Registration of pharmacists

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Chapter 5 Registration of pharmacists

LEARNING OBJECTIVES

Upon completion of the chapter you should be able to:

• describe the current state-based pharmacist registration system in Australia

• discuss the significant features of a national system of registration and management

• explain the criteria for registration common to the various state and territory Acts and how these criteria serve the public interest

• discuss how the current state and territory-based legislation is administered

• explain the concept of mutual recognition and the part it plays in pharmacy practice in Australia and New Zealand.

INTRODUCTION

The contemporary regulation of the profession has its foundations in a public benefit, rather than securing an outcome that bestows advantages on those practising pharmacy. While legislation restricts those who may practise pharmacy by requiring practitioners to possess certain qualifications, undergo a period of training and demonstrate a fitness to practise, the legislation also imposes on practitioners standards of behaviour and professional practice that are in the public interest.

Historically the regulation of pharmacy in Australia has been achieved through instruments of state-based Acts and regulations. However, recently there has been a move to establish a single national registration scheme for pharmacists — along with other health professions — that had its genesis in a 2006 Productivity Commission report recommending national registration and accreditation mechanisms for the health professions.^[1] The report was commissioned by the Council of Australian Governments (COAG) which required the Productivity Commission to examine a number of health workforce issues, including supply and demand pressures over the next 10 years.

In the foreword to the report the Productivity Commission Chairman stated:

While this has not been an investigation into health care and its funding, the efficiency and effectiveness of the health workforce is inextricably linked to that broader system, and to Australia’s education and training regime. The Commission considered that it could add most value by reviewing the institutional, regulatory and funding arrangements within its area of focus. It has sought to identify reforms that would produce a more sustainable and responsive health workforce, while maintaining a commitment to high quality and safe health outcomes.^[1]

NATIONAL REGISTRATION

At the time of writing there is no national registration of pharmacists in Australia. It is worth noting that the earlier (1999) National Competition Policy Review of Pharmacy, while not making specific recommendations about national registration, proposed that:

[I]n the interests of promoting occupational and commercial mobility, the Commonwealth, States and Territories explore and consider adopting nationally consistent or uniform legislation, or specific legislative provisions on pharmacy ownership, pharmacist registration and the regulation of pharmacy professional practice.^[2]

At the July 2006 COAG meeting it was agreed a single national registration scheme for health professionals, beginning with the nine professional groups currently registered in all jurisdictions, would be established.^[2] Pharmacy is included as one of the nine. This decision arose from a 2005 Productivity Commission Research Report titled Australia’s Health Workforce that recommended both a single national registration board for health professionals and a single national accreditation board for health professional education and training. The recommendation aimed to deal with workforce shortages and pressures faced by the Australian health workforce, to increase flexibility, responsiveness, sustainability and mobility of health professionals, and reduce red tape.^[1] At a meeting in 2008 COAG agreed to establish the scheme by 1 July 2010. It subsequently agreed:

[T]o establish a single national scheme, with a single national agency encompassing both the registration and accreditation functions. The national registration and accreditation scheme will consist of a Ministerial Council, an independent Australian Health Workforce Advisory Council, a national agency with an agency management committee, national profession-specific boards, committees of the boards, a national office to support the operations of the scheme, and at least one local presence in each State and Territory.^[3]

The objectives of the scheme, to be set out in legislation, are to:

(a) provide for the protection of the public by ensuring that only practitioners who are suitably trained and qualified to practise in a competent and ethical manner are registered;

(b) facilitate workforce mobility across Australia and reduce red tape for practitioners;

(c) facilitate the provision of high quality education and training and rigorous and responsive assessment of overseas-trained practitioners;

(d) have regard to the public interest in promoting access to health services; and

(e) have regard to the need to enable the continuous development of a flexible, responsive and sustainable Australian health workforce and enable innovation in education and service delivery.^[3]

Ignoring the issues of mobility and reduction of red tape, the objectives of the scheme broadly align with existing state- and territory-based legislative objectives of protecting the public and maintaining contemporary standards of practice within the profession.

