These proceedings are constituted by an Amended Complaint by which the applicant Health Care Complaints Commission complains that the respondent Priya Patel is guilty of unsatisfactory professional conduct and professional misconduct as those terms are defined in the Health Practitioner Regulation National Law (NSW) (the National Law) arising out of her practice as a pharmacist.
The Amended Complaint is in the following terms
"The Health Care Complaints Commission of Level 12, 323 Castlereagh Street, Sydney NSW, having consulted with the Pharmacy Council of New South Wales in accordance with sections 39(2) and 90B(3) of the Health Care Complaints Act 1993 (NSW) and section 145A of the Health Practitioner Regulation National Law (NSW) ("the National Law")
HEREBY COMPLAINS THAT
Priya Patel of [address supressed] ("the practitioner"), being a pharmacist registered under the National Law,
BACKGROUND TO ALL COMPLAINTS
The practitioner was first registered as a pharmacist in New South Wales on 7 December 2011.
During the period of the events that are the subject of the complaints ("relevant period"), the practitioner the co-owner of the David Wilson Day Night Chemist at Kirrawee ("the Pharmacy"). The other co-owner was the practitioner's husband, Mr Dillan Lal ("Lal").
COMPLAINT ONE
is guilty of unsatisfactory professional conduct under section 139B(1)(a) of the National Law in that the practitioner has 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.
BACKGROUND TO COMPLAINT ONE
This complaint relates to the practitioner's supply of restricted drugs to Patients A to H.
Annexures A to H to this Complaint identify drugs dispensed by the practitioner, Lal and other employees at the Pharmacy during the relevant period to Patients A to H respectively. Drugs dispensed by the practitioner are highlighted in yellow.
The drugs identified in Annexures A to H are in the following categories:
(i) drugs of addiction within the meaning of the Poisons and Therapeutic Goods Act 1966 (NSW) (PTGA), being drugs contained in Schedule 8 of the Poisons List proclaimed under section 8 of the PTGA (Schedule 8 drugs); and
(ii) prescribed restricted substances within the meaning of the PTGA, being drugs contained in Appendix D of the Poisons and Therapeutic Goods Regulation 2008 (NSW) (PTGR) (Schedule 4D drugs).
For the purposes of the particulars set out below, the recognised therapeutic standard of what was appropriate in the circumstances includes:
(i) the Australian Medicines Handbook as in force at the relevant time;
(ii) the Product and Consumer Medicine Information published by the Therapeutic Goods Association for the relevant drug at the relevant time; and
(iii) the NSW Ministry of Health Guidelines for prescribing flunitrazepam and alprazolam issued March 2013.
PARTICULARS OF COMPLAINT ONE
Particulars 2, 3, 5, 6, 8, 9 and 10 are relied upon as constituting unsatisfactory professional conduct individually or in combination with the other particulars. Particulars 1, 2, 3, 4 and 7 are relied upon as constituting unsatisfactory professional conduct only in combination with the other particulars.
Patient A
1. Between 25 July 2016 14 October 2015 and 15 March 2018, the practitioner supplied to Patient A a Schedule 8 drug (oxycodone) dispensed as set out in Annexure A:
(a) in quantities that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances, contrary to clause 109 of the PTGR;
(b) when Patient A was being supplied concurrently by the Pharmacy with benzodiazepines (diazepam) dispensed as set out in Annexure A;
(c) knowing that Patient A had an opioid dependence problem;
(d) in circumstances in which the prescriptions presented included non-Pharmaceutical Benefits Scheme (PBS) (private) prescriptions, when oxycodone was part of the PBS; and
(e) by reason of subparagraphs (a) to (d) above, in circumstances in which the practitioner knew or should reasonably have known that the supplies presented a risk to the patient's health and safety or were at risk of misuse or diversion, contrary to guidelines 1 and 2 of the Pharmacy Board of Australia Guidelines for Dispensing of Medicines (Dispensing Guidelines).
Patient B
2. Between 25 July 2016 8 June 2016 and 29 April 2018, the practitioner supplied to Patient B a Schedule 8 drug (oxycodone) dispensed as set out in Annexure B:
(a) in quantities that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances, contrary to clause 109 of the PTGR;
(b) when Patient B was being supplied concurrently by the Pharmacy with another Schedule 8 drug (alprazolam) and benzodiazepines (diazepam) dispensed as set out in Annexure B;
(c) in a pattern and quantities that, by themselves or in combination with the alprazolam and benzodiazepines being supplied to Patient B, should have indicated to the practitioner that the patient was or was at risk of becoming drug dependent;
(d) in circumstances in which the prescriptions presented included non-PBS (private) prescriptions, when oxycodone was part of the PBS; and
(e) by reason of subparagraphs (a) to (d) above, in circumstances in which the practitioner knew or should reasonably have known that the supplies presented a risk to the patient's health and safety or were at risk of misuse or diversion, contrary to guidelines 1 and 2 of the Dispensing Guidelines.
3. Between 25 July 2016 8 June 2016 and 29 April 2018, the practitioner supplied to Patient B a Schedule 8 drug (alprazolam) dispensed as set out in Annexure B:
(a) in quantities that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances, contrary to clause 109 of the PTGR;
(b) when Patient B was being supplied concurrently by the Pharmacy with another Schedule 8 drug (oxycodone) and benzodiazepines (diazepam) dispensed as set out in Annexure B;
(c) in a pattern and quantities that, by themselves or in combination with the oxycodone and benzodiazepines being supplied to Patient B, should have indicated to the practitioner that the patient was or was at risk of becoming drug dependent;
(d) in circumstances in which the prescriptions presented included non-PBS (private) prescriptions, when alprazolam was part of the PBS; and
(e) by reason of subparagraphs (a) to (d) above, in circumstances in which the practitioner knew or should reasonably have known that the supplies presented a risk to the patient's health and safety or were at risk of misuse or diversion, contrary to guidelines 1 and 2 of the Dispensing Guidelines.
Patient C
4. Between 25 July 2016 24 October 2015 and 5 September 2018, the practitioner supplied to Patient C a Schedule 8 drug (oxycodone) dispensed as set out in Annexure C:
(a) when Patient C was being supplied concurrently by the Pharmacy with benzodiazepines (diazepam) dispensed as set out in Annexure C;
(b) in a pattern and quantities that, in combination with the benzodiazepines being supplied to Patient C, should have indicated to the practitioner that the patient was or was at risk of becoming drug dependent;
(c) in circumstances in which the prescriptions presented included non-PBS (private) prescriptions, when oxycodone was part of the PBS; and
(d) by reason of subparagraphs (a) to (c) above, in circumstances in which the practitioner knew or should reasonably have known that the supplies presented a risk to the patient's health and safety or were at risk of misuse or diversion, contrary to guidelines 1 and 2 of the Dispensing Guidelines.
Patient D
5. Between 23 April 2017 and 17 December 2018, the practitioner supplied to Patient D a Schedule 8 drug (oxycodone) dispensed as set out in Annexure D:
(a) in quantities that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances, contrary to clause 109 of the PTGR;
(b) when Patient D was being supplied concurrently by the Pharmacy with benzodiazepines (diazepam) dispensed as set out in Annexure D;
(c) in a pattern and quantities that, by themselves or in combination with the benzodiazepines being supplied to Patient D, should have indicated to the practitioner that the patient was or was at risk of becoming drug dependent;
(d) in circumstances in which the prescriptions presented included non-PBS (private) prescriptions, when oxycodone was part of the PBS; and
(e) by reason of subparagraphs (a) to (d) above, in circumstances in which the practitioner knew or should reasonably have known that the supplies presented a risk to the patient's health and safety or were at risk of misuse or diversion, contrary to guidelines 1 and 2 of the Dispensing Guidelines.
Patient E
6. Between 22 April 2017 and 29 August 2018, the practitioner supplied to Patient E a Schedule 8 drug (oxycodone) dispensed as set out in Annexure E:
(a) in quantities that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances, contrary to clause 109 of the PTGR;
(b) when Patient E was being supplied concurrently by the Pharmacy with another Schedule 8 drug (fentanyl) and benzodiazepines (diazepam) dispensed as set out in Annexure E; and
(c) in a pattern and quantities that, by themselves or in combination with the fentanyl and benzodiazepines being supplied to Patient E, should have indicated to the practitioner that the patient was or was at risk of becoming drug dependent;
(d) by reason of subparagraphs (a) to (c) above, in circumstances in which the practitioner knew or should reasonably have known that the supplies presented a risk to the patient's health and safety or were at risk of misuse or diversion, contrary to guidelines 1 and 2 of the Dispensing Guidelines.
7. Between 22 April 2017 and 29 August 2018, the practitioner supplied to Patient E a Schedule 8 drug (fentanyl) dispensed as set out in Annexure E in quantities that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances, contrary to clause 109 of the PTGR.
Patient F
8. Between 23 April 2017 and 17 December 2018, the practitioner supplied to Patient F a Schedule 8 drug (oxycodone) dispensed as set out in Annexure F:
(a) in quantities that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances, contrary to clause 109 of the PTGR;
(b) when Patient F was being supplied concurrently by the Pharmacy with benzodiazepines (diazepam, clonazepam, nitrazepam, oxazepam and temazepam) dispensed as set out in Annexure F;
(c) knowing that Patient F had a problem with diazepam use and a tendency to misuse her medication;
(d) in circumstances in which the prescriptions presented included non-PBS (private) prescriptions, when oxycodone was part of the PBS; and
(e) by reason of subparagraphs (a) to (d) above, in circumstances in which the practitioner knew or should reasonably have known that the supplies presented a risk to the patient's health and safety or were at risk of misuse or diversion, contrary to guidelines 1 and 2 of the Dispensing Guidelines.
