Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Kollias v Pharmacy Council of New South Wales [2024] NSWCATOD 152 Hearing dates: 4 and 5 June 2026 Date of orders: 19 September 2024 Decision date: 19 September 2024 Jurisdiction: Occupational Division Before: R C Titterton OAM, Senior Member P Mcasey, Senior Member P Sinclair AM, Senior Member M Maher, General Member Decision: (1) The appeal is allowed. (2) The decision of the Pharmacy Council of NSW of 16 February 2024 set aside. (3) In lieu thereof the Tribunal orders that the conditions set out in Attachment A be placed on the appellant's registration. (4) Any party seeking costs is to file and serve submissions (and if necessary evidence), limited to 5 pages, within 14 days. The other party may respond within a further 14 days, and the costs applicant may reply within a further 7 days. Catchwords: OCCUPATIONS – pharmacists – suspension of registration under s 150 of the Health Practitioner Regulation National Law – external appeal under s 159 – nature of external appeal – appeal allowed – appropriate conditions on registration Legislation Cited: Health Practitioner Regulation National Law (NSW), ss 150, 159, 159C Poisons and Therapeutic Goods Act 1966 (NSW), s 18AA Poisons and Therapeutic Goods Regulation 2008 (NSW), cll 80, 175(1) Cases Cited: Ghosh v Medical Council of New South Wales [2020] NSWCA 122 Karimi v Medical Council of New South Wales [2017] NSWCATOD 180 Kirby v Dental Council of New South Wales [2018] NSWSC 1869 Knowles v Medical Council of NSW [2019] NSWCATOD 46 Kollias v Pharmacy Council of New South Wales [2024] NSWCATOD 49 Lee v Health Care Complaints Commission [2012] NSWCA 80 Liu v Chinese Medicine Council of NSW [2019] NSWCATOD 13 Medical Council of New South Wales v Lee [2017] NSWCA 282 Medical Council of New South Wales v Smithson [2021] NSWCA 53 Pharmacy Council of NSW v lbrahim [2020] NSWSC 708 Steel v Medical Council of NSW [2020] NSWCATOD 77 Category: Principal judgment Parties: John Kollias (Appellant) Pharmacy Council of New South Wales (Respondent) Representation: Counsel: M Hutchings (Appellant) A Petrie (Respondent) Solicitors: Mills Oakley (Appellant) Health Professional Councils Authority (Respondent) File Number(s): 2024/00064372 Publication restriction: Pursuant to s 64(1)(a) of the Civil and Administrative Tribunal Act 2013 (NSW) publication of the names of any patients referred to in the material filed by the parties is prohibited. REASONS FOR DECISION Introduction 1. By application filed 19 February 2024 the appellant appeals the decision of the respondent (Council) of 16 February 2024 (Decision) to suspend his registration as a pharmacist pursuant to s 150(1)(a) of the Health Practitioner Regulation National Law (NSW) (National Law). 2. The appeal is brought under s 159 of the National Law. Accordingly, the appeal is to be dealt with by way of a new hearing and fresh evidence, or evidence in addition to or in substitution for the evidence that was before the Council, may be given: National Law, s 159(3), 3. For the following reasons, we have decided to allow the appeal, set aside the Decision and to place conditions on the appellant's registration as a pharmacist. Appellant's materials 1. The appellant's evidence comprise two folders of documents filed on 13 June 2024. We will briefly summarise these documents. Amended External Appeal Form 1. Relevantly, this states that the appellant appeals pursuant to both s 159 and s 159B of the National Law. There is no need to refer to the grounds of appeal in the s 159B appeal in this decision. The s 150 Reasons for Decision Introduction 1. A s 150 hearing was convened in response to the receipt on 15 December 2023 of a complaint and report of an investigation conducted by the Council's Pharmaceutical Regulatory Unit (PRU) which found that the appellant was responsible for numerous breaches of the Poisons and Therapeutic Goods Act 1966 (NSW) (PTG Act) and Poisons and Therapeutic Goods Regulation 2008 (NSW) (PTG Regulation)in relation to the dispensing, supply, receipt, record-keeping and storage of Schedule 8 (S8) medicines and Schedule 4 (S4) cannabis medicines. 2. An inspection by the PRU of the appellant's pharmacy had taken place on 1 November 2023. 3. The PRU's subsequent review of records kept by the appellant revealed concerning patterns of dispensing cannabis medicines. Several patients were supplied with an unusually wide mix of cannabis products, often in greater doses, or on earlier dates than their prescriptions indicated. 4. The PRU advised the appellant that he would be subject to two Orders (issued on 7 December 2023 with immediate effect) for the purpose of protecting the life, or the physical or mental health, of him or any other person: 1. under cl 175(1) of the PTG Regulation, the appellant was prohibited, as a pharmacist, from supplying or having possession of, or manufacturing any preparation, admixture, or extract of a drug of addiction; 2. under s 18AA of the PTG Act, the appellant was prohibited, as a pharmacist, from having possession of, or supplying the restricted substance cannabidiol. 1. The s 150 decision notes that at the time of the hearing and due to the gravity of non-compliance, large amounts of S8 medicines might remain unaccounted for. The unknown fate of these medicines, combined with the potential for misappropriation posed an unacceptable risk to public health and safety. Issues to be determined 1. The decision states that the central issue for us to consider is whether it is appropriate to take action under s 150 of the National Law in respect of the appellant for the protection of the safety or health of the public or is otherwise in the public interest. To address this central issue, the Council posed it?self the following 6 questions to answer. Are there previous complaints in relation to the practitioner (see s.410 of the National Law (NSW)? 1. The Council found that in 2003, the relevant former Pharmacy Board of New South Wales considered a complaint about the appellant arising from a report from the PRU in relation to the supply to a single patient of large quantities of anabolic steroids on prescriptions dispensed by various pharmacists (including the appellant) at Kingsway Medical Centre Pharmacy. 2. The complaint was disposed of after a Council process determined that no further action should be taken in respect of the complaint. If there are previous complaints concerning the practitioner (s. 410 of the National Law (NSW) are they reasonably considered to be relevant to the current matter? If so, how are they relevant to the current matter? 1. The Council noted the 20-year timeframe since the previous complaint, but observed that that complaint was similar to the present complaint in that it relates to inappropriate supply of medicine. Is the practitioner impaired? 1. The Council found that the appellant was not impaired. Does the practitioner have the necessary standard of practice, knowledge and understanding so as not to pose a risk to the health or safety of the public? 1. The s 150 decision states that the PRU report identified many instances where the appellant's conduct did not demonstrate the necessary standard of practice, knowledge and understanding reasonably expected of a proprietor pharmacist of an equivalent level of training or experience. 2. In particular, the PRU report identified significant incidences of non-compliance by the appellant and his employed pharmacists with the PTG Act and PTG Regulation including but not limited to storage and record keeping, dispensing on invalid prescriptions, and concerning patterns of cannabis dispensing. 3. Following questioning at the hearing, the Panel formed a reasonable belief that the appellant had failed to exercise his professional judgment and autonomy when dispensing large quantities and combinations of cannabis medicines to individual patients, clearly demonstrating another area where his professional practice, knowledge and understanding posed a risk to the health and safety of the public. 4. Following questioning at the hearing, the Panel formed a reasonable belief that the appellant had failed to exercise his professional judgment and autonomy when dispensing large quantities and combinations of cannabis medicines to individual patients, which clearly demonstrated that the appellant's professional practice, knowledge and understanding posed a risk to the health and safety of the public. Has the practitioner implemented remedial action to eliminate the risk that his practise, knowledge and understanding pose a risk to the health or safety of the public? 