Akinci v Pharmacy Council of NSW

The First Decision

1. On 13 December 2019, pursuant to s 150(1)(a) of the National Law, the Council suspended the Appellant's registration as a pharmacist with effect from that date, written reasons being given on 28 January 2020 (First Decision).
2. On 24 May 2018, a complaint was received from the Pharmaceutical Regulatory Unit (PRU) by the Council following an inspection of the Appellant's Pharmacy in Redfern (Pharmacy), where a number of non-compliances with the NSW Opioid Treatment Program (OTP) had been identified.
3. The complaint followed a random audit of methadone and buprenorphine patient dosing points under the OTP on 29 March 2018 and the Alcohol and Other Drugs Branch of NSW Health (AOD), having concerns regarding:

• incorrect balances in the Pharmacy's drug register;
• unaccounted for missing stock;
• unchecked Subutex TM and Suboxone® balances;
• non use of the methadone subsidiary drug register;
• non recording of doctor prescriber names in the Pharmacy's drug registers and dispensing records;
• incorrect dispensing calculations; and
• supply to clients not listed in the Suboxone subsidiary register.

1. The delegates determined that no immediate action should be taken at the time, but that the matter would be dealt with as a complaint against the Appellant.
2. On 13 November 2019, a new complaint was received from the PRU following a further inspection of the Pharmacy. The First Decision records that this inspection had been triggered by advice from the Australian Border Force (ABF) in relation to the importation into Australia of 225 vials of phosphatidylcholine for injection (which has a brand name Lesfal). At the time of the hearing, that product had not been approved for use in Australia and does not appear on the Australian Register of Therapeutic Goods.
3. The complaint alleged that the Appellant did not hold a valid importation approval from the Therapeutic Goods Administration for the product.
4. Following receipt of the advice from the ABF, the PRU conducted two inspections of the Pharmacy. In the course of the inspections, additional issues were identified relating to apparent breaches of the Poisons and Therapeutic Goods Regulation 2008 (NSW) in respect of Sch 4 and Sch 8 medications, including the OTP. It was noted that a number of the non-compliances with the OTP were similar to those which were the subject of the 2018 complaint.
5. A PRU report dated 7 November 2019 was prepared by Senior Pharmaceutical Officer Jessie Wei and Principal Senior Pharmaceutical Officer Kim Dolan. They concluded: "37. According to the dispensing data obtained from Gold Cross Pharmacy Redfern,it is noted that Ms Akinci and her employee pharmacists have failed to record the name of the prescriber by whom the prescription was issued,on significant number of occasions, in contravention of clauses 55 and 113 of the Poisons and Therapeutic Goods Regulation 2008. 38. It is also apparent that Ms Mualla Akinci has obtained imported injectable therapeutic goods that are not registered on the Australian Register of Therapeutic Goods (ARTG), potentially for use and supply, in contravention of the provisions under the Commonwealth Therapeutic Goods Act 1989. It is also an offence under section 36A of the Poisons and Therapeutic Goods Act 1966 to supply by retail unregistered or unlisted goods. 39. Further it is evident that pharmacists at Gold Cross Pharmacy Redfern have supplied without prescription to patients, an unregistered Schedule 4 substance, namely Essentiale. It is not clear as to how the pharmacists satisfy themselves that there is an immediate need to supply such substance for continuation of current essential medical treatment of that person, in accordance with the requirements outlined in clause 45 of the Poisons and Therapeutic Goods Regulation 2008. 40. Ms Mualla McManus (Akinci) has attempted to facilitate the importation of 225 vials of Lesfal® for injection containing phosphatidylcholine by providing a prescription to ABF that is written in her name by a prescriber in South Australia. This quantity does not appear to be appropriate for the purpose of personal use. 41. It is also noted that Ms Akinci has compounded on prescription disulfiram capsules which are indicated for the management of chronic alcoholism for herself. Given the availability of a commercial suitable product, namely Antabuse® (disulfiram) 200mg effervescent tablets, the compounding of disulfiram that is a close formulation to Antabuse® would not be likely to produce a different therapeutic outcome to the commercial product. Accordingly Ms Akinci does not appear to have complied with the current "Guidelines on compounding of medicines" published by the Pharmacy Board of Australia dated August 2017. She also failed to record the name of the prescriber who authorised such supply. … 43. It is evident from the OTP inspection conducted on 30 September 2019 that Pharmacists at Gold Cross Pharmacy Redfern: i) Have breached clause 113 of the Poisons and Therapeutic Goods Regulation 2008 because they have failed to record the details required by clause 80(1)(h) to be included in the prescription, i.e. the name of the person by whom the prescription was issued. ii) Have supplied methadone or buprenorphine on prescription without endorsing the date on which the drug was supplied, the address of the place at which the drug was supplied or the prescription reference number, in contravention of clause 88(1) of the Poisons and Therapeutic Goods Regulation 2008. iii) Have failed to endorse in ink across the prescription for a drug of addiction the word "cancelled", in contravention of 88(2) of the Poisons and Therapeutic Goods Regulation 2008. iv) Have failed to report to the Secretary of the NSW Ministry of Health when the original prescription for OTP dosing was not received within 7 days after the drug is supplied on the direction given by the prescriber, in contravention of clause 96(2) of the Poisons and Therapeutic Goods Regulation 2008. v) Have supplied methadone or buprenorphine on non-compliant prescriptions whereby the directions for use was not in the handwriting of the prescriber, in contravention of clause 85(1) of the Poisons and Therapeutic Goods Regulation 2008. vi) Have dispensed and supplied a Schedule 4 opioid, codeine phosphate, and multiple Schedule 4 Appendix D benzodiazepines, to a current OTP patient in a quantity or for a purpose that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances, in contravention of clause 54 of the Poisons and Therapeutic Goods Regulation 2008. vii) Have dispensed and supplied Schedule 8 opioids to a current OTP patient for a purpose that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances, in contravention of clause 109 of the Poisons and Therapeutic Goods Regulation 2008. viii) Have not kept prescriptions for a special restricted substance (Schedule 4 Appendix B drug), DHEA (dehydroepiandrosterone), separate from other Schedule 4 prescriptions, in contravention of clause 42(2) of the Poisons and Therapeutic Goods Regulation 2008. ix) Have not kept the current OTP prescription with the photograph and other documentation identifying the patient, and have not referred to the patient's current prescription and the patient photograph at the time of dosing, contrary to the NSW OTP Community Pharmacy Dosing Point Protocol. x) Have supplied Suboxone® film takeaway doses in paper envelopes which is not considered appropriate as it does not comply with Australian Standard AS2216-1997, Packaging for Poisonous Substances."
6. On 13 December 2019, an urgent hearing was held. In its decision, the Council concluded that: "59. In relation to the current complaint, Dr Mualla Akinci has demonstrated significant deficiencies in the basic knowledge expected of a pharmacist at any stage of their practice, including the appropriate retention of Schedule 4, Appendix B prescriptions, and the illegality of obtaining a prescription in the name of a person other than the intended patient. She appeared unable to detect the signs of an apparent forgery, raising questions about the possibility of other forged prescriptions having been dispensed. 60. Dr Mualla Akinci has also demonstrated a lack of knowledge, judgement, diligence and care in her attempt to import and supply for patient use a product which is not registered in Australia, and in the process providing false information to the Australian Border Force. 61. Dr Akinci has demonstrated a lack of insight, judgement, diligence and care in relation to her role as a proprietor. Her explanations about the practice of the Pharmacy were confused and unconvincing, leading the delegates to conclude that she is not aware of many of the operational aspects. 62. Critically, it does not appear that Dr Mualla Akinci has heeded the warning given her by the Council as a consequence of a previous section 150 hearing. Deficiencies in the practice of the Pharmacy have not been rectified and continue to pose risks to the health and safety of the public. 63. Accordingly, the delegates find that the practice, knowledge, understanding, diligence and care of Dr Mualla Akinci falls substantially below the standard expected of a pharmacist of any level of experience and that she poses a risk to the health and safety of the public".
7. The delegates considered whether conditions could be put in place to reduce the risk to the safety and health of the public to an acceptable level. They declined to do so, noting that: "64. … the [Appellant's] deficiencies in practice, knowledge, understanding, diligence and care are significant and are of grave concern when demonstrated by a pharmacist with her years of practice. Further, she has failed to rectify previously identified deficiencies, and appears not to have taken sufficient heed of the advice and warnings given to her in past years, resulting in a pattern of ongoing non-compliance. 65. The delegates therefore concluded that any conditions which permitted Dr Akinci to continue to practise as a pharmacist at this time would be insufficient to ameliorate the risk to an acceptable level. They therefore concluded that only suspension of her registration was appropriate."

The Second Decision

1. On 7 April 2020, pursuant to s 150A(3) of the National Law, the Council set aside the First Decision and instead imposed a series of conditions on the Appellant including not to work as pharmacist in charge of the Pharmacy, only to enter the Pharmacy or work in a pharmacy in the presence of the pharmacist in charge, to submit to an audit of the Pharmacy and to provide a copy of the conditions to her employers and employees (Second Decision).
2. Before the Council, the Appellant had provided an overview of her current situation and outlined what she considered to be relevant changes to her circumstances. In summary, these were:

• stabilisation of her mother's health;
• staffing issues and continuity of care at the Pharmacy;
• the financial position of the Pharmacy;
• rectification of PTGR issues identified by the PRU; and
• the implementation of safety measures as a result of the COVID-19 pandemic.

1. After considering each of these matters, the Council concluded that it was satisfied that the changes in the Appellant's circumstances warranted a variation of the First Decision. The Council set aside the suspension of her registration and imposed the conditions summarised above.

The Third Decision

1. On 12 October 2020, pursuant to s 150C of the National Law, the Council decided to again suspend the Appellant's registration, with effect from 13 October 2020, with written reasons being given on 30 November 2020 (Third Decision).
2. The Council considered the audit report of Mr David Preswick of 18 June 2020 (Preswick Audit Report) which had identified five key negative issues being:

• invalid Sch 8 prescriptions (both regular and OTP);
• the failure to have invalid Sch 8 prescriptions rectified;
• the failure to follow OTP Guidelines;
• poor filing; and
• inadequate understanding and application of PTGR.

