Transcript International Pain Policy Fellowship: Improving Opioid

The International Pain Policy Fellowship:
Improving Opioid Availability and Access
[NAME OF FELLOW(S) AND GOVERNMENT COLLEAGUE]
SPONSOR:
Pain & Policy Studies Group
World Health Organization Collaborating Center
University of Wisconsin Carbone Cancer Center
www.painpolicy.wisc.edu
Madison, Wisconsin, USA
SUPPORT:
Lance Armstrong Foundation
Open Society Foundations, International Palliative Care Initiative
U.S. Cancer Pain Relief Committee
International Renaissance Foundation (Ukraine)
Open Society Foundation Albania
Soros Foundation Kyrgyzstan
Pain & Policy Studies Group (PPSG)
(Founded 1996)
World Health Organization Collaborating Center for Pain Policy and Palliative Care
Mission:
To improve global pain relief by achieving balanced access to opioids worldwide.
Terms of Reference:
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…to provide technical assistance to promote palliative care for patients with cancer or other life-limiting
conditions to WHO Member States… in response to increasing authoritative global calls for improving the
availability and accessibility of opioid medications.
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… to provide technical assistance using WHO Guidelines, assess the context of balance and barriers in
national pain policy, including controlled medicines laws and regulations; cooperate with and provide
related information, education and assistance to…national Governments, NGOs and individuals; develop
methods to communicate with and train health professionals, regulators and policy makers about
balanced drug control policy.
•
Develop methods, including establishment of demonstration projects, to make opioids available under
adequate control for the relief of pain in community-based programs and hospitals, consistent with
international drug control conventions and WHO Guidelines and policies; spread the use of such methods
nationally and internationally in developed and developing countries.
•
Collaborate and give technical assistance to…country projects regarding palliative care, especially those
concerning advocacy for availability of controlled medicines and development of pain policy.
The International Pain Policy Fellowship (IPPF)
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The aim of the IPPF is to improve the availability
of opioid analgesics in low- and middle-income
countries by developing national leaders.
The PPSG, in cooperation with international
experts, provides training and technical
assistance to Fellows for the entire 2-year period
of the Fellowship
International Pain Policy Fellowship,
2006
Nigeria
Uganda
Dr. Simbo Daisy
Amanor-Boadu
Dr. Henry Ddungu
Physician
Physician
Serbia
Argentina
Prof. Snežana Bošnjak
Dr. Jorge Eisenchlas
Physician
Physician
Republic of Panama
Colombia
Prof. Rosa Buitrago
Dr. Marta Ximena León
Pharm Professor
Vietnam
Physician
Sierra Leone
Mrs. Nguyen Thi
Phuong Cham
Senior Pharmacist
Mr. Gabriel Madiye
Hospice Administrator
International Pain Policy Fellowship, 2008
Armenia
Dr. Hrant Karapetyan
Jamaica
Dr. Dingle Spence
Physician
Physician
Mrs. Verna
Walker-Edwards
Dr. Irina Kazaryan
Pharmacist
Georgia
Pharmacist
Kenya
Dr. Pati Dzotsenidze
Dr. Zippy Ali
Physician
Guatemala
Physician
Nepal
Dr. Eva Duarte Juárez
Dr. Bishnu Paudel
Physician
Physician
International Pain Policy Fellowship, 2012
Ukraine
Ms. Nataliia Datsiuk
Sri Lanka
Dr. Nadarajah Jeyakumaran
Physician
Dr. Suraj Perera
Researcher
Physician
Bangladesh
Dr. Rumana Dowla
Physician
Dr. Priyadarshini Kulkarni
India
Dr. Nandini Vallath
Physician
Dr. Kristo Huta
Physician
Dr. Shalini Vallabhan
Global Health Policy & Program
Consultant
Dr. Farzana Khan
Albania
Physician
Physician
Kyrgyzstan
Dr. Taalaigul Sabyrbekova
Physician
IPPF Training Program
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Madison, Wisconsin – 5 day program
Provides framework to support the Fellow’s work over the
next 2 years
Presentations by expert faculty covering the relationships
between disease, pain, palliative care, and inadequate
opioid availability
Country reports that provide background information about
the extent of cancer and AIDS, status of opioid availability,
Impediments, and potential resources to improve patient
access to pain relief in each country.
Each country completes an initial Action Plan to guide their
in-country project to improve opioid availability
The need for pain relief, palliative care,
and opioid analgesics
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Cancer
• 22 Million in the world
• 10 Million diagnosed each year
• 6 Million die
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HIV/AIDS
• 33 Million living with HIV/AIDS
• 2.1 Million deaths
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Increasing, shifting to low and middle income
countries
Diagnosis often in late stage; severe pain
Drug regulatory and supply chain issues impede
access
Patient in South India presenting at a palliative care clinic
A picture of cancer and pain
Patient after a dose of morphine sitting up and enjoying tea
World Health Organization
The PPSG, as a WHOCC, follows the WHO approach.
