Health Care Complaints Commission v Akinci

Evidence

1. The Commission's evidence in support of its application consisted of a number of volumes, and other individual written materials. It called no witnesses.
2. The Respondent tendered a volume of material, some of which is relevant only to a Stage 2 hearing. The Respondent gave brief oral evidence and was cross examined.
3. The Respondent also, with leave, called an experienced pharmacist, Mr David Preswick, who was cross examined.

Complaint 1

1. The background to Complaint 1 is stated to concern the importation, or attempted importation of the Phosphatidylcholine described above.
2. The particulars of the unsatisfactory professional conduct in Complaint 1 are as follows: 1. Between 1 January 2018 and 30 September 2019, the Respondent inappropriately attempted to import Consignment 1 into Australia from Ukraine in circumstances where: 1. Phosphatidylcholine was not at the relevant time a registered therapeutic good listed on the ARTG; 2. the Respondent did not have an exemption or authority under any Act to import the goods lawfully; 3. the importation was for the purpose of retail supply; 4. it was contrary to Part 2.2 of the Pharmacy Board of Australia ("PBA") Code of Conduct. 1. Between 1 January 2018 and 30 September 2019, the Respondent inappropriately attempted to import Consignment 2 into Australia from Ukraine in the same circumstances as set out in Particular 1. 2. On 13 August 2019, the Respondent fraudulently provided a prescription to the TGA in order to secure the release of Consignment 1 and Consignment 2 in circumstances where the Respondent engaged another practitioner, namely Person N, to assist in obtaining the fraudulent prescription. 3. On 4 September 2019, the Respondent fraudulently provided a prescription to the TGA in order to secure the release of Consignment 1 and Consignment 2 in circumstances where the Respondent engaged another practitioner, namely Person N, to assist in obtaining the fraudulent prescription.
3. On the evidence before us, we are satisfied that in fact the Respondent did not intend to obtain two different consignments of the medicine and that the two prescriptions referred to above were provided to the TGA with the view to securing the release of the one (duplicated) order that she had placed, but which had apparently been believed to have gone astray and a replacement was then dispatched to the Respondent.
4. We are satisfied and find that the injectable formulation of Phosphatidylcholine was not at the time a registered therapeutic good listed on the ARTG, the Respondent did not have an exemption or authority to import the goods lawfully and that the attempted importation was not for personal use but for the purposes of retail supply.
5. The Commission relies on "Good Care" provisions in Part 2.2 of the PBA Code of Conduct to the effect that practitioners must ensure that the personal views of a practitioner do not affect the care of a patient or client adversely. We are not satisfied that Part 2.2 has application to the circumstances set out above.
6. The Respondent has admitted her fraudulent conduct in seeking to obtain the release of this medicine, that it was a circumvention of the rules and stated that she would not contemplate anything like this in the future.
7. The Respondent also admitted that her conduct was improper because it was contrary to subsection 19B(4A) of the Therapeutic Goods Act 1989, and it was wrong to provide prescriptions in her name so that the TGA would release the medicine which she intended to provide by retail sale to patients or customers of her Pharmacy.
8. In our view, the conduct engaged in by the Respondent was improper as it was wrong, not in accordance with truth or the applicable rules for the importation of such medicine.
9. The conduct was also unethical in the sense of being contrary to moral precepts.
10. The Respondent admitted Complaint 1.
11. The conduct as proven and admitted was serious misconduct.
12. Accordingly, on the materials before us we are satisfied and find that Complaint 1 has been established.

