Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Health Care Complaints Commission v Akinci (No 2) [2024] NSWCATOD 104 Hearing dates: 17 May 2024 Date of orders: 24 July 2024 Decision date: 24 July 2024 Jurisdiction: Occupational Division Before: H J Dixon SC, Senior Member H Dowling, Senior Member J Ludington, Senior Member B Seth, General Member Decision: (1) Pursuant to s 149A(1)(a) of the Health Practitioner Regulation National Law (NSW), the practitioner, Dr Mualla Kadriye Akinci is reprimanded. (2) Pursuant to s 149A(1)(b) of the Health Practitioner Regulation National Law (NSW), the following Conditions are to be imposed on the practitioner's registration for a period of 2 years: (a) the practitioner is not to work as the sole pharmacist or pharmacist in charge and upon entering a pharmacy premises in which to work must notify the pharmacist in charge; (b) the practitioner is to practise under Category C supervision in accordance with the Pharmacy Council of NSW's Compliance Policy – Supervision (as varied from time to time) and as subsequently determined by the appropriate review body; (c) the practitioner is not to practise until a supervisor has been approved by the Pharmacy Council of NSW and is then to conduct review meetings every three months with the approved supervisor and at each meeting is to review and discuss their practice with particular focus on: (i) proprietor oversight; (ii) all process relating to high-risk medicines including OTP; (iii) compliance with legislation, processes and procedures; (iv) record-keeping, including regular audits of documentation and prescriptions; (d) the practitioner is to authorise the approved supervisor to provide written reports to the Council in three monthly intervals, or as specified by the Council; (e) the practitioner is to authorise the Pharmacy Council of NSW to provide proposed and approved supervisors with a copy of full conditions, and any relevant decision or report; (f) the Pharmacy Council of New South Wales is the appropriate review body for the purposes of Division 8 of Part 8 of the Health Practitioner Regulation National Law (NSW). (3) Pursuant to clause 13 of Schedule 5D of the Health Practitioner Regulation National Law (NSW) the practitioner is to pay the Applicant's costs as assessed or agreed. Catchwords: OCCUPATIONS – pharmacists – misconduct and discipline – unsatisfactory professional conduct and professional misconduct – reprimand – conditions on registration Legislation Cited: Civil and Administrative Tribunal Act 2013, s 64 Health Practitioner Regulation National Law (NSW), ss 3B, 149A, 149C, 150, Sch 5D cl 13, Part 8 Div 8 Poisons and Therapeutic Goods Act 1966, s 36A Cases Cited: Akinci v the Pharmacy Council of New South Wales [2021] NSWCATOD 214 Chen v Health Care Complaints Commission [2017] NSWCA 186; (2017) 95 NSWLR 334 Council of the New South Wales Bar Association v EFA (a pseudonym) [2021] NSWCA 339; 106 NSWLR 383 Health Care Complaints Commission v Bradley [2022] NSWCATOD 47 Health Care Complaints Commission v Do [2014] NSWCA 307 Health Care Complaints Commission v Duggan [2015] NSWCATOD 142 Health Care Complaints Commission v Kesserwani [2020] NSWCATOD 65 Health Care Complaints Commission v Moses (No 2) [2019] NSWCATOD 190 Health Care Complaints Commission v Philipiah [2013] NSWCA 342 Health Care Complains Commission v Robinson [2022] NSWCA 164 Health Care Complaints Commission v Saab (No 2) [2020] NSWCATOD 64 Health Care Complaints Commission v Tran [2021] NSWCATOD 82 Health Care Complaints Commission v Yildirim (No 2) [2022] NSWCATOD 100 Lee v Health Care Complaints Commission [2012] NSWCA 80 Sabag v Health Care Complaints Commission [2001] NSWCA 411 Texts Cited: None Category: Principal judgment Parties: Health Care Complaints Commission (Applicant) Dr Mualla Kadriye Akinci (Respondent) Representation: Solicitors: Health Care Complaints Commission (Applicant) Respondent (In person) File Number(s): 2023/00165253 Publication restriction: It is noted that: (1) on 23 June 2023 the Tribunal made an order pursuant to s 64 of the Civil and Administrative Tribunal Act 2013 that the names of the 14 patients referred to as Patient A to Patient N in the Schedule to the Complaint is prohibited. (2) on 9 October 2023 the Tribunal made an order pursuant to s 64 of the Civil and Administrative Tribunal Act 2013 that the name of the person referred to as Person O in the Schedule to the amended Complaint is prohibited. reasons for decision 1. On 12 February 2024, the Tribunal handed down its decision in the Stage I hearing of the application dated 19 May 2023 and made orders that the Respondent was guilty of unsatisfactory professional conduct and professional misconduct (see [2024] NSWCATOD 15) ("Reasons"). 2. These reasons deal with Stage II of the application to consider what protective orders, if any, should as a result be made and must be read in conjunction with the Reasons published on 12 February 2024. Protective Orders Sought 1. The Applicant seeks an order pursuant to s 149C(1)(b) of the National Law that the Respondent's registration be cancelled with a non-review period of 1-2 years in that she has been found guilty of professional misconduct. 2. In respect of the seriousness of the proven conduct, the subject of Complaint 1, the Applicant relies in particular on paragraph [21], [22], [31]-[34], [35], [36], [37], [38], [40], [125] and [126] of the Reasons. 3. The Applicant also relied on the following to submit that the proven conduct in Complaint 1 is conduct that, alone or together with other conduct, is of a sufficiently serious nature to justify cancellation of the Respondent's registration because: 1. the Respondent knew that the medication (Phosphatidylcholine) which she was seeking to import was not listed by the Therapeutic Goods Administration (TGA) and should have been a red flag to her; 2. the Respondent knew that the medicine could not be obtained in Australia, which should have been a red flag to her; 3. the Respondent knew that there were no clinical trials in Australia or approval by the FDA for the medicine for tick-borne disease at the time, which should have been a red flag to her; 4. the Respondent had been told that another medical practitioner was in trouble for importing the medicine, which should have been a red flag to her; 5. the Respondent knew that the Australian Register of Therapeutic Goods (ARTG) is responsible for ensuring all medicines have been evaluated for efficacy, and she was aware of the Special Access Scheme ("SAS"), a legitimate process for importation, so she could have declined to provide the medicine, contacted the SAS about seeking approval, or sought advice from an experienced pharmacist, her professional regulator, or her insurer; 6. the Respondent used another medical practitioner to assist her plan to import an unlisted medicine by means of a prescription representing that the medicine was for personal use, which was false, which is inconsistent with the professional and ethical standards expected of pharmacists, and had the potential to bring the profession into disrepute; 7. the Code of Conduct applicable to the Respondent's practice provides that patients "trust practitioners" because they believe that, in addition to being competent, practitioners will display qualities such as integrity and truthfulness. 