n National Law an order is made prohibiting the publication of the name of the Patient A as set out in the schedule to the complaint.
[2]
Introduction
This is an application by the Health Care Complaints Commission, the Commission, for disciplinary findings and orders against Samuel Green under the Health Practitioners National Law NSW (Pharmacy).
Mr Green was first registered as a pharmacist in 2012.
Between January 2013 and January 2016, Mr Green held the position of Pharmacist in Charge at Chemist Outlet Dubbo ("the Pharmacy"). This pharmacy dispensed methadone to participants as part of an opioid substitution program. It is Mr Green's conduct whilst working at this pharmacy which is the focus of this case.
There are two main areas of complaint against Mr Green. Firstly how he stored Biodone, a sugarless form of methadone syrup and how he managed Biodone stocks and record keeping for not only that program but drug medication registers more generally. Secondly, the circumstances surrounding the dispensing of medication to a patient, Patient A, and to himself.
The Commission alleges that Mr Green constructed a modified methadone dispensing unit for the storage and dispensing of Biodone. It also alleges that he failed to do accurate stock checks and maintain proper records. There are a range of controls in place for pharmacists dispensing methadone from community pharmacies and it is alleged that these controls were not observed by Mr Green.
Towards the end of 2015 Mr Green resigned from his position. On 4 January 2016 Ms Sarah Dorman commenced working at the Pharmacy as Pharmacist in Charge.
On 28 January 2016, Ms Dorman called the Pharmaceutical Regulatory Unit, PRU, to express concerns about the manner in which she observed the Methadone to be stored at the Pharmacy. Her concerns related to a unit modified by Mr Green which meant that the Methadone was transferred from the manufacturer's bottles into a large plastic container similar to that used to store pool chlorine. The plastic container was stored in a safe. The methadone pump was affixed to the countertop and plastic tubing extended from the pump into the container via a hole drilled through the top of a safe.
Ms Dorman emailed the PRU photographs of the unit and advised that the police had attended and disposed of the contents of the container in the safe resulting in a shortfall of 2,418ml of Methadone solution (Biodone).
On 3 February 2016 Ms Dorman again spoke to officers at the PRU to advise that she had been approached by a patient, Patient A, seeking medication without a prescription. Patient A informed Ms Dorman that Mr Green had in the past provided the medication to him without a prescription.
On 19 February 2016 Mr Green was interviewed by officers of the PRU. On 7 April 2016 the PRU provided a report expressing a number of concerns in relation to Mr Green's conduct.
On 11 May 2016 the Pharmacy Council of New South Wales imposed conditions on Mr Green's registration as a Pharmacist pursuant to s150(1)(b) of the National Law. These conditions required that he not work as a Pharmacist in Charge, and that he not possess, supply, dispense, administer, or manufacture any substance detailed in Schedule 8 of the NSW Poison List (drug of addiction, derivative or compound medication) or any substance detailed in an equivalent list of any other Australian State or Territory. He was required to surrender his drug authority under the Poisons and Therapeutic Goods Regulation 2008 (PTGR). The matter was also referred to the Commission.
Mr Green is not currently registered. He surrendered his registration on 1 June 2016. He has not worked as a pharmacist since late 2015.
Mr Green was legally represented until shortly before the hearing. There was no request from Mr Green for an adjournment of the hearing due to legal representation not being available or on any other basis. At the hearing he represented himself with some limited assistance and representation provided by his mother, who sought and was granted leave by the Tribunal to do so. Mr Green's mother is not a legal practitioner and leave was granted under section 45 of Civil and Administrative Tribunal Act 2013.
[3]
The Application before the Tribunal
The application is dated 15 December 2017. It attaches a Complaint which initially contained five individual complaints.
At the hearing the Complaint was amended. Complaint Three as it then stood was withdrawn in its entirety, and complaint Two was refined and narrowed.
Accordingly the net position is that the Complaint comprises four individual complaints against Mr Green.
Three of these complaints are that Mr Green is guilty of unsatisfactory professional conduct under section 139B(1)(a) and (l) of the National Law in that he has:
1. engaged in conduct that demonstrates that the judgment possessed, or care exercised, in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or
2. engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy.
The final complaint is that Mr Green is guilty of professional misconduct under section 139E of the National Law in that he has:
1. engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of his registration, or
2. engaged in more than one instance of unsatisfactory professional conduct that, when the instances are considered together, amount to conduct of a sufficiently serious nature to justify the suspension or cancellation of his registration.
The first three complaints are each supported by a separate and distinct set of particulars. The particulars in support of the final complaint, the complaint of professional misconduct, are the same as those relied on in the earlier three complaints. As such it is based on the matters relied upon in support of the complaints of unsatisfactory professional conduct.
[4]
The particulars of this complaint are as follows:
1. Between 2013 and 2016 Mr Green failed to store Biodone in a manner that complied with the requirements of clause 73 and 76 of the Poisons and Therapeutic Goods Regulation 2008, PTGR, in circumstances where:
1. the safe used for storing the Biodone was not kept securely locked when not in immediate use as the modifications made by Mr Green to the storage unit and/or dose system involved the use of one large container into which all Biodone could be poured, with a hole drilled through the safe and a tube to allow for the pumping of Biodone from outside the safe;
2. the integrity of the safe was breached by Mr Green drilling a hole in it;
3. the neck of the container holding the Biodone liquid was open to environmental contamination;
4. the modifications made to the Biodone storage unit and/or dose system was not approved by the Director-General of the NSW Ministry of Health, as required.
[5]
The Second Complaint
The particulars of this complaint are as follows:
1. Mr Green failed to undertake accurate stock checks as required by clause 118 of the PTGR for Biodone in March 2013, September 2013, March 2014 and March 2015.
2. Between approximately January 2013 and January 2016 Mr Green failed to undertake at least monthly stock checks of methadone and/or Biodone in the circumstances of the high volume of usage of those medications at the Pharmacy.
3. In using the methadone storage unit and the methadone dose system at the Pharmacy, Mr Green poured multiple bottles of Biodone liquid from their original containers into one single large plastic container, in circumstances where the mixing and difficulty in extracting and balancing the various substances using a graduated device resulted in the quantity of Biodone in the container having to be estimated contrary to the requirement for the accuracy of stock checking required under clause 118 of the PTGR.
4. Between 2013 and 2016 Mr Green failed to keep any records of product batch numbers or expiry dates of Biodone liquid in using the modified methadone dose system, so that in the case of a recall, any relevant product was not able to be identified and issues were not able to be appropriately managed.
5. Mr Green failed to appropriately manage the Biodone liquid in that by pouring multiple bottles into one single large container, different batches of Biodone liquid were mixed together creating a risk that some quantity of medication in the container may reach, or pass, its expiry date, endangering patient safety.
