Health Care Complaints Commission v Saweris [2025] NSWCATOD 30

Health Care Complaints Commission v Saweris [2025] NSWCATOD 30 | Case summary | Zoe

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"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 Nader Saweris ("the practitioner") of MITTAGONG, NEW SOUTH WALES 2575, being a pharmacist registered under the National Law,

COMPLAINT ONE

The Respondent 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 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 Alexandria University, Egypt in 1997.

The practitioner was first registered to practise as a pharmacist in Australia in June 2010. 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 NS other than those highlighted green) and/or permitted the inappropriate dispensing by an employed pharmacist (on the occasions referenced with initials other than NS) of Schedule 8 and 4D drugs, in various strengths to Patients A, E and I in circumstances where:

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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."

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(1) Exhibit A4: Bundle of documents relevant to each of the Applications against the Proprietors.

(2) Exhibit A5: Bundle of documents relevant to the Respondent (noting pages 160 to 166 are 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 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 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 Mr Morcos and the Respondent. 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 Mr Samer Morcos, one of the co-proprietors of the West Gosford Pharmacy owned in conjunction with Mr Baher Derias and 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 were not read pending determination of objections raised by the Respondent.

(5) In relation to Exhibit A6 and A7, the objections were addressed on 15 October 2024. 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 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.

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Exhibit A5 is a bundle of documents relied upon by the HCCC to establish their case specifically in relation to the Respondent Nader Saweris. We commence by noting the evidence of the HCCC expert Ms Alexandra Torrens in relation to the Respondent. Ms Torrens set out her credentials, which include that she is a pharmacy owner with over 20 years' experience as a pharmacist in the area of community pharmacy. She attached her CV. She then set out a list of the documents which the HCCC had provided to her.
The Report then addresses specific dispensing by the Respondent. It specifies dispensing to named patients and states where the expert opined that the dispensing illustrated conduct significantly below that which ought reasonably to be expected of a practitioner with the equivalent level of training and experience as the Respondent. We address this report later in this judgment.
In Exhibit A5 the HCCC also included evidence arising from s 150 and s 150A proceedings involving this Respondent. There was objection to portions of this transcript. Those objections were identified in a document which was provided to the Tribunal on 15 October 2024 and which we have marked for identification as MFI 1. The objections are primarily aimed at the words of the delegates who questioned the Respondent in the s 150 hearing. The objections included the words of delegates, such as, "But there were a hell of a lot you didn't review supply". The objections also identified statements by a delegate which it is submitted misstated the evidence of the PRU report. There are other objections to "rambling opinions of delegates" which are not based on the guidelines and codes of conduct and in fact misstate the role of a pharmacist. The objection also alleges the identified portion of the transcript, demonstrates statements by delegates which are made "in a badgering condescending tone". One objection is said to be a "complete misstatement and inaccurate, regarding the rules pertaining to dispensing to OTP patients and as a result is misleading, unfair and simply impermissible".
When the objections were addressed on 15 and 16 October 2024, the HCCC informed the Tribunal that in relation to the objections to the evidence in the s 150 transcript, the statements of the delegates are not relied upon for opinion value or accuracy or any other purpose short of contextualising the Respondent's responses. Further the HCCC undertook, at the request of the Tribunal, to specifically identify any parts of the s 150 transcript it seeks to rely upon, when providing its written submission.
Included in Exhibit A5 are the notes for the patients as reviewed in the PRU Report. Those notes were the subject of cross-examination of the Respondent and we will refer to same, where that evidence is important, in the determination of an issue.
Also, in Exhibit A5 are examples of refused prescriptions. Again, that was a matter which was addressed in cross-examination. We have reviewed the refused prescriptions (p 264). There is an example of correspondence between the PRU and the Respondent regarding concerns between 4 May 2018 and 23 September 2019. We have reviewed that evidence (p 298 and following).
At page 301 and 302 of Exhibit A5 is a submission by the Respondent dated 11 November 2019. In that we noted the following:

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(g) The Respondent then addressed the alleged "Breach of s 109 of the Regulation". He said he acknowledged that the quantities of Sch 8 drugs, particularly opioids, dispensed could be considered in excess of the recognised therapeutic standard. At the time of each dispensing he sought assurances from the patient's prescribing doctor that the doses which were being prescribed were medically indicated and that the doctor was comfortable with the appropriateness in providing the medication. (We note from the oral evidence of the Respondent that action was not always taken by him if there was, or ought to have been, a concern by him about the appropriateness of the dispensing he was asked to perform.)

(h) The Respondent said that with the benefit of hindsight, he should not have accepted those assurances on the occasions which he did. He ought to have sorted advice from the Pharmaceutical Services at NSW Health. He would do that in the future.

(i) The Respondent then addressed the alleged breach of s 54 of the PTGR. He addressed the dispensing of Testogel and Sch 4D Benzodiazepines. He denied he had dispensed the identified prescribing of Testogel to Patient B. He said that had been dispensed by an employed pharmacist. He denied the dispensing was in breach of s 54 or s 39(3) of the PTGR.

(j) In relation to the dispensing of benzodiazepines by the Respondent as identified by the PRU report, the Respondent said he had reviewed the patient notes and dispensing records and he acknowledged the quantities of benzodiazepines dispensed could be considered to be in excess of the recognised therapeutic standard. He said it was his usual practice in such circumstances to confirm with the patient that he/she did not have any medication left, and to contact the prescribing doctor to raise my concerns regarding the quantity being prescribed. In each of his conversations with the prescribers, he was reassured as to the need for the dose being prescribed and that the medical practitioner was comfortable with the appropriateness in providing the medication. He said that he accepts with the benefit of hindsight, he ought not to simply have accepted reassurances from the medical practitioners where there was any doubt regarding the therapeutic benefit of a prescription.

(k) The Respondent addressed the allegation he had breached cl 88(2) of the PTGR. He acknowledged there were instances where prescriptions for Sch 8 drugs were dispensed and not endorsed with the word "Cancelled" but rather had been "crossed out" to indicate it was cancelled.

(l) In relation to the alleged breach of cl 90 of the PTGR he acknowledged there were instances where psychostimulants were dispensed where the prescription had not been endorsed with the required reference number.

(m) In relation to the dispensing for Patient A, the Respondent acknowledged that the quantities of oxycodone dispensed could be considered to be in excess of the recognised therapeutic standard unless the patient was suffering terminal cancer or chronic severe pain. He had contacted Dr Sriskanda, the prescriber, who informed him the patient was under the care of a pain specialist and required high doses of oxycodone to assist with his pain condition. He specifically recalled contacting Dr Sriskanda in relation to early supply. Dr Sriskanda informed the Respondent the patient was in share accommodation and was prone to losing or having his medication taken. The Respondent suggested staged supply with the patient coming in every day get his daily dose as an alternative option. Dr Sriskanda advised that this would not be convenient to the patients' circumstances. Whilst the respondent was concerned about the ongoing need for early supply, he felt satisfied by the doctor's explanation that it was safe and appropriate to dispense the medications and that the patient did not present signs of overuse. The Respondent stated that he accepted that with the benefit of hindsight he ought not to have solely relied on the assurances of Dr Sriskanda and that he ought to have challenged her and refused supply if he was not satisfied as to the safety and appropriateness of the medicine for the patient.

(n) In relation to Patient B and the dispensing of fentanyl patches the Respondent acknowledged that the product information indicated that each transdermal patch should be used for 72 hours. That concern was raised with the prescribing doctor who advised that the patient suffered from heavy sweats and had densely hairy skin, the combination of which caused the patch to get loose and fall off. Based on the explanation provided the Respondent dispensed a supply of the patch for every 2 to 3 days which he considered reasonable to accommodate the patient's circumstances.

(o) In relation to Patient C the Respondent acknowledged the quantities of oxycodone dispensed could be considered to be in excess of the recognised therapeutic standard, unless the patient was suffering terminal cancer or chronic severe pain. Dr Sriskanda was the patient's medical practitioner. She confirmed the patient suffered from chronic osteoarthritis of his right hip and the pain worsened after a long day at work. The patient was seeing a pain specialist. The Respondent said that if that situation arose again, the prescribing doctor would be asked to supply a recent pain management report or a current NSW Ministry of Health authority. The Respondent said there were five occasions between August and October 2017 where the patient presented requesting early supply. The early supply was verified by Dr Sriskanda. On the last of those occasions Dr Sriskanda personally attended the pharmacy with the patient to verify early supply.

(p) The Respondent acknowledged that he dispensed oxycodone to the patient on 13 October 2017, which he does not consider he should have done having properly analysed the patient's notes and dispensing history. He recognised and accepted that he did not always properly analyse the patients 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.

(q) In relation to his dispensing for Patient D the Respondent acknowledged the quantities of oxycodone dispensed could be considered to be in excess of the recognised therapeutic standard unless the patient was suffering terminal cancer or chronic severe pain. The Respondent dispensed early supply of oxycodone to Patient D on 29 September 2017, 20 October 2017 and 31 October 2017. Before dispensing on 29 September 2017 the Respondent had regard to the patient notes and a recording by Mr Morcos on 25 September that year where a dispensing of early supply was based on advice from Dr Sriskanda that she was writing a new prescription which was necessary based on her correspondence with the patient's specialist. The Respondent accepts with the benefit of hindsight, that he ought not to have solely relied on the assurances from Dr Sriskanda and that he should have challenged her and refused supply if he was not satisfied as to the safety and appropriateness of the medicine for the patient. He noted from the PRU report that this patient and another patient who had medicine dispensed by the pharmacy had the same residential address. The Respondent said that he was unaware of that at the time of his dispensing to Patient D.

(r) In relation to Patient E, the Respondent acknowledged that the quantities of oxycodone dispensed could be considered to be in excess of the recognised therapeutic standard unless the patient was suffering terminal cancer or chronic severe pain. Once again this patient was under the care of Dr Sriskanda. The notes on the patient held by the pharmacy showed a pharmacist working in the business had contacted Dr Sriskanda on two occasions in July 2017 and on another occasion in August 2017 in relation to early supply of the drug to Patient E. On each occasion the pharmacist had been assured the dispensing needed to be completed and that the patient was under a pain specialist who had confirmed the dose in writing. The Respondent dispensed early supply of oxycodone on 18 September 2017 and 20 October 2017. He dispensed having read and relied upon the patient's notes. The Respondent stated that he accepted that with the benefit of hindsight, he ought not to have solely relied on the assurances from Dr Sriskanda and he ought to have challenged her and refused supply if he was not satisfied as to the safety and appropriateness of the medicine for the patient.

(s) In relation to Patient F the Respondent stated that he acknowledged the quantities of oxycodone dispensed could be considered to be in excess of the recognised therapeutic standard unless the patient was suffering terminal cancer or chronic severe pain. The Respondent dispensed to Patient F on four occasions between 8 August 2017 and 26 November 2018. On the last three occasions he had contacted the prescribing doctors Dr Sriskanda and Dr Smith. On two occasions the patient had presented for early supply. He was assured on each occasion it was appropriate to dispense as prescribed. The Respondent accepted with the benefit of hindsight that the pharmacy ought to have ceased dispensing oxycodone earlier than was ultimately done. He was also unaware that the patient was on Opioid Treatment Program (OTP).

(t) For Patient G the Respondent stated he acknowledged the quantities of oxycodone dispensed could be considered to be in excess of the recognised therapeutic standard unless the patient was suffering terminal cancer or chronic severe pain. He recalled this patient was elderly and attended the pharmacy showing no signs of substance abuse. He understood she was receiving chemotherapy treatment which caused her baldness. Noted in the patient notes was that a pharmacist had contacted Dr Sriskanda expressing concern regarding the prescription and had been advised by the doctor the patient was an elderly cancer patient who was on chemotherapy treatment. She required strong doses of oxycodone to manage her pain. The Respondent dispensed oxycodone for this patient on three occasions between 19 September 2017 and 6 March 2018. On two of those occasions, he did not consider the interval between dispensing unreasonable.

(u) In relation to Patient H the Respondent only dispensed on one occasion and that was 20 October 2017. He did not consider the interval since the last dispensing as unreasonable. He was unaware this patient shared a residence with Patient D. He acknowledged that the total quantities of oxycodone dispensed to the patient by the pharmacist at his pharmacy could be considered in excess of recognised therapeutic standards unless the patient was suffering terminal cancer or chronic severe pain. He noted that it was recorded in the patient's notes that Dr Sriskanda was contacted by the pharmacist on three occasions in September 2017 regarding early supply.

(v) In relation to Patient I the Respondent only dispensed for this patient on one occasion on 18 May 2018. The notes for the patient showed that Dr Sriskanda had advised the patient was under the care of a psychiatrist for a psychiatric condition which required him to take higher doses of diazepam. That was said to be documented in a letter addressed to Dr Sriskanda. The notes also showed that on one occasion one of the pharmacists refused to dispense due to the short interval between the last dispensing. On 18 May 2018 the Respondent contacted Dr Sriskanda regarding the request for early dispensing. He was reassured by Dr Sriskanda that the patient's last supply had been stolen and the patient had verified this with a copy of a police report he made. Based on that reassurance Respondent dispensed the medication. The Respondent acknowledged that he should not have accepted the assurance of Dr Sriskanda.

(w) The Respondent set out the action taken by the proprietors upon receiving contact from the PRU. He also set out the action he had taken as a pharmacist.

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(a) The Respondent set out detail of his professional training, qualification and experience. He said he obtained a degree in Pharmacy in Egypt in 1997 and worked as a pharmacist there from 1998 to 2008. He described an entirely different method of dispensing to that he has learnt in Australia.

(b) The Respondent migrated to Australia in 2008. He undertook further study and work experience in Australia to obtain qualification for registration which he obtained in June 2010.

