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[2014] QCAT 459
General information, not legal advice.
Queensland Civil and Administrative Tribunal
2014-08-19
Original judgment source is linked above.
Pharmacy Board of Australia v Ciriello [2014] QCAT 459
Judge Alexander Horneman-Wren SC, Deputy President
PROFESSIONS AND TRADES - HEALTH CARE PROFESSIONALS - PHARMACEUTICAL CHEMISTS - DISCIPLINARY PROCEEDINGS - where it is alleged and admitted that the respondent engaged in unsatisfactory professional conduct - where the registrant contravened the Health (Drugs and Poisons) Regulation 1996 (Qld) by the method which the registrant dealt with and sold pseudoephedrine - where an agreed statement of facts and joint proposal on sanction are put forward - whether the sanction is within a permissible range in the circumstances
Medical Board of Australia v Martin [2013] QCAT 376
[1] The Pharmacy Board of Australia has referred a disciplinary proceeding to the Tribunal against Mr Antonio Cosimo Ciriello, a registered pharmacist, pursuant to s 193(1)(a)(i) of the Health Practitioner Regulation National Law (Queensland) ('National Law'). The referral, as referred by the Board, alleges that Mr Ciriello has engaged in professional misconduct within the meaning of that expression as set out in the National Law. Professional misconduct is defined by s 5 of the National Law to include, relevantly on the allegations of the Board:
(a) unprofessional conduct by the practitioner that amounts to conduct that is substantially below the standard reasonably expected of a registered health practitioner of an equivalent level of training or experience; and
(b) more than one instance of unprofessional conduct that, when considered together, amounts to conduct that is substantially below the standard reasonably expected of a registered health practitioner of an equivalent level of training or experience.
[2] Unprofessional conduct itself is defined by s 5 of the National Law to mean 'professional conduct that is of a lesser standard than that which might reasonably be expected of the health practitioner by the public or the practitioner's professional peers'.
[3] Certain specific matters are included in the definition, but it is otherwise not exclusive. Section 196(1)(b) of the National Law provides that:
After hearing a matter about a registered health practitioner, a responsible tribunal may decide one or more of the following -
(ii) the practitioner has behaved in a way that constitutes unprofessional conduct; [or]
(iii) the practitioner has behaved in a way that constitutes professional misconduct.
[4] By section 196(2) of the National Law 'If a responsible tribunal makes a decision referred to in subsection 196(1)(b)' that is, that the practitioner has behaved in any of the ways there set out 'the tribunal may decide to do one or more of the following -' a number of particular things set out in s 196(2).
[5] The referral of the Board of the proceedings to the Tribunal alternatively alleged that the registrant had engaged in conduct which amounted to unprofessional conduct as opposed to professional misconduct. The parties have reached agreement as to the facts upon which the matter is to proceed to be determined by the Tribunal and have jointly proposed a sanction. Part of that agreement is as to the nature of the finding which the Tribunal ought make pursuant to s 196(1)(b) of the National Law. The parties jointly seek a finding that Mr Ciriello, based upon his admissions, has behaved in a way that constitutes unprofessional conduct.
[6] It remains a question for the Tribunal as to what finding ought be made under s 196(1)(b). However, it will be evident from the definitions to which I have already referred that a finding of professional misconduct involves a finding of unprofessional conduct. In circumstances in which the Tribunal has not heard full argument on the matter, given the agreement reached, the Tribunal is content to proceed on the basis of a finding of unprofessional conduct pursuant to s 196(1)(b)(ii) of the National Law, without finally determining the issue, as it is no longer invited to do so by the Board, as to whether the conduct might also constitute professional misconduct.
[7] The conduct has been summarised by the parties as falling into three categories. First, a failure to comply with the pharmacy quality standard in contravention of s 273A of the Health (Drugs and Poisons) Regulation 1996 (Qld) ('the Regulation'); secondly, a failure to record sales of pseudoephedrine contrary to s 285A of the Regulation; and thirdly, a failure to assess the therapeutic need of persons to whom pseudoephedrine was dispensed contrary to s 277 of the Regulation.
