Health Care Complaints Commission v Tran

NCAT Occupational|2021-03-23|Before: Dr P

Solicitors: Health Care Complaints Commission (Applicant) Meridian Lawyers (Respondent) File Number(s): 2020/00254146 Publication restriction: An order is made pursuant to s 64 of the Civil and Administrative Tribunal Act 2013 (NSW) prohibiting the disclosure of the name, address or any other identifying information of Patient A.

Introduction

Mr Tran is a co-proprietor of Blooms the Chemist at Edgecliff (the Pharmacy).
As at September 2015, when Mr Tran became a proprietor of the Pharmacy, Patient A was a longstanding customer of the Pharmacy.
In late October 2017 Patient A was admitted to St Vincent's Hospital as a result of a drug overdose. Subsequently, police seized large amounts of medications from her home, including morphine for injection, fentanyl patches and oxycodone capsules.
These medications are listed as Schedule 8 drugs under the Poisons and Therapeutic Goods Regulation 2008 (NSW) (the PTGR). This reflects their significance as drugs of addiction. While these drugs have a proper therapeutic purpose, they are also known to be subject to abuse.

Background

Mr Tran completed a Master of Pharmacy at the University of Sydney in 2006. He completed his internship at Blooms the Chemist, Roselands in 2008 and was first registered as a Pharmacist on 31 January 2008.
Between 2008 and 2015 Mr Tran worked as a Pharmacist in Charge at Blooms the Chemist, Balmain.
In September 2015, Mr Tran became a co-proprietor of the Pharmacy. At this time Mr Tran's co-proprietors were Ms Caroline Diamantis and Mr Douglas Padman. Mr Tran was the only proprietor who regularly worked in the Pharmacy and was responsible for day-to-day activities.
In December 2019, Mr Tran's co-proprietors of the Pharmacy changed. Ms Diamantis and Mr Padman ceased their involvement. Mr Tran's co-proprietors became Mr Kim Duong and Ms Raelene Sidgreaves.
Following Patient A's admission to hospital the PRU conducted a quantitative analysis of the dispensing records for Patient A at the Pharmacy. This analysis identified that pharmacists, including Mr Tran, had dispensed the following to Patient A: 1. 2,300 morphine 30mg ampoules between 1 July 2016 and 25 October 2017 at an average apparent dose of 4.78 injections per day; 2. 160 Durogesic (fentanyl) 100mcg patches between 19 December 2016 and 13 October 2017 at an average dose of 0.54 patches per day.
The above dispensing represented an Oral Morphine Equivalent Daily Dose (OMEDD) of up to 931.65mg. It is accepted that this is a high dosage.
Information provided by Mr Tran to the PRU showed that there had been one clinical intervention by him with Dr Hollo on 18 December 2015 regarding the "potential overuse" of morphine.
By letter dated 2 January 2018 the Director of the PRU, Mr Battye, wrote to the Pharmacy Council of New South Wales (the Council) and amongst other matters informed them of the findings of the analysis of the dispensing records for Patient A at the Pharmacy.
The Council decided to convene proceedings to determine whether any action should be taken against Mr Tran under s 150 of the National Law.
Section 150 proceedings occur in the context of the Council's obligation under the National Law to take action at any time if it is satisfied it is appropriate to do so for the protection of the health and safety of the public or for reasons otherwise in the public interest.
On 24 January 2018, the Council conducted section 150 proceedings and on 12 February 2018 the Council provided its written reasons for decision.
The Council imposed conditions on Mr Tran's registration as a Pharmacist. They are summarised as follows: 1. must not possess, supply, dispense, administer or manufacture any substance detailed in Schedule 8; 2. must attend the PRU to surrender his Schedule 8 drug authority; 3. must not possess or have access to any keys, access cards or smart cards to Schedule 8 drug safes; 4. must provide specific documented policies in relation to the Pharmacy; 5. an audit condition; 6. must notify all pharmacists with whom he is working of the conditions; 7. must notify the Council within 5 days of any change in his employment.
With the exception of condition 4 above all these conditions remain in place. The evidence before us indicates that Mr Tran has complied with these conditions for some three years.

Patient A

Patient A was being treated for chronic pain issues. She has suffered spinal issues from a young age and has had a number of motor vehicle accidents. She has chronic spine problems, radiculopathy nerve root pressure and secondary trauma.
Patient A had been treated by a specialist for endometriosis and bowel adhesions or obstructions and pain prior to Dr Hollo's involvement. In 2002 Patient A had a total hysterectomy, including a bilateral oophorectomy. She has reported suffering from anorexia and bulimia in the past.
Patient A had been a longstanding patient of Dr Hollo. The evidence before us indicates that as a result of Patient A's numerous medical conditions, at the time Mr Tran was providing care to her she was taking a significant amount of medication and was largely housebound.
On 21 October 2017, Patient A was admitted to St Vincent's Hospital for treatment of a drug overdose. Ambulance records indicate that Patient A emailed a friend stating that she did not want to live anymore. The recipient of the email contacted the authorities. Police and ambulance officers went to Patient A's home to check on her welfare. Patient A was found in a semi-conscious state with a syringe in her right femoral region. She was treated by ambulance officers at her home and then taken to hospital.
Written records made by the police who attended Patient A indicate their belief that Patient A intended to commit suicide by overdose. Police subsequently seized large amounts of Schedule 8 medications from her home, including morphine injections, fentanyl patches and oxycodone capsules.

