[2025] NSWCATOD 32
General information, not legal advice.
NCAT Occupational
2025-04-01
Commissioner Walker, Member Decision
Original judgment source is linked above.
Briginshaw v Briginshaw [1938] HCA 34; (1938) 60 CLR 336
Health Care Complaints Commission v Attia [2017] NSWSC 1066
Health Care Complaints Commission v Azzer [2024] NSWCATOD 70
Health Care Complaints Commission v Bolton [2021] NSWCATOD 160
Health Care Complaints Commission v Elliott [2018] NSWCATOD 47.
Health Care Complaints Commission v Fearon [2018] NSWCATOD 26
Health Care Complaints Commission v Kesserwani [2020] NSWCATOD 65
Health Care Complaints Commission v Matta [2024] NSWCATOD 33
Health Care Complaints Commission v Nguyen [2018] NSWCATOD 168
Health Care Complaints Commission v Pickett [2019] NSWCATOD 53
Health Care Complaints Commission v Sathiyapal [2024] NSWCATAD 14
Health Care Complaints Commission v Sriskanda [2021] NSWCATOD 42
House of Peace Pty Ltd v Bankstown City Council [2000] NSWCA 44
R v Byrnes; R v Hopwood [1995] HCA 1; (1995) 183 CLR 501
Segal v Medical Council of NSW [2024] NSWCATOD 139
Australian Medicines Handbook 2018 (2018, Australian Medicines Handbook Pty. Limited)
Australian Medicines Handbook 2019 (2019, Australian Medicines Handbook Pty. Limited)
Australian Medicines Handbook 2024 (2024, Australian Medicines Handbook Pty. Limited)
Department of Health, Consultation Paper: Prescription strong (Schedule 8) opioid use and misuse in Australia - Options for Regulatory Response (January 2018)
Pharmaceutical Society of Australia, Australian Pharmaceutical Formulary and Handbook (2015)
Pharmaceutical Society of Australia, Code of ethics for Pharmacists (September 2011)
Pharmaceutical Society of Australia, Code of Professional Conduct (March 1998)
Pharmaceutical Society of Australia, Dispensing Practicing Guidelines (March 1997)
Pharmaceutical Society of Australia, Dispensing Practice Guideline (July 2017)
Pharmaceutical Society of Australia, Dispensing Practice Guideline (June 2019)
Pharmaceutical Society of Australia, Guidelines for pharmacists performing clinical inventions (December 2018)
Pharmaceutical Society of Australia, Professional Practice Standards Version 5 of 2017 (2017)
Pharmaceutical Society of Australia, Standards and guidelines for pharmacists performing clinical interventions (March 2011)
Pharmacy Board of Australia, Guidelines for dispensing of Medicines (August 2010)
Pharmacy Board of Australia, Guidelines for Proprietor Pharmacists (September 2015)
Pursuant to s 64(1)(a) of the Civil and Administrative Tribunal Act 2013 (NSW) an order is made prohibiting disclosure to any person or entity of the names of the patients set out in the schedule to the complaint.
Pursuant to s 64(1)(a) of the Civil and Administrative Tribunal Act 2013 (NSW) an order is made prohibiting disclosure to any person or entity of the residential address of the Health Care Complaints Commission expert witness Ms Torrens.
"FURTHER AMENDED COMPLAINT
The Health Care Complaints Commission of Level 12, 323 Castlereagh Street, Sydney NSW, having consulted with the Pharmacy Council of New South Wales ('the Council') in accordance with sections 39(2) and 90B(3) of the Health Care Complaints Act 1993 and section 145A of the Health Practitioner Regulation National Law (NSW) ("the National Law")
HEREBY COMPLAINS THAT
Mr Samer Morcos ("the practitioner") of ELIZABETH HILLS, NEW SOUTH WALES 2171, being a pharmacist registered under the National Law,
COMPLAINT ONE
is guilty of unsatisfactory professional conduct under section 139B(1)(a), and/or (l) of the National Law in that the practitioner has:
i. engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or
ii. engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy.
Each particular in itself justifies a finding of unsatisfactory professional conduct (in the case of Patients A and C, under section 139B(1)(l) only). In the alternative, when two or more of the particulars are taken together, a finding of unsatisfactory professional conduct is justified.
BACKGROUND TO ALL COMPLAINTS
The practitioner completed a pharmacy degree at Cairo University, Egypt in 2002.
The practitioner was first registered to practise as a pharmacist in Australia in January 2007. Since 2014, the practitioner has been part owner of the Christopher Discount Chemist ('CDC'), West Gosford, New South Wales.
PARTICULARS OF COMPLAINT ONE
1. On each of the dates as set out in Schedule 2 to this Complaint the practitioner inappropriately dispensed (on the occasions referenced with the initials SM other than those highlighted green) and/or permitted the inappropriate dispensing by an employed pharmacist (on the occasions referenced with initials other than SM ) of Schedule 8 and 4D drugs, in various strengths to Patients A, C, E, F and I in circumstances where:
a. the dispensing was contrary to Clause 54 and/or 109 of the Poisons and Therapeutic Goods Regulation ("PTGR") in that, it was in a quantity that does not accord with a recognised therapeutic standard;
b. the dispensing intervals and/or frequency did not accord with a recognised therapeutic standard;
c. the practitioner and the dispensing practitioner should have had regard to the patient's dispensing history;
d. on the occasions referenced with initials other than SM, the practitioner failed to:
i. maintain an awareness of the manner in which the pharmacy dispensing practice was being conducted, and
ii. intervene into dispensing practices at the pharmacy where necessary, contrary to the Guidelines for proprietor pharmacists ("Proprietor Guidelines").
2. On each of the dates as set out in Schedule 2 to this Complaint, the practitioner inappropriately dispensed (on the occasions referenced with the initials SM other than those highlighted green), and/or permitted the inappropriate dispensing by an employed pharmacist (on the occasions referenced with initials other than SM), of a Schedule 8 drug, in various strengths to Patients B, D, G and H in circumstances where:
a. the dispensing was contrary to Clause 54109 of the PTGR in that, it was in a quantity that does not accord with a recognised therapeutic standard;
b. the dispensing intervals and or frequency did not accord with a recognised therapeutic standard;
c. the practitioner and the dispensing practitioner should have had regard to the patient's dispensing history;
d. on the occasions referenced with initials other than SM, the practitioner failed to:
i. maintain an awareness of the manner in which the pharmacy dispensing practice was being, and
ii. intervene into the dispensing practices at the pharmacy when necessary, contrary to the Proprietor Guidelines.
COMPLAINT TWO
is guilty of unsatisfactory professional conduct under section 139B(1)(l) of the National Law in that the practitioner has engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy.
PARTICULARS OF COMPLAINT TWO
1. Between 9 June 2017 and 14 December 2018, the practitioner permitted the inappropriate dispensing of psychostimulants, on the dates and in the circumstances as set out in Schedule 3 to the Complaint in circumstances where:
a. on six occasions the prescription was not endorsed with a reference number;
b. the dispensing was contrary to Clause 90 of the PTGR in that a pharmacist must not supply a psychostimulant medication, unless the reference number of the authority to issue the prescription is shown on the prescription;
c. on one occasion the prescribing doctor did not have the authority to prescribe;
d. pharmacy by failing to:
i. maintain an awareness of the manner in which the pharmacy dispensing practice was being conducted, and
ii. intervene into the dispensing practices at the pharmacy when necessary, contrary to the Proprietor Guidelines.
COMPLAINT THREE
is guilty of unsatisfactory professional conduct under section 139B(1)(l) of the National Law in that the practitioner has engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy.
PARTICULARS OF COMPLAINT THREE
Between 4 April 2017 and 12 March 2018, the practitioner permitted the inappropriate dispensing of Schedule 8 drugs of addiction on 14 occasions on the dates and in the circumstances as set out in Schedule 4 to the Complaint in circumstances where:
a. one of the prescriptions did not state the quantity of the drug being sought in both words and figures, contrary to Clause 80(1)(c) of the PTGR;
b. two of the prescriptions lacked details of the address of the patient, contrary to Clause 80(1)(b) of the PTGR;
c. five of the prescriptions did not contain details of the drug handwritten by the prescriber, contrary to Clause 80(2) of the PTGR;
d. one of the prescriptions did not contain adequate directions for use, contrary to Clause 80(1)(d) of the PTGR; and
e. the practitioner failed to discharge his obligations as the proprietor of the pharmacy by failing to:
i. maintain an awareness of the manner in which the pharmacy dispensing practice was being conducted, and
ii. to intervene into the dispensing practices at the pharmacy when necessary, contrary to the Proprietor Guidelines.
COMPLAINT FOUR
is guilty of unsatisfactory professional conduct under section 139B(1)(l) of the National Law in that the practitioner has engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy.
PARTICULARS OF COMPLAINT FOUR
1. The practitioner failed to discharge his obligations as the proprietor of the pharmacy by failing to maintain an awareness of the manner in which the pharmacy dispensing practice was being conducted, and failed to intervene when necessary, contrary to the Proprietor Guidelines, by reason of Schedule 4B drugs being dispensed from the pharmacy on prescriptions that did not specify the interval of supply contrary to clause 39(2)(b) of the PTGR on the occasions as set out in Schedule 5 to the Complaint.
COMPLAINT FIVE
The practitioner is guilty of professional misconduct under section 139E of the National Law in that the practitioner has:
i. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration, and/or
ii. engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioner's registration
PARTICULARS TO COMPLAINT FIVE
Complaints One, Two, Three and Four and the particulars therein are repeated and relied upon individually and cumulatively."
"The Respondent replies to each of the grounds set out in the Application and Further Amended Notice of Complaint filed on 23 August 2024 as follows:
Background
1. The Respondent admits the background to all complaints.
Complaint One
- As to Complaint 1, the Respondent:
(a) admits that he engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy that was significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience pursuant to section 139B(1)(a) of the National Law in relation to particulars 1(c) and 2(c) in so far as they relate to his personal dispensing only;
(b) does not admit that he 'permitted' the inappropriate dispensing of an employed pharmacist;
(c) does not admit that he engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy that was significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience pursuant to section 139B(1)(a) of the National Law in relation to the remaining particulars; and
(d) does not admit that he engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy.
3. As to Complaint One Particular 1, the Respondent says that:
(i) he does not admit that he inappropriately dispensed to Patient A and Patient C as he did not dispense to either patient as evident from Schedule 2.
(ii) does not admit that he permitted the inappropriate dispensing of an employed pharmacist as he was unaware of their dispensing in relation to Patient A and C and does not admit that he failed to maintain an awareness of the manner in which the pharmacy dispensing practice was being conducted; and intervene into dispensing practices at the pharmacy where necessary.
(b) as to Patient E, Patient F and Patient I, relies on and repeats what is stated at paragraph 2 above under Complaint One, namely he admits Particular 1(c) as it relates to his personal dispensing and failure to have regard to the patients dispensing history, but does not admit the balance of particulars.
4. As to Complaint One Particular 2, the Respondent relies on and repeats what is stated at paragraph 2 above under Complaint One, namely he admits Particular 2(c) as it relates to his personal dispensing and failure to have regard to the patients dispensing history as to Patient B, Patient D, Patient G and Patient H, but does not admit the balance of particulars.
Complaint Two
3. The Respondent does not admit that he has engaged in improper or unethical conduct relating to the practice or purported practice of medicine, as particularised in Complaint Two, and therefore does not admit that he is therefore guilty of unsatisfactory professional conduct.
Complaint Three
4. The Respondent does not admit that he has engaged in improper or unethical conduct relating to the practice or purported practice of medicine, as particularised in Complaint Three, and therefore does not admit that he is therefore guilty of unsatisfactory professional conduct.
Complaint Four
5. The Respondent does not admit that he has engaged in improper or unethical conduct relating to the practice or purported practice of medicine, as particularised in Complaint Four, and therefore does not admit that he is therefore guilty of unsatisfactory professional conduct.
Complaint Five
6. As to Complaint Five, the Respondent:
(a) does not admit that he is guilty of professional misconduct in that he engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of his registration; and
(b) repeats his reply to the Particulars as set out in Complaints One, Two, Three and Four."
"HEALTH CARE COMPLAINTS COMMISSION v (2022/00317605)
HEALTH CARE COMPLAINTS COMMISSION v DERIAS (2022/00317607)
HEALTH CARE COMPLAINTS COMMISSION v MORCOS (2022/00317611)
STATEMENT OF AGREED FACTS AND ADMISSIONS
This document sets out facts that are agreed between the Applicant (Commission) and the Respondent in each of the above proceedings (together, Practitioners) for the purposes of their respective proceeding. It also sets out admissions made by the Practitioners for the purposes of section 149(b) of the Health Practitioner Regulation National Law (NSW) (National Law).
Background
1. From in or about September 2014 to in or about April 2020, each of the Practitioners was a proprietor of the Christopher Discount Chemist (the Pharmacy) in West Gosford, NSW.
2. The Pharmacy was located within a medical centre called the Reliance GP Super Clinic (Centre). From 2016 to 2020, the Pharmacy was a Quality Care Pharmacy Program accredited pharmacy.
3. During the period of the dispensing the subject of the complaints against the Practitioners (from 4 April 2017 to 10 January 2019):
(a) each of the Practitioners worked in the Pharmacy for approximately 20 hours per week, as pharmacist-in-charge;
(b) two employed pharmacists worked in the Pharmacy, being Mr Michael Azzer and Mr Mina Matta; and
(c) the Pharmacy was dispensing approximately 250 to 350 scripts per day.
Schedule 8 substances
4. Schedule 8 of the Poisons List proclaimed under section 8 of the Poisons and Therapeutic Goods Act 1966 (NSW) (PTGA) (Poisons List) contains substances which are addiction producing or potentially addiction producing. These are referred to as drugs of addiction or Schedule 8 substances.
5. At all relevant times, Schedule 8 substances included:
(a) alprazolam (sold under names including Kalma and Alprax);
(b) dexamphetamine;
(c) fentanyl (sold under names including Durogesic);
(d) flunitrazepam (sold under names including Hypnodorm);
(e) hydromorphone (sold under names including Dilaudid);
(f) lisdexamfetamine (sold under names including Vyanese).
(g) methylphenidate (sold under names including Concerta and Ritalin);
(h) morphine (sold under names including MS Contin);
(i) Oxycodone (sold under names including Oxycontin, Oxynorm, Endone, Novacodone and Targin); and
(j) tapentadol (sold under names including Palexia).
6. Fentanyl, hydromorphone, morphine, oxycodone and tapentadol are opioids.
7. Alprazolam and flunitrazepam are benzodiazepines.
8. Lisdexamfetamine and methylphenidate are type A drugs of addiction prescribed under clause 122 of the Poisons and Therapeutic Goods Regulation 2008 (NSW) (PTGR).
Schedule 4 substances
9. Schedule 4 of the Poisons List contains substances which in the public interest should be supplied only upon prescription. These are referred to as restricted substances or Schedule 4 substances.
10. Appendix D of the PTGR contains Schedule 4 substances to which additional restrictions apply under the PTGA and PTGR, including a prohibition on their possession except for specified purposes under section 16 of the PTGA. These are referred to as prescribed restricted substances or Schedule 4D substances.
11. At all relevant times, Schedule 4D substances included:
(a) clonazepam (sold under names including Rivotril and Paxam);
(b) diazepam (sold under names including Ranzepam, Antenex, Valium and Valpam);
(c) lorazepam (sold under names including Ativan);
(d) nitrazepam (sold under names including Alodorm and Mogadon);
(e) oxazepam (sold under names including Alepam and Murelax);
(f) phentermine (sold under names including Duromine);
(g) temazepam (sold under names including Normison and Temaze); and
(h) testosterone except when included in Schedule 6 of the Poisons List (sold under names including Testogel and Sustanon).
12. Clonazepam, diazepam, lorazepam, nitrazepam, oxazepam and temazepam are benzodiazepines.
13. Appendix B of the PTGR contains Schedule 4D substances to which further restrictions apply under the PTGR as to the form of the prescription. These are referred to as special restricted substances or Schedule 4B substances.
14. At all relevant times, Schedule 4B substances included testosterone except when included in Schedule 6 of the Poisons List (sold under names including Testogel and Sustanon).
Relevant obligations
15. Clause 54 of the PTGR provides that an authorised practitioner or pharmacist must not supply any restricted substance [Schedule 4 drug] in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
16. Clause 109 of the PTGR provides that an authorised practitioner or pharmacist must not supply any drug of addiction [Schedule 8 substance] in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
17. At the relevant times, the following professional codes and guidelines for pharmacists made pursuant to section 39 of the National Law were in force:
(a) the Pharmacy Board of Australia 'Code of conduct for pharmacists' dated 17 March 2014 (Code of Conduct);
(b) the Pharmacy Board of Australia 'Guidelines for dispensing of medicines' dated 7 December 2015 (Dispensing Guidelines); and
(c) the Pharmacy Board of Australia 'Guidelines for proprietor pharmacists' dated September 2015 (Proprietor Guidelines).
Dispensing at the Pharmacy
18. During the period from April 2017 to January 2019, practitioners at the Pharmacy dispensed Schedule 8, Schedule 4D and Schedule 4B substances to Patients A to BB (Patients) as set out in Schedules 2 to 5 of the Amended Complaint against each Practitioner.
19. The practitioner who performed each instance of dispensing is identified by the initials in the 'Pharm' column of Schedules 2 to 5 of the Annexure, as follows:
(a) 'NS' - Mr ;
(b) 'BD' - Mr Derias;
€ 'SM' - Mr Morcos;
(d) 'MA' - Mr Azzer; and
€ 'MB' - Mr Matta.
Procedural chronology
20. The dispensing of Schedule 8 and Schedule 4D substances by pharmacists at the Pharmacy came to the attention of the Pharmaceutical Regulatory Unit (PRU) during investigations in 2018 and 2019 into the prescribing of Dr Urmila Sriskanda and Dr David Daoud of the Centre, and dentist, Dr Kyle Mervin of Riverside Dental Spa West Gosford.
21. On 16 October 2019, the PRU wrote to the Pharmacy Council of New South Wales (Council) attaching their Investigation Report (of the same date) for the Council's information and action if deemed appropriate.
Respondent Mr Derias
22. On 29 October 2019 Mr Derias appeared pursuant to section 150 of the National Law before the delegates of the Council.
23. Mr Derias' registration was suspended on that day with written reasons handed down on 18 November 2019.
24. On 11 February 2020 Mr Derias appeared before the delegates of the Council upon application by him for a review pursuant to section 150A to set aside the suspension.
25. The suspension was lifted on 16 March 2020 with the condition: 'Must not practise as pharmacist in charge' (pharmacist in charge condition).
26. On 7 April 2020 Mr Derias appeared before the Council delegates pursuant to his review application under section 150A to have the pharmacist in charge condition lifted. This application was unsuccessful.
27. On 27 May 2020 Mr Derias appeared before the Council delegates pursuant to his review application under section 150A to have the pharmacist in charge condition lifted. The application was successful, and the condition was removed.
Respondent Mr Saweris
28. On 11 November 2019, Mr Saweris appeared pursuant to section 150 of the National Law before the delegates of the Council.
29. Mr Saweris' registration was suspended on that day with written reasons handed down on 3 December 2019.
30. On 10 February 2020 Mr Saweris appeared before the delegates of the Council upon application by him for a review pursuant to section 150A to set aside the suspension.
31. The suspension was lifted on 10 February 2020.
Respondent Mr Morcos
32. On 11 November 2019 Mr Morcos appeared pursuant to section 150 of the National Law before the delegates of the Council.
33. Mr Morcos' registration was suspended on that day with written reasons handed down on 28 November 2019.
34. On 11 February 2020 Mr Morcos appeared before the delegates of the Council upon application by him for a review pursuant to section 150A to set aside the suspension.
35. The suspension was lifted on 11 February 2020."
(1) Exhibit A4: Bundle of documents relevant to each of the Applications against the Proprietors.
(2) Exhibit A5: Bundle of documents relevant to Mr Saweris, one of the co-proprietors of the West Gosford Pharmacy owned in conjunction with Baher Derias and the Respondent (noting pages 160 to 166 were not read in the Stage One hearing). There were also objections to part of the transcript from a s 150 hearing at pages 101 to 158. The objections were provided in writing and answered in writing by the HCCC. A document was provided which set out each objection and answer thereto. On 15 October 2024, the objections were addressed. Given that it seemed many of the objections were to portions of the transcript which the HCCC said it would not rely upon, the objections were resolved on the basis that the HCCC would set out in its submission any portion of the transcript which it relied upon and the Tribunal would consider any objection which was relevant to that particular portion.
(3) Exhibit A6: Documents served by the HCCC in relation to Mr Baher Derias, one of the co-proprietors of the West Gosford Pharmacy owned in conjunction with the Respondent and Mr Saweris. The following documents are excluded from Exhibit A6: Pages 35 and 36, 149 to 160 and 204 to 217 (not read in Stage One hearing); and pages 115 to 148 which were not read pending determination of objections raised by the Respondent.
(4) Exhibit A7: Documents served by the HCCC in relation to the Respondent. The following documents are excluded from Exhibit A7: Pages 35 and 36, 195 to 213 (not read in Stage One hearing); and pages 132 to 194 which pages were not read pending determination of objections raised by the Respondent.
(5) In relation to Exhibit A5 and A6, the objections were addressed on 15 October 2024. Given that it seemed many of the objections were to portions on the transcript which the HCCC said it would not rely upon, the objections were resolved on the basis that the HCCC would set out in its submission any portion of the transcript which it relied on and the Tribunal would consider any objection which was relevant to that particular portion.
(6) Exhibit A9: Copy of the Pharmacy Board of Australia Guidelines for Proprietor Pharmacists dated September 2015.
(7) Exhibit A10: A bundle of documents relevant to each of the Complaints against the Proprietors. (On the first day of the hearing some pages in this document were the subject of objection which was withdrawn on 15 October 2024.)
(8) Exhibit A11: Email from Ms Alexandra Torrens dated 15 October 2024.
(1) Exhibit R3: Amended Reply. (Also, the Exhibits marked as R1 and R2 were relied upon in response to the HCCC Complaint against the Respondent as a proprietor with Mr Saweris and Mr Derias.)
(2) Exhibit R4: Volumes of documents numbered 1 to 4 containing 1552 pages relevant to each of the Proprietors.
(3) Exhibit R7: Bundle of documents relevant to the Respondent. (Also, the Exhibits marked as R5 and R6 in relation to the HCCC Complaint against the Respondent as a proprietor with Mr Saweris and Mr Derias.)
(4) Exhibit R8: A document dated 30 March 2023 titled "Notification Pharmacy Council of NSW".
(5) Exhibit R9: Copy of extract from the Australian Medicines Handbook 2018.
(6) Exhibit R10: Copy of extract from the Australian Medicines Handbook 2019.
(7) Exhibit R11: Copy of extract from the Australian Medicines Handbook 2014.
(8) Exhibit R12: Affidavit of Kelly Poh sworn 30 August 2024.
(9) Exhibit R13: Hornsby Heights Pharmacy Sch 4D and Sch 8 dispensing procedure policy dated 27 May 2024.
(10) Exhibit R14: Hornsby Heights Pharmacy dispensing procedure 27 May 2024.
(1) Tab 1: The PRU letter.
(2) Tab 2: The PRU Report.
(3) Tab 3: Appendix D, E, F, G, H, R, V, X.
(4) In Exhibit A5, the Saweris BOE: Tab 2 the PRU letter, Tab 3 the PRU Report, Tab 9 the s150 reasons for decision.
(5) In Exhibit A6, the Derias BOE: Tab 2 the PRU letter, Tab 3 the PRU Report, Tab 9 the s 150 reasons for decision. Tab 15 the s 150A reasons for decision, Tab 16 the s 150A reasons for decision.
