispensed, to Patient E, Durogesic Patches (fentanyl, Schedule 8 drug), on the dates and in the quantities set out in Schedule B to the Complaint, contrary to cl 109 of the PTGR, in that the drugs were supplied in a quantity and/or at an interval that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Expert evidence
1. The expert evidence is that the supply of 410 fentanyl patches over 714 days is 1.7 times the maximum dose, would be potentially fatal to the patient, and poses a risk to the public of diversion. The expert concluded that the practitioner's conduct was significantly below the standard required.
Practitioner's evidence
1. In his filed Reply, the practitioner admitted paragraph 12 without qualification.
2. In his submission to the Commission, the practitioner acknowledged that the supply was contrary to cl 109 of the PTGR and could have had fatal consequences. He said that he failed to identify the pattern of dispensing to Patient E, and acknowledged that it posed a risk of harm to the patient and to the wider public.
Tribunal finding
1. The practitioner dispensed fentanyl for this patient on 10 occasions himself and from November 2021 to March 2022, supplied 15 patches in monthly intervals which would have lasted 45 days if applied as directed. He also, of course, had access to the dispensing record, and had no excuse for not being aware of the dispensing record.
2. We find his conduct fell significantly below the standard required.
Paragraph 13 of Particulars
1. Between 5 August 2020 and 8 April 2022, the practitioner dispensed, or as proprietor permitted to be dispensed, to Patient E, Durogesic Patches, on the dates and in the quantities set out in Schedule C to the Complaint, contrary to cl 40(1)(e) of the PTGR, in that the prescriptions appeared to be forged or fraudulently obtained, in circumstances where:
1. the prescriptions contained red flags outlined in Schedule C to the Complaint;
2. the practitioner failed to contact the purported prescriber to confirm the legitimacy of the prescriptions before dispensing.
Expert evidence
1. The expert evidence is that the red flags that were present on the prescriptions which were dispensed on 29 occasions should have prompted confirmation with the prescriber. The red flags included the fact that all the prescriptions were private, the prescription was for a high dose and high quantity, and both the patient and the prescriber were 20 km away from the Pharmacy.
2. The expert also opined that the practitioner's evidence that prescriptions were initially confirmed does not mean that the ongoing long-term supply of the medication was therapeutically appropriate and should not have been questioned.
3. In the expert's opinion, failure to contact the prescriber prior to dispensing on 29 occasions where the prescriptions contained the obvious red flags, was conduct that falls significantly below the standard required.
PRU report
1. The PRU interim report found that the prescriptions (purportedly issued by Dr Vernugopalan) were forgeries. The doctor had seen Patient E once in 2019 and had issued one prescription for fentanyl 100 mcg/hr patches but he had not otherwise issued prescriptions for this patient.
Practitioner's evidence
1. In his filed Reply, the practitioner admitted that he dispensed, or as proprietor permitted to be dispensed, Durogesic patches to Patient E between 5 August 2020 and 8 April 2022. He admitted that the prescriptions contained red flags and may have been forged or fraudulently obtained and admitted that he failed to contact the purported prescribers to confirm the legitimacy of the prescriptions before dispensing.
2. He also said that he had previously contacted prescribers on 13 February 2022, 19 February 2020 and 3 July 2020 in relation to the Durogesic patches.
3. In his response to the PRU Final Report, the practitioner asserted that two prescribers (Dr Gunasekera and Dr Kobra) were contacted to confirm fentanyl prescriptions. The practitioner commented that Dr Vernugopalan "had supposedly been called once on 3 July 2020 to confirm an increase in fentanyl dose". However, the practitioner acknowledged that if independent verifications had been completed on each occasion, the later forgeries would have been detected.
4. In his s 40 Submissions, the practitioner could not recall contacting the prescriber (Dr Vernugopalan) to confirm the legitimacy of prescriptions dispensed between 5 August 2020 and 8 April 2022.
Tribunal finding
1. The prescriptions from Dr Vernugopalan were forgeries, and the practitioner failed to recognise and investigate the prescriptions notwithstanding they contained the identified red flags.
2. The dispensing note on 13 February 2022 to Dr Gunasekera simply said "Dr called". The dispensing note on 19 February 2020 said "Dr called early dispensing due to lost patches". We note that these contact notes do not justify failing to contact a different prescriber (Dr Vernugopalan) for later dispensing (on 29 occasions between 5 August 2020 and 8 April 2022). We also note that lost patches are, themselves, regarded as a "red flag", and would normally invite suspicion. Dr Vernugopalan had previously reported this patient to Police and Medicare as a "doctor shopper". It is likely that, had the practitioner or his staff pharmacists conducted an independent verification of prescriptions purportedly issued by Dr Vernugopalan, the forgeries would have been identified.
3. We accept the expert's opinion and find that the practitioner's conduct in continuing to dispense excessive quantities of Schedule 8 drugs to Patient E and particularly in circumstances where the prescriptions contained red flags requiring verification, was significantly below the required standard.
Patient F
Paragraph 14 of Particulars
1. Between 8 May 2020 and 24 March 2022 (22 months), the practitioner dispensed, or as proprietor permitted to be dispensed, to Patient F, Schedule 8 drug (buprenorphine, naloxone and oxycodone), on the dates (32 occasions) and in the quantities (including large quantities well over 200 tablets) set out in Schedule B to the Complaint, contrary to cl 109 of the PTGR, in that the drugs were supplied in a quantity and/or at an interval that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Expert evidence
1. The expert evidence is that for patients with chronic non cancer pain the therapeutic guidelines recommend doses of no more than 30 mg of oxycodone per day without specialist support. The 3236 oxycodone 80 mg tablets supplied to this patient from 8 May 2020 to 24 March 2022 (685 days) is equivalent to 4.7 tablets or 377 mg of oxycodone per day. This is equivalent to 566 mg of oral morphine per day. In addition, Patient A was supplied an average of 3.8 oxycodone 5 mg tablets per day over this period, increasing the oral morphine equivalent dose to 594.5 mg/day.
2. The expert stated that the supply of 280 Oxycontin 80 mg (10 boxes) on 3 August 2021 was particularly concerning due to the clear risk of patient harm, diversion, and potential harm to the public posed by dispensing such an excessive quantity in a single transaction.
3. Dr Benson noted that the directions for use of Oxycontin which were 1-2 tablets four times a day as required (which could potentially mean the patient was taking eight tablets in a single day) are clearly not in accordance with the recognised therapeutic standard which is one tablet twice daily as a maximum frequency. By increasing the number of dosage times, this could potentially lead to cumulative toxicity and overdose as the patient would be unable to clear sufficient drug prior to the next dosage time.
4. The expert concluded that dispensing the quantity and combination of drugs of addiction to a patient is significantly below the standard required and emphasised that it was a matter of real concern.
Practitioner's evidence
1. In his filed Reply, the practitioner admitted paragraph 14 without qualification.
2. In his response to the PRU Final Report, the practitioner stated that if he had had more knowledge of the therapeutic guidelines and regulations, and had been more aware of the growing illicit opioid market, he would have noticed that even at the maximum recommended daily dose, the tablets should have lasted longer than 24 days and he would have been inclined to question the need for such amounts, and considered the risk of potential overdosing and/or diversion that may have been at play.
3. In his s 40 Submissions, the practitioner stated that the dispensing was a result of complacency, a lack of knowledge as to the therapeutic guidelines and regulations, and a lack of awareness of the issue of illicit opioid use.
Tribunal finding
1. We accept the expert's opinion that this is a matter of real concern. It is inconceivable that a registered pharmacist, even with less practising experience than the practitioner, would not immediately recognise and calculate that 280 Oxycontin 80 mg tablets with directions to take 1-2 tablets four times a day, would last longer than 24 days.
2. In his statement to the Tribunal, the practitioner acknowledged that he dispensed Suboxone to Patient F on 22 May 2020 (112 films) and 25 June 2020 (140 films) and that the dispensing was inappropriate because the patient was concurrently dispensed opioid medication, with dosage at the maximum level. He said that he now understands that such dispensing is "rarely appropriate", and acknowledged that his actions placed the community and the patient at risk. He said that he should have declined supply.
