Health Care Complaints Commission v Elias

Issues to be determined

1. At the commencement of the hearing the Commission sought and was given leave to amend the complaint. For convenience, throughout these reasons the amended complaint will be referred to as "the Complaint".
2. The key issues we must decide are: 1. Whether, as alleged by the Commission in particular 4(a) of complaint 1, Mr Elias dispensed or permitted to be dispensed, Schedule 8 drugs in the quantities and on the dates listed in Schedule 4 to the Complaint, in circumstances where Mr Elias ought reasonably to have known that the prescription was forged, contrary to cl 86(f) of the Poisons and Therapeutic Goods Regulation 2008 (NSW) (PTGR). 2. Whether, as alleged by the Commission, and disputed by Mr Elias, the admitted and any proven conduct is of a "sufficiently serious nature" to justify suspension or cancellation of Mr Elias' registration, that is, that it amounts to "professional misconduct" as defined by s 139E of the National Law. 3. Whether protective orders should be made and, if so, what orders should be made.
3. The Commission bears the burden of proving the matters particularised in the Complaint and denied by Mr Elias on the balance of probabilities. In cases such as this, where the allegations, if found proven, carry potentially serious consequences, such as the loss of the practitioner's livelihood, the evidentiary standard necessary to prove them was identified by the High Court in Briginshaw v Briginshaw (1938) 60 CLR 336; [1938] HCA 34. It is insufficient to rely on "slender and exiguous proofs" (per Rich J at 350), or "inexact proofs, indefinite testimony, or indirect inferences" (per Dixon J at 362). As Dixon J said in Briginshaw (at 362), "the tribunal must feel an actual persuasion of its occurrence or existence before it can be found" and the more serious the consequences the more they will affect the consideration.
4. The authorities have cautioned against the use of the term "comfortably satisfied" (a phrase sometimes adopted from Rich J in Briginshaw at 350) to imply that proof to a higher standard than the balance of probabilities is required: Forster v Hunter New England Area Health Service [2010] NSWCA 106 at [22]; Neat Holdings Pty Ltd v Karajan Holdings Pty Ltd [1992] HCA 66; (1992) 67 ALJR 170; (1992) 110 ALR 449 at [1].

The conduct the subject of the Complaint

1. The conduct the subject of the Complaint spans the period 31 March 2014 to 13 August 2014 and relates to the dispensing, handling, recording and auditing of "drugs of addiction" and "prescribed restricted substances". A drug of addiction, commonly referred to as a "Schedule 8 drug", is any drug listed in Schedule 8 of the Poisons List as proclaimed under s 8 of the Poisons and Therapeutic Goods Act 1966 (NSW) (the PTGA). A "prescribed restricted substance", commonly referred to as a "Schedule 4D drug", is any substance listed in Appendix D of the PTGR. The prescribing and dispensing of Schedule 4 and Schedule 8 drugs is heavily regulated.
2. The particulars of the Complaint

Particular 1

1. Mr Elias admits particular 1(a): dispensing, or permitting to be dispensed, Schedule 8 medication where the form of the prescriptions did not comply with the requirements of cl 80 of the PTGR in breach of cl 85(1) of the PTGR. Clause 85(1) of the PTGR states that a pharmacist may supply a drug of addiction on prescription if the prescription is in the form required by Division 3. Clause 80 is contained in Division 3.
2. The 20 prescriptions the subject of particular 1 were dispensed through the Pharmacy throughout the period 16 April 2014 and 9 July 2014. Each prescription was for a Schedule 8 drug: Alprazolam (18), Morphine (1) and Oxycodone (1). The prescriptions were made out to five different patients. Each prescription was deficient because of non-compliance with cl 80, including: 1. That the details required by cl 80(1) to be included in the prescription were not in the handwriting of the issuing practitioner, as required by cl 80(2). 2. The prescription did not include the intervals at which the drug may be supplied on the prescription, as required by cl 80(1)(f).
3. The Pharmacy's dispensing records record Mr Elias as being the dispensing pharmacist for each of the 20 prescriptions. He claims that during the period of the Complaint, on occasion staff used his log in details to access the Pharmacy's electronic dispensing system and as a result the Pharmacy's dispensing recorded him as being the dispensing pharmacist. In support of that claim, he points to the entry in the Pharmacy's records which records him as being the dispensing pharmacist of a Durogesic prescription dispensed in January 2015 while he was overseas. He claims that throughout 2014 he worked at the Pharmacy for between 10 to 40 hours per week. Mr Elias admits to probably dispensing some of the 20 prescriptions the subject of particular 1, but claims that he is now unable to identify which of those prescriptions he dispensed.
4. In addition, Mr Elias admits particular 1(b): failing to discharge his obligations as the proprietor of the Pharmacy by failing to maintain an awareness of the manner in which the Pharmacy's dispensing practice was being conducted in accordance with cll 80 and 85(1) of the PTGR and failing to intervene, when necessary, contrary to the Australian Guidelines for Proprietor Pharmacists (the Proprietor Guidelines).
5. Mr Elias claims that in 2014 he was unaware of the staff practice of using his log in details to dispense medication using the Pharmacy's electronic dispensing system. He concedes that as proprietor of the Pharmacy he should have been aware of that practice and put in place mechanisms to ensure the Pharmacy's records accurately recorded the dispensing pharmacist.

