This document outlines the AMA position on government policy in relation to timely access to affordable medicines, and the safe, efficient, and quality use of medicines in Australia.

1. National Medicines Policy

1.1. The AMA is committed to achieving better health outcomes for all Australians by working with all stakeholders to realize the objectives of the National Medicines Policy . The term medicine includes prescription, over-the-counter (OTC) and complementary medicines.

2. Quality use of medicines

2.1. The AMA supports the National Strategy for Quality Use of Medicines , and the adoption of the QUM framework by all stakeholders to provide access to medicines. Under this framework, medical practitioners have a responsibility to:
(a) Select management options wisely by considering all treatment options to best manage a patient's health care needs
(b) Choose the most suitable medicines when medicines are considered appropriate, taking into account the potential for self-harm, and the ability of the patient to adhere to the dosage regimen
(c) Ensure medicines are used safely and effectively, and that patients are fully informed of the relevant side effects of medications as well as the relevant interactions between medications.

2.2. The AMA supports the activities of the National Prescribing Service to provide independent, accurate, balanced, evidence based information on the quality use of medicines.

3. Access to medicines

3.1. The AMA believes in the development of policy and infrastructure that improves access to medicines, improves population and individual health outcomes, and reduces the disparity in health outcomes for vulnerable groups.

3.2. The AMA supports the principles of the Pharmaceutical Benefits Scheme (PBS) to provide universal access to medicines through registered medical practitioners in an effective, efficient and equitable manner, and encourages the development of PBS policy that contributes to optimal patient care.

3.3. The PBS safety net plays a vital role in improving access to medicines by limiting the out of pocket expenses for people who use a large number of prescribed medicines within a calendar year. The Government has an obligation to evaluate the impact of any policy changes to the PBS safety net to ensure that all Australians continue to have timely access to affordable medicines.

3.4. The AMA supports the independence and transparency of PBS listing and pricing functions through the Pharmaceutical Benefits Advisory Committee (PBAC). The PBAC plays a fundamental role in ensuring that the PBS subsidises safe, effective and affordable medicines and must be allowed to make decisions independently and free from political interference and sectional interests. This can only be achieved by government funding of the PBS listing and pricing functions.

3.5. The AMA supports strategies to reduce the incidence of doctor and pharmacy shopping, prescription fraud and other diversion of medicines from the PBS.

3.6. The AMA upholds that medical practitioners must maintain clinical independence in order to make the best treatment recommendations for patients. It is vital that the medical profession remains free from the influence of third parties and be independent to make their own clinical judgments regarding treatment recommendations.

3.7. The AMA encourages medical practitioners to offer generic medicine choices when it is safe and appropriate to do so, and to discuss these options with patients. The AMA opposes any compulsion on medical practitioners to prescribe by generic name.

3.8. The AMA believes timely access to information in the Schedule of Pharmaceutical Benefits (the Schedule) is fundamental to achieve safe and cost-effective prescribing in the best interests of the patient. The Schedule must be available to medical practitioners free of charge in formats that acknowledge the variety of medical practice.

3.9. The AMA supports effective and efficient authority prescribing mechanisms and the development of data systems that provide evidence-based prescribing information to medical practitioners. The AMA accepts the need for selected control mechanisms around prescribing decisions for controlled drugs and high cost pharmaceuticals; however, such mechanisms should not pose a barrier to medical practitioners treating their patients.

3.10. 'Off-label prescribing' is the prescription of a registered medicine for a use that is not included in the product information. Off-label prescribing may be clinically appropriate, but is associated with a number of clinical, ethical and medico-legal issues. The AMA supports greater research and the application of evidence-based principles to provide guidance for medical practitioners when making decisions to prescribe off-label or unlicensed medicines.

3.11. There are certain situations where a face-to-face consultation in order to prescribe medicines may be impractical e.g. rural and remote areas. In these situations, the AMA supports the prescription of medicines related to clinical care by telephone or electronic means where the medical practitioner has determined it is clinically safe to do so, a face-to-face consultation is not immediately required, and where systems are in place to record this communication in the patient record.