1. In relation to Complaint 2, the Applicant argues, in summary, that the conduct proven, the inappropriate dispensing of the medicine on three occasions to Patient J, is conduct that, together with other conduct, was of a sufficiently serious nature to justify cancellation because: 1. before the conduct, the Respondent was clearly warned by the Pharmacy Council delegates at a s 150 hearing under the National Law about the importance of her responsibilities as proprietor pharmacist; 2. the Respondent supplied Patient J nine vials of the medicine, Phosphatidylcholine, contrary to s 36A of the Poisons and Therapeutic Goods Act 1966 and thus the Respondent's conduct was improper. 3. supplying to Patient J a total of nine vials over three dates, March, April and June 2019, of an unlisted injectable medicine obtained from overseas with non-English labelling, when she could not guarantee it had been refrigerated in transit, is inconsistent with the conduct expected of a pharmacist who had been registered since 1988. 1. In respect of Complaint 4, the Applicant argues, in summary, that the conduct established in respect of the records deleted relating to the dispensing of Phosphatidylcholine to Patient J, and Disulfiram to the Respondent and Patients K to M, is conduct that, alone or together with other conduct, is of a sufficiently serious nature to justify cancellation because: 1. the Respondent knew, or ought to have known, that accurate dispensing records are important for other pharmacists, hospitals, regulators, medical centres and other health practitioners who may request access to the dispensing records to know what medicines have been dispensed to patients; 2. between 6 September 2019 and 3 December 2020, the Respondent failed to discharge her obligations as the proprietor of the pharmacy in circumstances where records relating to Phosphatidylcholine and disulfiram to a number of patients and to the Respondent were deleted; 3. given the timing of the deletion after the PRU inspection, the conduct was engaged in with a view to removing scrutiny by the inspectors. Summary of Applicant's Submission on Non-review Period 1. The Applicant stressed the principle that in considering this issue of a non-review period, the protection of the health and safety of the public must be the paramount consideration (s 3B (formerly 3A)) of the National Law and Lee v Health Care Complaints Commission [2012] NSWCA 80 at [23] - [34]. 2. It was argued that a 1–2-year non-review period is appropriate because the Respondent had ample qualifications and training, and had been the sole proprietor of the Pharmacy since 2000, so she "ought to have known her conduct was wrong". The Applicant argued that the Respondent, when asked to obtain the particular medicine, could have declined or sought guidance from others. Given the nature and gravity of the Respondent's conduct, public and professional confidence cannot be reposed in her to uphold and observe the high ethical standards required of a pharmacist, and a non-review period will make clear to the practitioner and other practitioners the seriousness with which the practitioner's conduct should be viewed. 3. The Applicant argued that when determining the appropriate length of the non-review period, the Tribunal may take into account the practitioner's earlier dealings with the regulators and, notwithstanding having been put on notice to improve, her failures to comply with her obligations continued. 4. The Applicant also drew attention to the decision of the appeal panel in Akinci v the Pharmacy Council of New South Wales [2021] NSWCATOD 214 ("the Appeal"), when it was found that the Respondent had a significant history of demonstrating a lack of knowledge of the regulatory regime and guidelines under which she was operating and that there was a substantive history of allegations of non-compliance with, or breach of, relevant legislation and guidelines. 5. The Respondent had also previously tended to minimise and rationalise the concerns that had been raised in regard to her practice and that she had failed to demonstrate insight into previous failures and her performance when questioned. Summary of Respondent's Submissions 1. The Respondent tendered a written submission which contained statements by her about her previous conduct and current position. 2. In summary, the Respondent: 1. accepted that her past behaviour was below the standard expected by the profession and she was disappointed in herself and her past behaviour; 2. accepted her failures, especially in relation to the importation of Phosphatidylcholine, and also accepted that her past processes and overall management of the Pharmacy had strong deficits; 3. stated that she had now gained an insight into why she did certain things, but it had taken her time to do so; 4. believed that she was always been a knowledgeable pharmacist, servicing socially disadvantaged patients in the area of Redfern; 5. stated that she believed that the pharmacy is being run very professionally now with a team of pharmacists and technicians, and her own practice as a pharmacist is professional and fully compliant with regulations, codes and guidelines of the profession of pharmacy in New South Wales. 1. The Respondent then acknowledged her wrongdoing and took full responsibility for her lapses of judgments which, in relation to the attempted importation of the medicine, were unethical and unlawful and taught her never to consider shortcuts or breaches of regulations again. She submitted that the events of the past four years had served as a profound wakeup call, prompting her to reflect deeply on her actions and the potential consequences for patients, colleagues and the pharmacy profession as a whole. 