Registration of pharmacists

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Chapter 5 Registration of pharmacists

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:

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:

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:

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

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:

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:

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:

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:

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.

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:

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

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

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:

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:

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:

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.

The board may inquire into applications for general registration (and also applications for renewal of general registration) and before deciding an application may: investigate the application; require the applicant to provide additional information; require the applicant to undergo a written, oral or practical examination; and require any information provided to be verified by statutory declaration.

A person’s general registration may be cancelled pursuant to section 86 of the Act if it is found that the person was registered because of a materially false or misleading representation or declaration.

Queensland does not issue a practising certificate but is presently developing ‘recency of practice’ regulations. The regulations will require registrants to show that they have practised their profession (whilst registered) within the last three years. ‘Practise’ includes work in clinical, administration, research and education fields, using the knowledge, skills and attitudes of the profession, whether remunerated or not, whether retired or not, and regardless of job title. The board will not require a minimum number of hours to be completed over the last 3 years but may require a registrant to prove they have an adequate connection with their area of practice. In some areas of practice, for example drug information, a connection may be lost in a relatively short absence from regular work, whereas in other areas a connection might be sustained with a relatively long absence from active employment. This connection is adequately proven through the maintenance of a professional portfolio.

There are no current provisions required under the Queensland Act for the registration of pharmacy students. However, there are special purpose registration provisions which authorise persons who are not otherwise able to register to undertake activities related to the profession including studying or training at the postgraduate level, teaching, engaging in research and giving clinical demonstration. Such registration also enables the holders to call themselves a pharmacist without offending against Part 4 of the Act.

South Australia

Section 26 of the Pharmacy Practice Act 2007 states a person is eligible for registration if the Pharmacy Board of South Australia (the board) is satisfied that the person:

The ‘requirements determined by the board’ include undertaking 52 weeks of supervised practice after the completion of the qualification, successful completion of a pre-registration training program provided by the board and passing a board examination. There are no specific fitness-to-practise provisions in the Act or the Regulation other than, at section 26(1)(c) of the Act, the candidate for registration ‘… is medically fit to provide pharmacy services of the kind authorised by registration on that register …’.and at (e) ‘… is a fit and proper person to be registered on that register…’.

Section 26(2) states that persons who do not meet all the criteria for registration may be registered under limited registration provisions and the board may impose conditions on their registration.

The South Australian Act also provides for the registration of pharmacy students. All persons undertaking a course of study that provides qualifications for registration as a pharmacist must be registered under that provision and indeed are not entitled to undertake the course of study unless so registered.

In addition to registration, pharmacists seeking to practise in South Australia require a practising certificate, which the board will issue on application. Practising certificates may be subject to conditions, limiting the kind of pharmacy services the holder of the certificate my provide until the holder completes or obtains further education, training or experience as determined by ‘practice rules’. Practice rules establish a scheme for further education, training and experience for pharmacists and govern the requirements for practising certificates and the imposition of, and evidence of compliance with, conditions of practising certificates. A registered pharmacist must satisfy the Pharmacy Board of their competence as a provider of restricted pharmacy services. In order to gain a practising certificate a registered pharmacist must participate in, and successfully complete, the process of the board’s ENRICH program.

The ENRICH program was established by the board to provide a process for registered pharmacists seeking a practising certificate to demonstrate, through an accountable process, a measurable display of professional competence. Compliance with the ENRICH program enables the board to assure the community that registered pharmacists are maintaining professional competence. Appendix 1 of the program states:

If a pharmacist has not held a practising certificate for a period of 12 months immediately preceding the application, the board may require the applicant to undertake further education, training and experience, or the board may impose conditions.

Tasmania

The registration of a person as a pharmacist in Tasmania is regulated by the Pharmacists Registration Act 2001. The Act empowers the Pharmacy Board of Tasmania (the board) to supervise the practice of pharmacy in that state and monitor the standards and provision of services that pharmacists provide.

