Civil and Administrative Tribunal

New South Wales

Case Name: Health Care Complaints Commission v Saab

Medium Neutral Citation: [2019] NSWCATOD 179

Hearing Date(s): 5, 6 and 7 December 2018, 21 and 22 May 2019, 16, 18, 19 and 20 September 2019

Date of Orders: 27 November 2019

Decision Date: 27 November 2019

Jurisdiction: Occupational Division

Before:

S McIllhatton, Senior MemberM Cross, Senior MemberE Anderson, Senior MemberH Schutz, General Member

Decision:(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. 

Catchwords: PROFESSIONS AND TRADES – proprietor pharmacist – supervision of employed pharmacists – accuracy of drug registers – compliance with legislation – dispensing of non-compliant prescriptions – unsatisfactory professional conduct – whether unsatisfactory professional conduct is sufficiently serious to amount to professional misconduct

Legislation Cited:

Evidence Act 1995 (NSW)Health Practitioner Regulation National Law (NSW)Poisons and Therapeutic Goods Act 1966 (NSW)Poisons and Therapeutic Goods Regulation 2008 (NSW)

Cases Cited:

Briginshaw v Briginshaw (1938) 60 CLR 336; [1938] HCA 34Chen v Health Care Complaints Commission [2017] NSWCA 186Drummond v Dyer [2002] NSWPB (13 February 2002)HCCC v Phung (No. 1) [2012] 1 NSWDTHealth Care Complaints Commission v Do [2014] NSWCA 307Health Care Complaints Commission v Dowla [2019] NSWCATOD 117Health Care Complaints Commission v Dr Denise Perroux [2011] NSWDC 99Health Care Complaints Commission v Farhat [2018] NSWCATOD 193Health Care Complaints Commission v Litchfield (1997) 41 NSWLR 630Health Care Complaints Commission v Nguyen [2018] NSWCATOD 168Health Care Complaints Commission v Saedlounia [2013] NSWMT 13Khodary [2003] NSWPB 4Pharmacy Board of Australia v Tavakol [2014] QCAT 112R v Byrnes (1995) 183 CLR 501

Texts Cited: Pharmacy Board of Australia, “Guidelines on responsibilities of pharmacists when practising as proprietors”, 8 December 2010

Category: Principal judgment

Parties:Health Care Complaints Commission

(Applicant)Hussein Saab (Respondent)

Representation:

Counsel:A Petrie (Applicant)D Villa SC (Respondent) Solicitors:Health Care Complaints Commission (Applicant)WB Lawyers (Respondent)

File Number(s): 2018/00223382

Publication Restriction: Nil

REASONS FOR DECISIONIntroduction

1 Mr Saab graduated with a Bachelor of Pharmacy from the University of Sydney

in 1996. On 7 February 1997 he became a registered pharmacist. He is the

sole proprietor of Ingleburn Medical Centre Pharmacy, and a proprietor in

partnership of two additional pharmacies, Simply Pharmacy Toronto and

Simply Pharmacy Wallsend. He was previously the sole proprietor of Simply

Pharmacy Malabar which he purchased on 2 June 2006. He subsequently sold

this pharmacy in March 2018.

2 On 31 March 2015 the NSW Ministry of Health Pharmaceutical Services Unit

(PSU) received a statutory notification from Mr Saab reporting the loss of a

Schedule 8 drug register from the Malabar pharmacy. The prescribing and

dispensing of Schedule 8 drugs is heavily regulated. Drug registers are a

critical record keeping component in the regulation of Schedule 8 drugs.

3 On 20 April 2015, Ms Wei, a senior pharmaceutical officer at the PSU,

inspected the Malabar and Ingleburn pharmacies owned by Mr Saab. She

conducted an inventory count of all drugs of addiction stored at Malabar and

obtained a number of records including the Ingleburn drug register and

Schedule 8 prescriptions for both pharmacies. She also obtained records from

the licenced pharmaceutical company, Symbion, of purchases made by both

pharmacies.