2. The Respondent submitted that she had gained insights and personal growth through actively engaging in a process of self-reflection and professional development. She had read and re-read codes, regulations and guidelines, conducted role plays with her mentor as well as with her staff and had further educated herself. She has actively engaged in ongoing professional development opportunities, including redoing training in compounding. 3. The Respondent submitted that engaging Mr Preswick as her mentor in 2021, who is also her supervisor under the Pharmacy Council of New South Wales requirements, led her to accept past breaches without excuses. Mr Preswick had worked with her to develop systems and processes to ensure compliance with her obligations. 4. The Respondent stated that she believed that the processes and overall running of the Pharmacy by her, and her pharmacy team, are of a high standard. In that regard, the Respondent pointed to numerous improvements in the practice in the form of tangible changes in the daily operations and decision-making processes; through standard operating procedures; the application of audits and stock takes; the use of "Safescript"; enhanced communication with the Pharmacy team; a clear dispensing process and methods for handling items not in stock; extensive documentation of events; better filing; the introduction of newer software, and regular communications with staff. 5. The Respondent submitted that she believed that those changes demonstrate her commitment to patient safety and her commitment to compliance with codes of practice, regulations and guidelines. 6. The Respondent raised the fact that she makes positive contributions to the community of Redfern, providing drug and alcohol services to Aboriginal and non-Aboriginal communities and has a strong relationship with the Aboriginal Medical Service, working together for the betterment of patients' health and wellbeing. 7. As to the surrounding circumstances in which the Respondent's offending conduct occurred, the Respondent pointed to the personal hardships and challenges she faced during a period in which she was caring for her husband with a poorly defined illness, but an understanding of those circumstances will provide valuable context for her future actions. Reflecting on this has given her "opportunity for redemption and growth". 8. Under the heading "Commitment to Redemption" in her written submissions, the Respondent submitted that she was acutely aware of the impact her actions may have had on her professional reputation and the trust of colleagues, patients and the community. She has committed to earning back this trust through consistent ethical conduct, transparent communication and ongoing professional development. 9. The Respondent also relied on all the Supervision Reports prepared by Ms Preswick and her own observations recorded in those documents throughout the period of his supervision which demonstrate, she claimed, that she has improved her practice. 10. In relation to a non-review period, the Respondent submitted that her conduct in procuring an unregistered product filled her with deep disappointment in herself. She believes her self-development since that period, and her clear understanding of the ethical issues, precludes her from ever making a similar error of judgment again. 11. The Respondent pointed to the fact that although her breaches were serious, the conduct was in a different league, less serious, when compared to other practitioners who wrongly supply large quantities of opiates, Schedule 4D and Schedule 4B medicines putting many people at risk. 12. Finally, the Respondent proposed that a more appropriate order should be a continuation of supervision under Category C by the Pharmacy Council until it was fully comfortable with her performance. She also acknowledged that a reprimand should ensue. 13. The Respondent was also cross-examined. She rejected the suggestion that she was now a risk to the public. The conduct that was the subject of criticism in the Appeal was before "the penny dropped" and she accepted full responsibility for her conduct and the need for improvement. Previous Suspension and Conditions 1. The Respondent has a long history of coming to the attention of the regulatory authorities including the Pharmacy Council. The more recent history is as follows: 1. On 7 April 2020, the Pharmacy Council lifted a previously imposed suspension and imposed conditions on the Respondent's registration pursuant to s 150A of the National Law, including that she not practise as a pharmacist in charge and was required to submit to an audit of the Pharmacy to be held by 7 July 2020. 2. On 13 October 2020, the Respondent was suspended by the Pharmacy Council following proceedings under s 150 of the National Law. 3. On 12 September 2022, the Pharmacy Council lifted the previous suspension and imposed a number of conditions on the registration of the practitioner, conditions which currently apply and to which we will return. One of the conditions required the Respondent to be subject to Category C supervision by a person approved by the Pharmacy Council which turned out to be Mr Preswick. Mr Preswick's Involvement 1. In June 2020, Mr Preswick conducted an Opioid Treatment Program ("the OTP") audit of the Pharmacy and of the Respondent. He formed a view that the audit was not a positive one as he identified numerous gaps in the administration of the OTP and general compliance with certain regulations. However, he found no evidence of intention to defraud, frequent dispensing of inappropriate quantities of medicines such as Schedule 8 or Schedule 4D medicines, supply without prescription, or other active illegal actions. 2. It is also significant that in the mentoring report provided by Mr Preswick in December 2020 following mentoring sessions, he concluded that the Respondent showed progress, and a very good attitude. Following the dismissal of the Appeal in December 2021, it is clear he said that the Respondent significantly changed her approach and standard of practice. 3. Mr Preswick then undertook a mentoring program with the Respondent. In the months prior to the Appeal, in mid-2021, and since the decision of the Tribunal in that matter on 21 December 2021, he has worked with the Respondent and her pharmacists. He has provided mentoring, systems improvement, auditing, and education to the Respondent, her pharmacy staff and the Pharmacy. 