Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Health Care Complaints Commission v Saab (No 2) [2020] NSWCATOD 64 Hearing dates: 2, 3 and 4 March 2020 Date of orders: 16 June 2020 Decision date: 16 June 2020 Jurisdiction: Occupational Division Before: S McIllhatton, Senior Member M Cross, Senior Member E Anderson, Senior Member H Schutz, General Member Decision: (1) Mr Saab is reprimanded under s 149A(1)(a) of the Health Practitioner Regulation National Law (NSW). (2) The conditions set out in Schedule A headed "Health Care Complaints Commission v Hussein Saab – Conditions" (the Conditions) are to be imposed on Mr Saab's registration. (3) The Conditions may be altered, varied or removed at the discretion of the Pharmacy Council of New South Wales and the Council is the appropriate review body for the purposes of Div 8 of Pt 8 of the Health Practitioner Regulation National Law (NSW). (4) While Mr Saab's principal place of practice is in NSW, the Council is the appropriate review body for the purposes of Pt 8, Div 8 of the National Law. (5) Mr Saab is to pay 70 percent of the Health Care Complaints Commission's costs pursuant to Clause 13, Schedule 5D of the National Law for the Stage 1 hearing. (6) Mr Saab is to pay all the Health Care Complaints Commission's costs pursuant to Clause 13, Schedule 5D of the National Law for the Stage 2 hearing. Catchwords: PROFESSIONS AND TRADES – Health Practitioner –appropriate form of protective orders – costs Legislation Cited: Health Practitioners Regulation National Law (NSW) Poisons and Therapeutic Goods Act 1966 (NSW) Poisons and Therapeutic Goods Regulation 2008 (NSW) Cases Cited: Bar Association v Meakes [2006] NSWCA 340 Director-General, Department of Ageing, Disability and Home Care v Lambert [2009] NSWCA 102 Dodds Family Investments Pty Ltd v Lane Industries Pty Ltd [1993] FCA 259 Health Care Complaints Commission v Brittain [2019] NSWCATOD 161 Health Care Complaints Commission v Do [2014] NSWCA 307 Health Care Complaints Commission v Karimi [2018] NSWCATOD 197 Health Care Complaints Commission v Moslemi [2020] NSWCATOD 2 Health Care Complaints Commission v Philipiah [2013] NSWCA 342 Health Care Complaints Commission v Saab [2019] NSWCATOD 179 Health Care Complaints Commission v Sloane; Health Care Complaints Commission v Hayles [2018] NSWCATOD 37 Lee v Health Care Complaints Commission [2012] NSWCA 80 Northern Territory v Sangare [2019] HCA 25 Nusrat Deano v Health Care Complaints Commission [2012] NSWSC 693 Oshlack v Richmond River Council [1998] HCA 11 Category: Principal judgment Parties: Health Care Complaints Commission (Applicant) Hussein Saab (Respondent) Representation: Counsel: A Petrie (Applicant) D Villa SC (Respondent) Solicitors: Health Care Complaints Commission (Applicant) WB Lawyers (Respondent) File Number(s): 2018/00223382 Publication restriction: An order is made pursuant to s 64 of the Civil and Administrative Tribunal Act 2013 prohibiting the disclosure of the names, addresses or any other identifying information of any patients referred to in the evidence in the proceedings. REASONS FOR DECISION Introduction 1. These reasons are our reasons for the making of protective orders at the conclusion of professional disciplinary proceedings against Mr Hussein Saab. 2. On 27 November 2019 we published our reasons for decision in respect of a Complaint brought by the Health Care Complaints Commission (the Commission) against Mr Saab lodged with the Tribunal in July 2018. In Health Care Complaints Commission v Saab [2019] NSWCATOD 179 we found Mr Saab's conduct to constitute both unsatisfactory professional conduct and professional misconduct as defined in the Health Practitioner Regulation National Law (NSW) (the National Law). For convenience we will refer to these proceedings as the Stage 1 proceedings. 3. In a directions hearing conducted in December 2019 the matter was listed for further hearing in March 2020 for consideration of the appropriate protective orders to be made to conclude these proceedings. These became the Stage 2 proceedings. 4. Hearings for the Stage 2 proceedings were conducted on 2, 3 and 4 March 2020. Mr Saab was cross-examined as were his two witnesses. 5. These reasons deal with our consideration of appropriate protective orders to be made in the light of our findings made in the Stage 1 proceedings and the additional evidence before us in the Stage 2 proceedings. We also deal with the issue of costs of the proceedings. These reasons should be read in conjunction with our decision in the Stage 1 proceedings. The Stage 1 reasons 1. Mr Saab is the sole proprietor of Ingleburn Medical Centre Pharmacy, and a proprietor in partnership of two additional pharmacies, Simply Pharmacy Toronto and Simply Pharmacy Wallsend. He was previously the sole proprietor of Simply Pharmacy Malabar. He subsequently sold this pharmacy in March 2018. 2. The gravamen of the allegations which we found proven against Mr Saab related to his responsibilities as a proprietor in the oversight of his pharmacies and in his supervision and monitoring of his employed pharmacists to ensure that they were compliant with the Poisons and Therapeutic Goods Regulation 2008 (PTGR). 3. Major deficiencies were identified regarding the practices of Mr Saab's employed pharmacists at Ingleburn and Toronto with respect to the management and administration of Schedule 8 medications and their prescriptions, failures to carry out regular mandatory stock checks of Schedule 8 medicines, alteration of drug registers, and an inability to account for and notify authorities of discrepancies in stock levels of Schedule 8 medicines. In addition issues were identified regarding the dosing of patients on the Opioid Treatment Program (OTP) and the compliant affixing of a safe which contained OTP medications. 4. We found that Mr Saab abdicated his professional obligations as a proprietor in failing to adequately supervise and oversee the conduct of his employees. Issues to be determined at Stage 2 1. The issues to be determined at this Stage 2 hearing concern the orders which ought to be made about Mr Saab's conduct which are protective in the public interest. 2. At the conclusion of the evidence adduced over the course of the Stage 2 hearing and reflecting what came out of that evidence, oral submissions were made by the Commission that the appropriate order was cancellation of Mr Saab's registration. The Commission also sought an order under s 149C(7) of the National Law that Mr Saab be prohibited from making an application for review for a period of 12 months from the date of our orders. 3. In addition the Commission's Counsel, Ms Petrie, helpfully set out a range of alternate positions which canvassed in some detail the suite of protective orders available to the Tribunal. These included suspension, reprimand and specific conditions that could be placed on Mr Saab's registration to address the deficiencies which we identified in his conduct. 