Vohora v Professional Conduct Committee [2012] NZHC 507; [2012] 2 NZLR 668 (23 March 2012)

Last Updated: 26 January 2018

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IN THE HIGH COURT OF NEW ZEALAND DUNEDIN REGISTRY

CIV-2011-412-000762 [2012] NZHC 507

IN THE MATTER OF an appeal pursuant to s 106(2)(b) of the Health Practitioners Competence Assurance Act 2003

BETWEEN RAVI VAS VOHORA Appellant

AND A PROFESSIONAL CONDUCT COMMITTEE

Respondent

Hearing: 15 and 16 December 2011

Appearances: C S Withnall QC for Appellant

M McClelland and H Brown for Respondent

Judgment: 23 March 2012

_{JUDGMENT OF WHATA J}

[1] Over a period of some ten years Mr Vohora has objected to documenting standard operating procedures. He says that they are instruments of delegation. In his view pharmacists should not delegate key functions to staff and therefore standard operating procedures are not only unnecessary but are inappropriate. Mr Vohora was charged with professional misconduct within the scope of his practice, or in the alternative, professional misconduct bringing discredit to the profession. Key facts are agreed. Mr Vohora did not keep a controlled drugs register for a period of four years and has not, over some ten years, documented standard operating procedures. The Tribunal considered that this was both misconduct within the scope of his practice and misconduct bringing discredit to the profession. Mr Vohora appeals on the basis that standard operating procedures do not fall within the scope of his practice. There is no evidence of any harm to any patient and he has

_{always acted with due care in the dispensing of medicines. He also says that because}

VOHORA V A PROFESSIONAL CONDUCT COMMITTEE HC DUN CIV-2011-412-000762 [23 March 2012]

he was charged in the alternative, the Tribunal erred by mixing and matching the types of misconduct when it arrived at its penalty, namely cancellation of his registration.

[2] I must resolve whether Mr Vohora’s so called principled protest was professional misconduct attracting discipline, and if so whether it warranted the Tribunal’s sanction of cancellation.

Background

The charges

[3] Mr Vohora was notified of the following charges (among others):

1. The Committee charges that Mr Vohora as the proprietor and sole pharmacist of Pharmacare Highgate Maori Hill Pharmacy (‘the Pharmacy’) is guilty of professional misconduct in that he has committed acts or omissions that a) amount to malpractice or negligence in relation to his scope of practice (section 100(1)(a) of the Act) or, in the alternative, b) that he has committed an act or omission that has or is likely to bring discredit to the profession (section 100(1)(b) of the Act).

2. The acts or omissions that the Committee alleges amount to professional misconduct are that Mr Vohora:

[4] The particulars of the charge relevant to this appeal include:

a. Has acted in breach of the Medicines Regulations 1984 in that he instructed and/or allowed an unqualified person, Siraya O’Sullivan, to dispense prescription medicine in breach of regulation 42 of the Medicines Regulations.

...

c. Has acted in breach of the Misuse of Drugs Regulations 1977 in that from 30 June 2006 to 16 April 2010...

...

e Has failed to practise in accordance with the Pharmacy Council Code of Ethics in that he failed to document standard operating procedures ...

Agreed facts

[5] The background to the charges is recorded in an agreed summary of facts.¹

They set the frame for the proceedings. Relevantly the summary states:

1 Background

1.1 Ravi Vas Vohora is a registered pharmacist. At all material times, Mr Vohora was the proprietor and sole pharmacist of Maori Hill Pharmacy (the ‘Pharmacy’).

1.2 The Pharmacy is open Monday to Friday from 9 am to 5:45 pm.

1.3 At the time of the audit, the Pharmacy employed Siraya O’Sullivan and Amy Perkins. Following Ms O’Sullivan’s departure from the pharmacy, Mr Vohora employed Moselle Storm. Both Ms Storm and Ms Perkins were employed as full-time trainee pharmacy technicians enrolled with the Pharmacy Industry Training Organisation

(‘PITO’). Ms Perkins ceased employment at the Pharmacy in April

2011 and Ms Storm ceased employment in July 2011. Presently, the

Pharmacy employs a locum pharmacist who assists with dispensing. The Pharmacy employs casual staff for non-dispensing duties, as needed.

1.4 The Pharmacy dispenses approximately 65 prescriptions per day.

1.5 The Pharmacy has developed and operated its own software application for dispensing purposes and does not use Toniq or Healthsoft software.

2 Audit of the Pharmacy

2.1 Mr Vohora had refused all audits at the Pharmacy from 2002 to

2004. The Pharmacy underwent audits in 2005 and 2006, however, between 2007 and 2009 Mr Vohora refused all audits of the

Pharmacy.

2.2 Mr Vohora was informed on 23 March 2010, that an audit of the Pharmacy would take place on 14 April 2010 by David Sinclair, an Advisor in the Medicines Control team, a division of the Ministry of Health (the ‘Ministry’) (refer to the Agreed Bundle of Documents

(‘ABD’), tab 1, page 2). Medicines Control also sent Mr Vohora a letter explaining the audit process and attached a copy of the audit tool that was to be used for the audit. An audit tool is an approved checklist used by Medicines Control Advisors to gather evidence of compliance and effectiveness in meeting legislative requirements and published pharmacy quality standards.

¹ Common Bundle of Documents Volume 1 at 32.

2.3 Also on 23 March 2010 Medicines Control sent Mr Vohora a letter attaching a pre-visit questionnaire (also known as a ‘desk audit’) and asked Mr Vohora to complete the questionnaire prior to the audit and return this by 8 April 2010 (ABD, tab 2, page 4). The questionnaire was not returned prior to the audit. Mr Vohora recalls handing the questionnaire, partially completed, to the auditor at the start of the audit, however. Mr Sinclair does not recall receiving it.

2.4 Prior to the audit taking place, Mr Vohora sent Medicines Control a letter in which he described the deficiencies in his record keeping over the years (ABD, tab 3, page 15).

2.5 On 14 April 2010, David Sinclair carried out the announced audit of the Pharmacy.

2.6 The audit report is dated 14 April 2010 and sets out Medicines Control’s findings (ABD, tab 4, page 16). The report was sent to Mr Vohora on 21 April 2010.

2.7 As part of the audit, Medicines Control spoke to Mr Vohora and to

Ms Siraya O’Sullivan who was employed in the Pharmacy.

2.8 A summary of the findings of the audit are set out below.

3 Findings

Pharmacy Staff

3.1 The audit report explains the role of Siraya O’Sullivan, an employee of the Pharmacy. The audit findings state that Ms O’Sullivan’s employment status was described as a ‘pharmacy technician student’, that she had been employed in this role for 11 months, but that she was not enrolled in an approved training course for pharmacy technicians. Mr Vohora confirmed that Ms O’Sullivan was not enrolled with PITO.

3.2 The audit report describes this as being a ‘high-risk issue’ due to the fact that Ms O’Sullivan had not been enrolled and was not undertaking a recognised pharmacy technician course and therefore should not be performing any dispensing tasks.

...

3.4 At the date of the audit Mr Vohora did not hold a current Annual Practising Certificate. His annual practising certificate had expired on 31 March 2010 (ABD, tab 5, page 37).

3.5 Mr Vohora advised Medicines Control that he had submitted his application for renewal of his practising certificate to the Pharmacy Council.

Controlled Drugs Register

3.6 Medicines Control inspected the Controlled Drugs Register and found that entries had not been made in the Controlled Drugs Register since 30 June 2006.

3.7 Mr Vohora acknowledges that no entries were made in the

Controlled Drugs Register after the audit in 2006.