(6) In Exhibit A7, the Morcos BOE: Tab 2 the PRU letter, Tab 3 the PRU Report, Tab 12 the s 150 reasons for decision. Tab 13 the s 150A reasons for decision.
Exhibit A7: Documents relating to the Complaint against the Respondent
"A registered pharmacist who is a proprietor of a pharmacy business must:
- Maintain, be able to demonstrate an awareness of, the manner in which that pharmacy business is being conducted, and
- When necessary, intervene to ensure that the practice of pharmacy is conducted in accordance with applicable laws standards and guidelines."
"It appears that Mr Morcos either did not have an awareness of the conduct in the pharmacy or failed to intervene to ensure compliance with the applicable standards. I therefore consider Mr Morcos' conduct in this regard to be below what is reasonably expected of a pharmacist proprietor."
"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."
"...Mr Morcos was not the pharmacist involved in all of these supplies. However, when Mr Morcos accessed the patient record to dispense the prescriptions that he was involved with, he would have been able to see the patient's relevant dispensing history and make a professional judgement accordingly."
"This example, when combined with the other examples provided, indicates significant concerns in relation to the procedures for supply of Schedule 8 medications from this pharmacy.
I therefore consider Mr Morcos' conduct in this regard to be significantly below what is reasonably expected of a practitioner."
"This example, when combined with the other examples provided indicates significant concerns in relation to the procedures for supply of Schedule 8 medications from this pharmacy.
I therefore consider Mr Morcos' conduct in this regard to be significantly below what is reasonably expected [of a practitioner]."
"This example, when combined with the other examples provided, indicates significant concerns in relation to the procedures for supply of Schedule 8 medications from this pharmacy.
I therefore consider Mr Morcos' conduct in this regard to be significantly below what is reasonably expected of a practitioner."
"The dispensing records indicate that large quantities of Oxycodone were supplied to [Patient G] during the specified period. Additionally, the drugs appear to have been supplied at intervals which were at times very short... The frequency with which such dispensing patterns occurred suggest that the supply of these drugs was in excess of the recognised therapeutic standard."
"It is noted that the Mr Morcos was not the pharmacist involved in all of these supplies. However, when Mr Morcos accessed the patient record to dispense the prescriptions that he was involved with, he would have been able to see the patient's relevant dispensing history and make a professional judgement accordingly."
"The dispensing records indicate that large quantities of Oxycodone were supplied to [Patient H] during the specified period. Additionally, the drugs appear to have been supplied at intervals which were at times very short... The frequency with which such dispensing patterns occurred suggests that the supply of these drugs was in excess of the recognised therapeutic standard.
It is noted that [the Respondent] was not the pharmacist involved in all of these supplies. However, when [the Respondent] accessed the patient record to dispense the prescriptions that he was involved with, he would have been able to see the patient's relevant dispensing history and make a professional judgement accordingly.
Additionally, [the Respondent] is a proprietor of the pharmacy.
...
This example, when combined with the other examples provided, indicates significant concerns in relation to the procedures for supply of Schedule 8 medications from this pharmacy.
Therefore, I consider Mr Morcos' conduct in this regard to be significantly below what is reasonably expected of a pharmacy proprietor."
Letter of reflection by the Respondent dated 9 January 2020
"I accept that with the benefit of hindsight, I ought not to have so readily accepted reassurances I received from medical practitioners, where there was any doubt regarding the therapeutic benefit of a prescription... I realised that I should have declined the supply on many occasions if I had exercised my independent judgement. I should have sorted advice from PDL and PRU."
"As a co-proprietor of the Gosford Pharmacy, I understand that I am responsible for ensuring that the practices of the pharmacists at the pharmacy are conducted in accordance with applicable laws, relevant Pharmacy Board of Australia's Policies, Codes and Guidelines and applicable Professional Practice and Quality Assurance Standards and Guidelines."
Letter from Respondent to HCCC dated 25 November 2019 responding to the complaint by the Pharmaceutical Regulatory Unit
(1) The Respondent set out his practice in dispensing prior to the investigation by the PRU. He said:
"If I had any concerns regarding the prescription, I would seek information from the patient's prescribing doctor regarding the reason for early dispensing, the doses prescribed, confirming that the prescriptions were PBS approved and confirming that the patient was not doctor shopping... [noting guidelines which state] if there is any doubt as to the safety of prescriptions, the prescriber is to be contacted. In each of my conversations with the prescribers, I would only dispense the medication if I was reassured as to the need for the dose prescribed and that the medical practitioner was comfortable with the appropriateness in providing the medication.
I accept that with the benefit of hindsight, I ought not to have so readily excepted reassurances I received from the medical practitioners, where there was any doubt regarding the therapeutic benefit of a prescription."
(2) The Respondent addressed individual dispensing for named patients.
(3) The Respondent addressed the actions taken by him and the co-proprietors following the report from the PRU.
(1) Images of policies and procedures on display at the West Gosford Pharmacy (pp 284 to 288). We note it is not clear to us when the attached images were created and available in the pharmacy.
(2) Patient Notes.
(3) Minutes from proprietors meeting dated 1 February 2019.
(4) Dispensing records of Sch 4D and Sch 8 medications. (a very lengthy document).
(5) Specialists letters received by the West Gosford Pharmacy.
The Affidavit of the Respondent dated 21 July 2023
"I do not recall challenging the prescribing doctor's decision to supply any medication, or declining to supply medicines on the basis that the supply of the medicines was clinically inappropriate. I also do not recall [I] ever observed my supervisor challenge a doctor on the decision to prescribe or the appropriateness of the drug, dose or frequency"
"Gosford pharmacy was a busy pharmacy due to its location inside Reliance Medical Centre, which operated from 8am to 10pm 7 days a week... It was my understanding that the complex pain patients were all referred to Dr Sriskanda, who I was familiar with since she started at Reliance Clinic. I was told that she was one of the most experienced supervisors in that practice, and she was an OTP authorised prescriber to treat addiction."
"I recall that I had discussions with the other proprietor about the fact that Dr Sriskanda prescribed more opioids and benzodiazepines than other doctors in her practice but I considered it was appropriate based on her specialty and the practice at Reliance Clinic. I was aware that Mr Azzer [employed pharmacist] was contacting Dr Sriskanda on a regular basis when he was given a prescription he was concerned with. Mr. Azzer discussed this with me. I could also see this on the patient notes. I was aware that the dispensing of s4D and s8 medications were not from many different practitioners but from a single doctor, usually Dr Sriskanda, and this made me feel comfortable that the patients were not doctor shopping and there were no signs of substance abuse."
"I did exercise my clinical judgement on each occasion by assessing who the prescriber was, and from which medical practice, and considered the trust relationship I had between myself and the doctors at Reliance Clinic. I admit that my exercise of professional judgement was deficient based on me having placed too much confidence and trust, in the competence, expertise and greater long standing relationship between the patient and the prescribing doctor and as a result, believing they were in the best position to assess whether are new script or the dose and frequency of an existing script should be re-issued. In that regard I now accept that my conduct did not meet the standard reasonably expected of a practitioner of an equivalent level of training and experience. I do not admit that I was significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience because this expression is a legal question for others to determine. I recognise that I should have placed more confidence in my own clinical judgement and assessment and placed more confidence in my decision making to protect the patient."
"I also recognise and accept that I did not always properly analyse the patient's dispensing history to review the dispensing interval, particularly if the prescriptions were from the same prescribing doctor... and the patient did not present with signs of substance abuse..."
"I accept with the benefit of hindsight, I should not have solely relied on the reassurances from Dr Sriskanda and I should have challenged her on the clinical appropriateness of prescribing the quantities of sch8 and/or s4D medications prescribed and refused supply if I was not satisfied as to the safety and appropriateness of the medicine for the patient."
"I admit that the quantities of Oxycodone and Alprazolam (s8 medications) dispensed to Patient A for the period 24 July 2017 to 14 November 2017 may not be in accordance with the recognised therapeutic standard of what is appropriate, contrary to Clause 109 of the PTGR and further, the dispensing intervals and/or frequency may not be in accordance with the recognised therapeutic standard.
I also admit that the quantity of Diazepam dispensed, as well as the dispensing interval and/or frequency may not be in accordance with the recognised therapeutic standard of what is appropriate contrary to Clause 54 of the PTGR.
As I had not dispensed to Patient A, I had not sighted Patient A's dispensing history. I was therefore not aware that the dispensing was inappropriate. I therefore do not consider that I 'permitted' the inappropriate dispensing to Patient A during the relevant period."
Oral evidence of the HCCC expert Ms Alexandra Torrens (the expert)
"In dispensing a prescription, a pharmacist has to exercise an independent judgment to ensure the medicine is safe and appropriate for the patient, as well as that it conforms to the prescriber's requirements. If there is any doubt the prescriber is to be contacted."
"Contact the prescriber if there is a need to discuss the consumer's prescription or therapeutic regiment. This provides an opportunity to collaborate with the prescriber and contribute to clinical decision-making. Collaboration can optimise medicines use and consumer health outcomes. Obtain the consumer's consent (if possible) to contact their prescriber."
"Contact the prescriber if there is:
- concern about the suitability of the medicine for the consumer
- concern about the potential for medication-related programs
- doubt about the legality or validity of the prescription
- uncertainty about the prescribers intentions.
Offer evidence-based strategies or solutions to the prescriber to promote optimal medicines use for the consumer.
Document the outcome of the discussion with the prescriber, to provide a record of clinical decisions. Inform the consumer of the result of the collaborative discussion. If the prescriber is unavailable, or is unwilling to accept the pharmacist advice, use professional judgement to determine the most appropriate action to take to satisfy the duty of care to the consumer."
"Medicine supply involves both prescribing and dispensing, and pharmacists have a key role to play in addressing problems associated with opioid analgesic use and misuse. Pharmacists are in a position to detect potential misuse by patients and inappropriate/over-prescribing by practitioners, yet often feel powerless to act. Pharmacists need the authority to deny or delay supply of opioid analgesics where there are concerns about inappropriate prescribing, and require support in discussing concerns with the practitioner. This involves developing agreed-upon protocols to be followed by both prescribers and pharmacists, and educational programs as to the role of the pharmacist aimed at pharmacists, prescribers and consumers."
"Guidelines produced by the [PSA] are not definitive statements of correct procedure, but represent agreement by experts in the field. The guidelines do not set a prescribed course of action or a mandatory standard to which pharmacists must adhere".
"Pharmacists should exercise professional autonomy, objectivity and independence in the dispensing process. They have the right to decline to supply medicines if they believe use is unsafe or inappropriate, even if the prescriber is not in agreement".
"If the prescriber is not in agreement with the pharmacist's concerns, pharmacists should also consider the patient's therapeutic need while safety is being ascertained. As well as having the right to decline to supply medicines if they believe use is unsafe or inappropriate, pharmacist may consider alternative options such as suspending of supply, provision of a reduced quantity or increased monitoring."
"Collaboration does not alter the pharmacist's personal accountability for the care provided to patients, and pharmacist have the right to refuse to supply medicines if they believe it is unsafe or inappropriate.
If another healthcare provider insists that a medicine is supplied and the pharmacist believes supply is inappropriate or unsafe, the following options may be appropriate initially:
- Delay supply while gathering further information (e.g. through a literature search, consulting current and credible references).
- Seek further advice from reputable sources (e.g. drug information centres, other healthcare providers the patient may have consulted for the same condition previously, professional indemnity insurer).
A pharmacist must not supply a medicine where they believe it poses an unacceptable safety risk for the patient. If the pharmacist does not supply the medicine, they need to support the patient in receiving appropriate management and treatment. This may involve explaining to the patient the reasons for not dispensing the medicine and providing written information for the patient. Actions taken to ensure that the patient receives appropriate management will depend on the situation."
"My answers in relation to that specifically deal with whether it was below or significantly below (standard) was in relation to the dispensing profile, the quantity of drugs supplied, the frequency with which they were supplied and that in my opinion even if he had the belief that he, the doctor, had said to dispense it, that it was in excess and therefore, in my opinion, I considered it to be inappropriate."
"Q. Right, so I think you said you don't agree with his decision? And, Ms Torrens, do you maintain - so do you say that his thinking, his understanding of the guidelines and procedures that govern his practice do not influence your opinion with respect to where the standards lie?
A. Yes. So you asked me if I consider other factors? Yes, I do, and did. Such as the things you have pointed out was the phone call to doctors. However, even once I have considered those other factors, such as, for example, where the patient said they lost it, or had had it stolen, et cetera, I still did not - it didn't change my opinion that I thought it was below or significantly below.
"So requirements in regards to checking the validity of the prescriptions, checking that the dispensing profile, et cetera, of the patient is appropriate, that the prescriber is registered for example, things such as that. I don't have the full policy in front of me to read the full policy but they're some of the components."
"The only substantive admissions made in the Respondents' amended replies were to complaint 1, particulars 1c and 2c (to the effect that they failed to have proper regard to the patient's dispensing history when dispensing Schedule 8 and Schedule 4D drugs)."
"1. The complaints in these proceedings relate to excessive and otherwise inappropriate dispensing of drugs of addiction (Schedule 8 drugs), prescribed restricted substances (Schedule 4D drugs) and special restricted substances (Schedule 4B drugs) that occurred over a period of approximately 18 months at the Christopher Discount Chemist in West Gosford, NSW (Pharmacy).
2. Each of the Respondents was a proprietor of the Pharmacy during that period. The dispensing they oversaw in that capacity, and in some cases participated in personally, included:
(a) the dispensing of substantial quantities of Schedule 8 and Schedule 4D drugs, principally opioids and benzodiazepines, to nine patients (Patients) in circumstances where that dispensing did not accord with a recognised therapeutic standard (complaint 1); and
(b) the dispensing of Schedule 8 and Schedule 4B drugs to patients on numerous occasions where that dispensing was contrary to the Poisons and Therapeutic Goods Regulation 2008 (NSW) (PTGR) because the prescriptions on which he dispensed were not in the proper form (complaints 2 to 4).
3. The Respondents largely admit that, to the extent they participated in this dispensing personally, it was inappropriate. The Respondents also largely admit that the dispensing by their employed pharmacists (Mr Azzer and Mr Matta), who performed the bulk of the relevant dispensing, was inappropriate.
4. The main issue in dispute is whether the Respondents were responsible for the inappropriate dispensing by their employed pharmacists in their capacity as proprietors of the Pharmacy. The Respondents also do not admit that their conduct is properly characterised as unsatisfactory professional conduct for the purposes of s 139B(1)(a) or s 139B(1)(l) of the Health Practitioner Regulation National Law (NSW) (National Law), or professional misconduct for the purposes of s 139E of the National Law (complaint 5). The Respondents have elected for those issues to be determined before addressing the question of protective orders, meaning this is a 'Stage 1' hearing only."
Complaint One. Excessive dispensing of Sch 8 and Sch 4D drugs
"24. Complaint 1 for each Respondent relates to excessive dispensing of Schedule 8 and Schedule 4D drugs to nine patients (Patients A to I), which occurred during the period from July 2017 to December 2018. This dispensing is the subject of expert evidence from Alexandra Torrens, an experienced community pharmacist, for each Respondent (Torrens Reports).
25. The relevant instances of dispensing to each patient are set out in Schedule 2 to each complaint. They involve a range of opioids - including oxycodone, fentanyl, morphine and alprazolam - and benzodiazepines. These drugs can lead to physical and psychological dependence, tolerance and misuse, and are liable to be diverted for illicit use. Administering an opioid and benzodiazepine together increases the risks of central nervous system and respiratory depression including coma and death.
26. Particular 1 for each Respondent deals with patients to whom both Schedule 8 and Schedule 4D drugs were dispensed in excess, while particular 2 deals with patients to whom only Schedule 8 drugs were dispensed in excess. The sub-particulars deal with two situations, which are addressed in turn below:
(a) dispensing by each Respondent personally (sub-particulars a to c); and
(b) dispensing by pharmacists at the Pharmacy other than the relevant Respondent (sub-particular d)."
27. Each of the Respondents admits that most of the instances of their personal dispensing as set out in Schedule 2 of the Complaints against them (highlighted yellow for each Respondent) was inappropriate:
(a) Mr Saweris admits that the following instances of his dispensing as set out in Schedule 2 of the complaint against him were inappropriate:
(i) to Patient A - of Schedule 8 and Schedule 4D drugs on 8 September 2017, 29 September 2017 and 13 October 2017;
(ii) to Patient B - of Schedule 8 drugs on 28 June 2018 and 3 December 2018;
(iii) to Patient C - of Schedule 8 drugs on 18 August 2017, 8 September 2017, 18 September 2017 and 13 October 2017;
(iv) to Patient D - of Schedule 8 drugs on 18 September 2017, 29 September 2017, 20 October 2017 and 31 October 2017;
(v) to Patient E - of Schedule 8 drugs on 18 September 2017 and 20 October 2017, and Schedule 4D drugs on 18 September 2017;
(vi) to Patient F - of Schedule 8 drugs on 8 August 2017, 18 August 2017, 18 September 2017 and 26 November 2018;
(vii) to Patient G - of Schedule 8 drugs on 19 September 2017, 22 December 2017 and 6 March 2018;
(viii) to Patient H - of Schedule 8 drugs on 20 October 2017; and
(ix) to Patient I - of Schedule 4D drugs on 18 May 2018 and 29 June 2018."
"(b) Mr Derias admits that the following instances of his dispensing as set out in Schedule 2 of the complaint against him were inappropriate:
(i) to Patient A - of Schedule 8 drugs on 25 August 2017, 1 September 2017, 15 September 2017, 22 September 2017 and 6 October 2017, and Schedule 4D drugs on 22 September 2017;
(ii) to Patient B - of the Schedule 8 drugs tapentadol (Palexia), oxycodone (Novacodone) and fentanyl (Durogesic) on 31 December 2018;
(iii) to Patient C - of Schedule 8 drugs on 25 August 2017, 1 September 2017, 22 September 2017 and 3 November 2017, and Schedule 4D drugs on 3 November 2017;
(iv) to Patient D - of Schedule 8 drugs on 23 August 2017;
(v) to Patient E - of Schedule 8 drugs on 4 August 2017, 25 August 2017 and 1 September 2017, and Schedule 4D drugs on 4 August 2017 and 1 September 2017;
(vi) to Patient F - of Schedule 8 drugs on 6 October 2017;
(vii) to Patient G - of Schedule 8 drugs on 9 February 2018, 16 February 2019 and 2 March 2018;
(viii) to Patient H - of Schedule 8 drugs on 22 September 2017, 27 October 2017, 22 January 2018 and 25 May 2018; and
(ix) to Patient I - of Schedule 4D drugs on 9 March 2018 and 13 April 2018
"(c) Mr Morcos admits that the following instances of his dispensing as set out in Schedule 2 of the complaint against him were inappropriate:
(i) to Patient B - of Schedule 8 drugs on 6 November 2017, 19 February 2018 and 5 November 2018;
(ii) to Patient D - of Schedule 8 drugs on 25 September 2017, 23 October 2017 and 13 November 2017;
(iii) to Patient E - of Schedule 8 drugs on 25 September 2017;
(iv) to Patient F - of Schedule 8 drugs on 31 July 2017 and 25 September 2018;
(v) to Patient G - of Schedule 8 drugs on 22 August 2017 and 9 October 2017;
(vi) to Patient H - of Schedule 8 drugs on 4 September 2017; and
(vii) to Patient I - of Schedule 4D drugs on 22 August 2017."
"28. The admissions that the instances of dispensing set out above were 'inappropriate', in the context of these matters being characterised as admissions in reply to the Complaints, should be viewed as admissions of the matters set out in particulars 1 and 2 of complaint 1 in relation to those instances of dispensing: that is, that:
(a) the dispensing was in a quantity that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances and therefore was contrary to clause 54 (in relation to the dispensing of Schedule 4D drugs) and clause 109 (in relation to the dispensing of Schedule 8 drugs) of the PTGR;
(b) the dispensing intervals and/or frequency did not accord with a recognised therapeutic standard; and
(c) the Respondent did not have sufficient regard to the patient's dispensing history.
29. In any event, the Tribunal would be satisfied as to each of those matters on the basis of the Torrens Reports."
"33. Each of the Respondents admits that dispensing to Patients A to I as set out in Schedule 2 of each complaint by the employed pharmacists at the Pharmacy was inappropriate. Again, the admission of inappropriateness should be read in context as an admission of the matters set out in paragraph 28 above. In any event, the Tribunal would be satisfied of those matters on the basis of the Torrens Reports.
34. The area of dispute is as to whether, as a consequence, the Respondents breached their obligations as proprietors. Each Respondent's case appears to be that they cannot be said to have 'permitted' the inappropriate dispensing by employed pharmacists because they did not appreciate that it was inappropriate at the time. The essential basis for this position appears to be an assertion that the Respondents did not understand at the time that they were able (or obliged) to refuse to supply on a prescription, but instead believed they were required to defer to the prescribing doctor's clinical judgment.
35. If that is truly what the Respondents believed, then they were ignorant of the essential obligation of a pharmacist, reflected in the Dispensing Guidelines, to exercise an independent judgment in their dispensing. Ignorance of an essential professional obligation of pharmacists cannot be a basis for escaping liability as a proprietor. The Tribunal has held that it is not. It would be an absurd construction of the Proprietor Guidelines to say that they do not require a proprietor to intervene to ensure compliance with applicable laws, standards or guidelines if the proprietor is ignorant of what those laws, standards or guidelines require. Such an approach would undermine the evident purpose of the Proprietor Guidelines of making proprietors responsible for the proper conduct of their pharmacy businesses, and subvert the responsibility that attaches to the privileged position of proprietor pharmacists..."
36. The Respondents also accept that, at the time of the relevant dispensing, the Pharmacy had no or inadequate policies or standard operating procedures in the Pharmacy for the dispensing of Schedule 8 or Schedule 4D drugs. It also appears that there were no or inadequate audits conducted in relation to Schedule 8 or Schedule 4D drug dispensing at the time, and there is no evidence of any specific training having been conducted in relation to Schedule 8 or Schedule 4D dispensing. Those matters constitute a failure to take steps required by cl 3 of the Proprietor Guidelines to ensure the pharmacy business at the Pharmacy was conducted properly.
37. For these reasons, the matters raised by the Respondents are no defence to their failure to intervene to ensure the safe and otherwise appropriate dispensing of Schedule 8 and Schedule 4D drugs at the Pharmacy.
38. Accordingly, the Tribunal should find particulars 1 and 2 d of complaint 1 proved against each Respondent."
"39. The Respondents also do not admit that the conduct the subject of complaint 1, if proved, is properly characterised as unsatisfactory professional conduct under either s 139B(1)(a) or s 139B(1)(l) of the National Law.
40. It is relevant to observe at the outset the vastly excessive quality of the dispensing to Patients A to I when viewed overall, to the extent where the volume of drugs dispensed at the frequency with which they were dispensed could have caused death or serious harm if they had actually been consumed."
"41. As to s 139B(1)(a) of the National Law, the Applicant relies on the Torrens Report to the extent that Ms Torrens' opinion is that the Respondents' conduct was significantly below the standard reasonably expected. That is Ms Torrens' opinion in relation to the following patients for each Respondent:
(a) in relation to Mr Saweris - Patients A, B, C, D, E, F, G, H and I;
(b) in relation to Mr Derias - Patients A, B, C, D, E, F, G, H and I; and
(c) in relation to Mr Morcos - Patients D, E, F, G, H and I.
42. The Tribunal should accept Ms Torrens' opinions about these patients, which reflects the evidently excessive quality of the dispensing as set out in paragraph 40 above. Given that the relevant patients span particulars 1 and 2 of complaint 1 for each Respondent, and the complaint against each Respondent seeks a finding of unsatisfactory professional conduct at the level of the particulars, this is sufficient to justify a finding of unsatisfactory professional conduct under s 139B(1)(a) in respect of complaint 1 against each Respondent.
