Health Care Complaints Commission v Azzer

NCAT Occupational|2024-04-09|Before: Dr P

Background

The Respondent, a 34 year old practitioner, completed a pharmacy degree at Cairo University in Egypt in 2011. He completed his internship in Australia at Chemist Warehouse, Orange and Christopher Discount Chemist, Kogarah and was first registered as a pharmacist in Australia in April 2017.
At the time of registration, the Respondent worked at Christopher Discount Chemist, West Gosford ("the Pharmacy"). He worked at the Pharmacy most days, working approximately 70 hours per week. On some days, he was the pharmacist in charge for the day, or part of the day, and on other days, one of the proprietors of the Pharmacy was in charge.
The Pharmacy dispensed and supplied large volumes of prescriptions and drugs. Amongst the drugs dispensed, relevant to the current matter, were Schedule 8 and Schedule 4, Appendix D drugs. The dispensing of these drugs came to the attention of the Pharmaceutical Regulatory Unit ("PRU") during investigations into the prescribing practices of various doctors in a medical practice in West Gosford adjoining the Pharmacy.
The pharmacists the subject of that investigation were the Respondent and four other pharmacists, including two proprietors.
The PRU investigation focused its investigation into the Pharmacy for the period 22 January 2017 to 22 January 2019 and produced a report dated 16 October 2019.
Shortly thereafter, the Pharmacy Council of New South Wales ("the Council") held an inquiry pursuant to s 150 of the National Law, as a result of which the Respondent's registration was suspended effective from 30 October 2019.
In November 2019, the Respondent made an application under s 150A of the National Law for review of the Council's decision to suspend his registration. A hearing was held by delegates of the Council, and a decision was made to set aside the suspension of the Respondent's registration and impose certain conditions on his registration.
On 16 January 2020, the Respondent made a further application under s 150A of the National Law for review of the Council's November 2019 decision to impose those conditions.

Complaints

The Commission pressed six complaints against the Respondent. Complaint 3 was not pressed.
Five of the complaints rely on s 139B(1)(a) and/or (l) of the National Law.