3.8 Medicines Control concluded that the Controlled Drugs Register was not properly maintained for the following reasons:

a entries had not been recorded since 30 June 2006

b it did not comply with Schedule 1, Form 1 as required by regulation 37(2) of the Misuse of Drugs Regulations

c all controlled drugs purchased and dispensed and/or in the Pharmacy’s possession were not recorded in the Controlled Drugs Register within one business day from the dispensing taking place or the Pharmacy gaining possession of the controlled drug

d stock takes of all controlled drugs in the Pharmacy’s possession were not carried out on 30 June and 31 December of every year

e a quantity stock account had not been performed or entered into the Controlled Drugs Register from 30 June 2006

f any destruction and/or return of controlled drugs was not recorded

g there was no accurate record of the quantity of controlled drugs that were held at the Pharmacy.

3.9 Mr Vohora told Medicines Control that he had recorded purchases and dispensing of controlled drugs in a pharmacy diary. Mr Vohora showed Mr Sinclair a drawer where he retained the controlled drug prescriptions and invoices for controlled drug purchases.

3.10 Mr Sinclair contacted the Licensing Authority (Sue Scott) to ask for her advice as to what further course of action should be taken. Later that day, the Licensing Authority called Mr Sinclair and told him that she would be sending Mr Vohora a letter by fax that proposed to add a condition to his License to Operate the Pharmacy that would prohibit the storage and dispensing of Class A and Class B controlled drugs.

...

Standard Operating Procedures

3.12 Medicines Control found that the Pharmacy did not have a document describing the Pharmacy’s standard operating procedures in respect of:

a dispensing procedures, including information about how dispensing incidents (including errors and near misses) are managed, recorded and evaluated, and including procedures for dispensing medicines in unit dose packs

b compounding processes, including information about documenting the process, batch number and expiry dates of ingredients and documenting the assigned expiry date of new medicines

c the procedure for accounting for Pharmacy stock which included ordering and checking incoming medicines

d cleaning and monitoring the Pharmacy refrigerator and the appropriate action to be taken in the event of a refrigerator failure

e waste disposal, including allocating a clearly labelled area for the quarantine of rejected or returned medicines

f staff development and training, including the orientation and/or induction of new staff and locums

g infection control, including information describing the procedure for reporting incidents

h the procedures for dealing with complaints.

3.13 Medicines Control did locate a dispensing diary which recorded incidents. It also noted that during the audit it was shown ‘check lists’ of the procedures at the Pharmacy, that staff members could refer to. Mr Vohora described the check lists as ‘memory aids’ written by and for individual staff members to serve as reminders to instructions from Mr Vohora. In relation to these lists, Medicines Control noted that:

a it was normal practice for each staff member to write and keep their own lists

b the lists were discarded when it was considered that the staff member was performing to meet the requirement as documented on the list

c the lists were not formally approved, retained or reviewed.

Conclusion of audit

3.14 At the conclusion of the audit, Mr Sinclair told Mr Vohora that he was running out of time and would send him a fax the next day

attaching a ‘Declaration of Correction of Critical/High Risk Audit

Findings’.

3.15 Following the audit report, Mr Vohora requested that Mr Sinclair explain how the findings were determined as ‘high risk’. Mr Sinclair informed Mr Vohora that the high risk finding was made with reference to the audit tool ‘Risk Assessment Matrix’. In particular, the failure to implement the requirements for maintaining a Controlled Drugs Register were considered to be a significant departure from expected standards and that the consequences of not doing this put the public at risk. Mr Sinclair explained that the other high risk factor was Ms O’Sullivan working at the Pharmacy as a technician without being enrolled in an approved course.

[6] I have excluded agreed facts that are not relevant to the appeal. One agreed fact [at 3.3] is now disputed. It has been excluded.

The hearing

[7] Shortly after the commencement of the hearing the Chair of the Tribunal referred Mr Vohora to s 100(1)(d), namely:

The practitioner has practised his or her profession while not holding a current practising certificate ... .

[8] The Chair then noted that Mr McClelland wished to add s 100(1)(d) to the charge. The Chair then stated:

... the addition of the references to s 100(1)(d) is an appropriate addition.

[9] The hearing then progressed to address the substance of the complaints against Mr Vohora.

Decision

[10] On 7 September 2011, at the conclusion of the hearing, the Tribunal delivered its oral decision and found that the charge of professional misconduct in relation to particulars (a), (c) and (e) of the charge had been established. The Tribunal issued its written decision on 23 September 2011.

[11] For the purposes of this appeal the following findings are particularly relevant.

Particular (a): Breach of Medicines Regulations 1984

[12] The Tribunal found that an employee of Mr Vohora, Ms O’Sullivan, was performing dispensing duties. It observed that the starting point for consideration of Ms O’Sullivan’s role was that she had access to and was authorised to work in the dispensary. It stated that labelling is an aspect of dispensing² and that it is vital that correct information be conveyed to all users of prescribed medicine. The Tribunal was advised that Ms O’Sullivan’s role was to generate a label for the purposes of

prescription medicine. Ms O’Sullivan would be required to check a patient’s history, check product limits, capture important information for the pharmacist and then transcribe the information from the screen to paper for him to check.³

[13] The Tribunal then observed: ⁴

The evidence thus established that there was a process of interpretation involved in accessing and copying out relevant data. Part of the information which was being accessed was confidential patient information kept only for the purpose of dispensing.

[14] The Tribunal also found that Ms O’Sullivan was an unqualified person to dispense prescription medicine in breach of regulation 42. The Tribunal then observes that it is evident from Ms O’Sullivan’s statement to Mr Sinclair that she herself thought she was dispensing and was permitted to do so. Having found a breach, however, the Tribunal considered that in all the circumstances it was

_{borderline as to whether it would warrant discipline.}⁵

² Citing s 2 Medicines Act 1981

³ Decision of the New Zealand Health Practitioners Disciplinary Tribunal 400/Phar11/183P, 23

September 2011, at para 31.2

⁴ Ibid at para 31.2

⁵ Ibid at para 43

Particular (c): Breach of Misuse of Drugs Regulations 1977

[15] Dealing with particular (c), the Tribunal observed that Mr Vohora acknowledged that he had failed in his responsibility to maintain the register in the manner necessary since the time of the audit in 2006, and accepted that such failure was a significant breach of professional responsibility. The Tribunal observed that in a letter to the Tribunal Mr Vohora said that it became necessary for him to adopt an

act of principled protest to obtain the needed co-operation. It is further recorded⁶

that Mr Vohora strongly believed that steps such as those contained in Part 3 of a series of New Zealand Codes of Good Manufacturing Practice and the use of standard operating procedures (SOPs) were inconsistent with the recommendations of a report produced by the Nuffield Foundation in 1986. The Tribunal observed further that the non-compliance with the controlled drugs register (CDR) continued for four years. The Tribunal then observed:

55. The Tribunal considers there could never be a justification for deliberate non compliance with the obligations of the Misuse of Drugs Regulations for a period of some four years. The obligation to complete the CDR in a timely way was a significant one; and Mr Vohora for his own reasons decided not to comply with the law.

56. That is a very serious professional breach.

[16] The Tribunal then resolved that it was a significant breach of professional standards; considered on its own it would undoubtedly warrant discipline.

Particular (e) – Failing to practise in accordance with the Pharmacy Council Code of Ethics, by failing to document certain standard operating procedures

[17] The Tribunal stated that it was common ground that Mr Vohora maintained no SOPs. The Tribunal referred to the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods which makes specific reference to SOPs. It then referred to the quality standards for pharmacy in New Zealand which also make numerous references to standards requiring SOPs.

_{The following observations were then made:}

⁶ At para 47.3

71. SOPs are well known in the pharmaceutical sector as being:

71.1 Living documents that detail written instructions describing specific steps to follow in all activities under defined conditions.

71.2 Documents which are intended to manage risk and avoid harm.

71.3 Documents which are, as Mr Sinclair explained, pharmacy specific – that is, adapted for the particular exigencies of the given pharmacy.

[18] The rationale of the Tribunal is captured by the following comments:

72. The Tribunal is of the view that the purpose of SOPs is to ensure that accepted standards of practice are consistently performed; and ensure that all staff are aware of the expectations of the pharmacist with regard to the complexities of the particular operation.

