Health Care Complaints Commission v Sedrak [2014] NSWCATOD 114
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Civil and Administrative Tribunal
New South Wales
Medium Neutral Citation: Health Care Complaints Commission v Sedrak [2014] NSWCATOD 114
Hearing dates: 24, 25, 26, 27 June 2014 last written submissions 18th September 2014
Decision date: 15 October 2014
Jurisdiction: Occupational Division
Before: M Joseph SC (Principal Member)
E Anderson (Professional Member)
A Reynolds (Professional Member)
D Anderson (Lay Member)
Decision: Complaints of unsatisfactory professional conduct and professional misconduct proven.
Catchwords: Dispensing without retaining prescription, failing to record returned drugs, supplying by retail therapeutic goods, dispensing without a lawful prescription, failing to report theft from pharmacy, dispensing drugs in excessive quantities and for excessive periods, dispensing drugs knowing prescriber not appropriately qualified, dispensing drugs without lawful scripts and knowing prescriber did not have authority to so prescribe, failure to respond to statutory notice ; held proven unsatisfactory professional conduct and professional misconduct.
Legislation Cited: Civil and Administrative Act 2013 (NSW) s7;s38(2); cl 3 and cl17(3) of Schedule 1;
Health Practitioner Regulation Law (NSW) 2009 S139B; S139E;s165H
Poisons and Therapeutics Goods Act 1966 (NSW) S36A;
Poisons and Therapeutics Goods Regulation 2008; cl 35; cl39; cl 41(1); cl 42(2); cl 54; cl 67; cl 112;cl 89; cl 146(2);
Health Care Complaints Act 1993 (NSW) s34A;
Therapeutic Goods Act 1989 (Cth)
Cases Cited: Ayscough v Sedrak [2007] NSWPB 4
Briginshaw v Briginshaw [1938] HCA 34;(1938) 60 CLR 336
Browne v Dunn (1893) 6 R 67
Gianoutsos v Glykis [2006] NSWCCA 137; 65 NSWLR 547-9
Health Care Complaints Commission v Fraser [2014] NSWCATOD 29
Jones v Dunkel [1959]101 CLR 298;
Jones v National Coal Board ]1957] EWA Civ 3; [1957] 2 QB 55
Kuhl v Zurich Financial Services Australia [2011] HCA 11; 243 CLR 361
Polgaze v Veterinary Practitioners Board of NSW [2009] NSWSC 347
Stead v State Government Insurance Commission [1986] HCA 54; 161 CLR 141
In re Dr Gregory Wilcox and the Medical Practice Act [2007] unreported 26 April 2007 Medical Tribunal of NSW
Veterinary Surgeons Investigating Committee v Thompson [2007] NSWAT 107
Texts Cited: "Code of Conduct for registered health practitioners"; "Guidelines for dispensing of Medicines"; "Guidelines on practice-specific issues" issued by Pharmacy Board of Australia
"Dispensary Computers in NSW 2001" issued by Pharmacy Board of NSW;
MIMS Prescribing Information
Category: Principal judgment
Parties: Health Care Complaints Commission (Complainant)
Maged Sedrak (Respondent)
Representation: W Hunt (Complainant)
P Griffin (Respondent)
K Mobbs (Complainant)
Cambridge Law (Respondent)
File Number(s): 1420020
Publication restriction: Non Publication Orders Apply
Pursuant to Schedule 5D clause 7 of the Health Practitioner Regulation National Law (NSW), publication or disclosure of the name, address or any evidence or information which might tend to or lead to the identification of the names of patients of Dr Wilcox identified in these proceedings is prohibited.
reasons for decision
What the Tribunal decided.
1The Tribunal finds the 3 complaints lodged by the Complainant proven. It finds Mr Sedrak, the Respondent (a pharmacist) guilty of unsatisfactory professional conduct in respect of two of the complaints and guilty of professional misconduct in respect of one of the complaints.
2It orders the parties may now make submissions as to what protective orders and costs orders ought be made in the light of the Tribunal's findings, or have the matter relisted before the Tribunal in respect of further directions as to further evidence sought to be relied upon by the parties in respect to suitable protective orders and costs to be made by the Tribunal.
3The Tribunal has made a non-publication order. This order precludes publication of the name of the four patients or customers referred to in the schedule to the Complaint before the Tribunal, other than in these Reasons for Decision as provided to the parties to the proceedings.[Schedule 5D of Health Practitioner Regulation National Law (NSW) ]
Background
4Maged Sedrak who was at the time of these events a Registered Pharmacist (the Pharmacist) is currently aged 59 years. He was born in Egypt and came to Australia in 1983 having graduated from the Faculty of Pharmacy at Cairo University in 1979. He has lived and worked in and around Sydney since 1983 and became a Registered Pharmacist initially in Victoria in 1984 having re-registered after a short absence in 1993. [Ex K [6]-[16] His registration was suspended in 2012 and he chose not to renew his registration in 2013.
5Mr Sedrak opened a pharmacy at Engadine. Arising out of his conduct there, a complaint was laid which lead to his appearance in 10 October 2007 before a Professional Standards Committee in respect of dispensing of paediatric prescriptions and failures in his dispensing processes including failure to counsel. Issues were determined in respect to his failure to fully understand the uses and applications of certain drugs and his computer system. He admitted that that he was guilty of professional misconduct. As a result he was reprimanded and required to undertake some continuing education and maintain quality care pharmacy program.[Ex G Tab 43] There was no mention of these matters in Mr Sedrak's affidavit filed in this Tribunal.
6Mr Sedrak was at the time of the events the subject of complaint and as a consequence of one of the orders made by the Committee, undergoing education as to the appropriate ways he should work responsibly [Day 4 T44.25]. When asked how the conduct admitted and subject to complaint could take place considering this fact, Mr Sedrak couldn't find words. [Day 4 T44.40]
7Mr Sedrak opened a pharmacy known as Belgrave Pharmacy in Kogarah. It is as a result of conduct at that pharmacy that these complaints arise. Most pharmacists are retail pharmacists, however Mr Sedrak was a compounding pharmacist which meant that he compounded the products required by customer. Thus a large majority of his work did not involve
dispensing of proprietary pharmaceuticals.
8At Kogarah, Mr Sedrak formed a close personal [Day 3 T39.15] and professional relationship with a Dr G Wilcox, a medical practitioner, who practiced as a general practitioner. This relationship is critical to many of the complaints which have to be determined. Mr Sedrak admitted upfront that about 30-40% of his work was on referral from Dr Wilcox.[ Ex K [120];Day 3 T35;Day 4 T14-15] This is not so unusual. However this situation should not change dispensing responsibilities of the pharmacist, and thus the standard of care to be exercised.
9Mr Sedrak admitted that this situation created some economic imperative to his dispensing of "scripts" from Dr Wilcox [Ex K [120]]. The word "scripts" is in inverted commas, as some of the documents provided from Dr Wilcox clearly did not comply with the regulations as to form of prescriptions as required under the Poisons and Therapeutic Goods Regulation 2008 (NSW).
10Dr Wilcox was also the treating doctor of Mr Sedrak and his wife. No doubt this would have added to the difficulty in acting independently of Dr Wilcox.
11Some of the patients to whom drugs were dispensed were elderly. This creates particular issues of risk of increased harm because the metabolism of the elderly is different from a younger population. Thus the identification of dose and the drug is critical especially as the elderly's system may cause a build up to toxic levels because of their inability to break down the dose of a particular drug.
12Dr Wilcox has had his own professional issues. [Ex G Tabs 44-45] He was subject to a medical inquiry in 2003, which concerned his purchases of large quantities of anabolic/androgenic steroids and pituitary hormones. The inquiry ordered amongst other things that Dr Wilcox's prescribing conditions be limited and he was not to purchase or prescribe schedule 4D drugs. In another inquiry in April 2007 he was before a Medical Tribunal [Ex G Tab 44] concerning his failure to comply with certain conditions which included his inappropriate supply of drugs such as testosterone. He was found guilty of unsatisfactory professional conduct and professional misconduct and a practice condition was imposed that he was not to purchase or otherwise obtain, possess, take delivery of, administer, prescribe or supply any prescribed restricted substances in Schedule 4 Appendix D of the NSW Poisons List.
13At the time of these events, there was a lack of mandating provisions which formally informed pharmacists of any restrictions of the authority of any doctor's rights to prescribe. Whilst such information is now available, provision should be made for pharmacists to be directly informed of such restrictions especially in respect to doctors in the geographical areas of the pharmacist.
Mr Sedrak described Dr Wilcox as having a holistic approach to the treatment of his patients [Ex K [120]] In his interview, Mr Sedrak referred to Dr Wilcox as a bit eccentric [Ex F Tab 6 p4] and really eccentric Ex F Tab 6 p 30] however such epithets fail to reveal and in fact hide the real forces behind the conduct of Mr Sedrak (and Dr Wilcox).
14Mr Sedrak admitted that Dr Wilcox would itemise drugs (such as anabolic steroids) to be dispensed on a card and not a legal script. This conduct is the subject of particulars. At the time, Dr Wilcox was not permitted to prescribe these drugs. Mr Sedrak admitted that over time more than 95% of his practice included the dispensing of different steroids including testosterone, progesterone and oestrogens.[Ex K[128]]
15Other drugs which are subject to abuse were dispensed contrary to recommendations of the manufacturer's product information or accepted texts. Mr Sedrak has suggested because the card was not a lawful script he would not have dispensed drugs identified on the card. [Ex K [116] But he did. In the end, when pressed, Mr Sedrak, regretted everything (which) happened with Dr Wilcox and assessed his conduct as very shameful.[Day 4 T52.10]
16There was some suggestion that as a pharmacist's conduct is but consequential to that of the prescribing doctor, the pharmacist's responsibility is less. This was to misrepresent and diminish the critical role of the pharmacist. Their role is to make independent judgments in the interests of the patient. The pharmacist's role includes checking the legality, appropriateness, and safety of any prescription. Routine work of a pharmacist includes the application of their knowledge and expertise. Concerns about a prescription should be raised with the prescribing doctor and this intervention noted. Mr Sedrak agrees.[ Ex K at [74-75]]
17In any event, not all of the conduct the subject of the complaints found its genesis in the conduct of Dr Wilcox. Thus other particulars involved the supply by Mr Sedrak of amino acids to a person in Castle Hill for that person and others use, and his failure to report a theft from the Belgrave pharmacy. For this conduct Mr Sedrak alone must take responsibility. Similarly the lack of standard practices within the pharmacy such as recordings and labelling are also the subject of complaints were solely the responsibility of Mr Sedrak.
18Complaints one and two seek findings of "unsatisfactory professional conduct", whereas complaint three seeks a finding of "professional misconduct".
19 "Unsatisfactory professional conduct" is defined in by Section 139B(1) of the Health Practitioner Regulation National Law (NSW) , ("The National Law" ) is conduct which falls within one of the deficiencies or inadequacies contained in s139B of the National Law which relevantly includes -
(a) Conduct that demonstrates the knowledge, skill or judgement possessed or care exercised by the practitioner in the practice of the practitioner's profession is significantly below the standard reasonably expected of a practitioner of an equivalent level of training or experience and/or
........
(l) any other improper or unethical conduct related to practice or purported practice of the practitioner's profession.
20"Professional misconduct" is defined under section 139E of The National Law to mean that the practitioner's conduct was either:
(a) unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration, or
(b) more than one instance of unsatisfactory conduct that when the instances are considered together, amount to conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration.
21There was no issue that Mr Sedrak was at the time of the acts giving rise to the complaints a registered practitioner for the purposes of the National Law despite him now not being a registered pharmacist.[Ex H Tab 57] Prior to the date of hearing the Belgrave pharmacy has been removed from the Register of Pharmacies as an approved pharmacy premise and Mr Sedrak has been removed from the Register of Pharmacies as holding a pecuniary interest in Belgrave Pharmacy Pharmaceutical Compounding. [Ex H Tab 58]
22The process adopted by the Tribunal here, is to firstly to consider whether the conduct has been made out in point of fact ( including having regard to any admissions made by Mr Sedrak), then to evaluate whether the conduct proven falls within the definitions of "unsatisfactory professional conduct" and/or "professional misconduct".
23Mr Sedrak has admitted in his affidavit [Ex K] many of the particulars. This is of significance, although such admissions might be said to be inevitable given the state of the evidence. Section 165H of the National Law states that no inquiry need be conducted into a complaint referred to the Tribunal under this Law if the registered health practitioner or student who is the subject of the complaint admits the subject matter of the complaint in writing to the Tribunal. However the Tribunal has considered all the evidence in respect to each particular (despite the admissions), not because it does not accept the admissions, but to understand the nature and extent of the conduct and the reliability of the evidence as a whole in particular Mr Sedrak's explanations and the alleged mitigating circumstances. The reason for this is to be enable the Tribunal to make an assessment as to the seriousness of any breach of professional duty which should be attached to the (admitted) proven particulars.
24The parties sought and the Tribunal agreed, that the Tribunal shall adopt a two stage process, and thus the Tribunal shall not at this stage consider what protective orders ought to be made.
Specific Legislation in respect to the particulars of complaint.
25Particular 1 and particular 13 are admitted. They assert Mr Sedrak breached clause 42(2) of the Poisons and Therapeutics Goods Regulation 2008 (NSW) ("PTGR").
Clause 42 relates to prescriptions for certain substances are to be kept:
"(1)....
(2) A pharmacist must keep prescriptions for special restricted substances separate from other prescriptions."
26Particular 2 is admitted. It asserts that Mr Sedrak breached clause 112 of the PTGR.
Clause 112 relates to entries into drug registers as to receipt of relevant drug;
"(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, administered or used;
(c)....
(d) In the case where a drug is supplied or administered on prescription:
(i) The prescription reference number; and
(ii) The name and authorised practitioner by whom the prescription was issued;
Each entry in the drug register must be dated and signed by the person by whom it is made."
27Particular 3 is not admitted. It relates to failure to keep repeat prescriptions contrary to clause 89 of the PTGR.
Clause 89 relates to prescriptions and orders to be kept and relevantly states:
(1) A pharmacist who supplies a drug of addiction on prescription or by order under clause 97 or 103 must keep the prescription or order whether or not the prescription or order authorises more than one drug.
(2) A pharmacist must keep prescriptions or orders for drugs of addiction separately from other prescriptions."
28Particular 4 (a) is not admitted. It relates to supply by retail contrary to section 36A of the Poisons Goods Act 1966 (NSW) ("PTGA NSW")
Clause 36A (1) relevantly states
A person who supplies by retail therapeutic goods to a person is guilty of an offence unless:
(a) The goods are registered goods or listed goods;
(b) The goods are exempt goods or are subject to approval or authority under section 19 of the Commonwealth Act.
29"Therapeutic goods" are as defined in s3 of the Therapeutic Goods Act 1989 (C/W) which states that "therapeutic goods" means goods:
(a) that are represented in any way to be, or that are, whether because of the way in which the goods are presented or for any other reason, likely to be taken to be:
(i) for therapeutic use; or
(ii) for use as an ingredient or component in the manufacture of therapeutic goods; or
(iii) for use as a container or part of a container for goods of the kind referred to in subparagraph (i) or (ii); or
(b) included in a class of goods the sole or principal use of which is, or ordinarily is, a therapeutic use or a use of a kind referred to in subparagraph (a)(ii) or (iii);
30The word "supply" is defined in s3 of the PTGA, relevantly which states relevantly;
"supply includes;
(a) sell, dispense and distribute
(b) ....(g)
31The word "retail" is not defined by the legislation. The Tribunal adopts the reasoning stated in Health Care Complaints Commission v Fraser [2014] NSWCATOD 29 at [417]-[420] that retail carries its ordinary meaning of a sale to a member of the public but more importantly in the context of pharmacy by retail, no more in quantity than the ordinary consumer requires. Thus a supply by retail sale is to be distinguished from a supply say by a manufacturer.
32Particular 4(b) which is not admitted relates to labelling contrary to clause 146(2) of the PTGR.
Clause 146 relevantly states;
(1) This clause applies to all therapeutic goods that are not therapeutic devices and are not included in a Schedule of the Poisons List (in this clause referred to as
"unscheduled therapeutic substances").