Patient H
9. Between 25 July 2016 31 March 2016 and 29 July 2018, the practitioner supplied to Patient H a Schedule 8 drug (oxycodone) dispensed as set out in Annexure H:
(a) in quantities that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances, contrary to clause 109 of the PTGR;
(b) when Patient H was being supplied concurrently by the Pharmacy with benzodiazepines (diazepam) dispensed as set out in Annexure H;
(c) in circumstances in which the prescriptions presented included non-PBS (private) prescriptions, when oxycodone was part of the PBS; and
(d) by reason of subparagraphs (a) to (c) above, in circumstances in which the practitioner knew or should reasonably have known that the supplies presented a risk to the patient's health and safety or were at risk of misuse or diversion, contrary to guidelines 1 and 2 of the Dispensing Guidelines.
10. Between 25 July 2016 31 March 2016 and 29 July 2018, the practitioner supplied to Patient H a Schedule 4D drug (diazepam) dispensed as set out in Annexure H:
(a) in quantities that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances, contrary to clause 54 of the PTGR;
(b) when Patient H was being supplied concurrently by the Pharmacy with a Schedule 8 drug (oxycodone) dispensed as set out in Annexure H;
(c) in circumstances in which the prescriptions presented included non-PBS (private) prescriptions, when oxycodone was part of the PBS; and
(d) by reason of subparagraphs (a) to (c) above, in circumstances in which the practitioner knew or should reasonably have known that the supplies presented a risk to the patient's health and safety or were at risk of misuse or diversion, contrary to guidelines 1 and 2 of the Dispensing Guidelines.
COMPLAINT TWO
The practitioner is guilty of unsatisfactory professional conduct under section 139B(1)(a) or (l) of the National Law in that the practitioner:
(i) has 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; or
(ii) has engaged in other improper or unethical conduct relating to the practice or purported practice of pharmacy.
BACKGROUND TO COMPLAINT TWO
This complaint relates to the practitioner's failure to maintain proper oversight of the supply of Schedule 8 and Schedule 4D drugs at the Pharmacy in her capacity as pharmacist proprietor.
Annexures A to I record, in the 'dispensing pharmacist initials' column, the initials of the person recorded by the Pharmacy as dispensing Schedule 8 and Schedule 4D drugs to Patients A to I respectively during the relevant period.
'N/A' indicates that no person was recorded by the Pharmacy as dispensing pharmacist. The initials 'MS', 'KH' and 'EG' are initials of dispensary technicians, not pharmacists.
PARTICULARS OF COMPLAINT TWO
These particulars are relied upon individually or in combination.
1. The practitioner failed to take adequate steps to ensure that the quantities of Schedule 8 and Schedule 4D drugs supplied to Patients A to H during the relevant period by other pharmacists at the Pharmacy, dispensed as set out in Annexures A to H respectively:
(a) accorded with the recognised therapeutic standard of what was appropriate in the circumstances, as required by clauses 54 and 109 of the PTGR; and
(b) were clinically appropriate and consistent with the safety of the patient, as required by guidelines 1 and 2 of the Dispensing Guidelines,
contrary to the Pharmacy Board of Australia Guidelines for Proprietor Pharmacists (Proprietor Guidelines).
2. The practitioner failed to ensure that the name of the dispensing pharmacist was recorded as the supplier of all Schedule 4D drugs supplied by the Pharmacy to Patients A to I during the relevant period, as required by clause 55(1)(d) of the PTGR, contrary to the Proprietor Guidelines.
3. The practitioner failed to ensure that the name of the dispensing pharmacist was recorded as the supplier of all Schedule 8 drugs supplied by the Pharmacy to Patients A to I during the relevant period, as required by clause 113(1)(d) of the PTGR, contrary to the Proprietor Guidelines.
4. The practitioner failed to record, or ensure that the Pharmacy had records of:
(a) adequate notes of all conversations with prescribing practitioners in relation to the supply of Schedule 8 and Schedule 4D drugs to Patients A to H during the relevant period; and
(b) adequate notes of the clinical reasons for the concurrent supply of high doses of Schedule 8 drugs and benzodiazepines to Patients A to H,
contrary to clause 8.45(a) of the Pharmacy Board of Australia Code of Conduct (Code of Conduct) and the Proprietor Guidelines.
COMPLAINT THREE
The practitioner is guilty of unsatisfactory professional conduct under section 139B(1)(a), (b) or (l) of the National Law in that the practitioner:
(i) has 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;
(ii) has contravened a provision of the National Law; or
(iii) has engaged in other improper or unethical conduct relating to the practice or purported practice of pharmacy.
BACKGROUND TO COMPLAINT THREE
This complaint relates to the practitioner's failure to report, or take adequate steps to protect patients from, conduct engaged in by other health practitioners that presented a risk to the patients' health and safety.
PARTICULARS OF COMPLAINT THREE
Particular 1 is relied upon individually for the purposes of section 139B(1)(b) of the National Law. Particulars 1 and 2 are relied upon individually or in combination for the purposes of section 139B(1)(a) or (l) of the National Law.
1. The practitioner:
(a) held or, by reason of the matters in the particulars of complaints one and two, should have held a reasonable belief that the prescribing practitioners for each of Patients A to H were placing the public at risk of harm by practising medicine in a way that constituted a significant departure from accepted professional standards; and
(b) failed to notify the Australian Health Practitioner Regulation Agency (AHPRA) of those matters, as required by section 1410(2) of the National Law.
2. The practitioner failed to take adequate steps to protect Patients A to H from being placed at risk of harm by the conduct of their prescribing practitioners, contrary to clause 6.3 of the Code of Conduct, including by:
(a) asking adequate questions of their prescribing practitioners as to the appropriateness of the quantities of Schedule 8 and Schedule 4D drugs (individually or in combination) being prescribed for those patients;
(b) taking adequate steps to raise with the patients or their prescribing practitioners the possibility of referral to a qualified pain or addiction specialist or a drug dependence programme;
(c) seeking to confirm that the prescribing practitioner for Patient A had an authority to prescribe oxycodone to Patient A as required by section 28(3) of the PTGA; or
(d) seeking to confirm that the prescribing practitioner for Patient B had an authority to prescribe alprazolam to Patient B for a period exceeding two months, as required by section 28(2)(a) of the PTGA.
COMPLAINT FOUR
The practitioner is guilty of professional misconduct under section 139E of the National Law in that the practitioner has engaged in:
(i) unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or
(ii) 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.
PARTICULARS OF COMPLAINT FOUR
1. Complaints one and two are relied on individually.
2. Complaints one to three are relied on in combination."
We heard these proceedings concurrently with an Amended Complaint filed by the applicant against the respondent's co-proprietor of the pharmacy, Dillan Lal, with evidence in the one set of proceedings being evidence in the other, except to the extent that this would unduly prejudice the other respondent.
By letter dated 1 December 2021 addressed to the applicant's solicitor, Meridian Lawyers wrote on behalf of their "clients" being both respondents confirming that each had received a copy of the Complaints filed by the applicant and stating that "As they both wish to no longer practice as pharmacists, [they] have elected to not attend the hearing of the Complaints so as to mount a defence."
We proceeded to conduct the hearing of both matters on an ex parte basis, requiring the applicant to prove its case. We were informed during the course of the hearing that the Amended Complaint had been served on the respondents.
During the course of the hearing the applicant tendered a large volume of documentary material, and we shall refer to such parts of this as are relevant to our determination of the proceedings during the course of these reasons. In addition, Dr Helen Benson who had been retained by the applicant to provide expert advice gave sworn oral evidence.
These reasons deal only with the circumstances of this respondent. We shall publish a separate Decision with respect to the proceedings brought against Dillan Lal.
For completeness we note that because of the gravity of the allegations made against the respondent the applicant bears an enhanced onus of proof of any factual matter adverse to the interests of the respondent. The onus of proof remains the civil standard namely on the balance of probabilities, but consistent with the jurisprudence established in this Tribunal in dealing with matters of this kind we approach the determination of the proceedings on the basis that as to any such matter we must be "comfortably satisfied" that it has been established on the balance of probabilities.
[2]
Factual background
The narration which follows is based on the evidentiary material provided to us. It should be read in conjunction with each of the particulars of each of the complaints which are set out above.
The applicant retained Dr Helen Benson, a pharmacist with many years' experience and expertise who is a lecturer in Pharmacy Practice at UTS. Dr Benson was provided with extensive documentation including, but not limited to, information provided by NSW Police, a Pharmaceutical Regulatory Unit (PRU) investigation report, submissions made by the respondent in response to the PRU complaint to the applicant, and oral evidence given by the respondent during the course of a section 150 hearing. Dr Benson also had available to her a schedule of dispensing prepared by the applicant with respect to each of the patients named in the application. We accept and rely upon the expert opinion of Dr Benson.
[3]
Patient A
During the period 14 October 2015 to 15 March 2018 the following medication was dispensed to this patient from the pharmacy of which the respondent became a joint proprietor on 25 July 2016:
"1410 oxycodone 20 mg
2688 oxycodone 40 mg
2166 oxycodone 80 mg"
The bulk of these prescriptions were written by Dr Carlos Tahuil Ochoa, with others prescribed by Drs Christopher Nguyen, Shirjeel Malik, Nasheeth Usmani, and Masum Alam.
The respondent commenced dispensing for this patient from 15 December 2017. She personally dispensed 28 oxycodone 40 mg and 140 oxycodone 80 mg to this patient.
Multiple prescriptions for oxycodone in various strengths were regularly dispensed from the pharmacy to this patient on the same day.