Registration requirements are contained in Part 3 of the Act. A person applying for registration must hold a qualification approved by, or gained a qualification from an institution accredited by, a prescribed national pharmacists’ body or forum, or passed a qualifying examination in pharmacy held by a prescribed national pharmacists body or forum. As well as holding an appropriate qualification a person seeking registration must also complete an approved pre-registration program and pass an examination set by the board as well as completing an approved course in first aid.

The board may also consider the physical and mental capacity and skill of the applicant as well as their character and command of the English language. The board must be satisfied that the applicant is an Australian citizen or resident of an Australian state or territory. There is also a requirement for a person registered as a pharmacist to have adequate professional indemnity insurance. The registrar may grant an applicant interim registration if it would be unreasonable for them to wait until the board could consider the application and it is a reasonable presumption that the applicant would be entitled to registration.

Under section 25 the board may hold an enquiry into any applicant for registration. Such an inquiry must be undertaken by a committee appointed by the board. The applicant must receive a notice outlining the reasons for holding the inquiry and the date, time and place the inquiry is to be conducted. At the conclusion of the inquiry the committee must provide a written report with recommendation to the board outlining the evidence on which the findings were made.

In determining an applicant’s entitlement to registration the board may grant registration either unconditionally or subject to conditions. A person whose registration is conditional may apply to the board, at intervals of not less than 12 months, for review. Examples of conditions include: in the case where an applicant was not competent in English, to practise under the supervision of another pharmacist; or in the case where an applicant suffered from a psychiatric illness, to provide the board with regular medical reports from the treating psychiatrist.

Section 28 empowers the board to refuse registration on the basis of the suspension or cancellation of an applicant’s registration under a foreign pharmacists law, or on the basis that an applicant has a criminal record of a kind that it would not be in the public interest for the applicant to practise pharmacy.

The board issues certificates of registration to all pharmacists in such a form and containing such information as determined by the board. The certificate of registration will also include any details of practice conditions imposed by the board.

Registration fees are required to be paid annually. Although there is no specific reference to ‘recency of practice’ in the Act, section 37(7) requires the board not to issue a new registration certificate to a registered person who ‘… has not actively engaged in the practice of pharmacy in the 5 year period immediately preceding the due date …’ unless it is satisfied the registrant complies with the requirements of section 23.

There are no provisions in the Act for special purpose registration or the registration of pharmacy students or pharmacy interns.

Victoria

The registration of a person as a pharmacist (as with all other regulated health professionals in Victoria) is provided for in the Health Professions Registration Act 2005. For pharmacists this legislation replaces the repealed Pharmacy Practice Act 2004.

Generally a person applying for registration is required to have successfully completed a course of study in pharmacy practice approved by the Pharmacy Board of Victoria (the board) or a course of study that, in the opinion of the board, is substantially equivalent, or is based on similar competencies, to a course of study in pharmacy practice approved by the board. The applicant must have undergone a period of supervised training in pharmacy practice approved by the board or a period of supervised training that, in the opinion of the board, is substantially equivalent, or is based on similar competencies, to a period of supervised training in pharmacy practice approved by the board. Finally, the applicant must pass an examination set by the board or a person or body nominated by the board for the purpose of qualifying a person for registration as a pharmacist.

Under section 6(2), the board may refuse to grant registration on a number of grounds including:

The board may also consider whether an applicant has sufficient recency of practice to qualify for registration.

The board may grant specific registration as a pharmacist in circumstances in which the applicant has completed a course of study and supervised training in pharmacy practice that does not qualify them for general registration. The purpose of this specific registration is to enable an applicant to fill a teaching or a research position in pharmacy practice approved by the board. Such registration may also be extended (with conditions) to enable an overseas applicant to practise as a pharmacist in Victoria if that applicant, with the prior permission of the board, has exchanged practice with a registered pharmacist for a limited period, or has been engaged to provide locum pharmacy services for a registered pharmacist in Victoria.

The board has powers under section 8 to register pharmacy students to enable such persons to complete a period of supervised training as part of the course of study or to undertake supervised training requirements. The registration of a person as a student is for a period specified by the board, but must not exceed a period of 5 years and may be subject to any condition imposed by the board.