Complaint 1

Complaint 1 is that the Respondent is guilty of unsatisfactory professional conduct s 139B(1)(a), and/or (l) of the National Law in that the practitioner has: 1. engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or 2. engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy. Each particular is then relied upon to in itself justify a finding of unsatisfactory professional conduct. In the alternative, when two or more of the particulars are taken together, a finding of unsatisfactory professional conduct it was claimed is justified.
Particular 1 is that on the highlighted dates as set out in Schedule 2 to the Complaint with reference to the initials "MA", the Respondent inappropriately dispensed Schedule 8 and 4D drugs, in various strengths, to Patients A, C, E, F and I in circumstances where: 1. the dispensing was contrary to Clause 54 and/or 109 of the Poisons and Therapeutic Goods Regulation 2008 ("PTGR") in that, it was in a quantity that does not accord with a recognised therapeutic standard; 2. the dispensing intervals and/or frequency did not accord with a recognised therapeutic standard; 3. the Respondent was obliged to have regard to the dispensing history of the Patients and did not have sufficient regard to that dispensing history.
Particular 2 is that on the highlighted dates as set out in Schedule 2 to the Complaint with reference to the initials "MA", the Respondent inappropriately dispensed Schedule 8 drugs, in various strengths, to Patients B, D, G and H in circumstances where: 1. the dispensing was contrary to Clause 109 of the PTGR in that, it was in a quantity that does not accord with a recognised therapeutic standard; 2. the dispensing intervals and/or frequency did not accord with a recognised therapeutic standard; 3. the Respondent was obliged to have regard to the dispensing history of the Patients and did not have sufficient regard to that dispensing history.
The Respondent admitted the facts of Complaint 1, Particulars 1(a) and (b) but did not admit Particular 1(c).
In relation to Particular 1(c) the Respondent said in his Reply to the Complaint that the patients' dispensing histories were considered and vetted by him and he would, in accordance with his usual practice at the time, contact the prescribing doctors for their input in circumstances where the patients' dispensing histories were concerning.
In his Reply to the Complaint, the Respondent also stated that he acknowledged that at the time of the conduct, at an early stage of his career in Australia, there was a gap in his knowledge, and he did not believe he could reject a direction from a medical practitioner to supply medication. The Respondent now understands, it was said, that he can refuse to supply medication on a prescription, even if he had spoken to the doctors and had confirmed their instructions.
The Respondent also admits the facts of Complaint 1, Particulars 2(a) and (b).
The Respondent does not admit the facts of Complaint 1, Particular 2(c) and responds in his Reply in the same manner as set out in relation to Particular 1(c) above.
The Respondent further admitted that he was guilty of unsatisfactory professional conduct under s 139B(1)(a) of the National Law as alleged in Complaint 1 but did not admit that he was guilty of unsatisfactory professional conduct under s 139B(1)(l) of the National Law on the basis that his conduct was not improper or unethical.
As is apparent from Schedule 2, Complaint 1 relates to the Respondent's excessive dispensing of Schedule 8 and Schedule 4D drugs to nine patients (Patients A to I), which occurred during the period from July 2017 to December 2018. The relevant instances of dispensing are highlighted in Schedule 2 to the Complaint. The Commission pointed to the fact that the instances involve a range of opioids - including oxycodone, fentanyl, morphine and alprazolam - and benzodiazepines. These drugs, it is argued, can lead to physical and psychological dependence, tolerance and misuse, and are liable to be diverted into the community for illicit use. Administering an opioid and benzodiazepine together increases the risks of central nervous system and respiratory depression including coma and death.
The Commission further argued that the instances of dispensing that are the subject of the Complaint each involved dispensing that was excessive in the context of when, and in what quantities, the same or other Schedule 8 or Schedule 4D drugs had previously been dispensed to the relevant patient, and the prescribed doses (which indicated how quickly the patient should have been consuming the drug). Many of these dispensing instances were vastly excessive, to the point where they could have caused death or serious harm if they had actually been consumed. These are described in detail in the report of the PRU following the investigation of the dispensing of Schedule 8 and Schedule 4D drugs at the Pharmacy, the majority of which was performed by the Respondent.
The Commission drew specific attention, by way of example, to the dispensing by the Respondent, and other pharmacists, in relation to two patients, namely Patient A and Patient C.
In relation to Patient A, in a period of 88 days (24 July 2017 to 20 October 2017), pharmacists at the Pharmacy dispensed 50 prescriptions for oxycodone comprising 1,392 tablets in various strengths totalling 83,280 mg, which is an oral morphine equivalent daily dose ("oMEDD") of 1,419 mg. This is over 35 times the recommended daily dosage for non-cancer pain without the involvement of a pain specialist (40 mg for no more than 90 days), almost eight times Patient A's prescribed daily dosage (120 mg of oxycodone, equivalent to an oMEDD of 180 mg), and over four times the maximum recommended daily dosage for cancer pain (300 mg). The Respondent dispensed 30 of these 50 prescriptions (832 tablets) and had access to Patient A's dispensing history showing the dispensing by him and the other pharmacists in the Pharmacy. In the same period, 24 prescriptions for three different types of benzodiazepines were dispensed to Patient A, 15 of which were dispensed by the Respondent (600 tablets), despite Patient A's prescription for each benzodiazepine being for one tablet daily. The Respondent routinely dispensed at least two quantities of oxycodone and one quantity of a benzodiazepine on the same date, and dispensed at intervals as short as two days. Patient A commenced treatment for oxycodone dependence on 21 November 2017.
In relation to Patient C, in a period of 98 days (28 July 2017 to 3 November 2017), pharmacists at the Pharmacy dispensed to Patient C 48 prescriptions for oxycodone comprising 1,709 tablets or capsules in various strengths with an oMEDD of 1,080 mg. The Respondent dispensed 19 of these prescriptions. In a 32-day period (29 September 2018 to 30 October 2018), the Respondent alone dispensed a total of 27,480 mg of oxycodone to Patient C amounting to an average daily dosage of oxycodone of over 858 mg - more than four times higher than Patient C's prescribed daily dosages (a total of 200 mg per day). In the same period the Respondent supplied Patient C with 50 tablets of oxazepam, a benzodiazepine.
The Commission relied upon an expert report provided by Ms Alexandra Torrens dated 18 August 2020. Ms Torrens is an experienced pharmacist with other 20 years' experience as a pharmacist in the area of community pharmacy. She has experience at various locations as a registered pharmacist employee in metropolitan, regional and rural settings. For a period of approximately seven years, she was a compliance pharmacist for Medicare Australia in relation to compliance activities, education of pharmacists and in providing assistance to investigations teams. Since 2009 she has been the pharmacist proprietor at Hornsby Heights Pharmacy and her duties involve dispensing, customer service, business and staff management and medication reviews. She serves on various advisory committees.
The Commission sought the opinion from Ms Torrens on whether the Respondent's supply of oxycodone to the patients, the subject of Complaint 1, accorded with recognised therapeutic standards required by Clauses 54 and 109 of the PTGR.
In respect of Patient A, Ms Torrens' opinion was that oxycodone is a Schedule 8 drug of addiction. Schedule 8 substances are by their nature addiction-producing or potentially addiction-producing. She drew attention to Clause 109 of Part 4, Division 4, Subdivision 4 of the PTGR, namely, that an authorised practitioner or pharmacist must not supply any drug of addiction in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances. We note that the prohibition is strict - the practitioner "must not" act in a manner that does not accord with the standard.
Ms Torrens expressed the opinion that the dispensing records as attached to the complaint in relation to Patient A indicated that large quantities of oxycodone were supplied to Patient A during the specified period, namely 24 July 2017 to 20 October 2017. Additionally, the drugs appeared to have been supplied at intervals which were at times very short, for example, a packet of 28 tablets which would be expected to last the patient 28 days at the prescribed dose was dispensed to the patient four days after the previous supply of 28 tablets was given. The frequency with which such dispensing patterns occurred suggested to her that the supply of those drugs was in excess of the recognised therapeutic standard.
Ms Torrens noted that the Respondent was not the pharmacist involved in all of those supplies. However, she expressed the view that when the Respondent accessed the patient record to dispense the prescriptions that he was involved with, he would have been able to see the patient's relevant dispensing history and make a professional judgment accordingly.
Given the nature and combination of the drugs involved, and the frequency of those dispensing, Ms Torrens considered the Respondent's conduct in supplying those medications to be significantly below the standard required.
Ms Torrens expressed similar opinions in relation to the supply to patient A during the period 24 July 2017 to 20 October 2017 in respect of the dispensing of 500 tablets of Alprazolam 2 mg of which the Respondent dispensed 300 tablets to Patient A.
Ms Torrens noted that this was a Schedule 8 drug of addiction, it is a benzodiazepine and the Australian Medicines Handbook states that the use of benzodiazepines can lead to physical and psychological dependence, tolerance and misuse. Clause 109 of the PTGR applies similarly to this drug.
In relation to the supply to Patient A during the period 24 July 2017 to 20 October 2017 of 500 tablets of diazepam 53 mg of which 350 tablets were dispensed by the Respondent, Ms Torrens noted that this drug was a Schedule 4, Appendix D drug (Prescribed Restricted Substance). This is a benzodiazepine and can, according to the Australian Medicines Handbook, when used, lead to physical and psychological dependence, tolerance and misuse.
Clause 54 of the PTGR applied to the supply of this drug. An authorised practitioner or pharmacist must not supply any restricted substance in a quantity, for a purpose, that does not accord with a recognised therapeutic standard of what is appropriate in the circumstances. The obligation not to supply the drug rests on the pharmacist.
Ms Torrens was critical of the large quantities of the drug supplied and, additionally, the short intervals for supply.
In relation to the dispensing to Patient A of 100 tablets of nitrazepam 53 mg during the period 24 July 2017 to 20 October 2017, of which the Respondent dispensed 50 tablets, Ms Torrens noted that this, too, is a benzodiazepine which could lead to physical and psychological dependence, tolerance and misuse. She was critical of the supply as it did not accord with a recognised therapeutic standard of what is appropriate in the circumstances contrary to Clause 54 of the PTGR.
Having regard to the supply of all the drugs to Patient A referred to above, Ms Torrens was asked to provide her opinion as to whether the concurrent supply of those drugs was safe and/or appropriate for Patient A. She responded that the Australian Medicines Handbook stated as a precaution that taking drugs that cause central nervous system stimulation and respiratory depression (for example, opiates, administration with a benzodiazepine) increases the risk of those effects, including overdose leading to coma and death which raises as a precaution the avoidance of use or reduction of benzodiazepine dose and requires close monitoring.
Ms Torrens noted that the dispensing of the drugs referred to above suggested the concurrent supply of multiple strengths and formulations of opiates and benzodiazepines. If that combination of drugs were taken by the patient in the quantities suggested by the dispensing history, this would have presented a significant safety risk to the patient.
If the items were not being taken by the patient due to loss, theft, et cetera, as suggested in some of the documents provided to her for the purpose of seeking her opinion, the potential diversion of such a large quantity of dangers drugs in Ms Torrens' view posed a significant safety risk to the community. Ms Torrens therefore considered that the Respondent's conduct in supplying such quantities and combinations of medication to be significantly below the standard required.
Ms Torrens was asked for her opinion in respect of each of the Patients, the subject of Complaint 1, and her opinion was to the same effect as those expressed in relation to Patient A. We do not set them out in detail here.
The Commission argued that conduct which fell significantly below the standard reasonably to be expected of a practitioner in the Respondent's position meant that it constituted unsatisfactory professional conduct within the meaning of s 139B(1)(a) of the National Law.