43. In any event, the Tribunal should be satisfied that each Respondent's conduct was improper or unethical conduct for the purposes of s 139B(1)(l) of the National Law, for three reasons.
44. First, to the extent each Respondent admits (and, in any event, Ms Torrens expresses the opinion) that their personal dispensing was contrary to cl 54 and/or cl 109 of the PTGR, that is properly characterised as improper or unethical conduct for the reasons in paragraph 7 above. This applies to all of the patients set out for each Respondent in paragraph 27 above.
45. Second, for the same reasons, each Respondent's personal dispensing was contrary to the requirements in the Code of Conduct that practitioners must always act in accordance with the law, practise safely and effectively, and provide good care including by maintaining adequate knowledge and skills to provide safe and effective care. Conduct contrary to a code of professional conduct is also properly characterised as improper or unethical conduct.
46. Third, for the reasons in paragraphs 33 to 37 above, the Tribunal should be satisfied that each Respondent contravened their obligations under the Proprietor Guidelines. The Proprietor Guidelines are also a code of professional conduct, such that their contravention is also properly characterised as improper or unethical conduct.
47. Accepting any of these reasons is sufficient for the Tribunal to conclude that each Respondent's conduct the subject of complaint 1, particulars 1 and 2, was unsatisfactory professional conduct for the purposes of s 139B(1)(l) of the National Law."
"Complaint 2
50. Complaint 2 relates to the dispensing of type A drugs of addiction. These are Schedule 8 drugs prescribed under cl 122 of the PTGR, which include psychostimulants such as amphetamine and, in the case of the dispensing that is the subject of this complaint, lisdexamfetamine and methylphenidate. These drugs cannot be prescribed under the PTGA unless the prescriber holds an authority from the Ministry of Health, and cannot be dispensed by a pharmacist unless the prescription records the reference number of that authority (except in limited circumstances generally relating to in-patients).
51. Each of the Respondents admits that in relation to the dispensing by Mr Azzer of type A drugs of addiction to Patients L, O, P and Q as identified in Schedule 3 of the Complaints:
(a) on six occasions Mr Azzer dispensed on a prescription that was not endorsed with a reference number, contrary to cl 90 of the PTGR; and
(b) on one occasion Mr Azzer dispensed on a prescription issued by a practitioner who did not hold the necessary authority to prescribe type A drugs of addiction.
52. While this dispensing constituted a relatively small proportion of the dispensing that occurred during the relevant period, it is a serious matter to dispense Schedule 8 drugs without a proper prescription. The requirements for prescriptions in the PTGR help to ensure that proper attention has been given to the appropriateness and the other requirements for the supply of dangerous drugs to patients, and provide an important checking and record-keeping mechanism for pharmacists including to ensure the authenticity of a doctor's directions to supply. The importance and seriousness of those requirements is reflected in the fact that it is an offence to contravene the clauses imposing them.
53. It was therefore important that, as proprietors of the Pharmacy, the Respondents had implemented rigorous processes to ensure that breaches of this kind did not occur. There is no evidence of any documented policies or procedures, audits, training or other processes dealing with these requirements at the time of the relevant dispensing. The fact that several breaches of those requirements did occur, undetected, over more than a year suggests any such processes were inadequate. This is not a case like complaint 1 where the Respondents say they were unaware of or mistaken about those requirements.
54. For these reasons, the Tribunal should be satisfied that the Respondents breached the Proprietors Guidelines, and otherwise breached their obligations as proprietor pharmacists, in relation to the subject matter of complaint 4. For the reasons in paragraph 7 above, the Tribunal should be satisfied on this basis that the Respondents' conduct constituted unsatisfactory professional conduct within the meaning of s 139B(1)(l) of the National Law."
"Complaint 3
55. Complaint 3 relates to the dispensing of Schedule 8 drugs on seven prescriptions that did not meet the requirements of form in cl 80 of the PTGR. The Applicant does not press particular 1a of the complaint against each Respondent.
56. Clause 100 of the PTGR generally prohibits the possession or supply of Schedule 8 drugs other than in accordance with Part 4, Division 4 of the PTGR. Clause 85(1) of the PTGR provides as an exception to this general prohibition that a pharmacist may supply a Schedule 8 drug on a prescription that conforms with the requirements in Part 4, Division 3. Clause 80 of the PTGR (which forms part of Division 3) requires, among other things, that the prescription for a drug of addiction contains the patient's address, the quantity of the drug stated in both words and figures, adequate directions for use, and details of the drug handwritten by the prescriber.
57. Each of the Respondents admits that in relation to the dispensing of Schedule 8 drugs. as identified in Schedule 4 of the Complaints:
(a) one prescription (corresponding with two occasions of dispensing) did not state the quantity of the drug being sought in words and figures. (particular 1b in relation to Mr Saweris and Mr Morcos; particular 2b in relation to Mr Derias);
(b) two prescriptions (corresponding with two occasions of dispensing) lacked details of the address of the patient (particular 1c in relation to Mr Saweris and Mr Morcos; particular 1b in relation to Mr Derias);
(c) three prescriptions (corresponding with five occasions of dispensing) did not contain details of the drug handwritten by the prescriber (particular 1d in relation to Mr Saweris and Mr Morcos; particulars 1c and 2a in relation to Mr Derias);
(d) one prescription (corresponding with one occasion of dispensing) did not contain adequate directions for use (particular 1e in relation to Mr Saweris and Mr Morcos; particular 1d in relation to Mr Derias); and
(e) each prescription set out in subparagraphs (a) to (d) above did not meet the requirements in cl 80 of the PTGR.
58. Mr Derias personally dispensed on three of the prescriptions referred to... It follows that Mr Derias contravened cl 100 of the PTGR in dispensing on those prescriptions. That constituted improper or unethical conduct ... and therefore unsatisfactory professional conduct within the meaning of s 139B(1)(l) of the National Law.
59. The other prescriptions [set out above] were dispensed by Mr Azzer. However, the Respondents are responsible as proprietors for failing to intervene to ensure that those breaches did not occur ... In those circumstances, the Tribunal should find that each of the Respondents breached the Proprietor Guidelines and otherwise breached their professional responsibilities as proprietors, such that they engaged in improper or unethical conduct and therefore unsatisfactory professional conduct within the meaning of s 139B(1)(l) of the National Law."
"Complaint 4
60. Complaint 4 relates to Mr Azzer's supply of Schedule 4B drugs to three patients on ten occasions between 23 September 2017 and 23 October 2018. Schedule 4B drugs are Schedule 4D drugs to which further restrictions apply under cl 35 of the PTGR as to the form of the prescription, particularly that the prescription specifies the intervals at which the drug may be supplied. Pursuant to cl 39 of the PTGR, the mere fact that a prescription does not specify the intervals at which the drug may be supplied does not prevent a pharmacist from dispensing it the first time, but the pharmacist must not supply the drug if it appears to the pharmacist that the drug has previously been supplied on the same prescription. The pharmacist must also endorse the prescription with the word 'CANCELLED'.
61. Each of the Respondents admits that in relation to the dispensing of Schedule 4B drugs to Patients B, R and S as identified in Schedule 5 of the Complaints:
(a) on each occasion Mr Azzer dispensed on a prescription that did not specify the interval of supply as required by cl 35(1)(f) of the PTGR; and
(b) each occasion of dispensing was contrary to cl 39(3) of the PTGR.
62. Again, for the same reasons as set out in paragraphs 52 and 53 above, the Tribunal should be satisfied that the Respondents breached their proprietor obligations in relation to this dispensing. There is no evidence of any processes in place directed at preventing it from occurring, and the fact that it occurred repeatedly indicates that any general processes that were in place were inadequate. For these reasons, the Tribunal should be satisfied that each Respondent engaged in improper or unethical conduct and therefore unsatisfactory professional conduct within the meaning of s 139B(1)(l) of the National Law."
"65. It does not mitigate the seriousness of the Respondents' conduct for them to say they were unaware that a pharmacist could challenge the authority of a prescribing doctor. They should have known it was a pharmacist's own independent responsibility to ensure he was dispensing safely to his patients, in accordance with recognised therapeutic standards. That is especially so because of the privileged position they were in as proprietors. With that privilege came the responsibility of understanding their professional obligations, and ensuring those obligations were met in the conduct of their pharmacy business. It cannot be a defence for the Respondents to plead ignorance of those obligations. It is not to their credit that they seek to deploy their ignorance of an essential professional obligation as a defence in these proceedings."
"67. The Tribunal has previously commented on the importance of pharmacists adhering scrupulously to their obligations in relation to drugs of addiction and restricted substances, including those imposed by the PTGA and PTGR. For example, in Health Care Complaints Commission v Pickett, the Tribunal said:
'A pharmacist occupies a position of trust in our community by virtue of having access to drugs of addiction. They are responsible for the secure storage and safe administration to patients of such medication.'
68. Similarly, in Health Care Complaints Commission v Fearon, the Tribunal said:
'The effectiveness of the statutory scheme governing the retail supply of prescribed substances and drugs of addiction requires pharmacists to act with integrity and to scrupulously adhere to the statutory requirements governing the supply of those drugs.'
69. The Tribunal elaborated on these matters in Health Care Complaints Commission v Elliott:
'[54] Mr Elliott was dispensing considerable quantities of Sch 8 drugs over a lengthy period, but especially in 2013 and 2014. In our view, in those circumstances any trained pharmacist operating at the general standard required of his or her profession would have become highly attuned and attentive to the potential risks of dispensing such quantities of drugs. In particular, it would be reasonable to expect an experienced pharmacist to be alert to the possibility - perhaps even the probability - that some of the patients were likely to be opioid-dependent and therefore more likely than other patients to simulate symptoms in order to obtain prescribed drugs, to involve themselves in "doctor shopping" or to misuse drugs.
[55] Pharmacists are gatekeepers with responsibility, among other things, for dispensing drugs of addiction. To assist them in that serious task, regulations and guidelines are imposed so that the very real risks involved in dispensing drugs of addiction can be managed and mitigated. As the National Law emphasises, the protection of the public is paramount. And some members of the public, such as drug dependent patients, need protection from themselves. Medical practitioners and pharmacists share significant responsibility and are required to exercise their individual clinical judgments to ensure that individual consumers and the public are protected. The more experienced a pharmacist becomes, the better that practitioner's judgment might be expected to be. A pharmacist's failure to be attentive, or sufficiently attentive to the self-evident risks of dispensing Sch 8 drugs, undercuts the protective structure which the regulations and guidelines are intended to erect for the benefit of individual patients and the community as a whole.
[56] When compounded by a pharmacist's effective failure to exercise clinical judgment by, for example, not raising appropriate concerns with prescribing doctors (who may themselves be falling short of professional standards), the protective structure is rendered virtually useless. This would reduce a pharmacy almost to a supermarket level where customers can help themselves to whatever they want, no questions asked. ...
[57] Although failure to comply with regulations and guidelines might well evidence a fall from appropriate standards, professional standards in the health professions are not to be measured merely by compliance. The ultimate benchmark against which the professional conduct of health practitioners will be measured is the protection of the public. If the relevant conduct of a health professional fails to protect the public, and falls significantly short of the standards required to do so, or poses a real risk to the health and safety of the public, it might well justify suspension or deregistration because the community ought not be exposed to the risk inherent in such failures. Whether such a step is taken as a consequence will depend on the circumstances ...'
70. And in Saab No 2, in the context of proprietors' obligations, the Tribunal observed:
'[688]The PTGR sets out stringent statutory requirements in relation to the storage, handling and record keeping for drugs of addiction. It sets out what is required when dispensing prescriptions. These requirements include the content or the kind of information which a prescription must include, its form, provisions as to supply on prescription, and that quantity and purpose on supply to be appropriate. These Regulations exist to manage and address the very real risks to patients and the public more broadly in dispensing drugs of addiction.
[689] The [Proprietor Guidelines] focus on the professional responsibilities of proprietor pharmacists that impact on the safe, effective delivery of services to the public to ensure that the pharmacy business is conducted properly.
[690] A pharmacist who is a proprietor must maintain and be able to demonstrate an awareness of the manner in which their pharmacy business is being conducted and, where necessary, intervene to ensure that the practice of pharmacy is conducted in accordance with applicable laws, standards and guidelines. A failure to be attentive as to whether statutory requirements, standards and guidelines are being adhered to diminishes this protective structure.
[691] Pharmacists act as our caretakers in the community in the responsible and lawful dispensing of Schedule 8 medications and drugs of addiction and special prescribed restricted substances. It is their compliance with the protective architecture to which the Regulations and Guidelines are directed which ensure the safe benefits of such medications to individual patients and the community as a whole. As a proprietor and pharmacist [the practitioner] failed to ensure that these requirements were met.'
71. The observations in these cases resonate with the Respondents' conduct in this case, and reinforce its seriousness.
72. For these reasons, the Tribunal should be satisfied that each Respondent's conduct that is the subject of the Complaints (either individually or together) was sufficiently serious to justify the suspension or cancellation of their registration, and therefore constituted professional misconduct within the meaning of s 139E of the National Law."
"4. However, despite withdrawing their formal admissions to their own and the employed pharmacists' inappropriate dispensing as set out in AS [27] and [33], each of the Respondents made significant concessions in relation to those matters in their affidavits and oral evidence under cross-examination.
5. In relation to Mr Saweris:
(a) He conceded in his affidavit that his dispensing of Schedule 8 and Schedule 4D drugs to Patients A to I as set out in AS [27(a)] 'may not' have been in accordance with the recognised therapeutic standard of what was appropriate in the circumstances as required by cl 109 of the PTGR (for Schedule 8 drugs) and/or cl 54 of the PTGR (for Schedule 4D drugs);
(b) he specifically admitted in his affidavit that his dispensing to Patients A, C, D, F, G, H and I was 'inappropriate';
(c) he conceded in his affidavit that the dispensing of Schedule 8 and Schedule 4D drugs by an employed pharmacist to Patients A to I as set out in Schedule 2 of the complaint against him was 'inappropriate' or (in the case of Patient B) 'may not' be in accordance with the recognised therapeutic standard of what was appropriate in the circumstances; and
(d) he made further concessions in cross-examination that, while he did not consider himself to be in a position to say whether dispensing was contrary to the recognised therapeutic standard:
(i) his dispensing of oxycodone to Patient A on 8 September 2017 did not have any clinical justification;
(ii) his dispensing to Patient E on 18 September and 20 October 2017 was inappropriate;
(iii) his dispensing to Patient F on 8 and 18 August 2017 was inappropriate;
(iv) his dispensing to Patient G on 6 March 2018 was inappropriate;
(v) his dispensing to Patient I was inappropriate; and
(vi) the dispensing of Schedule 8 and/or Schedule 4D drugs from the Pharmacy to Patients C, D, E, F and H as set out in Schedule 2 of the complaint against him was inappropriate when viewed as a whole.
(a) He conceded in his affidavit that his dispensing of Schedule 8 and Schedule 4D drugs to Patients A, B, C, D, F, G and H as set out in AS [27(b)] 'may not' have been in accordance with, or 'could be considered' in excess of, the recognised therapeutic standard of what was appropriate in the circumstances as required by cl 109 of the PTGR (for Schedule 8 drugs) and/or cl 54 of the PTGR (for Schedule 4D drugs);
(b) He specifically admitted in his affidavit that his dispensing to each of Patients A to I was 'inappropriate';6
(c) He conceded in his affidavit that the dispensing of Schedule 8 and Schedule 4D drugs by an employed pharmacist to Patients A to I as set out in Schedule 2 of the complaint against him was 'inappropriate' and (in the case of Patients B, C and E) 'may not' be in accordance with, or could be considered in excess of, the recognised therapeutic standard of what was appropriate in the circumstances;7 and
(d) He made further concessions in cross-examination that:
(i) Based on his current knowledge, his dispensing of Schedule 8 and Schedule 4D drugs to each of the Patients other than Patient G highlighted in yellow in Schedule 2 of the complaint against him was contrary to the recognised therapeutic standard of what was appropriate in the circumstances even at the time of dispensing;
(ii) Based on his current knowledge, the dispensing of Schedule 8 and Schedule 4D drugs to each of the Patients other than Patient G as set out in Schedule 2 of the complaint against him, when viewed as a whole, was contrary to the recognised therapeutic standard of what was appropriate in the circumstances even at the time of dispensing;
(iii) In relation to Patient G, although he was not prepared to concede his dispensing or the dispensing as a whole was contrary to the recognised therapeutic standard of what was appropriate in the circumstances, he had 'a lot of concerns' and the prescribed dosage for the patient (which was in excess of 300mg oMEDD per day) was 'a big red flag'; and
(iv) The overall dispensing to each of Patients A to I was 'excessive'.
(a) He conceded in his affidavit that his dispensing of Schedule 8 and Schedule 4D drugs to Patients B, D, E, F, G, H and I as set out in AS [27(c)] 'may not' have been in accordance with the recognised therapeutic standard of what was appropriate in the circumstances as required by cl 109 of the PTGR (for Schedule 8 drugs) and/or cl 54 of the PTGR (for Schedule 4D drugs);
(b) He specifically admitted in his affidavit that his dispensing to Patients D, E, F, G, H and I was 'inappropriate';
(c) He conceded in his affidavit that, with the exception of the dispensing of nitrazepam to Patient F,10 the dispensing of Schedule 8 and Schedule 4D drugs by an employed pharmacist to Patients A to I as set out in Schedule 2 of the complaint against him was 'inappropriate' and/or (in the case of Patients A, B, C) 'may not' be in accordance with the recognised therapeutic standard of what was appropriate in the circumstances; and
(d) he made further concessions in cross-examination that:
(i) based on his current knowledge, his dispensing of Schedule 8 and Schedule 4D drugs to Patient D, E and F highlighted in yellow in Schedule 2 of the complaint against him was contrary to the recognised therapeutic standard of what was appropriate in the circumstances even at the time of dispensing; and
(ii) based on his current knowledge, the dispensing of Schedule 8 and Schedule 4D drugs to Patients A, B, C, D, F, G and I as set out in Schedule 2 of the complaint against him, when viewed as a whole, was contrary to the recognised therapeutic standard of what was appropriate in the circumstances even at the time of dispensing.
8. The Tribunal should accept these concessions, and otherwise find particulars 1(a) and (b) and 2(a) and (b) of complaint 1 to be proved in relation to each Respondent, for the reasons set out in the Torrens Report and the Supplementary Torrens Report: AS [29]¬[33] (noting AS [31(a)] and [31(b)] are not pressed). Ms Torrens did not relevantly depart from her opinions in cross-examination
""9. It is not to the point that Ms Torrens did not have information about the clinical histories of the relevant patients of the kind that may have been available to the prescribing doctor.
10. Clauses 54 and 109 of the PTGR impose a standard of appropriate supply of medications, as distinct from the prescribing of medications which is addressed in other clauses of the PTGR.12 In the context of cl 54 and 109, the recognised therapeutic standard of what is appropriate in the circumstances must be judged from the perspective of the supplier (relevantly, the pharmacist), based on the information available to them. That information includes the patient's dispensing history and notes made in the dispensing records, to which Ms Torrens had access.
11. It is apparent that the Respondents themselves had limited extrinsic clinical information when deciding whether or not to supply to these patients. Each Respondent accepted in cross-examination that they did not make adequate inquiries to determine whether dispensing which on its face was excessive was nevertheless appropriate in the particular circumstances of these patients, and that they continued to dispense in the face of what they accepted were inadequate clinical reasons given to them by the prescriber. It follows that, in the relevant circumstances of this case, there was a lack of adequate extrinsic clinical information to justify supplies that were excessive on the face of the dispensing records. The recognised therapeutic standard must be evaluated and applied in this context.
12. Similarly, it is not to the point that the Australian Medicines Handbook (AMH) may have described opioid doses as a guide only. That does not mean there is no recognised therapeutic standard for the supply of opioids. A supply of an opioid may still be in a quantity contrary to the recognised therapeutic standard of what is appropriate in the circumstances if it cannot be justified having regard to the patient's dispensing history and any known clinical information about the patient. That was the case here. It may be noted that the AMH described any opioid dose above 50 mg oMEDD as 'high', and the patients in this case were not infrequently receiving supplies in excess of 300 mg oMEDD."
"25. The Applicant understands the Respondents will contend that 'mere negligence' does not amount to knowledge, skill or judgment possessed or care exercised being significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience for the purposes of s 139B(1)(a) of the National Law. Rather, the Respondents will contend, the word 'significantly' should be read as synonymous with 'seriously', 'pronouncedly', 'conspicuously', 'markedly', 'substantially', 'to a high degree' or 'more than ordinarily'.
26. This attempt to place a gloss on the statutory language should not be accepted. 'Significantly' should be given its ordinary meaning: that is, below the standard reasonably expected in a significant way. To the limited extent that synonyms may be helpful, the appropriate synonym is 'noteworthy'. In the context of s 139B(1)(a) being a form of unsatisfactory professional conduct for health professionals, that means conduct justifying attention by the profession. In other words, the conduct should be sufficiently below the standard reasonably expected to warrant professional scrutiny.
27. This is consistent with the legislative history. The current form of s 139B(1)(a) was introduced into predecessor legislation by the Health Registration Legislation Amendment Act 2004 (NSW). Prior to this amendment, the word 'significantly' did not appear in the standard of unsatisfactory professional conduct. The second reading speech of the precursor bill described the purpose of the amendment in this way:
'The first main purpose of the bills is to refocus the Health Care Complaints Commission [HCCC] on investigating serious complaints about health service providers. To achieve this, Commissioner Walker recommended that unsatisfactory professional conduct be redefined so that only significant instances involving a lack of skill, judgment, or care will result in an investigation or disciplinary action. Unsatisfactory professional conduct will be defined as "any conduct that demonstrates that the knowledge, skill or judgment possessed, or care exercised, by the practitioner is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience". The reference to "significantly" in that context may refer to a single act or omission that demonstrates a practitioner's lack of skill, judgment or care, or it may refer to a pattern of conduct. In any individual case, that will depend on the seriousness of the circumstances of the case.'
28. The reference to 'Commissioner Walker' is to a Special Commission of Inquiry into Campbelltown and Camden Hospitals conducted by Bret Walker SC. The final report of that Inquiry raised concerns about the broad scope of the disciplinary provisions under the Medical Practice Act at the time. The concern expressed by the Commissioner was that, in the absence of a qualification requiring conduct to be significantly below the expected standard, 'shortcomings which would not even lead to civil litigation, because no real damage was caused, would nonetheless require disciplinary attention'. The Commissioner had earlier expressed this view:
'It needs to be stressed that, because all professionals are fallible and all humans are imperfect, it is unthinkable that professional reprobation, let alone suspension or deregistration, could be attracted by each and every occasion where a doctor lapses below his or her usual and acceptable standards of conduct.'
29. Accordingly, the Commissioner recommended that the definition of unsatisfactory professional conduct in the Medical Practice Act (and the corresponding definition in the Nurses Act) 'should be changed so as to require the professional deficiencies to appear to a significant degree'.
30. The legislative history is consistent with the view that 'significantly below' means below to an extent that would warrant professional reprobation of some kind, which would not be the case for every deficiency in a health professional's treatment of a patient. But it does not follow that 'mere negligence' is incapable of being significantly below the expected standard, or that 'significantly' should be read as 'substantially' or 'to a high degree'. While the Commissioner expressed the view that civilly actionable negligence may not necessarily warrant professional reprobation, that must depend on the circumstances. Negligence means a failure to take reasonable care, relevantly for a patient's health and safety. Such a failure must be capable of amounting to unsatisfactory professional conduct within the meaning of s 139B(1)(a), because the provision expressly accommodates a situation in which the 'care exercised' by a practitioner falls significantly below the expected standard. Asking whether conduct amounts to 'mere negligence' is therefore not a meaningful way of distinguishing conduct that meets the threshold in s 139B(1)(a) and conduct that does not.