3. The practitioner's explanation that he had become complacent is a matter of concern since, as a registered pharmacist, he must have received training about the risk of overdose or death with the supply of high quantities of drugs of addiction to a patient. The practitioner must have known that the supply of such large quantities in single transactions to Patient F was dangerous in the extreme, yet he did so repeatedly. His acknowledgment that he now understands the risk associated with the dispensing of Suboxone and high dose opioid medication at the same time to the same patient (we note this applies with respect to both Patient A and Patient F), does strike the Panel as being incredulous since he had been practising for almost 7 years at the time and must have known then, what he says he now realises.
4. We find the practitioner's conduct to repeatedly dispense such a high quantity of 80 mg oxycodone to Patient F particularly egregious and find that his conduct falls significantly and dangerously below the required standard.
Paragraph 15 of Particulars
1. Between 9 October 2020 and 24 March 2022, the practitioner dispensed, or as proprietor permitted to be dispensed, to Patient F, Schedule 8 drugs, on the dates and in the quantities set out in Schedule C to the Complaint, contrary to cl 40(1)(e) of the PTGR, in that the prescriptions appeared to be forged or fraudulently obtained, in circumstances where:
1. the prescriptions contained red flags outlined in Schedule C to the Complaint;
2. the practitioner failed to contact the purported prescriber to confirm the legitimacy of the prescriptions before dispensing.
Expert evidence
1. The expert evidence is that the oxycodone prescription (purportedly written by Dr Naseem) has a number of red flags, is clearly a non-compliant prescription, and should have been suspected as a forgery. The red flags include the fact that it was prescribed as a private item by the National Home Doctors Service, the patient details are barely legible, the patient's name address and Medicare number are missing, and the amount being supplied is a high quantity. Additionally, the expert noted that if this was a national home doctor service script it would be for a quantity that allowed the patient after hours treatment prior to seeing their regular doctor and therefore, a full month of a high dose opioid is therapeutically inappropriate in that context. The expert noted that no evidence was provided that the appropriateness of the prescriptions was questioned prior to supply. Dr Benson concluded that the practitioner's failure to contact the prescriber prior to dispensing and record that contact demonstrates conduct that falls significantly below the standard required of practising pharmacists and pharmacist proprietors.
2. Additionally, the expert evidence is that each of the supplies of Oxycontin between 8 July 2021 and 24 March 2022 on prescriptions attributed to Dr Victor Tadros was of a strength and quantity to raise concerns and should have resulted in a phone call to the prescriber for confirmation of the appropriateness of dispensing. Dr Benson found that the practitioner's failure to contact the prescriber prior to dispensing and record that contact demonstrates conduct that falls significantly below the required standard of practising pharmacists and pharmacist proprietors.
3. Further, the prescription dated 29 October 2020 for oxycodone issued by Dr Harry Johnson contained a handwritten alteration to the medication strength from 40 mg to 80 mg in two places on the face of the prescription. The PRU obtained a copy of Dr Johnson's prescribing records which indicated that 40 mg was prescribed on the day. The prescription was dispensed on 30 October 2020 and the back of the prescription contained a handwritten note by the practitioner stating that the doctor had confirmed the numeric strength mistake and authorised a change on the phone. The note also stated that an updated script had been requested. However, the PRU found no evidence of the authorised increase in strength in the doctor's prescribing records and no replacement prescription was received by the Pharmacy. As the new prescription for the correct strength of Oxycontin had not been received within 7 days, the practitioner was under a professional obligation to report this to NSW Health, in compliance with s 96(2)(b) of the PTGR. The expert found that, in failing to report the matter, the practitioner's conduct fell below the standard reasonably expected of a practitioner.
Practitioner's evidence
1. In his filed Reply, the practitioner admitted the dispensing activity identified was contrary to cl 40(1)(e) of the PTGR in that the prescriptions contained red flags and may have been forged or fraudulently obtained. He also admitted that he failed to contact the purported prescriber to confirm the legitimacy of the prescriptions before dispensing, but said that he had previously contacted the prescriber in relation to a prescription for Oxycontin 80 mg tablets.
2. In his s 40 Submissions, the practitioner said that when Patient F first presented to the Pharmacy, the prescriber (Dr Johnson) was contacted to verify prescriptions for Oxycontin and Endone. However, the practitioner did not contact Dr Johnson on each occasion that Patient F presented a prescription, and acknowledged that the high quantity required him to exercise independent clinical judgment as to the validity of the prescription, which he did not do.
3. With respect to his supply of Oxycontin and Endone to Patient F for the period 8 July 2021 to 24 March 2022, the practitioner admitted that he was inconsistent in his recording of conversations with prescribers, which is not acceptable practice. He also acknowledged that he should have kept detailed notes about the conversations, particularly where the prescriptions had red flags. The practitioner acknowledged that he should have had systems in place to uncover the various red flags on prescriptions for Patient F.
Tribunal finding
1. There is no evidence that the practitioner contacted Dr Naseem. Likewise, there is no evidence that he contacted Dr Tadros.
2. With respect to the practitioner's dispensing on 22 May 2020 of Oxycontin 80 mg (240 tablets) and Endone 5 mg (200 tablets) for Patient F, the Pharmacy's prescribing record simply noted "Called Dr Johnson". Immediately above that entry, the words "Called Dr confirmed increased qtty" appear, but without an identifying date. Another note in the record on 3 April 2020 related to a prescription for 140 Suboxone films (4 films per day), stating "Liaised with Dr Johnson - spoke with dr on his personal mobile phone, confirmed his willingness to prescribe Suboxone along with other strong pain killers at given doses – dr Johnson said he is closely monitoring patient and he knows better her requirements and her tolerance he has apparently been their family Dr for a while". We note that on the previous day (2 April 2020) a prescription for 140 Oxycontin 80 mg tablets was dispensed for Patient F. It would appear that the practitioner had some alertness regarding the combined medication of Suboxone and Oxycontin for this patient. This, we consider, indicates that the practitioner certainly knew enough about the combination of Suboxone and Oxycontin to cause him to call the prescriber. We are inclined to the view that he has downplayed the level of his knowledge about opiate medications at that time in his career, and that he dispensed medications knowing the risk involved based on assurances given to him by prescribers. In doing so, he failed to exercise his own independent judgment.
3. With respect to his asserted conversation with Dr Johnson on 30 October 2020, the practitioner's handwritten note said "confirmed numeric strength mistake change on phone requested updated rx".We note that Dr Johnson's prescribing records do not provide evidence of an authorised increase in strength of the prescription, and no replacement script was received in the Pharmacy. The practitioner failed to follow up with Dr Johnson regarding an updated prescription and failed to notify NSW Health within 7 days that he had not received the prescription authorising the increased dose. He could have refused supply until he had received the updated script. The litany of failures paints a picture of a pharmacist who repeatedly took risks, and failed to maintain records of integrity. It certainly does not reflect the approach of a pharmacist who asserted to the Tribunal that he was passionate about learning how medications interacted with the human body and passionate about helping people.
4. We note the expert's additional comment about the impact of the practitioner's conduct upon setting the culture and standard of practice. Dr Benson stated:
"By dispensing high quantities of high strength opioids to the same patient in an ongoing manner Mr Salloum was setting an example of practice that was below the standard required and this may have been seen as tacit approval of said practice by the other pharmacists employed at the pharmacy.
In failing to provide sufficient education and training to pharmacy staff in relation to S4D, S4B and S8 medications, and by setting a poor example of professional conduct Mr Salloum's conduct falls below that required of pharmacist proprietors."
1. We accept the expert's opinion. We find the practitioner's conduct to be egregious, and it falls significantly below the standard required.
Patient G
Paragraph 16 of Particulars
1. On 6 November 2020, the practitioner dispensed to Patient G, 9.1 mL 250 mg Sustanon ampoules (testosterone, Schedule 4D drug), contrary to cl 40(1)(e) of the PTGR, in that the prescription appeared to be forged or fraudulently obtained, in circumstances where:
1. the prescription contained red flags outlined in Schedule C to the Complaint;
2. the practitioner failed to contact the purported prescriber to confirm the legitimacy of the prescription before dispensing.
Expert evidence
1. The expert evidence is that the prescription contained multiple red flags which should have raised immediate concerns of potential forgery. For example, the script dated 1 November 2020 for Sustanon is prescribed by a doctor in Bondi on a private prescription with insufficient patient details (no address, difficult to read patient name, no Medicare number), the medication name is spelt incorrectly and the quantity is excessive (9 amps would last the patient 18 weeks and is clearly a diversion risk). According to the PRU report, the script was a forgery as the doctor concerned had never prescribed for Patient G.