Complaint 2

1. The background to Complaint 2 as outlined by the Commission is that on 6 September 2019 the Pharmaceutical Regulatory Unit ("PRU") conducted an inspection of the Pharmacy. A report was prepared that concluded that pharmacists at the Pharmacy had supplied Phosphatidylcholine to patients, at times without prescription.
2. The particulars of the unsatisfactory professional conduct in Complaint 2 are that between 10 September 2018 and 8 August 2019, the Respondent inappropriately dispensed and/or permitted the inappropriate dispensing by an employed pharmacist of Phosphatidylcholine on the dates and in the circumstances set out in a schedule, namely Schedule 1 to the Complaint, in circumstances where the medicine was not a registered therapeutic good under the ARTG.
3. Schedule 1 is said to be a record of dispensed Phosphatidylcholine.
4. Schedule 1 sets out in tabular form 10 Patients, Patient A to Patient J; "Vials supplied"; the dates of supply; "Repeats" and the "Prescriber".
5. In respect of Patient J, Schedule 1 records that there were three occasions on which three vials of Phosphatidylcholine were supplied to Patient J, namely 16 April 2019, 17 June 2019 and 5 March 2019.
6. On the evidence before us, we are satisfied that the Respondent did acquire from overseas 10 vials of Phosphatidylcholine most likely towards the end of 2018. That medication was supplied to Patient J as listed in Schedule 1 during the period March 2019 to June 2019. The Regulatory Compliance Section of the TGA informed an Investigation Officer of the Commission in March 2020 of a prior import of the product in the name of the Respondent on 3 April 2018 and that the goods were released as "they were complementary medicines and were within a three-month supply".
7. In our view, it is more than likely that the nine vials supplied to Patient J on the dates stipulated had been obtained by the Respondent unrelated to the attempted importation of the medicines the subject of Complaint 1. This medicine appears to be the medicine referred to above as having been received on 3 April 2018, which had been released as it was regarded as complementary medicine and within a three-month supply. The supply to Patient J occurred prior to the attempts by the Respondent to secure the release of the medicines ordered to be sent from Ukraine by the provision to the TGA of the two prescriptions obtained from Person N.
8. The Commission contends that the conduct set out in Complaint 2 is improper because it is contrary to s 36A of the Poisons and Therapeutic Goods Act 1966.
9. Section 36A of that Act is to the effect that a person who supplies by retail therapeutic goods to a person is guilty of an offence unless: "(1) The goods are registered goods or listed goods, or (2) The goods are exempt goods or are the subject of an approval or authority under s 19 of the Commonwealth Act."
10. The nine vials referred to in Schedule 1 supplied to Patient J do not come within the exceptions set out in s 36A.
11. Since the conduct complained of in Complaint 2 relates to "dispensing" it is also necessary to pay attention to what is meant by that term. The Guidelines for Dispensing of Medicines December 2015, published by the Pharmacy Board of Australia, defines dispensing as the "review of a prescription and the preparation, packaging, labelling, record keeping and transfer of the prescribed medicine including counselling, to a patient, their agent, or another person who is responsible for the administration of the medicine to that patient".
12. There is, therefore, a clear distinction made in the guideline between the preparation, on the one hand, and on the other, the transfer (or supply) of the medicine to the patient or other authorised person.
13. The Respondent in the course of responding to the complaints put to her by the Commission during its investigation stated in writing that she had "dispensed" Essentiale to three patients after receiving scripts from medical practitioners. She further stated that "as Essentiale was out of stock, Lesfal was supplied".
14. These comments by the Respondent are perplexing given that the records indicated "dispensing" to up to 10 patients. However, the Respondent indicated that whilst the records recorded "dispensing" of medicines it was anticipatory in the sense of not yet being able to supply the medicines. The explanations she gave to the Commission (Exhibit A1, pages 435 to 436) as a whole leave open the interpretation that "dispensed" did not mean supply. Once scripts were received from two doctors the Respondent undertook a search that indicated the medicines could be supplied from Ukraine. She did not have the medicine to "dispense" as that term is defined.
15. We are not persuaded that the complaint made by an employed pharmacist, namely Person O, takes the matter any further. Person O's written report dated 12 August 2019 to the TGA concerning the importation of "Essentiale" "from Russia" recorded also that "currently it's being held in customs and she has till Wednesday 14/8/19 to write a letter to be released". Although Person O wrote about "giving it to patients" it is unclear how that occurred in the absence of an identified supply which could be given to persons seeking the medicine. However, the comments could have been referring to earlier supplies and the images provided by Person O appeared to be "Lesfal", the Ukraine brand which was supplied to Patient J.
16. Had there been evidence before us proving that the Pharmacy had been in receipt of additional orders for the medicines we would be inclined to conclude that what the Respondent had said meant "dispensed" in the fullest sense, including transfer (or supply). In the absence of such evidence, we do not regard the Respondent's comments as admissions of supply.
17. Although the Respondent's records recorded as having "dispensed" the medicine set out in Schedule 1 to the complaint, the Respondent indicated that the Pharmacy did not have the medicine available to supply to the listed Patients, except Patient J, because the goods sought to be imported had not been released by customs and had been forfeited.
18. We are, however, satisfied that Complaint 2 has been made out insofar as it extends to the transfer (or supply) to Patient J of the nine vials on the nominated dates when, in doing so, it was contrary to s 36A of the Poisons and Therapeutic Goods Act 1966. That conduct, in our view was improper conduct.