The Complaint

At the commencement of the hearing, the Commission sought, and was given leave, to make amendments to the Complaint. The Complaint as amended is dated 23 March 2021.
The Complaint comprises two individual complaints.
The first complaint alleges unsatisfactory professional conduct under s 139B(1)(a) of the National Law by Mr Tran. Specifically, that Mr Tran has engaged in conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by him in the practice of his profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience.
The second complaint alleges that the unsatisfactory professional conduct which comprises the first complaint against Mr Tran amounts to professional misconduct under s 139E of the National Law.
Attached to the Complaint are two schedules of the medications dispensed by the Pharmacy to Patient A under prescriptions issued by Dr Hollo.
Schedule A sets out the date prescribed, the date dispensed, the medication dispensed including strength, dose and quantity, the number of repeats, prescription number, and the initials of the dispensing pharmacist. This schedule comprises 25 pages.
Schedule B provides a summarised overview of the medications dispensed, including the quantities, for the years 2015-2017.
All of the relevant prescriptions for Patient A that are the subject of the Complaint were dispensed at the Pharmacy.
The details of the first complaint are particularised as follows: 1. Between about 4 September 2015 and 25 October 2017, Mr Tran or his employed pharmacists dispensed prescriptions for morphine sulphate 30 mg/ml ampoules prn, a Schedule 8 drug of addiction, to Patient A in the quantities and on the dates set out in Schedule A for self-administration at home: 1. in combination with prescriptions for oxycodone 20mg and fentanyl 100mcg/hr, both Schedule 8 drugs of addition, in the quantities and on the dates set out in Schedule A; 2. without regular and ongoing consultation with Patient A's prescribing general practitioner directed at confirming the prescriptions for morphine sulphate were for a therapeutic purpose and in therapeutic quantities; 3. in circumstances where the quantities of morphine sulphate dispensed to Patient A increased over time as set out in Schedule B; 4. in circumstances where Mr Tran inappropriately accepted Patient A's assurances that she was not injecting morphine sulphate whilst wearing fentanyl patches and did not take further action to ensure the ongoing supply of medication to Patient A was safe. 1. Between about 4 September 2015 and 25 October 2017, Mr Tran or his employed pharmacists dispensed prescriptions for fentanyl 100mcg/hr to Patient A in the quantities and on the dates set out in Schedule A for self-administration at home: 1. in combination with prescriptions for morphine sulphate 30 mg/mI and oxycodone 20mg in the quantities and on the dates set out in Schedule A; 2. without regular and ongoing consultation with Patient A's prescribing general practitioner directed at confirming the prescriptions for fentanyl were for a therapeutic purpose and in therapeutic quantities; 3. in circumstances where the quantities of fentanyl dispensed to Patient A increased over time as set out in Schedule B. 1. Between about 4 September 2015 and 25 October 2017, Mr Tran or his employed pharmacists dispensed prescriptions for benzodiazepines, namely bromazepam and temazepam, both Schedule 4D prescribed restricted substances, in the quantities and on the dates set out in Schedule A: 1. in combination with Schedule 8 drugs of addiction as set out in Schedule A, placing Patient A at risk of excessive sedation and respiratory depression; 2. without regular and ongoing consultation with Patient A's prescribing general practitioner directed at confirming the prescriptions for benzodiazepines were for a therapeutic purpose and in therapeutic quantities; 3. in circumstances where the quantities of bromazepam and temazepam dispensed to Patient A exceeded the quantity she would require if she was taking the recommended dose. 1. Mr Tran or his employed pharmacists supplied Patient A quantities of morphine sulphate 30mg/mI at the request of Patient A on the dates set out in Table A: 1. in circumstances where there was no emergency; and 2. on the dates listed in Table A in bold, where the original prescription was not received within 7 days after the drug was supplied and no report was made to the Director General contrary to clause 96(2)(b) of the PTGR on the dates in Table A; and/or 3. on dates prior to the dates which appear on the associated prescriptions, being those occasions on the dates listed in Table B. Table A Year Dates 2015 15 October, 21 November, 26 November, 10 December, 18 December, 19 December 2016 25 February, 14 March, 15 March, 21 March, 21 May, 13 June, 6 July, 9 September, 24 September, 3 October

Table B Year Dates 2015 26 October, 30 October, 9 November, 13 November, 20 November, 26 November 2016 11 March, 13 May, 3 June, 30 September 2017 6 January, 13 January, 20 January, 3 February, 16 February

Mr Tran failed to ensure the Drug Register kept at the Pharmacy accurately recorded the dates of supply to Patient A of morphine sulphate 30mg/ml as required by clause 112 of the PTGR. 2. Mr Tran failed to make an accurate inventory of all drugs of addiction at the Pharmacy in September 2015, March and September 2016 and March and September 2017 as required by clause 118 of the PTGR. 3. Between about 4 September 2015 and 25 October 2017 Mr Tran failed to ensure that records were kept at the pharmacy of conversations with Patient A and her treating general practitioner.
The second complaint alleges professional misconduct against Mr Tran in that he has: 1. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; and/or 2. engaged in 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 the suspension or cancellation of the practitioner's registration.
In support of the complaint of professional misconduct the particulars of the first complaint are repeated and relied upon individually and cumulatively.

Mr Tran's response to the Complaint

In a written reply to the Complaint made on 19 February 2021, with the exception of particular 4, Mr Tran admitted all the facts contained in the particulars of the first complaint. However, after the amendments that were made to the Complaint by the Commission at the hearing, Mr Tran made full admissions as to the factual matters set out in the first complaint, in its entirety. This included conceding that prescriptions dispensed by the Pharmacy were not appropriate emergency supplies in accordance with the PTGR.
Reflecting on these concessions, Mr Tran admitted that his conduct amounted to unsatisfactory professional conduct. However, Mr Tran did not admit that his conduct constituted professional misconduct.
The central issues that emerged for resolution before us were: 1. Whether, as alleged by the Commission, and disputed by Mr Tran, the admitted conduct is of a "sufficiently serious nature" to justify suspension or cancellation of Mr Tran's registration, that is, that it amounts to "professional misconduct" as defined by s 139E of the National Law. 2. Whether protective orders should be made and, if so, what orders should be made. 3. Whether Mr Tran should be ordered to pay all of the Commission's costs.
To assist in determining the nature of Mr Tran's conduct and its seriousness we will set out Patient A's presentations to the Pharmacy and Mr Tran's dealings with Patient A and her GP, Dr Hollo. We will also set out the nature and extent to which Mr Tran raised concerns or clinical interventions in relation to the prescribing for Patient A, and the compliance by Mr Tran as proprietor of the pharmacy with legislative requirements at the time that the conduct the subject of the Complaint occurred. We will also reference an expert peer review report.
To assist in the determination of the appropriate protective orders we have referenced Mr Tran's compliance with conditions imposed on him by the section 150 proceedings, the findings of a recent audit, and character references.

