Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Health Care Complaints Commission v Negus [2021] NSWCATOD 50 Hearing dates: 1 – 3, 5 March 2021 Date of orders: 4 May 2021 Decision date: 04 May 2021 Jurisdiction: Occupational Division Before: O Shub, Senior Member P McAsey, Senior Member J Zwart, Senior Member Honorary Associate Prof P Macneill, General Member Decision: (1) The Respondent is guilty of unsatisfactory professional conduct and professional misconduct in respect of his behaviour while working as a registered pharmacist. (2) Had the Respondent been a registered pharmacist, the Tribunal would have cancelled his registration with immediate effect. (3) The Respondent shall not be entitled to apply for registration as a pharmacist for a period of one year from the date of this order. (4) The Respondent shall pay one third of the Applicant's costs as agreed or assessed. Catchwords: HEALTH — professional registration and discipline —— complaints — pharmacist — keeping of Schedule 8 drugs — failure to maintain dangerous drugs register — dispensing on improper prescriptions 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: Briginshaw v Briginshaw (1938) 60 CLR 336; [1938] HCA 34 Bronze Wing International Pty Ltd v SafeWork NSW [2017] NSWCA 41 Clyne v The New South Wales Bar Association (1960) 104 CLR 186; [1960] HCA 40 Health Care Complaints Commission v Do [2014] NSWCA 307 Health Care Complaints Commission v Duggan [2015] NSWCATOD 142 Health Care Complaints Commission v Meneghetti [2020] NSWCATOD 39 Health Care Complaints Commission v Philipiah [2013] NSWCA 342 Lee v Health Care Complaints Commission [2012] NSWCA 80 Prakash v Health Care Complaints Commission [2006] NSWCA 153 Texts Cited: Nil Category: Principal judgment Parties: Health Care Complaints Commission (Applicant) John Negus (Respondent) Representation: Counsel: A Petrie (Applicant) R Withana (Respondent) Solicitors: Health Care Complaints Commission (Applicant) Wotton & Kearney (Respondent) File Number(s): 2020/00212423 Publication restriction: Prohibition of the disclosure of the name of any patient referred to in the Complaint under section 64(1)(a) of the Civil and Administrative Tribunal Act 2013 (NSW). REASONS FOR DECISION 1. The reasons for the complaint brought by the Applicant appear from the amended Complaint lodged with the Tribunal under Case No. 2020/00212423 and dated 11 March 2021. The Complaint The Health Care Complaints Commission of Level 13, 323 Castlereagh Street, Sydney NSW, having consulted with the Pharmacy Council of New South Wales in accordance with sections 39(2) and 90B(3) of the Health Care Complaints Act 1993 and section 145A of the Health Practitioner Regulation National Law (NSW) ("the National Law") laid a Complaint against Mr John Negus ("the practitioner") of 58/29 Brunswick Rd Terrigal, New South Wales, being a pharmacist previously registered under the National Law, [who] was first registered to practise as a pharmacist on 8 June 1971. BACKGROUND In about 2012, the practitioner commenced employment as the pharmacist in charge at Erina Heights Chemist Outlet situated at 375 The Entrance Road, Erina Heights in the State of New South Wales ("the Pharmacy"). From 1 January 2017 to 3 September 2018, the practitioner was one of two pharmacists in charge at the Pharmacy working ordinarily 2 days per week as the sole pharmacist working. On 10 September 2018, the Pharmaceutical Regulatory Unit ("PRU") inspected the Pharmacy. On 13 September 2018, the PRU submitted a complaint to the Pharmacy Council of New South Wales. COMPLAINT ONE The Pharmacist is guilty of unsatisfactory professional conduct under section 139B(1)(a) and (I) of the National Law in that the practitioner has: i. engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or ii. engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy. PARTICULARS OF COMPLAINT ONE 1. Between 1 January 2017 and 3 September 2018, the practitioner was one of two pharmacists in charge at the Pharmacy, during which time large numbers of drugs of addiction were unaccounted for and were possibly lost, stolen or diverted including as follows: a) Mayne Pharma oxycodone 5mg (20 tablets pack) – 5,000 tablets; b) Kalma 0.5mg (alprazolam) (10 tablets pack) – 100 tablets; c) Kalma 0.5mg (alprazolam) (50 tablets pack) – 100 tablets; d) Kalma 0.25mg (alprazolam) (50 tablets pack) – 250 tablets; e) Kalma 1mg (alprazolam) (50 tablets pack) – 300 tablets; f) Kalma 2mg (alprazolam) (50 tablets pack) – 250 tablets; g) Alprax 2mg (alprazolam) (50 tablets pack) – 50 tablets; h) Oxycodone Sandoz 10mg (28 tablets pack) – 1,036 tablets; i) Oxycodone Sandoz 20mg (28 tablets pack) – 140 tablets; and j) Endone 5mg (oxycodone) (20 tablets pack) – 4,820 tablets. 2. Between 1 January 2017 and 3 September 2018, the practitioner was one of two pharmacists in charge at the Pharmacy, during which time proper records of drugs of addiction were not maintained in the dangerous drugs register contrary to Clause 56 of the Poisons and Therapeutic [Goods] Regulation 2008 (NSW) ("PTGR"), including as follows: a) Mayne Pharma oxycodone 5mg (20 tablets pack) – 5,000 tablets; b) Kalma 0.5mg (alprazolam) (10 tablets pack) – 100 tablets; c) Kalma 0.5mg (alprazolam) (50 tablets pack) – 100 tablets; d) Kalma 0.25mg (alprazolam) (50 tablets pack) – 250 tablets; e) Kalma 1mg (alprazolam) (50 tablets pack) – 300 tablets; f) Kalma 2mg (alprazolam) (50 tablets pack) – 250 tablets; g) Alprax 2mg (alprazolam) (50 tablets pack) – 50 tablets; h) Oxycodone Sandoz 10mg (28 tablets pack) – 1,036 tablets; i) Oxycodone Sandoz 20mg (28 tablets pack) – 140 tablets; and j) Endone 5mg (oxycodone) (20 tablets pack) – 4,820 tablets. 3. Between 1 January 2017 and 3 September 2018, the practitioner was one of two pharmacists in charge at the Pharmacy, during which time proper records of drugs of addiction were not maintained in the dangerous drugs register contrary to Clause 56 of the PTGR, including as follows: a) There was no record for Biodone liquid where there was a small amount stored at the Pharmacy (approximately 10mls); b) The stock balance of Kalma 250mcg tablets was incorrect, showing 210 tablets when the actual balance was 220 tablets; c) The stock balance of Norspan 40mcg patches was incorrect, showing nil patches when the actual balance was 2 patches; d) The stock balance of Oxynorm 10mg capsules was incorrect, showing 40 capsules when the actual balance was 20 capsules; e) The stock balance of Targin 5mg/2.5mg tablets was incorrect, showing 196 tablets when the actual balance was 152 tablets; f) The stock balance of Suboxone 8mg films was incorrect, showing 349 films when the actual balance was 105 films; and g) The stock balance of Subutex 8mg tablets was incorrect, showing 126 tablets when the actual balance was 98 tablets. 4. On 9 December 2016, the practitioner entered 140 tablets of Oxycodone into the dangerous drugs register without a corresponding invoice contrary to Clause 112 of the PTGR. 5. On 28 September 2017, the practitioner made incorrect entries into the dangerous drugs register contrary to Clause 112 of the PTGR for Oxycodone SZ 10mg modified release. 6. On and before 24 August 2018, the practitioner failed to appropriately store the drug of addiction Ritalin at the Pharmacy that had been dispensed for Patient A. 7. On and before 24 August 2018, the practitioner failed to appropriately store the drug of addiction Targin at the Pharmacy that had been dispensed for Patient B. 8. On and before 24 August 2018, the practitioner failed to appropriately store the drug of addiction Targin at the Pharmacy that had been dispensed for the recently deceased Patient C. 9. The practitioner failed to undertake accurate stock checks as required by Clause 118 of the PTGR for drugs of addiction at the Pharmacy as follows: a) in March 2017; b) in September 2017; c) in March 2018; and d) in September 2018. 10. Between 1 January 2017 and 3 September 2018, the practitioner did not change his password to the electronic dangerous drugs register, knowing it was accessible by others at the Pharmacy. 11. The practitioner dispensed and supplied drugs of addiction at the Pharmacy where the prescriptions were invalid contrary to Clause 80 of the PTGR as follows: a) On 24 January 2018, Endone 5mg 20 tablets for Patient D; b) On 30 March 2017, Endone 5mg 20 tablets for Patient E; c) On 22 March 2017, Oxycodone SZ MR 5mg 28 tablets for Patient F; and d) On 17 May 2017, Oxycodone SZ MR 5mg 28 tablets for Patient F. 12. On 8 December 2014, the practitioner dispensed and supplied the prescribed restricted substance Sildenafil 50mg 12 tablets with 2 repeats to Patient G in excess of what was prescribed, being Sildenafil 25mg 4 tablets with 5 repeats. 13. On 11 May 2017, the practitioner dispensed and supplied the prescribed restricted substance Sildenafil 100mg 72 tablets to Patient H in a quantity, or for a purpose, that did not accord with the therapeutic standard of what was appropriate in the circumstances contrary to cl 54 of the PGTR. 14. Prior to 6 September 2018, the practitioner whilst working at the Pharmacy did not secure blank prescription pads in the Pharmacy that had been provided to the practitioner for the purpose of shredding or appropriate disposal. 15. On or about 4 July 2015, the practitioner requested that the other pharmacist in charge Ms Kristen Haydon ("[Ms] Haydon") at the Pharmacy supply an out of date prescribed restricted substance Alphamox Suspension to the practitioner's cat without a valid prescription. 16. Between 1 January 2017 and 3 September 2018, the practitioner made a number of incorrect entries in the electronic dangerous drugs register including as follows: a) Entering medication without a corresponding invoice; b) Creating entries where the amount of medication was incorrectly specified; c) Creating entries to adjust the balance without sufficient detail or information to explain the adjustment being made and how the initial error actually occurred; and d) Failed to transfer the balances from the previous paper dangerous drugs register to the electronic dangerous drugs register when it was created. 17. The practitioner directed Ms Haydon at the Pharmacy to dispense prescription only medication to Patient A as owing prescriptions, without providing a copy of the prescription. 18. The practitioner took a vial of the prescribed restricted substance Saxenda from the Pharmacy's returned/unwanted medication ("RUM") bin and took it home for the purpose of demonstrating how the medication is used. 19. The practitioner took leftover Xenical from the Pharmacy for Patient A, without paying for it. COMPLAINT TWO is guilty of professional misconduct under section 139E of the National Law in that the practitioner has: i. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration, or ii. engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of the practitioner's registration PARTICULARS OF COMPLAINT TWO 1. Complaint One and the particulars thereof are repeated and relied upon both individually and cumulatively. Nature of the jurisdiction 1. The nature of the jurisdiction of the Tribunal is not to punish the Respondent but to protect the public and to maintain proper standards in the profession of pharmacy. 2. In Clyne v The New South Wales Bar Association (1960) 104 CLR 186; [1960] HCA 40 at 201‑202, the High Court said: "Although it is sometimes referred to as "the penalty of disbarment", it must be emphasised that a disbarring order is in no sense punitive in character. When such an order is made, it is made, from the public point of view, for the protection of those who require protection, and from the professional point of view, in order that abuse of privilege may not lead to loss of privilege." 1. Section 3A of the Health Practitioner Regulation National Law (the National Law), provides that "in the exercise of functions under a NSW provision, the protection of the health and safety of the public must be the paramount consideration". The interests of the public include patients or potential patients of the practitioner concerned. 2. As observed by Basten JA in Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91]: "… The purpose of any order made upon a finding that a complaint has been proved, is said to be protective of the interests of the public at large, but more particularly patients or potential patients of the practitioner concerned. However, the public interests include, indirectly, the standing of the medical profession and the maintenance of public confidence in the high standards of medical practitioners. There is also an element of deterrence or, to put it more positively, encouragement to other practitioners to recognise the importance of complying with professional standards and the risks of failing to do so. The powers of a Tribunal having two members of the medical profession should, at least in relation to professional standards be accorded a degree of flexibility which might not necessarily be accorded to a Tribunal differently constituted." 1. In determining the appropriate orders to be made, the paramount consideration for the Tribunal is the protection of the health and safety of the public pursuant to s 3A of the National Law. The issues 1. In essence, therefore, the issues which arise are clearly set out in the particulars of Complaint One above and then dealt with in detail by the expert at [8]–[9] below. Evidence of the Applicant 1. The Applicant in Exhibit 1 provided a series of reports by Ms Nerida Croker, a registered pharmacist. The report is significant in that it looks at each allegation made against the Respondent and expresses the expert's views on the appropriateness or otherwise of the behaviour of the Respondent. 2. The report and the conclusions of the expert are set out in detail as follows: 1) Mr Negus was one of two pharmacists in charge between 1 January 2017 – 3 September 2018. The PRU investigation found that during this period, large numbers of restricted medications became unaccounted for and were possibly lost stolen or diverted. What is your opinion of Mr Negus' assertion that he was not aware of this issue? In your response, please set out the responsibility of a pharmacist in charge with respect to accountability of restricted medication. … 2. It would be expected that on the days they were working in the pharmacy they were aware of any issues with medications and would take all necessary steps to ensure medications were not lost, stolen or diverted. 3. Mr Negus' assertion that he was not aware of this issue falls significantly below the standard expected. 