(2) An authorised practitioner, pharmacist or practitioner of alternative medicine must ensure that any unscheduled therapeutic substances that are supplied from his or her business premises for therapeutic use are labelled in accordance with the requirements of Appendix A.
Maximum penalty: 10 penalty units.
(3) This clause does not apply to the supply of a substance by a person referred to in subclause (2) if:
(a) the substance is supplied, unopened, in the container in which it was received by the person, and
(b) the container is labelled in accordance with the requirements of the Commonwealth therapeutic goods laws.
33Particular 4A which is admitted relates to provision of drugs without prescriptions for family members who at the time resided overseas.
Clause 39 of PTGR relevantly states;
(1) A pharmacist must not supply a restricted substance on prescription unless the prescription is in the form required by Division 3.
(2) This clause does not prevent a pharmacist from supplying a restricted substance on prescription merely because:
(a) The prescription fails to specify the maximum number of times the substance may be supplied, or
(b) In the case of a prescription for a special restricted substance, that prescription fails to specify the intervals at which the substance may be supplied, or
the address shown on the prescription indicates that it has been issued by a veterinary practitioner from some other State or Territory.
(3) A pharmacist must not supply a restricted substance on a prescription referred to in sub-clauses 2 a or b if it appears to the pharmacist that the substance has been previously supplied on the prescription, regardless of how many times the prescription was authorised for the supply of the substance."
34Particular 5 is admitted and Particular 6 are admitted and are in the alternative. Particular 6 relates to a breach of clause 67 of the PTGR.
Clause 67 states;
(1) A person must immediately notify the Director General or if the person loses a prescribed restricted substance or a prescribed restricted substance is stolen from the person.
(2) This clause does not apply to the loss of any substance by or theft of any substance from a person who has been supplied with the substance by or on the prescription of an authorised practitioner."
35Particular 7 (a);particulars 12, 12A,15 and 16 are admitted, 7(b) 12A are not admitted, all assert breaches of clause 35 which is set out above and alleged acts contrary to clause 39 of the PTGR.
Clause 35 identifies the form of a lawful prescription: It relevantly states that;
(1) A prescription for a restricted substance must include the following details:
(a) The date on which it is issued;
(b) The name and address of the patient
(c) The name, strength and quantity of the substance to be supplied;
(d) The adequate direction for use;
(e) The maximum number of times the substance may be supplied on the prescription;
(f) In the case of prescription for a special restricted substance, the intervals at which the substance may be supplied on the prescription;
(g) .....
(h) If the prescription is issued elsewhere than a hospital then the name and designation of the person by whom it is issued and the address and telephone number of the premises at which it is issued.
(2) The details referred to in sub-clauses 1(a-f) must be made out:
(a) In the handwriting of the person by whom the prescription is issued or ... and the prescription must be signed by the person by whom it is issued;
(3) .....
(4) A person who issues a prescription for a restricted substance must ensure the prescription complies with the requirements of this clause.
36Particular 8 is admitted, while Particular 9 is not admitted, both relate although not in terms, to ensuring drugs are only dispensed in accordance with recognised therapeutic standards. Clause 54 of the PTGR provides some assistance in understating this requirement and these particulars. It states
An authorised practitioner or pharmacist must not supply any restricted substance in a quantity or purpose, that does not accord with the recognised therapeutic standard of what is appropriate in the circumstances.
Complaint 2 which is admitted, asserts a failure to comply with Section 34A of the Health Care Complaints Act, 1993 This provision provides;
(1) If the Commission is investigating a complaint and is of the opinion that a person is capable of giving information, producing documents (including medical records) or giving evidence that would assist in the investigation, the Commission may, by notice in writing given to the person, require the person to do any one or more of the following:
(a) to give the Commission, by writing signed by the person (or, in the case of a corporation, by a competent officer of the corporation) and within such time as is reasonable, and in the manner, specified in the notice, any such information of which the person has knowledge,
(b) to produce to the Commission, in accordance with the notice, any such documents,
(c) to appear before the Commissioner or a member of staff of the Commission authorised by the Commissioner at a time and place specified in the notice that is reasonable and give any such evidence, either orally or in writing, and produce any such documents.
(3) Information and documents may be given or provided to the Commission in compliance with this section despite any other Act or law (but not despite a provision of Division 8 of this Part or Division 6B or 6C of Part 2 of the Health Administration Act 1982 ).
(4) A person who is subject to a requirement under subsection (1) must not, without reasonable excuse, fail to comply with the requirement.
Maximum penalty: 20 penalty units.
Complaint One
Particulars;
(1)On about 14 July 2001 the practitioner supplied dexamphetamine to Patient A and failed to retain the prescription contrary to clause 42(1) of the Poisons and Therapeutic Goods Regulation 2008 (NSW) ("PTGR").
(2)On about 14 July 2001 the practitioner failed to enter the receipt of 2 bottles of dexamphetamine tablets in the 'Belgrave Pharmacy - Goods Inward Register' contrary to clause 112 of the PTGR.
(3)The practitioner dispensed DHEA and failed to keep the repeat prescription on at least one occasion, contrary to clause 89 of the PTGR.
(4)The practitioner supplied amino acids to an unidentified person in Castle Hill:
(a)By retail contrary to section 36A of the Poisons and Therapeutic Goods Act, 1996 (NSW) ("PTGA NSW");
(b)Without labelling the amino acids contrary to clause 146(2) of the PTGR;
(c)Without entering the sales into his computer at Belgrave Pharmacy.
(4A) The practitioner prepared thyroxine (T4) and metformin, sildenafil and dapoxetine for dispensation (by way of proposed export to family members) without a prescription.
(5)Between 1 July 2010 and 14 July 2011 the practitioner failed to account for the following quantities of prescription only medication:
(a)3,854 zolpidem 10mg tablets;
(b)359 somatropin 1.5mg/mL vials;
(c)322.93 grams phentermine powder;
(d)44.96 grams of testosterone powder
(6)In the alternative to particular 5 the practitioner failed to report to the Director General of NSW Ministry of Health an alleged theft on or about 24 March 2011 of prescribed restrictive substances from the Belgrave Pharmacy contrary to clause 67 of the PTGR including:
(a)3854 zolpidem 10mg tablets;
(b)359 somatropin 1.5mg/mL vials;
(c)322.93 grams phentermine powder;
(d)100 diazepam 5mg tablets
(e)44.96 grams of testosterone powder
(7)The practitioner dispensed "aromatase inhibitors" without a prescription complying with clause 35 of the PTGR in that the prescription did not include the name, strength and quantity of the drug contrary to clause 39 of the PTGR on:
(a)7 October 2010 to Patient F;
(b)23 December 2010 to Patient G.
(8)The practitioner failed to contact the prescribing medical practitioner Dr Gregory Wilcox prior to dispensing 100 zolpidem tablets in circumstances where use of the medication is recommended to be limited to 1 tablet a day for 4 weeks maximum period under close supervision and Dr Wilcox was not a specialist on the following occasions:
(a)Patient H on 14 July 2010;
(b)Patient I on 9 November 2011;
(c)Patient J on 8 March 2011;
(d)Patient K on 17 March 2011;
(e)Patient L on 9 April 2011;
(f)Patient M on 10 May 2011;
(g)Patient N on 19th June 2011
(h)Patient O on:
(i)21 July 2010;
(ii)7 April 2011;
(i)Patient NN on:
(i)4 August 2010;
(ii)28 January 2011;
(j)Patient OO on:
(i)5 August 2010;
(ii)6 October 2010;
(iii)17 March 2011;
(iv)12 May 2011;
(v)25 May 2011.
(k)Patient PP on:
(i)25 June 2010;
(ii)8 March 2011;
(iii)24 May 2011;
(l)Patient QQ on:
(i)31 August 2010;
(ii)14 October 2010;
(iii)8 December 2010;
(iv)25 January 2011;
(v)11 March 2011;
(vi)29 April 2011;
(vii)15 June 2011;
(m)Patient RR on:
(i)25 September 2010;
(ii)16 December 2010;
(iii)24 February 2011;
(iv)20 May 2011
(n)Patient SS on:
(i)20 October 2010;
(ii)11 February 2011;
(iii)14 April 2011.
(o)Patient TT on:
(i)21 October 2010;
(ii)5 April 2011.
(p)Patient UU on:
(i)18 November 2010;
(ii)12 April 2011.
(q)Patient VV on:
(i)20 November 2010;
(ii)9 February 2011
(9)The practitioner dispensed somatropin on prescriptions issued by Dr Gregory Wilcox when he knew or ought to have known that Dr Wilcox was not appropriately qualified in the diagnosis and management of patients with growth hormone deficiency to:
(a)Patient Y on:
(i)1 March 2010;
(ii)6 July 2011.
(b)Patient L on:
(i)5 August 2010;
(ii)10 October 2010;
(iii)22 December 2010;
(iv)15 March 2011;
(v)9 April 2011;
(vi)9 July 2011.
(c)Patient AA on:
(i)6 August 2010;
(ii)16 January 2011;
(iii)3 July 2011.
(d)Patient BB on:
(i)1 June 2010;
(ii)1 February 2011;
(e)Patient CC on 29 April 2009.
(f)Patient DD on 29 June 2011.
(g)Patient EE on:
(i)20 July 2010;
(ii)15 February 2011;
(iii)9 April 2011.
(iv)
(h)Patient FF on:
(i)29 July 2011;
(ii)12 November 2011;
(iii)9 April 2011
(i)Patient GG on 15 March 2011.
(10)The practitioner dispensed testosterone that had been prescribed by Dr Gregory Wilcox with the knowledge that Dr Wilcox did not have authority to prescribe testosterone on:
(i)14 December 2010 to Patient HH;
(ii)20 May 2010 to Patient II.
(11)On 14 December 2010 the practitioner dispensed testosterone as requested by Dr Gregory Wilcox on a slip of paper to Patient HH without a prescription complying with clause 35 of the PTGR contrary to clause 39 of the PTGR.
(12)The practitioner dispensed DHEA as requested by Dr Gregory Wilcox on a slip of paper to the following patients without a prescription complying with clause 35 of the PTGR contrary to clause 39 of the PTGR:
(a)Patient B on 22 July 2009;
(b)Patient II on 26 November 2009;
(c)Patient V on 21 July 2009;
(d)Patient HH on 14 December 2010;
(e)Patient JJ on 23 November 2010;
(f)Patient T on 9 September 2010;
(g)Patient W on 16 September 2010;
(h)Patient F on 7 October 2010;
(i)Patient LL on 1 November 2010;
(j)Patient MM on 9 November 2010;
(k)Patient U on
(i)23 September 2009;
(ii)16 February 2011.
(l)Patient X on 26 March 2009.
(12A) The practitioner dispensed DHEA as requested by Dr Gregory Wilcox on a slip of paper to the following patients without a prescription complying with clause 35 of the PTGR contrary to clause 39 of the PTGR when he knew or ought to have known that Dr Wilcox did not have authority to prescribed DHEA.
(a)Patient B on 22 July 2009;
(b)Patient II on 26 November 2009;
(c)Patient V on 21 July 2009;
(d)Patient HH on 14 December 2010;
(e)Patient JJ on 23 November 2010;
(f)Patient T on 9 September 2010;
(g)Patient W on 16 September 2010;
(h)Patient F on 7 October 2010;
(i)Patient LL on 1 November 2010;
(j)Patient MM on 9 November 2010;
(k)Patient U on
(i)23 September 2009;
(ii)16 February 2011.
(l)Patient X on 26 March 2009.
(13)The practitioner failed to keep duplicate prescriptions directing the supply of anabolic steroids, a special restricted substance, and separate from duplicate prescriptions directing the supply of general prescription by only medicines contrary to clause 42(2) of the PTGR.
(14)On 4 September 2011 the practitioner was unable to produce on demand to an authorised official of a Government Department electronic copies of the patients' dispensing histories contrary to the Pharmacy Board of NSW dispensing computers in NSW 2001 Standard.
(15)The practitioner dispensed medication without a prescription complying with clause 35 of the PTGR in that the prescription did not include the patient's address, contrary to clause 39 of the PTGR to:
(a)Patient B on 22 July 2009 (2 scripts dated 22 July 2009);
(b)Patient Q on 17 August 2010;
(c)Patient E on or around 2 August 2011;
(d)Patient JJ on 26 November 2009;
(e)Patient V on 21 July 2009;
(f)Patient R on 20 December 2010;
(g)Patient D on 13 July 2011;
(h)Patient T on 9 September 2010;
(i)Patient W on 16 December 2010;
(j)Patient II on 20 May 2010;
(k)Patient S on 1 November 2010;
(l)Patient Z on 4 April 2011;
(m)Patient MM on 9 November 2010;
(n)Patient U on:
(i)23 September 2009;
(ii)16 February 2011.
(o)Patient X on 26 March 2009;
(p)Patient WW on 5 July 2010.
(16)The practitioner dispensed medication without a prescription complying with clause 35 of the PTGR in that he did not include the patient's full name contrary to clause 39 of the PTGR to:
(a)Patient XX on 16 November 2010;
(b)Patient G on 25 December 2010.
Complaint Two
The practitioner is guilty of unsatisfactory professional conduct under section 139B(1)(e) of the National Law in that the practitioner has contravened a requirement under the Health Care Complaints Act, 1993 (NSW) ("the Act").
Background to Complaint 2
(1)On 28 March 2013 the Commission sent a letter to the practitioner enclosing a notice that was issued under section 34A of the Act.
(2)The notice required the practitioner to give the Commission a statement of information in writing by 5pm on 16 April 2013.
Particulars
The practitioner failed to:
(1)Comply with the requirement of a notice issued under section 34A of the Act on 28 March 2013 in that he did not provide information required by the Notice on or before 5pm on 16 April 2013 or at any later stage;
(2)Provide a reasonable excuse for failing to comply with section 34A Notice issued by the Commission on 28 March 2013.
Complaint Three
Particulars
The practitioner is guilty of professional misconduct under section 139E of the National Law in that the practitioner has:
(1)Engaged in unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration; or
(2)Engaged in one than more instance of unsatisfactory professional conduct that when the instances are considered together amount to conduct of sufficiently serious nature to justify the suspension or cancellation of the practitioner's registration.
Background to Complaint 3
Reliance is made on the particulars in Complaints 1 or 2.
Particulars to Complaint 3
The particulars of Complaint 1 and Complaint 2 are repeated and relied on individually and cumulatively.
The Hearing
37This proceeding was originally commenced in the Pharmacy Tribunal of NSW but had not been heard as at 1 January 2014. On 1 January 2014 the Civil and Administrative Tribunal of NSW (NCATA) was established and on its establishment the Pharmacy Tribunal was abolished.[see Civil and Administrative Act 2013, [s7 and clause 3 of Schedule 1] By operation of clause 7(1) of Schedule 1 to NCATA, these proceedings are taken to have been duly commenced in NCAT and may be heard and determined by this Tribunal. For this purpose and under cl7(3), this Tribunal has and may exercise all the functions, which the Pharmacy Tribunal previously exercised, and the applicable legislation is that which would have applied if the NCATA had not be enacted. Consequently, the National Law as in force at 31 December 2013 and the legislation applicable to the conduct the subject of the complaints at the time the conduct occurred apply to these proceedings.
38The standard of proof is the civil standard however by reason of the seriousness of the allegations and gravity of the consequences the Tribunal has made its findings on the basis that it must be comfortably satisfied. [see Briginshaw v Briginshaw [1938] 60 CLR 336 at 362-3 as discussed in Gianoutsos v Glykis [2006] NSWCCA 137; 65 NSWLR 547-9 as applied in Polgaze v Veterinary Practitioners Board of NSW [2009] NSWSC 347 at [31]]
39The Tribunal heard this matter over 4 consecutive days commencing Tuesday 24th June 2014 and was concluded on Friday 27th June 2014. Mr Sedrak gave oral evidence as did Ms Dolan who was an Officer with Pharmaceutical Services within the Department of Health. [Her evidence was not transcribed however was listened to on transcription disc.]The Tribunal found her a forthright and reliable witness.