(c) During his training in Australia he was aware the pharmacists contacted many doctors in relation to aspects of their prescriptions which were unclear. He was unaware of a script being refused for dispensing during his training. Further he said he was not taught that the pharmacist could refuse to dispense.

(d) He has been a preceptor of a pharmacy student, foreign-trained pharmacist and newly registered pharmacist since 2012. This has occurred on approximately six occasions. The Respondent set out the role he played as a preceptor.

(e) The Respondent addressed his role as a proprietor of a pharmacy. In 2012 he became a joint proprietor (one of six) of Christopher Discount Chemist, Kogarah. There was no specific education or accreditation for ownership of a pharmacy.

(f) In September 2014 the Respondent became one of six proprietors for Christopher Discount Chemist West Gosford Pharmacy.

(g) On or about 10 January 2019 the PRU contacted the West Gosford Pharmacy and requested dispensing records.

(h) On 31 January 2019 the respondent was advised that Dr Sriskanda had been suspended as a medical practitioner.

(i) On 1 February 2019 the proprietors of the pharmacy convened an urgent meeting to address concerns raised by the PRU. Resulting from that meeting the proprietors instituted updated procedures for the dispensing of Sch 8 and Sch 4D drugs.

(j) On about 12 August 2019 the respondent was advised that the PRU had determined to commence an investigation into the dispensing practices of the pharmacy.

(k) On 16 October 2019 the PRU submitted a complaint to the Pharmacy Council of NSW following a report prepared by Ms Yang, Senior Pharmaceutical Officer.

(l) On 11 November 2019 the Respondent attended before the Pharmacy Council and participated in a s 150 hearing. The outcome of that hearing was the suspension of the Respondent's registration. On 10 February 2020 following a hearing pursuant to s 150A the Council lifted the suspension order and reinstated the Respondent's registration without conditions.

(m) In approximately April 2020, the West Gosford Pharmacy and the Kogarah Pharmacy, in which the Respondent held an interest, were sold. The Respondent remains a proprietor of the Mittagong Pharmacy.

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(a) As a registered pharmacy, the Respondent said the West Gosford Pharmacy premises were inspected about once every 12 to 18 months by a Council appointed inspector to ensure ongoing compliance. No concern about the pharmacy premises was raised with the Respondent.

(b) The West Gosford Pharmacy has a Quality Care Pharmacy Program. It gained accreditation in 2016. There have then been re-accreditation assessments every two years.

(c) The Respondent said he understood his "role as a proprietor was to maintain and be able to demonstrate an awareness of how the pharmacy business was being conducted; and where necessary, intervene to ensure that the pharmacy practice was conducted in accordance with the applicable laws, standards and guidelines." The Respondent set out the systems and processes the business instituted to attend to those requirements. It included having a proprietor work alongside employed pharmacists to ensure compliance with the dispensing practices were continuously monitored. He also described ongoing training for all pharmacy staff and monitoring of dispensing through Z-Software. There was implementation of an incident reporting system as required by QCPP standards. There was an established audit trail of pharmacists' responsibilities and actions. There was a system of documentation and evaluation of identified issues, and appropriate responses, in accordance with QCPP standards.

(d) The West Gosford Pharmacy was located inside a Reliance Medical Centre. The lead practitioner in that medical practice was Dr Sriskanda. The Respondent understood Dr Sriskanda had a special interest in pain management. She was referred complex pain patients.

(e) Prior to the PRU report the Respondent was aware that Dr Sriskanda was prescribing more opioids and benzodiazepines than other doctors whose prescriptions were received for dispensing. He had discussed that with the other proprietors in the pharmacy and they concluded that occurred because she was referred patients within the medical practice that needed pain management. He was aware that one of the employed pharmacists was contacting Dr Sriskanda on a regular basis with concerns about her prescribing. That pharmacist had discussed that with the Respondent. As the patients who were requiring dispensing of Sch 8 and Sch 4D drugs were all coming with scripts under the hand of Dr Sriskanda, the Respondent considered there was no evidence of doctor shopping and the patients did not present as suffering from substance abuse.

(f) The West Gosford Pharmacy served approximately 300 to 350 customers a day. About 98% of the scripts dispensed were from the Reliance Medical Centre doctors. Sch 8 and Sch 4D drugs dispensed represented only 3% to 4% of all dispensing.

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The Respondent then addressed Complaint Three (s 139B(1)(l) of the National Law). Under that heading we noted the following.
The Respondent admitted that for the period 10 July 2017 to 4 May 2018 (298 days), the eight prescriptions as set out in Schedule 4 to the Complaint document were inappropriately dispensed as they failed to comply with the requirements of cl 80 of the PTGR. The Respondent again minimized the extent of the offending by saying the dispensing represented 0.01% of the totality of the dispensing during that period. He did not admit the dispensing as set out for 4 April 2017 was contrary to cl 80(1)(c) and cl 80 (1)(h) of the PTGR. He did not admit he permitted inappropriate dispensing as set out in Schedule 4.
The Respondent addressed Complaint Four (s 139B(1)(l) of the National Law). Under that heading we noted the Respondent admitted that the dispensing as set out in Schedule 5 of the Complaint document was inappropriate as the prescriptions did not specify the repeat interval at which the substances may be supplied, to cl 39(3) of the PTGR.
The Respondent then set out in his affidavit detail of the action taken by himself and the Proprietors, in response to the Notification from the PRU. He set out what he had done during the period of suspension imposed upon him. He set out what action the Proprietors collectively had taken as a response to the Notification. He set out what he has done since having his suspension lifted. All of those matters are really matters to be considered in Stage Two of the hearing.
Exhibit R5 also attached all of the annexures to the affidavit of the Respondent sworn 19 July 2023. We have had regard to those without setting out herein the content of same as there are some 284 pages. When we address the submissions of the parties we will consider any specific portion of the Exhibits to the Respondent's affidavit which are drawn to our attention by their submission.
In the hearing, during the oral evidence of the Respondent he made admissions that identified dispensing which was inappropriate. We will now address that evidence.

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The first observation we make is in relation to our view of the Respondent as a witness. We were impressed with the candour of the Respondent. He unhesitantly and apologetically admitted matters put to him where a concession was properly made. The issue of greatest contest was the extent to which the Respondent was responsible for the dispensing of employed pharmacists and of his co-owners. Another significant issue was whether he ought to have known he had the discretion to refuse to dispense a prescription in whole or in part where he concluded the dispensing intervals and/or frequency did not accord with recognised therapeutic standard.
We noted the following in particular from the Respondent's oral evidence.
The Respondent said that the content of his affidavit (above referred to) was true and correct. The Respondent was then cross-examined by counsel for the HCCC.
The Respondent said he understood the potential danger to patients of Sch 8 and Sch 4D drugs. He understood that both before coming to Australia and since.
When he arrived in Australia he undertook training to gain registration as a pharmacist. That included 2000 hours as an intern. Part of that training was to familiarise himself with relevant legislation which impacts on the work of a pharmacist. That included the Pharmacy Board of Australia's codes of conduct and guidelines.
The Respondent confirmed his statement in his affidavit that when he commenced practice as a pharmacist he did not believe he had the power to override the direction of a prescribing doctor to dispense a script the subject of a concern raised by the pharmacist directly with the prescribing doctor. He stated nobody had told him during his training in Australia that he could not refuse to dispense where he considered that was necessary. He said however he had been told 14 years ago by a person named Vince that his discretion stopped when it came to the doctor. He agreed he had not said that in his affidavit.
By July 2017 the Respondent agreed he had been practising for seven years. He said he understood that in Australia a pharmacist was responsible for patient safety. He understood that required him to act and exercise independence. The Respondent was asked: "Wasn't it clear to you (presumably at July 2017) based on the code of conduct that you could not just defer to the prescriber when considering dispensing?" The Respondent said "No". He then denied that on any occasion of dispensing did he think the dispensing was unsafe (for the patient). We accept the Respondent would not have dispensed to a patient where he clearly understood that the medication, if ingested as prescribed, would seriously harm the patient's health. However, we do hold the view that he did not properly consider that possibility when he was making an early dispensing of Sch 8 and Sch 4D drugs as directed by Dr Sriskanda.
The Respondent conceded that dispensing required the exercise of professional discretion independent of the prescriber. He said he understood he was required to act when the dispensed drug was not in accord with therapeutic purpose. He said he understood he could not just do what the prescriber required if there was a risk to the patient.
The Respondent was taken to Exhibit R4 Volume 1. It consists of 1552 pages of documents. All those documents are in the nature of Codes of Conduct for pharmacists and publications which set out standards to be adhered to or guidelines for practice as a pharmacist. The Respondent was asked if he had read those documents at July 2017 (those published prior to that date). The Respondent said he had read most of them.
The Respondent was asked specifically about the first document in Exhibit R4 Volume 1 which is titled Pharmaceutical Society of Australia, Code of Professional Conduct (March 1998). He did not recall having read that before July 2017.
In 2012 the Respondent first became a proprietor of a pharmacy business. In 2014 he became an owner of the West Gosford Pharmacy. He understood the law regulates who can be an owner of a pharmacy. When the pharmacy became a QCPP accredited pharmacy the controllers of that group did not review dispensing records.
The Respondent said that in 2015 he had read the Pharmacy Guidelines. He said he had vigilantly maintained interest in the practice of the West Gosford Pharmacy. The Respondent agreed he was required to know what the laws relevant to conducting a pharmacy business were. He understood he could not escape compliance by professing that he did not understand what that law required of him. He accepted that as a proprietor he had to ensure the pharmacy business complied with the law. He did not accept that meant he was required to undertake audits to ensure other pharmacists working in the business were complying with the law. He did understand he was required to meet with employed pharmacists. He understood he was required to ensure record keeping was sufficient to be able to conduct an audit. He understood he was required to ensure the pharmacy was appropriately resourced.
The Respondent said that the employed pharmacist Mr Azzer was working 70 hours per week. He had asked to be able to work that time. He had commenced working as an intern and became registered in 2017. The Respondent denied that because Mr Azzer was working long hours he required overseeing by a proprietor.
The Respondent was asked if he had taught Mr Azzer that he had no right to override a prescriber when considering dispensing. The Respondent said: "If there is a risk to the patient." The Respondent said he did not accept any responsibility for Mr Azzer's dispensing.
The Respondent agreed that between July 2017 and December 2018, the West Gosford Pharmacy had no specific policy in place in relation to Sch 8 and Sch 4D drugs. He said there was no specific requirement to have such a policy.
The Respondent agreed that between July 2017 and December 2018 there was no policy in the pharmacy to calculate 'Oral Morphine equivalent daily dose' (oMEDD). There was no policy requiring the prescriber to provide a copy of a relevant Pain Management Plan. There was no policy as to when it was necessary to contact the PRU. There was a way in which to record conversations with doctors, namely in the software the pharmacy was using. The Respondent was asked about a policy in relation to putting notes into patient's files. He didn't directly answer. However, he said that he did write short notes in the system. Sometimes he made a physical note which he put on the system at the end of a shift. Sometimes he did not write up his notes onto the system.
In relation to a policy or procedure in relation to when a script for Sch 8 or Sch 4D drugs would not be dispensed, the Respondent said "It was in the Poisons Regulations."
The Respondent did not accept that prior to December 2018 the policies applicable to the West Gosford Pharmacy were deficient. The Respondent said there was a stock audit undertaken.
The Respondent conceded there was no specific training for employed pharmacists as to the dispensing of Sch 8 and Sch 4D drugs. He said they had access to documents. He agreed he did not have regular meetings with the other pharmacists who worked in the pharmacy. However, the Respondent said he was working with employed pharmacists who could ask him questions at any time. He denied he was not meeting his obligation as a pharmacist proprietor.
Although the PTGR sets out special requirements for scripts which prescribed Sch 8 and Sch 4D drugs, the pharmacy had no policy or procedure to address that need. He said he just looked carefully at the script. He agreed there was no random check of dispensed scripts for Sch 8 and Sch 4D drugs. He said there were no formal meetings with employees.
The Respondent conceded that between July 2017 and December 2017 there were occasions when he did not make a note of a conversation he had with a doctor to check on a script or other concern he had about a script. Sometimes he did not record the reason given for the requirement to dispense the script.
The Respondent was then taken to specific dispensing undertaken by him as set out in the schedules to the Complaint document. In relation to Patient A and a dispensing on 8 September 2017 the Respondent was asked if he had looked at the dispensing history before dispensing oxycodone and Alodorm tablets to the patient. He said "I should have". Having regard to the dispensing history for the patient, the Respondent agreed that the dispensing did not meet the recommended therapeutic purpose or standard for the patient unless there was a special reason for exceeding the recommended dispensing. In relation to that answer the Respondent was asked to look at pages 244 and 245 of Exhibit A5 which contained the notes made for this patient. The Respondent agreed he had made a note on 8 September 2017 and he agreed further the note did not give a sufficient reason to dispense the subject script.
In relation to Patient A the Respondent was asked to look at the dispensing on 29 September 2017. There he agreed there was 228 days' worth of oxycodone dispensed in one month. He agreed for that dispensing there was no patient note. He said he should have made a note. He agreed that prior to 13 October 2017 the patient notes show a number of excuses for lost medication. He said he did not see those notes when dispensing (on 29 September 2017). He agreed the dispensing was not in accord with recommended therapeutic purpose.
The Respondent was taken to a note he agreed he had made on Patient A's records of dispensing on 8 September 2017. He agreed the note, which stated "Doctor confirmed he is following up with specialist", was not a sufficient reason to dispense.
The Respondent agreed there was no note made on the patient record about the early dispensing of oxycodone on 29 September 2017. He agreed he should have made a note. In relation to the dispensing on 13 October 2017 the patient notes showed a number of excuses given for lost medication in recent dispensing. The Respondent conceded he did not see those notes before dispensing. He agreed that if he had seen the notes it would have raised alarm bells. The Respondent agreed that his dispensing for this patient in the range of dates he has been taken to above was not within the recommended therapeutic range.
It was put that his dispensing was contrary to the recommended therapeutic range. The Respondent said: "Yes but it depends what it means".
It was put that since 2017 the Respondent has done a great deal of study about dispensing. He agreed that was so. He was asked whether with that newfound knowledge he can see that his dispensing for this patient was wrong. The Respondent replied: "If I am to have regard to the therapeutic recommendation I have to have regard to what is ingested not what is supplied." When challenged about his assumption that the patient was complying with the prescribed doses and timing, the Respondent said: "We were told in Australia we cannot accuse a patient of lying. I should have insisted on staged supply".
We were concerned by the evidence of the Respondent as recorded in the prior paragraph. However, it seems to us that the Respondent did accept he should have exercised his independent judgment and staged the supply of the drug.
The Respondent said that at the time of dispensing to Patient A he did not think he was able to enforce a staged supply.
The Respondent was then taken to his dispensing for Patient B. He was asked about dispensing on 28 June 2018. He denied that dispensing was contrary to recommended therapeutic purpose. Even looking at prior dispensing for Patient B he denied there was a problem with that particular dispensing.
In relation to the dispensing on 3 December 2018 for Patient B the Respondent denied any error in that dispensing. He was asked to look at what he had said in paragraph 99 and 100 of his affidavit in Exhibit R5 (page 28). There he had admitted that the dispensing on 3 December 2018 may not be in accordance with recognised therapeutic standards. The Respondent said in response to that: "That is a mistake, the interval was not unreasonable" .
In relation to Patient C the Respondent agreed he dispensed on four occasions to this patient. He was asked about the dispensing on 8 September 2017. There he dispensed both 40 mg and 80 mg tablets (28 of each) of oxycodone. On 1 September 2017 the patient was dispensed the same quantity and strength of oxycodone. He agreed that dispensing should have lasted 28 days. The Respondent said he could not find any explanation for the early dispensing for this patient. There is no note providing an explanation.
In relation to the dispensing to this patient on 18 September 2017 (both 40mg and 80mg tablets (28 of each) of oxycodone together with Oxynorm Capsules 20mg 20 caps) the Respondent denied that was a large dose of opioid.
The Respondent agreed that taking the dispensing by him to Patient C as a whole it was inappropriate dispensing.
In relation to Patient D the Respondent conceded the dispensing to this patient on 29 September 2017, 20 October 2017 and 31 October 2017 was inappropriate. He did not agree however, that it was contrary to recommended therapeutic standards.
In relation to Patient E the Respondent agreed this his own dispensing to Patient E on 18 September 2017 and 20 October 2017 was inappropriate. He did not admit that it was contrary to recommended therapeutic standards.
In relation to Patient F the Respondent said he was not aware prior to dispensing to this patient that he was an OTP patient. He agreed that the dispensing on 8 August and 18 August 2017 was inappropriate. He denied the dispensing on 18 September 2017 was inappropriate. Looking at the dispensing "as a whole" the Respondent conceded it was inappropriate.
In relation to Patient G the Respondent denied the dispensing on 19 September and 22 December 2017 was inappropriate. He conceded the dispensing on 6 March 2018 was inappropriate.
In relation to Patient H the Respondent conceded that when the dispensing for this patient is considered as a whole, it was inappropriate.
In relation to Patient I the Respondent agreed the dispensing on 18 May and 29 June 2018 was inappropriate. He also agreed that when the dispensing for Patient I was considered as a whole, it was inappropriate.
The Respondent was asked whether as a proprietor of the pharmacy he should have been aware of the dispensing for Patients A to I, the Respondent said: "Some I saw but I didn't discover the problem until the investigation... but those things didn't come up on our screen. If I have a concern, I can do a print-out." The Respondent denied he failed in his responsibility as a proprietor of the pharmacy. He said: "I was never aware of this problem. It didn't come to our attention at all."
The Respondent was asked if he agreed it was inappropriate to dispense a script which did not comply with the PTGR. He responded: "If I note it, yes."
The Respondent said he did not accept any failure as a proprietor for the dispensing set out in Schedules 3, 4 and 5 to the Complaint document.