4. Given the large quantities of medications which were found to be unaccounted for, and the nature of these medications, being S8 medications with potential for misuse or abuse, I am strongly critical of Mr Negus' conduct. 5. There are a number of days on which Mr Negus was reported to work where S8 medications were not entered into the drug register correctly, either entered in smaller quantities than delivered (eg 10 boxes Endone entered into register when 20 boxes were received) or where S8 medications were not entered at all. Mr Negus also stated that he sometimes noted small numbers of S8 not correctly matching the register but that he did not follow up. 6. Please note, if it had been the case that none of the S8 medications which were not entered into the register had arrived on days Mr Negus was working I would not be critical of his conduct. If it was the case that he had never witnessed any of these quantities coming into the store, and assuming they were immediately diverted or removed from the pharmacy, it would be reasonable that he did not realise that stock was unaccounted for. However, this does not appear to be the case, as Mr Negus did sign for some deliveries which were then not entered into the drug register. 2) The PRU investigation found that between 1 November 2016 – 24 August 2018, on days that Ms Haydon worked, the stock not entered into the dangerous drugs register amounted to 8926 tablets of Oxycodone and Alprazolam, of varying strengths. What is your opinion of Mr Negus' responsibilities as the second pharmacist in charge? In your response, please address, whether Mr Negus ought to have been aware of the inaccuracies in the dangerous drug register and what steps (if any) should he have taken in this regard? … The pharmacist in charge would not generally be expected to be aware of what had happened on the day(s) previous to them working in the pharmacy, unless some handover had been given or stock was seen in the pharmacy. 8. Mr Negus' met his responsibilities as the second pharmacist in charge (conduct meets the standard expected) in the circumstance that he was not aware of what had been omitted the previous day. 9. Unless he found excess stock which had not been entered into the S8 register, or he came across an invoice showing quantities of S8 medication had been delivered previously but he noted these were not entered in the register, it would not be expected that Mr Negus would be aware that there was any discrepancy. 10. This is making the assumption that stock and the invoices, which were delivered to the pharmacy and which were not able to be accounted for during the BHS and PRU audits were removed from the pharmacy prior to Mr Negus coming on to his shifts. 11. In that situation it would be almost like the stock never existed (no stock in the pharmacy, no record in the drug register, no invoice in the pharmacy). 12. In the situation that any S8 medication was found in the pharmacy on a day that Mr Negus worked and which had not been entered into the drug register, then his conduct would fall significantly below the standard expected and I would be strongly critical of this conduct as all pharmacists should be aware of their responsibilities regarding S8 medication. 3) Mr Negus entered 140 tablets of Oxycodone into the dangerous drugs register without any corresponding invoice, so that it reconciled with the stock on hand. What is your opinion of Mr Negus' conduct in this regard? In your response, please address the extent of Mr Negus' enquiries to ascertain the reason for the discrepancy and what steps if (any) should Mr Negus have taken regarding this discrepancy. … 14. Mr Negus' conduct in entering 140 tablets of oxycodone into the dangerous drugs register without any corresponding invoice and so it reconciled with the stock on hand falls significantly below the standard expected. 15. Given the nature of the medication, which is an S8 [drug] and which could be misused, and which has strict legislative requirements regarding storage and record keeping, I am strongly critical of this conduct. 16. Mr Negus states that the balance of an [S8] drug "could not go into minus", so when he discovered there were still a number of tablets in the safe, he simply added them to the balance in the register. 17. As the S8 drug register is a legal document which should always reflect an accurate balance of medication, it is not sufficient to simply add stock in and not conduct any further investigations. 18. Regardless of whether Mr Negus had overall responsibility for the S8 register or not, if he was acting as the pharmacist in charge on the day he found this discrepancy it would be expected he take sufficient steps to rectify it. 19. To investigate the issue, he could print a full list of prescriptions dispensed (to ensure all had been entered into the register correctly) as well as search for any invoices to ensure supplies had been written up correctly. If this was not enough to find the discrepancy it would be recommended that he contact the wholesaler to receive a list of supplies received to cross check these had been entered correctly. 20. It does not appear that Mr Negus undertook any checks regarding this discrepancy. 4) The PRU investigation determined that other incorrect entries in the dangerous drugs register were made under Mr Negus' login. Entries on 4 April 2017 and 28 September 2017 correspond with dates that Mr Negus worked at the pharmacy. What is your opinion of Mr Negus' conduct in making incorrect entries in the register on 4 April 2017 and 28 September 2017? In your response, please set out the responsibility of a pharmacist in charge with respect to ensuring that periodic inventory of schedule 8 drugs is performed. … 22. Mr Negus' conduct in making incorrect entries in the register on the 4th April 2017 and 28th September 2017 falls significantly below the standard expected. 23. Given the fact that all pharmacists should be aware of their legislative requirements when keeping S8 medications, I am strongly critical of this conduct. 24. Although mistakes can be made at times, it is expected that the pharmacist would be rechecking numbers of tablets or at least an approximation when physically putting the medication into the safe, and a discrepancy of 200 tablets (10 boxes) might be expected to be noticed at that time, allowing for the register to be corrected. 5) During the audit carried out by BHS on 24 August 2018, Mr Negus was found with unboxed foil sheets of Ritalin in his belongings. What is your opinion of a. Mr Negus' practice to keep Patient A's medication with himself at the Pharmacy due to her history of exceeding her dosage? b. The manner in which Mr Negus stored the unused Ritalin? … 26. It is possible to store S8 medications which have been dispensed in the safe (eg prior to a patient picking medication up) and it could have been the case for Mr Negus to store Patient A's medication in the safe if it was in the original pack and was clearly labelled as dispensed and with appropriate directions etc. 27. If Mr Negus had stored Patient A's medication securely, in an original pack with the dispensing label attached, clearly marked that it was his own property and without any possibility of being inappropriately accessed… his conduct would not fall significantly below the standard. 28. However, as Mr Negus stored loose sheets of Ritalin with no apparent attempt to secure them, his conduct falls significantly below the standard expected and I am strongly critical of his conduct. 29. I also note that these Ritalin medications were found amongst Mr Negus' belongings in the pharmacy when he was on annual leave overseas and was planning on being away from the pharmacy for at least three weeks. In this situation it might have been expected if Patient A required this medication it would have needed to be available to her and not in the pharmacy. 6) During the audit carried out by BHS on 24 August 2018, a box of Targin labelled for a Webster pack patient was found in Mr Negus' belongings. What is your opinion of the appropriateness of a) Mr Negus' conduct in re-using the unused Targin in future Webster packs for this patient? b) The manner in which Mr Negus stored the unused Targin? … 31. Mr Negus' conduct in keeping an unused box of Targin labelled for a patient in his own belongings falls significantly below the standard expected. 32. Given the fact that all pharmacists should be aware of their professional obligations regarding storage of S8 medications, and the potential for these medications to be misused or misappropriated, I am strongly critical of Mr Negus' conduct. 33. If the Targin dispensed to Patient B had not left the pharmacy, and was being stored on the premises prior to packing into a Websterpak this would be reasonable, as if doses were being titrated it may be likely that Patient B would need further supply at a later date, even if his current dose had changed. 34. However, as the Targin was not secure in the safe this means it could have been accessed by any member of staff, and Mr Negus could not guarantee it would not be misappropriated. To leave the S8 in the drug safe with the label on it to show it was dispensed and as such not "stock" would have been the appropriate way to store this medication. 7) During the audit carried out by BHS on 24 August 2018, Mr Negus was found with a box of Targin labelled for a recently deceased patient. What is your opinion of a) Mr Negus' conduct in accepting return of dispensed Targin from a patient? b) Mr Negus' conduct in retaining the returned Targin, knowing the patient was deceased? c) The manner in which Mr Negus stored the returned Targin? … 36. Mr Negus' conduct in having a box of Targin which was labelled for a recently deceased patient within his possessions falls significantly below the standard expected. 37. Given the fact that all pharmacists should be aware of their professional obligations regarding storage of S8 medications, and the potential for these medications to be misused or misappropriated, I am strongly critical of Mr Negus' conduct. 38. If a patient wishes to return a medication to the pharmacy for safe disposal or destruction, whatever the medication (including expired or ceased medication, or if the patient is deceased and it is returned by another person) it is appropriate for the pharmacist to take possession of this medication. Non S8 medications are usually disposed of immediately in the pharmacy "RUM" (return of unwanted medicine) bin. 39. S8 medications cannot be put into the RUM bin as they may be misappropriated from the bin as it is not secure. 40. If an S8 medication is accepted for disposal, it is normal practice that the pharmacist who received this medication enters it into the drug register as an "expired" or "for destruction medication". It is usually quarantined from other stock but remains locked in the safe according to S8 legislation. 41. This medication would then be expected to be destroyed when the police or pharmacy inspector next visited the pharmacy. If there was a large quantity to destroy it may be necessary to contact the police or inspector to request a visit for destruction as soon as possible. 42. (Note this is simply return of unwanted medication, this is not a "refund" type return to which I am referring. No medication can be "refunded" or returned for use by any other person as the pharmacist cannot guarantee correct storage of the medication and in some cases it could be fraudulent if the medication has already been claimed on the PBS). 43. If Mr Negus had accepted… the deceased's Targin and then stored [it] in the safe and documented it in the drug register, his conduct would have met the standard expected. 44. The fact that Mr Negus stored the Targin within his possessions, so it was not secure, and it was not accounted for, is the reason his conduct falls significantly below the standard expected. 8) The PRU Investigation concluded that periodic inventory of schedule 8 drugs had not been performed between 1 January 2017 and 6 September 2018. What is your opinion of a) Mr Negus' decision to rely on Ms Haydon to carry out the legislated inventories of stock? b) Mr Negus' assertion that he assumed Ms Haydon would be carrying out the appropriate checks and audits? In your response, please set out the responsibility of a pharmacist in charge with respect to ensuring that periodic inventory of schedule 8 drugs is performed. c) The adequacy of Mr Negus' response when he noticed small discrepancies in the inventory of schedule 8 drugs? … 46. The requirements for S8 medications include undertaking a twice year stock check, which involves checking all S8 medications against the drug register. Medications must be physically counted and checked, and note must be made of this stock check in the drug register. The legislation indicates that this must be done in March and September. 47. Assuming Mr Negus' version of events is correct, and he and Ms Haydon had had a discussion regarding this and she was to undertake the inventory then his conduct in relying on Ms Haydon to undertake periodic inventory of the schedule 8 drugs between January 2017 and September 2018 would meet the standard expected. However, when Mr Negus found "small discrepancies" it would be expected that he should ensure that the discrepancy is investigated and corrected, and as such it would be expected that Mr Negus would have noted no stock check had been undertaken. Therefore, regardless of who was "in charge" of the S8 stock check, Mr Negus' conduct in noticing discrepancies but not ensuring the periodic inventory had been undertaken, plus not investigating and correcting these discrepancies, falls significantly below the standard expected and I am strongly critical of his conduct. 48. If Mr Negus relied on Ms Haydon to undertake the periodic inventory of the Schedule 8 drugs and had not had any discussion with her regarding this, or as in her version of events he had assumed this responsibility as he had previously in the hard copy books, his conduct would fall significantly below the standard expected. 49. In that situation and given the fact that all pharmacists should be aware of their legislative requirements when keeping S8 medications, I would be strongly critical of this conduct. 50. It may be reasonable for Mr Negus to assume Ms Haydon would be carrying out appropriate checks and audits, as she was the pharmacist in charge on 5 days of the week and he was working on only two days of the week. However, Mr Negus also stated that he had been responsible for this task prior to the electronic drug register being implemented, when the days of work were the same for the two pharmacists. There was no documentation regarding either pharmacist being designated this role by BHS or by the proprietor. 