Table 7.1 lists the eight pharmacy registering authorities and the legislation providing for the management of complaints, investigations and discipline of pharmacists.

Table 7.1 Pharmacy regulation legislation dealing with discipline

Jurisdiction	Authority	Legislation specifying disciplinary process
ACT	Pharmacy Board of the Australian Capital Territory	Health Professionals Act 2004 (ACT)
NSW	Pharmacy Board of New South Wales	Pharmacy Practice Act 2006 (NSW)
NT	Pharmacy Board of the Northern Territory	Health Practitioners Act 2004 (NT)
Qld	Pharmacists Board of Queensland	Health Practitioner (Professional Standards) Act 1999 (Qld)
SA	Pharmacy Board of South Australia	Pharmacy Practice Act 2007 (SA)
Tas	Pharmacy Board of Tasmania	Pharmacists Registration Act 2001 (Tas)
Vic	Pharmacy Board of Victoria	Health Professions Registration Act 2005 (Vic)
WA	Pharmaceutical Council of Western Australia	Pharmacy Act 1964 (WA)

In Queensland the legislative provisions directed to the discipline of registrants has been separated from the legislation dealing with the registration of pharmacists. The Health Practitioner (Professional Standards) Act 1999 (Qld) applies to all health professionals, except nurses. The objective of dealing with all health professionals under one piece of legislation is to improve consistency across disciplines with regard to disciplinary processes and outcomes.

The following is a brief outline of the current relevant sections of legislation in each jurisdiction that address complaints, investigations and discipline. There have been recent arrangements as part of the proposed national registration scheme for health professionals (further discussed in Chapter 5) that will impact on disciplinary processes.^[2]

OVERVIEW OF LEGISLATIVE FRAMEWORK

The Acts in each of the jurisdictions that identify the conduct or behaviour of a pharmacist that will generate disciplinary proceedings are not uniform. The types of categories of conduct that constitute a complaint differ between the jurisdictions. For example, there are differences in the definitions of ‘professional misconduct’ and ‘unprofessional conduct’ between the jurisdictions, and in some jurisdictions these terms are not used, relying on the term ‘unsatisfactory professional conduct’ instead. There is therefore a degree of inconsistency both with regard to the terms used, and the different meanings assigned to them.

However, the jurisdictions have similar step-wise processes in place whereby less serious breaches are streamlined and the more serious breaches are referred to committees or panels. However, a significant difference exists between the powers of the various authorities to impose sanctions; for example, in Queensland, Western Australia, Victoria, New South Wales, the Australian Capital Territory and the Northern Territory, the cancellation or suspension of registration is reserved for Tribunals overseen by a judge. In comparison, the Pharmacy Boards of South Australia and Tasmania have the power both to suspend registrations for up to 3 years, and to cancel registrations.

The current generation of Acts in most of the jurisdictions that reserve the authority to cancel or suspend registration, as mentioned above, are markedly different from their predecessors which provided the pharmacy boards with much more power. These changes resulted in part due to criticism that boards were perceived as being ‘soft on their own’ as the majority of board members are pharmacists. Boards were also seen as playing many roles; namely, investigator, prosecutor, judge, jury and executor (notwithstanding appeals to courts). Under such arrangements there was the perception of a lack of separation of powers. However, with contemporary arrangements in many jurisdictions, where the more serious breaches are heard by a tribunal presided over by a judge, there have been anecdotal reports of concerns being expressed that such structures have emasculated boards and contributed to increases in costs. However, there is a lack of evidence that this has in fact occurred.

Australian Capital Territory

The Pharmacy Board of the Australian Capital Territory (the board) is responsible for accepting and considering complaints against pharmacists and the general monitoring of the conduct of the profession under the Health Professionals Act 2004. The Act empowers the board to take disciplinary action against pharmacists who may be in breach of certain provisions of the Act. A complaint can become the subject of an investigation and disciplinary action through either a report made under the Act, a complaint made to the Human Rights Commission under the Human Rights Commission Act 2005, or as the result of a practice review. In general, complaints about the provision of health services are referred to the Human Rights Commission.

Section 18 of the Health Professionals Act 2004 defines the required standard of practice for a health professional as ‘the exercise of professional judgment, knowledge, skill and conduct at a level that maintains public protection and safety’.

The Act provides for the occupational discipline of health professionals by the ACT Civil and Administrative Tribunal (ACAT), established through the ACT Civil and Administrative Tribunal Act 2008. The board has to apply to the ACAT for an occupational discipline order if grounds for discipline exist. The ACAT may refer the matter to a Personal Assessment Panel (in case of physical or mental illness) or Professional Standards Panel. Section 107(1) of the Health Professionals Act 2004 defines the role of a Professional Standards Panel:

A professional standards panel decides whether a registered health professional is contravening, or has contravened, the required standard of practice or does not satisfy the suitability to practise requirements.

The panel must conduct a formal assessment before imposing any disciplinary measures, such as cautioning or reprimanding the pharmacist or imposing conditions on the registration of the pharmacist as considered appropriate. Cases that may require suspension or cancellation of registration need to be referred to the ACAT.

Impairment matters are dealt with by the Personal Assessment Panel. The panel provides a means by which health professionals, whose mental or physical health may be affecting their ability to meet the required standard of practice, can access assistance in dealing with the health problem proactively while simultaneously ensuring that the public is protected.

New South Wales

The Pharmacy Practice Act 2006 provides the Pharmacy Board of New South Wales (the board) with powers to receive complaints, appoint investigators and undertake investigations, initiate or refer disciplinary action, and manage pharmacists who may suffer from impairment.

Part 4 of the Act deals with complaints and disciplinary proceedings. Section 37 defines ‘unsatisfactory professional conduct’ to include:

(a) any conduct that demonstrates that the knowledge, skill or judgment possessed, or care exercised, by a pharmacist in the practice of pharmacy is significantly below the standard reasonably expected of a pharmacist of an equivalent level of training or experience,

(b) a contravention by the pharmacist of a provision of this Act or the regulations or of a condition of the pharmacist’s registration,

(d) a failure without reasonable excuse by the pharmacist to comply with a direction by the board to provide information with respect to a complaint under this Part against a pharmacist,

(e) a failure by the pharmacist to comply with an order made or a direction given by the board or the Tribunal under the act,

(f) a contravention by a pharmacist of section 34A (4) (Power of Commission to obtain further information, records and evidence) of the Health Care Complaints Act 1993,

(g) the supply of precursor drugs, or preparations, admixtures, extracts or other substances containing any proportion of precursor drugs, by a pharmacist in circumstances where the supply of those drugs, preparations, admixtures, extracts or other substances is unnecessary, not reasonably required, or excessive,

(h) any other improper or unethical conduct by a pharmacist in the course of the practice or purported practice of pharmacy (including, for example, commission of sex or violence, or drug related, offences).

‘Professional misconduct’ is defined in section 36 to mean ‘unsatisfactory professional conduct of a sufficiently serious nature to justify suspension or cancellation of the pharmacist’s registration’.

Any person may make a complaint about the professional conduct of a pharmacist. The board is required to notify the Health Care Complaints Commission, established under the Health Care Complaints Act 1993, of all complaints and will reach an agreement with the commission regarding the most appropriate course of action. In responding to a complaint, the board may resolve the complaint itself, decline to deal with the complaint or otherwise refer the complaint to the Health Care Complaints Commission, a Pharmacy Care Assessment Committee, an Impaired Registrants Panel or the Pharmacy Tribunal.

Complaints referred to a Pharmacy Care Assessment Committee may require the pharmacist to undergo skills testing. Both the board and the commission are under an obligation to refer complaints to the Pharmacy Tribunal if they are of the opinion a complaint may provide grounds for suspension or cancellation of a pharmacist’s registration. The board may: caution or reprimand; make an order for the withholding or refunding of fees; order the pharmacist to seek and undergo medical or psychiatric treatment or counselling; impose conditions on a pharmacist’s registration; order the pharmacist to undergo additional training; and order that the pharmacist report back to the board or obtain management advice.

Section 70 specifies that, if the board considers the matter indicates a pharmacist suffers from physical or mental impairment, the matter be referred to an Impaired Registrants Panel. The board may require a pharmacist to undergo an examination before or after it has referred the matter to the Impaired Registrants Panel.

