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.
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
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.
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
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
Background and setting

This increasing longevity will have far
reaching consequences for the provision
of palliative care for all countries of the
world.
Health Policy

The National Medicines Policy and the
Palliative Care Strategy facilitated a
process to improve community
availability of key medications for
palliative care
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
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
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
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.
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.
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.
EXECUTIVE
GROUP
Management
Advisory Board
Trial Management
Committee
Trial
Subcommittees
Trial
Subcommittees
Data Safety
& Monitoring
Committee
Trial
Subcommittees
Trial
Subcommittees
Scientific
Committee
Publications &
Implementation
Subcommittee
Phase 4 Committee




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
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.
Future challenges


There is much to learn from the cancer
programmes however the ageing
population and increasing prevalence of
use of medicines for chronic noncommunicable 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