Health Care Complaints Commission v Kazeme

The Application

1. The orders sought in the application for disciplinary findings and orders were stated to be "Orders pursuant to s 149A (powers to caution, reprimand, impose conditions on registration etc); s 149B (power to impose a fine) and/or s 149C (powers to suspend or cancel registration, make a prohibition order etc) of the Health Practitioner Regulation National Law (NSW)", and costs.
2. On 10 September 2019 the HCCC notified Ms Kazeme of the proposed orders the HCCC would seek at the hearing listed for 12 September 2019, being cancellation of her registration for a period of one to two years after the conclusion of the non-review period made by VCAT; a prohibition order under s 149C(5) of the National Law; and an order for payment of the HCCC's costs.
3. On 12 September 2019 the HCCC advised of amendments to those proposed orders, so that they now read: 1 Pursuant to s149C(4)(a) of the National Law (NSW), a DECLARATION that if the practitioner were still registered, the Tribunal would have cancelled the practitioner's registration as a Pharmacist for a period of one to two years commencing from 19 November 2020, being the conclusion of the non-review period made by the Victorian Civil and Administrative Tribunal in Pharmacy Board of Australia v Kazeme (Review and Regulation) [2019] VCAT 72 on 19 November 2018. 2 Pursuant to s149C(4)(c) of the National Law (NSW) the Tribunal requires the Pharmacy Board of Australia to record the fact that had the practitioner been registered the Tribunal would have cancelled the practitioner's registration for a period of one to two years from 19 November 2020, being the conclusion of the non-review period made by the Victorian Civil and Administrative Tribunal in Pharmacy Board of Australia v Kazeme (Review and Regulation) [2019] VCAT 72 on 19 November 2018. 3 Pursuant to s149C(5) of the National Law (NSW) the Tribunal finds that the practitioner poses a substantial risk to the health of members of the public and accordingly orders that the practitioner is permanently prohibited from providing health services offering intravenous infusions, intramuscular injections and other forms of injectables of vitamins, minerals, antioxidants and other similar products. 4 That the practitioner pay the Health Care Complaints Commission's costs of these proceedings pursuant to clause 13(1) of Schedule 5D of the National Law (NSW) as agreed or as assessed under the Legal Profession Uniform Law Application Act 2014 (NSW).

The Complaints

1. The application lodged on 25 March 2019 included 7 complaints relating to Ms Kazeme's conduct both in Victoria, including the criminal proceedings, and in New South Wales.
2. The HCCC filed an Amended Complaint on 21 May 2019, relating to Ms Kazeme's conduct in New South Wales only. A further Amended Complaint was filed on 22 October 2019.
3. There are four complaints. Complaints 1 and 2 are allegations that Ms Kazeme is guilty of unsatisfactory professional conduct as defined in s 139B(1)(a) and/or (l), and s 139B(1)(l) respectively, of the National Law. Complaint 3 is an allegation that by reason of Complaints 1 and 2 and the particulars of those complaints, Ms Kazeme is guilty of professional misconduct as defined in s 139E of the National Law. Complaint 4 is that pursuant to s 144(e) of the National Law Ms Kazeme is not a suitable person to hold registration as a pharmacist.

Complaint 1

1. Complaint 1 alleges that Ms Kazeme is guilty of unsatisfactory professional conduct under s 139B(1)(a) and/or (l) of the National Law, which provide: 139B Meaning of "unsatisfactory professional conduct" of registered health practitioner generally [NSW] (1) Unsatisfactory professional conduct of a registered health practitioner includes each of the following - (a) Conduct significantly below reasonable standard Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. … (l) Other improper or unethical conduct Any other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession.
2. Complaint 1 as amended has 11 particulars (particular 11 of 12 having been deleted), which relate to Ms Kazeme's conduct between January 2016 to 14 February 2016.
3. Particulars 1 and 7 relate to the process for obtaining consent from the patients for treatment at the Clinic, the allegations being that Ms Kazeme: 1. inappropriately signed patient consent forms for Patients B, C, D, E and H, signing as "medical staff" without appropriate qualifications, or appropriate supervision from a qualified health professional, and without the patients consulting with a medical practitioner regarding their suitability for treatment (particular 1); and 2. undertook an inadequate process for obtaining the consents of Patients A-J in that she failed to offer the patients a consultation with a medical practitioner regarding suitability of the treatment (particular 7).
4. Particulars 3, 4, and 10 relate to what Ms Kazeme requested of and advised a general practitioner, Dr Dick Quan, the allegations being that she: 1. requested the general practitioner to write prescriptions for Glutathione knowing the medication obtained from the prescription requested would not be used to treat the individuals in whose names the prescriptions were written (particular 3); 2. requested the general practitioner to write prescriptions for Glutathione in the names of patients he had not consulted with (particular 4); and 3. failed to advise the general practitioner from whom she had requested prescriptions that the prescriptions were not for use by the individuals to whom they were prescribed, dispensed and administered, being Patients K-O (particular 10).
5. Particulars 6, 8, 9, and 12 relate to Ms Kazeme's instructions and advice to a registered nurse employed by the Clinic, Ms Imogen Willis, the allegations being that she: 1. instructed the nurse to administer medications containing Glutathione to Patients B, D, E, H and I knowing that the medication had been prescribed and dispensed in the names of other individuals (particular 6); 2. inappropriately instructed the nurse to re-enter vials of Sodium Ascorbate Solution numerous times for use in the treatment of multiple patients, the vials being marked "single use" (particular 8); 3. inappropriately instructed the nurse to re-enter vials of Glutathione numerous times for use in the treatment of multiple patients, the vials being marked "single use" (particular 9); and 4. failed to advise the nurse that the products were not for use by the individuals to whom they were prescribed, dispensed and administered, being Patients K-O (particular 12).
6. Particular 5 relates to Ms Kazeme's dealing with another registered pharmacist, Dr Michael Serafin, the allegation being that she supplied prescriptions for Glutathione for compounding and dispensing knowing that the dispensed medications would not be used to treat the individuals in whose names the prescriptions were prescribed.
7. Particular 2 is that Ms Kazeme failed to discard or direct to be discarded an open vial of sodium ascorbate solution which was located on 17 February 2016 in the Clinic refrigerator and had been open for at least a week.
8. Disciplinary proceedings brought by the HCCC against Dr Quan and Ms Willis have been concluded, in Health Care Complaints Commission v Quan [2018] NSWCATOD 111 and Health Care Complaints Commission v Willis [2018] NSWCATOD 136 respectively. The Tribunal was informed that there are pending proceedings involving the registered pharmacist referred to in particular 5 of Complaint 1.
9. Ms Kazeme denies that she is guilty of unsatisfactory professional conduct, on the basis that her role in the Clinic was only ever administrative, and that she relied on the advice of others with experience, namely the general practitioner, the nurse, and the compounding pharmacist. As to the particulars of Complaint 1, Ms Kazeme: 1. Agreed that signing consent forms as "medical staff" without appropriate qualifications was a mistake; 2. Denied particular 2, stating that the vial was not in use on the day of the PRU inspection and should have been thrown out by the nurse at the end of the previous shift, as the nurse was responsible for management of stock at the end of each shift; 3. Denied particulars 3, 4, and 10, stating that Dr Quan was aware of the flow and operations of IV.ME and failed to recognise that the methodology was inappropriate; and he agreed to write the prescriptions understanding what the method of scripts and vitamins required was; 4. In response to particulars 6, 8, 9, and 12, stated that she did not know that Glutathione was a Schedule 4 medication; she did not know that the Sodium Ascorbate solution was for single withdrawal; and she did not instruct the nurse; 5. In response to particular 5, stated that at the time she accepted the advice of Dr Serafin, and understood that was what she needed to do to obtain stock for the Clinic.

Complaint 2

1. Complaint 2 alleges that Ms Kazeme is guilty of "unsatisfactory professional conduct" under s 139B(1)(l) of the National Law, that is, that she engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy in that between January 2016 and 14 February 2016 she worked unsupervised at the Clinic in contravention of her provisional registration conditions as a pharmacist.
2. Ms Kazeme responds that she is not guilty of unsatisfactory professional conduct as she was not working as a pharmacist in operating the Clinic.

Complaint 3

1. Complaint 3 is that Ms Kazeme is guilty of "professional misconduct" under s 139E of the National Law, which provides: 139E Meaning of "professional misconduct" [NSW] For the purposes of this Law, professional misconduct of a registered health practitioner means - (a) unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or (b) more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration.
2. Complaint 3 relies on Complaints 1 and 2 and the particulars of those complaints, both individually and cumulatively.
3. Ms Kazeme maintains that she is not guilty of professional misconduct as she was not working as a pharmacist.

Complaint 4

1. Complaint 4, that Ms Kazeme is not a suitable person to hold registration as a pharmacist, relies on the matters giving rise to and the conduct of Ms Kazeme at the Clinic including the hospitalisation of Patient J. The HCCC confirmed at the hearing that this complaint does not rely on Ms Kazeme's conduct in Victoria.
2. Ms Kazeme disputes this complaint, stating (ex R1) that she accepts the mistakes she has made in the past and the grave damage it did to her career as a pharmacist, and that she tried hard to focus her energy into IV.ME to make it successful; nothing was ever misappropriated or supplied without authority at IV.ME, and all parties involved in the operations of IV.ME knew what the flow of business was.

Tribunal proceedings

1. The HCCC relied on three bundles of documents, being: 1. Exhibit A1: documents filed on 14 August 2019 in two volumes, which include: 1. Reports of the PRU investigation, including photographs of items seized on the inspection of 17 February 2016; 2. Expert reports by Vaneshkumar Nayak dated 12 February 2017, 4 August 2017 and 26 September 2018, and associated documents; 3. Correspondence between the HCCC and Ms Kazeme; 4. Statements by the registered nurse and the general practitioner in the disciplinary proceedings against them; 5. Guidelines and policy documents; 6. Documents relating to the IV.ME Clinic, including dispensing records; and 7. Medical records for Patient J; and 1. Exhibit A2: patient notes for Patients A, B, C, D, E, F, G, H and I.
2. Ms Kazeme provided a document replying to the HCCC's written submissions of 11 September 2019 (exhibit R1), and a written statement dated 16 October 2019 with annexures (exhibit R2).
3. Mr Nayak and Dr Quan gave oral evidence by telephone. Ms Kazeme gave oral evidence on both days of the hearing.
4. The HCCC provided written submissions dated 11 September 2019, to which Ms Kazeme responded in her Reply. Ms Kazeme provided supplementary written submissions after the hearing, responding to the authorities referred to by the HCCC's representative in closing oral submissions.