Part 11 of the Act covers the prohibition against directing or inciting an employee to engage in unsatisfactory professional conduct or professional misconduct. This prohibition requires the employer to ensure that they do not direct or incite a pharmacist in their employ to practise at a standard that is significantly below the standard reasonably expected of a pharmacist of an equivalent level of training or experience. An employer found to have breached this prohibition is liable to pay a penalty of $22 000 for the first offence and $44 000 for a second or subsequent offence. If the employer is a corporation, the penalties are $44 000 for a first offence and $88 000 for a second or subsequent offence.

Northern Territory

The Health Practitioners Act 2004 provides the Pharmacy Board of the Northern Territory (the board) with powers to receive complaints, appoint investigators and undertake investigations, refer disciplinary action, and manage pharmacists who may suffer an impairment.

Section 56(2) defines that a health practitioner is guilty of professional misconduct if the health practitioner:

(a) contravenes this Act;

(b) contravenes a foreign health care practice law;

(c) contravenes a code that applies to the health care practice authorised by the health practitioner’s category of registration or enrolment;

(d) contravenes a condition subject to which the health practitioner is registered or enrolled;

(e) when required to have a practising certificate — practises without a practising certificate;

(f) practises in a restricted practice area without an authorisation to practise in the area;

(g) contravenes a condition of an authorisation;

(h) fails to pay, within the time specified, a fine imposed on the health practitioner under section 65(1)(d);

(i) fails to comply with a requirement made of the health practitioner under section 65(1)(f);

(j) fails to honour an undertaking given to the board or tribunal;

(k) is negligent or incompetent in health care practice; or

(l) behaves in a fraudulent or dishonest manner in the health care practice authorised by the health practitioner’s category of registration or enrolment.

Disciplinary hearings are undertaken by the Health Professional Review Tribunal which has the power to: cancel or suspend a pharmacist’s registration; fine a pharmacist, impose conditions on a pharmacist’s practice or advice; and caution or reprimand a pharmacist.

Impaired pharmacists are managed under Part 5 of the Act which provides the board with powers to investigate impairment and require a medical examination. The board may also obtain a performance assessment and undertake a performance assessment hearing.

Queensland

The administration of the Health Practitioners (Professional Standards) Act 1999 is vested in the various health practitioner boards. In essence the Act details both the complaint process, and the investigation process, and defines a number of disciplinary levels that may be invoked by the Pharmacists Board of Queensland (the board). Complaints that relate to service provision or medical records are referred to the Queensland Health Quality and Complaints Commission, established under the Health Quality and Complaints Commission Act 2006.

Pursuant to section 48 of the Health Practitioners (Professional Standards) Act 1999 a complaint to the board may be about ‘… any aspect of a registrant’s conduct or practice, or another matter relating to the registrant that appears to provide grounds for disciplinary action against the registrant’. Also, if the board reasonably believes that an aspect of a registrant’s conduct or practice may provide grounds for disciplinary action it may conduct an investigation on its own initiative; that is, without having received a complaint. In addition, the board may immediately suspend or impose conditions on a pharmacist’s registration if the board reasonably believes that: (a) the registrant poses an imminent threat to the wellbeing of vulnerable persons; and (b) immediate action to suspend, or impose conditions on, the registrant’s registration is necessary to protect the vulnerable persons.

Grounds for disciplinary action are included in section 124 of the Act and include the following:

• the registrant has behaved in a way that constitutes unsatisfactory professional conduct;

• the registrant has failed to comply with a condition of practice imposed by the board;

• the registrant has failed to comply with an undertaking entered into;

• the registrant no longer meets the criteria for registration;

• the registrant has been convicted of an offence against an Act related to the practice of the registrants profession;

• the registrant has been convicted of an indictable offence.

‘Unsatisfactory professional conduct’ is defined in the Schedule dictionary of the Act as:

(a) professional conduct that is of a lesser standard than that which might reasonably be expected of the registrant by the public or the registrant’s professional peers;

(b) professional conduct that demonstrates incompetence, or a lack of adequate knowledge, skill, judgement or care, in the practise of the registrant’s profession;

(d) misconduct in a professional respect;

(e) conduct discreditable to the registrant’s profession;

(f) providing a person with health services of a kind that are excessive, unnecessary or not reasonably required for the person’s wellbeing;

(g) influencing, or attempting to influence, the conduct of another registrant in a way that may compromise patient care;

(h) fraudulent or dishonest behaviour in the practice of the registrant’s profession;

(i) other improper or unethical conduct.

The Act describes the stepwise approach to be followed when disciplinary action is taken by the board. Disciplinary action by the board itself can be undertaken for less serious matters where the board’s powers are limited to advice, caution or reprimand or, with the registrant’s agreement, entering into an undertaking. Matters of a more serious nature may be referred to a Professional Conduct Review Panel under section 126(1)(b) of the Act. The panel can impose conditions on the practice of a pharmacist as well as advising, cautioning or reprimanding a pharmacist. Finally, in those cases where the board could reasonably form an opinion that a pharmacist could face cancellation or suspension of registration, the board will usually refer a matter to the Health Practitioners Tribunal under section 134(1) of the Act. The tribunal sits in the District Court and hearings are before a District Court judge.

The Act also empowers the board to manage impaired practitioners, including persons suffering from mental or physical illness and/or drug addiction. The impaired practitioner may be managed without recourse to disciplinary action, although disciplinary action may be invoked by the board depending on the circumstances.

South Australia

Part 4 of the Pharmacy Practice Act 2007 deals with disciplinary investigations and proceedings. Under the Act the Pharmacy Board of South Australia (the board) must investigate all complaints received. The board may also, by its own initiative, decide that a matter could be grounds for a complaint and refer it for investigation. The board may also refer matters to the office of the Health and Community Services Complaints Commissioner.

‘Unprofessional conduct’ is defined in the dictionary section of the Act as including the following:

(a) improper or unethical conduct in relation to professional practice; and

(b) incompetence or negligence in relation to the provision of pharmacy services; and

(i) a provision of this Act; or

(ii) a code of conduct or professional standard prepared or endorsed by the board under this Act; and

(d) conduct that constitutes an offence punishable by imprisonment for 1 year or more under some other Act or law.

If the board decides to proceed with a complaint it is referred to a Complaints Advisory Committee for investigation. After the investigation of the complaint is completed a committee must either:

1. recommend to the board that the complaint be dismissed; or

2. institute informal proceedings on the complaint or;

3. institute formal disciplinary proceedings on the complaint.

Informal disciplinary proceedings are usually held as part of a regular board meeting. The board may caution or reprimand the pharmacist concerned or accept an undertaking from the pharmacist to take or refrain from taking specified action.

Formal disciplinary proceedings are instituted if a complaint is of a serious nature. The Act empowers the board to act as a Disciplinary Tribunal during formal disciplinary hearings and the board has the power to take one or more of the following actions:

1. remove the defendant’s name from the register;

2. suspend the defendant’s registration, totally or partially;

3. impose on the defendant a fine;

4. impose a condition on the defendant’s registration;

5. require the defendant to take or refrain from taking specified action;

6. caution or reprimand the defendant; or

7. dismiss the complaint.

Section 64 of the Act prohibits a pharmacy owner, pharmacy manager or company providing pharmacy services to direct or pressure a pharmacist or pharmacy student to engage in unprofessional conduct. The maximum penalty is $75 000.

Section 51 of the Act imposes the responsibility on the pharmacist, or health professional that treats a pharmacist, or a university where a pharmacy student is enrolled, to notify the board if they are of the opinion that a student or pharmacist is ‘medically unfit’ to practise. The board then conducts an inquiry to determine whether the pharmacist or student is mentally or physically unfit to practise.

Tasmania

Part 4 of the Pharmacists Registration Act 2001 empowers the Pharmacy Board of Tasmania (the board) to receive complaints, undertake investigations through the instrument of an investigating committee, and undertake hearings both formally and informally. Section 43(2) provides a very broad definition of ‘professional misconduct’ as:

(a) contravenes section 31, section 59(4), section 71C or Part 6, or a regulation that is prescribed as a disciplinary regulation; or

(b) contravenes the Pharmacy Code; or

(d) contravenes a foreign pharmacists law; or

(e) contravenes a condition of the pharmacist’s registration; or

(f) fails to pay, within the time specified for payment, a fine imposed on the pharmacist under section 53(1)(c); or

(g) fails to comply with a requirement made of the pharmacist under section 53(1)(e) or section 56(3) or (4); or

(h) fails to honour an undertaking given to the board; or

(i) is negligent or incompetent in the practice of pharmacy; or

(j) behaves in a fraudulent or dishonest manner in the practice of pharmacy; or

(k) obstructs or otherwise prejudices any inquiry, investigation or disciplinary proceedings under this Act.