4. In his Stage I evidence, Mr Preswick identified, with supporting documentation, the changes made at the Pharmacy and areas which have been improved. Those include, proprietor oversight, teamwork, education, including through exams repeated in April 2022, which together with relevant CPD training, demonstrated to him that the Respondent has adequate regulatory knowledge (and her clinical knowledge has not been in question). 5. Mr Preswick identified distinct themes in the improvements which have occurred, in particular in relation to regulatory breaches, regulatory knowledge, poor processes and protocols, and lack of proprietor responsibility. He expressed the view in that evidence that each of those four items are practical areas that he believed have been largely resolved as issues. 6. Mr Preswick stated that he believed that the Respondent now has adequate regulatory knowledge, the pharmacy has adequate processes and protocols and by way of his own audits and the Pharmacy's own self audit processes, it now operates in a compliant manner. To the extent that the Respondent could demonstrate proprietor oversight whilst suspended, she attended meetings, reviewed processes and audits and had adequate understanding of those responsibilities. 7. Another issue identified by Mr Preswick was the earlier lack of insight by the Respondent in relation to her conduct. That was demonstrated to him with the Respondent not taking responsibility or ownership of events. It was an area of intense discussion between Mr Preswick and the Respondent. He expressed the view that the Respondent acknowledged that many of the regulatory breaches were continual repeats of the same issues, but she was committed to taking full responsibility for the regulatory compliance within the Pharmacy. 8. Mr Preswick then expressed the opinion that since the Respondent was suspended by the Pharmacy Council in October 2020 had not been wasted. The Respondent had, apart from increasing her regulatory knowledge, gained much greater personal insight into the importance of the Application brought by the Applicant in this matter. He recorded that the Respondent acknowledges prior failures and is committed to never repeat the same or any regulatory breaches in the future. 9. Mr Preswick provided a volume of attachments to his statement detailing his involvement. In relation to staff and mentor meetings, he pointed out that there were three types of meetings conducted and although only a sample were included, it involved staff meetings chaired by the senior pharmacist and attended by the Respondent (where she was a witness but without contribution when she was suspended); staff meetings and mentor meetings between Mr Preswick and the Respondent. For example, during the period 8 February 2022 and 22 June 2022, there were six mentoring meetings. During the period 17 March 2021 and 14 January 2022, there were 22 staff meetings of the kind described. 10. From 10 November 2022 to 7 May 2024, Mr Preswick provided 15 Supervision Reports in his role as Pharmacy Council approved supervisor of the Respondent. The areas of practice identified for attention were the OTP and high-risk medicines, Schedule 8 and Schedule 4D and Schedule 4B medicines, legislation and proprietor obligations including safe operation procedures, maintenance and development, staff training and self-audits recognising her previous shortcomings. 11. In support of her position, the Respondent again called evidence from Mr Preswick in this Stage II. 12. Mr Preswick's oral evidence was to the following effect: 1. he had spent considerable time with the Respondent and in auditing of the Pharmacy; 2. he regarded the Respondent as clinically quite good; 3. the processes which previously were wanting, particularly in relation to accurate patient records had been remedied, and if there were deletions in the records, the reason for the deletion was now being supplied; 4. in relation to the importation of Phosphatidylcholine, and whether he had a view as to whether a similar event could occur again, Mr Preswick stated that the Respondent had been on a journey, that it involved excuses being made for many years, including blaming others, and that up until the time of the Appeal, the Respondent did not have an insight into her conduct; 5. after he was hired, and it took a while, he believes that nothing like that would happen again and that the Respondent had now had a newfound caution and insight. This was demonstrated, for example, by a request from the Aboriginal Medical Service to destroy their unusable drugs, but the Respondent had done the necessary research, and based on that research, declined to carry out that request even though she would have preferred to assist that service; 6. the realisation (or "epiphany") arrived at by the Respondent as to her responsibilities was very gradual; 7. Mr Preswick regarded the Pharmacy as a decent pharmacy with difficult patients; 8. he regarded the Respondent now, post the Appeal, as a different pharmacist and he was confident that the Respondent never wanted to have the same conduct occur again; 9. Mr Preswick did not think that people would see the Respondent as a "soft touch to supply drugs", for example, by way of "doctor shopping" and that she now had a very strong approach to compliance; 10. the Respondent's judgment, in his view, is better and she seems clinically very aware; 11. Mr Preswick did not see the Respondent as a risk to the public if she continues to practise with, or without, conditions. She had greater insight, greater systems and awareness of what was required. 