The first Australian Pharmaceutical Formulary Handbook was published in 1902 with a range of formulae for non-official formulations.^[9] Other pharmacopoeias (Greek pharmakon, a drug and poieo, I make) still being referred to in drugs and poisons legislation include the British Pharmacopoeia (BP), the British Pharmaceutical Codex (BPC) and the Extra Pharmacopoeia (Martindale).

Pharmaceutical Defence Limited (PDL) was formed following a court case against a chemist, Francis Gough, who was sued for damages by a farmer, William Hilton, following an alleged poisoning in 1911. The farmer won the case and Gough had to pay damages. Chemists recognised their vulnerability and were alarmed as they realised that any alleged dispensing error, real or not, whether originating with the prescriber or the dispenser, could lead to a chemist being sued.^[10] PDL was hence set up to allow chemists to take out insurance against such happening.

NATIONAL MEDICINES POLICY FRAMEWORK

The changes in pharmacy practice in Australia have taken place against a background of government initiatives and developments in the pharmaceutical policy framework.

A major review of medication usage and waste by the federal government Department of Health and Ageing in the 1990s led to the launch of Australia’s National Medicines Policy (NMP) in 2000. The overall aim of this policy is to meet medication and related service needs through achieving both optimal health outcomes and economic objectives.^[11] The policy is based on four objectives, namely:

1. timely access to medicines at a cost the individual and community can afford

2. medicine of an appropriate standard of quality, safety and efficacy

3. quality use of medicines (QUM)

4. maintenance of a responsible and viable medicines industry.

QUM is defined as the judicious, appropriate, safe and effective use of medicines, with the term ‘medicine’ encompassing prescription and non-prescription medicines, including complementary health care products.

The Australian Pharmaceutical Advisory Council (APAC) was created in 1991 as a consultative forum to advise the government on a wide range of pharmaceutical policy issues. APAC includes representatives of peak health professions (pharmacy, medicine and nursing), the pharmaceutical industry (including over-the-counter and complementary medicines), consumer organisations, the media, indigenous peoples as well as government members, all with an interest in implementing the NMP. The council identifies and considers issues and needs in health care with particular reference to pharmaceuticals. The Pharmaceutical Health and Rational Use of Medicines (PHARM) Committee is a multi-disciplinary committee that is specifically responsible for reviewing and overseeing QUM implementation in Australia.

Following a formal review of the operational arrangements of APAC and PHARM in 2008, a need was identified to introduce new arrangements to support the implementation of the NMP. At the time of writing it has been recommended that APAC and PHARM be replaced with a National Medicines Policy Executive, a National Medicines Policy Committee and an annual National Medicines Policy Partnerships Forum.

Australia’s National Strategy for QUM was released in 2002 to complement the NMP, and specifically details the range of partnerships and activities to improve QUM.^[12] The strategy lists the key partners in achieving QUM, which include prescribers and providers of medicines. In fulfilling both these roles, pharmacists are crucial to the achievement of QUM. The strategy places a specific obligation on pharmacists, as health practitioners and educators, to:

• assist people in making informed decisions and learning more about health issues and health care through information, education and discussion

• become more aware of the risks and benefits of medicines, the possibility of non-drug options and the importance of a healthy lifestyle

• utilise objective information, resources and services to make decisions and take actions that enable medicines, when required, to be chosen and used wisely

• continually develop knowledge and skills to use medicines appropriately

• become more aware of the place of medicines within society.

There is overall agreement that the profession needs to accept these obligations because pharmacists, as the custodians of medicines, are particularly well situated to work both with the other members of the health team and health care consumers to promote the implementation of QUM initiatives.

Pharmacy education

Until the 1960s, pharmacy training in Australia was based on an apprenticeship where students spent part of their time at a tertiary institution and the remainder working under supervision of a ‘master’ pharmacist. In the early 1960s full-time degree standard courses were introduced throughout Australia.[2, 5]

In the late 1990s the undergraduate pharmacy degree courses were extended from three to four years. This followed a House of Representatives Standing Committee on Community Affairs inquiry in 1992.^[13] Additionally, university courses have also changed significantly over the last two decades with regard to context and level of expertise required to prepare students for the evolving role of pharmacists. Pharmacy schools offer either an undergraduate degree (BPharm), which is completed over four years, or a post-graduate degree (MPharm), which in many cases may be completed in less than four years. University education aims to enable graduates to provide patient-focused services with students being exposed to actual pharmacy practice through placement programs. These placements are a mandatory requirement for program accreditation by the New Zealand and Australian Pharmacy Schools Accrediting Committee (NAPSAC) and form a significant component of the various pharmacy education programs.