Section 9 empowers the board to grant provisional registration for a period not exceeding 12 months. Section 10 allows for interim registration in those cases where persons are entitled to registration under section 6 or section 9 but it is not practicable to wait until the board can consider their application.

Under section 11 a person may apply to the board as a non-practising pharmacist. In such cases the persons are registered subject to the condition that they not practise as a pharmacist during the period of the registration and also any other conditions imposed by the board.

Section 13 empowers the board to impose a condition when granting or renewing registration that a pharmacist must hold professional indemnity insurance for services they provide as health practitioners.

Before deciding an application for registration the board may investigate the applicant, require the applicant to answer any question relating to the application, require the applicant to undergo a written, oral or practical examination, or require the applicant to undergo a health assessment.

In all matters where registration has been obtained by fraud or misrepresentation, the board is required to refer the matter to the Victorian Civil and Administrative Tribunal (VCAT).

Western Australia

The regulation of pharmacists in Western Australia is carried out under the Pharmacy Act 1964 (WA). It was anticipated that this Act would be repealed and replaced by the Western Australian Pharmacists Act 2006 that is currently a Bill before the parliament, and which had its first reading and second reading in the Legislative Assembly on 29 November 2006 and its third reading on 5 April 2007. However, with the current development of a national registration scheme for health practitioners, some doubts have been expressed about whether the Bill will in fact be enacted, or whether it will be bypassed and legislation harmonious with national registration introduced in its place.

In regard to the Pharmacy Act 1964 (WA) one notable difference between that Act and registration Acts in other Australian jurisdictions is that the registering body for the purpose of the Pharmacy Act 1964 (WA) is the Pharmaceutical Council of Western Australia (the council), which is the management committee of the Pharmaceutical Society of Western Australia. to be registered under the Act a ‘pharmaceutical chemist’ is required to be a member of the Pharmaceutical Society of Western Australia. At the time of writing this arrangement is unique in Australia as it follows the model in Great Britain where the professional organisation (the Royal Pharmaceutical Society of Great Britain) is also the registering body. In all other Australian states and territories the registration Acts are administered by a board, constituted as a statutory body independent of the profession.

The council is required to register any person entitled to be registered as a ‘pharmaceutical chemist’. The register must be kept by the council and include the name, residence or place of business and qualification of all registrants (s20). Persons are entitled to registration if they have attained the age of 18 years, have passed all prescribed examinations (or examinations that in the opinion of the council are substantially equivalent to the prescribed examinations), have completed 2500 hours of practical training with a pharmaceutical chemist, and passed a first aid examination approved by council (s21). Section 22 also requires that applicants for registration have an adequate knowledge of the English language. In regard to the practical training, one-fifth (500 hours) may be undertaken before the trainee has passed all the prescribed examinations.

Under section 26, before a pharmaceutical chemist is able to practise in Western Australia he or she must possess a licence issued by the council and be ‘domiciled in the State’ (authors italics).

For completeness, the following comments relating to the Pharmacists Bill 2006 are included. There is no requirement in the Bill for a pharmacist registered in Western Australia to hold a licence to practise as a pharmacist, nor is there a requirement for a person to be domiciled in the state before being able to practise.

Section 26 requires the Pharmacy Board to register an applicant for registration if the board is satisfied the applicant has complied with section 26(2) and has paid the requisite registration fee. The effect of registration is to confer the right to carry on the practice of pharmacy and to use the title ‘pharmacist’.

Section 26(2) requires an applicant to hold a qualification approved by the board. Under normal circumstances this would be a qualification from an appropriately accredited bachelor or masters of pharmacy degree. This section also requires that an applicant acquire the knowledge and practice experience to efficiently perform the duties of a pharmacist. For new registrants this requires the completion of 2500 hours of supervised practice and successfully undertaking a training program.

