Health Care Complaints Commission v Saab

The Decision Making Process

1. On 20 July 2018 the Health Care Complaints Commission (the Commission), by way of application with attached complaint, applied to the Tribunal for disciplinary findings and orders under the National Law against Mr Saab.
2. As the hearing progressed and the evidence came out, it became clear that this matter needed to be conducted in two stages.
3. In this first stage we examine the Complaint and the evidence relevant to it. This is stage one of the proceedings. Because the Complaint has been substantiated, we will deal with the question of the making of appropriate protective orders in a second stage of the proceedings. These reasons only deal with how and why the Complaint is established.

The Hearings

1. The hearing of this matter took place across three tranches of hearings held on 5, 6 and 7 December 2018, 21 and 22 May 2019 and 16, 18, 19 and 20 September 2019. It is useful to explain why this occurred.
2. Following procedural directions the matter was listed for a hearing comprising three consecutive days commencing on 5 December 2018.
3. Due to the content of oral evidence that came out in the course of the hearing in December 2018, and in order to afford procedural fairness to Mr Saab, it was necessary to give him the opportunity to initiate formal processes for the production of further material. Accordingly, the matter was adjourned and listed for hearing for a further three days commencing on 21 May 2019.
4. On 20 February 2019, after the December 2018 tranche of hearings but before the scheduled May 2019 hearings, the PRU conducted another inspection of Mr Saab's pharmacy at Ingleburn. In essence the PRU identified areas of non-compliance which were similar to those identified by it in 2015.
5. Mr Saab was invited to an interview to discuss these issues. This interview occurred on 4 April 2019. He attended with his solicitor. A report dated 26 April 2019 was subsequently prepared by Ms Chun, Senior Pharmaceutical Officer.
6. Towards the conclusion of the hearing day on 21 May 2019 the Commission indicated that material had only come to hand which it wished to tender in the proceedings. It requested that the Tribunal take an approach analogous to section 189 of the Evidence Act 1995 (NSW) and determine the issue effectively as a voir dire. In essence the Commission sought to have documents admitted into evidence which it argued were relevant. At this point in time we were unaware of the nature of the documents.
7. The following day, and still unaware of the nature of the documents, the initial argument from the parties was about whether all members of the Tribunal should be told what the documents were or see the documents in order to decide admissibility or whether that task should be confined to the legal member. Further argument was then raised about whether the documents were admissible due to the late stage at which they were sought to be introduced. We decided that all members of the panel would look at the documents and that although it was not ideal for further evidence to be introduced at such a late stage, any procedural unfairness caused to Mr Saab by the documents potentially coming into evidence could be addressed in practical ways.
8. It subsequently became apparent that the material comprised the April 2019 PRU inspection report, a letter dated 13 May 2019 to Mr Saab from Mr Battye, Director of the PRU and Deputy Chief Pharmacist NSW Health and a letter dated 14 May 2019 from Mr Battye to Ms Beetson, Executive Officer of the Pharmacy Council of NSW.
9. The Tribunal heard submissions from both parties as to the admissibility of the documents including relevance, and ruled that they were admissible and relevant. They were admitted over the objection of Mr Saab whose position as best we could tell was that whilst the documents may be relevant to stage two of the proceedings, they were not relevant to stage one.
10. The documents concerned the same pharmacy the subject of the present Complaint and raised similar issues. We accepted the submissions made by the Commission that the documents were relevant to Mr Saab's credit, matters he had traversed in his reply and his conduct generally. They subsequently became an exhibit in the proceedings.
11. Again in order to afford Mr Saab procedural fairness the matter was adjourned on 22 May 2019 to give him the opportunity to deal with the new material and consider whether he needed to obtain further evidence including whether any new witnesses needed to be called or any past witnesses recalled. This is why the matter was then adjourned for a further four days commencing 16 September 2019. It became very clear at the conclusion of the September 2019 listings that it would only be possible, and indeed appropriate to complete stage one of the proceedings before embarking on stage two.
12. We interpolate here to note that in effect the further inspection by the PRU of the Ingleburn pharmacy and their report only became known to us on 22 May 2019 after the Commission raised it. It was not a matter to which Mr Saab or his legal representatives alluded to at any point, notwithstanding that they were aware of the PRU inspection that occurred on 20 February 2019, the related PRU interview conducted with Mr Saab on 4 April 2019 about continuing non-compliance issues and the PRU's subsequent written report dated 26 April 2019.
13. There was no attempt by Mr Saab to amend his reply after the PRU inspection in February 2019 but before the resumed hearing on 21 and 22 May 2019 to reflect any of these developments. Mr Saab subsequently made an affidavit dated 13 September 2019 which dealt with the PRU report of 26 April 2019 and associated documents, together with clarifying aspects of his reply. This affidavit also became an exhibit in the proceedings.
14. The reason we make the observation is because much was made by Mr Saab in his reply to the Complaint that he had addressed the compliance issues which had been identified by the PRU in their December 2015 reports. The Tribunal was part heard and engaged in the decision making process in May 2019. In our view at this time we ought to have been able to rely on a reply which represented the position in a transparent manner, particularly when that reply was prepared with legal assistance.
15. Following the PRU's report of their inspection of 20 February 2019, the Pharmacy Council of New South Wales (the Council) decided to convene proceedings to determine whether any action should be taken against Mr Saab under section 150 of the National Law by either suspending or imposing conditions on his registration. Section 150 proceedings occur in the context of the Council's obligation under the National Law to take action at any time if it is satisfied it is appropriate to do so for the protection of the health and safety of the public.
16. At the time we were conducting the Complaint hearings on 21 and 22 May 2019, Mr Saab knew that several days later on 28 May 2019, he was scheduled to attend Section 150 proceedings. The Section 150 proceedings were brought to our attention by the Commission.
17. The Section 150 proceedings have now been finalised and written reasons for the Council's decision dated 28 June 2019 were produced. The decision of the Council was to suspend Mr Saab's registration effective from 28 May 2019. Proceedings to vary or set aside the suspension under section 150A of the National Law were also conducted by the Council on 13 August 2019. The Council affirmed its decision under section 150. Written reasons dated 30 August 2019 set out the Council's reasons in this respect. Mr Saab's current registration status as a pharmacist is that he is suspended.

The Application before the Tribunal

1. The application and attached complaint comprises two individual complaints against Mr Saab.
2. The first complaint is of unsatisfactory professional conduct under section 139B(1)(a) and/or (l) of the National Law in that Mr Saab has: 1. engaged in conduct that demonstrates that the judgment possessed, or care exercised, by the practitioner in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience; and/or 2. engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy.
3. Complaint One is supported by 14 particulars. It is asserted that particulars 1-6 and 11 of Complaint One justify an individual finding of unsatisfactory professional conduct.
4. The second complaint against Mr Saab is of professional misconduct under section 139E of the National Law. It alleges 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.
5. Complaint Two relies on the same set of particulars both individually and cumulatively as set out in Complaint One.

Ingleburn and Malabar Pharmacies

1. The basis for the first complaint is particularised as follows: (1) On 27 January 2015 Mr Saab failed to immediately notify the Secretary of the NSW Ministry of Health when informed by the pharmacist in charge of missing Endone stock at Malabar contrary to Clause 124 of the Poisons and Therapeutic Goods Regulation 2008 (PTGR). (2) On 24 February Mr Saab inappropriately requested a pharmacist in his employ not to notify or report the missing Endone stock at Malabar to the Secretary of the NSW Ministry of Health contrary to Clause 124 of the PTGR. (3) On 19 March 2015 Mr Saab: 1. was made aware of a discrepancy of 600 Endone tablets in the drug register at Ingleburn and inappropriately requested that the matter not be reported to the Secretary of the NSW Ministry for Health contrary to clause 124 of the PTGR 2. declined a request by an employed pharmacist that a stock take of Endone be conducted which later identified 785 missing Endone tablets. (4) Between 21 April 2015 and 22 September 2015 Mr Saab failed to maintain an accurate inventory of the quantity of Schedule 8 drugs held at Ingleburn, contrary to clause 118 of the PTGR, in that the quantity recorded in the Register was not accurate. (5) Between 21 April 2015 and 22 September 2015 Mr Saab failed to ensure that the drug register held at Ingleburn was properly kept by pharmacists in his employ, and in compliance with clause 177(2) of the PTGR and that all mistakes were corrected in the margin or footnote, initialled and dated. (6) On 22 September 2015 Mr Saab failed to ensure that two Schedule 8 drug safes were affixed to the premises at Ingleburn, contrary to clause 76 of the PTGR. (7) Between 21 April 2015 and 22 September 2015 Mr Saab failed to report to the Secretary of the NSW Ministry of Health that original prescriptions confirming faxed or phoned prescriptions from the Opioid Treatment Program (OTP) prescribers were not received at Ingleburn within 7 days from the date of the fax/telephone call, contrary to clause 96(2)(b) of the PTGR. (8) Mr Saab failed to identify and report the loss of 10 Suboxone 2mg films at Ingleburn in circumstances where an audit on 22 September 2015 showed that 10 Suboxone 2mg films were not accounted for and the Director General of the NSW Ministry of Health was not immediately notified of any loss, contrary to clause 124 of the PTGR. It is not in dispute that Suboxone is a medication that is given to patients who have an addiction to opioid medications such as heroin or other prescription opioids. (9) Mr Saab failed to ensure that pharmacists at his employ at Ingleburn dispensed compliant prescriptions for Schedule 8 drugs in circumstances where in the case of computer generated prescriptions: (a) the name, strength and quantity (expressed in both words and figures) of the drug to be supplied were not specified, contrary to clause 80(1)(c) of the PTGR; and (b) adequate directions for use were not specified, contrary to clause 80(1)(d) of the PTGR.

Toronto (10) Between 13 October 2014 and 21 September 2015 Mr Saab failed to maintain an accurate inventory in the Pharmacy drug registers of the quantity of Schedule 8 drugs held, contrary to clause 118 of the PTGR, in that the quantity of Schedule 8 drugs recorded understated or overstated the actual quantity of drugs held. (11) Between 13 October 2014 and 21 September 2015 Mr Saab failed to ensure that pharmacists in his employ entered into the pharmacy drug register the records of supply on the day when he/she had supplied Biodone Forte and Subtex 8mg tablets, contrary to clause 112(1) of the PTGR. (12) Mr Saab failed to ensure that pharmacists in his employ endorsed with the word "cancelled" previously dispensed or expired methadone prescriptions, contrary to clause 88(2) of the PTGR. (13) Mr Saab failed to report to the Secretary of the NSW Ministry of Health, the fact that written confirmation of faxed or phoned prescriptions from the OTP prescribers were not received within 7 days from the date of the fax/telephone call, contrary to clause 96(2)(b) of the PTGR. (14) Mr Saab failed to ensure that pharmacists in his employ dispensed compliant prescriptions for Schedule 8 drugs in circumstances where, in the case of computer generated prescriptions: (a) the name, strength and quantity (expressed in both words and figures) of the drug to be supplied were not specified, contrary to clause 80(1)(c) of the PTGR; (b) adequate directions for use were not specified, contrary to clause 80(1)(d) of the PTGR; (c) intervals for the drug to be supplied were not specified, contrary to clause 80(1)(f) of the PTGR.

Mr Saab's Reply to the Complaint

1. In Mr Saab's reply dated 21 November 2018, he denied that his conduct amounted to either unsatisfactory professional conduct or professional misconduct.
2. In relation to particulars 1, 2 and 3 Mr Saab denied the factual basis upon which each particular rested. His reply was to the effect that as at 27 January 2015, he was unaware that Endone stock was missing from the Malabar pharmacy, and at no stage did he request anyone in his employ not to report that fact to the authorities. Upon becoming aware of a discrepancy in Endone tablets in the drug register at Ingleburn, he caused a stock take to be undertaken. He disputed that he requested anyone not to report the matter.
3. In broad terms in relation to the balance of the particulars, Mr Saab stated that he employed competent pharmacists in charge whom he believed were aware of their professional and legal obligations; and he attended all his pharmacies to oversee and confer with his pharmacists. In relation to a number of the particulars, he stated his own attendances at the pharmacies had not given any cause for concern; for example alterations in the drug register (particular 5), original prescriptions not provided (particulars 7 and 13), unaccounted for suboxone (particular 8), non-compliant prescriptions (particulars 9, 12 and 14), and inaccurate inventory (particular 10). Additionally in respect of some of these particulars, he stated that the pharmacist in charge had not alerted him to issues for example non-compliant prescriptions (particulars 9, 12 and 14), unaccounted for suboxone (particular 8) and inaccurate inventory (particular 10).
4. In respect of all the compliance issues raised by the particulars identified in the Complaint (particulars 4 to 14 inclusive), Mr Saab stated he had taken steps to rectify. He set out in detail the procedures, policies and guidance he has provided to his employed pharmacists as to what is required.