1. The Council noted that Mr Preswick had stated: "Many prescriptions for S8s generally and OTP specifically were simply illegal. Many missed patient addresses, quantity in words or other required items. This is basic stuff and I was astonished when Dr Akinci said (I was incorrect) as 'these doctors have been doing it for 20 years and of course they'd know the rules'."
2. The Council considered the Appellant's response, the Preswick Audit Report, the Medisca 'dry audit' conducted on 25 June 2020 and the Appellant's responses to each of those audits was the subject of the hearing. The delegates noted that the Preswick Audit Report highlighted several failings of Dr Akinci in complying with OTP guidelines including in relation to premises and procedures; filing of scripts; dispensing of OTP; ordering, storage and receipt of methadone and buprenorphine; prescription and patient information; and takeaway doses.
3. The delegates stated that they were concerned that the Appellant was not aware of breaches in legislation such as the correct storage of the safe key and their staff did not use the Pharmacy's measuring cylinder to accurately measure methadone. The delegates found her contemporary knowledge to be unsatisfactory and not compliant with the Code of Ethics of the Pharmaceutical Society of Australia (PSA) Pharmacist Competency Principle One, namely "a pharmacist demonstrates a commitment to the continual development of self and the profession to enhance pharmacy practice".
4. The delegates were concerned that the Appellant did not have adequate procedures in the Pharmacy to regularly review scan rates or sufficient oversight as a proprietor to implement procedures to ensure that medication was scanned after it arrived in the Pharmacy and before it was given to a patient.
5. The delegates were "very concerned" that despite her assurances to Mr Preswick that she had updated her forensic knowledge, the Appellant "remains unable to tell us that verification supply authorised the supply of no more than 2 days' treatment [PTGR clause 87]".
6. The delegates asked the Appellant to describe emergency supply of a Sch 8 prescription, but found that she: "was unsure and could not answer without referring to the legislation. She attempted to look it up but didn't know where to find it. Her support person helped her find PTGR online and guided her to PTGR clause 96 'Emergency Supply by pharmacists' which refers to PTGR clause 81 'Emergency prescriptions may be given by telephone or otherwise'."
7. Accordingly, the delegates were "extremely concerned" that the Appellant's knowledge of verification supply and emergency supply was well below the standard expected of any pharmacist let alone one of many years' experience. The delegates said that this was "even more concerning" noting that her Pharmacy provides a health service under the OTP for patients who are vulnerable. They found the Appellant's contemporary knowledge to be unsatisfactory and did not comply with the PSA Code of Ethics for Pharmacists Competency Principle 1 (namely that a pharmacist demonstrates a commitment to the continual development of self and the profession to enhance pharmacy practice).
8. The delegates were concerned that the Appellant had stated that "the pharmacists were afraid to call the PRU and reluctant to call the PRU" for advice or to report any issues given that the PRU regulates the supply of drugs in NSW for public health and safety. They noted that, as a pharmacist and proprietor, the Appellant should be encouraging the disclosures which were required to be made under legislation.
9. The delegates then considered the compounding undertaken at the Pharmacy. They found the layout to be unsatisfactory. They stated that they were "very concerned" that the Appellant did not have any plans to address the issue.
10. The delegates concluded that: 1. the Appellant had a significant lack of knowledge of the PTGR, OTP regulations and guidelines and compounding regulations and guidelines; 2. the Appellant had an extensive repeated history of non-compliance in PTGR and OTP dating back to 2004 and had demonstrated an inability to sufficiently rectify those non-compliances; 3. the Appellant did not have a sufficient knowledge as a pharmacist and oversight as a proprietor; 4. the Appellant had falsified documents and forwards to the staff member signatures and recorded their initials in the "Hazard Communication Trading Form"; and 5. the Appellant's conduct departed from the PSA Code of Conduct in relation to: 1. Care Principle 1, namely that "A pharmacist makes the health and well being of the patient their first priority"; 2. Integrity Principle 2, namely that "A pharmacist only practices under conditions which uphold the professional independence, judgement and integrity of themselves and others"; 3. Competency Principle 1, namely that "A pharmacist demonstrates a commitment to the continual development of self and the profession to enhance pharmacy practice".
11. In addition to those departures from the Code of Conduct, the delegates noted that the Appellant had a history of non-compliance with the PTGR and the OTP guidelines.
12. They further noted that:

• in 2004, a Department of Health inspection made similar findings to those contained in the 2018 PRU inspection and the September 2019 PRU inspection;
• the Council practice audit undertaken in June 2020 demonstrated non-compliance with the PTGR and the OTP guidelines, and formed the view that the Appellant's non-compliance with the PTGR and the OTP guidelines had persisted for many years and that the Appellant had not remediated non-compliance.

1. For those reasons, the delegates concluded that the Appellant posed a significant risk to the health and safety of the public, and thought it was appropriate to suspend her registration. They formed the view that her conduct and performance as a pharmacist posed an unacceptable risk to public safety and undermined public confidence both in her as a practitioner and in the profession.
2. The delegates considered that there were no conditions that could be imposed to minimise the risk to the health and safety of the public to an acceptable level.

The Fourth Decision

1. On 2 February 2021, pursuant to s 150A(3) of the National Law, the Council affirmed the Third Decision (written reasons published 15 March 2021) (Fourth Decision).
2. The materials considered by the Council included two reports prepared by Ms Wei, being an interim report dated 9 December 2020 and a further report dated 12 January 2021. By way of general summary, in the interim report of inspection of 9 December 2020 Ms Wei stated: "12. During the extraction of dispensing records from the pharmacy at the time of the inspection, it was apparent that all records relating to the supply on prescription of the following substances have been removed from the system: i) Essentiale ii) Phosphotydlycholine iii) Disulfiram capsules (records pertaining to the supply to Mualla Mcmanus) 13. It is of grave concern that the records of supply of these substances on prescription from Gold Cross Pharmacy Redfern had been tampered with, as they were previously present. 14. Furthermore; the following Schedule 8 drugs have been found on the premises of the medical centre adjacent to Gold Cross Pharmacy Redfern, where the pharmacy proprietor Dr Mualla Akinci has access while being suspended from practice as a pharmacist. These drugs were not kept in the pharmacy drug safes, noting there are 4 drug safes on the premises of Gold Cross Pharmacy Redfern. Some drugs appeared to be expired and others appeared to be patient's returned medications … 15. Given Dr Akinci's current registration status she is not lawfully able to have in her possession any scheduled medicines unless these are being prescribed to her for medical treatment"
3. By way of general summary, in the report of investigation of 12 January 2021 Ms Wei stated: "1. Schedule 8 drugs have been found on the premises of a medical centre (About Redfern Medical Centre - owned by Dr Akinci adjacent to the premises of Gold Cross Pharmacy Redfern, where Dr Akinci access to while being suspended from practice as a pharmacist. It is noted that About Medical Centre did not appear to be operational at the time of the inspection. The drugs appeared to be pharmacy stock while some drugs have expired and others are patient's returned medication in patient names. Accordingly, Dr Akinci has breached section 10 of the Drug Misuse and Trafficking Act 1985 for illegal possession of prohibited drugs (drugs of addiction listed in Schedule 1 of the Act). 2. Dr Akinci has breached the storage requirements stipulated under clauses 29 and 73 of the Poisons and Therapeutic Goods Regulation 2008 (the Regulation)for storing the Schedule 4 and Schedule 8 medications in an area to which the public has access. 3. Records of supply of restricted substances (Schedule 4 drugs) including Essentiale, Phosphotydlycholine and compounded disulfiram capsules from Gold Cross Pharmacy Redfern had been altered or removed, as they were previously present on the dispensing report obtained on 6 September 2019. Accordingly, Dr Akinci breached clause 177(2) of the Regulation as these records have been removed. 4. It is apparent that the pharmacists at Gold Cross Pharmacy Redfern are not maintaining the electronic drug register with respect to the receipt and supply of Schedule 8 cannabis medicines. They have failed to make accurate records of transactions relating to the receipt and supply of Schedule 8 cannabis medicines. i) Majority of the entries in the drug register accounting for the receipt and supply of Schedule 8 cannabis medicines have not been made on the day on which transactions take place. They have been made retrospectively, up to 14 months after the date of dispensing. ii) Some entries related to the supply of Schedule 8 cannabis medicines are either duplicated or omitted. Accordingly, pharmacists at Gold Cross Pharmacy Redfern have contravened the requirements stipulated under clause 112 of the Regulation. 5. Pharmacists at Gold Cross Pharmacy Redfern have failed to carry out the prescribed inventory of stock of Schedule 8 cannabis medicines in March and September 2019, in contravention of clause 118 of the Regulation. 6. Prescription duplicates for the supply of Schedule 8 cannabis medicines could not be located on the premises of the pharmacy on the day of the inspection. It is likely that pharmacists at Gold Cross pharmacy Redfern have failed to keep the prescriptions separate from other prescriptions, in contravention of clause 89 of the Regulation. 7. The pharmacists at Gold Cross Pharmacy Redfern have been holding stock of an unregistered Schedule 8 product in anticipation of a prescription. The pharmacist-in-charge Mr Loc Tran was unable to produce any repeat form for Schedule 8 cannabis product to account for the acquisition of 2 bottles of Althea cannabis product, at the time of the inspection. 8. Some deficiencies noted in the previous PRU inspections of the premises of Gold Cross Pharmacy Redfern are still apparent. These included: - Dispensing of invalid OTP prescriptions written by Dr Mokpel Greis. - Continued use of inappropriate takeaway container i.e. paper envelopes, for Suboxone® film for the supply of takeaway doses for Suboxone® sublingual films. (a breach of Australian Standard for packaging 2216-1997) 9. Pharmacists at Gold Cross Pharmacy Redfern have dispensed repeat prescriptions of Schedule 8 and Schedule 4 Appendix B drugs i.e. Althea® cannabis and DHEA, whereby the prescription fails to specify the intervals at which the substance may be supplied, in contravention of clauses 40 and 86 of the Regulation. 10. Pharmacists at Gold Cross Pharmacy Redfern have supplied a Schedule 8 psychostimulant on prescription that does not bear the reference number of the authority issued to the prescriber authorising the prescribing of such drug, in contravention of clause 90 of the Regulation. 11. Dr Akinci has failed to demonstrate the high level of skill and knowledge relevant to the discharge of her duties as a pharmacist, in accordance with the Pharmacy Board of Australia's Code of Conduct dated March 2014. She has failed as a registered pharmacist, who is a proprietor of a pharmacy business, to maintain and be able to demonstrate an awareness of and the manner in which that pharmacy business is being conducted and, where necessary, intervene to ensure that the practice of pharmacy is conducted in accordance with applicable laws, standards and guidelines, in accordance with the Pharmacy Board of Australia's Guidelines on Responsibilities of Pharmacists when Practicing as Proprietors. 12. It is evident from the compounding worksheet obtained from the premises of Gold Cross Pharmacy Redfern that Dr Akinci has supplied compounded disulfram 200mg capsules on at least 15 occasions between 11 December 2017 to 4 December 2019. …"
4. The delegates recorded in the Fourth Decision that that report raised further concerns in relation to the practices of the Pharmacy and the Appellant's practice before her suspension. The key issues identified included, but were not limited to:

• Sch 8 drugs being found on the premises of the medical centre, outside a locked cabinet, thus breaching the regulations for storing Sch 4 and Sch 8 drugs;
• records for the supply of Sch 4 drugs including phosphatidylcholine and compounded disulfiram capsules having been altered or removed;
• issues with the recording of the receipt and supply of cannabis;
• inventory checks not being carried out in March and September 2020 in convention of cl 118 of the PTGR; and
• the dispensing of invalid Sch 8 prescriptions.