On 29 August 2016, 23 November 2016, 1 and 28 December 2016, 11 and 27 January 2017, 6, 11 and 23 February 2017 the pharmacy dispensed multiple scripts to this patient consisting of 28 oxycodone 20 mg, 28 oxycodone 40 mg and 28 oxycodone 80 mg. The dosage differed but the majority indicated that each tablet should be taken 1 x 4 times a day. From 13 March 2017 the typical multiple dispensing changed by the addition of one more prescription for 28 oxycodone 40 mg. The dosage of each prescription was initially recorded as one to be taken four times a day. The second script of 28 oxycodone 40 mg was habitually written as a private script, the remaining being Pharmaceutical Benefit Scheme (PBS) scripts. From 31 March 2017 onwards the dosage changed to one tablet to be taken four times a day to be dispensed two to three times each week. This pattern of the dispensing of multiple prescriptions continued until December 2017 interspersed with many other instances of the frequent and regular dispensing of oxycodone 80 mg to this patient by the respondent and others in his pharmacy.
Four of these typical prescriptions were dispensed by a pharmacist in the respondent's pharmacy on 13 March 2017. Even allowing for this extraordinarily high dosage which should have lasted the patient for seven days, the pharmacy dispensed the same multiple prescriptions to this patient on 16, 22 and 31 March 2017. Even though the dosage had changed the same multiple prescriptions were dispensed from the respondent's pharmacy on 6, 13, 20 and 26 April 2017 and on 3, 10, 17, 24 and 30 May 2017. The pharmacy records demonstrate further dispensing of these same multiple prescriptions by the pharmacists in this pharmacy to this patient until December 2017. This pattern is interspersed with many other instances of the frequent and regular dispensing of oxycodone 80 mg to this patient by the respondent and others in her pharmacy.
On 33 occasions the interval between each supply of oxycodone was between two to four days, including dispensing by the respondent on 22 January 2018 and on 2 and 5 February 2018.
In her expert report Dr Benson noted that 53 of the 230 oxycodone prescriptions dispensed to this patient were private prescriptions. Furthermore, the identity of the dispensing pharmacist was not recorded for 37 of these prescriptions.
Dr Benson said that the supply of oxycodone to Patient A was in breach of clause 109 of the Poisons and Therapeutic Goods Regulation 2008 (NSW) (PTGR) which precluded the pharmacy from supplying oxycodone, being a Schedule 8 drug in a quantity, or for a purpose, that did not accord with the recognised therapeutic standard of what was appropriate in circumstances. Even though some of the prescriptions noted that the patient was to be provided with doses four times a day, there was no supporting documentation in the pharmacy records which would corroborate that this occurred.
In responding to the PRU investigation report concerning this patient the respondent, jointly with her co-proprietor Dillan Lal, described the patient as difficult to manage with a number of comorbidities. She said she had discussed the patient's circumstances with his treating doctors who confirmed that he should continue to take high opioid doses with the aim of gradually reducing the dosage. She relied on the integrity and expertise of the doctors concerned.
With regard to a submission made by the respondent to the Pharmacy Council of NSW (Pharmacy Council) concerning increased doses prescribed for this patient, Dr Benson referred to the Australian Medicines Handbook (21st ed, 2020) and observed that it was appropriate to increase doses in the case of opioid tolerance but an increase in dosing frequency should be avoided. She said "As OxyContin is a sustained release formulation it should be dosed twice daily. By increasing the frequency of dosing the patient is at risk of cumulative toxicity which may be fatal."
Dr Benson referred to an admission made by the respondent that she knew that Patient A was opioid dependent. She said that this increased the patient's risk of opioid related harm. Furthermore, the fact that 23% of prescriptions for this patient were prescribed privately "should have raised a red flag to Ms Patel as patients with clear addiction and tolerance issues should be managed with PBS authority prescriptions that are tracked and registered with Medicare to reduce the chance of doctor shopping." She thought that the respondent should have discussed the issue of private prescriptions with Dr Ochoa and that they could result in doctor shopping and patient harm. If Dr Ochoa had failed to respond appropriately this would have been an indication that his practice significantly departed from professional standards and posed a risk of significant harm to the public. By reason of the respondent's duty of care concerning the welfare of patients incorporated in clause 6.3 of the Pharmacy Board of Australia, "Code of Conduct" (March 2014) Dr Benson said that if Dr Ochoa had not changed his practice concerning the issue of private prescriptions for oxycodone, Dr Ochoa should have been reported to the Australian Health Practitioner Regulation Agency (AHPRA) by the respondent in accordance with the mandatory reporting guidelines, which we note are to be found in section 141(2) of the National Law:
141 Mandatory notifications by health practitioners other than treating practitioners
(1) This section applies to a registered health practitioner (the first health practitioner) who, in the course of practising the first health practitioner's profession, forms a reasonable belief that -
(a) another registered health practitioner (the second health practitioner) has behaved in a way that constitutes notifiable conduct; or
…..
(2) The first health practitioner must, as soon as practicable after forming the reasonable belief, notify the National Agency of the second health practitioner's notifiable conduct or the student's impairment.
Note -
See section 237 which provides protection from civil, criminal and administrative liability for persons who, in good faith, make a notification under this Law. Section 237(3) provides that the making of a notification does not constitute a breach of professional etiquette or ethics or a departure from accepted standards of professional conduct and nor is any liability for defamation incurred.
…
Dr Benson expressed the opinion that the supply of oxycodone to Patient A by the pharmacy demonstrated that the respondent's oversight as co-proprietor fell significantly below the standard reasonably expected of a practitioner with equivalent training or experience. She said the pharmacy should have refused to dispense the oxycodone prescriptions and should have asked that the patient be referred for management of opioid dependence as the patient was at significant risk of harm. In this regard Dr Benson referred specifically to the provisions of clause 6.3 of the Code of Conduct issued by the Pharmacy Board of Australia:
"6.3 Practitioner performance
The welfare of patients or clients may be put at risk if a practitioner is performing poorly. If there is a risk, good practice involves:
a) complying with statutory reporting requirements, including those under the National Law
b) recognising and taking steps to minimise the risks of fatigue, including complying with relevant state and territory occupational health and safety legislation
c) if a practitioner knows or suspects that they have a health condition that could adversely affect judgement or performance, following the guidance in Section 9.2 Practitioner health
d) taking steps to protect patients or clients from being placed at risk of harm posed by a colleague's conduct, practice or ill health
e) taking appropriate steps to assist a colleague to receive help if there are concerns about the colleague's performance or fitness to practise, and
f) if a practitioner is not sure what to do, seeking advice from an experienced colleague, the employer/s, practitioner health advisory services, professional indemnity insurers, the National Boards or a professional organisation."
Dr Benson also referred to clause 113 of the PTGR which provides that a pharmacist who supplies a drug of addiction on prescription must record the name of the person by whom the drug was supplied which would include entering the initials of the dispensing pharmacist in the dispensing software. She noted that the records provided demonstrated that on 37 occasions the initials of the dispensing pharmacist were not recorded for the dispensing of oxycodone to this patient. As a co-proprietor the respondent had a responsibility to ensure that pharmacists employed in her pharmacy were complying with all legal dispensing records.
Dr Benson also considered the supply of diazepam to Patient A during the period 14 October 2015 to 15 March 2018 being a total of 354 x 5 mg tablets. Even though the identity of the pharmacists dispensing this medication was not recorded, this was information which would have been available to the respondent through the records of this patient kept in the pharmacy computer system. Dr Benson said that, even though the dispensing of this quantity of diazepam over that time was not excessive, dispensing it concurrently with high doses of oxycodone increased the risk of central nervous system (CNS) depression and sedation and increased the risk of harm to the patient.
The failure to record the identity of the dispensing pharmacist was in breach of Part 3, Division 5, clause 55(1)(d) of the PTGR.
The supply of diazepam in all the circumstances was in breach of clause 54 of the PTGR:
54 Quantity and purpose of supply to be appropriate
An authorised practitioner or pharmacist must not supply any restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Maximum penalty - 20 penalty units or imprisonment for 6 months, or both.
In all the circumstances Dr Benson concluded that the respondent by reason of her overall responsibility as proprietor for oversight of the pharmacy had breached the provisions of this clause in that the pharmacy had supplied a restricted substance in a quantity that did not accord with the recognised therapeutic standard of what was appropriate in the circumstances.
Dr Benson concluded that by reason of each of these matters the respondent's conduct fell significantly below the standard reasonably required of a pharmacist with equivalent training or experience.
[4]
Patient B
The pharmacy records show that during the period 8 June 2016 to 29 April 2018 this patient was dispensed a total of 1162 oxycodone 80 mg. The respondent personally dispensed 28 oxycodone 80 mg on 19 November 2017 and on 10 February 2018. On six occasions during this period the interval between each supply of 28 tablets was between two to five days. Of the 38 oxycodone prescriptions dispensed to this patient three were private prescriptions.
Dr Benson noted that this patient was prescribed a sustained-release preparation with twice daily dosing and therefore each prescription of 28 tablets should have lasted the patient 14 days. On 1 April 2017 the pharmacy dispensed 112 tablets from a private prescription which should have lasted the patient until 26 May 2017. However, the patient collected a further 28 tablets on 20 April 2017, 3, 17 and 20 May 2017. The patient effectively received a double supply during this two-month period.
It was the opinion of Dr Benson that the pharmacists involved should have refused to dispense the oxycodone prescriptions that were being collected early and should have asked that the patient be referred for management of opioid dependence as the patient was at significant risk of harm. She said that the care and treatment of this patient by the pharmacy fell significantly below the standard reasonably expected of pharmacists with equivalent training or experience, with consequences for the respondent with respect to her general oversight of the pharmacy.
This patient was also supplied 1368 alprazolam 2 mg through the pharmacy during the period 8 June 2016 to 29 April 2018. The respondent personally dispensed 50 alprazolam 2 mg. Of the 29 alprazolam prescriptions dispensed with the pharmacy, 27 were private prescriptions.