40Much material was tendered without objection and to which no reference has been made by the parties in written submissions. It might be said that this material is background material, however, some of the material was important for assisting understanding of the particulars. This material was not challenged and therefore the Tribunal is able to accept it as true and accurate. This same material has been given careful consideration particularly in the presence of changing and unconvincing evidence from the Respondent.
41There was some material tendered by Mr Sedrak in respect of which he was not specifically cross examined, in particular some of the explanations provided by him in his statement [Ex F] to the Tribunal. This raises the application, if any, of the so called rule in Browne v Dunn. [[1894] 6R 67;This rule has been recently considered in HCCC v Fraser [2014] NSWCATOT 29 at [230]-239]].
42At the hearing, there was a general testing of the credibility of Mr Sedrak. This occurred on many of the issues which were before the Tribunal. The legal effect to a lack of testing of a particular piece of evidence finds texture in both statutory and common law considerations.
43Procedure before the Tribunal is governed by its enabling Act. In particular S38(2) of the Civil Administrative and Tribunal Act (NSW) 2013 (CATAct) states that the Tribunal is not bound by the rules of evidence however is subject to the rules of natural justice. Thus what impact does the so called rule in Browne v Dunn have on the decision making of the Tribunal? The rule has been described as "rule of practice or procedure, based upon general principles of fairness" and a "rule relating to the weight or cogency of evidence"[see State Rail Authority v Brown [2006] NSWCA 220 at [54] per Basten JA]. It is thus important to identify the nature of the conduct complained of in order to assess the relevance of the rule, and the consequences if any.
44Before the Tribunal Mr Sedrak has been given the opportunity to provide his explanations/reasons for the conduct which was the subject of the complaint. [see Jones v National Coal Board [1957] EWA Civ 3; [1957] 2 QB 55 at 67 approved in Stead v State Government Insurance Commission [1986] HCA 54; 161 CLR 141 at 145]
45There was significant questioning of Mr Sedrak's motivation and of his lack of professional protection of his customers to whom he was dispensing substances/drugs. Mr Sedrak and his legal representative would have been left in no doubt as to a level of disbelief to some of the explanations/reasons which must in turn impact on Mr Sedrak's general reliability. However, in weighing up the state of any acceptance of responsibility and of the explanations/reasons provided by Mr Sedrak in his statements, the Tribunal has taken into account what may be said an absence of specific cross examination on any given explanation/reason.
46Expert opinion was tendered by the Complainant. The Tribunal has been assisted by the expert opinions of Mr O'Donnell expressed in his various reports and his oral evidence.[His evidence was not transcribed but listened to on transcription disc.] The Tribunal found him forthright and balanced in his opinions. However the Tribunal found Mr O'Donnell a little too prepared to change or vary his opinions based on "materials" provided by Mr Sedrak [Ex J Tab 3] and must and has made its own assessment of the proffered explanations for the dispensing of the various drugs and the level of seriousness of the found conduct, while weighing up Mr O'Donnell's opinions.
47The Tribunal is a specialist tribunal, and has had the benefit of assessments made by its 2 pharmacists of the proven conduct, they being of the same profession as that of Mr Sedrak.[see HCCC v Fraser [2014] NSWCATOD 29 at [238]]
48Written submissions were provided by both parties, the last being received on 18th September 2014. These have been read and considered. [These will be identified hereafter as "CS" being the Complainant's primary submissions; "RS" as the Respondent's submissions and "CSR" as the Complainant's submissions in reply.]
49The Tribunal delayed the dates for provision of written submissions of the parties to permit the obtaining of transcript. The Tribunal for various reasons only obtained the evidence of Mr Sedrak which had been given over two days, namely the 26th and 27th of June. [Days 3 and 4] The remainder of his evidence was listened to form the transcription disc of his evidence. The discs were always available to the parties at no cost to them. The Tribunal advised the parties of the availability of the transcript and its intended reliance on it. There was of course never any doubt that the Tribunal would rely on all the oral evidence given at the hearing. It comes of some concern that the parties have elected in their primary submissions not to identify any of the oral evidence by reference to the available transcript nor in specific in terms. This has unfortunately led to some disconnect between the written submissions and the Tribunal's decision.
50As stated, Mr Sedrak was subject to lengthy questioning over 3 days. The Tribunal recognises that English is not his first language and he was entitled to be nervous given the issues placed his professional reputation at risk. However, the Tribunal found his evidence generally unsatisfactory and unreliable in many respects. This has led the Tribunal to find that corroboration is required to accept without reservation the evidence of Mr Sedrak. Such corroboration would have been generally be easy to provide, but was not. The particular matters are dealt with below in detail when The Tribunal considers each individual particular.
51The HCCC in its written submissions,[CS [25]-[33]] (and in its short oral submissions on Day 4-not transcribed) expressed its opinion, as to lack of candour and unreliability of Mr Sedrak as a witness. The Tribunal agrees with the submissions and for the reasons expressed. In particular the Respondent's desire to blame either Dr Wilcox, or his economic imperative and not himself (at least in the first instance) calls for a close assessment of the explanations offered by Mr Sedrak for the dispensing the subject of the complaints. Inconsistencies in evidence in some sense speak for themselves. The Tribunal notes that the Respondent made no contrary submission to these general submissions by the HCCC, however he did make some responses in respect to some specific particulars.[RS [50][71]]
52Mr Sedrak was an experienced pharmacist and his conduct needs to be considered in this light. Further his conduct has to be assessed in the light of the fact that, Mr Sedrak prior to the events the subject of the complaints had been subject to other professional proceedings and orders. He first came to the attention of the NSW Department of Health on 13 December 2006 in respect of supply of a drug which could only be supplied by prescription however was prescribed without a prescription at the time when the Respondent operated the Engadine Day & Night Pharmacy. By the time the Department was apprised of these matters the Respondent no longer held a pecuniary interest in the pharmacy and the matter lapsed. [Ex F Tab 3]
53In June 2011 the Department received information from the NSW Police in respect of the supply of certain drugs and as a result of which the Police and Ms Dolan on behalf of the NSW Department of Health conducted a search of the Respondent's pharmacy at Kogarah on 14 July 2011. Large amounts of metformin and zolpidem were found. A large number of unlabelled vials were also found.
54On 4 September 2011 Mr Battye together with Ms Dolan attended the pharmacy and seized the prescriptions which are the subject of this complaint. During that visit the Respondent was unable to retrieve a client's dispensing history on his dispensing system. [Ex F Tab 9]
55On 27 April 2012 some significant period of time after the initial Police raid an interview took place between Mr Sedrak and Ms Dolan and Mr Walters of the Pharmaceutical Services Section of the Department of Health. This was filmed and recorded and this material was before the Tribunal. The interview was transcribed and is of some 63 pages in length and includes references to some matters not before the Tribunal. [Ex F Tab 6]
56These complaints arise in most part from the contents of that interview. Mr Sedrak stated in his evidence that those answers were true and correct to the best of his knowledge and belief.
57In March 2013 a statutory notice was issued by the Health Care Complaints Commission seeking answers from Mr Sedrak to various questions as to explanations for his dispensing conduct and record keeping. Mr Sedrak chose not to answer these questions in accordance with this Notice and this is the subject of a complaint.
58Rather, Mr Sedrak provided an affidavit dated 15th May 2013 [Ex H Tab 54]. He stated that those answers were true and correct and asked the Tribunal to take it into account. He was asked some questions about this. A statement was filed in these proceedings dated 26th May 2014 . He swore that this latter affidavit was to the best of his knowledge and belief true and correct. As stated he was cross examined at length.
59It appears Mr Sedrak practices in a relatively isolated manner. He stated he knew of the Codes of Practice, and knew the relevant legislation such as the Poisons Act. He subscribed as Guild member to its news magazine. Mr Sedrak had access to MIMS (pharmaceutical information) for which updates are available monthly however Mr Sedrak stated he received a new edition every 2 years.
60The Tribunal will now proceed to consider each complaint.
Complaint One
Particular 1
61This particular is admitted. [Ex K [26] The drug is dexamphetamine which is a schedule 8 drug, a drug of addiction. Thus more than usual care needs to be taken in any dealings with either the script for the drug, or the drug itself. It is an amphetamine, a drug that may be abused in the community.
62The nub of this complaint arose when after having dispensed the drug, the mother of the child for whom the drug was to be used was said by Mr Sedrak to have returned the bottle of the drugs dispensed (less two tablets) and Mr Sedrak then returned the (dispensed) script to her. Thus Mr Sedrak had not retained a script from which he had dispensed the drug. Mr Sedrak admitted he should not have done this but claimed this as caused by pressure from the mother of the child. The mother allegedly was saying the drug was not working after 2 tablets had been taken by her child. Mr Sedrak stated he removed the evidence that this script had been dispensed thus permitting the drug to be dispensed at another pharmacy as an original script.
63The Respondent accepted [RS [8]] the Complainant's submission [CS [39]] as to the Respondent reasons for the return of the script being one to placate the mother's distress.
64However the Tribunal does not accept this from the evidence. There is an incongruent need for a script to be returned because of failure of an early drug effect and the desire of a customer to obtain dispensing of the same drug at a different pharmacy. Mr Sedrak stated that these events have never happened previously. The expected response of Mr Sedrak would be for him to ring Dr Wilcox to speak to the mother as to her concerns. There was no suggestion this occurred.
65The Tribunal finds the evidence of Mr Sedrak in respect to this particular to be unreliable.
66This complaint is comfortably proven.
Particular 2
67Particular two is admitted.
68This relates to same events giving rise to particular 1. When the mother returned the bottle of drugs dispensed with two tablets missing. [Ex F Tab 6 p59]
69The conduct was raised in the interview with Ms Dolan.[Ex F Tab 6 p59-61] When it was pointed out that a pharmacist cannot take a drug back once dispensed, Mr Sedrak replied put yourself in my situation. This response lacks understanding of the professional issue raised in this particular.
70Mr Sedrak stated [Ex K [25]] that he did it because the mother of the child was particularly distressed and he did not wish to add to her distress by refusing to allow her the opportunity to obtain the medication elsewhere. He admits it was a "mistake" and emphasised that he had not done it previously.
71Mr Sedrak initially did not admit this particular, stating that although the product was returned it was not available to be re-dispensed and as such did not need to be recorded in the register [Ex K [31]]. This demonstrates a lack of understanding of his legal duty. Mr Sedrak's practice was simply to place returned drugs of addiction into the safe awaiting destruction. If the safe was broken into, there would have been no record of the drug on the premises, if the drug was stolen.
72 This "defence" was erroneous. The terms of clause 112 of the PTGR do not centre on whether or not the product is available to be re-dispensed rather it requires the registration of all drugs of addiction in the register upon receipt.
73The purpose of this requirement is manifest, namely that the pharmacy has a register of all drugs of addiction on its premises regardless as to whether or not they are likely to be re-dispensed.
74 In this regard Mr O'Donnell in his report of 3 May 2013[Ex G Tab 22] , again in his second report of 25 October 2013 [Ex G Tab 24] and his final report of 12 June 2014 [Ex J Tab 3] addresses the issues of professional responsibility in regard to the recording of drugs of addiction of which dexamphetamine is one.
75 There is no dispute on the document identified as the "Belgrave Pharmacy Goods Inward Register" that there was no reference to the 2 bottles of dexamphetamine having been received or dispensed on 14 July 2011 .[Ex G Tab 41 "out"] In fact there was a significant gap in the register between August 2010 and February 2012. [Ex G Tab 41 p4 "in" or "out"] It should also be noted but which was not the subject to any particular, and thus not considered further, that the Belgrave Pharmacy Goods Inward Register does not satisfy all of the requirements of clause 112 in PTGR 2008 at that time.
76Under cross examination Mr Sedrak seemed to accept he should have put the returned drug into his DD Register.[Day 4 T52] He accepted the need to have the fact that the returned substance was destroyed corroborated by a third party.
77The Tribunal finds this particular comfortably proven. The breach is serious as it meant there was no check and balance as to the existence of the returned drug of addition. Mr Sedrak accepts this as fact. [RS at [12]]
Particular 3
78This particular is neither admitted nor denied. [Ex K [35]]
79The drug involved was DHEA which stands for "dehydroepiandrosterone", which is identified as a precursor of anabolic steroids. It is an endogenous steroid hormone. A prescription was required for it to be dispensed.
80Mr Sedrak accepted that Patient V was a customer of his but he had no recollection of him. [Ex F Tab 3 Appendix H p4-6] This is surprising given the dispensing history of this patient spans intermittently over 3 years. [Ex H Tab 54 p3] Mr Sedrak accepted that the prescription [Ex F Tab 3 Appendix H p4-6] the subject of this particular related to one of his customers (Patient V).
81On this "script" were markings that it was dispensed on 21 July 2009. The "script" was in two parts, the formal part and a business card for the Belgrave pharmacy. On the back of this card was a second set of drugs with the initials "DHEA".
82The formal script authorised a repeat for the dispensing of the drugs. No such repeat script was obtained on the search of the pharmacy.
83Mr Sedrak, in the light of the evidence, conceded that he might not have kept the repeat in this instance allegedly contrary to his usual practice.[Ex K [34]] The Tribunal considers it more likely given all the evidence, that given the nature of the second part of the "script" , record keeping was kept to the bare minimum.
84Mr Sedrak accepted that he did dispense DHEA to Patient V but could not recall the event.
85Mr Sedrak stated he kept all repeat scripts in relation to DHEA [Ex K[34] . However, the regulation was breached if for whatever reason the script is not produced. It was not on the premises at the time of the raid.
86Thus, the Tribunal is comfortably satisfied that this particular is proven.
Particular 4
87Particular 4 is not admitted. As stated above the Tribunal adopts the reasoning in the decision of HCCC v Fraser [2014] NSWCATOD 29 at [417-420] as to the meaning of s36A of the PTGA.
88This particular involves amino acids. Amino acids are biologically organic compounds.
89They are often used by bodybuilders or sportsmen and/or sportswomen to speed muscle repair and promote muscle growth. Using them is not without risks to health particularly when injectable forms are used.
90The basis for the non-admission by the Respondent of this particular, revealed a lack of understanding by Mr Sedrak as to his legal capacity to supply these substances in these quantities and without appropriate documentation. It is not clear why this was so given his state of knowledge. His reasoning seems to be that the sale was one of retail not manufacturer. [Ex K [38]] The Respondent in his submissions accepts there is evidence to support that the supply was a "retail supply".[RS [16] Mr Sedrak submitted that as amino acids are unscheduled he could sell them directly to a customer who uses the substance and does not need to record them. [RS [17]] It is also important to note that these amino acids were supplied by Mr Sedrak to customers for parenteral use.
91As defined above and in the context of the PTGA and its objectives, a sale by retail is where the end user is the customer who receives quantities for his/her personal use. Conversely, a sale is one by manufacturer if (as here) where the end user(s) is not the purchaser. Manufacture to supply in these circumstances requires a licence. Mr Sedrak did not hold a licence. [Day 4 T75.9]
92In his interview with Ms Dolan. [Ex F Tab6 p11-13] Mr Sedrak's attention was drawn to the distinction between manufacture and retail. Mr Sedrak admitted to having produced "batches" of amino acids over and above that for a particular patient opining that it's alright to do small batches but not massive amounts. [Day 4 T76-77]] Mr Sedrak claimed to have some informal approval for this conduct.
93At first, Mr Sedrak explained that the person to whom he supplied the amino acids was a patient of Dr Wilcox and identified him by name. [Day 4 T64] Mr Sedrak referred to the person as "his client" suggesting a one to one relationship. [Ex K [38]] This is in stark contrast to the description of the reference to an "unidentified person" made to Ms Dolan. [Ex K [38]] This inconsistent evidence supports the Tribunal's view on the unreliability of the evidence of Mr Sedrak and a level of manipulation of the truth depending on the circumstance.
94The gravamen of the particular is not whether the person to whom the supply occurred was now able to be identified [CSR [6]], but rather the purpose of the supply, was it for the use of the customer only or for use by others.
95Mr Sedrak didn't enter the sale into his dispensing log [Day 4 T65.8] giving rise to real concerns as to the accountability of the pharmacy and sales of this type of substance.