Complaints that are of a commercial nature, for example concerns regarding pricing, should be referred to the Health Complaints Commissioner.

An Investigating Committee refers complaints to an informal hearing if it is considered that the complaint relates to a less serious matter. This process provides a pharmacist with the opportunity to appear before the board and give a face-to-face explanation of his or her actions, or provide the board with a written explanation. Should the Investigating Committee consider that the matter is of a serious nature, a formal disciplinary proceeding will be instituted. These complaints are dealt with by the board acting in the capacity of a Disciplinary Tribunal. The board, in its discretion, may take one or more of the following actions as it considers appropriate in light of the findings:

• remove the defendant’s name from the register

• suspend the defendant’s registration, totally or partially, for a period not exceeding 12 months

• impose on the defendant a fine not exceeding 50 penalty units

• impose a condition on the defendant’s registration

• require the defendant to take or refrain from taking specified action

• caution or reprimand the defendant

• dismiss the complaint.

While the matter of impairment is not specifically mentioned in the Act, the board may, under section 43(c), investigate a pharmacist who, it is alleged ‘… lacks sufficient physical capacity, mental capacity or skill to engage in the practice of pharmacy …’

Victoria

The Health Professions Registration Act 2005 covers the regulation of a range of health professions in Victoria, including pharmacists and pharmacy students. Under the Act, the Pharmacy Board of Victoria (the board) investigates complaints of professional misconduct or unprofessional conduct. Section 3 of the Act defines ‘professional misconduct’ as:

(a) unprofessional conduct of a health practitioner, where the conduct involves a substantial or consistent failure to reach or maintain a reasonable standard of competence and diligence; and

(b) conduct that violates or falls short of, to a substantial degree, the standard of professional conduct observed by members of the profession of good repute or competency; and

(c) conduct of a health practitioner, whether occurring in connection with the practice of the health practitioner’s health profession or occurring otherwise than in connection with the practice of a health profession, that would, if established, justify a finding that the practitioner is not of good character or is otherwise not a fit and proper person to engage in the practice of that health profession; …

The Act clearly differentiates between professional misconduct and unprofessional conduct. Whereas the first is defined as a more severe breach of expected conduct, ‘unprofessional conduct’ is defined as:

(a) conduct of a health practitioner occurring in connection with the practice of the practitioner’s health profession that is of a lesser standard than a member of the public or the health practitioner’s peers are entitled to expect of a reasonably competent health practitioner of that kind;

(b) professional performance which is of a lesser standard than that which the registered health practitioner’s peers might reasonably expect of a registered health practitioner;

(d) providing a person with health services of a kind that are excessive, unnecessary or not reasonably required for that person’s well-being;

(e) influencing or attempting to influence the provision of health services in such a way that client care may be compromised;

(f) a contravention of section 94 or the guidelines issued under section 95;

(g) the failure to act as a health practitioner when required under an Act or regulations to do so;

(h) a finding of guilt of—

(i) an offence where the health practitioner’s suitability to continue to practise is likely to be affected because of the finding of guilt or where it is not in the public interest to allow the health practitioner to continue to practise because of the finding of guilt; or

(ii) an offence under this Act or the regulations; or

(iii) an offence as a health practitioner under any other Act or regulations;

(i) the contravention of, or failure to comply with a condition imposed on the registration of the health practitioner by or under this Act;

(j) in the case of a registered pharmacist, if the pharmacist owns or has a proprietary interest in a pharmacy business approved under Part 6, failure to comply with a condition of approval of that pharmacy business;

(k) the breach of an agreement made under this Act between a health practitioner and the responsible board that registered that practitioner.

Section 42 of the Act specifies that a person may notify the board about a practitioner’s ability to practise where there are concerns about the practitioner’s physical or mental health, his or her professional performance or if the practitioner has engaged in professional misconduct or unprofessional conduct. Section 47 provides for the board to investigate a matter on its own motion without having received a notification. Section 40 empowers the board to suspend a registrant’s registration at any time if the board is of the opinion that it is necessary to do so because there is a serious risk that the health and safety of the public will be endangered.

Complaints may also be directed to the Health Services Commissioner under the Health Services (Conciliation and Review) Act 1987. Complaints referred to the Commissioner are in relation to a person failing to provide a service, the service itself, or when a public or private health care institution has acted unreasonably in not properly investigating or not taking proper action upon a complaint about the service that was not provided, or if the complaint is about health records.

At the conclusion of the investigation, the board may caution the pharmacist for any breach of professional practice standards or refer the matter to a Professional Standards Panel or to the Victorian Civil and Administrative Tribunal (VCAT). Section 60 of the Act provides a mechanism for a complaint notifier to apply to the board to establish an Investigation Review Panel if the notifier is dissatisfied with the board’s decision in not taking action or not referring the case to the VCAT.

A Professional Standards Panel may caution or reprimand a registrant, recommend that the registrant undergo counselling, impose a condition on the health practitioner’s registration or endorsement of registration, prescribe changes to the ways in which the registrant practises, or direct the registrant to undertake and complete specified further education or training within a specified period.

In addition to the outcomes identified above, the VCAT may impose a condition on registration, impose a fine, suspend registration for a period of time, or order:

• the undertaking of a specified period of practice under specified supervision

• refraining from doing something in connection with the practice of his or her health profession

• that the practice be conducted for a specified period in a specified way or subject to specified conditions

• that the practice be subject to inspection for a specified period or report to a person at specified intervals

• not employing, engaging or recommending a specified person or class of persons.

VCAT may also cancel the registrant’s registration.

Section 36 of the Act requires medical practitioners to notify the board if they are treating a pharmacist or a registered pharmacy student who suffers from an illness or condition which, in their opinion, impairs or may seriously impair that person’s ability to practise as a pharmacist or that student’s ability to undertake clinical training, and may result in the public being at risk. Sections 51 to 54 provide the board with the power to initiate a health assessment of the registrant or student by a registered health practitioner following the outcome of an investigation.

Western Australia

The Pharmacy Act 1964 provides the Pharmaceutical Council of Western Australia (the council) with powers to undertake investigations and, where appropriate, refer disciplinary matters for hearing by the State Administrative Tribunal.

Section 32(1) of the Act details as follows the grounds for disciplinary action:

(1) There is proper cause for disciplinary action if a pharmaceutical chemist, company or friendly society —

(a) has been convicted of an offence that renders that person, company or friendly society unfit to continue to be engaged in carrying on the practice of a pharmaceutical chemist;

(b) being a pharmaceutical chemist, is by reason of mental or physical incapacity, alcohol, or addiction to any deleterious drug unfit to continue to practise;

(d) is guilty of the breach of an undertaking given by or on behalf of that party pursuant to previous proceedings commenced under this section; or

(e) is guilty of contravening the regulations relating to advertising.

Subsection 4 specifies that the council may deal with the matter if it is not of a serious nature and may fine a registrant up to $2500 in addition to payment of council legal costs. The council may also, subject to the approval of the Minister, by order suspend any licence or registration granted under the Act for a period not exceeding 21 days.

Subsection 2 provides for the council to refer cases to the State Administrative Tribunal that are of a more serious nature. The tribunal inter alia may suspend a pharmacist’s registration for up to 3 years or erase a pharmacist’s name from the register.

PROPOSED ARRANGEMENTS FOR HANDLING COMPLAINTS (‘NOTIFICATIONS’) UNDER A NATIONAL REGISTRATION SCHEME

As part of the establishment of a national registration and accreditation scheme for health professions (discussed in Chapter 5), there have been proposed arrangements for the handling of complaints or ‘notifications’ (to use the term favoured by the National Health Workforce Taskforce) and disciplinary issues in order to improve national consistency. Under the scheme regulatory tools will be implemented that will deal with practitioner competence, health and performance matters, and mechanisms to support a robust and publicly accountable notifications management and disciplinary system.^[2]

Health practitioner boards in the various jurisdictions will maintain the oversight of decisions made in the management of notifications against registered practitioners. It has been recommended to implement three streams for the handling of health practitioner notifications, including complaints, namely:

1. performance (competence) matters

2. health (impairment) matters

3. conduct (disciplinary) matters.

The performance and health management streams aim to protect the public through a proactive approach of identifying practitioners whose practice raises concern but who have not caused harm to a person (or potentially caused harm to a person). The disciplinary stream provides for the approach where harm has been caused or may potentially have been caused.