Particular 2

1. Mr Elias admits particular 2(a): dispensing, or permitting to be dispensed, clonazepam, a Schedule 4D drug at shorter intervals than indicated in the prescription, contrary to cl 40(1) of the PTGR. The subject conduct relates to the dispensing of clonazepam to five patients on 10 prescriptions, between 22 April 2014 and 12 August 2014.
2. Mr Elias concedes, as he did in relation to particular 1(a), that he was probably the dispensing pharmacist for some of the subject prescriptions but claims he cannot identify which of the 10 subject prescriptions were dispensed by him. With respect to those drugs he dispensed, he claims that the non-compliance with cl 40(1) of the PTGR was the result of his failure to check the patient's prescribing history.
3. A pharmacist must not supply a restricted substance on prescription if the interval of time that has elapsed since the substance was last supplied on the prescription is less than that indicated by the prescription as the minimum interval that must elapse between successive supplies of the substance: cl 40(1)(c) of the PTGR.
4. In addition, Mr Elias admits particular 2(b): that dispensing (or permitting to be dispensed) the 10 subject prescriptions contravened cl 54 of the PTGR. Clause 54 of the PTGR states that a pharmacist must not supply any restricted substance in a quantity that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances. Mr Elias concedes that because the repeat prescriptions were issued at shorter intervals than specified in the original prescriptions, the quantity of drugs dispensed exceeded the relevant recognised therapeutic standard.
5. Mr Elias also admits particular 2(c).: failing, as the proprietor of the Pharmacy, to maintain an awareness of the manner in which the Pharmacy's dispensing practice was being conducted in accordance with cl 54 of the PTGR, and to intervene when necessary, contrary to the Proprietor Guidelines.

Particular 3

1. Mr Elias admits particular 3(a): during the period 31 March 2014 to 11 August 2014, dispensing or permitting to be dispensed each of the prescriptions listed in Schedule 3 of the Complaint. Schedule 3 lists nine prescriptions for Alprazolam, a Schedule 8 drug. None of these prescriptions identify the intervals of repeats as required by cl 80(1)(f) of the PTGR. Clause 85(3) of the PTGR prohibits a pharmacist from supplying a drug of addiction on a prescription referred to in subclause (2) if it appears to the pharmacist that the drug has previously been supplied on the prescription, regardless of how many times the prescription purports to authorise the supply of the drug. Subclause (2) relates to a prescription which fails to specify the maximum number of times the drug may be supplied, or fails to specify the intervals at which the drug may be supplied.
2. Mr Elias concedes that in 2014 he was unaware of a number of key statutory requirements governing the handling and dispensing of Schedule 8 drugs including the prohibition on dispensing such drugs where the prescription presented by the patient did not specify the intervals between repeats.
3. In addition, Mr Elias admits particular 3(b): failing as the proprietor of the Pharmacy to maintain an awareness of the manner in which the Pharmacy's dispensing practice was being conducted in accordance with cl 85(3) of the PTGR, and to intervene when necessary, contrary to the Proprietor Guidelines.

