Health professionals, accustomed to the sales and marketing activities of pharmaceutical companies, may not be aware that considerations about the quality use of medicines (QUM) are fundamental to the activities of the industry. Australia's three peak industry groups the Australian Self Medication Industry, the Generic Medicines Industry Association and Medicines Australia are partners in Australia's National Medicines Policy. QUM principles supporting judicious, safe, appropriate and efficacious use of medicines are embedded in the industry codes of conduct of Medicines Australia and the Australian Self Medication Industry. Industry groups and their member companies are increasingly applying QUM principles in the development of educational and promotional activities. Individual companies are embracing QUM principles through internal staff training and the inclusion of QUM goals in the performance measures of key managers. One company has created a senior management position responsible for QUM. Medicines Australia includes a mandatory QUM training component in its continuing education program for medical representatives of member companies and for staff who have direct interaction with healthcare professionals or are involved in the review, development or approval of sales and marketing materials.
An important example of industry contribution to QUM is the production of consumer medicine information. This is based on the approved product information for prescription medicines.1
Twelve pharmaceutical companies have worked in partnership with the National Heart Foundation. Since its inception in 2003, the Heart Foundation Pharmaceutical Roundtable has conducted an extensive evaluation of the strengths and weaknesses of QUM in cardiovascular health, and selected a research project around an area of QUM which has strong potential to enhance cardiovascular health in both indigenous and non-indigenous Australians.2 The adoption of this model of partnership to other therapeutic areas where QUM is important to health outcomes could further the contribution of industry to QUM.
Another example of industry contribution to QUM is the work entitled 'QUM from the start for health outcomes' developed by members of the Medicines Industry Liaison Group of the National Prescribing Service (NPS). It demonstrates the influence of QUM in all stages of drug development from discovery to commercialisation. This work shows that the application of QUM principles through the development process is important to the eventual product offering.3
The pharmaceutical industry is an important provider of information about its products and services to prescribers and consumers. It does this in a highly regulated environment which is designed to ensure safe, appropriate and well-informed use of medicines. However, the regulatory requirements of the Therapeutic Goods Administration and the QUM requirements in submissions to the Pharmaceutical Benefits Advisory Committee are also important drivers of adherence to QUM.
The management of the relationship between pharmaceutical companies and healthcare professionals or health consumer organisations is critical to achieving QUM. In Australia the Medicines Australia Code of Conduct is an example of a rigorous, enforceable framework for promoting ethical relationships between industry and healthcare professionals in an open and transparent way. The 16th edition of the Medicines Australia Code was authorised by the Australian Competition and Consumer Commission in December 2009. Enhancements to the Code should deliver public benefits through provisions such as protecting the public from exposure to inappropriate advertising and specifically regulating disease education and awareness campaigns. There are specific provisions and principles dealing with relationships between industry and health consumer organisations and there are specific enforcement mechanisms to deal with false and misleading conduct.
Pharmaceutical companies can unequivocally contribute to QUM. The challenge for industry is to increase its contribution to QUM. This challenge will succeed in companies in which QUM becomes part of organisational culture and QUM considerations feature in product development planning and corporate strategic planning. Effective contribution to QUM needs the strong support and endorsement of company leadership to manage the tension between commercial objectives and QUM. The industry will also be challenged to expand its contribution to a wider range of activities, partners and settings. Partnering on QUM issues with relevant organisations, including consumers, government and healthcare professionals, will also contribute to QUM and better health outcomes for patients.
Mr Edwards is a consultant to Shire Pharmaceuticals, Independent Chair of the Medicines Australia Code of Conduct Monitoring Committee, and a shareholder of CSL. He has been a director of the Medicines Australia Board and is currently a director of the NPS Board.
Note: The views in this editorial are the author's and do not necessarily reflect the views of others in any of the organisations he is associated with.
- Medicines Australia. Quality use of medicines.www.medicinesaustralia.com.au/pages/page40.asp [cited 2010 Jul 7]
- Heart Foundation Pharmaceutical Roundtable.www.heartfoundation.org.au/Professional_Information/Research/Roundtable/Pages/default.aspx [cited 2010 Jul 7]
- NPS Medicines Industry Liaison Working Group. QUM from the start for healthy outcomes. In: ASMI annual report 2005–2006. Australian Self-Medication Industry. p.13.www.asmi.com.au/documents/Annual%20Reports/ASMI%20Annual%20Report-2006.pdf [cited 2010 Jul 7]