Health Care Complaints Commission v Visvis [2020] NSWCATOD 87

Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Health Care Complaints Commission v Visvis [2020] NSWCATOD 87 Hearing dates: 13, 14, 15 July 2020 Date of orders: 31 July 2020 Decision date: 31 July 2020 Jurisdiction: Occupational Division Before: J Millbank, Senior Member J Zwart, Senior Member P Murney, Senior Member A Johnston, General Member Decision: (1) Pursuant to s 149C(1)(b) the registration of the practitioner as a pharmacist is cancelled; (2) Pursuant to s149C(7) the respondent may not apply for review of Order 1 for a period of two years; (3) The respondent is to pay the applicant's costs of these proceedings, as agreed or assessed; (4) Per s 64 of the Civil and Administrative Tribunal Act 2013 (NSW) an order of non publication and non disclosure of the patients listed in the schedule to the complaint and all other patients named in the evidence. Catchwords: TRADES AND PROFESSIONS – Pharmacy – Proprietor Pharmacist – multiple dispensing of Sch 8 medications on forged scripts – multiple dispensing of Sch 8 medications at improper intervals – failure to account for missing Sch 8 and 4D medications Legislation Cited: Health Care Complaints Act 1993 (NSW) Health Practitioner Regulation National Law (NSW) Poisons and Therapeutic Goods Act 1966 (NSW) Poisons and Therapeutic Goods Regulation 2008 (NSW) Cases Cited: Health Care Complaints Commission v Do [2014] NSWCA 307 Health Care Complaints Commission v Elliott [2018] NSWCATOD 47 Health Care Complaints Commission v Philipiah [2013] NSWCA 342 Health Care Complaints Commission v Sadek (No 2) [2018] NSWCATOD 90 Texts Cited: Pharmacy Board of Australia, Guidelines for Proprietor Pharmacists (2015) Australian Institute of Health and Welfare, Alcohol, Tobacco and other Drugs in Australia, Cat PHE 221 (2020) Category: Principal judgment Parties: Health Care Complaints Commission (Applicant) Louis Visvis (Respondent) Representation: Counsel: A Britt (Applicant) L Fermanis (Respondent)

Solicitors: Health Care Complaints Commission (Applicant) Conomos & Spinak Lawyers (Respondent) File Number(s): 2019/00400852 Publication restriction: Per s 64 of the Civil and Administrative Tribunal Act 2013 (NSW) an order of non publication and non disclosure of the patients listed in the schedule to the complaint and all other patients named in the evidence.

REASONS FOR DECISION

Background 1. Mr Visvis has been a registered pharmacist since 1991. Mr Visvis has owned the Terry White Chemmart (previously known as the Town Centre Pharmacy) in Kogarah since 2000 ('the pharmacy'). From 2012 to 2017 Mr Visvis also owned Terry White Chemist Merrylands. 2. The complaints concern the period from January 2014 to July 2016. The basis of the complaints against the practitioner principally concern his failures as a proprietor pharmacist to ensure oversight of the Kogarah pharmacy and to supervise his employee pharmacists to ensure that they were compliant with the Regulations governing the dispensing and supply of Sch 8 and Sch 4D medications. 3. The practitioner's wife was the retail manager of the pharmacy at the relevant time, and remains so. Mrs Visvis was unwell and was not working during the period October 2015 to July 2016. Mr Visvis took time off to care for his wife over the October 2015-July 2016 period and attended the pharmacy approximately weekly over that period. 4. Apart from the period of his wife's illness, Mr Visvis was present in the pharmacy in a managerial capacity at least two or three days every week. Mr Visvis was usually not rostered on as a pharmacist, although he worked in the dispensary on an ad hoc basis to relieve other staff. 5. On 1 June 2016 the Pharmaceutical Regulatory Unit ('PRU') began an investigation into Mr Visvis and the pharmacy as the result of information received from police in April 2016. The PRU attended the pharmacy on 1 June 2016 and issued notices under s 35 of the Poisons and Therapeutic Goods Act 1966 (NSW) relating to various Sch 4D and 8 drugs known to be targeted for misuse, undertook a stock count, and removed copies of the Sch 8 drug registers and copies of retained Sch 8 prescriptions. 6. The alleged breaches concerned dispensing at the pharmacy of over 50 forged prescriptions for Sch 8 opioid medications, mostly in the highest available strength, to a number of patients. Further breaches were alleged in relation to the supply of a number of Sch 8 and 4D medications at intervals which exceeded the prescribed dose. There was also a shortfall of almost 35,000 5mg tablets of diazepam and a number of unaccounted Sch 8 drugs identified at the time of the PRU audit. 7. The practitioner was the dispensing pharmacist on some of the relevant occasions, but dispensing on most occasions was conducted by his employee pharmacists. 8. In August 2016 the PRU invited four pharmacists who were employed at the pharmacy for an interview. Three pharmacists declined via correspondence sent by Mrs Visvis in her managerial capacity, and one did not respond. 9. In August 2016 the PRU outlined in a letter to Mr Visvis a number of areas of alleged non-compliance with the Poisons and Therapeutic Goods Regulation (PTGR). Mr Visvis declined to attend an interview with the PRU through his solicitors in August 2016. 10. At the end of October 2016 the Pharmacy Council of NSW (the Council) held s 150 proceedings. Mr Visvis made a written submission to that inquiry and attended a hearing. 11. As a result of the s 150 inquiry on 7 November 2016 the Council imposed conditions upon the practitioner's registration, including that he not practise as a pharmacist. Those conditions remained in place at the time of the current proceedings.