In order to be eligible for registration as a pharmacist with the relevant state or territory pharmacy registering authority, a 12-month internship in a pharmacy must be completed following graduation, although there are some minor interstate variations in the period of the internship.^[14] During the period, interns undergo continuous assessment based on the competency standards developed by the PSA, and are also required to undertake the Australian Pharmacy Competency Assessment Tool (APCAT), a standardised assessment developed by the Australian Pharmacy Council (APC) and conducted throughout Australia.

Competency is defined by the PSA as the ‘skills, attitudes and other attributes attained by an individual based on knowledge and experience which together are considered sufficient to enable the individual to practise as a pharmacist’.^[3] The PSA Competency Standards consist of the following eight functional areas:

1. practise pharmacy in a professional and ethical manner

2. manage work issues and interpersonal relationships in pharmacy practice

3. promote and contribute to optimal use of medicines

4. dispense medicines

5. prepare pharmaceutical products

6. provide primary health care

7. provide medicines and health information and education

8. apply organisational skills in the practice of pharmacy.

The Competency Standards are used by APC through NAPSAC to evaluate and accredit new and existing pharmacy schools and their educational programs. The Australian Pharmacy Examining Committee (APEC), a standing committee of the APC, oversees the registration of overseas-trained pharmacists. All overseas-trained pharmacists are required to be assessed for competency to practise in Australia through a formal process, which ensures national consistency in the assessment and registration of overseas-trained pharmacists.^[15]

Consistent with the development of international pharmacy practice, and in response to the Wilkinson Review recommendations and national trends in other health professions, mandatory continuous professional development programs have been developed or are being developed in most states.^[16] Continuing professional education is most often carried out by the professional pharmacy organisations and, to a lesser extent, by some of the universities. Additionally, the National Prescribing Service (NPS), which is an independent, non-profit organisation providing medicines information and resources for consumers and health professionals, offers multi-professional education activities with a quality use of medicines focus.

As an example, the Pharmacists Board of Queensland is currently developing a recency of practice regulation that will prescribe the criteria for maintaining an adequate connection with the profession. It is anticipated such requirements will include the following information, pursuant to section 72(2) of the Pharmacists Registration Act 2001 (Qld):

a) the nature, extent and period of practice of the applicant

b) the nature and extent of any continuing professional education undertaken by the applicant

c) the nature and extent of any research, study or teaching, relating to the profession undertaken by the applicant

d) the nature and extent of any administrative work, relating to the profession, performed by the applicant.

PHARMACY SECTORS

Pharmacy provides opportunities for pharmacists to work in a variety of settings. These include community pharmacy, hospital pharmacy, academia, policy and regulation, drug information, consultant pharmacy and the pharmaceutical industry. However, the majority of pharmacists are to be found practising in either the community or hospital pharmacy sectors.

Community pharmacy

Community pharmacies are the main suppliers of medicines. However, in addition to supplying prescription and over-the-counter (OTC) medicines, community pharmacists also make an active contribution to the health care system through the provision of health advice and medication management services. The profession is also becoming involved in preventative care services for patients with chronic conditions.

Community pharmacists are the most accessible health care professionals in the Australian health care system as clients do not routinely have to make an appointment to receive professional attention. They are often the first health professional to be approached by patients or carers. Additionally, as those patients on medication for chronic conditions have their prescriptions filled on a regular basis (often monthly) they may have more contact with their pharmacist than with their doctor. Thus, the pharmacist is ideally placed to play a pivotal role in disseminating health information and managing medication-related issues.