6. Contrary to clause 118 of the PTGR, Mr Green failed to keep accurate records in the register of drugs of addiction (s8 register), in that he made a number of errors of subtraction and addition, including as follows:
1. on 16 March 2013 an error of subtraction was made in the s8 register in that the balance of Biodone was 1620.5mL, with a dispensed quantity of 502mL but the balance recorded was 1120.5mL, a discrepancy of 2mL;
2. on 16 March 2013 an error of addition was made in the daily dosing books in that the total daily doses dispensed were 530 mL, the amount written at the bottom of the page was 502 mL and this was transferred to the s8 register;
3. on 28 March 2013 an error of addition was made in the daily dosing books in that the total daily doses dispensed was 559 mL and this was entered as 557 mL;
4. on 11 May 2013 an error of addition in the s8 register was made was made in that the individual amounts written in the register when added together came to a total of 390mL, although the total was recorded as 460mL and the total written out of the s8 register was 354mL;
5. on 18 May 2013 an error of subtraction in the s8 register was made when the previous balance of Biodone read 3085.5mL, a quantity of 354mL dispensed and the balance was recorded as 2740.5mL, a discrepancy of 9mL;
6. on 24 May 2013 there is a discrepancy between the daily book and the s8 register in that the total daily dose is recorded in the daily book as 501mL and recorded in the s8 register as 608mL;
7. on 25 November 2013 an error of subtraction in the s8 register was made when the balance of Biodone on 23 November 2015 was 13348.5mL, a dispensed quantity of 324.5mL and a balance of 13024.5mL was recorded, a discrepancy of 0.5mL.
1. Mr Green failed comply with clause 177(2) of the PTGR in that he altered entries in the s8 register for Biodone by crossing off or scribbling over some of the figures including as follows:
1. on 31 May 2013 daily dosing - the figure in the "Out" column has been corrected;
2. on 1 January 2014, 4 January 2014 and from 3 February 2013 to 14 February 2013 inclusive, daily dosing - the balance has been corrected on each respective date;
3. on 4 January 2014 daily dosing - the figure in the "Out" column has been corrected.
1. Mr Green failed to correctly complete the s8 register in that he failed to enter patient address details, contrary to clause 112 of the PTGR, including as follows:
1. on 18 September 2013 with respect to Concerta 54mg;
2. on 2 October 2013 with respect to dexamphetamine 5mg;
3. on various dates in September and October 2013 with respect to Endone;
4. between 30 May 2014 to 4 February 2015 inclusive with respect to Oxycontin 10mg;
5. between 7 November 2014 and 5 February 2015 inclusive with respect to Norspan 20 mcg;
6. between 2 March 2015 and 6 March 2015 inclusive with respect to Endone.
[6]
The Third Complaint
There are two aspects to this complaint. The first is that in the absence of a valid prescription, and contrary to clause 39 of the PTGR, Mr Green dispensed Sildenafil, Viagra (Sildenafil) and Vedafil (Sildenafil), a Schedule 4 drug, to Patient A on dates and in quantities as set out in Schedule A which was attached to the Complaint.
The second aspect is that Mr Green inappropriately dispensed dexamphetamine, a Schedule 8 drug, to himself on prescriptions which were not valid as they did not include the necessary prescriber authorisation number, contrary to clause 90 of the PTGR.
[7]
The Final Complaint
The final complaint is of professional misconduct. It is based on the matters relied upon in support of the preceding complaints of unsatisfactory professional conduct. Accordingly, the particulars in complaints One, Two and Three are relied upon individually and cumulatively to support this complaint.
[8]
Mr Green's reply to the Complaint
In response to the complaint Mr Green prepared a written reply dated 12 April 2018 and a statement dated 4 June 2018. These documents were made with the benefit of legal advice.
Although the reply was prepared with reference to the initial complaint before it was amended, in general terms, the substance of the reply remained intact. Subject to explanations, Mr Green admitted the particulars set out in the first and third complaints. In relation to the second complaint, particulars 3 and 5 were denied whilst the remainder of the particulars were admitted.
In the reply Mr Green admitted he was guilty of unsatisfactory professional conduct in respect of the first and third complaints, being the storage of the biodone and the inappropriate dispensing of a Schedule 4 drug (Viagra) and a Schedule 8 drug (dexamphetamine). He denied he was guilty of unsatisfactory professional conduct in respect of the second complaint arising out of the allegations of inaccurate stock checks, how he conducted those stock checks and the appropriate management of Biodone liquid. In respect of the last complaint Mr Green denied he was guilty of professional misconduct.
At the hearing Mr Green repeated his previous admissions however, during the course of his evidence on the second day of the hearing, he took issue with six dates which appeared in Schedule A to the Amended Complaint relating to his dispensing of Viagra to Patient A. Mr Green had previously admitted this part of the complaint in its totality.
[9]
Evidence
The written material before the Tribunal and relied upon by the Commission is extensive. It comprises four volumes of documents consisting of some 1000 pages.
Mr Green provided additional documents just prior to and at the hearing. These included two further statements from him about proposed orders and costs, diagrams of the floor plan of the pharmacy and the modifications he made to the biodone dispensing unit together with information about the Socorex Calibrex bottle top dispensing unit which was used. He provided materials about his completion of a number of academic courses including the Pharmaceutical Society of Australia's Ethics and Dispensing in Pharmacy Practice Course.
[10]
Modifications to the dispensing unit the subject of the first complaint
The evidence discloses that Mr Green constructed a modified methadone dispensing unit for the storage and dispensing of Biodone. The modified unit was Mr Green's own creation without the input of the manufacturer of Biodone. He did not seek the approval of the Director-General of the Ministry of Health, as required under the law, Pharmaceutical Services or any other relevant authority in relation to the construction and use of the modified dispensing unit.
The modified methadone dispensing unit comprised a 15 Litre blue plastic container into which Mr Green poured bottles of Biodone. Mr Green estimated that a month's supply of Biodone was poured into the blue plastic container each month. The container was in turn stored in a safe. Mr Green drilled a hole into the safe from which a tube connecting to the blue plastic container holding the Biodone was fed. Mr Green created a stop valve inside the safe, which would be switched off at the end of each day to ensure that no Biodone could be accessed through the top of the safe. Mr Green attached the tubing out of the safe to a Socorex dispensing device and placed a bolt with a padlock above the Socorex dispensing device to prevent more than a few millilitres from being accessed through the top of the safe when locked.
The Biodone was stored and dispensed directly from this container to methadone patients at the Pharmacy.
In Mr Green's written reply to the complaint he admitted particulars 1 and 2 but explained that the safe was not left open or unattended. Further, the neck of the blue plastic container holding the liquid was not open to environmental contamination because it had a lid on it and into which he had drilled a hole for the tubing.
In the photographs provided by Ms Sarah Dorman, the pharmacist who took over as pharmacist in charge of the Pharmacy after Mr Green, there was no lid on the blue plastic container, with the tube being fed directly into the container. Whether there was a lid or not, the Commission submits that the container holding the Biodone was open to environmental contamination, placing the health and safety of the methadone patients at the Pharmacy at risk.
Under cross examination by the Commission Mr Green gave evidence, that although the modified methadone dispensing unit had not been approved by the Ministry of Health, it was an appropriate device and it did not place the health and safety of methadone patients at risk.
In an interview conducted by officers of PRU with Mr Green on 19 February 2016 it was suggested by Mr Green that others specifically the Pharmacy Council and the Quality Care Pharmacy Program, QCPP, had "cleared" the modified unit.
Mr Grahame Cox, Pharmacist, inspected the Pharmacy on two occasions whilst Mr Green was a Pharmacist in Charge and working at the time of both inspections. The inspections took place on 30 October 2013 and 17 March 2015. Mr Cox was the Pharmacy Inspector for the Ministry of Health (NSW).
On 14 December 2016, Mr Cox provided a statement which relevantly stated as follows:
I do not recall looking at the Methadone dispensing unit at Chemist Outlet Dubbo. Methadone medication and dispensing is under the authority of Pharmaceutical Services or the Pharmaceutical Regulatory Unit.