Legislative Context

1. The Poisons and Therapeutic Goods Regulation 2008 (PTGR) sets out requirements in relation to the storage, handling, dispensing and record keeping of drugs of addiction. To properly appreciate the stringent nature of these requirements, it is helpful to set out in detail the provisions raised by the particulars of the Complaint.
2. Part 4 Division 2 Clause 76 sets out how drugs of addiction are to be stored in pharmacies. It relevantly provides as follows: (1) The pharmacist for the time being in charge of a pharmacy must keep any drug of addiction stored apart from other substances or goods (other than cash or documents) in a separate safe. (2) Unless otherwise approved for the time being by the Director-General, such a safe must comply with the following requirements-- (a) it must be made of black mild steel plate at least 9 millimetres thick with continuous welding along all edges, (b) it must be fitted with a door made of mild steel plate at least 9 millimetres thick, the door being flush fitting with a clearance around the door of not more than 1.5 millimetres, (c) it must have a fixed locking bar, welded to the inside face of the door near the hinged edge, that engages in a rebate in the safe body when the door is closed, (d) it must be fitted with a five lever key lock (or a locking mechanism providing at least equivalent security) securely fixed to the rear face of the door, (e) if mounted on a brick or concrete wall or floor, it must be attached to the wall or floor by means of suitably sized expanding bolts through holes 9 millimetres in diameter drilled in the rear or bottom of the safe, (f) if mounted on a timber framed wall or floor, it must be attached to the wall or floor frame by means of suitably sized coach screws through holes 9 millimetres in diameter drilled in the rear or bottom of the safe, (g) if mounted on any other kind of wall or floor, it must be attached to the wall or floor in a manner approved for the time being by the Director-General. (3) The pharmacist must ensure that-- (a) the safe is kept securely locked when not in immediate use, and (b) any key or other device by means of which the safe may be unlocked-- (i) is kept on the person of a pharmacist whenever it is on the same premises as the safe, and is removed from the premises whenever there is no pharmacist at those premises, or (ii) is kept in a separately locked safe to which only a pharmacist has access, and (c) any code or combination that is required to unlock the safe is not divulged to any unauthorised person
3. Part 4 Division 3 Clause 80 contains requirements as to the form of prescriptions for drugs of addiction. For present purposes the following details must be included: the name, strength and quantity (expressed in both words and figures) of the drug to be supplied: Clause 80(1)(c) adequate directions for use: Clause 80(1)(d) the intervals at which the drug may be supplied on the prescription: Clause 80(1)(f)
4. Part 4 Division 4 Sub-Division 1 Clause 88 deals with the supply of a drug of addiction on prescription and how prescriptions are to be endorsed. Clause 88(2) provides as follows: A person who supplies a drug of addiction on prescription must endorse (in ink) across the prescription the word "CANCELLED" - …
5. Part 4 Division 4 Sub-Division 2 Clauses 95 and 96 deal with the emergency supply of a drug of addiction without prescription.
6. Clause 95 provides as follows: (1) A person who is authorised to supply drugs of addiction (whether by this Division or by an authority or licence under Part 8) may supply a drug of addiction to an "authorised person", being-- (a) any person who is authorised to have possession of such a drug of addiction, or (b) any other person if the other person is in possession of a certificate, signed by a person so authorised, to the effect that the other person is authorised to obtain the drug of addiction on behalf of the person so authorised. (2) A supplier may supply drugs of addiction under this clause on the basis of a written order signed by an authorised person or on the basis of an order received from an authorised person by telephone, electronic mail or facsimile. (3) A person who orders and receives a drug of addiction must notify the supplier of the receipt of the drug within 24 hours after that receipt. (4) The notice under subclause (3) must be in writing and must be dated and signed by an authorised person. (5) If a supplier, who supplies a drug of addiction on the basis of an order, does not receive written notice of the order under subclause (3) within 7 days after the drug is supplied, the supplier must report that fact to the Director-General. …
7. Clause 96 (2) relevantly provides: (2) A pharmacist who supplies a drug of addiction in accordance with this clause-- (a) must keep and cancel the prescription that is subsequently sent in confirmation of the direction, or (b) if such a prescription is not received within 7 days after the drug is supplied, must report that fact to the Director-General.
8. Part 4 Division 5 Clause 112 of the PTGR deals with the entries that must be made in drug registers. Clause 112(1) provides as follows: (1) On the day on which a person manufactures, receives, supplies, administers or uses a drug of addiction at any place, the person must enter in the drug register for that place such of the following details as are relevant to the transaction-- (a) the quantity of the drug manufactured, received, supplied, administered or used, (b) the name and address of the person to, from, or by, whom the drug was manufactured, received, supplied, administered or used, (c) in the case of a drug that has been administered to an animal or supplied for the treatment of an animal, the species of animal and the name and address of the animal's owner, (d) in the case of a drug that is supplied or administered on prescription-- (i) the prescription reference number, and (ii) the name of the authorised practitioner by whom the prescription was issued, (e) in the case of a drug that has been administered to a patient, the name of the authorised practitioner (other than a veterinary practitioner) by whom, or under whose direct personal supervision, the drug was administered, (f) in the case of a drug that has been administered to an animal, the name of the veterinary practitioner by whom, or under whose direct personal supervision, the drug was administered, (g) in the case of a drug that has been administered by a person authorised to do so by an authority under Part 8, details of the circumstances requiring administration of the drug, (h) in the case of a drug that has been used by a person who is in charge of a laboratory, or is an analyst, the purpose for which the drug was used, (i) the quantity of drugs of addiction of that kind held at that place after the transaction takes place, (j) any other details approved by the Director-General.
9. Part 4 Division 5 Subdivision 3 Clause 118 of the PTGR states that a periodical inventory of stock of drugs of addiction must be conducted in March and September each year.
10. Part 4 Division 7 Clause 124 deals with loss of drugs of addiction and provides that a person who is authorised to be in possession of drugs of addiction must immediately notify the Director-General if the person loses a drug of addiction or if a drug of addiction is stolen from the person.
11. Part 9 Clause 177 deals with false or misleading entries in records or registers. It provides as follows: (1) A person who is required by this Regulation to keep any record or register must not make any entry in the record or register that the person knows to be false or misleading in a material particular. (2) A person must not make any alterations, obliterations or cancellations in a record or register required by this Regulation, but may correct any mistake in any entry by making a marginal note or footnote and by initialling and dating it.

Evidence relevant to the particulars

1. Mr Saab denies the first three particulars of Complaint One. For the most part, the relevant evidence for particulars 1-3 is to be found in the evidence of Mr Saab and two witnesses who both appeared under summons issued by the Commission, Ms Mourad and Mr Farhat.
2. Ms Mourad was employed by Mr Saab as a pharmacist at Ingleburn and on occasions at Malabar. She worked for Mr Saab from 2011 until early May 2015. Mr Farhat was employed as a Pharmacist in Charge at Malabar and as a locum Pharmacist on Sundays at Ingleburn. He was employed by Mr Saab in about 2010 or 2011 and ceased working for Mr Saab around 23 March 2015.
3. Ms Mourad and Mr Farhat were engaged to be married. They commenced a personal relationship in September 2013 and held a religious and cultural engagement ceremony in February 2014. They were due to be married on 27 March 2015. The marriage did not go ahead.

On 27 January 2015 Mr Saab failed to immediately notify the Secretary of the NSW Ministry of Health when informed by the pharmacist in charge of missing Endone stock at Malabar contrary to Clause 124 of the Poisons and Therapeutic Goods Regulation 2008, (PTGR).

1. On 17 April 2015 Ms Mourad made a written notification to the Australian Health Practitioner Regulation Agency (AHPRA) seeking that her notification be "confidential" and not be provided to Mr Saab or Mr Farhat "in a way that relate to me as my life will be in danger".
2. The AHPRA notification stated as follows: Sunday 25/1/15: Hussein Farhat requests to borrow 30 boxes of Endone 5mg from Ingleburn Medical Centre Pharmacy to Malabar stating is is OOS [out of stock]. Tuesday 27/1/15: Hussein Farhat's cousin passes away. Hussein Farhat informs me that he is missing some boxes of Endone from Simply Pharmacy Malabar and that Hussein Saab (pharmacy owner) is aware of the problem. As per his Symbion ordering history 220 boxes of Endone were ordered in early January 2015.
3. Ms Mourad gave oral evidence on two separate occasions; 5 December 2018 and 21 May 2019. She sought leave to be legally represented on both occasions which was granted. Mr Tsolakis, solicitor, appeared on her behalf.
4. On the first day of hearing on 5 December 2018, Ms Mourad provided a statement dated 4 December 2018. This statement became an exhibit in the proceedings. Ms Mourad's statement is summarised as follows: 1. Ms Mourad was employed by Mr Saab at Ingleburn as the Pharmacist in Charge on 5 March 2011. She also worked at Malabar to cover other Pharmacists on approximately six occasions. 2. Mr Farhat was a trainee Pharmacist and had worked under Ms Mourad. 3. Mr Farhat and Ms Mourad began a personal relationship in September 2013. They had a religious ceremony and were planning to be married. They did not live together. They lived with their respective parents. 4. Mr Farhat worked at Malabar Monday to Friday and worked on Sundays at Ingleburn with Ms Mourad. 5. On Sunday 25 January 2015 Mr Farhat requested to borrow 30 boxes of Endone 5mg from Ingleburn. Ms Mourad told Mr Farhat that to borrow the boxes he must record the transfer in the Dangerous Drugs (DD) book. She said words to the effect, "Make sure you write it in the book". 6. On Tuesday 27 January 2015 Mr Farhat informed Ms Mourad that he was missing some boxes of Endone from Simply Pharmacy in Malabar and that Mr Saab was aware of the matter.
5. Ms Mourad gave oral evidence that in January 2015 she started to have doubts about her forthcoming marriage to Mr Farhat. She subsequently became aware of his misappropriation of Endone. It was her understanding that Mr Farhat was selling Endone and not taking it for self-administration as alleged by him to the Pharmacy Council and in his Tribunal matter. Ms Mourad gave evidence that she did not want to get married to someone who sells Endone, and the final decision to call off the wedding was made at the beginning of March 2015.
6. Ms Mourad gave evidence under cross-examination in relation to Mr Saab's knowledge as at 27 January 2015 of the missing Endone stock at Malabar as follows: MR VILLA: Okay then. Now, Ms Mourad, in January of 2015 when Mr Farhat informed you that he was missing some boxes of Endone from Malabar you did not at that time say anything to Mr Saab about that, did you? MS MOURAD: No, he knew about it. MR VILLA: Well, let's not worry about what you say he knew. Just answer the question please. MS MOURAD: No. MR VILLA: And the reason that you did not do so, may I take it, is because Mr Farhat had said to you that Mr Saab was aware of that fact. Is that right? MS MOURAD: Yes, he showed me text messages.
7. On 21 May 2019 Mr Farhat attended the hearing to give evidence under a summons issued by the Commission. He sought leave to be legally represented which was granted. Mr Soukie, solicitor, appeared on his behalf.
8. Soon after the commencement of Mr Farhat's oral evidence Mr Soukie sought the granting of a certificate under section 128 of the Evidence Act 1995 on behalf of Mr Farhat. This provision relates to privilege in respect of self- incrimination.
9. Section 38 of the Civil and Administrative Tribunal Act 2013 sets out the procedure of the Tribunal generally. It relevantly provides that: (1) The Tribunal may determine its own procedure in relation to any matter for which this Act or the procedural rules do not otherwise make provision. (2) The Tribunal is not bound by the rules of evidence and may inquire into and inform itself on any matter in such manner as it thinks fit, subject to the rules of natural justice. (3) Despite subsection (2): … (b) section 128 (Privilege in respect of self-incrimination in other proceedings) of the Evidence Act 1995 is taken to apply to evidence given in proceedings in the Tribunal even when the Tribunal is not required to apply the rules of evidence in those proceedings.
10. After submissions and consideration of the matter, a certificate under section 128 of the Evidence Act was issued in respect of the evidence given by Mr Farhat in these proceedings.
11. Mr Farhat said he began working for Mr Saab around 2010/2011. He has been the subject of disciplinary proceedings in relation to missing Endone at the Malabar and Ingleburn pharmacies. He gave evidence that he did not inform Mr Saab of any missing Endone. He did not discuss any missing Endone or irregularities with Endone with Mr Saab. He recalled having a meeting with Mr Saab but it was not about the missing Endone.
12. Mr Saab says that he was not aware that the Endone was missing from Malabar on 27 January 2015. As he was not aware of the missing Endone, he did not instruct an employed pharmacist not to report the matter.

On 24 February Mr Saab inappropriately requested a pharmacist in his employ to not to notify or report the missing Endone stock at Malabar to the Secretary of the NSW Ministry of Health contrary to Clause 124 PTGR.

1. The relevant parts of Ms Mourad's statement are summarised as follows: 1. Mr Farhat told Mr Mourad that he requested to have a meeting with Mr Saab about the missing boxes of Endone but that the meeting was delayed until 24 February 2015. 2. Ms Mourad was able to order Endone from home for delivery to the pharmacy using the Symbion Portal. 3. Ms Mourad asked Mr Farhat what he did with the Endone boxes and accused him of lying to her. She wanted to know how many boxes he ordered. Mr Farhat gave her his Symbion login details and she took a screenshot of Endone orders for each of the Pharmacies. 4. On 24 February 2015 Mr Farhat saw Ms Mourad at the Ingleburn pharmacy and told her that following a meeting between him and Mr Saab, they agreed that the matter will not be notified and that Mr Farhat will retain his employment.
2. Mr Saab's evidence is to the effect that he was not aware of any missing Endone tablets from the Malabar pharmacy on 24 February 2015. Mr Farhat did not inform him of any missing Endone. Although Mr Saab did have a meeting with Mr Farhat on 24 February 2015, this was to do with his attitude towards his office manager Ms Angela Michaels and there was no discussion at that meeting about missing Endone.
3. As set out above at paragraph 80 Mr Farhat's evidence is that he did not have any discussion with Mr Saab about the missing Endone.

a) was made aware of a discrepancy of 600 Endone tablets in the drug register at Ingleburn and inappropriately requested that the matter not be reported to the Secretary of the NSW Ministry for Health contrary to clause 124 of the PTGR

b) declined a request by an employed pharmacist that a stock take of Endone be conducted which later identified 785 missing Endone tablets.