[8] Section 273A of the Regulation prohibits the sale of Schedule 3 poisons, unless the pharmacist has prepared or adopted a quality standard for selling Schedule 3 poisons and, in selling the Schedule 3 poison, complies with that quality standard.
[9] Section 285A of the Regulation requires that a person who sells Schedule 3 pseudoephedrine must, at the time of the sale, make a record of each of the date of the sale, the brand and quantity of the Schedule 3 pseudoephedrine sold, and the purchaser's name and address.
[10] From 1 July 2010, s 285A of the Regulation required the person who sells pseudoephedrine to also keep an electronic record of the sale that is accessible online by both the Chief Executive and the Commissioner for Police.
[11] Section 277 of the Regulation prohibits pharmacists from selling Schedule 3 pseudoephedrine, unless the pharmacist is reasonably satisfied that the purchaser has a therapeutic need for the pseudoephedrine, and if the seller does not know the identity of the purchaser, the purchaser gives the seller an acceptable form of identification.
[12] Mr Ciriello has admitted contraventions of each of ss 273A, 285A and 277 of the Regulation.
[13] The conduct in respect of which the referral relates was discovered as a consequence of an audit of the pharmacy conducted by Mr Ciriello. Mr Ciriello has been practicing pharmacy since 1976 and, since 1 April 1985, has carried on the business at the Nerang Day and Night Pharmacy located in Nerang, Queensland.
[14] On 5 May 2011, officers from the Drugs and Poisons Policy and Regulation Unit of Queensland Health attended the pharmacy for the purpose of obtaining dispensing data and auditing the pharmacy's compliance with the Regulation. Dispensing data was obtained for the period between 1 January 2009 to 5 May 2011. It included the pharmacy's dispensing data for both Schedule 4 restricted drugs and Schedule 3 poisons.
[15] As a consequence of the findings of the audit, on 15 December 2011, Queensland Health issued a notice of decision to Mr Ciriello, pursuant to s 24 of the Regulation, cancelling his endorsement to deal with all Schedule 4 drugs and Schedule 2 and 3 poisons containing the active ingredient pseudoephedrine, for a period of 12 months.
[16] On 13 December 2012, the Australian Health Practitioner Regulation Agency ('AHPRA') took immediate action, pursuant to s 156 of the National Law, against Mr Ciriello, by which it imposed conditions on his registration. Those conditions were satisfied by Mr Ciriello and were removed in December 2013.
[17] In relation to the contravention of s 273A of the Regulation the pharmacy had implemented a quality standard for the sale of PSE products as was required by that provision. The quality standard of the pharmacy relevantly stated, in respect of the pharmacy's attitude towards supply of pseudoephedrine based products, the following:
We record all pseudoephedrine in Project STOP website which lists the date, license number and product number and quantity. We also keep a record, in the dispensing system, of all pseudoephedrine sales. And we don't supply quantities larger than allowed under the law which is 720 milligrams of pseudoephedrine in tablet form and 800 milligrams in liquid form. Therefore we don't sell multiple packs of pseudoephedrine based products.
[18] The audit revealed that during the audit period the pharmacy had sold 1,189 units of pseudoephedrine, but only recorded 1,010 sales in Project STOP. The audit also revealed that the pharmacy had failed to record 179 sales, or 15 per cent of transactions involving pseudoephedrine, on Project STOP. Pseudoephedrine was dispensed to one customer of the pharmacy, HB, on 12 occasions between 4 October 2010 and 3 December 2010. None of those transactions were recorded on Project STOP. Of those 12 occasions, the registrant was responsible for the sale of the PSE to HB on two of them. He also sold PSE to HB on 24 February 2011 without recording the transaction in Project STOP.
[19] Mr Ciriello has deposed, in an affidavit filed on 15 May 2014, to the fact that HB had been visiting the pharmacy for 15 years and was, at the time, well known to him as a long term customer of the pharmacy. He makes those observations whilst accepting that they do not provide an excuse for his conduct in failing to record those sales in Project STOP.