Complaint 3

1. The particulars of unsatisfactory professional conduct in Complaint 3 are that between 10 September 2018 and 12 June 2019 the Respondent inappropriately dispensed and/or permitted the inappropriate dispensing and/or inaccurate recording by an employed pharmacist of Phosphatidylcholine on the dates and in the circumstances set out in Schedule 2 to the complaint in circumstances where: 1. inadequate checks were made to ensure the validity of the prescriptions; 2. the practitioner ought to have known that the purported prescribing medical practitioners were no longer registered medical practitioners at the date of the prescriptions; 3. it was in breach of Guideline 1 of the PBA Guidelines for Dispensing of Medicines.
2. Schedule 2 then sets out in tabular form "Patient Name", (Patient D, G, H and I) the "Medication dispensed by the Pharmacy", "Vials dispensed", the "Date dispensed" and the names of the doctors in the column headed "Purported Prescriber".
3. First, it must be noted, that the evidence does not satisfy us that the Respondent, or an employed pharmacist, had available to dispense to those patients the medicine identified namely, a number of vials recorded, in the sense of transferring (or supplying) into their possession the relevant quantities stipulated.
4. As we point out above, the order for the vials, the subject of Complaint 1 from Ukraine was never received by the Respondent as the goods had been forfeited to the Crown. There is no other evidence satisfying us of any importation or acquisition of this medicine by the Respondent. In other words, the sum total of Phosphatidylcholine proven to have been received by the Respondent consisted of ten vials, nine of which were supplied to Patient J, and one which was defective.
5. Secondly, Complaint 3 is premised on the "dispensing" or permitting inappropriate dispensing, of the medicine. In circumstances where it has not been proved that the medicine stipulated in Schedule 2 could have been supplied to the four patients nominated, the term "dispensing" is an inaccurate description of what occurred. It appears to us, and we find, that it is more likely that the Respondent was using her dispensing software to enter into her records various orders and requests for the medicines in anticipation of supplying the medicines to those patients as and when those orders were received. The term "dispensed" only concerned the first element of the definition in the guidelines, but there was, in fact, no transfer (or supply) of the product as it was never received and those Patients listed in Schedule 2 were never supplied with the product.
6. Thirdly, Complaint 3 proceeds on the basis that prescriptions were required for the dispensing of this medicine and a complaint that the medicine had been dispensed without adequate checking of the validity of prescriptions, albeit, this medicine is categorised by the TGA as a "complementary medicine".
7. When questioned by the Tribunal the Commission was unable to point to any requirement in any legislation or other provisions to the effect that dispensing (in the fullest meaning) of this medicine was permitted 'only on prescription'. We must therefore accept that it is "non-prescription" medicine.
8. In circumstances where there was no necessity for the medicine to be supplied 'only on prescription' (and leaving aside the inability to actually supply the product) the alleged failure to check the prescriptions is not accepted. In addition, an alleged failure to check the validity of a prescription for medicine which was not supplied does not permit a finding of unsatisfactory professional conduct.
9. Fourthly, it was not disputed before us that in respect of Patient D the doctor listed as Dr Lucas died on 24 September 2003. The doctor listed in respect of Patient G, namely Dr Bruce Reading died on 16 February 2015. The doctor listed in respect of Patient I, namely Dr Schiller died on 12 August 2011. In addition, the doctor listed in respect of Patient H, namely Dr Susan Read retired from practice in 2017 and on the evidence never prescribed Phosphatidylcholine to any person.
10. This raises the question of whether there ever existed prescriptions from those doctors for the medicine listed in Schedule 2 as "dispensed". If such prescriptions were presented to the Pharmacy on or about the dates set out in Schedule 2 in 2018 and 2019 with the appropriate prescriber identified, and signed, a person or some persons must have fraudulently procured or produced such prescriptions.
11. For that to have occurred, the person or persons must have been able to obtain the prescriber's prescription forms, or recreated them, and then fraudulently provided all relevant details including a signature. How the nominated patients, or anyone else, could have achieved such an outcome, and in respect of four different medical practitioners, was not explained to us. In our view it is an improbable hypothesis. In addition, had such prescriptions existed the Respondent ought to have been able to provide them to the Commission when sought, but she was never able to do so.
12. In our view, it is far more probable that the Respondent never had these prescriptions but simply utilised from her own records a doctor and prescriber number chosen for the purposes of creating the record of "dispensing", but which was by the Respondent's account, "no more than the record" of "awaiting orders". Given the number of patients in these records, the Respondent was no doubt most anxious to obtain the release of the medicine motivating her unsatisfactory professional conduct, the subject of Complaint 1.
13. What is clear is that without having the medicine to supply, the Respondent was taking orders, and in some cases deposits or payment, for the medicine ordered but not yet released on this occasion by customs which did not occur.
14. That leads us to try and interpret and consider whether Complaint 3, as particularised, comes within either of the limbs of s 139B(1)(a) or (l) relied upon by the Commission. The particulars are awkwardly drafted. The insertion of "and/or inaccurate recording" appears to relate to the stated inappropriate dispensing.
15. Further, the alleged failures in Particular 1 need to be interpreted in the circumstances set out in sub-paragraphs (a), (b) and (c), all of which proceed on the basis that there were prescriptions which were not adequately verified or the guidelines for dispensing were not followed. It was not established that these circumstances have application to non-prescription medicines. The pleaded case, a failure to check the validity of prescriptions, which most likely never existed, does not, in our view, amount to unsatisfactory professional conduct.
16. Fifthly, the particulars to Complaint 3 also claim that the Respondent knew or ought to have known that the doctors identified by their names and prescriber number were no longer registered medical practitioners at the date of the prescriptions. The evidence does not support such a conclusion.
17. Sixthly, Complaint 3 is concerned with a breach of the Guidelines, namely, Guideline 1 of the PBA Guidelines for dispensing of medicines. In circumstances where there was no dispensing, in the fullest meaning of that term, it is difficult to see how Guideline 1 has any application to what more than likely occurred.
18. In our view, for the reasons set out above Complaint 3 has not been made out. We are confined in our approach to the Complaint as particularised.