2. The expert found the practitioner's conduct, with respect to the allegations in paragraph 16 and 17, fell significantly below the standard required of practising pharmacists and pharmacist proprietors.
Practitioner's evidence
1. In his filed Reply, the practitioner admitted both paragraphs 16 and 17, and said that Patient G was known to the Pharmacy and to the practitioner. The practitioner said he had previously contacted the prescriber, following which he was satisfied that earlier prescriptions had been appropriate, but he failed to make a written record of those conversations.
2. In his s 40 Submissions, the practitioner acknowledged that some prescriptions for Patient G had red flags which should have alerted him to scrutinise the prescriptions and contact the prescriber. The practitioner said that had he contacted the prescriber, it is likely the prescriptions would have been identified as forgeries. He stated further:
"However, I acknowledge that I failed to contact the prescribers in relation to the prescriptions in question, which was inappropriate in light of the red flags present. I also accept that I was inconsistent in my recording of conversation with prescribers, which is not acceptable practice. I should have kept detailed notes about those conversations, particularly where the prescriptions had red flags."
1. The practitioner acknowledged that he should have had systems in place to ensure that the red flags on prescriptions were identified, investigated and addressed.
2. Under cross-examination, the practitioner admitted that it was possible that he ceased contacting the prescriber.
Tribunal finding
1. There is no evidence that the practitioner contacted the prescriber and satisfied himself that the earlier prescriptions were appropriate.
2. We find the practitioner's failure to contact the prescriber before dispensing and failure to record the asserted contact demonstrates conduct that falls well below the standard required.
Paragraph 17 of Particulars
1. Between 6 November 2020 and 2 July 2021, the practitioner dispensed Schedule 8 drugs (oxycodone) to Patient G, on the dates and in the quantities set out in Schedule C to the Complaint, contrary to cl 40(1)(e) of the PTGR, in that the prescriptions appeared to be forged or fraudulently obtained, in circumstances where:
1. the prescriptions contained red flags outlined in Schedule C to the Complaint;
2. the practitioner failed to contact the purported prescriber to confirm the legitimacy of the prescriptions before dispensing.
Expert evidence
1. The expert evidence is that the prescriptions had multiple red flags including that it is a private prescription, the quantity prescribed (112 tablets) was excessive, the directions for use (1-3 tablets as directed), and the lack of patient details (not the full name, no address, no Medicare number). On the same date, a similarly poorly written prescription for 120 Endone was dispensed.
2. The expert's opinion as to the standard of conduct is otherwise noted with respect to paragraph 16 above.
Practitioner's evidence
1. We have considered the practitioner's evidence (refer above).
Tribunal finding
1. We find the practitioner's failure to contact the prescriber before dispensing and failure to record the asserted contact demonstrates conduct that falls well below the standard required.
Patient H
Paragraph 18 of Particulars
1. Between 23 February 2021 and 4 March 2022, the practitioner dispensed Kalma (alprazolam, Schedule 8 drug) to Patient H, on the (3) dates and in the quantities (total 630) set out in Schedule C to the Complaint, contrary to cl 40(1)(d) and/or (e) of the PTGR, in that the prescriptions were defaced and/or appeared to be forged or fraudulently obtained, in circumstances where:
1. the prescriptions contained red flags outlined in Schedule C to the Complaint;
2. the practitioner failed to contact the purported prescriber to confirm the legitimacy of the prescriptions before dispensing.
Expert evidence
1. The expert evidence is that the prescriptions do not meet the required legal standard for Schedule 8 prescriptions, and should have been immediately suspected as forgeries. The red flags included the fact that the scripts were private, there were insufficient patient details provided (address, name, Medicare number), the prescriber details had been clearly altered on several prescriptions, the amount to be supplied was excessive, the directions for use were unclear, and some prescriptions did not have the prescriber's signature.
2. The expert found the practitioner's conduct fell significantly below the standard required.
Practitioner's evidence
1. In his filed Reply, the practitioner admitted paragraph 18 without qualification.
2. In his s 40 Submission, the practitioner admitted that many of the prescriptions contained obvious red flags which should have led him to immediately suspect forgeries. He further admitted that, even if the prescriptions were not forgeries, the red flags were such that he ought to have denied supply.
3. The practitioner also claimed that his staff pharmacists had previously contacted the prescriber on several occasions to confirm the legitimacy of prescriptions and the appropriateness of ongoing treatment. However, he accepted that their recording of conversations with prescribers was inconsistent and that this was not acceptable practice. He said that he should have kept (and ensured that his staff kept) detailed notes about those conversations, particularly where the prescriptions had red flags.
Tribunal finding
1. We find the practitioner's failure to contact the prescribers and failure to record any purported contact demonstrates conduct that falls significantly below the standard required of practising pharmacists and pharmacist proprietors.
Patient I
Paragraph 19 of Particulars
1. On 20 November 2020 and 4 December 2020, the practitioner dispensed Schedule 4D drugs (testosterone) to Patient I, on the (2) dates and in the quantities set out in Schedule C to the Complaint, contrary to cl 40(1)(d) and/or (e) of the PTGR, in that the prescriptions were defaced and/or appeared to be forged or fraudulently obtained, in circumstances where:
1. the prescriptions contained red flags outlined in Schedule C to the Complaint;
2. the practitioner failed to contact the purported prescriber to confirm the legitimacy of the prescriptions before dispensing.
Expert evidence
1. The expert's report advised that since the prescriptions concerning this patient had been altered, and the quantity of medication had been altered, this would be considered defacement which is not consistent with cl 40(1)(d) of the PTGR.
2. The expert stated that the practitioner should have required the prescriber to provide a valid replacement prescription prior to dispensing, and concluded that his failure to do so fell significantly below the standard reasonably expected of a practitioner of equivalent training and experience.
Practitioner's evidence
1. In his filed Reply, the practitioner admitted paragraph 19 without qualification.
2. In his response to the PRU Final Report, the practitioner stated that he had contacted Dr Johnson on the day of dispensing (20 November 2020) regarding the name change and Dr Johnson confirmed that he had made the amendment and that he treats the family. This was recorded on the physical prescription. The practitioner also stated that Dr Johnson confirmed the intentional change in quantity with respect to the script dispensed on 4 December 2020, and that he and Dr Johnson agreed that remaining repeats would be voided and the interval before which the next prescription would be dispensed would be lengthened to more than six months' time at which point the doctor would be reviewing the patient. That arrangement was recorded in the Pharmacy's dispensing record, however, the change in name was not mentioned.
3. The practitioner acknowledged that had he better understood the therapeutic guidelines around the prescribing of anabolic steroids, he would not have agreed to dispense the prescriptions in the quantities prescribed which were inconsistent with therapeutic use.
Tribunal finding
1. We note from the prescription dated 23 June 2020 (Sustanon), dispensed on 20 November 2020, that the patient's name had been amended by hand. With respect to a prescription dated 29 October 2020 (Primoteston), dispensed on 4 December 2020, the same alteration to the patient's name was made by hand, and the quantity was increased from 3 to 45.
2. Clause 40(1)(d) of the PTGR provides that the pharmacist must not supply a restricted substance if the prescription is illegible or defaced.
3. Even though the practitioner contacted Dr Johnson and made notes of that contact, he should have recognised that the prescriptions had been defaced, contrary to the PTGR, and he should have obtained replacement prescriptions before dispensing. We find that his conduct fell below the standard reasonably expected of a practitioner of his equivalent training and experience.
Other Matters
Paragraph 20 of Particulars
1. By his conduct in particulars 1 to 19 of Complaint One, the practitioner, in his role as proprietor, failed to implement appropriate measures to reduce the risk of dispensing forged and fraudulent prescriptions, such as having policies and procedures in place to regularly review Schedule 4B, Schedule 4D and Schedule 8 prescriptions.
Expert evidence
1. The expert opinion is that, as a pharmacist proprietor, it is the practitioner's responsibility to ensure that all staff are aware of medications that are likely to be diverted and abused, and that this is particularly important in relation to S4D, S4B and S8 medications.
2. In the expert's opinion, the practitioner as a pharmacist proprietor should have had policies and procedures in place to regularly review S4B, S4D and S8 prescriptions at the Pharmacy to ensure compliance with appropriate standards.