The Commission argued that it follows that the Respondent's conduct was also contrary to the Pharmacy Board of Australia Code of Conduct for Pharmacists dated 17 March 2014 ("the Code of Conduct"). This Code of Conduct required, among other things, that practitioners must always act in accordance with the law (Clause 1.1), practise safely and effectively (Clause 1.2), and provided good care including by maintaining adequate knowledge and skills to provide safe and effective care (Clause 2.1 and 2.2).
In relation to Particulars 1(c) and 2(c) of Complaint 1, namely, that the Respondent failed to have sufficient regard for each patient's dispensing history when he was required to do so, the Commission submitted that while the Respondent says his 'usual practice' was to 'vet' each patient's dispensing history, any such vetting was plainly insufficient having regard to the quantities and intervals at which the Respondent dispensed Schedule 8 and Schedule 4D drugs to the relevant patients which the Respondent admits exceeded a recognised therapeutic standard.
Further, while the Respondent says that he 'maintained strong lines of communication with prescribing doctors' and, where he had concerns with dispensing, would only do so if he was 'reassured by the prescribing doctor as to the need and therapeutic purpose for the dose prescribed', it was the Respondent's responsibility under the Code of Conduct and the Pharmacy Board of Australia 'Guidelines for dispensing medicines' dated 7 December 2015 ("Dispensing Guidelines") to make an independent judgment as to whether dispensing was suitable for the patients, including having regard to their history, and to take steps to protect the patients from being put at risk by the conduct of other practitioners.
The Respondent also had an obligation under the National Law to notify the Australian Health Practitioner Regulation Agency ("AHPRA") if he reasonably believed another practitioner was placing the public at risk of harm by practising their profession in a way that constituted a significant departure from accepted professional standards.
The Commission argued that it is concerning that the Respondent says that, at the time, he was not aware that he could challenge the prescribing doctor in relation to dispensing and considered that contacting the prescribing doctor was sufficient to fulfil his duty of care to the public, when the Practitioner had only recently completed his intern training and examinations and says he knew what the law was.
In response, the Respondent argues that he did have regard to the dispensing history of the patients, and he did contact the prescribing doctor when he had concerns. The problem was, it is said, that he did not appreciate that he could contradict the authority of a prescribing doctor, who knows the patient and has confirmed that this is the correct dose.
The Respondent did not record each of the occasions when he spoke to a doctor. There were some occasions when a doctor who worked at the adjoining Medical Centre would attend on the Pharmacy. The Respondent explained in oral evidence that Dr Sriskanda would sometimes attend the Pharmacy with a patient to tell him why a script should be dispensed, because she, the doctor, knew he would question it.
The Respondent was the most junior pharmacist in a group of other pharmacists at the Pharmacy and it is said he was taught by other pharmacists that he could not contradict the doctor. The Respondent worked with his preceptor who told him that he should be dispensing if the doctor confirmed. The Respondent also knew the doctors concerned and was told that they were trustworthy and credible. He had no reason to think otherwise.
The Respondent says he did not think that any patients were put at risk because he was checking with the doctor and following what he had been advised by a doctor whom he thought at the time was well qualified. In fact, when he queried why Dr Sriskanda was prescribing higher quantities of Schedule 8's than other doctors, he was told that it was because she was the most experienced doctor in the medical practice and saw more difficult patients whose pain was harder to manage. Dr Sriskanda herself advised the Respondent that she was working with pain specialists.
The Respondent knew that he had to be careful when dispensing Schedule 8 and Schedule 4D drugs but did not believe that any of the Patients were at risk, after he had made the necessary phone call or spoken with the doctor in person. The Respondent explained that the doctor would always provide him with a reason the supply was required, for example, that the patient had lost the script or was not managing their pain.
It was said that the doctors were in the same medical practice and had access to the same patient history and data. It was the Respondent's normal practice when receiving a script from co-different doctors at the same practice to ring the doctor and notify them of the previous dispensing history of the presenting patient even if they already had access to their dispensing history. The Respondent was fully aware of patients who engage in "doctor shopping" and he refused to dispense if the situation indicated that the patient has been obtaining multiple scripts from different doctors.
In cross-examination, the Respondent said in relation to the supply of the drugs to the 9 Patients, the subject of Complaint 1, that he now understood that the supply was contrary to the required standards. He acknowledged that during the period of supply, he understood that the drugs were dangerous drugs and could lead to dependence.
However, the Respondent said he did not at the time think about the medical risks posed by the drugs supplied, or whether they were drugs which could be misused. He did not think about a risk of diversion of the drugs into the community. He did not think that they were a safety issue, or that there was any degree of danger.
At the time of the dispensing of these drugs, the Respondent had shortly before learnt the Code of Conduct, learnt the Pharmacy Council of Australia's Dispensing Guidelines, including the guidelines published in 2017. He said that he knew that he had to be careful dispensing Schedule 8 and Schedule 4D drugs but did not know that he had the authority to refuse a doctor's authority. He had never seen a pharmacist refuse a doctor's authority. The Respondent said that he exercised his own judgement to speak to the doctor and get an explanation. He was aware that he needed to look at the dispensing history of a patient and that is why he had spoken to the prescribing doctor.
How these explanations by the Respondent about his practice conform with his duty to exercise an independent judgment for the safety of the patient, and the public, beyond an enquiry of the prescribing doctor, is not explained. On the Respondent's own explanations, he had a sufficient awareness of his obligation to assess and question the dispensing history of the patients, a position consistent with the exercise of an independent judgment. The exercise of an independent judgment is not qualified in the manner put forward by the Respondent, namely, that the judgment extended to questioning and simply accepting the medical practitioner's explanations.
In respect of the Patients A to I in Complaint 1, the Respondent agreed that on many occasions, the quantity of drugs dispensed was vastly excessive but said that the doctor always gave him an explanation.
We are satisfied, and find, that the Respondent simply accepted the explanations without question and did not independently evaluate whether the explanation was credible, warranting the dispensing of the relevant drugs.
In Health Care Complaints Commission v Elliott [2018] NSWCATOD 47, the Tribunal very helpfully summarised the importance of the role of pharmacists in maintaining the protection of the public. The Tribunal expressed the position as follows: "55. Pharmacists are gatekeepers with responsibility, among other things, for dispensing drugs of addiction. To assist them in that serious task, regulations and guidelines are imposed so that the very real risks involved in dispensing drugs of addiction can be managed and mitigated. As the National Law emphasises, the protection of the public is paramount. And some members of the public, such as drug dependent patients, need protection from themselves. Medical practitioners and pharmacists share significant responsibility and are required to exercise their individual clinical judgments to ensure that individual consumers and the public are protected. The more experienced a pharmacist becomes the better that practitioner's judgment might be expected to be. A pharmacist's failure to be attentive, or sufficiently attentive to the self-evident risks of dispensing Sch 8 drugs, undercuts the protective structure which the regulations and guidelines are intended to erect for the benefit of individual patients and the community as a whole."
In circumstances where, over a lengthy period, quantities of the Scheduled drugs were dispensed by the Respondent in quantities vastly above the recommended dosage, any trained pharmacist operating at the general standard required of his or her profession would, in our view, have become highly attuned and attentive to the potential risks of dispensing such quantities of drugs.
We accept the evidence of Ms Torrens that the dispensing of the drugs the subject of Complaint 1 was in excess of the recognised therapeutic standard.
In our view, it would be reasonable to expect any registered pharmacist who was attentive to his or her obligations for the caring for patients or clients as the primary concern, and the general public, to take steps to ensure that the dispensing of a medicine is in accordance with a prescription, or order, but also consistent with the safety of the person named in that prescription or order.
The emphasis by the Respondent on the fact that he was sufficiently aware of his obligations to contact the prescribing doctor does not, in our view, satisfy the obligations imposed on a registered pharmacist. It is not sufficient merely to make an enquiry of the prescribing doctor and to accept at face value whatever the practitioner told the pharmacist. That is so, particularly, if the explanation was of dubious veracity.
By his own admission the Respondent did not apply any independent judgement as to whether the drugs which were being prescribed at vast quantities and, in many cases, following a pattern of prescription every two, three or four days by various practitioners could be misused. He did not turn his mind to the risks associated with the drugs dispensed finding their way into the community. He did not question the explanations given by the prescribing doctor. He did not give consideration as to whether, in respect of the particular instances, there was a safety risk associated with the dispensing of the drugs.
Raising an enquiry of the prescribing doctor, and simply accepting the response without an evaluation of the response by reference to the dispensing history, does not, in our view, satisfy the obligation to exercise an independent judgment required of the dispensing pharmacist.
The absence of proper questioning of the medical prescriber is illustrated, for example, in relation to the query of the prescribing doctor for Patient A on 20 October 2017. The patient notes record that there was a contact made with the doctor about early supply who advised that the patient was in court that day and medications had been stolen from him. The pharmacist, it appears, offered a staged supply but was told that this would be inconvenient to the patient. Inconvenience to the patient should not be the determinative factor. It also appears that on a number of occasions when enquiries were made, the explanation was that the relevant drugs had been either lost, thrown away or stolen. These were drugs that were thus potentially falling into the wrong hands but yet the practitioner continued to follow the usual practice of simply accepting whatever explanation was proffered by the prescribing medical practitioner.
Acceptance of the reason apparently given by the prescribing medical practitioner should also be viewed, not in isolation, but in the context of a clear and fairly regular pattern of prescription sought to be dispensed. For example, in respect of Patient A, the dispensing was regularly only 4 or 5 days apart. The "lost" or "stolen" explanations simply do not add up when dispensing occurred at such intervals even absent, it seems, such occurrences.
There also does not appear to have been any difficulty if, in fact, there was a refusal to fill a prescription. In respect of Patient I, the patient notes record that on 15 April 2018 he came to the Pharmacy with a script for Valium and Serepax but "I refused to supply bcoz [sic] the interval".
Counsel for the Commission argued that the effect of the admissions in Particulars 1(a) and (b) and 2(a) and 2(b) was that Particulars 1(c) and 2(c) were also established. We do not think that the admissions in respect of Particulars 1(a) and (b) and 2(a) and (b) achieve that result but in combination with the oral evidence and admissions made by the Respondent in cross-examination about his failure to have regard for risk and safety, the submission has force.
We are satisfied that Particulars 1(c) and 2(c) of Complaint 1 have also been made out.
In our view, and we find, the Respondent was obliged to have regard to the dispensing history of the patients. He did so only to a limited degree and did not have sufficient regard to that dispensing history so as to ensure the safety of the patients, or assess the potential risk to the Patients in Complaint 1.
Complaint 1 has, we find, been made out.