‘Unsatisfactory professional performance’ is proposed to be used to describe departures from an acceptable standard of professional competence or performance that are not so serious as to warrant suspension or cancellation of registration.

‘Unsatisfactory professional conduct’ or ‘unprofessional conduct’ is proposed to be used to describe conduct that is less serious and unlikely to result in suspension or cancellation of a practitioner’s registration, and therefore does not require referral to an external tribunal for hearing.

‘Professional misconduct’ is proposed to be used to describe conduct that is so serious that if the allegations are proven, might warrant suspension or cancellation of the practitioner’s registration, and therefore requires the board to refer the matter for hearing by the responsible tribunal.

COMPLAINTS AND INVESTIGATIONS

Under the jurisdictional arrangements currently existing in the states and territories, a client or carer, professional colleague or a board may initiate a complaint that may trigger an investigation into the conduct of a pharmacist. Complaints are usually required to be in writing. In certain circumstances boards may act on information received. Although there is a lack of uniformity in the use of terminology and definitions between jurisdictions, there is a significant overlap in intention and the underlying standards that operate to benchmark behaviour appear similar.

When a pharmacist practises in a way that is considered to be below the standard acceptable to the profession, it is likely that disciplinary proceedings will be initiated. Activities which justify the imposition of disciplinary action against a pharmacist can be summarised as:

• unprofessional conduct

• professional misconduct

• suspected mental or physical impairment

• alcohol or drug addiction

• conviction of a serious offence in a court of law

• failure to comply with the regulatory requirements of a board; committing an offence against the legislation

• the cancellation of registration in another jurisdiction.

What constitutes conduct of a sufficiently serious nature to discipline a pharmacist may vary between individuals, the experience a pharmacist has in a particular area and the subjective circumstances surrounding the incident.

The specific process of an investigation is set out in the respective legislation in each of the jurisdictions. In all jurisdictions certain complaints about pharmacists are simultaneously referred to a health complaints unit or commission which attempts to resolve complaints through conciliation and mediation. Conciliation is a confidential forum which seeks to encourage the parties to settle the health service complaint. It can be an effective alternative to litigation in relation to allegations of negligence or personal injury as it is inexpensive, collaborative and confidential. It is also privileged, which means that no information arising as part of the conciliation may be used in a court, tribunal or disciplinary proceeding. However, it should be realised that it can be argued that the aim of conciliation and the aim of investigation and discipline are quite different. The aim of the first is to reach an agreement between two parties; this may be at odds with the objective of registration legislation, which is to protect the public.

Professional misconduct versus unprofessional conduct

Professional misconduct is regarded as a more serious categorisation of misconduct than unprofessional conduct. This distinction was emphasised in the Tasmanian case of Adamson v Pharmacy Board (Tas) [2004] TASSC 32, where a pharmacist’s professional misconduct was defined as:

… behaviour on the part of a member of a profession that would reasonably be regarded as disgraceful or dishonest by members of that profession of good repute and competency.

and unprofessional conduct was defined as:

… conduct which may reasonably be held to violate, or fall short of, to a substantial degree, the standard of professional conduct observed or approved by members of the profession of good repute and competency.

Natural justice

Pharmacy registering authorities must act in accordance with the principles of natural justice throughout the investigative and disciplinary processes. Natural justice was described in Byrne v Kinematograph Renters’ Society [1958] 2 All ER 579 by Harman J as:

… the person accused should know the nature of an accusation made; secondly he should be given an opportunity to state his case; and thirdly of course that the tribunal should act in good faith. I do not think that there is anything more.

The notion of natural justice is to ensure that the proceedings are conducted fairly, impartially and without prejudice. The pharmacy registering authority must therefore provide the pharmacist, against whom the accusations are made, with a clear statement of the actual charge, adequate time to prepare a submission in response to the charge and the right to be heard on all allegations.

Hearings

A pharmacist should be able to put his or her case orally, although there may be circumstances where written submissions may be sufficient. The pharmacist may choose to have legal representation at the hearing, although in some jurisdictions when hearing matters of a less serious nature a legal representative may be present to advise the pharmacist but not present on his or her behalf.

Evidence and standard of proof

The legislation entrusts the pharmacy registering authorities with broad discretionary powers relating to the amount of evidence, the type of evidence, and the source of the evidence that may be admitted into the proceedings for consideration in determining the outcome of any matter.

The rules of evidence do not strictly apply in disciplinary proceedings involving health professionals.^[3] Therefore, a board, disciplinary committee, panel and even a tribunal may admit and inform itself of matters which, in the judicial adversarial process, would be excluded from consideration based on the inadmissibility of the content. The disciplinary body therefore has the potential to admit and consider a broader range of information or materials than that which may come before a court. However, although the rules of evidence do not need to be followed in disciplinary proceedings, they generally provide guidance in terms of fairness and the general conduct of proceedings.^[3]

As a general principle, the admissibility of evidence is determined initially on the relevance of the information to the facts in issue and, then, in weighing up the probative value (the extent to which admitting the evidence would assist in reaching the truth) of having the information against the prejudicial impact (the extent to which it operates against the defendant) that the information may have on the determination.

The common law test is used frequently in the form of ‘peer review’ evidence, as defined by Priestly JA in Qidwai v Brown [1984] 1 NSWLR 100 at 105–106:

Whether the practitioner was in such breach of the written or unwritten rules of the profession as would reasonably incur the strong reprobation of professional brethren of good repute and competence.

In all jurisdictions the standard of proof required for making a finding is the civil standard, ‘on the balance of probabilities’, and not the more onerous criminal standard of ‘beyond reasonable doubt’. This is in accordance with the Briginshaw test that was defined in Briginshaw v Briginshaw (1938) 60 CLR 336, and is the standard followed in Australia in regard to all disciplinary proceedings. The rationale for the lower standard is that the jurisdiction is protective towards the public, and a professional may need to be excluded from practice in order to protect the public on the basis of facts that are impossible to prove beyond reasonable doubt.^[3] However, according to the Briginshaw case, the clarity of proof required to discharge the burden must reflect the seriousness of the charge.

OUTCOMES OF DISCIPLINARY ACTION

Mutual recognition legislation gives effect to the results of disciplinary action in other jurisdictions. Therefore, in the case where a pharmacist’s registration is cancelled or suspended by a registering authority as a result of disciplinary action, authorities in other jurisdictions, whether interstate or overseas, may give effect to that order. The jurisdictions have similar stepwise processes in place whereby less serious breaches are managed through streamlined procedures and more serious breaches are referred to committees or panels. However, a significant difference exists between the powers of the various authorities to impose sanctions. In Queensland, Western Australia, Victoria, New South Wales and the Australian Capital Territory, the cancellation or suspension of registration is reserved for tribunals, presided over by a judge. In comparison, the Pharmacy Boards of South Australia, Tasmania and the Northern Territory have the power to both suspend registrations for up to 3 years and to cancel registrations.

In general, disciplinary bodies are able to apply a broader range of penalties that are more remedial than are those available through the courts.^[3] Disciplinary sanctions imposed on health professionals through regulatory authorities do not follow a punitive approach, but rather seek to protect the public by specific and general deterrence. Therefore, one of the aims of disciplinary actions is to deter other pharmacists from similar behaviour. Additionally, disciplinary outcomes also serve to maintain the reputation and standing of health professionals.^[4] These two outcomes need to be balanced.

Severity of penalties imposed

Weighing the interests of practitioners against the interests of the public may cause some difficulty. This is evident from the decisions of two disciplinary cases that have been appealed to the Supreme Court of Victoria following the imposition of sanctions by the Pharmacy Board of Victoria. Although the court upheld the board’s decisions in the two cases with regard to the pharmacists’ conduct, it did not support the penalties imposed by the board, as these were considered too severe, and less harsh penalties were subsequently imposed.

Mercer v Pharmacy Board (Vic) [1968] VR 72 dealt with a pharmacist who was absent from the pharmacy while it was open and professional services were provided. The court upheld the board’s finding that the pharmacist had been guilty of conduct discreditable to a pharmaceutical chemist, but found the cancellation of registration penalty imposed by the board too severe, and imposed a less harsh sanction. Pape J made the following comment in considering the board’s penalty (at 93):

I am conscious of the fact that the board, composed as it is of pharmaceutical chemists who are charged by statute with preserving discipline among pharmaceutical chemists, is infinitely better able to assess the appropriate penalty than I am, and I am not anxious to undermine their authority or discourage them from taking firm action in the interest of the public and the profession nor am I anxious to take any action which might be construed as an indication that I do not regard the conduct proved against the appellant as anything but most serious.