96The Tribunal is comfortably satisfied that Mr Sedrak was supplying "by retail" and did not have a licence to manufacture failing to comply with clause 36A of the PTGA. (Particular (a))
97Particular (b) does not relate to schedule drugs, but rather therapeutic goods. The issue here is the labelling. Appendix A to the PTGR identifies the extent of labelling necessary for unscheduled therapeutic substances. For example, in ss (g) of Appendix A it states that if the substance is intended for the treatment of a person, the name of the person needs to be on the label.
98Mr Sedrak rightly conceded that amino acids were "therapeutic" substances. [Day 4 T65.20]"Therapeutic substances" has the same meaning as therapeutic goods as the latter is defined in s3 of the Therapeutic Goods Act (C/W) as set out above.
99Mr Sedrak was asked about "labelling" which required amongst other things, the name of the patient. [Day 4T65.50] He told Ms Dolan that the person from Castle Hill simply told him that he wanted the drugs for "his clients", thus the name of the patient could not appear on the label. [Day 4 T65-66] At another point in his evidence he conceded that his computer at the time could not record the name of the patients on parenteral products.[Day 4 T66.30]
100Given the then stated lack of knowledge of Mr Sedrak as to whom the person at Castle Hill was supplying the substances, the Tribunal is comfortably satisfied that the substances were not labelled in accordance with Appendix A. Nor could he otherwise comply with the requirements of Appendix A given the circumstances. Further labelling must occur on each bottle. The lack of labelling and compounding records are demonstrative of conduct which falls significantly below the standard of care and demonstrate a lack of professional duty of care for whom the drug/substance is supplied.
101The Tribunal is comfortably satisfied that this particular (b) has been proven.
102It is evident from the lack of entries into the sales computer as to the dispensing of the amino acid sales that particular (c) has been proven.
Particular 4A
103Mr Sedrak admits this particular. Clause 39(1) of the PTGR requires scripts for any dispensing of restricted substances by a pharmacist.
104In his interview with Ms Dolan, Mr Sedrak suggested the drugs had been prescribed for members of his family Ex F Tab 6 p18] and he was providing them because of problems in obtaining drugs in Egypt at the time. [Ex K [44]]
105There is some doubt as to whether or not the drugs in fact left Australia. However, there is no doubt that Mr Sedrak did not have a prescription to dispense the specified drugs which is critical for compliance with s39 (1) of the PTGR.
106The HCCC invited the Tribunal to reject the assertions of Mr Sedrak that he was unaware of the regulatory requirements in relation to exporting the particularised substances without a prescription. It submitted that the Tribunal would also reject the assertion that Mr Sedrak's brother at an earlier point of time had been prescribed such drugs [CS [46]]. The Respondent submitted there was no cogent evident to the contrary. [RS[21]]
107The Tribunal accepts the submissions of the HCCC on this matter.
108Firstly ignorance of the law is no defence. Secondly, given the unreliability of Mr Sedrak as a witness for reasons described elsewhere in these reasons, the Tribunal is unable to accept without corroboration that Mr Sedrak had at an earlier point of time a script for the drugs. Another reason is that some of the medications intended to be sent may not have been appropriate for a post-operative cardiology patient..
109The Tribunal is comfortably satisfied that this particular is proven.
Particulars 5 and 6
110Particular 5 was admitted after some corrections [As to the method as used see Ex F tab 7 [21-25] see also Tab [8].] The admissions related only to the amounts of drugs referred to in clauses (a)(b) and (c) but not admitted as to the drug identified (d).Particular 6 is in the alternative to particular 5 and is admitted. Particular 5 is not dependent on proof of a theft from the pharmacy.
111The drugs involved are the subject of abuse in particular by sportsmen and/or sportswomen and/or body builders.
112The primary evidence of this particular is to be found in working papers of Mr Walter who assisted Ms Dolan in the investigation.[Ex F Tab 3 Annexure F and ex F Tab 8] Mr Walter was not in the end required for cross examination as to the calculations.
113The essence of the quantities referred in these particulars arise from either a short fall of the various drugs specified, being the difference between the supply documents, the dispensing documents and what was discovered during the raid. It assumes in favour of Mr Sedrak, that at each date of supply he had nil level of each drug in the pharmacy.
114Alternatively it is admitted that the quantities of unaccounted drugs were stolen, except for a certain amount of testosterone. It was suggested this amount of testosterone was prepared as compounded injections for a Dr Thompson who had failed to send a script for the drug and the compounded injections were seized during the raid.
115Thus for example Mr Sedrak purchased 8,400 tablets of zolpidem during the period 1 July 2010 and 14th July 2011 and dispensed according to his records 3,664 tablets during the same period, and had 822 boxes in stock on the day of the raid, which meant he could not (absent the theft) account for 3,854 tablets. [Ex F Tab 6 p7] Whether it be particular 5 or alternatively particular 6, such lack of accountability and responsibility is a matter of serious concern to the Tribunal especially given the nature of the drug concerned and its effect in high or prolonged doses and possible abuse potential.
116The amounts purchased of these tablets for such a period is in the Tribunal's experience inexplicable in terms of the usual experience of a suburban pharmacist.
117Mr Sedrak, perhaps ironically in the light of the other particulars, relies on his legal obligation to record dispensing of restricted drugs as his defence to any lack of accounting of these identified drugs, thus if they are not recorded (and thus accounted for) then they have been stolen in the break in. [Ex K[49][58]]
118Mr O'Donnell provided various assessments as to possible reasons that some of the drugs might have gone "missing" absent lack of professional care.[Ex F Tab 24 p8-9] Given the uncertain factual underpinnings of this particular, the Tribunal proceeds to consider only particular 6 given it is in the alternative.
119The break in is conceded [Ex K [50][58], as is the failure to report to the Director General [Day 4 T60.40] Mr Sedrak claims he obviously forgot¸ I didn't know I had to report it...cross my heart I didn't know.[Ex F Tab 6 p8] Such claimed lack of knowledge is unacceptable. Its reliability as an explanation is unlikely given the failure to report the same loss to the police and a refusal to make a claim on his insurance company for the losses which were in the order of $20,000-$25000 easy. [Day 4 T56.45].
120The drugs in particular 6 and identified in (a) (b) and (c) are admitted as having been stolen, but not the testosterone identified in (d) [Ex K[52]]. This admission should be compared with the list which Mr Sedrak initially identified as to what drugs were stolen. [Ex H Appendix D p32] This conflict is very suggestive that Mr Sedrak probably did not know what drugs he had in his pharmacy at the time of the theft. This only highlights the harm which could have been caused by a lack of reporting to the police or other agencies of theft of the drugs from the pharmacy.
121The obligation under clause 67 of PTGR to report immediately to the Director General relates to prescribed restricted substances.
Mr O'Donnell suggested that the quantity of diazepam was not large and an administrative error may have occurred [Ex G Tab 15 p8]. Clause 61(1) of the PTGR states 'For the purposes of section 16 of the Act, the substances specified in Appendix D are prescribed restricted substances'.The Tribunal considers diazepam was and is a prescribed restricted substance.
122Mr O'Donnell in unchallenged evidence stated that zolpidem, phentermine, and testosterone would all fall into the quantity to be reported [Ex G Tab 15 p8] and the Tribunal will proceed on this basis.
123The break in was said to have occurred on about 24 March 2011. The break in was in some senses fortuitous in providing some explanation for the unaccounted loss. However an employee Ms Savaa has provided an affidavit [Ex H Tab 54] swearing to the fact of a break in and the HCCC did not require her for cross examination. Surprisingly it was she, who told Mr Sedrak, to call the police. He declined to do so.
124The drugs unaccounted for relate to the date of the police raid in July 2011 some 3 months later. It was suggested that the theft accounts for the losses.
125The reason provided by Mr Sedrak as to why he did not fulfil his legal obligation to report the theft is totally unconvincing. He stated that in a previous break in at his Engadine pharmacy which he did reported it to both the Pharmacy Board and to the police, he claimed that experience was so bad, it taught him not to report this subsequent break in [Day 4 T58.25] [Also see Affidavit of Ms Savva. [Ex H Tab 54]] Specifically, Mr Sedrak suggested that because the police in the original theft did not find the thief and involved him with numerous calls with the police, he considered reporting this more recent theft was pointless.
126Mr Sedrak stated that there existed at the time of the raid, some vials of testosterone, not in a safe, which were being held waiting collection by a Dr "Mark" Thompson a veterinary practitioner
127The Tribunal asked the parties to make some inquiry as to the whereabouts of Dr Mark Thompson. No enquiry found his whereabouts. However, the parties identified a Dr "Andrew" Thompson whose name was removed from Register of Veterinary Surgeons on 14th May 2007 together with an order not to make any application for the restoration of his name to the Register prior to 10th May 2011. [Veterinary Surgeons Investigating Committee v Thompson [2007] NSWADT 107]. Included in the complaints proven was the inappropriate supply of steroids to an individual.
128 The Respondent stated that Dr Mark Thompson had ordered drugs from his practice. [Ex K [53]] Thus it is stated, that the short fall of this drug was much less than that particularised.
129The vials referred to relate to the seizing of compounded preparations on 14 July 2011. The visual evidence, photographs, taken at the time of the raid [Ex F Tab 12] show that these vials were accompanied by a label stating "CYP 200mg/mL". This would have indicated that the vials contain testosterone cypionate and not testosterone propionate. The number of vials and sizes correlate to the Respondent's submission. The Tribunal accepts these photographs as reliable and a true and complete record of items seized on that date. There are no additional vials that may have contained testosterone; the source of testosterone cypionate is unknown. Additionally the loss of testosterone propionate is not accounted for. Testosterone cypionate is a known substance used by bodybuilders. No batch nor expiry was noted for these vials on the label that was located in the plastic basket containing these vials. The photographs show other vials with labels only attached to the baskets. The names on these labels indicate they are substances used for possible reasons of increasing androgens, tanning, burning body fat and building body mass.
130Mr Sedrak gave conflicting evidence as to the circumstances of the "order" of Dr Thompson. The Tribunal rejects it as an explanation for a lesser level of testosterone on the date of the raid to that particularised.
131Initially at the hearing, Mr Sedrak suggested the first contact with Dr Thompson was by phone. This was in about February/March 2011. [Day 3 T 46.40] He organised to meet Dr Thompson at Berry. Dr Thompson sent a fax for purposes of that meeting. At the meeting Dr Thompson asked for testosterone for horses. Mr Sedrak asked that Dr Thompson send a script.[Day 3 T52.27] It is of some surprise that a veterinary surgeon would need to be told such a thing. The script never came. Despite this Mr Sedrak went ahead and prepared the testosterone "order". The order was worth in excess of $1,000 [Day 3 T49.20] Mr Sedrak stated that the fax set out the drugs Dr Thompson wanted, but Mr Sedrak claimed that this was not a script. The vials remained on the premises until the raid in July 2011. [Day 3 T48.38;51.20] which was past its used by date.[Day 3 T50.35]
132Earlier, to Ms Dolan, Mr Sedrak gave a different version of these events.[Ex F Tab 6 p51-52] He stated that Dr Thompson approached him in roughly early February 2011, about 5 months before he came to the pharmacy and gave half gram of clenbuterol asking him to compound it. He told Ms Dolan that a few weeks later Dr Thompson rang and gave the go ahead and that he would fax the script. [Ex F Tab 6 p51-52] It never arrived. When Ms Dolan interviewed Mr Sedrak still had Dr Thompson's card on him which he gave her as some corroboration of this evidence despite it being over 12 months since the meeting.[Ex F Tab 6 p52]
133When these inconsistencies were put to Mr Sedrak, he denied that Dr Thompson had ever been to his pharmacy but agreed Dr Thompson had given Mr Sedrak half a gram of clenbuterol [Day 3 T53-54] which is a sympathomimetic amine.
134Mr Sedrak blamed the inconsistencies on the fact that his first recount to the Tribunal came at the end of the day and he didn't think the atmosphere was allowing me to say more details.[Day 3 T54.47] The Tribunal does not accept this explanation.
135Mr Sedrak stated that Dr Thompson's 'order' was for 8 bottles of 50mL and that this order came by fax. This is inconsistent with the first version to the Tribunal when Mr Sedrak stated the fax was simply a request to meet prior to the Berry meeting.
136Whilst not central to the resolution of this particular, the Tribunal found the evidence as it relates to the "order" by Dr Thompson as evidencing evasiveness and lacking in credibility.
137In respect to this particular 6, the Tribunal needs to be comfortably satisfied as to whether firstly that testosterone was on the premises at the time of the raid and secondly the quantity stolen.
138The Tribunal is comfortably satisfied that there was testosterone on the premises at the time of the theft.
139As already stated, as to the quantity of testosterone, Mr Sedrak's evidence was also conflicting.
140In his oral testimony Mr Sedrak stated that the "order" from Dr Thompson was for 8 bottles of 50 mL of testosterone. In his affidavit referred to 8 vials 45 mL containing 200 mg/mL of testosterone and 3 vials of 10 mL containing 100 mg/mL of testosterone. Elsewhere in his evidence Mr Sedrak refers to 10-12 50 mL[Day 3 T46] while the other lot was 100 mg/mL and the total volume is 50 mL and there were 3 of them.[ Day 3 T46.30] In re-examination some distance was sought to be created as to the reliability of the affidavit [Ex K [53] with Mr Sedrak insisting he now realised that it was 100 and 200 mg/mL of testosterone and not 50 and 100 mg/mL.[Day 4 T71-72]
141The log prepared by Mr Walter as to what amount of testosterone was found at the time of the raid [Ex F Tab 3 Appendix B p3] was 96g of testosterone. On the evidence the Tribunal finds this as the most reliable source on this fact. The exact amount of testosterone is not critical to particular 6, rather it is its existence and the failure to report its theft is the kernel of the particularised conduct.
142The failure to report a theft from a pharmacy of prescription and non-prescription drugs is a matter of significance, more so where the drugs involved, as here, are known to be abused by members of the community and are sold on the black market. Failing to report to the police in particular seems to be an acceptance of the unlawfulness at another level.
143 Mr O'Donnell considered a practitioner in these circumstances, given the quantities of some of the drugs, should have reported the theft to the police. [Ex F Tab 24 p9]. The escape into the community of drugs of this type could create health risks to the community. Reporting to the police provides some protection to the community, as its investigation could lead to recovery of the stolen goods, and/or lead to arrests preventing further thefts.
144The Tribunal rejects the submission by Mr Sedrak [RS [25]] that he gave a truthful account of the events leading to the existence of the quantity of testosterone at the time of the raid.
145The Tribunal is comfortably satisfied that Particular 6 is proven and makes no finding as to particular 5.
Particular 7
146This particular is neither admitted nor denied. Mr Sedrak stated in the absence of the scripts he cannot admit this particular.[Ex K [71]]
147The particular involved the dispensing of drugs known as aromatase inhibitors (of which there are 3 three varieties; (exemestane, letrozole and anastrozole)). A legal prescription requires one of those drugs to be identified, as well as the strength and the dosage on the prescription to be dispensed. It is conceded that the "dosage" was identified [CS 49][RS [29] The Tribunal does not accept this concession given that there was no identification of the "drug" to be dispensed in the first place and thus the dose identified is not in relation to any "drug" which is to be dispensed.
148These drugs are subject to abuse by persons seeking to build or repair their bodies. Mr Sedrak conceded this state of affairs, and stated this would not be a correct use of the drugs. [Ex K [70]. Mr O'Donnell was unaware of other uses of these drugs, and only became aware of alternative use on suggestion of Mr Sedrak and his research.[Ex K [70] Mr O'Donnell accepted possible alternative use may be appropriate.[Ex J Annexure C p4] Importantly Mr O'Donnell had not experienced this alternative use.
149Mr O'Donnell indicated that this drug is indicated for use in early breast cancer and advanced breast cancer. [Ex G Tab 24 p113] He observed that as both patients F and G are male this does not suggest normal use of this drug. However the particular relates to the script rather than its use.
150Mr O'Donnell opined that he would like to see the patient, the patient's history and an understanding of the prescribing doctor before dispensing this drug for any alternative use. He stated he would take a precautionary attitude given the potential for misuse and in particular contact the prescribing doctor. There is no suggestion that Mr Sedrak took any precautions of this type.
