Background and setting

1. Improving Access and Quality Use of Medicines in Palliative Care within National Drug Policy, Regulatory, and Funding Frameworks Debra Rowett, Tania Shelby-James, Simon Eckerman, Janet Hardy, Lynn Weekes, David Currow.

2. Background and setting • Palliative care has grown significantly in the last 30 years • is progressively implemented within national health systems • In some countries palliative care is recognized only in the context of certain chronic diseases such as cancer

3. Background and setting • However, there is a growing need for even more attention to palliative care throughout the world with an ageing world population, an increasing incidence and prevalence of cancer and HIV/AIDS, and progressive advanced chronic illness.

4. Background and setting sub-Saharan Africa1 • In 2009 estimated 22.5million people living with HIV/AIDS • 67% of global disease burden • Over 700,000 new cancer cases and 600,000 cancer related deaths in 2007 • WHO’s estimation of the need for palliative care as being 1% of a country’s total population then approximately 9.67 million people are in need of palliative care across Africa. 1. Faith Mwangi-Powell and Olivia Dix: Palliative care in Africa: an overview Africa Health July 2011

5. Background and setting • It is estimated that 29 million older persons will be added to the world’s population each year between 2010 and 2025 • Over 80 per cent of those will be added in the developing countries. • By 2050, it is projected that around 80 per cent of the elderly will live in the developing world. 2. United Nations General Assembly , 4 July 2011, Human Rights Council, eighteenth session

6. Background and setting • This increasing longevity will have far reaching consequences for the provision of palliative care for all countries of the world.

7. Health Policy • The National Medicines Policy and the Palliative Care Strategy facilitated a process to improve community availability of key medications for palliative care

8. National Medicines Policy has four central objectives • Timely access to and affordable cost of medicines • Appropriate standards of quality, safety, efficacy • Quality use of medicines • Maintaining a responsible and viable medicines industry

9. National Palliative Care Strategy Improve access for palliative care medicines on the PBS. AND Raise awareness within the primary health care workforce of existing palliative care medicines already listed on the PBS. AND Promote quality use of palliative care medications to health professionals and the broader community

10. The Palliative Care Medicines Working Group (PCMWG) Established to investigate problems associated with access to palliative care medications in the community Membership is multidisciplinary and includes representatives from a broad range of stakeholders

11. Access and Quality Use of Medicines in Palliative Care • However, improving equity of access and quality use of medicines in palliative care is impeded by the limited evidence for efficacy, cost effectiveness, and safety data for medicines commonly used for symptom control.

12. Challenges identified is listing on PBS: • the medicine not registered for supply in Australia for use in any medical condition • In palliative care a large number of ‘old’ drugs and drugs for ‘off label’ indications • the medicine registered but not PBS-listed for indications for use in palliative care • the specific dosage and formulation needs for administration to palliative care patients, the discontinuation of older or low usage medicines by manufacturers.

13. Prescribing at the end of life • Adverse drug events may contribute to symptom burden, at a time when meticulous control of symptoms is paramount • The identification and attribution of adverse drug events in palliative care is complex and challenging as it is increasingly difficult to differentiate the pathology of the disease process from adverse drug events.

14. EXECUTIVE GROUP Management Advisory Board Trial Management Committee Data Safety & Monitoring Committee Scientific Committee Phase 4 Committee Trial Subcommittees Publications & Implementation Subcommittee Trial Subcommittees Trial Subcommittees Trial Subcommittees

15. 6 initial sites/ investigators working in 5 states • Prospective phase 3 clinical studies • Prospective phase 4 pharmaco-vigilance studies on phase 3 medicines being studied • Development of consumer impact statements on medicines being studied

16. A rapid reporting pharmacovigilance programme that builds on the work of the PaCCSC has been developed and is being extended into South East Asia and New Zealand. Further drug utilization methodologies to support ongoing monitoring of drug use in palliative care are being developed.

17. Future challenges • There is much to learn from the cancer programmes however the ageing population and increasing prevalence of use of medicines for chronic non- communicable disease pose new challenges for policy development for palliative care will require even greater medicines vigilance. • Establishment of processes which reduce the risk for unsanctioned use and diversion