4. The conditions that could be placed on Mr Saab's registration which were canvassed before us by the Commission included performance assessment, mentoring and practice audits. Although the Commission did not propose that conditions of this nature were the appropriate protective orders, its position being cancellation, both the Commission and Mr Saab were given the opportunity to comment on the detail and logistics of these sort of conditions if we chose that pathway. 5. Mr Saab's counsel, Mr Villa, submitted that the appropriate protective orders would be a reprimand and the conditions which had been canvassed by the Commission. 6. A further issue arose because Mr Saab's registration is currently suspended. 7. During the course of the hearings in the Stage 1 proceedings, and before we had concluded hearing the evidence and published our reasons, the Pharmacy Council of NSW (the Council) heard a complaint against Mr Saab. This complaint raised continuing and similar issues of concern in dispensing practices and storage of Schedule 8 medications at the Ingleburn pharmacy to that traversed in the Complaint before us. 8. On 28 May 2019 the Council convened proceedings to determine whether any action should be taken against Mr Saab under section 150 of the National Law by either suspending or imposing conditions on his registration. Section 150 proceedings occur in the context of the Council's obligation under the National Law to take action at any time if it is satisfied it is appropriate to do so for the protection of the health or safety of the public, or generally in the public interest. 9. The Section 150 proceedings have now been finalised and written reasons for the Council's decision dated 28 June 2019 were produced. The decision of the Council was to suspend Mr Saab's registration effective from 28 May 2019. Proceedings to vary or set aside the suspension under section 150A of the National Law were also conducted by the Council on 13 August 2019 and again on 9 December 2019. In both instances the Council affirmed its decision under section 150. Written reasons dated 30 August 2019 and 17 January 2020 were also produced which set out the Councils reasons in each instance. Mr Saab's registration as a pharmacist remains suspended. 10. Accordingly an ancillary issue before us was what impact any protective orders we made would have on Mr Saab's current suspension. 11. Section 150(1) and (2) of the National Law relevantly deals with suspension or conditions of registration to protect the public. It provides that: 150 Suspension or conditions of registration to protect public [NSW] (1) A Council must, if at any time it is satisfied it is appropriate to do so for the protection of the health or safety of any person or persons (whether or not a particular person or persons) or if satisfied the action is otherwise in the public interest-- (a) by order suspend a registered health practitioner's or student's registration; or (b) by order impose on a registered health practitioner's registration the conditions relating to the practitioner's practising the health profession the Council considers appropriate; or (c) by order impose on a student's registration the conditions the Council considers appropriate. (2) A suspension of a registered health practitioner's or student's registration under subsection (1) has effect until the first of the following happens-- (a) the complaint about the practitioner or student is disposed of; (b) the suspension is ended by the Council. 1. Section 150H of the National Law deals with the duration of conditions on a practitioner's registration. It provides as follows: 150H Duration of conditions—complaint matters [NSW] (1) This section applies if— (a) a Council for a health profession imposes conditions on the registration of a registered health practitioner or student under section 150; and (b) the matter is dealt with as a complaint against the practitioner or student. (2) The conditions imposed by the Council have effect until the first of the following happens— (a) the complaint about the registered health practitioner or student is disposed of; (b) the conditions are removed by the Council. (3) This section— (a) does not prevent conditions being imposed under another provision of this Law; and (b) is subject to anything done by the Tribunal on an appeal. 1. Both parties appeared to agree that any protective orders made by us do not "dispose of" the complaint which led to the Council's section 150 proceedings on 28 May 2019. Those proceedings dealt with a separate and distinct complaint, although similar issues were raised in the Complaint before us. 2. The Commission submitted that regardless of whatever protective orders we made, it would be appropriate to stay the operation of those orders for 21 days to enable the Council to convene section 150C proceedings under the National Law. Section 150C proceedings concern the power of the Council to end a suspension or remove or alter conditions. The appropriateness of a stay was not specifically addressed in Mr Saab's submissions. 3. The parties are also at issue in respect of costs. The Commission seeks an order that Mr Saab pay 70% of its costs for the Stage 1 hearing, and that he pay the entirety of its costs for the Stage 2 hearing. Although Mr Saab does not oppose those orders he seeks that in addition that a costs order be made in his favour and that the Commission ought to pay 30% of his costs in respect of Stage 1. Summary of the evidence in Stage 2 1. A significant amount of written material was before us as to the steps Mr Saab has taken to address issues raised by an inspection conducted in 2015 by the NSW Ministry of Health Pharmaceutical Services Unit (PSU) now known as the Pharmaceutical Regulatory Unit (PRU), which formed the factual matrix underlying the Complaint before us, and a subsequent inspection conducted by the PRU in February 2019. Although the 2019 inspection raised similar and additional issues it did not form part of the Complaint before us. 2. In broad terms Mr Saab has undertaken further professional development, sought advice and guidance from Mr Regoli, an experienced pharmacist and introduced changes in procedure and policy at his pharmacies based on that advice. 3. Mr Regoli, Mr Saab and Mr Medlej, an employee of Mr Saab, all gave oral evidence. Mr Regoli's evidence 1. Mr Regoli has been a registered pharmacist for some 38 years. He has been a pharmacy owner in partnership and solely. He has held positions in the Pharmacy Guild of Australia (NSW) Branch and at Pharmaceutical Defence Limited (PDL) which amongst providing other professional support for pharmacists also provides indemnity insurance for pharmacists. Mr Regoli is currently a locum pharmacist. He has completed a number of reports about the operation of the Ingleburn pharmacy. 