I have viewed the photographs of the modified Methadone unit provided by the Commission, and attached at Annexure B. I have previously seen these photographs when Kim Dolan referred the matter of [Mr Green] to the Pharmacy Council. At the time Kim asked me whether I had seen the unit during my inspection visit, and whether I had given my approval for the unit. I told her that I did not recall seeing it and that if I had I would have referred the enquiry to discuss the matter with the officers at Pharmaceutical Services.
I do not recall discussing the Methadone dispensing unit with [Mr Green] at Chemist Outlet Dubbo. If he did ask me about it, I would have said words to the effect "You had better check it out with the Pharmaceutical Services or Pharmaceutical Regulatory Unit to see if it's alright". I would have indicated that the storage of Schedule 8 substances such as Methadone were matters which were for Pharmaceutical Services and did not concern me in undertaking a routine pharmacy inspection for the Pharmacy Council.
I would not have indicated that I was in a position to approve or give advice on the dispensing unit as that is not the role of a Pharmacy Council Inspector undertaking a routine pharmacy inspection.
On 8 September 2016, Mr John Shand, Pharmacist and former QCPP Inspector, sent an email to the Commission advising that he had no recollection of having seen or approved any modification to the method of measuring Methadone doses at the Pharmacy and that as a registered Pharmacist with over 60 years of experience and an owner of pharmacies for over 40 years, he could not imagine condoning any method other than the acceptable.
On 11 February 2017, Mr Shand sent a further email to the Commission advising that he had no recollection of sighting the modified Methadone measuring system.
The proprietor of the pharmacy, Mr Bowen, visited the store twice a year. In a written statement dated 23 December 2016 Mr Bowen stated that he was aware of the modification being made in July 2013. He contacted Mr Green about the modifications who had assured him that he had made the necessary enquiries and the changes met legal requirements. He was satisfied with this response and took no further action. He referred to the store having mandatory inspections and had passed QCPP accreditation during the time the unit was modified. He was told by Mr Green that the methadone was inaccessible after hours. Mr Green also told him that because the pump used was the standard issued for the opioid substitution program, accuracy was not affected. He did not recall specifically assessing the methadone set up but as he had been assured that it was compliant and met all legal requirements he would not have found any need to pay attention to this aspect.
In his post hearing submissions Mr Green asserted that he was unaware of the legislative obligation to seek approval for the modifications. He referred to the insecure manner in which the Biodone was stored when he first started work at the pharmacy. He implied that his system was more secure. He asserted that the modifications he made resulted in an appropriate device that did not place the health and safety of methadone patients at risk. He contended he was not careless in the design and set out in some detail all the aspects of his design which indicated it was thoughtful and its various layers of security features. Indeed he suggested that the efficiency of the modified dispensing unit provided a positive outcome for the health and safety of the patients on the program.
Mr Green asserted that the risk of environmental contamination although not entirely impossible, was negligible given the screw-on lid and the diameter of the hole in the lid which matched the diameter of the tube. He said the risk of contamination was further reduced by the preservatives which are contained in Biodone, and the frequent turnover of Biodone (which has a shelf life of 24 months).
Mr Green submitted that there were opportunities for people more experienced than him to raise issues about the safe including representatives from the Quality Care Pharmacy Program and the proprietor of the pharmacy. He asserted that the modified methadone unit would have been difficult to miss being seen by the inspectors Mr Shand and Mr Cox. Further, the proprietor was aware he was purchasing the safe and made no effort to confirm that the changes complied. The proprietor saw the safe when he visited the pharmacy but raised no concerns nor did he ask to see the paperwork in relation to any approval.
Mr Green also referred to an expert's report which is summarised later in this decision. In essence the expert expressed the view that although Mr Green's conduct in modifying the storage unit and not obtaining the required approval fell significantly below the standard expected, in the light of his inexperience she was not strongly critical of his behaviour.
There are significant controls in place for pharmacists dispensing methadone in community pharmacies and the Commission submits that Mr Green placed the health and safety of the methadone patients at the Pharmacy at risk by using the modified device and not obtaining approval. Further, the drilling of a hole into the safe was said by the Commission to compromise the security and integrity of the safe. In this respect Mr Green had breached the requirements for the safe and secure storage of methadone in an appropriate safe.
[11]
Stock checks and record keeping for Schedule 8 medications the subject of the second complaint
The legislation requires a practitioner to conduct stock checks in March and September each year. The evidence discloses, and Mr Green concedes, that he did not keep accurate stock checks of Biodone in March 2013, September 2013, March 2014 and March 2015. He left some stock checks blank in the Controlled Drugs Register or recorded the same amount as the preceding line. Extracts of the drug registers were in evidence which showed errors in addition and subtraction. He also acknowledged that in contravention of the PTGR he had failed to keep accurate records by altering some entries and failed to correctly complete the register by entering some patient address details.
Mr Green did not keep records of the batch numbers and expiry dates of the Biodone bottles which he poured into the blue container. He asserted that the Biodone ordered by the Pharmacy each month would be from the same batch number. However, he conceded under questioning that on occasion the orders may have had separate batch numbers and the batches may have in fact been mixed on occasion.
The container containing the Biodone was not labelled, nor could the Biodone quantity be measured inside the container. Under cross examination Mr Green conceded that the blue container could not be removed from the safe when full without the risk of spilling the Biodone and that to measure the Biodone, it would need to be slowly extracted using the attached Socorex dispensing device which was calibrated to up to 20 millilitres. Mr Green also conceded under questioning that his method of conducting stock checks may not have been as accurate as he believed.
Mr Green agreed he did not conduct monthly stock checks between January 2013 and January 2016 but pointed out that there was no legislative requirement to do so. He explained that he had attempted to make corrections in a way that did not obscure the original entry. In relation to patient address details he pointed out that the patients were well known to him and their address was listed in the register next to previous entries.
In a submission made after the hearing Mr Green contended that he was not responsible for those entries where no values were recorded in September 2013 because he was not working at the pharmacy at that time. This claim was made for the first time in his post hearing submission.
In this submission Mr Green acknowledged that he would pour bottles from an individual batch of biodone into the drum. He conceded that he did not keep any records of product batch numbers or expiry dates. To the best of his recollection what he poured into the drum was only ever from one batch and he was careful not to mix new stock with older stock. He contended that as biodone has a shelf life of two years and given the preservative present, it was highly unlikely that any stock would have been past its use by date and therefore would not have presented any risk to public health and safety. He explained that when the drum was almost empty it was removed from the safe and the residue was decanted and measured.
[12]
Inappropriate dispensing of medication the subject of the third complaint
There are two allegations which comprise this complaint. The first allegation is that Mr Green provided Viagra (Sildenafil) to Patient A on multiple occasions without a valid prescription. Viagra (Sildenafil) is a Schedule 4 medication and requires a valid prescription prior to dispensing.
The second allegation is that Mr Green dispensed dexamphetamine, a Schedule 8 controlled drug to himself on multiple occasions without a valid prescription. Dexamphetamine is used for the control of narcolepsy.
[13]
Supply of Viagra (Sildenafil) to Patient A
Schedule A to the Complaint lists 47 separate occasions where Mr Green is alleged to have provided Viagra (Sildenafil) to Patient A.