Complaint 4

1. Complaint 4 is concerned with the inspections carried out by the PRU on 6 September 2019 and 3 December 2020 at the Pharmacy where officers extracted and reviewed what is said to be "dispensing records" for "blank" items for the period, first, between 1 September 2018 and 6 September 2019 and for the second inspection, for the period between 3 December 2018 to 3 December 2020. The background to the complaint records that the PRU identified that records of dispensed "blank items" which had been present in the first report from 6 September 2019 had been deleted and were not present on the second report which was dated 3 December 2020.
2. The particulars of unsatisfactory professional conduct in Complaint 4 are that between 6 September 2019 and 3 December 2020, the Respondent failed to discharge her obligations as the proprietor of the Pharmacy in that she did not maintain an awareness of the manner in which the Pharmacy dispensing practice was being conducted and failed to intervene when necessary in circumstances where: 1. records relating to the supply of restricted substances including Phosphatidylcholine and Disulfiram were altered or removed by the pharmacy as recorded in Schedule 3 to the complaint; 2. the failure was in breach of Part 8.4 of the PBA Code of Conduct for Pharmacists; 3. the failure was in breach of PBA Guidelines on Compounding Medicines.
3. The alleged failure is thus not maintaining an awareness of the manner in which the Pharmacy dispensing practice was being conducted and the failure to intervene when necessary in the circumstances set out in subparagraphs (1), (2) and (3) in relation to the supply of the specified medicines.
4. The written closing submissions by the Commission put the issue as the practitioner being guilty of unsatisfactory professional conduct "regarding deleted dispensing records for Phosphatidylcholine and Disulfiram".
5. The Commission argued that deleting the Disulfiram records was improper because Disulfiram is a Schedule 4 medicine and a pharmacist who supplies a Schedule 4 medicine on prescription must record details including the name of the prescriber and the date on which the substance was supplied, records of manufacture and supply must be kept for at least two years and a person must not make any alterations to the records unless correcting a mistake.
6. The Commission also contended that the deletion of the Disulfiram records was unethical because it was contrary to Part 8.4 of the PBA Code of Conduct which requires the maintenance of clear and accurate health records, records which are up to date, factual and objective. The Commission also relied on Guideline 12 of the PBA Guidelines on Compounding Medicines requiring pharmacists to document the preparation of compounded products in accordance with state, territory and Commonwealth legislation, practice standards and guidelines.
7. Schedule 3 is entitled "Altered or removed Pharmacy records" and lists 13 patients, namely, Patients A to M, and also includes the name of the Respondent on two occasions in respect of the medicine Disulfiram, namely, 26 April 2019 and 29 April 2019. The Patients set out include Patient J, who was the recipient of the nine vials of Phosphatidylcholine supplied to her during March 2019 to June 2019 which we have dealt with in Complaint 2.
8. The Respondent has admitted that between the inspections she deleted the Phosphatidylcholine records to ensure that the patients' medication histories were accurate. The Respondent has also admitted that she should not have deleted the entries for Patient J in respect of the nine vials that were supplied to her. This admission is made notwithstanding that the record in respect of Patient J was for a complementary medicine (non-prescription medicine) and there is the question as to the obligation, if any, to record the supply of this medicine in accordance with the PBA Code of Conduct.
9. However, this medicine was dispensed on prescription and the deletion of the records in respect of Patient J would, unless discovered, undermine the breach the subject of Complaint 2. Apart from the records for Patient J, and for the reasons set out above we are not satisfied that the deletion of the records relating to Phosphatidylcholine was in breach of the Respondent's obligations under s 139B(1) of the National Law.
10. The Respondent also admitted that she deleted the records of Disulfiram which were in her name, and submitted that she should have entered the records of that medicine as "a test run". In respect of the deletion of the Disulfiram records for Patient M and other Patients, the Respondent claimed that the particular medicine was not supplied to those Patients. There is no evidence to the contrary.
11. In defence of this complaint, the Respondent in written submissions says that the items were not supplied to the Patients listed in Schedule 3 and in leaving the dispensing record in those patient files in those circumstances would create a situation of incorrect patient histories. The Respondent further contends that deletion of records in pharmacy dispensing software does not mean that the record is "destroyed" and claims that such software does not allow the full destruction of records. The Respondent informed the Tribunal that when an item is "deleted from a pharmacy dispensing software, the record is 'greyed out' or a cross is put through the record or filtered out depending on the software". The net result is that if one is to run a patient record report, those "deleted" items do not appear, a step, she claimed makes perfect sense as another person, such as a hospital pharmacist looking at the report, did not wish to see items that the patient does not take, only those that they do.