To implement the scheme Queensland will host the substantive legislation giving effect to the national scheme. The other states and territories will subsequently enact their own legislation, which will effectively adopt the Queensland provisions.^[4] Each of the states and territories will ‘use their best endeavours’ to repeal their existing registration legislation covering the health professionals subject to the new scheme. The legislation will be introduced in the Queensland Parliament in two stages. The first stage will address the structural elements of the scheme and the second stage will cover other matters including arrangements for:

• registration

• accreditation

• complaints and discipline

• privacy and information sharing.

The consultation paper proposes that the registration provisions build on the best aspects of state and territory schemes, endeavouring to avoid a ‘lowest common denominator’ approach or merely replicating one registration scheme.^[4] One of the stated aims is to develop the least restrictive law necessary to achieve the policy directive of enabling a robust system designed to protect the public. Restrictions on practice will only be imposed where the benefits to the community outweigh the costs.

The consultation paper further proposes that the legislation provide powers to the national boards for the purpose of ensuring that registered practitioners meet minimum accepted standards of competence and are safe to practise.^[4] This reflects the increased community expectations that boards take a more active role with respect to ensuring health practitioners are safe and competent to practise. It is expected that the legislation will require the boards to establish recency of practice requirements within each profession to ensure registrants demonstrate continuing competence at the time of annual renewal.

The consultation paper also flags a requirement for registrants to be covered by professional indemnity insurance. The Queensland Pharmacists Registration Act 2001 is the only state pharmacy registration Act that does not include this requirement. Currently the major provider of professional indemnity insurance for pharmacists in Australia is Pharmaceutical Defence Limited (PDL). This defence organisation was formed in 1912 after legal action against a chemist, Francis Gough, in Echuca, who was sued for damages by a farmer, William Hilton, following an alleged poisoning in 1911. Hilton won the case and was awarded damages of £200 plus costs. Chemists realised their vulnerability in regard to such errors, whether the errors arose from their own practice, or the errors or omissions of others.^[5] Money was subsequently raised from the profession and was sufficient, not only to assist Gough, but also to form PDL. PDL provides legal advice and representation to pharmacists where complaints and allegations involving professional practice have the potential to result in a civil action. PDL will also provide legal representation if a pharmacist is called before an inquest.

The Australian Pharmacy Council Inc (APC) (formerly the Council of Pharmacy Registering Authorities [COPRA]) will also be a significant organisation in the development of a national system of registration. The APC was formed in 2002 as the national body for Australian state and territory authorities responsible for the registration of pharmacists. The principal purposes of the APC are to:

• provide leadership in developing and implementing nationally consistent policies, processes and approaches to pharmacy practice, regulation and registration

• accredit pharmacy schools and programs

• authorise agencies to accredit continuing professional development activities

• conduct examinations towards eligibility for registration for both Australian graduates and overseas-trained pharmacists

• assess the qualifications and skills of overseas-trained pharmacists toward Australian registration and permanent residency.

For the last 25 years the Australian Pharmacy Examining Council, now subsumed into the APC, had been the primary organisation assessing the suitability of the qualifications and skills of overseas-trained pharmacists for registration in Australia. During that period hundreds of overseas-trained pharmacists have been successfully integrated into Australian pharmacy practice.

STATE- AND TERRITORY-BASED REGISTRATION

As previously stated, pharmacy registration in Australia is currently managed through state-based processes where the responsibility for the regulation of pharmacy practice is vested with state or territory pharmacy boards. The effect of this is to require pharmacists to register in each state or territory in which they intend to practise, requiring those pharmacists providing locum services in areas straddling state or territory boundaries to hold concurrent registration with two (or more) boards. Likewise, pharmacists owning or having a beneficial interest in a number of pharmacies in different states or territories are required to be registered with all relevant boards.

While each of the state and territory boards is an independent entity there is a high degree of similarity in relation to regulatory processes. In general terms, initial registration as a pharmacist in Australia will require:

• a degree or qualification from a university or institution recognised by the relevant board

• satisfactory completion of a given period of supervised practice

• satisfactory completion of a training program recognised by the relevant board

• passing a board examination

• demonstrating fitness to practise as defined in the relevant Act.