Patient A was a methadone patient at the pharmacy having previously been an intravenous drug user. He had significant ongoing health issues including Hepatitis C, uncontrolled diabetes and high blood pressure.
Mr Green's dispensing of Viagra (Sildenafil) to Patient A came to the attention of the authorities through the pharmacist in charge at the pharmacy who succeeded Mr Green. She advised the PRU that Patient A had presented at the Pharmacy when she had taken over requesting Viagra without a prescription. Patient A advised her that he usually had Viagra (Sildenafil) dispensed by Mr Green without a prescription.
The majority of the Viagra (Sildenafil) dispensed by Mr Green to Patient A is recorded as having been prescribed by Dr Alam. The Medicare records and evidence provided by Dr Alam before the Tribunal indicate that Patient A only consulted Dr Alam on two occasions, being 24 March 2013 and 25 March 2013.
At the first consultation with Dr Alam Patient A had uncontrolled high blood pressure (160/99) having recently ceased his medication and complained of erectile dysfunction issues. Dr Alam did not prescribe Viagra to Patient A at that consultation.
At the second consultation, Dr Alam described Patient A as "desperate" for Viagra. Dr Alam counselled him about cardiovascular risk and erectile dysfunction including the need to have his cholesterol tested and to take medication for his blood pressure. Dr Alam noted that the status of Patient A's type II diabetes was unknown. Dr Alam prescribed Patient A four tablets of Viagra with 5 repeats and told him to get a blood test "ASAP". Dr Alam provided a statement in the proceedings that he was concerned about Patient A's overall health especially cardiovascular risk.
On the second day of hearing during the course of Mr Green's evidence in chief, he took issue with six dates which were listed in Schedule A alleging he dispensed Viagra to Patient A. Prior to this point he had previously admitted this part of the complaint.
Mr Green gave evidence that he did not work on six of the dates specified in Schedule A. He stated that a locum worked on one of these dates being 29 June 2015. There is evidence in relation to the last date contained in Schedule A suggesting that a locum pharmacist, Mr Okeson was working on 29 June 2015.
Mr Green identified another 5 dates which he said were Saturdays and stated that he did not work on Saturdays but rather another pharmacist, Mr Morgan who worked at the pharmacy, may have dispensed on Saturdays and may have used his initials.
The written evidence before the Tribunal from Mr Morgan is that he did not dispense Viagra (sildenafil) to Patient A. Mr Morgan was not required for cross examination by Mr Green.
Under cross examination Mr Green conceded that it was not appropriate to dispense Viagra without a script. He suggested that he obtained telephone prescriptions. However he was unable to respond in a meaningful way when it was put to him that the evidence of Dr Allam did not support this and no other prescriptions relevant to his dispensing could be located.
The Commission submitted that had they been put on notice that Mr Green was disputing the dates he had identified, it could have sought further evidence including from the proprietor of the pharmacy in relation to the dates and times he worked at the Pharmacy. It submitted limited weight could be placed on Mr Green's evidence in relation to the disputed dates, given his late notice of the withdrawal of his previous admissions, the absence of cross examination of the other witnesses by him on this issue and the inability of the Commission to meet such challenge after the close of its evidence in the proceedings.
In post hearing submissions Mr Green stated that in consultation with his solicitor he had agreed to this particular in its entirety because he could not access evidence to disprove the claim. Amongst other matters he re-iterated his claim that he had obtained telephone prescriptions from Dr Allam and suggested that Mr Allam's memory on this was not reliable. He suggested that the paperwork to support his assertion of telephone prescriptions may have been sent into storage. Mr Green said he was unaware of Patient A's medical background and the health concerns raised by Dr Allam. He expressed surprise at Dr Allam prescribing Viagra at all given what he now understood to be Patient A's health issues. He also asserted that Patient A's regime of Sildenafil was within the therapeutic range of a correct dosage.
[14]
Mr Green's dispensing of dexamphetamine to himself on prescriptions which were not valid.
Mr Green was prescribed dexamphetamine by his sleep disorder specialist, Professor Wark, for narcolepsy. Dexamphetamine is a Schedule 8 controlled drug.
The evidence does not suggest that Mr Green obtained the prescriptions outside a proper clinical setting. However, in accordance with clause 39 of the PTGR a prescriber authorisation number is required for dexamphetamine. Professor Wark did not obtain the necessary prescriber authorisation number. Although Mr Green had a prescription for this medication, the prescription was not valid because it did not include the necessary prescriber authorisation number.
In his evidence Mr Green explained that he was unaware of the requirement for his medical practitioner to have a specific and separate authority to dispense dexamphetamine. Further, other pharmacies had previously dispensed his dexamphetamine for him in the absence of the necessary authority.
The Commission pointed to a number of other factors around Mr Green's dispensing of medication to himself which it submitted were improper. These included that Mr Green dispensed the medication, which was a schedule 8 drug, to himself multiple times without another pharmacist being present over a prolonged period of time. He dispensed his prescriptions under his middle name and surname, but noted his full name in the dispensing program for Medicare purposes. Some of the prescriptions did not comply with the legislative requirements for Schedule 8 medications, including expressing the quantity in words as well as numbers and a repeat interval.
In his post hearing submission Mr Green referred to the requirement of a specific and separate authority to dispense dexamphetamine as not being widely known. He asserted it was not known by Dr Wark, other pharmacists who had dispensed the medication to him or indeed the Commission's expert until she researched the issue for the preparation of her peer report. In other respects he referred to the expert peer report which is set out in more detail below. In essence the expert stated that Mr Green's conduct in dispensing dexamphetamine to himself without a valid prescription fell below the standard expected however given the overall context including Mr Green's inexperience the expert was not strongly critical of his behaviour.
[15]
Expert Peer Report
The Tribunal had the benefit of an Experts Report prepared by Ms Nerida Croker which examined Mr Green's conduct. The report is undated but was received by the Commission on 16 March 2017. Ms Croker has been a registered pharmacist for some 16 years in both Australia and the United Kingdom. She has worked extensively in community pharmacy, including as a pharmacist in charge at various suburban and city pharmacies. She is currently involved in ensuring the provision of medication management services to over 340 aged care homes. She is also a casual University academic teaching post graduate pharmacy students.
Ms Croker indicated that the standard reasonably expected of a practitioner of an equivalent level of training or experience would be to follow legislation and guidelines regarding the storage of all schedule 8 medications. It would be expected that all bottles of methadone would be stored securely in the approved safe and no modifications would be made to that safe. Mr Green's conduct in modifying the storage unit fell significantly below the standard expected. Similarly his conduct in not obtaining approval from NSW Health or notifying them or the PRU of the modifications fell significantly below the standard expected. However, in the light of Mr Green's inexperience as a pharmacist she was not strongly critical of his behaviour.
More seriously however Ms Croker expressed the opinion that Mr Green's conduct in modifying the Methadone unit, when combined with not keeping batch details of biodone and not undertaking regular accurate stock checks, fell significantly below the standard expected. Given the fact that Mr Green was not able to meet his legislative requirements due to the modification of the Methadone dispensing unit, Ms Croker was strongly critical of his conduct.
Ms Croker observed that the s8 register for Biodone maintained by Mr Green was difficult to read. Some figures had been crossed off or scribbled over, such as 31 May 2013 where the daily dosing has been corrected and 3 February 2014 where the quantity received from Symbion has the balance written over. The legislation requires that no alterations be made to entries with no crossing out or writing over, only a new entry with a correction under a footnote explaining the correction added.