However (at 94):

There are, I think, a number of factors which would indicate that the penalty imposed by the board (which is the most severe penalty that it could impose) was excessive in all the circumstances.

The court instead imposed a 4-week suspension.

The case of Ha v Pharmacy Board (Vic) 18 VAR 465; [2002] VSC 322, did not directly involve the practice of pharmacy but rather, as stated by Gillard J (at [89]), was brought to ‘uphold the law’. Mr Ha, a pharmacist, indecently assaulted two young females (14 and 20 years old) during job interviews. In the Supreme Court of Victoria, Gillard J acknowledged (at [84]) that, in determining:

… the standard that one would expect of the reasonable competent pharmacist or the good character and reputation expected of a pharmacist, the members of the board are usually in a better position than this Court to make an assessment of those matters, and in those circumstances, the Court should attach substantial weight to their findings.

Gillard J further observed (at [86]) that the inappropriate behaviour of the appellant:

… was not confined to the practice of pharmacy … However, his conduct does have a connection with the practice of pharmacy in that he was able, by reason of his position as a pharmacist, to deceitfully induce the potential employees to go along with his investigation because, as a pharmacist, he was concerned about the theft of drugs.

He postulated that the Pharmacy Board of Victoria had a joint focus, namely the protection of the public as well as the protection of the reputation of the profession itself. However, Gillard J considered the order of the board that the pharmacist’s registration be suspended and concluded that, in this case, suspension was not necessarily to protect the public but rather to maintain the profession’s standing. He held (at [84]):

[W]here the issues involve matters that do not depend upon the practice of pharmacy, then the Court is in as good a position as the board to make its own assessment of the penalty.

Therefore, although the court upheld the board’s finding of professional misconduct, it found the 3 months’ suspension unreasonable considering the circumstances, and imposed a less severe penalty. Mr Ha was fined $1500 and given a 2-year community-based order to perform unpaid community work, and to undergo psychological or psychiatric treatment as directed.

As part of the disciplinary process is to maintain appropriate standards within the profession and to maintain public confidence in health professionals, it can be questioned whether the Supreme Court of Victoria’s lighter sanctions in these two cases were in the best interest of the public, or whether they acted to deter other pharmacists. The court does not consistently impose less severe sanctions than the board. In Loewy v Pharmacy Board (Vic) [1991] VSC 11301 the court upheld the Pharmacy Board of Victoria’s penalties and dismissed an appeal against a 3-month suspension for Mr Loewy. This case dealt with the supply of huge quantities of ephedrine to customers. Hedigan J, in his decision as to whether the penalty was appropriate, held (at [32]):

With respect to penalty, the court ought to give weight to the views formed by the relevant professional body created by the Act of Parliament to exercise supervision over the conduct of the members of the relevant profession. Those views have been expressed by the Pharmacy Board and I take them into account.

Another interesting decision was the Supreme Court of Tasmania’s decision to increase the penalty imposed on Mr Adamson in Adamson v Pharmacy Board (Tas) [2004] TASSC 32. This case involved a dispensing error whereby the pharmacist dispensed Panafcortelone® (prednisolone) 25mg instead of 5mg and thereafter incorrectly dispensed a repeat supply of the same tablets. The Pharmacy Board of Tasmania’s order was to allow Mr Adamson to continue to practise but only under the supervision of another pharmacist. However, Mr Adamson was the owner of the pharmacy and the court indicated that it would therefore not be appropriate to make him work under the supervision of an employee. As Mr Adamson was already 80 years old, the court held that his name be removed from the register, but in order to enable the selling of his pharmacy, deferred the deregistration until a later date. Mr Adamson was not allowed to dispense medication during the deferral of his deregistration.

The determination of appropriate sanctions is a complicated issue that will always be controversial: what may be an appropriate sanction in one case may not be so in another case involving a similar breach. The two outcomes that need to be achieved — namely, the protection of the public and the maintenance of professional standards — must be carefully considered.

Publicity of outcomes

An important function of professional disciplinary mechanisms is the publicity given to breaches.^[5] It is important that pharmacists are informed of disciplinary outcomes to enable them to predict the consequences of unprofessional conduct. The publication of disciplinary decisions therefore serves to educate other pharmacists regarding practice requirements and the disciplinary process. An analysis of the impact of the publication of the Royal Pharmaceutical Society of Great Britain Statutory Committee’s decisions in the Pharmaceutical Journal indicated that publication served to inform and deter other pharmacists from similar conduct and played a role in keeping the number of persistent offenders low.^[6]

New South Wales is the only jurisdiction that makes public all disciplinary case outcomes, and all disciplinary decisions since 1990 are published on the Australian Legal Information Institute (AustLII) website. The other jurisdictions mainly publish the more serious outcomes, namely suspension of registration or cancellation in detail, whereas the less serious sanctions are de-identified in newsletters and bulletins to registrants.

Case examples

The following legal cases appear under a number of practice headings and illustrate the range of case law relating to pharmacy practice accumulating in Australia, with a few references to international cases.

Dispensing errors

While the number of dispensing errors is small compared with the number of prescriptions dispensed, any mistake has the potential to cause harm to a patient. Dispensing errors represent a significant proportion of disciplinary cases, which is indicative of the percentage of time pharmacists are occupied with the activity of dispensing and the significance of the dispensing workload.

A 2005 survey of complaints received by the Pharmacy Board of Victoria indicated that over a 78-month period covering 1 July 1998 to 31 December 2004, 45% (73) of the 162 complaints received by the board were associated with dispensing errors.^[7] Labelling errors accounted for 21% and selection errors for 74% of the complaints. The remaining errors were either the dispensing of expired medicines, or the wrong quantity.

More than 50% of dispensing errors reported to Guild Insurance relate to human error.^[8] With regard to the most common pharmacy dispensing errors, PDL identified the two most frequent causes as selection of the incorrect strength of a medicine, and selection of the incorrect product.^[9]

Although most dispensing errors do not cause serious harm, others can have serious consequences. One Queensland case involved the death of a small child as a result of a methadone overdose. The pharmacist incorrectly administered 10 take-away methadone doses to a registered addict in a single bottle rather than separate bottles. Additionally, the pharmacist did not use a child-resistant cap on the bottle, or dilute the take-away doses as was required. The child subsequently swallowed the methadone. Justice Richards made the following comments during the case that was referred to the Queensland Health Practitioners Tribunal:

On the 9th of June Sarah Alder, who was approximately 2 and a half years, died when she ingested the contents of the methadone that was given to Phillips by the Registrant. As I say it is graphic illustration of the need for people who administer dangerous drugs to be scrupulous, not only in their record keeping, but in the procedures that are followed in issuing such medicine. Otherwise tragic consequences such as this can follow.

(Matter of John Allison Shay & Pharmacists Board of Queensland, Health Practitioners Tribunal, 2 November 2004, Richards DCJ)

The pharmacist was suspended from the register for a period of 3 years.

A New South Wales coroner made specific comments about a pharmacist’s responsibility to scrutinise prescriptions and intervene if necessary. These comments followed the death of a 17-year-old female after being prescribed and dispensed an overdose of the opioid Kapanol® with the active ingredient morphine:^[10]

I have formed the view that (the pharmacist) did not pay sufficient heed to that part of his professional role as a pharmacist to scrutinise prescriptions presented to him. He has an independent, professional role to scrutinise and consider every prescription presented to him. He seems to have allowed this aspect of his professional behaviour to be subservient to that of the prescribing doctor.

The public expects that the pharmacist to whom a prescription is presented will act as more than a mere dispenser. The public expects that the pharmacist will act in concert with the medical practitioner whilst performing an independent, scrutinising role.

One hopes that (the pharmacist) examines his practices and attitudes and brings them into line with the proper, professional role of an independent pharmacist. That is not to merely dispense and slavishly follow the directions of a medical practitioner but to scrutinise, question, consider and then act to dispense only if satisfied after those procedures are adopted in relation to each prescription.