The Complaints 1. There are three Complaints. Complaint One and Two are that the practitioner is guilty of unsatisfactory professional conduct under s 139B(1)(a),(b) and/or(l); that is by virtue of conduct below the professional standard, in breach of the Health Practitioner Regulation National Law (NSW) (the National Law) or regulations, and improper or unethical conduct. Complaint 3 is of professional misconduct. 2. The ten particulars of Complaint 1 concern dispensing or permitting the dispensing of Sch 4, 4D and Sch 8 medications to eight patients in the relevant period. Particulars 1, 2 and 3 relate to the failure of the practitioner to ensure that the pharmacy dispensing practice complied with regulatory requirements in detecting and reporting forged prescriptions concerning Sch 8 drugs dispensed to Patients A, B, C and D, and failures of the practitioner to implement and monitor adherence to policies to detect and report forged prescriptions. Particulars 4, 5, 6 and 7 concern dispensing or permitting the dispensing of Sch 8 medications to Patients A, E, F and G at intervals that meant the quantities dispensed exceeded therapeutic standards and/or the stated dose in breach of cl 109 of the PTGR. Particular 8 concerns the dispensing or permitted dispensing of Sch 4 and 4D medications to Patient H at intervals which meant that the quantities dispensed exceeded therapeutic standards and/or the stated prescribed dose in breach of cl 54 of the PTGR. Particulars 9 and 10 concerns breaches of the Guidelines for Proprietor Pharmacists in failing to intervene to prevent breaches of cl 54 and cl 109 of the PTGR. 3. Complaint 2 concerns missing Sch 8 and 4D medications. The four particulars of Complaint 2 are that the practitioner was: unable to account for 34,993 Diazepam 5mg tablets received between 31 May 2014 and 1 January 2016; unable to account for 140 MS Contin 100mg tablets and three 200ml bottles of Ordine strength10mg/ml as at 1 June 2016, and that between 1 January 2014 and 1 January 2016 he failed to ensure that the drug register was kept in compliance with cl 113 of the PTGR. 4. The practitioner's reply to the Complaints dated May 2020 admitted the majority of the particulars and conceded unsatisfactory professional conduct under s 139B(1)(a), but continued to deny (b) and (l), (that is, a breach of the National Law and improper or unethical conduct) and denied the complaint of professional misconduct. On the morning of the hearing the practitioner admitted the remaining contested particulars, and conceded the two complaints of unsatisfactory professional conduct under s 139B(1)(b) and (l) as well as the third complaint of professional misconduct.

The Hearing and Issues 1. The Health Care Complaints Commission (HCCC) filed four bundles of evidence including materials from the s 150 proceedings and substantial documentary evidence of the pharmacy dispensing records, script copies, drug purchasing records and drug registers. The witnesses relied upon by the HCCC were Mr Paul Smith of the PRU and a peer expert, Dr Betty Chaar. The respondent's evidence included a statement of Mr Visvis dated June 2020, a statement of Ms Daisy Cheung an employee pharmacist of the pharmacy dated May 2020, the practitioner's CPD records, and various pharmacy records as well as revised policies and checklists from the pharmacy. 2. The hearing was conducted during COVID-19 restrictions, with both parties, one Tribunal member and all witnesses appearing via AVL. Dr Chaar, Ms Cheung and Mr Visvis gave oral evidence. 3. Without actually seeking to exclude the peer expert report by Dr Chaar, counsel for the respondent made vigorous and sustained objection to the independence of the expert and the opinions expressed in her report. 4. The HCCC sought an order cancelling the practitioner's registration with a non-review period of three years, and its costs of the proceedings. 5. The respondent initially sought a four month period of conditions including requiring 300 hours of supervision by the pharmacist in charge at the Kogarah pharmacy, and limiting him from holding the keys to the Sch 8 drug safe for 2 months, not dispensing Sch 4D or 8 drugs for 1 month, two external audits of Sch 4D and 8 medications in a six month period, and completion of CPD units and an ethics course within 12 months. By the end of the hearing the respondent conceded that supervision of his practice by a pharmacist in charge who was his own employee may not be appropriate to protect the public interest, and he proposed both a non-employee supervisor and a mentor be appointed under a revised set of conditions to be in place for 6 months and require 700 hours of supervision. 6. The issues are: * What, if any reliance, should be placed on the peer expert report? * Is the Tribunal independently satisfied that the complaints of unsatisfactory professional conduct and misconduct are made out? * What are the appropriate protective orders? * Costs.