Ms Croker outlined significant errors in addition and subtraction in the drugs register. On this basis she concluded that it was clear that stock checks were not conducted as they should have or these errors would have been picked up. She pointed out that if the quantity of Biodone was physically and accurately checked, then the discrepancies, both in balances transferred to the s8 book and the errors in addition or subtraction, would have to be investigated as the balance on hand would not have corresponded to the balance in the s8 register. This suggested to her that Mr Green was not conducting an accurate stock check to the millilitre of the Biodone liquid.
Additionally Mr Green had indicated that the approximate usage of Biodone at the pharmacy was 12L per month. Ms Croker described this as being at a high volume and she would have expected that more frequent stock checks would have been undertaken. She referenced the Pharmacy Guild Opioid Substitution Resource Manual at point 2.5.12 where it recommends that as a matter of good practice pharmacists supplying a number of clients with Methadone and or Buprenorphine should carry out stock checks of Methadone and/or Buprenorphine on hand at more regular intervals than the minimum statutory twice-yearly inventory. In order to properly reflect the actual quantity of Methadone and/or Buprenorphine on hand in a drug register, an inventory of Methadone and/or Buprenorphine should be carried out at monthly, weekly or daily intervals, and in the case of Methadone at the completion of each bottle. This is because drug register balances must reflect the actual balance on hand.
Ms Croker stated that at least monthly checks would have been recommended to ensure the drug register balance did reflect the actual balance on hand. In this case she expressed the view that Mr Green appeared to have displayed inappropriate procedures and processes in regards to his management of s8 medications. Stock checks do not appear to have been undertaken accurately, or to the required and recommended timeframes. In her view it appeared unlikely that the Biodone was ever accurately measured. The documentation of the daily dosing subsidiary registers was not complete, for example no total daily dose was documented instead it was only ticked on occasions. The Socorex dispenser was also not calibrated. When viewed together Ms Croker's overall impression was that Mr Green did not appropriately follow legislative requirements, particularly around the management of s8 medications.
In relation to Patient A's receipt of Sildenafil from Mr Green Ms Croker stated as follows:
"[Mr Green] states that when [Patient A] presented at the Pharmacy without a prescription for Sildenafil that he telephoned Dr Alam for a telephone order. Telephone orders for prescriptions are more generally reserved for those medications which are life sustaining or which may be considered "urgent". It is possible for a prescriber to make a telephone order and for the Pharmacist to dispense this medication. If this is to be the case detailed notes including date of phone call, any discussion, the name, strength and quantity of medication prescribed and any other details should be clearly documented by the Pharmacist. It is also a requirement that the prescriber provides a hard copy of the prescription to the Pharmacy within 24 hours according to legislation.
Dr Alam provided documentation of prescribing Sildenafil for [Patient A] on two occasions only. This was further backed up by his practice information which indicated he did not see [Patient A] after 2013, and from the information provided by the Medicare report which indicates only two occasions (24th March and 25th March 2013) when Dr Alam billed Medicare for [Patient A's] attendance at the doctor's surgery.
Only one copy of a prescription for Sildenafil was provided with documentation for my preparation of this report. This was written by Dr Alam on the 25/3/13 and was for 4 tablets with 5 repeats. There were no other paper copies of any prescriptions for Sildenafil.
In respect of the dispensing of dexamphetamine Ms Croker explained in her oral evidence that she was not initially aware that a prescriber authorisation number was required. She also conceded that the requirement for authorisation would not probably be commonly known.
Ms Croker concluded that the standard reasonably expected of a practitioner of equivalent training and experience would be to ensure all legal aspects of prescribing were met prior to dispensing prescriptions, either to himself or to anyone else. In her view Mr Green's conduct in dispensing dexamphetamine prescriptions to himself which did not include the necessary authorisation number fell significantly below the standard expected:
However Ms Croker stated that given that the prescriptions were written by a specialist and there was no suggestion that the prescriptions were illegally obtained, in the light of Mr Green's inexperience led her not to be strongly critical of his behaviour. She did not believe that the fact that Mr Green dispensed his prescriptions under his middle name and surname fell below the standard expected. She noted that it is acceptable practice to dispense medications to any patient using a preferred name providing that the patient's Medicare name is also available.
Ms Croker noted that there are no guidelines presently in place in relation to self-dispensing. In view of this she did not believe that Mr Green's conduct fell below the standard expected. In the absence of another pharmacist available to dispense his prescription it was reasonable that he would ask a staff member to witness the dispensing.
[16]
Modifications to the storage and dispensing of Biodone
The modifications made by Mr Green to the storage and dispensing of Biodone at the Pharmacy did not comply with Clauses 73 and 76 of the PTGR. Further the modifications were not approved by the Director-General of the NSW Ministry of Health as required.
Mr Green submitted that there were opportunities for people more experienced than him to raise issues about the safe and the modifications he made including representatives from the Quality Care Pharmacy Program and the proprietor of the pharmacy.
It is not the role of the Pharmacy Inspector for the Pharmacy Council or representatives of Quality Care Pharmacy Program to approve modifications to the storage of schedule 8 substances. The material from the proprietor of the pharmacy Mr Bowen is to the effect that Mr Green assured him that he had made the necessary enquiries and the changes met legal requirements. He was satisfied with this response and took no further action. Whilst it may have been prudent for Mr Bowen to have sighted some official paperwork verifying that the modifications had been approved, it was Mr Green's responsibility to seek and obtain approval from the Director-General of the NSW Ministry of Health as required by the legislation.
Apart from Mr Green's assertions that his modifications did not result in environmental contamination there is no evidence that the Methadone dispensing unit was at all times secure from tampering and free from contamination. Mr Green did not provide any expert evidence in support of his claims. Nor did he discuss his modifications with the manufacturer of Biodone or a regulator or obtain any independent evidence as to the impact of his modifications.
We find on the evidence that by modifying the storage of biodone and the dose system in the way that Mr Green did, he did not comply with the stringent legislative requirements for the storage of Schedule 8 medications. The Tribunal is satisfied that all the particulars of the first complaint are made out.
[17]
Record keeping and stock checks
The report of Ms Croker makes it clear that if accurate stock checks were conducted as they should have been then the errors in subtraction and addition which she identified, and which Mr Green concedes he made, would have been picked up. We also accept her opinion that in a pharmacy with a high level of methadone dosing, monthly stock checks would have been good practice. Mr Green concedes that he did not do this.
The container containing the Biodone was not labelled, nor could the Biodone quantity be measured inside the container. Under cross examination Mr Green conceded that the blue container could not be removed from the safe when full without the risk of spilling the Biodone and that to measure the Biodone, it would need to be slowly extracted using the attached Socorex dispensing device which was calibrated to up to 20 millilitres. Mr Green also conceded under questioning that his method of conducting stock checks may not have been as accurate as he believed. We accept the opinion expressed by the expert that it is unlikely that the Biodone was ever accurately measured by Mr Green.
Mr Green did not keep records of the batch numbers and expiry dates of the Biodone bottles poured into the blue container. He asserted in the proceedings that the Biodone ordered by the Pharmacy each month would be from the same batch number. To the best of his recollection what he poured into the drum was only ever from one batch and he was careful not to mix new stock with older stock. He contended that as biodone has a shelf life of two years and given the preservative present, it was highly unlikely that any stock would have been past its use by date and therefore would not have presented any risk to public health and safety.