2. Mr Regoli first met Mr Saab in mid - March 2019. This introduction was made at the instigation of Mr Saab's solicitors. Although Mr Regoli has met with Mr Saab on several occasions and has been involved in developing a mentoring plan with Mr Saab, he has not had the opportunity to observe Mr Saab at work in the pharmacy. This is because Mr Saab was suspended in May 2019 and since that time he has not been able to enter any of his pharmacies. 3. Mr Regoli's evidence was limited to his attendance at and observations of the Ingleburn pharmacy. Initially Mr Regoli attended the pharmacy over several days in March 2019 and again for several days in June 2019. After this period in June he attended the pharmacy twice a week for a few months after which his attendance reduced to once per week. Apart from a brief hiatus due to ill health of a relative, at the time of giving evidence Mr Regoli has continued to attend the pharmacy once per week. 4. After Mr Saab's suspension Mr Regoli had been contacted by Mr Saab's solicitors and requested to work as a managing pharmacist. In this role he was instructed to oversee practices in the Pharmacy, assist and provide guidance to employed pharmacists to fulfil their legal duties and ensure that any non-compliance issues were eradicated. 5. During Mr Regoli's attendances at the pharmacy he oversaw operations, met with pharmacists, examined subsidiary registers and record keeping generally including checking on compliance with PRU requirements in relation to faxed prescriptions. He reviewed operations manuals and contributed to the maintenance of the quality care program. Given the view he formed as to the workload in the pharmacy, he suggested to Mr Saab that a pharmacy manager be employed full time. Mr Saab agreed and a position was created. Mr Medlej, who also gave oral evidence in these proceedings, currently occupies this role. 6. Mr Regoli gave evidence concerning scanning rates at the pharmacy. He explained that scanning allows a pharmacist to verify that when filling prescriptions the correct item has been dispensed. As such it is a tool to help improve safety within the pharmacy. In Mr Regoli's view the scanning rate typically ought to be above 90%. In this case at Ingleburn it was 78%. Mr Regoli raised this issue with Mr Saab who agreed it was an issue and asked Mr Regoli to rectify it. 7. In relation to the subsidiary drug register Mr Regoli observed that a locum pharmacist had improperly made obliterations and crossed out entries. Mr Regoli raised this with Mr Medlej in his capacity as the managing pharmacist. Mr Regoli did not report the issue directly to Mr Saab. 8. Mr Regoli indicated that he had done spot checks in relation to the Schedule 8 drug registers and had found no issues in reconciliation between the stock in the safes and the records. 9. On another occasion Mr Regoli observed an employed pharmacist not following protocol for the dispensing of a Schedule 3 drug. Mr Regoli raised this matter with Mr Saab. 10. Mr Regoli wrote a number of reports dated 5 August 2019, 4 September 2019, 25 November 2019 and 17 February 2020. Generally the purpose of Mr Regoli's earlier reports can be seen to set out his comments on changes and improvements in the pharmacy to address concerns raised by the PRU inspections. However, and as explained by Mr Regoli in his oral evidence over a number of months his work with Mr Saab progressed beyond, identifying operational and practice issues and presenting solutions, towards mentoring of Mr Saab. 11. Mr Regoli prepared a number of documents which were designed to bring a mentoring structure to his discussions with Mr Saab. His evidence was to the effect that mentoring was informed by the areas identified by the PRU reports along with what he identified as areas which Mr Saab needed to monitor in the oversight of the pharmacy. Mr Regoli indicated that he was willing and available to continue with further mentoring of Mr Saab. 12. Mr Regoli was taken by Counsel for the Commission to the methadone syrup 5mg/mL drug register for Ingleburn for the period 4 January 2019 to 26 May 2019. This register shows that on 21 and 25 January 2019 there were two missed entries, one appeared to be a calculation error and the other a missed entry. The register also shows nine missed entries or calculation errors on 12 February 2019. Further missed entries are recorded on various dates in March 2019. Mr Regoli agreed that these issues were more than he would expect to see in a controlled drug register. 13. Through Mr Regoli's work with Mr Saab he was able to provide insight into Mr Saab's response to the areas of concern identified in the PRU reports of 2015 and 2019. For example Mr Saab's response to ensuring the accuracy and content of the controlled drugs register in his pharmacies. This was a significant issue in the findings we made in the context of the Complaint before us. 14. Mr Regoli's evidence was to the effect that in his view Mr Saab clearly understood the requirements around record keeping of drug registers. He observed that Mr Saab was able to take action and put it into place however it was his follow up that was lacking. For example Mr Saab placed too much reliance on his staff to implement the measures he had decided upon. As a proprietor Mr Saab should have been checking to ensure that the implemented strategies were being complied with in the pharmacy. 15. Counsel for the Commission took Mr Regoli to the first section 150A decision of the Pharmacy Council of NSW. This decision was made on 30 August 2019 following a hearing which occurred on 13 August 2019. Mr Regoli agreed with observations made by the Council in their decision that he had been the one to implement changes to the pharmacy in a short space of time compared to what Mr Saab had actually done up to that point. 16. Specifically Mr Regoli recommended the employment of a full time pharmacy manager, developed and implemented a variations chart to identify errors in, and improve drug register record keeping, disseminated a newsletter to pharmacists regarding record keeping in subsidiary drug registers, utilised daily activity reports to identify errors in the electronic drug register, developed a range of checklists and ensured the use of an OTP self-audit tool sponsored by New South Wales Health. 17. Mr Regoli agreed with a suggestion from Counsel for the Commission that prior to his involvement his observation of Mr Saab was that he was not "on top of everything" happening in his pharmacy. 