[20] Mr Ciriello admits that as the owner of the pharmacy he was responsible for the pharmacy's recording of PSE in Project STOP, and that the failure to record sales has breached his professional obligations. However, he says that his failure to accurately record PSE in Project STOP did not occur with the intention of deliberately breaching or disregarding his professional obligations and did not occur with the actual knowledge that it breached his professional obligations; although he accepts that both of those matters do not provide an excuse.
[21] In respect of them he deposes in his affidavit to having been under the mistaken belief that the recording of PSE products on Project STOP was at the discretion of the pharmacist. He deposes to being no longer of that belief. He says that he does not recall having received, or having it brought to his attention by staff, the joint Pharmacy Guild Queensland Health mail out advising pharmacists of the mandatory recording requirements which came into effect on 1 June 2010.
[22] He deposes that whilst he implemented in the pharmacy a quality standard he was not aware at the time that it was a legislative requirement to comply with the quality standard, that he erroneously believed that the quality standard was an internal staff policy document, and that the dispensing of PSE in accordance with a valid doctor's script was legitimate practice.
[23] He states that he is no longer of those beliefs and now accepts that, as a pharmacist, he had an independent obligation despite the existence of a doctor's prescription.
[24] I shall return to those matters in the context of the failure to record. However, it should be observed that the independent obligation of the pharmacist to assess the therapeutic need of the patient, notwithstanding a doctor's prescription, is fundamental.
[25] In respect of that aspect of the pharmacy's quality standard concerning large volume sales, the audit revealed that on average the registrant sold 3.2 units of PSE per transaction and that he was responsible for dispensing the greatest number of multiple packs of PSE at the pharmacy.
[26] On 1 February 2011 and 1 March 2011 the registrant dispensed five units of PSE to a customer JP. In respect of JP, Mr Ciriello deposes that JP was a local resident who suffered from disabilities and was unable to stand or walk without assistance. He resided at a care facility within the region. The PSE was dispensed to JP in a Webster pack prepared by the pharmacy and those Webster packs were collected by JP's carers or delivered to the care facility. A doctor had prescribed PSE in respect of JP on eight occasions between 1 March 2010 and 23 July 2010. The doctor who had prescribed the PSE to JP had left the medical practice concerned suddenly. From that I infer that had Mr Ciriello wished to contact the doctor to confirm the prescription he was unable to do so. The dispensing of the PSE in the Webster pack had been in accordance with the previous prescriptions of the doctor.
[27] Mr Ciriello deposes to the, again with respect, somewhat misguided, belief that as a pharmacist he had a duty not to cease medication which was prescribed, in respect of a client, without the prescribing doctor's consent because it could have serious implications on the client. Again with respect, this belief seems to fundamentally misunderstand the responsibility of the pharmacist in the dispensing of medication.
[28] Multipacks of PSE were also sold by Mr Ciriello to a customer, BK. On 22 March 2011, 15 units were sold to BK. The PSE was dispensed upon two scripts from Dr E both written on 10 March 2011. The dispensing of the PSE to BK was in accordance with the scripts. Nonetheless, it was inconsistent with the pharmacy's quality standard and s 273A of the Regulation.
[29] In respect of the dispensing to BK Mr Ciriello deposes to having been informed by BK that he was travelling overseas to a remote part of Asia and that he suffered from a bad running nose. He says that BK was nearly in tears when speaking to him and that he claimed that no other pharmacist would believe him.
[30] Nonetheless, Mr Ciriello believed BK. As the two scripts were from Dr E, who was known to Mr Ciriello, he telephoned the doctor to verify the scripts. Notwithstanding his belief of BK, it is apparent, and he accepts in hindsight, that the fact that no other pharmacist would believe BK ought to have put him on notice that there may be a lack of therapeutic need.
[31] In respect of the failures to record the sales of PSE contrary to s 285A of the Regulation the audit revealed that during the audit period the pharmacy obtained 2,485 units of PSE from wholesalers. The pharmacy had recorded in the dispensing data that it had dispensed 1,924 units of PSE and held 228 units of PSE as stock on hand at the conclusion of the audit period. It had not recorded any units of PSE as being stolen. In respect of the registrant himself, the dispending data revealed that he was responsible for selling 574 items or 24 per cent of the PSE from the pharmacy. As noted, it revealed that he had sold on average 3.2 packets of PSE per transaction and was the person responsible for the greatest number of multi-pack dispensing of PSE at the pharmacy.