Peer Expert 1. Dr Betty Chaar provided a peer expert report dated June 2019 in which she opined that the practitioner's conduct fell below that reasonably expected of a practitioner of equivalent training and experience. Dr Chaar's opinion addressed both the matters concerning Mr Visvis' dispensing, and the many occasions where the dispensing were done by his employee pharmacists. In her view Mr Visvis retained responsibility for the dispensing of the employee pharmacists because of the Guidelines for Proprietor Pharmacists issued by the National Board. 2. The Guidelines for Proprietor Pharmacists state: 1 Proprietors to maintain an active interest in how the pharmacy business is conducted If the proprietor/owner or partner-in-ownership pharmacist is not the pharmacist usually in charge of that pharmacy, he or she must vigilantly maintain an active interest in how the practice of pharmacy is being conducted. This is to ensure that the pharmacy operation is in accordance with: • any applicable state, territory or Commonwealth law • relevant Pharmacy Board of Australia policies, codes and guidelines • applicable professional practice and quality assurance standards and guidelines, and • good pharmacy practice. If the proprietor finds that the practice of pharmacy does not operate in accordance with these, he or she must intervene to ensure that the pharmacy business is conducted properly. 2 Proprietor pharmacists cannot delegate their professional obligations A proprietor/owner or partner-in-ownership of a pharmacy cannot delegate his or her professional obligations, even if that partner is not regularly present at the pharmacy. This applies to pharmacists who own a pharmacy, or pharmacies, in all forms of business structures. 1. In addition, Dr Chaar noted that the Pharmaceutical Society of Australia Code of Ethics for Pharmacists (2011, in force at the relevant time) states: Professional judgment must be exercised to prevent the supply of products likely to constitute an unacceptable hazard to health or the supply of unnecessary and/or excessive quantities of medicines or products, particularly those which had a potential for abuse or dependency. 1. That is, the professional responsibility of Mr Visvis to ensure compliance with the regulations and to prevent the unnecessary or excessive supply of hazardous medications adhered to him as a proprietor of the pharmacy, beyond his own acts of dispensing. 2. In relation to Patients A, E, F and G the expert was strongly critical of the conduct of the practitioner in dispensing or allowing to be dispensed quantities of Sch 8 (and in the case of Patient H Sch 4 and 4 D) medications at short intervals which meant that the patient was receiving medication in excess of the prescribed dose. Dr Chaar was also strongly critical of the failure of oversight and professional judgment shown by the practitioner concerning the lengthy and continuous periods that some of the patients had been dispensed high strength opioids given the addictive qualities of the medications and the patients' presenting conditions. 3. Dr Chaar was strongly critical of the practitioner's inability to account for the missing diazepam and opioids. 4. In relation to the supply of Sch 8 medications on forged prescriptions the expert was strongly critical of the failure of the practitioner to make contact with prescribing doctors to assess the validity of scripts. It was the practitioner's position that in some instances no check had been made because the patient was known to the pharmacy. In the case of Patient C, who was not known to the pharmacy, the pharmacy had received a phone call purporting to be from the prescriber. In numerous other instances the pharmacist undertaking subsequent dispensing assumed that the pharmacist who had first received a Sch 8 script from that patient had undertaken the appropriate checks. 5. Concerning Patient A, Dr Chaar opined that: From a pharmacist's perspective, there were many indications of forged prescriptions in the evidence provided. There were erratic and seriously close intervals for example that would have triggered alarm bells for most pharmacists and a prompt to investigate. Calling doctors/prescribers to verify quantities and purpose is a crucial step in the dispensing process involved in supply of a drug of addiction [Sch 8]. …Pharmacists should not dispense blindly, even though they might consider themselves familiar with the prescribers handwriting or prescribing habits. It is almost unthinkable to consider dispensing such [high strength, short interval] prescriptions without proper and documented investigation. Pharmacists have a very significant role in the oversupply of drugs of addiction in the community and should be vigilant, even suspicious at every presentation of a prescription for S8s. 1. Dr Chaar also expressed an opinion on a number of other matters, including commenting on the veracity of some of Mr Visvis' explanations to the s150 inquiry, and on the propriety of Mrs Visvis' role in forwarding correspondence from three of the employed pharmacists to the PRU. Those matters did not properly fall within the scope of an expert review, and we accept the submission of the Respondent that such commentary was speculative and should be entirely disregarded by the Tribunal. 