We do not accept Mr Green's evidence and assertions on these points because he failed to keep accurate records of the Biodone prior to pouring it into the blue plastic container. Further, he conceded under questioning that on occasion the orders may have had separate batch numbers and the batches may have in fact been mixed. Apart from his own assertion there is no evidence that the presence of preservatives in Biodone and its shelf life meant that it was highly unlikely that any stock would have been past its use by date and therefore would not have presented any risk to public health and safety. The possibility that different batches of Biodone liquid were mixed together creating a risk that some quantity of medication in the container may reach, or pass, its expiry date, endangering patient safety cannot be ruled out.
In Mr Green's post hearing submission he took issue with the fact that no values were recorded in the daily dosing records for a period in September 2013. He asserted that he was not responsible for those entries because he was not working at the pharmacy at that time. In effect Mr Green sought to introduce new evidence after the hearing which the Commission has had no opportunity to address. Even if we were to accept his assertion, it does not alter the fact that he failed to keep accurate records in the schedule 8 register of drugs of addiction. This is because he made significant errors in subtraction and addition when recording amounts in the register and entries he made in the daily dosing registers and schedule 8 register did not match.
Mr Green also failed to keep appropriate records in the controlled drugs register for Schedule 8 medications. He altered entries by crossing off or scribbling over some of the figures. He also failed to record patients address details in the controlled drugs register.
We find that all the particulars in the second complaint are made out.
[18]
Supply of Viagra (Sildenafil) to Patient A
Schedule A to the Amended Complaint identifies 47 occasions between 20 January 2014 and 29 June 2015 on which it is claimed that Mr Green dispensed Viagra (sildenafil) to Patient A without a valid prescription.
In answer to this claim Mr Green contends that he obtained telephone prescriptions from Dr Allam. He also identified six dates listed in Schedule A which he said he could not have dispensed because they fell on a Saturday and he had stopped working Saturdays in 2014. He claimed the dispensing work on these days would have been done by a locum, Mr Morgan.
There is evidence before us in relation to the last date, 29 June 2015, contained in Schedule A suggesting that another locum pharmacist, Mr Okeson was working at the pharmacy for 10 days from 22 June 2015 until 3 July 2015. In view of this we accept that Mr Green could not have dispensed on this date.
In respect of the other 5 dates identified by Mr Green Mr Morgan's written statement states that he worked most Saturday mornings. He stated that he did not dispense Viagra to Patient A.
Mr Morgan was not required for cross examination by Mr Green and his evidence was not directly challenged.
As submitted by the Commission limited weight can be placed on Mr Green's evidence in relation to the disputed dates, given his late notice of the withdrawal of his previous admissions, the absence of cross examination of the other witnesses by him on this issue and the inability and disadvantage to the Commission to meet such challenge to this evidence given the late stage it was raised.
But even if we accept that Mr Green did not work on the five Saturday dates, this still leaves some 40 occasions where he dispensed Viagra to Patient A without any written prescriptions to support the dispensing.
In relation to this dispensing Mr Green asserts he obtained a telephone prescription from Dr Allam. We do not accept this assertion for a number of reasons. Firstly the claim is not supported by Dr Allam's evidence. Secondly Dr Allam only saw Patient A on two occasions on 24 and 25 March 2013 and he held specific concerns about Patient A's health including his cardio vascular risk. In our view it is implausible that Dr Allam would have been prepared to continue to prescribe Viagra on an ongoing basis via telephone for some two years into the middle of 2015. Thirdly as referenced by the expert, telephone orders for prescriptions are generally reserved for those medications which are considered to be life sustaining or considered urgent. That is not the case here. Further if a telephone order is utilised detailed notes by the pharmacist would be expected and it is a requirement for the prescriber to provide a hard copy of the prescription to the pharmacy within 24 hours. None of this paperwork was before us.
We do not accept the ancillary suggestions made by Mr Green in his post hearing submissions that Dr Allam's memory on this aspect is not reliable and the written records to support his claim could be in a storage facility. Mr Green did not seek to have Dr Allam available for cross examination and there was no evidence to support his proposition that records exist in storage. Further, there is no explanation as to why the prescription which was written by Dr Allam for Patient A was available, but other records for Patient A relating to the same medication would be held in storage.
We are satisfied that Mr Green dispensed Viagra to Patient A without a valid prescription on at least 40 occasions over a period of some 18 months. This was contrary to clause 39 of the PTGR. We are satisfied that the substance of the first particular of the third complaint is made out.
[19]
Mr Green's dispensing dexamphetamine to himself
Mr Green dispensed dexamphetamine, a Schedule 8 controlled drug to himself at the Pharmacy on multiple occasions on prescriptions which were not valid as they did not include the necessary prescriber authorisation number.
Although we accept that the requirement for the necessary prescriber authorisation number might not be widely appreciated by pharmacists, Mr Green had a professional obligation as a pharmacist to be aware of the requirements for a prescription of this nature. We are satisfied that second particular of the third complaint is made out.
[20]
Conclusions
We are satisfied that all the particulars set out in the complaints are established. The first, second and third complaints allege "unsatisfactory professional conduct" within the meaning of section 139B, via the two pathways contained in sections 139B(a) and (l) of the National Law. The fourth complaint alleges "professional misconduct" by Mr Green under section 139E of the National Law, relying individually and/or in combination on the particulars of the first three complaints.
For the reasons that follow we are is satisfied that the four complaints are proved
[21]
Relevant principles regarding unsatisfactory professional conduct
Section 139B(1)(a) of the National Law requires a determination as to whether Mr Green has been guilty of unsatisfactory professional conduct. It involves an objective assessment of Mr Green's conduct against the standard of conduct reasonably expected of an equivalent practitioner.
Section 139B(1)(l) of the National Law also requires a determination as to whether Mr Green has been guilty of unsatisfactory professional conduct. It involves an assessment as to whether his conduct was improper or unethical relating to the practice of pharmacy.
The words "unethical" or "improper" are not defined in the National Law. The Macquarie Dictionary defines "improper" relevantly as not 1. "in accordance with propriety of behaviour, manners etc. or abnormal or irregular and "unethical" as "contrary to moral precept; immoral"; and 2. "in contravention of some code of professional conduct." There is no reason to suppose that the words should be given a different meaning in the National Law.
Assistance in determining what is meant by "improper" can also be gained from what the High Court of Australia said of the word "impropriety" in R v Byrne [1995] 193 CLR 501 at 514-515: see HCCC v Phung (No. 1) [2012] 1 NSWDT at 68. If conduct is not in conformity with standards of professional conduct and practice it can be seen as improper.
The words improper and unethical were considered by the Tribunal (Dr J Renwick SC presiding) in Office of Local Government v Toma [2015] NSWCATOD 21. Dr Renwick, after quoting from R v Byrnes & Hopwood, noted:
Applying these authorities, I do not need to state an exhaustive definition of improper or unethical conduct. Rather it is enough to here note that the expression encompasses conduct which, viewed objectively, would be regarded by reasonable persons as falling below the standards of conduct to be expected of Councillors, in that it has a tendency to bring into disrepute the civic office held by Councillors, or the Council, or both. In Dallas Buyers Club LLC v iiNet Limited (No 3) [2015] FCA 422 at [5], Perram J said, aptly for present purposes:
The difficulty in locating where a line is to be drawn is a well-known problem in legal discourse. But here, as in other contexts, it is best answered not by seeking to find where the line is but instead by asking which side of the line one happens to be on.