9) The PRU and BHS investigation found that duplicates of schedule 8 prescriptions dispensed by the pharmacy, were not stored, separately or otherwise. What is your opinion of Mr Negus' conduct in relation to the retention and storage of duplicate scripts for schedule 8 medications? In your response, please set out the responsibility of a pharmacist in charge with respect to retention of duplicates of schedule 8 medications. … 52. Mr Negus states that duplicates of S8 medications were kept in a drawer and had been in the pharmacy prior to his annual leave. His statement corresponds to Ms Haydon's statement regarding duplicates being kept in a drawer. 53. All pharmacists must be aware of the need to keep prescription duplicates for S8 medications separate from other prescriptions 54. I believe this question should refer to the period of November 2016 to February 2017, which the PRU report states was the period duplicates for S8 prescriptions could not be located "possibly shredded". 55. I was provided with some duplicates from later dates as part of the evidence for my report (and referred to later in this report). Ms Haydon's evidence of text messages also refers to Michael and Robyn (from Bowen Health Services) taking out "all DD duplicates" which would indicate that at least some DD duplicates were located. 56. Assuming Mr Negus was storing the S8 medication duplicates separately from other prescriptions as he stated, his conduct would meet the standard expected. 57. If Mr Negus was not storing S8 medication duplicates separately his behaviour would fall significantly below the standard expected, and I would be strongly critical due to the fact that it is clear in the legislation that this is a requirement for all pharmacists to follow. 10) Mr Negus did not change his password to the electronic drug register and was aware it was accessible. What is your opinion of Mr Negus' conduct in this regard? … 59. Mr Negus' conduct in not changing his password to the electronic drug register, and being aware it was accessible, falls significantly below the standard expected. 60. It would generally be expected that all pharmacists were aware to keep their own passwords for any software secure and not share it with others. 61. However, given that Mr Negus has stated he did not know how to change his password, and there was no policy regarding the use of the electronic drug register provided to me, and as in the previous hard copy drug register system any person could have had access to the register, I am not critical of Mr Negus for this conduct. 62. It is my experience that many pharmacies and pharmacists do not have clear policies or understanding of need for security of passwords and it is not uncommon in my experience for passwords to remain at default, or to be shared between staff and proprietor etc. 63. Mr Negus stated during his interview that there was a request or directive from BHS for staff to provide their passwords to the head office, and while Mr Negus states he did not do so as he was concerned about who would access [it], it appears that computer password security may not always have been a priority for the company. 11) Mr Negus dispensed Endone and Oxycontin for patients, knowing the prescription was invalid. What is your opinion of Mr Negus' conduct in this regard? … 65. Mr Negus' conduct in dispensing prescriptions knowing they were invalid falls significantly below the standard expected. 66. Given the fact that all pharmacists should be aware of legislative requirements for S8 medications and apply these to all prescriptions, and as the medications involved are opioids with the potential for misuse or abuse, I am strongly critical of his conduct. 67. Mr Negus has stated that the patient was well known to the pharmacy, and although he recognised the prescription was invalid, he was not concerned about the legitimacy of the prescription. 68. The legislation clearly states all aspects of what constitutes a valid prescription for an S8 medication. These include prescription details (drug, strength and quantity prescribed) being written in both words and figures in the prescribers own handwriting. 69. One prescription provided did not meet these requirements, as the prescriber had printed the script and signed in their own hand, but not written prescription details by hand. 70. Regardless whether the pharmacist knows the patient or the prescriber or both, this is not a valid prescription and as such should not be used. 71. The pharmacist should contact the prescriber, discuss the issue and arrange for a new prescription (if appropriate) to be supplied, on receipt of which the medication could be dispensed to the patient. It would be possible for this prescription to be faxed so that the patient could receive their supply of medication. 72. Another prescription appears to have been altered, with the quantity changed from twenty tablets to twenty-eight. Again, if there is any question that the prescription may have been tampered with, regardless of whether you know the patient and/or prescriber, the prescription is not valid. The pharmacist would be expected to contact the prescriber to confirm the prescription. There was no documentation provided to indicate this was the case. 12) Mr Negus supplied Sildenafil to Patient G, in excess of what was prescribed. What is your opinion of Mr Negus' conduct in this regard? … 74. Mr Negus' conduct in supplying excess sildenafil than prescribed to a patient falls significantly below the standard expected. 75. As all pharmacists should be aware of the need to provide medication as prescribed, I am strongly critical of his conduct. 76. The prescription provided was prescribed as sildenafil 25mg tablets, four tablets and five repeats. This would equate to a total of six supplies (the original supply and 5 repeats) of four tablets, or 24 tablets. 77. A notation has been made on the prescription of "50mg Half a tablet, 12 tablets". The initials on the dispensing label attached are JN. It is not documented if Mr Negus checked with the prescriber prior to making this change. Although 12 tablets of 50mg may be equal to the total amount sildenafil originally prescribed, Mr Negus also dispensed this with two repeats, which then made the total amount of sildenafil dispensed to be 36 tablets of 50mg —significantly greater quantity than originally prescribed. 78. Sildenafil is a medication commonly used for erectile dysfunction. 13) Mr Negus supplied Patient H with all prescription repeats for Sildenafil on the same day. What is your opinion of Mr Negus' conduct in this regard? … 80. If increased quantities of medication were required it would be expected the pharmacist discuss with the prescriber, and document appropriately. 81. In the situation where Mr Negus checked Patient H's medication history, discussed any issues with him (such as cardiovascular conditions) and contacted the prescriber to ensure dispensing large quantities was appropriate, his conduct would not fall below the standard expected. 82. In the situation that appropriate checks were not undertaken, his conduct would fall significantly below the standard expected, and I would be strongly critical of his conduct, as supplying a greater than therapeutic quantity could lead to harm to the patient or misuse. 83. Mr Negus stated that he would have checked Patient H's medication history and any contraindications, however no evidence that this had happened (eg a note in the dispensing history, or in the diary) was provided. 84. Documents provided show that on the 11.5.17 a total of 6 prescriptions for 12 tablets each time (total 72 tablets) of sildenafil 100mg were dispensed to Patient H. Sildenafil is a medication for erectile dysfunction. The directions on the prescription showed "half to one tablet when required". The Australian Medicines Handbook states that no more than one dose should be taken a day. This supply would therefore last for between 72 ‑ 144 days and would not be considered a therapeutic quantity. 14) Mr Negus admitted that he accepted a number of blank prescription pads from Dr Moran, for the purpose of having these shredded or provided to a state health inspector. What is your opinion of Mr Negus' conduct In this regard? In your response, please address the manner in which Mr Negus stored the blank prescription pads 85. There is no clear standard expected of a practitioner as this is an unusual situation. The onus would generally fall on Dr Moran to keep his own prescription pads secure, and if he needed to have them destroyed to do so at his own premises. Mr Negus accepted the blank prescription pads although he states he did not know Dr Moran well. 86. Having accepted the possession of blank prescription pads, which could be misused, it would be expected that a practitioner keep the pads secure and have them destroyed at the earliest possible moment. 87. Mr Negus' conduct in keeping them in the pharmacy, in a location where they could potentially be accessed by any staff member (I note Mr Negus stated most employees could not reach, however this does not necessarily make them secure) falls significantly below the standard expected. 88. In the situation that none of these prescription pads was used, I would not be strongly critical of Mr Negus, due to the unusual aspects of the situation. 89. If any prescriptions had been used, I would be strongly critical of Mr Negus' conduct. 15) Mr Negus admitted he directed Ms Haydon over the phone to supply prescription only medication to a colleague of his. Mr Negus stated he confirmed repeat scripts were on file and later retrieved the repeat script through the internal courier system. What is your opinion of Mr Negus' conduct in this regard? … 91. Mr Negus' conduct in directing Ms Haydon to supply medication assuming the situation described by Mr Negus is correct, with a confirmed repeat prescription which was later retrieved and reconciled in the pharmacy meets the standard expected. 92. It is noted that a text message was provided as evidence where Mr Negus does state to give "a friend of NB" and later [provided] the name, Ibilex 500mg (a prescription antibiotic, cephalexin) and Bisolvon (an over the counter product). There was no mention of a prescription in the text message. 16) Mr Negus admitted he directed Ms Haydon to supply prescription-only medication to Patient A (for the treatment of bipolar disorder) on the basis of owing scripts. What is your opinion of Mr Negus' conduct in this regard? … 94. Mr Negus' conduct in directing Ms Haydon to supply medication for Patient A on the basis of owing scripts, without providing her any copy of that prescription (eg an email or fax) falls below the standard expected. 95. However, assuming there was a legitimate prescription, which was reconciled at the pharmacy and the supply was according to that prescription, Mr Negus' conduct does not fall significantly below the conduct expected. 96. It would be preferred that if Mr Negus required a prescription for Patient A that he arranged for the prescriber to directly fax or send them to the pharmacy in order to have a copy prior to any dispensing, and then the original prescription could be supplied later in order to meet legislative requirements. (Original prescription should be received within 7 days). 17) According to Ms Haydon, Mr Negus requested she supply Mr Negus' pet cat with medication (Alphamox) from the out of date stock. What is your opinion of Mr Negus' conduct in this regard? (assuming that Ms Haydon's version of events is correct) … 98. Assuming Ms Haydon's version of events is correct, Mr Negus' conduct would fall significantly below the standard expected. 99. Given that all prescription medication should be supplied according to legislation, and as it is not appropriate to direct your colleague to undertake an activity which is not according to legislation, I am strongly critical of this conduct. 100. It is noted that if Mr Negus had a valid prescription for his cat for amoxicillin (Alphamox) it would be appropriate for him to request Ms Haydon to supply this medication from the normal stock. It is also noted that amoxicillin antibiotics are not expensive (current price on Chemist Warehouse website for Alphamox 125mg/5mL liquid = $5.60 or 250mg capsules $7.39). Depending on the pharmacy policy, if Mr Negus was paying wholesale price it would be even less. 18) Mr Negus admitted he took half a packet of Xenical from the pharmacy, without payment, for Patient A. What is your opinion of Mr Negus' conduct in this regard? … 102. Mr Negus' conduct in taking half a packet of Xenical from the pharmacy and not paying for it, falls below the standard. 103. However, assuming Mr Negus' version of events was correct, and he planned to pay for them later this conduct is not significantly below what would be expected to be seen. 19) Mr Negus admitted he took a vial of used Saxenda from the pharmacy's RUM bin and took this home, for the purpose of demonstrating to Patient A how the medication is administered. What is your opinion of Mr Negus' conduct in this regard? … 105. Mr Negus' conduct in taking home a vial of used Saxenda from the pharmacy's RUM bin falls below the standard expected. 106. However assuming Mr Negus' explanation is correct, and he wished to show Patient A how the medication is administered (by injection) and assuming the medication was not used, and was returned to the pharmacy to be disposed of, his conduct is not significantly below the standard expected. 107. Generally, it would be suggested that a placebo device or demonstration device be obtained from the drug rep to use in the situation described by Mr Negus. 20) The PRU investigation found that between 1 January 2017 – 3 September 2018, Mr Negus made incorrect entries into the electronic drug register, including: a) Entries where the quantity received from a wholesaler was incorrectly entered b). Entries where the duplicate prescription could not be located c) Entries where the amount of medication was incorrectly specified d) Entries to make adjustments to the register, which did not contain sufficient information to explain the adjustment and how the error initially occurred e) Entries where the previous balance in the paper-based register were not transferred to the new electronic register What is your opinion of Mr Negus' conduct with respect to each instance listed in (a) – (e)? In your response, please address the responsibilities of a pharmacist in charge with respect to maintaining an accurate drug register. … 109. Given the fact that all pharmacists should be aware of their responsibilities to maintain appropriate S8 records I am strongly critical of Mr Negus' conduct. 