3. Dr Benson found that, in failing to implement appropriate measures to reduce the risk of dispensing forged and fraudulent prescriptions, the practitioner's conduct falls significantly below the standard required of proprietor pharmacists.
Practitioner's evidence
1. In his filed Reply, the practitioner admitted paragraph 20 and said further that while there were policies and procedures in place, the fact of his admission of the allegations indicate that the policies and procedures were inadequate.
Tribunal finding
1. We find that the practitioner failed to discharge his obligations and responsibilities as a proprietor pharmacist with discipline or rigour and, as such set a poor culture and poor professional standard in the Pharmacy. We find he failed to ensure his staff were aware of medications that are likely to cause risk to patients and likely to be diverted and abused. We find that he set a poor example of professional conduct for his staff and that this demonstrates conduct that falls significantly below the standard expected of a pharmacist proprietor.
Paragraph 21 of Particulars
1. During 2021, the practitioner, in his role as proprietor, failed to ensure that the Drug Register at the pharmacy was kept in accordance with the regulations, in that:
1. in September 2021, the practitioner failed to conduct stock checks of buprenorphine and methadone, contrary to cl 118(2)(a) of the PTGR;
2. n/a;
3. the practitioner failed to detect discrepancies in the drug register for buprenorphine and methadone;
4. the practitioner failed to ensure that the drug registers did not fall into a negative balance.
Expert evidence
1. In the expert's opinion, the practitioner's conduct in failing to conduct a compulsory stock check in September 2021 for buprenorphine and methadone fell significantly below that required of proprietor pharmacists.
2. Dr Benson's report explained that due to the "overage" contained in bottles of methadone, it is not usual for the stock check of methadone to exactly equal the previous entry. "Overage" means that the stock on hand should normally exceed the expected balance from the Drug Register. Despite this, many stock check entries of the Drug Register were duplicates of the previous entry, demonstrating that "overage" was not being accounted for in the stock checks. Dr Benson concluded that in failing to ensure accurate stock checks were undertaken, the practitioner's conduct fell significantly below the standard required of proprietor pharmacists. Further, Dr Benson concluded the following:
"If Mr Salloum was exercising appropriate proprietor oversight, he should have detected these discrepancies, educated the staff on appropriate recoding of schedule eight medications and ensured that the registers were not allowed to be put into negative balance. This conduct falls significantly below the standard required of proprietor pharmacists."
Practitioner's evidence
1. In his filed Reply, the practitioner admitted with respect to paragraph 21(a) that he did not conduct a stock check of buprenorphine and methadone in September 2021, and that he had conducted the stock check in July 2021.
2. With respect to paragraph 21(c) and (d), the practitioner said in his filed Reply that the entries in the Drug Register were accurate and were an accurate reflection of the level of medication held by the Pharmacy. He admitted there were numerous other issues with the Drug Register, including that entries were not always maintained in chronological order, resulting in the Drug Register being difficult to interpret and, at times, showing a negative balance. He admitted that he failed to identify or detect the discrepancies in the Drug Register.
3. In his response dated 24 August 2022 to the Commission, the practitioner noted the following with respect to his alleged non-compliant storage of Schedule 8 drugs during the PRU inspection:
"(a) Drugs of addiction including methadone, buprenorphine, fentanyl transdermal patches and oxycodone tablets were stored in a meta filing cabinet on 11 April 2022. I had previously been told by a Guild Inspector that this practice was appropriate. However, I acknowledge that I should have been cognisant of Clause 76 of the PTG Regulations, and it is my responsibility as a proprietor and pharmacist to ensure drugs are stored correctly.
(b) A box of drugs of addiction delivered on 9 April 2022 which contain Durogesic 100 transdermal patches, Subutex 8 mg tablets and Aspen methadone syrup were left on the floor in the dispensary and had still not been stored correctly by 11 April 2022. The Pharmacy was very busy on the day of delivery and I had not been able to put them away. I recognise that this practice is incorrect. As outlined in the updated procedures and protocols, drugs of addiction must be immediately secured in the locked DD safe upon receipt and must be kept in the safe unless in immediate use, and I have endeavoured to purchase a much larger safe than the one we had in order to facilitate the quick storage of Schedule 8 products upon receipt.
(c) the drug safe was not bolted to the brick, concrete floor or timber framed wall and the key was left in the door of the drug safe. A new large safe with a digital lock has been professionally supplied and installed, in compliance with legislative requirements…
(d) Methadone was left on the dispensary bench when not in immediate use. I recognise this is improper practice and should not have occurred. As stated above the Pharmacy's procedures and protocols have been updated to ensure that methadone which is not in immediate use is stored in the safe."
1. The practitioner said in his response to the Commission that the inappropriate storage of drugs of addiction had been an "honest mistake" which had occurred for the very first time due to the unexpected extreme surge in OTP clients at the time which created an "unexpected transient state of overload (and almost havoc)" in the Pharmacy. He added that it was one of the busiest and most overwhelming times, which is why he had an additional pharmacist on duty on the day of the PRU inspection.
Tribunal finding
1. Notwithstanding the practitioner's stated "guarantee" that the state of affairs as observed by the PRU inspectors on 11 April 2020 had happened for the first time ever, and acknowledging the influx of additional OTP clients, we accept the expert's opinion.
2. We find the practitioner's conduct fell significantly below the standard required of him as a proprietor pharmacist.
Paragraph 22 of Particulars
1. Between 15 October 2020 and 5 April 2022, in his role as proprietor, the practitioner failed to ensure that the loss of methadone was reported to the PRU for 10 entries relating to "spillage" in the Pharmacy's Drug Register, contrary to cl 124 of the PTGR.
Expert evidence
1. Dr Benson noted that while there were numerous losses due to spillage reported in the Drug Register, none of them were reported to the PRU. Dr Benson concluded the following:
"In failing to ensure the loss of methadone was reported appropriately on multiple occasions, Mr Salloum's conduct falls significantly below the standard required of proprietor pharmacists."
Practitioner's evidence
1. In his filed Reply, the practitioner admitted paragraph 22.
2. In his statement to the Tribunal, the practitioner said that he was not initially aware that loss/spillage of methadone was required to be reported to the PRU immediately. He said that he recorded loss/spillage, but considered they were not large discrepancies and he thought it was "ok" to allow some time to potentially figure out the reason for the discrepancy. Nonetheless, he conceded that the discrepancies were in part caused by his failure to appropriately maintain the registers. He accepted that he was the only person to blame.
Tribunal finding
1. We accept the expert's opinion and find that the practitioner's conduct fell significantly below the standard required of a practitioner pharmacist.
Overall finding on Complaint One
1. Noting our findings above with respect to each paragraph in the particulars to Complaint One, we find Complaint One to be proven and find the practitioner guilty of unsatisfactory professional conduct pursuant to s 139B(1)(a) of the National Law in that he has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by him in the practice of pharmacy was significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience.
Complaint Two
1. Complaint Two (constituted by the particulars of Complaint One) asserts that the practitioner is guilty of professional misconduct pursuant to s 139E of the National Law in that the practitioner engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration and/or engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amounts to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioner's registration.
2. The evidence relied upon in support of Complaint Two is the same evidence relied upon in support of Complaint One.
3. Under s 139E(a) of the National Law, "unsatisfactory professional conduct" of a sufficiently serious nature to justify suspension or cancellation of a practitioner's registration equates to "professional misconduct". In Chen at [19], the Court of Appeal per Basten JA regarded professional misconduct as merely a category of unsatisfactory professional conduct which is sufficiently serious to justify suspension or cancellation.
4. The practitioner admitted in his filed Reply that, cumulatively, the allegations admitted in relation to Complaint One are sufficient to constitute professional misconduct pursuant to s 139E of the National Law.
5. We find that the conduct found to be proven in Complaint One is of a sufficiently serious nature, and that the instances of unsatisfactory professional conduct when considered together, amount to conduct of a sufficiently serious nature, to justify the suspension or cancellation of the practitioner's registration. We therefore find that the practitioner's conduct meets the threshold of "professional misconduct" under s 139E of the National Law.
6. Complaint Two is therefore proven.
Consideration of appropriate protective orders consequent upon finding "professional misconduct"
1. Consequent upon our finding of professional misconduct, we now consider what protective orders are appropriate – whether the practitioner's registration should be suspended for a specified period, or cancelled, or whether he should be permitted to practice under conditions as proposed in submissions made on his behalf.