Dr Benson noted that an authority from the NSW Ministry of Health is required to prescribe alprazolam or flunitrazepam for a drug dependent person or a non-drug dependent person continuously for more than two months. She saw no evidence that Dr Ochoa was in possession of this authority and the predominant use of private prescriptions was evidence to her that it was unlikely that he held that authority. The pharmacy dispensed this medication to the patient on 31 May 2017 which was 26 days early and would have meant a potential oversupply of 52 tablets. On 17 November 2017 the pharmacy dispensed 100 alprazolam 2 mg tablets which should have lasted the patient for 50 days, giving sufficient supply until 7 January 2018. However, the pharmacy supplied a further 50 tablets on 8 December 2017.
On this history Dr Benson was concerned that the patient was either taking a higher dose than had been prescribed or was diverting medication. She assessed the pharmacy's care and treatment of this patient as falling significantly below the standard reasonably expected of pharmacists with equivalent training or experience.
Dr Benson noted an explanation provided by the respondent that the patient had been prescribed additional dosage of alprazolam because of the need to supply personal medication during a prolonged hospitalisation. Dr Benson rejected this explanation as being appropriate. Firstly, she said that alprazolam is a drug at high risk of misuse, diversion and abuse and its supply in these quantities may pose a risk to the public. Moreover, most hospitals in Australia have pharmacies and at most a patient would only require their own medication for a short period.
Again, Dr Benson expressed the opinion that in this regard the respondent's care and treatment of this patient through the pharmacy of which she was a co-proprietor fell significantly below the standard reasonably expected of a pharmacist with equivalent training or experience.
During the period the respondent's pharmacy supplied 100 diazepam 5 mg to this patient. The identity of the pharmacists was not recorded, as was required by clause 55(1)(d) of the PTGR. In addition, the combination of diazepam as a benzodiazepine to this patient concurrently with high doses of OxyContin and alprazolam increased the risk of CNS depression and sedation and may have been potentially fatal in overdose, and increased the risk of harm to the patient. This provided an additional reason why the pharmacy's care and treatment of this patient fell significantly below the standard reasonably expected of pharmacists with equivalent training or experience with resultant consequences for the respondent as co-proprietor.
[5]
Patient C
During the period 24 October 2015 to 5 September 2018 this patient was dispensed a total of 28 oxycodone 30 mg, 420 oxycodone 40 mg and 2478 oxycodone 80 mg. The respondent was personally responsible for dispensing 84 oxycodone 80 mg.
Having assessed the dispensing records of the pharmacy Dr Benson concluded that:
"multiple pharmacists working at the pharmacy were involved in repeatedly supply of [the patient's] oxycodone at intervals less than 14 days and that this may have led to the potential misuse or the diversion of this medication."
Dr Benson concluded that in relation to the oversight of the supply of oxycodone the respondent's supervision and oversight of the pharmacists in the practice fell below the standard reasonably expected of a proprietor of a pharmacy with equivalent training or experience.
Dr Benson was also asked to comment on the dispensing of diazepam to this patient. Between 24 August and 21 September 2017, a period of 28 days, the patient was supplied 150 tablets which should have been sufficient for almost 6 months' supply at a dosage of 5 mg a day. However, the patient was dispensed a further 50 tablets on 10 November 2017. During the period 24 October 2015 to 5 September 2018 the patient was dispensed a total of 650 diazepam 5 mg. The identity of the dispensing pharmacists was not recorded, in breach of clause 55(1)(d) of the PTGR. Dr Benson concluded that in relation to the supply of diazepam the respondent's supervision and oversight of the pharmacists in the practice fell below the standard reasonably expected of a proprietor of a pharmacy with equivalent training or experience.
Dr Benson also commented on the concurrent supply of all medication to this patient. Dr Benson noted that this combination has "additive CNS depressive and sedative effects and are dangerous in overdose", that the respondent as an experienced pharmacist should have known the potential danger that this combination of these medications posed to this patient and should have raised and documented these concerns. In failing to do so her conduct fell below the standard reasonably required of a pharmacy proprietor with equivalent training or experience.
[6]
Patient D
During the period 23 April 2017 to 17 December 2018 this patient was dispensed a total of 100 oxycodone 5 mg, 140 oxycodone 10 mg, 28 oxycodone 15 mg and 5133 oxycodone 20 mg. The respondent was personally responsible for dispensing 133 oxycodone 20 mg.
On 36 occasions during this period the interval between each supply of OxyContin 20 mg was between three and five days. On 45 occasions during this period the interval between each supply of Oxynorm (either 20×20 mg capsules or 20×10 mg +20×5 mg capsules) was only three days.
Of the 186 oxycodone prescriptions dispensed to this patient, 180 were private prescriptions.
Dr Benson noted the following matters of concern arising out of the dispensing history for this patient:
1. there were increasing doses of Oxynorm and OxyContin over time which indicated the patient was at risk of dependence and tolerance and an increased risk of misuse or diversion of this medication
2. OxyContin is usually dosed twice daily because it is a modified release formulation. There were incidents of increased prescribing frequency culminating in four times a day. This created a risk of cumulative toxicity which might be fatal
3. the fact that 97% of the prescriptions were prescribed privately should have raised a red flag to the respondent that a patient with clear addiction and tolerance issues should be managed with PBS authority prescriptions that are tracked and registered with Medicare to reduce the chance of doctor shopping
4. the respondent should have discussed the concerns raised by the use of private prescriptions with the prescriber, Dr Malik, and reported the matter to AHPRA in the absence of a satisfactory explanation.
In all the circumstances Dr Benson said that the respondent's conduct fell below the standard reasonably required of a pharmacy proprietor with equivalent training or experience.
Dr Benson also noted that this patient was dispensed during this period 500 diazepam 5 mg. All 10 prescriptions were private, and none of the identities of the prescribing pharmacists was entered in the pharmacy records. For reasons advanced with respect to her consideration of previous patients, Dr Benson was of the opinion that the concurrent supply of this medication with OxyContin posed a danger to the patient and should have been resisted. She was also concerned about the high incidence of private prescriptions and the failure to note the identity of the dispensing pharmacists. Each of these matters indicated that the respondent's conduct fell below the standard reasonably required of a pharmacy proprietor with equivalent training or experience.
[7]
Patient E
During the period 22 April 2017 to 29 August 2018 this patient was dispensed a total of 2260 oxycodone 5 mg. The respondent was personally responsible for dispensing 100 of these tablets. On four occasions during this period the interval between each supply of oxycodone was only one day. On another 27 occasions the interval between each supply was only two days.
Dr Benson noted from the dispensing history that this patient was prescribed 5 mg of oxycodone four times a day increasing to 10 mg six times a day by July 2018. She noted that the increasing oxycodone doses over time might indicate that the patient was developing tolerance and dependence to oxycodone or alternatively that the medication was being diverted or misused. Dr Benson concluded that in relation to the supply of oxycodone to this patient through the pharmacy, the care and treatment of the patient fell significantly below the standard reasonably expected of pharmacists with equivalent training or experience with consequences for the respondent as a proprietor.
This patient was also dispensed a total of 110 fentanyl patches 75 mcg/hr through the pharmacy during the same period.
Dr Benson noted that each supply of five fentanyl patches should have been sufficient to last the patient 15 days. By supplying the patches at intervals of between six and eight days there was a risk that the excess patches could be misused or diverted posing a risk to the community. She said that this supply through the pharmacy demonstrated that the care and treatment of the patient in this regard fell below the standard reasonably expected of pharmacists of equivalent training or experience with consequences for the respondent as proprietor.
Dr Benson said that even though the respondent was only sporadically supplying fentanyl to this patient, each time she dispensed it there was an opportunity and professional obligation for the respondent to review the complete dispensing history of the patient. She said that the respondent should have raised concerns about the pattern of fentanyl dispensing for this patient. Accordingly, the respondent's oversight of this supply fell below the standard reasonably expected of a practitioner with equivalent training or experience.
During the same period this patient was dispensed a total of 1100 diazepam 5 mg and 100 diazepam 2 mg. None of the dispensing records disclose the name of the dispensing pharmacist.
The prescribed dose was one tablet twice daily when required resulting in a bottle of 50 tablets lasting the patient at least 25 days. On two occasions the interval between each supply was between three and four days.
Dr Benson said that that the combination of fentanyl, oxycodone and diazepam dispensed to this patient could create additional CNS depressive and sedative effects. Dr Benson thought that the pattern of this patient's medication collection suggested medication dependence. The pharmacists concerned should have raised these matters with the patient and documented those concerns. Their failure to do so indicated that their oversight by the respondent fell below the standard reasonably required of a proprietor pharmacist with equivalent training or experience.
[8]
Patient F
During the period 19 February 2016 to 31 October 2018 this patient was dispensed from the pharmacy a total of 7362 oxycodone 5 mg and 1646 oxycodone 40 mg plus naloxone 20 mg. The respondent personally dispensed 960 oxycodone 5 mg and 140 oxycodone 40 mg plus naloxone 20 mg. Of the 78 oxycodone prescriptions, 30 were private. Of the 58 oxycodone plus naloxone prescriptions, 31 were private.
In submissions made to the Pharmacy Council the respondent has acknowledged that this patient was known to be an opioid and benzodiazepine dependent person under the care of a pain specialist whom she nominated as Dr Gorman. Dr Benson noted that on 2 March 2017 Dr Gorman prescribed 360 oxycodone 5 mg tablets to this patient which were dispensed on 2, 9 and 17 March, 2017. Dr Benson said that the fact that these prescriptions were private and dated on the same day should have raised a red flag with the pharmacy. This pattern was repeated on 22 August 2017 when Dr Gorman again prescribed 360 oxycodone 5 mg which were collected from the pharmacy on three occasions. This pattern was also repeated with respect to the other prescriptions issued by Dr Gorman for oxycodone plus naloxone all of which were private.