151The failure to identify the particular form of 'aromatase inhibitor' is the equivalent to prescribing "a penicillin" without identifying the type. Further on any script, there needs to be identified the amounts to be dispensed. Both scripts failed to have such relevant identifications.
152Mr Sedrak admitted he could not lawfully dispense the subject "scripts" given their failure to identify the specific aromatase inhibitors to be dispensed.
153The "script" of Dr Wilcox for patient F is now Ex N. The "drug" identified on the script was "aromatase inhibitors". The form of this document was of a note form rather than a script, leaving it to the discretion of the pharmacist to formulate both as which type of aromatase inhibitor to dispense (name) and the strength of aromatase inhibitors to be dispensed. Such further information was necessary for compliance with clause 35 of the PTGR.
154The "script" of Dr Wilcox in relation to patient G can also be described as a note. It was in these terms; "Karl needs some aromatase inhibitors...I haven't specified as you are leaving soon" Mr Sedrak went on holidays the next day.[Ex F Appendix D p3] Mr Sedrak made various inconsistent responses to this script. He initially stated he wouldn't dispense this, he then stated he didn't dispense, then stated he can't remember . This was further evidence of Mr Sedrak's unreliability as a witness.
155Mr Sedrak in his submissions [RS [50]] sought to diminish these conflicting pieces of evidence based on the fact that the evidence lasted for only about 2 minutes. If this was the only conflicting evidence the Tribunal would agree that its significance would be diminished on issues of general reliability and credibility. However, as explained elsewhere in these reasons, this inconsistent evidence was just another example of general unreliability and lack of credibility.
156The professional question that may be asked rhetorically (and was asked) of Mr Sedrak, why would Dr Wilcox send such a noncompliant "scripts" to him, if it was the practice of Mr Sedrak to require lawful scripts before dispensing any restricted substance. Mr Sedrak suggested that it was left to him to consider the appropriate kind of aromatase inhibitors that ought to be dispensed. This was an unacceptable response to an equally unacceptable "script".
157At another point Mr Sedrak sought to rely on his dispensing records [Ex G Tab 40] as to whether he did or did not dispense the aromatase inhibitors. He agreed the drug he dispensed does not appear on these records. The Tribunal then asked for any other records of dispensing. These were produced by Mr Sedrak, the next day. [Ex O] The books seemingly were used for dispensing zoplidem and other drugs which were proprietary lines. Surprisingly the books were not produced to the HCCC when initially requested. Mr Sedrak suggested it slipped his mind to produce these books. Yet he referred to them in his earliest affidavit.[Ex H Tab 54 at [35-36]] Thus only compounding lines were on the computer printout.[Ex G tab 40]
158Thus Mr Sedrak relied on the computer printout as the basis of his denial of dispensing the drugs the subject of this particulars.
159The Tribunal is comfortably satisfied that the "script" for patient G did not comply with clause 35 of the PTGR yet Mr Sedrak dispensed the drugs.
160Mr Sedrak also sought to justify his conduct of dispensing the script by reference to a phone call by him to Dr Wilcox [Day 3 T44.37] although there was no record of such events having occurred [Day 4 T63.47]. Yet at another point of his evidence Mr Sedrak stated at no stage did he ever ring Dr Wilcox to validate a script for dispensing purposes. [Day 4 T63.27]
161The Tribunal is comfortably satisfied that each of the "scripts" for aromatase inhibitors were dispensed by Mr Sedrak and rejects the evidence of Mr Sedrak of discussions he stated he had with Dr Wilcox as to the meaning of the terms of these scripts. The reasons for this rejection is based on the rejection of Mr Sedrak as a reliable witness and for each or all of the following reasons:
(a)The terms of the "script".
(b)The failure to initially produce his dispensing books.(Ex O)
(c)His other dispensing activities such as dispensing DHEA based on cards delivered and his failure to record them as having been dispensed at the time of dispensing, despite it being able to be recorded on the computer.
(d)His general noncompliance with PTGR.
(e)The type of drugs involved.
(f)The absence of any written record of any conversation with Dr Wilcox or witnesses to such calls.
(g)The recurrence of this type of script for this drug.
(h)The implicit expectation of Dr Wilcox that Mr Sedrak would know the type of aromatase inhibitor to be dispensed.
The Tribunal is comfortably satisfied that particular 7(a) and 7(b) are proven.
Particular 8
162This particular is admitted.[Ex K [75][76][Day 4 T18.16]]
163The drug in question is zolpidem which is dispensed under brand names such as Stilnox and Zolpibell.[MIMS prescribing information [Ex H Tab 77] The drug is a sedative hypnotic drug (causing such incidents as falling over in the middle of the night) and is recognised to cause tolerance and can cause dependence. Mr O'Donnell refers to the fact that the box containing this drug warns amongst other things to limit use to four weeks maximum under close supervision.[Ex G Tab 24 p11] Mr O'Donnell acknowledged some change in the level of concern in respect to the dispensing of zolpidem over recent times although box warning first appeared from about 2008. He did not consider he would dispense 100 zolpidem because of the risks associated with the drug. He has not seen this drug dispensed for more than 28 tablets.
164 The evidence upon which this particular relates was provided by Mr Sedrak.[Ex F Tab 3 Appendix D p10-15] The terms of his answers to the Notice issued was ...the following scripts was dispensed at the pharmacy "on". He then identified the dates relied upon in this particular together with the number of drugs dispensed, the identity of the patient and his/her address and the prescribing doctor.[ibid] Dr Wilcox was the only prescribing doctor for this drug and only 3 out of 39 scripts were for less than 100 tablets of zolpidem.
165The particular more specifically relates to repetitive dispensing of excessive quantities of this drug and thus gives rise to general consideration of clause 54 of the PTGR although this is not specifically pleaded.
166Mr Sedrak agreed that pharmacists should dispense in accordance with the manufacturer's recommendations.[Day 4 T9.46-10.2]
167 Mr O'Donnell opined that dispensing of large doses of this drug was a "concern". He stated that the warning on the box of this drug first appeared in about February 2008. Mr O'Donnel stated he would have taken up this issue with the prescriber if the script is at odds with the manufacturer's recommendations. However he described this as a 'grey area'. He considered Mr Sedrak was put into an "awkward" position by the prescriber. He conceded that the awkwardness is at least initially met by contact with the prescriber. Further the dispensing is always controlled by regulation 54 of PTGR and as always acceptable professional practice based in part on skill and knowledge.
168Mr O'Donnell stated that the prescriber should not prescribe outside the limits recommended and if the pharmacist knows this, he should contact the prescriber and seek an explanation as to why the ,prescriptions of this drug at levels has gone on for nine months or longer. He further opined that there was even less justification where the prescription was from a general practitioner and not a specialist doctor.[Ex G Tab 24 p11]
169Mr Sedrak at first considered that there was some justification to dispensing dosages which were more than that stated by the manufacturer's recommendations [Day 4 T10.4]. In doing this he stated that the manufacturer's recommendation was one or two tablets a night.[Day 4 T9.34,T3.49,T4.36,T6.33] In fact, the manufacturer's recommended dose of this drug was half tablet (for elderly) of 5 mg per night [Day 4 T16.5]. The tablets were available as 10 mg strength. Mr Sedrak agreed with [Day 4 T16.10] but then sought to rely on MIMS to increase daily permissible dose to 10mg, then he withdrew this wrong response.[Day4 T16.35]
170Mr Sedrak explained he purchased large quantities of zolpidem because Dr Wilcox would prescribe to elderly people like 60 years-80 years old in amounts of 100. [Ex F Tab 6 p5]. Mr Sedrak stated most of these patients were elderly and pensioners [Ex K [75] Of course not all "pensioners" are elderly. However it is clear not all these patients are elderly.[Day 4 T7.35] Assuming the patients were elderly, they may have renal or hepatic deterioration which may affect their capacity to metabolise and excrete higher doses. This may be a risk to the patient's safety.
171The Tribunal was taken in some detail to Patients OO and QQ as exemplars. However this does not mean they are typical of the other patients identified in this particular.
172Patient OO was described by Mr Sedrak as a person about 50-55. [Day 4 T2.10] Mr Sedrak suggested that he dispensed excess the therapeutic amount to Patient OO ,as she was going overseas and needed the drugs in advance.[Day 4 T2.12] The information provided by Mr Sedrak to the HCCC from his dispensing computer identifies, as the date on which dispensing took place by use of the work "on" followed by the date. If this is the correct interpretation, then Patient OO was dispensed the drugs "on" those dates and could not have been overseas. Further there was no reference to this alleged reason in Mr Sedrak's statement [Ex K [73-74]] as the Tribunal would have expected. He stated that this didn't come to mind. Further despite having stated that he dispensed the two May scripts on the same day, he stated that computer did not allow dispensing on the same day.[Day 4 T3.2]
173The Complainant submitted that the evidence of Mr Sedrak on this particular was "very unsatisfactory" and showed "disregard for the safety" of the patients [CS[51]] and "inconsistent" with earlier accounts.[CS[52]] Mr Sedrak responded to the first submission based on a lack of particularisation of this claimed a lack of procedural fairness.[RS[32] The evidence upon which the Complaintant's submission is based was not objected to, and in any event the evidence is but the logical consequence of the proven particular. The Tribunal accepts both submissions of the Complainant.
174The Tribunal is unable to accept the justifications of Mr Sedrak for dispensing the drug at the intervals he did, in respect to this patient and the other patients. The reasons for this rejection include:
(a)The Tribunal's general findings as to the credibility of Mr Sedrak and his reliability as a witness.
(b)The lack of corroboration of his explanations.
(c)The fact that many other patients in this particular were dispensed excessive quantities of this drug, it was not suggested they were all going overseas.
175Mr O'Donnell considered that in respect to both scripts which were dispensed in May to Patient OO, he would have contacted the prescriber. Mr Sedrak seemed to deny such communication.[Ex K [73]] Yet in oral testimony he suggested otherwise.[Day 4 T18-19] This conflict is further evidence of unreliability.
176Whilst frequent contact between a pharmacist and prescribing doctor would be unusual, if it occurred it would normally be recorded. No such evidence was produced. Further contact of this type would be more regular especially when the prescribing doctor prescribes drugs outside accepted guidelines.
177The Tribunal is unable to accept the evidence of Mr Sedrak as to any contact with Dr Wilcox concerning the dispensing of this drug absent corroboration such as the calling of Dr Wilcox or patients for the following reasons;
(a)The general lack of credibility of Mr Sedrak.
(b)Lack of corroboration of any phone call to Dr Wilcox such as calling Dr Wilcox or a member of the staff of the pharmacy who would or may have heard such calls.
(c)Lack of documentation in the pharmacy of such any phone calls.
(d)The inconsistent evidence referred to concerning this particular.
(e)The repetitiveness of this type of prescribing by Dr Wilcox to patients of this drug suggesting possible lack of such call(s).
(f)Lack of any change in manner of dispensing of this drug over a significant period.
178The Tribunal is comfortably satisfied that the patients did not remain under close supervision for prescribing of this drug and Mr Sedrak knew or ought to have known this was the fact.
179As to patient QQ, Mr Sedrak stated that Patient QQ is close to 80 [Ex F Tab 6 p7] but in fact Mr Sedrak had never seen her. [Day 4 T7.5]. This patient was dispensed 100 tablets in 42 days.
180To Ms Dolan, Mr Sedrak claimed to have had a discussion with Patient QQ along the lines, how are you how are you going.[Ex F Tab 6 p7] Given that Mr Sedrak never met this patient, leads the Tribunal to have serious doubts as to this alleged conversation, as well as Mr Sedrak's credibility and his capacity for a caring approach to his customers to excuse was the principal reason to explain his dispensing conduct.
181Mr Sedrak stated that in respect to Patient QQ he contacted Dr Wilcox as to these prescriptions, absent some corroboration of the call, given what appears to be inconsistencies in evidence and belated responses to his conduct, despite previous opportunities to explain it. Mr O'Donnell considered red flags should have gone up in the Respondent's mind before dispensing drugs within these short intervals.
182Given the dispensing history and circumstances revealed in this particular, and the conflicting evidence given by Mr Sedrak, the Tribunal rejects the justifications proffered by Mr Sedrak, (and supported to some extent by Mr O'Donnell) that he was in a very awkward position by the general practitioner .[ Ex K [74][75]]
183The reasons for this finding include:
(a)The close personal and professional relationship that existed between Mr Sedrak and Dr Wilcox.
(b)That Mr Sedrak was capable and did contact Dr Wilcox concerning one patient as to his prescription of this drug.[Day 4 T20.10]
(c)That Mr Sedrak did not contact Dr Wilcox after this first contact because the patients were allegedly "stable" and had a "therapeutic need" for the drug. However this evidence cannot be accepted generally given that some of these elderly patients were often prescribed 2 tablets a night [Day 4 T20.10], 4 times the manufacturer's recommended dose.
184Of significant concern to the Tribunal is when the serious issue of dependency was raised (the recommendation is for taking this drug for a maximum of 4 weeks. [Day 3 T36.26; Day 4 T10.15] and Mr Sedrak conceded that this was for safety reasons. [Day 4 T10.17], Mr Sedrak sought to justify the dosages being prescribed and dispensed over the manufacturer's recommendations on the basis of physiological dependency [Day 4 T16.45] and further the simple basis of the drug was on the market.[Day 4 T17.6] . This makes no sense, given it is on the market for a purpose, namely that identified by the manufacturer. It would be hardly against the manufacturer's interests not to expand in their recommendations, if approved, other uses for their drugs. But it was not.
185Unfortunately patient details were unavailable to the Tribunal.
186The Tribunal thus rejects the excuse(s)/reason(s) proffered by Mr Sedrak, that he dispensed large amounts of this drug, to assist the patients. The Tribunal finds no evidence to satisfactorily support his claim.
187Nor does the Tribunal accept that the patients remained under close supervision as recommended. It finds that Mr Sedrak knew this to be the case because of his intimate knowledge of Dr Wilcox's practice. He knew that Dr Wilcox's practice was very busy and knew that he could not see patients regularly (noting that this was a saving on Medicare). [Day 3 T30.15] Such close supervision given the number of patients wishing to see him.[Day 3 T31.3] Mr Sedrak stated that Dr Wilcox was seeing the patients only four times a year and believed that this was good regular supervision and sought to justify this on the basis that Mr Sedrak had not received any complaints.[Day 3 T32.5].
188The Tribunal finds that Mr Sedrak knowingly accepted an inferior form of appropriate management for the patients the subject of the particular because of Dr Wilcox's professional/economic needs.
189The Tribunal rejects the suggestion specialist care would have been the same as that supposedly offered by Dr Wilcox. [Day 3 T37.27] It seems clear that Mr Sedrak knew of the required standard of care and ignored its continuous breach.
190The Tribunal is comfortably satisfied this particular is proven.
Particular 9
191This particular is not admitted although dispensing is admitted.
192It concerns the drug somatropin which is a human growth hormone. [MIMS prescribing information; Ex H Tab 76]. Mr O'Donnell stated that in his experience it is only used in children (usually before puberty) who have problems with growth such as dwarfism. [Day 4 T27.29] It is not generally approved for use outside this condition. The Complainant submitted [CS [53] that the Tribunal would accept this evidence. It does.
193Mr Sedrak correctly pointed out that Mr O'Donnell is not a compounding pharmacist. [RS[4]] However, on this issue, this does not seem to be relevant as the indications for a drug do not change according to whether you are a regular or compounding pharmacist.
194MIMS stated that therapy should be initiated and monitored by doctors who are appropriately qualified and experienced in the diagnosis and management in patients with growth hormone deficiency. [Ex G Tab 24 p14] It is a drug abused by body builders, sportsmen and sportswomen. Opinion was expressed that this drug was very rarely dispensed and it would normally be ordered only for a single patient. [Ex H Tab 25 p9]
195This particular triggers by way of background consideration of clause 54 of PTGR and therapeutic use of this drug and the qualification of persons in diagnosis of a condition which would have justified the prescription leading to management of patients to whom it had been dispensed. Professional practice would also justify such considerations regardless of the regulation.