1. Ms Mourad gave evidence in her statement relevantly as follows: On Thursday 19 March 2015 I had a meeting with Mr Saab. I went to Ingleburn and took the Endone DD Register to show Mr Saab the discrepancy of 600 tablets that came to my attention. I was under the impression that Mr Saab would report the matter to the relevant authorities. Mr Saab asked me to keep everything hush hush as this issue is not good for him nor Hussein Farhat. After this meeting with Mr Saab, I returned the DD book to Ingleburn and contacted PDL who advised me to count the stock on hand of Endone before returning to work. I asked Mr Saab or his Human Resources Manager, Angela Michel, if it would be possible for me to run a stocktake on the following Friday. I recall I was advised to leave everything alone. I still performed a stock check of Endone when I returned to work. On 17 April 2015 I informed the Department of Health about this matter including 785 missing Endone tablets from Ingleburn.
2. The above extract is consistent with what Ms Mourad recorded in her notification to AHPRA dated 17 April 2015.
3. Ms Mourad stopped working for Mr Saab on 3 May 2015. In her statement she alleged that prior to Mr Saab receiving her resignation, he said to her over the phone words to the effect of "I go down you're going down too".
4. In December 2018 Ms Mourad relevantly gave oral evidence about the 19 March 2015 meeting as follows: MR VILLA: Now, on 19 March you also had a meeting with Mr Saab. Correct? MS MOURAD: Yes. MR VILLA: And you showed him the dangerous drugs register for Ingleburn. Correct? MS MOURAD: Yes. MR VILLA: And does it accord with your recollection that at that time that register consisted of two volumes? MS MOURAD: Yes. MR VILLA: There was one book which was A to M. Correct? MS MOURAD: From what I recall there was a register for purely just for Endone. Then there was one A to M and then I think there was another one for Suboxone, Methadone and Subutex and there was a last one, the rest down to Z but what I'm a hundred per cent sure is there was the Endone one was separate because we had so many entries. MR VILLA: Right, and you had identified within that register a discrepancy. MS MOURAD: Yes. MR VILLA: And does it accord with your recollection that that discrepancy was the discrepancy of 600 tablets? MS MOURAD: Yes. MR VILLA: And can you tell the tribunal the circumstances in which you became aware of that discrepancy? MS MOURAD: I was, it was March and in March we were meant to be doing the stocktake so I would normally print out all the Endone entries from the system between, because we used to do it on a weekly basis but still I'd print out all the Endone entries, go through them entry by entry by entry and then do all the additions and do a stocktake. Count what's in the safe and make sure that the numbers, so the numbers have to be exactly the same.
5. As best as Ms Mourad could recall, she became aware of the discrepancy for Endone in the register sometime between Monday 16 March and Thursday 19 March 2015. Her evidence about this and her meeting with Mr Saab on 19 March was as follows: MR VILLA: Ms Mourad, I want to go back to the stocktake that you say you did sometime between 16 and 19 March. MS MOURAD: It was completed on 19 March. … MS MOURAD: I completed the stocktake on 19 March and I contacted Hussein Saab on the same day and I saw him on the day ‑ ‑ ‑ … MR VILLA: What I want to suggest to you happened on 19 March, Ms Mourad, is that you went to see Mr Saab and you said to him that Mr Farhat had over ordered Endone and there was some missing from the dangerous drugs safe. You recall saying that? MS MOURAD: That's what the conversation was about but exactly what my words were I don't recall. MR VILLA: I want to suggest to you that at no stage did Mr Saab ask you to keep everything hush hush as the issue was not good for him or Mr Farhat, did he? MS MOURAD: Yes, he did. MR VILLA: And I want to suggest to you that that is something that you have made up in order to cover up your own failure to notify in a timely manner the authorities about information that you had been aware of for some time. Correct? MS MOURAD: No, he sent me a text message. Keep things hush hush as well. MR VILLA: All right, okay. Where is that text message? MS MOURAD: I don't have that. MR VILLA: That's because it doesn't exist, isn't it? MS MOURAD: No, it does exist. If you would like me to provide it I can provide it.
6. Ms Mourad was subsequently recalled to give evidence at the May 2019 hearing dates and in the intervening period produced documents pursuant to a Summons including email and text message communication between her and Mr Saab.
7. Relevantly two screen shots of emails were provided. The first is an email from Ms Mourad to Mr Saab on 16 March 2015 in which she advises him that her wedding to Mr Farhat had been called off. Ms Mourad wrote as follows: Out of courtesy, I would like to inform you before anyone else. The wedding is called off. I sincerely thank you for everything you have helped me out with. Thanks for the call yesterday. I will be taking today off to get my head around things and come fresh to work tomorrow…
8. In the second screen shot of the same date Mr Saab wrote back as follows: I am so sorry it came to this. I'll support you with whatever decision you make. Ps keep the reason hush hush. It's not good for me or Hussein Farhat.
9. It was suggested to Ms Mourad in cross examination that in the phone call she had with Mr Saab the previous day, on 15 March 2015, she had told Mr Saab that the wedding had been cancelled because Mr Farhat had been violent towards her. Ms Mourad denied this suggestion.
10. In relation to the telephone conversation between Mr Saab and Ms Mourad the day before the "hush hush" text message, Ms Mourad gave evidence as follows: MS MOURAD: The conversation was not because - him being violent with me has nothing to do with Mr Saab. Why would I call him even if it happened outside of work after hours? Why would I discuss it with Mr Saab? It's none of his business. We had a clear conversation, him and I, about him - we spoke about the Endone. It was about the Endone tablets and that's when he told me I - or he said something along the lines of, "I go down, you go - youse all go down with me."
11. In response to a question about why she thanked Mr Saab for the telephone call, as we understood Ms Mourad's evidence, she suggested that it was to do with advice Mr Saab had given her after raising the missing Endone with him.
12. In oral evidence Mr Saab stated that in a telephone call prior to the email exchange on 16 March, Ms Mourad had told him that the wedding had been called off. He had used the words "hush hush" in reference to her marriage being called off. As we understood his explanation for using the words "hush hush" and that it was "not good for" him or Mr Farhat; he was aware that Mr Farhat had been abusive to Ms Mourad, they were both employed by him and Ms Mourad did not want other staff to be aware of her personal circumstances.
13. Mr Saab's evidence was to the effect that he had not become aware of discrepancies in the drug register for Endone until 19 March 2015 when Ms Mourad showed him the drug register. He admits that on 19 March 2015 during the meeting with Ms Mourad he was informed that there was a discrepancy in Endone tablets recorded in the dangerous drug register at Ingleburn, and in particular that Mr Farhat had over-ordered Endone and Endone was missing from the Dangerous Drug safe.
14. After the meeting with Ms Mourad, Mr Saab instructed Mr Ali Jaafar, a pharmacist in his employ at Ingleburn to undertake a stocktake. He had not requested Ms Mourad or anyone else not to notify the Ministry of Health about the discrepancy. He did not recall denying a request from Ms Mourad to undertake a stocktake because on the same day and after the meeting with Ms Mourad he had instructed Mr Jaafar to do it. Mr Saab also denied saying "I go down, you go - youse all go down with me" to Ms Mourad or making any kind of threat towards her.
15. On 27 March 2015 Mr Jaafar sent an email to Mr Saab in relation to the stocktake he had undertaken at Ingleburn. In this email he set out his findings and listed discrepancies in the drugs register. He also identified specific patient entries which appeared to be suspicious. Mr Jaafar identified 785 missing Endone tablets.
16. On 31 March 2015 in a call logged to the PSU, Mr Saab reported "his suspicions of misappropriation of Schedule 8 drugs" from Malabar and Ingleburn.
17. Mr Saab explained the delay between 19 March 2015 when he became aware of the discrepancies and reporting the matter to the Ministry of Health on 31 March 2015 on the basis that he had wanted to conduct a thorough investigation at both the Ingleburn and Malabar pharmacies. He explained that it was around 19 March 2015 that he became aware that the drug register from Malabar was missing. Because the register was missing at Malabar it became necessary to examine invoices for the purchase of Endone and cross check that information against prescriptions and dispensing history.

Particulars 4 to 14

1. For the most part the evidence relevant to the balance of the particulars numbered 4 to 14 is contained in PSU OTP Inspection Reports prepared by Ms Wei, in respect of Ingleburn dated 7 December 2015, and in respect of Toronto dated 17 December 2015, together with oral evidence given by her and Mr Saab.
2. These particulars relate to a range of alleged contraventions of the PTGR in relation to the keeping of accurate drug register inventories, the proper keeping of drug register books, properly affixing Schedule 8 drug safes, failure to report a loss of a Schedule 8 drug, failure to report the non-receipt of original prescriptions, the dispensing of non-compliant prescriptions, and the proper endorsement of prescriptions.
3. For ease of reference, and because in the main these particulars elicited some qualified concessions from Mr Saab, the evidence relevant to these particulars including that of Mr Saab, the consideration of that evidence and the findings about the particulars is set out later in this decision under the heading "Findings on the Particulars" which can be located commencing at paragraph 196 through to paragraph 279 of this decision.
4. However evidence was given by two witnesses on behalf of Mr Saab that was relevant to aspects of some particulars. That evidence is summarised below.

Ms Michael

1. Ms Michael is the human resource manager at the Simply Pharmacy Group. She has held this position for 5 years. She works out of the group's head office located at Ingleburn. She described her role as being involved in the work roster, general employee relations and checking on staff training procedures. During 2015 she attended the Ingleburn pharmacy every few days.
2. In oral evidence Ms Michael stated that Mr Saab made his own arrangements to attend the Malabar and Ingleburn pharmacies. She could not recall how often Mr Saab attended Ingleburn and Malabar. She described it as frequent but could not recall the frequency.
3. Ms Michael provided two written statements. The first is a statutory declaration dated 8 October 2018.
4. In this document Ms Michael declares that she witnessed Mr Saab attempt to contact the HCCC by telephone to report an incident regarding missing Schedule 8 medication at Malabar. He was unable to get through and left a message for a call back. Ms Michael prepared this declaration herself. Although she was asked to prepare the declaration, she could not recall who asked her.
5. Ms Michael provided an affidavit dated 20 November 2018 in which she referenced that as at 27 January 2015, she understood Mr Saab to be on annual leave and due to return to work on 28 January 2015.
6. Ms Michael also referred to email contact with Ms Mourad. She stated that on 18 March 2015 Ms Mourad sent an email and advised Ms Michael that she was coming in to the head office the following day to talk to Mr Saab and also to talk to her about the Ingleburn pharmacy work roster.
7. On 20 March 2015 Mr Saab asked Ms Michael to go to the Malabar pharmacy the next day to arrange a locksmith. Ms Michael oversaw the locksmith. She believed that a pharmacist was present when the locks were changed because it occurred during store hours. On 22 March 2015 she sent an email to Mr Farhat in which she advised that due to the nature of his activities at Malabar, an investigation had been launched. He was placed on leave.

Mr Jaafar

1. Mr Jaafar is a registered pharmacist. He worked for Mr Saab at the Ingleburn medical centre Pharmacy from 2012 until October 2015. He was working as Pharmacist in charge 2-3 days per week. There were five pharmacists on a rotating roster and two pharmacists at any one time.
2. Mr Jaafar was asked by Mr Saab to do a stocktake of Endone in March 2015. After he did the Endone stocktake Mr Saab instructed him to undertake a full stocktake on all methadone, opioids, and Schedule 8 drugs.
3. Mr Saab was not present when he undertook the Endone stocktake, however he would come to the shop regularly to see how the process was going. In his written statement he said the stocktake for Endone took a few days. He agreed with Ms Benson's view, an expert engaged by the Commission whose evidence is dealt with later in this decision, that looking at how frequently Endone was dispensed, a comprehensive stocktake should have only taken about two hours. He qualified this period of time by stating that the pharmacy was dispensing 300 or 400 other scripts a day and so the stocktake took longer. Mr Saab did not undertake the stocktake nor did he take over dispensing duties so the stocktake could be done more quickly.
4. Mr Jaafar's evidence was to the effect that until 27 March 2015 his stocktake efforts were concentrated on Endone. On 27 March 2015 he sent an email to Mr Saab setting out his findings in relation to the Endone stocktake. He copied Ms Michael into this email.
5. Mr Jaafar conceded that when he did the stocktake and sent the email detailing his findings, duplicates of the Schedule 8 prescriptions were being held at a warehouse and not at the pharmacy as they should have been. It is a requirement of the PTGR that Schedule 8 prescriptions for the two years prior are to be held on site at the pharmacy.
6. Mr Jaafar gave evidence that Mr Saab attended the Ingleburn pharmacy about once or twice a week. On some occasions he would stay for 5 minutes and on other occasions he would stay for several hours.
7. In response to a series of questions in cross examination about what Mr Saab did when he attended the pharmacy, Mr Jaafar was not very specific. He referred to Mr Saab attending to general business and talking to the staff. He was not aware of Mr Saab doing anything in particular in relation to the dispensing of Schedule 8 drugs prior to the incident in 2015. In response to a question as to whether Mr Saab looked at the prescriptions he had dispensed as a pharmacist, he stated that Mr Saab would ask him how the dispensary was going. He was not sure if Mr Saab was doing external or internal audits separately. His evidence was to the effect that he did not actually see Mr Saab doing any audits but he could have done so when he was not there.

Expert Reports

1. Three reports were before the Tribunal relevant to stage 1 of the proceedings. The Commission tendered a report of Ms Benson. Mr Saab tendered two reports from Mr Mahoney. Ms Benson also gave oral evidence. Mr Mahoney did not. The reports of both experts and Ms Benson's evidence is summarised below.

Peer Review Report: Ms Benson

1. Ms Benson has been a pharmacist for some 19 years. She has held a range of positions in Australia and England including as a Pharmacist in Charge, Consultant Pharmacist for Medical Centres and General Practices, and as a proprietor pharmacist. She is currently a Clinical Practitioner Teacher, Discipline of Pharmacy, Graduate School of Health at the University of Technology and a Pharmacy Coach for the Pharmaceutical Society of Australia.
2. Ms Benson prepared a report dated 29 May 2017 which examined Mr Saab's conduct. The report canvassed Mr Saab's general conduct together with specific areas where it was said that he had acted significantly below the standard reasonably expected of a practitioner of equivalent training or experience.
3. Ms Benson identified the following areas where Mr Saab had acted significantly below the standard reasonably expected of a practitioner of equivalent training or experience and which invited her strong criticism: 1. Not performing periodical stock checks or reconciliation of the Schedule 8 stock holding at Ingleburn and Toronto. Ms Benson referenced Part 4 Division 5 Subdivision 3 Clause 118 of the PTGR which provide that periodical inventory of drugs of addiction must be conducted in March and September each year. She also referenced the Pharmacy Board Guidelines for proprietor pharmacists. These state that proprietors must maintain an active interest in how the practice of the pharmacy is being conducted to ensure that the pharmacy operation is in accordance with relevant Pharmacy Board of Australia policies, professional practice, quality assurance standards and good pharmacy practice. By not performing periodical stock checks or reconciliation of the Schedule 8 stock holding Mr Saab at Ingleburn and Toronto failed to adhere to these standards. 2. Alterations in the drug register. Ms Benson referenced Section 8.5 of the Guidelines of June 2015 entitled "Guide to Poisons and Therapeutic Goods Legislation for Pharmacists" issued by the PRU which state that alterations, obliterations or cancellations of entries must not be made in the Schedule 8 drug register. Mistakes may be corrected by a marginal or footnote, initialled and dated. Although Mr Saab was not the pharmacist involved in making the drug register entries it was his responsibility as a proprietor to ensure that his employee pharmacists were compliant with guidelines and practicing in an appropriate manner. 3. Compliant Schedule 8 medication safes. Ms Benson referenced Section 8.4 of the Guidelines of June 2015 entitled Guide to Poisons and Therapeutic Goods Legislation for Pharmacists which state that a pharmacist must keep all drugs of addiction separate from other goods (other than cash or documents) in a steel safe meeting specified requirements and fixed to the building. The Pharmacy Board Guidelines for proprietor pharmacists state that a proprietor is responsible for ensuring that the facilities and equipment required for the type of services delivered at the pharmacy comply with state legislation. Mr Saab departed from this standard.
4. Ms Benson drew a distinction between the areas identified in the paragraphs above in which Mr Saab's conduct was said to be significantly below the standard reasonably expected, and areas in which she viewed Mr Saab's conduct to fall below the standard reasonably expected of a practitioner of an equivalent level of training or experience. These areas and what we discerned to be the corresponding particulars in the Complaint were as follows: 1. In respect of the Ingleburn and Toronto pharmacies failing to report to the Secretary of the NSW Ministry of Health that original prescriptions confirming the faxed or phoned prescriptions from the Opioid Treatment Program (OTP) prescribers were not received within 7 days from the date of the fax/telephone call. As a proprietor pharmacist Mr Saab had an obligation to ensure that his employed pharmacists were complying with standards and guidelines. He was not vigilant in his supervision of his employed pharmacists in this regard (Particulars 7 and 13). 2. In respect of Ingleburn where the employed pharmacists were not able to account for the loss of 10 Suboxone 2 mg films in circumstances where the Ministry of Health was not informed of such loss. (Particular 8). 3. In respect of computer generated prescriptions failing to ensure that pharmacists at his employ at Ingleburn and Toronto dispensed compliant prescriptions for Schedule 8 drugs in circumstances where: 1. the name, strength and quantity expressed in both words and figures of the drug to be supplied were not specified (Particulars 9 and 14) 2. adequate directions for use were not specified (Particulars 9 and 14) 3. intervals for the drug to be supplied (Particular 14 Toronto only) 1. Failing to ensure that pharmacists in his employ entered into the pharmacy drug register the records of supply on the day when he/she had supplied Biodone Forte and Subtex 8mg tablets (Particular 11). 2. Failing to ensure that pharmacists in his employ endorsed with the word "cancelled" previously dispensed or expired methadone prescriptions. As a proprietor pharmacist Mr Saab had an obligation to ensure that his employed pharmacists were complying with standards and guidelines, and in this regard he was not vigilant in his supervision of his employed pharmacists (Particular 12).