Dr Benson said that the pharmacists, including the respondent, had a duty to question and, if deemed appropriate, report the prescribing practices of Dr Gorman. The fact that he prescribed large quantities of oxycodone on multiple private prescriptions on the same day was a clear breach of prescribing practices and the respondent was required by clause 6.3 of the Pharmacy Board Code of Conduct to take steps to protect patients from being placed at risk of harm posed by the conduct of a health practitioner. We have previously set out the provisions of this clause.
In failing to do so Dr Benson said that the respondent's conduct fell significantly below the standard reasonably required of a proprietor pharmacist and a pharmacist with equivalent training or experience. She should have been alerted to the "red flags" which were present in the circumstances of this patient.
This patient was also dispensed during the same period 3308 diazepam 5 mg, 600 clonazepam 0.5 mg, 50 nitrazepam 5 mg, 100 oxazepam 15 mg and 75 temazepam 10 mg. None of the dispensing records disclose the name of the dispensing pharmacist.
Dr Benson noted that the combination of oxycodone and these benzodiazepine drugs had additive CNS depressive and sedative effects and was not therapeutically appropriate. The dispensing of these drugs should have been tightly controlled by insisting that the patient see only one medical practitioner who issued only PBS prescriptions and that the patient be dosed using a staged supply or other similar supervised arrangements. In that the respondent would have been aware of the concurrent supply of multiple benzodiazepine drugs in addition to oxycodone, Dr Benson expressed the opinion that the respondent's conduct fell significantly below the standard expected of a pharmacist with equivalent training or experience.
The failure of the respondent to ensure that the initials of the dispensing pharmacist were recorded in this patient's records also resulted in her conduct falling significantly below the standard reasonably required of a proprietor pharmacist with equivalent training or experience.
[9]
Patient G
During the period 17 March 2017 to 3 May 2018 this patient was dispensed from the pharmacy a total of 1640 oxycodone 5 mg, 40 oxycodone 20 mg and 168 oxycodone 40 mg. All of the prescriptions for this patient were issued by Dr Ben Balzer. No details of the dosage were entered into the pharmacy records.
In an explanation provided to the Pharmacy Council the respondent said that this patient was suffering from throat cancer. In that it was clear that a PBS authority had been issued, Dr Benson was not critical of the respondent's conduct in this regard.
However, during this period this patient was also dispensed from the pharmacy a total of 150 diazepam 5 mg, 200 nitrazepam 5 mg and 50 oxazepam 30 mg. It was the opinion of Dr Benson that the concurrent supply of these drugs with oxycodone placed this patient at risk of additive CNS depression and sedation and that the combination of multiple benzodiazepine medications was not recommended and at best represented poor prescribing practice. She said that the respondent as a proprietor had a responsibility to address and document her response to this inappropriate prescribing. As such her conduct fell significantly below the standard expected of a pharmacist with equivalent training or experience.
The respondent was also under a duty as proprietor to ensure that the dosage was entered into the pharmacy records. In that she had failed to do so, Dr Benson said that her conduct fell significantly below the standard expected of a pharmacist with equivalent training or experience.
[10]
Patient H
During the period 31 March 2016 to 29 July 2018 this patient was dispensed through the pharmacy a total of 11,260 oxycodone 5 mg. The respondent personally dispensed 1400 of these tablets commencing from 8 September 2017.
Multiple private prescriptions of 40 oxycodone 5mg tablets of up to six at a time were regularly dispensed to this patient on the same day throughout this period, including dispensing by the respondent on 8 September 2017, 1 and 12 November 2017, 6 December 2017, 31 March 2018, 4 and 10 April 2018, 18 May 2018 and 13 June 2018.
On 43 occasions during this period the interval between each supply of 40 oxycodone 5 mg tablets was between one and five days, including dispensing by the respondent on 12 November 2017, 6 December 2017, 31 March 2018, 4 and 10 April 2018, 18 May 2018 and 13 June 2018.
Of the 283 oxycodone prescriptions dispensed to this patient during this period 280 were private prescriptions. All of these prescriptions were written by Dr Ochoa.
The respondent attended an interview with delegates of the Pharmacy Council on 23 August 2018 in the course of an enquiry conducted by the Pharmacy Council under section 150 of the National Law. During those proceedings the respondent provided information to the delegates which we find illuminating in the context of the respondent's understanding of her role and responsibilities as a pharmacist and as a pharmacist proprietor. The respondent made comments to the following effect:
1. she regarded Dr Ochoa as having specialist knowledge in the treatment of chronic pain. That assessment was made on the basis that she thought Dr Ochoa saw a lot of patients who were suffering from pain and her general impression of him as being a good person
2. every time the pharmacy questioned Dr Ochoa about the dosage of drugs that he was prescribing he always provided "a clear reason" for that dosage
3. Dr Ochoa was happy to write a private prescription for OxyContin if it suited the convenience of the patient
4. upon being questioned about the use of private prescriptions and that they are expensive, the respondent acknowledged that in the case of this patient, the cost to him of the purchase of Endone on the basis of the private prescriptions written by Dr Ochoa was between $8000 and $9000 a year, when the cost of equivalent PBS prescriptions would be of the order of $1500
5. this patient preferred private prescriptions because he travelled frequently, and he could therefore have the prescription and the five repeats filled at the one time.
6. after being informed that the dispensing history for this patient was that he was dispensed from the pharmacy 240 Endone 5 mg tablets on 2, 4 9, 11, 16, 23 and 25 August 2017 "etc", she acknowledged that these dates were close together, there were no large gaps, and each supply of one month's tablets was incompatible with frequent travel. She said that the patient had informed the Pharmacy that he had a number of injuries and required pain relief. On reflection, the respondent said that the overall picture might raise "red flags". This was especially so as she understood that the patient was taking 80 mg of OxyContin twice a day. She thought that there were seven to ten other patients on the same type of regime. When it was pointed out to her that the dosage shown on the prescriptions was generally two tablets every four hours a day as directed, the respondent was unable to explain the discrepancy between her understanding of the dose the patient was taking and the dosage directions on the prescriptions. The respondent conceded that the prescriptions were not "valid" because the prescribing interval was not shown on the repeats. Although the patient was obtaining 240 tablets almost weekly, and this did not coincide with the dosage written on the prescriptions, nevertheless she relied on what Dr Ochoa had said verbally about the true dosage being taken by the patient. In making that statement to the delegates, the respondent conceded that if the patient was taking 240 tablets every seven days that would amount to 34 tablets a day on average yet her understanding from Dr Ochoa was that the patient would be taking 20 to 30 tablets a day. In endeavouring to explain this discrepancy in terms of her responsibility as a pharmacist, the respondent said that she relied on the judgement of Dr Ochoa and did not exercise any of her own independent judgement. We note for completeness that in fact 240 tablets of Endone 5 mg were dispensed to this patient on each of 2, 9, 16, 25 August 2017, 1, 8, 15, 24 September 2017, 1, 8, 18, and 25 October 2017, and thereafter for some time. We do not regard this discrepancy as impacting upon the effect of the information provided by the respondent to the delegates.
It was the opinion of Dr Benson that this quantity of oxycodone exceeded the quantity that accorded with the recognised therapeutic standard of what was appropriate in the circumstances. She said that the respondent should have recognised this quantity and frequency of prescribing was inappropriate and this should have been reported to AHPRA. In addition, she said that the respondent should have refused to dispense ongoing supply and retained the prescriptions as evidence. The fact that 99% of these prescriptions were private should have further confirmed the inappropriate nature of this prescribing. She said that the respondent's conduct fell significantly below the standard reasonably required of a pharmacist with equivalent training or experience.
During the same period a total of 2700 diazepam 5 mg tablets were also dispensed to this patient from the pharmacy. Forty-six of the 54 prescriptions were private prescriptions. Two hundred of these tablets were dispensed by the respondent.
On seven occasions the interval between each supply of 50 diazepam tablets was between two and five days including the date on which the respondent dispensed this medication namely 6 April 2018. The patient was prescribed a dose of one to two diazepam 5 mg tablets at night. The dispensing history far exceeds the required tablets. Dr Benson said that this should have raised concerns to all pharmacists including the respondent. Diazepam is a Schedule 4D restricted substance which "is subject to misuse and diversion and should be treated as a potential risk to the public." She said that the respondent's conduct fell significantly below the standard reasonably required of a pharmacist and proprietor pharmacist with equivalent training or experience.
In addition, Dr Benson expressed concern that concurrent dispensing of diazepam and oxycodone created a risk to this patient's health and safety, for reasons which we have previously referred to in connection with other patients. She said that the respondent's conduct in this regard fell significantly below the standard reasonably required of a pharmacist with equivalent training or experience.
[11]
Relevant Codes of Conduct
The Pharmacy Board of Australia has developed Codes of Conduct which apply to the practice of pharmacy in Australia. By section 41 of the National Law, we are empowered to have regard to the contents of these Codes in assessing the conduct of the respondent in these proceedings:
41 Use of registration standards, codes or guidelines in disciplinary proceedings
An approved registration standard for a health profession, or a code or guideline approved by a National Board, is admissible in proceedings under this Law or a law of a co-regulatory jurisdiction against a health practitioner registered in a health profession for which the Board is established as evidence of what constitutes appropriate professional conduct or practice for the health profession.
The Pharmacy Board issued a Code, Pharmacy Board of Australia, "Guidelines for Dispensing of Medicines" (September 2015) with effect on 7 December 2015. Relevantly for our purposes, these guidelines describe the nature and extent of the professional responsibility of pharmacists when dispensing medication. In particular the guideline requires the following of a pharmacist:
"In dispensing a prescription, a pharmacist has to exercise an independent judgement to ensure the medicine is safe and appropriate for the patient, as well as that it conforms to the prescriber's intentions. Where clarification is required, the patient or their agent should be consulted and if necessary, the prescriber contacted.
…
In conforming to the above principle, dose, frequency and route of administration, duration of treatment, the presence or absence of other medicines, the patient's illness, medication history, allergies, and other relevant circumstances need to be taken into account. When this information is collected by the pharmacist, relevant details should be recorded in the dispensing record, and where possible in the patient's health record, so that the safety of any future medicines that are prescribed and/or dispensed for that patient can also be assured."