Mr Tran's dealings with Patient A and Dr Hollo

Prior to disciplinary proceedings being initiated, Mr Tran made extensive written submissions to the Commission about his dealings with Dr Hollo and the dispensing of medicines to Patient A. These written submissions were frank and mirrored the written material he had provided to the Tribunal and the oral evidence he gave at the hearing.
At a handover of the pharmacy business in September 2015 the previous pharmacy owner told Mr Tran that Patient A had multiple comorbidities and was very sick. Patient A was under the care of Dr Hollo, who had looked after her for many years. Reference was also made to an arrangement with Dr Hollo where, if Patient A required a prescription, Dr Hollo would fax the prescription and post the original.
Within the first week of becoming the proprietor of the Pharmacy Mr Tran reviewed Patient A's dispensing history. At around the same time Mr Tran called Dr Hollo to confirm Patient A's medication. To the best of his recollection, at this time he also spoke to Patient A to introduce himself as the new owner and discuss the medications she was on and her pain management regimen prescribed by Dr Hollo.
To the best of his recollection, there were several occasions during January 2016 when he delivered medication to Patient A after work.
At these home visits Mr Tran's conversations related to Patient A's life situation, her difficulties being homebound and her chronic pain. He observed Patient A to be severely debilitated and experiencing great difficulty just getting to the door. He did not observe any medications in larger than usual quantities.
Mr Tran was also given information from an employee who was a pharmacy student that Patient A had previously been a patient of another local pharmacy which had dispensed morphine to her. Patient A no longer used that pharmacy because it had stopped making home deliveries of medication.
Mr Tran recalled making three phone calls to Dr Hollo about Patient A. Only one of these calls was reflected in writing.
The first conversation occurred soon after taking over the Pharmacy to confirm that the medication was for a therapeutic use due to the large quantities prescribed.
The second call was made in December 2015 in response to Patient A requesting that morphine be dispensed and delivered before the interval date. Mr Tran made a note in the Pharmacy software system.
The third phone call was a follow up from the second call. Dr Hollo again stated that morphine was the only medication that was effective in managing Patient A's pain, and that she had been reviewed by a pain specialist.
Mr Tran stated that during his conversations with Dr Hollo, Dr Hollo was adamant about Patient A's treatment plan, which included a specialist and in-house carers. This, along with the fact that Dr Hollo had been looking after Patient A for many years and visited her at home regularly, resulted in Mr Tran feeling it was not his place to question Dr Hollo.
Mr Tran stated that his lack of experience as a pharmacy proprietor and his lack of knowledge in chronic pain management prevented him from questioning Dr Hollo's decision. Further, he acknowledged that he should have requested written documentation from Dr Hollo and called Pharmaceutical Services for advice regarding Patient A's prescribed dose before dispensing.
Mr Tran stated that post December 2015 he recalled an employed pharmacist, Politimi Spiroglou, confirming with Dr Hollo that Patient A's prescribing was to remain the same, as per review, but Mr Tran could not be sure since this was not documented. Mr Tran understood that his Pharmacy continued dispensing to Patient A because there was confirmation from Dr Hollo; however he has no corresponding supporting documentation.
Mr Tran supplied a letter from Dr Hollo which confirmed that Mr Tran was the only pharmacist to contact Dr Hollo via telephone to ask about Patient A's medication. Dr Hollo was unable to recall the date of the telephone conversation.
Mr Tran did not recall speaking to Dr Hollo between 18 December 2016 and 31 October 2017. However, he recalled his pharmacists mentioning that they spoke to Dr Hollo and confirmed the need to continue the morphine. Mr Tran was unable to recall whether it was pharmacist Politimi Spiroglou or Cyrus Kiani, or both, at various times during that period.
Mr Tran stated that he did not record visits, conversations and observations in relation to interactions with Patient A.
Mr Tran provided copies of the Schedule 8 dispensing process in place at Blooms the Chemist, Balmain and Blooms the Chemist, Edgecliff at the time of the Complaint.
Mr Tran advised that he dispensed Schedule 8 medicines to Patient A using practices he adopted from his time at Balmain, which was a departure from the system in place at Blooms the Chemist, Edgecliff.
In oral evidence Mr Tran stated that on learning at the section 150 proceedings that Patient A had tried to commit suicide and been hospitalised he was "devastated".
In oral evidence Mr Tran presented as genuinely remorseful and did not seek to avoid responsibility. He became visibly upset on a number of occasions. His evidence was to the effect that there was no doubt in his mind that Patient A needed the medication. When he saw photos of the amount of medication Patient A had in her possession he was shocked and speechless. He said Patient A's overdose had a profound impact on him because he had chosen the profession of pharmacy to help people.
Mr Tran has completed the Pharmaceutical Society of Australia "Ethics and Dispensing in Pharmacy Practice" course. He said that he wanted to share his learning and not have his staff go through what he has been through. From the day of the section 150 proceedings, he said, the protection of the public has not left his mind.