[120]

The expert was then asked to address the dispensing of 100 tablets of nitrazepam 5mg tablets in the period 24 July 2017 to 20 October 2017 of which the Respondent dispensed 25 tablets on 8 September 2017.
The expert stated that nitrazepam is a Schedule 4 Appendix D drug (Prescribed Restricted Substance). It is a benzodiazepine. She then quoted from the Australian Medicines Handbook in relation to benzodiazepines, as we have already set out above. She also stated that dispensing of the subject drug is covered by cl 54 of the PTGR. She pointed to short dispensing of the drug to Patient A. It included the dispensing of 25 tablets to Patient A three days after an earlier dispensing of the same number and dose of the drug. She stated that the supply of the drug therefore appears to be in excess of the recognised therapeutic standard. Although the Responded was not involved in the dispensing of all of the subject drug he would have been able to see the patient's relevant dispensing history and make a professional judgment accordingly.
Additionally, as the Respondent was a proprietor of the pharmacy, he was subject to the Proprietor Guidelines, as we have set out above. She stated: "This example, when combined with the other examples provided indicate serious concerns in relation to the procedures for supply of Schedule 4, Appendix D medications from this pharmacy". The expert then stated: "I therefore consider Mr Saweris' contact in this regard to significantly below what is reasonably expected of a practitioner."
The expert was asked to provide her opinion, having regard to all of the dispensing of the drugs for Patient A, as to whether the concurrent supply of the above drugs was safe and/or appropriate for Patient A. She referred to the Australian Medicines Handbook which setup details of precautions in relation to the administration of benzodiazepines. She stated that the evidence of dispensing to Patient A showed a concurrent supply of multiple strengths and formulations of opioids and benzodiazepines. If this combination of drugs was being taken by the patient in the quantities suggested by the dispensing history this would have presented a significant safety risk to the patient. If the items were not being taken by the patient due to loss, theft etc (as suggested in some of the documents provided) the potential diversion of such a large quantity of dangerous drugs poses a significant safety risk to the community. Therefore, she considers the Respondent's conduct in supplying or overseeing the supply of such quantities and combinations of medications to be significantly below the standard required.

[159]

The expert affirmed the content of her three reports. She also confirmed she had provided further information which is contained in Exhibit A10.
The expert was cross-examined by senior counsel for the Respondent. The cross-examination covered the three HCCC Complaints against each of the Proprietors of the West Gosford Pharmacy, of which the Respondent was one. We will address the evidence of the expert which addresses conduct of the Respondent as both an individual dispenser and as a proprietor of the pharmacy.
The expert was asked questions about her provided CV. She currently is an owner of a pharmacy business at Hornsby Heights, NSW. She works there approximately 38 hours per week. She employs three registered pharmacists. There are usually two pharmacists working with her each day. The pharmacy is open 5 ½ days a week from 9:00am till 6:00pm during the week and from 8:30am on Saturday.
The expert ensures her employed pharmacists are aware of the guidelines and codes of conduct which apply to their practice as a pharmacist. She said her pharmacy is a quality care accredited pharmacy (QCPP). On the days she works in the pharmacy she dispenses about 100 scripts personally. The pharmacy as a whole dispenses about 200 scripts a day.
The expert was asked about the policies and procedures she has in her pharmacy. She said she has procedures and policies which are specific to her place of practice, guided by the ones that the QCPP accreditation provide. Where there is a service that her pharmacy provides, she has a policy for that. An example which was applicable in the 2017 and 2018 years was a blood pressure monitoring service.
The expert does not provide an OTP service.
The expert does have a policy or procedure in place in relation to the dispensing of Sch 4D drugs which is in addition to that recommended under the QCPP accreditation. She has a similar policy or procedure in place in relation to the dispensing of Sch 8 drugs.
The expert advised that she does not routinely ask for a specialist report from the prescriber before dispensing a requested Sch 8 drug.
The expert was asked to look at paragraph 52 on page 17 of Exhibit R6. That is an affidavit by Mr Baher Derias, one of the three proprietors of the West Gosford Pharmacy in the period 2017 to 2019.
The expert was taken to Exhibit R4 Volume 4 page 1309 which set out requirements for QCPP accreditation. There are 18 defined requirements named as elements to meet a quality care pharmacy standard. Element 1 is the requirement for compliance with legal and professional obligations. At page 1309 the third paragraph (Element 3) requires evidence of a declaration by the proprietor or manager that the pharmacy complies with legislative requirements and professional obligations, and proof of access to the current edition of the professional practice standards.
The expert was asked if she educates her employed registered pharmacists in relation to the clauses of the PTGR. She said she did not. She was asked if she personally provided any education in relation to professional standards to her employed pharmacists. She does not. She does however, ensure they have access to education. The employed pharmacists have access to documents in the pharmacy such as the QCPP accreditation document currently being questioned on in this hearing. They also have training courses through the Pharmaceutical Society of Australia (PSA) or the Pharmacy Guild.
In relation to ensuring her employed pharmacists understand and follow legislative requirements and professional practice standards, the expert said the pharmacists are required to undertake continuing education and for that purpose create an education plan which identifies elements that they are proposing to obtain additional training in. Once that plan is completed the expert views it and then at a later time checks to see that they have completed the training which was outlined. The expert also ensures that the employed pharmacists are across the information relative to the dispensing of Sch 4D and Sch 8 drugs. There is no formal education however there are staff meetings where these matters are discussed.
The expert was asked to look at part of the QCPP documents which are set out at page 1355 of Exhibit R4 Volume 4. The heading is "Dispensing". She was asked to read paragraphs 12 to 18 under the further heading of "Processing the Prescription". The expert agreed it does not say in that list that the pharmacist may refuse to dispense the prescription.
The expert was then asked to look at the heading "Interpersonal Collaboration Policy" on page 1365 of Exhibit 4. She agreed it was one of the documents to be used to aid when making contact with a prescriber.
The expert was asked to read the content of page 1443 of the Exhibit under the heading "Interprofessional Collaboration Checklist". She agreed this was also a document which is used in aid of contacting a prescriber. She was asked if there was any other document which she would, or could, have regard to as an aid when contact with a prescriber was required. She said there would/could be other documents she would have regard to when contacting a prescriber. She does have cause to contact prescribers in her work as a pharmacist.
The expert was asked if she conducted audits in her pharmacy of Sch 4D and Sch 8 drugs. She said she does. She audits for stock-on-hand. If there was a concern she might do a more targeted audit. A report may be generated on those drugs which identifies the prescriber, the patient, who has dispensed the drug and when it was dispensed. There is no specific timeframe for carrying out such a report. The expert conducts spot checks on many aspects of the pharmacy business she conducts.
The expert was asked: "When you receive a script from a general practitioner that you know, is your starting position that this script is likely to be therapeutically indicated?" She answered: "No, I wouldn't assume that just because I know the doctor."
Following a long line of questions to which the expert gave non-specific answers, the expert agreed she did know of at least one GP who she trusted as a prescriber. She agreed that in general terms a competent GP will, on many occasions, have a far more detailed knowledge of symptoms and diagnosis for a patient who turns up at her pharmacy, than the pharmacist will have.
The expert confirmed she was not provided with the clinical records (kept by patients' GP) for the patients identified by the HCCC as Patient A to Patient I. Further she was not supplied with any patient statements. She could not recall seeing a statement from any treating doctor for the subject patients. She agreed she did not receive any evidence with respect to the social, psychological or physical histories of any patient the subject of the Complaint.
The Respondent asked the expert whether she agreed that the clinical records, the physical examinations, the pathology, the specialist reports, patients statements and doctors statements (about the subject patient) are all relevant to a determination as to what is or is not prescribing within a recognised therapeutic purpose. She agreed that was all relevant to decide if a drug was prescribed appropriately. She also agreed all of the guidelines and codes relevant to the practice of pharmacy state that if you are unsure about the intentions of the prescriber you must make contact with the prescriber.
The expert agreed that for the period between 1998 and 2019 the guidelines did not expressly say that a pharmacist could decline to dispense a drug if determined it was bona fide or not fraudulent. She further agreed that no guideline issued by the Pharmacy Board of Australia (PBA) or the PSA or any other organisation between the year 2000 and June 2019, being guidelines specifically in relation to dispensing, expressly stated that a pharmacist can decline a script.
The expert was asked: "Ms Torrens, did you understand that you could decline a script issued - decline a script if you'd had a conversation with the doctor and the doctor had said no you dispense that script?" She replied: "Yes, I understood that I had the ability to do that." She was asked: "And from what year did you have that understanding?" She replied: "From my graduate year in pharmacy." She also added she had been taught that at university as she was studying pharmacy.
The expert was asked the circumstances in which she believed she could decline to dispense a script. She said: "If there was a problem with the prescription, if it was fraudulent, if the item in question or quantity or dose could have presented a safety concern to the patient." She said she would do so after a review of the prescription, review of the dose and discussion with the prescriber. If the prescriber instructed her to dispense the script as is, she said: "Well if I was concerned about the dose or the safety of the patient then I would have declined to supply."
The expert was asked to look at the document titled Professional Practice Standards Version 5 of 2017. The document is published by the Pharmaceutical Society of Australia. She was asked to look at page 924 of the Exhibit where detail of the 1997 requirement was set out under the heading "Interaction with the Prescriber". There, it stated that in exceptional circumstances the pharmacist could decline supply. She agreed that is what she was taught at university. She could not recall what she was taught would constitute exceptional circumstances.
The expert was asked to look at the 1998 version of the Pharmaceutical Society of Australia, Code of Professional Conduct (March 1998) (1998 Code of Professional Conduct), and to Principle One and Principle Six in that document. Principle One stated: "The primary concern of the pharmacist must be the health and well-being of both clients and the community". Principle Six stated: "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".
The expert was then asked to look at a publication by the Pharmacy Board of Australia, titled "Guidelines for dispensing of Medicines". The document is said to be "retired", i.e., there is a subsequent version. We were told this version was published in 2010. The document is contained in Exhibit R4 Volume 2 at page 612. The expert was asked to look at page 614 and the heading "Guidelines". Her attention was taken to the following words:

[161]

The expert was asked to agree that in the 2010 version of the Guidelines for dispensing of Medicines (2010 Dispensing Guidelines), the Pharmacy Board of Australia did not expressly state that in exceptional circumstances you may decline a script. She confirmed this was correct.
The expert was able to continue her cross-examination on 28 August 2024.
The Respondent's senior counsel advised the Tribunal and the expert that she proposed to commence the cross-examination with questions about the report prepared in relation to the Respondent's co-proprietor Mr Morcos.
The Tribunal was told it is a conceded fact that Mr Morcos did not dispense any Sch 8 or Sch 4D drugs to Patient A. The expert had been asked by the HCCC to provide an opinion as to Mr Morcos' responsibility as a proprietor of the West Gosford Pharmacy for the dispensing to Patient A of those types of drugs.
The expert was asked to assume that the West Gosford Pharmacy held 500 scripts for patients who would return for repeat dispensing.
The expert was also asked to assume that over the 18 month period which is spanned by the HCCC Complaint, the pharmacy dispensed between 140,000 and 165,000 scripts.
Ms Torrens agreed that in 2017 or 2018 there was no obligation on a proprietor of a pharmacy to check every script dispensed by a registered pharmacist. Further she said she did not know of any mandated requirement on a proprietor of a pharmacy business in 2017 and 2018 to conduct an audit on Sch 4D drugs or Sch 8 drugs other than a stocktake audit. She further agreed that in that same period there was no guidelines or professional practice standard or code of conduct which recommended an audit on those drugs, other than for a stocktake audit.
The expert identified a copy of a Pharmacy Council of NSW Notification dated 30 March 2023. She was familiar with the content of the document having seen it at an earlier time. The document was tendered and marked as Exhibit R8.
Part of Exhibit R8 was read to the expert as follows: "Proprietors must maintain, and be able to demonstrate an awareness of, the way that pharmacy business is being conducted. Strategies and interventions are recommended to ensure that the practice of pharmacy is conducted in accordance with relevant laws, standards and guidelines." The expert agreed that requirement was in place in 2017 and 2018.
In that same Exhibit R8 the expert was asked to look at an attached document titled "Suggested Audit Areas" and in particular a column under the heading "Schedule 8". In that column an audit of "Prescription quantity and purpose of supply are deemed appropriate" is listed. The expert said that she could not recall any previous (prior to 30 March 2023) communication from the Pharmacy Council which stated that.
The expert was then asked again about her report in relation to Mr Morcos as set out in Exhibit A7. In particular she was taken to her reference to the PBA guidelines. Having regard to those guidelines, as they applied to a pharmacy proprietor, the expert agreed the guidelines did not require a proprietor to maintain an awareness of the dispensing in his pharmacy of every script. The expert stated however, that the guidelines created an obligation on the proprietor to be satisfied that the dispensing in the pharmacy was complying with the guidelines.
The expert had been asked to assume that there was no matter of concern in relation to the dispensing to Patient A which was brought to the attention of Mr Morcos during the relevant period. She was asked then, if there was no matter of concern in relation to that dispensing brought to his attention how could she find that he had breached the Proprietor Guidelines as set out in her report. She responded that it was because the dispensing profile for Patient A indicated to her there were excessive supplies of drugs being supplied to Patient A and Mr Morcos was not aware of that. Her opinion was that this meant he did not have adequate oversight of dispensing in the pharmacy.
The expert also said that in her own pharmacy, if the quantity of Sch 8 or Sch 4D drugs being dispensed was similar to those in the West Gosford Pharmacy, that would have alerted her as being unusual and she would have looked into the dispensing further. Her view of the dispensing histories she was asked to review for her report was that for a community pharmacy, the dispensing of Sch 8 and Sch 4D drugs was out of the ordinary.
The expert conceded that there was nothing out of the ordinary for the West Gosford Pharmacy, as a community pharmacy, about its overall dispensing of Sch 8 and Sch 4D drugs. However, the individual dispensing she regarded as "out of the ordinary".
The expert was asked about her report in relation to the dispensing of alprazolam to Patient A where although Mr Morcos had not himself undertaken any of the dispensing of that drug to Patient A, she nonetheless concluded that he had failed to comply with the applicable standards because he was unaware of the conduct of the pharmacy in relation to that particular dispensing which the expert had concluded was inappropriate.
The expert agreed she had no evidence to suggest that the stocktake for Sch 8 and Sch 4D increased during the 2017 or 2018 years for the West Gosford Pharmacy.
In relation to the dispensing to Patient A during the relevant period it was put (and not challenged) that there were 15 occasions revealed in the patient's notes where the prescriber was contacted by a dispensing pharmacist. The expert was asked whether that did not demonstrate there was a system in place. The expert stated: "My concern when I reviewed this, was that the frequency with which it happened with varying reasons given (why early dispensing was required) and that was just accepted rather than questioned."
The expert was asked to look at the 2010 Dispensing Guidelines contained in Exhibit R4 Volume 2, Tab 14. She agreed these Guidelines stated: "If there is any doubt [with respect to the script], the prescriber is to be contacted."
The expert was then asked to look at the excerpt "Dispensing Practice" from the 2015 edition of the Pharmaceutical Society of Australia, Australian Pharmaceutical Formulary and Handbook (2015) (2015 Formulary and Handbook). She was asked to assume the wording in the 2010 Dispensing Guidelines is in identical terms. In the 2015 Formulary and Handbook there is a heading "Promote optimal medicines use." The expert then read onto the record the following extract from that 2015 Formulary and Handbook as follows:

[177]

The expert was asked if she assumed all of the specific directions in guidelines and practice standards codes applicable to pharmacists she had been taken to in the cross examination and which cited a specific right for a pharmacist to decline supply of medicine even where a prescriber directed the supply should be dispensed, following the Parliamentary enquiry into pharmacist dispensing in early 2018, would she not agree that there had been an express shift in the guidance given to pharmacists with respect to the relationship between prescriber and pharmacist. The expert agreed that was the case based on the assumptions which she had been asked to accept. She did not however, in light of that, reconsider any of the criticisms she had levelled at the pharmacist Mr Morcos. When she was asked why she would not reconsider her criticism, she said that even before the Parliamentary enquiry she understood, as a pharmacist, that she had the right to refuse supply of medication the subject of a prescription, notwithstanding it had not been specifically spelled out in such detail in the guidelines at that time.
The expert was asked about her opinion expressed in relation to Mr Morcos' dispensing and oversight of dispensing to Patient B. She opined that when considering the dispensing of hydromorphone to the patient it may not be excessive when considered in isolation however when considered in the dispensing history of other opioids it could be considered to be in excess of the recognised therapeutic standards. It was put that in the absence of having full access to the patients' medical history and diagnosis it was not possible to say that the prescribing of hydromorphone to Patient B may be considered to be in excess of the recognised therapeutic standards when considered in conjunction with other opioid dispensing. The expert disagreed. She stated further, that although she had said the dispensing could be in excess of the recognised therapeutic standards, she actually considered it was in excess of that standard.
The expert was asked about her answer to question 14 in the report she had written on Mr Morcos. This question addressed the dispensing of oxycodone. The expert had opined that the history of dispensing for Patient B suggested supply that is in excess of the recognised therapeutic standard. When questioned about that phrase she agreed that her opinion was based on the dispensing and the intervals of dispensing for the patient. She stated that she did not have access to the patient's medical history. She nonetheless continued to support her opinion as stated.
In relation to the answer to question 13 asked of her in the report on Mr Morcos, she had stated that the dispensing of tapentadol when combined with the other opioid medications in his history could be considered to be in excess of recommended therapeutic standards.
The expert was cross-examined about that part of her report on Mr Morcos which addressed dispensing to Patient C. This was a patient that Mr Morcos did not dispense to. She was asked if she adhered to the opinion provided that the dispensing breached the guidelines which applied to Mr Morcos as a proprietor. She said she did.
The expert was asked to concede she had not set out the reasoning of Mr Morcos in relation to his dispensing to Patient C, Patient D and Patient E, in her report, that reasoning being contained in the evidence of Mr Morcos given by him to the HCCC and in his affidavit filed in this proceeding. She conceded that was the case and stated further:

[183]

The expert was asked about whether she had policies in place in her pharmacy in 2017 and 2018 in relation to dispensing Sch 4D drugs and Sch 8 drugs, in relation to employee pharmacists confirming that scripts are valid and in relation to having regular meetings with pharmacists who work in her pharmacy. She answered that she did not recall however, she does have those policies in place today. She did not have a policy in place regarding having regular meetings with employed pharmacists about dispensing Sch 8 and Sch 4D drugs. She does not have today a policy in relation to asking prescribers for pain management plans for patients. She does not have a policy in relation to asking patients if they are on an OTP program. She does have a policy in place addressing compliance with cl 90 of the PTGR (requirements each script must contain).
In 2017 and 2018 years she was asked if she satisfied herself that every single script dispensed by her pharmacy was compliant with cl 90 of the PTGR. She said she relied upon her staff to do that and she would conduct random audits and spot checks. She also had the expectation that a pharmacist would bring to her attention any script about which they had a concern. She has a policy which states that.
The expert has not asked her software supplier to be able to run a report on the number of Sch 8 drugs being dispensed through her pharmacy. However, she is able to run reports in relation to specific named drugs.
The expert was shown a document which became Exhibit R9. It is an extract from the 2018 version of the Australian Medicines Handbook (2018 AMH). She was then shown an extract from the 2019 version of the same handbook which had been marked as Exhibit R10. Finally, she was shown a copy of Exhibit R11 which is the 2024 version of the same handbook.
The expert was then directed to those parts of Exhibits R9, R10 and R11 under the heading "Dosage". That related to the drug oxycodone. She agreed the consistently stated message in each Exhibit is that dosages are a guide only. Secondly the point made is that doses can vary according to the clinical situation and condition of a patient and previous analgesic requirements. She agreed that when she gave her opinion, she did not have any information to guide her with respect to a clinical condition of previous analgesic requirements of each patient.

[210]

"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."

[216]

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."

[238]

'[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 ...'

[253]

"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."

[269]

"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:

[279]

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."

[322]

"'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."

[383]

"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."

[391]

"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:

[451]

"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'."

[459]

"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])."

[485]

(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 NS other than those highlighted green) and/or permitted the inappropriate dispensing by an employed pharmacist (on the occasions referenced with initials other than NS) of Sch 8 and 4D drugs, in various strengths to Patients A, E, and I in circumstances where:

(a) the dispensing was contrary to cll 54 and/or 109 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 NS, the practitioner failed 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.

(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 NS other than those highlighted green), and/or permitted the inappropriate dispensing by an employed pharmacist (on the occasions referenced with initials other than NS), of a Sch 8 drug, in various strengths to Patients B, C, D, F, G and H, in circumstances where:

(a) the dispensing was contrary to cl 109 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 BD NS, the practitioner failed 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.

[487]

As set out in the submissions of the Respondents, Mr Saweris admits he is guilty of unsatisfactory professional conduct as defined by s 139B(1)(a) and only because of the Particulars set out in 1(c) and 2(c) as set out above. Otherwise he does not admit the balance of the Particulars and does not admit he is otherwise guilty of unsatisfactory professional conduct as defined in s 139B(1)(a). Further he does not admit he is guilty of unsatisfactory professional conduct as specified in s 139B(1)(l), namely: "that he engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy."
We pause here to note that the admission made by the Respondent is maintained for this hearing where he is represented by Senior Counsel who has learnedly developed and provided the submission for the Respondent in relation to the meaning of "significantly below the standard expected" as used in s 139B(1)(a). The particular conduct which the Respondent admits establishes his guilt is contained in Particulars 1(c) and 2(c). Those two Particulars are succinctly worded as: "The practitioner and the dispensing practitioner should have had regard to the patient's dispensing history."
The admission by the Respondent that his conduct in relation to the identified dispensing by him (and not other pharmacists) details conduct on his part which is "significantly below the standard which ought to have been expected of a practitioner of an equivalent level of training or experience."
The Particular 1(c) and 2(c) both use the words "should have had regard to". That means more than an allegation that he did not look at the patient's dispensing history. It must mean that if he did look at the dispensing history, he did not take that history into account at all or as was required of him, when agreeing to dispense and thereafter dispensing a subject prescription.
We note here that the evidence of Mr Derias (one of the proprietors) is that the patient record system used by the West Gosford Pharmacy at the time of the alleged offending only displayed dispensing in a chronological format. It did not (and inferentially could not) display the dispensing by drug type or as an aggregate of all dispensing for a patient of Sch 8 and/or Sch 4D drugs, in any selected date range.
We also note that Particulars 1(c) and 2(c) are quite separate from Particulars 1(a) and 1(b) in the nature of the conduct addressed. The counts do not rely on the same conduct.
Added to the above, there must also have been a realisation of the importance of that requirement to have regard to a patient's dispensing history when dispensing Sch 8 and Sch 4D drugs. There must also have been a realisation that although the HCCC do not allege actual harm was caused to patients who were dispensed Sch 8 and Sch 4D drugs by the Respondent, there was actual potential for that to have occurred.
The Respondent did, during his cross-examination, admit some of his dispensing as detailed in the annexures to the Complaint document was inappropriate. That admission related to the amount of Sch 8 and Sch 4D drugs which had been dispensed to a patient over a specified time period. Most of his admissions were made in circumstances where there was a short interval between dispensing of the same drugs. That is where a patient had been dispensed a quantity of drugs specified to last a fixed period (usually 28 days) if ingested in the quantity and frequencies as specified in the script.
His admissions included:

[490]

We propose to consider these two Particulars at the same time as the evidence in the case tended to group them together.
We consider it is important to note that Complaint One alleges the conduct in Particulars 1(a) and 1(b) occurred in two aspects of pharmacy practice. Firstly, in the work of the Respondent in the pharmacy in his personal dispensing. Secondly, in the responsibility he had as a pharmacy owner, to ensure the dispensing by employed pharmacists was appropriate and legal. In that later case the allegation is that the Respondent permitted inappropriate dispensing.
The Particulars addressed the dosage and quantity of pills dispensed as the subject prescription prescribed given the "recognised therapeutic standard" for the drug prescribed. The second part of the allegation (1(b)) related to dispensing intervals and/or frequency of the dispensing to a particular patient. The evidence disclosed that often occurred when a doctor wrote a script for a patient who claimed he/she had either lost or misused the drugs obtained from the immediately prior dispensed prescription. It also occurred when a patient sought an early dispensing of a repeat prescription. The particular conduct addressed by 1(b) is the action taken by the Respondent when confronted with such an event. In particular, should he have refused to dispense or should he have taken some other action, such as dispensing a reduced portion of the prescribed drug. Alternatively, could he have required the production of some other evidence to support a dispensing to the patient. In the evidence before us this type of dispensing has been referred to as "short interval dispensing."
The first matter to note is that Particular 1 only relates to the dispensing of Sch 8 and Sch 4D drugs. We consider that is an important fact to have regard to as we consider the findings we are required to make in relation to both Particular 1 and 2. During the hearing all of the Respondents emphasised that the dispensing of those drugs represented a very small percentage of all of the pharmacy's dispensing. However, the potential for harm to the safety or health of a patient if drugs of that nature are inappropriately dispensed was uncontroversial in this hearing.
Turning then to consider the allegation that the Respondent "inappropriately dispensed" Sch 8 and 4D drugs (on occasions referenced with the initials NS as set out in the Schedule 2 to the Complaint), we turn to the evidence, as we have specifically referred to in this judgment. In so doing we need firstly to consider the weight which we should give to the evidence of both the HCCC expert Ms Torrens and also to the evidence of the Respondent.
The Respondent provided his evidence in both written and oral form. We were very impressed with him as a witness when we saw and heard him give his evidence during the hearing. He made admissions without hesitation and expressed remorse for his errors.
In relation to the expert, we observed she was subjected to a lengthy precision delivered cross-examination by an experienced and well-practised Senior Counsel (no criticism of Senior Counsel is made or implied by that statement). The point we make is that such a cross-examination has the capacity to reveal weakness, inconsistency and errors in the evidence of a witness.
This Tribunal is accustomed to hearing the evidence of experts engaged by parties in the Occupational Division of the Tribunal. As such, the difference in delivery and accuracy of relevant information and opinion is observed. In the case of the expert we observed she was either not prepared for the range of questions she would be asked (especially in relation to the systems, protocols and guidelines she employed within her own pharmacy business for both herself and employed pharmacists) or was, at times, excessively guarded in her responses to questions asked or propositions put to her. As a consequence, she was either unable, or not prepared, to answer all of the detailed questions about those matters. The questions asked of the witness, in that area of pharmacy operations, were important to the case the Respondents were making as part of their defence to the whole of the Complaint.
We find the expert was a witness of truth. We did not form the opinion that she was deliberately evasive in her answers, however, we do consider she could have been more helpful to us had she been prepared to provide oral evidence, on some occasions, which represented the best of her recollection or knowledge on a particular topic, even if it was qualified by a phrase such as "I would need to look at a particular document to be able to assure you of further detail."
The unfortunate consequence of the above observations about the way in which the expert gave her evidence was that she was being presented to the Tribunal as an expert in her field, yet her working knowledge of some of the important requirements for a pharmacy owner seemed to us to be less than we had anticipated would be the case.
We now turn to consider the admissions made by the Respondent in his evidence.
As set out earlier, the Respondent did acknowledge his errors in dispensing contrary to cll 54 and/or 109 of the PTGR. That evidence is set out earlier in these reasons at length and we do not repeat it here.
In his admissions he acknowledged the failures in his personal dispensing. Partly he attributed those failings to his reliance on a misunderstanding of his ability to legally refuse to dispense a Sch 8 and Sch 4D drug where he was not satisfied it was an appropriate dispensing in the sense of being consistent with recognised therapeutic standards or purpose for the subject drug. Some of his dispensing was inappropriate because he did not contact a prescriber when he clearly should have before dispensing. On occasions when he did contact the prescriber, the explanation provided for a short interval dispensing was not adequate to warrant the responsible dispensing of the drug sought. Some was inappropriate, as he has conceded, because he did not have any or considered regard to the dispensing history of the patient. Had he had regard to that history he would have, in the examples he was taken to, been on notice of the inappropriateness of the dispensing being considered at that time.
Other evidence from the Respondent included an admission that the quantity and strength of a Sch 8 or Sch 4D drug, which he acknowledged he had dispensed, was very large even for a patient suffering cancer. In such examples he agreed the dispensing was inappropriate.
We note that the Respondents in this case were the victims of conduct on the part of a medical practitioner who was the main prescriber of all the Sch 8 and Sch 4D drugs dispensed by the West Gosford Pharmacy. When the Respondent, or another pharmacist, was presented with a script for either of that category of drug, and was concerned about the dosage, number of pills prescribed, or early dispensing having regard to the patient's dispensing history, they would contact the practitioner, Dr Sriskanda (or sometimes it was Dr Daoud). Dr Sriskanda worked from the very premises in which the West Gosford Pharmacy was conducted. The medical practice was called Reliance Super-Clinic Medical Centre. Dr Sriskanda, who the Tribunal was told has now been disqualified from practice, would address the questions asked by the pharmacists in a manner which made clear she was instructing them to dispense the script notwithstanding the concerns they raised.
It appears the Respondent's evidence, in some of his written material, is that based upon his knowledge at the time of the dispensing under examination, he did not see the dispensing as inappropriate, however, based on his knowledge today, it was inappropriate dispensing. We think this relates to the fact that he believed he was bound to dispense once the prescribing doctor had authorised it, following questioning by the pharmacist, and that the doctor had provided a reason to dispense.
The Respondent also raises the issue of whether the dispensing was not in accordance with recognised therapeutic standards. Such a concern could only really be applicable to dispensing which was not a "short interval" dispensing at the direction of Dr Sriskanda.
We have set out the expert's evidence earlier in these reasons. Her opinion was stated in relation to each dispensing the subject of the Complaint in Particulars 1 and 2 to Complaint One. As can be seen, she opined on numerous occasions, that the conduct that demonstrated the knowledge, skill or judgment possessed, or care exercised by the Respondent, in the particular dispensing under consideration, was significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience.
The question of the expert's use of the words "could be in excess of the recognised therapeutic purpose" was challenged in cross-examination in relation to her evidence in relation to Mr Morcos. There, as we hereafter set out, she stated she considered that the dispensing was in excess of the recognised therapeutic purpose. The question remains as to the action which the Respondents should have taken to satisfy themselves that dispensing a script which could be in excess of the recognised therapeutic standard or purpose, other than contacting the doctor and accepting that practitioner's direction to dispense.
In the oral evidence of the expert, the cross-examination addressed extensively the policies and procedures the expert employed in her own pharmacy in 2017 and 2018. Her pharmacy is an accredited QCPP pharmacy. She did in those years and now does have a policy or procedure in place for the dispensing of both Sch 8 and Sch 4D drugs, which is additional to, that recommended by QCPP.
The expert does not routinely ask for a specialist report from the prescriber before dispensing a requested Sch 8 drug.
The expert does not educate her employed pharmacists in relation to the PTGR clauses. Nor does she provide any education in relation to professional standards. She ensures they have access to education in relation to those subjects. The employed pharmacists have access to documents in the pharmacy such as the QCPP accreditation document currently being questioned on in this hearing. They also have training courses through the Pharmaceutical Society or the Pharmacy Guild.
In relation to ensuring her employed pharmacists understand and follow legislative requirements and professional practice standards, the expert said the pharmacists are required to undertake continuing education and for that purpose create an education plan which identifies elements that they are proposing to obtain additional training in. Once that plan is completed the expert views it and then at a later time checks to see that they have completed the training which was outlined. The expert also ensures that the employed pharmacists are across the information relative to the dispensing of Sch 4D and Sch 8 drugs. There is no formal education however there are staff meetings where these matters are discussed.
The expert agreed that the QCPP documents which are set out at page 1355 of Exhibit R4 Volume 4 under the heading "Dispensing" and "Processing the Prescription" do not say the pharmacist may refuse to dispense the prescription. She also said she used the "Interpersonal Collaboration Policy" of the QCPP document when contacting a prescriber. She said there could be other documents she might us in relation to contacting a prescriber however, she did not name any such other document.
The expert said she conducts stock audits of Sch 8 and Sch 4D drugs in her pharmacy.
The expert would not assume a script is complying as "therapeutically indicated" merely because she knows the prescribing doctor.
The expert confirmed she had not been provided with any clinical records for the Patients A to I. Nor any other information about the patients or letters from their treating practitioners. She agreed all that information, together with additional information was necessary to determine if a drug has been prescribed appropriately. She agreed the guidelines and codes require contact with the prescriber if the pharmacist is unsure about the intentions of the prescriber.
The expert agreed that for the period between 1998 and 2019 the guidelines did not expressly say that a pharmacist could decline to dispense a drug if determined it was bona fide or not fraudulent. She further agreed that no guideline issued by the PBA or the PSA or any other organisation between the year 2000 and June 2019, being guidelines specifically in relation to dispensing, expressly stated that a pharmacist can decline a script.
However, the expert was clear when she said she had understood since her university training, she could decline to dispense a script, even where the prescriber had insisted it be dispensed.
The cross-examination of the expert in relation to Mr Morcos also contained evidence which is relevant to the Respondent's case. In that evidence we see the following.
The expert agreed that in 2017 or 2018 there was no obligation on a proprietor of a pharmacy to check every script dispensed by a registered pharmacist. Further she said she did not know of any mandated requirement on a proprietor of a pharmacy business in 2017 and 2018 to conduct an audit on Sch 4D drugs or Sch 8 drugs other than a stocktake audit.
Although the Respondent only dispensed to Patient A on three occasions (as identified in Schedule 2 to the Complaint document), and did not have any concern about the dispensing to Patient A brought to his attention, the expert said that did not relieve him as a proprietor.
She conceded that there was nothing out of the ordinary for the West Gosford Pharmacy, as a community pharmacy, in the quantity and type of Sch 8 and Sch 4D drugs dispensed, when considered as a whole. There was no evidence that the dispensing of the Sch 8 and Sch 4D drugs increased during the 2017 or 2018 years for the West Gosford Pharmacy.
The 2015 Formulary and Handbook on dispensing practice included: "If the prescriber is unavailable or is unwilling to accept the pharmacist advice, use professional judgment to determine the most appropriate action, to take to satisfy the duty of care to the consumer".
A publication dated December 2018 was shown to the expert, which did state, at that time, that the pharmacist did have the right to refuse supply if they considered it is unsafe or inappropriate. In the 2019 Dispensing Guidelines there was a specific heading "Declining Supply".
Notwithstanding the above publications of 2018 and 2019, the expert would not change her opinion about the dispensing to Patient A, or any of the other subject patients, because she was personally aware during the relevant dispensing period, that she could refuse supply.
The following exchange, which followed questions about Mr Morcos' dispensing, is recorded in the transcript :

[497]

The PTGR provisions cast an obligation on the dispensing pharmacist to be satisfied the prescription they are being requested to dispense "accords with the recognised therapeutic standard of what is appropriate in the circumstances." The submission of the Respondent is that the knowledge of what is the recognised therapy, is in the hands of the prescribing doctor and the basis of the prescription is not within the knowledge of the pharmacist. We consider that is not exclusively so and also that it is not what is required to comply with the PTGR provisions in cll 54 and 109.
As we were told during the hearing the pharmacists have available multiple publications and resources to know what doses of a specified Sch 8 and Sch 4D drug are recommended for the treatment of the range of illnesses (or symptoms such as pain) for which such drugs are stated to be therapeutic. Evidence was given by the Respondents that they were aware that a dose of Sch 8 drugs might be higher for a person suffering late stage cancer symptoms than a person who was not a diagnosed cancer patient. To the extent that the prescription being presented to the pharmacist suggests a higher than expected dosage of a Sch 8 or Sch 4D drug for the presenting patient, then it is for the pharmacist to undertake an action to ensure the safety of the patient and the public at large. In this case the Respondents and the employed pharmacist mostly undertook action when presented with such a circumstance. That action was to contact the prescribing doctor to ensure that the dispensing of the script would accord with recognised therapeutic standards. We consider that in most cases that would provide a pharmacist with all necessary information (and perhaps corroborating documentation) to proceed to the dispensing. However, it may not. In that later circumstance, the pharmacist has to take action to protect the safety and health of the patient and perhaps the community at large.
Unfortunately, the Respondents and their employed pharmacist, in the subject cases, highlighted by the Complaint, failed to take the further and appropriate action such as declining supply or dispensing a smaller quantity of the drug or even requiring daily attendance for dispensing of a single dose. The Respondents' stated reason for that conduct was that although they did have concerns about the identified dispensing in the Complaint document, they (the Proprietors of the West Gosford Pharmacy) were all of the one mind, namely that they were not permitted to contradict the prescriber's direction to dispense. They were to defer to the medical practitioner's assertions, or assurances, that it was safe and appropriate to dispense the prescription as had been written.
The argument submitted by the Respondent is that in order to establish Particular 1(a) and (b) it is necessary for the HCCC to establish that the dispensing did in fact contravene cll 54 and 109 of the PTGR rather than having the possibility of doing so. The Respondent submits that to achieve that proof the HCCC needed to establish "what was appropriate in the circumstances". The Respondent draws attention to the evidence that it may be appropriate in the circumstances of late stage cancer sufferers to be prescribed and dispensed significantly higher doses of Sch 8 and Sch 4D drugs than that which might be appropriate for non-cancer patients. The Respondent drew attention to the decision in Segal at [181]-[183]. There the Tribunal determined the following in relation to the case being conducted on behalf of the Medical Council.