These requirements for registration broadly align with the objectives of the regulation of pharmacists, which are in general terms protection of the public and the maintenance of contemporary standards of practice within the profession.

The term ‘pre-registration trainee’ or ‘pre-registration pharmacist’ has traditionally been used in Australia to indicate a university graduate holding a degree recognised by registration boards for the purpose of registration as a pharmacist, who is undertaking an additional period of training prior to registration. However, the term ‘intern’ or ‘internship’ is becoming more common when referring to such trainees.

Periods of supervised practice to be undertaken to fulfil the requirement for registration vary slightly from state to state, but equate to a period of approximately one year. Some Acts or regulations express the period as a number of hours to be worked over not less than a defined period (the Queensland Act for example expresses the period as ‘… 1824 hours to be worked over at least 48 weeks …’).

Training programs are either prescribed in the relevant Act or regulation or approved by the board. The training program can either be provided by the board itself or provided by another entity, such as a professional society; for example, the Pharmaceutical Society of Australia (PSA). In some cases a board is able to accept a training program that is substantially equivalent to a prescribed training course, having regard to the course objectives and competencies, outcomes and subject matter.

Many Acts authorise a board to have regard to an applicant’s fitness to practise the profession. Generally, in deciding whether an applicant is fit to practise, the board may have regard to a range of matters including an applicant’s:

• mental and physical health

• command of the English language

• criminal history

• history if a previous registrant

• qualification, if the current qualification is more than 3 years old

• any other issue relevant to the applicant’s ability to competently and safely practise pharmacy.

In most jurisdictions the boards are authorised to conduct examinations prior to granting registration for the purpose of satisfying themselves that candidates are competent to practise. These examinations may be in addition to any examinations or assessments undertaken as part of the training required for general registration.

Acts usually stipulate that a board provide general registrants with notice of the imminent expiry date of their registration. However, it is the responsibility of registrants to ensure they fulfil the procedures required for the renewal of registration. Applications are generally required on a standard form and are accompanied by a registration fee together with any documents the board reasonably requires to approve or reject applications. Any additional information required for the purpose of registration is to be verified by a statutory declaration.

Legislation may require applicants to provide the board with information relating to their recent practise and/or continuing professional development or education programs that have been undertaken during the previous registration period. The aim of this information is to assist in informing the board of registrants’ competency to practise. If a board is not persuaded an applicant has satisfied recency of practice requirements of an Act, or has been deficient in continuing professional development or education, it may choose to renew registration and impose conditions considered sufficient to address the extent to which an applicant has failed to satisfy the requirements. In extreme cases a board may refuse to renew registration. For example, where an applicant can not demonstrate any reasonable connection to the profession over a number of years.

The requirements of the individual jurisdictions regarding initial registration are summarised in Table 5.1.

Table 5.1 Overview of registration requirements

The following section provides a general overview of the registration requirements for each Australian state and territory.

Australian Capital Territory

Section 23 of the Health Professionals Act 2004 addresses the suitability to practise requirements for health professionals in the ACT. For the purposes of the Act a pharmacist is recognised as a regulated health professional. The Act requires that the criteria for suitability to practise for each regulated health profession must be satisfied for a person to be unconditionally registered to practise in the health profession. This would include requirements as to: qualifications; mental and physical health; admission to a specialist area (if any) within the profession; maintenance and demonstration of continuing competency, recency of practice and professional development. The qualifications required to practise as a pharmacist are found in section 5.5 of the Health Professionals Regulation 2004 (the Regulation).

Pursuant to the Regulation an individual must be a graduate of a course of education in pharmacy offered in the ACT or a local jurisdiction that is accredited by COPRA (now the Australian Pharmacy Council) or approved by the Pharmacy Board of the Australian Capital Territory (the board) or the regulatory authority of a local jurisdiction. In addition a candidate for registration is required to complete training in the ACT or a local jurisdiction that is accredited by COPRA or approved by the board or the regulatory authority of a local jurisdiction.