31. The Applicant otherwise relies on the principles set out in AS [6] as to the application of s 139B(1)(a).
32. In any event, even accepting the Respondents' approach, the Tribunal would be satisfied that their conduct (particularly the conduct the subject of complaint 1) was below the standard reasonably to be expected to a serious or high degree for the reasons in AS [40]-[42] and [64]-[72]."
"33. The Applicant understands the Respondents will contend that the authorities referred to in AS [7] as to the meaning of 'improper or unethical conduct' in s 139B(1)(l) of the National Law should not be followed. This contention should not be accepted for four reasons.
34. First, the construction of 'improper' as conduct that is not in conformity with standards of professional conduct, practice or ethics is consistent with its ordinary meaning. The dictionary meanings of the word include:
(a) 'not truly or strictly belonging to the thing under consideration; not in accordance with truth, fact, reason, or rule; abnormal, irregular; incorrect, inaccurate, erroneous, wrong';
(b) 'not in accordance with the nature of the case or the purpose in view; unsuitable, unfit, inappropriate, ill-adapted';
(c) 'not proper; not strictly belonging, applicable, or right'; and
(d) 'not in accordance with propriety of behaviour, manners, etc.'.
35. Second, that construction of improper also accords with its context in s 139B(1)(l). The reference in s 139B(1)(l) is to '[a]ny other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession'. The use of the word 'other' directs attention by way of comparison to the categories of unsatisfactory professional conduct that appear in s 139B(1)(a) to (k). Those categories of unsatisfactory professional conduct can all be seen to be forms of conduct that is not in conformity with appropriate standards of professional behaviour, such as to warrant disciplinary attention and professional reprobation.
36. Third, the High Court gave a corresponding meaning to the word in R v Byrnes. That case concerned the proper construction of an offence provision in companies legislation which provided:
'An officer or employee of a corporation shall not make improper use of his position as such an officer or employee, to gain, directly or indirectly, an advantage for himself or for any other person or to cause detriment to the corporation.'
37. After referring to several earlier decisions, the majority expressed the following opinion:
'Impropriety does not depend on an alleged offender's consciousness of impropriety. Impropriety consists in a breach of the standards of conduct that would be expected of a person in the position of the alleged offender by reasonable persons with knowledge of the duties, powers and authority of the position and the circumstances of the case.'
38. There is no reason why a similar construction should not be adopted in the context of s 139B(1)(l) of the National Law. The fact that Byrnes (and its predecessors) were dealing with a statutory offence does not call for a different approach. The construction of 'improper' in Byrnes has been adopted in other contexts.
39. Fourth, while the Tribunal's prior decisions are not binding on the Tribunal in this case, 'it is permissible, if not desirable, for members to follow such decisions unless they are convinced the decision was clearly wrong, in the interests of consistency and predictability in decision-making and maintaining public confidence in the legal process'. In those circumstances, it is incumbent on the Respondents to clearly articulate why they say the Tribunal's prior decisions are wrong, and what construction they say should be given to s 139B(1)(l)."
"SUMMARY OF RESPONSE
1. More than five years ago, on 29 January 2019 Messrs Saweris, Derias and Morcos (the Respondents) were contacted by one of their employed registered pharmacists, Mr Azzer, and informed that the Pharmaceutical Regulatory Unit (the PRU) had concerns regarding the frequency of schedule 8 and schedule 4D medications being dispensed to some patients from Gosford Pharmacy, a pharmacy located adjacent to Reliance Medical Centre. That discovery occurred as a result of the PRU's investigation into two general practitioners of the Reliance Medical Centre, Dr Sriskanda and Dr Daoud. Mr Azzer requested an urgent meeting with the Respondents. Two days later the Respondents were informed that Dr Sriskanda had been suspended from medical practise. The Respondents conducted an urgent meeting on 1 February 2019 in response to the concerns raised by the PRU. The following day, namely 2 February 2019, they had amended existing dispensing procedures, and notably the procedures in relation to Sch 8 and Sch 4D dispensing. The detail and excellence of the procedure they implemented regarding the dispensing of SCH 8 and SCH 4D far surpasses the Commission's own expert's current (and very recent) dispensing policy regarding SCH 8 and SCH 4D dispensing.
2. The speed of the Respondents implementation of new policies to address an area of concern, namely a considered response within four days of the issue being raised and immediately following a proprietors meeting, is powerful evidence of their character and their commitment and diligence to the practice of pharmacy, both then and now. It is also the single most powerful piece of evidence to rebut any allegation of proprietorial failures.
3. In brief summary, each Respondent admits that they are guilty of unsatisfactory professional conduct in relation to Complaint One, Particular (1)(c), and Particular (2)(c), regarding only those patients that they personally (and actually) dispensed to. This admission is on the basis that each Respondent accepts that by failing to conduct a more fulsome review of the pattern of the patient's dispensing history prior to dispensing the relevant medication, they fell significantly below the standard expected of an equivalently trained pharmacist. This admission is an admission to unsatisfactory professional conduct pursuant to section 139B(1)(a) of the Health Practitioner Regulation National Law NSW (the National Law) only. No admission is made that such conduct is unethical or improper pursuant to section 138B(1)(l) of the National Law.
4. Each Respondent does not admit that they 'permitted' inappropriate dispensing by an employed pharmacist, as particularised in Complaint One, Particulars 1 and 2.
5. Each Respondent does not admit that they engaged in improper or unethical conduct as particularised in Complaint One.
6. Each Respondent does not admit that they engaged in improper or unethical conduct as particularised in Complaints Two, Three and Four.
7. Each Respondent does not admit Complaint Five, being that they are guilty of professional misconduct.
8. In relation to each Complaint and each Particular of a Complaint which is not admitted, the Respondent submits that the Applicant Health Care Complaints Commission (the Commission) has failed to prove to the requisite standard the conduct and failures alleged. A critical analysis of the history of dispensing and pharmacy guidelines, which evince the context in which the alleged conduct must be assessed, together with a proper understanding of the legal principles relevant to the operation of the National Law squarely rebut proof in this case.
9. Pertinently, the particular factual matrix and evidence tendered and relied upon by each Respondent further rebuts proof of the Particulars and Complaints not admitted. Although imperfections and even failures may be found in each pharmacist's decision making, the gravity of their failures is not of an order to establish proof of unsatisfactory professional conduct, let alone professional misconduct, when considered in all the circumstances of the case.
10. Each Respondent has stated from the outset, that they did exercise clinical judgement prior to dispensing the medications particularised in Complaint One Schedule 2 namely they:
i) Assessed who the prescriber was - namely known or unknown to them;
ii) Assessed from which medical practice the script was issued - again assessing whether the medical practice and prescribers were known or unknown to them;
iii) Assessed what if any trust relationship existed between themselves and the prescriber;
iv) Believed as a result of their training that they could not challenge- let alone refuse- a bona fide script as it reflected the prescriber doctor's clinical decision making;
v) As to (iv) above, this belief was held on the basis that the doctor's skill, experience and knowledge regarding the patient's history, illness, diagnosis and management was superior to their own as to the clinical indication for the medication;
vi) As to (iv) above, this belief was held on the basis that the prescribing doctor was in the best position to assess the truthfulness of their patient's account regarding lost, misplaced, stolen or medication the subject of misadventure; and
vii) As to (v) above, for scripts written by Dr Sriskanda, the Respondents had been informed that along with being a Fellow of the Royal Australian College of General Practitioners, having graduated from New South Wales University, Dr Sriskanda had been selected by the International Association of Health Care Professional to be featured in the 'Leading Physicians of the World' publication due to her outstanding performance in the field of general practise. She was the most experienced GP at Reliance Medical Clinic, supervised many of the training doctors and was an approved Opioid Treatment Program provider.
11. As outlined below, the beliefs held by each of the Respondents, which explains the dispensing they engaged in, were firstly honestly held beliefs. That honesty is most powerfully demonstrated by their immediate remedial action in January 2019 when the PRU raised concerns about the GP prescribers at Reliance Medical Clinic. The mere fact of their corrective measures immediately after the Regulator had informed them of an issue, reflects that this is not a case of intentional or reckless failures in dispensing, but rather an honest but mistaken belief as to the relationship between dispenser and prescriber.
12. Secondly, the evidence not only supports a finding that each Respondent held an honest belief, but that their belief as to the power structure between prescriber and pharmacist was one that was reasonable in light of their training and education. This submission is borne out by proper and critical consideration of the foundational documents that guide a pharmacist's practice, namely practice guidelines, codes of conduct and the prevailing culture at the relevant time."
"Proprietor Guidelines
13. The Commission relies upon the Proprietor Guidelines in support of aspects of each of Complaints One, Two, Three and Four. The conduct the Commission relies upon in Complaints Two - Four, alleged to be evidence of a failure to properly discharge the obligations of a proprietor pharmacist, is revealing of the Commission's attitude to the standard to be expected of a proprietor pharmacist. The standard the Commission appears to endorse and advocate for, and which it is alleged the Respondents fell below, is tantamount to a standard of perfection. Competence is not synonymous with perfection. To seek perfection in the practise of pharmacy is irrational, untenable and inconsistent with the objectives of the National Law, which include to enable the continuous development of a 'flexible, responsive and sustainable Australian health workforce': section 3(f) National Law.
14. Specifically, while there is no dispute that a proprietor pharmacist has an obligation to 'maintain an awareness of the manner in which the pharmacy dispensing practice was being conducted', there is a dispute between the parties as to the actual and practical scope of this obligation. The requirement to 'maintain an awareness' must be considered in its proper professional and commercial context. The obligation is not tantamount to a requirement to be aware of every single instance of dispensing, some of the dispensing, or even the vast majority of dispensing. Such a standard would be unrealistic, unworkable, and inconsistent with the terms of the guidelines.
15. The Commission's written submissions will be referred to as 'AS' (Applicant's written submissions dated 21 August 2024) and 'SS' (Supplementary Submissions dated 12 November 2024."
"16. Section 41 of the National Law provides that 'an approved registration standard' for a health professional, or a 'code or guideline approved by a National Board', is admissible as 'evidence of what constitutes appropriate professional conduct or practice for the health profession'.
17. In this case, consideration of relevant codes and guidelines reveals the prevailing culture and recommended best practice at the time of the relevant conduct, and the notable shift in guidelines for dispensing in late 2018 and early 2019. This shift, articulated more fully below, post-dates the dispensing relevant to these Complaints
"19. It is not disputed that at the relevant time the Pharmacy Board's Dispensing Guidelines, and other relevant codes of conduct, included an express requirement to 'exercise an independent judgment': cf SS at [21] and [23]. It is also not suggested that prior to late 2018 the professional guidelines and codes set out below simply permitted pharmacists to 'defer' or to 'just defer' to the judgment of the prescriber: cf SS at [21] and [24]. Nor is it suggested that permission to decline supply was not recognised by the profession prior to late 2018: cf SS at [24].
20. Instead, it is submitted that when consideration is given to how pharmacists were encouraged to exercise their independent judgment, proper attention must be paid to the following:
a. Pharmacists were repeatedly encouraged to 'respect the skills and expertise' of the prescriber;
b. There was no express or clear endorsement that pharmacists had the right to refuse supply prior to December 2018;
c. Instead, there was an expectation that a pharmacist would only refuse to dispense in 'exceptional circumstances';
d. Prior to December 2018 the profession had publicly expressed concern about being 'powerless to act', and did not feel they had the clear or express 'authority to deny or delay supply'.
21. Those matters, in particular, were reflective of the operative and prevailing professional culture at the time, an appreciation of which is essential to properly and fairly consider each of the Respondents' conduct in its proper context.
22. As to the Commission's submission at SS [22], the material relied upon by the Respondent is largely published by the Pharmaceutical Society of Australia. The Commission does not submit that that material is 'irrelevant' to identifying the 'content of the expected standard'. If the Commission concedes that the material is relevant, the mere fact that the documents may be 'subsidiary sources' does not diminish their importance to guiding the profession. The profession is entitled to have regard to, and rely on, material published by reputable and leading bodies such as the Pharmaceutical Society of Australia.
23. This is consistent with the Medical Board's Guidelines for Dispensing for Medicines which relevantly provides that pharmacists are encouraged to maintain an awareness of the standards published by the profession, which the Board will have regard to in considering complaints against pharmacists. Standards can be accessed on the websites of the professional bodies, including Pharmaceutical Society of Australia and the Pharmacy Guild of Australia. This is consistent with the evidence from the Commission's own expert, Ms Torrens who gave evidence that she had regard to all the relevant guidelines and standards published by the profession, including those published by the Pharmaceutical Society of Australia.
24. Moreover, if there is any ambiguity, uncertainty, or inconsistency within or as between the Pharmacy Board and the Pharmaceutical Society of Australia, that only serves to highlight the mixed or unclear messages that were being sent to the profession at the relevant time. Such ambiguity or inconsistency in the material must inform an assessment of the degree of any alleged departure from them, and thereby the degree of any alleged failure in conduct. The issue of the degree of failure in conduct is central to assessing whether any one of the Respondents' conduct amounts to conduct that is significantly below the standards expected or conduct that is improper or unethical."
"'If the prescriber is unavailable, or is unwilling to accept the pharmacist's advice, the pharmacist must make a professional judgment as to what action is required to satisfy their duty of care to the patient. Possible actions may include adjusting the dose, recommending against supply, or in exceptional circumstances actually declining supply."
"28. In summary, as at March 1997, while a pharmacist was encouraged to use their professional judgment, the relevant guidelines only endorsed a pharmacist actually declining supply in 'exceptional circumstances'.
29. The Commission's expert, Ms Torrens, gave evidence that she did not recall what constituted exceptional circumstances where supply could be declined. Ms Torrens could not recall that there was any guidance or list as to what constituted 'exceptional circumstances'."
"'A pharmacist must exercise professional judgment to prevent the supply of products likely to constitute an unacceptable hazard to health .... or excessive quantities of medicines and other products, particularly those that have the potential for abuse or dependency.'"
"'...must respect the skills and expertise of other health professionals and work cooperatively with them to optimise the health outcomes of their mutual clients.'"
"a. Maintaining 'effective professional relationships with colleagues and other health professionals';
b. Endeavouring to 'maintain the confidence and trust placed in colleagues by clients';
c. To 'refrain from making comment which could detract from the professional reputation of other health professionals'."
"does not explain how a pharmacist would give effect to the mandatory requirement ('must') to respect the skills and expertise of other health professionals, if the prescribing doctor's view as to the script they prescribed conflicted with the pharmacist's own view as to the dispensing of the script."
"In summary, in March 1998, the PSA's 'Code of Professional Conduct', similar to the 1997 Dispensing Guidelines, encouraged the exercise of professional judgment, but also expressly required pharmacists to 'respect' the 'skill and expertise' of other health professionals."
"'A pharmacist must take reasonable steps to ensure that the dispensing of a medicine in accordance with a prescription or order is consistent with the safety of the person named in that prescription or order.
Guidelines
"In dispensing a prescription, a pharmacist has to exercise an independent judgment to ensure the medicine is safe and appropriate for the patient, as well as that it conforms to the prescriber's requirements. If there is any doubt, the prescriber is to be contacted.
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, and other relevant circumstances needs to be taken into account.'"
"In summary, while there is a general exhortation in the 2010 'Guidelines for dispensing medicine' to exercise 'an independent judgment', the guideline gave no express direction, recommendation, or even suggestion, that a pharmacist could challenge the prescriber with respect to the script, and/or refuse to dispense. The guideline states no more than that a prescriber should be contacted if a pharmacist has 'doubt' about a script."
"'In communications with other healthcare providers, pharmacists should be respectful, exercising appropriate professional tact. Pharmacists should be aware of and familiar with the PSA Code of Conduct, particularly principle 6, which states that 'a pharmacist must respect the skills and expertise of other health professionals and work cooperatively with them to optimise the health outcomes of their mutual clients.'"
"In summary, while the 2011 guidelines set out circumstances in which communication with a prescriber may be required, the guideline, like the PSA Code of Conduct referred to above, simultaneously endorsed a degree of deference to the clinical judgement and decision making of the prescriber."
""Contact the prescriber if there is:
- Concern about the suitability of the medicine for the consumer
- Concern about the potential for medication related problems
- Doubt about the legality or validity of the prescription
- Uncertainty about the prescriber's intentions
Offer evidence based strategies or solutions to the prescriber to promote optimal medicines used for the consumer. Document the outcome of the discussion with the prescriber to provide a record of clinical decisions. Inform the consumer of the results of the collaborative discussion. If the prescriber is unavailable or is unwilling to accept the pharmacist's advice, use professional judgment to determine the most appropriate action to take to satisfy the duty of care to the consumer".
"In summary, as at 2015, while there was encouragement to contact the prescriber if there was a 'need' to do so, the Handbook does not give any direction, recommendation, or suggestion that a pharmacist could challenge the prescriber with respect to the script, or refuse to dispense the script."
""The guideline states that they provide 'guidance on expected professional practice', and can be used 'as a tool to support balanced and professional decision making'. However, the guideline also expressly specifies that they are 'not definitive statements of correct procedure but represent agreement by experts in the field' and 'do not set a prescribed course of action or a mandatory standard to which pharmacists must adhere.' Instead, pharmacists are expected to 'exercise professional judgement when adapting the guidance provided in these guidelines to specific circumstances'."
"'Pharmacists are encouraged to collaborate with the prescriber to optimise patient care.
Pharmacists should obtain the patient's consent prior to contacting a prescriber. When communicating with a prescriber or other health professional the pharmacist should specify their particular concern, provide supporting evidence and suggest appropriate alternatives.
Contact with the prescriber may be required if there is:
• Doubt about the legality or the validity of the prescription
• Uncertainty about the prescriber's intention
• Clear potential for drug misadventure
• Apparent over or under use of medication
• Doubt about the suitability of the medicine for the patient
Outcome of the communication with prescribers should be documented in the patient healthcare record where relevant."
"On the following page, under the heading 'pharmacist responsibilities', the guideline does state that a pharmacist is responsible for assessing the appropriateness of the medicine in relation to the medication (not dispensing) history (p 988)".
"'The pharmacist must ensure that the supply of dispensed medicines is consistent with the prescriber's intention and [Quality use of Medicines]. The prescriber determines appropriate therapy and communicates this to the pharmacist via details on the prescription including quantity to be supplied (number of), and interval between repeats' (p 989).
Further, in relation to risk management, the guideline expressly states that pharmacists are permitted to dispense an early repeat supply in certain circumstances:
'Under the PBS, pharmacists are permitted to dispense a prescription as an early repeat supply (i.e. the minimum required interval between supplies has not been met) if the patient's PBS medicine has been lost, stolen or destroyed, or the medicine is required without delay for treatment. The pharmacist must be satisfied that one of these conditions is met. The pharmacist must sign a prescription and annotate it with 'immediate supply necessary'. In addition, there may also be circumstances where simultaneous supply of multiple quantities of the medicine is genuinely in the best interests of the patient to show a continuity of therapy': (p 990)."
"expressly provides that it is the prescriber who determines appropriate therapy. There is no part of the 2017 Guideline which expressly encourages, permits or requires pharmacists to refuse to dispense medication in the exercise of professional judgment, contrary to any intention of the prescriber.
The 2017 guideline was the guideline in operation at the time of the alleged misconduct in this prosecution."
"Notably, there is no change regarding those recommendations as between 2015 and 2018. In mid 2018 consultations had commenced which resulted in changes to the PSA guidelines for pharmacists. They were not reflected in relevant guidelines or handbooks until the 'Guidelines for pharmacist performing clinical interventions' was published in December 2018' - which post-dates the dispensing in this prosecution."
"In summary, in 2018 the Handbook contained substantially the same recommendations as in 2015, which offered some encouragement to contact the prescriber if there was a 'need' to do so, but did not give any direction, recommendation, or suggestion, that a pharmacist could challenge the prescriber with respect to the script or refuse to dispense the script."
"Other suggestions
The role of pharmacists
Medicines supply involves both prescribing and dispensing and pharmacists have a key role to play in addressing problems associated with opioid analgesic use and misuse. Pharmacists are in a position to detect potential misuse by patients and inappropriate/over-prescribing by practitioners, yet often feel powerless to act. Pharmacists need the authority to deny or delay supply of opioid analgesics where there are concerns about inappropriate prescribing and require support in discussing concerns with the practitioner. This involves developing agreed upon protocols to be followed by both prescribers and pharmacists and educational programs as to the role of the pharmacist aimed at pharmacists, prescribers and consumers."
(emphasis added by the Respondents).
"Following the TGA Consultation Paper in 2018, and the cultural changes in the practice of pharmacy following the coronial inquest into the death of a man in Melbourne following complications of methotrexate toxicity, there is a notable shift in the relevant pharmaceutical guidelines.
It is essential, in the context of this case, to appreciate the shift in late 2018 regarding how pharmacists should communicate with other health care providers."
"'When communicating with prescribers and other healthcare providers, pharmacists should gather as much information about the patient and presenting situation as required to ensure that communication is productive. Where appropriate and available, pharmacists should use resources such as My Health Record and real time prescription monitoring to gather required information, and assist in making clinical recommendations and decisions. When discussing a clinical intervention with other healthcare providers, pharmacists should be clear and concise about the reasons for their concerns and have potential solutions to discuss or stop.' (p 1052)
...
'Pharmacists must make the health and wellbeing of the patient their first priority and demonstrate responsibility and accountability for all decisions made and actions taken.'
...
'Collaboration does not alter the pharmacists' personal accountability for the care provided to patients and pharmacists have the right to refuse to supply medicines if they believe it is unsafe or inappropriate.
If another healthcare provider insists that a medicine is supplied and the pharmacist believes the supply is inappropriate or unsafe the following options may be appropriate initially:
- Delay supply while gathering further information (example through literature research, consulting current and credible references).
- Seek further advice from a reputable source (example drug information centres, other healthcare providers of patient they have consulted for the same condition previously, professional indemnity insurer).
A pharmacist must not supply a medicine where they believe it poses an unacceptable safety risk for the patient. If the pharmacist does not supply the medicine they need to support the patient in receiving an appropriate management and treatment. This may involve explaining to the patient the reasons for not dispensing the medicine and providing written information for the patient. Actions taken to ensure that the patient receives appropriate management will depend on the situation...
Pharmacists should also use their professional judgement to determine whether it is essential that the medicine is supplied immediately, or whether it is appropriate to delay supply until further information can be gathered.
...
Pharmacists should document all communication made with other healthcare providers and the patient's history, for example in the form of clinical notes': p1053
When communicating with prescribers and other healthcare providers, pharmacists should gather as much information about the patient and presenting situation as required to ensure that communication is productive. Where appropriate and available, pharmacists should use resources such as My Health Record and real time prescription monitoring to gather required information, and assist in making clinical recommendations and decisions. When discussing a clinical intervention with other healthcare providers, pharmacists should be clear and concise about the reasons for their concerns and have potential solutions to discuss or stop." (p 1052)"
"The emboldened portions of the extracts above represent for the first time, express guidance that Pharmacists have the right to refuse supply. This was not in place during the relevant time of the impugned conduct in this prosecution."
"For the first time the dispensing process is described as including the following:
Step 3: considering supply arrangements
- Make decision to supply or decline supply,
- Comply with legal and professional obligations for specific supply arrangements. (p 1095
"In the June 2019 dispensing guideline there is included for the first time, a heading titled 'Declining to supply' which says:
"'Declining to supply:
Pharmacists should exercise professional autonomy, objectivity and independence in the dispensing process. They have the right to decline to supply medicines if they believe use is unsafe or inappropriate even if the prescriber is not in agreement.