1. The Decision states that his written submission, and in his opening and closing statements at the hearing, the appellant stated that he was "deeply shaken" by the findings outlined in the PRU report, that he had reflected on the causes of the deficiencies, and expressed remorse that he had allowed practices at his pharmacy to fall below the standards he expected of himself. 2. The appellant told the Panel that he did not intend to rebut the findings of the PRU report but wished to use his submission and discussions at the hearing as a means of describing the remedial actions he had implemented to address the deficiencies. The Decision states that the appellant assured them that since the PRU report he had employed some new pharmacists, one of which had specific knowledge in cannabis medicines dispensing, and that he had also engaged the services of a mentor pharmacist, who also had experience in the use of cannabis medicines for patient health. 3. The Decision then states: 45. At the hearing we dealt initially with the findings of the report which Mr Kollias accepted and did not intend to rebut. With respect to these findings, he had two significant opportunities (in his written submission and this hearing), to convince the panel that he had improved deficiencies in: record-keeping of S8 and S4 medicines procedures within the pharmacy his personal dispensing practice of cannabis medicines 46 He failed to do this. 47 Rather than being assured by Mr Kollias that the prima facie concern about diversion had been mitigated, our concerns about likely diversion were in fact heightened during the hearing when we learned that 171 cannabis products still remained unaccounted for. It was our view that with the motivation we would expect him to apply to address this issue, Mr Kollias had ample time between the PRU inspection (1 November 2023), his receipt of the PRU report (December 2023) and the date of this hearing (22 January 2024) to have reconciled this difference. This led us to the view that it may not be likely for these products to be found. In our mind, there remains a high risk that these products have been diverted, potentially posing serious risks to the health and safety of the public. … 50. Of greatest concern to us however was that even during the hearing Mr Kollias failed to understand the significance of the "red flags" which several of his patients, who had been dispensed cannabis medicines, had displayed. He was of the view that his current practice of confirming prescriptions with an interstate telehealth prescriber (e.g. a nurse practitioner) was sufficient to alleviate any concerns he might have about drug dose titration, mixing of cannabis medicines, and quantity and purpose of supply to be appropriate. He did not believe that consulting with a pain specialist or a psychiatrist was a worthwhile additional source of information. He provided no indication that he intended to change the level of his enquiry with treating prescribers and specialists in the future to mitigate the risks of these "red flags 1. The Panel was unconvinced that the remedial actions purportedly undertaken by the appellant to address deficiencies in his practice were sufficient to remove the risks to the health or safety of the public. Are the circumstances such that it is otherwise in the public interest that action be taken that affects the practitioner's practice? 1. The Panel formed the belief that the practices of the appellant were not in accordance with the public interest. They stated that the appellant had failed to exercise the responsibilities entrusted to him as a pharmacist, a pharmacist proprietor and a custodian of medicines. They stated that his practice showed evidence of unsatisfactory knowledge, care and judgement. it was therefore in the public interest that action should be taken against him. Conclusion 1. The Panel then considered whether there were conditions that could be imposed on the practitioner's registration that would sufficiently mitigate any identified risks to the health or safety of the public, or mitigate concerns regarding the public interest. 2. The Panel stated that the significant evidence of deficiencies in the appellant's standard of practice, knowledge and understanding uncovered during the PRU investigation, particularly in relation to the storage, management and dispensing of cannabis medicines and the inability of the appellant to provide reassurance that he had implemented remedial actions to address these deficiencies. The Panel was of the opinion that imposing conditions on the appellant's registration would not mitigate the risks to the health or safety of the public, or mitigate concerns regarding the public interest. 3. Accordingly, the Panel suspended the appellant's registration on 22 January 2024 with effect from 23 January 2024 A transcript of the s 150 hearing 1. Where relevant this will be referred to later in these reasons. The documents at the s 150 hearing. 1. Again, where relevant these will be referred to later in these reasons. Statement of the appellant dated 6 May 2024 1. The contents of this statement can be summarised as follows. 2. First, the appellant sets out his qualifications and experience. 3. Secondly, the appellant then briefly describes the lead up to and his appearance at the s 150 hearing. 4. Thirdly, the appellant sets out his prior complaints history. This is sufficiently summarised above. 5. However, he also states that the "Practitioner Summary" in the briefing materials provided to the s 150 delegates incorrectly states that the 2003 complaint involved me dispensing anabolic steroids. He says that after he filed his appeal the Council acknowledged that the description of the complaint in the Practitioner Summary was incorrect. 6. Fourthly, the appellant recounts the business of the sale of medicinal cannabis at his pharmacy. In summary he states that: * in the several months prior to 1 November 2023, the workload related to the dispensing of medicinal cannabis increased significantly; * as the workload increased, the management of the pharmacy became more challenging; * he was adversely affected by staff shortages, including the main Pharmacist In Charge, and found it very hard to recruit new pharmacists; * he attempted to maintain records of both stock received and prescriptions dispensed and supplied but became overwhelmed by the volume and workload. 1. This section of the appellant's statement concludes: 21 The increase in workload from medicinal cannabis dispensing was a significant reason I failed to comply with regulatory requirements relating to record keeping, stock counts and storage. Prior to the PSU inspection, I found myself working 7 days per week, and personally covering for the absences of the main Pharmacist in Charge. The workload was very demanding and far exceeded any workload that I had ever encountered. The toll on me personally was very significant. I became exhausted and the standards at Mazzei's Pharmacy fell as a result, This is not an excuse but an explanation. 22 At the time, I recognised the issue of staff shortages. In hindsight, I recognise that better systems and more manageable workloads would have assisted me to meet my obligations as a pharmacist and a proprietor. 1. Fifthly, the appellant then sets out the research he did when he commenced dispensing medical cannabis. He says that he also reviewed information about medicinal cannabis products daily when dispensing. 2. The appellant says that he has now undertaken further education to improve his understanding of medicinal cannabis, high-risk medications, and his role as a proprietor pharmacist. 3. The appellant then sets out the extensive further education he has undertaken. We will refer to this in the Consideration Section of these reasons. 4. The appellant then states that while suspended from practice, he has engaged with a mentor, Ms Marina Holt (a pharmacist and former member of the Council) to address the issues raised by the PRU and to ensure the suitability of the procedures at his pharmacy. He has commenced regular fortnightly meetings. 