2. In determining what protective orders are appropriate, the paramount consideration is the protection of the health and safety of the public.
3. The national scheme provides for the protection of the health and safety of the public by ensuring that "only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered": s 3(2)(a) of the National Law.
4. When making protective orders, we note that no order should be made which has more serious consequences for the practitioner than is reasonably necessary. We also have regard to the following recognised principles:
1. maintaining the standards of the profession, to preserve public confidence in the integrity of the profession and thereby protect the community: Prakash at [91];
2. protecting the health and safety of the public is not confined to protecting current or potential patients but includes protecting the public from similar misconduct of others and upholding public confidence in the standards of the profession: Health Care Complaints Commission v Do [2014] NSWCA 307 at [35];
3. deterring both the practitioner and others from engaging in similar conduct, to maintain professional standards and thereby ensure public safety and faith in the profession: Litchfield at 637;
4. whilst the Tribunal's jurisdiction is primarily protective and not punitive, it is unavoidable that protective orders may be incidentally punitive: Clyne at [201]-[202]; Litchfield at 637; Liu at [42] and Meneghetti at [97]; Lee at [20] and [31] and Meneghetti at [98].
1. The Commission argued that cancellation of the practitioner's registration is needed in order to:
1. denounce his serious misconduct;
2. deter him from similar misconduct;
3. deter other practitioners from similar misconduct;
4. uphold high professional standards of the pharmacy profession.
1. It was submitted on behalf of the practitioner, that his misconduct (though acknowledged on his behalf to have been "terrible") did not warrant cancellation of his registration, and that the imposition of conditions on his registration was an appropriate protective remedy. A Schedule of Conditions proposed to be imposed for a period of two years was put forward on behalf of the practitioner as offering protection for the health and safety of the general public. The Schedule of Conditions included conditions that the practitioner not hold a financial interest in any pharmacy business or practise as the pharmacist in charge for two years. They also included conditions that the practitioner practise under Category C supervision for one year, and engage in mentoring for a period of six months.
2. The practitioner argued that the whole of his conduct should be considered, consistent with the Court of Appeal's decision in Gad v Health Care Complaints Commission [2002] NSWCA 411 ("Gad") at [54]. Reference was then made to the Tribunal's decision in Health Care Complaints Commission v Fearon [2018] NSWCATOD 26 ("Fearon") to cancel Mr Fearon's registration as a pharmacist with a non-review period of 12 months. In that case, the pharmacist had been found to not be a suitable person to hold registration. On multiple occasions, Mr Fearon had supplied patients with Schedule 8 and Schedule 4 drugs without a prescription. He was not considered to be a credible witness in relation to a number of patient records where a hospital was recorded as the prescriber. In an interview with police, Mr Fearon knowingly provided false and/or misleading information in relation to one patient.
3. Reference was also made to the Tribunal's decision in Health Care Commission v Ahmad [2015] NSWCATOD 103 ("Ahmad") to cancel the pharmacist's registration, with a non-review period of 24 months. In that case, the practitioner had dispensed Schedule 8 medication in excessive quantities, without prescriptions, and received cash in return. The practitioner was found to have given untruthful evidence and to have no genuine insight into his obligations or failures.
4. In another case, Health Care Complaints Commission v Sadek [2017] NSWCATOD 181 ("Sadek 1"), the pharmacist's conduct on multiple occasions was found to amount to professional misconduct. In Health Care Complaints Commission v Sadek [2018] NSWCATOD 90 ("Sadek 2"), the practitioner's registration was cancelled, with a non-review period of two years. The practitioner was found to have engaged in professional misconduct by dispensing very large quantities of high strength Oxycontin in highly irregular and inappropriate circumstances in multiple instances. The Tribunal found that more than mere incompetence was involved, and that Mr Sadek's conduct was improper and unethical since he had actual or constructive knowledge that the drugs were very likely being misused. Further, the Tribunal made a finding that Mr Sadek was prepared to tailor and falsify his evidence under oath. The Tribunal concluded that, in light of the severity of the conduct and the practitioner's lack of insight and remorse, the only appropriate outcome was cancellation, accompanied by a non-review period of 2 years.
5. It was submitted that, unlike the practitioners in Fearon, Ahmad and Sadek, the practitioner had been honest and had not given false information, but had provided multiple detailed submissions which contained acceptance of his misconduct, explanations as to his lack of knowledge and poor standards of practice and some contextual information as to how and why the misconduct had occurred. It was further submitted that the practitioner had done his best to give clear and cogent evidence, and at no point was it suggested that he was not telling the truth.
6. It was argued that the practitioner's explanations and contextual evidence, whilst far from excusing his conduct, should be accepted as his honest beliefs at the time of dispensing. With respect to Patient A, eight of the forty Schedule 8 scripts were dispensed by another pharmacist. Whilst acknowledging that the practitioner had not exercised sufficient oversight, it was argued that the fact that eight of the forty scripts were dispensed by another pharmacist in the Pharmacy, was relevant to severity and context. We do not accept this argument having regard to his responsibilities as proprietor and managing pharmacist to exercise appropriate oversight over his employed pharmacists, and in light of the many other occasions on which the practitioner dispensed medications in breach of regulations. We have no confidence that the practitioner would have acted differently with respect to those eight scripts in light of the number of occasions on which he deferred to prescribers (or the alleged prescribers), despite the red flags.
7. On behalf of the practitioner, reference was also made to the Tribunal's decision in Health Care Complaints Commission v Elliott [2018] NSWCATOD 47 ("Elliott"). In that case, the pharmacist in charge dispensed Schedule 8 drugs to 11 patients who were on the OTP in circumstances where the prescribing doctor lacked the authority to prescribe such drugs. Mr Elliott had also dispensed excessive doses of drugs of addiction to three other patients. The practitioner admitted that his conduct amounted to unsatisfactory professional conduct, but argued that his conduct did not amount to professional misconduct since there was no "moral turpitude" on his part, he genuinely believed he was adhering to his legal obligations, he made regular contact with prescribing doctors, the patients presented as suffering chronic pain and were not "doctor shopping", and one of the patients was being treated by a doctor who Mr Elliott believed to be a pain specialist. It was also argued that Elliott should be distinguished from other cases in which it was demonstrated there was a profit motive for improperly dispensing drugs, and in other cases the oversupply of drugs had been accompanied by multiple other departures from proper standards such as failures to maintain records or store dangerous drugs appropriately. The Tribunal decided that Mr Elliott should be reprimanded and that an order for suspension or cancellation was not appropriate.
8. We agree that the practitioner's whole conduct should be taken into account when deciding what protective orders are appropriate (in line with the reasoning in Gad). In that respect, we acknowledge that the practitioner has been cooperative and forthcoming with his explanation of matters raised and in providing context for his conduct during all stages of the Commission's investigation following the PRU audit. Whilst his truthfulness as a witness was not put into question, the evidence was at times inconsistent with respect to whether he had contacted a number of prescribers. We held reservations about the level of his knowledge of the illicit black market for fentanyl and anabolic steroids.
9. We find comparison with the cases cited on behalf of the practitioner (Fearon, Ahmad, Sadek 2 and Elliott) to be of some, though limited, value. Those cases offer no unifying principle (as referred to in the Court of Appeal's decision in Lee) such that a precedent is discernible for application to the case before us. We therefore make an evaluative judgment (consistent with the rationale in Chen), having regard to the nature and seriousness of the matters which we have found to be proven.
Issues considered by the Tribunal in deciding appropriate protective orders
1. In determining the appropriate protective orders to be made, the Tribunal considered a number of issues including:
1. what corrective action the practitioner has undertaken to address his areas of risk including his knowledge gaps;
2. whether the practitioner has expressed genuine remorse for his conduct, demonstrated insight into the gravity and impact of his conduct and accepted full responsibility for his conduct;
3. the practitioner's assertion that his personal circumstances had been a significant cause for his conduct and the impact of those circumstances upon his future conduct;
4. whether the practitioner has become a reformed person such that we can be confident that his future conduct will not pose a risk to the health and safety of the public.
What corrective action has the practitioner undertaken?