[499]

We know from the evidence of the expert that in relation to Patient A, for example, her opinions varied between expressions such as "suggests that the supply of these drugs was in excess of the recognised therapeutic standard" (page 61 Exhibit A5) and "supply appears to be in excess of the recognised therapeutic standard" (page 65 Exhibit A5).
In the oral evidence of the expert she said in relation to the dispensing by Mr Morcos for Patient B and the drug hydromorphone, although she had given the opinion, in her report, that the dispensing (as required by the prescription) "may be considered in excess of the recognised therapeutic standards when considered in conjunction with other opioid dispensing", she did in that instance hold the opinion that it actually was in excess of that standard. She was not challenged further on that answer. However, she conceded she did not have access to the patient's medical history. Her opinion was based on the dispensing and the intervals of dispensing for the patient.
The other aspect of the argument mounted by the Respondent, having referred the Tribunal to the decision recently delivered in Segal, is the failure of the HCCC to include in Particular 1(a) and 1(b) the complete wording of cll 54 and 109 of the PTGR. The Particulars set out only the words "it was in a quantity that does not accord with a recognised therapeutic standard" and "did not accord with a recognised therapeutic standard", whereas the clauses use the words "that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances." As such the Respondent says that to establish an action which is contrary to cll 54 and/or 109, it is necessary to show "the circumstances" of the patient are such that the supply of the particular drug (dosage and frequency) whether in conjunction with other drugs supplied or not, is not in accord with the recognised therapeutic standard". As such the Respondent submits that without having any or sufficient evidence about "the circumstances" of the patient it is not possible to establish the cll 54 and 109 have been breached.
We know from the evidence of the Respondents that the number of scripts received in the West Gosford Pharmacy which required the dispensing of Sch 8 and Sch 4D drugs represented a very small proportion of the overall number of scripts dispensed. With the dispensing of Sch 8 and Sch 4D drugs, additional time is required for the pharmacist to ensure the dispensing complied with the requirements of the PTGR. The evidence shows that on some occasions when one of the Respondents received a script for Sch 8 or Sch 4D drugs, they would consider the patients notes and if there was a record of a recent dispensing of an earlier script, following a conversation with Dr Sriskanda, on that earlier occasion, then the new script may have been dispensed without a further conversation with the doctor. We consider that type of conduct arose because there was not a clear policy or universally adopted procedure, undertaken in the West Gosford Pharmacy, to require a cascading list of actions for the pharmacist to undertake when presented with such a script to dispense.
Following the conclusion of the hearing and the receipt of the written submissions from each of the parties, we requested a further submission from the HCCC which addressed the Respondent's submission in relation to the wording of cll 54 and 109 of the PTGR. We now turn to consider that further submission from the HCCC.
The Tribunal made the following request for a further submission from the HCCC on 20 February 2025. The HCCC provided its response on 24 February 2025.
The request from the Tribunal was as follows:

[515]

What is at the heart of the dispute between the parties in relation to this Particular 1(a), is the extent of the information the pharmacist should have in order to determine if a prescription of a Sch 8 or Sch 4D drug is appropriate "in all the circumstances" and is in accord with "the recognised therapeutic standard" of the drug being prescribed. The Respondent says that information must necessarily include all the relevant medical history of the patient and any supporting document such as a letter from a specialist medical practitioner treating the patient and/or a pain management plan approved for the patient. That is not necessarily the end of the list of required information the Respondent submits is required for a pharmacist to comply with the cll 54 and 109 of the PTGR.
The HCCC submission is that a pharmacist does not need to have the degree of information suggested by the Respondent in order to make a decision as to the appropriateness of dispensing a Sch 8 or Sch 4D drug. It says the pharmacist has a range of referral documents available to see detail of the drug prescribed, its therapeutic purpose, its recommended dosage and frequency of ingestion and the variations in that dosage as the diagnosis of the patient requires. During the hearing the Tribunal heard evidence about the availability of such reference documents in both the pharmacy conducted by the expert and the Respondent's pharmacy. It may be that some information is required to be obtained from the prescribing doctor to confirm a diagnosis made for the patient, if there is some aspect of the prescription of a Sch 8 and/or Sch 4D drug which is contraindicated to a therapeutic purpose in the reference documents to which the pharmacist has had access.
The HCCC case is that the interpretation of the requirement for a pharmacist to comply with cll 54 and 109 of the PTGR, as urged on the Tribunal by the Respondent, would make the dispensing of any Sch 8 or Sch 4D drug by a pharmacist and the prescribing doctor, far more onerous, time consuming and thereby expensive, than is intended by the legislation.
Having considered all of the above arguments and evidence on this Particular 1(a) we conclude that the provisions of cll 54 and 109 of the PTGR require a pharmacist in the dispensing of a Sch 8 and Sch 4D drug to undertake, as a minimum, the following.

[519]

In our observation this topic of the responsibility to oversee the work of an employed pharmacist and the operation of the pharmacy business as a whole, is the most contentious of the issues between the parties.
The evidence establishes to our satisfaction that there was inappropriate dispensing by an employed pharmacist. That fact is not disputed by the Respondent. The evidence also establishes that like the Respondent and the other proprietors of the West Gosford Pharmacy, the employed pharmacist was the subject of direction by Dr Sriskanda and followed that direction when she was questioned about the appropriateness or timeliness of a dispensing request by one of her patients.
We have set out the extensive submission of the Respondent on this issue and also the HCCC's initial submission and its reply to the Respondent's submissions. We don't repeat those here. We find that the Respondent is guilty of unsatisfactory professional conduct as alleged in relation to these Particulars 1(a) and 1(b) of Complaint One, for the following reasons which stand out for us.
Part of the decision requires us to determine if the Respondent's conduct was "significantly below" the standard required for a proprietor of a pharmacy business which employs other pharmacists, or, as in this case, involves other pharmacists as owners. The determination of whether the conduct is "significantly below" the standard involves the Tribunal accepting expert evidence which alleges that, balancing that evidence against the evidence of the Respondent who denies the conduct is significantly below the standard, and then determining that issue, applying the relevant provisions of the National Law and the principles set out in decisions such as Briginshaw v Briginshaw [1938] HCA 34; (1938) 60 CLR 336, which decision is relied upon by each of the parties.
It seems to us that in this decision we need to determine whether we are comfortably satisfied, that the Respondent and his co-proprietors, had undertaken sufficient supervision of employed pharmacists, and had sufficient systems and measures in place for the day to day running of the pharmacy business, to alert them in a timely manner, to any failures, of significance, by a dispensing pharmacist. That once alerted to a particular issue with the dispensing practices of the pharmacy, they took timely action to ensure the pharmacy was, thereafter, functioning legally and appropriately. In this case the finding is that the proprietors did not have sufficient supervision or sufficient systems and measures in place as it is conceded their employed pharmacist did participate in inappropriate dispensing. We do not find that the systems put in place in this pharmacy business had to alert the proprietors to a single error by an employed pharmacist in his/her dispensing. Rather, what we expect would be required is a system which would alert the Proprietors to a series of errors which collectively reveal a necessity to take action to ensure it does not continue.
The insufficiency of the systems, protocols, procedures and supervision of employees is amply evidenced by the very appropriate action the Proprietors of the pharmacy did take when notified by the PRU. One question to consider is whether the systems, protocols, procedures the Proprietors had put in place (prior to the PRU notification) were in keeping with the usual, and acceptable, practice of proprietors of pharmacies in 2017 and 2018. The Respondent submits that the pharmacy had obtained accreditation from QCPP. They had in place a very similar system of management of a pharmacy as the expert had at that time. There were exceptions such as no specific audit of Sch 8 and Sch 4D drugs. However, if they did have in place a specific procedure for auditing the supply of Sch 8 and Sch 4D drugs, for these proprietors, the inappropriate dispensing which had taken place, may not have been recognised as inappropriate because it had been checked with the prescribing doctor, who they believed could not have been over-ruled. A random audit of prescriptions dispensed by the pharmacy which dealt with Sch 8 and Sch 4D drugs alone, may have detected a problem with some prescription forms not complying with the PTGR. However, as will be seen later, the proportion of defective prescription forms was so small when compared with the overall dispensing for the pharmacy business, as to make it unlikely that a random audit would show such defects in numbers which would have been of concern.
Given that there was an acknowledged failure in their supervising and monitoring system, we need to determine if that failing amounts to conduct which is "significantly below" the standard applicable to this Respondent Mr Saweris. In so determining we need to be cognisant of the dates upon which the alleged conduct occurred in 2017/2018 and thereby be applying the standard which would have applied to the Respondent and his co-owners at that time. We also need to keep in mind that this alleged offending conduct related to the dispensing of Sch 8 and Sch 4D drugs which have the capacity to be injurious to health of a patient if not prescribed correctly, dispensed correctly or administered as directed. Further there is the possibility of the drugs being illegally and/or inappropriately distributed by the receiving patient to the broader community.
In this case the Respondent gave evidence that he did not supervise the work of the employed pharmacist whilst working with him or otherwise. There is no evidence that the employed pharmacist sought advice from the Respondent as they worked together in the pharmacy business. Nor did the Respondent notice any aspect of the dispensing by the employed pharmacist which might have alerted him to a problem with dispensing by that employee. Quite simply, the Respondent appeared to trust in the employed pharmacists dispensing as being appropriate and legal. The employed pharmacists had the same registration as the Respondent and each of the Proprietors.
We have decided the threshold of "significantly below the standard", has been met for the following reasons:

[520]

(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 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.

(d) The importance of the role of a pharmacist in our community was referred to in Health Care Complaints Commission v Saab [2020] NSWCA 145 (Saab No 2) and the following words have been extracted in the HCCC submission which we adopt.

[528]

(n) 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.

(o) 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.

(p) 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.

(q) We accept that the Respondents (including Mr Saweris) 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.

(r) The Respondent made submission on the words of the Complaint "permitted the inappropriate dispensing by an employed pharmacist". The submission includes:

[538]

These two Particulars address the Respondents responsibility as a proprietor of the West Gosford Pharmacy. The primary allegation in Complaint One is that the Respondent permitted the inappropriate dispensing by an employed pharmacist. The Particulars address two aspects of how it is alleged he permitted that dispensing. Those two aspects raise the following questions for determination: (a) Did the Respondent fail to maintain awareness of the manner in which the pharmacy dispensing practice was being conducted, and (b) Did he fail to intervene into the dispensing practices at the pharmacy when necessary, contrary to the Proprietor Guidelines.
The HCCC case is that the Respondent had no measures, policies or procedures in place in the West Gosford Pharmacy at a relevant time to enable the Proprietors of the pharmacy to properly and adequately oversee the dispensing of Sch 8 and Sch 4D drugs. Such a conclusion is based on, in part, the measures the Proprietors did put in place to oversee the dispensing of those drugs after receiving notice of the PSU report which ultimately gave rise to this proceeding.
Turning then to address the complaint that the Respondent did not maintain awareness of the manner in which the pharmacy dispensing practice was being conducted.
The Respondent has set out the action he took to satisfy his obligation to maintain awareness of the manner in which the pharmacy dispensing was conducted. That included working in the pharmacy two days a week, alongside the employed pharmacist. In that working in the day-to-day conduct of the business we consider he would receive multiple different types of information in relation to dispensing in the pharmacy. The pharmacy was dispensing approximately 300 scripts per day. In the case of the Respondent, we accept that had he seen any conduct on the part of the employed pharmacist, which he recognised as inappropriate, he would have acted on that immediately. There was no evidence however that the Respondent did any active supervising of the employed pharmacist.
The Gosford Pharmacy was an accredited QCPP pharmacy. The evidence shows (Exhibit R4 Tab 41 Appendix 1) that to be accredited the pharmacy is required to have "systems to ensure medicines, medical devices and poisons are supplied accurately and appropriately." It thus follows that the accrediting officer for QCPP who accredited the pharmacy, was satisfied such systems were operating in the West Gosford Pharmacy. The evidence also shows that the QCPP organisation currently accredits approximately 94% of Australian community pharmacies. The pharmacy has to be re-accredited every two years. The first accreditation took place for this pharmacy in 2016.
The Gosford Pharmacy had in place a system which enabled the pharmacist to see a dispensing history for a patient and any notes made on the patient's record by a pharmacist. There are multiple examples of notes being made by pharmacists working at the Gosford Pharmacy which included contact with a prescriber. There is evidence that the computer program in use in the pharmacy could not show a history of a particular type of drug dispensed to a patient or all Sch 8 and/or Sch 4D drugs dispensed to a patient.
The Respondent made submission in relation to the dispensing procedure related to Sch 8 and Sch 4D drugs in the expert's own pharmacy. The document is contained in Exhibit R13. The Respondent states that the policy document does not contain the following:

[540]

We note that the fact that the written policy may not contain the items listed above does not mean they are excluded from the pharmacists' dispensing procedure. Nonetheless the written policy document does identify the standard which operates at the time of this hearing, in the expert's own pharmacy business.
In relation to the requirement to intervene in the dispensing practices of an employed pharmacist, where necessary, the Respondent accepts that if any of the Proprietors did become aware that inappropriate dispensing practices were taking place, then necessarily they had an obligation to intervene. That obligation arose if in all circumstances it was reasonable for the Respondent to have knowledge of an inappropriate dispensing. The reasonableness is related to firstly whether the Respondent had sufficient systems, policies and procedures in place to detect any such inappropriate dispensing practices. In this case, the Respondent says they had all the systems and policies which the QCPP accreditation provided and then accredited. The fact that the Respondent with his co-proprietors implemented other systems and policies following receipt of the PRU report which identified problematic dispensing of Sch 8 and Sch 4D drugs, does not establish that in 2017/2018 when the alleged inappropriate dispensing occurred, the systems which were in place were not considered by pharmacists at large to be sufficient for managing a pharmacy. The question remains, were the systems, procedures and protocols which were in place in 2017 and 2018, in the pharmacy, adequate for the pharmacy at that time? Our conclusion is that the Respondents relied on the QCPP system to carry out all the necessary supervising roles in their pharmacy. The expert, who was practicing at the same time, did not. She had additional systems to deal with the monitoring of dispensing Sch 8 and Sch 4D drugs in her pharmacy. We consider the Respondents should not have relied solely on the QCPP system to meet all of their responsibilities as proprietors.
Another matter which the evidence discloses is that the Respondent and his co-proprietors were aware of potential inappropriate prescriptions emanating from Dr Sriskanda. The doctor was contacted on many of the occasions in relation to the dispensing of Sch 8 and Sch 4D drugs. On many of those occasions the contact was noted and on occasions some reference to what was said by her was included on the notes. There were other occasions when before dispensing a prescription of concern, either no contact was made with Dr Sriskanda or, where contact was made, an insufficient note was made of the reason dispensing was directed. The problem for the Respondent and each of the Proprietors, and the employed pharmacist, was not so much the failure in a system to detect inappropriate dispensing, rather it lay in the belief they each held that they were powerless to take action other than to dispense as directed on the prescription presented. Further, the Proprietors had been operating on the understanding that Dr Sriskanda had some special knowledge and skill in relation to the use of Sch 8 and Sch 4D drugs in the treatment of chronic pain.
The Respondent draws attention to the changes which were made by the Proprietors in response to the PRU report. Those changes included the following (at page 86 of the Respondents' Submissions):

[544]

The evidence satisfies us that there were failures in the Proprietors' obligations to have systems in place which would, in a timely manner, alert the Proprietors to a failure by an employee to comply with the legal requirements for dispensing.
Having stated the above, we turn to s139B(1)(a) of the National Law to determine if the conduct of the Respondent, as alleged in Particulars 1(d) and 2(d) was significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience.
Having considered the evidence of the expert in this case, we do accept her opinion that this conduct was, at the time it occurred, significantly below the standard rather than below that standard. We so conclude noting that this finding is one which was difficult for us and is only marginally beyond what is required to establish the conduct was "significantly" below the standard. The Proprietors had obtained QCPP accreditation for the West Gosford Pharmacy, something the evidence shows the vast majority of the pharmacies in Australia had also implemented. It was a robust system of managing a pharmacy to ensure it operated as required by the law and the applicable codes of conduct. Unfortunately, the subject proprietors were subjected to the work of a medical practitioner who was operating inappropriately and unethically as this Tribunal, differently constituted, has found when it considered the case the HCCC brought against her.
Added to that most unusual circumstance of being subjected to the prescribing of a rogue medical practitioner, all of the pharmacists operating in the pharmacy in 2017 and 2018 had their basic training in a country outside Australia. Although they had undertaken further training in Australia, as was required for their registration, the important instruction that the responsibility caste upon a pharmacist in Australia, to ensure the safety of patients they were dispensing for, carried with it the obligation/power to decline to dispense a script, even after the prescriber had told them it was/is safe and appropriate to undertake the dispensing.
It was the erroneous belief of the Respondent and the employed pharmacist and the other owners of the pharmacy business that they could not decline the supply of drugs prescribed by a medical practitioner if the practitioner, after being contacted by the pharmacist, directed the dispensing take place. Added to that circumstance there was also the ability of the rogue medical practitioner to provide a reason for the dispensing which, potentially, could have been legitimate and convincing.
We conclude, the likelihood is that had the pharmacists working in the pharmacy as either owners or employees, not been the subject of the professional misconduct of Dr Sriskanda, or any other professional misconduct of a prescribing medical practitioner, they would never have been required to dispense Sch 8 and Sch 4D drugs in an inappropriate manner. Their systems which were in place would have been deemed sufficient by any audit the PRU might have undertaken when it did. It is hoped and anticipated that as cases such as the present were brought to the attention of the QCPP organisation, amendments to the systems that entity markets to pharmacists in Australia will be adjusted and reinforced to enable detection, in a timely way, of inappropriate dispensing of the nature experienced in this case.
Had the Respondent, or any of the other proprietors or employed pharmacists declined supply of a prescription of a Sch 8 or Sch 4D drug, prescribed by Dr Sriskanda, at any stage before the PRU investigation, we are satisfied it would have led to a meeting of all the Proprietors. Had that meeting led to further enquiries by the Proprietors as to their obligations, powers and responsibilities arising from a prescription of Sch 8 and Sch 4D drugs, we accept, armed with a greater understanding of their powers to decline to dispense in such a circumstance, they would have declined all concerning prescriptions which were received under the hand of Dr Sriskanda.
The fact which for us satisfies the requirement to be comfortably satisfied the HCCC has established these two Particulars 1(d) and 2(d) of Complaint One, is the extent of the inappropriate dispensing which is embodied in the Schedule 2 to each of the Respondents' Complaint documents. This was not an isolated and difficult to detect occasion of inappropriate dispensing by an employed pharmacist, it was a very extensive and long standing (12 months) history of inappropriate dispensing of Sch 8 and Sch 4D drugs.
Ultimately, we are comfortably satisfied that the Respondent, at all relevant times, practised honestly and with a clear intention to conduct the pharmacy business legally, ethically and appropriately.
Our finding is that the HCCC has established Particulars 1(d) and 2(d) of Complaint One. In so finding we are satisfied (a) the Respondent did fail to "maintain awareness of the manner in which the pharmacy dispensing practice was being conducted, and (b) the Respondent did fail to intervene into the dispensing practices at the pharmacy, when necessary, contrary to the Proprietor Guidelines. That failure occurred at times prior to the receipt by the proprietors of the notification of concerns raised by the PRU into the dispensing of Sch 8 and Sch 4D drugs. That is the time which is relevant, we find, to the Particulars 1(d) and 2(d) of Complaint One.

[545]

This Complaint addresses the conduct of the Respondent as an owner of the pharmacy business in "permitting" the inappropriate dispensing by his employed pharmacist Mr Azzer.
The Complaint is that the Respondent acted in an improper or unethical manner in relation to the practice or purported practice of pharmacy by failing to discharge his obligations as the proprietor of the pharmacy. There are two ways in which the Complaint Two alleges the Respondent failed. Firstly, it alleges that in relation to the dispensing set out in Schedule 3 to the Complaint document, he failed to maintain an awareness of the manner in which the pharmacy dispensing practice was being conducted. Secondly it is alleged he failed to intervene into the practices of the pharmacy when necessary (in this case when he became aware of the inappropriate dispensing set out in Schedule 3), contrary to the Proprietor Guidelines.
The Respondent does not admit he is guilty of this Complaint. He did admit that for the period of 9 June 2017 to 14 December 2018 (553 days), the six prescriptions of psychostimulants, as set out in Schedule 3 to the Complaint document, were inappropriately dispensed, by Mr Azzer, without the prescription being endorsed with a reference number, pursuant to cl 90 of the PTGR and on one occasion where the prescribing doctor did not have authority to prescribe. The Respondent said that at the time of the dispensing he was not aware that it had occurred without proper endorsement and or without a reference number or valid authority. He did not admit that he permitted inappropriate dispensing in those circumstances.
As set out above, the HCCC submits the Respondent is guilty of Complaint Two because of a failure of the proprietor obligations. It submits the 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.
The dispensing which is caught by Complaint Two consists of six occasions when Mr Azzer, an employed pharmacist, dispensed on a prescription that was not endorsed with a reference number, contrary to cl 90 of the PTGR; and 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.
The Complaint is made pursuant to s 139B(1)(l) of the National Law. The section requires the establishment of a case that the Respondent "engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy".
The Respondents addressed at length on the meaning of "improper and unethical" conduct. It is submitted the conduct relied upon by the HCCC to establish its case for a s 139B(1)(l) conviction is not made out.
In this case, in relation to Complaint One, the Respondent argues that 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".
The Respondent further submits that the Commission asserts that the exact same Particulars, in Complaint One, also justify a finding that each Respondent engaged in 'improper or unethical conduct' in relation to the practice or purported practice of pharmacy: s 139B(1)(l). The Respondent then argues that if the Tribunal finds any of Complaint One, Particulars 1(a), (b) and (d) established in relation to the dispensing by an employed pharmacist pursuant to s 139B(1)(a), then it is inappropriate to proceed to address the possibility the Respondent may also be guilty of conduct as described in s 139B(1)(l) of the National Law. See Health Care Complaints Commission v Attia [2017] NSWSC 1066. In that case, Walton J made a number of observations which are relevant to the construction of subsection (1)(l). At [160] his Honour explained that the apparent purpose of subsection (1)(l) is to capture conduct not otherwise captured by the provisions of subsections (a)-(k):

[547]

The HCCC concedes that if a finding is made by the Tribunal in relation to Complaint One under s 139B(1)(a) then the Tribunal would not proceed to hear the additional s 139B(1)(l) portion of Complaint One.
In our view Complaint Two does not address the same dispensing as Complaint One. The dispensing in Complaint One is set out in Schedule 2 to the Complaint document. The dispensing addressed by Complaint Two is restricted to that described in Schedule 3 to the Complaint document. It also relies on a different basis for alleging the dispensing was improper or unethical. That basis relates to the requirements for specific detail to be included on the prescription presented for dispensing.
The evidence which is relied upon to support Complaint One is expert evidence that the dispensing did not accord with a recognised therapeutic standard. The evidence supporting Complaint Two is that other dispensing (as set out in Schedule 3) was permitted in circumstances where there were omissions on the face of the prescription document which were statutorily required by cl 90 of the PTGR.
We therefore do not accept that Complaint Two addresses the exact same conduct as that supporting Complaint One.
In the case of the Respondent, it is shown in Schedule 3 that he did not personally dispense any of the items listed. However, the HCCC case is stated as being that the Respondent permitted an employed pharmacist to conduct himself in that manner on seven occasions. The dates of that dispensing ranged from 9 June 2017 to 25 August 2018.
The HCCC case is that the Respondent permitted such dispensing to occur because he did not ensure there was a sufficiently rigorous system, protocol or procedure in place in the pharmacy at those times to detect such departures from the requirements of the PTGR. The Respondent's case is that he ensured the West Gosford Pharmacy was QCPP accredited and had extensive systems, policies and procedures as stipulated by that accreditation. Further he says that the requirements of a proprietor of a pharmacy are not that he oversees or inspects every script dispensed by the pharmacy business.
In this case the extensive list of dispensing set out over multiple pages in Schedule 2 to the Complaint, relates to dispensing of Sch 8 and Sch 4D drugs. Clause 80 (Division 3) of the PTGR sets out extensive requirements to be included in the prescription document issued by prescribing doctor. Clause 85 specifies "(I) A pharmacist may supply a drug of addiction on prescription if the prescription is in the form required by Division 3". It follows that a pharmacist may not dispense a drug otherwise.
We note in the Complaint One Particulars it is not alleged the Respondent dispensed a prescription which, in its form, did not fulfil the prescription requirements as above stated in the PTGR. It may be that the HCCC chose not to pursue such conduct, if there was evidence of same, however, in this case we have no evidence that in the extensive dispensing of Sch 8 and Sch 4D drugs (set out in Schedule 2 to the Complaint document), the non-complying form of the prescription, was a feature in that dispensing.
The HCCC submits that the Tribunal should be satisfied that the Respondents breached the Proprietor Guidelines. 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.
We first note the HCCC concisely worded submission in its first written submission as follows:

[581]