5. The appellant says that if he is permitted to return to work, it is his intention that this mentorship will continue for a period of at least 12 months to improve his standard of practice as a proprietor and pharmacist. 6. Sixthly, the appellant then sets out the changes he has made to his pharmacy, being the Mazzei Pharmacy at Eastwood (Pharmacy). In summary: * two new pharmacists commenced working at the Pharmacy in late December 2023; * a new pharmacy manager commenced in January 2024. The pharmacy now has four to five full time pharmacists working on weekdays (Monday to Friday). On weekends there are a least two full time pharmacists working in the Pharmacy. The appellant says that if he is allowed to practice, he would be the fifth or sixth pharmacist on roster. The new staffing levels means the workloads can be better managed, which will assist with compliance. * new standard operating procedures for S8s and medicinal cannabis products have now been implemented; * the Pharmacy Manager, Mr Kieron Ng, has conducted staff training on the new procedures; * each employed pharmacist at the Pharmacy will complete specific education in medicinal cannabis and the SafeScript NSW training modules as part of the current CPD year. 1. Seventhly, the appellant then discusses the drugs dispensed to each of the patients referred to by the PSU. 2. Attached to the appellant's statement are over 400 pages of documents. Where relevant we will refer to these below. We note that these attachments include (as Annexure 9) a 5 page document titled "John Kollias – self reflection on CDP – March 2024". In summary, this document sets out what the appellant learned from each of the four Council podcasts he has listened to. 3. The attachments also include a proposed mentoring plan for the appellant prepared by Ms Holt, prepared on or about 17 April 2024 4. Following the attachments are two publications of NPS MedicineWise: Medicinal Cannabis: process for dispensing and Medicinal Cannabis: seven questions pharmacists are asking. 5. The appellant was cross-examined extensively by the Council's counsel Ms Petrie. The supplementary statement of the appellant dated 12 June 2024 1. The bulk of this statement deals with Appendix C referred to above. 2. The appellant says after the PRU inspectors had left the Pharmacy, he realised that during the inspection a number of products which were stored in the back room had not been counted. He exhibits to this statement photos he took on 1 November 2023 showing the location of some of the products not counted by the PRU. After the PRU's departure, he counted these products and made a record of the additional stock on hand. 3. He says that he asked the PRU inspectors for a copy of their handwritten record of the manual stock count. One of the inspectors, Ms Katharina Nicholson, allowed him to take a photograph of one page of her handwritten notes only (being EX JK-1 p429). The appellant says the first entry records a count of 68 items of Tasmanian Botanics' THC 18 Midlands Afghan Haze lOg. However, Appendix C incorrectly states that none of these products were found by the PSU during the manual count. The appellant says that he does not know if there are other, similar, errors made by the PRU that day. 4. Since the PRU inspection, he has attempted to reconcile the discrepancies identified in Appendix C. This process has included reviewed the dispensing software (Z Dispense) and the Modeus drug register to identify whether (and if so, when) dispensed products were not entered into Modeus or where an invoice may have (which would result in Modeus recording that the pharmacy had received double the number of items it in fact received). 5. Since his suspension, he has continued his attempt to reconcile the medicinal cannabis products based on records he can access from his home computer. He has not entered the Pharmacy or made any adjustments to the drug register based on his reconciliation, and that his ability to undertake a comprehensive reconciliation has been hampered by being unable to view databases which he cannot access from home or to review paperwork stored at the pharmacy. 6. The appellant states that most of the discrepancies identified in Appendix C were due to the following circumstances: * invoices for stock received were entered into Modeus twice; * items were not counted by the PSU on 1 November 2023; * items showing as dispensed on Z Dispense were not recorded as supplied in Modeus, including because stock cards were not linking; * an invoice emailed to the pharmacy was entered into Modeus as stock received before it actually arrived. The delivery was then lost in transit but the stock was not then removed from Modeus; and * products were incorrectly recorded in Appendix C as different products but were in fact the same product, due to duplicated stock card entries in Modeus or a product being discontinued and replaced with another product. 1. The appellant then provides a Table setting out the current reconciliation as at the time of this statement. 2. The next part of the statement then sets out the steps the Pharmacy Manager has taken to improve practices at the Pharmacy. These include: * organising the S8 safe in alphabetical order based on each product's brand name. * moving all medicinal cannabis dispensary activities to the same area, to reduce the time needed to walk between areas and allow for better communication between staff members. * cleaning up the duplicate stock cards in both the Z-Dispense system and drug register, and trying to ensure that they are linked and connected with each other. * organising the invoices and scripts into folders so that they can be accessed quickly and easily. * implementing clear processes from when an order is taken in, all the way to when the patient/customer receives their order, including by reference to the Standard Operating Procedures and checklist. * clearly displaying a message board, to reflect what is currently out of stock with the suppliers or has been discontinued by the suppliers. * facilitating staff training through medicinal cannabis suppliers. * conducting regular reviews of daily Z Dispense records to check all supplies are recorded in the drug register. * conducting weekly audits of a random number of medicinal products to check for any stock discrepancies; * conducting monthly stock take of S8 medicines; * having two dedicated dispense workstations located next to the two largest drug safes for medicinal cannabis only; 1. The appellant states that the Pharmacy now has a minimum of four fulltime equivalent registered pharmacists with a fifth registered part time pharmacist to assist when required. Two pharmacists attend to medicinal cannabis patients and dispensing, and two pharmacists work in the dispensary. 2. The appellant says that if he is allowed to return to the pharmacy, all current pharmacists will be retained on the same roster. 3. The final part of this statement responds to the witness statement of Ms Katharina Nicholson. Ms Nicholson is a Council witness. 4. The appellant says: 1. the Pharmacy has not deferred written paper (hard copy) prescriptions. If a patient asks the Pharmacy to hold a hard copy prescription for a S8 medication, these are filed and retained (separate from other prescriptions) until the patient requests that they be dispensed; 2. if requested by a patient to retain their e-prescription, the previous practice at the Pharmacy was to enter an e-prescription into the patient's file and defer it. A deferred prescription is not dispensed or supplied to the patient; 3. the current practice at the Pharmacy is to ask patients consent to allow the Pharmacy to access their e-prescriptions stored in an active script list (ASL) so that staff can locate tokens on the "cloud". Alternatively, they can store the e-prescription themselves in any valid form and present it to pharmacist when required. Statement of Albert Regoli dated 12 June 2024 1. Mr Regoli is a pharmacist. He was asked by the appellant to verify his stock reconciliation of medicinal cannabis products following the PRU inspection on 1 November 2023 2. Mr Regoli states that he had read the PSU's report concerning the Pharmacy of 7 December 2023, including Appendix C. 3. He attended the Pharmacy on 29 April 2024 where he accessed the Z Dispense and Modeus Drug register. Based on his review of this material, he "verified" the appellant's notes of his reconciliation of 10 products contained in Appendix C. 4. Mr Regoli states that the records he reviewed showed that in some instances an invoice was entered into Modeus twice thereby doubling the number of items recorded as being in stock on Modeus. In other cases, a medication was recorded as dispensed on the Z dispense software but there was no corresponding entry in Modeus. Accordingly, the drug register record did not reflect the fact that one or more units of a product had been dispensed. 