Applicants are also required to be a fit and proper person with an adequate written and oral knowledge of the English language and have sufficient physical and mental capacity and skill to practise pharmacy. The conviction for an offence that in the reasonable opinion of the board might render the applicant unfit to practise as a pharmacist could be a barrier to registration.

In registering an applicant the board may impose such conditions as it sees fit, including that ‘… a pharmacist must hold professional indemnity insurance; or the practice of pharmacy by a pharmacist must be covered by professional indemnity insurance …’ (s27).

The board is also empowered to register a person as a non-practising pharmacist pursuant to section 28. The effect of this registration is to impose a condition on the registration that ‘… the person does not practise pharmacy’. The term ‘practise pharmacy’ includes any of the following:

Registration is renewed annually through the payment of a fee prescribed in a regulation.

MUTUAL RECOGNITION

Mutual recognition legislation was enacted and commenced in most Australian states and territories in 1991. While the importance of this development would be difficult to overstate, it is acknowledged that prior to mutual recognition legislation all Australian jurisdictions had recognised one another’s registration. Through mutual recognition, pharmacists registered by one Australian registering authority are able to register with any other registering authority that has enacted enabling legislation. However, it is axiomatic that with the advent of the national registration of pharmacists, mutual recognition legislation for the purposes of health professional registration for Australian states and territories will be redundant. However, trans-Tasman mutual recognition legislation will continue to be relevant for the recognition of New Zealand registered pharmacists in Australia, and vice versa.

The principal purpose of mutual recognition legislation is to enact legislation (authorised by the parliaments of states under paragraph (xxxvii) of section 51 of the Commonwealth Constitution, and requested by the legislatures of the Australian Capital Territory and the Northern Territory) for the purpose of promoting the goal of freedom of movement of goods and service providers in a national market in Australia.

In relation to services, the mutual recognition principle enables a person who is registered in the first state or territory for an occupation, to be recognised by an authority in a second state or territory for the purposes of registration as a practitioner in an equivalent occupation.

For the purposes of legislation:

A person who is registered in the first state or territory for an occupation may lodge a written notice with the local registration authority of the second state or territory for the equivalent occupation, seeking registration for the equivalent occupation in accordance with the mutual recognition principle.

For example, under section 19(1) of the Mutual Recognition (Queensland) Act 1992 (Qld) the notice must:

The notice must be accompanied by a document that is either the original or a copy of the instrument evidencing the person’s existing registration (or, if there is no such instrument, by sufficient information to identify the person and the person’s registration). The statement and other information in the notice must be verified by statutory declaration. However, a registration authority may permit the notice to be amended after it is lodged.

The local registration authority may grant registration and may grant renewals of such registration. Once a person is registered the entitlement to registration continues, whether or not registration (including any renewal of registration) ceases in the state or territory where the person was first registered.

If a person’s registration in an occupation is cancelled or suspended or is subject to a condition on disciplinary grounds, or as a result of or in anticipation of criminal, civil or disciplinary proceedings, then the person’s registration in the equivalent occupation in another state or territory is affected in the same way. The local registration authority of the other state or territory may, however, reinstate any cancelled or suspended registration or waive any such condition if it thinks it appropriate in the circumstances.

In 2003 all states and territories in Australia enacted mutual recognition legislation with New Zealand (the Trans-Tasman Mutual Recognition Agreement). The scope and intent of the trans-Tasman legislation is identical to the mutual recognition legislation previously enacted in Australia.

It should be noted that where a state or territory requires both registration and a license or practising certificate to practise, a second jurisdiction, which may only require registration to practise may not register a person from the first jurisdiction who was merely registered but held neither a license nor practising certificate. For example, a pharmacist from New Zealand who was registered with the Pharmacy Board of New Zealand did not hold a current practising certificate in that country, therefore could not register under mutual recognition with an Australian jurisdiction which did not require a practising certificate to practise pharmacy. The recognition would not be mutual as the Australian registration may entitle the person to practise where the registration in New Zealand would not.

ADMINISTRATION OF REGISTRATION ACTS

The following section is a general overview of the administrative functions in the various registration Acts and regulations in Australian states and territories. Matters of registration, ownership, and investigation and discipline are discussed elsewhere.