110. In regards a) where the quantity received from the wholesaler was incorrectly entered into the register, the entries at Tab 7 and 8 seem to refer to medications being entered into the drug register without having matching invoices. The invoice numbers which were documented appear to not be correct. 111. It is also noted that at tab 8, page 1 of 16 of the Targin 10/5mg tablets all the entries on the 8th and 9th of December were entered into the register at times close together, including three (incorrect) Symbion invoices on the 9th December within 2 hours (and two within 2 minutes) which would be unlikely, as wholesalers supply once per day, plus there were two entries of invoices the previous day. The prescriptions which were written out of the book at that time were also entered within a few minutes, but had prescription numbers which were far apart, meaning they were not dispensed at the same time. So, it seems that on the 8th and 9th Mr Negus was working to balance the S8 register. 112. There is nothing wrong with him balancing the register, however it was noted that he stated this was "not his chore". He may have been assisting Ms Haydon on that occasion and not as a general rule. 113. It appears he has "made up" invoices to account for medications supplied, as it is not possible to go into negative in the S8 register. 114. The total quantity of Targin 10/5mg which was on the incorrect invoices entered on the 9th December was 192 tablets. Targin was not one of the medications which appeared on the list from BHS of discrepancies when they undertook their audit. 115. In regards b), where the duplicate prescription could not be located. All pharmacists must only dispense S8 medications if the patient provides a valid prescription. The duplicates of these prescriptions must be kept on the pharmacy premises for at least 2 years from the date of dispensing. If Mr Negus dispensed medications without prescriptions, or if he did not keep the duplicate prescription separate with other S8 prescriptions, his conduct would fall significantly below the conduct expected. If however, he did have a valid prescription for the supply, and the duplicate was kept separate at the time but then was later shredded or discarded inadvertently, his conduct would meet the standard expected. 116. I note that the information at Appendix 9 shows a number of prescriptions all in the period between Dec 2016 and February 2017, which appears to be the time when the duplicate S8 prescriptions were missing from the pharmacy and "may have been shredded" according to the PRU and BHS reports. 117. In regards c) where the amount of medication was incorrectly specified, it is noted that it is possible to make errors in calculations (when putting the total number of tablets into the register). However generally if you then add the medication into the safe you should also do a count of the medication, in which case if you accidentally entered in 200 less tablets than received (on examples given where 400 tablets were written into the register as 200) you should then pick up your error immediately. 118. In regards d) where entries to make adjustments to errors did not contain sufficient information, it was noted that Mr Negus wrote "wrong entry previously, one short by me" as his explanation. It should have included the invoice information, or when it was previously entered, or more information to be able to cross check the register. This conduct does fall below the standard expected. However, as Mr Negus did not have training in how to use the system, and as it appears he was correcting an honest mistake, I am not strongly critical of this particular conduct. 119. In regards e) where the previous balances were not transferred into the electronic register — Mr Negus has indicated he believed this to be Ms Haydon's responsibility, although she has stated she thought it to be Mr Negus' "job". There was no information provided by BHS to indicate which pharmacist had been allocated this task to manage the register. Either pharmacist should have noted when entering medication in and out that the balance was not correct, and this could have led to an investigation and realizing that the balance had not been transferred from the old book. However, given the reported conflict over whose responsibility this was, although Mr Negus' behaviour does fall significantly below the standard expected, I am not strongly critical of this conduct. 21) After considering the issues in the Statement of Facts and the materials provided to you in the folder of documents, please make any other comments that you consider to be relevant to the Commission's investigation. 120. It is noted that Mr Negus was not implicated in loss of medication according to the PRU report. However, the lack of following correct procedures regarding S8 medications, and making errors in the S8 register, may have made it more difficult to pick up the issue of apparent loss of medications. 121. In text messages which Ms Haydon states are from Mr Negus he refers to his "spare DDs in my tub" which show he was aware that this medication was not within the S8 safe. 122. There is also noted to be a mention in a text message provided and purported to be from Mr Negus to Ms Haydon which states "don't mention the list of stuff you had to give his (Bowie — Niels Bowen) mates — keep that powder dry" which appears to show Mr Negus was aware of the instances which Ms Haydon has alleged she was required to give medications to Mr Bowen's friends, as well as a text which states "I gave the Diprosone OV to [patient's name] as it was out of date... instead of throwing it away... and I pinched a Rx for Seretide for it" which appears to indicate Mr Negus gave customers out of date medication, as well as "covering the cost" of this medication by dispensing a Seretide (Seretide is an inhaled medication for asthma. This appears to indicate the pharmacy would claim from the PBS the cost of the Seretide, but not have actually provided this to a patient, so the money obtained from the PBS would "cover the cost" of the other item). 123. These messages may indicate that Mr Negus did not always follow legislative requirements in areas other than management of S8s. 1. The Tribunal also had available to it a copy of proceedings under s 150 of the National Law in respect of a hearing on 4 October 2018. The report of the proceedings sets out in detail the complaints against the Respondent and the determination made by the Pharmacy Council of New South Wales (the Council). The decision of the Council is set out below as follows: INTRODUCTION 1. On 30 August 2018 the Pharmaceutical Regulatory Unit (PRU) of NSW Health was notified of the loss and possible diversion of a large number of Schedule 8 (S8) medicines at the Chemist Outlet Erina Heights Pharmacy (the Pharmacy). The PRU notification alleged that the large amount of missing S8 stock was attributed to employee pharmacist Ms Kristen Lee Haydon. Mr Negus (the Practitioner) was also employed at the Pharmacy. 2. The interim report of an ongoing investigation by the PRU at the Chemist Outlet Erina Heights Pharmacy also stated: • Large quantities of oxycodone and alprazolam tablets are unaccounted for at the Pharmacy — during the period 17 February 2017 to 3 September 2018 there was a loss of or possible diversion of 6,700 oxycodone 5mg tablets, 1,036 oxycodone 10mg tablets, 140 oxycodone 20mg tablets, 200 alprazolam 0.5mg tablets, 250 alprazolam 0.25mg tablets, 300 alprazolam 1mg tablets and 300 alprazolam 2mg tablets; • The periodic inventory of Schedule 8 drugs has not been performed between 1 January 2017 and 6 September 2018; • On 24 August 2018, an independent check of S8 stocks by a pharmacist employed by the Chemist Outlet group revealed 43 out of 60 S8 stock lines were incorrect in the electronic drug register at the Pharmacy; • All Schedule 8 prescription duplicates dispensed between November 2016 and February 2017 were missing; • Multiple discrepancies in the electronic drug register including duplicate drug entries, invoices entered incorrectly or late, stock adjustments for no clear reason; • There was a box at the Pharmacy containing 8 prescription pads belonging to Dr Benjamin Moran and 1 prescription pad with no doctor's name specified. 3. On 26 September 2018, the Pharmacy Council of NSW (Council) initiated a complaint against Practitioner, Mr John Negus following the s150 hearing of Ms Kristen Haydon. It is alleged that Mr John Negus failed to make accurate entries in the Schedule 8 register and provided his Schedule 8 drug register user name and password to another pharmacist. 4. On 27 September 2018, Mr Negus was informed that the Council was considering taking action under section 150 of the Health Practitioner Regulation National Law (NSW) (the National Law (NSW)) with proceedings to be held on 4 October 2018. Mr Negus was invited to provide written submissions. Written submissions from Mr Negus dated 27 September 2018 were received. 5. Section 150 of the Health Practitioner Regulation National Law (NSW) (the National Law (NSW)) provides for the Council to impose conditions on or to suspend the registration of a Pharmacist for the protection of the public or generally in the public interest. Action taken under section 150 is intended to be interim and may be reviewed under section 150A. The full text of these sections and other relevant provisions is set out at Attachment 1. 6. An urgent hearing before the delegates of the Council was held on 4 October 2018. Mr John Negus was assisted by his legal adviser Mr Patrick Boardman of Wotton Kearney Lawyers during the hearing. 7. We heard oral evidence and considered written evidence submitted by Mr Negus. The proceedings were recorded… BACKGROUND 8. Mr Negus graduated from Sydney University and was registered as a pharmacist in 1972. He has been employed at the Pharmacy since 2012. 9. Mr Negus has practised as a pharmacist for over 40 years including as an owner/proprietor. 10. There are no other complaints regarding Mr Negus' practice as a pharmacist that are known to us. 11. The Pharmacy is open 7 days per week and Mr Negus works regularly on Tuesdays and Wednesdays. He is the pharmacist in charge on those days. ISSUES 12. The central issue for us to consider is whether Mr John Negus poses a risk to the safety or health of the public which warrants action to be taken by the Council. We may also consider whether it is generally in the public interest for the Council to take action. To determine these issues, we must answer the following subsidiary questions: i. Does the practitioner have the necessary standard of practice, knowledge and understanding to handle S8 medicines? ii. What is the public interest? If we conclude that Mr John Negus does pose a risk to the safety or health of the public and/or that the public interest warrants action being taken, then we must consider the following questions: iii. Are there conditions that could be imposed to minimise that risk? iv. If not, should Mr John Negus's registration be suspended? Does Mr Negus have the necessary standard of practice, knowledge and understanding to handle S8 medicines? 13. Mr Negus provided a written submission and oral evidence responding to the points raised in the PRU interim report. 14. Mr Negus informed us that the Pharmacy's DD recording transitioned from a paper based register to an electronic system on or about November 2016. He stated that prior to the change, he was responsible for the hardcopy DD book and performed periodic checks and audits of the stock of drugs in accordance with the legislation. He stated that after the change, Ms Haydon was in charge of the eDD book. He assumed she was conducting appropriate checks in accordance with legislation. 15. Mr Negus was asked to explain why another pharmacist had access to his password. Mr Negus stated that his password was allocated to him by Ms Kristen Haydon. Ms Haydon was the one responsible for the eDD, so she had the mastercode, and allocated his password to him. He did not change the password when allocated. 16. We showed Mr Negus examples of occasions when S8 drugs were not entered in the register when he was rostered in the Pharmacy. Mr Negus stated "I don't have an answer to those. I don't know and I can't remember." 17. Mr Negus was asked to explain why he had added 120 x oxycodone 5mg (Endone) to the electronic DD register without an invoice. He stated that he noted that the balance was incorrect and entered the drugs to balance the register. Mr Negus stated he sent a text message to Ms Haydon to enquire if she was aware of the discrepancy. Ms Haydon replied she was not aware. Mr Negus did not investigate further. 18. The periodic inventory of Schedule 8 drugs had not been performed between 1 January 2017 and 6 September 2018. Mr Negus stated "I was in charge of the DD books up till eDD came. I said to Kristen 'You can enter the drugs and it is your baby from now on.'" 19. When asked why he had not been vigilant in terms of the accountable drugs register, Mr Negus stated 'when I said to Kristen "are you on top of the S8's she said 'yes'. I should have had a look myself. I should have been more vigilant." He also stated 'I wasn't as vigilant as I should have been. That's all I can say.' 20. Mr Negus was asked if he could explain why a box of prescription pads were found at the Pharmacy, and if he had placed them there. He replied that a customer of the Pharmacy, who was also an anaesthetist, had asked him if he could dispose of them as he (the doctor) had left his place of employ that was listed on the pads and no longer needed them. Mr Negus agreed to have them destroyed when next the Council Inspector visited. Mr Negus had missed the last three visits of the inspector, so the pads had remained at the Pharmacy. The delegates asked Mr Negus how long they had been at the Pharmacy, to which he replied "six or seven months". The delegates found his explanation difficult to believe, or in any event, a very irresponsible action given the possibility that the pads could have been used illicitly. 21. The delegates considered that there are areas of concern when reviewing the evidence and Mr Negus' submissions: • Lack of responsibility for maintaining records of schedule 8 drugs and purportedly deferring this responsibility to someone else. 22. We therefore conclude that, by his own admission, Mr Negus does not possess the necessary standard of practice, knowledge and understanding to handle schedule 8 drugs. Is there a risk to the health and safety of any person/s due to Mr Negus' alleged conduct and/or performance? 