73. System failures are often cited as contributing to patient harm, perhaps as a result of steps in a process being omitted or overlooked. Documentation of this kind can be a valuable tool providing for avoiding foreseeable system failures; or for ensuring that problems which have occurred in the past are not repeated.

[19] In relation to Mr Vohora’s response that SOPs are an instrument for co-ordination of delegation, the Tribunal observed that the issue was not one of delegation; it was one of safety.

[20] The Tribunal then identified the following aggravating factors:

91.1 The issue was long standing.

91.2 Mr Vohora had taken no real initiatives to address his “cause”, such as seeking to make a personal presentation to the Pharmacy Society or the Pharmacy Council in a timely way.

91.3 More importantly, however, there were issues of harm minimisation, and of patient safety; the Tribunal was not satisfied that Mr Vohora’s methods (drills, checklists and prompts) were an adequate substitute.

[21] Ultimately the Tribunal resolved that this was a serious breach that had implications for public safety and on its own it would warrant discipline.

[22] There is then a brief discussion on s 100(4) which provides that no person may be found guilty of a disciplinary offence “merely because that person has ... practised any theory of medicine”. The Tribunal did not accept that the various breaches were committed in furtherance of a theory of medicine.

[23] The Tribunal then observed by way of summary:

103. In respect of professional misconduct particulars, the charge requires the Tribunal to consider established particulars both separately and cumulatively. Considering Particulars A, C and E cumulatively, the Tribunal is satisfied that they amount to malpractice, and to the bringing of discredit to the profession. Together, they warrant discipline for the following reasons:

103.1 The variety of the breaches involved, particularly the failure to maintain a CDR, raise significant issues of public safety.

103.2 Cumulatively, the three established particulars also raise significant issues for the maintenance of professional standards.

103.3 In the case of the deliberate breach of the Misuse of Drugs Regulations, there was a deliberate breach of the law which the Tribunal must regard as being very serious indeed.

103.4 Generally, there has been a failure to maintain the professional obligations of the pharmacy profession.

[24] The Tribunal also found that Mr Vohora failed to obtain a new practising certificate and that the charge brought under s 100(1)(d) was made out.

Penalty

[25] On the question of penalty the Tribunal traversed relevant legal principles and leading authorities. It was not satisfied that Mr Vohora would now maintain a proper commitment to his legal and professional obligations. It identified the principal purpose of the Act, namely, “to protect the health and safety of members of the public by providing for mechanisms to ensure that health practitioners are competent and fit to practise their professions”. Given these factors, it considered that the only reasonable step the Tribunal could take on the basis of the circumstances disclosed to it was that Mr Vohora’s registration be cancelled; and that conditions be imposed under s 102. If Mr Vohora wished to reapply, he would have to satisfy the Pharmacy Council that he was a fit and proper person for that privilege and he would have to

persuade the Pharmacy Council that he was willing to submit to the legal and professional requirements. The requirements were then detailed, including satisfaction that he would comply with relevant legislation, with the Code of Ethics, and relevant standards. Orders as to costs were also made.

Issues

[26] Mr Withnall QC identified four main grounds for appeal:

(a) The Tribunal wrongly held that the particulars amounted to malpractice or negligence in relation to the scope of Mr Vohora’s practice.

(b) The Tribunal wrongly conflated ss 100(1)(a) and (1)(b) of the Health Practitioners Competence Assurance Act 2003 (“the Act”) when reaching a conclusion that Mr Vohora’s conduct discredited the profession.

(c) The Tribunal erroneously had and without lawful authority assessed Mr Vohora’s conduct by reference to Quality Standards and Standard Operating Procedures that were not relevant as a matter of law or fact.

(d) The penalty was disproportionate and manifestly excessive.

Jurisdiction

[27] This is an appeal pursuant to s 106(2)(a) and (b) of the Act against the Tribunal’s deregistration of the appellant. It is therefore an appeal against findings of culpable professional misconduct as well as an appeal against penalty.

[28] Pursuant to s 109 of the Act, an appeal is heard by way of rehearing. This Court may confirm, reverse or modify the order appealed against. The Court may also make any other decision or order that the Tribunal made or could have made. This procedure on appeal reflects the general right of appeal afforded to litigants

from first instance decisions. It is therefore subject to the observations of the

Supreme Court in Austin, Nichols & Co Inc v Stichting Lodestar.⁷

[29] There is, however, an apparent division amongst the relevant High Court authorities as to how the requirements of Austin, Nichols & Co Inc apply in the context of an appeal against penalty. In the relatively recent decision in O v Professional Conduct Committee⁸ the Court noted, in short, that an appellate Court has the responsibility of arriving at its own assessment of the merits of the case.⁹ By contrast the Court in GS v A Professional Conduct Committee¹⁰ observed that an appeal as to penalty is an appeal against a discretion. The judgment notes that the Court of Appeal confirmed in Blackstone v Blackstone¹¹ that appeals from a discretion are not affected by Austin, Nichols & Co Inc and that the principles in May v May¹² apply to appeals from an exercise of discretion. As a consequence, the Court concluded that it is for the appellant to show that the Tribunal made an error of principle, considered irrelevant matters, failed to consider relevant matters or was plainly wrong.

[30] For my part I respectfully prefer the approach taken in O v Professional Conduct Committee. First, there is nothing in the language of s 106(1) or (2), or s 109 that draws a distinction between the two decision making exercises subject to appeal under those provisions. They are treated in the same way. Indeed the penalty decision involves a substantive assessment of the gravity or seriousness of the misconduct,¹³ and such assessment, in my view, is not simply a matter of discretion,

_{but an evaluation of the facts against the statutory purpose.}

⁷ Austin, Nichols & Co Inc v Stichting Lodestar [2007] NZSC 103; [2008] 2 NZLR 141 (SC)

8. O v Professional Conduct Committee [2011] NZAR 565 (HC); refer also Harman v Director of Proceedings HC Auckland CIV 2007-404-003732, 12 March 2009; A v Professional Conduct Committee HC Auckland CIV 2008-404-2927, 5 September 2008; D v The Professional Conduct Committee HC Wellington CIV 2010-463-382, 29 October 2010.

⁹ O v Professional Conduct Committee [2011] NZAR 565 (HC) at [7]

10. GS v A Professional Conduct Committee [2010] NZHC 458; [2010] NZAR 417 (HC); refer also L v Professional Conduct Committee of New Zealand Psychologists Board (2009) 20 PRNZ 92 (HC); Consider also Dr E v Director of Proceedings [2008] NZHC 879; (2008) 18 PRNZ 1003 (HC) at [15].

¹¹ Blackstone v Blackstone [2008] NZCA 312; (2008) 19 PRNZ 40 (CA)

¹² May v May [1982] 1 NZFLR 165 (CA)

¹³ IRG v Professional Conduct Committee of the Psychologists’ Board [2009] NZCA 274; [2009] NZAR 563 at [49]

[31] Second, the Court of Appeal decision in Blackstone v Blackstone endorsed the proposition that appeals from an exercise from a discretion are not affected by Austin, Nichols & Co Inc. But the Court of Appeal also went on to note that the appeal against parenting orders in that case was not an appeal against an exercise of discretion, citing the Court of Appeal decision in D v S.¹⁴

[32] Third, the leading case on appeals from an exercise of discretion, May v May¹⁵ involved a very different type of decision from the decisions subject to appeal in this case. In May v May the Court was concerned about whether the time should be extended to make an application. In that context, the Judge had a genuine procedural discretion, which is whether the Court ought to exercise its jurisdiction to grant the extension. It was not functionally appropriate to then make it subject to a full substantive appeal. With respect to the different view reached in GS, I do not consider that the reasoning in May v May has application in this context in light of Austin, Nichols & Co Inc.¹⁶

[33] On that basis I will proceed by examining whether or not the Tribunal was wrong about its decisions on misconduct and on penalty based on my assessment of the merits. Nevertheless, it remains for the appellant to show why the Tribunal got those decisions wrong. On matters pertaining to professional context and standards, I will need to be persuaded why it is I should depart from a panel including experts on the particular areas of concern. In short, the appellant must show why those

experts got their evaluation wrong.¹⁷

Scope of Practice?