1. We recognise the corrective action taken by the practitioner to rectify the issues identified by the PRU. We also acknowledge the efforts made by him to undertake continuing professional development (CPD) in the areas where his knowledge was deficient and to engage in five mentoring sessions with Mr Albert Regoli. The reports from Albert Regoli detail the topics covered in the mentoring sessions and offer some confirmation of the practitioner's positive progress in educating himself on his obligations both as a pharmacist and proprietor.
2. As helpfully noted in the Chronology provided by the Commission, the practitioner has attended to a number of matters to address areas of risk and self-educate as summarised below:
Date Practitioner's Activity/Education/Mentoring
27 April 2022 Practitioner purchased a new drug safe
12 June 2022 Practitioner started conducting regular pharmacist staff meetings and started systems to regularly review/audit the prescriptions dispensed by pharmacist staff to identify any issues
26-27 June 2022 Practitioner completed SafeScript training modules
28 June 2022 Practitioner emailed to his staff pharmacists the PRU letter to review links to the PTGR and included links to the PGTR, resources and OTP protocol.
28 June 2022 Practitioner emailed his letter to the PRU, including a new Schedule 8 checklist so that pharmacists were required, as a new accountability, to independently verify the prescription with the prescriber as well as cross-reference contact details on the prescription against a reputable resource such as the AHPRA health practitioner's register, and advising of new procedures so that alert emails in the pharmacy email inbox were to be checked daily by pharmacists on duty and later covered in meetings.
5 July 2022 Practitioner emailed the PRU attaching requested photographs, further information and further updated policies.
12 July 2022 Practitioner emailed to the PRU his notification forms regarding lost methadone.
13-18 August 2022 Practitioner completed training modules about opioid use disorder, opioid harm and fentanyl.
Practitioner attended his first mentoring session with Albert Regoli. The areas of focus and matters discussed included:
• Diversion of fentanyl patches and fentanyl availability on darknet markets
• Opioid-use Disorder
• Opioid harm in Australia
• Oversight of the Pharmacy - use of checklist to develop a structured approach to his oversight and creating documentation to evidence his oversight
• Review of the s 150 reasons for suspending the practitioner's registration
• Practitioner's acknowledgment of PRU's concern that a large number of forged prescriptions for S8 drugs had been dispensed and that some supplies were dispensed in a single transaction
17 August 2022 • Practitioner's lack of knowledge on prescribing requirements for psychostimulant drugs
• Difference between a PBS approval and a NSW Health approval
• red flags with respect to private prescriptions
• Verification of S8 prescriptions if the pharmacist does not know the patient and prescriber
• Identifying patients seeking supplies on fraudulent prescriptions – obtain treatment plan from the prescriber
• Patients' dispense files should be used for clinical notes, and not for primarily recording overdue accounts
• How to apply OMEDD (oral morphine equivalent daily dose) calculations in practice
• Practitioner's over-reliance on a prescriber's competency to make decisions as he was not inclined to question their judgment
• Gap in practitioner's knowledge regarding the use of anabolic steroids for bodybuilding – discussion of "off-label" prescribing
Practitioner attended his second mentoring session with Albert Regoli. Matters discussed included:
• Prepared list of issues identified in the s 150 hearing and proposed actions to address those issues
• Large number of forged scripts and large quantity of S8 (including psychostimulants) dispensed, sometimes in a single transaction – Practitioner suggested he develop S8 checklist for his staff pharmacists to use prior to dispensing including matters to evaluate if script is forged
• Compliance with PTGR and professional standards
• Inadequate levels of knowledge, judgment, skills & care in dispensing S8 and S4B (such as testosterone)
• Vigilance in calling prescribers and confirming legitimacy of S8 prescriptions
• OTP patients being prescribed drugs of addiction from non-OTP prescribers
• Dispensing S4D prescriptions that have been altered
22 August 2022 • Vigilance in confirming appropriate therapeutic quantities
• OTP knowledge to be improved
• Non-compliant S8 safe and storage of S8 drugs
• Understanding and utilising OMEDD calculations in prescription procedure
• Considering potential for diversion of drugs to illicit drug market
• Autonomy in decision-making and practice choices
• Improve understanding of testosterone
• Recognising red flags
• Off-label prescribing "legal" vs "illegal"
22 August 2022 Practitioner submitted PSA Ethics in Dispensing module (Part 4)
24 August 2022 Practitioner response to the Commission, attaching a number of documents including his new Schedule 8 checklist to ensure the practices of his employed pharmacists dispensing Schedule 8 medications adhere to the legislative requirements, meeting records, CPD and Learning Plan
14 January 2024 to 11 July 2024 Practitioner accessed CPD resources including about opioids, risk and "the importance of saying no".
Practitioner attended his third mentoring session with Albert Regoli Practitioner. Matters discussed included:
• Review of CPD records and review of Pharmacy Board Guidelines on CPD
• Review of Pharmacy Board Guidelines on Dispensing
• Review of Pharmacy Board Guidelines on Practice Specific issues
• Review Professional Practice Standards
• Review Pharmacy Council newsletter for May 2022 (particularly concerns on high dose fentanyl and forged prescriptions and red flags), practitioner noted requirement to retain and report suspected forged prescriptions to police and NSW Health
20 May 2024 • Review Pharmacy Council newsletter for December 2022, supporting resources for managing S8, S4B and S4D medicines
• "Emergency supply" provisions within PTGR and "continued dispensing"
• Pharmacist's autonomy and need to arrive at an independent decision and that the prescription should reflect an acceptable therapeutic standard as well as being valid
• Criteria for issuing a printed computer-generated S8 prescription in NSW, noting the required hand-written elements
• Exemptions to S8 prescriptions supplied under the OTP
• Discussed patients categorised as "drug dependent" treated differently from other patients
• Value of Pharmacy Board guidelines that apply to pharmacy practice and Pharmacy Council newsletters to inform pharmacists of more recent developments and issues relating to high risk medicines.
Practitioner attended his fourth mentoring session with Albert Regoli. Matters discussed:
• CPD planning for current year
• Electronic system (MethDA) superior to paper-based systems
10 June 2024 • Mandatory stock checks of Schedule 8 drugs
• OMEDD
• Use and misuse of opioids – multiple references reviewed – risks associated with poor management of opioid dispensing
• Illicit markets in opioids
• Schedule 4b and Schedule 4d categories in the PGTR
Practitioner attended his fifth mentoring session with Albert Regoli. Relevantly, the following matters were discussed:
• PGTR (monitored medicines, special restricted substances, prescribed restricted substances, persons authorised to possess and use substances)
• Electronic DD Book and MethDA software
• Prescriptions that require verification
24 June 2024 • Pharmacy Council newsletters
• Discussions on e-scripts
• Discussions on "off-label" use – risks and pitfalls
• Staged supply of medicines
• Recent changes to the prescribing of psychostimulants and the use of class authorities
1. We acknowledge Mr Regoli's overview of the practitioner's progress in addressing his areas of risk. Mr Regoli's second report noted that the practitioner appeared "to have good insight of the issues identified, made significant changes to his procedures, improved his knowledge" and appeared "determined to improve his practice". His third report noted that the practitioner was "demonstrating a better understanding of the use and misuse of opioids. He is making use of the resources provided and appreciates the risks associated with poor management of opioid dispensing".
Has the practitioner shown remorse, demonstrated insight into the gravity of his conduct and accepted full responsibility for his conduct?
1. We observed the practitioner when giving his oral evidence to be a quietly spoken man who appeared to be tentative, struggling with the embarrassment and humiliation over his misconduct. At times he appeared to not understand the questions asked of him. This may have been due to his general unease and anxiety when being cross-examined over matters that he has conceded many times in writing made him feel extremely upset. Overall, he appeared to be very remorseful, and quite sad that his practice of pharmacy had fallen short of acceptable standards.
2. We do not discount the sincerity of the practitioner's apology for creating a risk to the safety of the public and wider community as set out in paragraph 74 of this statement:
"My dispensing and my lack of oversight created a risk to the safety of the public and the wider community, for which I apologise. I should have done better and provided an effective safeguard to those medications entering the community."
1. Further, in paragraph 97, the practitioner acknowledged the role of pharmacists as gatekeepers and that he had been unaware of just how significant the risks to the public were from high risk medications:
"I have previously provided comments in relation to the identified dispensing on prescriptions which contained red flags, particularly in relation to high risk medications. Pharmacists occupy a key role in the health industry and are the final line of defence against medication inappropriately entering the community and being subjected to issue. I was unaware at the time of just how significant the risk to the public were from those medications. I am distressed by and deeply regret that my actions placed the public at risk."