Compliance with legislative requirements

Mr Tran stated that since acquiring the Pharmacy in September 2015 he has not strictly complied with the legislative requirements in relation to drug register checks.
Mr Tran stated that, in hindsight, he did not utilise a methodical approach to supervising his pharmacists and did not have a risk prevention strategy in place, which now exists.
Mr Tran stated that in relation to the delayed recording of Schedule 8 medications in the drug register, he and his pharmacists would try and reduce the number of deliveries to Patient A, hence requesting prescriptions be faxed by Dr Hollo and dispensing multiple boxes of morphine per delivery.
At the relevant time Mr Tran did not have a system in place for monitoring and auditing staff compliance in relation to guidelines and legislative requirements in handling, supplying and recording Schedule 8 medications.
With regard to the mandated twice-yearly stock checks of the drug register, Mr Tran was aware that stock checks of the drug register were due twice annually (in March and September). He accepted that stock checks were not done in the mandated months and acknowledged that during 2017 he had only completed one review of the drug register.
Mr Tran dispensed Schedule 8 medications as "owing" without a hard copy prescription and would then request these from the prescribing doctor, which would generally arrive in the mail a few days later.
Mr Tran acknowledged that if an "owing" prescription was dispensed but not received by the Pharmacy then that drug would not get recorded in the drug register. By way of example he acknowledged there was an "owing" prescription written on 11 November and dispensed by him on the same day, however this was not entered into the register until 15 November, as this was the day the prescription was received by the Pharmacy.
Mr Tran accepted that he had become "a bit sloppy" in recent years with his documentation and paperwork and that some of these issues related to putting entries into the drug register.

Expert evidence

Expert evidence from Nerida Croker, Registered Pharmacist was available to the Tribunal including her final report dated 16 December 2019.
Mr Tran did not cavil with Ms Croker's evidence and she was not required to give evidence in the proceedings.
Ms Croker outlined that the standard expected would be to ensure that any dispensed medication which appeared to be a higher than usual dose was carefully investigated to ensure the pharmacist felt confident the prescription and medication were appropriate and for a therapeutic use.
In Ms Croker's view, Mr Tran's explanation that his lack of experience as a pharmacy proprietor and his lack of knowledge in chronic pain management prevented him from questioning Dr Hollo's high level of prescribing of Schedule 4D and Schedule 8 medications would fall significantly below this standard.
Given the nature of the medications involved, particularly fentanyl patches and morphine ampoules, which are potent Schedule 8 medications and could be open to misuse (either intentional or accidental), which all pharmacists should be aware of, Ms Croker was strongly critical of Mr Tran's conduct.
Ms Croker stated that given the high doses of fentanyl coupled with frequent use of morphine ampoules, it would be expected that these doses be discussed with the prescriber and continue to be confirmed.
The requirements for Schedule 8 medications include that, for all medications that are dispensed, prescriptions are available and medication is not provided as owing prescriptions. In Ms Croker's view, Mr Tran's supply (and/or oversight of supply) of morphine 30mg/ml to Patient A between 28 July 2015 and 25 October 2017 fell significantly below the standard expected.
Given the potent Schedule 8 medication involved, which can be associated with misuse or harm, as well as the clear legislative requirements for supply of this medication, Ms Croker was strongly critical of Mr Tran's conduct.
Ms Croker reported that the standard expected would be to ensure that the therapy was appropriate for the patient and Mr Tran's reliance on an "assurance" from Patient A that she was not using morphine and fentanyl together fell significantly below the standard expected. Ms Croker stated that it would be expected that further discussion with the prescriber would be undertaken.
In Ms Croker's view the large quantities of morphine which were dispensed, and the regularity of dispensing, indicate this could not be a true statement if Patient A was using these medications in a therapeutic manner. Ms Croker was concerned that Mr Tran using this "assurance" as justification for his actions in dispensing shows that he had limited therapeutic knowledge about these medications and may not have been meeting his professional responsibilities.
In relation to Mr Tran dispensing Schedule 8 medications to Patient A prior to receipt of a prescription, with the prescriptions being faxed to the Pharmacy by Dr Hollo post dispensing, Ms Croker concluded at pars 58 to 64 of her report as follows: "The standard reasonably expected of a practitioner of equivalent training and experience would be to ensure that S8 medications are only dispensed to patients on receipt of a valid prescription. It would also be expected that if an emergency supply of any medication, but particularly S8 medication, was to be made, that appropriate legislation was followed. Mr Tran's conduct in dispensing S8 medications to [Patient A] prior to the receipt of a prescription would fall significantly below the standard expected. Given the nature of the medication involved which is a potent opioid, morphine 30mg/ml injections, and the apparent frequency of these supplies which occurred without prescriptions, I am strongly critical of Mr Tran. Mr Tran dispensed multiple prescriptions for morphine 30mg//ml for [Patient A] which the dispensing record provided to me indicates were dispensed prior to the prescribing date. It is not legal to supply any prescription medication on a forward dated prescription. There is a provision for an emergency supply of S8 medication, Clause 81 of the Poisons and Therapeutic Goods Regulation 2008, however this must be done by the prescriber either by phone, fax, email or orally, and the prescription must be made out that day. If Dr Hollo had given an emergency authorization you would expect this to be documented, and you would also expect that there would be no need for dispensing on a date prior to prescribing, as the prescription would be made out on the day the emergency supply was authorized… It would generally be expected that if a prescriber did give an emergency order for an S8 medication this would be a rare occurrence. This does not appear the case here."