1. The delegates noted that the central issue for them to consider was whether there had been a change in the Appellant's circumstances that warranted the setting aside or varying of the Third Decision. The Appellant's solicitor had sent a letter to the Council identifying evidence the Appellant was relying on as a change of circumstances being: 1. her application for approval of a Professional Services Room/Relocation of Compounding laboratory; 2. compounding courses and further education (CPD) undertaken by the Appellant; 3. access to the Pharmacy being required to enable the NBN to be installed otherwise the phones would be cut off; and 4. as computers at the Pharmacy needed to be updated to Windows 10 because the current computer platform was too slow, the Appellant required access to the Pharmacy.
2. The delegates advised the Appellant that the application for the Professional Services Room was not a change in her circumstances or practice. They further advised her that, to attend the Pharmacy to enable the installation of the NBN and upgrades to the computer system, she was required to apply to Council to obtain consent for her to access the Pharmacy under cl 5(4) of Sch 5F of the National Law, a s 150A review not being the correct forum for this to be discussed or determined.
3. As such, those three matters were not considered by the Council.
4. The Appellant told the Council that, in addition to completing the CPD, she had also engaged in a mentoring program with Mr David Preswick.
5. During the course of the hearing, the delegates considered the Appellant's evidence in relation to the following matters.
6. First, the Appellant's compounding operations. Here the delegates set out an extended analysis of the evidence at [24(a)(i) - (x)]. They observed that: 1. the Appellant's explanations about the failure to record certain information in worksheets was "completely implausible", and that "the use of a completed worksheet to appease aggressive customers makes no sense"; 2. the lack of appropriate training of pharmacists undertaking complex compounding posed serious health and safety issues, worsened by the Appellant's admission that the pharmacist in charge on the day in question who supervised the interns' compounding also did not have appropriate competency. The delegates observed that it was "very troubling" that the Appellant did not have any insight into the dangers that were presented by this practice.
7. Secondly, the compounding of Disulfiram at the Pharmacy. The delegates noted that the Appellant's responses to the compounding of Disulfiram at the Pharmacy lacked credibility; they were critical of her "ever changing explanations"; and queried whether there was "an intention on her part not to provide the full picture of what [was] occurring in her pharmacy".
8. Thirdly, the dispensing of Phosphatidylcholine/Lefsal/Essentialle. The delegates:

• noted that, having reviewed the documents prepared for the hearing, the Appellant had provided "very different statements regarding what was and wasn't dispensed and supplied, and who were the patients in the prescribers";
• observed that the "September 2019 'Blank' report raise[d] numerous concerns";
• found the Appellant's account that a patient would re-present with new prescriptions in subsequent months if they had not received a supply of certain medication to be "completely implausible", and were very critical of the differing accounts of events she had provided to the Commission and the Council, which it found appeared to be a "deliberate attempt to deceive the regulators".

1. Fourthly, deleted records. The delegates noted that the PRU investigation report of 13 January 2021 found that numerous records that appeared in the September 2019 'Blank' report were not included in the December 2020 'Blank' report which was extracted from the dispensing software. Specifically, records of phosphatidylcholine and compounded Disulfiram capsules had been removed. The delegates considered that the deletion of the records "adds further to our concerns that Dr Akinci is less than candid with the Council and may be attempting to deceive the regulators".
2. Fifthly, knowledge of poisons legislation. Here the delegates:

• expressed their concern that, given the history of the Appellant's interactions with the Council concerning her lack of compliance with regulations, she continued to practice without consulting relevant legislation and guidelines;
• observed that the fact the Appellant did not recognise that dilution of Vyvanse capsules was complex compounding and did not seek the appropriate permission was "again of significant concern";
• were concerned that the Appellant did not appear to have policies in place to ensure the safe and legally appropriate storage of scheduled medications within the Pharmacy;
• were concerned that, "despite the repeated legal and safety issues identified by the PRU on several occasions", the Appellant had not rectified the safety issues with appropriate and workable processes.

1. The delegates concluded: "Do these changes justify setting aside the decision to suspend? 31. During the 150C hearing in October 2020, which resulted in the suspension of Dr Akinci's registration, the delegates formed the view that Dr Akinci had a significant lack of knowledge of the PGTR, OTP protocol, legislative framework enabling pharmacist compounding and compounding guidelines. The delegates noted an extensive repeated history of non-compliance in OTP and PGTR requirements that dates back to 2004 and that Dr Akinci has demonstrated an inability to sufficiently rectify these non-compliances. The report from the December PRU inspection also raises a number of further concerns as noted above. 32. We note that Dr Akinci has undertaken some training in compounding and further training is planned to improve her practice. We also note training in OTP and an application for an associated professional services room in which she has indicated she will undertake her compounding. 33. We also note that since the suspension was imposed a further inspection of the Pharmacy by the PRU raised multiple serious issues of concerns which has not been adequately addressed by Dr Akinci in this review. 34. Some of Dr Akinci's explanations during the hearing were implausible and we have not been presented with any evidence to support her assertions. We found that Dr Akinci has been less than candid in her responses and explanations in relation to the dispensing of disulfiram and phosphatidylcholine and the deletion of dispensing records. Further, the issues noted in the PRU report show that despite many past assurances that she is aware of the legislation and regulations, Dr Akinci's non-compliance with the regulations persists and this is supported by her a written procedure for destruction of [Sch] 8s in an illegal manner. 35. We also note the many discrepancies between the submissions that Dr Akinci has provided at different times to different people. These discrepancies are also supported by the records that paint a very different picture to the explanation she has given. Given this, we have very low confidence that Dr Akinci is being truthful in her representations to Council and cannot be certain that she can and will practice the profession in a way that is protective of public health and safety. 36. Having considered the changes presented by Dr Akinci, being the courses that she has undertaken and information about the improvement of her knowledge, we believe this does not justify the setting aside of the decision to suspend her registration. We are of the opinion that Dr Akinci still poses a risk to the health and safety of the public and that is in the public interest that Dr Akinci's registration remain suspended." (emphasis added.)

Summary of evidence before the Tribunal

1. There was a vast amount of material before the Tribunal.
2. In summary, the written materials relied on by the Appellant included two volumes numbering over 1,000 pages. These materials included but were not limited to various materials and submissions relied on by the Appellant before the various Council proceedings; correspondence; references; supporting documentation referred to in a "Dry Audit Update"; a gap analysis report; various submissions; a statement of the Appellant; a "Mentor Report" of Mr David Preswick; and evidence attesting to courses undertaken by the Appellant.
3. In summary, the written materials relied on by the Council included four volumes numbering over 3,000 pages. These materials included but were not limited to the documents considered by the Council at the various s 150 hearings; transcripts of those hearings; various reports of the PRU; copies of the various complaints; and correspondence.
4. In addition to the written materials, the following witnesses attended the hearing to give further evidence and to be cross-examined. These included the following.

The Appellant herself

1. It is appropriate to briefly summarise the Appellant's statement filed in the appeals.
2. She was born in Turkey in 1960.
3. She and her family emigrated to Australia in 1971 when she was 11 years old. At the time they did not speak English at all.
4. After completing her secondary education, she studied a Bachelor of Science at Monash University, majoring with Honours in Immunology in 1983.
5. She then commenced a PhD at the University of Melbourne, but due to the indisposition of her supervisor, she completed a Master of Science (Haematology) instead. When she was writing her Masters, she commenced a Bachelor of Pharmacy at Monash University, graduating in 1988.
6. She then moved to Sydney in 1990 to start a PhD at the University of Sydney, Department of Pharmacology. Her supervisor was Prof Graham Johnston. During her PhD she worked as a pharmacist all over Sydney including Redfern.
7. Following completion of her PhD, she was awarded a postdoctoral fellowship at the Garvin Institute.
8. Following her research at the Gavan Institute, and a short "career in the pharmaceutical industry", she purchased the Pharmacy in 2000. That same year she married her late husband, Karl McManus.
9. Mr McManus was bitten by a tick in 2007. They found it difficult if not impossible to find appropriate treatment and Mr McManus died in July 2010.
10. Following his death, the Appellant started what she describes as a "crusade" to raise research funding for understanding of tick borne diseases. She established the Karl McManus Foundation, which was awarded significant grants to conduct research into tick-borne diseases.
11. Currently, the Appellant is involved in various organising committees to get a better understanding of tick-borne diseases in the world globally.
12. She had a daughter born by surrogacy in July 2020.

Mr David Preswick

1. As noted above Mr Preswick prepared the Preswick Audit Report. Since then he has carried out mentoring of the Appellant. He provided a Mentoring Report dated 22 December 2020. In that report he concluded: "Executive Summary: Mentor sessions and exam I conducted two mentoring sessions via zoom, the first on Thursday 17th Dec 2020 and the second on Friday 18th Dec 2020. The total time was just under 4 hours and the mentoring concentrated on the forensic area of pharmacy practice. A summary of each session follows. I also produced an exam which was conducted on Mon 21st Dec 2020 at 3:30 which ran for approximately 70 minutes. Details of the exam format, delivery and marking are detailed in appendix one with the exam. All notes on the exam paper were written in black during exam. I acknowledge weaknesses in exam format and even delivery of exam where time allocations were sometimes incorrect. Questions were generally well understood by Dr Akinci and I acknowledge there was some ambiguity in a few. During mentoring, Dr Akinci demonstrated acceptable knowledge of OTP and we worked from top to bottom through TG201/5. Theoretically Dr Akinci has good knowledge of OTP and the exam questions on OTP were answered well. I have concerns about prescriptions submitted to the Pharmacy Council response that were not valid as these were post my audit and I would have assumed Dr Akinci would know if they were valid or not. I have not seen these. After mentoring and during exam Dr Akinci demonstrated a good ability to navigate the PTGR's but during exam still made errors of fact. There was some confusion with verification supply. I found Dr Akinci a keen learner and she spent considerable time over the weekend doing extra study of standards etc. The mentoring sessions and exam showed progress and a very good attitude by Dr Akinci but it is inescapable there are gaps in her knowledge and practical application of this knowledge. Dr Akinci has agreed and is keen to do 4-5 mentoring sessions with homework in the period leading up to her NCAT appeal." (emphasis added.)