4. Community Pharmacy

4.1. Community Pharmacy plays an important role in providing medicines information to consumers and ensuring that all Australians have access to medicines in a timely and safe manner. The AMA supports cost-effective models of Community Pharmacy that maintain professional, quality and safety standards, and which contribute to a sustainable PBS and a viable retail pharmacy industry irrespective of where a pharmacy is located.

4.2. The AMA upholds the importance of timely, clear and consistent communication between the medical practitioner and the pharmacist to improve patient care and enhance the professional medical practitioner/pharmacist relationship. This is particularly important where a medicine is not dispensed in accordance with the medical practitioner's prescription.

5. Quality, safety and efficacy

5.1. The AMA supports the role of the Therapeutic Goods Administration as the regulator of medicines in Australia.

5.2. Within that framework, the AMA advocates for a Medicines Scheduling function independent of the Poisons Scheduling function with representation from practising medical practitioners to ensure consistency in decision making processes, and access to safe medicines.

5.3. The AMA recommends medicines should only be down scheduled where there is strong evidence it is safe to do so, and where there is demonstrated patient benefit and safety in dispensing the medication by this method.

5.4. Adverse drug events are in themselves a significant public health problem. The AMA acknowledges the important role played by the Adverse Drug Reactions Advisory Committee (ADRAC) and supports improvements to adverse drug reaction (ADR) reporting systems and post-market ADR monitoring to reduce the risk of adverse events associated with the use of prescription drugs.

5.5. The AMA supports a comprehensive product vigilance system in line with international best practice, and the development of proactive product vigilance strategies that improve data linkage and enhance the robustness of post market surveillance processes.

5.6. Government systems should ensure that product information and consumer medicines information for medicines is in line with best practice. Where evidence supports a change in clinical practice, product information must be updated in a timely manner in consultation with relevant medical craft groups and pharmaceutical manufacturers.

5.7. It is essential that both the brand name of the medicine and the generic (active ingredient) name are given equal prominence on the medicines label in the interests of safeguarding public health and safety.

6. Prescribing rights

6.1. Only medical practitioners are trained to make a complete diagnosis, monitor the ongoing use of medicines and to understand the risks and benefits inherent in prescribing. The AMA advocates for the continuation of a medical prescriber model in the interests of patient safety and quality care.

6.2. The AMA does not support the introduction of prescribing privileges to non-medical practitioners. However, where Commonwealth, State and Territory authorities have granted limited prescribing privileges (including access to PBS medicines) the principles of QUM principles must be applied to those practitioners. Further, the AMA recommends a system of mandatory referral to a registered medical practitioner where appropriate clinical criteria and outcomes are not achieved within a specific time frame.

7. Policy development

7.1. The AMA supports the maintenance of an independent national medicines advisory body, with membership from groups who have an interest in quality use of medicines and medicines policy in Australia. This forum is important to discuss and debate changes in the medicines environment and to promote, influence and assist in the implementation of the National Medicines Policy in Australia.

8. A responsible and viable pharmaceutical industry

8.1. The AMA believes that an efficient, financially viable, and innovative pharmaceutical industry producing products of high quality will ensure Australia has access to new medicines at a price the patient, tax payer and industry can afford.

8.2. The AMA supports a balance between the right of generic pharmaceuticals to be marketed as soon as an originator patent expires and the extension of patents where an inventive step leads to genuine clinical improvement and the economic case is fair.

8.3. The AMA supports international harmonisation of the medicines industry, where access to a safe supply of medicines, and Australian standards for medicines regulation and therapeutic practice, are maintained.

8.4. The AMA supports self-regulation of the pharmaceutical industry through codes of conduct designed to safeguard public health and safety.

See also:
AMA Position Statement on Complementary Medicines 2002
AMA Position Statement on Direct to Consumer Advertising 2007
AMA Position Statement: Doctors' Relationships with the Pharmaceutical Industry - 1994. Revised 2002
AMA Position Statement on Electronic Prescribing and Dispensing 2008 (tba)
AMA Position Statement on Safety and Quality of E-Health Systems 2006
AMA Position Statement on Task Substitution in Hospital Settings 2006