Particular 4

1. Mr Elias denies particular 4(a). He admits particular 4(b). Particular 4 reads: a. Between around 16 April 2014 and 9 July 2014, the practitioner dispensed, or permitted to be dispensed Schedule 8 drugs in circumstances where the practitioner ought reasonably to have known that the prescriptions were forged, contrary to Clause 86(f) of the PTGR, in the quantities and on the dates set out in Schedule 4. b. In the alternative to particular 4(a), the practitioner failed to discharge his obligations as the proprietor of the pharmacy by failing to maintain an awareness of the manner in which the pharmacy dispensing practice was being conducted in relation to Schedule 8 drugs, and failed to intervene when necessary, contrary to the Proprietor Guidelines.
2. A pharmacist must not supply a drug of addiction on prescription if the prescription appears to have been forged or fraudulently obtained: cl 86(f) of the PTGR.
3. The conduct the subject of particular 4(a) relates to 34 prescriptions dispensed through the Pharmacy between 16 April 2014 and 9 July 2014 for Schedule 8 drugs Alprazolam (31), Morphine (2) and Oxycodone (1). It is not in issue that each of the subject prescriptions were forged. The issue in dispute is whether, as the Commission alleges, Mr Elias "ought reasonably to have known" that the prescriptions were forged.
4. An examination of the subject prescriptions reveals that each were defective in some way. The Commission contends this ought to have caused Mr Elias to doubt their authenticity. The defects include: that the information in some prescriptions was not written by hand as required by cl 80(2)(a) of the PTGR; the prescribed doses were particularly high; the patient's name was misspelt; incorrect/unknown medical abbreviations were used; the intervals at which the drug may be supplied were not specified.
5. The Commission asked Associate Professor Rohan Lakshman Rasiah to provide an opinion about whether the conduct the subject of the Complaint fell significantly below the standard reasonably expected of a practitioner of an equivalent level of training and experience. He prepared a report outlining his conclusions and, in addition, gave oral evidence. In oral evidence, when taken to a sample of prescriptions the subject of particular 4, he stated that various deficiencies on the face of each prescription ought to have alerted Mr Elias to the possibility that they were forgeries.
6. Mr Elias concedes that he should have known that the subject prescriptions did not comply with the relevant requirements of the PTGR but contends that the Commission has failed to establish that he ought reasonably to have known that the prescriptions were forged.

Consideration

1. As formulated, particular 4(a) requires that the Commission establish on the balance of probabilities that Mr Elias ought reasonably to have known that each of the 34 prescriptions listed in Schedule D to the Complaint were forged. While each prescription is defective in some way, a careful examination reveals that some are better forgeries than others. For example, the prescription at Exhibit A1, Tab 26, C, p 1 for Kalma, in our view, is an example of a fairly amateurish attempt at deception and ought to have alerted Mr Elias to the possibility, if not probability, that it was a forgery. No directions for use were entered on that prescription and the intervals between which the prescribed drug could be supplied were not specified as required by cll 80(1)(d) and 85(3) of the PTGR. In addition the abbreviation "ADBP" was entered on the prescription which is neither a known acronym or medical term. At the other end of the scale is the prescription for the drug Xanox at Exhibit A1, Tab 26, B, p 9. That prescription complies with the requirements as to form mandated by cl 80(1) and is written by hand as required by cl 80(2). In addition, because the purported prescriber did not authorise repeat prescriptions no issue with compliance with the requirements of cl 85 arises (the requirement to specify the maximum number of times the drug may be supplied and the intervals at which the drug may be supplied). While there are some indicators which viewed in combination should have prompted Mr Elias to make enquiries of the prescribing practitioner, such as the relatively large number of drugs prescribed (100) and the relatively high dosage (2 mg), we are not satisfied that Mr Elias ought reasonably to have known that the prescription was forged. In reaching that conclusion we note that, in assessing whether Mr Elias ought reasonably to have known that that prescription was forged, regard must be had to the context in which its authenticity was required to be evaluated: a busy pharmacy dispensing 130 to 150 prescriptions per day. In addition, we note that it was not until their suspicions were confirmed by the purported prescribers that the PSU investigators concluded that each of the 34 prescriptions was forged.
2. Particular 4(a) is not established.

Particular 5

1. Mr Elias admits particular 5(a): failing to check the authenticity of each of the 34 prescriptions the subject of Particular 4 with the prescribing practitioner before dispensing the subject drug, contrary to cl 87 of the PTGR. Clause 87 of the PTGR states: 87 PRESCRIPTIONS REQUIRE VERIFICATION (1) A pharmacist must not supply a drug of addiction on prescription unless he or she: (a) is familiar with the handwriting of the person who issued the prescription, or (b) knows the person for whom the drug is prescribed, or (c) has verified that the person who is purported to have issued the prescription has actually issued the prescription. (2) This clause does not prevent a pharmacist who is otherwise authorised to supply drugs of addiction from supplying a drug of addiction on prescription in a quantity sufficient for no more than 2 days' treatment.
2. Mr Elias admits particular 5(a) subject to the qualification that because of his claimed practice of staff using his log in details to access the Pharmacy's dispensing system he is unable to say which of the subject 34 prescriptions dispensed were in fact dispensed by him.
3. In addition, Mr Elias admits particular 5(b) which is in the same terms as particular 4(b).