12. As we have pointed out above, we are satisfied that other than in respect of Patient J, these records did not in truth relate to "the supply" of what is said to be a restricted substance, namely, Phosphatidylcholine as this particular importation was seized and unavailable to be supplied, and it has not been established to the requisite degree of certainty that other supplies were received and available to the Respondent to dispense to patients.
13. Mr Preswick gave evidence at the behest of the Respondent in relation to this issue. In questioning by the Respondent, he indicated that it would not be inappropriate to delete records if a pharmacist was not able to supply the medicine recorded in the records. There may be many reasons for the deletion. If recorded in the records prior to supply, and then there is no stock available which has been ordered and is not delivered he had no difficulty in conceding that the records should be deleted. We accept that evidence.
14. Clause 8.4 of the PBA Code of Conduct relied upon in the particulars to Complaint 4 deals with the issue of the keeping of "health records", a term that is not defined.
15. An issue arises as to whether the dispensing of Phosphatidylcholine (including supply), a non-prescription medicine, and stated by the TGA to be a "complementary medicine" required the keeping of health records as defined in Part 8.4 of the Code of Conduct. We did not have identified for us by the Commission the obligation or good practice for that medicine to be recorded, if supplied, in the manner set out in Part 8.4 of the PBA Code of Conduct. In the absence of the Commission arguing that (unlike Disulfiram) the deletion of a record of this medicine was in breach of the Code of Conduct, and in the absence of it being clearly established that this medicine comes within the scope of Part 8.4 of the Code of Conduct, this particular is not made out.
16. The Respondent argued that the PRU identified the deletions by comparing dispensing reports prior to the admitted deletions and that the PRU could quite easily identify the records by looking in individual patient files from which it could be seen that the record was still there in deleted form, namely, greyed out.
17. In respect of the deletion of the records in respect of Disulfiram under the Respondent's own name, the complaint relates to compounding carried out by the Respondent. She accepts that the record should have shown and been entered as a test, not under her own name. However, the Respondent submits that this medicine was not supplied to, or taken by, the Respondent or any other person, and it was only a test procedure and the product was disposed of. There is no evidence to the contrary. The Guidelines do not set out the terms of the applicable relevant state, territory or Commonwealth law provisions. The Commission did not identify whether the records failed to comply with such legislation.
18. In respect of the deletion of the record as set out in Schedule 3 relating to the supply to the Respondent in her own name of 60 capsules of 100 mg Disulfiram and 50 capsules of 150 mg Disulfiram, we accept that the Respondent did not "supply" this medicine to herself but had recorded the compounding of this medicine in her own name for a test carried out by her.
19. The purpose of proper recording of the dispensing of medicine of this kind is to enable regulators to monitor the standards of practice by practitioners. Inaccurate recording, and then deletion of the record undermines the system of regulatory oversight.
20. The deletion of the record in the Respondent's own name does not come within the reasoning of the Respondent referred to above, namely, to show an accurate patient history, and does not assist her in this respect.
21. The timing of the deletion of this record is also relevant. The Respondent had been made aware of the first inspection. She did not seek to correct the error she made by not recording the compounding as a test. Instead, the record was deleted leaving open the inference that the Respondent more likely wished to hide what she had done.
22. We are accordingly satisfied and find that the deletion of the Disulfiram records relating to the Respondent was conduct substantially below the standard expected of her.
23. The conduct complained of in Complaint 4, the failure to maintain awareness, and the failure to intervene when necessary is concerned with records relating to "the supply" of Disulfiram. The records clearly have some relationship to whether Disulfiram was supplied by the Pharmacy.
24. Schedule 3 is a summary of the removal of records including that Disulfiram 200mg capsules were dispensed to three Patients, namely, Patient K, L and M. The Respondent said the records were deleted because the medicine had not been supplied and, therefore, not dispensed (in the full sense) to those Patients. The records were thus inaccurate.
25. The deletion of these records as and when it occurred was, in our view, intended to remove scrutiny by the inspectors. The Respondent did not explain why, in respect of this drug, the records show that it was dispensed when that did not occur. The position is to be contrasted with the unavailability of medicine not released by customs.
26. We therefore find that Complaint 4 has been made out to the extent identified above in respect of records relating to the dispensing of Phosphatidylcholine to Patient J and Disulfiram to the Respondent and Patients K to M.