We note in particular the emphasis on the responsibility of a pharmacist in dispensing a prescription to exercise an independent judgement. This must refer to a judgement independent of the prescriber where it is appropriate to do so.
There is no evidence from the respondent that she was aware of and cognisant of the contents of these regulatory documents. The burden of demonstrating such awareness lies with the respondent. If she had been so, she would have noted that each regulatory document contains the following important information:
"Non-compliance with these guidelines and the practice standards and guidelines may be notified to the Board for appropriate action under the National Law. Under section 41 of the National Law, these guidelines can be used in disciplinary proceedings under the National Law or law of a co-regulatory jurisdiction as evidence of what constitutes appropriate professional conduct or practice for pharmacists. When considering notifications (complaints) against proprietors, the Board will give consideration to whether a breach of these guidelines has taken place. The Board will also have regard to the relevant legislation and requirements for pharmacy premises, and the practice standards and guidelines relevant to pharmacy practice."
The Board also developed the Pharmacy Board of Australia, "Guidelines for Proprietor Pharmacists" (September 2015), with effect on 7 December 2015. The respondent was a shareholder with her husband Dillan Lal in a company structure which was the proprietor of the pharmacy which is at the heart of these proceedings. As such she was bound by these guidelines. They include the following:
"1 Proprietors to maintain an active interest in how the pharmacy business is conducted
If the proprietor/owner or partner-in-ownership pharmacist is not the pharmacist usually in charge of that pharmacy, he or she must vigilantly maintain an active interest in how the practice of pharmacy is being conducted. This is to ensure that the pharmacy operation is in accordance with:
• any applicable state, territory or Commonwealth law
• relevant Pharmacy Board of Australia policies, codes and guidelines
• applicable professional practice and quality-assurance standards and guidelines, and
• good pharmacy practice.
If the proprietor finds that the practice of pharmacy does not operate in accordance with these, he or she must intervene to ensure that the pharmacy business is conducted properly.
2. Proprietor pharmacists cannot delegate their professional obligations
A proprietor/owner or partner-in-ownership of a pharmacy cannot delegate his or her professional obligations, even if that partner is not regularly present at the pharmacy. This applies to pharmacists who own a pharmacy, or pharmacies, in all forms of business structures.
3. Responsibilities of proprietor pharmacists
For the purposes of these guidelines, ensuring the pharmacy business is conducted properly includes
…..
• maintaining an awareness of and responsibility for the services being provided including unregulated services, and goods being sold, particularly those known to be subject to abuse or misuse and those not regulated through the Therapeutic Goods Administration (TGA) or the pharmacy premises registering authorities
….."
[12]
Factual findings with respect to each of the complaints
During the course of the hearing counsel for the applicant, Mr D Fuller, carefully took us through all the documentary material which formed the basis of the Particulars of the Complaints brought against the respondent. There is corroborative validated evidence supporting the dispensing history with respect to each of the patients. It is not necessary that we refer to each and every one of the documents and their contents, which occupy many hundreds of pages. We rely in particular on the expert report of Dr Benson, and we have regard also to the information provided by the respondent to which we have referred.
[13]
Complaint One
We are able to summarise the effect of the dispensing by the respondent to each of the patients as referred to in the report of Dr Benson. We note that in particular:
1. the quantities of Schedule 8 drugs and Schedule 4D drugs were contrary to the recognised therapeutic standard of what was appropriate in the circumstances and therefore contrary to clauses 109 of the PTGR for Schedule 8 drugs and 54 for Schedule 4D drugs.
109 Quantity and purpose of supply to be appropriate
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.
Maximum penalty - 20 penalty units or imprisonment for 6 months, or both.
54 Quantity and purpose of supply to be appropriate
An authorised practitioner or pharmacist must not supply any restricted substance in a quantity, or for a purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Maximum penalty - 20 penalty units or imprisonment for 6 months, or both.
1. the respondent supplied Schedule 8 drugs concurrently with other Schedule 8 drugs and benzodiazepines contrary to the safe dispensing of medication
2. the respondent knew, or should have known that the patients were drug dependent or at risk of becoming drug dependent having regard to the pattern of the prescriptions and the quantities involved
3. the patients presented with private prescriptions in circumstances which should have alerted the respondent that the health and safety of her patients were being compromised
4. the respondent knew or should have known that the supply of these drugs to these patients presented a risk to their health and safety, or there was a risk of their misuse or diversion
5. the dispensing of these drugs was contrary to guidelines 1 and 2 of the Pharmacy Board of Australia Guidelines for Dispensing of Medicines:
"1 The dispensing process
…The pharmacist should ensure that the prescription is valid, that the medicine is clinically appropriate for the patient, and that information is provided to ensure safe and appropriate use of the medicine.
2 Dispensing precaution - safety of prescriptions
A pharmacist must take reasonable steps during the dispensing process (detailed in Guideline 1 The dispensing process) to ensure that the dispensing of a medicine in accordance with a prescription or order is consistent with the safety of the person named in that prescription or order."
In summarising the evidence of Dr Benson with respect to each of the patients we have noted her assessment that the respondent's conduct fell significantly below the standard reasonably expected of a pharmacist of an equivalent level of training or experience. We endorse her opinion.
It follows that we are comfortably satisfied to the required standard that all the factual matters referred to in Complaint One have been established.
In written submissions the applicant asserted that the contravention of the PTGR and the Dispensing Guidelines would constitute improper or unethical conduct pursuant to section 139B(1)(l) of the National Law. We apprehend that no such allegation is contained within Complaint One, and we reject this submission.
[14]
Complaint Two
This Complaint is based upon the additional obligations assumed by the respondent as a co-proprietor of the pharmacy. We have previously set out extracts from the relevant Proprietor Guidelines. We agree with the submissions of the applicant that each of the Particulars of this Complaint is evidence of a failure by the respondent to comply with these obligations.
It is not necessary to traverse the evidence in detail. It is clear from the recitation of the facts contained in the Particulars which we have found proven to the requisite standard that the respondent, as co-proprietor:
1. failed to take adequate steps to ensure that Schedule 8 and Schedule 4D drugs were being dispensed in accordance with the PTGR and Dispensing Guidelines
2. failed to take adequate steps to ensure that the dispensing pharmacists recorded their names for each instance of dispensing these drugs.
These are all matters upon which Dr Benson made comment. There can be no doubt concerning the underlying factual situations which are the bases for each of Particulars 1, 2 and 3. We are comfortably satisfied to the requisite standard that the respondent in her role as co-proprietor failed to ensure that there was appropriate compliance with these requirements. As such, we are comfortably satisfied that each of these Particulars has been established.
It is necessary to refer to the evidentiary material which applies to Particular 4 of Complaint Two. This Particular is based on a failure to make adequate notes of conversations with prescribing practitioners in relation to the supply of the relevant drugs and adequate notes of the clinical reasons for the concurrent supply of high doses of Schedule 8 drugs and benzodiazepines to the patients. It is based on clause 8.4 of the Pharmacy Board of Australia Code of Conduct:
"8.4 Health records
Maintaining clear and accurate health records is essential for the continuing good care of patients or clients. Practitioners should be aware that some National Boards have specific guidelines in relation to records. Good practice involves:
a) keeping accurate, up-to-date, factual, objective and legible records that report relevant details of clinical history, clinical findings, investigations, information given to patients or clients, medication and other management in a form that can be understood by other health practitioners
….
d) ensuring that records are sufficient to facilitate continuity of care
The evidence before us is that eight persons in the pharmacy were responsible for the dispensing of prescriptions during the relevant period. There is a computer readout of notes which predominantly record conversations with Dr Ochoa concerning prescriptions which he had written, and some interaction with patients. These notes do not record the name of the patient involved. There is a notation of communications occurring on 24 occasions between 25 July 2016 and 27 July 2018. The initials indicating the name of the pharmacists involved are predominantly DR and PP. The respondent's initials PP occur on eight occasions. Some notes do not record the initials of any person. These notes record the fact of contact with Dr Ochoa, mostly in relation to the "interval" for dispensing. In the main they indicate reliance on the response of Dr Ochoa, but, as submitted by the applicant, they record "almost no independent clinical reasoning on the part of any pharmacists."
During the course of an interview conducted by delegates of the Pharmacy Council the respondent produced copies of 12 prescriptions for Endone written for Patient H by Dr Ochoa which contain handwritten notations which are indicative of the interval of dispensing having been altered. She said that she had made these alterations after discussion with Dr Ochoa.
These are the only records available that are indicative of compliance with clause 8.4 of the Code.
In a signed submission to the Pharmacy Council made jointly by the respondent and Dillan Lal on 28 February 2019 they said inter alia:
"We are aware of the nature of risks in relation to drug misuse. In dealing with these patients we are aware that we had to be vigilant of the patient's history and carefully review intervals of dispensing and regularly engage in discussions with the patient's doctors. If we were not satisfied to dispense such medications, we would not supply it…
…
Whilst we did not record each and every interaction with the prescribers we did record them from time to time. We acknowledge that in future we will be much more vigilant to record these discussions…."
The sparse nature of such notes that are available enables us to conclude that we are comfortably satisfied that Particular 4 has been established. The applicant asserted that this misconduct also fell within the provisions of section 139B(1)(l) of the National Law. We shall return to this matter shortly in these reasons for decision.
[15]
Complaint Three
This Complaint is based on a number of assertions that the respondent failed to adequately and appropriately protect her patients. As is obvious from the factual narration which we have set out, and as corroborated by records made available to us, as well as in a submission made jointly by the respondent and Dillan Lal to the Pharmacy Council on 28 February 2019, almost all the prescriptions issued to the patients whose circumstances are the subject of these proceedings were issued from a group medical practice adjoining the pharmacy, the bulk of them having been written by Dr Ochoa.