Australian Capital Territory

In the ACT pharmacists are regulated through the Health Professionals Act 2004 (ACT) and the Health Professionals Regulation 2004 (ACT). The Act is umbrella legislation covering not only the regulation of pharmacists but also of all designated health professionals. A pharmacist is defined as a health professional in Part 3 of the Act. Part 3 also provides definitions of a ‘health service’ and a ‘regulated health service’.

The main object of this Act is to protect the public from risk of harm by ensuring that the people who provide health services are competent and maintain the required standard of practice. The Act achieves its object by:

Part 4 of the Act, Regulation of health professions, addresses the processes to be undertaken by the ACT Executive to regulate a profession.

Part 5 of the Act, Health professional boards, covers the establishment and functions of the boards together with the obligations of the boards and their reporting functions. This Part also defines the legal status of the boards and other statutory matters.

Part 7, Health professions tribunal, Part 9, Reporting, Part 10, Joint consideration with commission, Part 11, Personal assessment panels, and Part 12, Professional standards panels, all cover matters relating to complaint, investigation and disciplinary hearings and are discussed in Chapter 7 (Investigation, discipline and legal proceedings).

Part 8, Offences, deals with offences created under the Act including the provision of regulated health services by unregistered persons and the false representation of a person as a health professional. It also requires that a registrant comply with any condition imposed on this registrant and makes it an offence to direct a person to engage in unprofessional conduct, practise without indemnity insurance if such is required by regulation, or to supply drugs or medicines that do not comply with standards applicable under the Therapeutic Goods Act 1989 (Cth) or a standard stated in the Australian Pharmaceutical Formulary Handbook.

The objective of the Health Professionals Regulation 2004 (the Regulation) is to prescribe particulars and information relating to the Health Professionals Act 2004. The Regulation also prescribes particulars relating to the health professional boards including their establishment, membership and elections, meetings and functions.

Standards required for practice are set out in section 4. This section identifies the minimum standards of practice and provides that a breach of the standards may be the basis for allegations of incompetence.

The Regulation also includes Pharmacy Standards Statements which are the detailed benchmark for professional standards for pharmacists in the ACT. These are contained in a Notifiable Instrument to the Act and can be found on the ACT legislation register. Currently there are 23 Standards Statements which are added to or reviewed on an ongoing basis. All pharmacists practising in the ACT should be familiar with the statements.

New South Wales

The regulation of pharmacists in New South Wales is achieved by the Pharmacy Practice Act 2006 (NSW) and the Pharmacy Practice Regulation 2008 (NSW). The object of the Pharmacy Practice Act 2006 (the Act) is to protect the health and safety of members of the public in relation to the practice of pharmacy by, in part, providing mechanisms to ensure that pharmacists are fit to practise.

Part 5, Impairment, provides powers for the Pharmacy Board to deal with impairment of pharmacists. For the purposes of the Act, a person suffers from an impairment:

Matters involving possible impairment of pharmacists may be referred to the board by any person or by the Health Care Complaints Commission and are assessed by an Impaired Registrants Panel constituted under the Act.

Part 7, Pharmacy Board, provides for the constitution, functions, membership and other provisions of the board.

Part 8, Pharmacy Care Assessment Committee, outlines the constitution, functions, membership and other provisions relating to the committee.

Part 9, Impaired Registrants Panels, outlines the constitution, functions, membership and other provisions relating to a panel.

Part 10, Pharmacy Tribunal, outlines the constitution, functions, membership and other provisions relating to a tribunal. The Part also provides for the proceedings of a Tribunal and matters relating to inquires, appeals and other proceedings before a tribunal.

Part 11, Prohibition against directing or inciting misconduct, prohibits a person who employs a registered pharmacist from directing or inciting the pharmacist to engage in conduct in the course of professional practice that would constitute unsatisfactory professional conduct or professional misconduct. The Part contains extended definitions of the terms ‘employment’ and ‘carrying on business’, where a conviction may prohibit an offender from carrying on a pharmacy business.