Complaint 5

1. Complaint 5 is concerned with compounding of capsules of Disulfiram by the Respondent.
2. The unsatisfactory professional conduct as particularised in Complaint 5 is that on 26 April 2019, the Respondent inappropriately compounded 50 capsules of Disulfiram (150 mg) in circumstances where: 1. a proprietary product was available; 2. the drug was compounded in the Respondent's own name; 3. that conduct was contrary to Guideline 2 of the PBA Guidelines on Compounding Medicines.
3. Particular 2 is that on 29 April 2019, the Respondent inappropriately compounded, on prescription, 60 capsules of compounded Disulfiram (100 mg) in circumstances where: 1. a proprietary product was available; 2. the drug was compounded in the Respondent's own name; 3. the conduct is contrary to Guideline 2 of the PBA Guidelines on Compounding Medicines.
4. Particular 3 is that on 11 December 2017 and 4 December 2019, the Respondent inappropriately compounded and dispensed and/or permitted the inappropriate compounding and dispensing by an employed pharmacist of Disulfiram (200 mg) capsules on approximately eight occasions, in circumstances where: 1. from 26 June 2018 proprietary product was available; 2. the conduct is contrary to Guideline 2 of the PBA Guidelines on Compounding Medicines.
5. Guideline 2 sets out the appropriate circumstances for compounding medicines. It provides that a compounded medicine should be prepared only in circumstances where:

• An appropriate commercial product is not available.
• A commercial product is unsuitable (e.g., if a patient experienced an allergy to an excipient in the commercial product).
• When undertaking research sanctioned by recognised human research ethics committee.

1. As will be seen from the second bullet point in Guideline 2 set out above, there is no absolute obligation to refrain from compounding where a proprietary product is available.
2. During the hearing the Commission acknowledged that it should have established that there were no circumstances rendering the commercial product unsuitable.
3. The Respondent argued that pharmacists are allowed to compound medicines for various reasons, including:

• A commercially made product is not available.
• A liquid may be required where a patient cannot swallow a solid dose form or various other patient specific requirements.
• The patient may have an allergy or sensitivity to an excipient of an ARTG registered product e.g., lactose or gluten.
• An ARTG listed product may be discontinued.
• An ARTG listed product may be temporarily unavailable.
• A product may need to be freshly made.