In the joint submission previously referred to the respondent said that she had relied upon and trusted the prescribing medical practitioners in fulfilling her duty of care to her patients. The submission also said:
"We also fully understand that we cannot accept at face value what other health care professionals advise and (sic) exercise our own independent judgement."
We refer to the provisions of Particular 1. Based on the expert opinion of Dr Benson we conclude that the respondent should have held a reasonable belief that the prescribing practitioners for each of the patients were placing the public at risk of harm by practising medicine in a way that constituted a significant departure from accepted professional standards. As such, the respondent should have notified AHPRA of these matters as required by section 141(2) of the National Law, the provisions of which we have earlier set out.
We note that Particular 1 alleges that the respondent did hold the belief referred to in [99] above. Because of her overall lack of knowledge about these matters, as conceded by her in submissions to the Pharmacy Council, we cannot be comfortably satisfied that it has been established that the respondent did hold that belief.
On this basis we are comfortably satisfied to the extent that we have found that Particular 1 has been established.
Particular 2 details the steps that it is alleged the respondent should have taken to protect her patients from being placed at risk of harm as required by clause 6.3 of the Code of Conduct, the provisions of which we have earlier set out. Steps (c) and (d) refer to section 28 of the Poisons and Therapeutic Goods Act 1966 (NSW) and the allegations are confined to the prescription of oxycodone to Patient A and the prescription of alprazolam to Patient B. For completeness we note that oxycodone is a type C drug and alprazolam a type B drug for the purpose of this section.
28 Prohibition on prescribing drugs of addiction in certain cases
(1) A medical practitioner or nurse practitioner must not, without the proper authority, prescribe for or supply to any person a type A drug of addiction.
(2) A medical practitioner or nurse practitioner must not, without the proper authority, prescribe or supply a type B drug of addiction:
(a) for continuous therapeutic use by a person for a period exceeding 2 months, or
(b) for a period that, together with any other period for which that drug or any other type B drug of addiction has been prescribed or supplied by the medical practitioner or nurse practitioner or has, to the medical practitioner's or nurse practitioner's knowledge, been prescribed or supplied by any other medical practitioner or nurse practitioner, would result in that drug, or that drug together with any other such drug, being prescribed or supplied for continuous therapeutic use for a period exceeding 2 months.
(3) A medical practitioner or nurse practitioner must not, without the proper authority, prescribe for or supply to a person who, in the opinion of the medical practitioner or nurse practitioner, is a drug dependent person a type C drug of addiction.
(4) For the purposes of this section, the proper authority means an authority under section 29 that authorises the medical practitioner or nurse practitioner to prescribe or supply the drug of addiction to the person concerned.
(5) A drug of addiction may be prescribed for or supplied to a person by a medical practitioner or nurse practitioner without the proper authority if the medical practitioner or nurse practitioner is authorised by the regulations to prescribe or supply the drug without an authority under section 29.
(6) In this section:
type A drug of addiction means a drug of addiction prescribed by the regulations under this section as a type A drug of addiction.
type B drug of addiction means a drug of addiction prescribed by the regulations under this section as a type B drug of addiction.
type C drug of addiction means any drug of addiction (other than a type A drug of addiction).
These steps as particularised are based on the expert opinion of Dr Benson. Even though Dr Benson did not specifically refer to the section 28 authority in considering the circumstances relating to Patient A, it is clear on the evidence that he was opioid dependent, as was conceded by the respondent. There is no evidence that the respondent asked adequate questions of the prescribing doctors as to the appropriateness of the quantities of drugs being prescribed to these patients, that she took any adequate steps to raise the possibility of referring the patients to a qualified pain addiction specialist or drug dependence program, or that she sought to confirm the existence of any authority to prescribe these drugs to patients under section 28 of the Poisons and Therapeutic Goods Act. The burden of establishing these matters rests on the respondent, albeit to the civil standard of proof.
We are comfortably satisfied in all the circumstances that these factual matters have been established to the requisite standard, and that the Particulars of Complaint Three have been established.
[16]
Is the respondent guilty of unsatisfactory professional conduct?
Unsatisfactory professional conduct is defined in the National Law in section 139B which we reproduce in part:
139B Meaning of "unsatisfactory professional conduct" of registered health practitioner generally [NSW]
1) Unsatisfactory professional conduct of a registered health practitioner includes each of the following -
(a) Conduct significantly below reasonable standard
Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience
(b) Contravention of this Law or regulations
A contravention by the practitioner (whether by act or omission) of a provision of this Law, or the regulations under this Law or under the NSW regulations, whether or not the practitioner has been prosecuted for or convicted of an offence in respect of the contravention.
….
(l) Other improper or unethical conduct
Any other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession.
We refer to the factual findings which we have made concerning each of the Particulars contained within Complaints One, Two and Three. In each case Dr Benson has concluded that the conduct of the respondent falls within the description of unsatisfactory professional conduct contained within section 139B(1)(a). Based upon this opinion, we are comfortably satisfied that the respondent is guilty of unsatisfactory professional conduct under section 139B(1)(a) with respect to all the Particulars of Complaints One, Two and Three.
With respect to Complaint Two, we note that there is an allegation that the conduct of the respondent falls within section 139B(1)(l). This contains a reference to "other" conduct, which prima facie is a reference to conduct which falls outside that within section 139B(1)(a). The applicant has not particularised the manner in which the provisions of subsection (1)(l) apply. As we are able to deal with these proceedings appropriately without considering this particular aspect, we decline to consider this particular matter, because it was not the subject of submissions before us.
In the same way, we are able to make a determination about Complaint Three without considering the provisions of subsection (1)(l).
Based on the opinion of Dr Benson and having regard to the factual findings which we have made, we find that the respondent has breached section 141(2) of the National Law by failing to have notified AHPRA of the inappropriate prescribing practices of a number of the medical practitioners at the adjoining medical practice, and especially Dr Ochoa, who as we have previously noted issued a substantial number of the prescriptions to these patients. In this regard we note the opinion of Dr Benson that the prescribing practices of Dr Ochoa and the other practitioners were in all the circumstances inappropriate.
This failure constitutes a contravention of the National Law and therefore constitutes unsatisfactory professional conduct as described in section 139B(1)(b). It follows that we are comfortably satisfied that this Particular has been established.
[17]
Is the respondent guilty of professional misconduct?
Complaint Four asserts that the respondent is guilty of professional misconduct. That expression is defined in section 139E of the National Law in the following terms:
139E Meaning of "professional misconduct" [NSW]
For the purposes of this Law, professional misconduct of a registered health practitioner means -
(a) unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or
(b) more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration.
The discriminating factor which transforms unsatisfactory professional conduct into professional misconduct is that it is sufficiently serious to justify suspension or cancellation of registration. Suspension or cancellation of registration is part of the armoury of protective orders that this Tribunal may make consequent upon a finding of professional misconduct. The orders which can be made must be protective in nature, having regard to the health and safety of the public. The underlying principles have been succinctly summarised in the NSW Court of Appeal in Health Care Complaints Commission v Do [2014] NSWCA 307. Meagher JA (Basten and Emmett JJA agreeing) said at [35] to [37]:
"[35] The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise.
[36] In Law Society of New South Wales v Foreman (1994) 34 NSWLR 408 Mahoney JA described (at 441) the scope of the objective of protecting the public interest in the context of disciplinary proceedings against a solicitor as follows:
"The protection of the public has been described as, for example, the primary purpose or primary object of such proceedings: ... In the relevant sense, the protection of the public is in my opinion not confined to the protection of the public against further default by the solicitor in question. It extends also to the protection of the public against similar defaults by other solicitors and has, in this sense, the purpose of publicly marking the seriousness of what the instant solicitor has done.
But, in my opinion, it would be wrong to confine the objects of disciplinary proceedings and the purposes to be achieved by the orders made in them strictly to matters of this kind. Those purposes and objectives have traditionally been seen as having a wider operation. In the end, the question to be determined is whether the solicitor is a fit and proper person to be a solicitor of the Court and the orders to be made are to be directed to ensuring that, to the extent she is not, her practice is restricted."
[37] In Herron v McGregor (1986) 6 NSWLR 246 McHugh JA referred more briefly to the same consideration (at 258):
"It is, of course, of fundamental importance to bear in mind the public interest in disciplining doctors who are guilty of professional misconduct. In many cases the protection of the public and the maintenance of professional standards requires that the names of doctors be removed from the register. However, it is present fitness to practise which is the principal and ultimate issue of public interest."
Some assistance in exercising the value judgment which is inherent in determining whether unsatisfactory professional conduct is sufficiently serious to constitute professional misconduct is provided in the judgment of Basten JA (Leeming JA agreeing) in the NSW Court of Appeal in Chen v Health Care Complaints Commission (2017) 95 NSWLR 334; [2017] NSWCA 186 at [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. Some, perhaps all, categories include conduct which may reveal a defect of character as to which the Tribunal may conclude that the person should not be allowed to practise his or her profession unless at some future date the practitioner is able to satisfy the Tribunal that the defect has been overcome. Incompetence or inadequate care may in some circumstances be remediable by specific steps; in other circumstances the Tribunal may be concerned that the carelessness, for example, is such as to cast doubt on the suitability of the person to practise medicine. Each of the criteria for cancellation or suspension may be analysed in this way. Each case will depend upon an evaluative judgment to be made by the Tribunal as to the nature and seriousness of the conduct..."
We proceed on the basis that it is appropriate to consider all the findings that we have made in the aggregate. In so stating we should not be taken to have determined that there are no individual findings which in themselves would justify a determination that the respondent is guilty of professional misconduct. Indeed, the respondent's misconduct with respect to each of the patients as particularised against her and as it related to her co-proprietorship of the pharmacy is of a most serious nature.