2. The Respondent's attack on the expert, however, went well beyond this to a claim of lack of independence, apprehended bias and a failure by Dr Chaar to meet her obligations under s 30(3) of the Health Care Complaints Act 1993 (NSW) (HCC Act) by reason of not disclosing her relationship with Ms Cheung. 3. Ms Cheung was, and is, an employed pharmacist at the pharmacy and was on some occasions the dispensing pharmacist involved in matters that are the basis of some of the particulars of Complaint One. Ms Cheung was also employed for a period on a part time casual basis in the same University Department as Dr Chaar, and they worked directly together in 2018. When she enrolled in a postgraduate degree in March 2019 in the same faculty Ms Cheung was allocated Dr Chaar as a co-supervisor. In this capacity there were, on Dr Chaar's account one or two meetings supervisory between them, and on Ms Cheung's account 'regular' meetings, until August 2019 when Dr Chaar removed herself as a supervisor. 4. It was the evidence of both Dr Chaar and Ms Cheung that they had never discussed Mr Visvis, or the present proceedings, although Ms Cheung did make Dr Chaar aware that she had conditions imposed upon her own practice as a result of unintentionally dispensing forged scripts. 5. The HCCC commissioned Dr Chaar in a letter dated 18 January 2019. Dr Chaar's report is dated 14 June 2019. Thus Dr Chaar was Ms Cheung's colleague and appointed academic supervisor, and likely met with her on at least one occasion during the period she was writing her report. 6. It was Dr Chaar's evidence that she did not 'connect' the Ms Cheung she knew with the name of a pharmacist which appeared in the dispensing records provided to her by the HCCC. Once she made the connection, in August 2019, she terminated the supervisory relationship. 7. The respondent submitted that the Tribunal should doubt the credit of Dr Chaar concerning the above. We see no basis upon which to do so. 8. Section 30(2) of the HCC Act states that the HCCC 'may not' obtain a report from an expert with a financial connection to the health practitioner against whom a complaint is made. Section 30(3) requires that a person giving an expert report 'must include in it, or annex to it, a statement in the following form, completed as appropriate: I have/do not have a personal, financial or professional connection with the person against whom the complaint is made. Particulars of the connection are as follows…' Taken together the provisions of s 30 suggest that the HCCC may engage an expert who does have a personal or professional connection with subject of complaint as long as that connection is disclosed. 9. The respondent called for the statement of personal, financial and professional connection made by Dr Chaar under s 30(3) of the HCC Act which was duly produced by the HCCC. Dr Chaar completed this form on 14 June 2019.The declaration form directed the person completing it to indicate that they 'have/do not have' a personal, financial and/or professional connection with Mr Louis Visvis. 10. It was the HCCC's position that Dr Chaar's obligation was to report upon details of her connection with Mr Visvis and as she had no direct connection with him this obligation was satisfied. 11. In the context of proceedings under the National Law it is not uncommon for peer experts, and indeed professional members of the Tribunal, to have some past professional experience of a party or a witness, or of those associated with them such as employees or collegiate connections through professional associations. Disclosure of such connection is important as it allows the extent of any real or perceived conflict of roles or interests to be examined. Arguably, a professional relationship with someone who was an employee of the practitioner at the time of the complained of conduct, or at the time of the proceedings, could constitute a 'connection' in the broad sense, although it is unlikely that such a broad meaning was contemplated by the Act. However, we have accepted Dr Chaar's evidence that she was unaware of this connection at the time she made the declaration. 12. Examining the connection now, the Tribunal is not convinced that it is such as to cause a reasonable apprehension of bias in the mind of the respondent or the public. Dr Chaar was a witness for the applicant and Ms Cheung a witness for the respondent. There was no discussion of the proceedings or the respondent's conduct. Dr Chaar was not called upon to form any opinion of the conduct of Ms Cheung or any of the employee pharmacists, nor could her professional knowledge of Ms Cheung be seen to have influenced the opinions she was called upon to form concerning Mr Visvis' conduct. There was no question, for example, of Mr Visvis seeking to exculpate himself by inculpating Ms Cheung. 13. Furthermore, having admitted that the conduct was below the standard reasonably required, and that it was so serious as to amount to misconduct, it is hard to see what end the respondent's attack on the peer expert's report could ultimately serve. In any event, the Tribunal as a specialist body with expert professional knowledge, is entitled to form its own view. While we have discounted the opinions of the peer expert which fell outside of the proper role of an expert witness, we concur with her strong criticism of the practitioner's conduct and adopt the criticisms cited from the report above.