Complaint 2

Complaint 2 is that the Respondent is guilty of unsatisfactory professional conduct under s 139B(1)(a), and/or (l) of the National Law in that the practitioner has: 1. engaged in conduct that demonstrates the knowledge, skill or judgement possessed, or care exercised, by the Respondent in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or 2. engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy.
The Particulars of Complaint 2, as finally pressed, are as follows: 1. The concurrent dispensing was contrary to Clause 54 of PTGR in that it was in a quantity that does not accord with a recognised therapeutic standard; 2. The dispensing intervals and/or frequency does not accord with a recognised therapeutic standard; 3. [Not pressed]. 4. The concurrent dispensing presented a safety risk to Patient J.
This complaint relates to the Respondent concurrently dispensing two supplies of Alprazolam 500 mcg (50 tablets) and two supplies of diazepam 5 mg (50 tablets) to Patient J on the same date, namely 19 May 2018. Both drugs are benzodiazepines and were prescribed by two prescribers.
Patient J was in fact a medical practitioner himself who had received the prescriptions from other medical practitioners.
The Respondent does not admit Particulars 1(a) and 1(b) and also does not admit that the concurrent dispensing presented a safety risk to Patient J. The Respondent sought to explain his reasoning for dispensing these drugs in his written statement in evidence, namely, that Patient J was a doctor working at the adjoining medical centre, he knew this patient and believed him to understand the risks of the medications, in view of his medical training.
The Respondent went on to say that according to his practice and procedures at that time, he would not have dispensed two supplies of the same Schedule 8 and Schedule 4D drugs unless the prescribing doctor had confirmed with him that there was an appropriate reason for doing so, such as the patient requiring a supply in advance due to planned overseas travel. Otherwise, it was never part of his practice to dispense multiple supplies in the same day, he said.
During the course of s 150 proceedings held by delegates of the Council on 29 October 2019 the Respondent was asked about his understanding of the kinds of drugs that are trafficked in the community. He responded by identifying benzodiazepines, Schedule 8 drugs and steroids. He was asked to assume that if those drugs were not taken by the patients and were trafficked or were given to someone, whether it was possible that some harm could have come to those people, to which he replied "yes, of course".
Ms Torrens in her expert report expressed the opinion that her concern in relation to this issue was the dispensing of more than one prescription for two types of drugs supplying 100 tablets of each. It was the quantity which was of concern to her. In her report, she expressed the opinion that the supply of more than one prescription of such drugs on the same day is consistent with supply in excess of the recognised therapeutic standard and may have presented a safety risk to the patient. The potential diversion risk of such drugs poses a significant safety risk to the community. Therefore, Ms Torrens considered the Respondent's actions in supplying these medicines to be significantly below the required standard.
The Respondent argued that his conduct in dispensing these medications was not significantly below what could be expected of a pharmacist of the same years of experience and the Tribunal should take into account the following factors:

The patient was himself a doctor.
The Respondent knew Patient J well.
Patient J suffered anxiety and there was a legitimate basis for the prescription.
Patient J showed no signs of having any problem with drug use himself or of diverting the drugs to others.
There is no evidence that the drugs were used or misused in any problematic way.
The Patient was not self-prescribing.
Given his usual practice, it is likely the Respondent spoke to the prescribing General Practitioner and was reassured as to the reason for the medication.
A General Practitioner is privy to medical history that the practitioner is not, including private consultations, medical records, and family history.
This was one-off dispensing in circumstances where a young pharmacist in the position of the Respondent had a reasonable basis to trust the information he was given.
The Respondent understood that the patient wanted to go overseas to see his father, for a period of a few months. The Respondent knew then that the patient had a valid reason for wanting the scripts dispensed so that he could take the medication with him.

The Respondent also drew attention to the evidence that he did not in the circumstances identify any red flags. Patient J was a regular patient of the Pharmacy. The Respondent knew the patient, and this was a single instance. It was argued there was a valid reason for the dispensing.
We are not convinced on the evidence that the Respondent spoke to the prescribing general practitioners. His evidence appeared to us to be based far more on his reliance on his conversation with Patient J about his planned overseas trip. It is unlikely, therefore, that, in this instance, assurances were received from the prescribers.
Clause 54 of the PTGR provides that a practitioner must not supply any restricted substance, which this was in this case, in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
We accept Ms Torrens' evidence that the large volume of the drugs may have presented a risk to a patient and that, in general, such volumes could pose a risk to the community if diverted. However, given that Patient J was in fact a medical practitioner himself, and given the purpose for which the medications were being supplied to him, and for the reasons set out by the Respondent at paragraph [88] above, other than that the Respondent was a young pharmacist, we are not satisfied that the dispensing posed a risk to Patient J and that Complaint 2 has been made out.

Complaint 4

Complaint 4, as pressed at the hearing, is that the Respondent is guilty of unsatisfactory professional conduct under s 139B(1)(l) of the National Law in that the Respondent has engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy.
The Particulars to Complaint 4 are that between 9 June 2017 and 14 December 2018, the Respondent inappropriately dispensed psychostimulants (type A drugs of addiction), on the dates as set out in Schedule 3 to the Complaint in circumstances where: 1. on six occasions the prescription was not endorsed with a reference number; 2. on one occasion the prescribing doctor did not have the authority to prescribe; 3. the dispensing was contrary to Clause 90 of the PTGR in that a pharmacist must not supply a psychostimulant medication, unless the reference number of the authority to issue the prescription is shown on the prescription.
The Respondent admits to dispensing psychostimulants on the dates set out in Schedule 3, which are attached to his initials "MA", and also the balance of the Particulars of Complaint 4.
The Respondent, however, does not admit that he is guilty of unsatisfactory professional conduct under s 139B(1)(l) of the National Law.
Clause 90 of the PTGR provides that a pharmacist must not supply substances of the kind dispensed and supplied set out in Schedule 3 by the Respondent unless the reference number of the authority to issue the prescription is shown on the prescription.
The effect of noncompliance with Clause 90 was that the prescriptions were in fact not valid prescriptions and the drugs should not have been supplied.
Ms Torrens in her expert report also indicated that some of these prescriptions issued by general practitioners from the adjoining Reliance Medical Practice. She was of the view that in the community pharmacy setting, it is unusual to see psychostimulant prescriptions written by general practitioners as they are unlikely to hold the authority to prescribe such substances. This should have alerted the pharmacist involved to question these prescriptions.

Improper or Unethical Conduct - s 139B(1)(l)

The words "unethical" or "improper" are not defined in the National Law. The Macquarie Dictionary defines "improper" relevantly as "not in accordance with propriety of behaviour, manners etc." or "abnormal or irregular" and "unethical" as 1. "contrary to moral precept; immoral"; and 2. "in contravention of some code of professional conduct".
Assistance in determining what is meant by "improper" can also be gained from what the High Court of Australia said of the word "impropriety" in R v Byrnes & Hopwood [1995] HCA 1. If conduct is not in conformity with standards of professional conduct and practice it can be seen as improper.
In Health Care Complaints Commission v Nguyen [2018] NSWCATOD 168 the Tribunal considered the scope of "improper conduct" in s 139B(1)(l) stating at [47]-[48]: "The High Court has noted that "improper" is not a term of art: The Queen v Byrnes (1995) 183 CLR 501 at 514, citing Grove v Flavel (1986) 43 SASR 410 at 420. In Byrnes at 514-5, Brennan, Deane, Toohey and Gaudron JJ explained the concept of impropriety as follows: "Impropriety does not depend on the alleged offender's consciousness of impropriety. Impropriety consists in a breach of the standards of conduct that would be expected of a person in the position of the alleged offender by reasonable persons with knowledge of the duties, powers and authority of the position and the circumstances of the case." This approach to determining whether conduct is "improper" has been adopted in a disciplinary context in numerous cases, including Health Care Complaints Commission v Liu [2016] NSWCATOD 133 at [54] and [55] and the cases there cited."
The meaning of the expression "improper or unethical conduct" in s 139B(1)(l) of the National Law was also considered by the Tribunal in Health Care Complaints Commission v Kesserwani [2020] NSWCATOD 65. The Tribunal stated at [25]-[26]: "25. The use of the word 'or' in s 139(1)(l) suggests that the words unethical and improper should be read disjunctively and do not carry the same meaning. However, their meanings may overlap. While not necessary to reach a concluded view arguably a broader class of conduct is caught by the term improper conduct, than unethical conduct. 26. In our view, the test of 'unethical conduct' has both objective and subjective elements. The word 'unethical' connotes moral opprobrium. The term 'unethical conduct' implies that the conduct concerned not only objectively falls short of a certain professional standard but that the person involved has performed subjectively in a way that is morally dubious or unprincipled and is therefore reprehensible on that ground. It is unnecessary here to provide exhaustive categories of conduct that may be unethical. Conduct may be unethical if it is constituted by a deliberate flouting of significant professional standards. Reckless disregard of, or wilful blindness to, significant ethical standards or principles may also constitute unethical conduct. All will depend on the relevant circumstances." (emphasis omitted). See also Health Care Complaints Commission v Matta [2024] NSWCATOD 33 at [66]-[69]; and Health Care Complaints Commission v Sathiyapal [2024] NSWCATOD 14 at [119] to [121].
The dispensing that is the subject of Complaint 4 was of type A drugs of addiction to four patients, between 9 June 2017 and 14 December 2018, in circumstances where the prescriptions did not record the reference number of the prescriber's authority to prescribe a type A drug of addiction, including one (Patient L) where the prescriber was a general practitioner who did not hold such an authority.
The drugs so dispensed were Schedule 8 drugs prescribed under Clause 122 of the PTGR. These drugs cannot be prescribed under the Poisons and Therapeutic Goods Act 1966 (NSW) ("PTGA") unless the prescriber holds the authority to do so from the Ministry of Health (s 28) and cannot be dispensed by a pharmacist unless the prescription records the reference number of that authority (except in limited circumstances generally relating to in-patients).
The Commission points to the admission by the Respondent of each of the particulars of Complaint 4. The Commission argues that it follows from the matters admitted by the Respondent that he contravened Clause 90 of the PTGR. The Commission argues that the conduct amounts to improper or unethical conduct for the purposes of s 139B(1)(l) as it is contrary to a code of conduct prescribed by Clause 90 of the PTGR which sets a standard of proper and ethical behaviour for pharmacists such as in Clause 54 and Clause 109.
The Respondent responded to Complaint 4 by saying that he did not recall the exact circumstances in which he dispensed those prescriptions in the absence of an authority number. However, he did recall rejecting prescriptions for psychostimulants on many occasions during the course of his employment at the Pharmacy on the basis that those prescriptions were not endorsed by an appropriate authority number.
The Respondent argues that the errors were not regarded by Ms Torrens to be serious enough to be significantly below the standard expected and thus do not constitute improper or unethical conduct.
In her report and evidence Ms Torrens did not address the question as to whether the conduct amounted to improper or unethical conduct. She expressed the opinion in her expert report that the action of supplying the medications the subject of Complaint 4 without the necessary endorsement is in breach of the legislation (Clause 90 of the PTGR) and is therefore below the standard required.
Counsel for the Respondent sought to rely on the decision of the Tribunal in Health Care Complaints Commission v Khalighimonfared [2022] NSWCATOD 78. In that decision, the Tribunal considered the question of unethical or improper conduct and quoted from Health Care Complaints Commission v Bolton and Health Care Complaints Commission v Nguyen, we have set out above. As we understood the argument, it was accepted that a breach of the PTGR provisions can amount to improper conduct, but if it was a mistake, a different view should be taken. In that regard, Counsel sought to rely on paragraph [78] and the paragraph [85] of that decision. We do not accept this argument.
The Tribunal in that case did not consider, at least expressly, whether a breach of the regulations amounted to improper conduct.
In our view, the decision relied upon does not assist us and it is not contrary authority to a conclusion that the admitted breaches in this case do amount to improper conduct.
In our view, and we find, the dispensing of the drugs the subject of Complaint 4 was in breach of Clause 90 of the PTGR. We also find that a breach of Clause 90 of the PTGR amounts to improper conduct. It is conduct which does not accord with the standard of professional conduct mandated by the provisions of the PTGR. It is not necessary to consider whether it is also unethical conduct, although there are reasonably strong arguments to come to that conclusion as well.
Accordingly, we find that Complaint 4 has been made out and it follows that the Respondent's conduct also amounts to unsatisfactory professional conduct as specified in this Complaint.
The absence of a conclusion that the impugned conduct is contrary to s 139B(1)(a) of the National Law does not exclude the operation of subsection (1)(l) (see: Attia v Health Care Complaints Commission [2017] NSWSC 1066 at [161] and [162] per Walton J).
We are satisfied that Complaint 4 has been established.