1. Mr Preswick was cross-examined, particularly in relation to the Supervision Reports that he had produced on the Respondent and the Pharmacy. In our view, none of the cross-examination undermined his evidence to which we refer to above, and which we accept. Where some issues were identified in the Reports for attention they had been attended to, and Mr Preswick had no further concerns about them. 2. We accept the evidence of Mr Preswick. There was no serious challenge to Mr Preswick's oral or written evidence which was also, in our view, substantiated by the many supervision reports and documentary evidence tendered in evidence during Stage I of the proceedings and in this Stage II. Findings 1. We are, satisfied, and find, that: 1. there has been gradual and ongoing improvement in the Respondent's performance and, over time, she has built up knowledge and an awareness of her responsibilities which are now adequate; 2. the Respondent now has adequate systems at the Pharmacy to avoid breaches of her obligations as a proprietor; 3. the Respondent's previous shortcomings identified in s 150 proceedings and in the Appeal have been sufficiently remedied; 4. extensive work has been done on improving her knowledge on the regulatory regime applicable to her practice, and the approach to the regulatory regime such that her knowledge is now adequate; 5. the Respondent has shown significant insight into her conduct, including in relation to the attempted importation of the complementary medicine, Phosphatidylcholine, had a gradual awareness and acceptance of her poor previous behaviour and no longer takes the view that others should be blamed for her conduct for which she accepts responsibility; 6. the Respondent's record keeping has significantly improved and the system of deleting data entries into dispensing records has been rectified and improved, particularly so as to ensure that if there is a deletion of an entry, a record is made as to the reason for such deletion; 7. if the Respondent were to continue practising, she would not be a risk to the public; 8. the Respondent has been practicing since September 2022 under conditions and supervision scrutinising her practice without default, or a need for any regulatory action against her; 9. on the evidence revealed in the regular monthly Supervisor Reports prepared by Mr Preswick, his other written and oral evidence, and the evidence of the Respondent the Respondent is highly unlikely in the future to engage in conduct of the kind proven in these proceedings and her deficiencies and failures are no longer present. Protective Orders 1. Having found that a number of complaints have been established, and that the Respondent is guilty of professional misconduct, the Tribunal's power to make protective orders under s 149C of the National Law in the form of suspension or cancellation of registration is enlivened. 2. In exercising its powers, the Tribunal must observe the objectives and guiding principles of the National Law, the paramount consideration being to ensure the protection of the health and safety of the public (s 3B, formerly s 3A). 3. In Health Care Complaints Commission v Do [2014] NSWCA 307 ("Do"), Meagher JA (with whom Basten and Emmett JJA agreed, held: "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 protective objectives under the National Law thus encompass considerations of specific and general deterrence, as well as upholding public confidence in the standards of the profession, including by denouncing misconduct as unacceptable (Do at [35] and [39]). 2. The Tribunal has given effect to the principles formulated in Do in numerous decisions, for example, in Health Care Complaints Commission v Duggan [2015] NSWCATOD 142, the Tribunal approached the issue as follows at [42]-[43]: "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 the health professions. 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 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." 1. In Health Care Complaints Commission v Bradley [2022] NSWCATOD 47, the relevant principles, as stated on many occasions by earlier decisions of the Tribunal considering the making of protective orders, were stated to include the following (at [101]): "The relevant principles in determining a protective order have been stated on many occasions and include the following: (1) the protection of public safety and health is paramount; National Law, s 3A; (2) public protection is achieved by ensuring that only health practitioners who are suitably trained and qualified to practice in a competent and ethical manner are registered; National Law, s 3(2)(a); (3) the Tribunal must consider the maintenance of standards of the profession, preservation of public confidence in the profession and, more broadly, the protection of the community: Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91]; (4) protective orders also involve 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: Prakash at [91]; (5) the indirect but important effects of a protective order which must be considered when determining the appropriate protective order. These include general deterrence to the profession and a public statement of the unacceptability of the conduct: see Health Care Complaints Commission v Do [2014] NSWCA 307 and New South Wales Bar Association v Meakes [2006] NSWCA 340; (6) whether seriousness of the conduct is sufficient to warrant suspension or deregistration is a matter of degree and judgment: Sabag v Health Care Complaints Commission [2001] NSWCA 411 at [82]; (7) the protective order should be "the least serious outcome that is reasonably necessary to protect the health and safety of the public (through specific and general deterrence, denunciation and promoting public confidence in the profession)": Health Care Complaints Commission v Ly [2010] NSWMT 20 at [20]; New South Wales Bar Association v Meakes [2006] NSWCA 340 at [113]-[114];" 1. We bear in mind in this case the principles set out at (7) that no order should be made which has more serious consequences for the practitioner than is reasonably necessary for the protective purpose of the Tribunal's jurisdiction: see also Health Care Complaints Commission v Tran [2021] NSWCATOD 82 at [123]; Health Care Complaints Commission v Saab (No 2) [2020] NSWCATOD 64 at [82] (and the cases there referred to). 2. The finding of professional misconduct exposes the Respondent to the possibility of her registration being suspended or cancelled, but that outcome is not automatic: Chen v Health Care Complaints Commission [2017] NSWCA 186; (2017) 95 NSWLR 334 at [14] per Basten JA. The Tribunal's choice of appropriate order following a finding of professional misconduct involves a "matter of degree and judgment" of seriousness sufficient to warrant deregistration (see, e.g. Sabag v Health Care Complaints Commission [2001] NSWCA 411 at [82]). 