Argument

[34] Mr Withnall emphasised that s 100(1)(a) deals with professional misconduct within Mr Vohora’s “scope of practice”. He said that scope of practice is

¹⁴ D v S [2003] NZFLR 81 (CA)

¹⁵ May v May [1982] 1 NZFLR 165 (CA)

¹⁶ I reached a similar conclusion in the context of the Family Protection Act 1955, see JEW v TAB

and HJH and JEW [2012] NZHC 202.

¹⁷ Refer also Austin, Nichols & Co Inc at [5].

legislatively defined and does not incorporate the administration of the practice, including bookkeeping or SOPs. He says those matters might give rise to disciplinary action, but not under s 100(1)(a). He then says that the particulars (c) and (e) of the charge relate to acts or omissions that are not within the appellant’s scope of practice. Particular (c) is an admitted failure to keep records in a prescribed form. Particular (e) is a failure to document “standard operating procedures”. As the scope of practice is, he says the provision of specific healthcare services to the public, the form and content of documentation used in Mr Vohora’s business is not within the scope of practice and it is purely administrative.

[35] Mr Withnall accepts that the failure to keep a CDR was not purely administrative failure, but a substantive one as it is integral to the pharmacist’s clinical service. But he adds that in order to constitute malpractice or negligence, there must also be some substantive wrong doing or incompetence. There was no evidence of that.

Analysis

[36] Section 100(1)(a) dealing with scope of practice states:

100 Grounds on which health practitioner may be disciplined

(1) The Tribunal may make any 1 or more of the orders authorised by section 101 if, after conducting a hearing on a charge laid under section 91 against a health practitioner, it makes 1 or more findings that-

(a) the practitioner has been guilty of professional misconduct because of any act or omission that, in the judgment of the Tribunal, amounts to malpractice or negligence in relation to the scope of practice in respect of which the practitioner was registered at the time that the conduct occurred; or ...

[37] Scope of practice is defined in s 5(1) of the Health Practitioners Competence

Assurance Act 2003 as:

scope of practice -

(a) means any health service that forms part of a health profession and that is for the time being described under section 11; and

(b) in relation to a health practitioner of that profession, means 1 or more of such health services that the practitioner is, under an

authorisation granted under section 21, permitted to perform, subject to any conditions for the time being imposed by the responsible authority

[38] Under s 11, responsible authorities must specify the scope of practice. For the present purposes, as Mr McClelland states, the Pharmacy Council included the following within the scope of practice pursuant to s 11:

The pharmacist acts as a medicines manager, ensuring safe and quality use of medicines and optimising health outcomes by contributing to the selection, prescribing, monitoring and evaluation of medicine therapy.

[39] Scope of practice is therefore literally concerned with the management of medicines so as to ensure “safe and quality use of medicines” and “optimising health outcomes” via “selection, prescribing, monitoring and evaluation”. There is some force in Mr Withnall’s submission that exactly how a medicines manager documents his procedures for handling the medicines is not within the scope of practice. Plainly the procedures employed are a core component of that practice. But the method of documentation is incidental to, rather than within, the scope of practice.

[40] I also consider that maintaining a clear definition of scope of practice, namely in this case, the clinical management of medicines, as opposed to incidental administrative activity, is necessary given the punitive consequences of s 100(1)(a). Clear rules and powers enforcing those rules is a fundament of the principle of

legality.¹⁸ An ambulatory definition of scope of practice would not accord with this

principle. Conversely, the scope of practice is the anchor for discipline under s 100(1)(a). Both the responsible authority and health professionals must be able to proceed on the basis of a clear understanding of what that means.

[41] But I do not accept Mr Withnall’s contentions that the deliberate failure to

document SOPs is incapable of relating to scope of practice for the purpose of s 100(1)(a) for the following reasons.

¹⁸ Refer, Lord Steyn in R v Home Secretary, ex p Pierson [1997] UKHL 37; [1998] AC 539 (HL) at 588. See also Refugee Council of New Zealand Inc v Attorney-General [2002] NZAR 717 (HC) at [57]; Matthew Smith New Zealand Judicial Review Handbook (Brookers, Wellington, 2011) at 14.6.1; HWR Wade and CF Forsyth Administrative Law (10^th ed, Oxford University Press, Oxford,

2009) at 17-20.

[42] First, s 100(1)(a) is concerned with “professional misconduct because of any act or omission that ... amounts to malpractice or negligence in relation to the scope of practice... .” The section is not exclusively concerned with misconduct within the scope of practice. Rather, it is concerned with a slightly broader concept of misconduct relating or directly connected to that scope of practice. This does not include conduct extraneous to performance of specialist clinical functions. But it literally and logically includes any conduct directly incidental to the performance of those functions.

[43] Second, the purpose and scheme of the Act supports this construction. Section 3(1) of the Act records:

3 Purpose of Act

(1) The principal purpose of this Act is to protect the health and safety of members of the public by providing for mechanisms to ensure that health practitioners are competent and fit to practise their professions.

...

[44] This purpose is to be achieved via (among other methods) a consistent accountability regime for all health professionals;¹⁹ provision for the determination of the scope of practice;²⁰ and for systems to ensure that no health practitioner practises in a capacity outside his or her scope of practice. ²¹

[45] As outlined at s 4, the Act provides a comprehensive regime for ensuring competence and fitness to practice. Part 1 of the Act deals with prohibitions against acting outside the scope of practice. Part 2 details the conditions that the health professional must satisfy in order to practice, and Part 3 provides the mechanisms for improving the competence of health professionals, including reviews and competency programmes. Parts 4 and 5 deal with discipline. Part 6 then establishes and empowers responsible authorities, including the Pharmacy Council, to review

_{and maintain competence, and to set standards of clinical competence.}

¹⁹ Health Practitioners Competence Assurance Act 2003, s 3(2)(a)

²⁰ Ibid, s 3(2)(b)

²¹ Ibid, s 3(2)(c)

[46] In my view, this combination of purpose, methods and functions means that conduct affecting competency and fitness to practice, including administrative tasks directly associated with the performance of clinical functions, logically must be amenable to sanction under s 100(1)(a).

[47] Third, there is longstanding authority that administrative practice can amount to professional misconduct. Their Lordships in Roylance v General Medical Council (PC)²² in a case dealing with professional misconduct by a medical practitioner observed:²³

Their Lordships would add in relation to the generality of the problem that the philosophy which seeks to divorce the administration from the medical care so as to leave the administrator free from any responsibility for deficiencies in the care of the sick cannot be sound.

[48] There are then the observations of the Court of Appeal in Wislang v Medical

Council of New Zealand, cited by the Privy Council as follows: ²⁴

In our view, the concept of competency in the 1995 Act is related to the principal purpose of protecting the health and safety of members of the public and encompasses any conduct of a practitioner which the Council reasonably considers may directly or indirectly affect their health and safety.

... For instance, the administrative mismanagement of a practice which leads to financial problems for the practitioner, perhaps pushing him towards

bankruptcy, may so distract him that it results in a deterioration of his health

and, as a consequence, his clinical abilities may be affected. It must therefore surely be permissible for the Council when considering the

issuance of a certificate to interest itself in the applicant’s ability to

administer his or her practice.

[49] The Privy Council in the same case then record their agreement with the following:²⁵

Disorganisation in this respect would clearly impact upon the health and safety of his patients. The Council was entitled to consider that Dr Wislang’s inadequacies might well indirectly affect his clinical performance. The imposition of the conditions was a valid exercise of the Council’s power under section 54.