Prof Andrew McLachlan AM

1. Prof McLachlan is the Head of School and Dean, Pharmacy, at the University of Sydney. He provided a Letter of Support dated 13 January 2021. He has known the Appellant for over 30 years. He says: "I have had the chance to follow Mualla's career and contribution as a pharmacist and researcher over the last 3 decades. Mualla has been generous in sharing her experience with students and researchers at the University where she has been actively involved in teaching and has held positions as an affiliate. I am very much aware of her passion and interest in providing help and support for people experiencing tick borne illness. Her commitment to raising awareness and generating evidence to inform the best care is well recognised by her colleagues. As a pharmacist, Mualla has actively served the community in one of the most diverse and challenging settings. I am aware that Mualla has always tried to put the care of her patients first and actively worked to support vulnerable people. In summary, my experience of Mualla is that she is a pharmacist who displays considerable personal integrity and demonstrates respect for colleagues and the patients she cares for in her practice."

Dr Anthony Byrne

1. Dr Byrne is an Addictions Physician practising in Redfern. He provided a character reference dated 17 December 2020. He has known the Appellant for over 20 years. He relevantly says: "…have known Dr Mualla McManus (née Akinci) for over 20 years as a professional pharmacist in Redfern. She has a sound vocational reputation and to my best knowledge she is respected by local health workers, colleague pharmacists and her customers/patients. Dr Akinci has been of great assistance to patients of mine over many years, oflen going beyond the normal expectations to ensure correct medication is available to Redfem residents even outside of normal business hours, often at no charge and always with polite, respectful and professional service I am aware that out of a personal tragedy Dr Akinci has become a tireless advocate for sufferers of Tick Borne diseases. She has established a philanthropic organisation to advocate for victims and to support research. I am also aware of Dr Akinci's previous extensive work in the pharmaceutical industry and neurosciences. She was involved in diverse research including haemopoetic drugs which I personally required on the occasion of my having lymphoma some years ago. Her scientific publication CV is very impressive. Dr Akinci has also provided the services of a Justice of the Peace to the residents of Redfem, a service which is hard to find in the present day. I would commend Dr Akinci as being an upstanding, law-abiding and respected member of the Redfern community who. For many years. Has shown herself to be a committed, caring and honest professional in every way."

Emeritus Prof Graham Johnston AM

1. Prof Johnston was the Appellant's PhD supervisor in 1990-1994. He provided a character reference dated 25 January 2021. He also has known the Appellant for over 30 years. He relevantly stated: "I have known Mualla since I was her PhD supervisor 1990-1994. I have kept in close contact with her ever since. She was an exceptional student and produced key findings on the effect of stress on neurotransmitters in the brain. When her husband died from a tickborne disease she showed great initiative in setting up a foundation in his honour to study such diseases in 2010. Mualla invited me to become a Director of the Karl McManus Foundation and I served as such until 2017. Both the Foundation and the Karl McManus Institute of Tickborne Diseases are a thriving tribute to Mualla's drive and perseverance I have great admiration for her. She shows great resolve and tenacity in her interactions with fellow scientists, government officials and members of the concerned public. I have no hesitation in recommending Dr McManus as an exceptional person of good character."

Ms Ann Cincotta

1. Ms Cincotta is a pharmacist and a casual academic. She provided a character reference dated 13 December 2019. She has also known the Appellant for over 30 years. She says that: "Presently the proprietor of a busy Redfern community pharmacy, [the Appellant] provides accurate and professional handling of all medications, respecting directives and policies to maximise safety. She is a dedicated effective pharmacist and able to withstand the stresses and strains of sometimes difficult customers especially noted in "after-hours" trading as a sole pharmacist, where she has had to deal with many confronting face-to-face medical situations. Her manner is always one of concern, practicality and frankness, stemming from a strong sense of social justice and compassion and she quickly gains patient trust and confidence. [The Appellant] also has embraced the aboriginal community in this locality. She shows understanding and empathy and formed strong ideas to aid and support this medically vulnerable group. In summary, Mualla is a thoroughly honest and kind person who ultimately values herself and all those around her, working very hard to deliver a professional pharmacy service in an often difficult urban area."

Dr Armin Schwarzbach.

1. Dr Schwarzbach is a specialist in diagnosing tick-borne diseases and practises in Ausburg, Germany. He provided references dated 17 August 2020 and 17 December 2020. He has known the Appellant for 10 years. In his first reference he relevantly states: "[The Appellant] is diligent and has ethical understanding of the needs of patients. She is always professional. At all times she works to ensure public health and safety is protected. She has published in peer revlewed International Journals. I am very surprised with her being contacted by the Pharmacy Board of NSW as she always ensures people are informed of all aspects of medicines. The one off purchase of Essentiale (phosphotidlycholine IV) is a slight overlook. Essentiale is available in the USA. Phosphotidyicholine is an unrestricted product avallable in health food shops, as a chemical entity it is in our bodies, ie is an integral part of the cell membranes. With the intravenous form the only danger would be the sterility of the vial contents. This product is administered in a doctor's surgery by a nurse so any complications can be identified quickly. A product brand owned by Sanofi or its cross licenced brand Lesval Is manufactured using GMP (good manufacturing practice) which is the gold standard for manufacturing by all pharmaceutical organisations. The use of phosphotidylcholine in the world is common and safe. I am very sure the same mistake will not be repeated. She has no predisposition to engage in improper conduct in the discharge of her duties as a pharmacist."
2. In his second reference, after acknowledging "allegations against her about her pharmacy administrations" states: "She has a busy pharmacy in a low socio-economic suburb which provide a big challenge for her and her staff. In addition, she provides opioid treatment program which provides even more challenges as large number of her clients have mental health issues. Her suspension on 13 Oct is unfair as allegations against her are unfounded. She is a pharmacist with high professional standards. She is a honest person with impeccable reputation amongst her colleagues in Australia and overseas. The Federal Health Dept and the Federal Health minister communicate with her regarding tick borne disease issues in Australia as it was her endeavours that enabled tick borne diseases to be in the forefront of health issues in Australia, prior to Covid-19. She is a benefit to the public not a hazard. Her suspension prevents her providing essential pharmacy services to her clients."

Prof Paul Habin AM

1. Prof Habin is Head of Discipline, Discipline of Addiction Medicine, in the Faculty of Medicine and Health at the University of Sydney. In his letter dated 16 December 2020 he says that that the Appellant had successfully completed the Fundamentals Training in Opioid Treatment (online) course, which is an introductory program covering the basic concepts of the NSW Opioid Treatment Program and the prescribing of opioid pharmacotherapies.

Mr Thomas Adams

1. Mr Adams was an intern pharmacist and pharmacist-in-charge for the Appellant in 2020. He provided a reference dated 21 January 2021. He says: "Through my tenure at the pharmacy and in my interactions with Dr McManus I found her to be knowledgeable, professional, passionate and caring of the clients she interacted with. Even in instances where other matters seemed more pressing for her attention, she always gave priority to her patients and did her best to look after their health. I recall an instance in which a distressed patient presented to the pharmacy concerned about the amount of medication she had been prescribed. The patient plainly had other life stresses in addition to her medication. Dr McManus was able to calmly speak to the patient, address each of her medication concerns and in addition provide consolation on some of her Social and psychological stresses. By the end of the interaction, Dr McManus had changed what could have been a volatile and hostile situation into a positive outcome for the patient. To surmise [sic - summarise], I can say that for the duration I have known her, I believe Dr McManus to be a hardworking, caring professional and I have great respect for her personal and professional accomplishments. She is clearly passionate in her convictions which is an asset to her quality as a leader, a pharmacist and a healthcare advocate."

Ms Jessie Wei

1. Ms Jessie Wei attended the hearing to be cross-examined by the Appellant's counsel. Ms Wei is a Senior Pharmaceutical Officer with the PRU and prepared investigation reports in respect of the Appellant dated 7 November 2019, 9 December 2020 and 12 January 2021. The report of 7 November 2019 was before the Council at the time of the First Decision and is summarised above at [21].
2. The reports of 9 December 2020 and 12 January 2021 were before the Council at the time it made the Fourth Decision. They are summarised above at [44] and [45] respectively.

Mr Preswick and Ms Cincotta

1. We will discuss in further detail Mr Preswick's and Ms Cincotta's evidence below.

Additional evidence in chief

1. At the commencement of the cross-examination, the Appellant's counsel Mr Fernandez adduced some additional evidence in chief. That evidence was as follows: "MR FERNANDEZ: Dr Akinci, you're asking this Tribunal to end your suspension to allow you to practice as a pharmacist again; is that correct? DR AKINCI: Yes. MR FERNANDEZ: Why would you like to be able to act as a pharmacist again? DR AKINCI: I have been a pharmacist for 30 years and the people of Redfern need me, and I have been serving them and my duties to look after my patients and the people in Redfern."