1. The Commission acknowledged the practitioner's admissions (almost all of which were unqualified) but submitted that there were concerns that the practitioner had not fully accepted accountability for his misconduct and had not demonstrated full insight into the magnitude of his actions.
2. In a number of his submissions and his statement to the Tribunal, the practitioner deflected some of the responsibility onto the previous proprietor of the Pharmacy and had found fault with the pharmacist who had not provided a handover of the business and its patient information. However, we note that the practitioner first purchased the Pharmacy in December 2016 and had a period of three and a half years before the inspection in April 2022 to become fully acquainted with details concerning his patients, including those being treated under the OTP.
3. The practitioner had also pointed to the impact of the COVID pandemic, as a mitigating factor. We fail to see how the COVID pandemic environment exerted pressures on the practitioner such that he or his employed pharmacists would succumb to ignoring obvious red flags on prescriptions, and breach regulations.
4. The practitioner's personal reflections in the fourth mentoring report are eloquent, and identify a number of contributory factors to the opioid misuse problem in Australia. However, his reflections appear to be expressed from a theoretical perspective and from the general perspective of the pharmacy profession as a whole. He refers to "our" responsibility, as opposed to his own personal responsibility as a pharmacist. In our view, the practitioner's reflections offer only limited insight into his own contribution to the harm (or potential harm) caused by dispensing Schedule 8 and Schedule 4 drugs in excessively large quantities to vulnerable patients who need to be protected from their addiction. His reflections do not acknowledge the potential diversion of opioids into the illicit black market and his contribution to that diversion by his past offending conduct.
5. We are of the view that the practitioner has genuinely reflected on the gravity of his failure to practice pharmacy to the expected standard. However, in light of the matters he attempted to explain in mitigation of his conduct, we are uncertain as to whether the practitioner has accepted full responsibility for his conduct. In seeking to deflect some blame onto others, and to excuse his conduct through the COVID pandemic, he has not demonstrated that he accepts that he is fully responsible for his own failures.
The practitioner's contention that his personal circumstances were a significant cause for his conduct
1. The practitioner emphasised in his written statement to the Tribunal and in various submissions made to the PRU, the Council, the Commission that he was under extreme pressure in his personal life generally. This is a matter that we have considered carefully, since he linked the extent of his deficiency in practice, and his complacency, to the personal stress he was suffering.
2. In his statement to the Tribunal, there are multiple references to his personal circumstances. In particular, in paragraph 71, he drew linkages between his lack of knowledge, complacency, and over-reliance on prescribers to his personal circumstances (including issues at home which left him short on time and energy such that he began to cut corners):
"My lack of understanding and knowledge, along with my complacency as a result of my personal circumstances led to me placing over-reliance on prescribers. If they said a dose was appropriate, I was very unlikely to disagree with them because I just did not have the time or energy to do so and had begun cutting corners by that point as result. It got to the point where I stopped contacting prescribers if the same (inappropriate) dosage was consistent with an earlier prescription, as I just relied on the prescriber to have exercised clinical judgment. That is not appropriate in any circumstance for a pharmacist, let alone in relation to high risk medication such as fentanyl patches. While I accept exercising independent judgment without appropriate therapeutic knowledge may not have changed much, it would certainly have resulted in some of the prescriptions not being dispensed."
1. In paragraph 73 of his statement, the practitioner also acknowledged that due to his personal circumstances he failed as proprietor of the Pharmacy to provide proper oversight of the dispensing practices by his staff pharmacists:
"My lack of understanding and knowledge, along with my complacency as a result of my personal circumstances, caused my failure to provide proper oversight of the dispensing of my staff pharmacists I didn't know what should be done, and so I couldn't properly educate or supervise or identify issues with the dispensing activity of my staff. My role as a proprietor was not only to provide effective oversight of the Pharmacy's operations, but also to be a leader and mentor to my staff. My lack of knowledge meant I could not effectively do that."
1. In paragraph 66 of this statement, the practitioner explained that the sudden influx of methadone clients shortly before the PRU audit caused further stress to him as he was unable to properly support his wife and assist with the care of his children, and things were "just so crazy" that although he had hired some new staff, he did not properly onboard them. Indeed, we obtain a sense of his feeling of intense personal stress in his expression that there was "overall sense of mayhem at the Pharmacy".
2. In terms of failing to exercise his own independent judgment on the appropriateness of dispensing drugs of addiction in high quantities and at intervals that did not accord with s 109 of the PTGR, the practitioner candidly acknowledged in paragraph 78 of his statement that his family issues caused him to be inattentive and complacent:
"I took the view that if a prescriber had prescribed that medication, then they must have exercised professional judgment after undertaking a risk assessment, and I failed to exercise my own professional judgment. That corner cutting is not acceptable. As I have set out above, I was struggling to juggle four children, sick parents, my wife's health issues and a business with high staff turnover and very little time off. That caused me to become inattentive and complacent in my practice. That is of course, not an excuse for my conduct."
1. In his letter dated 24 August 2022 to the Commission (responding to the PRU Final Report in the context of commenting upon his dispensing of large quantities of Suboxone films and Oxycontin 80 mg tablets on the same day to Patient A), the practitioner referred to his lack of self-confidence at the time:
"My trust in the prescriber's reassurance, I now realise, is indicative of some lack of self-confidence in my practice at the time, easily swayed and prematurely trusting in a prescriber's authority."
1. Whilst we acknowledge that these admissions are frank and demonstrate the practitioner has reflected upon the reasons why his practice lapsed so significantly below the expected standard, we are concerned that the misconduct complained of extended beyond the period specified in the Complaint, from the time when he first commenced operations in the Pharmacy.
2. On the subject of the practitioner missing or ignoring red flags on prescriptions, he conceded his failures were particularly concerning however he again linked these failings to his personal circumstances (in paragraphs 98 and 99):
"98. There are a large number of red flags on the prescriptions identified in the NCAT Complaint. Some were missing patient addresses or other key patient details. Others had insufficient patient instructions, spelling mistakes, handwritten amendments or had particularly unclear handwriting. Many had signatures which would not ordinarily correspond with the name of the prescriber.
99. While some of the red flags could potentially be explained (for example, spelling mistakes or messy handwriting), the number of red flags on each of the identified prescriptions in question should have led me, at the very least, to contact the prescriber, if not decline supply altogether. The red flags for the most part were obvious and should have been noticed immediately. I failed to properly scrutinise the prescriptions in question and was just not vigilant enough in the circumstances. I have explained my difficult personal circumstances already, but again, that is no excuse for my failures which are particularly concerning in relation to high risk medications."
1. The level of the practitioner's personal and marital distress (to the extent that his marriage became strained and was on the brink of collapse on several occasions) apparently caused him to seek professional treatment from a clinical psychologist, for anxiety and depression.
2. The practitioner has not provided any report from the clinical psychologist with whom he consulted. In his own assessment, his difficult personal circumstances were a large part of the cause for his failings in pharmacy practice, exacerbated by his conceded knowledge gaps with respect to drugs of addiction, the OTP, the use and misuse of opioids, the operation of the illicit black market regarding fentanyl, and the obligations of a pharmacist and of a proprietor. For the reasons explained above, we are of the view that it is possible that these failings accompanied the practitioner's practice of pharmacy from the outset, and he was not equipped to properly acquire the Pharmacy and discharge his obligations.
3. This, in turn, leads us to consider whether his failings had become entrenched conduct.
4. We retain some discomfort with the possibility that his practice of pharmacy for a number of years early in his career was deficient, with corners being cut when he was feeling under personal and family pressures. On an application for reinstatement, a Tribunal would need to be confident that the practitioner's past behaviour had not become so entrenched that he would relapse when under pressure. A Tribunal would need to be confident that the practitioner has achieved some stability in his personal circumstances such that he is not impeded in the execution of his professional responsibilities.
Whether the practitioner has become a reformed person such that his future conduct would not pose a risk to the health and safety of the public
1. It was submitted on behalf of the practitioner that his knowledge deficiencies have been remedied and that his previous dispensing misconduct (acknowledged to be seriously unacceptable) will not be repeated.