3. In Health Care Complaints Commission v Kesserwani [2020] NSWCATOD 65, the Tribunal considered the question of denouncement of misconduct and the impact of a reprimand. It was held at [104]-[105]: "The real issue is whether a suspension, as opposed to a reprimand, adequately serves to denounce Dr Kesserwani's conduct. A reprimand is self-evidently a "lighter" disciplinary measure than suspension. There is no doubt that Dr Kesserwani's conduct ought to be denounced. These proceedings are, in effect, denunciatory. An order to issue Dr Kesserwani with a reprimand, which will appear on the public record of his registration maintained by the Australian Health Practitioner Regulation Agency, also serves to denounce his conduct. While in exercising the power to make disciplinary orders, the protection of the health and safety of the public is the paramount consideration, nonetheless the form of order must be proportionate (which takes into account the public interest) and individualised (which takes into account the actual person upon whom measures are imposed). In our view, the orders proposed by Dr Kesserwani serve to denounce his conduct and, in addition, take into account the objective and subjective features of this case. In addition, they take into account that four and a half years have now passed since the Council imposed a series of conditions on Dr Kesserwani's registration with which he has fully complied." 1. Further, in Health Care Complaints Commission v Yildirim (No 2) [2022] NSWCATOD 100, the Tribunal drew attention to the need to also take into account an individualised and proportioned approach at [17]: "There can be no argument that Mr Yildrim's conduct must be denounced. The issue is whether as the Commission implicitly submits, any order short of cancellation, fails to achieve that objective. In exercising the power to make protective orders, the form of order must be proportionate (which takes into account the public interest) and individualised (which takes into account the actual person upon whom measures are imposed): Health Care Complaints Commission v Kesserwani [2020] NSWCATOD 65 at [105]. We have concluded that in the circumstances of this case, cancellation would amount to what Basten JA described in Chen at [14], as an "unreasonable or disproportionate exercise of the power" conferred on the Tribunal." 1. In Health Care Complains Commission v Robinson [2022] NSWCA 164 it was held at [31] (per Kirk JA): "The question is whether or not the conduct in question is of a sufficiently serious nature to justify suspension or cancellation. The conduct "must have the capacity to justify such an order, whether or not such an order should be made in particular circumstances": Health Care Complaints Commission v Karalasingham [2007] NSWCA 267 at [67]. Thus the Tribunal can make an order less severe than suspension or cancellation even though it has previously found that the conduct was sufficiently serious to justify such a remedy: Karalasingham at [67]; Lucire v Health Care Complaints Commission [2011] NSWCA 99 at [65]; note similarly EFA at [163]-[164]. For example, it may be that the subjective circumstances of the practitioner militate against such an order: note EFA at [171]-[172]." 1. The reference to EFA in that passage is a reference to the decision of the Court of Appeal in Council of the New South Wales Bar Association v EFA (a pseudonym) [2021] NSWCA 339; 106 NSWLR 383. 2. The Applicant stressed the relevant principles which the Tribunal should apply, namely, the maintenance of standards of a profession, preservation of public confidence in the profession and the protection of the community, the latter to be achieved by ensuring that only health practitioners who are suitably trained and qualified to practice in a competent and ethical manner are registered. It also emphasised the principle of general deterrence and the purpose of protecting the public from similar misconduct of others. It contended that asserted reformation of a practitioner's character is exceptional and requires clear proof. 3. The Applicant then also emphasised the approach as summarised by the Tribunal in Health Care Complaints Commission v Moses (No 2) [2019] NSWCATOD 190 at [28]: "It is well-established that the orders which this Tribunal is empowered to make consequent upon a finding of professional misconduct are protective in nature, and consistent with the provisions of the National Law which are directed to the protection of the public from the misconduct of health practitioners. There are four elements to the consideration of what are appropriate protective orders. The first is the protection of the public from the conduct of the practitioner. The second if the deterrent effect which a protective order will have on the future conduct of a practitioner. The third is the deterrent effect which such an order will have on the conduct of other practitioners, so as to dissuade them from engaging in the same or similar misconduct. The fourth element is the enhancement of the integrity of the practitioner's profession and the confidence that the public may have in the practise of that profession." Consideration 1. In this matter, the real alternatives available to the Tribunal are cancellation of the Respondent's registration with a non-review period, or a reprimand together with conditions attached to her registration. No party suggested that suspension of registration would meet the protective purpose of the orders to be made. 2. In considering the issue of cancellation we accept that the Applicant's submissions which we have summarised at [5] and [7] above have force. The submissions must, however, be weighed with the findings we have made on the evidence now before the Tribunal, and any relevant subjective circumstances at the time of the offending conduct. 3. In considering what protective orders, if any, are required in this case to meet the principles enunciated above, we again turn to identify the categories of conduct the subject of the proven Complaint. 4. First, Complaint 1 is the attempted importation of medicines and the dishonest conduct in seeking to achieve that outcome. 5. The second category, Complaint 2, involves the supply of a medicine which was not registered under the Poisons and Therapeutic Goods Act 1966 although as the Respondent explained, she was sympathetic to the young woman to whom this medicine was supplied, Patient J, because she was very ill. 6. The third category, Complaint 4, involved the deletion of records. 7. The conduct of the Respondent, the subject of the first category was, as we have found, serious misconduct and requires strong denunciation. The dishonest means in which the Respondent sought to achieve her goal renders this conduct, in particular, serious. 