Discussion and findings

1. The Tribunal is not bound by the rules of evidence in these proceedings (cl 2 Sch 5D National Law). The standard of proof is the civil standard on the balance of probabilities. Due to the protective nature of the jurisdiction, and the seriousness of the complaints, if established, both for the practitioner and the public, in making its findings the Tribunal is required to have regard to the gravity of any allegations made and to the seriousness of the consequences that may flow from the making of a particular finding or order: Forster v Hunter New England Area Health Service [2010] NSWCA 106; Neat Holdings Pty Ltd v Karajan Holdings Pty Ltd (1992) 67 ALJR 170.
2. The evidence before the Tribunal includes the decisions on the disciplinary proceedings before differently constituted Tribunals in Health Care Complaints Commission v Quan [2018] NSWCATOD 111 and Health Care Complaints Commission v Willis [2018] NSWCATOD 136, and the statements in evidence before those Tribunals by Dr Quan and Ms Willis (ex A1, tabs 38, 50). The Tribunal has had regard to those findings, as permitted by cl 5 Sch 5D, National Law.

Complaint 1

1. Complaint 1 and its particulars require consideration of the evidence as to how the Clinic operated, and Ms Kazeme's role in that operation.

The Clinic

1. It was not in dispute that Ms Kazeme worked at Como Compounding Pharmacy for 18 months, from November 2013 as a placement and then from January 2014 on provisional registration as a pharmacist. The Tribunal accepts her evidence that in the course of that work she dispensed medication under supervision, counselled patients, and considered drug interactions, experience which she acknowledged was broad experience.
2. Ms Kazeme became aware of vitamin infusions based on personal experience while on a trip overseas. In September 2015 when her employment at Como Compounding Pharmacy had been terminated, she opened her first IV.ME clinic in Melbourne with the support of Dr O'Gorman, director and general practitioner at a medical clinic in Melbourne. In November 2015 she met Dr Quan, managing director of Holdsworth House Medical Practice (Holdsworth House), and his partners, to discuss operating from their practice for the expansion of IV.ME in Sydney.
3. The agreed statement of facts in the disciplinary proceedings against Dr Quan (ex A1, tab 51) includes the following information about Holdsworth House: … 2. Holdsworth House is an integrated, holistic practice. It provides medical services encompassing general practice, sexual health, women's health and travel medicine. It also offers allied health services, including physiotherapy, podiatry, dietetics and exercise physiology, as well as specialists and dental services. 3. A particular focus for the Sydney clinic has been on sexual health, HIV, Hepatitis and virology. From the time it began, the Sydney clinic was at the forefront of providing holistic care to persons living with HIV and other sexually transmitted diseases, and supporting ongoing education for patients and practitioners. …
4. Dr Quan's statement dated 20 March 2018 to the Tribunal in those disciplinary proceedings (ex A1, tab 50) stated that many of the Holdsworth House patients regularly go to an intravenous vitamin clinic and many had been vocal advocates for those services and encouraged him to explore the provision of those services in his clinic.
5. While the precise terms of the arrangement with Holdsworth House are not clear on the evidence before the Tribunal, it was not in dispute that Ms Kazeme was approved for a trial tenancy of rooms in the Holdsworth House premises. A document headed Private Practice Agreement between Holdsworth House and Ms Kazeme (ex R2, annexure B) provides for an initial term of three months from 27 January 2016, with Holdsworth House to provide reception facilities including telephone answering, use of equipment and instruments and basic medical stock and supplies, accounting services and practice management, and cleaning; and for the Clinic to assign its gross receipts, with transfer of funds to the Clinic after deduction of service fees. A term of the agreement provides for the practice's GPs to provide scripts for the IV stock "in a timely manner". The resources made available to IV.ME include the Holdsworth House "trained staff, including nursing and administration staff". There is no reference to consultation of Holdsworth House medical practitioners by Clinic patients.
6. The agreement is not signed. An email from the Holdsworth House practice manager to Ms Kazeme (ex R2, annexure A) dated 5 January 2016 confirms that it was at that time the subject of negotiation. Dr Quan's evidence to the Tribunal was that he did not sign it because he did not agree to it and it is likely that his practice manager prepared the document. Whether or not that document represents the complete agreement between Holdsworth House and Ms Kazeme, it is not in dispute that the Clinic used the Holdsworth House reception facilities, and rooms, and that billing for the Clinic was arranged through the Holdsworth House reception.
7. In her interview during the PRU inspection of the Clinic premises on 17 February 2016 (ex A1, tab 13) Ms Kazeme explained to the PRU investigator that the Clinic procedure was that the client made an appointment on-line or in person; the client presented to the medical centre and filled out a 7 page detailed questionnaire; the client was then assessed to ensure nothing in their medical background would deter them from having the treatment, and if need be one of the GPs from the practice could be consulted; and blood pressure, temperature, oxygen levels and pulse were all standard vitals that were taken.
8. The Clinic had 5 different infusions in predetermined dosages: "Replenish.Me": 500ml Hartmanns; "Rejuvenate.Me": 3ml Glutathione and 500mls Hartmanns; "Vit-C.Me": 7ml ascorbic acid and 500mls Hartmanns; "Energise.Me": Myers Cocktail Vial A & Vial B and 500mls Hartmanns; and "Revive.Me": Energise and 1ml Glutathione injection (ex A1, tab 13, Annexure H to PRU investigator statement). The Tribunal notes that the active components of Hartmann's Solution are sodium lactate, sodium chloride, potassium chloride and calcium chloride; and Myers Cocktail contains magnesium, calcium, vitamin C, selenium and vitamin B complexes. Glutathione is a peptide with antioxidant properties, and when administered parenterally, it is a Schedule 4 medicine and requires prescription.
9. Ms Kazeme's evidence to the Tribunal was that she would respond to email inquiries, and explain what the five options were. Some patients would contact Holdsworth House directly to book. She was there in the first week of operation to ensure that there were the right supplies and thereafter split her time between Sydney and Melbourne. She spent three weeks in Sydney for the initial training of the nurse. She did not carry out any risk assessments. She stopped the Sydney Clinic after Patient J was unwell, and continued the Melbourne clinic for about 6 months and then stopped, as the business was failing.
10. There is no evidence that any medical practitioner in Holdsworth House assessed any of the Clinic patients. Ms Kazeme was not aware of any while she was at the Sydney Clinic. Ms Kazeme agreed she was present on the day Patient J had the treatment, and when taken to the clinical notes for Patient J (ex A1 tab 13 pp 40-47) which showed a drop in blood pressure after the infusion, acknowledged that in hindsight she should have arranged for Patient J to be seen by a medical practitioner. She arranged for transport home for Patient J and kept in contact with Patient J's mother afterwards.
11. Copies of the patient questionnaires are in evidence, including those completed by Patients A, B, C, D, E, F, G, H, and I (ex A2), and J (ex A1, tab 13). The Patient Questionnaire includes a request for the patient to list any current or recent medical conditions, and current medications and allergies. Ms Kazeme was taken to the records for Patients A-J in cross examination. She agreed that if she had seen the detailed medical history and medications for Patient B she would have suggested she see a doctor before the treatment; however Patient B had not noted medications recorded in her Holdsworth House medical records on her patient questionnaire. Ms Kazeme agreed that Patient G, who stated he had recently had a fever and whose blood pressure was very high, should not have had the infusion. She agreed that Patient H, who had very high blood pressure, should have been referred to a doctor.
12. The IV.ME Clinic Consent Form required the patient to sign that they are aware of the risks of complications or injury and side effects; and that they consent and authorise a registered nurse to perform treatments. That document concludes with an acknowledgment that it is "a written confirmation of this discussion" and that all questions have been answered. Following the patient signature is space for signature by "Medical staff". The Consultation & Treatment document includes details of the infusion administered, with space to record vital signs at Baseline, 5 min-Infusion, and End of Infusion.
13. Ms Kazeme's signature as "Medical Staff" appears on the consent forms for Patients B, C, D, E, H and J. Her evidence was that the consent forms were kept at the reception. The practice was that the forms signed by patients were put aside and a person present at the Clinic would confirm that they had seen it and sign. In signing the consent forms she was signing that the consent form had been signed by the patient. The early versions of the consent form were from the Melbourne clinic, and the later ones were on Holdsworth House letterhead. Ms Kazeme stated that she did not check for anything adverse in the forms, the nurse checked the forms. The patient would select the treatment, and observations were checked by the nurse; if they were ok the nurse would administer the treatment. It was not her role to assess risks for patients, the nurse would have that conversation and it was her call whether there was a need to consult. Dr O'Gorman had advised her there were some key conditions where the treatment should not be given, for example patients who were pregnant, had liver disease or cancer. She would not have access to clinical notes for patients who were already patients of Holdsworth House. She trusted the patients to disclose details of other medications on the form.
14. It was common ground that Ms Kazeme requested, and Dr Quan provided, prescriptions for the medications that required a prescription, which included the Glutathione administered parenterally and the compounding of the vitamins, and that the prescriptions were for the purpose of stock for the operation of the Clinic. In an email dated 11 January 2016 to Dr Quan (ex R2, annexure C) requesting scripts for vitamins for the start of operation, Ms Kazeme specified the quantity of Myers Cocktail required, and the advice of the compounding pharmacist as to how the script should be written so that she could dispense 12 bottles each month per script. That email also specifies details for the prescriptions requested for Glutathione, Methylcobalamin B12, and L-carnitine. A subsequent email dated 14 January 2016 confirms that the prescriptions were sent to the compounding pharmacist by Holdsworth House. Dr Quan acknowledged in the disciplinary proceedings against him that he knew that the quantities he prescribed would predominantly be used for stock.
15. It was common ground that the prescriptions were written in the names of people who were not the ultimate users of the prescribed items. The PRU investigation found that none of the clients who were purporting to have received Glutathione had had a prescription for Glutathione for parenteral use written in their names (ex A1, tab 10, p 4). In her email of 11 January 2016 to Dr Quan requesting prescriptions Ms Kazeme offered to provide names from the Melbourne clinic if he did not have enough employee names for the prescriptions that were needed. In an email from Ms Kazeme to the Holdsworth House practice manager on 15 February 2016 Ms Kazeme explained, in response to concerns about writing a script and the compounding used on others, that the compounder had explained that they had to compound and dispense under a certain name and dispense a specific amount per person each month, which is why she required multiple scripts for the names.
16. The Tribunal finds that both Ms Kazeme and Dr Quan knew that the prescriptions requested were not for the patients identified on them, and were intended to provide stock for the operation of the Clinic. Some of the people in whose names prescriptions were written were clinic staff. Ms Kazeme's evidence was that it was not her responsibility to provide information to the doctor writing the prescriptions, and Dr Quan should have taken his own steps. She denied she had the skills as a trainee pharmacist to give that information to Dr Quan, her position was that she was not experienced enough and was not acting as a pharmacist. She was not aware that it was illegal to dispense medicines to a person other than the person to whom it was labelled. The medications were prescribed by Dr Quan, and that after the initial supply had been dispensed each of the patients would have a prescription written in their name so all of the paperwork would be correct.
17. It was not in dispute that Ms Kazeme employed her own nurse for the Clinic. Documents relating to her employment of Ms Willis (ex R2, annexure J) include a Job Description for the position, which states the duties of "The role of registered nurse manager at iv.me Sydney-Holdsworth House Medical Practice…". The specified duties include: to explain to patients the treatments and how they work; assess medical history and record patient observations; correctly and accurately inject the saline bags with the correct vitamins for each infusion; safely and appropriately cannulate the patient and connect the infusion; and correctly record notes and put billing through to reception. That list includes "Be responsible for managing stock at the end of each shift, and reporting to Shadi Kazeme what is on low stock and what must be ordered urgently".
18. Ms Kazeme's evidence was that she decided on the procedure for the Clinic, and prepared the document Nurse Protocols and Procedures (ex A1, tabs 59-62) with material she sourced from the internet. Ms Kazeme denied instructing the nurse to administer the product, stating that she was not there all the time, and that the nurse had that role. She did not direct the nurse what to do, and the nurse could have taken it on herself to consult a doctor.
19. In the disciplinary proceedings against her Ms Willis admitted most of the complaints, including allegations that she had failed to follow safe medication handling practice in her handling of parenteral medications by drawing from single-use vials multiple times for the treatment of multiple patients and by preparing infusion bags of sodium ascorbate prior to immediate use; and had in relation to nine patients failed to undertake an adequate assessment prior to administering parenteral medications and failed to provide adequate care when she provided a treatment that was not indicated for their presenting complaints and that was not appropriate given their medical history, and in circumstances where she knew that the patients had not been assessed by a medical practitioner and did not hold a valid prescription for the medication.
20. The Tribunal finds, on the basis of the admitted conduct and the documents and evidence referred to above, that: 1. Ms Kazeme signed consent forms as "medical staff" when she did not have appropriate qualifications to do so. Having regard to the wording on the forms, in which the patient is acknowledging awareness of and acceptance of the risks and possible side effects of the proposed treatment, and refers to a "discussion" and answering questions, the Tribunal finds that the forms could not appropriately have been countersigned on the basis asserted by Ms Kazeme, that is, to confirm that the patient had signed. The Tribunal does not accept Ms Kazeme's position in oral evidence that patient perception was not an issue because she was not the one advising the patient about treatment. The Tribunal concludes that there was no proper basis on which informed consent was obtained from those patients whose forms Ms Kazeme signed. 2. While Ms Kazeme stated to the PRU investigator that the Clinic practice was that if need be one of the medical practitioners at Holdsworth House would be consulted, there is no evidence that that arrangement was understood as part of the agreement between Ms Kazeme and Holdsworth House, or that any patient of the Clinic was offered a consultation with, or actually consulted, a medical practitioner, despite at least some of those patients recording information on the patient questionnaire that suggested that the treatment may have been unsafe. 3. Ms Kazeme requested Dr Quan to write prescriptions for medications requiring a prescription, namely Glutathione to be administered parenterally and at the request of the compounder for the other medications to be compounded, in the names of patients that he had not consulted and who she knew were not the persons who would receive the medications. 4. Ms Kazeme supplied prescriptions to, and obtained from, the compounding pharmacist medications, knowing that the dispensed medications would not be used to treat the individuals in whose names the prescriptions were prescribed. While the prescriptions may have been faxed by Holdsworth House staff, the communications between Ms Kazeme and the compounding pharmacist make it clear that they did so on behalf of the Clinic, which Ms Kazeme operated.
21. The Tribunal is satisfied that the conduct particularised in particulars 1, 3, 4, 5, 7, and 10 of Complaint 1 is established.
22. Particulars 6, 8, and 9 are framed in terms of instructions given by Ms Kazeme to Ms Willis, the registered nurse employed by the Clinic. Ms Kazeme denied the allegations in those particulars, stating that it was the nurse's responsibility. The Tribunal did not have the benefit of evidence from Ms Willis. Her evidence before the Tribunal in the disciplinary proceedings against her was that she "took direction from her new employer, a registered pharmacist": Health Care Complaints Commission v Willis [2018] NSWCATOD 136 at [23]. At its highest, the findings of the Tribunal in those disciplinary proceedings were that she followed what she was told by Ms Kazeme about the procedures and practices used by the Clinic, and trusted Ms Kazeme: Health Care Complaints Commission v Willis [2018] NSWCATOD 136 at [82]-[83]. It is not in dispute that Ms Kazeme prepared the procedures and protocols adopted by her employee. While Ms Willis was also required to exercise her professional judgment as a registered health practitioner, the Tribunal is satisfied that in devising and implementing the procedures adopted for provision of stock medications and the preparation and administration of infusions, the conduct particularised in Particulars 6, 8 and 9 of Complaint 1 is proven.
23. The photographs of the medications seized on the PRU inspection (ex A1, tab 13) show the names of the persons in whose name the medications were prescribed (including one in the name of Ms Kazeme). The registered nurse was the person who administered the medication to the patient, and she was in a position to observe the names. While she had her own professional responsibilities, that does not detract from the obligations imposed on Ms Kazeme as the person who devised and implemented the business model to ensure that medications were administered appropriately, to the persons to whom they were prescribed and dispensed. The Tribunal is satisfied that particular 12 of Complaint 1 is established.
24. Particular 2 of Complaint 1 relates to the failure to discard the open vial of sodium ascorbate solution located on 17 February 2016 in the refrigerator. The Tribunal does not accept that the obligation on the registered nurse to be responsible for "managing stock" at the end of each shift can be read as more than keeping track of supplies and informing Ms Kazeme what stock needed to be ordered. While the registered nurse had her own professional obligations in relation to safe handling of medications, that does not mitigate Ms Kazeme's obligations as the person ultimately responsible for the business to implement safe procedures for storage and handling of medications used in the operation of the business. Particular 2 of Complaint 1 is established.