4 On 7 May 2015 Ms Wei performed a quantitative analysis of data in relation to

the acquisition and supply of Endone tablets at Ingleburn for the period 1 May

2014 to 9 April 2015 and found that 780 Endone tablets (39 proprietary packs)

were unaccounted for in the Drug Register. Mr Hussein Farhat was employed

as a locum Pharmacist on Sundays at Ingleburn during the period analysed.

5 On the same day Ms Wei also performed an analysis of data at Malabar for the

period 4 June 2014 to 20 April 2015 and found a further 9,260 Endone tablets

(463 proprietary packs) were unaccounted for at the Pharmacy. Mr Farhat was

employed as a Pharmacist in Charge at Malabar during the period analysed.

6 Endone is the brand name of a medicine containing the active ingredient

oxycodone hydrochloride. Oxycodone is available in different dosages and

forms such as tablets, capsules and liquid. It is a narcotic like morphine and

heroin. It is part of a group of drugs known as prescription opioids. It is a

Schedule 8 drug. This reflects its significance as a drug of addiction.

7 It is not in dispute that the amounts of unaccounted Endone that were identified

by the PSU in their inspections of the Malabar and Ingleburn pharmacies

owned by Mr Saab are very substantial.

8 As a drug of addiction, if opioids without a prescription like Endone make their

way into the community at large, there are potential consequences that flow to

the health and wellbeing of the public. Opioid overdose can be fatal. The

effects of taking oxycodone with other drugs or alcohol can be unpredictable

and dangerous. Using oxycodone without a prescription from a doctor or selling

or giving them to someone else is illegal. The improper use of oxycodone can

affect a person’s health, family, relationships, work, school, financial or other

life situations: see Alcohol and Drug Foundation, Fact Sheet Oxycodone, 29

July 2019.

9 There is no suggestion that Mr Saab misappropriated the unaccounted

Endone. In this respect, Mr Farhat was the subject of disciplinary proceedings

before the Tribunal: see Health Care Complaints Commission v Farhat [2018]

NSWCATOD 193.

Pharmacists as Proprietors of Pharmacies

10 This case is about Mr Saab’s conduct as a proprietor pharmacist. It concerns

three of his pharmacies; Malabar, Ingleburn and Toronto.

11 Under the National Law (NSW), a person cannot carry on a pharmacy business

in NSW unless the premises have a current approval and all the holders of the

financial interest in the pharmacy business are registered in the National

Register of Pharmacists, maintained by the Australian Health Practitioner

Regulation Agency (AHPRA): see Clauses 3 and 5 of Schedule 5F of the

National Law. In New South Wales, there is a limit of five pharmacies that an

individual pharmacist can own: see Clause 9(1) of Schedule 5F.

12 In effect only a registered pharmacist can own a pharmacy, and only a

pharmacist can lawfully dispense Schedule 8 drugs.

Previous Investigations

13 Mr Saab has been the subject of investigations by the predecessor of the PSU,

the Pharmaceutical Services Branch (PSB) on two prior occasions in 2000 and

2007. These investigations concerned allegations of inappropriate handling

and supply of pseudoephedrine; and unaccounted loss of methadone syrup for

the purposes of dosing under the NSW Opioid Treatment Program (OTP).

14 In July 2000, the PSB concluded an investigation into concerns in relation to Mr

Saab’s supply of large quantities of pseudoephedrine (single ingredient)

tablets. Mr Saab was the proprietor of Arncliffe Station Pharmacy at the time.

He made admissions to have handled and supplied pseudoephedrine tablets in

a manner that was in contravention of the then Pharmacy Board’s Guidelines.

The matter was not taken further.

15 In April 2007, an inspection of the Toronto Amcal Pharmacy owned by Mr Saab

revealed a number of serious deficiencies with respect to the supply of

Methadone and Buprenorphine from the Pharmacy. In addition, Mr Saab had

failed to account for 7,369ml of Methadone syrup and to report the loss of a

Drug Register despite PSB Officers’ repeated attempts to contact him at the

time.