8. In relation to the second category, the Respondent supplied this medicine without a proper appreciation of the regulatory framework governing its supply. We do not consider this conduct, on its own, to be of sufficient seriousness to warrant cancellation of the Respondent's registration. 9. There is no evidence of any harm caused to anyone as a result of the supply of this medicine to Patient J. We do not regard the issue of the claimed absence of refrigeration during transportation of this medicine as reliably supported by the evidence to alter our view. The Applicant also did not raise this issue as part of the particularised complaint. 10. We also do not consider that the conduct the subject of the third category, Complaint 4, as sufficiently serious on its own, to warrant cancellation of the Respondent's registration. As we found in our Reasons, there may be many reasons for the deleting a dispensing record. For example, if an entry is made prior to supply, and there is then no stock available, deletion of the entry would not be inappropriate. 11. Although the deletion of the records were intended to remove scrutiny by the inspectors the conduct must be viewed in context. The records inaccurately reflected "dispensing" which was not a correct record of what had occurred as most of the medicine so recorded had not been supplied. As we determined at Stage I there is no evidence that most of the medicines so recorded had been supplied. The records as they stood were therefore inclined to mislead. 12. The subjective circumstances present at the time of the offending conduct, in our view, weighs in favour of the Respondent. As she explained, she lost her husband from tick-borne disease, she was enduring considerable personal hardship and was in part motivated to help others by the provision of the medicine she was seeking to import and supply. 13. On one view, all of the conduct, in the three categories referred to above, the attempted importation, the supply of the stock of vials the Respondent did have, the recording of orders as "dispensed" and the deletion of records relate primarily to the issue of this complementary medicine, Phosphatidylcholine, in the circumstances outlined immediately above. 14. In our view, and we are satisfied, it is highly unlikely that conduct of the kind in categories 1 and 2 is likely to be repeated. The Respondent clearly learnt from her errors, and the evidence does not support a conclusion that the public requires to be protected from a repeat of conduct of that kind. We are reinforced in that view by the evidence of Mr Preswick based on a current example of the Respondent declining to dispose of unusable drugs when requested to do so to the effect that the Respondent has now demonstrated judgment and skill in properly assessing whether the conduct sought of her is permissible. 15. We recognise that the Respondent's recordkeeping over a lengthy period of time was very poor. However, the current systems in the Pharmacy are also adequate to overcome those deficiencies. The changes in this regard which have been made appear to be reasonably embedded and have been in place for some time which provides a level of confidence that a relapse is highly unlikely. 16. We accept that up to the time of the Appeal, the Respondent's failure to have a full and proper appreciation of all of her responsibilities as a pharmacist were present and that in various early proceedings before the Pharmacy Council, she showed no real insight into the failings and lack of knowledge in certain areas. 17. If the Respondent's practice remained at the unacceptable level considered in the Appeal we would be satisfied that protective measures in the form of cancellation of her registration is called for. However, there has been, in our view, and as we have found, a material improvement in the Respondent's practice and she is unlikely to again engage in conduct the subject of our findings in Stage I. 18. We have therefore concluded, on balance, that in considering the protective nature of our jurisdiction it is not necessary to cancel the Respondent's registration for the protection of the public. 19. In addition, if contrary to our view, there remains a risk that the Respondent might repeat any of the conduct and failings in the future, the imposition of conditions of the kind that we deal with below should provide additional protection to the public to prevent similar conduct from possibly occurring in the future. 20. The paramount protective nature of our jurisdiction should not lead us to independently punish the Respondent for prior misconduct. Cancellation will in our view be a disproportionate exercise of our jurisdiction. 21. For the reasons which follow, the guiding principles of our protective jurisdiction will, in our view, be satisfied by the following: 1. denouncement of the Respondent's conduct; 2. conditions on the Respondent's registration as a practitioner. Denouncement 1. As the cases we refer to above make clear, a finding that a practitioner is guilty of professional misconduct does not, of itself, lead to cancellation of registration. 2. The Tribunal's decision in Stage I clearly denounced the Respondent's conduct which was proven. In addition, in our view, a reprimand, which we will issue in respect of the seriousness of the misconduct found, is a further denouncement of the Respondent's conduct in her practice. Specific Deterrence 1. We accept that, notwithstanding a conclusion that a cancellation order should not be issued, specific deterrence is a relevant and important consideration. In our view that objective will be satisfied by the imposition of conditions on the Respondent's registration which we intend to order as dealt with below. 2. Conditions of that kind have an adverse impact on a practitioner's ability to practise as a pharmacist in charge and subject to ongoing supervision especially where the practitioner is the proprietor of a pharmacy. 3. A reprimand and the conditions will therefore, in our view, provide adequate specific deterrence on the Respondent. General Deterrence 1. As to the question of general deterrence, in our view that principle will be satisfied by indicating to other practitioners, and the public at large, that conduct of the kind engaged in by the Respondent will visit upon practitioners the consequences which are reflected in these reasons. The reprimand and conditions that we intend to impose have a significant impact on the manner in which a pharmacist of many years' experience can conduct his or her practice and should act as a warning to others, and as necessary for the protection of the public. 