Complaint 5

Complaint 5 also relies on conduct contrary to s 139B(1)(a) and/or (l) of the National Law.
The Particulars of Complaint 5 are that between 3 July 2017 and 12 March 2018, the Respondent on eight occasions inappropriately dispensed Schedule 8 drugs of addiction, on the dates and in the circumstances as set out in Schedule 4 to the Complaint in circumstances where: 1. [not pressed]. 2. two of the prescriptions lacked details of the address of the patient, contrary to Clause 80(1)(b) of the PTGR; 3. one of the prescriptions did not contain details of the drug handwritten by the prescriber, contrary to Clause 80(2) of the PTGR; and 4. one of the prescriptions did not contain adequate directions for use, contrary to Clause 80(1)(d) of the PTGR.
Complaint 5 is thus concerned with conduct that the Respondent dispensed Schedule 8 drugs on seven prescriptions that did not meet the requirements of form in Clause 80 of the PTGR. Clause 80 of the PTGR (which forms part of Division 3) requires, among other things, that the prescription for a drug of addiction must contain the patient's address, the quantity of the drug stated in both words and figures, adequate directions for use, and details of the drug handwritten by the prescriber.
Clause 100 of the PTGR generally prohibits the possession or supply of Schedule 8 drugs other than in accordance with Part 4, Division 4 of the PTGR. Clause 85(1) of the PTGR provides as an exception to this general prohibition that a pharmacist may supply a Schedule 8 drug on a prescription that conforms with the requirements in Part 4, Division 3.
The Respondent admits that he dispensed on: 1. two prescriptions that lacked details of the address of the patient (Patient W) (Particular 1(b)) (and thus contrary to Clause 80(1)(b)); 2. one prescription that lacked details of the drug handwritten by the prescriber (Patient X) (Particular 1(c)) (and thus contrary to Clause 80(2)); and 3. one prescription dispensed by the Practitioner that did not contain adequate directions for use (Patient Y) (Particular 1(d)) (and thus contrary to Clause 80(1)(d)).
The supply of these drugs was thus contrary to Clause 100 of the PTGR.
The Commission argues that dispensing of these medications contrary to Clause 100 of the PTGR was improper or unethical conduct for the purposes of s 139B(1)(l) of the National Law, and accordingly, the Tribunal should find that Complaint 5 amounts to unsatisfactory professional conduct by reason of admitted Particulars 1(b), 1(c) and 1(d).
The Respondent argues that these failures reflect an error made by the Respondent in not picking up an error made by the prescribing doctor. It was argued that while every effort must be made by a pharmacist to avoid errors of this kind, and the independent duty of the pharmacist to check is accepted, the errors are understandable in the context of a young pharmacist who had a punishing workload of 70 hours per week. The Respondent pointed to evidence from Ms Torrens that mistakes can be made in dispensing.
With regard to the two prescriptions for Patient W in Schedule 4, which lacked an address, and the one prescription for Patient X which did not have the drug handwritten by the prescriber, the Respondent said that he acknowledged that those were regrettable mistakes. He went on to say in his written statement that since being made aware of the PRU's report, he brought his knowledge of the PTGR up to date including in respect of Clause 80 and now always confirms that the patient's address is endorsed on the prescription before dispensing, and that the prescription specifies the drug in the prescriber's handwriting. This explanation suggests that these omissions were not simply mistakes but a failure on the part of the Respondent to apply the standards required of him in the PTGR - his knowledge was not up to date at the relevant time.
We are satisfied that the dispensing of the identified drugs contrary to Clause 100 of the PTGR, a regulation that expressly prohibited the supply if the dispense was not authorised by a valid prescription to do so and was thus improper conduct for the purposes of s 139B(1)(l) of the National Law. Accordingly, we find that Complaint 5 amounts to unsatisfactory professional conduct in respect of Particulars 1(b), 1(c) and 1(d).
Complaint 5 has, we find, been made out.

Complaint 6

Complaint 6 is that the Respondent is guilty of unsatisfactory professional conduct under s 139B(1)(l) of the National Law in that the Respondent has: 1. engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy.
The Particulars to Complaint 6 are that between 23 September 2017 and 30 October 2018, the Respondent inappropriately dispensed Schedule 4B drugs, on the dates, and in the circumstances, as set out in Schedule 5 to the Complaint, where the prescriptions did not specify the interval of supply, contrary to Clause 39(2)(b) of the PTGR.
As will be seen, this Complaint relates to the supply of testosterone, a Schedule 4B drug to three patients on 10 occasions between 23 September 2017 and 30 October 2018. Schedule 4B drugs are Schedule 4D drugs to which further restrictions apply under Clause 35(1)(f) of the PTGR as to the form of the prescription, particularly that the prescription specifies the intervals at which the drug may be supplied. Pursuant to Clause 39 of the PTGR, the mere fact that a prescription does not specify the intervals at which the drug may be supplied does not prevent a pharmacist from dispensing it the first time, but the pharmacist must not supply the drug if it appears to the pharmacist that the drug has previously been supplied on the same prescription (Clause 39(2)(b) and (3) of the PTGR).
The pharmacist must also endorse the prescription with the word "cancelled" after dispensing is completed as required by Clause 88 of the PTGR which reads as follows: 88 Prescriptions to be endorsed (1) A person who supplies a drug of addition on prescription must (on each occasion the drugs is supplied) endorse the following particulars (in ink) on the prescription - (a) the date on which the drug was supplied, (b) the address of the place at which the drug was supplied, (c) the prescription reference number. Maximum penalty - 20 penalty units. (2) A person who supplies a drug of addition on prescription must endorse (in ink) across the prescriptions the word "CANCELLED" - (a) if the maximum number of times the prescription is to be dispensed is not clearly specified, or (b) if the intervals at which the drug may be supplied are not clearly specified, or (c) if the prescription has reached the last occasion on which it can be supplied according to the maximum number of times specified on it. Maximum penalty - 20 penalty units.
Each of the occasions of dispensing the subject of Complaint 6 involved the Respondent dispensing repeat supplies in circumstances where the prescription did not specify the interval of supply, contrary to Clause 39(3) of the PTGR.
The Respondent admits that he should have, but did not, cancel these prescriptions.
The Respondent acknowledges that there was a regrettable failure to cancel the repeat prescriptions in the absence of a written interval of supply on the respective prescriptions but does not admit he is guilty of unsatisfactory professional conduct under s 139B(1)(l) of the National Law on this basis.
This Complaint is addressed by the Respondent at paragraphs [43] to [46] of his statement as follows: "[43] In respect of dispensing the prescriptions set out in Schedule 5 to the Complaint which did not specify the interval of supply, I confirm that I recognised the repeat interval was not specified and had contacted the respective prescribing doctors seeking their confirmation as to the repeat interval. [44] Upon receipt of the prescribing doctor's verbal confirmation of the repeat interval, I would leave a note on the patient's profile in the Pharmacy's dispensing software, detailing the appropriate interval, so as to alert my pharmacist colleagues to that information at the next dispensing request. [45] At the time of the incident, I was under the impression that the verbal confirmation from the prescribing doctor was equivalent to having interval of supply written on the prescription. [46] After close study and examination of the PTGR 2008 and if I were presented with a similar situation with my current knowledge and understanding, I would cancel the repeats and only dispense the requested script once."
We do not accept that the Respondent's impression that verbal confirmation from the prescribing doctor would suffice when no such exception is provided for in the relevant Regulations.
Accordingly, we find that Complaint 6 has been made out in that the Respondent engaged in improper conduct by reason of his failure to comply with a clear regulatory obligation. We find that Complaint 6 amounts to unsatisfactory professional conduct under s 139B(1)(l) in relation to Particulars 1(b), 1(c), 1(d).