16 Mr Saab explained that he was in hospital at the time. His partner attended a

meeting with officers of the PSB and presented documents. The PSB did not

take the matter further.

Opioid Treatment Program (OTP)

17 In 2005 Mr Saab purchased the Toronto Amcal Pharmacy currently Simply

Pharmacy Toronto. In 2003 this pharmacy was approved to supply methadone

and buprenorphine preparations under the New South Wales Opioid Treatment

Program (OTP). On 28 February 2011 Mr Saab purchased the Ingleburn

pharmacy.

18 Each of the pharmacies that are the subject of this case, Ingleburn, Malabar

and Toronto, were approved to dispense Schedule 8 drugs under the OTP.

19 The PSU is now known as the Pharmaceutical Regulatory Unit (PRU). A

protocol produced by the PRU, Legal and Regulatory Services Branch, NSW

Ministry of Health exists for all pharmacies participating as a dosing point for

the NSW OTP. The protocol together with the Poisons and Therapeutic Goods

Act 1966 (PTGA), the Poisons and Therapeutic Goods Regulation 2008

(PTGR) and the NSW Clinical Guidelines: Treatment of Opioid Dependence -

2018, assist pharmacists in complying with the legislative and policy obligations

regarding the supply of methadone and buprenorphine on the OTP.

20 The legislative requirements for the receipt, storage, and supply of methadone

and buprenorphine under the OTP are, at a minimum, the same as for any

other Schedule 8 medication. However the specific monitoring and supervisory

requirements of the OTP imposes additional obligations. As stated in the most

recent iteration of the protocol, compliance with the protocol provides proper

accountability, minimises the risks associated with the program, and protects

the health and safety of patients: see NSW Opioid Treatment Program:

Community Pharmacy Dosing Point Protocol Pharmaceutical Regulatory Unit,

Legal and Regulatory Services Branch, NSW Ministry of Health Issued April

2019.

Background to the Complaint

21 In addition to reporting the loss of the Schedule 8 drug register for the Malabar

Pharmacy to the PSU in writing on 31 March 2015, Mr Saab also verbally

reported his suspicions of misappropriation by Mr Farhat of Schedule 8 drugs

from his pharmacies at Malabar and Ingleburn. On 4 June 2015 Mr Saab was

interviewed by officers of the PSU arising from their investigation into Mr Farhat

concerning the misappropriation of Schedule 8 drugs at Malabar and Ingleburn.

22 In a report dated 2 July 2015 Ms Wei, a Senior Pharmaceutical Officer with

PSU, set out issues identified in her investigation into missing Schedule 8

drugs from Ingleburn and Malabar and the missing drug register from Malabar.

As a result of this investigation a number of instances of apparent non-

compliance with the provisions of the NSW Poisons and Therapeutic Goods

legislation were identified at Ingleburn and Malabar. Ms Wei reviewed the drug

registers from Ingleburn on 20 April 2015. She noted alterations, obliterations

and cancellations made to the register by the pharmacists at the pharmacy,

and there did not appear to have been a complete March 2015 stock check.

23 Ms Wei’s review and analysis of prescriptions of drugs of addiction and

restricted substances which were seized from Ingleburn pharmacy revealed:

(1) Repeat prescriptions for Schedule 4 Appendix B substances had been issued by pharmacists at Ingleburn where no interval of repeat was specified by the prescriber.

(2) Pharmacists at Ingleburn dispensed a number of Schedule 8 prescriptions with apparent alterations made by a person other than the authorised practitioner by whom it was issued.

(3) Where the prescription was computer generated there was no complete confirmation of the prescription in the prescriber’s own handwriting.

(4) The quantity of drug was not written in both words and figures.

24 Following on from this report between 21 and 22 September 2015 the PSU

carried out inspections with respect to the OTP dosing at three pharmacies in

which Mr Saab held a pecuniary interest, being Ingleburn Medical Centre

Pharmacy, Simply Pharmacy Toronto and Simply Pharmacy Wallsend. These

inspections identified further areas of concern to the PSU. Reports were

produced about these inspections. Relevantly the reports for Ingleburn dated 7

December 2015 and Toronto dated 17 December 2015 formed part of the

evidence in these proceedings.