Particular 6

1. Mr Elias admits particular 6: failing to ensure that drug registers were kept for methadone and subutex in accordance with the requirements of cll 111 and 112 of the PTGR. Methadone and subutex are Schedule 8 drugs.
2. Clauses 111 and 112 of the PTGR state: 111 DRUG REGISTERS TO BE KEPT (1) A person who has possession of drugs of addiction at any place must keep a separate register (a "drug register" ) at that place. (2) A drug register is to be in the form of a book: (a) that contains consecutively numbered pages, and (b) that is so bound that the pages cannot be removed or replaced without trace, and (c) that contains provision on each page for the inclusion of the particulars required to be entered in the book. (3) Separate pages of the register must be used for each drug of addiction, and for each form and strength of the drug. … 112 ENTRIES IN DRUG REGISTERS (1) On the day on which a person … supplies … a drug of addiction at any place, the person must enter in the drug register for that place such of the following details as are relevant to the transaction: (a) the quantity of the drug manufactured, received, supplied, administered or used, (b) the name and address of the person to, from, or by, whom the drug was manufactured, received, supplied, administered or used, (c) … (d) in the case of a drug that is supplied or administered on prescription: (i) the prescription reference number, and (ii) the name of the authorised practitioner by whom the prescription was issued, (e) in the case of a drug that has been administered to a patient, the name of the authorised practitioner (other than a veterinary practitioner) by whom, or under whose direct personal supervision, the drug was administered, (f) … (g) … (h) … (i) the quantity of drugs of addiction of that kind held at that place after the transaction takes place, (j) any other details approved by the Director-General. (2) Each entry in a drug register must be dated and signed by the person by whom it is made. …
3. While Mr Elias accepts that he failed to maintain a drug register in the form required by cll 112 and 113 of the PTGR, he claims that he maintained a daily register which recorded the details of all Schedule 8 drugs dispensed. However, he concedes that he did not transfer, or cause to be transferred, the information from that register to the main register on a daily basis as required by cl 112(1).

Particular 7

1. Mr Elias admits particular 7(a). Clause 118 of the PTGR required Mr Elias, among other things, to make an accurate inventory of all drugs of addiction held in the Pharmacy in March and September of each year.

Summary

1. All particulars the subject of complaint 1, except particular 4(a), are admitted. Particular 4(a) is not proven.

Does the admitted conduct amount to professional misconduct?

1. "Unsatisfactory professional conduct" is defined by s 139B(1) of the National Law to mean: … (a) Conduct that demonstrates the knowledge, skill or judgment possessed, or care exercised, by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience. ... (l) Any other improper or unethical conduct relating to the practice or purported practice of the practitioner's profession.
2. Mr Elias admits that the conduct the subject of the Complaint constitutes "unsatisfactory professional conduct" as defined by s 139B(1)(a) of the National Law. While he admits that the conduct was "improper" for the purpose of s 139B(1)(l) of the National Law, he does not admit that the conduct was "unethical".
3. In addition, Mr Elias does not admit, as alleged by the Commission, that the admitted conduct amounts to "professional misconduct". "Professional misconduct" is defined by s 139E to mean: (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.
4. The central question to be determined is whether the admitted unsatisfactory professional misconduct amounts to "professional misconduct", that is, whether it was of a "sufficiently serious nature" to justify an order for suspension or cancellation. This requires us to make an evaluative judgement: Chen v Health Care Complaints Commission [2017] NSWCA 186 (Chen) at [20]. As Basten JA emphasised in Health Care Complaints Commission v Karalasingham [2007] NSWCA 267, in referring to the definition of professional misconduct in the now repealed Medical Practice Act 1992 (NSW), which is in similar but not identical terms to the definition contained in the National Law, the definition of professional misconduct is focused on the nature of the conduct, not whether an order for suspension or cancellation should be made: [67].
5. In evaluating whether the subject conduct is of a sufficiently serious nature to justify suspension or cancellation, circumstances that bear on the objective assessment of that conduct must be taken into account. These include the nature and duration of the conduct, any mitigating factors and an assessment of where the offending conduct falls on the spectrum of unsatisfactory professional conduct.
6. The offending conduct is to be measured by the extent to which it departs from proper standards and not by reference to the worst cases. To do the latter would risk the misconduct of some practitioners indirectly setting the standards to be applied by the Tribunal: Health Care Complaints Commission v Litchfield [1997] NSWSC 297; (1997) 41 NSWLR 630 at 638.