Schedule 5, section 5.6 of the Regulation details the requirements for a corporation to practise as a pharmacist. The corporation must have the board’s written approval, and have provisions in its constitution that comply with the Regulation. For example, the constitution is required to include provisions limiting a directorship to a pharmacist, and limitations on beneficial ownership to a pharmacist or a ‘close relative’ of the pharmacist. For the purposes of the Regulation a ‘close relative’ of a pharmacist means a domestic partner, parent, child or grandchild.

Re-registration also requires demonstrated continuing professional development, competence and recency of practice. To show adequate professional development at the time of application for registration as an individual pharmacist, the applicant must, if required by the board:

• give the board written evidence that they attended and satisfactorily completed a training program approved by the board

• show they have undertaken professional development activities

• show they otherwise demonstrate professional development that the board considers adequate.

To show continuing competence the applicant may be required to give the board:

• written evidence of their competence assessed against the board’s standards statement

• or otherwise demonstrate continuing competence that the board considers satisfactory.

To demonstrate recency of practice the applicant may be required to give the board written evidence that he or she:

• has practised as a pharmacist in the 5 years before the day the application is made

• attended and satisfactorily completed a training course approved by the board

• can otherwise demonstrate recency of practice that the board considered adequate.

In this section: an activity is a ‘professional development activity’ if it complies with a standard about professional development for pharmacists developed or endorsed under section 131.

New South Wales

Pharmacists in New South Wales are regulated through the Pharmacy Practice Act 2006 (the Act). The object of this Act is to ‘… protect the health and safety of members of the public in relation to the practice of pharmacy, including by providing mechanisms to ensure that pharmacists are fit to practise …’. Part 2 of the Act makes it an offence for persons who are not registered as a pharmacist to indicate they practise or are qualified to practise pharmacy.

To satisfy the requirements for registration an applicant must hold the necessary qualifications (which may be prescribed by regulation or otherwise approved by the board), be competent to practise pharmacy (which includes physical and mental capacity, and the skill to practise including an adequate command of the English language), and not suffer an impairment within the meaning of the Act. Prior to seeking full registration a person holding a prescribed qualification must successfully undertake 2000 hours of supervised practice and complete the New South Wales Graduate Training Course.

Under section 11 of the Act a person is entitled to registration as a pharmacist if the Pharmacy Board of New South Wales (the board) is satisfied that the person has the necessary qualifications for registration as a pharmacist, and is of good character. However the granting of full registration does not prevent the imposition of conditions on the registrant by the board. In addition, the board may grant ‘supervised registration’ to an intern so as they may undertake a period of practical experience. While a person assumes the responsibilities of a registered pharmacist under ‘supervised registration’, such registration is not recognised by the Act for the purposes of pharmacy ownership: section 25.

The board is able to grant ‘provisional registration’ to a person entitled to full registration pending a decision of the board. ‘Temporary registration’ may be granted for a limited period to a person who is not normally resident in New South Wales, for the purpose of the person carrying out educational or research activities or such other activities as the board considers to be in the public interest.

Section 16 of the Act empowers the board to refuse registration if the board reasonably believes the person is not competent to practise or otherwise suffers from an impairment, has been found guilty of a criminal offence such as to render a person unfit to practise pharmacy, or if the person has had his or her registration cancelled or suspended under a health practitioner registration Act or pharmacist registration law. A person’s name can be removed from the registers as a consequence of disciplinary proceedings.

Persons who believe they have been unjustly dealt with by the board for the purposes of registration may appeal to the Pharmacy Tribunal constituted under Part 10 of the Act.

Under the Health Care Liability Act 2001 a person is not entitled to practise as a pharmacist unless the person is covered by professional indemnity insurance, and the Pharmacy Board (the board) cannot register a person as a pharmacist unless satisfied that the person is covered by professional indemnity insurance. Further, the board may cancel or suspend the registration of a person as a pharmacist, if the board is satisfied that the person is not covered by professional indemnity insurance while practising as a pharmacist. This requirement does not apply to, or in respect of, a pharmacist who is exempt under the regulations from the requirement of being covered by approved professional indemnity insurance.

The Pharmacy Practice Regulation 2008 covers matters regarding: the practice of pharmacy; advertising; infection control standards; a number of miscellaneous items; and includes 4 schedules.