Expert evidence

1. Expert evidence was provided by Vaneshkumar Nayak, a pharmacist with more than 20 years experience as a community pharmacist. In his first report (12 February 2017) Mr Nayak was critical of the co-ordination of the work flow of the Clinic, and concluded that Ms Kazeme's conduct was below the standard of a practitioner of an equivalent level of training or experience in the following respects: 1. obtaining and supplying prescriptions for dispensing; 2. signing the consent forms; 3. requesting Dr Quan to write prescriptions knowing that the product obtained would not be used for the individual in whose name the prescription was written and that those persons had not consulted him; and 4. supplying prescriptions to Dr Serafin for dispensing knowing that the dispensed product would not be used to treat the individuals in whose names the product was prescribed, especially Glutathione being a Sch 4 item when administered parenterally.
2. Mr Nayak commented that in instructing Ms Willis to administer product to clients knowing that the product was prescribed and dispensed in the name of other individuals Ms Kazeme's conduct was below the expected standard, and put the conduct of another health professional under unnecessary scrutiny. His conclusion was that Ms Kazeme should have arranged her work flow so that a patient would receive a proper consultation with a medical practitioner, a script could have been written for necessary medication, and the patient called after the required products had arrived from the compounding service.
3. In circumstances where the patients did not consult a medical practitioner and Ms Kazeme had signed the consent forms as "medical staff", Mr Nayak's opinion was that that was conduct significantly below the standard of a practitioner of an equivalent level of training or experience, especially as Ms Kazeme appeared to be working as an independent health professional without appropriate qualification or supervision from a qualified health professional. Not discarding the single use vial and using it more than once was conduct below the standard of a practitioner of an equivalent level of training or experience, as it placed the patient at increased risk of infection from contamination. In her communication with Dr Quan Ms Kazeme should have provided more details about the treatment regimens, and co-ordinated the work flow so that patients could be seen by a doctor at the practice before commencement of the treatment.
4. In his second report (4 August 2017), Mr Nayak was asked to provide a more detailed opinion of Ms Kazeme's overall work flow, on the assumptions that she requested prescriptions from Dr Quan and supplied them to Dr Serafin for dispensing and instructed her employee to administer products knowing that the dispensed product including a Sch 4 item would not be used to treat the individual in whose names the prescriptions were written; kept those products at the Clinic as stock; and co-signed patient forms attesting to provision of information concerning risk of treatment in circumstances where the forms did not offer the client an opportunity to be assessed by a doctor or provide space to give a definite yes or no answer to questions or confirm that the client had read the list of ailments. Mr Nayak stated that his view was that the conduct was significantly below the standard of a practitioner of an equivalent level of training or experience, especially as Ms Kazeme acted as a fully qualified health professional while not holding a qualification as a fully qualified pharmacist and was not working under supervision of a registered pharmacist.
5. In the request for a third report, Mr Nayak was asked, and responded to, the following questions: 1. whether there is a relevant connection between Ms Kazeme's conduct at the Clinic and the practice of pharmacy: Response: there may be no connection between the Clinic and the practice of pharmacy: the premises may not be described as a pharmacy, all the items supplied could be obtained without a prescription except parenteral Glutathione which when prescribed by a doctor may be obtained from a source which is not a pharmacy, the activities would not normally happen at a pharmacy except the supply of parenteral Glutathione, and Ms Kazeme had named the business "Hydration Clinic" and not a pharmacy; 1. whether her conduct was such as to demonstrate a lack of adequate knowledge, skill, care or judgment necessary in the practice of pharmacy: Response: Mr Nayak was unable to provide an opinion whether Ms Kazeme demonstrated a lack of adequate knowledge, skill, care or judgment necessary in the practice of pharmacy, commenting that in a traditional pharmacy medications are not administered parenterally and at the Clinic the parenteral administration was by a registered nurse, and hence it appeared Ms Kazeme was just coordinating the activities of the clinic; 1. whether she breached the relevant Codes of Conduct and Policies relevant to pharmacists: Response: Mr Nayak was unable to provide an opinion whether Ms Kazeme breached any relevant Codes of Conduct and Policies: he assumed that the clinic was not registered as a pharmacy, and from the facts as presented it appeared she had not presented herself as a pharmacist to any of her clientele ; and 1. whether the Clinic nurse protocols and procedures demonstrate a breach of Ms Kazeme's professional and/or ethical obligations as a pharmacist: Response: Mr Nayak was unable to provide an opinion from the evidence presented including Ms Kazeme's statement that she never provided services at the Clinic as a pharmacist.
6. Mr Nayak maintained his opinions in his oral evidence. He commented that multiple withdrawals from a single use vial may be appropriate if the manufacturer said so; however medication should be prescribed for one patient, and there could be 3 or 4 withdrawals only for one patient and not others. He would not comment on whether there was no relationship between an IV clinic and a pharmacy, stating that he was giving evidence on conduct as a pharmacist.
7. Ms Kazeme agreed in cross examination that her role as proprietor of the Clinic required her to ensure safe practices, and that as proprietor and manager she was entrusted with safe custody and distribution of pharmaceuticals. She admitted her inexperience put the health and safety of patients at risk. Taken to the Pharmacy Board of Australia Code of Conduct for Pharmacists (ex A1, tab 52), Ms Kazeme stated that the statement at section 1.2 that practitioners have a duty to make care of patients or clients their first concern and to practise safely and effectively did not apply to her as she was not working as a pharmacist. She agreed that the Clinic methodology was below standard and not as safe and effective as it could be. She thought she was providing a safe service, and in hindsight it was not. She denied that she was working beyond the limits of her competence and experience, and stated that she was supported by the doctor and the nurse. She relied on the doctors and compounding pharmacist to advise her that the flow and operations of the Clinic were not of a satisfactory standard. She did not know that Glutathione was a Schedule 4 product, or that the vials provided were single use. She acknowledged that the patients, Dr Quan and the nurse had put trust in her. They were all to blame, and she was ultimately responsible as the operator.
8. Ms Kazeme's admissions that the methodology of the Clinic operations was below standard, and that the practices adopted were not safe, support the opinions expressed by Mr Nayak. The Tribunal finds, on the basis of that evidence, that Ms Kazeme's conduct in requesting prescriptions knowing the product would not be used for the individual named on the prescription, supplying those prescriptions to the compounding pharmacist for dispensing, keeping the dispensed products in the Clinic as stock, co-signing the consent forms, and instructing the nurse to administer products prescribed and dispensed in the names of other individuals, was conduct significantly below the standard reasonably expected of a practitioner of equivalent level of training or experience.
9. The issue is whether that conduct was engaged in by Ms Kazeme "in the practice of" the profession of pharmacy, so as to be unsatisfactory professional conduct under s 139B(1)(a) of the National Law, or was conduct "relating to the practice or purported practice of pharmacy", for the purposes of the definition in s 139B(1)(l) of the National Law.