Mr Saab's general conduct

1. Ms Benson opined that as an employer it was not necessary for Mr Saab to personally undertake the periodical inventory of drugs of addiction as required by the legislation. However he was required to ensure that the periodical stocktakes occurred and, as a proprietor in order to demonstrate that he took a vigilant active interest, he should have verified that the results of these stocktakes were correct by conducting an audit in person. She expressed the view that in this regard Mr Saab's conduct was below the standard reasonably expected of a practitioner of equivalent training or experience.
2. However, Ms Benson expressed the view that Mr Saab's general conduct in the following areas was significantly below the standard reasonably expected of a practitioner of equivalent training or experience and invited her strong criticism.

• By not ensuring that stocktakes had been undertaken at Ingleburn and Toronto he had failed to discharge his responsibility as a pharmacy proprietor
• By not checking the drug registers undertaken at Ingleburn and Toronto he had failed to discharge his responsibility as a pharmacy proprietor
• By not intervening to ensure that the practice of the pharmacies undertaken at Ingleburn and Toronto was conducted in accordance with applicable laws, standards and guidelines he had failed to discharge his responsibility as a pharmacy proprietor

Ms Benson's oral evidence

1. The Commission sought to elicit Ms Benson's opinion about the steps Mr Saab took upon becoming aware on 19 March 2015 about the discrepancy in Endone stocks at Ingleburn.
2. Ms Benson gave evidence that upon being informed on 19 March 2015 of a discrepancy of Endone held at Ingleburn, she would have expected that as a proprietor Mr Saab would have instructed and ensured that a stocktake occur immediately. In relation to Mr Saab being informed by an email from his employed pharmacist Mr Jaafar some 8 days or 9 days later on 27 March 2015 which set out the issues in relation to the stocktake, Ms Benson did not think that this was a reasonable amount of time for the enquiry to be made. Her evidence was that if she had been made aware of a significant discrepancy as had occurred in this instance, then as an owner she would have looked into what had occurred to have the issue resolved immediately.
3. Ms Benson was asked to comment on Mr Saab's evidence that it was not until 31 March 2015 that he placed a report with the PSU of his suspicions of misappropriation of Schedule 8 drugs from Ingleburn as well as Malabar, and whether that was an appropriate amount of time to act on his awareness of the missing Endone at Ingleburn. Ms Benson expressed the view that it was not, and believed there was a requirement to inform either the police or PSU immediately when you know a discrepancy cannot be resolved. In her view on the day that Mr Saab was told that the stocktake could not sort out the issue then at a bare minimum that is the day PSU should have been informed.
4. Ms Benson was asked to reflect on how long it would take for a stocktake to be done given the number of prescriptions that Ingleburn pharmacy was dispensing. In her view it would take about 2 hours to do several months' worth of checks. She expected that a proprietor would be involved in the process by calling and checking that the stocktake had been done and if the problem had not been resolved then reporting the discrepancy.
5. As to Mr Saab's evidence that he was aware on 19 March 2015 of the problem but did not report it to PSU until 31 March 2015 she stated that if a stocktake was done over a weekend then a report to PSU might not occur until a Monday but the police could be contacted at any time. For example if a discrepancy was discovered on a Friday night then the maximum amount of time to report it would be 4 days. However in other circumstances if the discrepancy could not be resolved a report should be made within 24 hours.
6. Ms Benson was given access to the Ingleburn drug register for Suboxone for the period that is relevant to particular 8. This document became an exhibit in the proceedings. It had not been available to her at the time she prepared her written report. Ms Benson explained that Suboxone is a medication that is given to patients who have an addiction to opioid medications such as heroin or other prescription opioids. It is a medication that usually a patient will receive daily under supervised dosing at a pharmacy.
7. Ms Benson gave evidence that normally with an OTP pharmacy a subsidiary register is kept which reflects the names of patients, the date and the amount of Suboxone dispensed. She explained that when you are dispensing to a large volume of patients you can keep a subsidiary register and then only one daily entry needs to be made into the dangerous drug register. It was apparent to her from looking at the Ingleburn drug register for Suboxone that a subsidiary register was being used.
8. Ms Benson agreed that in order to determine the accuracy of the two entries which appeared on the register of 20 February 2016 which recorded a "Missed entry" of 10 September 2015 of ten films and "Entry error" of 11 September of two films; access to the subsidiary register and the relevant prescriptions would be needed. Ms Benson explained that you would need to see which patients were being dosed on that day, confirm how many films were meant to go out and then check that the adjustments were appropriate. Ms Benson agreed that when the error entries were considered in the light of Ms Wei's stocktake done on 22 September 2015 which found that the amount of Suboxone in the safe was ten less than that reflected in the controlled drug register, this suggested a surplus of two Suboxone films.
9. In cross examination Ms Benson explained that when she prepared her report she had access to Guidelines for Proprietor Pharmacist, produced by the Pharmacy Board of Australia issued in December 2010 and September 2015.
10. In cross examination Ms Benson agreed that a variation between 2010 and 2015 guidelines was that the 2010 guideline stated that "A proprietor/owner cannot abdicate his or her professional obligations", and the 2015 iteration replaced the word "abdicate" with "delegate". In her report she had used the language of the 2015 guidelines. She agreed that the December 2015 guidelines did not apply to Mr Saab's practice of pharmacy at the period of time to which the Complaint related and with which the Tribunal was concerned.
11. Ms Benson agreed that Mr Saab could not report a matter that he might be required to report if he were unaware of it. For example in the case of fax or phone prescriptions where an original prescription had not been received from a prescriber. However her criticism of Mr Saab's conduct related both to his failure to be aware of that fact and a failure to ensure that his staff were doing what they should be doing. In her view Mr Saab needed to make sure that his employees were aware of their responsibilities and he needed to be checking that they were doing the right thing.
12. Ms Benson also expressed the view that if a proprietor identified an issue at one pharmacy then that ought to cause them to look more closely at other pharmacies that they owned. If there are multiple sites and problems at all of them, then it would suggest that it is not just one random pharmacist who is not acting correctly.

Mr Mahoney

1. Mr Mahoney was registered as a pharmacist in 1965. He is not currently registered as a pharmacist but previously practised in community pharmacy for over 50 years. He has conducted peer reviews over many years for the Pharmacy Council and other professional bodies.
2. In his first report dated 16 October 2018 Mr Mahoney based his opinions on a number of documents that had been provided to him by Mr Saab's solicitors. These documents included the volume of documents relied upon by the Commission that were in evidence before us.
3. Mr Mahoney noted that the investigation by PSU as it was then known had been very thorough. His stated that his experience was that PSU was always very thorough and as a result PSU would inevitably discover shortcomings in the process. In Mr Mahoney's view the main issue uncovered in the investigation was an assumed lack of overall supervision of an employee pharmacist, as well as a general sloppiness in clerical procedures. In Mr Mahoney's view Mr Saab took prudent steps to correct serious omissions in procedures, and his actions on becoming aware of the problems were appropriate.
4. Mr Mahoney noted that the Ingleburn pharmacy had approximately 50 patients currently enrolled in the Opioid Treatment Program (OTP). He expressed the view that this was a large number when one considers the daily dosage requirements of the program. A missed entry in the separate register required for OTP is almost inevitable when so many patients are being treated. He opined that this would probably explain the Subutex shortage. He suggested a reduction in the number of OTP patients may be in order.
5. Mr Mahoney concluded that notwithstanding Mr Saab's twenty years of experience in pharmacy he demonstrated considerable omissions in his appreciation of his responsibilities as a proprietor of pharmacies. This was probably explained as naiveté but he felt that it had led to a big wake up call for Mr Saab. He considered Mr Saab to now be a responsible and competent pharmacist and that the public is protected, safe and not at risk based on his current practice.
6. Mr Mahoney completed a second report dated 4 December 2018. In preparation for this report Mr Mahoney attended the Ingleburn pharmacy to conduct an inspection, to scrutinise the Schedule 8 register, and to examine the protocols followed in dispensing prescriptions with a focus on Schedule 8 medication. He found the procedures in place at Ingleburn to be adequate and sufficient to safely meet the needs of the public.

Mr Saab's Evidence

1. Much of Mr Saab's evidence was to the effect that he employed competent pharmacists and he was not given cause for concern. For example his employed pharmacists undertook the stock checks and they did not inform him of any discrepancies.
2. There is however an aspect of Mr Saab's evidence which is not captured elsewhere in this decision. The PRU report dated 26 April 2019 prepared by Ms Chun had led Mr Saab to take further steps to ensure compliance at his pharmacies. To this end he had engaged an expert pharmacist Mr Regoli to oversee the addressing of the concerns raised by the PRU in their 2019 report.
3. Mr Saab agreed with a suggestion from the Commission that notwithstanding Mr Mahoney's recommendation that it would be in order to reduce the number of OTP patients at Ingleburn this had not occurred until Mr Regoli's involvement.

Pharmacy Board of Australia Guidelines on responsibilities of pharmacists when practising as proprietors.

1. Although both the 2010 and 2015 iteration of Guidelines issued by the Pharmacy Board of Australia were available to us, we have referred only to Guidelines issued in December 2010 because they applied at the time of Mr Saab's conduct as raised by the Complaint. They relevantly provide as follows: Summary of guideline A registered pharmacist who is a proprietor of, or who has a pecuniary interest in a pharmacy must maintain and be able to demonstrate an awareness of, the manner in which that pharmacy business is being conducted and, where necessary, intervene to ensure that the practice of pharmacy is conducted in accordance with applicable laws, standards and guidelines. Guideline … … If the proprietor/owner or partner-in-ownership pharmacist is not the pharmacist usually in charge of that pharmacy, he or she must determine regularly how the practice of pharmacy is being conducted to be satisfied it is in accordance with any applicable state, territory or Commonwealth law applicable to the practice of pharmacy, with any relevant Pharmacy Board of Australia policies, codes and guidelines and with good pharmacy practice. If the proprietor finds otherwise, he or she must intervene to ensure that the pharmacy business is conducted properly. For the purposes of this guideline, determining how the pharmacy business is conducted includes: Ensuring appropriate risk management procedures are in place … … … Maintaining a direction over the kinds of services being provided and goods being sold, particularly those known to be subject to abuse or misuse Ensuring business procedures and policies established by the proprietor/s are being followed. The vigilance of the practice described in this guideline includes regular on-site visits and regular staff meetings. The proprietor/owner or partner-in-ownership pharmacist must ensure that procedures and policies relevant to the conduct of the pharmacy are documented and available within the pharmacy. A proprietor/owner or partner-in-ownership of a pharmacy cannot abdicate his or her professional obligations, even if that partner is silent operationally or present only infrequently not regularly present at the pharmacy. This applies to pharmacists who own a pharmacy, or pharmacies, in all forms of business structures.

On 27 January 2015 Mr Saab failed to immediately notify the Secretary of the NSW Ministry of Health when informed by the pharmacist in charge of missing Endone stock at Malabar contrary to Clause 124 of the Poisons and Therapeutic Goods Regulation 2008, (PTGR).

Finding

1. The factual issue to be determined is whether on 27 January 2015 Mr Saab was informed by the pharmacist in charge, Mr Farhat of missing Endone at Malabar.
2. Mr Saab denies that he was aware of missing Endone at Malabar on 27 January 2015. His evidence is that he was on leave in and returned to Sydney on 26 January 2015. He was not at work on 27 January 2015. He was due to return to work on 28 January 2015.
3. This is consistent with the affidavit of Ms Michael dated 20 November 2018 in which she stated that she understood Mr Saab to be on annual leave until 28 January 2015.
4. Mr Saab states he did not become aware of missing Endone until the meeting he had with Ms Mourad on 19 March 2015.
5. Ms Mourad's evidence is that she did not tell Mr Saab that Mr Farhat had told her that he was missing some boxes of Endone from Malabar. She believed Mr Saab was aware of the missing Endone. She held this belief because that is what Mr Farhat had told her. In her oral evidence she added that Mr Farhat had showed her text messages to this effect.
6. Mr Farhat's evidence is that he did not at any stage tell Mr Saab about the missing Endone.
7. Mr Farhat's evidence about this is consistent with the evidence of Mr Saab. Mr Farhat stated that he did not inform Mr Saab about the missing Endone. He did not discuss the missing Endone with Mr Saab nor did he have a meeting with Mr Saab about the missing Endone. There are no text messages in evidence before us between Mr Saab and Mr Farhat about the missing Endone.
8. The only evidence before us that suggests that Mr Saab knew about the missing Endone as at 27 January 2015 is that of Ms Mourad. That evidence is not based on Ms Mourad's direct knowledge. It is based on what Mr Farhat told her.
9. We accept that Mr Farhat may well have told Ms Mourad that he informed Mr Saab of the missing Endone. However this is not evidence of the fact that Mr Farhat did tell Mr Saab or that Mr Saab was actually aware of the missing Endone on 27 January 2015.
10. In our view the evidence does not support a clear finding that Mr Saab actually knew on 27 January 2015 about the missing Endone from Malabar.
11. We find that particular 1 is not proved.

On 24 February 2015 Mr Saab inappropriately requested a pharmacist in his employ to not to notify or report the missing Endone stock at Malabar to the Secretary of the NSW Ministry of Health contrary to Clause 124 of the PTGR.