Part 12, Miscellaneous, covers a number of miscellaneous matters which includes: the service of documents on the board; notice of disciplinary action to other boards; false or misleading entries and statements; authentication of documents; and the appointment and powers of inspectors.

The following Schedules are included in the Act:

The Pharmacy Practice Regulation 2008 covers matters regarding the practice of pharmacy, infection control standards, advertising, a number of miscellaneous items, and 4 Schedules.

Northern Territory

In the Northern Territory pharmacists are regulated through the Health Practitioners Act 2004 (the Act). The Act is umbrella legislation covering not only the regulation of pharmacists but also all health professionals registered or enrolled under the Act. Pharmacy is a category of health care practice defined under section 6 of the Act.

The objectives of this Act are:

Part 2 of the Act, Health practitioner registration boards, covers the establishment and functions of the boards together with the obligations of the boards, their reporting functions and the legal status. Under this part the Pharmacy Board of the Northern Territory is empowered to adopt policies and guidelines for the purpose of providing practical guidance to health practitioners in the category of health care practice for which it is established. Therefore the board of the Northern Territory is able to adopt a code of professional practice, or other standards or guidelines for the purposes of the Act.

Part 4, Professional conduct, includes matters of complaint and discipline and are discussed in Chapter 7 (Investigation, discipline and legal proceedings).

Part 5, Impaired health practitioners, provides the board with powers to address matters relating to impairment. A person may notify the relevant board if he or she considers a health practitioner’s ability to practise is or may be affected by the health practitioner’s addiction to alcohol or another drug, lack of mental or physical competence, or state of health. In these circumstances the board may appoint a person or persons to investigate the allegations. If it is satisfied that a health practitioner’s ability to practise is or may be affected it may do either or both of the following: accept an undertaking from the health practitioner to take or refrain from taking specified action; impose any condition it thinks fit on the health practitioner’s right of practice or authorisation to practice; or decide to take no action under this Part but refer the matters to be investigated under Part 4 or 6.

Part 6, Performance assessment, empowers the board to assess:

This Part further defines the assessment process by an assessor and the performance assessment hearing by the board.

Part 7, Appeals, covers the appeals process.

Part 8, Offences, identifies those actions that are offences against the Act, which include: practising when not registered; unauthorised use of certain titles; offences of dishonesty and obstruction; intimidation; and unconscionable conduct.

Part 9, Miscellaneous, includes the obligations to provide information and administrative and legal matters.

The following Schedules append the Act:

Queensland

The Pharmacists Registration Act 2001 replaced the Pharmacy Act 1976. The Act is part of a legislative scheme consisting of the health practitioners registration Acts, the Health Practitioners Registration Boards (Administration) Act 1999 and the Health Practitioners (Professional Standards) Act 1999.

The objects of the Act are to protect the public by ensuring health care is delivered by registrants in a professional, safe and competent way, to uphold the standards of practice within the profession, and to maintain public confidence in the profession. These objects are to be achieved through establishing the Pharmacists Board of Queensland, providing for the registration of persons under this Act, imposing obligations on persons in relation to the practice of the profession, and providing for compliance with the Act to be monitored and enforced.

Part 2 of the Act, Pharmacists Board of Queensland, addresses the establishment and functions of the board, its membership, the business of the board, board committees, disclosure of interest by board members and committee members, the Minister’s power to give directions to the board in the public interest, and matters to be included in the board annual report.

Part 4, Obligations of Registrants and Other Persons, details the issues of restricted titles and ‘holding out’, notification of business names and other details, the obligations of advertisers and information that may appear in advertisements, the autonomy of registrants and court orders and injunctions and reprisals

Part 5, Investigation and Enforcement, defines the appointment, functions and powers of inspectors. Inspectorial power includes powers to enter places, seize evidence and obtain information. This part also includes general enforcement provisions such as the penalties for providing false or misleading information or documents or obstructing or impersonating inspectors.