Whether conduct in the practice of pharmacy

1. The HCCC submits that Ms Kazeme was practising as a pharmacist in carrying out her role in the Clinic. Ms Kazeme held herself out as a pharmacist with expertise in vitamins and complementary medicines to Dr Quan, Ms Willis and Dr Serafin, all three of whom appeared to have deferred to her specialised knowledge as a pharmacist in relation to the supply and administration of the medications to patients at the Clinic. The HCCC submits that it is relevant that Ms Kazeme was at the time a newly qualified pharmacist who was still subject to conditions imposed on her registration holding provisional registration and required to practice under supervision. The HCCC submits that the legislation contemplates a broad interpretation of the concept of whether or not conduct was in the practice of pharmacy. Arguably Ms Kazeme lacked adequate knowledge as a pharmacist to identify the need for a prescription for Glutathione, to ensure prescriptions were written in the names of the patients receiving treatment, to ensure that dispensed products would be used for patients in whose names they had been prescribed, and to ensure that single use vials were only used once and disposed of immediately; and her failings in that regard demonstrate that she lacked one or more qualities indispensable to the practice of pharmacy. She also lacked adequate experience to ensure the safe administration of medications, placing the patients' health and safety at risk.
2. The HCCC submits that while Ms Kazeme was not working in a pharmacy at the relevant time, she was proprietor of the Clinic and was responsible for determining what medications each patient should receive and whether or not such medications were suitable; and arguably she was using her clinical knowledge as a pharmacist to make such determinations. Ms Kazeme placed the health and safety of the patients at the Clinic at risk by not ensuring the adequate, suitable and safe administration of the products provided by the Clinic. Her actions as proprietor of the Clinic were sufficiently connected to the practice of pharmacy in circumstances where she sourced the prescriptions, arranged the compounding and stocking of the products, initially spoke to the patients to determine what treatment they would be administered, and directed Ms Willis as to what medications to administer to patients. The responsibilities of a pharmacist are wide and varied, and include procuring medications safely, safe handling and storage of medicines, ensuring patients get suitable medication, and providing medicines safely.
3. Ms Kazeme's position is that her role in the Clinic was solely that of a director, and she was not engaging with anyone as a pharmacist or holding herself out to be one, or deceiving anyone as being a fully registered pharmacist. Ms Kazeme described her role at the Clinic as administrative: she carried out the marketing, bookings, took phone calls, liaised with suppliers regarding ordering of supplies, liaised with the doctors regarding writing of scripts, paid staff and did bookkeeping, and spoke about IV.ME with regards to spreading knowledge about what the Clinic offered and the services conducted. She maintained that she never acted in the Clinic as a pharmacist, and she did not draw on her skills in pharmacy and microbiology.
4. Ms Kazeme submitted that she took every measure that she thought was correct at the time to operate in the most legal way. She based and operated her clinics in medical clinics with the support and co-work of doctors to ensure the business was deemed medically approved. She did not realise that the flow of method was not perfect or above standard and not once did anyone flag to her it was incorrect.
5. Ms Kazeme denied that she chose or advised treatments, stating that the medications and dosages were pre-formulated. As proprietor she asked the doctors for scripts and their staff would fax them, she would pay the compounder for the dispensed products and her nurse would administer them; and none of that had any relevance to a pharmacist. Any lay person can operate this exact clinic. It is incorrect to state that because she is a pharmacist she used her knowledge to operate the clinic. There are current existing clinics operated by lay people who go down the same pathway and source the same products and people.
6. There has been limited judicial consideration of the required connection between a practitioner's conduct and the practice of a profession for the purposes of the definitions of unsatisfactory professional conduct in the National Law. Health Care Complaints Commission v Wingate [2007] NSWCA 236 was an appeal against disciplinary orders made against a medical practitioner who had been convicted of offences relating to possession of child pornography. The complaints against the practitioner were that he was guilty of unsatisfactory professional conduct within the meaning of s 36 of the Medical Practice Act 1992 (NSW), the complaint alleging that he: Has been guilty of unsatisfactory professional conduct within the meaning of section 36 of the [Medical Practice ] Act and/or professional misconduct within the meaning of section 37 of the Act in that he has: demonstrated that the knowledge, skill or judgment possessed, or care exercised, by him in the practice of medicine is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or engaged in improper or unethical conduct relating to the practice of medicine.
7. The Court of Appeal (Basten JA; McColl JA and Harrison J agreeing), commented on the way in which the complaint had been framed: 13. The Court has recently commented on the indiscriminate use of statutory language in such complaints: see Health Care Complaints Commission v Karalasingham [2007] NSWCA 267 at [27]-[28]. As might have been expected, there was no case presented before the Tribunal to suggest that the private possession on a home computer of child pornography said anything about the knowledge, skill or judgment possessed, or care exercised by the practitioner in the practice of medicine. Rather, the case presented was that the possession of child pornography constituted improper or unethical conduct "relating to" the practice of medicine. The complaint should properly have been limited in that way. 14. When the Medical Tribunal came in due course to consider this complaint, it formed the view that the relevant conduct did not fall within the definition of "unsatisfactory professional conduct" in s 36 of the Medical Practice Act and therefore could not constitute professional misconduct under s 37 of the Act. The reasoning of the Tribunal in that respect was that s 36 did not deal with "a matter that is unconnected in any way with the practice of medicine", and that the practitioner's conduct "is not professional conduct at all": Tribunal Reasons at [50] and [51]. Although the definition of "unsatisfactory professional conduct" included conduct that results in the practitioner being convicted of certain specified offences, the Tribunal correctly noted that the offence in question was not one of those specified in s 36(1)(d) of the Medical Practice Act: indeed no crime specified in the Crimes Act fell within that part of the definition.
8. In Health Care Complaints Commission v Gillett [2007] NSWNMT 7 (decided before Wingate) the Nurses and Midwives Tribunal had reached a different view, holding (at [5]) that in determining whether a nurse who had been found guilty of possessing child pornography had engaged in conduct that meant he did not possess the requisite knowledge or judgment expected of him as a nurse that the conduct was of a sufficiently immoral, outrageous and disgraceful character to make that determination, and also that there was no need for the conduct to occur in the clinical context of the practice of nursing.
9. Wingate is authority for the proposition that conduct unconnected in any way with the practice of medicine should not be considered by reference to the level of knowledge, skill or judgment possessed by a practitioner, that is, under s 139B(1)(a) of the National Law, but rather whether it is improper or unethical conduct "relating to" the practice of medicine, that is, under s 139B(1)(l). In these proceedings the HCCC has pleaded both s 139B(1)(a) "and/or" s 139B(1)(l).
10. In Childs v Walton [1990] NSWCA 41, which concerned the conduct of a psychiatrist in pursuing a relationship with a former patient, the Court of Appeal considered s 27(1)(a) of the Medical Practitioners Act 1938 (NSW), which defined professional misconduct to include any conduct that demonstrates a lack of adequate knowledge, experience, skill, judgment or care "by the practitioner in the practice of medicine". Samuels JA (with whom Priestley and Meagher JJA agreed), held at p 4: …The phrase "in the practice of medicine" does not have a temporal meaning, but rather a qualitative or descriptive character. It does not circumscribe the period during which the conduct impugned must occur if it is to be capable of satisfying the prescription; it describes its nature. The conduct must be such as to demonstrate the lack of a quality (eg adequate knowledge) necessary in the practice of medicine. The conduct is the vehicle by which a specified defect is revealed. Hence the act or omission constituting the conduct (see the definition of "conduct" in s27(1)) need not occur while the relationship of doctor and patient exists between a complainant and the practitioner. It may occur at any time. It need not be conduct which occurs in the course of treating a patient. The only requirement is that it must demonstrate one of the specified deficits. It is often risky to construe by paraphrase, but in this case I think it is accurate to say that s27(1)(a) contemplates conduct by a practitioner that demonstrates his or her lack of one or more qualities indispensable to the practice of medicine; or, in the case of lack of adequate experience, to the particular procedure undertaken.
11. That approach has been adopted recently in the interpretation of the phrase "practice of the practitioner's profession" for the purposes of s 139B(1)(a) of the National Law in Attia v Health Care Complaints Commission [2017] NSWSC 1066, an appeal from a decision of this Tribunal in Health Care Complaints Commission v Attia [2016] NSWCATOD 167. In those proceedings a registered pharmacist, who owned a number of pharmacies, also operated a pharmacy wholesale business (Hillmear) which had a licence to wholesale pharmaceutical goods under the Poisons and Therapeutic Goods Regulation 2008 (NSW), being goods which in general terms were restricted substances and required a prescription from a medical practitioner before they could be sold to the public. In the course of that business Mr Attia acquired an amount of Viagra from an individual who had previously supplied wholesale general products and over the counter medication. Mr Attia on sold the Viagra to other wholesalers. Some of the Viagra was counterfeit. The Tribunal found that Mr Attia had purchased a substance purporting to be Viagra tablets by wholesale from a person without a wholesaler licence, in breach of a condition of his wholesale licence; he had failed to ensure the product was genuine; and in all the circumstances he should have known the product was not genuine; and he had provided untruthful information to investigators and made false and misleading statements to the Therapeutic Goods Administration. The Tribunal found that Mr Attia's conduct fell significantly below the relevant standard being that of a pharmacist of an equivalent level of training or experience, and he was guilty of professional misconduct.
12. On appeal from the Tribunal's decision to cancel his registration, Walton J considered whether Mr Attia's conduct fell within s 139B(1)(a), as conduct in the practice of pharmacy, notwithstanding that he had initiated and transacted the acquisition of the medication as director of the pharmacy wholesale business. While noting that the point had not been put squarely in the Tribunal proceedings, where the practitioner had accepted that his conduct occurred while in the practice of pharmacy and had relied on a dual role as director of Hillmear in mitigation, his Honour referred to Childs v Walton [1990] NSWCA 41 and held: 146. In approaching that question, I consider that the judgment of Samuels JA (with whom Priestley and Meagher JJA agreed) in Childs at 4 is apposite. His Honour's judgment concerned a counterpart provision to s 139B(1), albeit in the context of the definition of professional misconduct, (namely, s 27(1)(a) of the Medical Practitioners Act 1938 (NSW)). His Honour opined that the gravamen of the definition was that the conduct, the subject of the complaint, must be such as to demonstrate the lack of a quality (such as "judgment possessed" and/or "care exercised") "necessary in the practice" of pharmacy (at [4]). The conduct is the vehicle by which a specified defect is revealed (s 27 also concerned any "other improper or unethical conduct relating to the practice of medicine"). In my view, his Honour's construction of s 27(1)(a) of the Medical Practitioners Act is, represents a sure guide to the interpretation of s 139B(1)(a). 147. The preposition "in" in the phrase does require a relevant connection between the conduct, the subject of a complaint, and the practice of pharmacy. Thus, Samuels JA used the word "necessary" in the aforementioned passage from Childs. 148. However, the word "conduct" is defined very widely in s 138(1) to mean "any act or omission". This must be wide enough to capture an act or omission of the plaintiff as a director of Hillmear in purchasing medications permitted by the wholesaler license of Hillmear, if, in the course of that conduct, the plaintiff's acts and omissions had the necessary connection to his practice as a pharmacist which he held or operated at the time of the requisite purchase. As Spigelman CJ described in Cummins (at [56]) the question is whether the acts were sufficiently connected to the actual practice. 149. The word "practice" in the phrase is not defined in the National Law. Nor is the phrase itself. There appeared to be common ground that the word and the phrase were attended by some ambiguity. I consider that is an appropriate concession. 150. The ordinary meaning of the word "practice", when read in the context of the phrase, and in the context of the profession of pharmacy, is the application of the principles and practices of pharmacy or the application of its ideas or methods. 151. The practice of pharmacy, so defined, was the subject of evidence, without objection, in these proceedings in the form of various Codes of Conduct which prescribed the standards or obligations attending upon or expected of practitioners of the profession of pharmacy. 152. The Codes made clear that the practice of pharmacy extended beyond direct clinical care such as the filling of prescriptions or the giving of the advice to clients to direct non-clinical care which impacts upon the safe delivery of health services. The National Code specifically refers to the purchase (or sale) of any medicinal product and the prevention of the supply of products which constitute an unacceptable hazard. 153. That approach to the interpretation of the phrase "the practice of the practitioner's profession" for the purpose of s 139B(1)(a) is consistent with the requirement to give an expansive meaning to such provisions when instrumentally used in protective legislation (that is, protective of the public who are supplied with pharmaceuticals: see the paramount consideration in s 3A); Day & Dent Constructions Pty Ltd (in liquidation) v North Australian Properties Pty Ltd (provisional liquidator appointed) (1982) 150 CLR 86 at 108 (per Mason J). 154. It follows that the conduct simpliciter engaged in by the plaintiff in purchasing the counterfeit Viagra fell within the scope of the phrase the practice of his profession in that, as the respondent described it, the acts involved non-clinical judgment or the exercise of care which impacted upon the safe delivery of pharmaceutical products.