5. Mr Regoli then provides a table of products where he says confirmed the appellant's reconciliation. The Council's evidence 1. The Council relied on a 328 page folder of materials filed on 5 June 2024. After providing the appellant's external appeal form and the Tribunal's decision of Kollias v Pharmacy Council of New South Wales [2024] NSWCATOD 49 (which refused the appellant's application for a stay of the Council's decision to stay the appellant's registration), the documents were organised under the following categories: * s 150 proceedings * documents considered at the s 150 proceedings; * appellant's submissions (at the s 150 proceedings); * additional material (being regulatory guidance and codes of conduct; * new complaint from PSU; * 2003 complaint material; * PSU Statement; * Expert Evidence. 1. We shall briefly summarise some of the more important materials filed. New Complaint by PSU 1. The material first includes a letter from Mr Bruce Battye to Mr Mark Watson dated 29 February 2024. Mr Battye is the Director, Legal Operations, Legal and Regulatory Services Branch of the OSU. Mr Watson is the Executive Officer of the Council. 2. Mr Battye states that since 8 December 2023 further information has come to light including, but not limited to apparent breaches of the 8 December 2023 orders by the appellant, and continued non-compliance of Pharmacy pharmacist with the PTG legislation. 3. Mr Battye states that, accordingly, the appellant's professional practice and conduct as a registered pharmacist, in addition to that of the pharmacists employed at the Pharmacy was referred to the Council for review and any further action deemed appropriate. 4. A 15 page Report On Investigation is attached to the letter. The "key issues" identified in the report are: 1. despite the regulatory intervention of 8 December 2023, non-compliance with the provisions of the PTG Act and PTG Regulation by pharmacists at the Pharmacy has continued. Furthermore, records of dispensing as captured in the real time monitoring system SafeScript® NSW, and reports extracted from the Pharmacy's Modeus® electronic drug register suggest the appellant may have possessed, dispensed and/or supplied S8 medicines in breach of the above-mentioned 8 December orders; 2. a review of the Pharmacy's electronic S8 drug register for the period 9 December 2023 to 5 January 2024 suggests: 1. the appellant may have breached the Orders prohibiting him from possessing, dispensing and supplying S8 medicines on approximately 24 occasions. 2. the accountability of S8 medicines kept at the Pharmacy remains an issue of concern, with approximately 77% of balance checks recorded in the register identifying a discrepancy between the physical stock and the balance of medicines recorded in the drug register; 3. pharmacists at the Pharmacy manually reduced the balance recorded the drug register on 25 occasions indicating a losses of oil, vape cartridges, soft gels and dried flower; 4. pharmacists at the Pharmacy have failed to record entries in the drug register in accordance with cl 117(1) of the PTG Regulation, including failure to record the name of the prescriber and who the medicine is being supplied to or been received from; 1. pharmacists did not record adequate instructions for use for the cannabis medicines they dispensed in contravention of cl 113(1)(a) of the PTG Regulation, with includes but is not limited to: 1. approximately 20% of instructions referencing only a unit measure (e.g. Ig, 1mI) 2. approximately 15% of instructions were limited to as directed' 3. nonspecific instructions; 1. individual patients are still being supplied with large quantities of Cannabis medicines from the Pharmacy. For the 28-day period 9 December 2023 to 5 January 2024 records of dispensing as captured in SafeScript NSW and records extracted from the Pharmacy's Modeus® electronic drug register indicate: 1. approximately 2,100 prescriptions for cannabis medicines were dispensed to approximately 950 patients 2. approximately 63% of these patients received two or more supplies 3. approximately 18% of patients received four or more (up to 9) supplies 4. a review cannabis medicines supplied to a selection of patients revealed pharmacists at Pharmacy supplied patients with up to an average of 1,050mg THC per patient per day. 1. it is not known how pharmacists at the Pharmacy determined the S8 cannabis medicines they dispensed were in a quantity and/or purpose which accords with the recognised therapeutic of what is appropriate in the circumstances as specified in cl 109 of the PTG Regulation; 2. it appears that one pharmacist may have dispensed S4D and S8 medicines at the Pharmacy over a 17-month period during which their AHPRA registration was subject to conditions not to possess, supply and dispense these medicines, in circumstances where the appellant signed a declaration in May 2022 and again in December 2022 stating he was aware of the conditions on Ms Toumeh's registration. Of further concern to the PSU is that the appellant appears to have been appointed by the Council to be the pharmacist's supervisor; 3. it appears that the appellant, as the proprietor of the Pharmacy, has failed to ensure the Pharmacy operates in accordance with the provisions of the PTG Regulation and failed to intervene and rectify areas of non-compliance contrary to the Pharmacy Board of Australia's (Board) Guidelines for Proprietor Pharmacists. Statement of Ms Katharina Nicholson dated 4 June 2024 1. After setting out her qualifications and experience and describing her roles at the PRU/PSU Ms Nicholson then comments on the appellant's statement of 6 May 2024. 2. She states that she is aware of the appellant's comments relating to the PSU's calculations. She states in response there is no rationale to defer a prescription for an S8 medicine because: 1. with respect to deferring a prescription for an S8 medicine: 1. cl 80(4) of the PTG Regulation outlines a person must not issue a S8 prescription with more than one preparation; 2. accordingly, there is no rationale to defer a prescription (paper or otherwise) for a S8 medicine 1. with respect to deferring an e-script: 1. an e-script 'lives' on the Prescription Exchange Service (PES), a cloud based server; 2. when an e-script is issued, a QR code (often referred to as a token) is issued which can be sent to a patient's phone (or that of the patient's authorised agent); 3. the token is required to access the e-script on the cloud; 4. a patient cannot delete an e-script as the appellant states. A patient may accidently delete a token, but the e-script remains on the cloud; 5. a token can be printed, to address patient concerns about 'accidently' deleting it. The prescriber could also be contacted if a token has been 'lost'; 6. there is no rationale to defer an e-script regardless of the drug schedule. Expert Evidence 1. Mr Michael Robertson is a pharmacologist and forensic toxicologist. 2. The Council sought his expert opinion on the quantities and combinations of medicines, both cannabis and other medicines, dispensed by the pharmacy and the likely effect and/or any risks to the health and safety of the patients who were dispensed cannabis from the Pharmacy. 3. Mr Robertson was asked to provide his expert opinion in two distinct scenarios, first on the assumption that the PSU data was correct and second, on the assumption that the appellant's explanations of the data were correct. 4. Mr Robertson stated a summary of his conclusions as follows: 35. In summary: 35.1. While THC is generally safe in high doses, the use of THC will result in mental and physical impairment for a number hours after each use. The dispensing pattern described for the patients above in either scenario 1 or scenario 2 are high and would likely result in daily mental and physical impairment, tolerance and the risk of withdrawal symptoms if dose reductions are not managed appropriately. 