Cross-examination

1. The cross-examination then commenced, which lasted the best part of two days. The topics covered a range of topics including but not limited to the complaints of 2004; the Appellant's absence from the Pharmacy while her husband was ill; the Preswick Audit Report; Mr North's report; what she did to address the concerns expressed in the various PRU and other reports; and the conditions she proposed the Tribunal place on her registration were the Tribunal minded to lift her suspension.
2. In relation to the 2004 complaints, the Appellant had limited memory of some of these events as they occurred a long time ago, such as the Pharmaceutical Services Branch writing to her in 2004 about some concerns with the Pharmacy.
3. In relation to, in 2014, a complaint being made in August of a dispensing error that the Appellant dispensed a prescription for Methotrexate 10mg, with directions to take a dose of ten tablets rather than a dose of 10mg, the Appellant said that: "This complaint was when I first went to the pharmacy after being absent for a long time and I remember the lady was very rude, demanding, and I wasn't going to dispense it but the manager had popped out to go to the Aboriginal Medical Service and she was in a very angry mode and so I thought I will help out and that's when the mistake happened because I hadn't been in the pharmacy for a long time."
4. The Appellant accepted that this should not have happened and that she should have waited until the manager came and let him dispense.
5. In relation to Mr North's Professional Performance Assessment dated 20 February 2015, the Appellant said that she "supposed" she accepted Mr North's assessment for a need for remediation in her counselling structure demonstrating the use of medicine devices, her obligations to the Poisons and Therapeutic Good Acts 1966 (NSW) (PTG Act) and the PTGR and current guidelines for pharmacist only medicines. She also accepted as fair Mr North's assessment that delegation of tasks may not have been monitored as closely as they should have been.
6. Mr Stafford asked the Appellant what she had done to address her understanding of the PTG Act and the PTGR. The Appellant said: "I did go through the Poisons and Therapeutic Goods Regulation and the Act and instigated procedures for handling of pharmacist only medication, and assessing staff adherence and developing checklist areas and me monitoring, however, the manager at the time would not, because I had been away for a large, you know, a significant amount of time, he would not take directions from me and we were at loggerheads, and he would not adhere to procedures that I put out for him and we had a clash."
7. The Appellant explained that after giving the manager three warnings she terminated him in about 2015. The following questions and answers ensued: "MR STAFFORD: There's no secret to why I'm asking you this question, Dr Akinci, because this report was 20 February 2015. I'm trying to get an understanding from you as to when these issues were rectified, if they were rectified. I understand, incorrectly from you, that these issues weren't rectified while this person remained the pharmacist in charge. DR AKINCI: There were attempts to, like there were attempts to get them rectified but with his presence I could not because he did not respect me as his proprietor. MR STAFFORD: Well, as the proprietor the buck stops with you, doesn't it, in making sure that the pharmacy is compliant? DR AKINCI: That's right, but I terminated his position and reinstated a new pharmacist but he would not leave. MR STAFFORD: So how long was it before these issues that were raised by Mr North were ultimately addressed?"
8. A little later, the following exchange took place: "MR STAFFORD: Do you understand now though that the responsibilities of the owner of a pharmacy as such, that responsibility of supervising him always sat with you? DR AKINCI: Yes. MR STAFFORD: Did you appreciate that at the time? DR AKINCI: I did, but it was - he was not a person who would allow me to supervise him. MR STAFFORD: Let me suggest to you that that's not an excuse for the way the pharmacy was being conducted. DR AKINCI: I agree it's not an excuse, but you have to understand I had been away. I had been traumatised. I had lost my husband and I'm coming back into the pharmacy and this person does not want to take instructions from me. I have a battle in front of me. So this is the time when this battle was happening."
9. As to the Performance Review Panel Review of 23 June 2015, Mr Stafford asked the Appellant what she wanted to say to the Tribunal about the concerns that were expressed. The following discussion took place: "DR AKINCI: Yes. I would like you to realise that this was back in 2014 where I was just coming back into working as a pharmacist, so what took place then does not reflect what's happening now, currently. MR STAFFORD: Well, this, in fact, was mid-2015, wasn't it? DR AKINCI: Well, the whole of that process was because of the 2014 error. So this was all an ongoing process. MR STAFFORD: But this is the assessment of the performance review panel in mid-2015 after they have been able to have you in a room saying that they don't think that your understanding of this legislation is sufficient. DR AKINCI: This was still when I was affected, as I said to you, because I was still just getting into practice at the time. MR STAFFORD: But you had had about 12 months by this time, hadn't you, to get back into practice? DR AKINCI: No, because I wasn't in there, like it was saying, that I was there 13 hours a week. MR STAFFORD: So during that period you were practising 13 hours a week? DR AKINCI: Which was not significant."
10. Mr Stafford then noted that the Review Panel had stated: "Dr Akinci blamed the computer program, Z Dispense software. She stated that the computer program ignored the 'm' with '10' and instead printed 'Take 10 tablets a week,' instead of 'Take 10 milligrams a week'."
11. Mr Stafford put to the Appellant that she did not check the label in the dispensing program before printing it and then did not read the label and verify the directions with the prescription before labelling the product. The Appellant's response and the following questions and answers were as follows: "DR AKINCI: But that still refers to 2014 with my first dispensing after being absent for a long time and at that time still Mr Petros was still in the pharmacy. MR STAFFORD: Well, having reviewed these materials again do you still say today to the tribunal that it was a computer error ‑ ‑ ‑ DR AKINCI: No, what I'm saying ‑ ‑ ‑ MR STAFFORD: ‑ ‑ ‑ with what happened in 2014? DR AKINCI: What I'm saying is it was a genuine mistake. MR STAFFORD: It goes on to say that: You did not scan the product and that an experienced pharmacist would be expected to follow the PDL 'Guide to good dispensing' which incorporates a number of routine checks and procedures that should be observed on each occasion that a prescription is dispensed. DR AKINCI: This was 2014. Again, I had been absent. There had been changes in the pharmacy which I haven't been aware of. So this still goes back to 2014. MR STAFFORD: The panel notes - and you mentioned the QCPP accreditation before - but the panel notes that: Dr Akinci's pharmacy is QCPP accredited. She does not always follow her written procedures and at times it appears she is not fully aware of what these require. DR AKINCI: This is still 2014. MR STAFFORD: It then goes on to say: It is also of concern that during the performance assessment you demonstrated some incorrect processing and labelling practices which were similar to the key issues of the complaint. DR AKINCI: This was still 2014 where I hadn't been in the pharmacy for, you know, a considerable amount of time."

Re-examination by Mr Fernandez

1. Mr Fernandez re-examined the Appellant in ten areas relating to: 1. the proposed conditions; 2. how the Appellant's care of her late husband affected her management of the Pharmacy; 3. Mr Pertsis; 4. the historical incidents involving the Appellant's contact with the authorities dating back to 2004; 5. Dr Akinci commencing compounding at the Pharmacy in and around about 2015 and 2016; 6. the performance reviews of 2016; 7. recent developments with staff, including her efforts to find a pharmacy manager, and questions about her employee Mr Abdul Rahman; 8. Pharmacy software; 9. Photographs of the Pharmacy as it currently is; 10. The Appellant's goals and intentions if her suspension is removed and she has difficulties or problems in the future.

Evidence of Ms Cincotta

1. Ms Cincotta gave some brief oral evidence at the hearing. Mr Fernandez asked if she was aware of the First, Second, Third and Fourth Decisions and that the Appellant had had difficulties which had brought her before the Council. Ms Cincotta told the Tribunal that: "… I've been trying to assist because she isn't allowed on site. She has a team working without their leader. I've been attending staff meetings to try and identify any gaps or any bridging that I could be doing. Yes, it's been very difficult and her team are a good team, and they need ‑ needed may be some liaising between her being separated, yes. MR FERNANDEZ: When you use the word "bridging", are you describing yourself "bridging", Dr Akinci who can't be on the premises or wasn't on the premises with her staff who were actually at the pharmacy? MS CINCOTTA: Yes, because she has been trying to fix ‑ correct all the imperfections or procedures in methodology, and trying to allay that to her staff, but she's not ‑ hasn't been there to see how busy they are, whereas I can enter the pharmacy and I have been popping in to see how they're going, if they had any issues or concerns. I just wanted to be there to help, nothing in any official manner, though I thought important to attend the staff meetings because that's where that main translation and see how she was coping and how they were coping, yes, with this stipulation and yet to try and continue to run the pharmacy. MR FERNANDEZ: How often have you been going into the pharmacy within the last year for example? MS CINCOTTA: In the last year, well, when Mualla needed to go overseas, she asked me to look after the staff, and I attended may be only once a week or twice a week and may be at the end of the week and when I went, it was very busy, and I just had to leave them alone. If you interrupt somebody when they're so busy they'll make a mistake, but that was my error. When she started having problems ‑ I didn't really understand or know that she was having problems with the Pharmacy Council, she asked me if I could help and I said I can, if you want me to go in I'll check on your staff. I was going, may be it had been once a week or may be once every two weeks. Before the last hearing I made it about two or three times in that proceeding week in case the Panel or anyone wanted to ask me how I thought it was going. Thereafter that, it was the end of my semester, I could not go in and I was a bit frightened to be honest to you, I didn't know who I was supposed to talk to or what I was supposed to do, but I was very busy myself. In this last week I'd been may be at least every second day because I want to again, just check how the staff are going, how Mualla's going. I just hope I can help, yes."
2. Mr Fernandez then took Ms Cincotta to the conditions the Appellant was proposing. These are set out in [119]. She said that she had had discussions with Mr Preswick who: "had a great checklist which I really liked, because I think the regulations are a bit scary, frightening, and a checklist sort of narrows it down to the most important points, and that helps me and I think it helps everybody. We talked it ‑ so he's mainly to get the ‑ I understood that he was mainly to make sure that we had the regulations right and we need someone there to make sure we have and that I'm there to identify if there's any gaps into executing these, aiming for seamless methodology, and to look after the team, to make sure that they've got time. I mean you can put in these problems ‑ not problems, put in these methods and if they don't have time to do it, you've got to go back to step one. So I see it as review and refine, so ‑ and I'm looking forward to working with him. "
3. She also gave evidence about the implementation of appropriate protocols and procedures in the Pharmacy.
4. Mr Fernandez then asked Ms Cincotta about Section 3 of the conditions, being the conditions which required her support. In summary Ms Cincotta said that "Yes, this has been very all thought out. I am a busy person, and this is comfortable for me. It's all points, one to four weeks, a bit more frequent contact which I've been doing in the last couple of weeks anyway, just to work on each of these staff shifts and the ‑ to (indistinct) staff members, and then to continue with staff meetings because I think they're very telling. I can correct, I don't understand this agenda item, I work with Mualla, Dr Akinci to make sure that it's quite clear, that the (indistinct) items are good and that's another role that I play."
5. Ms Cincotta was then briefly cross-examined by Mr Stafford. Broadly speaking she confirmed that there was nothing in the Council Decisions which affected the views she had expressed in her reference. She confirmed that she would assist Mr Preswick to "implement the regulations". When Mr Stafford suggested that that was not a role that was contemplated by the conditions (the role being providing assistance with team building) Ms Cincotta said that she thought that implementation of the regulations was "sort of inbuilt".

Oral evidence in chief

1. Mr Fernandez asked Mr Preswick to explain certain statements in the Preswick Audit Report.
2. In relation to his comment that "Dr Akinci has a history with breaches" and that he had spent some time "rather forcefully impressing upon her" the need to give this the utmost priority, Mr Preswick said that: "Most of the issues in and of themselves were breaches and you could call them technical breaches but they were breaches nonetheless about prescriptions missing, items which makes them technically invalid and so invalid illegal, however you want to call them. And because some of these had come up before, I said to her that there comes a point where people just get fed up, the authorities, and if she doesn't pay more attention to these - what some would call minor, but I would call it breaches and breaches, a breach is a breach, that her whole registration would be at risk. And so, I kind of laid down the law and said, 'You've got to get your act together now' and that's essentially what I said and she seemed to take a very positive - she had a very positive response to that and she said, 'I really want to' and, and that goes back to what I said of 'Getting it' and I felt encouraged because this other pharmacist, this Kamal was of a similar mind and she was young and seemed keen to, to learn and there was another young guy called Tom who was intern who also seemed keen to, you know, just do their best and do everything correctly.
3. In relation to his comment that he gave the Appellant and her staff "the tools, processes, systems et cetera", when asked to explain what he was referring to, stated: "I didn't give them in huge detail, but I tried to leave them to (indistinct) to do it in, in other words, I said, "You're going to have to write SOPs" cause we went through that standard operating processes. For each aspect of what to view and when they got my report, they'd find out each of those and so I taught them lots of things when I was there but I said they'd have to document and do them properly in the future but most of them were fairly simple fixes but in the long run you need documented procedures for them to work and also monitoring systems for it. So, in pharmacy it's not as simple as putting SOP in place, its monitoring, checking and feedback that's the most important thing in any pharmacy. So, you can't say "Okay I'm going to put a process in place, goodbye", it's the part of the - it's standard operating procedures, it's got a structure and the structure would be the planning part of it, if you break down an SOP, there's the planning, there's the doing, then there's the checking and then there's the acting. And someone used an SOP properly will actually continually be checking and acting on deviations from it. So, I gave them just a start - nothing beyond that."
4. Mr Preswick gave the following explanation for agreeing to mentor the Appellant: "My time with her at the pharmacy gave me some encouragement that firstly I thought, most of the issues were easy fixes which a few good processes put in place. I certainly didn't see signs of drugs subject to abuse floating through the pharmacy, as many cases like this you see quantities of things like fentanyl and oxycodone, this was - most of Dr Akinci's identified issues were and I don't like to use the word technical breaches because they're just breaches anyway but they were breaches of process. So, I thought well I can help her with knowledge and with processes and certain I was impressed the staff and I thought this was a really challenging place and they seemed to be very good with their customers. I myself, have had huge methadone programs, one of the biggest in New South Wales at one stage, so I'm experienced and it is a challenging work environment and I think apart from the historical breaches and the ones I saw, I thought they were doing quite a good job there in the way they dealt with the clients, which was a challenging clientele."
5. As to the Appellant's demeanour, Mr Preswick said: "she was the leader, I saw her deal with people and it was - she's empathetic. I think she's had a tough time hurting in her own personal life which I didn't know about and I'm just learning about. But I could see this is someone who I used the term, who's got sympatico. She seems to be understanding people and I saw her even with people who were aggressive, she spoke quietly and they'd calm down and she just seems to be a good person to be in that kind of program."
6. After discussing the process undertaken in preparing his mentoring report dated 22 December 2020, Mr Fernandez then discussed with Mr Preswick the proposed conditions on the Appellant's registration.