Unsatisfactory Professional Conduct 1. The Tribunal is independently satisfied that the complaints of unsatisfactory professional conduct are made out. 2. As proprietor pharmacist Mr Visvis was responsible for the adherence to regulations concerning the dispensing of Sch 8 and 4D medications. Mr Visvis had direct knowledge of the high strength and increasing volume of Sch 8 medication being dispensed by the pharmacy at the relevant time. The practitioner's failure to ensure that the dispensing of every Sch 8 script was in adherence to the requirement that the dispenser be familiar with the doctor or patient, both in his own dispensing and that of his employees, was very serious. 3. Recollecting Mr Visvis' evidence that in the case of Patient A and C various pharmacists dispensing forged scripts had 'assumed' that the 'first' pharmacist to dispense had made the proper checks by contacting the prescribing doctor directly, we reject the practitioner's claim that this was 'not common practice' at the pharmacy. Such failures were not isolated but occurred over a considerable period. We find that it was systemic in the sense that for a number of the patients multiple pharmacists did not personally make the proper checks before dispensing Sch 8 medications. 4. Despite, on his own evidence, having put in a third Sch 8 drug safe to cope with demand for opioids in 2016, and issuing an average of 7 Sch 8 scripts per day, the practitioner was not alert, and did not ensure that his employees were alert, to risk factors for opioid misuse and fraud such as: private scripts for PBS medications, high volume and high strength opioids, and inappropriately short intervals between supply. 5. Patient C, for example, was supplied with 5 boxes or 25 Durogesic (fentanyl) 100mcg patches on a private script. Such patches are prescribed for use over a three day period, so this was a 75 day supply of a high strength opioid. One fentanyl 100mcg transdermal patch applied every three days is the equivalent of 300mg of morphine orally daily. Approximately sixty days later Patient C was again supplied by the pharmacy with another 25 patches. 6. This last supply occurred in July 2016, i.e. several weeks after the PRU had visited the pharmacy and seized the Sch 8 register, so the practitioner was well and truly on notice that there were issues with the pharmacy dispensing practices concerning Sch 8 medications. In his written statement to the s 150 inquiry in October 2016 the practitioner stated that 'the moment the investigation came to light on 1 June 2016, I immediately took action to make appropriate changes to our policies, procedures and practices…' That 'immediate action' did not prevent at least two further dispensings that were particularised in the Complaint. 7. When questioned by the Tribunal the practitioner conceded that he was unable to think of any appropriate clinical indication for the continuous use of such high strength fentanyl over such a time period as occurred with Patient C. 8. Nor did the practitioner exercise appropriate professional judgment to question the continuous supply of high strength opioids over several years to patients who were long term customers of the pharmacy such as Patient G, E and H for chronic pain associated with old injuries and migraine. The practitioner claimed that Patients G and E had never presented themselves as intoxicated or shown any signs of drug toxicity when in the pharmacy, but he also characterised them both as highly tolerant to opioids and acknowledged in response to questions from the Tribunal that this meant they were unlikely to exhibit such signs. The practitioner claimed to have been in regular contact with prescribing doctors for both Patient G and E but presented no evidence of file notes or records of these inter-professional consultations. 9. Concerning Patients A-G the failures in Complaint 1 were both below the professional standard and involved breaches of the regulations. Concerning Patient H, the practitioner's conduct was also improper and unethical. 10. Patient H was a long-term customer of the pharmacy. The practitioner had direct knowledge of this patient and dispensed to him on many occasions. Patient H was being medicated for a schizoaffective disorder and was also regularly prescribed large quantities of paracetamol 500mg/codeine 30mg (Panadeine Forte, a Sch 4 medication) and diazepam 5mg. Patient H was unable to manage his financial affairs and was subject to a financial management order. 11. In his written statement the practitioner characterised Patient H as, 'addicted to both Codeine and Diazepam' and noted that the patient had informed him of consumption of 8 to 10 tablets of Panadeine Forte and between 5 to 9 tablets of diazepam per day. While the practitioner claimed to have counselled the patient in relation to the risk of damage to his liver from the paracetamol he produced no file notes or documentary evidence of these discussions; nor, he conceded, did he ever raise the risks of codeine dependence with the patient. Mr Visvis could not recall what malady the Panadeine Forte was being prescribed to treat. 12. Pharmacy records relied upon by the peer expert indicate that between January 2014 and November 2016 the pharmacy supplied Patient H with 4,550 diazepam and 8,400 Panadeine Forte. Panadeine Forte was dispensed in amounts of up to 240 tablets at a time, and diazepam up to 150 tablets at a time. Mr Visvis was the dispensing pharmacist on a number of those occasions. 13. Despite the large quantities, and long term use of an addictive substance such as Codeine, by a patient with impaired capacity, Mr Visvis never contacted the prescribing doctor to discuss the appropriateness of this medication regime. To his credit, Mr Visvis readily conceded in questioning by the Tribunal that this was what he ought to have done. 14. In his written statement Mr Visvis claimed that, 'As a result of [Patient H's] inability to self-manage, the pharmacists and I decided to stagger supply…'. Mr Visvis stated that this was to protect the health of Patient H and to prevent staff from being harassed 'as he was continually presenting himself to the staff claiming that he ran out of medicine.' In oral evidence Mr Visvis clarified that this process involved dispensing the medication on the script and then bagging it in smaller quantities which were held at the dispensary counter and provided by 'the girls' (the employed pharmacists) to Patient H over some time. 15. In oral evidence Ms Cheung denied that she had any part in the decision to 'stagger' supply or that she was involved in providing the bagged supply, although she did not deny that this practice occurred. Ms Cheung was restrained but generally direct in her evidence, and the Tribunal prefers it to that of Mr Visvis when they are in conflict. 