Finding

1. It is the Commission's position that Mr Saab requested Mr Farhat not to notify or report the missing Endone. The particular is premised on Mr Saab's knowledge about the missing Endone. For this particular to be made out we would have to be satisfied that on 24 February 2015 Mr Saab knew about the missing Endone, and instructed Mr Farhat not to report it to the NSW Ministry of Health.
2. The Commission points to the evidence from Ms Mourad. In her statement dated 4 December 2018 she stated that Mr Farhat had told her that he had requested to have a meeting with Mr Saab about the missing boxes of Endone. The meeting was to be held on 24 February 2015. Ms Mourad states that on 24 February Mr Farhat came to the Ingleburn pharmacy and told her that following the meeting with Mr Saab they agreed that the matter would not be notified.
3. Consistent with Ms Mourad's written statement is the following extract from her written notification to AHPRA dated 17 April 2015: 24/2/15: Hussein Farhat presents to Ingleburn Medical Centre Pharmacy and informs me he has a meeting with Hussein Saab. As per Hussein Farhat they both agree that the matter will remain un-notified and Hussein Farhat will remain at work. Hussein Farhat resumes work as per normal.
4. Mr Saab denies this particular. His evidence is that although there was a meeting with Mr Farhat on 24 February 2015, this was about Mr Farhat's attitude and behaviour towards other staff. There was no discussion at this meeting about missing Endone.
5. Mr Farhat gave evidence that although he had a meeting with Mr Saab there was no discussion about the missing Endone.
6. Similar to particular one, there is no direct evidence to indicate when or how Mr Saab became aware of the missing Endone at Malabar on or prior to the 24 February 2015. Nor is there any evidence to establish that Mr Saab actually requested Mr Farhat not to notify or report the missing Endone to the NSW Ministry of Health.
7. The extent of the evidence to suggest that Mr Saab was aware of the missing Endone and that it was not to be reported is found in Ms Mourad's evidence. Her evidence is based on what she says Mr Farhat told her. We accept that Mr Farhat may well have told Ms Mourad that he had a meeting with Mr Saab where it was agreed that the missing Endone was not to be reported. However it is not evidence of the truth of those matters
8. In our view the evidence does not support a clear finding that as at 24 February 2015 Mr Saab actually knew about the missing Endone at Malabar, and further that he requested Mr Farhat not to notify or report the missing Endone to the Secretary of the NSW Ministry of Health.
9. We find that particular 2 is not proved.

Particular 3

1. Particular 3 consists of two parts, a) and b). Both relate to 19 March 2015.

a) was made aware of a discrepancy of 600 endone tablets in the drug register at Ingleburn and inappropriately requested that the matter not be reported to the Secretary of the NSW Ministry for Health contrary to clause 124 of the PTGR

Finding

1. The Commission contends that Mr Saab inappropriately requested Ms Mourad not to report to the Ministry of Health the discrepancy she had identified in Endone tablets in the Ingleburn register. It points to the evidence of Ms Mourad and to Mr Saab's text to Ms Mourad of 16 March 2015 where he says, "keep the reason hush hush. Its not good for me or Hussein Farhat".
2. The Commission's position is that Mr Saab was complacent in his response upon finding out about the missing Endone on 19 March 2015. He failed to properly notify the relevant authorities for some 12 days. He did not personally investigate, choosing instead to abrogate his responsibilities to employed pharmacists. Those pharmacists were under pressure as a result of their workload and were not provided with any relief to enable them to concentrate on the stock check as a matter of priority. It was submitted that because Mr Saab did not take any active steps to report the matter immediately, this supported Ms Mourad's assertion that he told her to keep the matter "hush hush". The Commission submitted that these matters combined with the significant amount of Endone that was missing, Mr Saab's decision to continue to employ Mr Farhat for several days after 19 March 2015 and Mr Saab's failure to take immediate steps to address risk was consistent with Ms Mourad's evidence. The Commission invited the Tribunal to draw the inference from Mr Saab's conduct to find this particular made out.
3. In Ms Mourad's statement dated 4 December 2018 she stated that when she showed Mr Saab the Endone DD Register from Ingleburn, Mr Saab asked her to keep everything hush hush as this issue is not good for him nor Hussein Farhat. However under cross-examination her evidence was that this request was made in a text message. This evidence eventually led to the production of screenshots of an email that was sent by Mr Saab to Ms Mourad on 16 March 2015.
4. In the first tranche of her cross-examination on 5 December 2018, Ms Mourad admitted that she called Mr Saab on a Sunday and told him that she was intending to break off the wedding and she believed this date to be 22 March 2015.
5. During further cross-examination on 21 May 2019 Ms Mourad was asked about when it was that she told Mr Farhat that she was not going ahead with the wedding. She replied it was a Sunday but she did not recall the date. It was suggested to her that it was Sunday 15 March to which she agreed. She was then asked about the emails dated 16 March 2015 and a series of questions about the reason for the wedding being called off, namely that Mr Farhat was physically violent towards her. Ms Mourad denied that she had discussed this with Mr Saab on 15 March 2015. In re-examination Ms Mourad again denied discussing calling off her engagement to Mr Farhat during this conversation with Mr Saab.
6. On behalf of Mr Saab, Mr Villa pointed to the shift between Ms Mourad's statement dated 4 December 2018 and her oral evidence the next day on 5 December 2018 as to when and how Mr Saab made a reference to keeping everything "hush hush".
7. Mr Villa submitted that in determining what to make of the "hush hush" email, the conversation between Mr Saab and Ms Mourad on 15 March 2015 was important. He referred to the first tranche of Ms Mourad's cross-examination in December 2018, when the significance of what was said during the conversation on 15 March 2015 was not apparent, because the emails of 16 March had not been produced, Ms Mourad admitted that she called Mr Saab on a Sunday and told him that she was intending to break off the wedding. He submitted that this evidence should be accepted, although he argued that it was apparent from the email exchange on 16 March 2015 that the date of this conversation was in fact 15 March and not 22 March 2015 as Ms Mourad had said in her cross-examination. In contrast he submitted that her evidence of 21 May 2019 where she denied that she discussed with Mr Saab calling off her engagement to Mr Farhat at all should not be accepted.
8. On the one hand we have Ms Mourad's evidence given in May 2019 that in the phone call she had with Mr Saab on 15 March 2015 she discussed the missing Endone. She says she did not discuss the cancellation of the wedding in that call. The next day she told Mr Saab by email on 16 March 2015 that as a matter of courtesy she wanted to inform him before anyone else that the wedding had been called off.
9. We also have her evidence that she made a phone call to Mr Saab in which she told him she was intending to break off the marriage. This evidence was given in December 2018 before the production of the emails of 16 March 2015. Accordingly what is not completely clear is whether this is a reference to the same call that occurred on 15 March 2015 or indeed whether it is a reference to her email of 16 March 2015. In this respect Ms Mourad's evidence was somewhat confusing.
10. In our view the quality of Ms Mourad's evidence is to an extent explained by the passage of time between when the events occurred and when she was asked to give evidence about them. Her recollections were not assisted by having to give evidence on more than one occasion and several months apart. Further, Ms Mourad was asked to recall events from a time that was personally difficult for her. She was due to be married to Mr Farhat. The wedding was cancelled at her instigation about a week before it was supposed to take place. It was cancelled because of what she had found out about Mr Farhat's role in the missing Endone.
11. We also formed the view that Ms Mourad's evidence lacked some coherence because she was a reluctant participant in these proceedings. We formed this view for a number of reasons. Ms Mourad's statement was secured the day before the first hearing day and only became available on the first day of the hearing. The Commission indicated, and we accept, that it had made a number of efforts to secure Ms Mourad's evidence well before this but had not been successful. On both occasions that Ms Mourad gave evidence a summons had to be issued to secure her attendance. Having the benefit of seeing her give evidence on two occasions, it was apparent to us that she gave her evidence somewhat reluctantly.
12. Whatever difficulties exist in Ms Mourad's evidence there has been a constant to it commencing from her 2015 AHPRA notification and which is supported by objective evidence and; that is, Mr Saab used the words "keep the reason hush hush. Its not good for me or Hussein Farhat".
13. On Mr Saab's evidence it is submitted that the "hush hush" email was in reference to the breaking off of the engagement between Ms Mourad and Mr Farhat and not in reference to the missing Endone.
14. We do not accept this contention. In our view it makes no sense for Mr Saab to say that it is "not good for me or Hussein Farhat" in response to merely being told about the breaking off of the engagement between Ms Mourad and Mr Farhat. In our view Mr Saab's response is consistent with being told about the missing Endone. We find that Ms Mourad told Mr Saab about the missing Endone in the phone call on 15 March 2015.
15. However that does not prove that Mr Saab inappropriately requested that Ms Mourad not report the discrepancy in Endone to the Department of Health. There is no evidence that Ms Mourad was going to notify the Department of Health. The evidence discloses that after becoming aware of the discrepancy Mr Saab took steps to investigate. It is understandable that until he could carry out an investigation and determine the extent of the problem concerning missing Endone, that he might request that the matter be contained to a select few people.
16. We are not bound by the rules of evidence in these proceedings: see Schedule 5D cl 2 of the National Law.
17. Equally however, it is well established, due to the protective nature of the jurisdiction, and the seriousness of the complaints, if established, both for the practitioner and the public, that the standard of proof is on the balance of probabilities, but to the level of satisfaction described by the High Court in Briginshaw v Briginshaw (1938) 60 CLR 336; [1938] HCA 34: see Health Care Complaints Commission v Dowla [2019] NSWCATOD 117 at 36.
18. In this case we approach the question of proof by having regard to the matters stated by Dixon J in Briginshaw at 362: But reasonable satisfaction is not a state of mind that is attained or established independently of the nature and consequences of the fact or facts to be proved. The seriousness of an allegation made, the inherent unlikelihood of an occurrence of a given description, or the gravity of the consequences flowing from a particular finding are considerations that must affect whether the issue has been proved to the reasonable satisfaction of the tribunal. In such matters "reasonable satisfaction" should not be produced by inexact proofs, indefinite testimony or indirect inferences. Everyone must feel that, when, for instance, the issue is on which of two dates an admitted occurrence took place, a satisfactory conclusion may be reached on materials of a kind that would not satisfy any sound and prudent judgment if the question was whether some act had been done involving grave moral delinquency.
19. The onus or burden of proof is on the Commission. The allegation against Mr Saab of requesting another pharmacist not to report a significant discrepancy of 600 Endone tablets to the authorities involves improper conduct with a serious moral dimension to it.
20. In our view what the Commission is asking us to do is elevate the significance of the "hush hush" reference. We are not prepared to do this. We have already indicated what significance we attach to the words used. What the Commission is also asking us to do is to draw an inference from Mr Saab's conduct, including; by not immediately reporting the discrepancy and reporting it some 12 days later, to prove that when he was informed of the discrepancy by Ms Mourad he inappropriately requested her not to report the matter to the NSW Ministry of Health. We are not satisfied that the evidence is persuasive or clear enough to draw this inference.
21. We find that particular 3 a) is not proved.

b) declined a request by an employed pharmacist that a stock take of Endone be conducted which later identified 785 missing Endone tablets.

Finding

1. The Commission contends that in the context of Ms Mourad showing Mr Saab her concerns about the drug register on 19 March 2015, she requested to undertake a stocktake of Endone which Mr Saab declined.
2. Mr Saab did not specifically recall any such request but accepts that if such a request was made it was declined by him. In view of the existence of a personal relationship between Ms Mourad and Mr Farhat, it is understandable that Mr Saab saw it as preferable to have another pharmacist undertake the stocktake. Mr Saab instructed Mr Jaafar to undertake that stocktake.
3. Ms Mourad's unchallenged evidence was to the effect that she made this request. We accept that the request was made and it was declined by Mr Saab.
4. Whilst this particular is made out in the circumstances, and for the reasons set out in paragraphs 301 and 302 of this decision, it does not support a finding of unsatisfactory professional conduct as contended for by the Commission.
5. In the light of Ms Benson's evidence although Mr Saab is potentially open to criticism for the delay in completing the stocktake and for not reporting the loss of Endone to the PSU immediately, this is not how this sub particular or its counterpart are framed.

Between 21 April 2015 and 22 September 2015 the practitioner failed to maintain an accurate inventory of the quantity of Schedule 8 drugs held at Ingleburn, contrary to clause 118 of the PTGR, in that the quantity recorded in the Register was not accurate

1. The PSU report in relation to Ingleburn compiled by Ms Wei dated 7 December 2015 details that at her inspection on 22 September 2015, she inspected the previous drug register for Schedule 8 drugs and observed that the legally required twice yearly stock checks (March and September) were not carried out at Ingleburn for all Schedule 8 drugs.
2. Ms Wei noted from the relevant drug register for methadone and buprenorphine, that an inventory check had been performed on 9 September 2015 for Biodone Forte, Subutex tablets and Suboxone films but not for methadone syrup. Ms Abbas, the Pharmacist in Charge at the time of the inspection, was unable to explain why the stock check for methadone syrup had not been performed on the same day. Ms Abbas said that the routine stock checks for methadone or buprenorphine were not performed by pharmacists working at Ingleburn.
3. Ms Wei performed a full inventory count for methadone syrup, Biodone Forte, Subutex tablets in various strengths and Suboxone films in various strengths. In the cross-reference check against the balance in the drug register she identified discrepancies of 541.5 mls in Methadone syrup and 10 films Suboxone 2mg film. A subsequent reconciliation of methadone syrup was able to account for this discrepancy.
4. In Mr Saab's oral evidence in response to Ms Wei's report he referenced that he had until the end of September 2015 to undertake the mandated stock take. He disagreed with Ms Wei's contentions that the inventory check for methadone syrup had not been done at the same time as other Schedule 8 drugs. He added that Ms Abbas had been mistaken about routine stock checks for methadone or buprenorphine not being performed by pharmacists at Ingleburn and appeared to suggest that a record of methadone dispensed was kept on a daily basis.
5. In contrast in Mr Saab's written reply he acknowledged that the inventory of the quantity of Schedule 8 drugs at Ingleburn during the period 21 April 2015 and 22 September 2015 was not accurate. He made no mention at all in his reply of the matters he had referred to in his oral evidence as it related to Ms Wei's report.
6. In written submissions made on behalf of Mr Saab by Mr Villa this particular appeared to elicit a qualified concession. It was admitted that between 21 April 2015 and 22 September 2015 an accurate inventory of the quantity of Methadone syrup held at Ingleburn had not been maintained in that there were missing entries and addition/subtraction errors as identified in the DD register on 22 September 2015. It was submitted that to that extent the particular is made out. As we understand the submissions made on Mr Saab's behalf, his concession is limited to Methadone syrup and is confined to missing entries and arithmetical errors.
7. We accept Ms Wei's evidence. That evidence indicates that the stipulated March and September stock takes had not been carried out for all Schedule 8 drugs. Her report also refers to the inventory count she undertook which was cross checked against the drug register for various Schedule 8 drugs. She identified discrepancies of 541.5 mls in Methadone syrup and 10 films Suboxone 2mg film. Although a subsequent reconciliation of methadone syrup was able to account for that discrepancy, the fact remains that at the time of the PSU inspection half a litre of methadone was unaccounted for. We agree with the Commission's submission that this was a significant quantity.
8. We found Mr Saab's evidence about this particular and indeed his concession to be confusing. This is because Mr Saab's response appeared to shift over time; from a full acknowledgment in his reply to a purported refuting of it in his oral evidence about Ms Wei's conclusions. The concession made on his behalf was qualified as being limited to Methadone syrup and confined to missing entries and arithmetical errors.
9. We also found the way the concession was qualified to be unhelpful. The fundamental question raised by the particular is about whether during a specified timeframe the register accurately reflected the quantity of Schedule 8 drugs that were present in the pharmacy.
10. Ms Wei's evidence which we have accepted indicates that between 21 April 2015 and her inspection on 22 September 2015 the register was not accurate. It cannot be said that during this period an accurate inventory of the quantity of Schedule 8 drugs was maintained at Ingleburn.
11. We find particular 4 proved.