Cross-examination

1. Mr Preswick confirmed that he had held two "formal" mentoring meetings with the Appellant, in addition to telephone calls, and that there had been no mentoring meetings since 30 April 2021. The mentoring meetings did not touch on compounding. Mr Preswick agreed, by reference to the Preswick Audit Report, that in June 2020 he had real concerns about the opportunities that Dr Akinci had already had in the past to rectify problems at the Pharmacy, real concerns about her role as proprietor of the Pharmacy.
2. Mr Stafford put to Mr Preswick that "you'd have to accept wouldn't you, that when you start adding up the attitude reflected in these types of responses, that although she has acknowledged in her evidence on a number of occasions that she understands she has ultimate responsibility as proprietor, that she still in fact has a misunderstanding that the buck stops with her in respect of the practice?"
3. The following dialogue ensued: "MR PRESWICK: I just can't be a hundred per cent sure either way with that. Certainly in all conversations I've had with Dr Akinci in the sessions I've had with her, whenever she has thought to allocate responsibility to others I just say, "Listen, this is your responsibility" and I think that got through quite well, and this is the reason for this, yes, and once she gets systems in place and to ensure that she really understands. Dr Akinci came from a bit of a different background entering into pharmacy ownership. Most people would go through deployment, becoming a manager, becoming a partner, becoming an owner, and she's had ‑ she came through academia and through locuming, so I don't know that she's really had that intense training in some disciplines. I think she's on a pharmacist scale generally she's good, but there's ‑ on management, there's work to be done and that's why I have advocated mentoring both by the combination of myself and Ann Cincotta and she's got certainly skills that I don't have, and I've got skills that she doesn't have. So I think it's this embedding management skills and responsibilities to be sure and I think six months is certainly adequate for that. MR STAFFORD: It's one thing, isn't it, to provide mentoring assistance to overcome gaps or shortcomings in performance which on the one hand can be readily fixed by improving knowledge or processes? MR PRESWICK: Yes. MR STAFFORD: It's another thing all together isn't it, to overcome attitudinal or conduct problems where a particular practitioner has been given numerous opportunities to improve performance, but still maintains attitudes that tend to suggest that a lack of understanding or a lack of willingness to implement her role as proprietor? MR PRESWICK: If I saw evidence of wilful misconduct or deceit, fraud or if I saw large quantities of drugs subject to abuse going through that pharmacy, I would be worried about her ethics, et cetera, and I concur with you, attitudes are hard to change, but hers are mainly functional skill based gaps. There was some knowledge gaps, I think mostly (indistinct) but they're mainly functional and skill based. So it's getting processes in place and good habits, and I think once she's got there and some proper management skills, I think that's different to ‑ if I was trying to argue with someone who has been involved in fraud or something like that, that's a personality trait that's very hard to ‑ you know, it's inbuilt to someone, but to say that ‑ let's look at it another way. If this is ‑ if we call this competence, you can teach competence, and so the attitude will change as the competence becomes better I think. So the short answer, I concur with ‑ there's an element of risk, but I think with a good attitude on her part, and with intense work on behalf of myself and Ann Cincotta, I believe the risk is actually quite small."
4. The balance of the cross-examination was taken up with the workability of the proposed conditions on the Appellant's registration were the Tribunal to lift the suspension.

Additional evidence of the Appellant's referees

1. We will not paraphrase the oral evidence of the various referees. Suffice it to say that without exception they were supportive of the Appellant.
2. We have referred to the evidence of Ms Cincotta and Mr Preswick because of their proposed roles in the conditions the Appellant asks to be placed on her registration.

Ms Wei

1. Ms Wei's evidence is of some importance to the Appellant. As we note below, the Appellant made submissions to the effect that the "untested information, untested evidence, and the information provided by Ms Wei about the compounding worksheets" was incorrect, but was one of the reasons why in the Fourth Decision the delegates did not lift the Appellant's suspension.
2. Ms Wei was extensively cross-examined by Mr Fernandez about her inspection of the Pharmacy on 3 December 2020 which was the subject of her reports of 9 December 2020 and 12 January 2021. In particular, he asked questions about the layout of the Pharmacy and the separate area referred to as a medical centre or a proposed medical centre.

Appellant's proposed conditions on registration

1. The Appellant asks that her suspension be lifted and that she be allowed to resume practising, subject to various conditions.
2. Those proposed conditions (Conditions) are as follows: "1. MENTORING BY DAVID PRESWICK 1.1 Week 1 after lifting of suspension: (a) Audit style Assessment review of current processes and records to identify gaps by David Preswick. 1.2 Weeks 2 to 4 after lifting of suspension: (a) Weekly Audit style assessment review of S8s, OTP and Compounding; (b) Identify and request tour of a similar large OTP pharmacy and a Compounding Pharmacy for Dr Akinci to compare and contrast her own processes. (c) Identify peers for ongoing interaction and support. (d) Work with Dr Akinci to develop, review, refine, and implement detailed Standard Operating Procedures or Processes (SOPs) for the following: SOP Title/description Rationale OTP Dosing The pharmacy needs a detailed and documented process for the actual dosing process OTP handling of prescriptions and recording and filing This includes receipt of scripts, filing, scanning and naming rules, a process of daily auditing etc Update Dispensing procedures The pharmacy already has one based on QCPP, but it needs updating. Develop a Drugs subject to abuse SOP This gives a framework of action for staff when presented with prescriptions subject to abuse. It would also describe a system of monitoring. An induction SOP for new pharmacists with emphasis on OTP. This pharmacy has a challenging demographic and although OTP regulations are standard, this pharmacy has peculiarities including short term OTP transfers from the aboriginal medical service. The induction should also include a cultural awareness component. An S8 audit program (already in place) This has not been assessed to ensure effectiveness Destruction of S8 medicines SOP A note taking process and retrieval SOP Supply without prescription SOP This would cover situations of emergency supply of prescriptions, reporting and tracking. Develop an intranet portal for documents and training resources for staff. A start has been made on this and assessment and planning for future would be beneficial Review Existing SOPs for Compounding and creation of any other SOPs required for Compounding

(e) Dr Akinci to undertake any CPD if weaknesses identified. 1.3 Weeks 5-26 after lifting of suspension (a) Ongoing mentoring, audit style assessment review of current processes and records to identify gaps on a fortnightly basis. 1.4 By Week 26 after lifting of suspension (a) Proposed mentorship plan for Dr Akinci (b) Audit by pharmacist nominated by Pharmacy Council of NSW of S8s, OTP and Compounding; (c) Monthly Mentor Report by mentor, David Preswick to Pharmacy Council to end 26 weeks after lifting of suspension. 2. COMPOUNDING (a) No compounding for 6 weeks after suspension lifted. (b) Mentor, David Preswick, to approve commencement of Compounding, based upon procedures in place ready to commence Compounding. 3. SUPPORT BY ANN CINCOTTA 3.1 Ann Cincotta to provide assistance with teambuilding amongst staff at Gold Cross Pharmacy by: (a) From lifting of Dr Akinci's suspension to 4 weeks later (i) Attend at the Gold Cross pharmacy 2 days per week, for up to 2 hours at each visit, ensuring that each 2 weeks Ann Cincotta has a session with each of the pharmacists in charge; (b) From 4 weeks after lifting suspension until 26 weeks after lifting suspension: (i) Attend at the Gold Cross pharmacy 1 day per week for up to 2 hours on each visit ensuring that in each 4 week period Ann Cincotta has a session with each of the pharmacists in charge (c) From lifting suspension until 26 weeks after lifting suspension Ann Cincotta will attend staff meetings."