35.2. Further, there is a risk of mental illness or exacerbation of pre-existing mental illness when high doses are prescribed for an extended period of time. 35.3. When it is assumed that all of the dispensed THC-containing products (flower, oil etc.) were used by the individuals as prescribed, the amount of THC dispensed is high relative to recreational drug use patterns and in my experience evaluating medical cannabis prescriptions. 35.4. For some patients, the apparent inconsistency between the amount of THC-product dispensed and the prescribing notes suggest that either more THC is being used than prescribed or the risk of diversion exists. 35.5. The frequent daily use of THC by many, if not most, of the patients referred to above, would likely result in the presence of the THC in the saliva. During this time, operating a motor vehicle would be illegal (presence of THC in oral fluid) and possibly unsafe given the associated impairment following use. Relevant law and principles 1. We accept as correct the relevant provisions of the National Law and principles to be discerned from the authorities referred to by the Commission. Relevant law 1. The relevant law is found in ss 159 and 159C of the National Law which provide as follows: 159 Right of appeal [NSW] (1) A person may appeal to the Tribunal against any of the following decisions of a Council for a health profession— (a1) against a reprimand by the Council for the health profession under Division 3; (a) against a suspension by the Council for the health profession under Division 3 or a refusal to end a suspension; (b) against conditions imposed by the Council for the health profession on the person's registration under section 127AA or Division 3 or 4 or the alteration of the conditions by the Council; (c) against a refusal by the Council for the health profession to alter or remove conditions imposed by the Council under Division 3 in accordance with a request made by the person under section 150I; (d) against a decision by the Council for the health profession to give a direction or make an order in relation to the person under section 148E; (e) against a refusal by the Council for the health profession to alter or remove conditions imposed on the person's registration, or to end a suspension, imposed under Division 4 in accordance with a request made by the person under section 152K. Note— An appeal under this section is an external appeal to the Tribunal for the purposes of the Civil and Administrative Tribunal Act 2013. (2) An appeal may not be made in respect of a request by a person that is rejected by a Council because it was made during a period in which the request was not permitted under section 150I or 152K. (3) The appeal is to be dealt with by way of a new hearing and fresh evidence, or evidence in addition to or in substitution for the evidence that was before the Council, may be given. 159C Tribunal's powers on appeal [NSW] (1) On an appeal against a decision of a Council, the Tribunal may by order— (a) confirm the decision; or (b) set aside the decision; or (c) set aside the decision and make a new decision (being a decision that the Council could have made). (2) The Tribunal's order must not cause a suspension or conditions imposed by a Council to have effect beyond the day on which a related complaint about the person is disposed of. 1. Given s 159C, the Council submits, and we accept that: 1. an appeal under s159 is de novo in nature and requires the merits of the matter to be considered afresh as at the date of the Tribunal hearing (not as at the earlier date when the Council made its s150 decision); 2. the Tribunal can receive new/fresh evidence in a s159 appeal that goes beyond the evidence that was before the Council when it made the s150 decision; 3. the question on appeal is whether, at the time of the Tribunal hearing, it is appropriate to take action under s 150 of the National Law in respect of the appellant for 1. the protection of the health or safety of the public or 2. otherwise in the public interest. 1. the task under s150 of the National Law involves a risk assessment, having particular regard to: 1. the urgent nature of the power; 2. the interim protective nature of the provision; and 1. the Tribunal's role is to determine, based on the material that is presented to the Tribunal by both the Council and the appellant the Tribunal hearing, whether the suspension imposed should be set aside, varied (by imposing conditions) or confirmed. In doing so, the Tribunal's role is to re-exercise the power and substitute its own view on a consideration de novo of the evidence before it. 1. In summary, the Tribunal must consider afresh for itself whether or not it is satisfied under s150 that it is appropriate to impose conditions on the appellant's registration as a pharmacist for the protection of the health or safety of any person or persons or if satisfied the conditions are otherwise in the public interest. Principles 1. The Commission invokes the following authorities. 2. First, Medical Council of New South Wales v Smithson [2021] NSWCA 53, where the Court of Appeal stated at [20]: As error has been conceded it is appropriate first to set out the principles applicable to the determination of an appeal under s 159. Those principles have been extensively discussed in recent decisions of this Court in Ghosh v Medical Council of New South Wales (2020) 102 NSWLR 303; [2020] NSWCA 122 and Kirby v Dental Council of NSW [2020] NSWCA 91. The most important are: (1) The role of the Tribunal in a s 159 appeal of the present kind is to apply s 150 standing in the shoes of the Council. The hearing is de novo and not limited to evidence before the Council. The legal standard to be applied is fixed by s 150: Kirby at [117]-[119]; Ghosh at [9]. (2) The subject matter, scope and purpose of s 150 makes clear that it is a protective provision with two independent limbs. The touchstone for the exercise of the Council's role under s 150(1) to make an order suspending the practitioner's registration or imposing conditions on it is that the Council be satisfied that it is appropriate to do so for (i) the protection of the health or safety of any person or persons (the first limb), or (ii) that the action is otherwise in the public interest (the second limb): Kirby at [15]; Ghosh at [5]. The two limbs may overlap but the public interest is not subsumed in the first limb: see Pharmacy Council of NSW v Ibrahim [2020] NSWSC 708 at [35]. The two limbs are disjunctive; satisfaction of either will suffice to trigger the obligation imposed by s 150. (3) The proceedings are not disciplinary and are not necessarily referable to a complaint. The National Law otherwise makes provision for dealing with complaints against registered health practitioners: see Div 3 Subdivs 2-6. The function of a s 150 hearing is purely protective in character: Kirby at [15]; Ghosh at [5]. By s 150D, a Council must, after taking action under s 150(1) (except in the case of impairment), refer the matter to the Health Care Complaints Commission ("HCCC") to be investigated as a complaint. By s 150F, in a case of impairment, the Council must consult with the HCCC to see if agreement can be reached as to whether the matter should be dealt with as a complaint or referred to an Impaired Registrants Panel: Ghosh at [3]. (4) Principles relating to judicial review of administrative decisions are inappropriate to the exercise required by s 159. References by the Tribunal to the Council "taking into account irrelevant considerations" or references to the Wu Shan Liang [1] principle (in [84(2)] of the decision) are a distraction from the task the Tribunal is required to perform in a s 159 hearing. (5) Because the circumstances in which action under s 150 may be taken include that there may be a continuing dispute as to the relevant facts and that investigations into complaints concerning the practitioner by bodies such as the HCCC may not have been completed or even commenced, the Tribunal is not required to make conclusive findings of fact based on the material before it. The s 159 hearing does not involve determination of the merits of a claim: Kirby at [14], [139]; Ghosh at [9]. (6) The role of the