Complaint 7 - Professional Misconduct

Complaint 7 is that the Respondent engaged in professional misconduct.
"Professional misconduct" is defined in s 139E of the National Law as meaning: 1. unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or 2. 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.
The Commission argued that the Respondent's conduct in this case was very serious.
The conduct that is the subject of Complaint 1 involved the Respondent dispensing large quantities of dangerous drugs to numerous patients repeatedly and over an extended period of time. These were drugs of a kind known to be liable to generate dependence and therefore prone to misuse, or abuse, by patients themselves, or illicit redirection into the community. Some of the quantities supplied to these patients were extraordinary - in some cases several times the highest recommended dose for serious cancer pain. More than one patient either had been, or subsequently had to be, treated for opioid dependence. It should have been obvious, even to the most junior practitioner, that this dispensing was manifestly excessive and liable to cause serious harm, either to the patients or others in the community. Indeed, as a junior pharmacist, the Respondent had only recently completed his intern training which he acknowledged included training about requirements for practising as a pharmacist in NSW.
To the extent that the Respondent says he relied on what prescribers or other pharmacists told him, it was argued that does not mitigate the seriousness of his conduct. As the Respondent should have known, it was his own independent responsibility to ensure he was dispensing safely to his patients, in accordance with recognised therapeutic standards. It is not to the Respondent's credit that he says he was unaware of his capacity (and obligation) to not follow prescribers' directions where appropriate, especially so soon after completing his training.
The matters that are the subject of Complaints 4 to 6 are also categorised by the Commission as serious. The requirements for prescriptions in the PTGR help to ensure that proper attention has been given to the appropriateness, and the other requirements, for the supply of dangerous drugs to patients, and provide an important checking and record-keeping mechanism for pharmacists including to ensure the authenticity of a doctor's directions to supply. The fact that the PTGR makes it an offence to supply Schedule 8 and Schedule 4B drugs in the circumstances that are the subject of Complaints 4 to 6 reinforces their seriousness.
The Commission argued that the Tribunal places importance on pharmacists adhering scrupulously to their obligations in relation to drugs of addiction and restricted substances, including those imposed by the PTGA and PTGR. (See, for example, Health Care Complaints Commission v Pickett [2019] NSWCATOD 53 at [61]; and Health Care Complaints Commission v Fearon [2018] NSWCATOD 26 at [165]).
Each of the parties relied on the decision of the Tribunal in Health Care Complaints Commission v Elliott referred to above. The Commission specifically drew to the Tribunal's attention paragraph [55] quoted above and the following paragraphs from that decision: "[54] Mr Elliott was dispensing considerable quantities of Sch 8 drugs over a lengthy period, but especially in 2013 and 2014. In our view, in those circumstances any trained pharmacist operating at the general standard required of his or her profession would have become highly attuned and attentive to the potential risks of dispensing such quantities of drugs. In particular, it would be reasonable to expect an experienced pharmacist to be alert to the possibility - perhaps even the probability - that some of the patients were likely to be opioid-dependent and therefore more likely than other patients to simulate symptoms in order to obtain prescribed drugs, to involve themselves in "doctor shopping" or to misuse drugs. … [56] When compounded by a pharmacist's effective failure to exercise clinical judgment by, for example, not raising appropriate concerns with prescribing doctors (who may themselves be falling short of professional standards), the protective structure is rendered virtually useless. This would reduce a pharmacy almost to a supermarket level where customers can help themselves to whatever they want, no questions asked. ... [57] Although failure to comply with regulations and guidelines might well evidence a fall from appropriate standards, professional standards in the health professions are not to be measured merely by compliance. The ultimate benchmark against which the professional conduct of health practitioners will be measured is the protection of the public. If the relevant conduct of a health professional fails to protect the public, and falls significantly short of the standards required to do so, or poses a real risk to the health and safety of the public, it might well justify suspension or deregistration because the community ought not be exposed to the risk inherent in such failures. Whether such a step is taken as a consequence will depend on the circumstances ..."
We endorse the remarks by the Tribunal in that case.
The Respondent argued that the objective seriousness in this matter is mitigated by the Respondent's lack of experience and the poor guidance he had at the critical stage of his career, such that his conduct should not be characterised as professional misconduct.
The seriousness of unsatisfactory professional conduct is to be measured by the extent to which it departs from proper standards. It is not measured by reference to worst cases. That would risk the misconduct of some practitioners indirectly setting the standards to be applied by the Tribunal: Health Care Complaints Commission v Litchfield [1997] NSWSC 297; (1997) 41 NSWLR 630 at 638.
The Tribunal has previously commented on the importance of pharmacists adhering scrupulously to their obligations in relation to drugs of addiction and restricted substances, including those imposed by the PTGA and PTGR. For example, in Health Care Complaints Commission v Pickett [2019] NSWCATOD 53 at [61], the Tribunal said: "A pharmacist occupies a position of trust in our community by virtue of having access to drugs of addiction. They are responsible for the secure storage and safe administration to patients of such medication."
Similarly, in Health Care Complaints Commission v Fearon [2018] NSWCATOD 26 at [165], the Tribunal said: "The effectiveness of the statutory scheme governing the retail supply of prescribed substances and drugs of addiction requires pharmacists to act with integrity and to scrupulously adhere to the statutory requirements governing the supply of those drugs."
We have found that the Respondent's conduct the subject of Complaints 1, 4, 5 and 6 amounted to unsatisfactory professional conduct.
We are satisfied, and find, that when taken together, the conduct was of a sufficiently serious nature to justify suspension or cancellation of the Respondent's registration.
In relation to the conduct the subject of Complaints 4, 5 and 6 the Respondent's primary answer about his usual practice, that he followed what prescribers said, does not apply.
The conduct the subject of these Complaints occurred in the face of clear regulatory requirements designed to protect patients and the public. The failures on the part of the Respondent were multiple, (see Schedules 3, 4 and 5 to the Complaint) and occurred even after the Respondent had been practising for some time following his registration. The nature of the drugs the subject of these Complaints, and the care which should have been taken with their dispensing, but which was lacking, is also relevant. The objective seriousness of the conduct outweighs the mitigating factors relied upon by the Respondent.
The parties agreed that the most serious of the Complaints is Complaint 1. In our view, and we find, that is a correct characterisation of the conduct. The Respondent's failure to exercise his independent judgment to a limited degree, but then simply to accept whatever explanation he was given by the prescriber, when raised, fell significantly below what is required of any registered pharmacist. The failures had the real potential of causing risk to the patients involved, or the public at large.
Taken on its own, the established conduct the subject of Complaint 1 is, in our view, sufficiently serious to justify suspension or cancellation of the Respondent's registration. In coming to that view we have taken into account the relative inexperience of the Respondent in Australia at the time (which must be viewed, however, also with the knowledge that he had only recently gone through the learning required for registration); the environment the Respondent worked in where there appears to have been a wrongly held view that full independent judgment could be put to one side if a prescriber provided an answer; and the hours worked by the Respondent, the latter factor disavowed by the Respondent as excusing his conduct.
The degree to which the Respondent's conduct fell short of what is required of a registered pharmacist is evident from the very different practice he now adopts and the measures he has in place at the Junee Discount Pharmacy which he described in detail in his evidence. The Respondent did not exercise his own judgment that the practice of pharmacy dictates. He failed in his duty to take steps to protect the public's exposure to risk and harm. He failed in his role as gatekeeper and failed in his duty to properly assess prescriptions he dispensed where more thorough judgments were calling out to be made.
Taking and viewing all proven Complaints together, we are satisfied, and find, that the Respondent's unsatisfactory professional conduct was sufficiently serious to justify suspension or cancellation of the Respondent's registration and amounts to professional misconduct.