We accept that part of the Respondent's submission which submits that whether conduct is improper is a matter that depends upon the facts and circumstances of the particular case. We do not see such a submission as creating new law. We also accept that in some circumstances, conscious conduct will clearly be capable of being seen as improper and possibly unethical at the same time. However, we take the view that failure to have a sufficient system, protocol or procedure in place in the operation of a pharmacy may mean the proprietor is guilty of improper conduct. In that sense, failure to take action, which in all the circumstances is reasonable, and necessary, in the conduct of a pharmacy business, which will guard against illegal dispensing, may amount to "improper conduct" and, by extension, the illegal dispensing which occurs is thereby "permitted".
Dispensing a Sch 8 or Sch 4D drug contrary to the provisions of the PTGR, where that breached provision is well known to the pharmacist, would, in our view, be prima facie evidence of improper conduct for the purpose of s 139B(1)(l). However, we agree such a prima facie view may be capable of changing when all of the circumstances surrounding the alleged conduct, said to constitute improper conduct, are examined.
Applying the above to the facts alleged and conceded in the current Complaint Two, the Tribunal has evidence that an employed pharmacist and two of the Proprietors of the West Gosford Pharmacy (not the Respondent Mr Saweris), dispensed drugs the subject of specific provisions in the PTGR, contrary to the very specific requirements in relation to the information required to be set out on the prescription presented for dispensing.
There is no evidence before the Tribunal to suggest any of the dispensing specified in Complaint Two was done intentionally contrary to the PTGR requirements. We are left to accept that the conduct was unintentional and occurred within the work of a busy pharmacy business. The case for the Respondents is that for the vast majority of all dispensing of Sch 8 and Sch 4D drugs the specific requirements for the information required on a prescription document, were met.
The HCCC's case is that the conduct must have arisen because the Proprietors did not have any system, protocol or procedure in place to ensure the conduct alleged did not occur. Alternatively, if they did have a system, protocol or procedure in place in relation to the dispensing of Sch 8 and Sch 4D drugs, it was not robust enough to detect the failures identified as having occurred on the eleven occasions set out in Schedule 3 to the Complaint document.
The Respondents clearly were of the view that their systems, protocols and procedures relating to the dispensing of Sch 8 and Sch 4D drugs were insufficient (not robust enough) to meet their obligations as pharmacy proprietors once they were contacted by the PRU following that bodies inspection of dispensing records from the pharmacy. They immediately made significant alterations to the monitoring and compliance detecting system, protocols and procedures they did have in 2017/2018. However, the system inadequacy which did occur arose in a circumstance which, in our view was most unusual in the practice of pharmacy. That circumstance was the receiving of prescriptions of Sch 8 and Sch 4D drugs, for dispensing, from a medical practitioner who was practising in an improper and unethical manner (see Health Care Complaints Commission v Sriskanda [2021] NSWCATOD 42) (Sriskanda).
In the decision of the Tribunal in Sriskanda [2021] NSWCATOD 42 we note the following:

[584]

The respondent (in Sriskanda) did not attend the Stage One hearing and the Tribunal accepted the evidence of the expert called by the HCCC in finding the Complaints against Dr Sriskanda established. The list of patients, the subject of the Complaints, was extensive. The Tribunal found Dr Sriskanda guilty of professional misconduct pursuant to s 139E of the National Law.
Although the Tribunal in Sriskanda did not make a specific finding that the conduct of Dr Sriskanda was unethical, the facts of the case, as set out in the judgment, leave no doubt that her conduct was, at the very least improper and unethical.
The dispensing set out in Schedule 3 to the Complaint document, shows all but three of the prescriptions identified were dispensed by the employed pharmacist at the time.
If the principles of strict liability were to apply to this Complaint Two conduct, then any failure to ensure compliance with the PTGR, so far as the information required for a prescription is concerned, would make the Proprietors guilty of the unsatisfactory professional conduct as set out in s 139B(1)(l) of the National Law. That would be the case from the moment the contravention of the PTGR provision occurred and not as at the date it could reasonably have been discovered in the proper conduct of the pharmacy business. We note the HCCC expert does not suggest that daily audits of all of the pharmacy dispensing is a requirement.
Because the HCCC moves on subsection (l) of section 139B(1) only in relation to Complaint Two, it is possible that it did not see a sufficient basis for pursuing a case under s 139B(1)(a). That is, "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."
Whatever the reason may have been for the HCCC to move only on a complaint of unsatisfactory professional conduct as described by s 139B(1)(l), the fact is that the selected provision does not provide for any calibration of the degree of the unsatisfactory nature of the conduct as s 139B(1)(a) does. It is further clear now that if a finding is made of a complaint being established under s 139B(1)(a), a further complaint based on the same facts cannot additionally be pursued under s 139B(1)(l).
We now turn to consider whether the conduct of the Respondent was, in all of the circumstances, improper.
The special requirements for information to be included on all prescriptions of Sch 8 and Sch 4D drugs, as set out in the PTGR, are clearly very important to ensure such potentially dangerous drugs are dispensed appropriately and so far as can be controlled, only consumed by the patient to whom they were intended by the prescribing health practitioner.
There is no evidence before the Tribunal to suggest the dispensing of the subject Sch 3 prescriptions actually gave rise to harm to the patient who received the drugs or were inappropriately and/or illegally distributed to the public at large.
The Respondents had taken action to ensure, as they understood, compliance with the obligations of proprietors of a pharmacy. They had sought and obtained for the pharmacy QCPP accreditation which had been renewed every two years. The HCCC expert Ms Torrens agreed the systems which are required for QCPP accreditation are robust. Further they did take immediate action once the PRU brought deficiencies in their systems to their notice.
Although we are satisfied the action of dispensing was improper as described in Particular 1 (a), (b) and (c) to Complaint Two, the Particulars as they relate to the Respondent, allege he permitted the inappropriate dispensing on the dates specified in Schedule 3 to the Complaint document. Then in Particular 1(d) to Complaint Two the conduct of the Respondent is stated as his failure to discharge his obligations as a proprietor of the pharmacy. That failure is stated to be: (i) Failure to maintain an awareness of the manner in which the pharmacy dispensing practice was being conducted, and (ii) Failure to intervene into the practices at the pharmacy when necessary.
In relation to this Respondent Mr Saweris, we are not comfortably satisfied that Complaint Two is made out to the requisite standard. We find that he did not actively permit the improper dispensing on the occasions and in the circumstances specified in Schedule 3 to the Complaint document. We are not satisfied that he failed to maintain the degree of awareness of the dispensing in the pharmacy which realistically was likely to provide evidence of the inappropriate dispensing, the subject of this Complaint Two, as that dispensing occurred. We are satisfied that when he did become aware of the inappropriate dispensing, he took steps to intervene in the dispensing practices of the pharmacy to add additional layers of systems, protocols and procedures which would capture any future inappropriate dispensing of the nature specified in Complaint Two.
There is an important and relevant difference between the detail in Complaint One, and the decision we have reached in relation to the responsibility the Respondent had to maintain an awareness of the manner in which the dispensing practices of the pharmacy were being conducted, and the circumstances of Complaint Two. That important difference is the quantity of the inappropriate dispensing. In Complaint One, that quantity is voluminous. In Complaint Two, there are only 10 such items listed. The omissions in compliance with the PTGR are evidence of oversight rather than deliberate action, in our view.
The only additional system which could have been initiated or engaged by the Respondent at the time of the alleged conduct would have been the requirement for an audit of all Sch 8 and Sch 4D prescriptions to ensure they had complied with the requirements of the PTGR. The work involved in such an audit, sufficient to detect any, if not all of the 10 lots of dispensing set out in Schedule 3, would have been extensive given the number of prescriptions which the pharmacy was dispensing monthly. It is to be remembered there are extensive lists of dispensing of Sch 8 and Sch 4D drugs set out in the Schedule 2 to the Complaint document.
Given that the requirement for a random audit of those prescriptions could have been warranted at the time (2017 to 2018) to fulfil the requirements of the Proprietors obligations, the prospect of finding any one of the seven identified prescription, dispensed by the employed pharmacist, or in deed any of the total of 10 prescriptions in total set out in that Schedule 3 was in our view unlikely. We note the accepted fact in this hearing that it was not a requirement for a proprietor to view every prescription dispensed in the pharmacy in order to have proper oversight of the dispensing compliance for the pharmacy. In this case the subject pharmacy was dispensing between 200 and 300 prescriptions each day of the year. That would produce between 6000 and 9000 prescriptions per calendar month. The chances of finding any one of 10 prescription forms in a monthly random audit would, in our view, be insignificant.
Further, in the case of the stated offending in Complaint Two, it is no part of the Respondents' case that they were mistaken as to the law in relation to the requirements for the content of the prescription form for Sch 8 and Sch 4D drugs and otherwise as required by the PTGR.
In reaching a decision in relation to Complaint Two, we are satisfied the failure to comply with the PTGR, by an employed pharmacist, as alleged, was accidental and occurred in the circumstance of the running of a very busy pharmacy business. There is no evidence that the employed pharmacist referred to in Schedule 3 to the Complaint document, did not know the law and requirements for the prescription document as stipulated by the PTGR. It is clearly not a regularly occurring omission on the part of the pharmacist dispensing as can be seen from the number of drugs the subject of the PTGR. The failure for the prescription document to comply with the PTGR was, in the first place, created by an omission and/or oversight by the prescribing doctor.
We find the HCCC has failed to establish Complaint Two to a level where we could be comfortably satisfied of the Respondent's guilt.
Given what we have set out in this judgment, we are satisfied that in all the circumstances of this case, the conduct of the Respondent, as alleged in Complaint Two, was not unethical.

[588]

This Complaint is essentially the same as the Complaints in Complaint Two and Complaint Three, although it addresses different dispensing to that set out in those Complaints and it also addresses a different reason that the prescription documents did not comply with the PTGR on the five occasions identified in Schedule 5 to the Complaint document.
Once again, Complaint Four is founded upon s 139B(1)(l) of the National Law. The Respondent did not dispense any of the prescriptions identified. The conduct which Complaint Four identifies is "failure 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 failure to intervene when necessary, contrary to the Proprietor Guidelines." Those are essentially the same grounds upon which Complaints Two and Three are made.
Again, we take the view that the failure to comply with the requirements of the PTGR as alleged in this case was likely to be an accidental omission. It is not alleged by the HCCC that it was a deliberate and conscious action on the part of the Respondent.
Schedule 5 to the Complaint document lists five offending prescription forms. Again, that number, when compared to the bulk of dispensing between 6000 and 9000 each month, would be unlikely to produce a result in a random audit of all of the dispensing of the pharmacy.
The system engaged would have required far greater sophistication than that which the Respondents had in place in 2017 and 2018. There is no evidence that such a system was available at that time. The expert now has a computer system to monitor her dispensing which does have greater capacity to identify particular drug dispensing than that which was available to the Respondents in this case during the 2017/2018 years. There is no evidence that the Respondent could have obtained that same system in the 2017/2018 period or that it was reasonable for the pharmacy to have acquired such a system then.
We refer to our reasons for the findings on Complaint Two and Complaint Three for those same reasons we find the HCCC has not established Complaint Four to our satisfaction.

[591]

The HCCC relies on the Particulars to all of the Complaints One to Four both individually and cumulatively.
We have set out earlier in these reasons the extensive submission made by the HCCC in support of a finding of Professional Misconduct as sought in Complaint Five.
The HCCC relies, at the very least, on the cumulative instances of unsatisfactory professional conduct which it has established against the Respondent, to show the seriousness of that conduct is such as to justify a suspension or cancellation of the Respondent's registration. The HCCC argues that the seriousness of the conduct is not reduced even if the Tribunal is satisfied the Respondent did not know he could "challenge the authority of a prescribing doctor".
It is the HCCC case that the Respondent should have known he could refuse or moderate the extent or frequency of supply, in order to fulfil his obligation to the patient and the community at large. It was something which the expert had known since her time at university studying to obtain her degree in pharmacy.
At one level it is the HCCC case that without the capacity to refuse or modify the supply of a Sch 8 or Sch 4D drug, a pharmacist would never be able to ensure his dispensing was safe for a patient. The absence of such a power would remove any responsibility from a pharmacist for inappropriate dispensing which was strictly in accordance with the prescription presented. Such a circumstance would defeat what is a clear legislative intent to have a failsafe system in place in relation to the prescribing and dispensing of those very powerful and potentially health damaging drugs. The PTGR requires both the prescriber and the dispenser of those drugs to satisfy a very strict procedure to ensure, as far as possible, patients and the community are kept safe from the inappropriate use or dissemination of those drugs.
We have read the decisions cited for our benefit by the HCCC. Those include Health Care Complaints Commission v Pickett [2019] NSWCATOD 53 at [61], Health Care Complaints Commission v Fearon [2018] NSWCATOD 26 at [165], and Health Care Complaints Commission v Elliott [2018] NSWCATOD 47.
The HCCC also cited the decision in Azzer at [145]-[146]. In that case the Tribunal stated:

[594]

"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."

[595]

Mr Azzer, in the above cited decisions, was the employed pharmacist who is referred to in the evidence in this hearing and who is identified in the schedules to the Complaint document by the initials MA.
We have considered all the evidence in support of Complaint One and our findings in relation to same. We conclude that the conduct of the Respondent as established by the HCCC in Complaint One was of itself so serious as to amount to professional misconduct. The quantities and the strengths of the Sch 8 and Sch 4D drugs that he dispensed were such, that on many of the occasions the expert's opinion was that the dispensing was, without further evidence, contrary to recommended therapeutic standards.
The dispensing identified in Complaint One was for nine different patients. There are some 53 occasions of dispensing identified in Schedule 2 to the Complaint document, with the Respondent's initials noted. The identified dispensing mainly arose in a circumstance where the prescribing doctor (who was practising improperly and unethically), provided some explanation, after being questioned by the pharmacist. The Respondent believed in such circumstances he was required to dispense the prescription in question.
The HCCC set out in the Complaint One that "Each particular in itself justifies a finding of unsatisfactory professional conduct. In the alternative, when two or more of the particulars are taken together, a finding of unsatisfactory professional conduct is justified."
We have set out earlier our finding in relation to Complaint One Particulars 1(c) and 2(c), where the Respondent agreed he was guilty of unsatisfactory professional conduct based upon his failure to have regard to the patients' dispensing history. In his oral evidence, the Respondent agreed on many occasions, that his dispensing under examination was inappropriate. He expressed remorse and professional embarrassment for his conduct.
Without having to consider his separate responsibility as a proprietor of the pharmacy as it related to the identified dispensing by Mr Azzer, we are satisfied the Respondent is guilty of professional misconduct. The findings we made in relation to Complaint One relating to the Respondent's failures as a pharmacy proprietor add weight to the decision we have already made that he is guilty of professional misconduct as defined in s 139E of the National Law.

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