Between 21 April 2015 and 22 September 2015 the practitioner failed to ensure that the drug register held at Ingleburn was properly kept by pharmacists in his employ, and in compliance with clause 177(2) of the PTGR, and that all mistakes were corrected in the margin or footnote, initialled and dated

1. Ms Wei observed alterations, obliterations and cancellation of the entries in the drug register made by the pharmacist at Ingleburn. It is not in dispute that alterations, obliterations or cancellations are not to be made in the drug register, any mistake in an entry may be corrected by a marginal footnote and initialled and dated.
2. Mr Saab acknowledged in his reply he did not ensure that the Drug Register at Ingleburn was properly kept by the Pharmacists in his employ and in compliance with clause 177(2) of the PTGR. He explained he was not given cause for concern in relation to the manner of recording amendments in the Dangerous Drugs (DD) Register, although he acknowledges he did not inspect the subject pages of the DD Register that had been incorrectly amended.
3. In Mr Saab's oral evidence he conceded that the corrected mistakes in the register were not done in accordance with the PTGR. He agreed that he did not take a "hands on" approach and as a result did not pick up on these errors. He also agreed that given the number of OTP patients at Ingleburn he should have checked the registers for compliance.
4. In written submissions made on behalf of Mr Saab this particular also appeared to elicit a qualified concession. It was said that Mr Saab admitted that between 21 April 2015 and 22 September 2015 the drug registers for methadone and buprenorphine held at Ingleburn were not properly kept by the pharmacists in his employ, because mistakes had not been corrected in the margin or footnote, initialed and dated as required. It was submitted that to that extent the particular was made out. As we understood the submissions made on Mr Saab's behalf his concession was limited to methadone and buprenorphine as distinct from all drug registers held at Ingleburn. It was argued that the particular was overly broad and insufficiently detailed.
5. In our view as a proprietor if Mr Saab had been looking at the registers maintained by his employed pharmacist, he would have seen that the corrected mistakes did not lawfully comply. It would have been obvious on inspection. In our view the sheer number of OTP patients at Ingleburn being some 45 to 50, required Mr Saab's attention and warranted him checking the registers to ensure they were accurate.
6. We did not find the distinction drawn in Mr Saab's submissions between the drug registers for methadone and buprenorphine as distinct from all drug registers held at Ingleburn to be helpful.
7. The issue here is that the mistakes in the dangerous drugs register were not corrected in a manner which complied with the PTGR. Proper recording in the dangerous drug register is essential. By not checking the registers Mr Saab failed to ensure that the drug register held at Ingleburn was being properly kept by pharmacists in his employ.
8. We find particular 5 proved.

On 22 September 2015, the practitioner failed to ensure that two Schedule 8 drug safes were affixed to the premises at Ingleburn, contrary to clause 76 of the PTGR

1. Mr Saab admits in his reply that on 22 September 2015 two Schedule 8 safes at Ingleburn were not affixed to the premises. He stated that the two safes were in place when he purchased the pharmacy. He had since taken steps to rectify.
2. In Mr Saab's oral evidence he explained that his reply was inaccurate as one of the safes had in fact been installed by him. In other respects his oral evidence was to the effect that the safes had not been bolted to the floor or otherwise securely affixed as required by the PTGR.
3. We find particular 6 proved.

Between 21 April 2015 and 22 September 2015 the practitioner failed to report to the Secretary of the NSW Ministry of Health, that original prescriptions confirming faxed or phoned prescriptions from the Opioid Treatment Program ("OTP") prescribers were not received at Ingleburn within 7 days from the date of the fax/telephone call, contrary to clause 96 (2)(b) of the PTGR.

1. Ms Wei detailed that a prescription of Suboxone 8mg film for a patient had expired on 6 September 2015. There was no evidence of any fax prescription or notes confirming the verbal authorisation from the prescriber. It appeared to Ms Wei that the pharmacists at Ingleburn had been dosing the patient without a valid prescription or obtaining an authorisation from the prescriber. Ms Wei identified two fax prescriptions that were outstanding from 11 September 2015.
2. Mr Saab admits in his reply that during the period 21 April 2015 and September 2015, the original of some prescriptions confirming the corresponding faxed prescriptions from the prescriber had not been received at Ingleburn within the prescribed time period. In his oral evidence he admitted that when he attended the pharmacy he did not inspect the list of missing prescriptions.
3. Mr Saab also admitted that it was a serious matter to continue to dose a patient in the absence of a valid prescription.
4. On Mr Saab's behalf the concession that was made in submissions in relation to this particular was limited to the specific number of prescriptions which were identified by Ms Wei.
5. In our view by not inspecting or looking at the list of missing prescriptions Mr Saab did not turn his mind to the obligation to secure the original prescriptions within the required time frame. Further, it is not in dispute that Mr Saab failed to report to the Secretary of the NSW Ministry of Health that the original prescriptions identified in Ms Wei's report had not been received within the required time frame.
6. We find particular 7 proved.

The practitioner failed to identify and report the loss of 10 Suboxone 2mg films at Ingleburn in circumstances where an audit on 22 September 2015 showed that 10 Suboxone 2mg films were not accounted for and the Director-General of the NSW Ministry of Health was not immediately notified of any loss, contrary to clause 124 of the PTGR.

1. Mr Saab's reply is to the effect that he employed ostensibly competent Pharmacists in Charge. He admitted that he did not report to the Director-General the loss of 10 Suboxone 2mg films at Ingleburn Medical Centre in circumstances where an audit on 22 September 2015 showed that 10 Suboxone 2mg films were not accounted for.
2. Mr Saab attended the pharmacy to oversee its operations and confer with the Pharmacist in Charge. He states he was not informed by the Pharmacist-in-Charge that 10 Suboxone 2mg films were not accounted for and his general enquiries about the operation of the pharmacy or any difficulties being encountered did not disclose that 10 Suboxone 2mg films were not accounted for.
3. Mr Saab says that at the time he relied on the Pharmacist-in-Charge to report to him such matters and he acknowledges he did not personally check the Drug Register page for Suboxone 2mg films to ensure that the count and balance were accurate. He did, however, check the Drug Register from time to time to ensure its accuracy.
4. In his reply and in oral evidence Mr Saab says that he was not aware of the loss of 10 Suboxone 2mg films at Ingleburn Medical Centre until 4 January 2016 when he received correspondence from the NSW Ministry of Health, following an inspection of the pharmacy on 22 September 2015 by PSU. He states that had he known he would have reported it.
5. The PSU inspection report for Ingleburn compiled by Ms Wei dated 7 December 2015, at paragraph 33, relevantly observes as follows: I performed a full inventory count for methadone syrup, Biodone Forte, Subutex tablets in various strengths and Suboxone films in various strengths, at Ingleburn Medical Centre Pharmacy. The cross-reference check against the balance in the current drug register held at the pharmacy relating to the period 21 April 2015 to 22 September 2015, shows the following apparent discrepancies, for which Ms Abbas has not been able to explain during the inspection, I noted and remain unaccounted for: Drug Balance in Register Actual Balance as of 22 September 2015 Discrepancy Suboxone 2mg film 272 films 262 films -10 films

1. At the time of doing her inspection on 22 September 2015, and after noting the unaccounted Suboxone, Ms Wei advised Mr Abbas to conduct a reconciliation of stock on hand. On 1 October 2015 PSU received a fax from George Beshay, pharmacist at Ingleburn, containing the drug register pages relating to the OTP. It showed that after Ms Wei's inspection a reconciliation of stock on hand for methadone syrup had subsequently been performed. A number of adjustments were made and a stock check done on 30 September 2015 for methadone syrup showed that the balance matched the stock on hand. However, there was never any corresponding evidence provided to PSU of a reconciliation of Suboxone.
2. Ms Wei went on to observe at paragraph 38 in her report as follows: There was no evidence of the reconciliation of stock for Suboxone 2mg films in the records, therefore 10 (ten) Suboxone 2mg films remain unaccounted for.
3. Under cross examination Ms Wei's evidence was to the effect that she identified 10 Suboxone films that were "unaccounted for" by which she meant there was a discrepancy between the stock on hand and the entry in the DD Register. Ms Wei acknowledged that this might be a result of the Suboxone in fact being missing, or it might be a result of an error in the DD Register. She explained that the only way to determine whether the discrepancy was due to the fact they were missing or due to a recording error would be to undertake an audit, meaning a full reconciliation of prescribing records against the register which was a process that she did not undertake. Ms Wei acknowledged that she was unable to say one way or the other whether the discrepancy was a result of loss of drugs or an inaccuracy in the records.
4. Much was made by Mr Villa that the evidence did not demonstrate that 10 Suboxone films were actually lost. He pointed to the evidence of Ms Wei that the "unaccounted for" Suboxone might be a result of it being missing, or it might be a result of an error in the Dangerous Drugs Register. He pointed to a subsequent reconciliation done on 20 February 2016 and the relevant page of the register showing a "missed entry (10)" and "entry error (2)", which in effect purported to show a surplus of 2 suboxone films.
5. Ms Benson provided an opinion about the page from the Ingleburn drug register which showed an entry made on 20 February 2016 recording a "missed entry" on 10 September 2015 of 10 Suboxone tablets, and an "entry error" on 11 September 2015 of 2 Suboxone tablets. Ms Benson stated that in order to accurately determine those entries, access would be needed to the subsidiary register and the relevant prescriptions.
6. In our view, and as submitted by the Commission, it is the position as at 22 September 2015 which is critical and not what the position is said to be with the benefit of hindsight.
7. For all intents and purposes as at 22 September 2015 the number of Suboxone films held in the safe at the Ingleburn pharmacy did not match the dangerous drug register. Irrespective of whether the Suboxone was missing or unaccounted for, it amounted to a loss at that time which Mr Saab's employed pharmacist was unable to explain.
8. Mr Saab says that he did not become aware of the loss of the Suboxone until 4 January 2016 when he received correspondence from the Ministry of Health. Accordingly on his evidence between the inspection on 22 September 2015 and 4 January 2016 he had no idea that the 10 Suboxone films which had been identified by Ms Wei in her inspection remained unaccounted for. Mr Saab's evidence was to the effect that his employed pharmacists undertook the stock checks and they did not inform him of any discrepancies.
9. In our view if Mr Saab were actively involved in the operation of his pharmacy and a vigilant proprietor ensuring that accurate stock checks had been done by his staff, he would have identified the discrepancy.
10. Mr Saab's evidence is also to the effect that a reconciliation of Suboxone subsequently occurred on 20 February 2016. In this light we agree with a submission made by the Commission that from the time of the PSU inspection until 20 February 2016, an obligation arose on Mr Saab to report the discrepancy. He did not do this.
11. Further Mr Saab's evidence about the reconciliation of Suboxone that occurred on 20 February 2016 does not adequately explain the unaccounted Suboxone. We accept the evidence of Ms Benson that without access to the subsidiary register and the relevant prescriptions we are unable to determine the accuracy of those entries.
12. Neither the subsidiary register nor the prescriptions were available to us.
13. Pharmacists are only required to retain prescriptions for 2 years. We accept that at this point in time now there is no obligation on Mr Saab to have retained these records.
14. However, at the time of the PSU inspection on 22 September 2015 and the preparation of their December 2015 report, Mr Saab would have had the subsidiary register, relevant prescriptions and the drug histories of individual patients receiving Suboxone available to him. He could have undertaken a thorough reconciliation based on these records when he saw the report from PSU. He could have retained the records. He knew it was an issue. He did none of these things.
15. We find that Mr Saab failed to identify and report the loss of 10 Suboxone 2 mg films at Ingleburn in circumstances where an audit on 22 September 2015 showed that 10 Suboxone 2mg films were not accounted for.
16. We find particular 8 proved.

The practitioner failed to ensure that pharmacists in his employ at Ingleburn dispensed compliant prescriptions for Schedule 8 drugs in circumstances where, in the case of computer generated prescriptions:

a) the name, strength and quantity (expressed in both words and figures) of the drug to be supplied were not specified, contrary to clause 80(1)(c) of the PTGR; and

b) adequate directions for use were not specified, contrary to clause 80(1)(d) of the PTGR.

1. Mr Saab says that he was not informed by the Pharmacist-in-Charge that some prescriptions for Schedule 8 drugs were not compliant with the requirements under the PTGR. His general enquiries about the operation of the pharmacy or any difficulties being encountered did not disclose that Ingleburn Pharmacy had received, and pharmacists had dispensed, medications on some prescriptions for Schedule 8 drugs that were not compliant with the requirements under the PTGR.
2. Mr Saab concedes that during his attendances at the pharmacy he did not review the subject prescriptions for Schedule 8 medications. However, it was his practice to periodically review the prescriptions for Schedule 8 medications.
3. Evidence of prescriptions that failed to comply with the legislative requirements for Schedule 8 prescriptions that were dispensed at Ingleburn is contained in the two reports made by Ms Wei.
4. Non-compliant prescriptions for drugs of addiction were annexed to Ms Wei's interview report dated 2 July 2015 (relating to a PSU interview with Mr Saab on 4 June 2015) and her report dated 7 December 2015. The subject prescriptions concerned where the quantity of the drug supplied was not expressed in both words and figures; and where the directions for use were not in handwriting.
5. Again on Mr Saab's behalf the concession that was made in relation to this particular was limited to the particular number of prescriptions which were identified by Ms Wei. By our count there were some 16 prescriptions identified by Ms Wei.
6. Mr Saab admits that in respect of the particular prescriptions that are annexed to the Report of Jessie Wei dated 2 July 2015 and 7 December 2015, he failed to ensure that pharmacists in his employ at Ingleburn only dispensed Schedule 8 drugs in accordance with prescriptions that complied with Clause 80(1)(c) of the PTGR, in that those computer-generated prescriptions did not specify the quantity of the drug to be supplied expressed in both handwritten words and figures.
7. Mr Saab also admits that in respect of various prescriptions that are annexed to the Report of Jessie Wei dated 2 July 2015 and 7 December 2015, he failed to ensure that pharmacists in his employ at Ingleburn only dispensed Schedule 8 drugs in accordance with prescriptions that complied with Clause 80(1)(d) of the PTGR, in that the directions for use required by clause 80(1)(d) of the PTGR were not in handwriting as required by Regulation 80(2).
8. We find particular 9 a) and b) proved.
9. The remaining particulars 10 to 14 relate to the Toronto pharmacy. This pharmacy was the subject of inspection by PRU on 21 September 2015. The Inspection Report by Ms Wei dated 17 December 2015 sets out the results of this inspection.