One of the issues that community pharmacists have to face is the tension that exists between retail activities, the provision of professional services and the perception of the extent to which one may influence the other. This dichotomy differentiates community pharmacy practice from other primary health care providers.^[17] However, the division between the provision of professional services and the selling of products is yet to be resolved as many community pharmacists balance demands of sensible financial management with professional practice.^[18]

There has been a shift in focus towards the incorporation of pharmacist professional services in community pharmacy practice. This shift has in part been driven by opportunities created as a result of the Community Pharmacy Agreements. These agreements are five-year co-operative arrangements between the Commonwealth and the PGA to formalise the price paid by the Commonwealth to approved pharmacists for providing Pharmaceutical Benefits Scheme (PBS) medicines and other pharmacy-related services. The introduction of government remuneration of pharmacists for the provision of medication review services was an example of the changed role of community pharmacists and a significant step towards recognising the role of the pharmacist in the medication management process. However, these contemporary services not only provide commercial and professional opportunities, but also create new responsibilities for pharmacists.

Hospital pharmacy

There are two main aspects to hospital pharmacy practice. First are those activities relating to the dispensing, supply and distribution of medicines, including the aseptic preparation of cancer chemotherapy and other products requiring sterile preparation. In addition, many hospital pharmacies offer formulation services to facilitate the preparation of oral liquid preparations for children; for example, where there is no commercially available product.^[19]

Second is the provision of clinical pharmacy services. These services usually involve pharmacists working in patient care areas such as wards or clinics, as an integral part of the health care team to provide advice on the safe and effective use of medicines. Clinical pharmacists have a wide range of roles including admission interviews, therapeutic drug monitoring, discharge counselling, adverse drug reaction reporting, drug information services and medication reviews. The availability of pharmacists in the wards provides patients with direct access to a pharmacist.

An ongoing challenge for pharmacists in both the community and hospital practice settings is to address the problems of medication management as health consumers move from one episode of care to another, as characterised by the hospital/community interface. To assist with the development of systems to improve the continuity in medication management between different health care settings, APAC developed the following 10 Guiding principles to achieve continuity in medication management:^[20]

• leadership for medication management

• responsibility for medication management

• accountability for medication management

• accurate medication history

• assessment of current medication management

• medication action plan

• supply of medicines information to consumers

• ongoing access to medicines

• communicating medicines information

• evaluation of medication management.

FUTURE ROLES FOR PHARMACISTS

New roles for pharmacists are evolving. Australia has been at the forefront of an international trend towards the incorporation of cognitive services in pharmacy practice, with the focus moving away from the distribution of medicines towards providing and being paid for professional services. For example, payment for the provision of diabetes medication assistance is being trialled as part of the Fourth Community Pharmacy Agreement.

Wider prescribing rights for pharmacists are being considered and various prescribing models are currently being trialled, including admission prescribing in hospitals and continued prescribing in aged care facilities.^[21] This trend is following the pattern in other countries such as the United Kingdom, Canada and the United States of America.^{[22, 23]} These prescribing models vary. In some instances pharmacists need to follow strict protocols and may only supplement what has already been prescribed by a doctor.^[24] However, in other instances, pharmacists with specified training may carry out independent prescribing. Not surprisingly, concerns have been raised by the medical profession with regard to pharmacist prescribing. These concerns include the lack of pharmacist access to medical records, accountability and compromised patient safety in not separating prescribing and dispensing. Although research has shown some pharmacists may be reluctant to take up these new roles, many others are enthusiastic about the opportunity to provide these extended services.^[22]

It is worth noting that United Kingdom legal experts have commented that these new prescribing rights bring new responsibilities. Pharmacists will have to accept a higher level of legal responsibility in cases of prescribing errors, similar to that of doctors;^[24] with new rights and responsibilities comes changed legal liability.

With growing health care costs and the escalation of diseases such as type 2 diabetes, pharmacists increasingly become more involved in disease state management. Being accessible, community pharmacists are indeed well placed to contribute to disease state management programs. specifically targeted through the Fourth Community Pharmacy Agreement are the management of patients with asthma and type 2 diabetes. Pharmacists participating in these programs are required to complete a competency-based training course and undertake a credentialing process administered by the Australian Association of Consultant Pharmacy (AACP).