Audit reports

Since the section 150 proceedings, Mr Tran and his Pharmacy have been subject to regular audit reports. Four audits have been completed. These audits have been conducted by David North, Pharmacist.
A comprehensive audit report dated 10 July 2020 was available to the Tribunal. In this report Mr North records, referencing supporting evidence, that Mr Tran has been fully compliant with all conditions imposed on him arising from the section 150 proceedings.
Again referencing supporting evidence, Mr North further recorded that Mr Tran provided proprietor oversight in not permitting supply without prescription and/or frequent dispensing of Schedule 4 (including Appendix B and Appendix D) and Schedule 8 medicines. He notes that the PTGR and Pharmacy Board guidelines as to the dispensing of such medications appeared to have been met.
Mr North found that Mr Tran had maintained an active interest in how the Pharmacy business was conducted and that he had fulfilled his professional responsibilities as a proprietor. Mr North was satisfied that Mr Tran provided proprietor oversight and met his obligations as set out in the "Guidelines for Proprietor Pharmacists" issued by the Pharmacy Board.
Specific mention was made by Mr North that Mr Tran had demonstrated insight into understanding the behaviour that had led to the imposition of the section 150 conditions. He observed that Mr Tran did not blame others, did not make excuses, made every attempt to change non-compliant issues with improved measures and complied with all improvement measures.
Mr North suggested that it was perhaps time for the Council to consider permitting Mr Tran the opportunity to show the Council he can take on the responsibilities for the handling, supply and recording of drugs of addiction. Safety of the public could be assured by monitoring, over a period, Mr Tran's performance in the handling, supply and recording of drugs of addiction.

Character references

On behalf of Mr Tran references were provided from Mr Tran's business partners, Kim Duong and Luke Owens, Pharmacist. Mr Owens is employed by Blooms the Chemist Group and amongst other duties offers support to pharmacists within Blooms the Chemist with compliance. Mr Owens also gave oral evidence.
Both referees were aware of the Complaint and the conditions on Mr Tran's registration. Both referenced his insight into his past conduct, the audit reports and professional development courses he has completed. We found the references of somewhat limited assistance in determining the central issues however we accept that Mr Tran is well-regarded by these colleagues, who found him to be dedicated and hardworking.

Submissions made by the parties

Given the admissions made by Mr Tran the primary focus of the submissions made by each party was whether Mr Tran's conduct constituted professional misconduct as defined in the National Law and, depending on that outcome, the appropriate protective orders to be made.
The Commission submitted that the unsatisfactory professional conduct of Mr Tran is of a sufficiently serious nature to fall within the definition of professional misconduct to justify suspension or cancellation of his registration.
It was submitted that Mr Tran should have recognised that the quantities, frequency and combination of medication dispensed to Patient A were inappropriate. Mr Tran's failure to take steps to address Patient A's medications in both his capacity as proprietor and a pharmacist working in the Pharmacy placed Patient A's health and safety at significant risk. He had not complied with provisions of the PTGR. He failed to accurately record the dates of supply of morphine to Patient A and twice-yearly stock takes for drugs of addiction were not carried out in the mandated months.
On behalf of Mr Tran it was submitted that Mr Tran's conduct did not amount to professional misconduct. Various factors were identified including that Patient A's condition was complex and therefore unusual. Mr Tran did not have previous experience of such patients. Mr Tran had information from various sources confirming Patient A's medication regimen. Patient A was under the continuous care of an experienced and longstanding GP and was seeing a pain specialist. The visits Mr Tran made to Patient A at home confirmed his understanding as to the extent of her pain. Mr Tran did question the quantities and medication regimen with Dr Hollo and was assured that a pain specialist was managing Patient A's condition.
If the complaint of professional misconduct is found proven the Commission requests the Tribunal exercise its power to make disciplinary orders against Mr Tran. Specifically, the suspension of Mr Tran's registration for a period of 6 to 12 months and at the end of the suspension period the imposition of a range of practice conditions, including that he not work as pharmacist in charge, and conditions related to audits and mentoring. It also seeks an order for costs.
In contrast, on behalf of Mr Tran, it was submitted that suspension would be counterproductive. The purpose of protective orders was protective not punitive. Mr Tran has reflected on his conduct and shown insight. Mr Tran would comply with any conditions imposed on his registration by the Tribunal, such as audits or mentoring. A reprimand would serve as an appropriate message of deterrence to the profession as a whole.

Complaint One: Unsatisfactory professional conduct - section 139B(1)(a) of the National Law

Complaint One alleges "unsatisfactory professional conduct" within the meaning of s 139B(1)(a) of the National Law. Mr Tran admitted all the facts as particularised in the Complaint and concedes his conduct amounts to unsatisfactory professional conduct. Taking into account all the evidence before us we are independently satisfied that the complaint of unsatisfactory professional conduct is proved.