2. We have given this aspect careful consideration since repetitive behaviour can become ingrained and may require active effort in order to arrest and change the behaviour and avoid recidivism. Given the extent of the practitioner's knowledge gaps and practice deficiencies, and his admission that he was shocked by the PRU findings, we are concerned that he had been practising significantly below the required standard for quite some time, and possibly from the time that he acquired the Pharmacy.
3. Other than the practitioner's own statements that he is now aware of the law and regulations, and that in the future he will not be afraid to challenge prescribers, there is no independent objective evidence by an appropriate expert before the Tribunal to support those assurances about his future conduct.
Decision to cancel the practitioner's registration
1. In Chen, the Court of Appeal at [38] noted that the Tribunal's decision below had recognised the treatment of the cohort of patients who are prescribed drugs of addiction as a serious matter, with significant responsibilities attaching to the prescribing doctor. We consider that the Court of Appeal's comments apply equally to pharmacists, in their role as 'gatekeepers' of drugs of addiction:
"The appellant's actions in improperly prescribing and managing patients who are administered drugs of addiction was a 'serious matter':
[137]… Medical practitioners are in a unique position in enabling members of the public to have access to drugs of addiction and the community is entitled to rely on the integrity and professional expertise of medical practitioners to avoid creating drug addicts and to avoid feeding the habits of drug addicts. This is not necessarily an easy task, but there are well-recognised protocols for the administration of drugs of addiction and well-recognised resources to assist medical practitioners in treating their patients."
1. We consider the practitioner's misconduct to be very serious, on multiple occasions over an extended period of time, with significant risk posed to his patients and potentially the general public if dangerous drugs were being diverted into the illicit black market, that continued suspension of his registration would be inadequate.
2. His misconduct was all the more egregious in a number of circumstances where red flags were plainly evident that some prescriptions were forged and/or fraudulent. Rather than exercise independent professional judgment and refuse to supply, the practitioner dispensed addictive medication in dangerously large amounts.
3. In all the circumstances, we conclude that the professional misconduct which we have found, and which we have described, is sufficiently serious to warrant the cancellation of the practitioner's registration. This decision does not suggest or imply that the practitioner is permanently unfit for registration (applying the rationale in Chen that it is not necessary to find that a practitioner is probably permanently unfit to practise before registration can be cancelled). Against that, we have balanced the consideration as to whether the practitioner has become a reformed person (applying the rationale in Litchfield) in the sense that we could be confident that in future he will execute his professional autonomous decision-making responsibilities. Whilst we do not doubt the sincerity of his personal warranty about his future conduct, there is no independent evidence to support such an assurance.
Consideration of non-review period
1. The Tribunal has the power and discretion to set a non-review period with respect to an order cancelling a practitioner's registration. The effect of setting a non-review period is that a practitioner may not make an application for review of the cancellation order during the non-review period: s 163A(3) of the National Law.
2. At the end of the non-review period, the practitioner is entitled to make an application to the Tribunal for reinstatement: s 163A(1) of the National Law.
3. We note that, after all that the practitioner has experienced and learned as a result of the Complaint, despite having his registration suspended, he has said that he would "cherish" the chance to return to pharmacy practice in the future.
4. The paramount consideration when determining the length of a non-review period is the protection of the health and safety of the public. The duration of the non-review period indicates the minimum period within which the Tribunal considers the practitioner should not be able to practise his profession by sending a clear message of denouncement of the offending conduct to the practitioner, the pharmacy profession and the public about professional standards to be maintained.
5. The general public needs to be confident that they are protected from this practitioner and to be confident that the conduct is strongly denounced. In this case, where concern for the susceptibility to addiction by vulnerable patients receiving Schedule 8 medications weighs heavily, the practitioner's conduct is particularly offensive.
6. We are of the view that a non-review period is needed in the circumstances of this case. Whilst we do not make light of the mental, emotional and financial stresses the practitioner has experienced and continues to experience, a non-review period will allow him further time to demonstrate whether:
1. he has accepted full responsibility for the gravity of his conduct without seeking to deflect blame onto the previous proprietor of the Pharmacy or the impact of the COVID epidemic;
2. he has completed meaningful further education, to ensure that his technical knowledge continues to be up to date and particularly to address the exercise of his professional judgment and ethical pharmacy practice;
3. his character and behaviour are truly reformed such that he can demonstrate his acceptance of his professional responsibilities to scrutinise prescriptions in appropriate circumstances, and can be relied upon to practice pharmacy to the expected standards in the future.
1. The decision on the period of time during which a practitioner may not apply for review, is dependant on the facts and circumstances of each case. As already noted, the predominant consideration is the protection of the public: Lee at [23]-[24]. The non-review periods imposed in previous Tribunal decisions do not, however, set a benchmark for subsequent cases: Health Care Complaints Commission v Elshaimy [2019] NSWCATOD 17 ("Elshaimy") at [47]. The gravity of the misconduct is not to be measured by reference to the worst cases: Litchfield at 638.
2. The Commission argued that cancellation with non-review period of two years was appropriate.
3. On balance, for the reasons set out above, we consider that a non-review period of one year is appropriate in the circumstances of this case. In our opinion, this order serves a number of purposes:
1. It protects the public from the risk that the offending conduct might be repeated if the practitioner lacks the confidence to exercise his independent professional judgment and refuse to supply Schedule 8 or Schedule 4 drugs contrary to regulations in the face of a prescriber's reassurance that a patient is being monitored. This requires strength of character, recognition of the pharmacist's duty of care as "gatekeeper" of dangerous drugs toward patients, appropriate assessment of the risk in each circumstance and independent decision-making.
2. It provides the practitioner with an opportunity to firmly consolidate his newly acquired technical knowledge through CPD and be in a position to apply that knowledge upon seeking to be registered.
3. It unequivocally denounces the conduct, sending a clear message to the profession of the responsibilities of pharmacists as "gatekeepers" and the grave consequences of failing to comply with the required professional standards.
4. It acts as a deterrent to both the practitioner and other members of the profession.
5. It maintains the high standard of the profession.
6. It allows the practitioner to engage in such remedial or counselling processes as he may determine before applying for re-registration, if he desires to do so.
1. Whilst we do not propose to order the practitioner to undergo psychological counselling, we urge him to explore that course of action in anticipation of an application to seek to be re-registered at the end of the non-review period. This would assist him to explore his past reticence to challenge prescribers in circumstances warranting further scrutiny, and to assist him in putting strategies in place to act as protective measures against feeling he was "easy" to be "taken advantage of" as expressed in his statement to the Tribunal. This may assist him in providing independent probative material to persuade the Tribunal that he has the personal confidence to exercise his own independent judgment in the future, and to grant him reinstatement as a registered pharmacist upon application once the period of non-review has expired.
Awarding costs against the practitioner
1. Under cl 13(1) of Schedule 5D in the National Law, the Tribunal has the power to order the practitioner to pay the Commission's costs. Under cl 13(3A) of Schedule 5D, the Tribunal may fix the amount of costs itself or order that the amount of costs be assessed by a costs assessor under the applicable legal costs legislation or on any other basis.
2. The Court of Appeal has affirmed that, as a general rule, costs of proceedings before the Tribunal should follow the event (that is, the successful party is entitled to receive their costs), and mere impecuniosity on the part of another party is not a justifiable reason for departing from that rule: Elshaimy at [47].
3. The presumption that a successful party is entitled to receive their costs is generally only displaced where there has been some disentitling conduct by the successful party: Oshlack v Richmond River Council [1998] HCA 11; 193 CLR 72 at [40] applied by the Tribunal in several decisions including HCCC v CSM [2016] NSWCATOD 125 at [98] and HCCC v Brush (No. 2) [2015] NSWCATOD 154 at [9].
4. The Tribunal accepts there has not been any disentitling conduct by the Commission to warrant a departure from the general rule. Accordingly, we have decided to order the practitioner to pay the Commission's costs as agreed or assessed in accordance with the applicable costs legislation.
ORDERS
1. We make the following orders:
1. Pursuant to s 149C(1)(b) of the Health Practitioner Regulation National Law (NSW), the respondent's registration as a health practitioner is cancelled, with a non-review period of one year.
2. Pursuant to clause 13 of Schedule 5D of the Health Practitioner Regulation National Law (NSW), the respondent is to pay the Commission's costs as agreed or assessed in accordance with the applicable costs legislation.
Schedule to Reasons for Decision (90969, rtf)
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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
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Decision last updated: 18 February 2025