Submissions

1. The Commission accepts that no single instance of unsatisfactory professional conduct in this case is sufficiently serious to justify the sanction of suspension or cancellation. While conceding that the admitted conduct could not be characterised as being the most serious type of unsatisfactory professional conduct, nonetheless the Commission contends that, when considered as a whole, the conduct is sufficiently serious to justify an order for suspension or cancellation.
2. The Commission does not suggest that the admitted conduct is in the nature of dishonest conduct. Rather the Commission contends that the conduct is in the nature of reckless indifference to the professional obligations imposed on pharmacists and the dispensing requirements imposed by the PTGR. The Commission points out that as the proprietor of the Pharmacy, Mr Elias was responsible for ensuring that adequate systems were in place to prevent medication being dispensed in circumstances where the subject prescription did not conform with those requirements.
3. Mr Elias agrees that the admitted conduct was of a serious nature but contends that it is not sufficiently serious to warrant the cancellation or suspension of his registration. He points out that the conduct in the main related to the dispensing of medication on repeat prescriptions in circumstances where either the interval between repeats had not been entered on the prescription or where the medication was dispensed on a repeat prescription at shorter intervals than specified in the original prescription. While acknowledging the seriousness of that conduct, he contends it is not of a sufficiently serious nature to justify the cancellation or suspension of his registration.
4. Mr Elias asserts that in assessing the seriousness of the conduct, the Tribunal should have regard to the difficulties he encountered in finding and retaining suitable staff in 2014, his failure to devote sufficient resources to overseeing the management of the Pharmacy, together with his own lack of knowledge of the relevant requirements governing the handling and dispensing of prescription medication, in particular drugs of addiction. He claims that throughout 2014 he was preoccupied in caring for his father who was then gravely ill and undergoing chemotherapy.
5. In support of his claim that the problems evident in the Pharmacy were the result of the particular difficulties that arose in 2014, Mr Elias points out that on reviewing the Westcare Pharmacy in Bankstown in early 2015 the PSU found no issues of concern. Mr Elias has owned the Bankstown Pharmacy since 2000.

Was the conduct of a sufficiently serious nature to justify suspension or cancellation?

1. While as the Commission concedes the admitted conduct was not conduct of the most serious nature, it nonetheless fell a long way short of the standards expected of a practitioner of Mr Elias' level of experience. While Mr Elias was not motivated by personal gain and the conduct did not involve the deliberate flouting of the regulations governing the dispensing and handling of prescription medication, nonetheless the conduct was objectively serious. Given that at the time Mr Elias had been practising for close to 14 years, his lack of knowledge of key requirements contained in the PTGR is troubling.
2. The evaluation of whether the cumulative effect of the admitted conduct is of a sufficiently serious nature to justify an order for suspension or cancellation requires an assessment of the nature of the subject conduct itself. Remedial steps taken by Mr Elias after the conduct occurred, while relevant to the determination of the form of any protective orders, are not relevant to the assessment of the nature of the conduct.
3. Relevant to the evaluation of the seriousness of the admitted conduct is the potential for harm. The conduct had the potential to contribute to the misuse and abuse of prescription medication, including drugs of addiction. It is a matter of common knowledge that the misuse and abuse of drugs of addiction poses a real and serious risk to the health and safety of individuals and the community at large. As the Tribunal noted in Health Care Complaints Commission v Elliott [2018] NSWCATOD 47 at [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.
4. Also relevant to the evaluation of the seriousness of the conduct is its frequency and duration. This was not a case of a one-off contravention of the requirements of the PTGR but of multiple contraventions over a five month period. While not deliberate, these failures were nonetheless serious.
5. We are satisfied that, considered as whole, the admitted unsatisfactory professional conduct is of a sufficiently serious nature to justify the suspension or cancellation of Mr Elias' registration.

What protective orders should be made?