Tribunal is to make an assessment of the evidence and determine whether it is satisfied that it is appropriate to make one of the orders referred to in s 150(1). The s 159 hearing is not the occasion to consider, let alone determine, whether a practitioner is currently a fit and proper person to carry on the role: Ghosh at [9]. (7) The "protection of the health and safety of any person or persons" does not require there be actual harm suffered by any person. Because s 150 is concerned with protection, it is sufficient if it can be demonstrated that there is a potential for harm: Ghosh at [9]. The Tribunal's role in this case was to make an assessment of the evidence and determine whether it was appropriate, on either of the bases for which s 150 provides, that an order be made under s 150 for the protection of the health or safety of any person or persons or otherwise in the public interest. (8) As s 150 is a protective provision, it is appropriate ordinarily for the Tribunal, in deciding whether it is satisfied that it is appropriate to make an order under the first or second limb, to make an assessment about the nature and degree of risk to the health or safety of any person or persons or to the public interest (in the sense of the chance of the suggested harm being realised) and the consequences of the suggested harm being realised (in the sense of the seriousness of the harm that will ensue if the risk is realised): see X v The Commonwealth (1999) 200 CLR 177; [1999] HCA 63 at [41], which addresses risk in a different context. Reaching that state of satisfaction involves the Tribunal making an assessment of all of the evidence before it. (9) The essential question which the proper conduct of a s 159 hearing de novo requires the Tribunal to address is whether allowing the medical professional to practise, or to practise with certain conditions, involves an unacceptable risk to the health and safety of the public, or otherwise involves an unacceptable risk to the public interest: Ghosh at [103]. 1. Secondly, in Karimi v Medical Council of New South Wales [2017] NSWCATOD 180 at [123] (approved by the Court of Appeal in Ghosh v Medical Council of New South Wales [2020] NSWCA 122 by Brereton JA at [9]), where the Tribunal stated: Section 150A(2) provides that on receiving an application for review, unless the Medical Council refuses to reconsider its decision because the application is frivolous, the Medical Council must reconsider its decision and, in so doing, must consider any new evidence or material submitted by the practitioner that the Medical Council reasonably considers is relevant. Upon reconsideration, the Medical Council may affirm or vary the decision or set it aside and take any action the Medical Council has the power to take under s 150. However, under s 150A(4), the Medical Council may not vary or set aside a decision unless the Medical Council is satisfied that there has been a change in the registered practitioner's circumstances that justifies the variation or setting aside of the decision. 1. Thirdly, Pharmacy Council of NSW v lbrahim [2020] NSWSC 708, where Harrison AsJ stated: 10 In determining whether it must act under s 150 of the National Law, the role of the relevant Council or Tribunal is not to make findings of fact or a determination of the merits of any complaint. 11 In Lindsay v NSW Medical Board [2008] NSWSC 40 ("Lindsay"), Hall J considered the interlocutory nature of an action made under s 66 of the Medical Practice Act 1992 (NSW), which was the predecessor provision to s 150 of the National Law. His Honour's comments are equally applicable to s 150 of the National Law. In Lindsay, Hall J stated at [79]: "[79] An inquiry, hearing or interview process conducted for the purposes of the Board or its delegates determining the matters under s.66(1) could be considered to be preliminary or interim in nature or, as it was termed in the present proceedings, 'interlocutory'. Such a process, in the present case, as earlier observed, did not involve the making of findings of act or the determination of the merits of any complaint. Any observations or conclusions expressed by the Board or its delegates under s.66 following an inquiry, hearing or interview, are, and can only be, strictly for the limited purposes of s. 66(1). Such observations or conclusions are not to be equated to findings on material questions of fact as may be made by the Medical Tribunal in proceedings conducted by the Tribunal under Part 11 of the Act." 1. Fourthly, Kirby v Dental Council of New South Wales [2018] NSWSC 1869, where Barrett JA stated at [6]: Section 150(1) assumes, clearly enough, that a Council will perform an evaluative task in relation to circumstances concerning a practitioner that come to its notice. The evaluation must focus entirely on what is required to protect the health and safety of relevant persons and on the requirements of the public interest. Considerations of punishment are foreign to the assessment. 1. Fifthly, Steel v Medical Council of NSW [2020] NSWCATOD 77, where Boland ADCJ stated at [115]: … the task with which delegates are entrusted under s 150 (1) is an "evaluative" risk assessment based on the evidence before them which must be focussed entirely on whether they are satisfied it is appropriate to protect the public or otherwise in the public interest to suspend or impose conditions on a practitioner's registration. 1. The Council accepts that every matter needs to be determined on its own individual facts and merits. The Council submits that the Tribunal should have regard to the risk that inappropriate supply, record keeping and storage of cannabis medicines poses to the health and safety of the public and the need to take action to address this in the public interest. The appellant's alleged non-compliance with the prohibition orders imposed by the PSU is also relevant to the determination of his appeal and whether conditions will appropriately mitigate any risks posed to the public. 2. Finally, the Council submits that an inevitable consequence of protective orders is that they may be punitive in nature: Lee v Health Care Complaints Commission [2012] NSWCA 80 Barrett JA at [20]-[21]; Liu v Chinese Medicine Council of NSW [2019] NSWCATOD 13 at [37]. 3. To those principles can be added the following passage from Karimi: 123 Hanna v Medical Council of NSW [2017] NSWCATOD 27 and Crickitt v Medical Council of NSW (No 2) [2015] NSWCATOD 115 provide useful guidance as to the nature of an external appeal under s 159 of the National Law against a decision of the Council to suspend a medical practitioner's registration under s 150. The applicable principles derived from the relevant provisions of the National Law, as discussed in Crickitt and Hanna, may be summarised as follows: … (4) No need for a detailed enquiry The existence of the power, and the fact that it may be exercised without any formal complaint having been made against the practitioner, and without any disciplinary proceedings having been commenced, is indicative that the Tribunal need not embark upon a detailed enquiry, and may base its reasons on material which would not conventionally be considered as evidence in a strict sense as would be admissible in a court. (Crickitt at [56]; see also Lindsay at [76]) (5) Not required to make any conclusive findings Because the circumstances in which the power under s 150 is to be exercised include that there may be a continuing dispute as to precisely what occurred and why and that investigations into complaints concerning the practitioner by bodies such as the HCCC may not have been completed or even commenced, the Tribunal is not required to make conclusive findings of fact based on the material before it. (s 150 of the National Law and Hanna at [19]). Submissions of the appellant 1. By way of high level summary, in his written submissions the appellant submits: 1. he does not pose any risk to the public in respect of the storage, management and dispensing of cannabis medicines and he ought not remain suspended in consequence of a non-existent risk; 2. it is not in the public interest that he remain suspended; 3. he has made plain the circumstances which surrounded his failure to keep the Modeus electronic drug register at Mazzei's Pharmacy up to date and the Zed dispensing records. He deeply regrets those circumstances; 4. it is significant that he has not previously come to notice for such failures (the only prior complaint about him being in 2003 and related to dispensing by an employed pharmacist of which he was unaware until the complaint was made). 