In another matter, Daniew [2007] NSWPB 5 (14 November 2007), a pharmacist dispensed five morphine tartrate ampoules 120mg/1.5mL for a patient with chronic back pain. the patient self injected one ampoule resulting in his death the following morning from a morphine overdose. The board report on the matter stated:

The complaint of professional misconduct concerned the dispensing of a drug of addiction, morphine tartrate ampoules 120mg/1.5mL by the pharmacist on or about 29 September 2004, for Mr Wayne Ritchie on a prescription written by Dr Garry Gow. The pharmacist was employed at the relevant time as the pharmacist in charge and is an experienced pharmacist with no prior disciplinary history. Shortly after the morphine tartrate ampoules were dispensed by the pharmacist, Mr Ritchie self injected an ampoule and died. The direct cause of death was a morphine overdose.

The complaint alleged that the morphine tartrate ampoules had been dispensed in circumstances where this was the first occasion in which a drug of addiction had been dispensed for Mr Ritchie at the pharmacy. Mr Ritchie was known to the pharmacist. It was alleged that the pharmacist failed to make appropriate inquiries of the prescriber, Dr Gow and of Mr Ritchie and that contrary to clause 109 of the Poisons and Therapeutic Goods Regulation 2002, the pharmacist supplied the morphine tartrate ampoules in an excessive quantity that did not accord with appropriate recognised therapeutic standards.

The Professional Standards Committee found that the particulars had been proven and made a number of orders including cautioning the respondent against ignoring her legal and professional obligations in the dispensing of drugs of addiction ordered on the prescription of a medical practitioner — in particular, the need to exercise professional judgment to satisfy herself on each occasion that the medication ordered is in a quantity and for a purpose in accordance with recognised therapeutic standards.

The UK case of Dwyer v Roderick (1983) 127 SJ 805 is usually referred to as the Migril case. In this case the doctor negligently directed the patient to take an overdose of Migril® (ergotamine) and the pharmacist failed to spot the error. The patient subsequently took an overdose and suffered gangrene in both feet, requiring extensive surgery. Justice Stuart-Smith rejected the pharmacist’s argument that his position is secondary to that of the doctor, and the court held that it was the pharmacist’s duty to ensure not only that the prescription was correctly dispensed, but also that it was suitable for the particular patient:

… pharmacists have to exercise an independent judgement to ensure that the drug is appropriate for the patient as well as that it conforms to the physician’s requirements.

Mr Justice Keith confirmed the court’s approach towards pharmacists’ liability to ensure the dosage is correct in the recent High Court case of Horton v Lloyds Pharmacy Ltd (2006). In this case the plaintiff, a USA lawyer, Cathy Horton, had an incorrect prescription prescribed by a UK doctor in July 2001, and the pharmacist at Lloyds Pharmacy dispensed the prescription without questioning the dose. The prescription was for dexamethasone 4mg daily instead of her maintenance dose of 0.5mg daily — eight times the dose that she had taken for a number of years. On her return to the USA, a doctor continued to prescribe 4mg daily after reading the dispensing label. By the end of October 2001, Ms Horton had developed Cushing’s syndrome and subsequently required multiple hospital admissions and was unfit for work for many months. She claimed that the negligent over-dispensing ‘wrecked’ her life and robbed her of the chance of making millions from a new business venture. The judge ruled that the accepted wisdom was that pharmacists should consider whether a prescribed medication was suitable for the patient. It should have occurred to the pharmacist that the dose was eight times the strength of those that had been dispensed on seven previous occasions. It was accepted that the deterioration in Ms Horton’s health did not result from the tablets dispensed by Lloyds Pharmacy. However, it was ruled that there was a direct causal link between the pharmacist’s failure to question the prescription and the American doctor providing the 4mg daily dose. Ms Horton claimed £5 million in damages.

In each of these cases the UK courts held that pharmacists possess expertise regarding the supply of medications, and that reliance for that expertise is placed on them by patients and prescribers. This approach has also been followed in the USA; for example, in Riff v Morgan Pharmacy, 508 A.2d 1247 (Pa. Super. Ct. 1986), a case which is very similar to the Migril case. In this case the jury’s verdict was upheld on appeal, awarding 65% fault against the pharmacist for not warning a patient against the maximum dosage for the dangerous and potentially toxic migraine medicine, namely Cafergot® (ergotamine) suppositories. The pharmacy dispensed the medication with the prescriber’s directions on the label to use one by rectum every four hours, with no maximum dose information. As a result of overuse, the plaintiff’s foot suffered permanent damage, causing the patient constant discomfort. The court reviewed pharmacists’ training, internship requirements, and comprehensive licensure examination and stated that:

… a pharmacist is a professional. In the performance of his professional duties, he will be held to the standard of care, skill and intelligence, which ordinarily characterises the profession. In judging the degree of skill, consideration will be made of the advanced state of the profession at the time of the injury.

These cases clearly indicate the responsibility and potential legal liability on pharmacists during dispensing.

Generic substitution

Generic substitution increases the risk that medication errors will not be identified by patients as patients may assume that the incorrectly dispensed medicine is a generic version of the correct medicine. A Victorian pharmacy error, which led to the hospitalisation of a 7-year-old asthmatic boy, involved the incorrect dispensing of Risperdal® (risperidone) instead of Redipred® (prednisolone). The boy’s parents subsequently gave him large doses of risperidone for his asthma.^[11] An important factor that contributed to this potentially fatal incident was the fact that the parents did not identify the error, even though the boy’s father said that they had been issued at least two bottles of the wrong medication by their pharmacy. He further commented:

It comes in the same size bottle, it’s liquid and looks the same. We just thought this other drug was a generic brand of the same drug.^[12]

These comments suggest system failures in both the dispensing and patient counselling processes and the need to educate patients to focus on active ingredients rather than on the brand names.

It has been suggested in the USA that courts should more closely examine pharmacists’ expanded role with regard to cases that involve generic substitution. This is a result of two reported appellate court cases involving drug product selection in which pharmacists were sued for damages.^[13] In Ulman v Grant (1982) 450 NYS 2d 955, the patient presented a prescription to a pharmacy for Septra DS®, a specific brand of sulphamethoxazole/trimethoprim. The prescriber wrote ‘substitution permitted’ on the prescription, and the pharmacy dispensed Bactrim DS®. The plaintiff suffered an adverse reaction and sued the pharmacy. In Bichler v Willing (1977) 397 NYS 2d 57 a pregnant mother was prescribed diethylstilbestrol (DES) and the pharmacy dispensed the Eli Lilly brand. The daughter of the mother claimed severe and permanent injury due to the medicine, and sued the pharmacy.

It is important to note that claims against health professionals in the USA are more common than negligence claims in Australia and the UK. This is mainly because in the USA there are no patient cost disincentives to initiate legal action; for example, an absence of the ‘loser pays’ legal cost rule. However, these cases do provide some insight as the courts had to consider whether the pharmacist’s choice of a specific brand would have made a difference in determining their liability. The courts held that a pharmacist is not negligent unless the pharmacist knowingly dispenses a medication that is inferior or defective. Hence, if the generic medicine is not inferior or defective, the injury is not foreseeable. Therefore, both plaintiffs in these cases were unsuccessful in establishing pharmacist liability. However, it has been argued that these cases were considered before the role of pharmacists had expanded, and that today’s courts would give closer examination to pharmacists’ expanded role in selecting an appropriate generic product.^[13] An in-depth analysis of the theories of potential pharmacist liability and claims of professional negligence had subsequently been undertaken by legal and pharmacy practice experts in the USA.^[13] The authors concluded that pharmacists undertake new responsibilities under medication selection law (common law and legislation), and might be exposed to liability if injuries were to occur when generic medicines were substituted for prescribed brand medicines. Three possible theories were identified under which pharmacies might be held liable for injuries sustained in medication product selection situations, namely: (1) negligence; (2) express or implied warranties; or (3) strict product liability.

It is not known which theories would apply in Australia, as there is a lack of case law, and therefore precedent. However, it is clear that the increase in generic dispensing places additional time constraints on pharmacists. There is also an increased need for professional judgment, and hence increased risk of error.

Lack of advice or written information

The provision of advice fulfils an important risk management activity. However, a 2004 review of 51 investigations involving dispensing errors undertaken by the Pharmacists Board of Queensland found that in all but one case, counselling had not been provided by the pharmacist.^[14] Similarly, the Pharmacy Board of New South Wales, in investigating more than 6000 complaints over 10 years, estimated that, had the patient been counselled, at least 25% of medication errors might have been detected before handing out the medication.^[15] Both the Queensland and New South Wales boards indicated that they accept there is little need for counselling to be provided on every occasion a prescription is dispensed, and that pharmacists need to use professional judgment.