1. The Commission seeks the suspension of Mr Elias' registration for a period of six months. Citing the comments of Meagher JA in Health Care Complaints Commission v Do [2014] NSWCA 307 at [34]-[39], the Commission contends that the making of a suspension order would serve the public interest by denouncing Mr Elias' conduct and signalling to the profession its unacceptability. In addition, the Commission requests that conditions be imposed on Mr Elias' registration requiring that he submit to an audit of his records by a person nominated by the Pharmacy Council of NSW for a period of six months.
2. While Mr Elias accepts that the admitted conduct is deserving of a reprimand and the imposition of conditions on his registration, he contends that given the passage of time and his determined efforts to address the deficiencies in his practice, an order for suspension is neither necessary nor appropriate. He accepts that it is appropriate for conditions to be imposed on his registration but argues that the continuation of the existing conditions is not necessary or appropriate. He agrees with the Commission's proposal that as a condition of his registration he should be required to submit to an audit of his practice. In addition, he proposes that he be required to submit to a performance assessment and possibly supervision.

Remedial steps taken by Mr Elias

1. According to Mr Elias, once the issues identified by the PSU were brought to his attention in late 2014, he made concerted efforts to address the deficiencies in his practice. These include addressing the gaps in his knowledge of the regulations governing the dispensing, handling and auditing of prescription medication by, among other things, undertaking the "Ethics and Dispensing in Pharmacy Practice" course conducted by the Pharmaceutical Society of Australia; and reading widely about those regulations, including the online material produced by the Pharmaceutical Society.
2. In addition, he claims to have taken the following steps once he had been alerted to the problems within the Pharmacy: scrutinising all prescriptions especially for drugs of addiction for possible forgeries; refusing supply if the medication was assessed as not being "therapeutically appropriate"; ensuring that staff conduct a daily stocktake and that the pharmacist in charge conducts a bi-annual stocktake of all methadone products; monitoring staff performance on an ongoing basis by, among other things, personally reviewing the dangerous drug register to ensure all stock on hand is recorded; and, implementing a system to prevent staff from using the log in details of other pharmacists when dispensing medication.
3. Mr Elias claims to be "deeply ashamed" of his actions. In support he points, first, to the candid admissions he made to the PSU when first interviewed on 13 January 2015; and, second, to his decision to voluntarily relinquish his drug authority in relation to drugs of addiction.

Statutory framework and principles that govern the making of protective orders

1. Where a complaint made under the National Law is proven or admitted, the Tribunal may exercise any of the powers in Sub-div 6 of Pt 8 of the National Law. They include the powers to caution, reprimand, impose conditions on a practitioner's registration, order a practitioner to undergo medical or psychiatric treatment or counselling, or complete an educational course. As noted above, if satisfied that the practitioner has been found guilty of professional misconduct, the Tribunal may suspend or cancel the practitioner's registration: s 149C(1) of the National Law.
2. The National Law directs that in exercising the power to make an order under Sub-div 6 of Pt 8, the paramount consideration is the protection of the health and safety of the public: s 3A. While the health and safety of the public is the paramount consideration, the jurisdiction exercised by the Tribunal is nonetheless protective not punitive. Any order designed to protect the public from a repetition of the conduct that is the subject of a complaint found proven requires an evaluation of the seriousness of that conduct and the nature and extent of any justifiably apprehended harm that might be caused if it were to be repeated. No order should be made which has more serious consequences for the practitioner than is reasonably necessary for the execution of the protective purpose: NSW Bar Association v Meakes [2006] NSWCA 340 at [114].
3. In Lee v Health Care Complaints Commission [2012] NSWCA 80, Barrett JA at [20] stated that the task of the decision-maker in making protective orders centres not on punishment as such but on the protection of the public and the maintenance of proper professional standards, citing with approval the comments made by Basten JA in Director-General, Department of Ageing, Disability and Home Care v Lambert [2009] NSWCA 102; (2009) 74 NSWLR 523 at [83]:

Proposed orders

1. We have decided to issue Mr Elias with a reprimand and not, as the Commission urges, to suspend his registration for the following reasons. First, close to five years have now passed since the subject conduct occurred and in that period Mr Elias has taken steps to remedy the defects in his practice and knowledge. Second, in that time there have been no reported issues of concern about Mr Elias or the Pharmacy. Third, we are satisfied that Mr Elias is contrite and determined not to repeat the types of conduct which are the subject of the Complaint. A reprimand, in our view, is sufficient to signal to the profession and the community the unacceptability of Mr Elias' conduct.
2. While we are satisfied that Mr Elias has taken action to address his lack of knowledge of the relevant requirements and is committed to not repeating the offending conduct, because he has not been involved with the dispensing of drugs of addiction since his authority to do so was withdrawn in early 2015, his claim that his knowledge of the relevant regulations is now sufficient to ensure the events of 2014 are not repeated has not been tested. For that reason, in addition to the audit condition supported by both parties, we have decided to require Mr Elias to submit to a performance review and to participate in a mentoring relationship. The former will enable Mr Elias' claim to have addressed the shortcomings in his knowledge and practice to be assessed. The latter will assist Mr Elias to critique and, if necessary, make improvements to his practice. In our view, a formal mentoring arrangement is more appropriate than supervision because, among other things, as he revealed in these proceedings, Mr Elias now works only three to five hours a week as a pharmacist. This may make it difficult for Mr Elias to remain abreast of the ever changing and increasingly complex regulatory regime which governs the practice of pharmacy in NSW. It may be prudent that Mr Elias review his commitment of time devoted to the profession as it may impact on his ability to maintain a thorough working knowledge of the relevant rules.

Form of conditions

1. The parties are invited to comment on the form of conditions we propose to place on Mr Elias' registration. The Commission must file and serve its submissions within 14 days of the date of this decision. Mr Elias must file and serve his submissions within 14 days of receipt of the Commission's submissions. We are of the view that the issue of the proper form of orders can adequately be dealt by way of written submissions without holding a hearing, as permitted by s 50(3) of the Civil and Administrative Tribunal Act 2013 (NSW). The parties are invited to indicate in their respective submissions whether they share this view.
2. The condition which the Tribunal proposed to place on Mr Elias' registration are as follows: 1. Pursuant to s 163(4) of the National Law the following conditions are imposed on Mr Elias's registration for a period of 12 months or such longer period as determined by the Pharmacy Council (the Council):

1. Mentor relationship 1. 1.1 Mr Elias must accept a mentor approved by the Pharmacy Council of NSW (the Council) to advise and assist him in the management of his pharmacy practice, focusing on legislative compliance with obligations pursuant to the Poisons and Therapeutic Goods Act 1966 (NSW) (PTG Act) and the Poisons and Therapeutic Goods Regulation 2008 (PTG Regulation). 2. 1.2 Mr Elias must provide the mentor with a copy of the decision made by the New South Wales Civil and Administrative Tribunal which imposed these conditions [Heath Care Complaints Commission v Elias [2019] NSWCATOD 19] (the NCAT decision) and the mentor must provide a signed copy of the decision to the Council within four weeks of being appointed as a mentor. 3. 1.3 The mentor relationship is to continue for a period of 12 months from the date of the Council's appointment or approval of the mentor. The mentor shall report to the Council as and when he or she sees fit during the term or his or her appointment and shall report to the Council at the conclusion of the 12 month period of mentorship.

2. Audit 1. 2.1 Mr Elias must submit to an audit of his records by a person (the Auditor) appointed by the Council. 2. 2.2 The first audit must occur within three (3) months of the NCAT decision and thereafter at a frequency to be determined by the Council. 3. 2.3 The Auditor is to examine and assess the following aspects of Mr Elias's practice: 1. 2.3.1 dispensing systems, and 2. 2.3.2 the storage, supply, recording and destruction of drugs, including drugs of addiction. 1. 2.4 Mr Elias must authorise the Auditor to provide the Council with a report of the Auditor's findings following each audit. 2. 2.5 Mr Elias must bear all reasonable costs associated with any audit conducted by the Auditor.

3. Performance review 1. 3.1 Mr Elias must submit to a performance review to be conducted by a nominee of the Council within six months of the date of the NCAT decision. 2. 3.2 Mr Elias must bear all reasonable costs associated with the conduct of the performance review.

Appropriate review body 1. While Mr Elias's principal place of practice is NSW, the Pharmacy Council is the appropriate review body for the purposes of Pt 8, Div 8 of the Health Practitioner Regulation National Law (NSW).

Costs

1. Mr Elias concedes, properly in our view, that there has been no disentitling conduct by the Commission which might justify a departure from the "general rule" that he pay the Commission's costs.
2. We order that Mr Elias pay the Commission's costs, as agreed or assessed.

I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales. Registrar DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated. Decision last updated: 08 February 2019