²² Roylance v General Medical Council [1999] UKPC 16; [1999] 3 WLR 541 (PC)

²³ Ibid, at 559

²⁴ Cited with approval in Wislang v Medical Council of New Zealand [2004] UKPC 59 at [18]

²⁵ Ibid, at [22]; refer also Sadler v GMC [2003] UKPC 59 at [63]

[50] While both Roylance and Wislang dealt with different statutory contexts and were concerned with professional misconduct per se, the underlying reasoning is apposite here, namely that administrative tasks that directly touch and concern public health and safety relate to conduct within the scope of practice. Furthermore, as those authorities make clear, health professionals must not discard their duties as medical practitioners when undertaking administrative duties as they must at all

times have regard to patient care.²⁶ For example, the simple “administrative task” of

recording the drug to be dispensed to a patient could have drastic consequences if done negligently. It would be nonsensical to suggest that this recording exercise is not conduct in relation to Mr Vohora’s scope of practice.

[51] Fourth, “context is everything”.²⁷ Section 100(1)(a) is specifically concerned with discipline for professional misconduct at the interface of health professionals and the public. In my view, the integrity of the disciplinary process, in this context, requires a net of fine mesh. Any doubt about the capability of the Tribunal to discipline health professionals in relation to their scope of practice as it relates to patient safety must be resolved in a way that favours greater scrutiny and accountability. This in turn strongly suggests that s 100(1)(a) includes conduct necessarily and directly incidental to securing safe clinical practices, and in particular administrative procedures identified by the responsible authority as providing surety.

[52] Finally I prefer to approach s 100(1)(a) in this way as it avoids the artifice of trying to force all conduct associated with professional services into the definition of scope of practice for the purpose of discipline. The critical issue will be one of proof of direct nexus between the scope of professional practice, patient care and the conduct in question. That will be a matter also of transparent assessment of fact,

_{rather than a mobile concept of scope of practice.}

²⁶ Refer R (on application of Remedy UK Limited) v The General Medical Council [2010] EWHC,

1245 (Admin), Elias LJ at [37] for a summary of the key propositions arising from Roylance and other authorities. See also O Bradfield “Serving Two Masters? Recent Legal Developments Regarding the Professional Obligations of Medical Practitioners in Australia” (2001) 18 JLM

545 at 548

²⁷ McGuire v Hastings District Council [2001] UKPC 43; [2002] 2 NZLR 577 (PC) at 589, per Lord Cooke

[53] Turning to the present facts, Mr Vohora admits that he did not keep a CDR or SOPs relating to dispensing of pharmaceutical products. He accepts that the former was actionable as professional misconduct under s 100(1)(a) while the latter was not. I disagree with this last aspect. Documented SOPs relating directly to the clinical management of medicines provide surety to the responsible authority that the professional is cognisant of the standards and procedures expected of him or her. Their functional value to the responsible authority lies in securing, in a readily transparent and workable way, awareness of acceptable procedures by professionals. There may be occasions where an SOP is irrelevant to the safe conduct of the practice. That will be a question of fact in each case.

[54] On that basis, I do not accept Mr Vohora’s claim that the Tribunal erred by including particulars (c) and (e) for the purposes of exercising its disciplinary powers under s 100(1)(a). The related substantive issue remains however, namely whether Mr Vohora’s deliberate administrative failures amounted to malpractice. I now turn to address this issue.

“Malpractice”?

[55] While the threshold test is simply one of malpractice, I prefer to approach the threshold for discipline under s 100(1)(a) on the basis that there must be a serious departure from acceptable ethical and clinical standards. Mere carelessness will not suffice.²⁸ I proceed on that basis.

No CDR

[56] The failure to keep a CDR was serious professional misconduct. While Mr Withnall says that failure attracts only a fine, the deliberate nature and prolonged period of the failure demands sanction, as the Tribunal found. Mr Withnall submitted however that the Tribunal’s findings about the potential harm were conclusory, there

_{being no evidence that the controlled drugs were improperly distributed. I disagree.}

²⁸ Consider Joanna Manning “Professional Discipline of Health Practitioners” in PDG Skegg and Ron Paterson (eds) Medical Law in New Zealand (Brookers, Wellington, 2006) at 632-633 and cases cited therein.

The functional value of a CDR is obvious – it provides a transparent method for accounting for the controlled drugs. The potential for harm is proportionate to the capacity of regulatory agencies to monitor the distribution of controlled drugs. In short, the weaker the capacity to monitor, the greater the potential for unchecked abuse and therefore harm. While there may be no evidence of actual harm – and with respect it is not difficult to see why that might be so – the “potential” for harm was high because the complete absence of the register greatly inhibits the capacity of regulatory agencies to monitor abuse.

[57] There is, however, evidence of a different record of controlled drugs, and the agreed statement of facts records that Mr Vohora showed Mr Sinclair a drawer where he retained the controlled drug prescriptions and invoices for controlled drug purchases. I accept that this mitigated the potential for harm. But the independent assessment remained that the absence of a CDR was a high risk.²⁹ I have no reason to disagree with that independent assessment.

[58] Overall therefore I agree with the Tribunal that the failure to maintain a CDR for a period of four years supported a finding of misconduct amounting to malpractice.

No SOPs

[59] The failure to document the SOPs does not give rise to the same issues in terms of risk to public health. Indeed the Tribunal says:³⁰

103.1 The variety of the breaches involved, particularly the failure to maintain a CDR, raise significant issues of public safety.

[60] There are then however the findings by the Tribunal linking the absence of the SOPs to harm minimisation and patient safety.³¹ But read as a whole the dominant concern of the Tribunal in relation to the SOPs concerned maintenance of

²⁹ Common Bundle of Documents Volume 1, para 3.15 at 36

³⁰ Decision of the New Zealand Health Practitioners Disciplinary Tribunal 400/Phar11/183P, 23

September 2011, at para 103.1

³¹ Ibid, at paras 91.3 and 93.

professional standards as a method for securing patient safety,³² rather than suggesting that there was any proof of high risk of harm to patients. I see nothing wrong with this reasoning process.

[61] But all of that does leave open an issue as to the severity of the misconduct. In the absence of a finding of actual harm, does the failure to document SOPs amount to malpractice? In this regard there was evidence that Ms O’Sullivan was engaging in activities relating to dispensing of pharmaceutical product. The full extent of her role is disputed. I address whether she was dispensing product below. There was however a sufficient evidential basis for the Pharmacy Council to be concerned that SOPs dealing with dispensation should have been in place and were not. Balanced against this I accept that Mr Vohora maintained a close eye on

Ms O’Sullivan’s work.³³ There is also the suggestion from Mr Withnall that many of

the activities requiring SOPs were not undertaken at Mr Vohora’s pharmacy.³⁴ There was also evidence that Mr Vohora kept a dispensing diary, and employed a check list method used by other health professionals. All of this mitigated the scale of the non- compliance.

[62] Nevertheless, overall, the valid concern remains that the Pharmacy Council, as the responsible authority, could not be sure that the standards expected by the profession were documented and made known to staff so that there could be some basic surety that those standards were being maintained if and when needed.

[63] The tipping point is the deliberate extent of the failure. Mr Vohora’s principled protest, extended over a very lengthy period, is plainly contrary to the objective of securing standards of practice across pharmacists. Uncensored protest of this kind impacts on the integrity and capacity of the profession to self regulate. It is also a substantial departure from a stated purpose of the Act, namely to secure a

_{consistent accountability regime across all health professionals.}

³² Ibid, at para 103.2.

³³ Refer, for example, transcripts at 66-69.

³⁴ Submissions of appellant at 84

[64] Accordingly, for the reasons I have set out above, I have come to the view

that Mr Vohora’s first ground of appeal must fail.

Conflating s 100(1)(a) and (b)

Argument

[65] Mr Withnall complains that the committee did not deal with the alleged breach under s 100(1)(b) in “the alternative” in accordance with the charges brought against Mr Vohora.

[66] Section 100(1)(b) in contrast to s 100(1)(a) states:

100 Grounds on which health practitioner may be disciplined

(1) The Tribunal may make any 1 or more of the orders authorised by section 101 if, after conducting a hearing on a charge laid under section 91 against a health practitioner, it makes 1 or more findings that—

...