In regard to registration, section 33 identifies the additional information to be provided in the pharmacist’s annual return and includes:

• the name of the insurer issuing professional indemnity insurance to the pharmacist

• whether the pharmacist has practised during the return period

• whether the practice has been part-time or full-time and, if part-time, the estimated number of hours worked per week.

Section 34 requires a notice of mental incapacity where a pharmacist may be a mentally incapacitated person.

Northern Territory

Pharmacists and other health practitioners are regulated in the Northern Territory through the Health Practitioners Act 2004. A person may only apply for registration if they have ‘… successfully completed an accredited course in the category of registration in the Territory …’ or ‘… successfully completed a course in the category of registration or enrolment outside the Territory that the Pharmacy Board of the Northern Territory (the board) considers is at least substantially equivalent to an accredited course in the category of registration or enrolment …’. In establishing an entitlement to register, the board must be satisfied that the person is eligible to apply, is competent to practise pharmacy, has sufficient mental and physical capacity to practise, has adequate command of the English language, has adequate professional indemnity arrangements in place and is of good character.

Practising certificates are issued to a pharmacist at the time of registration. Any conditions on registration are specified in the certificate, as is any authorisation the pharmacist has in relation to practising in a restricted practice area.

For the purposes of establishing an entitlement to practise the board may establish a committee to evaluate a particular applicant. The applicant is entitled to be given reasons why the evaluation is taking place and 14 days notice prior to an evaluation occurring. Grounds for refusing registration include:

• the applicant’s right to practise has been cancelled or suspended under foreign health care practice law

• the applicant has been convicted in the Territory or elsewhere of a crime or an offence of a kind that in the board’s opinion, makes it not in the public interest to allow the applicant to practise

• the applicant’s use of alcohol or a drug may, in the board’s opinion, impact on his or her ability to practise.

Pursuant to section 30 the board, at any time, may review any conditions to which the registration of a pharmacist is subject or impose conditions on the registration of a pharmacist.

Part 6 of the Act authorises the board to undertake an assessment of a pharmacist’s professional performance. For the purposes of the Act a pharmacist’s professional performance ‘… is unsatisfactory if it is below the standard reasonably expected of health practitioners of an equivalent level of training or experience …’. The appointment of assessors is subject to section 89 of the Act and an assessor must be a person who is considered to have skill, knowledge or experience relevant to the assessment.

Queensland

Section 44 of the Pharmacists Registration Act 2001 sets out the eligibility requirements for an applicant for general registration. The application must:

• be qualified

• be fit to practise the profession

• have completed training in the practice of the profession

• have completed a period of practice in the profession.

Qualifications are prescribed under the Pharmacists Registration Regulation 2001 (the Regulation). In addition, the Act gives the Pharmacists Board of Queensland (the board) power to recognise a qualification that is substantially equivalent to that required for a current Australian or New Zealand qualification, or a qualifying examination.

Fitness to practise the profession is addressed in section 46 of the Act. The board is empowered to consider an applicant’s mental and physical health, command of the English language, criminal history, any previous history associated with registration, the nature, extent and period of any practise of the profession if the qualification the applicant relies upon is older than 3 years, and ‘any other issue relevant to the applicant’s ability to competently and safely practise the profession’.

The training program recognised in the Regulation is the Pharmaceutical Society of Australia (Qld Branch) Pre-registration Training Program. In addition, the board may recognise a training course that is substantially equivalent to the prescribed training course (s47(b)). The board, in common with boards in all Australian states and territories, has recognised training programs in other jurisdictions for the purposes of registration.

The period of supervised practice prescribed under the Regulation is 1824 hours to be completed over at least 48 weeks, with at least 912 hours over 24 weeks to be completed under the supervision of the same registrant. Section 48 gives the board discretionary powers in regard to the period of practice applicable to applicants undertaking postgraduate qualifications or undertaking their supervised practice in another state or territory.

There are no board examinations in Queensland for those applying for registration at the completion of their intern year. The examinations that interns sit as part of the PSA Training Program form part of the training program and establish whether an intern has successfully completed the program.

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