Summary of Appellant's submissions

1. We had the benefit of lengthy oral and written final submissions of Mr Fernandez (in addition to earlier submissions filed by the Appellant). He submitted that the suspension of the Appellant's registration should be lifted and that the Conditions discussed above be imposed on her registration.
2. He commenced his oral submissions by noting that the Tribunal had heard from various referees including Prof Johnston, Dr Byrne and Prof McLachlan about the Appellant's skills, experience and devotion to her patients, who are "substantially indigenous people, people with mental illness and people with social disadvantage" and for whom the Appellant has committed herself for working. He noted that Dr North described her as "a very talented and gifted pharmacist. Her understanding of immunology, haematology and pharmacology I believe far exceeds that held by most pharmacists".
3. Then Mr Fernandez noted that the consequences of the Appellant working in Redfern had been that is was difficult to find staff and she had been "held up" with a machete on three occasions.
4. He accepted that while Dr North talked about the Appellant's "firm basis in knowledge", there was a need for assistance with certain aspects of her practice.
5. Mr Fernandez noted that Mr Preswick had said: "If I saw evidence of wilful conduct, deceit, fraud or large quantities of drugs, I would be worried about her ethics. I agree her attitudes are hard to change. Her gaps are mainly functional, and skill based once she's got that. If someone is involved in fraud, that is a personality trait that is inbuilt. If this is called a lack of competence," referring to Dr Akinci, "you can teach competence. Her attitude will change as competence comes. With a good attitude on her behalf and with intense work by myself and Ann, her risk is small. … We've identified a dispensing error in 2015. I'm not seeing evidence of her as a high risk pharmacist from the point of view of mistakes. I don't want to diminish the breaches, but these are mainly process breaches and good habits will be formed. I don't think she's ever had management training and process training. In the period, the risk to the public should be minimised. Within six months, the conditions will not be needed anymore."
6. Mr Fernandez emphasized that Ms Cincotta and Mr Preswick were "two people who have put themselves forward, who have undertaken specific responsibility to look after Dr Akinci and to support her". He noted that their mentoring was a two step process, with Mr Preswick: "identifying the technical aspects, and Ann Cincotta letting [the Appellant] know which pharmacists, if any, are showing any signs of inadequate performance. Part of Ann Cincotta's role in team building is to direct the culture of the pharmacy or assist in directing the culture of the pharmacy to ensure it operates well."
7. In oral submissions he submitted that: "Mr Preswick said in his evidence, and I've quoted this at paragraph 10 of my written outline, "I say these processes will work. I will put myself on the line." That's what he is doing and that's what Ms Cincotta is doing. Each of them is putting themselves on the line. This Tribunal had the opportunity to see and to hear from both. This Tribunal can see that they are both committed, competent, intelligent people, and they're putting themselves forward as people who will take responsibility to help Dr Akinci with the deficiencies that she has had. Ms Cincotta has a different set of skills and expertise that she is going to contribute and that can be seen in the conditions. Her involvement ‑ she's been involved in retail pharmacy for many, many years. More recently she's been involved with the academic side of pharmacy. She is an educator. Part of her work, and that's why there's reference in the conditions to team building, is to reinforce technical deficiencies that may very well be found, and that's what this Tribunal heard from Ms Cincotta is her expertise, those beyond the building of the team, but supporting what Mr Preswick identifies as being the areas that Dr Akinci needs help with. That's why I say at paragraph 12 that the mentoring by Mr Preswick and Ms Cincotta is in two steps."
8. Mr Fernandez also made lengthy submissions about the Conditions. In summary he submitted that they comprehensively and carefully provided for "supervised staged return to full practice as a pharmacist" by the Appellant. He submitted that the protection of the health and safety of the public would be ensured through the imposition of the Conditions.
9. Mr Fernandez said that each breach had to be seen in its particular context and that: "This is not one uninterrupted course of conduct or one episode of breaches. The difficulties Dr Akinci has had were a consequence of the particular circumstances she found herself in, at each of the particular times involved".
10. By reference to the oral evidence of Ms Wei, he submitted that: "Now that the Tribunal knows that the worksheets were not inside the pharmacy but instead were inside the premises of the Medical Centre, the Tribunal can draw a different inference and can accept more easily Dr Akinci's evidence on that point. That's why the location of the compounding worksheets was important. The other aspect is of course that the report prepared by Ms Wei which was later relied upon in the pharmacy by the pharmacy delegates, was on this point simply wrong, and that would allow this Tribunal to draw its own inferences."
11. Mr Fernandez further submitted that: "Can I make the point lastly about untested information, untested evidence, and the information provided by Ms Wei about the compounding worksheets, was one that was very substantial because it provided the basis on others in the February 2021 section 150A hearing for the Pharmacy Council to draw inferences, and it was one of the reasons why the suspension of October of last year was not lifted. As this Tribunal now knows, that was a factually wrong state of the information about the location of the compounding worksheets, and therefore, the Pharmacy Council in February of this year relying on that factually wrong statement by Ms Wei, precluded Dr Akinci from having her suspension lifted. That just makes the point about prejudice to Dr Akinci as a result of having to wait for this final investigation to take place, and to be concluded, and wait further after the, if a prosecution is commenced until she can in fact test that evidence. This could be a very long time. I won't even try and guess how long that is, because at this stage there's no evidence as to when the HCCC investigation will be concluded or even at what stage the HCCC investigation is at."
12. Mr Fernandez noted the Appellant's recent efforts to improve the state of the Pharmacy.
13. In relation to the ongoing Commission investigation, he submitted: "… one of the difficulties in waiting for the HCCC investigation is, there will be a continuation of information which is not tested, and it's unfair to Dr Akinci to keep her suspension in place, when she won't be in a position to test that evidence until quite some time in the future. This Tribunal has a powerful example of how the information that's been prepared in investigations of Dr Akinci, can be wrong, and that information being wrong had consequences for her, because it was relied on by the Pharmacy Council in its determination."
14. He submitted that another reason why the suspension should be lifted was that: "even though there's a HCCC investigation going on, and that is because of delay. There is simply no evidence about what stage this investigation is at, and when it's going to conclude. Any attempt to identify that would be pure guesswork, yet the consequence is, as the Pharmacy Council would submit, that the suspension should remain in place, even though at some future time, unknown, there might ultimately be a further and a final investigation into Dr Akinci. That is an indeterminate period of time. Dr Akinci has put forward a concrete proposal as to how she can practice in such a way as the … health and safety of the public can be assured …"
15. He adopted Mr Preswick's evidence that: "… there has to be an end point' to the suspension. A suspended Pharmacist has very limited opportunity to implement process. They are not in practice. You are dammed if you do and dammed if you don't. She cannot establish these things. There is no doubt about the difficulty in staff at Redfern. It is very hard anywhere in Sydney to get a good manager anywhere. Hopefully she will be that good Pharmacist."
16. And, in answer to Mr Stafford's question "As the suspension is on an interim basis, isn't the safer course in relation to the risk to the public to leave the suspension in place?" Mr Preswick's response was that: "This is a decision for the Tribunal. My submission is that all indications are that her attitude is very good. Her knowledge has increased, her various breaches are mainly functional, and competence related, rather than deceitful and wilful actions".
17. Finally, Mr Fernandez submitted: "I turn then to the final part of my submissions, which is another aspect that Mr Preswick was asked about by the Pharmacy Council and which will form part of the Pharmacy Council's submissions to this Tribunal, which is that Dr Akinci has had a number of chances in the past, and there's been, according to the Pharmacy Council, no satisfactory remediation. The answer to that is that the health and safety of the ‑ sorry, the protection of the health and safety of the public doesn't rely on a finite number of chances being given to a person, it relies on evidence put forward to this Tribunal by Dr Akinci, that the removal of her suspension can assure that very goal, that is the protection of the health and safety of the public, and it can assure that goal through the conditions imposed, and the various other changes made by Dr Akinci, which the Tribunal has heard evidence of."

Council's submissions

1. At the outset of his oral submissions, Mr Stafford was asked to address what the Tribunal described as the "compounding worksheets issue", described by Mr Fernandez as "'misinformation' provided in Ms Wei's report which the Council relied on in its decision not to remove the suspension in the [F]ourth [D]ecision". Mr Stafford submitted: "We already know that Dr Akinci had been compounding Disulfiram because she answered questions about it and said she was, so in that context, there is ‑ if Ms Wei got something wrong, it is the fact that she said that the compounding worksheets that were in appendix A were found on the premises, when she acknowledged in the report, though she acknowledged very freely in cross‑examination they were found in the adjacent office, but I'm not sure how that helps Dr Akinci at the end of the day because the real question is, why was she compounding Antabuse at all when there's a commercial product available and in the circumstances that I cross‑examined her on, associated with those orders, sorry, those worksheets. So I'm not sure that Ms Wei's testimony lies in tatters as a result of that difference between the sheet that Mr Adams was dealing with and the sheets that were found on the adjacent premises, and certainly one couldn't say that one, if we want to call it a slip, the fact that she said the compounding worksheets in appendix A were found on the premises of the Pharmacy, I mean she didn't deny that at all and in fact she gave the willing evidence that it was found in the adjacent property, but I'm just not sure that it helps Dr Akinci because the compounding worksheets were found in her office, and that's to be added to the fact that Mr Adams was observed compounding Disulfiram capsules.
2. The balance of Mr Stafford's oral and written submissions may be summarised as follows.
3. First, the history of complaints and compliance issues against the Appellant was extensive: 1. commencing on 10 May 2004 when the Pharmaceutical Services Branch within New South Wales Health wrote to the Appellant advising that she did not appear to be complying with certain requirements of the provisions of the PTGR; 2. continuing with her conduct leading to the First, Second, Third and Fourth Decisions summarised above; and 3. including various other complaints made concerning the Appellant or her Pharmacy including: 1. an inspection report of the Pharmacy Board of New South Wales of 16 November 2004 identified deficiencies in equipment and outdated publications; 2. on 6 December 2005 an inspection report of the Pharmacy Board of New South Wales identified that the name of the pharmacist in charge was not correctly displayed, in that the wrong name was displayed and it was partially covered. The complaint was considered by the Board on 23 February 2006, at which it considered a submission from the Appellant that the pharmacy was in the process of making a new name plate for a new pharmacist and the situation had been rectified, and the Board decided to take no further action; 3. on 29 February 2012 a complaint that when Medicare details were not showing on the system the client was made to pay the full amount for scripts rather than the discounted pension rate; 4. on 28 August 2014 a complaint that the Appellant had recorded a number of tablets rather than a number of milligrams on the dispensing label; 5. on 6 August 2016 a complaint made in respect of takeaway methadone being charged two weeks in advance; 6. on 3 January 2019 the Chief Executive Officer of the Aboriginal Medical Service Redfern made a complaint concerning the Pharmacy regarding Webster packs containing regular medications being provided to clients of the service that dispensed one months' worth of medication, rather than it being limited to weekly or fortnightly packs; 7. on 19 February 2020 a complaint that despite her suspension the Appellant was continuing to dispense under other pharmacists' initials, including Sch 8 scripts.
4. Secondly, the Appellant had been given every chance and every indulgence to address concerns with the operation of the Pharmacy over many years.
5. Thirdly, the Appellant's suspension needed to be maintained so that the Commission can have the "breathing space it needs" to properly investigate the matters.
6. Fourthly, the assurances that the Appellant had given in the past, and if given again, are no assurance that the safety of the public can be assured in the interim.
7. Fifthly, there is an unacceptable risk to the health and safety of the public if the Appellant were permitted to practice because: 1. the Appellant has a significant history of demonstrating a lack of knowledge of the PTGR, the OTP regulations and guidelines, and the compounding regulations and guidelines; 2. there is a history of allegations of non-compliance with, or breach of, legislation or regulations, or of departure from guidelines, relevant to the operation of the Pharmacy; 3. the Appellant does not have sufficient knowledge as a pharmacist and oversight as a proprietor to ensure that she and her pharmacy practice in accordance with the relevant legislation, regulations and guidelines; 4. the Appellant has repeatedly asserted that she will rectify deficiencies in the pharmacy or her practice, or that she can manage concerns with further education and training, or mentoring, whereas history has proven that these assurances have in many respects not come to fruition; 5. the Tribunal should not place any real weight on the Appellant's assurances of compliance or her asserted ability to ensure compliance and this tends against conditions being appropriate to protect public health and safety in lieu of the suspension; 6. the lack of candor found by the Council in respect of the Third Decision; 7. the Appellant demonstrates a lack of insight into her conduct.
8. Sixthly, the Appellant has repeatedly asserted that she will rectify deficiencies in the Pharmacy or her practice, or that she can manage concerns with further education and training, or mentoring. However, a number of issues have recurred frequently and the evidence continues to suggest that the Appellant lacks the knowledge to practice safely or to procure the compliance of her employees with the law and the standards that are expected of pharmacists.
9. Seventhly, the suspension is also in the public interest to maintain the public's trust in the regulation of pharmacists and pharmacy ownership. Pharmacists are the gatekeepers of public access to important drugs and medications and the regulatory framework, in restricting pharmacy ownership and regulating the way pharmacists perform their role, seeks to promote public health and safety.