Between 13 October 2014 and 21 September 2015 the practitioner failed to maintain an accurate inventory in the Pharmacy drug registers of the quantity of Schedule 8 drugs held, contrary to clause 118 of the Poisons and Therapeutic Goods Regulation 2008 ("PTGR"), in that the quantity of Schedule 8 drugs recorded understated or overstated the actual quantity of drugs held at Toronto

1. The PSU inspection report for Toronto compiled by Ms Wei dated 17 December 2015 observed that upon inspection of the latest drug register, she noted that the book was commenced on 13 October 2014. There had been only two stock checks performed since that date, being 1 December 2015 and 18 May 2015. There was no record of reconciliation of actual stock holdings since May 2015 for any of the Schedule 8 drugs. Ms Wei recorded that the Pharmacist in Charge, Mr Michel said that he did not know how to record the outcome of an inventory check into the electronic drug register.
2. The stipulated twice yearly stock checks (March and September) were not carried out at Toronto for all Schedule 8 drugs. Mr Michel is reported as advising that the routine stock checks for methadone or buprenorphine were not performed by pharmacists working at Toronto.
3. Ms Wei performed a full inventory count for methadone syrup, Biodone Forte solution, Subutex tablets in various strengths and Suboxone films in various strengths. Ms Wei detailed the cross-reference check against the drug register held at the pharmacy relating to the period 13 October 2014 to 21 September 2015, and identified apparent discrepancies which Mr Michel was unable to explain. Ms Wei noted the following drugs which remained unaccounted for: Drug Balance in Register Actual Balance as of 21 September 2015 Discrepancy Biodone Forte 1,211ml 1,165ml -46ml Subutex 8mg tablet 49 tabs 44 tabs -5 tabs

1. On Mr Saab's behalf a concession was made in relation to this particular in respect of the two drug registers identified by Ms Wei.
2. Mr Saab admits that as at 21 September 2015 there was a discrepancy between the balance in the register and the stock on hand in relation to Biodone Forte and Subutex 8mg tablets, and to that extent admits that he failed to ensure that pharmacists in his employ maintained an accurate inventory in the controlled drug registers relating to those two drugs. This admission was consistent with his oral evidence.
3. In cross examination Mr Saab agreed that he was reliant on his employed pharmacists to ensure that the controlled drug register balanced. He did not carry out any of his own stocktakes to make sure they balanced. He agreed that as a proprietor he had a responsibility to make his own enquiries and make sure that the controlled drug register balanced. Whilst he did not review the subject pages of the drug register he periodically reviewed the pages of the register from time to time. He conceded that in hindsight he should have taken a more active role and his own checking procedures should have been better.
4. We are satisfied on the evidence before us that the balances for the Schedule 8 drugs identified by Ms Wei were not accurately stated in the drug register. We are further satisfied that as a proprietor Mr Saab was responsible for maintaining an accurate inventory in the drug registers.
5. We find particular 10 proved.

Between 13 October 2014 and 21 September 2015 the practitioner failed to ensure that pharmacists in his employ entered into the Pharmacy drug register the records of supply on the day when he/she had supplied Biodone Forte and Subutex 8mg tablets, contrary to clause 112(1) of the PTGR at Toronto

1. Mr Saab conceded in his Reply that between 13 October 2014 and 21 September 2015, his employed Pharmacist did not enter into the DD Register the drugs supplied on the day when the Pharmacist had received Biodone Forte and Subutex 8mg tablets from the wholesaler supplier.
2. Ms Wei relevantly concluded in her report as follows: Pharmacists at Simply Pharmacy Toronto have not entered in the drug register the records of supply on a day when he/she had supplied Biodone Forte and Subutex 8mg tablets, contrary to the provisions under clause 112(1) of the Poisons and Therapeutic Goods Regulation 2008.
3. On Mr Saab's behalf a limited admission was made about this particular as it related to three specific occasions.
4. Specifically Mr Saab admits that on 4 March 2015 a dose of Biodone was not recorded in the drug register, and on 11 August and 15 August 2015 doses of Subutex 8mg were not recorded in the drug register. To that extent he conceded he failed to ensure that pharmacists in his employ entered into the pharmacy drug register the records of supply on the day when they had supplied Biodone Forte and Subutex 8mg tablets.
5. This particular is about whether Mr Saab ensured that the PTGR was being complied with as it related to his employed pharmacists. Specifically that they entered into the DD register the drugs supplied on the day when the pharmacist received the Biodone Forte and Subtex tablets from the wholesale supplier. Whilst Mr Saab's concession and admission is limited to three occasions when doses were not recorded, there was a deafening silence from Mr Saab as to what steps he actually took to ensure that clause 112(1) of the PTGR was being complied with.
6. We find particular 11 proved.

The practitioner failed to ensure that pharmacists in his employ endorsed with the word "CANCELLED" previously dispensed or expired methadone prescriptions, contrary to clause 88(2) of the PTGR at Toronto

1. In Ms Wei's report she found prescriptions which had been previously dispensed or expired which had not been marked "cancelled".
2. Mr Saab said he attended Toronto to oversee the pharmacy operation and confer with the Pharmacist in Charge. He was not informed by the Pharmacist-in-Charge that some prescriptions for Schedule 8 drugs were not compliant and his general enquiries about the operation of the pharmacy did not disclose this as an issue.
3. During Mr Saab's attendances at the pharmacy he conceded that he did not review the subject prescriptions for Schedule 8 medications. Ordinarily, however, he would review the prescriptions for Schedule 8 medications from time to time.
4. Although copies of the relevant prescriptions were not provided, Mr Saab does not dispute that during Ms Wei's inspection of Toronto she observed previously dispensed or expired methadone prescriptions that were not endorsed with the word "Cancelled". He admits that he failed to ensure that pharmacists in his employ endorsed with the word "CANCELLED" previously dispensed or expired methadone prescriptions
5. We find particular 12 proved.

The practitioner failed to report to the Director-General of the NSW Ministry of Health, the fact that written confirmation of faxed or phoned prescriptions from the OTP prescriber's were not received within 7 days from the date of the fax/telephone call, contrary to clause 96 (2)(b) of the PTGR at Toronto

1. Ms Wei observed one fax prescription that was outstanding from 11 August 2015 and therefore greater than 7 days.
2. Mr Saab admits that in respect of the prescription identified by Ms Wei the original prescription confirming the faxed prescription from an OTP prescriber was not received at Toronto within 7 days from the date of the fax, and that he did not report that fact to the Secretary of the NSW Ministry of Health.
3. We find particular 13 proved to the extent that it relates to a single faxed prescription.

The practitioner at Toronto failed to ensure that pharmacists in his employ dispensed compliant prescriptions for Schedule 8 drugs in circumstances where, in the case of computer generated prescriptions:

a) the name, strength and quantity (expressed in both words and figures) of the drug to be supplied were not specified, contrary to clause 80(1)(c) of the PTGR;

b) adequate directions for use were not specified, contrary to clause 80(1)(d) of the PTGR;

c) intervals for the drug to be supplied were not specified, contrary to clause 80(1)(f) of the PTGR

1. Ms Wei observed that all of the mandatory particulars on a number of computer generated prescriptions issued by a particular Doctor did not appear to have been rewritten in his own handwriting.
2. Mr Saab admits that in respect of the two prescriptions that are referred to by Ms Wei he failed to ensure that pharmacists in his employ only dispensed Schedule 8 drugs in accordance with prescriptions that complied with Clause 80(1) of the PTGR, in that: 1. those prescriptions did not specify the quantity of the drug to be supplied expressed in both words and figures, and the information required by clause 80(1)(c) of the PTGR was not in handwriting as required by Regulation 80(2); 2. the directions for use required by clause 80(1)(d) of the PTGR were not in handwriting as required by Regulation 80(2); 3. the intervals for drug supply required by clause 80(1)(f) of the PTGR were not in handwriting as required by Regulation 80(2).
3. Mr Saab's oral evidence was to the effect that he employed competent pharmacists in charge and he attended Toronto pharmacy to oversee and confer with his pharmacists. His own attendances had not given him any cause for concern that his pharmacists had dispensed some non-compliant prescriptions and the pharmacist in charge had not informed him of prescriptions for Schedule 8 drugs that were not compliant. During his attendances he did not review the subject prescriptions for Schedule 8 medications but he would review Schedule 8 prescriptions from time to time.
4. We find particular 14 proved.

Complaint One: Unsatisfactory Professional Conduct sections 139B(1)(a) and (l)

1. The first complaint against Mr Saab is that of unsatisfactory professional conduct. The two avenues identified by the Complaint are sections 139B(1)(a) and (l) of the National Law.
2. The first avenue is that Mr Saab's conduct demonstrates that the judgment possessed, or care exercised, by him in the practice of pharmacy is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience: see section 139B(1)(a) of the National Law.
3. The Commission framed Complaint One in terms that Particulars 1-6 and 11 justify an individual finding of unsatisfactory professional conduct. This was explained on the basis that it reflected and was consistent with Ms Benson's evidence. As we understood the Commission's submission, in respect of the balance of the particulars, 7-10 and 12-14 that; if some, or all of these particulars were found proven then, cumulatively they were capable of supporting a conclusion of unsatisfactory professional conduct.
4. Particulars 10 and 11 relate to Toronto. Particular 10 related to maintaining an accurate inventory. Particular 11 related to recording the day of supply. In respect of particular 11 Ms Benson did not appear to categorise Mr Saab's conduct as significantly below the standard to be reasonably expected. In this sense it is not entirely clear to us how this impacts on the way in which the Commission has framed its Complaint.
5. However Ms Benson did express the view that Mr Saab had acted significantly below the standard reasonably expected of a practitioner of equivalent training or experience by not performing periodical stock checks or reconciliation of the Schedule 8 stock holding at Toronto. In addition by not checking the drug registers undertaken at Toronto, he had failed to discharge his responsibility as a pharmacy proprietor. In this respect she formed the view that his conduct was significantly below the standard reasonably expected. As far as we can discern Ms Benson's views about this aspect of Mr Saab's conduct can be seen to relate to particular 10.
6. At the hearing we understood Mr Villa to put Mr Saab's position to be that accumulating the concessions he had made, then that taken together his conduct amounted to unsatisfactory professional conduct.
7. We have found particulars 4, 5, 6 and 10 proved. Particulars 4 and 10 related to maintaining an accurate inventory of the quantity of Schedule 8 drugs at Ingleburn and Toronto. Particular 5 related to ensuring that the drug register at Ingleburn was properly kept.
8. In written submissions made on Mr Saab's behalf as to Particulars 4 and 5, and by implication Particular 10, it was contended that while each of those particulars demonstrate that the procedures and systems in place at the time did not prevent the non-compliance in the registers from occurring, that of itself does not establish that his conduct was significantly below the standard to be reasonably expected of him. Perfection is not possible and there will always be some degree of human error. Ms Benson's evidence that it was not incumbent upon Mr Saab as a proprietor pharmacist to check everything himself, that sampling was an appropriate basis upon which to monitor compliance, and that errors would therefore still occur undetected was relied on to support this position. We note that in effect these contentions were repeated to address particulars 7-14.
9. We do not accept these submissions.
10. The PTGR sets out the legal requirements for pharmacists in handling, storing and dispensing medication. The Guidelines produced by the PSU about the PTGR guide pharmacists in meeting their legislative responsibilities in this regard. The Pharmacy Board's Guidelines for Pharmacist Proprietors inform us as to what the profession as a whole reasonably expects of its members who are proprietors.
11. The accurate and proper keeping of drug registers are integral to protective structure set out in the PTGR. As a proprietor Mr Saab should have been aware of the problems in the registers.
12. In the light of the totality of the opinions expressed by Ms Benson as to Mr Saab's conduct relating to maintaining an accurate inventory of the quantity of Schedule 8 drugs at Ingleburn and Toronto and ensuring that the drug register at Ingleburn was properly kept, we are satisfied that the judgment demonstrated and care exercised by Mr Saab was significantly below the standard reasonably expected. We are satisfied that each of these particulars justifies an individual finding of unsatisfactory professional conduct on the basis of section 139B(1)(a).
13. Particular 6 related to two drug safes at Ingleburn.
14. It was submitted on Mr Saab's behalf that while the safes were not affixed as required and contravened the regulations, this did not amount to a significant departure from the standard reasonably expected of him because: 1. with respect to one safe he made the entirely reasonable assumption that the safe that he had purchased along with the pharmacy from a respected and reputable member of the Pharmacy Guild of Australia would have been affixed in accordance with the regulatory requirements; 2. with respect to the other safe, the failure to affix the safe was inadvertent and having regard to its bulk posed no material risk to the public by reason of its non-affixation (it cannot sensibly be suggested that a person prepared to go to the effort and expense of getting a crane capable of lifting the safe and then transporting it somewhere to (somehow) open it for its contents is going to be deterred by 9mm dyna-bolts).
15. We do not accept these submissions. In our view this was a significant breach of Mr Saab's responsibilities as a proprietor. At the time he acquired the pharmacy and thereafter he had an obligation to ensure that everything in the pharmacy was compliant. Particularly when the safes are required to store significant quantities of Schedule 8 medications. The evidence indicates that Ingleburn was dispensing for 45-50 OTP patients which demonstrates that it was dispensing significant quantities of Schedule 8 drugs on an ongoing basis. For these reasons and in light of Ms Benson's evidence, Mr Saab's conduct was significantly below the standard reasonably expected.
16. We have found Particular 8 proven in that Mr Saab failed to identify and report the loss of 10 Suboxone 2 mg films at Ingleburn in circumstances where an audit on 22 September 2015 showed that it was not accounted for. Mr Saab ought to have made enquiries about the unaccounted Suboxone. He ought to have been aware that his employed pharmacist had not provided any material to PSU which reconciled or explained the unaccounted Suboxone. He ought to have reported the loss.
17. In our view Mr Saab's conduct in failing to supervise his employee pharmacist's practice in this regard was significantly below the standard reasonably expected. This is because Suboxone is a Schedule 8 drug and once Mr Saab was put on notice by PSU that it was unaccounted for he should have taken immediate steps to ensure his employees were able to reconcile it or if unable to do so to report the drug as missing. We note that Ms Benson categorised Mr Saab's conduct in this regard as not being significantly below the standard reasonably expected however, for the reasons we have stated we do not share her view.
18. We have found particular 11 proved. This particular is about whether Mr Saab ensured that his employed pharmacists complied with the PTGR as it related to the supply of Biodone Forte and Subtex tablets.
19. Although Ms Benson did not appear to directly categorise this conduct as significantly below the standard, she was strongly critical of Mr Saab's general conduct in not checking the drug registers. By not checking the registers she said he failed to discharge his responsibility as a proprietor and therefore his conduct was significantly below the standard reasonably expected.
20. In oral evidence there was little specific detail from Mr Saab as to what steps he actually took to ensure that the Toronto pharmacy was operating in compliance with clause 112(1) of the PTGR. For this reason and the opinion expressed by Ms Benson as to Mr Saab's general conduct in our view his conduct was significantly below the standard to be reasonably expected.
21. We have also found particulars 7, 9, and 12-14 proven. In broad terms these particulars related to Mr Saab's failure to ensure that his employees dispensed compliant prescriptions. In our view when considered cumulatively this conduct is significantly below the standard reasonably expected.
22. We found particular 3b) proved to the extent that Mr Saab declined a request by Ms Mourad to undertake a stocktake of Endone. However, as canvassed at paragraph 194 above, in the circumstances it does not support a finding of unsatisfactory professional conduct as contended for by the Commission. In view of the previous relationship between Ms Mourad and Mr Farhat, it is understandable that Mr Saab declined this request. Mr Saab subsequently instructed that the stocktake be performed by Mr Jaafar. This stocktake identified 785 missing Endone tablets and the results of that stocktake were used as a basis for Mr Saab making the report that he did to the PSU.
23. Although Mr Saab is potentially open to criticism for the delay in completing the stocktake and for not reporting the loss of Endone to the PSU immediately as referenced in Ms Benson's evidence, this is not how this particular is framed. This particular does not ground a conclusion of unsatisfactory professional conduct.
24. The second avenue to unsatisfactory professional conduct identified in the Complaint is that Mr Saab has engaged in improper or unethical conduct relating to the practice or purported practice of pharmacy.
25. If the Commission had proved particulars 1, 2 and 3 a) it is arguable that Mr Saab's conduct could have been characterised as improper and unethical.
26. In our view the matters which the Commission has proved go squarely to the judgment possessed, or care exercised, by Mr Saab in the practice of pharmacy. We have found that in this regard Mr Saab's conduct is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience.
27. Accordingly we are satisfied that Complaint One, unsatisfactory professional conduct under section 139B(1)(a) is established. However we are not satisfied that the second avenue agitated in the Complaint of unsatisfactory professional conduct under section 139B(1)(l) is established.