23. When considering the public interest, we are mindful of the dangerous nature of the medicines involved and the need for a pharmacist to be vigilant and abide by the legislative requirements in maintaining proper records. 24. We are also mindful of Principles 2 and 7 of the Regulatory Principles for the National Registration and Accreditation Scheme when considering the public interest aspects of the decision making regarding Ms Haydon's registration: Principle 2: We protect the health and safety of the public by ensuring that only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered. Principle 7: Community confidence in health practitioner regulation is important. Our response to risk considers the need to uphold professional standards and maintain public confidence in the regulated health professions. 25. We are of the opinion that along with the primary protection of the public, it is also a serious responsibility of the Council to ensure that the public has confidence that practitioners deliver effective, regulated health services in an ethical framework. 26. Maintaining a high level of professional competence and conduct is essential for good care. Practitioners must also display a standard of behaviour that warrants the trust and respect of the community. 27. We are also mindful that the matter is subject to ongoing investigation. We are of the view that it is important to maintain public trust in the regulatory system until further investigation and considerations have reached a conclusion. We therefore believe it to be both in the public interest and prudent to exercise abundant caution in placing restrictions on Mr Negus' practice at this time. Are there conditions that could be imposed to minimise the risk? 28. As we have concluded, Mr Negus does pose a risk to the health and safety of the public and the public interest compels the Council to take action. We considered what conditions could be imposed to minimise the risk. 29. There is clearly a deficiency in Mr Negus' practice around the handling of S8 medicines, leading to discrepancies as well as a lack of accountability by the Practitioner. Therefore, to minimise risk, Mr Negus should be restricted from handling S8 medicines as a pharmacist. 30. In addition, Mr Negus should not work as the pharmacist in charge whilst the investigation is ongoing. This would mean that there would have to be another pharmacist on the premises at all times when Mr Negus is working, to provide direction to Mr Negus as necessary. 31. During this time, we would strongly advise that Mr Negus takes the necessary steps to address the deficiencies in his practice and consider further education in this area. ORDER 32. Pursuant to section 150(1) (b) of the National Law (NSW) the delegates imposed the following conditions on Mr John Negus's registration: 1. Must not work as a pharmacist in charge. Upon entering the pharmacy premises in which he works, he must notify the pharmacist in charge. 2. Must not possess, supply, manufacture or dispense any "drug of addiction" including derivatives or compounded medication (Schedule 8 of the NSW Poisons List) as defined by Poisons and Therapeutic Goods Act 1966 (NSW) or any controlled drug listed in the Poisons Standard (the SUSMP), or an equivalent list in any other Australian state or territory. 3. Must provide written evidence to the Pharmacy Council of NSW that he has attended the offices of the Pharmaceutical Services of the NSW Ministry of Health and consented to an Order being made under the Poisons and Therapeutic Goods Regulation 2008 to prohibit him from possessing, supplying, manufacturing or dispensing any Schedule 8 drug by close of business Friday 12 October 2018. 4. In the event that the practitioner changes his employer, must within seven days of the event provide written evidence to the Pharmacy Council of NSW (a) of change of employment (b) that he has notified his new employer of the conditions on his registration … 1. The Tribunal had available to it a report of an investigation conducted by the Pharmaceutical Regulatory Unit (PRU) into the pharmacists working in the chemist outlet. This report analyses all irregularities found at the pharmacy but addresses in particular the fact and amount of missing Schedule 8 and other drugs from the pharmacy. The report essentially indicates that the Respondent was not believed to be responsible for the missing drugs and accordingly the report is not recorded in these reasons. Evidence of the Respondent 1. The Respondent filed an amended reply to the Applicant's amended Complaint which is a document dated 22 February 2021 and which addresses the complaint as follows: Adopting the headings and defined terms used in the Application for disciplinary findings and orders dated 17 July 2020, the respondent ("the practitioner") provides the following Reply. BACKGROUND TO COMPLAINT 1 As to the un-numbered paragraphs under this heading, the practitioner: (a) admits he was first registered to practice as a pharmacist on 8 June 1971; (b) admits he commenced employment at the Pharmacy in 2012; (c) says he worked 19 hours per week, usually on Wednesday and Thursday on which days he was the sole pharmacist and accordingly pharmacist in charge at the Pharmacy; (d) says he was not present at the Pharmacy when the PRU conducted an inspection; and (e) says on 9 October 2018, the Pharmacy Council of NSW provided correspondence to the HCCC which attached a report titled 'Interim Report of Investigation' in respect of the conduct of another pharmacist employed by the Pharmacy dated 12 September 2018 signed by Aleksander Gavrilovic (PRU Report). In relation to the practitioner, the PRU Report: (i) did not draw or make any adverse findings against him; (ii) did not make any allegation that he was aware of or involved with, the loss, theft or diversion of drugs of addiction; and (iii) did not make any recommendations in relation to him. COMPLAINT ONE 2 As to Complaint One: (a) the practitioner admits subparagraph i; and (b) the practitioner denies subparagraph ii. PARTICULARS OF COMPLAINT ONE 3 In answer to particular one of Complaint One the practitioner: (a) repeats paragraph 1(c) of this Reply; (b) denies he had any personal knowledge or involvement in the drugs of addiction being lost, stolen or diverted; (c) says the drugs of addiction were being diverted prior to being entered in the software program that provides an electronic version of the traditional pharmacy controlled drug register ("DD Book"); (d) says that insofar as any drugs of addiction were delivered on days on which he worked in respect of which he signed for but failed to enter those drugs into the DD Book, the dates were: (i) 25/10/17; (ii) 9/11/17; and (iii) 22/2/18; (e) says that insofar as any drugs of addiction were delivered on those days on which he worked in respect of which he signed for but failed to enter those drugs into the DD Book as identified in the previous sub-paragraph, he was on notice of the risk of those drugs being lost, diverted or stolen and was below the standard expected of a practitioner of his level of training and experience to ensure that all prescription medications were able to be accounted for while acting as a pharmacist in change. (f) says a pharmacist in change would not be expected to be aware of what had happened on the day(s) previous to them working in the Pharmacy and accordingly in circumstances where he could not (and was not) aware of what had been omitted on days in which he did not work in the Pharmacy denies the particulars in respect of those days in which he was not the pharmacist in charge of the Pharmacy. 4 In answer to particular two of the Complaint the practitioner: (a) admits the particulars in respect of those days in which he was the pharmacist in charge of the Pharmacy; (b) says a pharmacist in change would not be expected to be aware of what had happened on the day(s) previous to them working in the Pharmacy and accordingly in circumstances where he could not (and was not) aware of what had been omitted on days in which he did not work in the Pharmacy denies the particulars in respect of those days in which he was not the pharmacist in charge of the Pharmacy. 5 [In respect of particular 3] [t]he practitioner repeats paragraph 4 of this Reply. 6 The practitioner admits particular 4 of [C]omplaint One. 7 The practitioner admits particular 5 of [C]omplaint One. 8 In answer to particular 6 of [C]omplaint One, the practitioner says: (a) [P]atient A… lived with the practitioner; (b) [P]atient A had been prescribed Ritalin by her psychiatrist and had a history of exceeding the prescribed dosage; (c) he was concerned for [P]atient A's safety; (d) to limit the risk of overdose, he ensured that only limited quantities of Ritalin was available at their home; (e) his practice was to only keep smaller supplies at home with the balance of the medication stored at the Pharmacy in his personal box. (f) the Ritalin referenced in particular 6 was [P]atient A's and had been correctly dispensed; and (g) accepts that the medication should have been more appropriately stored. 9 In answer to particular 7 of [C]omplaint One, the practitioner says: (a) [P]atient B was an elderly and poor patient; (b) the practitioner's practice was to pack and deliver his Webster Pack on a weekly basis; (c) [P]atient B's use of Targin was intermittent and his doctor was often slow in providing prescriptions which resulted in him having to wait for medication; (d) the unused box had been collected from [P]atient B's unused medications to be used in his Webster Pack the following week. The Targin was his and had been correctly dispensed; and (e) accepts that the medication should have been more appropriately stored. 10 In answer to particular 8 of [C]omplaint One, the practitioner says: (a) Patient C had returned the Targin to the practitioner at the Pharmacy for disposal prior to going to hospital for the last time as she felt they were not effective; (b) the practitioner's intention was to destroy the medication in accordance with his usual practice by providing the medication to Max Scwarzcberg (State Health [I]nspector) on his next visit for its destruction; and (c) admits that he failed to appropriately store the medication while awaiting the State Health Inspector's next visit. (d) accepts the medication should have been placed in the return of RUM bin. 11 In answer to particular 9 of [C]omplaint One, the practitioner: (a) admits stock [checks] were not undertaken on the dates and intervals particularised; (b) says he had a discussion with Ms Haydon in which it was agreed that Ms Haydon was to undertake the inventory as Ms Haydon was more computer literate and worked the majority of the shifts at the Pharmacy; (c) on the basis of the discussions in (b) above he accordingly assumed that Ms Haydon was responsible (other than his own individual entries) for [the] DD Book and the period checks that were required under the relevant laws; (d) says that the arrangement in (b) does not of itself fall below the standard reasonably expected of a pharmacist of his level of experience and training; (e) admits that insofar as he found small discrepancies in the inventory of schedule 8 drug stocks, he should have ensured that those discrepancies were investigated and corrected and ensured that periodic inventory checks had been done properly. 12 [I]n answer to particular 10 of [C]omplaint One, the practitioner: (a) admits the facts alleged in particular 10; (b) says further that: (i) the password was the default password that was generated by, and given to him by, Ms Haydon as the designated manager of the electronic system of the DD Book (a new default password being provided every 6 months); (ii) he did not know how to change his password and there was no Pharmacy policy regarding the secure use of [the] electronic drug register including with respect to the need to change his password; and (iii) any person could have had access to the previous hard copy drug register. 13 The practitioner admits particular 11 of [C]omplaint One. 14 The practitioner admits particular 12 of [C]omplaint One. 15 The practitioner admits particular 13 of [C]omplaint One. 16 As to particular 14 of [C]omplaint One, the practitioner: (a) admits that the blank prescription pads were provided to him by Dr Moran (a customer at the Pharmacy) for disposal either by shredding or to be provided to the local State [H]ealth [I]nspector (on his visits) and that the blank prescription pads were not in a secure location; (b) says further: (i) that the blank prescription pads were awaiting the health inspector's visit; (ii) Dr Moran's request was unorthodox and there is no clear standard expected of a practitioner in such a situation; (iii) the blank prescription pads were kept in a generic brown box on the top of the schedule 8 safe (the size of [a] regular fridge) in the corner of the [dispensary] away from the line of sight and easy access of other employees; and (iv) none of the blank prescription pads were used. 17 The practitioner admits particular 15 of [C]omplaint One. 18 In answer to particular 16 of Complaint One, the practitioner: (a) say[s] particulars 16(a)-(c) are so deficient in particularity that the practitioner cannot properly respond in its current form; and, (b) say[s] in respect of particular 16(d) that he: (i) admits the particular; and (ii) says further that he had agreed with Ms Haydon prior to the transfer of the paper-based drug register to the electronic DD Book that she would be responsible for the installation of the new DD Book software and the transfer of data from the paper-based drug register to the electronic DD Book. 19 In answer to particular 17 of [C]omplaint One, the practitioner: (a) admits this conduct occurred; (b) denies this conduct is below the standard reasonably expected on the following basis: (i) there was a legitimate prescription that was reconciled at the Pharmacy; (ii) the supply was according to the prescription; and (iii) it was permissible to dispense it as an owing script. 20 In answer to particular 18 of [C]omplaint One, the practitioner: (a) admits this conduct occurred; (b) says that: (i) the medication was not used, was returned the next day and placed back in the return of unwanted medicine ("RUM") bin, and (ii) in the circumstances his conduct is not significantly below the standard expected. 