Complaint Two: Professional misconduct - section 139E of the National Law

In determining whether a finding can be made of professional misconduct the Tribunal must determine, as outlined in Health Care Complaints Commission v Perroux [2011] NSWDC 99 at [18], "whether, when the respondent's contraventions are considered as a whole, they are of a sufficiently serious nature to justify suspension or deregistration".
It has been held that the "gravity of professional misconduct is not to be measured by reference to the worst cases, but by the extent to which it departs from the proper standards": see Health Care Complaints Commission v Litchfield (1997) 41 NSWLR 630 at 638.
There is no comprehensive exploration in the case law as to when unsatisfactory professional conduct will amount to professional misconduct. The concept as contained in s 139E of the National Law should be given a purposive interpretation. The Tribunal is required to not only consider the object of the protection of the public but to recognise that object also includes deterring the practitioner, and other practitioners, from repeating the same misconduct: Health Care Complaints Commission v Saedlounia [2013] NSWMT 13 at [43]-[50] and Health Care Complaints Commission v Do [2014] NSWCA 307 at [35].
As explained by Basten JA in Chen v Health Care Complaints Commission [2017] NSWCA 186 at [19]: "[t]he term 'professional misconduct' does not have a specific meaning; it is merely a category of 'unsatisfactory professional conduct' which is sufficiently serious to justify suspension or cancellation." His Honour further notes: [20] 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. …
The PTGR sets out stringent statutory requirements in relation to the handling of, and record keeping for, drugs of addiction. It sets out what is required when dispensing prescriptions. These requirements include a provision that a 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. These regulations exist to manage and address the very real risks to patients, and the public more broadly, in dispensing drugs of addiction.
Pharmacists act as our caretakers in the community in the responsible and lawful dispensing of Schedule 8 medications, drugs of addiction and special prescribed restricted substances. It is their compliance with the protective architecture to which the regulations and various guidelines are directed which ensures the safe benefits of such medications to individual patients and the community as a whole.
A hallmark for a pharmacist in dispensing medication is the requirement to exercise independent judgment in accordance with their professional responsibilities. Pharmacists have legislative and professional responsibilities to assess whether it is safe and appropriate to dispense a prescription. They should not merely assume that when a prescription is presented that all is well. In this context Mr Tran did not meet his legislative and professional responsibilities.
A pharmacist should possess the judgment and skill to question where prescribing patterns raise suspicions and to seek further advice or counsel. If there was no role for the pharmacist in this regard, then doctors would be dispensers as well as prescribers.
The evidence discloses that apart from the conversations Mr Tran had with Dr Hollo in late 2015, no further interventions were made by Mr Tran in relation to Patient A's treatment from December 2015 until to her attempted suicide in October 2017. We accept the submissions of the Commission that given the quantity, frequency and combination of medication dispensed by the Pharmacy, Mr Tran's failure to take steps to address Patient A's medications in both his capacity as proprietor and dispensing pharmacist, placed Patient A's health and safety at significant risk. This was a risk that was ultimately realised by Patient A's hospital admission for a drug overdose.
Due to Patient A's co-morbidities and high levels of pain she was a vulnerable person. She was able to obtain large quantities of drugs of addiction on prescription over several years without adequate intervention by Mr Tran. Enabling Patient A's access to large quantities of drugs of addiction placed her at risk of drug dependency and misadventure.
Mr Tran in both his capacity as proprietor and dispensing pharmacist failed to have regular and ongoing consultation with Dr Hollo, Patient A's prescribing GP, to ensure that the prescriptions for opioids and benzodiazepines were for an appropriate therapeutic purpose and in therapeutic quantities.
Many of the factors referred to in the submissions made on behalf of Mr Tran go to the totality of the information that was available to him which arguably gave him some comfort and support for what he understood to be Patient A's needs. However, by not raising appropriate concerns with Dr Hollo on a regular and ongoing basis about Patient A's medication, especially its escalating nature, Mr Tran's clinical judgment was seriously deficient. This was compounded by the fact that Mr Tran made no inquiries of Patient A's pain specialist and did not seek any advice on Dr Hollo's prescribing patterns. Further, Mr Tran failed to comply with the protective structures within the PTGR in relation to drugs of addiction.
The Tribunal concludes that when considered as a whole the unsatisfactory professional conduct displayed by Mr Tran is of a sufficiently serious nature to fall within the definition of "professional misconduct" under s 139E of the National Law. It constitutes conduct which is sufficiently serious to justify suspension or cancellation. The Tribunal is satisfied that Complaint Two is established.