Part 6, Appeals, details the processes related to appealing decisions of the board in regard to matters of registration, either general or special purpose.

Part 7, Legal Proceedings, relates to evidence and proceedings brought by the board for offences against the Act (rather than matters related to disciplinary action). For the purposes of the Act the offence of reprisal is an indictable offence while all others are summary offences.

Part 8, Register, Records and Information, defines the information to be kept in the board’s register of pharmacists, the circumstances of inspection of the register by members of the public, other records that must be kept such as cancellation or conditional registration, and the confidentiality of information.

Part 9, Miscellaneous, covers a number of miscellaneous items including abandoned and other health records, continuing professional education of registrants and other provisions.

Part 10, Repeal, transitional and savings provisions, contains the repeal, transitional and saving provisions related to the commencement of the legislation.

Currently the Act contains two schedules, Schedule 1, Decisions for which information notices must be given, and Schedule 4, Dictionary.

It is noted that the Pharmacists Registration Act 2001 does not include matters relating to complaint, investigation or discipline. These are addressed in the Health Practitioners (Professional Standards) Act 1999.

The Pharmacists Registration Regulation 2001 lists the qualifications for general registration, the prescribed training course for general registration, requirements for supervised practice and the period of registration. It also requires a pharmacist to notify the board of a change of name or address.

The Regulation also sets out the fees payable under the Act.

South Australia

The Pharmacy Practice Act 2007 is:

Part 2, Pharmacy Board of South Australia, addresses the establishment, composition, registrar and staff of the board, general functions and powers, board’s procedures, and the accounts, audit and annual report, constitution, functions and administrative provisions of the board. The functions of the board are defined in section 13 and are as follows:

Part 3, Registration and practice, includes a Division on the restrictions relating to provision of pharmacy services and covers:

Part 5, Appeals, addresses matters relating to appeals to the Supreme Court against any decision or order of the board. The Supreme Court may suspend an order of the board while the appeal is being determined. The Supreme Court may also vary or revoke any condition imposed by the board.

Part 6, Miscellaneous, addresses a range of other matters including:

The Pharmacist Regulations 2007 (the Regulations) provide a series of rules or orders that apply to the Pharmacy Practice Act 2007. The Regulations provide a definition of ‘representative body’, state the information to be included in the board’s annual report, detail the requirements for premises to be registered as a pharmacy and a pharmacy depot, and identify relevant fees.

Tasmania

The objectives of the Pharmacists Registration Act 2001 (the Act), through the activities of the Pharmacy Board of Tasmania, are to ensure that:

Part 2, Pharmacy Board, covers the membership, function, powers and objectives of the board. The board comprises five registered pharmacists nominated by the Minister and two persons (not pharmacists) who represent the consumers of the services that pharmacists provide. This part also addresses board committees, employment of staff including a registrar, and financial and reporting requirements. Part 2 also empowers the board to make by-laws, referred to as the ‘Pharmacy Code’.

Part 6, Offences, addresses offences against the Act including engaging in the practice of pharmacy when not a registered pharmacist, holding out to be a pharmacist when not registered, making use of unauthorised titles, or directing, inducing, assisting or allowing a registered pharmacist to engage in any conduct which is likely to constitute professional misconduct. This Part also limits the number of pharmacy businesses a pharmacist may have a beneficial interest in to four.

Part 7, Miscellaneous, covers a number of assorted matters including: fitness-to-practise notices; information about bodies corporate; administrative and legal matters; and a section addressing consequential and transitional sections of the Act.

Seven Schedules are appended to the Act.

Victoria

The objectives of the Health Professions Registration Act 2005, a generic Act covering health practitioners, are to protect the public by:

Part 4, Investigations and panel hearings, Part 5, Proceedings and review by VCAT, and Part 6, Offences and regulated conduct, will be addressed in Chapter 7.