25 This case is about the steps that Mr Saab as a proprietor took or should have

taken in relation to the missing quantities of Schedule 8 drugs. It is also about

his role in the supervision of his staff in their dispensing of compliant

prescriptions, record keeping, and failing to report written confirmation of

prescriptions from OTP prescribers to NSW Ministry of Health as required by

the PTGR.

The Decision Making Process

26 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.

27 As the hearing progressed and the evidence came out, it became clear that

this matter needed to be conducted in two stages.

28 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

29 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.

30 Following procedural directions the matter was listed for a hearing comprising

three consecutive days commencing on 5 December 2018.

31 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.

32 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.

33 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.

34 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.

35 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.

36 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.

37 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.

38 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.

39 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.

40 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.

41 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.

42 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.

43 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.

44 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.

45 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

46 The application and attached complaint comprises two individual complaints

against Mr Saab.

47 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.

48 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.

49 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.

50 Complaint Two relies on the same set of particulars both individually and

cumulatively as set out in Complaint One.

The Particulars

Ingleburn and Malabar Pharmacies

51 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:

(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.

(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

52 In Mr Saab’s reply dated 21 November 2018, he denied that his conduct

amounted to either unsatisfactory professional conduct or professional

misconduct.

53 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.

54 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).

55 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

56 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.

57 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

58 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)

59 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"—

…

60 Part 4 Division 4 Sub-Division 2 Clauses 95 and 96 deal with the emergency

supply of a drug of addiction without prescription.

61 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.

…

62 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.

63 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.

64 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.

65 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.

66 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

67 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.

68 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.

69 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.

Particular 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).

70 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”.

71 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.

72 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.

73 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.

74 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.

75 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.

76 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.

77 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.

78 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.

79 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.

80 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.

81 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.

Particular 2

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.

82 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.

83 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.

84 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.

Particular 3

On 19 March 2015 Mr Saab:

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.

85 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.

86 The above extract is consistent with what Ms Mourad recorded in her

notification to AHPRA dated 17 April 2015.

87 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”.

88 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.

89 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.

90 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.

91 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…

92 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.

93 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.

94 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."

95 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.

96 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.

97 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.

98 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.

99 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.

100 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.

101 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

102 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.

103 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.

104 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.

105 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.

Mr Saab’s Witnesses

Ms Michael

106 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.

107 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.

108 Ms Michael provided two written statements. The first is a statutory declaration

dated 8 October 2018.

109 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.

110 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.

111 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.

112 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

113 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.

114 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.

115 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.

116 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.

117 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.

118 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.

119 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

120 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

121 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.

122 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.

123 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.

124 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:

(a) the name, strength and quantity expressed in both words and figures of the drug to be supplied were not specified (Particulars 9 and 14)

(b) adequate directions for use were not specified (Particulars 9 and 14)

(c) intervals for the drug to be supplied (Particular 14 Toronto only)

(4) 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).

(5) 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

125 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.

126 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

127 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.

128 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.

129 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.

130 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.

131 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.

132 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.

133 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.

134 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.

135 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.

136 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.

137 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.

138 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

139 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.

140 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.

141 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.

142 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.

143 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.

144 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

145 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.

146 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.

147 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.

148 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.

Findings on the Particulars

Complaint One

Particular 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).

Finding

149 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.

150 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.

151 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.

152 Mr Saab states he did not become aware of missing Endone until the meeting

he had with Ms Mourad on 19 March 2015.

153 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.

154 Mr Farhat’s evidence is that he did not at any stage tell Mr Saab about the

missing Endone.

155 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.

156 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.

157 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.

158 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.

159 We find that particular 1 is not proved.

Particular 2

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

160 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.

161 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.

162 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.

163 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.

164 Mr Farhat gave evidence that although he had a meeting with Mr Saab there

was no discussion about the missing Endone.

165 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.

166 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

167 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.