13. These authorities support the following propositions relevant to the present proceedings: 1. There must be a relevant connection between the conduct, the subject of the complaint, and the practice of the profession of pharmacy: Childs v Walton at 4; Attia at [147]; 2. Conduct unconnected with the practice of the profession may be "improper or unethical" conduct "relating to" the practice of the profession: Wingate at [13]; 3. The term "conduct" is defined widely, and is wide enough to capture an act or omission that has the necessary connection to the practice or pharmacy: Attia at [148]; 4. The phrase "in the practice of [the profession of] …" has a qualitative or descriptive meaning, referring to conduct such as to demonstrate the lack of a particular quality, or reveal a specified deficit: Childs v Walton at 4; 5. In the context of the practice of the profession of pharmacy, the term "practice" is the application of the principles and practices of pharmacy or the application of its ideas or methods: Attia at [150]; 6. Codes of Conduct prescribing expected standards or obligations of the profession inform the consideration of what the practice of pharmacy means: Attia at [152]; and 7. An expansive meaning in interpreting the provision is consistent with the context of application of legislation protective of the public who are supplied with pharmaceuticals, and the paramount consideration in s 3A of the National Law: Attia at [153].
14. Applying that reasoning, the Tribunal is satisfied, for the following reasons, that there is a relevant connection in the present circumstances between Ms Kazeme's conduct and the practice of the profession of pharmacy.
15. The term "conduct" is defined broadly, to mean "any act or omission": s 138(1) National Law. Ms Kazeme's conduct in the operation of the Clinic included obtaining stock, which included medications requiring a prescription by a medical practitioner and dispensing by a registered pharmacist; ensuring a supply of that medication available at the Clinic; and arranging for its administration by the registered nurse. As explained by Walton J in Attia at [150]-[152], the ordinary meaning of the word "practice" in the context of the profession of pharmacy, is "the application of principles and practices of pharmacy or the application of its ideas or methods". In that regard, the practice of pharmacy extends beyond direct clinical care such as the filling of prescriptions or giving advice, to direct non-clinical care that impacts on the safe delivery of health services.
16. The Pharmacy Board of Australia Code of Conduct (March 2014) (ex A1 tab 52) states at 1.2 that practitioners have a duty to make the care of patients or clients their first concern and to practise safely and effectively. At 2.2(p) it states that providing good care includes facilitating the quality use of therapeutic products based on the best available evidence and the patient or client's needs. The PSA Code of Ethics for Pharmacists (ex A1 tab 53), endorsed in the Code of Conduct, notes in Principle 4: Quality Use of Medicines, that a pharmacist must ensure responsibility and accountability in the control, procurement, manufacture, handling and supply of therapeutic goods. Pharmacists must be cognisant of the nature and level of responsibility the community expects of the pharmacy profession.
17. Based on those statements as to professional obligations and expectations, the Tribunal is satisfied that Ms Kazeme's conduct was conduct engaged in by her in the practice of her profession. Ms Kazeme was permitted to operate a clinic in the Holdsworth House premises, a medical practice, in circumstances where (as discussed below) there was an understanding that she was a qualified pharmacist. As she admits, in operating the Clinic she was required to ensure safe practices and was entrusted with safe custody and distribution of therapeutic products.
18. The Tribunal notes that Mr Nayak was unable in his third report to comment directly on whether there was a relevant connection between Ms Kazeme's conduct and the practice of pharmacy. In the Tribunal's view, his approach to that question, and the related questions asked of him in that report, focus more on the premises on which the activities were carried out and how they were described, rather than the broader issue of safe delivery of health services. In interpreting the term as used in the National Law, the Tribunal is guided by the approach and reasoning of the authorities considered above.
19. For the same reason, the Tribunal would place less weight on Ms Kazeme's assertions that she did not hold herself out to be working as a pharmacist in operating the Clinic. The Tribunal acknowledges that the documents in evidence do not include any reference to Ms Kazeme being a registered pharmacist. The evidence as to what Dr Quan, and Holdsworth House, understood to be the position was disputed. In oral evidence Ms Kazeme stated that Dr O'Gorman had introduced her to Dr Quan, and she denied telling him that she was a pharmacist, or holding herself out as a pharmacist to Dr Quan or his practice manager, or that she was aware that Dr Quan understood she was a pharmacist. Her evidence was that Dr Quan knew, from Dr O'Gorman in Melbourne, that she had a pharmacy background, and he did not check her registration.
20. Dr Quan's evidence to the Tribunal was that he was introduced to Ms Kazeme by Dr O'Gorman who told him about the clinic services, and that Ms Kazeme had called his practice manager and set up a meeting. Asked who told him that Ms Kazeme was an experienced pharmacist and vitamin specialist as recorded in his statement in the disciplinary proceedings against him, Dr Quan stated that she did, and he commissioned the manager to research her. That would have been before the meeting, as he met her on the basis she was a pharmacist. He could not recall whether he spoke to Ms Kazeme about her qualifications as a pharmacist. He did not check the AHPRA website, stating the staff would do that.
21. Having considered the evidence of Ms Kazeme and Dr Quan, in the context of the circumstances in which Ms Kazeme, then based in Melbourne, came to be obtaining agreement to open a clinic in the Holdsworth House premises in Sydney, the Tribunal prefers the evidence of Dr Quan to that of Ms Kazeme where there is disagreement. The Tribunal considers it unlikely that Ms Kazeme would be referred to Dr Quan as someone "with a pharmacy background" without it being mentioned that she was a qualified pharmacist. In 2015 Ms Kazeme was still provisionally registered as a pharmacist, the criminal proceedings not taking place until November 2016 and the VCAT proceedings in November 2018. The Tribunal accepts the evidence of Dr Quan that any research into Ms Kazeme's qualifications and experience would have been left to his practice manager. The Tribunal is satisfied that to the extent that a subjective understanding is relevant, at least from the perception of Dr Quan, director of Holdsworth House, Ms Kazeme was a qualified pharmacist operating the Clinic.
22. Ms Kazeme's position was that her conduct in operating the Clinic was not "in the practice of …" pharmacy, because she was carrying out the administrative functions of a business which could have been performed by a person who was not a pharmacist. However, having regard to the evidence as to how the procedures of the Clinic were devised and implemented, and in particular to Ms Kazeme's direct interactions with the general practitioner and the compounding pharmacist, and the clinical issues associated with her signing the consent forms as "medical staff", the Tribunal does not accept that her role was purely administrative. Rather, she was entrusted with safe custody and distribution of therapeutic products, and in providing non-clinical care that impacted on the safe delivery of health services.
23. The Tribunal is satisfied that Ms Kazeme's conduct in operating the Clinic was conduct "in the practice of ..." pharmacy. Based on the expert evidence of Mr Nayak, in circumstances where patients did not consult a medical practitioner, and Ms Kazeme signed the consent forms; and in implementing a work flow that depended on medications being prescribed, supplied, and kept as stock and administered to persons who were not the persons in whose names the prescriptions were written, that was conduct significantly below the standard of a practitioner of an equivalent level of training or experience. The Tribunal finds that Ms Kazeme is guilty of unsatisfactory professional conduct under s 139B(1)(a) of the National Law.
24. The alternative basis on which unsatisfactory professional conduct is alleged in Complaint 1 is under s 139B(1)(l) of the National Law. In Health Care Complaints Commission v Achurch [2019] NSWCATOD 20 the Tribunal noted: 31. Section 139B(1) begins with the words "Unsatisfactory professional conduct of a registered health practitioner includes each of the following". Paragraphs (a) to (k) set out different forms of conduct which are, by force of the section, unsatisfactory professional conduct. Paragraph (l) then provides that "[a]ny other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession" is also unsatisfactory professional conduct. It is arguable that the word "other" in s 139B(1)(l) limits the operation of the provision to conduct not falling within s 139B(1)(a) to (k).
25. That is consistent with the conclusion reached by Walton J in Attia at [160] that by reason of the opening words of s 139B(1)(l), if the impugned conduct falls within s 139B(1)(a), subsection (1)((l) has no work to do.
26. The Tribunal has concluded that s 139B(1)(a) applies, in which case s 139B(1)(l) does not arise for consideration. However, in case we are wrong in our conclusion on s 139B(1)(a), we make the following findings on s 139B(1)(l) of the National Law.
27. Having explained the relationship between s 139B(1)(a) and (l), Walton J in Attia considered s 139B(1)(l): 163. Secondly, the sub-section does not operate directly or exclusively in conjunction with "fit and proper person requirements" as contended by the plaintiff. As I observed, the opening words of sub-s (1)(l) made clear that ethical and related considerations may arise under sub-ss (1)(a)-(k) as applicable. 164. Thirdly, it is true the words "related" and "purported" do widen the scope of the meaning of "unsatisfactory professional conduct" for the purposes of s 139B(1) but those words operate upon the phrase "practice of the practitioner's profession". It follows that, if the conduct is something which is "in" that practice then, when read with the opening words of sub-s (1)(l), it cannot be "related to" the same or in the nature of something purported to be the practice. 165. Little attention was paid by the parties to examples of the scope of sub-s (1)(l) but it is conceivable that the provisions would act upon personal conduct which did not have or require the application of knowledge, skills, judgment or care in the practice of pharmacy but which nonetheless had implications for the continued practice of the practitioner. However, once the conduct of the plaintiff engaged his knowledge, skill, judgment or care as a registered pharmacist then, in my view, the provisions of sub-s (1)(a) came into operation. As discussed by Samuels JA in (Childs at 4) the conduct by the plaintiff as a practitioner pharmacist, having regard to the findings of the Tribunal, demonstrated he lacked one or more of the qualities indispensable to the practice of pharmacy. (It may be noted that, in Childs, the misconduct alleged was that a psychiatrist had, inter alia, engaged in a sexual encounter after the termination of the doctor-patient relationship. The Court found that the definition of "professional misconduct" had no such temporal limitation and, as I have earlier observed, the relevant question was whether the nature of the conduct was such as to demonstrate the requisite lack of quality in the profession).
28. The terms "improper" and "unethical" were considered in Achurch: 41. "Improper" and "unethical" are not defined in the National Law and should be given their ordinary meaning. The word "improper" means, relevantly, "not proper," and "not in accordance with propriety of behaviour, manners, etc.: improper conduct" (Macquarie Dictionary Online; see also Health Care Complaints Commission v Liu [2016] NSWCATOD 133 at [51]). "Unethical" means, relevantly, "contrary to moral precept; immoral" or "in contravention of some code of professional conduct" (Macquarie Dictionary Online; see also Health Care Complaints Commission v Liu [2016] NSWCATOD 133 at [52]). In this disciplinary context, impropriety may refer to a breach of the standards of conduct that would be expected of a person in the position of the respondent (see Health Care Complaints Commission v Liu [2016] NSWCATOD 133 at [54]).
29. The Tribunal finds that Ms Kazeme's conduct in establishing the procedures and processes for the Clinic, which she acknowledges were not safe and effective, and in its operation which resulted in the hospitalisation of Patient J and the administration of treatment to individuals who she acknowledges should not have had the treatment or who should have consulted a doctor, was in breach of the requirements of the Pharmacy Board of Australia Code of Conduct and the PSA Code of Ethics as outlined above. Mr Nayak's oral evidence was that Ms Kazeme's conduct did not have the safety of the patients at the Clinic as the first concern, nor did she recognise and work within the limits of competence, or provide safety and quality in health care, or code. Her conduct at the Clinic did not uphold the reputation of a pharmacist.
30. The Tribunal accepts the assessment of Mr Nayak, and finds that Ms Kazeme's conduct, which was in contravention of the applicable Codes of professional conduct, and which placed the health and safety of her patients at risk, was unethical. For the reasons above, the Tribunal is satisfied that that conduct was conduct at least relating to the practice of pharmacy in the broad sense explained in Attia, and Ms Kazeme is guilty of unsatisfactory professional conduct under s 139B(1)(l) of the National Law.