Complaint Two: Professional Misconduct section 139E of the National Law

1. At the hearing Mr Saab confirmed the position set out in his reply that his conduct did not amount to professional misconduct. However, there was one qualification to this which was; if particular 8 was made out, then once Mr Saab became aware of the missing Suboxone and did not report it to the Department of Health, it was conceded that this would amount to professional misconduct.
2. 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. The Tribunal is required to not only consider the object of the protection of the public but to recognise that object also includes deterring the practitioner, and other practitioners from repeating the same misconduct: see Health Care Complaints Commission v Saedlounia [2013] NSWMT 13 at paragraphs 43-50 and Health Care Complaints Commission v Do [2014] NSWCA 307 at paragraph 35.
3. In determining whether a finding can be made of professional misconduct the Tribunal must determine whether as outlined in Health Care Complaints Commission v Dr Denise Perroux [2011] NSWDC 99 at [18] "when the Respondent's contraventions are considered as a whole, they are of a sufficiently serious nature to justify suspension or deregistration".
4. As explained by Basten JA in Chen v Health Care Complaints Commission [2017] NSWCA 186 the 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: see paragraph 19. There is no category of unsatisfactory professional conduct which is not capable, depending on the circumstances, of giving rise to professional misconduct and hence engaging the power of either suspension or cancellation of registration. The only requirement is that it be "sufficiently serious" to justify such an order, a characterisation which must depend upon an evaluative judgment made by the Tribunal: see paragraph 20.
5. A practitioner's conduct is considered on a case-by-case basis. The gravity of professional misconduct is not to be measured by reference to the worst cases, but by the extent to which it departs from the proper standards. If this is not done there is a risk that the conduct of the delinquents in a profession will indirectly establish the standards applied by the Tribunal: see Health Care Complaints Commission v Litchfield (1997) 41 NSWLR 630 at 638.
6. It is the seriousness of the nature of the conduct which is found to have been established which is relevant to professional misconduct.
7. As far as we can discern Mr Saab's position appears to be that the contraventions of the PTGR were done by his employed pharmacists, and he was not told by them of any compliance issues.
8. A number of authorities were referred to by the Commission in relation to the obligations of proprietor pharmacists.
9. In Khodary [2003] NSWPB 4, the Pharmacy Board of New South Wales observed as follows: It is the view of the Board of Inquiry that an owner can allocate tasks to staff but cannot devolve the owner of the ultimate responsibility for all the activities which are carried on within the pharmacy. The Act provides for a pharmacist only to own a pharmacy. This ensures that the person directing the business has the knowledge and understanding of legal and ethical requirements relating to the practice of pharmacy and of the profession generally. It also ensures that the owner is directly accountable through their own registration for all activities carried on within the pharmacy. This view, with which the Board of Inquiry agrees, was encapsulated by the Professional Standards Committee in the case of Walton v Vivienne Lois Beck [1998] NSWPB 8 (9 December 1998): The ownership of a pharmacy by a pharmacist is a privileged position. The legislation has accepted that this form of exclusive right is granted so as to provide the maximum possible protection to the public. The responsibility of ownership extends to ensure that at all relevant times, suitable procedures, protocols and validation are in place to eliminate professional misconduct in the pharmacy.
10. In Drummond v Dyer [2002] NSWPB (13 February 2002), the Pharmacy Board considered co-proprietors of a pharmacy's obligations and concluded as follows: …co-owners have a professional and personal responsibility for the day to day running of that pharmacy or those pharmacies, and to ensure that the proper procedures and protocols were followed at each of the pharmacies owned. Mr Dyer… admits he should have been aware of the problems, but was not told or made aware. As a co-owner he made no inquiries neither did he raise any questions regarding the operations of Pharmacy A. …The Board finds that the co-owners' have overriding professional responsibilities in the day to day management of one or more pharmacies whether they are physically and regularly present in each or either pharmacy or not.
11. In Pharmacy Board of Australia v Tavakol [2014] QCAT 112, in considering a proprietor of a pharmacy's responsibilities for the conduct of employed pharmacists, the Queensland Civil and Administrative Tribunal at paragraph 33 referenced David Loewy and Sandra Loewy v Pharmacy Board of Victoria [1992] VSC 630 (7 December 1992) as follows: In my view such a responsibility is not capable of being discharged by holding personal belief in the integrity and professionalism of one's employee or partner. It requires supervision and acquaintance with what is occurring at the pharmacy when the relevant person is not present …
12. In our view Mr Saab's unsatisfactory professional conduct is of a sufficiently serious nature to fall within the definition of "professional misconduct" pursuant to s 139E of the National Law for the following reasons.
13. The unsatisfactory professional conduct which has been proved against Mr Saab involved two pharmacies at Toronto and Ingleburn. The conduct was not limited to a discrete period of time but occurred over several months.
14. The Ingleburn pharmacy was inspected by officers of the PSU on two occasions in 2015. The first inspection was undertaken on 20 April 2015. The observations made in this investigation were discussed with Mr Saab in an interview conducted with him and officers of the PSU on 4 June 2015. Mr Saab's attention was drawn to a number of concerns. These included alterations, obliterations and cancellations made in the drug register, a complete March stocktake had not been undertaken, and prescriptions for drugs of addiction did not comply with legislation. The Ingleburn pharmacy was inspected on a second occasion on 22 September 2015 where it was observed that many of the previous issues remained.
15. The PTGR sets out stringent statutory requirements in relation to the storage, handling and record keeping for drugs of addiction. These Regulations exist to manage and address the risks to patients and the public more broadly in dispensing drugs of addiction. Guidelines for Proprietor Pharmacists issued by the Pharmacy Board of Australia (December 2010 and reissued in more detail in September 2015) focus on the professional responsibilities of proprietor pharmacists that impact on the safe, effective delivery of services to the public to ensure that the pharmacy business is conducted properly. The Board's guidelines exist to provide guidance to pharmacy proprietors not specifically set out in legislation.
16. As the National Law emphasises, protection of the public is paramount. Therefore there is coherence to the protective objects of the National Law, individual statutory requirements that might apply under the PTGR legislation and guidelines as they relate to the standard of oversight that a proprietor is expected to give to the pharmacies in which they hold a pecuniary interest.
17. A pharmacist who is a proprietor must maintain and be able to demonstrate an awareness of the manner in which their pharmacy business is being conducted and, where necessary, intervene to ensure that the practice of pharmacy is conducted in accordance with applicable laws, standards and guidelines. A failure to be attentive as to whether statutory requirements, standards and guidelines are being adhered to diminishes this protective structure.
18. Mr Saab failed to ensure that Schedule 8 drug registers were properly and accurately kept by his employed pharmacists. This included recording incorrect quantities on hand, alterations of the drug registers by crossing out entries, failure to make accurate inventories twice yearly as required by law, and a failure to notify the Department of Health about missing drugs (Suboxone) when a discrepancy was identified. The failure to properly store drugs of addiction involved not ensuring that two Schedule 8 drug safes were affixed at Ingleburn.
19. The PTGR also sets out what is required when dispensing prescriptions. These requirements include the content or the kind of information a prescription must include and its form. As a proprietor Mr Saab failed to ensure that these requirements were met.
20. Prescriptions were dispensed which were not compliant as to content and form. Non-compliant computer generated prescriptions as to content were dispensed at both Ingleburn and Toronto pharmacies. At one pharmacy an expired prescription was not marked cancelled. Original prescriptions confirming a fax prescription were not received within specified time frames and were not reported to the Ministry of Health.
21. At Ingleburn Mr Saab's own evidence was that he did not inspect the pages of DD register which had been incorrectly amended and he did not inspect the list of missing prescriptions. He did not personally check the DD register for Suboxone to ensure the count and balance were accurate but his practice was to check the register from time to time to ensure its accuracy. He did not review the subject prescriptions for Schedule 8 medications although it was his practice to periodically review prescriptions for Schedule 8 medications. He employed competent pharmacists and he relied on them to report any issues.
22. Similarly at Toronto Mr Saab did not review the subject pages of the drug register but his practice was to review the register from time to time. He did not review the prescriptions for Schedule 8 medications the subject of the Complaint although it was his practice to periodically review prescriptions for Schedule 8 medications from time to time.
23. This was not a case of a one off contravention of the requirements of the PTGR by one pharmacist or at one pharmacy but of multiple contraventions over a period of months across two pharmacies. We do not accept the view expressed by Mr Mahoney, Mr Saab's expert, that the main issue uncovered in the PSU investigation was an assumed lack of overall supervision of an employee pharmacist, as well as a general sloppiness in clerical procedures.
24. When we look at what Mr Saab's responsibilities as an owner were, that being; to assure himself that his employed pharmacists were complying with legislation, standards and guidelines compared to what he actually did as a whole, in our view his conduct was seriously deficient.
25. For example if he had been inspecting the drug registers carefully he would have noticed the obvious improper alterations to the register. For several months he had no idea that the amount of Suboxone films held at his pharmacy did not match the drug register. There was little we could discern from Mr Saab's evidence or indeed that of Mr Jaafar, that gave us any confidence that when Mr Saab actually attended his pharmacies he actively participated in how the pharmacy business was conducted to ensure that it operated in accordance with the PTGR and relevant Guidelines.
26. Pharmacists act as our guardians in the community in the responsible and lawful dispensing of Schedule 8 medications and drugs of addiction. It is their compliance with the protective structures to which the Regulations and Guidelines are directed which ensure the safe benefits of such medications to individual patients and the community as a whole.
27. Troublingly Mr Saab appeared to explain the compliance issues identified at his pharmacies on the basis of human mistakes. Human beings make mistakes all the time. The point is as a proprietor Mr Saab had certain duties to perform and responsibilities to fulfil. It was important that they were performed and fulfilled adequately.
28. In our view Mr Saab abdicated his professional obligations as a proprietor. The deficiencies in his oversight as a proprietor are revealed by the nature and extent of the problems identified at his pharmacies. If he had been vigilant and intervened where necessary as far as requirements and standards are concerned, then the extent and range of contraventions identified at his pharmacies would not have been made by his employed pharmacists.
29. It is arguable that Mr Saab's conduct in failing as a proprietor to be aware of the manner in which his pharmacies dispensing practices were being conducted over a significant period of time, created an environment for Mr Farhat to misappropriate significant quantities of Endone from both Malabar and Ingleburn.
30. We are satisfied that the complaint of professional misconduct which forms Complaint Two is proved.
31. As indicated in paragraph 28 of this decision, these reasons only deal with stage one of the process. An order will be made listing the matter for directions with a view to fixing a date for the hearing of stage 2, and appropriate protective orders.
32. There is one significant issue remaining.
33. A precursor to the Complaint before us is that on 31 March 2015 the PSU received a statutory declaration from Mr Saab reporting the loss of a Schedule 8 drug register from Malabar. On 20 April 2015 the PSU carried out an inspection of both Malabar and Ingleburn pharmacies under section 43 of the PTGA for the purpose of investigating the circumstances surrounding Mr Farhat. Following on from these inspections the PSU identified significant amounts of Endone tablets unaccounted for at the Ingleburn and Malabar pharmacies.
34. Before Mr Saab made the notification to the PSU, he was faced with the need to identify a large and unaccounted amount of Endone at Ingleburn. He instructed his employed pharmacist to perform a stocktake. He did not provide any more resources to his staff to undertake this task. Given the large amount of Endone involved this should have been a priority for him. Being a Schedule 8 drug he should have intervened. He could have undertaken the stocktake himself. He could have worked as the pharmacist on duty freeing up his staff to undertake the stocktake. He did none of these things.
35. In broad terms Ms Benson's evidence was to the effect that the steps taken by Mr Saab; including his efforts to ensure the timely completion of the stocktake, and upon not being able to resolve the discrepancy within an appropriate time frame to report the missing Endone, were inadequate. Although we accept that view, the Complaint as formulated did not contain a particular which reflected this criticism. Rather the only particular which had some connection to Ms Benson's evidence was framed in terms that Mr Saab inappropriately requested Ms Mourad not to report the matter and declined her request to perform a stocktake.
36. In our view the time Mr Saab took to report the matter constituted a substantial and unacceptable delay. As submitted by the Commission, although this conduct is not captured in a particular, it is potentially a matter which may be the subject of submissions in stage two of the proceedings in the context of the appropriate protective orders to be made.

Future hearing of this matter

1. We have found the complaints of unsatisfactory professional conduct and professional misconduct proved. As noted at the beginning of this decision, the matter is to be heard in two stages. We understand that at a further hearing the parties will want to make submissions as to the protective orders the Tribunal should make and the issue of costs.
2. To that end, this matter will be listed for directions on 9 December 2019 at 9.00 a.m. to fix a date for hearing to complete the matter.

Orders 1. The complaints of unsatisfactory professional conduct and professional misconduct are proved. 2. Having found the complaints of unsatisfactory professional conduct and professional misconduct proved, in respect of the conduct of stage 2 of the proceedings the matter is listed for directions on 9 December 2019 at 9.00 am.

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: 27 November 2019