21 In answer to particular 19 of… [C]omplaint One, the practitioner: (a) admits he took leftover Xenical from the Pharmacy for Patient A; (b) says that Xenical is not a prescription drug; and (c) denies that he did not pay for the leftover Xenical and says that he took the drug with the intention of paying for it which he did pay in cash by handing $27 to one of his staff to process the payment. COMPLAINT TWO 22 The Practitioner denies Compliant Two. 1. The Tribunal was provided with an affidavit of the Respondent sworn on 23 February 2021 in which he admitted that the conduct the subject of Complaint One, as outlined in the particulars of that complaint, cumulatively fell significantly below the standard reasonably expected of a pharmacist of his level of training and experience. He pointed out that in order to offer some clarification and/or explanation to provide context or clarity he wished to address elements of his behaviour. He indicated that he did not intend these explanations to be excuses for his conduct, which he admits and accepts fell below the standard reasonably expected of a pharmacist of his level of training and experience. 2. The Respondent's specific responses to each of the complaints are set out below: 1. He accepted that he should have been more diligent in recording and accounting in the dangerous drugs register (DD book) Schedule 8 medications that were delivered on days when he worked, which allowed for the conditions for the drugs to be lost, stolen or diverted, albeit not by him. 2. On 9 December 2016, he sought to dispense a prescription for oxycodone. When he made the entry into the electronic DD book, a negative quantity was presented, which was not accepted by the system and the drug could not be dispensed. He searched the pharmacy for the appropriate paperwork and could not locate any invoices in relation to those packets. He followed up this anomaly with Ms Haydon who stated that she did not know anything about the extra packets in the DD store but it was probably an oversight which she would address when she was in next. As the DD book did not reconcile with the inventory, he entered those packets into the electronic DD book so that it reconciled with what was actually present in the cupboard. He accepts that this was a mistake and amounts to conduct that falls below the standard expected. 3. Patient A had been prescribed Ritalin by her psychiatrist. She had a history of exceeding the prescribed dosage and Mr Negus was concerned for her safety. To limit the risk, he ensured that only limited quantities of Ritalin was available at their home with the balance of the medication stored at the pharmacy in his personal box. The Ritalin was hers and had been correctly dispensed. He accepts that the medication should have been stored more appropriately. 4. In respect of the Targin, Patient B is an elderly and poor patient. Mr Negus stated that his usual practice was to pack and deliver the patients' Webster Pack on a weekly basis. The Patient's use of Targin was intermittent and the GP was often slow in providing DD prescriptions which resulted in him having to wait for medication. Mr Negus collected the unused box from Patient B's unused medications to be used in his future Webster Pack. The Targin was the patient's and had been correctly dispensed. Mr Negus accepts that the medication should have been stored more appropriately. 5. In respect of Patient C, she had returned her Targin to him at the pharmacy for disposal prior to going to hospital for the last time as she felt they were not effective. His intention was to destroy the medication in accordance with his usual practice. That is, expired (or unused) Schedule 8 stock would be destroyed by Max Scwarzcberg (State Health Inspector) on his next visit. He accepts the medication should have been appropriately secured prior to destruction. 6. He worked with Ms Haydon for over 5 years, believed that she was a trustworthy person and a good pharmacist and never suspected (or had any knowledge) that Ms Haydon was involved in the diversion of Schedule 8 drugs. In 2016, the Pharmacy transitioned from a paper-based drug register to an electronic system. Mr Negus did not have any prior experience with an electronic system. Prior to the transfer to an electronic system, he was responsible for the hardcopy DD book and performed all required periodic checks and audits of the Schedule 8 drugs in accordance with the legislation. Based on conversation(s) it was agreed that as Ms Haydon was more computer literate and worked the majority of the shifts at the pharmacy, Ms Haydon would be responsible for the electronic DD book, including the 6-monthly checks that were required under the relevant laws. Mr Negus would continue to be responsible for entries on the days/shifts on which he worked. 7. In respect of a password, Ms Haydon would provide him with a new password every 6 months as required by the software system for the DD book. He could not issue passwords to himself and the software system for the electronic DD book required the designated manager of the system to issue the password, which is why he relied on Ms Haydon. She would write the new default password on a note which he then used for the next 6 months. He did not change the new default password when it was given to him by Ms Haydon at 6-monthly intervals. Upon reflection he accepts that he should have changed the password, however, he trusted Ms Haydon. Further, his employer never provided him with a policy about the use of the electronic drug register. 8. In respect of the Sildenafil, Patient G was a very difficult customer that was aggressive. Mr Negus said that he checked with the prescriber in relation to the change in strength of the tablets and noted that the total amount was equal to the amount of Sildenafil originally prescribed. He accepts that if two repeats were dispensed the amount dispensed would be greater than the quantity originally prescribed. 9. He explained that the scripts provided by Dr Moran (a customer at the pharmacy) were to be shredded or provided to the local State Health Inspector for destruction. As the respective dates of the shredding or attendance of the local State Health Inspector were missed, the scripts remained at the pharmacy for a period of time but none of them had been used. 10. In respect of the owing prescriptions for Patient A, he noted that Patient A was bipolar and often changed medications prescribed by her psychiatrist. Her psychiatrist would on occasion provide instructions that the prescription had been mailed and it was permissible to dispense it as an owing script. This was always confirmed with the surgery and the prescription always arrived. 11. In relation to the vial of Saxenda, Patient A intended using Saxenda for weight loss purposes. He formed the view that this drug was not suitable for her because she was not significantly overweight. The purpose of taking the medication home was for demonstration purposes as Patient A is needle-phobic and his intention was to dissuade her from using the medication. He returned the vial the next day and placed it back in the returned/unwanted medications bin. 12. He admits that he took leftover Xenical from the pharmacy for Patient A. He took the drug with the intention of paying for it. Xenical is not a prescription drug. About a month after taking the drugs he paid in cash by handing $27 to one of his staff and requested they process the payment. He assumed they did. 13. Having had sufficient opportunity to consider the Complaint and reflect on the matters the subject of the Complaint, he appreciates that there are additional steps which he can take to ensure that his conduct consistently accords with the high standards reasonably expected of a practitioner and where his conduct fell short. 14. In order to assure the Applicant and himself that he has taken steps to be certain that he is acting at all times in accordance with the highest levels of professional conduct, he has downloaded and studied the following publicly available material for pharmacists: 1. "Professional Practice Standards", version 5, published by the Pharmaceutical Society of Australia in June 2017; 2. "Guide to Poisons and Therapeutic Goods Legislation for Pharmacists" (TG79/32) issued by the Pharmaceutical Services Unit, NSW Ministry of Health in June 2015; 3. "Frequently Asked Questions - Dispensing S8 or S4 prescriptions" produced by the Pharmaceutical Regulatory Unit, NSW Ministry of Health; and 4. "Approved Systems for Recording the Supply of Substances on Prescription Generally or in an Emergency to Health Professionals" (TG50/6) issued by the Pharmaceutical Services Unit, NSW Ministry of Health in November 2015. 1. He contacted Modeus (formerly MethSof), the supplier of the eDD register used by the Chemist Outlet group, and went through important items including: 1. password security and generation; 2. entry and recording of drugs; and 3. entry of Schedule 8 drugs for stock and performing an eDD check at least twice a year. 1. He completed the "Ethics and Dispensing in Pharmacy Practice" course – Part 1, "Legislation and pharmacy practice" (the course). The course includes the following specific module: 1. applying Australian legislation as it applies to pharmacy practice — covers skills and knowledge required to practise as a pharmacist in Australia ethically and in accordance with the law; He enrolled in the course in order to ensure his conduct accords with appropriate professional standards. 1. To ensure nothing of this nature occurs again, he stated that, going forward, he will: 1. not be working as a regular pharmacist at any pharmacy for an extended period; and 2. be doing locum work on a casual basis for the Chemist Outlet group. 1. Further, he undertakes to implement the following Modeus protocol in his normal practice: 1. on entry to any store he works in he will give himself a temporary password which will be acknowledged by the regular Pharmacist in Charge, if not present at the time, the next day; 2. the password will not be known or disclosed to any other person; 3. any Schedule 8 stock coming in will be entered on the day and counter-signed by a "tech" or shop staff; 4. all Schedule 8 scripts will be entered and recorded on the day and scripts will be left for the Pharmacist in Charge to look at the next day; and 5. any discrepancies noted when dispensing stock and on hand numbers will be noted and an alert provided to the Pharmacist in Charge. A photo will be taken of the alert and a follow-up made the next day. 1. He also stated that he is prepared to undertake any other training the Applicant or the Council deem appropriate. 2. He acknowledges the seriousness of the issues the subject of the Complaint and admits that his conduct fell significantly below the standard expected of a practitioner of his level of training and experience. He deeply regrets that he failed to exercise the due care and diligence expected of him that has led to the Complaint. 3. He states that he now understands how failing to adhere to the highest standards of professional conduct has (and will if repeated) risked his professional reputation, livelihood and his ability to remain engaged in the community in a role as a community pharmacist. It is deeply regrettable to him that it took these proceedings for him to learn this lesson. 4. He sought for the Tribunal to be aware that he has not worked for the last 2.5 years as a pharmacist because of the investigations relating to the matters the subject of the Complaint and has not earned any income. His wife has had to support both of them; with the sole burden of ensuring they continue to meet their living and other expenses. He deeply regrets that his conduct has burdened her and his family in this way. Applicant's submissions 1. The Applicant provided the Tribunal with very lengthy submissions which address a number of issues. The Applicant referred to the standard of proof and in particular that they bear the burden of proof. It is submitted that the Tribunal is not bound by the rules of evidence and whilst neither the Briginshaw civil standard nor s 140 of the Evidence Act 1995 (NSW) directly apply to the Tribunal's decision‑making, the principles remain relevant and the Tribunal should be informed by matters including the seriousness of an allegation and the gravity of the consequences of making a finding: see Bronze Wing International Pty Ltd v SafeWork NSW [2017] NSWCA 41 at [127]; Health Care Complaints Commission v Meneghetti [2020] NSWCATOD 39 at [14]. 2. The Tribunal accepts that the Applicant has the burden of proof and its decision will be based on that submission. 3. In addition, the submissions deal with the question of the protection of the health and safety of the public which has been addressed by the Tribunal in these reasons and the Tribunal is comfortable with the obligation to protect the health and safety of the public and the standing of the profession. 4. The submissions address all of the evidence in detail including the expert report, the reports of the PRU and other evidence. Those matters have been addressed in various places in this decision. It is not necessary, therefore, for the decision to repeat the arguments submitted by the Applicant in any further detail. 5. The Applicant made submissions in regard to the seriousness of the alleged conduct the subject of the Complaint, appropriate protective orders and costs, which are set out below. The seriousness of the alleged conduct the subject of the Complaint 1. Section 145D(1) of the National Law provides as follows: 145D Serious complaints must be referred to Tribunal [NSW] (1) Both a Council for a health profession and the Commission are under a duty to refer a complaint to the Tribunal if, at any time, either forms the opinion that it may, if substantiated, provide grounds for the suspension or cancellation of a registered health practitioner's or student's registration. 1. The National Law does not provide a definition of the word "serious". 2. The Applicant submits that the Tribunal should find on the balance of probabilities that the Respondent's conduct was of an objectively serious nature. 3. In relation to the breaches of the Poisons and Therapeutic Goods legislation, the Applicant submits that the scale of such breaches was significant. The conduct also occurred over a significant period including over a period subsequent to when the PRU commenced its investigation. Appropriate protective orders 1. The Applicant initially submitted that given the gravity of the conduct and the issues the subject of the proceedings, the appropriate orders for the Tribunal to make are suspension for 12 months and mentoring upon the Respondent's resumption of practice. In oral submissions the Applicant changed its position, seeking an order that, had the practitioner been registered, the Tribunal would have cancelled his registration with a non-review period of 12 months. 