1. In her written response to the Commission through her solicitors on 4 October 2022, the Respondent indicated that Disulfiram 200 mg was compounded when Antabuse was out of stock for various extended periods. She stated that the pharmacy is in Redfern, a suburb a where alcoholism is rife, and her situation is not unique, but the lack of stock of Disulfiram is a much bigger issue in Redfern than other localities.
2. Mr Preswick also stated in relation to the compounding of 200 mg of Disulfiram, that in dealing with a challenging subset of patients, it is permissible to compound even if the product is available provided it can be justified as to its unsuitability.
3. In relation to the 100 mg and 150 mg strengths, the Respondent indicated that the products were made not anticipating a particular patient, but to ensure that if she did get a prescription for those strengths, she would have an established process for making the product. That would be because she had requests from medical practitioners who prescribed patients non-standard doses.
4. She further stated that some patients in her area could not tolerate effervescence, which is present in propriety products, as it made them nauseous. That was part of her reason for compounding.
5. We are satisfied on the material before us that the compounding the subject of particular 1 and particular 2 recorded under the Respondent's own name was a test and that the product was disposed of, and not compounded for the supply to any patient or client of the Pharmacy.
6. The fact of recording the test compounding in her own name does not in this Complaint add anything.
7. We are also satisfied that the Commission has not established that in relation to the compounding of the 200 mg capsules as set out in Particular 3 the Respondent did not have the available discretion to meet the requirements of the particular patient and was not contrary to Guideline 2.
8. Complaint 5 has not been made out.

Complaint 6 - Professional Misconduct

1. Complaint 6 is that the Respondent is guilty of professional misconduct under s 139E of the National Law in that the Respondent has: 1. engaged in unsatisfactory professional conduct of a sufficient serious nature to justify suspension or cancellation of her registration; and/or 2. engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, around to conduct of a sufficient serious nature to justify the suspension or cancellation of the practitioner's registration.
2. The Particulars to Complaint 6 are Complaint 1, and the particulars to that complaint relied upon individually, and Complaint 1 to 5, and the particulars to the Complaints repeated and relied upon cumulatively.
3. As we have set out above, we have concluded that Complaint 1, Complaint 2 relating to Patient J, and Complaint 4 in a limited extent, have been made out.
4. Section 139E of the National Law provides: 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.
5. In Chen v Health Care Complaints Commission [2017] NSWCA 186 at [20], Basten JA explained: "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."
6. In our view, and we find, the unsatisfactory processional conduct of the Respondent, the subject of Complaint 1 was of a sufficiently serious nature to justify suspension or cancellation of the Respondent's registration. The conduct involved a deliberate attempt to circumvent the legislative restrictions on the importation of the medicines and to do so in the face of clear warnings. The conduct involved knowingly false representations by means of requesting and supplying two prescriptions from a medical practitioner prescribing Phosphatidylcholine in the Respondent's name in order to obtain the release from customs of the ordered medicines intended for retail sale.
7. In addition, the Respondent intended to supply the medicine at some considerable cost to patients thereby benefitting financially from the course of conduct she was engaging in. We are of the view notwithstanding, that the Respondent may have been motivated by her circumstances to assist persons suffering from Tick-borne disease, or who needed the medicine for detoxification purposes.
8. When we consider the other unsatisfactory professional conduct as a whole and add it to our conclusions in respect of Complaint 1, we are reinforced in our view that the Respondent's conduct was sufficiently serious to justify a finding of professional misconduct. The Respondent supplied imported therapeutic goods to a Patient in breach of legislation. The Respondent deleted records of compounding of medicines and the dispensing of a Schedule 4 medicine to avoid potential detection. The Respondent's conduct was significantly below the standards required of her and involved improper conduct.
9. Accordingly, we find that Complaint 6 has been made out.

Orders 1. The Respondent is guilty of unsatisfactory professional conduct. 2. The Respondent is guilty of professional misconduct. 3. The proceedings are listed for directions in respect of the conduct of the Stage 2 hearing which must follow upon orders (1) and (2) at a date to be determined by the Registrar.

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: 12 February 2024