16. The Tribunal finds that the 'staggered' supply of medication to Patient H occurred at the behest of Mr Visvis, that it was both improper and grossly unethical as a practice and did not prioritise the patient's health or respect the patient's informed choice of provision of healthcare. 17. When asked by the Tribunal to reflect on what was inappropriate in this course of conduct, Mr Visvis struggled for a reply but did finally acknowledge that it was a breach of patient autonomy, and that the better course would have been to consult the prescribing doctor and perhaps even NSW Health about the patient's needs. 18. Concerning Complaint 2, the Tribunal is satisfied that the conduct was below the professional standard, in breach of the regulations and improper and unethical. The missing drugs were all drugs of addiction and prone to misuse. The explanations given by the practitioner concerning the nearly 35,000 missing diazepam are inconsistent and implausible. The practitioner offered no explanation in his written statement for the missing Sch 8 drugs, which should have been secured in the pharmacy drug safe. 19. At the end of October 2016 Mr Visvis wrote to the s 150 inquiry that the loss of the diazepam was of minimal financial value and 'therefore went unnoticed by me'. Mr Visvis also claimed that large quantities of diazepam were present in the pharmacy as a result of bulk orders placed on the first of each month. 20. This volume of diazepam equated to approximately 700 boxes of 50 tablets, disappearing at the rate of one box per day over the relevant period. 21. Mr Smith's report notes that there were 82,150 diazepam received during the period. In the s 150 hearing the delegates noted that this amounted to 42 per cent of that stock line unaccounted for. When asked in the s 150 hearing what steps he had taken to resolve the discrepancy, Mr Visvis said he had 'had a look' for them in the stockroom but didn't find them. At that point Mr Visvis said, 'I've got theories but I haven't got proof' about what had occurred. Mr Visvis was asked for his theory and replied, Well – at-at-at the-at some stage, we had a lot of out-of-date stock, we had a lot of credits, especially when that vitamin – big vitamin buy-up for the last two years and we used to put dispensary – an excess dispensary stock in the storeroom. And I got a gut feeling that my wife has thrown them out. 1. Mr Visvis clarified that by 'thrown out' he meant in RUM bins. He did not state that he had actual knowledge that this was what occurred or that it was based on information from Mrs Visvis or any other person, rather that it was his 'only theory.' It was a mess. There was a lot of out-of-dates, a lot of this, and I've got a suspicion that, you know, there's a chance she's confused stuff and threw it out….that's the only theory that I have at this stage. I don't have any other theory. 1. Delegates at the s 150 hearing queried whether all 700 boxes could have been in the storeroom at one time and Mr Visvis stated that they 'could have been in the credit tubs'. When queried about the unlikelihood of diazepam going out of date, Mr Visvis stated that it could have been confused with out of date stock. 2. Despite the fact that Mr Visvis claimed no actual knowledge of what had occurred, he continued to state that it was likely or possible that the diazepam had been thrown out. When questioned about the possibility of misuse he responded, I don't believe it went into the community. I truly believe there's more – you know, more possibility it was thrown out rather than actually entering the community. 1. In his written statement and in oral evidence Mr Visvis restated his claim that the diazepam had mostly been ordered in bulk at the beginning of each month (a task which was delegated to Mrs Visvis at the relevant time). This account was contradicted by Ms Cheung, who stated that all of the pharmacists placed orders for diazepam, and by the ordering records of the pharmacy. 2. The pharmacy ordering records in evidence indicate that diazepam was ordered in varying quantities, frequently, and at irregular intervals, in addition to the usual first of the month order, over the relevant period. There is no basis to conclude, and we suggest no basis for Mr Visvis ever to have theorised, that this huge quantity of diazepam came into the pharmacy through erroneous over-ordering in bulk, or that it then came to be placed in bulk in the storeroom. 3. In his June 2020 written statement Mr Visvis stated, After the PRU examination of [the pharmacy] dispensary and stock data [Mrs Visvis] and I conducted an internal investigation into the stock discrepancies. This was when I discovered that credits were not being executed and task were not being completed. The most important discovery was that credits were not being acquired for stock that needed to be returned for credit to the suppliers. …The stock was bagged and left in the storeroom. On the odd occasion when [Mrs Visvis] visited the store [during the period October 2015 to June 2016] she questioned [the stock manager] about these bagged item credits and tried to tidy the storeroom. Unfortunately, by the time [Mrs Visvis] had noticed these bagged credits the period in which to obtain a credit for the majority of this stock had passed and much of the stock had to be thrown out. 1. Mr Visvis then related a conversation with the stock manager said to have occurred in November 2016 in which the stock manager stated to him that she had been accumulating excess dispensary stock in the storeroom, and that she had seen Mrs Visvis in the period December 2015 to April 2016 periodically attending the pharmacy and throwing excess dispensary stock from