Comments made by this Tribunal in Health Care Complaints Commission v Elliott [2018] NSWCATOD 47 concerning the professional responsibilities of pharmacists, including their interaction with medical practitioners, are relevant to our consideration, albeit that there are some factual differences to the circumstances of these proceedings. At [54] to [57] the Tribunal said:
"[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.
[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.
[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. In this case, even his own expert, Mr Regoli, considered that Mr Elliott had fallen significantly short of the standards required.
[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..."
For present purposes we note that in determining whether the conduct of the respondent may be characterised as professional misconduct justifying cancellation or suspension of registration, such a characterisation is not necessarily determinative of any consequential appropriate protective orders. Our current task is to determine whether or not the conduct is such that cancellation or suspension is warranted. In determining this matter, we have regard to the protection of the public, the maintenance of public confidence in the integrity of the profession, and the deterrent effect both on the respondent and on other members of the pharmacy profession.
As has been endorsed often by this Tribunal, a health practitioner who prescribes or handles drugs of addiction recklessly and contrary to the law engages in conduct which constitutes professional misconduct. In Spicer v NSW Medical Council (Court of Appeal (NSW), 19 February 1981, unrep), Hope JA (Reynolds and Hutley JJA agreeing) said:
"In my opinion it is clear beyond argument that the proper handling and prescribing of drugs by medical practitioners are of the greatest importance to the community. If a medical practitioner handles or carries out that very great responsibility in a way that is reckless and which shows a disregard to the law it cannot be said that he is fitted at such a time to be a medical practitioner. In my opinion the view expressed by the Tribunal has implicit in it that not merely was he presently unfitted to treat those addicted or habituated to drugs but that that unfitness in itself demonstrated his present unfitness to be a medical practitioner"
There is no reason why these comments made in Spicer should not apply equally in the case of pharmacists who are also given the privilege of supplying restricted drugs to the public, including drugs of addiction in response to a prescription issued properly and appropriately, and subject to the duty of care which is inherent in the exercise of their profession. Indeed, pharmacists have been described in this Tribunal as being representative of the "gatekeepers" to access to these drugs by the public. As such there are very good policy reasons why the responsibility of pharmacists extends beyond the mere filling of prescriptions. As will have been seen from our reference to some of the various provisions of the PTGR, pharmacists are required by law to make an assessment of the authenticity of a prescription for these drugs, the appropriateness of those drugs for use by patients especially having regard to the quantity and frequency of their use, and the period over which the drugs are to be used. There are also extensive requirements to ensure that these drugs are secured and that appropriate records are kept so as to ensure that the receipt and dispersal of these drugs are recorded by pharmacists. It is not necessary to refer to these provisions in detail. They are contained within Division 4 of Part 4 of the PTGR, and especially Subdivision 1.
We have described in some detail the regulated quantities of the drugs of addiction dispensed by the respondent to each of the patients referred to in the Complaints, as well as the overall circumstances pertaining to those patients. We have also set out the observations of Dr Benson, the expert retained by the applicant with respect to the conduct of the respondent. We emphasise that not only did she engage in the inappropriate dispensing of these dangerous drugs of addiction to these patients, but also, she was aware or should have been aware of the prescribing regime of these patients and their medical conditions. Our conclusions which follow are based on all these matters. There is no benefit in our attempting to summarise these matters, because an appropriate assessment of the respondent's conduct requires attention to the detailed factual circumstances which we have previously described.
We do however make specific mention of the circumstances pertaining to Patient H. At [73] we set out information provided by the respondent to delegates of the Pharmacy Council concerning this patient. We note that it was only after the delegates referred the respondent to the prescribing history that she indicated that it should have made her aware of the "red flags". At face value this seems to have been the first occasion on which the respondent thought about the circumstances of this patient in terms of either excessive ingestion of these drugs or whether he might have been diverting the supply of the restricted drugs. If so, this discloses a naïveté inappropriate for a pharmacist dispensing large quantities of drugs of addiction to a cohort of patients. These observations are additional to the serious nature of the respondent's misconduct which is clearly incompatible with the safe practice of the profession of pharmacy.
We add for completeness that the respondent was co-proprietor of the pharmacy, that she had some experience as a pharmacist, that her conduct extended to a number of patients over an extended period of time and substantially pertained to the inappropriate dispensing of dangerous drugs of addiction as well as oversight of the pharmacy practice.
We assess the conduct of the respondent as we have described it as constituting a flagrant breach of her legal, professional and ethical obligations as a practising pharmacist and as a co-proprietor. Her conduct is clearly incompatible with the practice of her profession at a standard which can reasonably be expected by the public. This rendered her unfit to practise as a pharmacist and as such would justify the cancellation of her registration. It follows that we find that the respondent is guilty of professional misconduct.
[18]
Appropriate protective orders
It is now necessary to determine what protective orders should be made consequent upon the finding of professional misconduct which we have made. We have previously set out the principles which are to be applied in framing appropriate protective orders. Most significantly, it is necessary to protect the interests of the public and in the case of a pharmacist the interests of current and potential patients. In addition, protective orders are appropriate to deter the respondent and other pharmacists from engaging in the same or similar conduct. Finally, it is necessary to uphold public confidence in the high standards and integrity of the pharmacy profession.
The range of available protective orders are contained in section 149A(1) of the National Law
149A General powers to caution, reprimand, counsel etc [NSW]
(1) The Tribunal may do any one or more of the following in relation to the registered health practitioner -
(a) caution or reprimand the practitioner;
(b) impose the conditions it considers appropriate on the practitioner's registration;
(c) order the practitioner to seek and undergo medical or psychiatric treatment or counselling (including, but not limited to, psychological counselling);
(d) order the practitioner to complete an educational course specified by the Tribunal;
(e) order the practitioner to report on the practitioner's practice at the times, in the way and to the persons specified by the Tribunal;
(f) order the practitioner to seek and take advice, in relation to the management of the practitioner's practice, from persons specified by the Tribunal.
Because of the finding of professional misconduct which we have made we are also empowered by section 149C of the National Law to cancel or suspend the respondent's registration. Section 149C provides in part:
149C Tribunal may suspend or cancel registration in certain cases [NSW]
(1) The Tribunal may suspend a registered health practitioner's registration for a specified period or cancel the registered health practitioner's registration if the Tribunal is satisfied -
…
(b) the practitioner is guilty of professional misconduct; or
…
In considering appropriate protective orders we are required to determine whether the respondent can safely practise as a pharmacist. We emphasise that it is no part of this consideration to punish the respondent for her misconduct, although, as is well acknowledged, protective orders may have a punitive effect.
The respondent sought to provide information to delegates of the Pharmacy Council, when considering her application to remove the suspension of registration, concerning knowledge which she said she had acquired of the legislative and other responsibilities of pharmacists and of the proper and appropriate practice of pharmacy. The delegates found that the respondent had not then acquired sufficient knowledge to enable them to remove that suspension.
The respondent provided a brief submission to the applicant on 6 October 2020. She referred to detailed submissions which had previously been made with respect to each of the patients. In general terms the respondent asserted that she and other pharmacists at the pharmacy had frequently spoken to the patients' prescribing medical practitioners, the patients had been referred back to their doctors when necessary and the patients had been counselled about adhering to their prescribed dosages.
In that submission the respondent said that she had reflected on the issues raised by the applicant and acknowledged that her practice was below the appropriate pharmacy practice standards. She expressed regret for her conduct and stated that she had made errors in judgement in relying on the judgement of the prescribing medical practitioners. The respondent said that she no longer intended to practise as a pharmacist and asked that the applicant take no further action in relation to the complaints being investigated.
There is no information available to us which would provide us with any comfort that the respondent is now able to practise pharmacy safely. Because of the egregious nature of the respondent's misconduct, the serious risk to the health and safety of patients which it created, and the lack of any information that would persuade us that in some way she might be able to practise pharmacy safely, we conclude that it is appropriate that in all the circumstances her registration be cancelled, and we shall so order.
We are entitled to fix a minimum period under section 149C(7) of the National Law before the respondent may apply for a review of the order of cancellation of her registration. Having regard to all the matters to which we have referred, we assess a minimum period of three years from this date. This will allow the respondent an appropriate period in which to reflect on her prior conduct and to take such steps as she may deem fit to engage upon a process of education, rehabilitation and reformation in the event that she may seek registration as a pharmacist in the future.
[19]
Costs
The applicant sought a costs order in its favour. This is a costs jurisdiction. There is no conduct on the part of the applicant which would disentitle it to a favourable costs order and we propose to make such an order accordingly.
[20]
Dr Carlos Ochoa
We are conscious that the bulk of the prescriptions which were found to have been inappropriately dispensed by the respondent were written by Dr Carlos Ochoa out of the adjoining Australian Health Care Centre. Dr Benson who has expertise in regulated drugs of addiction has commented unfavourably on the prescribing conduct of Dr Ochoa. Although Dr Ochoa's prescribing conduct with respect to these patients was the catalyst for the respondent's misconduct leading to the cancellation of her registration, this does not excuse the respondent. However, we would be remiss in discharging our duty to uphold the health and safety of the public which is enshrined in the National Law if we did not take steps to ensure that the conduct of Dr Ochoa and perhaps also other medical practitioners in the same Medical Centre is brought to the attention of the relevant authorities. We note that the applicant is one such authority. We ask the Health Care Complaints Commission to consider these comments and if thought appropriate to refer them to any relevant authority for consideration as to whether they should be the subject of further investigation.
[21]
Orders
Consequent upon the finding of professional misconduct which we have made we make the following orders:
1. the registration of the respondent as a pharmacist is cancelled
2. pursuant to the provisions of section 149C(7) of the Health Practitioner Regulation National Law (NSW) an application for review may not be made until three years from the date of this decision
3. the respondent is to pay the costs of the applicant assessed in default of agreement.
[22]
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: 24 January 2022