196 Mr Sedrak stated that he himself had been prescribed this drug by Dr Wilcox and had taken it as he had had previously two heart attacks and wanted to strengthen his heart muscles [Day 3 T40.48]. Mr Sedrak's wife had also used the drug to overcome tiredness. [Day 3 T41.15] The prescriber was again Dr Wilcox. The Tribunal again notes that the patient records would have provided assistance in respect to both these statements.
197Dr Wilcox prescribed the drug at least to Mr Sedrak, on Mr Sedrak's own recommendation after Mr Sedrak reading and obtaining books on the subject. [Day 3 T41,35] On this evidence, it might be said that Mr Sedrak had the relevant knowledge rather than Dr Wilcox to justify the prescribing of this drug, although the latter's prescribing of this drug preceded this obtaining and reading by Mr Sedrak.
198In Mr Sedrak's first response to this allegation he annexed a contents page and an article [Ex H Tab 54 Annexure B p3 at [13]] neither of which he referred to in his evidence before the Tribunal. It is suggested by Mr Sedrak that this material justifies the dispensing in the circumstances identified in this particular.
199Mr Sedrak in this particular placed at issue whether or not Dr Wilcox was appropriately qualified in the diagnosis and management of this drug in persons with growth hormone deficiency [Day 3 T37.43] namely in elderly patients whom he says are the patients referred to in this particular.
200Unfortunately patient details were unavailable to assist with information about age and medical need. There was no issue the patients are over 18 years of age, however we are to infer without records the basis of the prescription by Dr Wilcox what if any management of the patient took place after the dispensing of this drug. This evidentiary absence is most regrettable.
201Thus the evidence relating to this aspect has to be a matter of inference and from admissions made by Mr Sedrak.
202Mr Sedrak admitted that endocrinologists are the medical specialists which would supervise a general practitioner who was treating a patient with growth hormone deficiency.[Day 3 T37.50] He admitted that it was endocrinologists who should prescribe such drugs.[Day 4 T31.30]
203The terms of this particular are based upon the dispensing of somatropin in the absence of a suitable qualified doctor in relation to growth hormone deficiency. The response by Mr Sedrak was in terms that both he and Dr Wilcox became qualified in a new use of the drug and took appropriate precautions in its use.
204Mr Sedrak opined that he considered this drug was suitable for non- young persons, indeed suitable for elderly persons to counter the effects of ageing. As the Tribunal understands the evidence, Mr Sedrak considered that this different cohort can be (and was) appropriately diagnosed and managed by Dr Wilcox [Ex K [104]-[106]] while acknowledging that he knew Dr Wilcox was a bit eccentric.[Day 4 T35.45] In another context he referred to Dr Wilcox as a bit eccentric in diagnosis [Day 4 T35.28]. In this context Mr Sedrak was explaining why he insisted on seeing the patient's blood tests to justify the dispensing of the drug.[Day 4 T35.47] This in itself was some acceptance by Mr Sedrak of the hazardous nature of dispensing this and other drugs on a "script" from Dr Wilcox.
205The Tribunal in respect to this particular and more generally has great difficulty in understanding what Mr Sedrak was intending to convey by the use of the word "eccentric". On one view, it may mean "not mainstream."[Day 4 T35.30] The Tribunal takes a less benign approach to its meaning, in the context of prescribing this drug, and infers its meaning to be a gross departure from accepted medical practice in the prescribing of this drug. Further the Tribunal finds that Mr Sedrak knew this to be the case.
206Mr Sedrak sought to justify his dispensing the drug contrary to the manufacturer's recommendations. He claimed that apart from children the other recognised cohort for dispensing of the drug by the manufacture in adults are if they are suffering from renal failure.[Day 4 27.35] In fact the manufacturer's indications are short stature due to decreased or failed pituitary GH secretion' Turner syndrome, Prader-Willi syndrome, growth disturbance in children with chronic renal impairment, severe GH deficiency in adults. This drug will not assist renal impairment in adults.
207 A lack of knowledge was exhibited in this statement by Mr Sedrak as the only indication in adults according to the manufacturer for somatropin is severe growth hormone deficiency. Mr Sedrak accepted that his dispensing of this drug was for a new usage which can loosely be described as anti-ageing.[Day 4 T27.48] Elsewhere he described the dispensing as new trend.[Day 4 T 36.24] Another description used but not accepted by Mr Sedrak was left field medicine.[Day 4 T 28.3] However to Ms Dolan, Mr Sedrak admitted that he understood that the purpose of somatropin is for young patients when their growth is not up to standard for that group of persons.[[Ex F Tab 6 p24] It was not approved for any other use. [Ex F Tab 6 p26]
208The Tribunal finds that these descriptors were attempts to justify what could only be described as idiosyncratic medicine and unjustified dispensing.
209Mr Sedrak claimed that he was justified in his dispensing behaviour as it was based on information he obtained by attending conferences.[Day 4 T28.20] and by attending lectures[Day 4 T 70.6] and from obtaining books [Day 4 T 28.32; Exs S and T] or the exchanging of books with Dr Wilcox and from Mr Sedrak's own personal interest to live longer.[ Day 4 T29.7] Mr Sedrak described this contact with Dr Wilcox as we are educating each other ...but not going outside the relationship to seek further opinions. [Day 4 T34.29]
210The Tribunal is satisfied that this form of exchange of information and/or education of Dr Wilcox, absent corroboration such as evidence from Dr Wilcox, or an independent assessor or the provision of patient records, did not make Dr Wilcox appropriately qualified to diagnose and manage this unusual cohort of patients.
211Mr Sedrak submitted that the documents produced by him to justify the use of this drug because they were written by "reputable international authors". The Tribunal has of course to acknowledge the existence of such material, however due to absent peer review and critical appraisal of such material in high impact journals, and the lack of acknowledgement by global endocrine societies of the use of this drug in this manner of the justification of the drug being dispensed in accordance with this material, the Tribunal does not accept the material produced as justifying the dispensing of this drug to this cohort. In coming to this conclusion, the Tribunal considers that if the drug was able to be used for this cohort a medical opinion to this effect would have been produced whilst acknowledging the onus of proof remains at all times on the Complainant.
212Mr Sedrak submitted that the failure by the HCCC to call Dr Wilcox should tell against the finding of the lack of justification in the dispensing of this drug to this cohort and/or the qualifications of Dr Wilcox. [RS [36]] Such a submission is also relevant to other particulars.
213There is some forensic force in this submission in reliance on the so-called rule in Jones v Dunkel [[1959]101 CLR 298; as explained in Kuhl v Zurich Financial Services Australia [2011] HCA 11; 243 CLR 361 at [64]]. The Tribunal has been concerned generally as to the absence of Dr Wilcox (and his patient notes). However, there was evidence of the nature of Dr Wilcox's disciplinary hearings and its findings and outcome which does to some extent explain his absence. Further in one sense Dr Wilcox is not in "one camp" as this phrase is used in such forensic circumstances. [Parker v Payne [1976] 1 NSWLR 191 at p200-202] Alternatively, given the nature of the proceedings the rule has less application although the onus of proof at all times is on the Complainant to prove each particular.
214Despite Mr Sedrak's acknowledgement as to the usual use of this drug by endocrinologists, he never sought their opinions as to the use of this drug in the manner proposed.[Day 4 T31.28] His response it is allowable [Day 4 T31.36] is of great concern to the Tribunal. The Tribunal finds this answer demonstrative of a cavalier and irresponsible attitude to dispensing of drugs and in particularly this drug.
215Mr Sedrak sought to claim some professional responsibility in his role of dispensing the drug, in that he claimed he knew of and relied on the fact that Dr Wilcox before prescribing this drug always carried out detailed blood tests. [Ex K [104]] This need arose seemingly early in the dispensing of this drug and Mr Sedrak's suggestion to Dr Wilcox that he should be on the safe side, that before prescribing, Dr Wilcox should order blood tests. Mr Sedrak stated the reason for this was the patient concern being the ultimate thing ...to be right with the patient [Day 3 T39.14-T39.34]
216 At one point Mr Sedrak stated that he presumed that Dr Wilcox had organised the blood test. [Day 3 T38.11] . At another point, he stated that he insisted on the patients produce the results of blood tests.[Day 3 T37.29] He stated he would also engage in professional conversations with Dr Wilcox concerning his prescriptions.[Day 3 T39.40]
217The Tribunal does not accept as reliable the evidence offered by Mr Sedrak of his cautionary role in dispensing this drug to the elderly. While acknowledging that it is essentially the role of the doctor to diagnose and manage patients there remains a role for the pharmacist to be satisfied that prescriptions for a drug are appropriate and safe prior to dispensing the drug. The Tribunal cannot accept the evidence of Mr Sedrak including the alleged safety checks having taken place at the pharmacy before dispensing this drug. The reasons for these conclusions include the following matters;
(a)The failure to mention by Mr Sedrak some of these important facts in his affidavit prepared for this hearing.
(b)Given the faith Mr Sedrak had in the system of assessment by Dr Wilcox, why would there would have been any requirement by Mr Sedrak for checking up on the blood tests.
(c)Mr Sedrak's general lack of care in his dispensing as found in other particulars provide little confidence to the Tribunal that he would have treated the dispensing of this drug any differently to, for example, his lack of being able to access patient histories which was so important to appropriate dispensing of medications for patients.
(d)Mr Sedrak stated that to dispense this drug, he considered it necessary to check bone density which he stated came in the blood test [Day 3 T38.20] . However he subsequently conceded that to establish bone density, it was acquired from a separate test from normal blood test.[Day 4 T39.49] He then told the Tribunal that the patients in the majority of cases brought bone density results despite it being necessary before prescribing this drug in adults.[Day 4 T40.9] His claimed lack of memory is unconvincing.
(e)Although the onus is at all times on the Complainant, given the credibility issues, the lack of patient medical records/patient's being called, add to the uncertainty of the Tribunal in accepting this evidence of care by Mr Sedrak.
(f)Mr Sedrak in the end claimed a team approach [Day 4 T39.27] to the dispensing of this drug. The failure to call Dr Wilcox adds further the stated uncertainty of the Tribunal as to the existence of appropriate level of care for these patients.
(g)Mr Sedrak expressed the opinion [Ex K[106] that he 'did not observe any indications that caused him to suspect that Dr Wilcox was not appropriately knowledgeable or qualified to undertake a proper assessment of the patients'. This opinion can be given little to no weight given the self-interest involved, and the lack of material as to what observations Mr Sedrak made and for what indications he was looking for.[Makita (Aust) Pty Ltd v Sprowles [2011] 52 NSWLR 705]
218For these reasons the Tribunal cannot accept as reliable, the evidence of Mr Sedrak that he had in place checks on Dr Wilcox's prescribing of this drug to ensure that drug was appropriate to these patients and that Dr Wilcox was appropriately qualified to manage these patients. The Tribunal is comfortably satisfied that Mr Sedrak knew Dr Wilcox did not have such checks in place before prescribing these drugs.
219Mr O'Donnell [Ex G tab 24 p14] stated that due to the dangers with the use of somatropin, he does not believe that a practitioner with similar experience to Mr Sedrak would dispense this drug to the elderly. The Tribunal accepts this opinion especially as it was not challenged.
220The Tribunal is comfortably satisfied that this particular has been proven.
Particular 10
221This particular is not admitted nor denied.
222The drug involved is testosterone. Testosterone is an androgenic anabolic steroid. Androgenic anabolic steroids have abuse potential.
223The reason expressed for the non-admission of this particular was because of a lack of recollection by Mr Sedrak of the actual dispensing of a script for testosterone from Dr Wilcox. [Ex K [111-113]] This is to be contrasted with the recollections by Mr Sedrak of his conversation with Dr Wilcox about sending business cards seeking dispensing of testosterone. [Day 3 T2-T3]
224Mr Sedrak admitted that he had knowledge that Dr Wilcox did not have authority to prescribe testosterone.[Ex K [110] Mr Sedrak stated when he first found that Dr Wilcox was sending him an "authority" to dispense testosterone on a slip of paper he then asked Dr Wilcox why and Mr Sedrak was told by Dr Wilcox that he was not allowed by the authorities for the time to prescribe testosterone.[Day 3 T2.48]
225Elsewhere Mr Sedrak stated that he recalled this practice started when he had a patient with a script for HRT ingredients to be compounded, written on the prescription and a DHEA written separately on the back of a business card. [Ex H Tab 54 [6]] To this topic we will return.
226Mr Sedrak sought to justify his denial of this particular on the basis that he cannot recall ever dispensing a script written by Dr Wilcox for testosterone. [Ex K [110]] Of course the paper work here is not of compliant "script".
227As for particular (a) tendered in evidence is the script for Patient HH dated 14th December 2010 with an annexed card with a reference to "test" which is taken to be short hand for "testosterone".[Ex F Tab 3 p24-26]
228 As for particular (b) patient II's relevant script dated 20th May 2010 was tendered. It contains the words "T4/T3" (thyroid hormones) however it also had not in the appropriate area, the words "testosterone" followed by initials "1MG/Gm". The log of scripts for the same day as the script identifies as dispensed to that patient, T3 and T4 capsules.[Ex G Tab 40 p12]
229There was no direct evidence that either "script" the subject of this particular was dispensed by Mr Sedrak. The HCCC relied on a number of facts to infer this having occurred including:
(a)The documents themselves.
(b)The retention of the documents by Mr Sedrak, as any pharmacist would do this only after dispensing.
(c)The fact that there was evidence that Mr Sedrak dispensed drugs with similar documentation.
(d)Unreliable records of Mr Sedrak in relation to drugs which were dispensed using the 'card' system.
(e)Admissions by Mr Sedrak that he would dispense drugs using the 'card' system.
230The Tribunal is comfortably satisfied that particulars (a) and (b) have been proven.
Particular 11
231This particular is not admitted. This particular also relates to the drug testosterone.
232 The reason given by Mr Sedrak for not admitting this particular was confusing. Mr Sedrak admitted to dispensing DHEA on a "script" from Dr Wilcox which had been written on a slip of paper but in relation to this particular he states except for non-scheduled drugs, he would not dispense any item unless on a script.[Ex K [116]] Elsewhere in his evidence Mr Sedrak admitted if I had a card I did dispense it.[Day 4 T61.40] The Complainant submits [CS[57]] the oral evidence of Mr Sedrak was inconsistent with his statement. The Tribunal accepts it was.
233There was no suggestion that testosterone was not a scheduled drug pursuant to the PTGR. Mr Sedrak admits as much.[Ex F tab 6 p31]
234Tendered in evidence was the relevant script for Patient HH dated 14th December 2010 together with a card of the Belgrave Pharmacy which had written on the back of that card "Test 2/DHEA troche 1/2/d SL".
235The Tribunal has already been satisfied in particular 10 that testosterone was dispensed. It repeats its reasoning to find that the script the subject of this particular was in fact dispensed.
236There was a total absence of many of the requisite pieces of information necessary for the slip of paper to be a "script" in accordance with clause 35 of the PTGR.
237The Tribunal is comfortably satisfied that this particular is proven.
Particulars 12 and 12A
238It is convenient for both these particulars to be dealt with together, the only addition to be considered in particular 12A is the state of mind of Mr Sedrak when he dispensed the same "scripts". The dates range from March 2009 to February 2011. The drug "DHEA" is a short hand method to refer to the drug dehydroepiandrosterone which is a precursor of anabolic steroids. There was some suggestion that DHEA was a nutritional supplement and thus a natural steroid. Regardless, the drug was a Schedule 4D drug. Mr Sedrak acknowledged that these drugs are often subject to misuse and abuse.
239Given its scheduling, when there was a repeat "script" of such a drug, there is a requirement that the repeat interval be indicated on the "script". This was absent for example on the card accompanying the script of Patient V.[Ex F Tab 3 Appendix H p5] The accompanying script had a "repeat" to those drugs specified on it. Its absence in the 'accompanying' card is a matter of serious concern given the drugs on the script were dispensed more than once. The ingredients on the card were to be added to the drugs dispensed from the 'legitimate' script.