(b) the practitioner has been guilty of professional misconduct because of any act or omission that, in the judgment of the Tribunal, has brought or was likely to bring discredit to the profession that the health practitioner practised at the time that the conduct occurred; or ...

[67] Mr Withnall says that this procedural error then manifested itself in the form of a substantive error, whereby the Committee in effect mixed and matched the offending under both s 100(1)(a) and (b) to arrive at findings of malpractice, bringing discredit to the profession and final penalty. Mr Withnall thus contends that by conflating the two sections and alleged offending under each, the Committee has both acted outside its statutory powers and then compounded that error by taking a cumulative approach for the purposes of discipline. Referring by analogy to s 10 of the Crimes Act 1961, Mr Withnall submitted that it must be wrong to prosecute the same misconduct under two different subsections.

[68] Mr McClelland says the Council did not conflate s 100(1)(a) and (b). Rather, Mr Vohora’s conduct was considered cumulatively and warranted discipline in that the particulars amounted to malpractice and to bringing discredit to the profession.

The different tests under these subsections were also identified. There is no mixing and matching of the requisite tests. He says that the approach taken was consistent with previous Tribunal decisions and with authority.³⁵

Assessment

[69] The Tribunal observed:

103. ... Considering Particulars A, C and E cumulatively, the Tribunal is satisfied that they amount to malpractice, and to the bringing of discredit to the profession. ...

[70] As Mr McClelland contends, the Tribunal formed the view that the misconduct crossed both the threshold for malpractice and for bringing the profession into disrepute.

[71] The Tribunal also approached penalty on a totality basis. The Tribunal said:

121. Thus, the Tribunal was left with a situation where there was a wide range of breaches, and lukewarm commitment to the maintenance of professional standards following the liability findings of the Tribunal. Mr Vohora appeared to have no real appreciation of how serious the difficulties are for which he was responsible. An example of the lack of insight was the submission that an outcome for the professional misconduct charge and the failure to hold a practising certificate should simply be dealt with by way of a censure only.

[72] The Tribunal thus concluded:

128. ... In the end, the two key criteria that weigh with the Tribunal are that it must ensure that the health and safety of members of the public is properly protected on the one hand, and that the maintenance of professional standards is also recognised. Given all the factors that it has considered, and having particular regard to the two criteria just mentioned, the only responsible step the Tribunal could take on the basis of the circumstances disclosed to it is that Mr Vohora’s registration be cancelled; and that conditions be imposed under section 102. ...

³⁵ IRG v Professional Conduct Committee of the Psychologists Board [2009] NZCA 274; [2009] NZAR 563 (CA)

at [4]

[73] As Mr Withnall asserts, the Tribunal combined misconduct under s 100(1)(a) and (b) and then arrived at a penalty for both. In doing so the Tribunal fell into procedural error. I preface my reasons for this conclusion by observing that there is nothing jurisdictionally inappropriate in charging a health practitioner under both subsections in relation to the same conduct. Nor do I see any inherent flaw in adopting a totality approach to the misconduct in arriving at a final penalty. If the professional conduct committee considers that the conduct in question triggers both thresholds, then the committee may lay the relevant charges and the Tribunal may rule on them. That is specifically contemplated at s 100(1). If both elements are established, then the Tribunal may take a totality approach to them. Indeed it would

be artificial not to do so.³⁶

[74] Mr Withnall’s analogue to s 10 of the Crimes Act is inapposite insofar as concerns the jurisdiction of the Tribunal to make more than one finding of professional misconduct. Section 10 provides, in short, that where an act constitutes an offence under more than one provision of the Crimes Act (or other Acts), the offender may be prosecuted only pursuant to one of those provisions. However, s 100(1) confers a broad power upon the Tribunal to discipline a health professional if it “makes 1 or more findings” of misconduct. If the charge is properly laid, I can see no basis for reading down that discretion to making one finding only or to penalising in relation to one finding only.

[75] But Mr Withnall’s procedural complaint is valid. A Tribunal cannot lawfully commence the hearing with charges laid “in the alternative” but then discipline the professional on a cumulative basis. That is what happened in this case. Mr Vohora was charged under s 100(1)(a) “or in the alternative” under s 100(1)(b).³⁷ Yet Mr Vohora was found guilty and penalised on the basis of findings of misconduct under both subsections. This is procedurally irregular because Mr Vohora was facing

_{one or other allegation of misconduct, not both.}

³⁶ Ibid

³⁷ Refer also paragraph 3 of the charge:

“3. The Committee, pursuant to section 81(2) and 91 of the Act, charges that the conduct of Mr Vohora particularised in paragraphs 2a to e above, either separately or cumulatively, amounts to professional misconduct pursuant to section 100(1)(a) or (b) or (d) of the Act.”

[76] These facts do not resemble the relevant reported facts in IRG.³⁸ This case was cited by Mr McClelland as authority for the proposition that a combined approach was allowable. In that case the practitioner was jointly charged under both s 100(1) (a) and (b). The present type of unfairness did not arise.

[77] I see nothing in the comprehensive scheme of the Act that empowers the Tribunal to conduct its hearings in this way. Part 4 proceeds on the basis that the professional conduct committee will “formulate an appropriate charge” and “lay it before the Tribunal.”³⁹ The Tribunal may make any one or more orders authorised by s 101 after conducting a hearing “on a charge laid.”⁴⁰ Its power therefore to make an order under s 100 is circumscribed by the scope of the hearing and the charge

laid.

[78] Nor am I prepared to overlook the exercise of a disciplinary power beyond the scope of the charge laid. The principle of legality I have already touched upon demands minimum standards of fairness and Parliament is to be presumed to legislate consistently with them.⁴¹

[79] But I am not concerned about mixing and matching of the elements of the alleged misconduct for the purposes of the s 100 evaluations. I agree with Mr McClelland that the Tribunal enunciated the thresholds for each subsection and then applied them. I also consider that the conduct was amenable to findings under both subsections. Mr Vohora was engaged in a principled protest, directly challenging the policy of the Pharmacy Council to require SOPs. It was designed to discredit that policy and therefore the Council. It is not difficult to see why a charge under s 100(1)(b) was therefore appropriate. Furthermore Mr Withnall’s complaint that the particulars A, B and C must fall under one or other category of professional

_{misconduct with respect conflates “cause” and “effect”. The cause of complaint may}

³⁸ Supra at 35.

³⁹ Health Practitioners competence Assurance Act 2003, ss 81(2) and 91(1)(b).

⁴⁰ Ibid, s 100(1).

⁴¹ See Lord Steyn in R v Home Secretary, ex p Pierson [1997] UKHL 37; [1998] AC 539 (HL) at 588. See also Refugee Council of New Zealand Inc v Attorney-General [2002] NZAR 717 (HC) at [57]; Matthew Smith New Zealand Judicial Review Handbook (Brookers, Wellington, 2011) at 14.6.1; HWR Wade and CF Forsyth Administrative Law (10^th ed, Oxford University Press, Oxford,

2009) at 17-20. See also the New Zealand Bill of Rights Act 1990, s 27.

well relate to professional conduct within the scope of practice. The effect may nevertheless bring the profession into disrepute. Plainly the two types of misconduct are not co-extensive. But the critical issue is whether the conduct amounts to malpractice and/or brings the profession into disrepute. While no clear line is drawn by the Tribunal between the reasons for the respective findings under s 100(1)(a) and (b), I am satisfied that the decision identifies reasons for reaching its view that both

thresholds are met.⁴² I therefore see no substantive error in this regard.

[80] I further apprehend that the final penalty was based on the features of the misconduct rather than its combined categorisation. I therefore do not consider that Mr Vohora was significantly prejudiced by the cumulative approach taken.