18. Counsel for the Commission also took Mr Regoli to the second section 150A decision of the Pharmacy Council. This decision was made on 14 January 2020 following a hearing which occurred on 9 December 2019. Mr Regoli agreed with observations made by the Council that it was not until he was employed that significant improvements in a number of critical areas had been apparent. He conceded that the bulk of improvements had been initiated by him and not by Mr Saab. He did however reference Mr Saab's active involvement in the development of policies around phone/fax prescriptions. He agreed that his role was more in the nature of a coach for Mr Saab rather than as a mentor, and that his role was to some degree predicated on him giving operational information and advice to Mr Saab which they would both work on. 19. Mr Regoli gave evidence about staffing issues within the pharmacy. His view was that the workload of the pharmacy required that the position of pharmacy manager which had been created ought to remain. He noted that current staff pharmacists had been responsible for some of the issues that were the subject of the PRU investigations. However he believed that these pharmacists were otherwise competent staff and that the issues identified were related more to workload. 20. The totality of the evidence before us from Mr Regoli's written reports of 5 August, 2019, 4 September 2019 and 25 November 2019 demonstrate that since his involvement there has been a consistently improving performance over time by employed pharmacists and an accompanying increase in the level of compliance with the legislation. Mr Saab's evidence 1. Mr Saab has completed a number of ethics courses conducted by the Pharmaceutical Society of Australia (PSA), including Ethics and Dispensing in Pharmacy Practice Course (September 2019) and the Pharmacy Guild of Australia's Opioid Dependence Management Workshop (November 2019). He has completed a number of case studies using the PSA's self-assessment tool available on its website and provided a copy of his Continuing Professional Development Course Summary. 2. Mr Saab made an affidavit dated 18 February 2020 the purpose of which was to specifically address those matters the subject of Stage 2 of these proceedings. In his affidavit he set out the measures he has taken at various stages of the process in response to the PRU inspections, the Stage 1 decision and the steps he intends to take both personally and professionally moving forward. 3. A past difficulty identified by Mr Saab has been his responsibilities arising from his ownership of multiple pharmacies. This has impacted his ability to spend the time needed in each pharmacy. As noted in the Stage 1 decision Mr Saab sold his pharmacy at Malabar in 2018. He believes that reducing his workload further by selling Ingleburn Medical Centre Pharmacy will give him more time to fulfil his responsibilities as a proprietor pharmacist. He would maintain his ownership, which he holds in partnership, of Wallsend and Toronto pharmacies. 4. To this end in Mr Saab's oral evidence he indicated that he has exchanged contracts for the sale of the business to Mr Sadek Medlej. A copy of the contract was tendered in evidence. Mr Saab explained that the sale would proceed subject to the finalisation of Mr Medlej's finance and approval by the Pharmacy Council. 5. It is Mr Saab's intention to spend a minimum of one day at each pharmacy in Wallsend and Toronto on a weekly basis. 6. Mr Saab's evidence traversed the current workload at Ingleburn pharmacy and what action had been taken in response to the issues that had formed the basis for the factual findings made in our earlier decision as well as those issues identified more recently by Mr Regoli. 7. The number of OTP patients at Ingleburn had been reduced to 32 and the average number of daily prescriptions dispensed over the last 6 months was around 300. A major improvement in managing the workflow at Ingleburn had been the suggestion by Mr Regoli of the appointment of a full time pharmacy manager working Monday to Friday. Management tools such as variation charts for drug registers had also been introduced at the suggestion of Mr Regoli. 8. Mr Saab acknowledged that the introduction of the pharmacy manager position had not occurred until after Mr Regoli's involvement. He accepted that in hindsight he should have made this change earlier. He was unable to explain why he did not. 9. Mr Saab accepted the evidence and findings made in Stage 1 of the proceedings and the problems identified in the PRU inspections in 2015 and 2019. After the inspection of 2015 he stated he had done the best he could to address the issues raised however errors continued to occur. This was highlighted by the findings of the 2019 PRU inspection. 10. As to what Mr Saab could have done to prevent these problems he acknowledged he should have been more diligent in his checking procedures. He acknowledged that he had not actively involved himself sufficiently in his pharmacies. His evidence was to the effect that he had not spent enough time in and at his pharmacies. He should have been more "hands on" and referenced his ownership of four pharmacies for a part of the relevant period. Although he had taken action in response to the problems identified in the 2015 PRU inspection he conceded his actions had not been good enough and he had not resolved the problems. This was why in March 2019, after the further PRU inspection, and in consultation with his solicitors he decided to involve Mr Regoli. 11. Mr Saab explained Mr Regoli's focus on Ingleburn pharmacy on the basis that it appeared to have more issues than that of his other pharmacies and it had been the one subject to the 2019 PRU inspection. 12. Mr Saab agreed with evidence given by Mr Regoli that the missed entries and wrong additions contained in the methadone syrup 5mg/mL drug register for Ingleburn for the period 4 January 2019 to 26 May 2019 were more than one would expect to see. In response to a question from Counsel for the Commission as to what he had done to address this issue, Mr Saab stated that through working with Mr Regoli protocols had been updated, and he was looking at installing a new program that would limit such errors. 13. When Mr Regoli raised the issue of scanning rates at Ingleburn, Mr Saab contacted his pharmacy manager Mr Medlej. He asked him to investigate and report back to him on the reasons for the lower than normal scanning rate. Various reasons were identified including errors made by pharmacists, recognition by the computer system of entries and related process issues arising from the use of generic brands. Mr Medlej then spoke individually to the pharmacists and reminded them of their duty in this regard. Mr Saab said that over the last few months scanning rates have increased to acceptable levels. 