the storeroom into the RUM bins. This was followed by a conversation said to have occurred in November 2016 between Mr and Mrs Visvis in which Mr Visvis claims his wife stated, On a number of occasions I disposed of a large number of bagged items that had cluttered the storeroom. I was of the view that the bags contained out of date stock that the pharmacy had been credited for. 1. The difficulties with this account are manifold. There is no reasonable explanation for how 700 boxes of a Sch 4D drug came to accumulate in the storeroom and yet still continue to be periodically ordered, sometimes five or six times a month. There is also the inexplicable prescience by which Mr Visvis could have had a theory in October that his wife had disposed of the stock, before having this confirmed to a month later by a third party, and then by his wife. 2. In oral evidence Mr Visvis could not recall which month his and his wife's joint 'investigation' into the missing stock occurred, but he conceded that it most likely occurred after receiving the PRU letter (in July 2016) and his attending the s 150 hearing (in late October). Both Mr and Mrs Visvis were back at work by this time, and on Mr Visvis' account to the s 150 hearing had acted to immediately rectify the identified flaws in the pharmacy practice. This is inconsistent with him not having discussions with Mrs Visvis and the stock manager about the missing stock until November, after the s 150 hearing. 3. Another difficulty is that neither Mrs Visvis nor the stock manager provided evidence of the conversations which Mr Visvis purported to relay. Mr Visvis stated that he had received medical advice from his wife's doctors that she should not give evidence, but that medical advice was also not in evidence. Mrs Visvis returned to work in July 2016 and is currently the full-time manager of the pharmacy. The stock manager remained in her role for a further two years and yet was never asked to provide a statement concerning what occurred. 4. The Tribunal is entitled to draw, and does draw, an adverse inference from the failure to call evidence from the two witnesses whom Mr Visvis claims could provide the 'most likely' account of what occurred to the diazepam. 5. Under cross examination Mr Visvis did concede that it was possible that the diazepam could have ended up in the community but stated that he had only become aware that there is a 'black market' or illicit demand for Diazepam and MS Contin since the investigation. Mr Visvis also stated that he was unaware of the shelf life of diazepam. 6. The Tribunal returned to these issues with Mr Visvis, and asked how he could be unaware of the black market in benzodiazepines and opioids after some 25 years in practice as a pharmacist. He stated that he had been aware of 'problems' with the misuse by drug dependent members of the public of illicit use of temazepam 5mg and Endone 5mg, but not diazepam 5mg or MS Contin or OxyContin 100mg until 'someone told him' about it during the investigation. 7. The practitioner's failure to account for a such a substantial quantity of missing Sch 4D, and a quantity of Sch 8 medications, combined with his failure to demonstrate any real effort to identify whether there had been theft or misappropriation, or any understanding of the risks that such misappropriation would entail to the health and safety of members of the public, is very concerning. In our view these failures involve such a profound neglect of the practitioner's professional responsibilities and ethical duties that they amount to improper and unethical conduct, over and above being conduct below the professional standard and conduct in breach of the regulations.

Professional Misconduct 1. The gravity and repetition of the practitioner's unsatisfactory professional conduct taken together amounts to professional misconduct. This includes the conduct below the professional standard involved in failing to ensure compliance with the Sch 8 dispensing regulations, and in allowing high quantities of opioids to be dispensed on forged scripts and in excessive quantities on legitimate scripts, to a number of patients over a lengthy period. These were non-delegable responsibilities which inhered in the practitioner as proprietor of the pharmacy. 2. The improper and unethical conduct in unilaterally intervening in the supply of Sch 4 and 4D medications to an impaired patient whom the practitioner believed to be drug dependent, as well as in failing to account for missing Sch 4D and Sch 8 medications, taken together also demonstrate such gross disregard of professional standards as to amount to professional misconduct. 3. The danger to the health and safety of the public posed by the improper use of prescription drugs, in particular by opioids and benzodiazepines is very high. The findings of this Tribunal, and current evidence in the public domain, suggests that this hazard is increasing, with more deaths in Australia caused over the past decade by misuse of prescription drugs than illicit drugs: Health Care Complaints Commission v Sadek (No 2) [2018] NSWCATOD 90 [46]. The most recent web report from the Australian Institute of Health and Welfare on Alcohol, Tobacco and other Drugs in Australia, Cat PHE 221 (2020) notes that: The non-medical use of pharmaceutical drugs is an increasing public health problem in Australia, with evidence suggesting increasing prevalence of misuse and associated harms including mortality. The rate of dispensed prescriptions for pharmaceutical opioids [controlled for population] has been climbing—up 11% between 2012–13 and 2016–17. … Between 2009 and 2018, the number of deaths where benzodiazepines were present rose by 70%. … Between 2013–14 and 2017–18, benzodiazepines and other sedatives and hypnotics (excluding alcohol) continued to result in more drug-related hospital[isations] than opioids. 1. As noted in Health Care Complaints Commission v Elliott [2018] NSWCATOD 47 [55], 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. 1. Any sense of shared responsibility with medical practitioners, or exercise of individual clinical judgment, to protect patients and the public from the risk of oversupplied or illicit opioids and Diazepam was utterly lacking in the practitioner's practice.