Complaint 2

1. Complaint 2 is that Ms Kazeme is guilty of unsatisfactory professional conduct under s 139B(1)(l) of the National Law in that contrary to the condition on her registration that she only practice with supervision by an approved supervisor, namely Mr Alavi-Moghadam at Como Compounding Pharmacy, between January 2016 and 14 February 2016 she worked unsupervised at the Clinic.
2. The HCCC submits that at the time of operation of the Clinic Ms Kazeme was subject to provisional registration but was no longer working for her Board approved preceptor at the pharmacy premises recorded on her provisional registration. She was yet to complete her supervised practice, the pharmacy intern training programme, and the relevant examinations to enable her to obtain general registration. The HCCC submits that Ms Kazeme did not, as required by s 131 of the National Law, notify the Pharmacy Board of Australia that she was no longer practising under the supervision of Mr Alavi-Moghadam at Como Compounding Pharmacy.
3. Ms Kazeme responds that she had passed the pharmacy oral examination in June 2015, providing confirmation by letter dated 26 June 2015 from the Pharmacy Board of Australia (ex R2, annexure F). She submits she had completed her supervised hours and the intern training programme and was in a position to obtain general registration, however due to the termination of her employment her preceptor Mr Alavi-Moghadam withheld all her documents which were at the pharmacy on the day she was terminated; she asked for them back, but they were never returned. Further, she was not working at the Clinic as a pharmacist. She did not realise that she was required to notify the Board that she was no longer practising under the supervision of Mr Alavi-Moghadam, and she submits that she did not need to contact AHPRA because she was not practising at the Clinic as a pharmacist.
4. It is not in dispute that by the time she was operating the Clinic Ms Kazeme had ceased working for Mr Alavi-Moghadam at Como Compounding Pharmacy. She does not dispute that she did not inform the Board that she was no longer working for Mr Alavi-Moghadam. The Board's letter dated 26 June 2015 states the requirements for any application for general registration, and Ms Kazeme's Reply does not dispute that she had not made that formal application.
5. Complaint 2 does not formally allege a failure to comply with the obligation under s 131 of the National Law as a registered health practitioner to give within 30 days written notice of a change in principal place of practice. The Complaint is instead framed in terms of Ms Kazeme's conduct in working unsupervised. The Board's letter of 26 June 2015 includes the note that "you are not permitted to practise unsupervised as a pharmacist" until granted general registration, however the evidence before the Tribunal does not include a copy of the conditions on the provisional registration to which Ms Kazeme was subject in January and February 2016. The AHPRA Confirmation of Registration Status provided at the hearing records her current registration status as "Unregistered" (registration having been cancelled on 19 November 2018), and as Previous Conditions an undertaking from 9 March 2016 to 21 March 2016 (the date of suspension) that Ms Kazeme "undertakes not to work as a pharmacist until approved to do so by the Pharmacy Board of Australia".
6. Having regard to the evidence before the Tribunal and the way in which Complaint 2 is pleaded, the Tribunal is not satisfied to the requisite standard that the complaint in the terms alleged in Complaint 2 is established.