240Particular 12 is admitted. In short it relates to dispensing DHEA to various patients for a period of over of nearly 20 months without scripts as required by the PTGR. It is significant to record that the first evidence of the cards being used as specified in particulars was in March 2009. On the basis of his evidence, it was not until late 2009/early 2010 that Mr Sedrak stated he took the issue up with Dr Wilcox. The last occasion in the particulars is February 2011. Thus the conduct in question ranged over 2 years seemingly without any changes in form nor substance.
241The "slips of paper" were in fact business cards of Mr Sedrak's pharmacy which Mr Sedrak had provided to Dr Wilcox. The cards came to the pharmacy unattached from the 'other' proper script, and Mr Sedrak then stapled the cards to the accompanying "script" once dispensed. Only Dr Wilcox practiced in this manner which must have provided serious alerts to Mr Sedrak, despite Mr Sedrak having provided the cards to other doctors.
242Mr Sedrak suggested that dispensing on these cards happened about 10-20 times. On some of those occasions the extra script was not on the cards, but other documents. [Ex F Tab 3 Appendix E p28] This is rejected by the Tribunal given lack of corroboration and lack of confidence in the evidence given by Mr Sedrak as reasoned above.
243Remarkably Mr Sedrak defended his conduct on the basis that there was no danger in doing this. He relied on his knowledge of Dr Wilcox's practices of taking blood tests, his knowledge of Dr Wilcox's knowledge of safe levels, and his own practice of checking on the safe dose. Mr Sedrak stated he was looking at and checking pathology reports. Mr Sedrak claimed that there were occasions when he rejected the 'prescriptions' of Dr Wilcox. This is at odds with the stated confidence he had in Dr Wilcox's knowledge and practice. Mr Sedrak claimed he had conversations every 2-3 weeks with Dr Wilcox, discussions about patients for over 1-2 hours in respect of these scripts. The Tribunal has great difficulties in accepting these recollections and does not, especially given the length of time over which he accepted these cards as "scripts" and the internal inconsistencies in this evidence. Further if there were such conversations it is not unreasonable to expect some variations in practice over the period as a result of such conversations, and no such variations are evident.
244In his affidavit of May 2013 [Ex H Tab 45 Annexure B p2 at [6]] and his statement,[Ex K [121] Mr Sedrak stated that he recalled the practice on writing scripts on the back of business cards started when he had a customer with a script for HRT (hormone replacement therapy) ingredients to be compounded, written on the prescription and a DHEA written separately on the back of a business card.[Ex H Tab 54 Annexure B p3 at [6]] He then recounted a conversation he had with Dr Wilcox about this. In that conversation Dr Wilcox simply stated "I will sort it out".[ Ex H Annexure B p 3 at [8]] Mr Sedrak stated he dispensed a few "scripts" in this form for female patients with the expectation that he would get a legal script for DHEA. After those "few scripts" were dispensed he decided only to dispense DHEA on legal scripts.[Ex H Tab 54 Annexure B p 3 at [9] Ex K at [122]]
245This explanation does not survive scrutiny when the period over which the "scripts" were dispensed and which are the subject of these particulars namely from March 2009 to February 2011. Nor does the statement seem credible that after his conversation with Dr Wilcox, I then decided to dispense only what was written on the normal prescription and not to include the DHEA on the card [Ex K at [123]] leading to unhappy customers.[Ex K at [124]] The Tribunal cannot accept either of these statements as having occurred without some form of corroboration.
246In his oral evidence Mr Sedrak explained the use of these business cards by Dr Wilcox as having been initially brought to his attention when "testosterone" [Day 3 T3.1] first appeared on cards.[Day 3 T2-3] It was said that the practice started only in respect to "testosterone" and later Dr Wilcox added DHEA to the practice of using cards.[Day 3 T3.8]. However, it is clear from the admitted particular 12 that as early as March 2009 Dr Wilcox was using the card system in respect to DHEA.
247In another but a contradictory explanation provided by Mr Sedrak was the suggestion that this course of conduct started with the cards being used for the drug DHEA.[Ex K at [121]] Mr Sedrak stated prior to the first conversation concerning Dr Wilcox's use of the cards, he stated that most of the time the patient came with the prescription and a card and they saying he was in a hurry and I asked him to add DHEA so he added it on the card. I accepted it a few times and then when I asked him why it is then he revealed the fact that he's not- he's not allowed to- to prescribe it.[Ex K at [121]] In short, Mr Sedrak excused this lack of a script on the basis that Dr Wilcox was in a hurry. This in itself provides no justification for ignoring the requirements of the PTGR.
248In any event, this explanation should be rejected. Common sense would have led Mr Sedrak to infer, that if Dr Wilcox could write one prescription, he would have had the time to add DHEA (or testosterone) onto it, and not create another document being the card. The explanation does not survive even superficial scrutiny and could not lead Mr Sedrak to accept it as a reasonable explanation for the card system.
249Mr Sedrak denied he acquiesced in this practice of Dr Wilcox to add DHEA or testosterone to cards and that he knew Dr Wilcox had no right to prescribe this drug and that he dispensed it to fit in with the way Dr Wilcox practiced medicine. The Tribunal cannot accept this denial. The reason for this, is not only the fact it was a card separate to a formal prescription pad, but also the nature and characteristics of the drug in question, and the nature of the personal and professional relationship with Dr Wilcox and the length of time over which the conduct occurred.
250Mr Sedrak's other explanation for this practice was that a pharmacist could dispense without a script which is called 'owing'. An owing script can be dispensed as 'owing' usually after a faxed script has arrived or after a conversation with the doctor. However the expectation would be that the original script would arrive shortly after dispensing. Such a procedure cannot be used, as in some instances here, as a form of authority for a script. Even assuming the computer could not be used, owing scripts could/must be recorded in a book. In any event the dispensing of the drug in the first place could have been recorded on the computer and it was not. This lack of recording on his computer of the dispensing of this drug for these patients, reveals in the Tribunal's mind what was the real purpose behind the card system.
251The Tribunal accepts that in certain circumstances 'owing' is permitted, but there is no evidence that the circumstance existed with these patients. In short, Mr Sedrak was suggesting that the card represented a script in escrow, with the script proper to be presented later [Day 4 T43.2;T61.33]. This explanation is also rejected by the Tribunal. There was no evidence that Mr Sedrak ever received a proper script subsequent to dispensing a drug as a result of the card being present. Even if a legal prescription were to be presented at a later date and back-dated this would be in contravention of Dr Wilcox's prescribing restrictions. Nor does the evidence reveal a circumstance where the patient was relying on their dispensing history or urgency to have the drug on the card dispensed. In any event the presentation of a current proper script with the card annexed, exposes the artificiality of this explanation.
252The HCCC submitted [CS [58] that the cards were retained for purposes of a repeat (second) dispensing of the DHEA. Absent any evidence of an earlier dispensing, the Tribunal is not able to find such a however not necessary to make such a finding for the purpose of these particulars. To this end the Tribunal accepts the submissions of Mr Sedrak on this allegation [RS [44] despite the submission made by the Complainant in reply.[CSR [11]]
253Mr Sedrak was asked if this card system created "suspicion", he answered "somewhat but not 100%".[Day 3 T6.22] Later he conceded he had been on high alert [Day 3 T6.34] and later had alarm bells.[Day 4 T42.45] He agreed that such a system did not happen with other doctors and should have created alarm bells when it first occurred whether it be testosterone or DHEA.[Day 4 T42] The Tribunal finds the system blatantly illegal, and that Mr Sedrak must have known this immediately on receiving the first of such cards.
254Mr Sedrak stated he discovered the lack of authority for Dr Wilcox to prescribe Schedule 4D drugs, when he had a discussion with Dr Wilcox arising from the use of the cards for dispensing testosterone. Mr Sedrak stated that at the time of this discussion (the first conversation) he did not raise the issue of DHEA, rather this drug was raised a few months later (the second discussion). [Day 3 T3.50; T5.10;Day 4 T40.45] If the first use of cards was testosterone, and that DHEA was prescribed later, and even assuming that the first DHEA card is that of March 2009 (Patient X) then the first conversation would not have been until late 2009.
255As stated, Mr Sedrak admitted he knew (from this first discussion) that Dr Wilcox did not have an authority to prescribe testosterone in late 2009 early 2010. [[Ex K at [112]] However on the evidence of Mr Sedrak, these dates must be wrong placing doubt as to the alleged conversation itself in serious doubt with Mr Sedrak having known earlier than late 2009 as to when he first knew of the limited prescribing rights of Dr Wilcox.
256Mr Sedrak stated that after the first discussion with Dr Wilcox took place, Dr Wilcox stopped sending or writing on the back of the cards (testosterone)... then I found that he is putting DHEA and then I said why it is not on the script. He said I'm not allowed but there is like an application to the authorities, you know, to re-allow me for it and it's a matter of time. (the second discussion). Mr Sedrak did dispense DHEA for 10-20 patients, whom Dr Wilcox claimed needed it.
257Further, tendered were cards seeking testosterone dated as late as December 2010. (particular 11) This allegedly was meant to have stopped after the first conversation. From the scripts the commencement of DHEA on cards was as early as March 2009. This was meant to have started after the first conversation.
258Mr Sedrak stated that he did not link to a satisfaction level of 100% as to whether Dr Wilcox did not have authority for prescribe testosterone, he would not have had it for DHEA.[Day 4 T40.45] He then claimed his level of uncertainty/certainty for this was 50/50 although he agreed that an average pharmacist would have realised there was a problem.[Day 4 T41.22]
259 After the second discussion (which Mr Sedrak stated took place in about March 2010) Dr Wilcox continued to use the card system prescribing DHEA and Mr Sedrak kept dispensing using this system for nearly a further 12 months based on the admitted particular 12. In response to these facts, Mr Sedrak responded that was wrong, and I regret it, I shouldn't allow myself to do it at all.[Day 3 T5.12] It was for Mr Sedrak the biggest mistake I ever done. [Day 4 T44.2]
260Mr Sedrak was asked if he had told Dr Wilcox to stop prescribing DHEA after the second conversation, he evasively responded he's in a different world mentally in this regard. [Day 3 T13.10] The Tribunal is satisfied that there was clearly at least an implicit agreement between Mr Sedrak and Dr Wilcox to dispense DHEA using the cards to hide the fact of unlawful dispensing to the benefit of both Dr Wilcox and Mr Sedrak.
261The Tribunal is comfortably satisfied that particular 12 is proven.
262As to particular 12A, the Tribunal is comfortably satisfied that Mr Sedrak not only ought to have known that Dr Wilcox did not have authority to prescribe DHEA but in fact knew of this fact when dispensing the "scripts" particularised.
263This is not to say that it is always obvious to a pharmacist whether a doctor has or has not restricted authorities to prescribe drugs especially if a normal prescription script is used. However given the nature of the drugs and the history of false scripts being used, Mr Sedrak must have known regardless. In other circumstances it might be said, that at the time of these particulars,it was not easy to find out what if any limitations there existed on a given doctor to prescribe drugs.Mr Sedrak at least as a result of his contact with Dr Wilcox on this issue at all relevant times knew of Dr Wilcox's prescribing limits but ignored them and dispensed the unauthorised drugs regardless.
Particular 13
264This is admitted.[Ex K at [129]]
265The drug involved in this particular is anabolic steroids which are known to be abused. Clause 42(2) of the PTGR requires the keeping of prescriptions for special restricted substances separate from other prescriptions (other than drugs of addiction). No date is particularised. However the evidence reveals that it occurred on 4 September 2011.[Ex F Tab11 p2 at [6]]
266The particular in terms does not in specific terms identify the number of occasions this failure occurred. However from the primary evidence, it appears to have been admitted to having occurred over a number of years and on over 20 occasions.[ Ex F Tab 3 Annexures E and H; Ex K at [127]]
267There is a clear public interest in pharmacists being compliant with their obligation to keep duplicates of special restricted substances separate from other scripts. The keeping of patient duplicates provide a form of dispensing history and a check of what has been dispensed. Each is necessary for a safe dispensing process and accountability.
268Mr Sedrak in his statement sought to minimise his admitted failure due to the small number of non-steroid scripts he dispensed claiming that it was because of this they were mixed in with the steroid "scripts".[Ex K at [128]] However on the date when the failure occurred Mr Sedrak claimed to be ignorant of the regulation requiring the separation of scripts. [Ex F Tab 11 p2 at [7]]
269The question remains whether this mixing of scripts was a form of cover or incompetence. The Tribunal is unable to be comfortably satisfied of either possible explanations.
270The Tribunal comfortably finds this particular proven.
Particular 14
271This particular is not admitted. [Day 4 T61.8]
272The particular relates to a particular day when Mr Sedrak was asked to produce full patient histories.[Ex F Tab 9 p3 at [9]] On this day, Mr Sedrak was interviewed by Ms Dolan [ibid]. Ms Dolan was not cross examined on this evidence. Mr Sedrak claimed his computer software could not produce these details. [ibid] There was no mention of any book system at that time.
273Mr O'Donnell opined that the patient dispensing history is of high importance and is one of the most basic functions necessary to dispense safely. [Ex G Tab 22 at p23] He opined either the computer was non- compliant or that Mr Sedrak did not know how to operate the computer. Mr O'Donnell was not challenged on this evidence.
274In his statement, Mr Sedrak stated that the only system that enabled him to record all the prescriptions that in any way complied with the regulations was his computer system. Mr Sedrak stated he has changed the system since this time.[Ex F Tab 3 p12] Mr Sedrak suggested that by a combination of the book system he kept and his computer, there was compliance with the said standard. The so called book system was said by Mr Sedrak to record manually all the details of the script, including full details of prescriber, the patient, the drug prescribed, the dose intervals and the amount dispensed. The so called "books" were on the invitation of the Tribunal produced and tendered. [Ex O] A cursory inspection of the books demonstrate they fall well short of the description of them by Mr Sedrak.
275The relevant standard was "Dispensing Computers in NSW 2001".[Ex H tab 66] It clearly sets out the mandatory provisions for pharmacists. Ms Dolan confirmed that compliance with this standard was mandatory for registered pharmacists. Mr Sedrak has set out his 'continuing education' as a pharmacist. [Ex K at [16-17]] Mr Sedrak confirmed he was a member of the Pharmacy Guild which would every 6 months send out relevant information to pharmacists [Day 3 T15] and which the Tribunal understands advised pharmacists of developments in professional practice.
276Mr Sedrak suggested that his limited "computer system" was in some way approved by inspectors whom visited his pharmacy.[ Ex K at [14]] Given its alleged limitations, the Tribunal has difficulty in accepting this view. Regardless, it is clear that causal patient records were not permitted by the standard. Thus Ex O could be no substitute for compliance with the standard as there was a lack of important dispensing details in those books.
277Mr Sedrak admitted (in the later interview) to Ms Dolan that the computer was noncompliant with the standard. [Ex F Tab 6 p21] He also admitted he did not know how to look at a patient's dispensing history.[Ex F Tab6 p22] Such a failure was significant given the need to assess whether a drug was safe and appropriate for a therapeutic purpose for a particular person. Such admissions make it unlikely that Mr Sedrak ever thought his book system and his computer were compliant to the standard. The explanation of being too stressed to produce the 'report' required because of the presence of police [Ex K at [140]] seems to relate to the time of the raid and not the date particularised. Mr Sedrak repeats this in his submissions.[RS [47]]
278The HCCC submitted that if the failure to produce the required information was intentional the breach was more serious. [CS [62]] No doubt this is so. Mr Sedrak was able pursuant to a statutory notice produced dated 4th August 2011 [Ex F Tab 3 Appendix C p1] to produce an itemised account of patients to whom he has dispensed certain drugs. This information came from his computer. Apart from the evidence of Mr Sedrak, there is little to no evidence as to the capacity of the said computer to produce the information required. The Tribunal has doubts whether all the relevant information was in fact stored in the computer and thus could not be produced. The books did not contain the relevant information. The Tribunal is not satisfied that the failure to produce the information requested was intentional or not.
279Mr O'Donnell expressed the observation that it has been 25 years since he experienced a recording system of dispensing which was not included in the computer system available. Mr O'Donnell expresses his disapproval of a "system" which cannot obtain patient information on demand.[Ex F Tab 22 p23]
280The Tribunal is comfortably satisfied this particular is proven.