While respecting the autonomy of the patient and the prescriber, the pharmacist must ensure that the patient is adequately informed about:
• The reasons for declining including the benefits and risks associated
• Recommended action to be taken by the patient to pursue safe and appropriate treatment in a timely manner
Information should be provided verbally and in writing to the patient, preserving patient confidence. The justification for declining to supply a medicine and recommended action is to be taken by the patient should be recorded in the patient healthcare record in the dispensing software": (p 1100)".
"The pharmacist must be satisfied as to the safety of the medicine for the patient before the medicine is dispensed. ....
If the prescriber is not in agreement with the pharmacists' concerns, pharmacists should also consider the patients' therapeutic need while safety is being ascertained. As well as having the right to decline to supply medicines if they believe use is unsafe or inappropriate, pharmacists may consider alternative options such as suspending of supply, provision of a reduced quantity or increased monitoring.
Where the pharmacist has declined to supply medicine verbal communication with the prescriber should be followed up with written information sent to the prescriber about the action taken for their records" (p 1101)."
"93. Pharmacy guidelines do not speak with one clear voice on this issue.
94. For example, the Pharmacy Board of Australia's 2023 'Guidelines for dispensing of medicine' version does not incorporate the newly implemented December 2018 PSA 'Guidelines for pharmacists performing clinical interventions' which has express guidance for refusing to supply despite the authenticity of a script.
95. Further, the 2023 'Guideline for dispensing medicine' by the Pharmacy Board further makes no reference at all to the December 2018 PSA 'Guidelines for pharmacists performing clinical interventions'.
96. In relation to 'dispensing precautions - safety of prescription' under guideline 2, the Pharmacy Board states:
'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 judgement must be exercised by the pharmacist in deciding appropriate action to take.' (p 1255)
"If the pharmacist decides not to dispense the prescribed medicine the patient must be informed about the reasons for the decision and the alternative options available to the patient regarding their medication needs. Appropriate documentation should be kept to support the action taken": (p 1255)
98. So, while the PBA 2023 Guideline acknowledges that a pharmacist may decide not to dispense, this should be contrasted with a more involved position under the PSA 'Guidelines for pharmacists performing clinical interventions', dated December 2018. There is evidently somewhat mixed, and at least ambiguous messaging being sent to the profession with respect to empowering pharmacists with an ability to refuse to dispense medication.
99. It is apparent that, at the relevant time, each of the Respondents' belief that they could not decline supply, in particular once directed to do so by the prescriber, was a belief reasonably held based on the codes and guidelines that existed at the time of their training to be registered pharmacist in Australia; at the time of their supervised practise in Australia; and following their full registration. The late 2018 submission from the Faculty of Pharmaceutical Policy Network makes plain that the Respondents belief that they could not decline a bona fide script issued by a prescriber, was a belief held by others, arguably many in the profession. The Respondents were not outliers in this regard."
"Those express encouragements to trust, or develop a relationship of trust, with other health care providers is particularly relevant in the context of this case, and in light of the evidence from each Respondent as to the established relationship of trust between themselves and prescribing general practitioner Dr Sriskanda and Reliance Medical Clinic."
"Does dispensing contrary to the Pharmaceutical and Therapeutic Goods Regulation 2008 (NSW) ('PTGR') or cl 1 of the Pharmacy Board of Australia 'Guidelines for dispensing of medicines' dated 7 December 2015 (Dispensing Guidelines) constitute improper or unethical conduct for the purposes of s 139B(1)(l)?"
""Does the characterisation of conduct as improper for the purposes of the National Law depend on consciousness of impropriety or the conduct being intentional, relying on: Nguyen and Aref?"
"185. Finally, the Respondents do not accept that there is a general proposition that conduct can be improper even where it is 'not intentional', as contended for by the Commission.
186. It is respectfully submitted that whether conduct is improper is a matter that depends upon the facts and circumstances of the particular case. To cite again from Grove v Flavel, set out above, (noting the limitations of importing reasoning from cases that concerned very distinct issues):
'[W]hat is 'improper' for the purposes of s.124(2) cannot be determined by reference to some common, uniform, or inflexible standard which applies equally to every person who is an officer, but rather must be determined by reference to the particular duties and responsibilities of the particular officer whose conduct is impugned.'"
"187. As expressly provided for in section 41 of the National Law, professional guidelines are admissible and relevant to an assessment of 'what constitutes appropriate professional conduct or practice for the health profession'.
188. In that sense, the following material is relevant to (but not determinative of) an assessment of whether or not the Respondent's conduct constitutes 'improper' or 'unethical' conduct."
"195. A close analysis of the Ethics Workshop identifies that it is simplistic and naïve to suggest that the answer to various ethical dilemmas is straightforward or self-evidently results on each occasion to a single correct response or outcome. The nuances identified in the Ethics Workshop should inform the Tribunal's evaluative assessment as to what if any Particular of any of the Complaint has in fact been proven regarding the dispensing particularised, when proper consideration is given to each Respondent's reasons for dispensing as outlined in short form at paragraph 8 and 9 of these submissions."
"At [22] - 'On 10 January 2019 Mr Morcos was advised by an officer of the PRU requesting dispensary record for the last two years. Those documents were provided both electronically and physically.
At [24] - On 29 January 2019 Mr Azzer requested an urgent meeting with the co-proprietors to address concern about dispensing of schedule 8 and schedule 4D medication. An urgent meeting was convened on 1 February 2019, that is, two days later, to 'address concerns raised by the PRU and measures to be implemented to address the issues raised'."
"201. The use of the word 'permit' by the Commission must require some active state of mind, and corresponding conduct, on the part of each of the Respondents. To construe the word 'permit' as contemplating any lower or lesser standard, would be inconsistent with the practical realities of being the proprietor of a Pharmacy, including that a proprietor pharmacist is lawfully permitted to be completely absent from the day-to-day activities of the pharmacy.
202. In these circumstances, 'permit' must, at a minimum, require:
a. Knowledge or awareness of the dates of each dispensing by another employed pharmacist;
b. Knowledge or awareness that at the time of the dispensing, that the dispensing was in fact inappropriate;
c. Intentionally allowing or tolerating the inappropriate dispensing by not taking any steps to intervene and stop it.
203. In circumstances where each relevant 'employed pharmacist' was themselves registered, and as such subject to their own legal and professional obligations, it cannot be incumbent upon a proprietor pharmacist to supervise each instance of dispensing. This is consistent with the Tribunal's reasoning in Health Care Complaints Commission v Ashour at [45], considered in more detail below.
204. If that construction is accepted, and each Respondent pharmacist can only be considered to have 'permitted ... inappropriate dispensing' if they have a corresponding degree of knowledge or awareness, it is difficult to see how they could be guilty of Complaint One on the basis of either Particular (1)(d) or (2)(d), both of which allege a failure to maintain an awareness."
"205. In their oral evidence before the Tribunal, both Mr Derias and Mr Morcos 'admitted' that their conduct was contrary to clause 54 and/or 109 of the Poisons and Therapeutic Goods Regulation (PTGR) in that it was in a quantity that did not accord with a recognised therapeutic standard. This could be taken as, in effect an 'admission' to Complaint One - Particular (1)(a) and Particular (2)(a), and consequentially an admission to Complaint One - Particular (1)(b) and Particular (2)(b).
206. Nonetheless, the Tribunal must still come to its own state of satisfaction to the relevant Briginshaw v Briginshaw standard regarding whether the Commission has in fact proved Particulars 1(a)/(b) and 2(a)/(b)- despite what appears on its face to be an 'admission' in the witness box.
207. As set out above, satisfaction on the 'mere' balance of probabilities, is not sufficient, in cases such as this. There are questions of misconduct in a professional sense, and so the Tribunal must feel an 'actual persuasion' that those particulars are established. This is particularly so where Regulation 54 and Regulation 109 of the PTGR are each offence creating provisions, which carry as a maximum penalty 20 penalty units, or 6 months imprisonment."
"218. In circumstances where Mr Derais and Mr Morcos, in their respective affidavits, offered a qualified acceptance that some instances of dispensing may be contrary or in excess of a recognised therapeutic standard, a blanket admission that the dispensing was not in accordance with a recognised therapeutic standard during their evidence should be approached with great caution.
219. The Respondents' respective evidence in their affidavits (also in Mr Saweris' affidavit) that instances of dispensing may be contrary to a recognised therapeutic standard (as opposed to is or was), is a qualified or partial admission on the basis that the Commission bears the onus of proof in relation to each and every particular.
220. Moreover, as is articulated more fully below, the Tribunal must consider whether it is satisfied, in the terms of the Complaint, that 'on each of the dates' relied upon by the Commission, the dispensing was in fact contrary to the PTGR, or otherwise in a quantity that does not accord with a recognised therapeutic standard.
221. Messrs Derias and Morcos' global or blanket 'admissions' that the dispensing generally was contrary to the relevant provision of the PTGR, does not answer the Commission's Complaint in relation to each of the specific dates as alleged by the Commission, when consideration is given to what is required to establish a contravention of either Reg 54 or 109 of the PTGR, as set out below."
"223. Accordingly, when considering whether or not those particulars are established, regard should be had to the precise terms of both regulations 54 and 109, which are as follows:
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. (italics for words omitted in the Complaint but contained in the legislative provision)
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."
(italics for words omitted in the Complaint but contained in the legislative provision)
"Consideration of whether or not an instance of supply or dispensing is appropriate in the circumstances, necessarily, requires consideration of the precise and specific circumstances related to each instance of supply."
"228. Following that line of reasoning, before the Tribunal could be satisfied of Complaint One, Particular (1)(a) or Particular (2)(a), the Tribunal must be satisfied, to the relevant standard, that on each of the occasions particularised in the schedule, the practitioner:
a. Inappropriately dispensed to the relevant patient in circumstances where;
b. The dispensing was contrary to regulation 54 or 109 of the PTGR;
c. In that it was in a quantity that did not accord with a recognised therapeutic standard;
d. Of what is appropriate in the circumstances."
"231. A conclusion that the dispensing was contrary to the terms of regulations 54 or 109 of the PTGR mandates consideration of what was appropriate 'in the circumstances'. Similarly, before the Tribunal could be satisfied that the 'dispensing intervals and/or frequency did not accord with a recognised therapeutic standard', proper consideration should be given to the circumstances of the dispensing.
232. The relevant 'circumstances' contemplate matters such as:
a. Any diagnosis;
b. Any formulated prognosis;
c. Any management plan;
d. Any records from a general practitioner regarding the rationale for the prescription or the dosage;
e. Evidence from the patient regarding their circumstances;
f. Evidence from the patient of matters they communicated to the dispensing pharmacist, for example an explanation for repeat dispensing or a short interval between dispensing, such as a change in their management plan, dose, or the script or medication being lost or stolen, travel plans, interstate holidays or business;
g. The opinion of a specialist or other expert regarding whether the dosage, intervals or frequency is consistent with a recognised therapeutic standard with the knowledge of the matters raised in (a) - (f) above.
233. In this case, there is no evidence before the Tribunal of any of those matters. Not a single clinical record from any prescriber for Patients A-I was tendered by the Commission. Not a single statement was tendered from any of the prescribing doctors as to their rationale behind the prescribing based on their assessment of the patient's clinical history and symptoms.
234. Importantly, the Commission's own expert Ms Torrens accepted in cross examination that there must exist other information, not before the Tribunal, which is relevant to whether or not the prescribing was for a recognised therapeutic purpose. She also accepted that it is the prescriber who is in the best position to assess whether the prescribing of the medication was for a recognised therapeutic purpose
""236. The AMH in 2018 for opioids relevantly provided under the heading "Dosage" (Exhibit R9):
"Doses are a guide only and may vary according to the clinical situation, condition of the patient and previous analgesic requirements. Older patients generally require lower opioid doses. Higher doses may be required to achieve adequate analgesia in patients on chronic opioid treatment or with a history of opioid misuse."
237. As to Oxycodone, the AMH (see Exhibit R9) again repeats under "Dosage" that the doses are a guide only and will vary depending on the indication, eg acute or chronic pain, and previous analgesic requirements. It states that in acute pain and palliative care:
"there is no maximum dose; only adverse effects limit the dose".
238. For "acute pain: adult", for oral doses, the guide is initially 5-15mg every 4 hours; and to titrate dose according to response and sedation score. The guide also recognises that the dosing requirements will be different with opioid-naïve patients, which will require a lower initial dose.
239. The AMH in 2018 for chronic pain relevantly provided as to the use of opioids, to consider involving a specialist pain team to assess and manage patients, particularly if they are already taking opioids: - in high doses (eg >50mg morphine equivalent daily); - long term, eg years."
"240. Ms Torrens stated that in giving an opinion about whether or not the medication dispensed was in excess of the recognised therapeutic standard she did not need to know the diagnosis of the patient. Nonetheless, Ms Torrens agreed that the following factors were relevant to whether or not the regime in place was within the recognised therapeutic standards, namely:
a. different patients received different drug regimes depending on their medical conditions;
b. opiate naïve patients received different drug regimes to those that are not;
c. patients respond differently to dose frequency and as a result these can be titrated up or down;
d. a patient's pain condition can change over time as their tolerance to opiates increases;
e. if a patient was presenting early as a result of a misadventure with their tablets that would have an impact on the recognised therapeutic standard being met;
f. further, she accepted as relevant whether or not the patient had an updated medication plan from a pain specialist when they presented earlier for the dispensing of a script; and
g. she further agreed that the reasons of an early presentation are relevant factors in assessing whether or not something is within the therapeutic standards.
"244. Effectively, the Commission's position is that the Tribunal could be satisfied that the dispensing was 'inappropriate', in that it was in a quantity, interval or frequency that did not accord with a recognised therapeutic standard, in the absence of any evidence of the surrounding circumstances, which is essential to making an assessment of the appropriateness of the dispensing, where Pharmacists are expressly advised by the AHM that:
a. Doses are a guide only;
b. Doses may vary according to the clinical situation;
c. There is no maximum dosage; and
d. Dosage will vary depending on the patient's personal circumstances."
"Mr Saweris
245. In reference to Patient A, Mr Saweris gave evidence that when considering therapeutic dose, the AMH stated that there was no maximum dose for opioids. This is set out above.
246. In reference to Patient C, Mr Saweris gave evidence that the AMH provided that the starting dose for Oxycotin was 15mg for every 4 hours, which is nearly 90mg of oxycodone daily. If it is not controlled, it can be increased by 25-30% until the pain is controlled. Oxynorm could also be added for breakthrough pain. There was no maximum dose in the AMH. Rather, it was according to the tolerability of the patient.
247. In terms of the dispensing of a combination of Sch 8 and Sch 4D medications, Mr Saweris gave evidence that this is permitted under the AMH but required more support and counselling for the patient.
248. As to Mr Saweris' dispensing on 18 September 2017, it was suggested to Mr Saweris that Patient C was dispensed 260mg of opioids, and that this was a very large quantity. Mr Saweris did not accept the proposition. He explained that the two prescriptions (80mg and 40mg) added up to about 300mg OMEDD. This is equivalent to one patch of Durogesic patch.
249. As above, the AMH provides that the starting dose for Oxycotin is 15mg for every 4 hours, which is nearly 90mg of oxycodone daily. If pain is not controlled, it can be increased by 25 - 30% until the pain is controlled. Oxynorm could also be added for breakthrough pain. There was no maximum dose in the AMH. It is according to the tolerability of the patient. Mr Saweris therefore considered the dose was within the therapeutic dose per AMH. Mr Saweris noted that if a patient used two patches of Duragesic, this would add up to more than 400mg per day.
250. Mr Saweris also gave evidence that after the TGA submissions (in late 2018), they cancelled the 80mg oxycodone medications, which were taken off market. He was unsure about the 40mg. However, he stated that with SafeScript, most prescribers are following the guideline.
Mr Morcos
251. Mr Morcos only dispensed to Patients B, D, E, F, G, H and I. In total, Mr Morcos was only involved in approximately 17 of the dispensing occasions, out of approximately 181 dispensing occasions. He was therefore personally involved in less than 10% of the total dispensing occasions set out in Schedule 2.
252. In reference to Patient B, Mr Morcos gave evidence that he was not aware at the time of dispensing that Patient B was previously on OTP. There was no system or requirement back then to check if the patient was previously an OTP patient at a different pharmacy. There is now a system to check this history.
253. Mr Morcos also gave evidence (in reference to Patient B) that Durogesic patches were not something unusual to supply at that time. This changed in 2020.
Mr Derias
254. In reference to Patient D, Mr Derias did not agree that the dispensing as a whole was contrary to dispensing as he could not remember if Patient D was a cancer patient. Mr Derias gave evidence that it is his understanding that cancer patients are allowed up to 300mg. He agreed that he could not say one way or the other with this patient.
255. In reference to Patient G, Mr Derias gave evidence that this patient was a cancer patient. He was therefore not able to say one way or the other whether the dispensing to this patient was contrary to recognised therapeutic standards."
"256. In the same way that the conduct of each of the Respondents should be considered in its proper context, being the relevant professional guidelines and prevailing culture, and an analysis of each occasion of dispensing, rather than a global retrospective assessment of Schedule 2, the relevant conduct should also be considered in the context of the many instances of dispensing that did not constitute early dispensing. This is relevant to Particular 1(a) and also to the issue of the Respondents 'awareness' of any pattern based on the previous entry of dispensing.
257. As set out in Annexure A to these submissions, for Patient B, there were 29 occasions when medications were dispensed to Patient B that did not represent early or excessive dispensing. For Patient G, there were 26 occasions when medications were dispensed to Patient G that did not represent early or excessive dispensing.
258. For the reasons outlined above, each Respondent submits that the Commission has failed to prove that on 'each of the dates' as set out in Schedule 2 the dispensing amounts to a criminal offence contrary to regulations 54 and/or 109 of the PTGR and therefore amounted to 'inappropriate dispensing'. Further the Commission has failed to prove inappropriate dispensing based on the intervals or frequency not according with recognised therapeutic standards. The failure to lead a scintilla of evidence from a general practitioner as to the basis for the prescribing 'on each date' particularised, or even generally- must prove fatal to proof of Particulars 1(a) and (b) and Particular 2(a) and 2(b)."
"261. The particulars allege that on those occasions the relevant Pharmacist failed to:
a. Maintain an awareness of the manner in which the pharmacy dispensing practice was being conducted, and
b. Intervene into the dispensing practices at the pharmacy where necessary, contrary to the Guidelines for Proprietor Pharmacists.
262. The Respondents submit that the Commission's position is not consistent with either the actual terms of the Proprietor's Guidelines, the practical realities of being a proprietor Pharmacist, or the manner in which the Tribunal has interpreted the Proprietor's Guidelines in other decisions."
""267. It is accepted that guidelines are 'admissible' in proceedings as evidence of 'what constitutes appropriate professional conduct', as per the terms of section 41. However, in all cases, the terms of any guidelines or codes do not exist as an inflexible, arbitrary, or uniform standard. The use of the words 'may be' and 'can be' (as opposed to 'will be') is important as it constitutes a recognition by the authors of the Proprietor's Guidelines that it does not automatically flow that non-compliance with the guidelines will result in action under the National Law.
...
269. The Commission submits (at AS [21]-[22]) that when considering whether or not a registered pharmacist has breached a provision of the Proprietor Guidelines, the question is not one of 'intentional wrongdoing or negligent omission', but that the proprietor is 'liable' if 'the relevant standards were not adhered to except, potentially, if they made an honest and reasonable mistake of fact'. This submission is made in reliance on earlier decisions of the Tribunal in Health Care Complaints Commission v Ashour ; and Saab No 2 .
270. The paragraph of Saab relied upon merely states that Mr Saab's failure to report losses of methadone on the basis of a 'calibration issue' and that he otherwise did not have an obligation to report constituted 'a seriously deficient understanding of his legislative responsibilities', and therefore unethical and improper conduct. That is not authority for the proposition contended for by the Commission.
271. In Ashour, the Tribunal observed (at [43]) that the Commission complained that Mr Ashour failed to ensure that pharmacy dispensing records complied with certain requirements including those imposed by the Proprietor Guidelines, including the guidelines issued in September 2015 (which is Exhibit A9 in these proceedings).
272. The Tribunal's reasoning in Ashour, while not supporting the point contended for by the Commission, are otherwise useful and relevant to the determination of the issues in this case.
273. At [25]-[27] the Tribunal acknowledged that the Proprietor Guidelines:
a. State that 'if the proprietor... is not the pharmacist usually in charge, [they] must vigilantly maintain an active interest in how the practice of pharmacy is being conducted... to ensure that the pharmacy operation is in accordance with' any applicable legislation, policies, codes, guidelines, quality assurance standards, and good pharmacy practice (Exh A9, p 4, guideline 1);
b. Require the proprietor to intervene if they find the practice of pharmacy does not operate in accordance with these matters to ensure that the pharmacy business is conducted properly (Exh A9, p 4, guideline 1);
c. Require the proprietor to ensure that appropriate policies and procedures are in place and are being followed, including in relation to risk management (Exh A9, p 4, guideline 3);
d. Require the proprietor to maintain oversight of services being offered and goods being sold, especially those known to be subject to misuse or abuse (Exh A9, p 4, guideline 3);
e. Require the proprietor to ensure that the pharmacy is suitably resourced by suitably trained and supervised staff (Exh A9, p 4, guideline 3); and
f. Not delegate their professional obligations (Exh A9, p 4, guideline 2).
274. At [45] and [46] the Tribunal observed that the Proprietor Guidelines cannot be understood to mean that in every case where there is a failure to comply with the guidelines, the proprietor also 'failed to ensure' compliance:
'[45] We accept that the Proprietor Guidelines cannot be construed as meaning that in every case where a pharmacist fails to comply with their obligations under the PTGR or relevant guidelines, that it can be said that the proprietor "failed to ensure" compliance. The Proprietor Guidelines cannot be read as imposing an obligation on proprietors to supervise their employed pharmacists. Whether a proprietor "failed to ensure" that a pharmacist in their employ complied with a requirement of the PTGR or the relevant guidelines, depends on the facts of the particular case.
[46] Had this been a case of a single instance of a dispensing pharmacist failing to record their name in the dispensing records, the argument made by Mr Ashour would have greater force. However, here, on 74 occasions over an 18-month period, pharmacists employed by Mr Ashour failed to record their names in the dispensing records when supplying Schedule 4 substances or Schedule 8 drugs.'
275. The Tribunal's observations at [45] and [46] are consistent with the approach that has been advanced throughout these submissions regarding a finding of improper or unethical conduct. Consideration must be given to the specific facts and circumstances, rather than adopting an inflexible and uniform approach to the effect that any single instance of non-compliance is evidence of a more generalised failure.
276. It appears the Commission's submission as to 'strict liability' comes from the balance of the Tribunal's reasons, at [47] and [48] as follows:
'[47] We reject the contention that the Proprietor Guidelines should be read as meaning that a proprietor's obligation to "ensure that the pharmacy operation is in accordance with: any applicable state, territory or Commonwealth law, [and] relevant Pharmacy Board of Australia policies" is only enlivened where a proprietor becomes aware of the non-compliance and fails to "intervene". To accept that proposition would reward indolence or negligence on the part of a proprietor. It would be an invitation to lower rather than maintain standards.
[48] This is a regulatory scheme intended to maintain high standards of practice and patient safety. In our view, the concepts of strict or absolute liability in the criminal law are, by analogy, relevant here. An onus is placed on proprietors to comply with the scheme. The question is not one of intentional wrongdoing or negligent omission. The question is whether relevant standards were adhered to. Extending the analogy of strict liability, the facts do not and could not give rise to a defence of honest and reasonable mistake of fact. Mr Ashour did not make any reasonable effort to ascertain the facts. This is clear from the evidence that he failed to detect 74 instances of pharmacists not recording their names in the dispensing records.'