14. On the occasion when Mr Regoli observed an employed pharmacist to not follow protocol for the dispensing of a Schedule 3 drug, Mr Saab spoke directly to the employee about the matter. As it was the employee's first infraction Mr Saab gave him an official warning. Evidence of Mr Saab's handling of the matter and addressing the issue with the employee was before us and is contained in an email dated 3 September 2019. 15. In November 2019 a checklist was completed by Mr Saab's pharmacist co-proprietor at Toronto, Mr Zoghbi, which identified the misappropriation of Schedule 8 drugs by a locum pharmacist. Mr Saab was aware of the incident, discussed the matter with Mr Zoghbi and the matter was reported to the PRU. 16. On 23 October 2019 the PRU conducted a re-inspection of Ingleburn pharmacy focusing on the previously identified areas of non-compliance. In its report dated 20 November 2019, it noted a missing entry for methadone syrup spillage on 22 September 2019. 17. Mr Saab gave evidence that he was aware of this issue at the time it occurred. He discussed the matter with the pharmacist manager over the telephone, advised him to document everything and to report the matter to the PRU. The PRU's report of 20 November notes that a loss notification of methadone had been received by them on 23 September 2019. 18. Mr Saab agreed with a number of suggestions from Counsel for the Commission that the work done by Mr Regoli to review the practice of the Ingleburn pharmacy in relation to Schedule 8 requirements were things he should have been doing prior to his suspension. He also agreed the appointment of a pharmacy manager at Ingleburn, and the use of variations charts, newsletters, daily activity reports and self-audits had not been employed in his pharmacies until the involvement of Mr Regoli. Mr Saab further conceded that in the context of his suspension his ability to rectify issues was untested. Character References 1. A number of character references which were made in October 2018 were provided on behalf of Mr Saab. References were provided by Ms Roache, (Pharmacy Guild of Australia), Mr Thompson (Mr Saab's business insurance agent), Mr Crawley (Symbion drug wholesaler representative), Mr Kharroubi (Pharmacist), Mr Beshay (employee pharmacist) and Mr Medlej (employee pharmacist and colleague). 2. These references are of somewhat limited value because although they refer to an awareness of the disciplinary proceedings against Mr Saab, they were completed prior to our decision in Stage 1. The references do not, and nor do they purport to, traverse any details as to Mr Saab's conduct in the intervening period that would assist in our assessment of his development of insight into his past misconduct. However we accept that Mr Saab is well regarded by his referees. 3. Mr Medlej did however provide a further reference after the Stage 1 decision. This reference was received on 4 March 2020 and Mr Medlej gave oral evidence. 4. In the 2020 reference Mr Medlej was aware of the disciplinary findings we made against Mr Saab. He stated that although Mr Saab was suspended and not permitted to enter the pharmacy he maintained a high level of interest and concern for the professional running of the pharmacy. He had been in regular contact with Mr Saab regarding the day-to-day running of the pharmacy, implementing new procedures for staff and the recommendations given by Mr Regoli. He provided a weekly update to Mr Saab on the OTP program and any issues that arise from the audits he performs. Mr Saab is apprised of all OTP and monthly DD stocktakes. Mr Saab is copied into all emails sent to the PRU regarding outstanding facsimile Schedule 8 prescriptions. 5. Mr Medlej is in the process of purchasing the Ingleburn pharmacy from Mr Saab. Mr Medlej owns other pharmacies; one at Ingleburn, and two others in partnership at Wallsend and Valentine. 6. Mr Medlej gave evidence about the alterations made in the Ingleburn controlled drug registers. These were made by locum pharmacists. Mr Medlej explained that at the time two regular pharmacists were on leave from Mr Saab's Ingleburn pharmacy and so locums had been employed. Unfortunately at around the same time Mr Medlej had his own staffing issues at his pharmacy in Ingleburn due to the resignation of his full time pharmacist. He was required to attend to his own pharmacy and as a result he was not working full time as the Pharmacy Manager at Mr Saab's Ingleburn pharmacy. This situation continued from late January to February 2020. Mr Medlej has now hired a new pharmacist and has returned to Mr Saab's Ingleburn pharmacy as the Pharmacy Manager. 2019 PRU inspections 1. As set out in our Stage 1 decision the PRU conducted an OTP inspection on 20 February 2019 at Ingleburn. It identified a number of areas of concern including some that were the same or similar to those identified in 2015 and which formed part of the Complaint before us. 2. On 23 October 2019 the PRU conducted a re-inspection of Ingleburn pharmacy. Its report dated 20 November 2019 noted that apart from the missing entry for methadone syrup spillage on 22 September 2019, a significant improvement in record keeping at Ingleburn pharmacy was observed. Regular stock check entries were observed, and no discrepancies were observed with randomly selected drugs of addiction. It appeared pharmacists were familiar with the NSW OTP Community Pharmacy Protocol and the Regulation. In the context of drugs of addiction dispensed on a faxed order, notifications had been received by the PRU from pharmacists where original prescriptions had not been received within 7 days. The principles relevant to the making of protective orders 1. There was broad agreement in the written submissions from the parties about the principles relevant to making protective orders 2. In its submissions the Commission, referred us to the decision in Lee v Health Care Complaints Commission [2012] NSWCA 80. In his reasons, Barrett JA with whom Macfarlan JA and Tobias AJA agreed, referred to and quoted from the reasons of Basten JA in Director-General, Department of Ageing, Disability and Home Care v Lambert [2009] NSWCA 102; (2009) 74 NSWLR 523. At [20], Barrett JA explained that Basten JA "made several important points". He then set out three points as follows: 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. 1. At [21] his Honour said: 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. 1. Both parties referenced the summary of relevant principles applicable to protective orders by Meagher JA in Health Care Complaints Commission v Do [2014] NSWCA 307. At [35] his Honour explained: The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise. 1. The Tribunal exercises a protective jurisdiction with the health and safety of the public the paramount consideration. 