In the case where a pharmacist has not counselled a patient or carer and the patient suffers a medication adverse event, it would be reasonable in a disciplinary investigation to establish whether the lack of counselling is professional conduct ‘of a lesser standard than those expected’, or whether the pharmacist’s conduct demonstrates a lack of judgment or care.^[14] In a 2005 Pharmacists Board of Queensland investigation involving the dispensing of the cytotoxic medicine methotrexate, it was found that lack of counselling by the pharmacist and the failure to provide any written information had significantly contributed to the patient’s dosing error.^[16]

Pharmacists could potentially be liable for not providing appropriate written information in the case of an adverse event. This legal liability was demonstrated by the US case of Cottam v CVS Pharmacy (2002) 436 Mass 316, 764, NE 2d 814. In this case the court found the pharmacy 51% negligent for not warning a patient of priapism as a potential side-effect of the antidepressant trazodone; the patient was left permanently impotent as a result of using the trazodone. The court found that the pharmacy voluntarily assumed a duty to provide information, advice and warnings to a patient as it was the pharmacy’s normal practice to issue a ‘long form’ list of side-effects when a medicine was dispensed for the first time. By giving out a list of information as part of normal practice the pharmacy voluntarily assumed a duty to warn and in so doing had to perform that duty with due care. The court found that where the information provided could be reasonably understood by the patient as a complete list of side-effects, it is appropriate to impose the duty to warn as to all potential side-effects. The Illinois Appellate Court in Frye v Medicare Glaser Corp. (1992) 605 Ill NE 2d 557 similarly ruled that a plaintiff may maintain an action against a pharmacist who voluntarily assumes a duty to warn of a medicine’s adverse reactions, but does so in an incomplete manner.

In the matter of Sedrak [2007] NSWPB 4 (10 October 2007), the Pharmacy Board of New South Wales brought disciplinary action against a pharmacist, in part for the lack of adequate counselling on three occasions that lead to complaints. The board report on the matter stated:^[17]

The complaint of professional misconduct encompassed events arising from the dispensing of paediatric prescriptions by the pharmacist, the sole proprietor and pharmacist in charge of the pharmacy. In the first incident the medication for a 20 months old infant was placed in a box containing a directions label for another adult patient. The child had an adverse reaction to the medication. The complaint alleged certain failures in the pharmacist’s dispensing process, including a failure to counsel. In the second incident the pharmacist dispensed a medication for a 10 year old girl, which had an approved indication for the treatment of a prostatic condition, without verifying with the prescriber the intended use of the medication in a female child or satisfying himself as to the therapeutic purpose of such supply contrary to clause 53 of the Poisons and Therapeutic Goods Regulation 2002. The pharmacist had also failed to counsel the mother of the patient as to the dosage and administration of the medication. In the third incident the pharmacist had supplied antibiotic eye drops and eye ointment for a 20 months old child, without a prescription from a medical practitioner, contrary to Section 10(3) of the Poisons and Therapeutic Goods Act 1966. The pharmacist admitted some of the particulars of the complaint. No witnesses were called for cross examination by the Respondent.

The dispensed medicines involved in the three instances were prednisolone, tamsulosin (used for prostatic hyperplasia), and Chlorsig® eye ointment and Chlorsig® eye drops (active ingredient chloramphenicol) respectively. The Professional Standards Committee found these matters were proven to its satisfaction and the pharmacist was:

… reprimanded and educative orders were imposed including the submission of written dispensing process, a related tutorial presentation and inspection/audit of such procedures. The pharmacist was required to obtain and maintain Quality Care Pharmacy Program Accreditation for any pharmacy in which he has a pecuniary interest with annual assessments for 3 years following accreditation and assessment results being provided to the board. The costs of complying with these orders are to be borne by the pharmacist.

PROFESSIONAL NEGLIGENCE

Disciplinary proceedings through the pharmacy registering authorities to the tribunals are distinct from proceedings initiated through the adversarial court system. Action through the adversarial court system in the main involves a claim of medical negligence, which is a civil action initiated under the law of torts. The focus of civil litigation is to seek financial compensation. Although health care negligence litigation in Australia has historically mostly involved medical practitioners, the case law principles are applicable to all health professionals, and all health professionals are potentially liable for damage or injury sustained by a patient while under their care.^[21]

In terms of a civil action of negligence, a person alleging that a pharmacist was negligent must prove, on the balance of probabilities, that an act or omission was causally linked to an injury. For a claim to be successful there must have been a legal duty to take care on the part of the pharmacist, and the breach thereof resulting in damage suffered by the person. To succeed in a claim of negligence, the patient (plaintiff) must be able to establish, on a balance of probabilities, all four elements of a negligence action, namely that:

1. a duty of care was owed by the pharmacist (defendant)

2. there was a breach of that duty in that the pharmacist’s conduct fell below the required standard of care, which includes omitting or failing to do something or by doing something incorrectly

3. the breach of duty caused or materially contributed to the damage suffered — be it physical, mental or economic loss

4. the loss or damage suffered was reasonably foreseeable.

The question of whether a duty of care was owed by a pharmacist in particular circumstances is determined by reference to the case law based on a general formula for the ‘duty’ in the English landmark case of Donoghue v Stephenson [1932] AC 562. In this case Lord Atkin defined persons to whom a duty of care is owed as (at [580]):

You must take reasonable care to avoid acts or omissions which you can reasonably foresee would be likely to injure your neighbour. Who, then, in law is my neighbour? The answer seems to be — persons who are so closely and directly affected by my act that I ought reasonably to have them in contemplation as being so affected when I am directing my mind to the acts or omissions which are called in question.

Following this argument it is clear that pharmacists have a duty of care to patients when providing professional services such as the dispensing of prescriptions, supplying over-the-counter (OTC) medicines or giving medication advice.

A breach of the duty of care refers to a failure on the part of the pharmacist to meet the standard of care that the law requires. The test to determine a breach is an objective one and the court will aim to determine whether a reasonable pharmacist failed to take reasonable precautions to avoid foreseeable risk. The benchmark in determining whether the conduct fell below the required standard is the reasonable man test as defined in the UK case of Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 (at [586]):

Where you get a situation which involves the use of some special skill or competence, then the test whether there has been negligence or not … Is the standard of the ordinary skilled man exercising and professing to have that special skill … In the case of a medical man, negligence means failure to act in accordance with the standards of reasonable competent medical men at the time … a doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art … merely because there is a body of opinion that would take a contrary view.

This case involved assertions that both the standard of treatment and the information provided to the patient were deficient. According to the Bolam test the court would consider the professional standards applicable at the time and the practice followed by peers. In England, the Bolam test has been applied and extended beyond the diagnosis and treatment to the duty to warn of risks involved. The test is therefore applied to procedural and diagnostic errors, known as ‘technical blunder’ cases, as well as failure to warn of risks. However, in 1992 the High Court of Australia in Rogers v Whitaker (1992) 175 CLR 479 held that the Bolam principle had no application to the giving of advice or information. This case involved an extremely rare complication (sympathetic ophthalmia) about which the patient was not warned before she agreed to a procedure. The majority of the High court held (at 494):

Whether a medical practitioner carries out a particular form of treatment in accordance with the appropriate standard of care is a question in the resolution of which responsible professional opinion will have an influential, often a decisive, role to play; whether the patient has been given all the relevant information to chose between undergoing and not undergoing the treatment is a question of a different order. Generally speaking, it is not a question the answer to which depend upon medical standards or practices. Except in those cases where there is a particular danger that the provision of all relevant information will harm an unusually nervous, disturbed or volatile patient, no special medical skill is involved in disclosing the information, including the risks attending the proposed treatment. Rather, the skill is communicating the relevant information to the patient in terms which are reasonably adequate for that purpose having regard to the patient’s apprehended capacity to understand that information.

The court made it clear that the information a professional ought to supply to a patient was patient-focused rather than clinician-focused. The decision in Rogers v Whitaker has since been used in Australia as a reference for allegations of negligence in the form of failure to advise, warn or inform a patient. The majority judgment was based on the opinion that as far as technical blunders are concerned, the doctor–patient relationship requires little contribution from the patient, as the medical practitioner should perform at a level requiring professional knowledge and skill. However, where the allegations involve the provision of information and advice, the medical practitioner should provide the appropriate amount and level of information necessary for the patient to reach a decision.

Health professionals therefore need to use their judgment in deciding what information to provide to patients and make an assessment as to whether the individual patient would be likely to attach significance to it.