Protective Orders

Having found that a number of complaints have been established, and that the conduct of the Respondent justified suspension or cancellation of his registration, the Tribunal's power to make protective orders under s 149C of the National Law is enlivened.
As we point out above, in exercising its powers we must observe the objectives and guiding principles of the National Law, the paramount consideration being to ensure the protection of the health and safety of the public (s 3 and s 3A).
In Health Care Complaints Commission v Do [2014] NSWCA 307 at [35], Meagher JA (with whom Basten and Emmett JJA agreed) ("Do") held: "The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise."
The protective objectives under the National Law thus encompass considerations of specific and general deterrence as well as upholding public confidence in the standards of the profession, including by denouncing misconduct as unacceptable (see Do at [35] and [39], Meagher JA, with Basten and Emmett JJA agreeing).
The Tribunal has given effect to the principles formulated in Do in numerous decisions. For example, in Health Care Complaints Commission v Duggan [2015] NSWCATOD 142 the Tribunal approached the issue as follows: "42. The Tribunal's role in protecting the health and safety of the public is not limited to consideration of the direct protection of individual members of the public from the incompetent or unethical practice of the relevant practitioner in proceedings, but rather extends to an interest in protecting the public more broadly by maintaining and communicating professional standards, signalling disapproval of unethical and incompetent conduct and thereby enhancing both professional standards and the public's trust in the health professions. 43. In Re Parajuli [2010] NSWMT 3 the former Medical Tribunal determined that in exercising its functions under the former Medical Practice Act 1992 (NSW) (which similarly had an objects provision concerning the paramount purpose of protecting the health and safety of the public) that it "may consider five matters being on protection": (a) Any need to protect the public against further misconduct by the practitioner; (b) The need to protect the public through general deterrence (of other practitioners); (c) The need to protect the public by reinforcing high professional standards and denouncing transgressions; (d) The maintenance of public confidence in the profession; (e) The desirability of making available to the public any special skills possessed by the practitioner."
In Health Care Complaints Commission v Bradley [2022] NSWCATOD 47 the relevant principles as stated on many occasions to be applied in determining protective orders were stated to include the following (at [101]): "(1) the protection of public safety and health is paramount; National Law, s 3A; (2) public protection is achieved by ensuring that only health practitioners who are suitably trained and qualified to practice in a competent and ethical manner are registered; National Law, s 3(2)(a); (3) the Tribunal must consider the maintenance of standards of the profession, preservation of public confidence in the profession and, more broadly, the protection of the community: Prakash v Health Care Complaints Commission [2006] NSWCA 153 at [91]; (4) protective orders also involve an element of deterrence or, to put it more positively, encouragement to other practitioners to recognise the importance of complying with professional standards and the risk of failing to do so: Prakash at [91]; (5) the indirect but important effects of a protective order which must be considered when determining the appropriate protective order/ These include general deterrence to the profession and a public statement of the unacceptability of the conduct: see Health Care Complaints Commission v Do [2014] NSWCA 307 and New South Wales Bar Association v Meakes [2006] NSWCA 340; (6) whether seriousness of the conduct is sufficient to warrant suspension or deregistration is a matter of degree and judgment: Sabag v Health Care Complaints Commission [2001] NSWCA 411 at [82]; (7) the protective order should be "the least serious outcome that is reasonably necessary to protect the health and safety of the public (through specific and general deterrence, denunciation and promoting public confidence in the profession)": Health Care Complaints Commission v Ly [2010] NSWMT 20 at [20]; New South Wales Bar Association v Meakes [2006] NSWCA 340 at [113]-[114]; …"
We bear in mind in this case the principle set out at (7) that no order should be made which has more serious consequences for the practitioner than is reasonably necessary in execution of the protective purpose: see also Health Care Complaints Commission v Tran [2021] NSWCATOD 82 at [123]; Health Care Complaints Commission v Saab [2020] NSWCATOD 64 at [82] (and the cases there referred to).
The finding of professional misconduct exposes the Respondent to the possibility of his registration being suspended or cancelled, but that outcome is not automatic: Chen v Health Care Complaints Commission [2017] NSWCA 186, 95 NSWLR 334. The Tribunal's choice of appropriate order is a "matter of degree and judgment" (see, e.g. Sabag v Health Care Complaints Commission [2001] NSWCA 411, at [82]).
The Commission contends that to give effect to the principles referred to above the appropriate order is the suspension of the Respondent's registration for a period of 6 months. The Commission no longer seeks the cancellation of the Respondent's registration. It is argued that the Respondent's conduct represented a complete dereliction of his responsibilities for dealing with dangerous drugs, and the public confidence in the pharmacy profession as gatekeeper for access to those drugs.
The Commission, however, recognised, appropriately, that since the conduct the subject of the Complaints the Respondent has practised without complaint at his pharmacy and has taken appropriate steps to address the shortcomings in his practice. It is unlikely that the Respondent will repeat the conduct giving rise to the Complaints.
The Respondent argued that "the reputation of the medical and nursing profession is robust" and "denunciation" should not override "the significance of the restraint" built into s 3A(2)(c) of the National Law. The guiding principle under subsection (2)(c) is that restrictions on the practice of a health profession are to be imposed under the scheme only if it is necessary to ensure health services are provided safely and are of an appropriate quality. The Respondent then argued that the appropriate protective order may be a caution. We reject that argument. It is not consistent with the paramount principles of the National Law or the principle in subsection (2)(c).
The Respondent also argued that a reprimand serves the purpose of the misconduct being "openly condemned" (see Health Care Complaints Commission v Hollenbach [2019] NSWCATOD 118 at [552]). A range of subjective facts were then pointed to in support of the appropriateness of a reprimand including that the conduct occurred in the first and second year of the Respondent's registration as a pharmacist, that he was the most junior of the pharmacists employed in the Pharmacy, that when alerted to the conduct he took steps to change his practise, that there is no risk that the conduct will be repeated, he helps others in the profession, demonstrated insight into his conduct, and performs what is said to be a vital role in the community of Junee, a community "that would be greatly disadvantaged losing a pharmacist of his calibre and commitment".
The Respondent also relied upon a number of references presented by doctors in Junee who have regular dealings with the Respondent in respect of his current practice.
We accept that the Respondent has fundamentally changed his practice and now appears to comply with his obligations as a registered pharmacist.
The issue which is forefront in our determination of the appropriate protective order which should be made in this case goes to the wider question than denouncing and deterring the Respondent from repeating his misconduct.
In our view, the protection of public safety and health, the paramount consideration required by s 3A of the National Law, count against a caution or reprimand.
The conduct the subject of the established Complaints before us requires more than a caution or reprimand in order to achieve the maintenance of standards of the profession, preservation of public confidence in the profession and, more broadly, the protection of the community.
It is important that the public be protected from similar conduct or incompetence of other practitioners, whether recently registered or experienced. The public must have confidence that the profession as a whole meets the standards of practice required and that practitioners comply, at all times, with the regulatory regime laid down by the PTGR.
The need to protect the public through general deterrence, to signal disapproval of conduct of this kind, is, in our view, important following our findings in this matter. The Respondent testified that other pharmacists with whom he worked appeared to have an understanding, or perception, that pharmacists dispensing Scheduled drugs should not question a prescriber's 'direction' or explanation, and thereby subjugate their independent judgments to the prescriber. To the extent that that understanding, or perception, exists the profession as a whole should be disabused of that approach.
Pharmacists act as gatekeepers by ensuring the safe and appropriate use of medications. They are required to assess prescriptions, verify dosages, identify potential drug interactions or contraindications, and must make timely identifications of misuse or substance abuse.
The maintenance of public confidence requires, in our view, that the appropriate protective order we make extends beyond any order directed specifically at the Respondent.
We have therefore concluded that the appropriate protective order is to suspend the Respondent's registration for a specified period.
We have taken account of the impact on the Respondent and potentially on the community of Junee, but those considerations do not outweigh the need for general deterrence arising from the serious nature of the conduct the subject of the Complaints. There is no reason for us to conclude that the other pharmacy in Junee, the Junee Capital Chemist, will not be able to adequately cater for the community during a period of suspension if required to do so as the only pharmacy in the town.
We have therefore decided to suspend the Respondent's registration for a period of 3 months. In our view, the impact on the Respondent by such a period of suspension is reasonably necessary for the protective purposes under the National Law. The consequences are not more serious than reasonably necessary to achieve the principles.
During the hearing an issue arose between the parties as to the financial consequences of a suspension of registration of less than 6 months, in particular whether in the event of an order for suspension of less than 6 months being made it would require the Respondent to divest himself of his financial interest in the Junee Discount Pharmacy.
After the hearing the parties filed supplementary submissions to address this issue by reference to s 5 of Schedule 5F of the National Law which relevantly provides: 5 Restrictions on who may have financial interest in pharmacy business [NSW] (1) A person must not own or otherwise have a financial interest in a pharmacy business (including as a partner or member of a firm) unless as one of the following - (a) a pharmacist; … Maximum penalty - 100 penalty units. (2) SubClause (1) does not prevent a person from having a financial interest in a pharmacy business - … (c) if the person - (i) is a pharmacist whose registration is cancelled or suspended; and (ii) owned or otherwise had a financial interest in a pharmacy business immediately before the cancellation or suspension took effect; and (iii) does not have the financial interest for a period of more than 6 months immediately following the day on which the cancellation or suspension took effect; or … (3) Despite subClause (2)(b) and (c), a person may have a financial interest in a pharmacy business under those paragraphs only if the business is in the charge of a pharmacist who personally supervises the carrying on of that business. (4) A person who has a financial interest in a pharmacy business under subClause (2)(c) must not, during the period which the person holds the interest, enter or be in premises in which that business is carried on unless the person - (a) has the Council's consent; and (b) complies with any conditions imposed by the Council in giving its consent. (5) The Council may, at any time - (a) vary or revoke a consent; or (b) vary or revoke a condition imposed on a consent.
A person whose registration as a health practitioner is suspended under the National Law is taken not to be registered for the period of the suspension (other than for the purposes of Part 8 of the National Law). It follows that the effect of Clause 5(1) of Schedule 5F would be to require a pharmacist to give up any financial interest in a pharmacy if they were suspended, but for the exception in Clause 5(2)(c).
The Commission argued that the effect of the exception in Clause 5(2)(c) (as far as suspension is concerned) is that a pharmacist whose registration is suspended for 6 months or less does not have to give up their financial interest in a pharmacy. This is subject to the proviso in Clause 5(3), but the premise on which that proviso operates is that there is a "carrying on of" a "pharmacy business". The term "pharmacy business" is defined not as the pharmacy premises but as "the business of a pharmacist … in which the dispensing and compounding of prescriptions … occurs". Accordingly, the proviso in Clause 5(3) is directed only to a situation in which pharmacy operations continue to be carried on during a period when a pharmacist's registration is suspended (or cancelled). It is not directed to a situation in which the physical pharmacy premises are shut down during that period - in which case, there is no "pharmacy business" being "carried on".
It follows that, if the Respondent's registration were suspended for a period of 6 months or less and he did not locate another pharmacist to supervise the operations of the Junee Pharmacy during his suspension, he would not have to divest himself of his financial interest if he "closed the doors" and did not operate the pharmacy business (in the sense set out in paragraph 174 above). To the extent he wished to keep the business operating, he would need to find another pharmacist to take charge of its operation under their personal supervision.
To avoid any doubt, if the Respondent's registration were suspended for more than 6 months, he would have to divest himself of his financial interest because the exception in Clause 5(2)(c) would not apply.
The Respondent's counsel argued that Clause 5 of Schedule 5F is ambiguous but recognised that the submissions by the Principal Legal Officer, Health Professional Council's Authority which we received would be of assistance.
We accept the submissions by the Commission and those helpfully provided by the Authority. Section 5 appears to accommodate a suspension of 3 months without the suspended pharmacist having to divest his or her financial interest in the pharmacy if another registered pharmacist, such as a locum, is placed in charge or, in the absence of such a person, the pharmacy is closed for that period and the pharmacy did not operate.
We recognise that the Respondent may not readily find a locum to take charge during the 3 month suspension we have decided upon.
However, he has been able to do so in some instances in the past. We will, in the circumstances, provide that suspension will not take effect for a period of 30 days from the date of the orders we propose to make to allow time for a replacement to be obtained.
We note that in the submissions which we requested on Clause 5 the Respondent included arguments that the "public interest" suggested that suspension is not the appropriate protective order. The Respondent relied on various decisions concerning the meaning of public interest. It was then argued that a competing factor to "general deterrence" and "denunciation" which weighs heavily against those considerations is the public interest in having the benefit of the services of the Respondent who has in all other respects demonstrated his competence.
We do not accept that this is a public interest consideration which the National Law and paramount objective is concerned with. This interest of the local community does not counter the need for the protective orders we make aimed at deterring other practitioners and maintaining public confidence in the profession to adhere to the rigorous standards required of registered practitioners.