Complaint 3

1. The Tribunal has found above that Ms Kazeme's conduct in operating the Clinic had the requisite connection to the practice of pharmacy that she is guilty of unsatisfactory professional conduct under s 139B(1)(a) of the National Law, and in the alternative, that she is guilty of unsatisfactory professional conduct under s 139B(1)(l) of the National Law.
2. In considering whether that conduct is professional misconduct as defined in s 139E of the National Law, the Tribunal notes that the gravity of professional misconduct is not to be measured by reference to the worst cases, but by the extent to which it departs from the proper standards: Health Care Complaints Commission v Litchfield (1997) 41 NSWLR 630; [1997] NSWCA 264.
3. As explained by Basten JA in Chen v Health Care Complaints Commission [2017] NSWCA 186 at [19], the term "professional misconduct" does not have a specific meaning, and it is merely a category of "unsatisfactory professional conduct" which is sufficiently serious to justify suspension or cancellation. At [20] his Honour continued: There is no category of unsatisfactory professional conduct which is not capable, depending on the circumstances, of giving rise to professional misconduct and hence engaging the power of either suspension or cancellation of registration. The only requirement is that it be "sufficiently serious" to justify such an order, a characterisation which must depend upon an evaluative judgment made by the Tribunal. Some, perhaps all, categories include conduct which may reveal a defect of character as to which the Tribunal may conclude that the person should not be allowed to practise his or her profession unless at some future date the practitioner is able to satisfy the Tribunal that the defect has been overcome. Incompetence or inadequate care may in some circumstances be remediable by specific steps; in other circumstances the Tribunal may be concerned that the carelessness, for example, is such as to cast doubt on the suitability of the person to practise medicine. Each of the criteria for cancellation or suspension may be analysed in this way. Each case will depend upon an evaluative judgment to be made by the Tribunal as to the nature and seriousness of the conduct. It follows that the legislative scheme is inconsistent with the implication of the abstract condition sought to be imposed by the practitioner on the language of s 149C(1).
4. The HCCC submits that Ms Kazeme's conduct was sufficiently serious to justify an order suspending or cancelling her registration, having regard to the gravity of the conduct, the number of patients affected, and the serious nature of the health risks concerned, including the hospitalisation of Patient J.
5. Ms Kazeme submits that while she made an error as business owner with the method and flow of the business, she put her trust in those supporting her, and her conduct had nothing to do with her being a pharmacist.
6. The Tribunal has found, as discussed above, that the flow of work and methodology implemented by the Clinic posed risks to health and safety of the clients of the Clinic, including hospitalisation of Patient J. The Clinic operated in accordance with the practices and procedures devised by Ms Kazeme, albeit for a short time only. The other health professionals involved had their own professional obligations and standards to uphold, however as a registered pharmacist Ms Kazeme had qualifications that would enable her to discharge her independent obligation to ensure safe practices in the obtaining, storing, handling and dispensing of therapeutic products. The Tribunal is satisfied that her conduct is unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of her registration, and she is guilty of professional misconduct.

Complaint 4

1. Complaint 4 is that pursuant to s 144(e) of the National Law, Ms Kazeme is not a suitable person to hold registration as a pharmacist. Section 144 provides: 144 Grounds for complaint about registered health practitioner [NSW] The following complaints may be made about a registered health practitioner - (a) Criminal conviction or criminal finding A complaint the practitioner has, either in this jurisdiction or elsewhere, been convicted of or made the subject of a criminal finding for an offence. (b) Unsatisfactory professional conduct or professional misconduct A complaint the practitioner has been guilty of unsatisfactory professional conduct or professional misconduct. (c) Lack of competence A complaint the practitioner is not competent to practise the practitioner's profession. (d) Impairment A complaint the practitioner has an impairment. (e) Suitable person A complaint the practitioner is otherwise not a suitable person to hold registration in the practitioner's profession.
2. The HCCC confirmed that the matters on which it makes this complaint are limited to the conduct of Ms Kazeme at the Clinic including the hospitalisation of Patient J, and that this complaint is the basis on which it is seeking a prohibition order.
3. The word "otherwise" in s 144(e) limits the operation of s 144(e) to complaints which are not complaints set out in paragraphs (a) to (d): Health Care Complaints Commission v Simpson [2018] NSWCATOD 49; Health Care Complaints Commission v Haasbroek [2018] NSWCATOD 177; Health Care Complaints Commission v Achurch [2019] NSWCATOD 20. In these proceedings the HCCC has alleged, and the Tribunal has found, that Ms Kazeme is guilty of unsatisfactory professional conduct (Complaint 1) and professional misconduct (Complaint 3). Those conclusions depend on findings that Ms Kazeme's conduct was "in the practice of the … profession" of pharmacy, or that it was conduct "relating to the practice…" of pharmacy.
4. In case we are wrong on the analysis that led to those conclusions, and Ms Kazeme's conduct in operating the Clinic cannot be regarded as relevantly connected to the practice of pharmacy so as to sustain Complaints 1 and 3, the Tribunal considers it appropriate to determine whether Complaint 4 is established.
5. The term "not suitable" in s 144(e) is not defined. That is to "…ensure that bodies such as this Tribunal and the Boards charged with the important responsibility of ensuring high standards are maintained in registered professions are able to consider each case on its individual merits": Health Care Complaints Commission v Bosanquet [2012] NSWDT 2 at [103]. The approach to be adopted in considering s144(e) was discussed in Health Care Complaints Commission v Elshaimy [2019] NSWCATOD 17 in the following terms: 27. The expression "not a suitable person to hold registration" is not defined by the National Law. Section 55 of the National Law provides some guidance as to its meaning. Headed "Unsuitability to hold general registration", s 55 of the National Law states that a National Board may decide that an individual is not a suitable person to hold general registration, if, among other things: … (b) having regard to the individual's criminal history to the extent that is relevant to the individual's practice of the profession, the individual is not, in the Board's opinion, an appropriate person to practise the profession or it is not in the public interest for the individual to practise the profession; or … (h) in the Board's opinion, the individual is for any other reason - (i) not a fit and proper person for general registration in the profession; or (ii) unable to practise the profession competently and safely. 28. The meaning of the expression "not a suitable person to hold registration" in s 144(e) of the National Law was considered by the Tribunal in Health Care Complaints Commission v Brush [2015] NSWCATOD 120 (Brush) at [72]- [73]: [I]n considering whether [the practitioner] "is a suitable person to hold registration", it is useful to have regard to the expression "fit and proper person". The latter has been the subject of detailed consideration by the authorities in various regulatory environments. Neither expression carry any precise meaning and take their meaning from their context, from the activities in which the person is or will be engaged and the ends to be served by those activities (see, for example, Australian Broadcasting Tribunal v Bond [1990] HCA 33; (1990) 170 CLR 321 at 380 per Toohey and Gaudron JJ.) In this case the context is the statutory scheme established for the registration and accreditation of health practitioners, a scheme designed to protect members of the public by ensuring that only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered (ss 3(1) and 3(2)(a) of the National Law). While some overlap between the concepts of "good character" and "being a suitable person to hold registration" / "fit and proper person" they are not identical. The former encompasses matters such as integrity, probity and scrupulosity; the latter embraces those concepts but also includes matters such as competence and technical skills. 29. That interpretation was cited with approval by the Tribunal (A/J Boland presiding) in Health Care Complaints Commission v Istephan (No 2) [2017] NSWCATOD 116 at [116]-[118] and by the Court of Criminal Appeal (Hoeben CJ, Johnson J and Latham J) in Jung v R [2017] NSWCCA 24 at [56].
6. The HCCC submits that when Ms Kazeme's conduct at the Clinic is looked at in the context of the background of her prior criminal convictions, arguably there is evidence to suggest that her prior conduct of misappropriating and supplying medications without authority to do so has been repeated at the Clinic particularly in relation to Glutathione. There is a material risk that the conduct will be repeated in circumstances where she continues to operate similar clinics.
7. Ms Kazeme contends that this complaint is not established, submitting that during the stressful time she tried her hardest to focus her energy into IV.ME to make it successful.
8. While acknowledging that the procedures and processes adopted by her for the Clinic were not safe, Ms Kazeme's position throughout the hearing was to deflect blame for the shortcomings of the Clinic's practices and procedure to the other health professionals associated with the Clinic. The Tribunal considers that in addition to the serious health and safety risks inherent in the Clinic procedures and processes which she devised, Ms Kazeme's unwillingness to take responsibility for her own lack of judgment and care demonstrates a lack of the character and integrity inherent in suitability for registration as a health practitioner. In reaching that conclusion, it is not necessary to have regard to the prior conduct for which Ms Kazeme was prosecuted and sentenced in Victoria. The Tribunal concludes that Ms Kazeme is not a suitable person to hold registration as a pharmacist.