The High Court of Australia’s rejection of the Bolam principle in cases of negligence involving failure to warn is of particular importance to pharmacists, as pharmacists’ role increasingly extends to an advisory role through the provision of information. On a daily basis pharmacists need to counsel particular patients to ensure they’re aware of, and understand, how to take prescribed and OTC medication, and to inform patients of relevant side-effects as a result of taking the medication. The ultimate question to be considered by the court will be whether the conduct conformed to the standard of reasonable care demanded by the law. Hence, it will not be sufficient to prove that other pharmacists practise in a similar way if the practice is not to a standard that provides safe patient care.

Pharmacists therefore need to disclose real and foreseeable risks. However, Gaudron J in Rogers v Whitaker stated there is no obligation to disclose those risks that were ‘far-fetched’ and ‘fanciful’. Accordingly, pharmacists should use their judgment in disclosing, for example, medication side-effect risks, and the gravity of potential harm to the patient should impact on the information provided.

As advances in technology, such as computer systems that maintain patient profiles and automatically warn of drug interactions, expand the capabilities and responsibilities of pharmacists, it is important to evaluate potential liability in an effort to make the profession aware of potential litigation scenarios and to assist the profession to develop risk management procedures. However, Australian litigation involving negligent claims regarding pharmacists’ expertise in the more recently evolved areas of practice do not exist, and pharmacists’ legal liability towards patient care services has therefore not been well defined yet.^[22]

In predicting pharmacists’ potential civil liability, two issues would need to be considered, namely:

1. the changed role of pharmacists, which increasingly extends to an advisory role through the provision of information as well as other roles (e.g. diagnosing and prescribing)

2. the factors that will be taken into consideration by a court in making a determination of civil liability.

The courts would consider the precedent laid down through Rogers v Whitaker. However, the new civil liability Acts in the various Australian states and territories would also be considered, and accordingly will be discussed.

Review of Australian negligence law

The Review of the Law of Negligence in 2002 followed the Australian medical indemnity crisis, which was caused by an increased number of claims and amounts awarded in damages as the principal source of compensation for those injured through the fault of medical practitioners. The review was an attempt by Australian governments to reform common law and balance the scales between the interests of both plaintiffs and defendants. The objective was to implement the recommendations into a single statute that could be adopted uniformly in the various states and territories, thereby creating a consistent approach to the law governing liability and damages for personal injury and death resulting from negligence.^[23]

As a result of the review, civil liability legislation was introduced in all Australian jurisdictions, as summarised in Table 7.2.

Table 7.2 Sources of civil liability legislation

Jurisdiction	Civil liability legislation
ACT	Civil Law (Wrongs) Act 2003 (ACT); Civil Law (Wrongs) Amendment Act 2003 (ACT)
NSW	Civil Liability Act 2002 (NSW); Civil Liability Amendment (Personal Responsibility) Act 2002 (NSW)
NT	Personal Injuries (Liabilities and Damages) Act 2003 (NT); Personal Injuries (Civil Claims) Act 2003 (NT)
Qld	Civil Liability Act 2003 (Qld); Personal Injuries Proceedings Act 2002 (Qld)
SA	Volunteers Protection Act 2001 (SA); Recreational Services (Limitation of Liability) Act 2002 (SA); Wrongs (Liability and Damages for Personal Injury) Amendment Act 2002 (SA)
Tas	Duties Act 2001 (Tas); Civil Liability Act 2002 (Tas)
Vic	Wrongs and Other Acts (Law of Negligence) Act 2003 (Vic); Wrongs and Other Acts (Public Liability Insurance Reform) Act 2002 (Vic); Wrongs and Limitation of Actions Act (Insurance Reform) Act 2003 (Vic)
WA	Civil Liability Act 2002 (WA); Volunteers (Protection from Liability) Act 2002 (WA); Insurance Commission of WA Amendment Act 2002 (WA)

The following discussion uses the Queensland Civil Liability Act 2003 (the Act) by way of illustration. For example, section 21 of the Act specifically addresses a doctor’s proactive and reactive duty to warn a patient or patient’s carer (substitute decision-maker) of risk before the patient undergoes any medical treatment, stating:

Proactive and reactive duty of a doctor to warn of risk

(a) information that a reasonable person in the patient’s position would, in the circumstances, require to enable the person to make a reasonable informed decision about whether to undergo the treatment or follow the advice;

(b) information that the doctor knows or ought reasonably to know the patient wants to be given before making the decision about whether to undergo the treatment or follow the advice.

This section refers specifically to doctors; hence it is not clear whether the standard would be applicable to other health professionals. In relation to the standard of care provided by a professional, the Act states in section 22:

Standard of care for professionals

(1) A professional does not breach a duty arising from the provision of a professional service if it is established that the professional acted in a way that (at the time the service was provided) was widely accepted by peer professional opinion by a significant number of respected practitioners in the field as competent professional practice.

(2) However, peer professional opinion can not be relied on for the purposes of this section if the court considers that the opinion is irrational or contrary to a written law.

(3) The fact that there are differing peer professional opinions widely accepted by a significant number of respected practitioners in the field concerning a matter does not prevent any 1 or more (or all) of the opinions being relied on for the purposes of this section.

(4) Peer professional opinion does not have to be universally accepted to be considered widely accepted.

(5) This section does not apply to liability arising in connection with the giving of (or the failure to give) a warning, advice or other information, in relation to the risk of harm to a person, that is associated with the provision by a professional of a professional service.

Of specific relevance is subsection (5) above, creating a vagueness regarding the approach to be followed by the court in the case of the giving of (or the failure to give) a warning, advice or other information. Therefore, the Act is unclear regarding the standard of care that will be applied to the duty of the pharmacist to warn patients of medication risks, and what evidence the court would use in the case of health professionals other than doctors.

Section 49B covers failed contraceptive procedure or contraceptive advice:

(1) This section applies if, following a contraceptive procedure on an individual or the giving of contraceptive advice on an individual, the individual gives birth to, or fathers, a child because of the breach of duty of a person in advising about, or performing, the procedure or giving the advice.

(2) A court can not award damages for economic loss arising out of the costs ordinarily associated with rearing or maintaining a child.

This section may be relevant to pharmacists in circumstances of supplying and giving advice regarding the use of contraceptives and the emergency post-coital contraceptive.

The impact of the new legislation on health professionals, and specifically on pharmacists, has not yet been tested in the courts, and it has been suggested that the real impact of the changes effected by the civil liability Acts will not be apparent for some years.^[24] As the professional responsibility and subsequent legal liability of pharmacists in the evolving areas of practice is less predictable than the more routine focused technical functions that were primarily and traditionally a pharmacist’s main role, pharmacists’ potential liability with regard to the expanding role has yet to be determined.

Availability of pharmacy incident data

As mentioned, there are very few reported Australian cases initiated through the adversarial court system that involve pharmacists in claims of professional negligence. This does not mean cases have not been initiated, but rather reflect the fact that pharmacist indemnity insurers tend to settle out of court.^[20] PDL or Guild Insurance do not make available incident data. The reason quoted for this is because incident report information is considered ‘commercially sensitive’.^[20] Tito already highlighted the unavailability of data in 1994 through the Australian Review of Professional Indemnity Arrangements:^[5]

Minimum information on claims data is publicly available in Australia … the overall poor quality of the information and the difficulties the Professional Indemnity Review (PIR) faced in obtaining it indicate a need to work with the medical defence organisations (MDOs) to improve their data holdings … the potential richness of the data held by MDOs in relation to their claims could be better used by the Colleges, medical schools, the profession and, in appropriate circumstances, the Commonwealth and State Governments, to ensure proper prevention and avoidance strategies are put in place.

As indicated by Tito, incident data should be made available, as the information could be used to develop risk management processes and as examples in the training of graduates. Tito specifically commented on the absence of pharmacy claims data:

Detailed figures on the incidence of injuries and claims in pharmacy health care were not available. The incidence of injuries is said to be very low. Allegations of negligence against pharmacists do not appear to be high, indicating that the public will only complain to the Pharmacy Board if the incidence is regarded as severe.

PDL reports only limited data regarding incident reports filed, and the reported information does not give statistics on the seriousness of errors.^[25] Therefore, Australian data involving pharmacists’ incidents and claims are not publicly available. However, incident data provide valuable insights into the vulnerabilities of dispensing procedures and identifies areas for improvement. The data should be used to develop measures and systems to prevent medication errors; the lack of available information precludes regulatory authorities or the profession from identifying practice shortcomings that need to be urgently addressed to prevent similar incidents in the future.