277. The Respondents do not take issue with the Tribunal's findings at [47]. However, the suggestion that the regulatory scheme is analogous to 'concepts of strict or absolute liability' is at odds with the Tribunal's own observations merely two paragraphs earlier.
278. A finding that the relevant threshold was 'strict or absolute liability' would exclude the Tribunal's earlier observations that 'the Proprietor Guidelines cannot be construed as meaning that in every case where a pharmacist fails to comply with their obligations ... that it can be said that the proprietor "failed to ensure" compliance. Applying a standard of 'strict or absolute liability' would result in a finding that any single breach is a 'failure to ensure' compliance.
279. It is accepted that ignorance of the law, obligations, or other legal requirements is not an 'excuse' for failing to comply. That is what the Tribunal, in Ashour, appears to be grappling with. Respectfully, that is not tantamount to a standard of strict or absolute liability.
280. The Tribunal's observations in Ashour at [48], when importing concepts of criminal liability, are inconsistent with the Tribunal's own reasoning, and inconsistent with the more nuanced and fact specific approach to be taken in matters such as these.
281. Otherwise, the Tribunal's reasoning at [45] and [46] is compelling, and apposite to the circumstances of this case.
282. It is similarly open to this Tribunal to find that the Proprietor's Guidelines:
a. '[C]annot be construed as meaning that in every case where a pharmacist fails to comply with their obligations under the PTGR or relevant guidelines, that it can be said that the proprietor "failed to ensure" compliance.'
And
b. '[C]annot be read as imposing an obligation on proprietors to supervise their employed pharmacists.'
283. By the terms of Complaint One, Particular (1)(d) and (2)(d) the Commission seeks to make each Respondent liable and responsible, by way of the Proprietor's Guidelines, for the dispensing of the other registered pharmacist. In this case, it is the equivalent of a requirement that each of the Respondents review every instance of dispensing of each other proprietor pharmacist and employed pharmacist. This is an unrealistic, untenable, unworkable, and unduly high standard, and not what the Proprietor's Guidelines require.
284. That Commission's allegation, appears to be derived from the following passage of the Proprietor's Guidelines, under the heading 'Summary of guidelines' (Ex A9, p 3):
'A registered pharmacist who is a proprietor of, or who has a pecuniary interest in, a pharmacy business, must:
- maintain, and be able to demonstrate an awareness of, the manner in which that pharmacy business is being conducted, and
- where necessary, intervene to ensure that the practice of pharmacy is conducted in accordance with applicable laws, standards and guidelines'
"What is the level of awareness that a proprietor is required to demonstrate? What constitutes an 'awareness of' or an 'active interest in' will necessarily depend upon the particular circumstances of each case."
"'Q: In 2017 and 2018 how did you satisfy yourself that every single script was compliant [with legislative requirements]?
A: I did rely upon my staff to do that. I conducted various types of audits, and spot checks.
Q: Did you also rely on the fact that your staff are registered with AHPRA?
A: As a minimum, but also that they are appropriately trained, and I rely on policies."
"[I]n this case, the instances of dispensing in Schedule 2 relied upon by the Commission represent 3-4% of the total scripts dispensed in the pharmacy. If the Commission's interpretation is accepted, it is tantamount to a practical requirement that pharmacist proprietors are aware of, effectively 100% of the instances of dispensing in the pharmacy. Ms Torrens' evidence was that she did not consider that a proprietor was required to have knowledge of every script dispensed to every patient, however, her opinion was that a proprietor had a responsibility to ensure that if there are 'things of concern', they are brought to the attention of the proprietor."
"The infrequency of personal dispensing, and the lengthy intervals between instances of personal dispensing, the history is not such that the Respondents were likely to have been alarmed, or likely to have noticed there was (in Ms Torrens words) 'a thing of concern'."
"Ms Torrens accepted that there was no mandated requirement on a proprietor to conduct an audit of Schedule 4D or Schedule 8 drugs other than a stocktake audit. She held a view, however, that 'an audit was one way of a proprietor keeping an eye on the practice of what's happening in their pharmacy'. It is of note that Ms Torrens could not in fact recall within what time frame she commenced Schedule 4D or Schedule 8 audits in her own pharmacy or how often they were conducted."
"302. Importantly, Ms Torrens acknowledged that her own audit system may not have identified any anomaly with respect to the dispensing history of, for example- Patient A. She gave evidence that the dispensing profile of Patient A indicated to her that there was excessive supplies of that drug for the patient which, in her opinion reflected inadequate oversight by the proprietors in that respect. Ms Torrens said that the overall quantities of drugs being dispensed would have prompted her to look more specifically at where they were going. However, importantly, Ms Torrens ultimately agreed that there was nothing out of the ordinary in relation to the overall dispensing of Schedule 4D and Schedule 8 drugs for this particular pharmacy that would have alerted her to being the dispensing being out of the ordinary.
303. The fact that an audit is not mandatory, and even if an audit had been conducted it may not have identified the anomaly, is fatal to the Commission's complaint that the Respondents failed to 'maintain an awareness'. Moreover, this case is a far cry from that alluded to and warned against in Exhibit R8 - being that of 'a silent partner' who does not work at the pharmacy nor have any practical or day to day oversight. In the case of the respondents, they each worked approximately 20 hours per week, such that a proprietor was always on site at Gosford Pharmacy as part of their active engagement to have oversight of the pharmacy."
"16. Enter the details of the prescribed item into the dispensing software. Check the patient history for the appropriate dose, drug interactions, allergies, unintended dosage changes, medicine duplication, inappropriate drug therapy, contraindicated medicines, unusual usage, and drug misuse or abuse.
17. If necessary, interact with the prescriber and document any changes on the prescription and in the dispensing record."
"agreed that the QCPP reaccreditation process was 'robust'. She gave evidence that the reaccreditation process reviewed the policies and procedures that a proprietor had in place at the pharmacy. She said it was a broad assessment, covering different areas, and that the process asked for some evidence of compliance with the policies and procedures at the pharmacy. She did not consider it necessarily did a 100% check of every activity occurring in the pharmacy but agreed more than once that the process was 'quite robust'."
"a. Require the dispensing pharmacist to have regard to the 'Oral Morphine equivalent daily dose' (oMEDD) for any dispensed medication;
b. Require the dispensing pharmacist to check the previous or last supply;
c. Check the patient's history to ascertain whether they are on the OTP program and/or the Doctor Shopper program;
d. Specify what is required to be written by the prescriber in handwriting aside from referring to 'necessary details';
e. Require that all discussions with the prescriber be documented;
f. Set out what to do if the pharmacist disagrees with the supply, for example to decline supply or to contact the PRU, aside from a generic endorsement to raise 'concerns' with the pharmacist in charge or proprietor; or
g. Specify how to manage prescriptions that are received via telephone or fax."
"319. When considering whether or not each of the Respondents properly discharged their obligations, and the repeated submission that regard should be had to the practical realities of how a proprietor pharmacist may properly discharge their obligations, regard should be had to the Commission's own expert's policy document in relation to Schedule 8 and 4D drugs."
"321. It is accepted that if any of the Respondents did become aware that inappropriate dispensing practices were taking place, then necessarily they had an obligation to intervene. However, that obligation can only realistically arise if (1) the Respondent was aware, and (2) it is reasonable to expect that the Respondent be aware."
"a. Exhibit R5, Tab 2, p 16 at [57]-[58], where Mr Saweris sets out his understanding of his role as a proprietor, including to demonstrate an awareness of how the pharmacy business was being conducted; and specific measures in place;
b. Exhibit R6, Tab 2, p 17 at [56] (Mr Derias), and
c. Exhibit R7, Tab 2, p 16 at [58]-[59] (Mr Morcos)."
"335. Evidently, each Respondent has, in fact, complied with their obligations under the Proprietor Guidelines to intervene into dispensing practices upon becoming aware that there was a concern, and they have done so in a timely manner, consistent with their obligations to promote the health and safety of the public."
"336. As set out above, each of the Respondents admit that they engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy that was significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience in relation to Particulars 1(c) and 2(c) in so far as they relate to personal dispensing only. The Respondents' Amended Reply admit unsatisfactory professional conduct based on each Respondent's individual failure to have a more fulsome regard to the patient's dispensing history on the limited occasions when they themselves dispensed.
337. This admission to unsatisfactory professional conduct should be reviewed within the context as to why the failure occurred- namely- the context of the thinking and conduct as outlined in paragraphs 8 and 9 of these submissions.
338. The Respondents submit that the Tribunal could not be satisfied, to the relevant standard, that any of the Respondents engaged in conduct that demonstrated the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy was significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience, on the basis of Complaint One, Particulars (1)(a), (1)(b), (1)(d), or (2)(a), (2)(b), (2)(d) particularly where the Commission must prove its case to a level of 'reasonable satisfaction', 'comfortable satisfaction', and the Tribunal must feel an 'actual persuasion' that the particulars as alleged are established. Reliance is placed on the submissions made under Section H from page 49 onwards of these submissions as to why the Commission has failed to prove these Particulars of Complaint One.
339. Further, the Commission's own expert provides little support in proving the allegations regarding the Particulars of Complaint One not admitted [by the Respondents]..."
"'My answers in relation to that specifically deal with whether it was below or significantly below in relation to the dispensing profile, quantity of drugs supplied, frequency of which they were supplied and, in my opinion, even if he had the belief that the doctor had said to dispense that it was in excess and therefore, in my opinion, I considered it to be inappropriate'."
"In her evidence on 15 October 2024 Ms Torrens slightly tempered her earlier answers, stating that she looked at both 'overall dispensing profiles' and individual instances of dispensing. She said that she had regard to 'quantities supplied', the 'intervals' of dispensing, and 'individual dates'. However, she agreed that she could not give an opinion as to whether or not an individual instance was within recognised therapeutic standards 'in isolation', including in the absence of information as to why there was an early presentation. She nonetheless maintained that the dispensing intervals would have been such as to 'raise[d] red flags'."
"343. In her evidence on 15 October 2024 Ms Torrens said 'I did consider what you term "state of mind", but it didn't change my thinking'.
344. Plainly, Ms Torrens has ascribed determinative significance to the global 'patterns of dispensing' when assessing the Respondents' conduct. Her answers, set out above, indicate that she did not take into consideration the Respondents thinking or state of mind at the time of each act of individual dispensing. She did not in fact take into account any 'circumstances' at all. She simply reviewed Schedule 2 and formed an opinion."
""347. Moreover, the Tribunal should also take great care not to consider the Respondents' conduct, and in particular as set out in Schedule 2, with the benefit of hindsight. What is plainly evident from a reading of Schedule 2 now may not have been evident or discoverable to the Respondents at the time of the dispensing, particularly when regard is had to the information available to each Respondent at the time of dispensing, the instances of dispensing that they personally engaged in, the intervals between dispensing, and the relationship of trust reposed in the prescribing doctor.
348. Specifically, the Tribunal is reminded of the evidence regarding what each pharmacist was able to identify at the time of dispensing. At Exhibit R7, page 20, [67]-[68], Mr Morcos says:
'The schedules annexed to the Amended Notice of Complaint do not reflect the dispensing history displayed when I entered the patient's name in the software system.
When I enter in a patient's name in the software system, it shows all of the dispensing history in chronological order. You cannot filter the dispensing history based on the medication. In order to do so, you have to generate a separate report, which was not the usual practice at the time when dispensing a medication.'"
"350. If the Tribunal was satisfied of Complaint One, being that the Respondents' conduct was significantly below the relevant standard, on the basis of any of the Particulars of Complaint One, the Tribunal could not then find that the conduct was improper or unethical on the basis of the same particulars.
351. Section 139B(1)(l) provides:
Unsatisfactory professional conduct of a registered health practitioner includes each of the following:
...
(l) Any other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession.
'Any other'
352. The words 'any other' in s. 139B(1)(l) must have work to do when considering the scope of conduct that may be captured by that provision. As a matter of ordinary statutory construction, those two words must be given meaning. 353. The fact that the legislature specified eleven precise categories of conduct which may constitute unsatisfactory professional conduct, and then specified a further category (s. 139B(1)(l)), indicates that something separate and distinct from the conduct which may otherwise be captured by ss. 139B(1)(a) - (k) is required in order to substantiate a finding of 'improper or unethical' conduct.
354. Support for this contention can be found in Chen v HCCC [2017] NSWCA 186 at [19]:
'The phrase "unsatisfactory professional conduct" is broadly defined by reference to 12 separate categories of conduct relating to professional practice. They include demonstrating competence or care below the standard reasonably expected of a practitioner of an equivalent level of training or experience, making a referral in circumstances where the practitioner has a financial interest in giving that referral without disclosing the interest, overservicing and, finally, any other improper or unethical conduct relating to the practice of the practitioner's profession.' (emphasis added)
355. The words 'separate' and 'any other' in the Court of Appeal's judgment are noted.
356. More recently, the Supreme Court considered a similar point in Health Care Complaints Commission v Attia [2017] NSWSC 1066. Walton J made a number of observations which are relevant to the construction of subsection (1)(l).
357. At [160] his Honour explained that the apparent purpose of sub-section (1)(l) is to capture conduct not otherwise captured by the provisions of subsections (a)-(k):
[160] This conclusion is also supported by the terms of s 139B(1)(l), the opening words of which are, "any other improper or unethical conduct". This not only makes clear that the provision is dealing with conduct not otherwise dealt with in s 139B(1)(a)-(k) but that the conduct caught by sub-s (1)(a)-(k) does concern, inter alia, "unethical conduct".
358. Therefore, the starting point is that 'ethical and related considerations' may ordinarily arise under sub-sections (1)(a)-(k).
359. Further, his Honour plainly stated that if the relevant conduct satisfies the terms of s. 139B(1)(a), then s. 139B(1)(l) does not apply. At [162] his Honour said:
'[The] provision, as I observed, operates only in circumstances where the earlier parts of the sub-section do not apply. Thus, if the impugned conduct falls within sub-s (1)(a), sub-s (1)(l) has no work to do'.
360. The mere fact that conduct is capable of falling within the scope of sub-sections (1)(a) does not, in and of itself, lead inevitably to a conclusion that the conduct is also improper or unethical. As Walton J observed, if conduct is capable of satisfying sub-section (1)(a), then the provisions of sub-section (1)(l) 'has no work to do' and accordingly does not apply.
361. In this case, in relation to Complaint One, the Commission relies upon s. 139B(1)(a) (conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, is significantly below the standard reasonable expected of a practitioner of an equivalent level of training or experience) in relation to a complaint that each Respondent 'inappropriately dispensed and/or permitted the inappropriate dispensing of an employed pharmacist of Schedule 8 and 4D drugs'.
362. The Commission asserts that the exact same particulars also justify a finding that each Respondent engaged in 'improper or unethical conduct' in relation to the practice or purported practice of pharmacy: cf s. 139B(1)(l).
363. Respectfully, in this case it is unclear how the conduct relied upon by the Commission could offend s. 139B(1)(a), and also s. 139B(1)(l). Even if it is accepted that the conduct falls significantly below the relevant standard (and if the Respondent's submissions regarding how the phrase 'improper or unethical' is to be construed), there is nothing in the relevant conduct that is, in and of itself, improper or unethical. Conversely, if the conduct does not offend s. 139B(1)(a), there is no other basis on which to find it is separately improper or unethical.
364. Otherwise, Walton J's observations in Attia are binding in this Jurisdiction and should be followed. If the conduct is capable of satisfying s. 139B(1)(a), then the provisions of s. 139B(1)(l) have 'no work to do'."
"In this case there is no evidence before the Tribunal to support or justify a finding that any of the respondents are guilty of Complaint One on the basis that they engaged in improper or unethical conduct."
""370. Complaints Two, Three and Four are in substantially similar terms against each Respondent. Each complaint alleges that the practitioner is guilty of unsatisfactory professional conduct on the basis that they engaged in improper or unethical conduct relating to the practise of pharmacy.
371. For the reasons that follow, the Tribunal could not find that the conduct relied upon by the Commission justifies a finding that any of the Respondents are guilty of unsatisfactory professional conduct on the basis that they engaged in improper or unethical conduct."
...
373. While professional codes, standards and guidelines are relevant to the determination of whether or not a health professional has conducted themselves 'improperly', that is only one of a range of matters that is relevant. Specific consideration should be given to the context and practical reality, and all other relevant facts and circumstances.
374. What is 'improper' cannot be determined by reference to some 'common, uniform, or inflexible standard' which applies equally to every person, but must be determined by reference to 'the particular duties and responsibilities of the particular' person whose conduct is impugned: Grove v Flavel.
375. Complaint Two, Three and Four each allege that the Respondents 'permitted' inappropriate dispensing. Each Respondent denies that they 'permitted' inappropriate dispensing. The detailed submissions set out above regarding the obligations of a proprietor pursuant to the Proprietor Guidelines, and what constitutes 'permitting' inappropriate dispensing, are relied upon and repeated in relation to Complaints Two, Three and Four."
"391. Amended Schedules 3, 4, and 5 relate to a total of 23 scripts which were identified over a period of two years. The PRU requested from the Respondents dispensing records for the period 22 January 2017 to 22 January 2019 . Assuming that the pharmacy dispensed between 250-300 scripts per day in that two year period, the pharmacy dispensed between 182,500 and 219,000 scripts in total. 23 individual scripts represents approximately 0.01% of those total scripts.
392. There is nothing about the dispensing that suggests that the Respondents engaged in unethical or improper conduct. The dispensing is not, in and of itself, immoral or unethical, for example in the sense that prescriptions were inappropriately dispensed for personal gain, or with deliberate knowledge that they were improperly dispensed. The dispensing was not deliberately in contravention of the relevant legislative requirements.
393. Nor do the instances of dispensing demonstrate a pattern which reveals a disregard for the obligations of a proprietor pharmacist. Rather, the particulars allege matters that are attributable to oversight or simply human error.
394. To suggest that an error rate of 0.01% amounts to conduct that is significantly below, or even below, the standard reasonably expected of a practitioner of an equivalent level of training or experience is plainly untenable. If the Commission had maintained that position, it would be arguing that a 99.99% accuracy rate is not adequate. To require the Respondents to achieve a standard of perfection is plainly unrealistic and unworkable, and otherwise contrary to the objectives of the National Law, including subsection 3(f) - which is 'to enable the continuous development of a flexible, responsive and sustainable Australian health workforce and to enable innovation in the education of, and service delivery by, health practitioners.'
395. Accordingly, the Commission have since abandoned their allegation that Complaints Two, Three and Four amount to unsatisfactory professional conduct, and now allege that the conduct is evidence of improper or unethical conduct.
396. Whether taken in isolation or totality, the Particulars and Schedules relied upon in support of Complaints Two, Three and Four do not justify a finding that any of the Respondents engaged in improper or unethical conduct. To find as much would again be requiring a standard of perfection, without any allowance for reasonable and expected human error.
397. When proper consideration is given to the 'standards of conduct' expected of each Respondent, by a reasonable person, with knowledge of the duties, powers and authority of the position, and in all the circumstances of the case, the instances of dispensing relied upon by the Commission do not fall into a category of conduct that is either 'improper' or 'unethical'."
"411. An assessment of the Respondent's conduct should take place in its proper historical context, with regard to the professional guidelines, codes, and prevailing culture, regarding dispensing practices, and the relationship of trust that was encouraged between pharmacists and the prescribing doctor, and the pervasive belief that pharmacists did not have the authority to deny supply.
412. As should be apparent from the summary of various guidelines and standards set out above, the December 2018 guideline is the first occasion when pharmacists are provided with clear and unambiguous guidance that:
a. They have the right to refuse to supply medication;
b. Even if a prescriber insists the medicine is supplied, they may delay supply or seek further advice; and
c. A pharmacist must not supply where they believe it poses an unacceptable safety risk for the patient.
...
415. A proper assessment of whether or not conduct is of such gravity that it amounts to professional misconduct cannot be conducted in a formulaic, inflexible way. It must involve consideration of the context in which the conduct took place.
416. Drawing from the authorities set out above, the Respondents did not engage in 'gross negligence', nor have they demonstrated 'a lack of concern for the welfare' of their patients. They have not acted with 'overconfidence' or 'ill-advisedly', or even with 'recklessness' or 'indifference'. There is no evidence of 'gross inattention to the welfare of the patient' nor 'inexcusable ignorance or incompetence'. Nor is this a case where the conduct demonstrates 'obstinate indifference to the consequences of one's acts'.
417. To the contrary, each Respondent held an honest, genuine, and reasonable belief, in the circumstances of the case, that they were not in a position to refuse to dispense the medication that they did.
419. In this case, the context, and the Respondents' state of mind, is particularly significant. The guidelines and prevailing culture at the time, including the belief that pharmacists did not have the ability to challenge the prescriber's intention, and were encouraged to foster a relationship of trust with other health professionals, must be relevant to an assessment of the conduct. To assess the conduct completely devoid of that context, is artificial."
Submission in Reply from the HCCC dated 2 December 2024
"the Respondents' analysis of what is said to be the 'prevailing professional culture' at the time of their dispensing (RS [20]-[107], [413]-[414]) is distorted by:
(a) its lack of attention to the context of the overarching and primary obligations set out in the relevant Pharmacy Board codes and guidelines to exercise an independent judgment to ensure medicine they dispensed was safe and appropriate for the patient, and to prioritise patient care; and
(b) its selective approach to the PSA and other professional documents relied upon, which, when read fully and fairly, reinforce the obligation to exercise an independent professional judgment with a focus on ensuring patient care and safety and do not imply that it was adequate for a pharmacist to defer to a prescriber (even a trusted prescriber) if they considered dispensing to be unsafe or inappropriate."
"5. ... as to the meaning of 'significantly below' (RS [128]-[145]), the point sought to be made in SAS [26]-[30] is that 'significantly' should be read as referring to the kind of conduct that justifies or warrants professional attention or scrutiny not just of any kind but of a disciplinary kind. That is, as set out in SAS [30], it should be read as meaning 'below to an extent that would warrant professional reprobation of some kind'. This is consistent with the legislative history and context for the reasons set out in SAS [27]-[30].
6. The Applicant accepts that other kinds of professional attention may be warranted by conduct that is below but not significantly below the expected standard, including performance assessment (RS [139]). But performance assessment does not have a disciplinary quality or amount to professional reprobation. Any disciplinary consequences depend on a complaint being made following the performance assessment, which may occur if, among other things, the relevant Council is satisfied that the assessment raises a prima facie case of professional misconduct or unsatisfactory professional conduct by the health practitioner. In this way, the performance assessment provisions themselves distinguish between conduct that warrants performance assessment and conduct that warrants disciplinary attention. This distinction supports, rather than detracting from, the Applicant's approach to the meaning of 'significantly below'.
7. In contrast, to the extent the Respondents seek to elevate the standard of 'significantly' below to a higher level - for example, by reference to 'epithets' (to use the Respondents' language) such as 'seriously', 'substantially' or 'to a high degree' (RS [142], [143d]) - that approach is not justified by the text or context of s 139B(1)(a). Further, the Respondents' attempt to distinguish 'mere negligence' from conduct satisfying the requirements of s 139B(1)(a) draws a false dichotomy for the reasons in SAS [30]."
"8. ... contrary to the Respondents' suggestion at RS [161], they have not clearly articulated why the Tribunal's prior decisions as to the meaning of 'improper' conduct are inconsistent with Byrnes or otherwise wrong. On the contrary, those decisions are consistent with Byrnes for the reasons in SAS [36]-[38].