Costs

Clause 13 of Sch 5D of the National Law enables the Tribunal to make an order for payment of costs. 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 on the part of the Commission in its conduct of the proceedings.
It is appropriate to order that the Respondent pay the costs of the Commission.

Orders 1. The Respondent is guilty of unsatisfactory professional conduct in respect of Complaints 1, 4, 5 and 6. 2. The Respondent is guilty of professional misconduct in respect of Complaint 7. 3. Pursuant to s 149C(1) of the Health Practitioner Regulation National Law (NSW), the Respondent's registration is suspended for a period of 3 months, such suspension to commence 30 days from the date of this order. 4. The Respondent is to pay the Commission's costs as agreed or assessed.

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: 05 June 2024

Medical Practice Act 1992(NSW)

reasons for decision

By application dated 18 October 2022, the Health Care Complaints Commission ("the Commission") seeks orders pursuant to s 149C(1)(b) of the Health Practitioner Regulation National Law (NSW) ("the National Law") for the cancellation of the registration of Mr Michael Ezzat Helal Azzer ("the Respondent"), a practitioner registered under the National Law, with a non-review period of 12 months. In addition, the Commission seeks an order that the Respondent pay the Commission's costs as agreed or assessed under Clause 13 of Schedule 5D of the National Law.
In the application, the Commission also sought an order prohibiting the disclosure of the names of the persons listed in the Schedule to the Further Amended Complaint filed by the Commission on 5 April 2024. Counsel for the Respondent did not oppose this application and, accordingly, we agreed to make an order that pursuant to s 64 of the Civil and Administrative Tribunal Act 2013 (NSW), disclosure of the names of the persons listed in the Schedule to the Further Amended Complaint filed on 5 April 2024 is prohibited.
The objectives and guiding principles of the National Law, which are set out in s 3 relate, among other things, to the maintenance of the high standards of the health professions, in both the practice of the health professions, and with respect to the ethics of practice of the health professions. Section 3A of the National Law provides that, in the exercise of functions under a NSW provision, the protection of the health and safety of the public must be a paramount consideration. The National Law, in s 4, requires an entity which has functions under the National Law, to exercise those functions having regard to the objectives and guiding principles in s 3.
The Tribunal's function is thus to be exercised having regard to s 3 and s 3A. Our role is protective rather than punitive (see Clyne v New South Wales Bar Association (1960) 104 CLR 186 at 201-202). The Tribunal's function in this context is to make findings as to whether the subject matter of a complaint has been proved against the practitioner (s 149 of the National Law) and, if it has, to exercise its discretion in relation to the powers conferred by ss 149A, 149B or 149C of the National Law.
The applicable standard of proof is proof on the balance of probabilities (see Bronze Wing International Pty Ltd v SafeWork NSW [2017] NSWCA 41). In view of the nature of the allegations, we will apply the requirements set out in Briginshaw v Briginshaw (1938) 60 CLR 336, namely that we will find that a fact has been proven to the requisite standard only when we feel an actual persuasion of the existence of that fact because evidence of sufficient probative force has been adduced, bearing in mind the seriousness of the findings and their potential for significant impact upon a party (see Sullivan v Civil Aviation Authority (2014) 226 FCAFC 93).

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