2. The protective purpose of disciplinary legislation is not peculiar to health professionals. As referenced by Counsel for Mr Saab the decision of Basten JA in NSW Bar Association v Meakes [2006] NSWCA 340 has elaborated upon the protective purpose in the public interest and the direct and indirect aspects of protective orders. 3. After considering a number of decided cases relevant to legal practitioners, Basten JA, said at [113]-[114]: The point sought to be made in the authorities is, no doubt, that the Court or Tribunal making an order in disciplinary proceedings must have squarely in mind the protective purpose of the order, in the public interest. That is not to say that the adverse (punitive) effect on the practitioner should be ignored; clearly no order should be made which has more serious consequences for the practitioner than is reasonably necessary in execution of the protective purpose. That being said it may also be noted that the protective purpose may operate in different ways. First, by its direct effect upon the practitioner, the order will either remove that practitioner from membership of the profession (by disbarment or suspension) or will provide a deterrent against the repetition of such conduct (in the case of a fine or reprimand). There are also important but indirect effects to be considered. First, the order reminds other members of the profession of the public interest in the maintenance of high professional standards. Secondly and more specifically, it may give emphasis to the unacceptability of the kind of conduct involved in the disciplinary offence. Thirdly, by speaking to the public at large, it seeks to maintain confidence in the high standards of the profession... 1. Each one of these paragraphs has been individually referenced in decisions concerning health professionals: see Health Care Complaints Commission v Brittain [2019] NSWCATOD 161 at [114] (which references paragraph 113) and Nusrat Deano v Health Care Complaints Commission [2012] NSWSC 693 at [55] (which references paragraph 114). 2. The observation by his Honour that no order should be made which has more serious consequences for the practitioner than is reasonably necessary in execution of the protective purpose has been applied in the context of disciplinary proceedings against health professionals: see Health Care Complaints Commission v Sloane; Health Care Complaints Commission v Hayles [2018] NSWCATOD 37, [149]; and Health Care Complaints Commission v Moslemi [2020] NSWCATOD 2, [61]. Relevant provisions of the National Law 1. After making a finding of unsatisfactory professional conduct, the Tribunal may exercise any of the powers in s 149A in making protective orders. 2. Section 149A so far as is relevant to these proceedings provides as follows: 149A General powers to caution, reprimand, counsel etc [NSW] (1) The Tribunal may do any one or more of the following in relation to the registered health practitioner— (a) caution or reprimand the practitioner; (b) impose the conditions it considers appropriate on the practitioner's registration; (c) order the practitioner to seek and undergo medical or psychiatric treatment or counselling (including, but not limited to, psychological counselling); (d) order the practitioner to complete an educational course specified by the Tribunal; (e) order the practitioner to report on the practitioner's practice at the times, in the way and to the persons specified by the Tribunal; (f) order the practitioner to seek and take advice, in relation to the management of the practitioner's practice, from persons specified by the Tribunal. Conclusions Protective orders 1. Applying the statutory provisions to which we have referred, including those reflecting the discretion reposed in us by those provisions as to the content of protective orders, we are satisfied that the health and safety of the public will appropriately be protected without cancelling Mr Saab's registration, subject to appropriate conditions being imposed. We have reached this view for the following reasons. 2. Although Mr Saab could have and should have done more to address the issues raised by the 2015 PRU report, the evidence before us indicates that he acknowledges that his level of supervision and oversight was inadequate. He acknowledges that the steps he took following the initial 2015 PRU to improve compliance with regulatory obligations did not rectify the issues. The evidence is to the effect that from the period 2015 to 2019 Mr Saab lacked sufficient insight to appreciate that in addition to the steps he did take after the PRU report in 2015 he needed to do much more to improve compliance with the regulatory obligations within his pharmacies. 3. The evidence is also that the additional steps that were ultimately taken in 2019 were in the main developed for Mr Saab by Mr Regoli. They were not steps identified by Mr Saab. 4. Nonetheless the steps that have been taken at Ingleburn, the introduction of a pharmacy manager, reduction of OTP patient numbers, use of variation charts, checklists and other tools have had tangible results in improving regulatory compliance. This is evidenced by the PRU report of 20 November 2019. 5. Although Mr Saab may not have generated the additional steps that have led to improvements, he identified that he needed help to rectify the issues identified by the PRU inspections. 6. In our view Mr Saab has benefited greatly from the involvement of Mr Regoli. It is clear that by using Mr Regoli's skills and experience, and taking his advice, Mr Saab is now in a better position than he has been previously to address his own limitations. 7. Due to his suspension Mr Saab has not been able to enter his pharmacy since 28 May 2019. However, he has continued to involve himself in the oversight of his pharmacies by obtaining reports and dealing with issues as they have arisen. In our view he dealt appropriately with various issues brought to his attention by Mr Regoli such as low scanning rates and non-compliance by an employee with protocols around the dispensing of Schedule 3 medication. In addition there has been more rigour in the accounting of stock levels of Schedule 8 medicines and the PRU have been appropriately notified of discrepancies on the two occasions when they have occurred. 8. Our primary focus is upon the health and safety of the public. Mr Saab has embarked on a process with Mr Regoli which has gone some way to improving Mr Saab's capability and insight but in the context of his suspension his practical ability to rectify issues as they arise within his pharmacies remains somewhat untested. However, subject to the safeguards that we have identified in the form of conditions, we do not see the necessity to cancel Mr Saab's registration. In our view this would amount to a more serious consequence for Mr Saab than is reasonably necessary in execution of the protective purpose. 