168 We find that particular 2 is not proved.

Particular 3

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

On 19 March 2015 Mr Saab

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

170 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”.

171 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.

172 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.

173 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.

174 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.

175 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”.

176 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.

177 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.

178 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.

179 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.

180 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.

181 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”.

182 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.

183 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.

184 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.

185 We are not bound by the rules of evidence in these proceedings: see Schedule

5D cl 2 of the National Law.

186 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.

187 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.

188 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.

189 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.

190 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

191 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.

192 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.

193 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.

194 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.

195 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.

Particular 4

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

196 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.

197 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.

198 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.

199 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.

200 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.

201 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.

202 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.

203 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.

204 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.

205 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.

206 We find particular 4 proved.

Particular 5

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

207 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.

208 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.

209 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.

210 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.

211 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.

212 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.

213 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.

214 We find particular 5 proved.

Particular 6

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

215 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.

216 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.

217 We find particular 6 proved.

Particular 7

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.

218 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.

219 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.

220 Mr Saab also admitted that it was a serious matter to continue to dose a patient

in the absence of a valid prescription.

221 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.

222 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.

223 We find particular 7 proved.

Particular 8

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.

224 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.

225 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.

226 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.

227 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.

228 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:

DrugBalance in

RegisterActual Balance as of 22 September 2015

Suboxone 2mg

film272 films 262 films

229 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.

230 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.

231 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.

232 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.

233 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.

234 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.

235 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.

236 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.

237 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.

238 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.

239 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.

240 Neither the subsidiary register nor the prescriptions were available to us.

241 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.

242 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.

243 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.

244 We find particular 8 proved.

Particular 9

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.

245 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.

246 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.

247 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.

248 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.

249 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.

250 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.

251 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).

252 We find particular 9 a) and b) proved.

253 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.

Particular 10

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

254 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.

255 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.

256 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:

DrugBalance in

RegisterActual Balance as of 21 September 2015

Biodone Forte 1,211ml 1,165ml

Subutex 8mg

tablet49 tabs 44 tabs

257 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.

258 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.

259 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.

260 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.

261 We find particular 10 proved.

Particular 11

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

262 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.

263 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.

264 On Mr Saab’s behalf a limited admission was made about this particular as it

related to three specific occasions.

265 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.

266 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.

267 We find particular 11 proved.

Particular 12

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

268 In Ms Wei’s report she found prescriptions which had been previously

dispensed or expired which had not been marked “cancelled”.

269 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.

270 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.

271 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

272 We find particular 12 proved.

Particular 13

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

273 Ms Wei observed one fax prescription that was outstanding from 11 August

2015 and therefore greater than 7 days.

274 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.

275 We find particular 13 proved to the extent that it relates to a single faxed

prescription.

Particular 14

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

276 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.

277 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).

278 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.

279 We find particular 14 proved.

Conclusions

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

280 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.

281 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.

282 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.

283 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.

284 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.

285 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.

286 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.

287 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.

288 We do not accept these submissions.

289 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.

290 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.

291 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).

292 Particular 6 related to two drug safes at Ingleburn.

293 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).

294 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.

295 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.

296 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.

297 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.

298 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.

299 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.

300 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.

301 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.

302 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.

303 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.

304 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.

305 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.

306 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

307 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.

308 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.

309 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”.

310 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.

311 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.

312 It is the seriousness of the nature of the conduct which is found to have been

established which is relevant to professional misconduct.

313 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.

314 A number of authorities were referred to by the Commission in relation to the

obligations of proprietor pharmacists.

315 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.

316 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.

317 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 …

318 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.

319 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.

320 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.

321 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.

322 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.

323 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.

324 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.

325 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.

326 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.

327 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.

328 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.

329 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.

330 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.

331 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.

332 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.

333 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.

334 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.

335 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.

336 We are satisfied that the complaint of professional misconduct which forms

Complaint Two is proved.

337 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.

338 There is one significant issue remaining.

339 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.

340 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.

341 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.

342 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

343 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.

344 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.

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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

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