Particular 15
281This particular is admitted. [Ex K at [145]
282The period in question was from March 2009 to August 2011. The scripts were all from Dr Wilcox. Mr Sedrak suggested that he contacted Dr Wilcox many times [Ex K at [144] as to the shortfalls in the scripts which did not comply with clause 35 PTGR. Of course if there were such objections by Mr Sedrak, it made his conduct of continuing to accept the non-complying scripts more serious a breach of his professional duties.
283However the Tribunal does not accept the evidence of alleged contact by Mr Sedrak with Dr Wilcox as his objection to the non-complying scripts, for the following reasons;
(a)Given other findings on credit, and unreliability, the Tribunal requires some corroboration of the calls, and there was none provided.
(b)The regularity of the breaches, the number of breaches and the period over which they occurred is all consistent with acquiescence of such conduct by Mr Sedrak.
(c)The failure to have a patient's address on a script is fundamental to dispensing, the Tribunal cannot accept that Mr Sedrak permitted, against his wishes, or after contact with Dr Wilcox for this practice to have been allowed to continue.
(d)The nature of the drugs involved.
(e)The nature of the 'professional' relationship between Dr Wilcox and Mr Sedrak namely what appears to be an agreed regular disregard to regulations regarding dispensing by a registered pharmacist and registered medical practitioner. It seems unlikely that Mr Sedrak would wish to override or make objections to Dr Wilcox's conduct.
284 While Mr O'Donnell stated Dr Wilcox was a serial offender and correctly identifies his conduct as the "primary" cause, in this particular, the actions of Mr Sedrak permitted these failures to be implemented thus the actions by Mr Sedrak were a "necessary" for Dr Wilcox's misbehaviour to give rise to the risks from which Dr Wilcox had been banned.
285Mr Sedrak accepted his conduct in respect to this particular was wrong. [Ex K at [144]]
286The Tribunal is comfortably satisfied that this particular has been proven.
Particular 16
287This particular is admitted.[Evidence to be found in Ex F Tab 3 Annexure E and Tab 3 Annexure H; Ex K at [148]Ex K at [144]]
288In respect to Patient XX the note from Dr Wilcox reads "Vanna" with the name of the drug and strength. Clearly this does not comply with clause 39 the PTGR. There was no issue of dispensing.
289In respect to Patient G, this note was written it appears on 23 December 2010, not 25th December. In any event it sought dispensing "aromatase inhibitors" without any indication which of the 3 different aromatase inhibitors should be dispensed. Nor was there any mention of the relevant dose. Clearly this was not a script written in accordance with the PTGR.
290 Yet in a similar situation involving another patient, Mr Sedrak asserted that such wording was a script [Day 3 T43.45] adding he would have to ring the doctor to find out the relevant material in order to dispense.[Day 3 T43-44] This did not make the script compliant with clause 39 of PTGR and thus could not be legally dispensed.
291Mr Sedrak relied on his response to particular 15, which the Tribunal has rejected for the reasons stated. It repeats the same reasoning. The failure to have the proper name of a patient on a script is fundamental to the responsibility of the pharmacist to ensure that the drug is dispensed to the correct person.
292The Tribunal is comfortably satisfied this particular is proven.
Conclusions as to Complaint 1
293Mr O'Donnell expressed the opinion that given the nature of the drugs and circumstances in which they were dispensed, it was likely the drugs were used for non-therapeutic uses, probably weight lifting or by athletes and Mr Sedrak should have practiced more caution in the dispensing of the particularised drugs from Dr Wilcox.
294The Tribunal is satisfied that Mr Sedrak did not exercise the obvious and necessary precaution in respect to "scripts" or "notes" from Dr Wilcox. Mr O'Donnell opined if he was provided with a business card with a drug on it for dispensing, albeit a schedule 4 or 4D, he would have checked with the medical authorities as to prescribing rights of the prescribing doctor.
295However, Mr Sedrak's conduct was not circumscribed only by the conduct of Dr Wilcox. Mr Sedrak's failure to report the theft, to account for the drugs in his pharmacy, his failure to maintain proper records, and to practice contrary to legislation was all conduct absent the operating presence of Dr Wilcox.
296The Tribunal is comfortably satisfied that Mr Sedrak is guilty of unsatisfactory professional conduct with the meaning of s139B of the Health Practitioner Regulation National Law in that he has engaged in improper and unethical conduct relating to his practice as a pharmacist (section 144(b) of the National Law) on the basis of each particular found to be proven and in the circumstances so found. However The Tribunal finds that particular 3 does not amount to unsatisfactory professional conduct because of the various possible reasons for there to be an absence of a repeat script.
297This is not to find that each particular carries with it the same level of disapproval. Thus for example, the failure to keep the duplicate prescriptions of special restricted substances (particular 13) or dispensing a script which did not include the patient's address (particular 15) especially if the patient was known to the pharmacist or has the address on his computer are of a lesser concern to the Tribunal than for example the conduct which permitted anabolic steroids to be dispensed without a proper script.
Complaint Two
298The particular involved in this complaint is admitted. The finding of unsatisfactory professional conduct is also admitted.[Ex K at [154]; RS at p3/29]
299The circumstances of the notice (issue 30th March 2013). [Ex G [31][32]]The documents were to be provided by 16th April 2013.There was no response from Mr Sedrak in terms to this notice.
300Such a failure seriously compromises the capacity of the HCCC to undertake timely and effective investigations. As the HCCC submitted, the circumstances of the notice [Ex G Tabs [25]-39]] and the various opportunities provided by the Commission for compliance, compounded this failure to comply. Further as the HCCC submitted [CS [67], the nature of the admitted breach has the character of a lack of candour or co-operation with the investigative authority. The significance of this will be more appropriately considered in the second stage of the Tribunal's considerations of this complaint.
301Mr Sedrak while not stating he had reasonable excuse, relied on alleged legal advice for his non-compliance. [Ex K at [153]] No such advice was provided or identified. But it would be surprising if lawyers would advise against compliance with a lawful statutory notice [see generally NSW Food Authority v Nutricia [2008] 72 NSWLR 456]. There was no challenge as to its lawfulness. The further explanation proffered of not wishing to prejudice his appeal prospects [Ex K at [153] seems without more explanation without merit.
302The Tribunal is comfortably satisfied this complaint is proven.
303The HCCC sought to characterise the proven failure as akin to a breach of a condition of practice.[CS [71] Mr Sedrak disputes this characterisation because the reliance on alleged legal advise.[RS [52] The Tribunal makes no further finding on this aspect. Nor does it seek to characterise the failure other than on its own terms.
304The Tribunal is comfortably satisfied that Mr Sedrak is guilty of unsatisfactory professional conduct with the meaning of s139B (1) of the Health Practitioner Regulation National Law by contravention of a requirement under Heath Care Complaints Act 1993.
Complaint Three
305The terms [S139E of National Law] of the National Law as to the definition of "professional misconduct" has to and has been kept in the forefront of our deliberations on this complaint as we must evaluate our own findings on each particular in any assessment of the satisfaction of the definition.
306The Tribunal was taken to the decision of the Stanoevski v Council of the Law Society of NSW [[2008] NSWCA 93 at [52]-[54]] and the recent decisions of this Tribunal of HCCC v Dr Della Bruna [[2014] NSWCATOD 31]. The Tribunal also considered another decision of this Tribunal, that of HCCC v Fraser [[2014] NSWCATOD 29 at [164][-[167]] The legal reasoning of each of these decisions have been considered by this Tribunal and adopts their reasoning.
307It must be remembered at this stage of the decision making, namely the first stage, the Tribunal is not considering what protective orders should or should not be made and thus we should focus on the nature of the found conduct, which must have the capacity to justify such an order [suspension or cancellation] and whether or not such an order should be made in these particular circumstances.
308The Tribunal has been provided with a number of Guidelines in respect to good practice [Ex H Tabs [61]-[66] which it has considered in the assessment of the found conduct. Although no specific attention has been drawn to them by the parties, the Tribunal considers that they provide a useful background to assessing the gravity of the proven misconduct. Similarly the Tribunal has considered in its assessment of the conduct proven, the assessments by Mr O'Donnell, most of which are unchallenged. With this body of evidence in mind the Tribunal is required to form its own views as to whether the unsatisfactory professional conduct is of sufficient seriousness to justify suspension or cancellation of the practitioner's registration.
309The HCCC submitted [CS [77]] that in considering (proven) particulars of complaints 1 and 2, the (proven) conduct can be characterised either as "deliberate departure" (particularly in terms of choices made to continue to dispense in very irregular/illegal circumstances) or at the very least "serious negligence". The Tribunal is comfortably satisfied that the proven particulars of unsatisfactory professional conduct were as a result of deliberate departures from professional standards.
310Mr O'Donnell referred correctly to the fact that both Dr Wilcox and Mr Sedrak were treating and dispensing to a specialised cohort of patients in respect very rare medical conditions. He considered this unusual especially absent a specialist. He stated as there are other uses for these drugs I am highly sceptical, unless presented with better evidence that such a narrow cohort would be obtaining medication for the conditions outlined by Mr Sedrak from Dr Wilcox and Mr Sedrak.[Ex J Tab 3]
311Critical in placing the conduct of the Mr Sedrak into context was his knowledge that Dr Wilcox had been disciplined for improperly prescribing to body builders.[Day 3 T3.5] Thus the use of cards and the dispensing of particular drugs which may be abused by body builders created suspicion but Mr Sedrak claimed, not 100%. [Day 4 T6.22] This must have placed him on high alert in respect to the "scripts". Yet the continuation of the conduct was inconsistent with any such level of alertness.
312The following individual and/or collective facts lead the Tribunal to be comfortably satisfied that many of the drugs dispensed and which are the subject of the proven particulars were likely to be abused and that Mr Sedrak knew this was a possible outcome on many of the occasions he dispensed those drugs and yet took no professional precautions to prevent this potential outcome. The reasons for this conclusion include the following considerations:
(a)The nature of drugs dispensed.
(b)The fact that a number of drugs were dispensed inconsistently with manufacturer's recommendations both for use and quantities.
(c)The fact that this was often done with noncompliant scripts.
(d)The quantities ordered by the pharmacy, as well as those dispensed or compounded.
(e)The period over which this conduct prevailed and without change.
(f)The unexplained shortfalls in accountable drug stock.
(g)Lack of recording of many substances dispensed or sold.
(h)That scripts were dispensed in an irregular and illegal manner at the request of a GP.
(i)That prescribed restricted substances were dispensed when Mr Sedrak knew that Dr Wilcox did not have authority to prescribe restricted substances and Mr Sedrak knew the reasons for this.
(j)The rejection by the Tribunal of many of the explanations for his conduct.
(k)The lack of corroboration of many of the explanations for his conduct.
(l)The lack of any reliable evidence of a response to the obvious illegalities of the scripts used to dispense the drugs/substances.
313Given these reasons and the Tribunal's findings on the credibility of Mr Sedrak as a witness, the Tribunal rejects the bald assertion by Mr Sedrak that none of his clients the subject of these complaints were body builders. [Ex K at [105]] The Tribunal is unaware as to what and how Mr Sedrak was assessing when he came to this conclusion.
314The Tribunal in considering this complaint also considers it relevant the fact that at the time of some of these events, Mr Sedrak, had been the subject of hearing and a determination by the Pharmacy Council and was undergoing continuing education by order of that Council. Thus he must have had a heightened state of awareness of his professional and legal responsibilities.
315The only acceptable explanation of Mr Sedrak's acquiescence to use by Dr Wilcox of cards rather than compliant scripts and upon which Mr Sedrak dispensed the drugs, in particular DHEA and testosterone, was either wilful blindness or connivance. Mr O'Donnell describes this as aiding and abetting.[Ex G Tab 22 p24]
316The Tribunal comfortably finds evidence of connivance, acknowledging the seriousness of such a finding. The reason for doing this on Mr Sedrak's own admission was for pure economic benefit to Mr Sedrak, however it placed members of the public at great risk of harm.
317The dispensing of zolpidem and somatropin demonstrated reckless indifference [see HCCC v Fraser [2014] NSWCATOT 29 at [282]-[287] in the established circumstances.[see generally MIMS prescribing information. Ex H Tabs 76-77]
318It thus comes as no surprise that the records of the pharmacy were inadequate and noncompliant. This was a consequence of the manner and purpose for which the pharmacy was conducted.
319Mr O'Donnell opines at an early stage in his considerations, that Mr Sedrak had wanton disregard for the regulations that control his practice.[Ex G Tab 22 p24] The Tribunal agrees with this opinion.
320The HCCC submitted that without limitation, examples of particulars which of themselves support a finding of professional misconduct include particulars 4,5, 8 and 9. [CSR [14]] Mr Sedrak submitted that none of the proven particulars on their own is sufficient to find professional misconduct. [RS [58]]. The Tribunal disagrees.
321Central to the professional conduct of any pharmacist is to ensure that accepted prescriptions are legal and appropriate. This is followed by appropriate dispensing for an individual patient. At all times a patient-centred approach is required to ensure optimal outcomes and minimise harm.
322With this in mind and given the various reasons expressed above in respect to this complaint and each particular, the Tribunal is comfortably satisfied that the given the findings as to particulars 4,7,8,9,10,11,12 ,12A, and 16 of complaint one is unsatisfactory professional conduct and that each these particular is of a sufficiently serious nature to justify suspension or cancellation of the practitioners registration and thus each particular amounts to professional misconduct.[S139E(a) of the National Law]
323Further central to the lawful running of a pharmacy is the maintenance of proper records and reporting systems to the authorities. Similarly the need for a proper response to investigator and statutory notice are essential to supervision of the profession. With this in mind and given the various reasons expressed above in respect to this complaint and each particular, the Tribunal is comfortably satisfied that the unsatisfactory professional conduct found and identified in particulars 6 and 14 of complaint one and particulars of complaint 2 ,that each particular and the second complaint are of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration and thus each particular amounts to professional misconduct.[S139E(a) of the National Law]
324Mr Sedrak submitted the "admitted" conduct does not meet the test of professional misconduct but rather revealed deficiencies in his knowledge in respect to specified obligations and a failure to exercise sufficient independence in respect to dealings with Dr Wilcox and some patients. The submissions suggested his underlying motive was a desire to help others. [RS [60]]. The findings of the Tribunal go beyond the "admitted conduct" as members of the public were placed at risk by conduct found by the Tribunal to have occurred. This conduct demonstrated a lack of adequate knowledge, skill, judgment and care in the practice of pharmacy, disregard for the laws and regulations governing pharmacists, and a betrayal of trust expected by and owed to the public by all pharmacists.
325In any event, the Tribunal rejects this characterisation of the proven conduct for the various reasons expressed above in respect to this complaint and each particular held to amount to professional misconduct.
326In the alternative, the Tribunal is comfortably satisfied that all the proven particulars of unsatisfactory professional conduct of complaints one and two when considered together amount to conduct of a sufficiently serious nature to justify suspension or cancellation of the practitioner's registration [139E(b) of National Law] and thus is comfortable satisfied that professional misconduct is proven for the various reasons expressed above.
Two stage hearing
327As noted above, at the request of the parties, the Tribunal agreed that there should be a "two stage" hearing. Accordingly the Tribunal now makes the following orders:
(1)The Complainant by the 31st October 2014 and the Respondent by the 21st November 2014 to each file in the Registry of the Tribunal such evidence which each seeks to rely upon as to the appropriate protective orders which ought be made by the Tribunal having regard to the findings made in this decision.
(2)The parties are the serve such evidence on each other at the same time as in (1).
(3)The parties are each to file on the dates identified in (1) the proposed orders they consider ought to be made including proposed costs orders.
(4)Outline of written submissions in response to both the evidence filed and orders proposed be filed by each party in the Registry on 12th December 2014.
(5)The matter is set down for further hearing on the 18th December 2014, and if necessary, 19th December 2014.
(6)The parties have liberty to approach the Principal Member if a variation or amendment to these orders is sought after having provided notice to the other party 24 hours prior to the approach outlining the purpose of the approach.
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I hereby certify that this is a true and accurate record of the reasons for decision of the Civil and Administrative Tribunal of New South Wales.
Registrar
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Decision last updated: 15 October 2014