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.

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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.
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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

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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.

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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

• WHOs estimation of the need for palliative care
  as being 1 of a countrys 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
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Background and setting

• It is estimated that 29 million older persons
  will be added to the worlds 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
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Background and setting

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

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Health Policy

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

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• 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

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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

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• 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

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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.

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• 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.

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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.

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• 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

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• 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.

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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