Protective Orders 1. The respondent's case was that the practitioner had 'bitten off more than he could chew' at the relevant time. Mr Visvis was running two pharmacies, one of which was struggling financially, and was caring for his wife who was undergoing treatment for a serious illness. As a result, he 'spread himself too thin' and paid insufficient attention to the running of and dispensing practices at the Kogarah pharmacy. 2. Counsel for the respondent submitted that Mr Visvis had made candid admissions and was in essence a capable pharmacy practitioner who had a period of carelessness. The practitioner had kept up his CPD in excess of the required level for the past four years, and he had suffered financially and professionally through a prolonged period in which he had been unable to practise. Counsel submitted that the practitioner should be permitted to practise subject to conditions. 3. The HCCC submitted that the Tribunal could not be satisfied that the conduct would not recur, on the basis that the practitioner had done so little to ensure compliance with statutory requirements, standards and guidelines in the past and his tendency to explain the failures of compliance as human mistakes. It was the HCCC submission that the practitioner had demonstrated very little insight into the seriousness of the admitted conduct. 4. The HCCC submitted that the public protection goals enunciated by the Court of Appeal in Health Care Complaints Commission v Do [2014] NSWCA 307 [35] required a strong message of general deterrence to the profession to ensure that proprietor pharmacists adhere to their professional and ethical responsibilities and do not sacrifice them out of pecuniary considerations or laziness. 5. Further, the HCCC submitted that the practitioner's CPD and training since the time of the events was in the nature of general education to maintain registration (although acknowledged to be in excess of the required points) and did not address the areas of particular areas of deficiency such as dispensing practice, the maintenance of drug registers, or an ethics course. Mr Visvis' evidence that he was waiting to do the most 'current' and up to date ethics course should be disregarded as self-serving given the standards and regulations on ethical dispensing of Sch 8 drugs are unchanged in recent years. 6. The HCCC submitted that the Tribunal does not have before it solid and substantial grounds for conclusion that the practitioner's standards have changed since the time of the events or that he will act differently in the future. 7. The Tribunal accepts the HCCC submissions. The matters are very serious and occurred over a considerable period. They involved the practitioner's own dispensing, his failures of supervision of other less experienced pharmacists who were his employees, and the management of restricted medications held within his pharmacy. The practitioner demonstrated belated contrition, and little insight. 8. The practitioner sought to minimise his responsibility by painting himself as rarely present in the pharmacy, rarely working as a pharmacist, and absent for a prolonged period during his wife's illness. However it is clear that: many of the matters complained of predate Mrs Visvis' illness, the practitioner was regularly present in the pharmacy, he was closely involved in overseeing the overall workings of the pharmacy, and personally dispensed in some of the complained of matters. When pressed under cross examination Mr Visvis described himself as 'a silly man'. 9. In essence, the practitioner fell back on claims of naiveté, delegation and distraction. As a very experienced pharmacist, who had at the time of events been registered for 25 years, and who had also been a proprietor pharmacist for many years, Mr Visvis' account of his own conduct is at best woefully inadequate and at worst disingenuous. 10. Even if the practitioner's account were to be accepted in its entirety, it would raise serious doubts about the practitioner's commitment to professional standards in the face of commercial pressures. 11. The Tribunal has grave doubts as to Mr Visvis' candour concerning his professed account of his search for, and theory of, the missing medications. We reject as false the sworn testimony of the practitioner that he was unaware at the time that such medications were liable to misuse. This, in turn, causes the Tribunal concern for the trustworthiness and professional integrity of the practitioner in the longer term. 12. In light of all of our findings, we do not consider that conditions or a period of suspension could offer sufficient protection to the health and safety of the public. Cancellation of registration is the only appropriate order. 13. The setting of a non-review period can signal to the profession and the public the seriousness with which professional misconduct is judged, and also gives guidance to the practitioner on the period of time which the Tribunal believes will be necessary in order for them to demonstrate rehabilitation and/or remediation from which to base a possible application for review to return to practice. 14. The Tribunal concludes that public and professional confidence, as well as public safety, require a period of reform and rehabilitation, and we set that as a period of two years.

Costs 1. Mr Fermanis for the respondent submitted that there should be a reduction in the costs awarded to the HCCC on the basis that the proceedings: involved delay including an earlier expert report that was not proceeded with; that the HCCC had abandoned one particular, and amended the dates in another to accord with the dates which had always been advanced by the respondent, and that the respondent had largely admitted the complaint in his June 2020 reply. 2. The HCCC sought its full costs based upon its success in the proceedings. Mr Britt noted that the costs sought were costs of the proceedings and so did not include costs of the expert report which was not utilised. Mr Britt submitted that the withdrawal of one particular and change of date in another made no difference to the length of proceedings and could not be seen to amount to a partial success in the respondent's case or any other form of disentitling conduct as contemplated by Health Care Complaints Commission v Philipiah [2013] NSWCA 342 [42]-[46]. 3. The Tribunal accepts the submissions on behalf of the HCCC concerning costs and finds that there was no disentitling conduct or partial success such as to reduce the award of costs.

Orders 1. Pursuant to s 149C(1)(b) the registration of the practitioner as a pharmacist is cancelled; 2. Pursuant to s149C(7) the respondent may not apply for review of Order 1 for a period of two years; 3. The respondent is to pay the applicant's costs of these proceedings, as agreed or assessed; 4. Per s 64 of the Civil and Administrative Tribunal Act 2013 (NSW) an order of non publication and non disclosure of the patients listed in the schedule to the complaint and all other patients named in the evidence.

********** 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: 31 July 2020