[32] In respect of the dispensing of PSE to the patient JP, to which I have already referred, on two occasions, 1 February 2011 and 1 March 2011, the registrant dispensed multiple packs to him without recording details of the prescribing doctor in the dispensing data. The audit also revealed that of the stock obtained by the pharmacy during the audit period, 333 items, or 13 per cent of all stock obtained by the pharmacy, were not accounted for in the dispensing record.
[33] Mr Ciriello accepts that as the owner of the pharmacy he was responsible for the dispensing data for the pharmacy. As already noted, Mr Ciriello has deposed to being unaware of the mandatory requirement to record subsequent to 1 June 2010. He also deposes that, of the 333 units of PSE that were not accounted for in the dispensing records, 114 of them were manually recorded in a book, but he accepts that that was not in accordance with his professional obligations.
[34] Further, he believes that PSE purchased by staff and doctors who attended the pharmacy to purchase PSE for personal use was not recorded, although he does not offer any explanation in his affidavit as to why that would be so. He also refers in his affidavit to various drugs having been stolen from the pharmacy after a ram raid in November 2009, but otherwise does not link the unaccounted for PSE to those circumstances.
[35] He accepts that the pharmacy's failure to accurately record PSE was in breach of s 285A of the Regulation, the practice guidelines and the proprietor's guidelines. However, he says that his failure to accurately record the PSE did not occur with the intention of deliberately breaching or disregarding his professional obligations or with the actual knowledge that it breached those obligations. Although, again, he accepts that neither of those matters provide an excuse.
[36] In respect of the failure to assess therapeutic need contrary to s 277 of the Regulation, I have already referred to the circumstances of the dispensing of products to the patient HB and to the patient BK. In respect of BK, I have already referred to the fact that BK had informed Mr Ciriello that no other pharmacist would believe him in relation to his condition. It is apparent from the statement of agreed facts that Mr Ciriello sold the PSE to BK on 22 March 2011 in circumstances where Project STOP indicated that a pharmacy located close to Mr Ciriello's pharmacy had denied the sale of PSE to BK the previous day, and that Project STOP indicated that BK had attended 10 different pharmacies to purchase PSE. Mr Ciriello says that he had attempted to assess the therapeutic need of BK and believed that he was satisfied of that need at the time, but accepts now with the benefit of hindsight that he ought not to have been reasonably satisfied of a genuine therapeutic need.
[37] That said, the sale of PSE to BK was in accordance with a doctor's script, and Mr Ciriello recorded the sale from his pharmacy in Project STOP. Mr Ciriello also made a safety sale of PSE to another customer, SW, on 25 November 2010 in circumstances where that customer had attended seven other pharmacies prior to obtaining the PSE from Mr Ciriello. Following that safety sale on 25 November 2010 the pharmacy dispensed PSE to SW on 17 occasions, with Mr Ciriello being responsible for the sales on five of those occasions. Mr Ciriello says that at the time of dispensing he had attempted to assess SW's therapeutic need and believed that he was satisfied of a therapeutic need, but again accepts, with the benefit of hindsight, that he ought not have been so satisfied.
[38] A safety sale was made to another customer, NG, on 22 October 2009. On 29 October 2009 the pharmacy denied the sale of PSE to NG, however, dispensed PSE to NG on nine subsequent occasions. The registrant was not, however, the pharmacist who dispensed the PSE to NG on any of those occasions but accepts that as the owner of the pharmacy he had an obligation to ensure that the pharmacy business was conducted in accordance with the Regulation and his professional obligations.
[39] Another customer, AD, was sold PSE by Mr Ciriello on 15 October 2010 in circumstances whereby Project STOP indicated that a nearby pharmacy had denied AD PSE the previous day and also recorded a pattern of sales of PSE to AD, including four prior safety sales and a prior denied sale. Again, Mr Ciriello says that at the time of dispensing he had attempted to assess AD's therapeutic need and believed that he was satisfied of that need although in hindsight accepts that he ought not to have been.