2. The Applicant submits that the Respondent's conduct in the present case is clearly serious and capable of attracting the above orders. 3. In Health Care Complaints Commission v Duggan [2015] NSWCATOD 142, the Tribunal concluded at [42]–[46] as follows: "[42] The Tribunal's role in protecting the health and safety of the public is not limited to consideration of the direct protection of individual members of the public from the incompetent or unethical practice of the relevant practitioner in proceedings, but rather extends to an interest in protecting the public more broadly by maintaining and communicating professional standards, signalling disapproval of unethical and incompetent conduct and thereby enhancing both professional standards and the public's trust in health professions. [43] In Re Parajuli [2010] NSWMT 3 the former Medical Tribunal determined that in exercising its functions under the former Medical Practice Act 1992 (NSW) (which similarly had an objects provision concerning the paramount purpose of protecting the health and safety of the public) that it "may consider five matters bearing on protection": (a) Any need to protect the public against further misconduct by the practitioner; (b) The need to protect the public through general deterrence (of other practitioners); (c) The need to protect the public by reinforcing high professional standard[s] and denouncing transgressions; (d) The maintenance of public confidence in the profession; (e) The desirability of making available to the public any special skills possessed by the practitioner. [44] This statement was approved in Health Care Complaints Commission v Bours (No 1) [2014] NSWCATOD 113 at [24] applying the National Law. [45] In HCCC v Do [2014] NSWCA 307 Meagher JA, with whom the other members of the NSW Court of Appeal agreed, reflected the first four of these factors... [46] In HCCC v Do, the Court of Appeal held that the Tribunal had fallen into legal error by focusing only upon the risk of recurrence of misconduct of the relevant practitioner and not upon the public interest in denouncing unacceptable conduct, nor the full implications of the findings that the practitioner's skill and judgement had fallen significantly below the standard reasonably expected: [39]. In so doing the Tribunal had failed to give proper consideration to the protection of the health and safety of the public as required by ss 3A and 4 of the National Law: [40]." 1. Further cases referred to are Lee v Health Care Complaints Commission [2012] NSWCA 80 and Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91]. 2. The Applicant submits that the Tribunal should be satisfied that the proposed orders are necessary to protect the public, are in the public interest and there is a need for general deterrence in this matter. Costs 1. The Applicant submits that the Respondent should be ordered to pay the Applicant's costs. In relation to the actual hearing, as the matters of Ms Kristen Haydon and the Respondent were run together, the costs should be apportioned between Ms Haydon and the Respondent equally. 2. An order for costs is discretionary; however it is commonly held that costs will follow the cause. 3. Clause 13 of Schedule 5D to the National Law provides as follows: 13 Tribunal may award costs [NSW] (1) A Tribunal may order the complainant (if any), the registered health practitioner or student concerned, or any other person entitled to appear (whether as of right or because leave to appear has been granted) at an inquiry or appeal before the Tribunal to pay costs to another person as decided by the Tribunal. (2) When an order for costs has taken effect, the Tribunal is, on application by the person to whom the costs have been awarded, to issue a certificate setting out the terms of the order and stating that the order has taken effect. (3) The person in whose favour costs are awarded may file the certificate in the District Court, together with an affidavit by the person as to the amount of the costs unpaid, and the Registrar of the District Court must enter judgment for the amount unpaid together with any fees paid for filing the certificate. … 1. In Health Care Complaints Commission v Philipiah [2013] NSWCA 342 Meagher JA, Emmett JA and Beech-Jones J held at [44], in relation to costs orders and the consideration of a respondent's individual financial circumstances: "… It is not an appropriate basis for the exercise of the discretion that an order for costs may cause hardship to the party against whom the order is made." 1. Accordingly, the Applicant submits that it would be appropriate in the present proceedings for the Tribunal to make an order as to costs in favour of the Applicant as sought. Respondent's submissions 1. The Respondent provided the Tribunal with closing submissions in regard to the questions of unsatisfactory professional conduct and professional misconduct, the appropriate protective orders, and costs, which are set out below and in light of admissions made address mainly appropriate penalties. It is submitted by the Respondent that: PART 1: LIABILITY – CONDUCT AMOUNTS TO UNSATISFACTORY PROFESSIONAL MISCONDUCT AND PROFESSIONAL MISCONDUCT 5. The Tribunal must determine whether the allegations in the Application have been proven to the requisite standard. The requisite standard of proof is on the balance of probabilities. In the context of disciplinary proceedings, having regard to the seriousness of the allegations and the gravity of the consequences of a suspension or cancellation order, to meet this civil standard the quantity and sufficiency of the evidence must be such that the Tribunal is comfortably satisfied that the matters in the complaint have been established: Briginshaw v Briginshaw (1938) 60 CLR 336 at 350, 362; Health Care Complaints Commission v Elias [2019] NSWCATOD 19 at [9]. Although 'comfortably satisfied' does not imply that proof to a higher standard than the balance of probabilities is required: Gianoutsos v Glykis [2006] NSWCCA 137; (2006) 65 NSWLR 539 at 547‑9. 6. Mr Negus accepts that the HCCC has discharged its burden in respect of the allegations in its case against him. Mr Negus has also made a number of admissions. Unsatisfactory Professional Conduct 7. He admits that his conduct amounts to unsatisfactory professional conduct (UPC) under s 139(1)(a) of the (NSW) National Law in that he engaged in conduct that fell significantly below the standard reasonably expected of a practitioner of his level of training and experience. 8. He also admits that his conduct amounts to UPC under s 139(1)(1) of the National Law in that he engaged in "improper" conduct within the meaning of that term in that sub-section. That is, his conduct involved impropriety in the sense of a breach of standards of conduct expected of a person in the position of Mr Negus, by reasonable persons with knowledge of the duties, powers and authorities of a pharmacist in charge: HCCC v Ford [2021] NSWCATOD 20 (Ford) at [42] adopting the approach in HCCC v Nguyen [2018] NSWCATOD 168 at [47] to [49]. Professional Misconduct 9. In considering whether that conduct is professional misconduct as defined in s 139E of the National Law, the Tribunal notes that the gravity of professional misconduct is not to be measured by reference to the worst cases, but by the extent to which it departs from the proper standards: Health Care Complaints Commission v Litchfield (1997) 41 NSWLR 630. … 11. Mr Negus admits that his failures identified in particulars 1 to 19 — which he largely admits (other than particulars 10, 17 and 19 for which Mr Negus admits the conduct but denies it fell below the standard expected) — amount to UPC represent a departure from proper standards such as to warrant the characterisation of his conduct as professional misconduct in that it is conduct that is of a sufficiently serious [nature] to justify suspension or cancellation of his registration. This is especially so because of his awareness of other discrepancies in the Dangerous Drug (DD) Register which he had observed, and his failure to properly record the delivery of consignments of drugs on the days he worked, he was on notice of the risk of drugs being lost, diverted or stolen. There is no suggestion Mr Negus himself, stole or diverted drugs. … 13. It is clear from the evidence that vastly more deliveries of s 8 drugs which failed to be entered into the DD Register were made on days when Ms Haydon worked... That is not surprising given the number of days each [that] Ms Haydon and Mr Negus worked, with her working 5 of 7 days per week as compared to his 2 of 7 days per week… and thus greater opportunity for Ms Haydon to cause the loss, theft or diversion of s 8 drugs. 14. It should be noted that each of the particulars alleged against Mr Negus do not have the same level of objective seriousness notwithstanding that cumulatively the particulars make out complaint one and two. … PART 2: THE APPROPRIATE PROTECTIVE ORDERS IN THIS CASE Legal principles 24. The discretionary power of this Tribunal to make any of the orders specified in s 149C is protective rather than punitive: Health Care Complaints Commission v Ford [2021] NSWCATOD 20 at [61]. 25. In Lee v Health Care Complaints Commission [2012] NSWCA 80 at [20] the Court of Appeal held: 20. Essential to a proper assessment of a tribunal's discretionary judgment in a disciplinary jurisdiction in accordance with these criteria is a clear understanding of the nature of the jurisdiction and an appreciation of the purpose of orders made in exercise of it. These matters were explained by Basten JA in Director-General, Department of Ageing, Disability and Home Care v Lambert (2009) 74 NSWLR 523 at [83]. His Honour made several important points: 1. The specific purpose for which orders are made is protective in the public interest and is not punitive with respect to the individual. 2. That is not to deny that such orders may be punitive in effect and that punitive effects may be relevant in formulating a protective order. 3. The punitive effects may be directly relevant to the need for protection so that, in a particular case,-there may be a factual finding that the harrowing experience of disciplinary proceedings, together with the real threat of loss of a livelihood, may have opened the eyes of the individual concerned to the seriousness of his or her conduct so as to diminish significantly the likelihood of its repetition and to produce a level of insight into his or her own character or misconduct which did not previously exist. 21. The task of the Tribunal (and of this Court on appeal) centres not on punishment as such but on the protection of the public and the maintenance of proper professional standards. … 27. The Tribunal's discretionary powers in this case may (not "must") be exercised pursuant to, relevantly, s 149A of the National Law (power to caution, reprimand and other things) and s 149C of the National Law (power to suspend or cancel registration in certain cases). 28. In the present case, where the Tribunal finds Mr Negus guilty of professional misconduct justifying cancellation or suspension of registration, because Mr Negus is no longer registered… it may exercise its powers under s 149C(1)(b) pursuant to sub-s 4 of that provision relating to persons no longer registered. … 30. The Tribunal's concern in making a protective order is whether or not the conduct is such that cancellation or suspension is warranted having regard to the protection of the public, the maintenance of public confidence in the integrity of the profession, and the deterrent effect both on the respondent and on other members of the pharmacy profession: Health Care Complaints Commission v Tane [2020] NSWCATOD 112 at [42]. 31. To justify deregistration (or an order that the Tribunal would have deregistered a person if they were registered) it is "demonstrated current unfitness, not a prophesy of permanent unfitness" that is required: Health Care Complaints Commission v Ahmad [2015] NSWCATOD 103 at [28] (emphasis added) (and cases cited therein). 32. The question of what protective order to make turns on having regard to factors like the seriousness of the conduct, a practitioner's insight, steps taken to remediate deficiencies in practice such that the person is not a risk to the public or profession. ... Mr Negus' credit … 35. Mr Negus made himself available for cross-examination. The Tribunal should find Mr Negus to be a credible witness. He sought to explain his conduct and was candid about and admitted to, his failings. He has admitted the allegations against him. There is no reason to doubt his evidence and candour with the Tribunal. 36. Nothing in the cross examination of Mr Negus by Ms Haydon undermined his evidence or credit. Moreover, the Tribunal should accord little or no weight to the matters (if any) that arose from her cross‑examination of Mr Negus. He was cross examined about the correctness of his version of events specifically about the initial agreement he had with Ms Haydon for her to take responsibility for the electronic DD Register when it transferred from the paper register. He was consistent in his evidence that it was the agreement that she would be responsible for it as evidenced in the fact that she was the "designated manager" for the purposes of the software system for the electronic DD Book and was the only person capable of issuing passwords for the system. Ms Haydon has not herself deposed in these proceedings about anything relating to her conduct, including about her version of what if any agreement between Ms Haydon and Mr Negus existed. 37. Further, the Tribunal should draw an adverse inference from her failure to give evidence in these proceedings... 38. Accordingly, the Tribunal should infer from the respondent's refusal to give sworn testimony in this matter that her evidence would not have assisted her case in resisting a finding of professional misconduct: Meakes at [77] cited in Farrell at [21]. Nothing in the medical evidence would suggest that notwithstanding her medical conditions she was not competent to give evidence. 