In my opinion the conduct I have found and which the Respondent has not contested clearly falls on the wrong side of the line. It reduces public confidence in the institution of local government. It amounts to improper and unethical.
This test was adopted in HCCC v Liu [2016] NSWCATOD 133 at 56.
[22]
Modifications to Methadone dispensing Unit
Mr Green failed to give consideration to and comply with the stringent legislative requirements for safes in pharmacies for the storage of Schedule 8 medications when acquiring and installing the safe. He made modifications to the methadone dispensing unit without any consultation with others or a regulatory agency. He made no arrangements to have the device tested as to its safety. He did not have approval for the device as required by legislation. He then used the untested and unapproved device for some two and half years. As referenced by the expert his conduct in this regard fell significantly below the standard expected.
We are satisfied that the first complaint is proved and amounts to unsatisfactory professional conduct.
[23]
Stock checks and Record keeping
Mr Green did not keep accurate records in the controlled drugs register and methadone daily dosing charts for Biodone. He did not pay attention to ensuring that accurate records were maintained by the Pharmacy for Biodone. At times he recorded different quantities that did not balance between the two records causing the Pharmacy's records for Biodone to be inaccurate.
The expert observed in relation to Mr Green's record keeping and stock checks of Biodone, it would be expected that more frequent accurate stock checks would be undertaken for Methadone or Biodone.
Pharmacists must maintain accurate records and comply with their professional obligations in this regard. Mr Green's failings were compounded by the fact that he did not conduct appropriate and accurate stock checks.
Mr Green's conduct in failing to undertake the necessary stock checks, failing to keep accurate records in the schedule 8 register and daily dosing charts for Biodone, and failing to follow legislation regarding the way records were written into the schedule 8 register fell significantly below the standard expected.
Mr Green failed to manage biodone liquid appropriately by pouring multiple bottles into one single large container. Notwithstanding the care he said he took not to mix batches the evidence does not rule out that different batches of Biodone liquid were not mixed together creating a risk that some quantity of medication in the container may reach, or pass, its expiry date, endangering patient safety. This conduct was not in conformity with the standards of professional conduct and practice and it was improper.
We are satisfied that the second complaint is proved and amounts to unsatisfactory professional conduct.
[24]
Dispensing medication
The third complaint relates to dispensing medication without a valid prescription. In this regard there were two issues. Mr Green's conduct in the dispensing of Viagra to Patient A and the dispensing of dexamphetamine to himself.
We accept that Mr Green's knowledge about dispensing dexamphetamine to himself in the absence of a prescriber authorisation number as required by the legislation was inadequate. Indeed from the evidence before us including the experts report, it may be that other pharmacists' knowledge on this issue may be similarly inadequate. There is no suggestion that the prescriptions were not properly obtained. In this context, the expert was not strongly critical of Mr Green's behaviour, and referred specifically to his inexperience.
Although the Commission submitted that there were aggravating features to Mr Green's conduct such as dispensing the medication without another pharmacist present and dispensing the prescriptions under his middle name, we are not persuaded that this is so. The expert was not critical of this aspect of his conduct and specifically referred to the fact that there are no guidelines in place in relation to pharmacists dispensing medications to themselves. Although it is arguable that it may have been preferable for Mr Green to have had his dexamphetamine dispensed by another pharmacist, particularly given that it was a Schedule 8 medication, we do not view it as an aggravating feature of his conduct.
However, and as submitted by the Commission, it was Mr Green's obligation to ensure all legal aspects of prescribing were met prior to dispensing prescriptions whether to himself or indeed to anyone else and he cannot be excused by relying on the inadequacies in the knowledge held by other pharmacists.
Although we accept that Mr Green did not appreciate the legislative requirement for a prescriber authorisation, his conduct in dispensing dexamphetamine to himself in the absence of a prescriber authorisation number and as required by the legislation fell significantly below the standard expected. We are satisfied that this conduct amounts to unsatisfactory professional conduct.
However, in our view the more serious aspect of this complaint is the dispensing of Viagra to Patient A without a valid prescription.
Viagra (Sildenafil) is a Schedule 4 medication that requires a valid prescription prior to dispensing. The telephone authorisations subject to the provision of written prescriptions as asserted by Mr Green do not constitute a valid prescription for the dispensing of Viagra (Sildenafil).
Mr Green's conduct in providing Viagra (Sildenafil) to Patient A is a significant breach of his professional obligations as a pharmacist, placing Patient A's health and safety at risk. As submitted by the Commission, Patient A was a particularly vulnerable patient given his medical history and refusal to obtain appropriate treatment for his cardiovascular disease including high blood pressure. He also had Hepatitis C, making the risk of hepatic toxicity greater. The quantity and frequency of supply of Viagra (Sildenafil) by Mr Green to Patient A in the absence of proper medical care and oversight is a significant deviation from his ethical and professional obligations as a pharmacist.
Mr Green dispensed Viagra on at least 40 occasions over a period spanning about 18 months. The evidence did not cast any light on why Mr Green took this course. The gravity of Mr Green's conduct is serious because it occurred over a prolonged period of time. It was unethical and improper. We are satisfied that the third complaint is proven and amounts to unsatisfactory professional conduct.
[25]
Relevant principles regarding professional misconduct
The Commission submits that the conduct of Mr Green, which has been shown to constitute unsatisfactory professional conduct, is sufficiently serious to amount to professional misconduct. Alternatively when the instances of unsatisfactory professional conduct are considered together they amount to sufficient seriousness for the complaint to be made out.
In determining whether a finding can be made of professional misconduct as outlined in HCCC v Perroux [2011] NSWDC 99 at 18 a determination must be made that when contraventions are considered as a whole, they are of a sufficiently serious nature to justify suspension or deregistration.
It has been held that the "gravity of professional misconduct is not to be measured by reference to the worst cases but by the extent to which the conduct departs from the proper standards": see Health Care Complaints Commission v Litchfield [1997] 41 NSWLR 630 at 638.
There is no comprehensive exploration in the case law as to when unsatisfactory professional conduct will amount to professional misconduct. The concept as contained in s.139E should be given a purposive interpretation. We are required to not only consider the object of the protection of the public but to recognise that object also includes deterring Mr Green, and other practitioners from repeating the same misconduct: HCCC v Saedlounia [2013] NSWMT 13 at 43-50 and Health Care Complaints Commission v Do [2014] NSWCA 307 at 35.
As explained by Basten JA in Chen v Health Care Complaints Commission [2017] NSWCA 186 "[t]he term 'professional misconduct' does not have a specific meaning; it is merely a category of 'unsatisfactory professional conduct' which is sufficiently serious to justify suspension or cancellation". His Honour further notes:
"[t]here 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".
In our view Mr Green's conduct is of a serious nature. It included breaches of Poisons and Therapeutic Goods Regulations 2008. These breaches extended to both the manner in which he managed and stored biodone and the dispensing of medication in the absence of a valid prescription. Mr Green's use of the modified methadone dispensing unit was further compounded by his failure to keep proper records.
The quantity and frequency of supply of Viagra (Sildenafil) by Mr Green to Patient A in the absence of proper medical care and oversight is serious. The gravity of Mr Green's conduct is compounded because it occurred over a prolonged period of time of some 18 months.