Consideration

1. In Medical Council of New South Wales v Smithson [2021] NSWCA 53, the Court of Appeal noted that the principles applicable to the determination of an appeal under s 159 had been extensively discussed in Ghosh v Medical Council of New South Wales (2020) 102 NSWLR 303; [2020] NSWCA 122 and Kirby v Dental Council of NSW [2020] NSWCA 91. The Court of Appeal observed at [20] that the most important principles were: "(1) The role of the Tribunal in a s 159 appeal of the present kind is to apply s 150 standing in the shoes of the Council. The hearing is de novo and not limited to evidence before the Council. The legal standard to be applied is fixed by s 150: Kirby at [117]-[119]; Ghosh at [9]. (2) The subject matter, scope and purpose of s 150 makes clear that it is a protective provision with two independent limbs. The touchstone for the exercise of the Council's role under s 150(1) to make an order suspending the practitioner's registration or imposing conditions on it is that the Council be satisfied that it is appropriate to do so for (i) the protection of the health or safety of any person or persons (the first limb), or (ii) that the action is otherwise in the public interest (the second limb): Kirby at [15]; Ghosh at [5]. The two limbs may overlap but the public interest is not subsumed in the first limb: see Pharmacy Council of NSW v Ibrahim [2020] NSWSC 708 at [35]. The two limbs are disjunctive; satisfaction of either will suffice to trigger the obligation imposed by s 150. (3) The proceedings are not disciplinary and are not necessarily referable to a complaint. The National Law otherwise makes provision for dealing with complaints against registered health practitioners: see Div 3 Subdivs 2-6. The function of a s 150 hearing is purely protective in character: Kirby at [15]; Ghosh at [5]. By s 150D, a Council must, after taking action under s 150(1) (except in the case of impairment), refer the matter to the Health Care Complaints Commission ("HCCC") to be investigated as a complaint. By s 150F, in a case of impairment, the Council must consult with the HCCC to see if agreement can be reached as to whether the matter should be dealt with as a complaint or referred to an Impaired Registrants Panel: Ghosh at [3]. … (5) Because the circumstances in which action under s 150 may be taken include that there may be a continuing dispute as to the relevant facts and that investigations into complaints concerning the practitioner by bodies such as the HCCC may not have been completed or even commenced, the Tribunal is not required to make conclusive findings of fact based on the material before it. The s 159 hearing does not involve determination of the merits of a claim: Kirby at [14], [139]; Ghosh at [9]. (6) The role of the Tribunal is to make an assessment of the evidence and determine whether it is satisfied that it is appropriate to make one of the orders referred to in s 150(1). The s 159 hearing is not the occasion to consider, let alone determine, whether a practitioner is currently a fit and proper person to carry on the role: Ghosh at [9]. (7) The 'protection of the health and safety of any person or persons' does not require there be actual harm suffered by any person. Because s 150 is concerned with protection, it is sufficient if it can be demonstrated that there is a potential for harm: Ghosh at [9]. The Tribunal's role in this case was to make an assessment of the evidence and determine whether it was appropriate, on either of the bases for which s 150 provides, that an order be made under s 150 for the protection of the health or safety of any person or persons or otherwise in the public interest. (8) As s 150 is a protective provision, it is appropriate ordinarily for the Tribunal, in deciding whether it is satisfied that it is appropriate to make an order under the first or second limb, to make an assessment about the nature and degree of risk to the health or safety of any person or persons or to the public interest (in the sense of the chance of the suggested harm being realised) and the consequences of the suggested harm being realised (in the sense of the seriousness of the harm that will ensue if the risk is realised): see X v The Commonwealth (1999) 200 CLR 177; [1999] HCA 63 at [41], which addresses risk in a different context. Reaching that state of satisfaction involves the Tribunal making an assessment of all of the evidence before it. (9) The essential question which the proper conduct of a s 159 hearing de novo requires the Tribunal to address is whether allowing the medical professional to practise, or to practise with certain conditions, involves an unacceptable risk to the health and safety of the public, or otherwise involves an unacceptable risk to the public interest: Ghosh at [103]." (emphasis added.)
2. We accept the Council's submission that the essential question to address is whether allowing the Appellant to practise, or to practise with certain conditions, involves an unacceptable risk to the health and safety of the public, or otherwise involves an unacceptable risk to the public interest.
3. Notwithstanding the thousands of pages of evidence and submissions relied on by the Appellant, we consider that there is substance in the Council's submissions that there would be an unacceptable risk to the health and safety of the public if the Appellant were permitted to practice.
4. This is for the following reasons.
5. First, the Appellant has a significant history of demonstrating a lack of knowledge of the PTGR, the OTP regulations and guidelines, and the compounding regulations and guidelines. We do not accept that the online course completed by the Appellant on 16 December 2020 sufficiently overcomes our concerns in this regard.
6. Secondly, there is a substantive history of allegations of non-compliance with, or breach of, relevant legislation and guidelines, and we are not confident that the Appellant has a sufficient knowledge and capacity as a pharmacist and oversight as a proprietor to ensure that she practices in accordance with the relevant legislation and guidelines.
7. Thirdly, while the Appellant has repeatedly asserted that she will rectify deficiencies in the Pharmacy or her practice, or that she can manage concerns with further education and training or mentoring, these assurances have in many respects not come to fruition.
8. Fourthly, we are disturbed by the Appellant's lack of candor found by the Council in the Third Decision.
9. Fifthly, the evidence of the Appellant in these proceedings continues to show a significant lack of insight into her conduct, some of which gave us considerable cause for concern. This was demonstrated in her cross-examination where there was a continual theme of blaming others or other circumstances for a failure to comply with professional ethical standards. This included but was not limited to blaming her staff; her staff not following her instructions; her personal circumstances; her manager not leaving despite being terminated; being "affected"; being away from the Pharmacy for a period of time; and having a "blank mind" during Council s 150 hearings due to being intimidated by delegates. Even Mr Preswick agreed that there was an element of the Appellant "blaming other people or tools for deficiencies in her practice".
10. Sixthly, the various "risk issues" identified by the Council in Mr Stafford's closing oral submissions, including but not limited to poor file keeping of prescriptions; failing to properly address non-compliant prescriptions; poor stocktaking; unaccounted for stock; poor dispensing record keeping e.g. failure to record prescriber, deleted records; issues with photographs of opioid treatment program clients; not observing dosing of opioid treatment program clients; not reporting to NSW Health failures of medical practitioners to supply original prescription where supplying on facsimile; the evolution over time of answers around purpose of compounding; poor records of compounding lab; poor training records (which the delegates considered involved forged initials); unsecured scheduled medicines; difficulties in supervising staff; and poor knowledge of law (albeit improving) all support the conclusion that the Appellant's suspension should not be lifted.
11. Seventhly, during the course of the 2018 s 150 proceedings, the delegates noted that in 2004 there had been concerns regarding the Appellant's administration of the OTP and summarised those concerns. The delegates noted the Appellant's acknowledgement of breach of the legal requirements and failure to discharge responsibility as a proprietor in certain areas that had been identified by the PRU, and that she had made submissions and given assurances she would address those issues fully. The delegates gave the Appellant a very clear warning about the similarities with the 2004 issues, that proper professional standards must be kept at all times and the Appellant could not go "off duty". They noted that the Guidelines for Proprietors state explicitly that a proprietor's professional obligations cannot be delegated.
12. Eighthly, we reject the Appellant's submission that Ms Wei's incorrect evidence about the compounding sheets should lead to the conclusion that her suspensions should be lifted.
13. Ninthly, with every respect to Mr Preswick and Ms Cincotta, we are not satisfied that the mentoring regime proposed in the Conditions would provide appropriate protection of the public.

Conclusion

1. Given all of our concerns about the Appellant's evidence, insight, lack of candor and continued failure to comply with relevant legislation and guidelines, we do not consider in all the circumstances that the proposed conditions will adequately protect the public were the suspension lifted.
2. The two appeals in respect of the Third and Fourth Decisions should be dismissed.

Costs

1. As the Appellant has been unsuccessful, we propose to make an order that the Appellant pay the Council's costs as agreed or assessed. This is a costs jurisdiction, and usually costs follow the event: Health Care Complaints Commission v Philipiah [2013] NSWCA 342; Qasim v Health Care Complaints Commission [2015] NSWCA 282.
2. However, if either party seeks some other order, it should provide submissions (of no more than three pages) to the other party, and to the Tribunal, within 28 days of receiving these reasons. The other party may respond within 28 days.
3. We consider that any decision as to costs should be made "on the papers" and without a hearing. If either party thinks otherwise, it should address that issue in their submissions.

Other

1. By application 2020/00121575 dated 23 April 2020, the Appellant appealed the First Decision and the Second Decision. In his final oral submissions, Mr Fernandez confirmed that those two appeals would no longer be pursued. This was because those decisions had been effectively superseded by the Third Decision. For completeness, I will order that the application is dismissed as having been withdrawn.

Orders

1. The Tribunal orders: 1. The appeal in proceedings 2020/00304014 is dismissed. 2. The appeal in proceedings 2021/00062272 is dismissed. 3. The appeals in proceedings 2020/00121575 are dismissed. 4. The Tribunal proposes to make an order that the Appellant pay the Council's costs as agreed or assessed. If either party seeks some other order: 1. they should provide submissions (of no more than three pages) to the other party, and to the Tribunal, within 28 days of receiving these reasons; 2. the other party may respond within a further 28 days; 3. any decision as to costs should be made "on the papers" and without a hearing. If either party thinks otherwise, they should address that issue in their submissions.

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

Amendments 22 December 2021 - Reasons amended to insert after [163] a new heading "Other" and new paragraph [164] as follows: "By application 2020/00121575 dated 23 April 2020, the Appellant appealed the First Decision and the Second Decision. In his final oral submissions, Mr Fernandez confirmed that those two appeals would no longer be pursued. This was because those decisions had been effectively superseded by the Third Decision. For completeness, I will order that the application is dismissed as having been withdrawn." 22 December 2021 - Reasons amended to insert after [165(2)], a new paragraph [165(3)] as follows: "(3) The appeals in proceedings 2020/00121575 are dismissed." and to renumber existing [165(3)] as [165(4)]. 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: 22 December 2021