9. The Respondents do not appear to submit that the Pharmacy Board codes and guidelines, including the Proprietor Guidelines, or the PTGR do not impose professional standards applying to the Respondents at the relevant times. The reference to considering 'all the relevant circumstances' in Byrnes was directed to identifying the relevant standard of proper behaviour: here, there is no dispute about that standard. To the extent the Respondents suggest that the need to consider the relevant circumstances imports a requirement of deliberateness, knowledge of wrongdoing or immorality (eg RS [184], [387], [392]), that does not reflect Byrnes (SAS [37]) or the ordinary meaning of 'improper' (SAS [34]), and has not been adopted in other cases applying Byrnes including outside the criminal context (SAS fn 63; cf RS [184]). In any event, the Respondents gave evidence in cross-examination that they were aware of their relevant obligations under the Pharmacy Board codes and guidelines and the PTGR.
10. Accepting that an isolated instance of a shortfall from professional standards by reason of an honest mistake may not amount to 'improper' conduct (RS [396]), again, that is not this case. As set out in AS [50]-[62], the conduct the subject of complaints 2 to 4 involved multiple failures by employed pharmacists (and, in Mr Derias' case, failures by him personally) to comply with requirements imposed under the PTGR for the dispensing of dangerous drugs which the drafters of the PTGR have seen fit to make offences. As set out in SAS [16], the Respondents acknowledged that the policies and procedures they had implemented at the Pharmacy for dealing with Schedule 8 and Schedule 4D drugs were generally deficient at the time of this dispensing. In those circumstances, their failures cannot be characterised merely as isolated mistakes, notwithstanding that the particular instances of dispensing may have related to a small proportion of the total number of prescriptions dispensed (RS [394])."
"If the Tribunal finds that the conduct the subject of Complaint One is unsatisfactory professional conduct under s. 139B(1)(a), the HCCC accepts that the Tribunal would not also find that same conduct to be unsatisfactory professional conduct under s. 139B(1)(l)".
Findings of the Tribunal against the Respondent Mr Samer Morcos, in this Stage One hearing
""6. Assessing whether conduct falls significantly below the standard reasonably expected for the purposes of s 139B(1)(a) involves first determining the 'benchmark standard which is expected of practitioners in the relevant field', and then assessing whether and how far below that standard the proven conduct falls. The Tribunal may rely on codes or guidelines approved by a National Board (including the Pharmacy Board of Australia (Pharmacy Board)) to identify the expected standard. The Tribunal may also draw on the expertise of its professional members.
7. Improper or unethical conduct for the purposes of s 139B(l) is conduct that is not in conformity with standards of professional conduct, practice or ethics. The Tribunal has held in several cases that conduct is properly characterised as unethical for the purposes of the National Law when it is 'contrary to some code of professional conduct', and conduct is properly characterised as improper for the purposes of the National Law when 'viewed objectively, [it] would be regarded by reasonable persons as falling below the standards of conduct to be expected of [the practitioner]'. The Tribunal has specifically held that dispensing contrary to the PTGR, or cl 1 of the Pharmacy Board of Australia 'Guidelines for dispensing of medicines' dated 7 December 2015 (Dispensing Guidelines) (requiring pharmacists to exercise independent judgment as set out in subparagraph 18(a) below), constitutes improper or unethical conduct for the purposes of s 139B(1)(l). The characterisation of conduct as improper for the purposes of the National Law does not depend on consciousness of impropriety or the conduct being intentional."
"9. Whether conduct is sufficiently serious as to amount to professional misconduct is an evaluative judgment for the Tribunal. (see: Chen v Health Care Complaints Commission [2017] NSWCA 186; (2017) 95 NSWLR 334 at 340 [20] (Basten JA, Leeming JA agreeing). Any form of unsatisfactory professional conduct may amount to professional misconduct. 'Moral obliquity' is not necessary, nor is a defect in character that has not been overcome, although '[s]ome, perhaps all categories [of professional misconduct] include conduct which may reveal' such a defect (see Chen [2017] NSWCA 186; (2017) 95 NSWLR 334 at 338-40 [12]- [20] (Basten JA, Leeming JA agreeing). 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 the proper standards" see: (Health Care Complaints Commission v Litchfield (1997) 41 NSWLR 630 at 638 (Gleeson CJ, Meagher and Handley JJA)."
"10. The Applicant bears the onus of proving the Complaints. Two principles are relevant in considering whether the Applicant has discharged its onus in this case.
11. First, the Tribunal is not bound by the rules of evidence and may inform itself in any manner it thinks fit. However, the Tribunal 'must base its decision upon material which tends logically to show the existence or non-existence of facts relevant to the issues to be determined'.
12. Second, the standard of proof is upon the balance of probabilities, although the level of persuasion the Tribunal must feel to find a matter proved to that standard increases with the gravity of the matter to be proved (See, eg, Tsolis v Health Care Complaints Commission [2023] NSWSC 1599 at [92]- [93] (Harrison AsJ); applying Briginshaw v Briginshaw [1938] HCA 34; (1938) 60 CLR 336, 361-62 (Dixon J). See also, eg, Health Care Complaints Commission v Thurlow [2024] NSWCATOD 119 at [17]- [19].). The requirement has been expressed as one of feeling 'comfortably satisfied' (See, eg, Health Care Complaints Commission v Naamo [2021] NSWCATOD 109, [11]. See also Gautam v Health Care Complaints Commission [2021] NSWCA 85, [87] (Payne JA, Leeming JA and Simpson AJA agreeing)."
"113. If those Complaints are proved, the orders available to this Tribunal include cancellation of each pharmacist's registration with a non-review period. The Tribunal has the power to take away each pharmacist's livelihood. The consequences are to remove a fully trained Pharmacist from practise and service to the community. The potential consequences for the Respondents are severe.
114. It is precisely for these reasons that Rich J in the decision of Briginshaw observed:
'The nature of the allegation requires as a matter of common sense and worldly wisdom the careful weighing of testimony, the close examination of facts proved as a basis of inference and a comfortable satisfaction that the tribunal has reached both a correct and just conclusion.'
115. In NSW the standard of proof to be applied in medical disciplinary proceedings is either "reasonable satisfaction" or "comfortable satisfaction". Re Anderson and the Medical Practitioners Act (1967) 85 WN (NSW) 558, stands explicitly for the proposition that the "reasonable satisfaction" test involves, in professional disciplinary proceedings, the application of a third, intermediate standard of proof. In Re Anderson, Asprey JA said at 587:
'Where there is any question of misconduct in a professional sense, that should not be regarded as established on a mere balance of probabilities.'
116. The position is best stated by J.R.S. Forbes in his authoritative textbook Justice in Tribunals (2019), where he says:
'Clearly the standards of proof in a tribunal dealing with a serious matter should be higher than a mere balance of probabilities ... in practice "reasonable satisfaction" is a variable standard that rises as issues become more serious, the consequences of an adverse finding more onerous, and allegations inherently less probable.'
117. In short, the Tribunal in these proceedings must, at a minimum:
a. bear in mind that the degree of satisfaction for which the civil standard of proof calls may vary according to the gravity of the allegation to be proved;
b. bear in mind both the gravity of the allegations against each Respondent and the gravity of the consequences which would befall him in the event of adverse findings;
c. act only upon clear and cogent proof;
d. not act upon inexact proofs, indefinite testimony or indirect inferences; and
e. give detailed reasons for any adverse findings."
"142. As to s 139B(1)(a), it is submitted that adverbs such as "seriously" or "pronouncedly" or "conspicuously" or "markedly" or "substantially" come closest to capturing the statutory meaning of "significantly". The phrases "to a high degree" or "more than ordinarily" would also serve the purpose."
"143. Finally, the last indicia of unsatisfactory professional conduct is an examination of whether the practitioner's skill and knowledge is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. It requires a fair and measured appraisal of the training and experience of the practitioner in which alleged failures occur.
144. 'Training' must encompass education and education naturally encompasses the content of relevant guidelines and codes that pharmacists are expected to read and apply. The historical analysis of the relevant guidelines and codes outlined in detail earlier in these submissions and their ambiguities or deficiencies must form part of an assessment of whether in fact each or any Respondent has fallen significantly below the standards expected pursuant to the terms of s 139(1)(a) of the National Law."
"i. engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or
ii. engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy."
"1. On each of the dates as set out in Schedule 2 to this Complaint the practitioner inappropriately dispensed (on the occasions referenced with the initials SM other than those highlighted green) and/or permitted the inappropriate dispensing by an employed pharmacist (on the occasions referenced with initials other than SM ) of Schedule 8 and 4D drugs, in various strengths to Patients A, C, E, F and I in circumstances where:
a. the dispensing was contrary to Clause 54 and/or 109 of the Poisons and Therapeutic Goods Regulation ("PTGR") in that, it was in a quantity that does not accord with a recognised therapeutic standard;
b. the dispensing intervals and/or frequency did not accord with a recognised therapeutic standard;
c. the practitioner and the dispensing practitioner should have had regard to the patient's dispensing history;
d. on the occasions referenced with initials other than SM, the practitioner failed to:
i. maintain an awareness of the manner in which the pharmacy dispensing practice was being conducted, and
ii. intervene into dispensing practices at the pharmacy where necessary, contrary to the Guidelines for proprietor pharmacists ("Proprietor Guidelines").
2. On each of the dates as set out in Schedule 2 to this Complaint, the practitioner inappropriately dispensed (on the occasions referenced with the initials SM other than those highlighted green), and/or permitted the inappropriate dispensing by an employed pharmacist (on the occasions referenced with initials other than SM), of a Schedule 8 drug, in various strengths to Patients B, D, G and H in circumstances where:
a. the dispensing was contrary to Clause 54109 of the PTGR in that, it was in a quantity that does not accord with a recognised therapeutic standard;
b. the dispensing intervals and or frequency did not accord with a recognised therapeutic standard;
c. the practitioner and the dispensing practitioner should have had regard to the patient's dispensing history;
d. on the occasions referenced with initials other than SM, the practitioner failed to:
i. maintain an awareness of the manner in which the pharmacy dispensing practice was being, and
ii. intervene into the dispensing practices at the pharmacy when necessary, contrary to the Proprietor Guidelines."
Findings on Particulars 1(c) and 2(c) of Complaint One
Finding on Particular 1(a) and 1(b) Personal Dispensing
"A. Yes. So you asked me if I consider other factors? Yes, I do and did. Such as the things you have pointed out was the phone call to doctors. However, even once I have considered those other factors, such as, for example, where the patient said they lost it, or had had it stolen, et cetera, I still did not - it didn't change my opinion that I thought it was below or significantly below."
Consideration of the legal argument about the use of the words of Clauses 54 and 109 of the PTGR in Particulars 1(a) and 1(b) of Complaint One
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.
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.
(italics for words omitted in the Complaint but contained in the legislative provision)
"[181] Fourthly, where a prosecutor, here the respondent, alleges that a crime has been committed, here potentially cumulatively carrying a maximum fine of $60,000 and up to 3 years imprisonment for each offence, it hardly needs stating that is incumbent on the prosecutor to provide precise particulars that conform with the terms of the statute by which the crime is defined. Instead, here, there is a disjunctive mismatch between the terms of the complaint and the terms of the statute.
[182] Fifthly, when the terms of the complaint (alleging the applicant was "stating that he is a doctor" and that he has been "masquerading as a doctor") are compared to the multiplicity of specific and alternative statutory elements of the offences alleged and which are required to be proven, namely alleged breaches of either s 113(1)(a) and (b), S 113(2)(a) and (b) or s 116(1)(a), (b), (c) and (d), and s 116(2)(a), (b), (c) and (d) of the National Law, that disjunctive disconformity of language cannot properly form the basis of an adverse finding of criminality against the applicant.
[183] In that sense, from the perspective of procedural fairness, we cannot be comfortably satisfied on the balance of probabilities that the applicant was in breach of those statutory offences concerning the misuse of protected titles, recognising and applying what was said in Bronze Wing International Pty Ltd v SafeWork NSW [2017] NSWCA 41, at [126] to [128], which discussed and explained the limited but analogous use of the principles in Briginshaw v Briginshaw (1938) 60 CLR 336; [1938] HCA 34, at pp 358 - 363, in relation to the task of fact finding in NCAT cases."
"In the submission of the Respondents commencing at paragraph 222, the Respondents address a submission in respect of Complaint One Particulars (1)(a) and (2)(a). The thrust of the submission is that the wording of those Particulars does not contain the entirety of the clauses 54 and 109 of the PTGR. The missing words from the Particulars are "of what is appropriate in the circumstances". The Respondent submits the words are crucial and have not been addressed by evidence put before the Tribunal by the HCCC. The decision in Segal v Medical Council of NSW [2024] NSWCATOD 139 [181] to [183] is relied upon in support of the submission that the HCCC has failed to establish Particulars (1)(a) and (2)(a). Could the HCCC please respond to the submission or direct the Tribunal to that portion of its written submission which addresses it."
"The Commission acknowledges that complaint 1, particulars 1(a) and 2(a) do not reproduce the full statutory text of cl 54 and 109 of the PTGR, and that the Tribunal will need to have regard to the full text of the clauses (including the words 'of what is appropriate in the circumstances') to determine whether the allegation that the dispensing was contrary to those clauses is made out. However, it does not follow that the Commission cannot prove those sub-particulars, for two reasons."
"[A]s to the Respondents' submission that the Commission has not proved complaint 1, particulars 1(a) and 2(a) because there is a lack of evidence as to the relevant 'circumstances' in which the dispensing occurred, this appears to be based on the premise that the relevant 'circumstances' include the circumstances in which the prescriber prescribed the relevant drug (eg RS [232]). The Tribunal should not accept that those are circumstances relevant to whether a pharmacist's dispensing was appropriate for the reasons in SAS [9]-[12]. The focus in an assessment of whether a pharmacist's dispensing accorded with the recognised therapeutic standard of what was appropriate in the circumstances must be on the circumstances of the dispensing. Matters known only to the prescriber and not communicated to the pharmacist cannot be relied upon as making that dispensing appropriate."
"This approach to cl 54 and 109 of the PTGR is supported by the fact that pharmacists are required to play a 'gatekeeping' role in relation to dangerous drugs.(see: Health Care Complaints Commission v Elliott [2018] NSWCATOD 47 at [55].) As set out in AS [18]-[19], pharmacists must make their own judgment, independent of prescribers, as to whether it is appropriate to dispense. In light of that role, it cannot be the case that the standard of appropriate dispensing by a pharmacist is determined by the circumstances in which the relevant drug was prescribed.
"Each of the Respondents gave evidence as to the circumstances relevant to their dispensing - that is, the circumstances known to them that influenced their dispensing of particular drugs to particular patients. As set out in SAS [11], it is apparent from this evidence that the Respondents had limited extrinsic information available to them in deciding whether or not to dispense on a given occasion, and the information they did have (for example, a patient telling them repeatedly that he had lost his medication) warranted further inquiries which they did not make. The Tribunal should find that the information available to the Respondents was not sufficient to justify dispensing that was clearly excessive having regard to the dispensing history for each patient. This finding would be consistent with the concessions made by the Respondents in cross-examination as set out in SAS [5]-[7]."
"2. With respect to the Commissions Response at paragraphs 4 and 5, the Respondent's submissions from paragraph 222 onwards do not raise an issue of procedural fairness, but rather an obligation by the Commission to prove each 'element' of the alleged offence under cl 54 and 109 of the PTGR when considering Complaint One Particulars 1(a) and 2(a). Namely, proof of dispensing where the first element for consideration is non accordance with the recognised therapeutic standard and the second element of which is 'what is appropriate in the circumstances.' Both elements need to be proved.
3. The Commissions Response at paragraph 6, assert that the rationale by the prescribing doctor is not a 'circumstance' relevant to dispensing. The respondent submits that this submission fails to address and rebut the earlier submissions of the Respondent namely:
i) The concessions made by the Commissions own expert Ms Torrens as outlined in the earlier submissions of the Respondent at paragraph 240, which are all matters pertaining to the prescriber's considerations as to the recognised therapeutic standard for individual patients. This in turn informs 'what is appropriate in the circumstances.'
ii) Part B of the Respondents Submission which outlines the history of dispensing guidelines and the long-standing relationship between prescriber and dispenser, including a requirement to contact and consider a prescriber's rationale for prescribing and only in exceptional circumstances reject the script, which must inform 'what is appropriate in the circumstances.'
iii) The relevance of the Australian Medical handbook outlined in the Respondents Submissions at paragraphs 235-239, 244 which speak directly to 'therapeutic standards' an element of cl 54 and cl 109 of the PTGA which has not been addressed in the Commissions Response.
4. The Commissions Response at paragraph 6, stating "Matters known only to the prescriber and not communicated to the pharmacist cannot be relied upon as making that dispensing appropriate" (emphasis added) should be rejected for the following reasons:
i) It assumes a general failure in communication between prescriber and dispensing Respondent or invites such an inference in circumstances where that inference is not available from direct evidence in light of the Commission's decision not to tender and rely upon any prescriber clinical records or prescriber statements which would address the issue of 'communication' or lack thereof, with the respondents.
ii) The assumption or inference of a total absence of communication between prescriber and any one of the Respondents is contrary to the direct evidence of the Respondents, namely that they did communicate with the prescriber on occasion or had knowledge of contact with the prescriber in relation to the dispensing. By way of example, Mr Morcos unchallenged evidence, as outlined in his first response to the Commission dated 25 November 2019 was that contact was made with the prescriber on a number of occasions - Patient A, Higgins see [42]-[43]; Patient B Putland, see [46]-[47] Patient C Grant, see [53]-[54]; Patient D Thew see [58]-[59]; Patient E Fenton see [65]-[67]; Patient F Jackson see [71]-[72], Patient G Nicholls see [77], Patient H Thew see [83], Patient I Griggs see [86]-[87].
iii) The Commissions Response implying no communication is contrary to the sworn oral evidence, for example, of Mr Morcos, namely when questioned under cross examination regarding his communication with the prescriber he said the following:
- He could not recall a specific instance as the concerns were brought to the respondent's attention 10 months after the last prescription;
- At the time, his usual practice was to contact the prescribing doctor where there is a short interval, to speak to her [Dr Sriskanda] about why she needed to give the medication to the patient;
- Dr Sriskanda would give Mr Morcos a reason behind the prescribing which he deemed satisfactory; and
- He was sure he spoke to Dr Sriskanda as she would come to the pharmacy with the patient or sometimes, he would go to the medical centre to seek clarity regarding the prescribing.
5. The unparticularised term "gatekeeper" introduced in 2018 in one Tribunal decision referred to in paragraph 7 of the Commissions Response, does not trump the express directions articulated in the guidelines in existence at the relevant time as outlined in Part B of the Respondents Submission.
6. In response to paragraph 7 of the Commissions Response, the Respondent's case is not that the standard of appropriate dispensing is "determined" by the prescriber's intention, but rather, that a relevant 'circumstance' which must be considered to establish what is in fact the 'therapeutic standard' applicable to each individual patient are the matters outlined in paragraphs 232 and 240 of the Respondents Submissions. The prescriber's rationale behind prescribing is directly connected to 'what is appropriate in the circumstances' and the Commission has failed in tendering any evidence in that regard."
Conclusion in relation to Particulars 1(a) and 1(b) of Complaint One as it relates to the personal dispensing of the Respondent
(a) Consider the type of drug being prescribed.
(b) Ensure the prescription document complies with the requirements of the PTGR.
(c) Take into account the recommended dose and frequency for the taking of the drug as published in the reference material available to the pharmacist in the pharmacy.
(d) Take into account detail of prior dispensing to the subject patient.
(e) If there is a conflict between the information available to the pharmacist as to the recommended therapeutic dose and frequency, on ingestion, and that prescribed for the patient, then contact the prescriber.
(f) Take into consideration the information provided by the medical practitioner in relation to the patient together with the stated reason for the prescription provided to the patient.
(g) Ask the prescriber for copies of any pain management plan or relevant specialist advice, or any other such document, relevant to the dose size, daily consumption, duration of prescribing of the drug and any other relevant advice which will inform the dispensing.
(h) If the information at that stage available to the pharmacist still raises a concern about the appropriateness of dispensing the prescription which has been presented, then decide what action to take.
(i) Implement one of the range of possible actions available to the pharmacist including declining dispensing of any part of the prescription.
Findings in relation to Particulars 1(a), and 1(b), Complaint One as it relates to the responsibility of a pharmacy owner for the dispensing of an employed pharmacist. Did the Respondent permit the inappropriate dispensing by an employed pharmacist?
(a) We accept the submission of the HCCC that ignorance of the law or relevant code or applicable guideline for a proprietor of a pharmacist at the time of the offending is not an acceptable reason to avoid a finding of unsatisfactory professional conduct in this case. The issue for us is whether it was reasonable for the Respondents to know what that applicable law or relevant code or applicable guideline was at that time.
(b) The applicable Proprietor Guidelines at page 801 of Exhibit R4 sets out in chapter 3 the responsibilities of proprietor pharmacists. That makes clear that the proprietor is responsible for ensuring the business is conducted properly and that includes making sure employed pharmacists comply with the PBA registration standards and guidelines. The proprietor is also required to maintain awareness of and responsibility for services being provided, particularly those known to be subject to abuse or misuse. Further the proprietor must ensure that procedures and policies for all services provided are documented and available within the pharmacy for all staff to access.
(c) We find that the Respondent did not, as a proprietor, have adequate systems and processes in operation in the West Gosford Pharmacy to detect and bring to his notice the extent and character of inappropriate dispensing at the time of the alleged conduct by an employed pharmacist. The fact that the alleged conduct of the employed pharmacist continued for over a 12 month period establishes an insufficient system of oversight. This, we accept, was contributed to by the Respondent's misunderstanding of the actions available to him as a dispenser of Sch 8 and Sch 4D drugs, such as to refuse supply, or to implement another action, contrary to the direction of the prescribing doctor. It was that misunderstanding which led to an inadequate surveillance of the dispensing of Sch 8 and Sch 4D drugs by pharmacists employed in the business. The fact that the employed pharmacist was engaging in the same conduct as the Respondent in respect of failing to take action on the dispensing of scripts generated and defended by Dr Sriskanda, meant that his conduct was overlooked as it was seen as appropriate action. Further, the system the Respondent did have in place did not and, without a targeted internal audit process for Sch 8 and Sch 4D dispensing, probably could not bring to the attention of the Respondent the inappropriate dispensing of Sch 8 and Sch 4D drugs which was occurring in the West Gosford Pharmacy.
(1) The importance of the role of a pharmacist in our community was referred to in Health Care Complaints Commission v Saab [2020] NSWCA 145 (Sabb No 2) and the following words have been extracted in the HCCC submission which we adopt.
"[690] A pharmacist who is a proprietor must maintain and be able to demonstrate an awareness of the manner in which their pharmacy business is being conducted and, where necessary, intervene to ensure that the practice of pharmacy is conducted in accordance with applicable laws, standards and guidelines. A failure to be attentive as to whether statutory requirements, standards and guidelines are being adhered to diminishes this protective structure.
[691] Pharmacists act as our caretakers in the community in the responsible and lawful dispensing of Schedule 8 medications and drugs of addiction and special prescribed restricted substances. It is their compliance with the protective architecture to which the Regulations and Guidelines are directed which ensure the safe benefits of such medications to individual patients and the community as a whole. As a proprietor and pharmacist [the practitioner] failed to ensure that these requirements were met."
(2) We reject the submission of the Respondent that the standard which the HCCC advocates for is tantamount to a standard of perfection. We accept that the requirement for a proprietor to maintain awareness of the manner in which the pharmacy dispensing practice is being conducted must be considered in its proper professional and commercial context. We do understand the requirement to differentiate between the degree of awareness and oversight which needs to be applied to the dispensing of drugs the subject of the Poisons and Therapeutic Goods Act 1966 (NSW) as opposed to other medicines dispensed which do not have the same potential for harm or abuse if not properly and appropriately dispensed.