5. since 7 December 2023, he has: 1. commissioned the drafting of new standard operating procedures for the Pharmacy; engaged in further education in an effort to meet the respondent's concerns about his knowledge about medicinal cannabis (and to further his knowledge); 2. engaged in a review of records to establish the sources of discrepancy in the records of the Pharmacy; 3. retained Mr Regoli to assist in the review of records; 4. had the benefit of the mentorship of Ms Marina Holt; 5. reflected upon the content of the PRU reports; and his practice. 1. In short, the applicant submits that he has done the very things that could be expected of him following coming to the notice of the Council. 2. The appellant accepts that aspects of his practice, in particular with respect to the management of medicinal cannabis stock and its dispensing, fell below acceptable standards and acknowledges the validity of concerns raised by the PRU. 3. As to the experts, the appellant submits that: 1. the report and oral evidence of Dr Robertson does not establish that the dispensing of medicinal cannabis was harmful or ill-advised; 2. Ms Nicholson's evidence as to the alleged supply to one patient identified by the Pharmacy of multiple scripts on the same day was "plainly" unreliable; 3. Ms Nicholson's manner in evidence was very strongly suggestive of a witness advancing a preferred narrative, rather than that of a witness doing her best to answer the questions put to her; 4. Ms Nicholson was an intransigent and unimpressive witness. 1. The appellant emphasises that he does not seek as a function of the appeal to have a right to supply, possess, or manufacture any preparation, admixture or extract of a drug of addiction nor to possess or supply cannabidiol. Submissions of the Council 1. By way of high level summary, the Council submits that: 1. the appellant's alleged conduct is serious, both in his capacity as a proprietor and as a pharmacist. 2. the appellant failed to provide probative evidence to the Tribunal of the significant steps that he asserted the Pharmacy had taken to rectify the deficiencies identified in the PSU reports including a proper audit of the Pharmacy and evidence from the current manager of the Pharmacy; 3. the appellant demonstrated a lack of insight in relation to: 1. identifying red flags and safeguarding against inappropriate supply and potential diversion of cannabis medicines, including determining appropriate combinations and quantities of cannabis medicines were dispensed to patients; 2. understanding the key role that pharmacists play as gatekeepers to provide comprehensive safe care. 1. the appellant was at times combative and argumentative and failed to reflect in any meaningful way on the risks posed to the patients at the Pharmacy by the numerous and significant breaches of the PTG Act and PTG Regulation that therefore there was an unacceptable risk that the conduct the subject of the two PSU reports may continue. 1. In summary, the Council submits that: 1. the appeal application should be dismissed and the Tribunal should confirm the Council's decision to suspend the appellant's registration as pharmacist; 2. the need for the protection of the health and safety of the public and to take action in the public interest should take precedence; 3. the PRU reports, the appellant's response to the s 150 delegates and the evidence before the Tribunal will leave the Tribunal comfortably satisfied that it is appropriate that the appellant's registration be suspended and that the imposition of conditions does not mitigate the widespread and obvious risks. 1. While the Council submits that the appeal should be dismissed, it submits that if we were minded to set aside the Decision and make a new decision, it provided a form of conditions to be considered by the Tribunal. The appellant in reply 1. In summary, in reply the appellant submits: 1. if the Tribunal were to adopt the approach advocated by the Council it would be led into error, the Council's punitive approach not reflect the operation of the National Law, citing Medical Council of New South Wales v Lee [2017] NSWCA 282. 2. what must be carefully considered is whether a suspension is truly necessary or if the imposition of conditions would suffice to protect the public. In Knowles v Medical Council of NSW [2019] NSWCATOD 46, the Tribunal set aside the Council's suspension of a practitioner pursuant to s 150 and imposed conditions, stating at [51]: It may be that when proceedings are ultimately heard against the practitioner for unsatisfactory professional conduct, or even professional misconduct, the complaints against him may be dismissed. Even if the charges be established, the protection of the public may be achieved in the interim by the imposition of conditions. It must be borne in mind that the purpose of disciplinary proceedings under the National Law is protective rather than punitive. To suspend the appellant on a suspicion would result in the community being deprived of medical services by the appellant, and would result in the termination of his livelihood. Such consequences would be punitive, in circumstances where no trial of the issues has taken place. These are serious penalties indeed, especially when the success or failure of any future complaint, which might not be brought to the Tribunal for up to two years is unknown. 1. that the appellant's stay application was declined, and the reasons for that order can have no bearing on the determination of this appeal; 2. further, some of the Council's submissions are advanced despite the evidence adduced at the hearing: Dr Robertson's oral evidence did not assist the Council's attack upon dispensing of medicinal cannabis products at the Pharmacy and has been overlooked in the written submissions and Ms Nicholson's oral evidence was far from compelling; 3. some of the criticisms of the appellant that were articulated in the first and second PSU reports might reasonably be thought to have significantly less weight than first understood; 4. in determining this appeal, the Tribunal is to consider the application of s 150 in respect of the appellant's practice as a pharmacist. The Tribunal must consider whether it is presently necessary to take action for the protection of the health or safety of any person or persons; 5. since 7 December 2023, the appellant has been the subject of an order made by the PSU pursuant to cl 175(1) of the PTG Regulation, prohibiting him from supplying or having possession of, or manufacturing any preparation, admixture or extract of a drug of addiction, and an order pursuant to s 18AA of the PTG Act prohibiting him from possessing, or supplying cannabidiol. The appellant submits that these facts are important in determining whether the appellant's return to practice would adversely affect the health or safety of any person or persons (whether or not a particular person or persons) or otherwise not be in the public interest. 1. Finally, the appellant submits that he be permitted to return to practice with the following conditions placed on his registration: 1 Must not be pharmacist in charge; 2 To notify the pharmacist in change when he enters the pharmacy; 3 Not to possess, manufacture any preparation, admixture or extract, or supply drug of addiction (Schedule 8 drug) as defined by the Poisons and Therapeutic Goods Act 1966 (NSW); 4 Not to possess or supply the restricted substance cannabidiol; 5 To authorise and consent to any exchange of information between the respondent and Medicare Australia and Pharmaceutical Regulatory Unit for the purpose of monitoring compliance with these conditions; 6 To report to the PSU within 60 days of returning to practice any unaccounted for stock; 7 Category C supervision via one-hour fortnightly meetings (with communication with the supervisor by telephone or Video Link — and not to require in person meetings) with supervisor written reports provided to the Council quarterly; 8 Completion of Ethics and Dispensing in Pharmacy Practice course within 12 months; 9 Monthly self-audits of the management of Schedule 8 medications at the Pharmacy; and 10 The appropriate review body for the purpose of a review under s 163 -163C of the Health Practitioner Regulation National Law is the Pharmacy Council of NSW. 1. The appellant comments that the principal differences between the parties is the form of Category C supervision and the subject matter of a monthly audit. It is submitted that the Tribunal should not mandate face-to-face supervision meetings on every occasion and that fortnightly meetings and reporting every two months as required are, in all of the circumstances — which include the context of the PSU's oversight of dispensing via Safescript— appropriate. Consideration Introduction 1. The appellant was extensively cross-examined on a range of topics by Ms Petrie. 