Principles regarding protective orders

Where a complaint made under the National Law is proven or admitted, the Tribunal may exercise any of the powers in Pt 8, Div 3, Subdiv 6 of the National Law. They include the powers to caution, reprimand, impose conditions on a practitioner's registration, or order a practitioner to undergo medical or psychiatric treatment or counselling or complete an educational course. If a complaint of professional misconduct is proven against a practitioner the Tribunal may suspend or cancel the practitioner's registration: s 149C(1) of the National Law.
In determining the appropriate orders, the paramount consideration is the protection of the health and safety of the public: see s 3A of the National Law.
As the Tribunal's paramount consideration is the protection of the health and safety of the public, the imposition of restrictions on the practice of a health professional is only to be made in pursuit of this higher objective.
The guiding principles of the national registration and accreditation scheme include that restrictions on the practice of a health professional are only to be imposed where necessary to ensure health services are provided safely and are of an appropriate quality: see s 3(3)(c) of the National Law. This determination may only be made by reference to the facts of the particular case before the Tribunal and by considering what measures are needed to ensure future behaviour of the practitioner, and others, is shaped in such a way that is consistent with these protective goals: Lee v Health Care Complaints Commission [2012] NSWCA 80 at [34].
In Lee v Health Care Complaints Commission Barrett JA at [20] stated that the task of the decision maker in making protective orders centres not on punishment as such but on the protection of the public and the maintenance of proper professional standards, citing with approval the comments made by Basten JA in Director-General, Department of Ageing, Disability and Home Care v Lambert (2009) 74 NSWLR 523; [2009] NSWCA 102 at [83]: "… 1. The specific purpose for which orders are made is protective in the public interest and is not punitive with respect to the individual. 2. That is not to deny that such orders may be punitive in effect and that punitive effects may be relevant in formulating a protective order. 3. The punitive effects may be directly relevant to the need for protection so that, in a particular case, there may be a factual finding that the harrowing experience of disciplinary proceedings, together with the real threat of loss of a livelihood, may have opened the eyes of the individual concerned to the seriousness of his or her conduct so as to diminish significantly the likelihood of its repetition and to produce a level of insight into his or her own character or misconduct which did not previously exist."
The protection of the public is a broad concept. It has been held that other relevant purposes of disciplinary proceedings include the need to maintain the standards of the relevant profession and to deter others from engaging in like conduct: see, for example, Health Care Complaints Commission v Litchfield at 637.
The purpose of disciplinary orders was discussed in Prakash v Health Care Complaints Commission [2006] NSWCA 153, where Basten J said, at [91]: "… The purpose of any order made upon a finding that a complaint has been proved, is said to be protective of the interests of the public at large, but more particularly patients or potential patients of the practitioner concerned. However, the public interests include, indirectly, the standing of the medical profession and the maintenance of public confidence in the high standards of medical practitioners. There is also an element of deterrence or, to put it more positively, encouragement to other practitioners to recognise the importance of complying with professional standards and the risks of failing to do so. The powers of a Tribunal having two members of the medical profession should, at least in relation to professional standards be accorded a degree of flexibility which might not necessarily be accorded to a Tribunal differently constituted."
In Health Care Complaints Commission v Do [2014] NSWCA 307 Justice Meagher (with whom Basten and Emmett JJ agreed) referred at [35] to the importance of denunciation of misconduct, in the context of ss 3 and 3A of the National Law, as follows: "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 health and safety of the public is the paramount consideration and our task is protective not punitive. Any order designed to protect the public from a repeat of the conduct that is the subject of a complaint which has been found proven, requires an evaluation of the seriousness of that conduct and the nature and extent of any justifiably apprehended harm that might be caused if it were to be repeated. No order should be made which has more serious consequences for the practitioner than is reasonably necessary in execution of the protective purpose: NSW Bar Association v Meakes [2006] NSWCA 340 at [113].
The definition of professional misconduct is focused on the nature of the conduct, which must have the capacity to justify such an order. While a finding of professional misconduct is a prerequisite for the making of a protective order that cancels or suspends a health professional's registration, not all findings of professional misconduct warrant cancellation or suspension. That is, cancellation or suspension does not automatically follow a finding of professional misconduct: see Health Care Complaints Commission v Karalasingham [2007] NSWCA 267 at [67].
Applying these principles, the purpose of the disciplinary powers available to us is not to punish a practitioner but rather to protect the public and maintain proper professional standards.
In our view, for the reasons that follow, suspension of Mr Tran's registration would have a punitive effect and would not advance the protection of the public.
Mr Tran has consistently made admissions throughout his dealings with the Council, the Commission and the Tribunal. He concedes that as a proprietor and a pharmacist he should have taken steps to stop Patient A receiving the medications at an earlier point in time. In our view he is genuinely remorseful.
Mr Tran has not sought to minimise the seriousness of his involvement in this matter. In acknowledging his failures at an early stage, in the care he provided to Patient A and the errors of judgment he made, he has demonstrated insight. He has undertaken remedial educational courses to address shortcomings and improve his knowledge.
With the exception of Mr Tran's failure to ensure that twice-yearly stock takes were completed in the months of March and September as specified by the legislation, his conduct the subject of the Complaint was limited to the care provided to a particular patient who intentionally overdosed with excess medications which she had in her home and which had been obtained from the Pharmacy. Specifically, the dispensing to that patient of Schedule 4D prescribed restricted substances and Schedule 8 drugs of addiction, including morphine 30mg/ml ampoules, fentanyl 100mcg patches and oxycodone capsules.
It is not the case that Mr Tran made no effort to check Patient A's medication regimen with the prescriber. Nor is it the case that there were irregularities on the face of the prescriptions. With the exception of the medications dispensed as a prescription owing, the medications dispensed by Mr Tran and his Pharmacy were referable to prescriptions issued by Patient A's GP.
Nor is there any clear evidence that Mr Tran's conduct represented a wilful disregard for the legislation, policies and procedures expected of a pharmacist. Rather, in our view, Mr Tran as a new pharmacy owner was working in a situation possibly beyond his ability to cope and without adequate collegial support. Mr Tran acknowledged that his record keeping had become "sloppy".
The key issue however is that for some two years Mr Tran did not identify and take steps to address the serious and escalating problems with the prescribing pattern for Patient A. His intervention was limited and as a consequence ineffectual.
We have found in relation to very specific allegations Mr Tran's knowledge, skill, judgment and care in the practice of pharmacy to be significantly below the standard reasonably to be expected of a practitioner of his level of training and experience.
Equally, however, the evidence did not suggest, nor was there any allegation by the Commission, that there were other deficiencies in Mr Tran's general clinical practice apart from the care he provided to Patient A in dispensing Schedule 4D prescribed restricted substances and Schedule 8 drugs of addiction.
Mr Tran has been subject to conditions on his registration for some three years. He has complied with those conditions. There is no evidence that he has been the subject of further complaints.
Over the last three years audits have been undertaken in respect of Mr Tran's practice as a pharmacist and the level of oversight he has provided as a proprietor. Only the most recent audit report prepared in July 2020 was available to the Tribunal. However, there is no evidence before us that previous audits have not been satisfactory. The audits have been overseen by the Council and the evidence does not suggest they have identified any complaint or concern as to Mr Tran's clinical practice and professional conduct.
In our view, significant weight should be attached to the audit report prepared in July 2020. This is because the auditor, Mr North, was well placed to give an accurate, thorough and longitudinal assessment of Mr Tran's practice as a pharmacist and his oversight as a proprietor in a public health and safety context. We note that Mr North indicated that it was possibly time for the Council to consider permitting Mr Tran the opportunity to show the Council he can take on the responsibilities of the handling, supply and recording of drugs of addiction as a trusted and responsible pharmacist.
In our view further audits are unnecessary. The safety of the public could be assured by mentoring of Mr Tran in the handling, supply and recording of drugs of addiction liable to abuse and misuse.
Similarly, we are not satisfied that Mr Tran poses a risk to the public requiring a condition that he not work as a pharmacist in charge. Mr Tran has been working as pharmacist in charge for the last three years without issue. We do not believe that such a condition is necessary to protect the public.
We accept that Mr Tran has been chastened by this experience. In our view, given this and his insight now, he is unlikely to repeat his errors if faced with a similar set of circumstances in the future. In our view, Mr Tran will not present a risk to patients in the future by like conduct.
Taking into account all these matters, in our view suspension of Mr Tran's registration for a period of 6-12 months would be punitive. It amounts to a punishment and represents a more serious consequence for him than is reasonably necessary to promote the protective purpose. We are satisfied that the protection of the public can be achieved by other mechanisms and those mechanisms will still serve to denounce Mr Tran's conduct as unacceptable.
We have considered the range of orders open to us and in our view those under s 149A of the National Law are the most relevant to this case.
We are conscious that protection of the public includes sending a strong message to practitioners and the public that the seriousness of the conduct which we have found proved in this case represents unacceptable practice, and that it ought to be denounced as such. Moreover, it includes maintenance of public confidence in the standards of the profession.
We are satisfied that a reprimand issued to Mr Tran represents an appropriate signal of denouncement of the misconduct which we have found existed in this case and operates both as a deterrent to the practitioner as well as to the general body of practitioners.
As discussed in Health Care Complaints Commission v Quan [2018] NSWCATOD 111 at [80]-[81], the reprimand, the fact that the practitioner was the subject of these disciplinary proceedings and our reasons, which are publicly available on NSW Caselaw, will serve as a deterrent to like conduct and uphold the standards of the profession.
The ordering of a reprimand of Mr Tran that follows a finding of professional misconduct in a decision published by the Tribunal imparts a clear deterrent message to other professionals that conduct of the kind found against Mr Tran will not be tolerated. The reprimand together with our published finding of professional misconduct confirms the seriousness and unacceptability of the professional misconduct which we have found proven.
Mr Tran has expressed remorse and contrition concerning the conduct the subject of the Complaint. He has undertaken further education. In the particular circumstances of this matter, we do not believe that the maintenance of public confidence in the standards of the profession requires that Mr Tran's registration be suspended.
Due to the current restrictions on Mr Tran's registration he has not been able to handle or dispense Schedule 4D and Schedule 8 medications. However, he has continued to involve himself by way of oversight of his Pharmacy in the dispensing of Schedule 4D and Schedule 8 medications by obtaining reports.
Mr Tran has embarked on a process including the preparation of policies which has gone some way to improving his capability and insight into the dispensing of Schedule 4D and Schedule 8 medications. However, in the context of the restrictions, his practical ability to rectify issues as they arise within his Pharmacy remains somewhat untested.
In view of these matters, it is appropriate that the mentoring have a particular focus on Schedule 4B, 4D and 8 medications.
In our view, mentoring will also address the somewhat narrow and confined practical nature of Mr Tran's work history. It will also serve to ensure that Mr Tran's future behaviour is informed in such a way which reflects the paramount consideration of the protection of the public.