39. Ms Haydon by way of submission has sought to rely on her mental health as an explanation as to why she did not give evidence. There is nothing in Ms Haydon's medical evidence to the effect that her mental health prevented her from giving evidence or any opinion that she should not do so. This explanation should be rejected by the Tribunal. Insight 40. Mr Negus' evidence, which was unchallenged in cross-examination, recognises his wrongdoing and its seriousness… 41. Mr Negus' evidence under cross-examination further confirms the deeply chastening experience the events the subject of these proceedings, and the fact of these proceedings, has produced in him. Contrition 42. Mr Negus' evidence, which was unchallenged in cross-examination, demonstrates that he deeply regrets his professional failings... Remediation steps 43. Mr Negus' evidence, which was unchallenged in cross-examination, is that he has taken a number of steps to ensure that he acts consistent with his professional responsibilities. … 45. If he were able to register again, Mr Negus wishes to work as a locum pharmacist on a casual pharmacist [basis]... … The appropriate protective order 54. Having regard to Mr Negus' evidence, it is clear that Mr Negus understands his wrongdoing, is contrite, and has learnt a very difficult lesson. He is an obviously caring and engaged community pharmacist. Having regard to the foregoing, the Tribunal should find Mr Negus to be a trustworthy practitioner who does not pose such a risk to the public and profession to warrant deciding that if Mr Negus were registered he would have been suspended or cancelled under s 149C(4) of the National Law. 55. Mr Negus submits that the appropriate penalty in this case is that he be reprimanded (s 149(1)(a) National Law), require him by way of conditions imposed when he is registered to submit to a performance review and participate in a mentoring relationship (s 149(3)(b) National Law). Reprimand 56. As has been recognised by several cases in this Tribunal… a finding of professional misconduct is not determinative of any consequential appropriate protective orders. … 58. Nonetheless we submit that while the Tribunal cannot make an order reprimanding him, the Tribunal is not precluded from stating in its reasons that he is reprimanded. That would still have an important effect in denouncing his conduct. … 60. There are several cases in this Tribunal [where] a pharmacist's conduct was found to amount to professional misconduct and where a reprimand was ordered: e.g. Health Care Complaints Commission v Saab (No 2) [2020] NSWCATOD 64 (Saab No 2); Health Care Complaints Commission v Elias [2019] NSWCATOD 19 (Elias); Health Care Complaints Commission v Murray (No 3) [2019] NSWCATOD 125; Health Care Complaints Commission v Elliott [2018] NSWCATOD 47; Health Care Complaints Commission v Kennedy [2017] NSWCATOD 72. 61. Whilst each case turns on its own facts, these cases demonstrate that it is far from unprecedented to order that the practitioner be reprimanded (whether together with other conditions or not) even though the conduct was sufficiently serious to warrant a finding of professional misconduct. As the cases cited above demonstrate it is commonly deployed where the conduct is serious but isolated in the context of a person's professional life and is otherwise unlikely to be a risk to the public or the profession having regard to the insight they demonstrate about their wrongdoing and/or steps taken to remediate deficiencies in professional practise. 62. Mr Negus submits that his circumstances — as to insight, contrition and remediation — justify a reprimand. 63. A reprimand is a serious matter and "not a slap on the wrist" (Legal Services Commissioner v Sapountzis [2010] VCAT 1124 at [21]) and "has the effect of identifying standards the establishment and maintenance of which protect the public": Prothonotary of the Supreme Court of New South Wales v Chapman (unreported, CA(NSW), 14 December 1992) at 22. 64. In Saab No 2 (at [93]) the Tribunal stated: The ordering of a reprimand that follows a finding of professional misconduct in a decision published by the Tribunal imparts a clear deterrent message to other professionals that conduct of the kind found against [the practitioner] will not be tolerated. The reprimand together with our published finding of professional misconduct confirms the seriousness and unacceptability of that conduct. Maintenance of the highest standards of the pharmacy profession and the public confidence in the profession are not diminished in the circumstances in which we make the orders proposed in these proceedings. 65. Accordingly, Mr Negus submits that a reprimand fulfils the necessary purpose of a protective order to publicly denounce the conduct and to achieve general and specific deterrence. Conditions 66. Pursuant to s 149A(3) of the National Law, the Tribunal can require conditions to be imposed when the practitioner is registered in the case of a person who is no longer registered. 67. Mr Negus submits that the Tribunal could if it considered necessary impose two conditions if he is registered for a period of 12 months or such longer period as determined by the Pharmacy Council of NSW (Council). 68. One, that Mr Negus must accept a mentor approved by the Council to advise and assist the practitioner in the management of his pharmacy practice, focusing on legislative compliance with obligations pursuant to the Poisons and Therapeutic Goods Act (PTG Act) and the Poisons and Therapeutic Goods Regulation 2008 (PTGR), and further: a. Mr Negus must provide the mentor with a copy of the decision made by the Tribunal which imposed these conditions and the mentor must provide a signed copy of the decision to the Council within four weeks of being appointed as a mentor; and b. The nomination of a mentor must occur within four weeks of the Tribunal's decision. Such mentoring is to continue for a period of 12 months from the date of the Council's appointment or approval. The mentor shall report to the Council as and when required by it during the term [of] his or her appointment. 69. Two, Mr Negus must submit to a performance review. The terms of such a condition would be that: a. Mr Negus must submit to a performance review conducted by a nominee of the Council within six months of the date of the Tribunal decision; and b. Mr Negus must bear all reasonable costs associated with the conduct of the performance review. 70. Mr Negus submits that these conditions are appropriate… … 74. No order should be made which has more serious consequences for the practitioner than is reasonably necessary in execution of the protective purpose of the legislation: NSW Bar Association v Meakes [2006] NSWCA 340 at [14] cited in Health Care Complaints Commission v Schmaman [2019] NSWCATOD 82 at [88]. Mr Negus submits that the above proposed protective orders are appropriate and proportionate to balance the need to protect the public and the profession and to make [a] clear deterrent message to other professionals that conduct of the kind found against Mr Negus will not be tolerated. Whether an order under s 149C(4) should be made? 75. If the Tribunal finds Mr Negus guilty of professional misconduct justifying cancellation or suspension of registration, since Mr Negus is not registered, it may exercise its powers under s 149C(4) of the National Law. 76. Mr Negus submits that having regard to the evidence… above regarding insight, contrition and remedial steps, in all the circumstances he is no longer a risk to the public. The cancellation or suspension of his registration (or in this case deciding that if he were registered the Tribunal would have suspended or cancelled his registration) is not warranted having regard to the protection of the public, the maintenance of public confidence in the integrity of the profession. … PART 3: COSTS 78. This Tribunal has the power under Cl 13(1) of Sch 5D of the National Law to order the registered health practitioner or any other person entitled to appear at an inquiry before the Tribunal to pay costs to another person decided by the Tribunal. 79. Mr Negus, not being a registered health practitioner, is "any other person" within Cl 13(1). 80. In exercising the power to award costs, conferred by cl 13, Sch 5D of the National Law, the general 'rule' is that costs follow the event: Health Care Complaints Commission v Philipiah [2013] NSWCA 342 (Philipiah) at [42]; Qasim v Health Care Complaints Commission [2015] NSWCA 282 at [85]; and Health Care Complaints Commission v Do [2014] NSWCA 307 at [51]. Cost orders are compensatory not punitive: Philipiah at [43]. 81. The HCCC is entitled to its costs given its success in these pursuant to the usual rule that costs follow the event. 82. Nonetheless, Mr Negus submits that the circumstances of the present case justify a departure from the general rule. There are a number of circumstances that may justify departure from the general rule. One such departure is apportionment of costs as between parties. 83. Mr Negus submits that there should be an apportionment of the HCCC's costs as between himself and Ms Haydon in respect of the costs of the first day of the hearing such that he is only liable for half of HCCC's costs of the first day. 84. That is because at least half of day 1 was devoted to Ms Haydon's objections to the admissibility of parts of the HCCC's evidence. Those objections were misconceived (because the Tribunal is not bound to observe the rules of evidence: Cl 2 of Sch 5D) and which objections in any event largely failed. The Tribunal ruled that the objectionable evidence was relevant since it may inform itself of any matter in the way it thinks fit (Cl 2 of Sch 5D) and that evidence was relevant to the evaluative task of the Tribunal in the proceedings. 85. In that circumstance, it is both just and fair for the tribunal to make an assessment of, and take into account, each party's responsibility for the costs incurred: Commonwealth v Gretton [2008] NSWCA 117 at [121] cited in HCCC v Elliott [2018] NSWCATOD 47 at [79]. Accordingly, the Tribunal should apportion the HCCC's costs for day [1] of the hearing in the manner sought by Mr Negus. Decision and Reasons 1. The Tribunal, having read the evidence contained in the exhibits provided to the Tribunal; having heard the evidence presented by the Applicant and given by the Respondent; having considered the expert report of Ms Croker; and having taken into account the Applicant's and the Respondent's submissions, is comfortably satisfied that the Respondent is guilty of unsatisfactory professional conduct and professional misconduct. The Tribunal also notes that, following the events the subject of this Complaint, the Respondent allowed his registration to lapse. 2. The Tribunal is satisfied that this leads to a decision as to whether the respondent should be entitled to practise as a pharmacist and what disciplinary action would be appropriate in the particular circumstances of the matter. In considering appropriate disciplinary findings, the Tribunal had regard to a number of factors. These included the transcript of the s 150 proceedings, the report of Ms Croker in respect of each and every element of the Complaint, and the approach of the Respondent to the complaint against him. The Tribunal had regard to the age and experience of the Respondent and the expectations of the profession of a member of the profession with that level of experience. The Tribunal found that the breaches of the obligations of a pharmacist as set out in the Complaint were extremely serious and should not have been committed by a pharmacist with that level of experience. While the Respondent did demonstrate a level of insight did admit that all of his behaviour constituted unsatisfactory professional conduct and professional misconduct, the Respondent's behaviour and his failings are very serious. A large part of the allegations relate to the handling and control of Schedule 8 drugs which are highly regulated due to the extreme danger posed by them, their abuse and misuse and their highly addictive nature. 3. In the circumstances, the Tribunal is comfortably satisfied that had the Respondent been registered, the Tribunal would have cancelled his registration and provided for a non‑review period of one year (which the Tribunal believes is appropriate and necessary to send a message to the profession and the public that the protection of the public and the standing of the profession are significant). In coming to this view, the Tribunal had regard to the decision in Health Care Complaints Commission v Do [2014] NSWCA 307. 4. In that case, the Court of Appeal held that the Tribunal had fallen into appealable error by focusing only upon the risk of reoccurrence of misconduct of the relevant practitioner and not upon the public interest in denouncing unacceptable conduct, nor the full implication of the finding that the practitioner's skill and judgment had fallen significantly below the standard reasonably expected. In so doing, the Tribunal had failed to give proper consideration to the protection of the health and safety of the public as required by ss 3A and 4 of the National Law. 5. The Tribunal also had regard to the Respondent's submissions which called for a reprimand. The Tribunal rejected this view and determined that even if it were entitled to reprimand the Respondent under the National Law, a reprimand would not be appropriate in the circumstances of this matter. 6. In respect of costs, the Applicant sought an order that the Respondent pay the Applicant's costs and that in relation to the actual hearing, the costs should be apportioned between Ms Haydon and the Respondent equally. 7. The Tribunal is comfortably satisfied that an order for costs should be made in favour of the Applicant. However, having regard to the fact that the Respondent, prior to the hearing, conceded almost all of the allegations against him which operated to reduce the time spent in respect of the Respondent's portion of the joint case with Ms Haydon, and the fact that almost a full day was spent by Ms Haydon making objections to documents and evidence being tendered and presented by the Applicant, that it would be appropriate for the costs to be divided between Ms Haydon and the Respondent on the basis of two thirds by Ms Haydon and one third by the Respondent. 8. Accordingly, the Tribunal makes the following orders: Orders 1. The Respondent is guilty of unsatisfactory professional conduct and professional misconduct in respect of his behaviour while working as a registered pharmacist. 2. Had the Respondent been a registered pharmacist, the Tribunal would have cancelled his registration with immediate effect. 3. The Respondent shall not be entitled to apply for registration as a pharmacist for a period of one year from the date of this order. 4. The Respondent shall pay one third of the Applicant's costs as agreed or assessed. ********** 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: 04 May 2021