2. The Applicant was also not able to persuade us that, as an alternative to cancellation or suspension, a reprimand and the imposition of conditions of the kind that we set out below would not satisfy the protective purpose and principles relied upon by the Applicant and as set out in the paragraphs [56] to [57] above. Conditions 1. In our view, a reprimand and conditions of the kind we set out below are sufficient to achieve the protective purpose that guides the Tribunal in the exercise of its powers under s 149C of the National Law. 2. The following conditions imposed by the Pharmacy Council on 12 September 2022 apply to the Respondent's registration: 1. Not to work as the sole pharmacist/pharmacist in charge. Upon entering the pharmacy premises in which they work, they must notify the pharmacist in charge. 2. To practise under Category C supervision in accordance with the Pharmacy Council of NSW's Compliance Policy – Supervision (as varied from time to time) and as subsequently determined by the appropriate review body. 3. Not to practise until a supervisor has been approved by the Pharmacy Council of NSW: 1. To conduct review meetings every week for the first two months and then monthly thereafter with the approved supervisor; 2. To authorise the approved supervisor to provide written reports to the Council in one monthly intervals, or as specified by the Council; 3. At each meeting the practitioner is to review and discuss their practice with their approved supervisor with particular focus on: 1. Proprietor oversight; 2. All process relating to high-risk medications including OTP; 3. Compliance with legislation, processes and procedures; 4. Record-keeping, including regular audits of documentation and prescriptions, 1. To authorise the Pharmacy Council of NSW to provide proposed and approved supervisors with a copy of full conditions, and any relevant decision or report. 2. Not to compound except for the purpose of undertaking a compounding course or assessment as approved by the Pharmacy Council of NSW. 3. Not to allow compounding in any pharmacy in which they have a financial interest. 1. We consider that the restrictions which currently apply to the Respondent's registration by means of the conditions set out in the Schedule attached to these reasons should continue subject to some changes. 2. As we point out above the continuation of these conditions have a threefold purpose, namely, continuing protection against a repeat of the established conduct, specific deterrence and general deterrence. 3. The need for continuing protection against a repeat of the established conduct is, in our view, desirable notwithstanding Mr Preswick's confidence of the unlikelihood of repetition in circumstances where the Respondent took a long time to come to grips with her wrongdoing, and then only gradually, even after the failure of the Appeal. 4. In addition, the Respondent acknowledged that she had benefitted greatly from the mentoring and supervision provided to her by Mr Preswick and agreed that a continuation of a mentoring arrangement will be beneficial to her practice in a complying manner. 5. As to the changes, in the first instance, the conditions should apply for a period of two years which will allow the Respondent further opportunity to further improve and embed the standard of her practice, and allow her conduct to be monitored by a supervisor, although that would not be necessary on the same regularity as presently applies. 6. The restriction that the Respondent should not be a pharmacist in charge and must be the subject of Category C supervision is a significant restriction and achieves the protection of the public on an ongoing basis. 7. We do not regard the conditions in respect of compounding as stated should remain, a position acknowledged by the Applicant. Costs 1. The Applicant seeks an order that the Respondent pay its costs as agreed or assessed pursuant to Clause 13 of Schedule 5D of the National Law. 2. The power to award costs is discretionary and as a general rule, costs will follow the event. 3. There are, however, circumstances where disentitling conduct on the part of a party might be a factor militating against the usual order as to costs (see Health Care Complaints Commission v Philipiah [2013] NSWCA 342 at [42] - [46]. 4. No argument was raised that there was disentitling conduct in this case. 5. We shall issue an order that the Respondent pay the Applicant's costs as agreed or assessed. Orders 1. Pursuant to s 149A(1)(a) of the Health Practitioner Regulation National Law (NSW), the practitioner, Dr Mualla Kadriye Akinci is reprimanded. 2. Pursuant to s 149A(1)(b) of the Health Practitioner Regulation National Law (NSW), the following Conditions are to be imposed on the practitioner's registration for a period of 2 years: 1. the practitioner is not to work as the sole pharmacist or pharmacist in charge and upon entering a pharmacy premises in which to work must notify the pharmacist in charge; 2. the practitioner is to practise under Category C supervision in accordance with the Pharmacy Council of NSW's Compliance Policy – Supervision (as varied from time to time) and as subsequently determined by the appropriate review body; 3. the practitioner is not to practise until a supervisor has been approved by the Pharmacy Council of NSW and is then to conduct review meetings every three months with the approved supervisor and at each meeting is to review and discuss their practice with particular focus on: 1. proprietor oversight; 2. all process relating to high-risk medicines including OTP; 3. compliance with legislation, processes and procedures; 4. record-keeping, including regular audits of documentation and prescriptions; 1. the practitioner is to authorise the approved supervisor to provide written reports to the Council in three monthly intervals, or as specified by the Council; 2. the practitioner is to authorise the Pharmacy Council of NSW to provide proposed and approved supervisors with a copy of full conditions, and any relevant decision or report; 3. the Pharmacy Council of New South Wales is the appropriate review body for the purposes of Division 8 of Part 8 of the Health Practitioner Regulation National Law (NSW). 1. Pursuant to clause 13 of Schedule 5D of the Health Practitioner Regulation National Law (NSW) the Respondent is to pay the Applicant's costs as assessed or agreed. ********** 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: 24 July 2024