[40] Another safety sale was made to a customer LS on 21 January 2011 in circumstances where Project STOP recorded that LS had attempted to purchase PSE on 19 January 2011 from a nearby pharmacy and one in Brisbane.
[41] Overall, Mr Ciriello accepts that he ought to have known that the quantity and frequency within which PSE was dispensed to HB, BK and SW was beyond the extent necessary to safely practice pharmacy and in breach of s 277 of the Regulation and the terms of his endorsement. In conceding that he ought not to have been satisfied of therapeutic need at the times at which he attempted to assess the customers, he accepts that he was too trusting in assessing that therapeutic need at the time.
[42] Whilst it is unnecessary for me to make a finding as to whether or not Mr Ciriello's conduct would also constitute professional misconduct - it being accepted that it constitutes unprofessional conduct - it should be observed that there are a number of features of the sales in this case which distinguish it somewhat from earlier cases which have been before the Tribunal. Particularly a number of the sales seem to have been supported by prescriptions issued by doctors. Of course, it remains the obligation of a pharmacist to not simply dispense in accordance with the prescription, but to assess the therapeutic need of the patient for whatever medication it is which is being dispensed at the time. As I have already observed, Mr Ciriello's earlier deposed belief to the contrary seems at odds with the fundamental understanding of the obligation of the pharmacist.
[43] The draft order which has been jointly proposed by the parties is, in my view, within the reasonable range of sanctions which ought be imposed so as to ensure the protective purpose for which proceedings such as this is achieved. It imposes a period of suspension of Mr Ciriello's registration for a period of two months. That is, in my view, an appropriate sanction and is in accordance with earlier decisions of the Tribunal.
[44] It also imposes conditions upon Mr Ciriello's registration which require him to undertake a period of mentoring of not less than two hours per month for a period of three months, focusing on ethical decision making in a dispensing environment, and imposes reporting obligations in that regard. That too is appropriate.
[45] The conditions also prohibit Mr Ciriello from applying for reinstatement of his unrestricted endorsement for PSE for a period of two years.
[46] Mr Ciriello has indicated in the proceedings that the pharmacy no longer dispenses PSE and has no intention of doing so in the future. In other proceedings, the Tribunal has observed that the matter of the endorsement for the dispensing of PSE is a matter which is controlled by Queensland Health. However, in the circumstances of this case I consider it appropriate, given the parties have agreed to the imposition of that condition, to include it amongst the conditions to be imposed on Mr Ciriello's registration.
[47] Proposed order 4 is that the details of the conditions imposed on the registration are to be recorded on the Board's register for the period the conditions are enforced. Section 225 of the National Law provides that the national register must include, if a condition has been imposed on the practitioner's registration, the details of the conditions, unless s 226(1) applies, which provides a discretion so as not to record the detail, but rather the fact of the condition.
[48] In my view, proposed order 4 is unnecessary. It seeks to impose a period in respect of which the Act is silent. In my view, for reasons which I have earlier expressed, it is inappropriate to make that order.
[49] Section 196(3) provides that if the Tribunal decides to impose a condition on a practitioner's registration, the Tribunal must also decide a review period. Proposed order 5 proposes a review period of one year, which is appropriate.
[50] Proposed order 6 provides for the payment of the Board's costs of and incidental to the proceedings in a sum to be agreed or assessed, which is also appropriate.
[51] In my view, the orders proposed satisfy the purposes of the Act and the protected purposes of proceedings such as these.
[52] For reasons which the Tribunal has explained in the Medical Board of Australia v Martin [2013] QCAT 376, where the orders proposed fall within a reasonable range of outcomes for such a case, there are strong public policy reasons why orders agreed between the parties should not be interfered with by the Tribunal. This is such a case.
[53] Pursuant to s 66 of the Queensland Civil and Administrative Tribunal Act 2009 (Qld), I order that the publication of any material filed or given in evidence that might facilitate the identification of any person other than the registrant.
Pharmacy Board of Australia
Ciriello [2014] QCAT 459