We conclude that when considered as a whole the unsatisfactory professional conduct displayed by Mr Green is of a sufficiently serious nature to fall within the definition of "professional misconduct" under section 139E of the National Law. It constitutes conduct which is sufficiently serious to justify suspension or cancellation. We are satisfied that the fourth complaint of professional misconduct is established.
[26]
Principles regarding protective orders
The relevant principal sections provide that the Tribunal may exercise any power conferred on it by Subdivision 6 of Division 3 of part 8 of the National Law in relation to proven claims against registered health practitioners: see sections 149A, 149B and 149C. In determining the appropriate orders, the paramount consideration is the protection of the health and safety of the public: see s.3A of the National Law.
As the paramount consideration is the protection of the health and safety of the public, an imposition of restrictions on the practice of a health professional is only to be made in pursuit of according with this higher objective: see s 3A National Law. Such restrictions are only to be imposed where necessary to ensure health services are provided safely, at an appropriate quality: see s 3(3)(c) National Law. This determination may only be made by reference to the facts of this particular case and by considering what measures are needed to ensure future behaviour of Mr Green, and others, is shaped in such a way that is consistent with these protective goals: see Lee v Health Care Complaints Commission [2012] NSWCA 80 at 34.
In addition to the protection of the public being the paramount consideration, it has also been held that other relevant purposes of such proceedings include the need to maintain the standards of the relevant profession, and to deter others from engaging in like conduct: see, for example, Health Care Complaints Commission v Litchfield.
In Health Care Complaints Commission v Do, [2014] NSWCA 307 Justice Meagher (with whom Justices Basten and Emmett agreed) referred at 35 to the importance of denunciation of misconduct, in the context of s. 3 and s. 3A of the National Law as follows:
The objective of protecting the health and safety of the public is not confined to protecting the patients or potential patients of a particular practitioner from the continuing risk of his or her malpractice or incompetence. It includes protecting the public from the similar misconduct or incompetence of other practitioners and upholding public confidence in the standards of the profession. That objective is achieved by setting and maintaining those standards and, where appropriate, by cancelling the registration of practitioners who are not competent or otherwise not fit to practise, including those who have been guilty of serious misconduct. Denouncing such misconduct operates both as a deterrent to the individual concerned, as well as to the general body of practitioners. It also maintains public confidence by signalling that those whose conduct does not meet the required standards will not be permitted to practise.
As such, the purpose of disciplinary powers is not to punish a practitioner but rather to protect the public and maintain proper professional standards.
Whether offence(s) are sufficiently serious to warrant suspension or cancellation is a matter of degree and judgment: Sabag v HCCC [2001] NSWCA 411 at 82.
Although Mr Green made some admissions his evidence and particularly his post hearing submission did not give any confidence that he had developed any insight how his conduct impacted on public health and safety.
As submitted by the Commission Mr Green was steadfast in his evidence under cross examination, that whilst the modified methadone dispensing unit had not been approved, it was an appropriate device that did not place the health and safety of methadone patients at risk. This position was again forcefully taken in his submissions to the extent that he suggested that his modification provided a positive outcome for the health and safety of patients. Mr Green's actions and views in this regard are concerning and reflected a degree of naivety and little, if any, insight.
Mr Green's conduct in dispensing medication in the absence of a valid prescription is a serious breach of the standards that the public have a right to expect of a practitioner. Moreover looking at his submissions there was a degree of reticence to fully accept the implications of his actions. For example he attempted to deflect the responsibilities he had to Patient A by his suggestion that he was surprised that Dr Allam prescribed Viagra to Patient A at all given his health problems. We are unconvinced that he has any insight into this aspect of his conduct and the potential dangers it posed, or that there is minimal risk of its reoccurrence.
A key aspect of the protection of the public extends beyond protecting the individual patients of an individual practitioner. It goes to the protection of the public as a whole by means of the denunciation of the type of conduct such as that which occurred in this case. Having regard to the findings made above as to the nature of the conduct and the protection of the public, we are satisfied that if Mr Green had been registered we would have cancelled his registration.
As Mr Green is not currently registered the Commission sought a period of disqualification of two to three years. Mr Green stated that he wished to return to practice as a pharmacist. He sought a suspension period of 6 to 9 months and that upon re-registration he be mentored.
In our view the disqualification period of two to three years as sought by the Commission amounts to a more serious consequence for Mr Green than is reasonably necessary to promote the protective purpose. In the light of Mr Green's inexperience and the courses he has undertaken to address his knowledge base and ethical obligations in our view such a period is too severe and would amount to a punishment. Equally however we are not satisfied that the outcome sought by Mr Green adequately reflects a denunciation of his conduct given his limited insight. We find that the protection of the public can be achieved by a period of disqualification of 18 months. This will allow Mr Green sufficient time to take steps to demonstrate insight into his conduct and address any obligations he may have towards continuing professional education.
Accordingly if Mr Green were still registered we would have cancelled his registration and disqualified him from being registered as a pharmacist for a period of 18 months.
[27]
Costs
The power to award costs in health profession cases is contained in Schedule 5D, Clause 13 of the National Law.
The Commission seeks its costs. Mr Green referred to the award of costs being discretionary and pointed to his co-operation with the Commission during its investigation stage and in the proceedings before the Tribunal. He referred to his lack of legal representation, his capacity to pay a costs order, restrictions on his capacity to earn an income and potential financial implications.
The purpose of an order for costs is to compensate the person in whose favour it is made and not to punish the person against whom the order is made: see Allplastics Engineering Ply Ltd v Dornoch Ltd [2006] NSWCA 33; Dr Douglass v Lawton Pty Ltd (No 2) [2007] NSWCA Generally the presumption will only be displaced where there has been some sort of disentitling conduct on the part of the successful party: see Arian v Nguyen [2001] NSWCA 5 at 36. It is not an appropriate basis for the exercise of the discretion that an order for costs may cause hardship to the party against whom the order is made. These principles have been re-affirmed by the Court of Appeal: see Health Care Complaints Commission v Philipiah [2013] NSWCA 342 at 42-45.
Although Mr Green made a number of admissions in relation to specific particulars there was nothing in how the Commission conducted its case which would warrant disallowance of costs or an offset to them. There is no evidence of some disentitling conduct on the part of the Commission. We are not satisfied that there are features of this case which make it an appropriate one to exercise the discretion to depart from the general presumption.
Mr Green should bear the Commission's costs so as to compensate it for the costs it has incurred in prosecuting the proceedings in the public interest.
Accordingly for these reasons, we have decided to exercise the power to order Mr Green to pay the Commission's costs, as agreed or failing agreement as assessed under the Legal Profession Uniform Law Application Act 2014 (NSW).
[28]
Orders
The Tribunal, having found the complaints of unsatisfactory professional conduct and professional misconduct proved, orders that:
1. If Mr Green were still registered, the Tribunal would have cancelled his registration.
2. Mr Green is disqualified from being registered as a pharmacist for a period of 18 months.
3. The National Board is to record in the National Register the fact that the Tribunal would have cancelled Mr Green's registration.
4. The Registrar is requested to notify the Pharmacy Council of NSW and the Australian Health Practitioner Regulation Agency of Orders 1, 2 and 3 above as soon as practicable.
5. Mr Green is to pay the costs of the Health Care Complaints Commission of and incidental to these proceedings as agreed, and failing agreement as assessed under the Legal Profession Uniform Law Application Act 2014 (NSW)
[29]
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: 12 November 2018