[81] Nevertheless I remain concerned that the Tribunal, dealing with a lay litigant, unfairly combined the categorisation of the offending to the ultimate detriment of Mr Vohora. With respect to the otherwise careful approach taken by the Tribunal, if the professional conduct committee wanted to seek a penalty on a cumulative basis, then it should have laid a charge to that effect. As a minimum this affords a health professional with the opportunity to consider his or her response to the combined allegations of misconduct. In this case, the Tribunal should also have adjourned the proceedings and required an amended charge when it resolved to proceed on a cumulative, not alternate basis.

[82] In those circumstances, I record that the Tribunal proceeded in error by taking a combined approach to s 100(1)(a) and (b). In doing so it acted outside of the scope of the charge laid. I address the implications of this in my discussion on penalty.

Vires of Quality Standards and Code of Ethics

Argument

[83] Mr Withnall contends that the quality standards do not derive from the Code of Ethics 2004, or if they do, the Code of Ethics 2004 is ultra vires the Act insofar as

it purports to require SOPs. He submits that while s 118(i) of the Health Practitioners Competence Assurance Act 2003 provides that the Pharmacy Council may promulgate a code of ethics, that code of ethics must deal with clinical, cultural and ethical competency, not administrative competency. He also says that there is no evidence to suggest that Mr Vohora was issuing the wrong medicines or drugs to customers or dealing with customers in a culturally inappropriate or unethical manner. Therefore, he contends that particular (e) of the charge had no proper basis.

Assessment

[84] This contention essentially drives from Mr Withnall’s primary submission about scope of practice and that administrative tasks have nothing to do with that scope of practice. I disagree. I consider that the quality standards are properly sourced in the Code of Ethics 2004 and that the Code is vires the Act. I accept that a responsible authority must promulgate codes of conduct that relate to the scope of practice and not in relation to matters extraneous to that practice. I accept that the Code must be concerned with clinical, cultural and ethical competency. But the overriding consideration must be to maintenance of competency and fitness to practice so as to secure patient safety. Provided that the Code of Ethics demonstrably seeks to achieve this outcome via maintenance of standards relating to the scope of practice, then in my view there can be no proper basis for challenging the ambit of the Code or the vires of it.

[85] I also consider that linkage between the quality standards, the Code of Ethics, the scope of practice and patient care is sufficiently clear. I do not consider it necessary to burden this already lengthy judgment with a detailed essay as to why that is so. In short, the standards demonstrably relate to clinical management of medicines and delivery of services to the public. Plainly not all standards will be relevant to every pharmacy all of the time. They must also be applied in a commonsense and relevant way. But Mr Vohora’s complaint has always focused on

SOPs relating to delegation of dispensing duties to staff.⁴³ He thinks that such SOPs

are inappropriate, because core clinical functions should not be delegated. Whatever the merits of Mr Vohora’s personal view, there can be no doubt that SOPs dealing with dispensing relate to the concept clinical competency envisaged by s 118(i) of the Act.

[86] Mr Withnall also complains that there is no logical connection between ethical considerations and the standard operating procedures. I would need more than an argument of apparent logic to find that the Pharmacy Council, comprised of health professionals, had erred in drawing such linkage. No doubt there will be examples where I might disagree with the Council. I might query why a SOP dealing with waste disposal is attached to that part of the Code of Ethics dealing with “Spirit

of Enquiry.”⁴⁴ But the Pharmacy Council is empowered to make decisions about

what best serves the professional ethics of pharmacists and it is not for me to usurp the function of the Council on these matters, in the absence of illegality (in the administrative law sense)⁴⁵ or impropriety⁴⁶ or perhaps in this case evident logical

fallacy.⁴⁷ There is nothing before me that shows that any of those flaws are present.

[87] Mr Withnall refers to the 2011 code, which does not refer to “Quality Standards for Pharmacy.” He seeks that I infer from that, that there has been a change in thinking on the part of the Pharmacy Council such that non-compliance with Quality Standards and SOPs no longer assumes the same significance. He says this is relevant to penalty. I am not prepared to adopt Mr Withnall’s reasoning on this. First, I am not prepared to undertake a detailed review of a statutory document that postdates the alleged misconduct. Section 100(1)(a) specifically states that the misconduct must arise from any act or omission in relation to scope of practice “in

_{respect of which the practitioner was registered at the time that the conduct}

⁴⁴ Clause 5.4 of the code of Ethics 2004 refers to “Principle 5; Spirit of Enquiry”. That principle

states:

“The pharmacist shall actively seek out contemporary pharmacy knowledge and skills to

ensure a high standard of professional competence”.

⁴⁵ Peters v Davison [1999] 2 NZLR 164 (CA) at 180-181. See also Matthew Smith New Zealand

Judicial Review Handbook (Brookers, Wellington, 2011) at 4.1.3.

⁴⁶ Lab Tests Auckland Ltd v Auckland District Health Board [2008] NZCA 385, [2009] 1 NZLR

776 at [382]-[384]. See also Matthew Smith New Zealand Judicial Review Handbook

(Brookers, Wellington, 2011) at 4.1.4.

⁴⁷ Re Erebus Royal Commission; Air New Zealand Ltd v Mahon [1983] NZLR 662 (PC) at 681.

occurred.” It would be wrong in my view to then measure the severity of that conduct by reference to documents that postdate that conduct. Second, there may be many reasons why the Pharmacy Council elected to remove references to quality standards and SOPs in the subsequent code. Without undertaking a thorough review of those reasons, including other changes that might have been brought about, it would be dangerous to infer that quality standards and SOPs are no longer significant or important.

Other problems

[88] There are related complaints including:

(a) There was no evidence that Ms O’Sullivan was “dispensing” drugs at law. Mr Withnall contended that the activities undertaken by Ms O’Sullivan do not come within the definition of dispensing and therefore there is no proper basis for complaint.

(b) The failure to have a practising certificate was a de minimis issue and never really should have been put to Mr Vohora, given that it did not form part of the original charge.

[89] I am prepared to accept that in a literal sense Ms O’Sullivan was not “dispensing” drugs. “Dispense” or “dispensing” is not defined in the Regulations. The Medicines Act 1981 defines “dispensing” as follows:⁴⁸

dispensing, in relation to a medicine, includes, without limitation, -

(a) the preparation of that medicine for sale to the public (whether in response to the issue of a prescription or a request by an individual to be supplied with the medicine); and

(b) the packaging, labelling, recording, and delivery of that medicine.

[90] I am also prepared to accept Ms O’Sullivan had an essentially clerical

function of accessing existing data, and transcribing it to a check list for approval in the electronic generation of a printed label to be subsequently affixed to the

48 _{s 2}

container if approved. Logically also issuing of the medicines is the primary dispensing function. There is then the evidence that Mr Vohora undertook that aspect of the dispensing exercise.

[91] But with respect to Mr Withnall’s detailed submissions on this point, the meaning given to dispensing must accord with the purpose of the Act, and that meaning, as I have said, must err on the side of greater not less accountability for actions directly concerning public health. While Ms O’Sullivan’s role may have been a purely clerical one, a clerical error could logically impact on patient care. Mr Vohora’s supervision is relevant to the gravity of the misconduct, rather than to the question of whether Ms O’Sullivan was dispensing medicine. Accordingly, I see no merit in this point.

[92] On the failure to have a practising certificate, I agree that this was a relatively minor issue, and I also agree that the Tribunal ought not to have suggested that the amendment was only a technical one given the consequences of a finding of failing to practise with a practising certificate. Having said that, viewing the decision as a whole, I do not consider it had any significant influence on the outcome.

Penalty

Argument

[93] Overall, the essential complaint made by Mr Vohora is that the Tribunal never got the scope of its jurisdiction correct, acted outside the bounds of the legislation, and followed incorrect procedure with the concomitant result that the Tribunal took a cumulative approach to the alleged offending with a most serious disciplinary result. It is accepted that the failure to keep a CDR was a serious breach of professional standards. But to put this in perspective, Mr Withnall noted that this offending, if prosecuted in the proper way, would result only in a punishment of $500 together with a $20 per day penalty. It follows from this that the assumption made by the Tribunal that this was an egregious breach with serious health consequences or public safety consequences was exaggerated and again, without a proper basis.