(3) As is submitted by the Respondent we accept that at the dates of dispensing by the Respondent the relevant PBA dispensing guidelines or codes of conduct together with other relevant codes of conduct included an express requirement to exercise an independent judgment when dispensing. Further, we note the concession in the Respondents submission that it is not suggested by them that permission to decline supply was not recognised by the profession prior to late 2018.
(4) We have taken into consideration the submission of the Respondent that: "When consideration is given to how pharmacists were encouraged to exercise their independent judgment, proper attention must be paid to the following:
"a. Pharmacists were repeatedly encouraged to 'respect the skills and expertise' of the prescriber;
b. There was no express or clear endorsement that pharmacists had the right to refuse supply prior to December 2018;
c. Instead, there was an expectation that a pharmacist would only refuse to dispense in 'exceptional circumstances';
d. Prior to December 2018 the profession had publicly expressed concern about being 'powerless to act', and did not feel they had the clear or express 'authority to deny or delay supply'."
(5) We accept the submission of the Respondents that: "The issue of the degree of failure in conduct is central to assessing whether any one of the Respondents' conduct amounts to conduct that is significantly below the standards expected or conduct that is improper or unethical."
(6) We accept there was and probably still is, a tension between the requirement to optimise professional and supportive relationships between a pharmacist and other health professionals AND the obligation a pharmacist has, when he/she concludes that the health and safety of a patient is potentially at risk if a dispensing is made. Such a circumstance will require the pharmacist to over-ride the direction from a prescribing medical practitioner to dispense as the prescription has stated. However, in our view, the health and safety of a patient must be a paramount consideration in cases of such tension.
(7) We have taken into account the submission made by the Respondent as to 2017 Dispensing Guidelines and the particular submission:
"that the July 2017 document expressly provides that it is the prescriber who determines appropriate therapy. There is no part of the 2017 Guideline which expressly encourages, permits or requires pharmacists to refuse to dispense medication in the exercise of professional judgment, contrary to any intention of the prescriber."
(8) We conclude that the requirement for a pharmacist to exercise and "independent judgment" means it cannot be constrained by a requirement to always dispense as a medical practitioner directs unless there is some extraordinary aspect to that direction. "Independent" should be seen to include a meaning of separate from any countervailing influence such as maintaining a good relationship with a prescriber, whether that prescriber is a medical practitioner who often provides scripts for the pharmacist to dispense, or not. That is, commercial considerations and short cuts based upon expected competency in the prescriber, fall away when it comes to exercising an independent judgment about the appropriateness for a particular dispensing under consideration.
(9) We understand that in many circumstances a pharmacist may feel the brunt of a power imbalance between the prescriber and him/herself given the nature of their different training and a possible reliance of one upon the other of a commercial nature. That may have been the case for these Respondents who clearly held Dr Sriskanda in high respect until they were confronted with her misconduct.
(10) We accept that the Pharmaceutical Society of Australia, Guidelines for pharmacists performing clinical inventions (December 2018) was concise and directive when it stated:
"Collaboration does not alter the pharmacists' personal accountability for the care provided to patients and pharmacists have the right to refuse to supply medicines if they believe it is unsafe or inappropriate.
If another healthcare provider insists that a medicine is supplied and the pharmacist believes the supply is inappropriate or unsafe the following options may be appropriate initially:
Delay supply while gathering further information (example through literature research, consulting current and credible references).
Seek further advice from a reputable source (example drug information centres, other healthcare providers of patient they have consulted for the same condition previously, professional indemnity insurer).
A pharmacist must not supply a medicine where they believe it poses an unacceptable safety risk for the patient."
(11) We do not accept that at the time of the alleged conduct of the Respondent there was no ability for a pharmacist to refuse supply or take another action in relation to dispensing a Sch 8 or Sch 4D drug where the pharmacist concluded the health or safety of the patient could be at risk if the presented script was dispensed as required by the medical practitioner. The concept of accountability by a pharmacist for dispensing was clearly applicable in 2017 and 2018 at the time of the dispensing by the Respondent and employed pharmacists in his business.
(12) We accept that since December 2018 the PSA guidelines have been more direct and clear for pharmacists, particularly those whose first language is not English and who may not appreciate the nuances of the English language.
(13) Although the submissions to the Parliamentary enquiry conducted in 2018 stated that pharmacists did not have a clear understanding of their ability to refuse supply, there were pharmacists, such as the expert, who understood a pharmacist had that obligation after exercising an independent judgment that such an action was required. The Respondents ought to have known they had a problem prescriber in Dr Sriskanda. She had been contacted on many occasions about her prescribing. They now know she has been the subject of disciplinary proceedings, and her registration was cancelled. They now know that if in doubt about what action to take in a difficult conflict between a prescriber and their role as dispensers they can call on advice from the PRU.
(14) We accept that the Respondents (including Mr Morcos) acted upon receiving information that there were irregularities in the dispensing of Sch 8 and Sch 4D drugs from their pharmacy. That action included putting in place systems within their pharmacy which would properly monitor the dispensing of Sch 8 and Sch 4D drugs and would alert them to any aspect of the dispensing which was problematic. They also put in place other policies, measures and procedures to increase the level of oversight which they could exercise over the management of their pharmacy. Such action was a clear indicator to them of what was required to fulfil their obligations as proprietors of the pharmacy.
(15) The Respondent made submission on the words of the Complaint "permitted the inappropriate dispensing by an employed pharmacist". The submission includes:
"In these circumstances, 'permit' must, at a minimum, require:
a. Knowledge or awareness of the dates of each dispensing by another employed pharmacist;
b. Knowledge or awareness that at the time of the dispensing, that the dispensing was in fact inappropriate;
c. Intentionally allowing or tolerating the inappropriate dispensing by not taking any steps to intervene and stop it."
We do not accept that "permitted the inappropriate dispensing" requires the ingredients of knowledge and intent as submitted by the Respondent. We are satisfied that if the proprietor fails to put in place adequate measures, checks and procedures which would allow that proprietor to adequately and properly monitor the work of an employed pharmacist, he cannot absolve himself of responsibility for inappropriate dispensing by that employee with the excuse "I didn't know it was happening." Further, the proprietor must ensure that he understands the proper role of a dispenser to be able to monitor if the employee is conducting him/herself within the law and codes and guidelines which the National Law requires. Again, as in this case, we do not consider an excuse such as "I did not know the discretion/right I had as a pharmacist included being able to refuse to dispense a script where the doctor directed that it be dispensed."
Findings in relation to Particular 2 (a) and 2 (b) as it relates to the personal dispensing of the Respondent as set out in Schedule 2 to the Complaint document and addressing different patients to those set out in Particular 1
Findings in relation to Particular 2 (a) and 2 (b) as it relates to the responsibility of a pharmacy owner for the dispensing of an employed pharmacist. Did the Respondent permit the inappropriate dispensing by an employed pharmacist?
Findings on Particulars 1(d) and 2(d) of Complaint One
(1) Require the dispensing pharmacist to have regard to the oMEDD for any dispensed medication;
(2) Require the dispensing pharmacist to check the previous or last supply;
(3) Check the patient's history to ascertain whether they are on the OTP program and/or the Doctor Shopper program;
(4) Specify what is required to be written by the prescriber in handwriting aside from referring to 'necessary details';
(5) Require that all discussions with the prescriber be documented;
(6) Set out what to do if the pharmacist disagrees with the supply, for example to decline supply or to contact the PRU, aside from a generic endorsement to raise 'concerns' with the pharmacist in charge or proprietor; or
(7) Specify how to manage prescriptions that are received via telephone or fax.
"a. (2) - a requirement that the pharmacist is familiar with the patient, or otherwise verifies the patient's identification; and that the pharmacist is familiar with the doctor, or otherwise contacts the doctor and check the AHPRA register for authority to prescribe.
b. (3) that the 'script requirements are filled' including (g) - 'maximum number of times the prescription may be dispensed'.
c. Under (3), the procedure expressly stated that if a pharmacist is not satisfied with the authenticity of a prescription by any of the above means and the doctor is not contactable, then a sufficient quantity of the drug may be supplied for two days treatment, pending verification.
d. (4) include a requirement to check the patient's history, including regarding the usage of the drug and the supply interval.
e. Further (4)(d) set out steps the pharmacist can take if the supply interval is short, including what steps to take when satisfied an extra supply is appropriate, and where not satisfied."
"Each Respondent has, in fact, complied with their obligations under the Proprietor Guidelines to intervene into dispensing practices upon becoming aware that there was a concern, and they have done so in a timely manner, consistent with their obligations to promote the health and safety of the public."
"[160] This conclusion is also supported by the terms of s 139B(1)(l), the opening words of which are, 'any other improper or unethical conduct'. This not only makes clear that the provision is dealing with conduct not otherwise dealt with in s 139B(1)(a)-(k) but that the conduct caught by sub-s (1)(a)-(k) does concern, inter alia, 'unethical conduct'."
"7. Improper or unethical conduct for the purposes of s 139B(l) is conduct that is not in conformity with standards of professional conduct, practice or ethics.(see 5 below). The Tribunal has held in several cases that conduct is properly characterised as unethical for the purposes of the National Law when it is 'contrary to some code of professional conduct' (see 6 below), and conduct is properly characterised as improper for the purposes of the National Law when 'viewed objectively, [it] would be regarded by reasonable persons as falling below the standards of conduct to be expected of [the practitioner]' (see 7 below). The Tribunal has specifically held that dispensing contrary to the PTGR, or cl 1 of the Pharmacy Board of Australia 'Guidelines for dispensing of medicines' dated 7 December 2015 (Dispensing Guidelines) (requiring pharmacists to exercise independent judgment), constitutes improper or unethical conduct for the purposes of s 139B(1)(l).(see 8 below). The characterisation of conduct as improper for the purposes of the National Law does not depend on consciousness of impropriety or the conduct being intentional. (see 9 below)."
""(5) See, eg, Health Care Complaints Commission v Murtagh [2024] NSWCATOD 127 at [94]- [95]; Health Care Complaints Commission v Nguyen [2018] NSWCATOD 168 at [47]- [49].
(6) See, eg, Health Care Complaints Commission v Bolton [2021] NSWCATOD 160 at [86]; Health Care Complaints Commission v Le [2022] NSWCATOD 85 at [54]; Health Care Complaints Commission v FLX [2022] NSWCATOD 185 at [89]; Health Care Complaints Commission v Sathiyapal [2024] NSWCATOD 14 at [119]- [121] (5 February 2024); Health Care Complaints Commission v Tran [2024] NSWCATOD 1 at [114] (8 January 2024).
(7) See, eg, Health Care Complaints Commission v Liu [2016] NSWCATOD 133 at [55]- [56]; Health Care Complaints Commission v Achurch [2019] NSWCATOD 20 at [41]; Sathiyapal [2024] NSWCATOD 14 at [119]- [121]; Tran [2024] NSWCATOD 1 at [114].
(8) Health Care Complaints Commission v Matta [2024] NSWCATOD 33 at [64]- [74]; Health Care Complaints Commission v Azzer [2024] NSWCATOD 70 at [104]- [115], [126], [137].
(9) See, eg, Nguyen [2018] NSWCATOD 168 at [47]- [49]; Health Care Complaints Commission v Aref [2018] NSWCATOD 133 at [19]."
"a. Improper or unethical conduct is conduct that is 'not in conformity with standards of professional conduct, practice or ethics', relying on Murtagh and Nguyen;
b. Conduct can be properly characterised as unethical when it is 'contrary to some code of professional conduct', relying on Bolton, Le, FLX, Sathiyapal and Tran;
c. Conduct can properly be characterised as improper when 'viewed objectively [it] would be regarded by reasonable persons as falling below the standards of conduct to be expected of [the practitioner]', relying on Liu, Achurch, Sathiyapal and Tran;
d. Dispensing contrary to the Pharmaceutical and Therapeutic Goods Regulation 2008 (NSW) ('PTGR') or cl 1 of the Pharmacy Board of Australia 'Guidelines for dispensing of medicines' dated 7 December 2015 (Dispensing Guidelines) constitutes improper or unethical conduct for the purposes of s 139B(1)(l), relying on Matta and Azzer;
e. The characterisation of conduct as improper for the purposes of the National Law does not depend on consciousness of impropriety or the conduct being intentional, relying on Nguyen and Aref."
(1) It is accepted that conduct may be unethical if it is not in conformity with "standards of professional ... ethics", depending on the facts and circumstances of the relevant conduct.
(2) The Tribunal's decisions relied upon which base their decision on the High Court cases of R v Byrnes; R v Hopwood [1995] HCA 1; (1995) 183 CLR 501 do so by oversimplifying the dicta of those cases.
(3) In Health Care Complaints Commission v Liu ([2016] NSWCATOD 133 at [54], an often-cited passage, the Tribunal said:
"Decisions involving professional disciplinary proceedings have adopted as relevant the discussion of the term "impropriety" in R v Byrnes and R v Hopwood as being a breach of the standards of conduct that would be expected of a person in the position of the alleged offender. The test of whether the conduct is improper is an objective one." (Citations omitted, emphasis added). The Respondent says that "For the reasons that follow, that interpretation is, respectfully, a superficial gloss on the reasoning and findings of the High Court in R v Byrnes; R v Hopwood, and should not be followed."
"a. Consideration of the content of 'improper' must be guided by the context in which that word appears. As Jacobs J said in Grove v Flavel, improper is not 'a term of art' and should be understood 'in its commercial context'.
b. Similarly, what is 'improper' cannot be defined by a 'common, uniform, or inflexible standard' which applies equally to any person who holds the position of the person whose conduct is being examined.
c. When considering whether conduct is improper, specific consideration should be given to the 'particular duties' and 'particular responsibilities' of the relevant person whose conduct is being examined.
d. Consideration of whether conduct is improper requires consideration of whether or not the person has properly discharged their obligations. That requires examination of 'all the relevant circumstances'."
e. Similarly, whether conduct is improper requires consideration of each of the following:
i. whether conduct breaches 'standards of conduct' expected of the person;
ii. by reasonable persons;
iii. with knowledge of the duties, powers and authority of the position; and
iv. the circumstances of the case."
(1) Conduct is not unethical merely because it is 'contrary to some professional code of conduct'.
(2) The submission states:
"An often-cited passage in this line of decisions is from Health Care Complains Commission v Liu [2016] NSWCATOD 133. At [51]- [52] the Tribunal said:
'[51] The words "improper" and "unethical" are not defined in the National Law. The Macquarie Dictionary defines improper as follows:
1. not proper; not strictly belonging, applicable, or right: an improper use for a thing.
2. not in accordance with propriety of behaviour, manners, etc.: improper conduct.
3. unsuitable or inappropriate, as for the purpose or occasion: improper tools.
4. abnormal or irregular.
1. contrary to moral precept; immoral.
2. in contravention of some code of professional conduct.'"
(3) The Respondent submits: "As a general principle of statutory construction, the dictionary definition is one matter that can be taken into account when construing the scope of a phrase. The dictionary definition should not, however, be determinative." The submission is that decisions which adopt the dictionary definition of "unethical" are unnecessarily restrictive. The legislation clearly did not intend such a restriction to apply.
(4) In House of Peace Pty Ltd v Bankstown City Council [2000] NSWCA 44, at [28], Mason P made the following observation regarding the limitation on the usefulness of a dictionary definition:
"A dictionary may offer a reasonably authoritative source for describing the range of meanings of a word, including obsolete meanings. Dictionaries recognise that usage varies from time to time and place to place. However, they do not speak with one voice, even if published relatively concurrently. They can illustrate usage in context, but can never enter the particular interpretative task confronting a person required to construe a particular document for a particular purpose.'" (emphasis added in Respondent's submissions).
(5) More recently, in Health Care Complaints Commission v Kesserwani [2020] NSWCATOD 65 the Tribunal made a number of observations regarding what conduct might constitute 'unethical' conduct. At [26] the Tribunal (A Britton, Principal Member, presiding) said:
'"In our view, the test of 'unethical conduct' has both objective and subjective elements. The word 'unethical' connotes moral opprobrium. The term 'unethical conduct' implies that the conduct concerned not only objectively falls short of a certain professional standard but that the person involved has performed subjectively in a way that is morally dubious or unprincipled and is therefore reprehensible on that ground. It is unnecessary here to provide exhaustive categories of conduct that may be unethical. Conduct may be unethical if it is constituted by a deliberate flouting of significant professional standards. Reckless disregard of, or wilful blindness to, significant ethical standards or principles may also constitute unethical conduct." (emphasis added in Respondent's submissions).
""Those observations, in particular the underlined words, articulate the distinction between conduct that is improper, and conduct that is unethical. If that passage in Kesserwani is to be followed, for conduct to be unethical, it must have as a component a morally dubious, unprincipled, or reprehensible character. There may be a reckless or deliberate component. The Tribunal's observations are at odds with the oft repeated conclusion in earlier decisions of the Tribunal that conduct may constitute unethical conduct merely because it is in breach of a standard or code of conduct. In Kesserwani, the Tribunal considered that conduct may be unethical if it involved 'reckless disregard of, or wilful blindness to, significant ethical standards or principles'. That formulation requires a significantly greater departure than the mere fact of breaching a standard or code of conduct."
(1) The Commission submits that this Tribunal should follow the approach taken in Matta at [64]-[67] and Azzer at [104]-[115], [126], [137].
(2) The Respondent argues that:
"The Tribunal's reasoning in Matta (at [64]-[69]) does little more than follow previous decisions in the Tribunal, including Nguyen and Sathiyapal, which rely on R v Byrnes; R v Hopwood, and the dictionary definitions of 'improper' and 'unethical' in reaching a conclusion that conduct contrary to dispensing guidelines constitutes improper or unethical conduct. See in particular Matta at [69]."
(3) The Respondent relies on the earlier submission he made in his submission in relation to reliance on a dictionary definition of the words "improper" and "unethical".
(1) The notion that impropriety in the context of the National Law does not depend on consciousness of impropriety, nor the conduct being intentional, is derived from the following passage of R v Byrnes; R v Hopwood (also set out above):
"Impropriety does not depend on the alleged offender's consciousness of impropriety. Impropriety consists in a breach of the standards of conduct that would be expected of a person in the position of the alleged offender by reasonable persons with knowledge of the duties, powers and authority of the position and the circumstances of the case."
(2) However, regard must also be had to what the High Court said earlier, (pp 513-514, also set out above):
"Impropriety in the context of s.229(4) and its statutory antecedents has not been understood to be limited to conscious impropriety on the part of the offender."
(3) The Respondent argues that the High Court decision in R v Byrnes; R v Hopwood was not laying down a general principle as to how the word "improper" should be construed in all circumstances and all legislative regimes. Relevantly, s 229 of the Companies (New South Wales) Code 1981 (NSW) dealt with the duties and liabilities of directors. The Respondent argues that caution should be applied before relying on authorities such as R v Byrnes; R v Hopwood to extrapolate a general principle that improper conduct, within the meaning of s 139B(1)(l), need not be either conscious nor intentional. Consideration of the scope and content of the word must be specific to the particular circumstances in which it appears.
(4) The Respondents do not accept that there is a general proposition that conduct can be improper even where it is 'not intentional', as contended for by the Commission.
(5) The Respondents submitted that whether conduct is improper is a matter that depends upon the facts and circumstances of the particular case.
""[8] The Pharmaceutical Regulatory Unit conducted an investigation into the respondent's prescribing practices and found, as set out in its letter to the applicant dated 15 March 2019, that the respondent:
1. Prescribed drugs of addiction without prior authority under Section 29 of the Poisons and Therapeutic Goods Act to at least sixteen persons whom she knew or ought to have known are drug dependent as they were all on the NSW Opioid Treatment Program, contrary to Section 28(3) of the Act.
2. Prescribed drugs of addiction for a continuous period longer than two months without an authority under Section 29 of the Poisons and Therapeutic Goods Act to at least seventeen persons during the period 6 January 2017 to 6 January 2019, contrary to Section 28(2)(a) of the Act.
3. Prescribed large quantities of opioid drugs of addiction of over 200mg oMEDD [oral morphine equivalent daily dose] to at least eighteen persons during the period 6 January 2017 to 6 January 2019 of which she prescribed over 400mg oMEDD to at least eleven of these persons, over 800mg oMEDD to at least three of these persons and an oMEDD of 1320mg to one of these persons. The opioid drugs of addiction were prescribed at intervals and at a rate that exceeds the reasonable quantities required for therapeutic treatment for patients concerned and therefore not within recognised therapeutic standards of what is appropriate, contrary to clause 79 of the Poisons and Therapeutic Goods Regulation 2008.
4. Prescribed quantities of multiple benzodiazepines, sometimes concurrently, to at least twenty one persons, some of whom she knew or ought reasonable [sic] to have known are drug dependent during the period 6 January 2017 to 6 January 2019. Some of these persons were concurrently on the NSW OTP."
(1) maintain an awareness of the manner in which the pharmacy dispensing practice was being conducted, and
(2) to intervene into the dispensing practices at the pharmacy when necessary, contrary to the Proprietor Guidelines.
(1) engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration, and/or
(2) engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioner's registration.
"148. The seriousness of unsatisfactory professional conduct is to be measured by the extent to which it departs from proper standards. It is not measured by reference to worst cases. That would risk the misconduct of some practitioners indirectly setting the standards to be applied by the Tribunal: Health Care Complaints Commission v Litchfield [1997] NSWSC 297; (1997) 41 NSWLR 630 at 638.
149. The Tribunal has previously commented on the importance of pharmacists adhering scrupulously to their obligations in relation to drugs of addiction and restricted substances, including those imposed by the PTGA and PTGR. For example, in Health Care Complaints Commission v Pickett [2019] NSWCATOD 53 at [61]."
"155. The parties agreed that the most serious of the Complaints is Complaint 1. In our view, and we find, that is a correct characterisation of the conduct. The Respondent's failure to exercise his independent judgment to a limited degree, but then simply to accept whatever explanation he was given by the prescriber, when raised, fell significantly below what is required of any registered pharmacist. The failures had the real potential of causing risk to the patients involved, or the public at large.
156. Taken on its own, the established conduct the subject of Complaint 1 is, in our view, sufficiently serious to justify suspension or cancellation of the Respondent's registration. In coming to that view we have taken into account the relative inexperience of the Respondent in Australia at the time (which must be viewed, however, also with the knowledge that he had only recently gone through the learning required for registration); the environment the Respondent worked in where there appears to have been a wrongly held view that full independent judgment could be put to one side if a prescriber provided an answer; and the hours worked by the Respondent, the latter factor disavowed by the Respondent as excusing his conduct.
157. The degree to which the Respondent's conduct fell short of what is required of a registered pharmacist is evident from the very different practice he now adopts and the measures he has in place at the Junee Discount Pharmacy which he described in detail in his evidence. The Respondent did not exercise his own judgment that the practice of pharmacy dictates. He failed in his duty to take steps to protect the public's exposure to risk and harm. He failed in his role as gatekeeper and failed in his duty to properly assess prescriptions he dispensed where more thorough judgments were calling out to be made.
158. Taking and viewing all proven Complaints together, we are satisfied, and find, that the Respondent's unsatisfactory professional conduct was sufficiently serious to justify suspension or cancellation of the Respondent's registration and amounts to professional misconduct."
(1) The Respondent is guilty of unsatisfactory professional conduct pursuant to s 139B(1)(a) of the Health Practitioner Regulation National Law (NSW) (National Law).
(2) The Respondent is guilty of professional misconduct pursuant to s 139E of the National Law.
(3) The matter is to be listed for the Stage Two hearing on 23 July 2025 or otherwise directed by the Tribunal.
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.
Health Care Complaints Commission
Morcos [2025] NSWCATOD 32
(1938) 60 CLR 336
(1995) 183 CLR 501
(2017) 95 NSWLR 334
(1997) 41 NSWLR 630