Protective Orders

1. The Tribunal has found that Complaints 1, 3 and 4 are established. The Tribunal may exercise any of the powers in Subdiv 6 of Part 8 of the National Law, which includes powers to caution or reprimand, impose conditions on registration, or require a practitioner to undergo specified treatment or complete an educational course. In addition, having found that Ms Kazeme is guilty of professional misconduct, and that she is not a suitable person for registration in the profession of pharmacy, the Tribunal may under s 149C(1) of the National Law, suspend or cancel her registration.
2. Where as in the present proceedings the person is no longer registered, s 149C(4) of the National Law provides: (4) If the person is no longer registered, the Tribunal may - (a) decide that if the person were still registered the Tribunal would have suspended or cancelled the person's registration; and (b) if the Tribunal would have cancelled the person's registration, decide that the person is disqualified from being registered in the health profession for a specified period or until specified conditions have been complied with; and (c) require the National Board with which the person was registered to record the fact that the Tribunal would have suspended or cancelled the person's registration in the National Register kept by the Board.
3. The HCCC submits that the Tribunal should make an order under s 149C(4) of the National Law declaring that if Ms Kazeme were still registered the Tribunal would have cancelled her registration, and an order that she be disqualified from being registered for a period of between 1-2 years from the conclusion of the non-review period ordered by VCAT, that is, from 19 November 2020.
4. Ms Kazeme disagrees, contending that she had not practised for three years before the cancellation of her registration making it five years by the end of the period imposed by VCAT; and she should not be cancelled any further. In her written submissions received after the hearing, Ms Kazeme states that if she is found guilty in relation to the practice of pharmacy, any further cancellation period should be only one year.
5. The findings of professional misconduct and that Ms Kazeme is not a suitable person to be registered do not mean that an order under s 149C(4) must be made. The power to make any of the orders specified in s 149C is protective rather than punitive. In Lee v Health Care Complaints Commission [2012] NSWCA 80 the Court of Appeal held: 20. Essential to a proper assessment of a tribunal's discretionary judgment in a disciplinary jurisdiction in accordance with these criteria is a clear understanding of the nature of the jurisdiction and an appreciation of the purpose of orders made in exercise of it. These matters were explained by Basten JA in Director-General, Department of Ageing, Disability and Home Care v Lambert [2009] NSWCA 102; (2009) 74 NSWLR 523 at [83]. His Honour made several important points: 1. The specific purpose for which orders are made is protective in the public interest and is not punitive with respect to the individual. 2. That is not to deny that such orders may be punitive in effect and that punitive effects may be relevant in formulating a protective order. 3. The punitive effects may be directly relevant to the need for protection so that, in a particular case, there may be a factual finding that the harrowing experience of disciplinary proceedings, together with the real threat of loss of a livelihood, may have opened the eyes of the individual concerned to the seriousness of his or her conduct so as to diminish significantly the likelihood of its repetition and to produce a level of insight into his or her own character or misconduct which did not previously exist. 21. The task of the Tribunal (and of this Court on appeal) centres not on punishment as such but on the protection of the public and the maintenance of proper professional standards.
6. The Tribunal is required in the exercise of functions under the National Law to have regard to the objectives and guiding principles of the national registration and accreditation scheme set out in s 3. The most directly relevant of those principles is that in s 3(2)(a), to provide for the protection of the public by ensuring that only health practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered. The protection of the health and safety of the public must be the paramount consideration: s 3A.
7. In Health Care Complaints Commission v Do [2014] NSWCA 307 the Court of Appeal said: 35. The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise.
8. The Tribunal considers that of the findings on which we have found Ms Kazeme guilty of professional misconduct and that she is not suitable for registration, the most serious relate to her implementation of unsafe and deficient practices and processes for the Clinic in which she involved other health professionals and on to whom she has deflected blame. While stating that she had responsibility as director, Ms Kazeme has not acknowledged that she, as a qualified and registered health professional, had her own obligations to ensure safe and effective procurement, storage and dispensing of therapeutic products. There was no indication in her evidence of any reflection on her personal professional responsibilities, rather an insistence on the obligation of the other health professionals to point out the shortcomings of her business model. The protection of the public from the apprehended harm that might be caused by Ms Kazeme, and the general deterrence and maintenance of public confidence in the profession, confirm that the orders sought by the HCCC should be made, and that Ms Kazeme should be precluded from applying for re-registration for a further period of one year after 19 November 2020.
9. The HCCC also seeks an order under s 149C(5) of the National Law, which provides: (5) If the Tribunal suspends or cancels a registered health practitioner's or student's registration and it is satisfied the person poses a substantial risk to the health of members of the public, it may by order (a prohibition order) do any one or more of the following - (a) prohibit the person from providing health services or specified health services for the period specified in the order or permanently; (b) place specified conditions on the provision of health services or specified health services by the person for the period specified in the order or permanently. Note. Section 102(3) of the Public Health Act 2010 provides that it is an offence for a person to provide a health service in contravention of a prohibition order.
10. The Tribunal has decided that it would have cancelled Ms Kazeme's registration had she still been registered, and pursuant to s 149C(5A) the Tribunal has power to make a prohibition order under subsection (5).
11. The HCCC submits that a prohibition order should be made in respect of specified health services, on a permanent basis.
12. Ms Kazeme opposes such an order. She submits that she is no longer operating an IV clinic, and has moved her interests to the construction field. She is currently completing a degree in construction. Potentially one day she may want to get her registration back. She is not operating any business of a health nature but wants to keep her option open and opposes a permanent ban on providing health services, which would be harsh. Although she is focussing all her efforts in construction, she is 31 years old and does not know what business opportunities may present in future. She has learned from and takes responsibility for her mistakes as a previous business owner.
13. The Tribunal must be satisfied that Ms Kazeme poses "a substantial risk to the health of members of the public" before it can consider whether a prohibition order should be made. That is a risk that is material, and real or apparent on the evidence, and not a risk that is without substance or speculative: Health Care Complaints Commission v Brush [2015] NSWCATOD 120 at [96]; Health Care Complaints Commission v Choi [2017] NSWCATOD 82 at [75].
14. The Tribunal accepts Ms Kazeme's evidence that she has no current intention of engaging in health services including services similar to the IV.ME clinic. However, it is clear that she has not ruled out some similar business venture in the future. In circumstances where Ms Kazeme has not taken responsibility as a qualified health professional whose professional obligations include ensuring safe and effective procurement, storage and dispensing of therapeutic products, the Tribunal is satisfied that there is a material risk that the conduct the subject of our findings could be repeated. In those circumstances, the Tribunal considers that Ms Kazeme would pose a substantial risk to the health of members of the public.
15. The Tribunal considers that a prohibition order should be made; however, agrees with Ms Kazeme that a permanent prohibition would not be warranted to achieve the protective purpose enabled by such an order. Ms Kazeme has admitted that she made mistakes as business owner, and with further reflection she may be able to demonstrate insight into the misconduct that fell well short of the expectations and obligations of a qualified health professional. In the Tribunal's view, the process of review and possible reinstatement after the end of the cancellation period may enable Ms Kazeme to demonstrate that insight, such that it can be concluded that she does not pose a risk to public health and safety. The Tribunal considers that a prohibition order for specified health services in the terms proposed by the HCCC should be made, for a period specified to be the time at which she obtains a reinstatement order under Div 8 of Part 8 of the National Law or its equivalent, or is re-registered as a health practitioner.

Costs

1. The HCCC seeks an order that Ms Kazeme pay its costs of the proceedings. Ms Kazeme opposes a costs order, submitting that she should pay only 50% of the HCCC's costs of the investigation, due to her mistakes and errors as proprietor of the Clinic.
2. Clause 13 of Sch 5D of the National Law enables the Tribunal to make an order for payment of costs. The Tribunal has, on 12 September 2019, ordered Ms Kazeme to pay the costs of the HCCC thrown away by reason of the adjournment of the hearing on 12 September 2019. The relevant principles applicable to the costs of the proceedings were summarised by the Court of Appeal in Qasim v Health Care Complaints Commission [2015] NSWCA 282, and are that ordinarily costs should follow the event unless there are reasons to conclude otherwise. The purpose of these proceedings is protective rather than punitive, as mandated by the principles stated in ss 3 and 3A of the National Law. There is no disentitling conduct as on the part of the HCCC in its conduct of the proceedings. It is appropriate to order that the practitioner pay the costs of the HCCC.

Orders

1. The Tribunal orders: 1. The practitioner is guilty of unsatisfactory professional conduct and professional misconduct. 2. The complaint that the practitioner is otherwise not a suitable person to hold registration in the profession of pharmacy is proven. 3. Pursuant to s 149C(4)(a) of the Health Practitioner Regulation National Law (NSW), if the practitioner were still registered, the Tribunal would have cancelled the practitioner's registration as a Pharmacist for a period of one year commencing from 19 November 2020, being the conclusion of the non-review period made by the Victorian Civil and Administrative Tribunal in Pharmacy Board of Australia v Kazeme (Review and Regulation) [2019] VCAT 72 on 19 November 2018. 4. Pursuant to s 149C(4)(c) of the Health Practitioner Regulation National Law (NSW) the Tribunal requires the Pharmacy Board of Australia to record the fact that had the practitioner been registered the Tribunal would have cancelled the practitioner's registration for a period of one year from 19 November 2020, being the conclusion of the non-review period made by the Victorian Civil and Administrative Tribunal in Pharmacy Board of Australia v Kazeme (Review and Regulation) [2019] VCAT 72 on 19 November 2018. 5. Pursuant to s 149C(5) of the Health Practitioner Regulation National Law (NSW) the Tribunal finds that the practitioner poses a substantial risk to the health of members of the public and accordingly orders that the practitioner is prohibited from providing health services offering intravenous infusions, intramuscular injections and other forms of injectables of vitamins, minerals, antioxidants and other similar products, for the period until she obtains a reinstatement order under Div 8 of Part of the Health Practitioner Regulation National Law (NSW) or its equivalent, or is re-registered as a health practitioner. 6. The practitioner is to pay the Health Care Complaints Commission's costs of these proceedings pursuant to clause 13(1) of Schedule 5D of the Health Practitioner Registration National Law (NSW) as agreed or as assessed under the Legal Profession Uniform Law Application Act 2014 (NSW).

I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales. Registrar DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 19 March 2020