9. Mr Saab should be reprimanded. 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 Mr Saab 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. 10. The conditions we intend to impose will be onerous. Mr Saab will be required to attend mentoring, submit to performance assessment and regular audits. Mentoring is to take place onsite in situ at all pharmacies and over the next 12 months. Audits are to be conducted every three months and are to continue for a period of 18 months. Mentoring and audits should occur at all pharmacies in which Mr Saab holds a financial interest. We have also detailed the specific areas that mentoring and audits are to review. Stay of the operation of the orders 1. Mr Saab is currently suspended arising from a decision made by the Pharmacy Council. Proceedings to vary or set aside the suspension under section 150A of the National Law were also conducted by the Council on two occasions. In both instances the Council affirmed its decision. 2. The Commission submitted that regardless of whatever protective orders we made, it would be appropriate to stay the operation of our orders for 21 days to enable the Council to convene s 150C proceedings under the National Law. Section 150C proceedings concern the power of the Council to remove or alter conditions or end suspension. 3. The matter before the Council raised continuing and similar issues of concern in dispensing practices and storage of Schedule 8 medications at the Ingleburn pharmacy to that traversed in the Complaint before us. However it was not the same complaint as that which was before us. 4. Further as discussed in Health Care Complaints Commission v Karimi [2018] NSWCATOD 197 there is a degree of separateness between the Council's section 150 process and that of the Tribunal. For example the purpose of a suspension imposed by a Council, is different to the purpose of a suspension imposed by a Tribunal under s 149C. A suspension under s 150 is imposed, often on an urgent basis, to protect the health and safety of the public. A suspension imposed under s 149C, a protective order, serves a number of purposes. Such an order is made to protect the public, to uphold the standards of the profession and to act as a deterrent to similar conduct: see Karimi at [137]. 5. We are not persuaded as to the need to stay our orders for a period of 21 days to enable the Council to convene proceedings under section 150C. In our view a stay on the orders is of no utility. The conditions we have specified are to be imposed on Mr Saab's registration. They will have no operative effect until Mr Saab regains his registration. It seems to us that Mr Saab's registration remains suspended until that suspension is lifted. Costs 1. The principles relevant to the exercise of discretion in awarding costs are the subject of recent discussion in the High Court of Australia in Northern Territory v Sangare [2019] HCA 25. The High Court stressed that the awarding of costs is a discretionary matter, but the discretion must be exercised judicially by reference to relevant considerations. Their Honours further explained the general rule that costs follow the event reflects the position that a successful party should be compensated for the expenses it has incurred. These long established principles are also relevant to professional disciplinary proceedings: see Health Care Complaints Commission v Philipiah [2013] NSWCA 342. 2. The purpose of an award of costs is to compensate a successful party. It is not for the purpose of penalising an unsuccessful party: see Philipiah at [42]. Where there is a mixed outcome in proceedings, the question of apportionment is very much a matter of discretion. Mathematical precision is illusory and the exercise of the discretion will often depend upon matters of impression and evaluation: see Dodds Family Investments Pty Ltd v Lane Industries Pty Ltd [1993] FCA 259 at [29]. 3. The presumption that a successful party is entitled to costs is generally only displaced where there has been some "disentitling conduct" by the successful party: see Oshlack v Richmond River Council [1998] HCA 11; 193 CLR 72 at [40]. 4. The Commission was largely successful in these proceedings. It established both unsatisfactory professional conduct and professional misconduct. There was no disentitling conduct by the Commission in the way in which it prosecuted the proceedings before us. 5. The complaint of unsatisfactory professional conduct comprised 14 particulars. The dispute between the parties as to costs arises from the fact that the Commission was not successful on the first 3 particulars of the complaint of unsatisfactory professional conduct. To reflect this, the Commission concedes that it should be entitled to 70% of its costs of Stage 1. Mr Saab submits that correspondingly the Commission should pay 30% of his costs of Stage1. He submits that this is to properly compensate him for the expense incurred in addressing the issues upon which the Commission failed. 6. The first two particulars which were not proved by the Commission related to whether Mr Saab was made aware of missing Endone from his Malabar pharmacy in January 2015 by Mr Farhat, an employed pharmacist, and whether Mr Saab subsequently requested Mr Farhat not to notify or report this fact to the authorities. The third particular related to an allegation that when Mr Saab was made aware of a discrepancy of 600 endone tablets in the drug register at Ingleburn by his pharmacist at Ingleburn, Ms Mourad, he inappropriately requested her not to report it to the authorities and declined her request that a stock take of Endone be conducted which later identified 785 missing Endone tablets. 7. The evidence relevant to these allegations largely came from a written notification made by Ms Mourad on 17 April 2015 to the Australian Health Practitioner Regulation Agency (AHPRA). We accept the submission of the Commission that it was this notification that served as a catalyst for the 2015 PRU investigation into Ingleburn, Malabar and Toronto pharmacies and the Complaint agitated before us. 8. It was necessary to obtain oral evidence under summons from both Mr Farhat and Ms Mourad to determine these allegations. We found that the evidence did not support clear findings that Mr Saab actually knew on 27 January 2015 about the missing Endone from Malabar and that he requested Mr Farhat not to notify or report the missing Endone. 