2. In her oral submissions Ms Petrie submitted that the appellant was very defensive during his cross-examination. We consider this to be expected; the appellant is after all a suspended pharmacist who is seeking to practise again. We would characterise the appellant's his oral as being forthright and direct manner. 3. We note that the appellant made appropriate concessions of his past conduct. 4. Ms Petrie asked the appellant questions about the identity of the prescribers who prescribed the cannabis medications, and the appellant's processes for identifying red flags with patients. It appears to us that the appellant had an appropriate understanding of both matters. 5. The appellant explained how he would ensure, if not dispensing himself, how his pharmacists would comply with all legislation standards for the dispensing of S8 medication, and the role of the new pharmacy manager in effecting this. 6. The appellant explained any dispensing attributed to him (after 7 December 2023) was not correct and that he was very conscious of not dispensing S8 medications. He said that there was no reason for him to dispense. 7. We see no reason not to accept that evidence. 8. We also note that we detected a tendency of the Council to emphasise the appellant's evidence to the Council in February 2024, and to put insufficient emphasis on the appellant's evidence to the Tribunal. Seriousness of the conduct 1. The first principal submission put by the Council as warranting a continuation of the appellant's suspension is the seriousness of the appellant's conduct the subject of the PRU/PSU reports, both as a pharmacist and a proprietor. 2. We agree that the appellant's conduct was serious, and had the appellant not recognised this to be the case, this would have been a matter favouring a continuation of the appellant's suspension. 3. But this was not the case, the appellant accepting the seriousness of his conduct; being appropriately contrite, demonstrating insight and satisfying us that, while his conduct was unacceptable, there were factors which went some way to explaining why the conduct occurred, but not excusing that conduct). These matters include the increase in cannabis dispensing and staff shortages. Failure to take steps to rectify deficiencies. 1. The second principal matter relied on by the Council is the failure to provide probative evidence of the steps the appellant has taken to rectify the deficiencies identified in the PRU/PSU reports. 2. We consider that this submission is overstated. The appellant has engaged with a mentor, Ms Marina Holt (a pharmacist and former member of the Council) to address the issues raised by the PRU and to ensure the suitability of the procedures at the Pharmacy. The appellant proposes to continue that mentorship over the next 12 months. 3. In addition, the appellant has employed additional pharmacists, a new pharmacy manager, and introduced new standard operating procedures for S8s and medicinal cannabis products have now been implemented. These procedures are summarised above. 4. While we would have been assisted by a statement of the new pharmacy manager, we are satisfied that the appellant has taken appropriate and adequate steps to address the identified deficiencies. 5. In short, we reject the Council's submission that the appellant has made no genuine attempt to fix the problems in the two PRU/PSU reports. Lack of insight 1. The third principal matter relied on by the Council is the appellant's lack of insight, particularly in relation to identifying "red flags", and having a sufficient and understanding of the key role that pharmacists play as gatekeepers to provide safe care. 2. Again, we consider this submission to be overstated, and overlooks the considerable additional education undertaken by the appellant. This includes listening to the four podcasts on the Council's website (namely Episode 1: the dangers of high-risk medications; Episode 2: Keeping the public safe — what pharmacists need to know; Episode 3: The importance of proprietor oversight; and Episode 4: Managing pharmacy workloads), which he has found very useful. 3. The appellant has also completed SafeScript NSW training modules 1 to 3, and completed the following courses related in medicinal cannabis namely: * Pharmacists Guide to Medicinal Cannabis; * TGA Guidance for Medicinal Cannabis Clinical Indications; * Appropriate Management of Medicinal Cannabis Patients; * Integrative Approaches in Chronic Pain Management; * The Risks and Benefits of Cannabinoids in Mental Health Patients; * Practical Considerations in Medicinal Cannabis Dosing: Cannabis has a high safety profile; * Exploring the Ethics of Medical Cannabis Practice; and, * Medicinal Cannabis Brand Substitution and Compounding Guidelines. Public adequately protected by conditions 1. As we have noted above, the essential question which a de novo s 159 hearing requires the Tribunal to address is whether allowing the practitioner to practise, or to practise with certain conditions, involves an unacceptable risk to the health and safety of the public, or otherwise involves an unacceptable risk to the public interest: Ghosh at [103]. 2. We do not consider that allowing the appellant to practise, including under conditions, poses an unacceptable risk to the public. 3. This is primarily because since 7 December 2023 the appellant has been the subject of an order made by the PSU pursuant to cl 175(1) of the PTG Regulation, prohibiting him from supplying or having possession of, or manufacturing any preparation, admixture or extract of a drug of addiction, and an order pursuant to s 18AA of the PTG Act prohibiting him from possessing, or supplying cannabidiol. 4. We accept the appellant's submissions that these facts are important in determining whether his return to practice would adversely affect the health or safety of any person or persons or otherwise not be in the public interest. 5. We are satisfied that there is a public interest in allowing the appellant to practise again under the conditions set out in Attachment A. Conclusion 1. For the above reasons, the appeal is allowed, the Decision is set aside and in lieu thereof we order that the conditions set out in Attachment A be placed on the appellant's registration. Costs 1. A timetable for submissions (and if necessary evidence) as to the costs of the appeal is included in our orders. 2. The Tribunal proposes to deal with the question of costs on the papers, and without a hearing. If either party opposes that course they should address that issue in their submissions. 3. Submissions are to be limited to five pages. Other 1. We note that the appellant also filed an appeal pursuant to s 159B of the National Law. 2. We assume that that appeal will no longer be pursued. If that is the case the appellant should inform the Registry as soon as possible, otherwise that appeal will be listed for directions. Orders 1. The Appeal Panel makes the following orders: 1. The appeal is allowed. 2. The decision of the Pharmacy Council of NSW of 16 February 2024 is set aside. 3. In lieu thereof the Tribunal orders that the conditions set out in Attachment A be placed on the appellant's registration. 4. Any party seeking costs is to file and serve submissions (and if necessary evidence), limited to 5 pages, within 14 days. The other party may respond within a further 14 days, and costs applicant may reply within a further 7 days. ********** ATTACHMENT A - Conditions (102163, pdf) I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales. Registrar DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 19 September 2024