Part 7, Administration, covers the establishment, membership and the powers, functions and consultation requirements of the Pharmacy Board. Also included are sections addressing matters of resignation or removal of board members, approved methods of communication for the board, and delegations and procedures. Note that the Pharmacy Board of Victoria was actually set up under the short-lived Pharmacy Practice Act 2004 (Vic), the immediate predecessor to the Health Professions Registration Act 2005 (Vic).

Part 8, Reporting and financial provisions, addresses the board fund, investment powers, powers in relation to fees and the repayment of advances.

Part 9, Enforcement and supplementary provisions, detail the proceedings for offences, authorised persons to assist in enforcement and the powers associated with entry to premises, examination of documents and the seizure of things. While the Act protects against self-incrimination it is an offence to give false or misleading information or to hinder or obstruct authorised persons.

Part 10, Regulations, gives powers to the Governor in Council to make regulations with respect to a number of board functions including: registration; the approval of pharmacies; the maintenance of records of dispensing; forms for the purposes of the Act; time limits; penalties; and any matter of thing required or permitted necessary to be prescribed to give effect to the Act.

The Health Professions Registration Regulations 2005 prescribe particulars and information relating to registration and other matters under the Health Professions Registration Act 2005. Currently they prescribe the particular details that must be contained in an application for registration as a pharmacist, and the prescribed information that must be included on a certificate of registration.

Western Australia

The Pharmacy Act 1964 commenced on 1 July 1965. While the objects of the Act are not specifically expressed, it is clear that the intent is to protect the public by ensuring pharmacy services are delivered in a professional, safe and competent way, thereby upholding standards of practice within the profession and maintaining public confidence in the profession.

Part 2 of the Act, Administration, addresses the establishment, function and powers of the statutory body, the Pharmaceutical Council of Western Australia (the council). Unlike other states and territories the council is also required by the Act to manage the affairs of the Pharmaceutical Society of Western Australia, a professional body for pharmacists. Part 2 includes the election of council, meetings of council, how the funds accumulated by council may be utilised and the provision of an annual report.

Part 3, Registration of pharmaceutical chemists and pharmacies, includes the qualifications for registration, the processes of registration for pharmacists and the restrictions on the carrying on of a pharmacy. Also included are fees for registration and the requirement to publish a list of pharmacists in February of each year.

Part 4, Provisions relating to the practice of pharmacy — under this part a pharmacist, as well as being registered with the council must also be licensed to practise as a pharmacist. Part 4 also includes:

Part 5, Miscellaneous provisions, includes matters related to:

The Schedules appending the Act lay out the register of pharmaceutical chemists and the pro forma certificate of registration as a pharmaceutical chemist.

The Pharmacy Act Regulations 1976 (the Regulations) provide a series of rules or orders that apply to the Pharmacy Act 1964.

Part 2, Council of the Pharmaceutical Society, provides the rules for the operation of the Pharmaceutical Council of Western Australia.

Part 3, Examinations and practical training, states the prescribed examinations, the process of applying to undertake the examination, and the practical training requirements.

Part 4, Registration of pharmaceutical chemists, lists the recognised board and societies, the form of application for registration and the information to be provided by the applicant to the council.

Part 5, Annual licences to practise, states the process for applying for a licence, the form of the licence, the form of the notice of refusal, and the fact that the licence must be kept at a place of practice.

Part 6, Registration of pharmacies, covers the application, consideration by council, requirements, conditions that may be placed on registration, alteration, cancellation and the notification thereof, the fact that registration of a pharmacy is not transferable and the processes in the case where a business is ceased.

Part 7, Advertising, states what is permitted and not permitted in advertising, that signs must be removed where a premises is vacated, and an interpretation, including definitions, of the terms ‘advertising’ and ‘pharmaceutical chemist’.

Part 8, Proceeding, is the form of certificate given pursuant to section 40A(6)(a) of the Act.

Part 9, Miscellaneous, states: that books or records must be kept for 2 years; that a council officer may inspect premises, books or other records; that making false or misleading statements in relation to any application for registration as a pharmacist or of premises is an offence against the Act; and that persons who contravene or neglect, refuse, or fail to comply with any provisions of these Regulations shall be guilty of an offence.

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