9. The third particular contained two parts. The first was the allegation that Mr Saab through words and conduct requested Ms Mourad not to report the discrepancy. We accepted Ms Mourad's evidence about what Mr Saab had said to her, but in our view his conduct stopped short of finding that this part of the particular was made out. The second part of the particular related to Mr Saab declining a request from Ms Mourad to undertake a stocktake. Whilst this particular was made out in the circumstances, and for the reasons set out in our earlier decision, it did not support a finding of unsatisfactory professional conduct as contended for by the Commission. 10. In Mr Saab's written reply to the Complaint he denied unsatisfactory professional conduct and professional misconduct. 11. After all the evidence in Stage 1 was taken, subject to a qualification that if particular 8 were made out, (failure to report a missing Schedule 8 drug) Mr Saab argued in broad terms that his conduct did not amount to professional misconduct. His position in relation to unsatisfactory professional conduct was also qualified and limited to the accumulation of all the concessions he had made to that point. 12. Although the Commission was not successful on every particular overall it was successful. It was successful in proving the majority of the particulars. It was wholly successful in proving both unsatisfactory professional conduct and professional misconduct. 13. The Tribunal is not persuaded by Mr Saab's submissions that he should be compensated for the costs he incurred in dealing with the discrete matters upon which the Commission failed. 14. The Tribunal is not satisfied that any disentitling conduct has been established on the part of the Commission. Nor is the Tribunal satisfied that this is an appropriate case to exercise the discretion to depart from the general "rule". 15. In our view the Commission's concession that it should only be entitled to 70% of its costs of Stage 1 is entirely appropriate. In our view it reflects a proper exercise of our discretion to reduce the costs allowed to the Commission because of its lack of success on three of its particulars. Orders 1. For the reasons we have stated, the Tribunal makes the following orders: 1. Mr Saab is reprimanded under s 149A(1)(a) of the Health Practitioner Regulation National Law (NSW). 2. The conditions set out in Schedule A headed "Health Care Complaints Commission v Hussein Saab – Conditions" (the Conditions) are to be imposed on Mr Saab's registration. 3. The Conditions may be altered, varied or removed at the discretion of the Pharmacy Council of New South Wales and the Council is the appropriate review body for the purposes of Div 8 of Pt 8 of the Health Practitioner Regulation National Law (NSW). 4. While Mr Saab's principal place of practice is in NSW, the Council is the appropriate review body for the purposes of Pt 8, Div 8 of the National Law. 5. Mr Saab is to pay 70 percent of the Health Care Complaints Commission's costs pursuant to Clause 13, Schedule 5D of the National Law for the Stage 1 hearing. 6. Mr Saab is to pay all the Health Care Complaints Commission's costs pursuant to Clause 13, Schedule 5D of the National Law for the Stage 2 hearing. SCHEDULE A: "HEALTH CARE COMPLAINTS COMMISSION V HUSSEIN SAAB – CONDITIONS" (1) Pursuant to s 149A of the Health Practitioner Regulation National Law (NSW) the following conditions are imposed on Mr Saab's registration for a period of 12 months or such longer period as determined by the Pharmacy Council of New South Wales (the Council): Performance Assessment (a) Mr Saab is to undergo a performance assessment within 2 months from the date of the Tribunal's orders and at the frequency determined by the Council. Mentoring (b) Mr Saab is to undergo mentoring by an experienced pharmacist approved by the Council for a period of 12 months or for any further period as determined by Council and at the frequency and terms determined by Council. (c) Mr Saab is to provide to the mentor approved by Council a copy of the Tribunal's decision and reasons in Stage 1 of the proceedings together with this decision and reasons being Stage 2 of the proceedings; and any and all performance assessment report(s). (d) Mr Saab is to provide a mentoring plan to the Council for approval. (e) At each meeting Mr Saab is to review and discuss his practice with his approved mentor with a particular focus on: (i) Management of his pharmacy practice (ii) Duties and responsibilities as a proprietor pharmacist (iii) Supervision of pharmacy staff (iv) Schedule 8 drugs of addiction (v) The OTP program (vi) Compliance with his obligations under the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW) (f) Mr Saab is also to discuss with his mentor any issues identified by any Performance Assessment (g) Mr Saab is to authorise the mentor to inform Council within 1 business day if there is any concern about his professional conduct. (h) Mr Saab is to authorise the mentor to provide reports at the frequency determined by Council and at the conclusion of the mentoring period to Council about his professional conduct. (i) Mr Saab is to meet all costs associated with the mentoring conditions. (2) Under s 149A of the National Law the following conditions are imposed on Mr Saab's registration for a period of 18 months or such longer period as determined by the Council. Audits (a) Mr Saab is to submit to audits of his practice as a pharmacist and pharmacy proprietor by a person or persons approved by the Council. The audit to occur in each pharmacy business in which Mr Saab has a financial interest. (b) Mr Saab is to provide to the auditor(s) approved by Council with a copy of the Tribunal's decision and reasons in Stage 1 of the proceedings together with this decision and reasons being Stage 2 of the proceedings. (c) The audits are to be conducted every three months and are to continue for a period of 18 months and thereafter at a frequency and term determined by the Council. (d) The first audit is to be held within 3 months of the Tribunal's orders. (e) The auditor(s) should include a review of all aspects of the practitioner's practice and his pharmacy businesses including review of: (i) the drug register; (ii) storage, supply, recording and destruction of drugs of addiction; (iii) the process and procedures relating to the dispensing of regulated substances in the pharmacy businesses; (iv) Mr Saab's and his pharmacy businesses' compliance with the Poisons and Therapeutic Goods Act (1966) and Poisons and Therapeutic Goods Regulation (2008). (f) Mr Saab is to authorise the auditor(s) to provide the Council with a report on their findings. (g) Mr Saab is to meet all costs associated with the audit(s) conditions. Appropriate review body (3) While Mr Saab's principal place of practice is in NSW, the Council is the appropriate review body for the purposes of Pt 8, Div 8 of the National Law. ********** 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: 16 June 2020