[94] He also notes that insofar as concerns allegations of danger to public safety, the findings are simply conclusory. It is simply assumed by the Tribunal that the relevant administrative breaches raise serious and significant public safety issues. He says that given the gravity of the discipline, the Tribunal is obliged to bring much more rigour to its assessment and to fully and properly assess the real public danger consequent upon the alleged administrative errors. In this case, he says all of the evidence points to Mr Vohora closely and carefully managing in a direct sense the operation of his pharmacy and thereby securing public safety. He says further that while a CDR was not kept, all relevant information that might inform such a register was kept. Nor is there any evidence from any third party that drugs were being issued inappropriately or in a manner that was dangerous to public health. Mr Withnall complains that none of this was factored into the reasoning process, because the Tribunal simply assumed that failing to keep the proper records meant that there was a danger to the public. All of which meant that the penalty imposed on Mr Vohora was entirely disproportionate to his alleged offending.

[95] Mr McClelland submits that the purpose of disciplinary powers are well established, namely protection of the public, maintenance of professional standards, appropriate punishment and due consideration to rehabilitation. Mr McClelland submits that the issue of appropriate penalty is ultimately a discretionary matter for the Tribunal and not amenable to general appeal with the principles of general appeal. Overall the totality of Mr Vohora’s conduct was considered and after considering the alternatives the Tribunal found that cancellation was appropriate. Accordingly, Mr McClelland submits that the ultimate result was a fair and proportionate one.

Assessment

[96] I have found that:

(a) The Tribunal was correct to find serious professional misconduct, including in relation to the CDR and SOPs, amounting to malpractice, in relation to Mr Vohora’s scope of practice;

(b) Subject to my comments about procedural irregularity, the Tribunal also had a proper basis for finding that the misconduct brought or was likely to bring discredit to the profession.

(c) The Tribunal should have limited its finding to misconduct under s 100(1)(a) or misconduct under s 1001(1)(b), but this error did not lead to a mix and match approach to the s 100 exercise.

[97] In these circumstances, I consider that the remaining issue for me to determine is whether cancellation was wrong and disproportionate to the findings of misconduct under s 100(1)(a) or, in the alternative, s 100(1)(b). I preface this by observing that, irrespective of its characterisation, the nature of the misconduct is such that the sanction must be significant. Indeed, in my view, little turns on the fact that a cumulative approach was taken to the findings.

[98] For the purpose of my assessment I endorse the following guideline objectives previously employed in various Tribunal decisions when fixing penalty: protection of the public, maintenance of professional standards, punishment, and rehabilitation.⁴⁹

[99] I also respectfully adopt the 5 points identified by Keane J in A v

Professional Conduct Committee: ⁵⁰

[81] First, the primary purpose of cancelling or suspending registration is to protect the public, but that ‘inevitably imports some punitive element’. Secondly, to cancel is more punitive than to suspend and the choice between the two turns on what is proportionate. Thirdly, to suspend implies the conclusion that cancellation would have been disproportionate. Fourthly, suspension is most apt where there is

⁴⁹ Dawson, New Zealand Health Practitioners disciplinary Tribunal 200/Nur09/139P, 28 April

2010; Wallace, New Zealand Health Practitioners Disciplinary Tribunal 221/Nur08/110P,

28 April 2009 at 84 – though there the Tribunal refers to the functions rather than guideline objectives. Refer also A v Professional Conduct Committee HC Auckland CIV 20-08-404-2927,

5 September 2008; Dentice v The Valuers Registration Board [1992] 1 NZLR 720 (HC); J v Director of Proceedings HC Auckland CIV 2006-404-2186, 17 October 2006; Patel v Complaints Assessment Committee HC Auckland CIV 2007-404-1818, 13 August 2007; Taylor v General Medical Council [1990] 2 All ER 263; Ziderman v General Dental Council [1976]

2 All ER 344.

⁵⁰ A v Professional Conduct Committee HC Auckland CIV 2008-404-2927, 5 September 2008

‘some condition affecting the practitioner’s fitness to practise which may or may not be amenable to cure’. Fifthly, and perhaps only implicitly, suspension ought not to be imposed simply to punish.

[100] Having regard to those guideline objectives and points, I consider that cancellation was disproportionate for the following reasons (in no particular order of importance):

(a) First, Mr Vohora was openly protesting what he saw as flawed and irrelevant SOPs. He was stubborn, but he was not acting in a covert way.

(b) Second, there has been no complaint against Mr Vohora by a member of the public. So to that extent there is no evidence of actual harm or grievance caused by Mr Vohora’s practices. Nor is there any evidence of actual (as opposed to potential) harm.

(c) Third, it is likely that some of the SOPs were not in fact needed at Mr Vohora’s pharmacy. While this does not excuse Mr Vohora’s non compliance, the non compliance was not the most egregious of its kind.

(d) Fourth, as I have said, I also accept his evidence that he kept a close eye on the dispensing process and this mitigated the potential for harm.

(e) Fifth, Mr Vohora kept records of his controlled drugs – so he was not completely derelict in his duties.

(f) Sixth, I do not accept the Tribunal’s reasoning that there was no reasonable alternative to cancellation. With respect, that reasoning was intuitive as no other form of formal disciplinary sanction had been tried previously. In the absence of evidence of actual harm, there

should at least be some attempt at a lesser sanction before resort to the most punitive penalty.⁵¹

(g) Finally, there is then the delay taken in bringing this misconduct to a head. The Council and other regulatory agencies really should have acted to enforce appropriate standards with more speed, especially if they had a real concern about patient safety or integrity of professional standards. There is evidence of Mr Vohora’s overt

recalcitrance dating back more than 10 years.⁵² I also note that a

report for the Otago DHB in 2006 dealing with among other things deficiencies in controlled drug records, identified no high risk or critical issues. All of this suggests that the so called protest was in effect allowed to mature without formal censure. By itself this would not be determinative, but in combination with the other matters identified, to now impose the most severe sanction available to the Tribunal appears manifestly excessive.

[101] Having said that I am in no doubt that Mr Vohora should be strongly sanctioned. Mr Vohora cannot now seriously complain when his years of protest and dereliction of duty results in significant sanction for malpractice in relation to the scope of his practice (or, in the alternative, for conduct likely to bring discredit to the profession). I also acknowledge that from the Pharmacy Council’s perspective, Mr Vohora’s refusal to adhere to SOPs, if allowed to continue, would significantly undermine its apparent capacity and integrity to regulate the profession.

[102] I therefore have in mind suspension as the most appropriate level of penalty in this context. I am not prepared however to set a final penalty without hearing from the parties. The gravity of the assessment warrants care. I am also mindful that this may be a case where the Tribunal should be afforded the opportunity to reflect on the

_{appropriate penalty in light of my decision.}

⁵¹ Compare approach taken by Lang J in Patel v Complaints Assessment Committee HC Auckland

CIV 2007-404-1818, 13 August 2007 at [82]

⁵² Refer letter dated 19 April 2001.

Result

[103] I have found that:

(a) The Tribunal erred procedurally by combining findings under s 100(1)(a) and (b) for the purpose of discipline; and

(b) The cancellation was disproportionate; but

(c) Serious sanction is warranted.

[104] In the interim however I prefer to defer my decision to quash the cancellation pending final determination of the appropriate penalty. The current interim orders shall remain in place.

[105] I now invite submissions from counsel as to penalty within 10 working days from the respondent, with ten working days for reply by the appellant.

[106] I also reserve my position on whether, in the circumstances, the question of the term and conditions and period of suspension (if any) should be a matter for the Tribunal. Submissions should address that potential course as well.

[107] Costs are reserved pending final determination.

Solicitors:

Rodgers Law, 151 Princes Street, Dunedin

Kensington Swan, PO Box 10246, Wellington 6143

Copy to:

C S Withnall QC, PO Box 7161, Dunedin