€¦ · Web viewThese reasons only deal with how and why the Complaint is established. The...
Transcript of €¦ · Web viewThese reasons only deal with how and why the Complaint is established. The...
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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:
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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
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(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.
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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.
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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.
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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
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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
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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.
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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.
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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
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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.
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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,
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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.
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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.
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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:
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(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)
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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.
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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.
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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].
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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:
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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
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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.
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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?
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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
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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."
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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.
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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.
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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
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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.
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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.
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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
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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
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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.
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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
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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
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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
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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
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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.
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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.
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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.
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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
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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”.
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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
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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
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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
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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
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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
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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.
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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
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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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
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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
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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.
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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.
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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
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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.
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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.
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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
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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
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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.
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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
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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
DISCLAIMER - Every effort has been made to comply with suppression orders or statutory provisions prohibiting publication that may apply to this judgment or decision. The onus remains on any person using material in the judgment or decision to ensure that the intended use of that material does not breach any such order or provision. Further enquiries may be directed to the Registry of the Court or Tribunal in which it was generated.