Costs

The Commission seeks that Mr Tran pay its costs.
On behalf of Mr Tran, it is submitted that he should pay no more than 70% of the Commission's costs. In support of this position, reference was made to the late amendment of the Complaint and it was suggested that if the revisions had been made at an earlier point in time the matter could have been prepared and heard in less time.
The Commission responds to this submission by referring to the amendments to the Complaint occurring in the context of when it was served with Mr Tran's Reply.
The principles relevant to the exercise of discretion in awarding costs were the subject of recent discussion in the High Court of Australia in Northern Territory v Sangare (2019) 265 CLR 164; [2019] HCA 25. The High Court stressed that the awarding of costs is a discretionary matter, but the discretion must be exercised judicially by reference to relevant considerations. Their Honours further explained that the general rule that costs follow the event reflects the position that a successful party should be compensated for the expenses it has incurred. These long-established principles are also relevant to professional disciplinary proceedings: see Health Care Complaints Commission v Philipiah [2013] NSWCA 342.
The purpose of an award of costs is to compensate a successful party. It is not for the purpose of penalising an unsuccessful party: see Health Care Complaints Commission v Philipiah at [42]. The presumption that a successful party is entitled to costs is generally only displaced where there has been some "disentitling conduct" by the successful party: see Oshlack v Richmond River Council (1998) 193 CLR 72; [1998] HCA 11at [40].
The Commission was successful in these proceedings. It established both unsatisfactory professional conduct and professional misconduct. There was no disentitling conduct by the Commission in the way in which it prosecuted the proceedings before us.
The Tribunal is not satisfied that any disentitling conduct has been established on the part of the Commission. Nor is the Tribunal satisfied that this is an appropriate case to exercise the discretion to depart from the general "rule".

Orders

Consequent upon the findings which we have made we make the following orders: 1. Mr Tran is reprimanded under s 149A(1)(a) of the Health Practitioner Regulation National Law (NSW); 2. The Pharmacy Council of New South Wales (the Council), or Mr Tran subject to the Council's approval, is to nominate a registered experienced practitioner who is not an employee of or associated with Blooms the Chemist, within 14 days of the Tribunal's decision, to act as his professional mentor, for approval by the Council in accordance with the Council's "Compliance Policy - Mentoring" (as varied from time to time); 3. Mr Tran is to be mentored for a minimum period of 12 months or as subsequently determined by the Council, with a particular focus upon the dispensing of Schedule 4B, 4D and 8 medications; 4. Mr Tran is to participate in meetings with the mentor on a monthly basis; 5. Mr Tran is to authorise the mentor to report to the Council on a quarterly basis; 6. Mr Tran is to authorise the mentor to inform the Council immediately if the mentoring relationship ends, or of any significant concerns; 7. Mr Tran is to be responsible for any costs associated with mentoring; 8. Mr Tran is to pay all the Commission's costs of and incidental to these proceedings as agreed or failing agreement as assessed under the Legal Profession Uniform Law Application Act 2014 (NSW).

I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales. Registrar DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 18 June 2021

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