Education
Of the public
Of health care professionals
(doctors, nurses, pharmacists)
Of others
(health care policy-makers,
administrators, drug regulators)
Drug availability
Changes in health care regulations/
legislation to improve drug availability
(especially of opioids)
Improvements in prescribing,
distributing, dispensing, and
administration of drugs
Government policy
National or state policy emphasizing the need to alleviate
chronic cancer pain
World Health Organization
Recommendations
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Oral opioids
• Morphine is an “Essential
Medicine” (since 1977)
• For relief of moderate to
severe pain
• Cancer, HIV/AIDS, other
conditions
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Cancer Pain Relief
(1986)
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Three-step Analgesic
ladder
Global Consumption of Morphine, 2010
mg/capita
Global mean, 5.9912 mg/capita
80
**Austria
122.5037
70
60
50
40
30
20
Albania
0.9429
10
0
152 countries
**Austria’s consumption includes use of morphine for substitution therapy
Sources: International Narcotics Control Board; World Health Organization population data
By: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2012
Ukraine
0.6418
S ri Lanka
0.3872
Kyrgyzstan
0.1048
India
0.0913
Bangladesh
0.0502
Global disparities in access
In 2010, eight countries together
accounted for 85% of global
consumption of morphine.
These countries represent less
than 13% of the world’s
population.
Pain & Policy Studies Group, 2012. Based on 2010 INCB data.
International Narcotics Control Board (INCB) to
Governments:
“The low level of consumption of opioid
analgesics for the treatment of pain in many
countries, particularly developing countries,
continues to be a matter of concern to the
Board. The Board stresses that the medical use
of narcotic drugs continues to be indispensable
for the relief of pain and suffering and that it is
the responsibility of Governments to ensure
their adequate availability. The Board urges
Governments to develop plans of action to
facilitate the supply and availability of opiates for
all appropriate indications, taking into
consideration the Access to Controlled
Medications Programme, which was prepared
by WHO in consultation with the Board.” (INCB
2009 Annual Report, p. 25)
International Narcotics Control Board (INCB) to
Governments:
Recommendation 35: Large parts of the
world remain seriously undersupplied with
medications that are necessary to alleviate
patients’ pain and suffering. The Board
urges the Governments of the countries
concerned, in particular the Governments
of countries with consumption of opioids
below 100 defined daily doses for
statistical purposes (S-DDD) 46 per million
inhabitants per day, to take appropriate
action to ensure that their populations
have adequate access to opioid-based
medications, in line with the international
drug control conventions.
(INCB 2010 Annual Report, p. 125)
Many Impediments to Pain Relief:
Outdated Knowledge, Attitudes, and Policies
Why is opioid use so low?
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INCB Survey of government drug
control authorities 1995 (65
countries) and 2007 (144 countries)
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Impediments to opioid availability:
1)
Fear of addiction
2)
Lack of training of health
care providers
3)
Excessively restrictive laws
and regulations
4)
Fear of legal consequences
5)
Insufficient supply of opioids
6)
Cost of opioids
7)
Reluctance to Rx or stock
8)
Lack of national policy,
guidelines
Why is opioid use so low?
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2006 Survey of Health
care workers, and
hospice/PC staff in Asia,
Africa and Latin America
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Impediments to accessing
oral morphine:
1) Excessively strict
national drug laws
and regulations;
2) Fear of addiction;
3) Poorly developed
health care
systems;
4) Lack of knowledge
Adams, V. (2007). Access to Pain Relief – an essential human right.
Help the Hospices, Worldwide Palliative Care Alliance.
Impediments can be found in:
1) Opioid Regulatory Policy
2) Drug Distribution System
3) Cost of Opioid Analgesics
4) Knowledge & Attitudes
Summary of Impediments in
{Country name}
Establishes a balanced
legal framework to:
1. Prevent abuse and
diversion, and
2. Ensure the adequate
availability of drugs
for medical purposes
“the medical use of
narcotic drugs
continues to be
indispensable for the
relief of pain and
suffering… adequate
provision must be
made to ensure the
availability of
narcotic drugs for
such purposes.”
(Preamble, p. 13)
A sense of urgency from
UN Organizations
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International Narcotics Control Board
World Health Assembly
UN Economic and Social Council
World Health Organization
Commission on Narcotic Drugs
 Resolution in 2010: “Promoting adequate availability
of internationally controlled licit drugs for medical
and scientific purposes while preventing their
diversion and abuse”
Report on DIVERSION
“The system of control measures laid down in the
1961 Convention provides effective protection of
international trade in narcotic drugs against
attempts at their diversion into illicit channels. In
2009, no cases were detected of diversion of
narcotic drugs from licit international trade into
the illicit traffic.” (paragraph 51)
International Narcotics Control Board, 2009 report
World Health Assembly
Cancer Prevention and Control 58.22
25 May 2005
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Urges member states to ensure the medical
availability of opioid analgesics
Requests the WHO Director General:
(1) to explore mechanisms for funding cancer
prevention, control and palliative-care,
especially in developing countries.
(2) to examine with the International Narcotics
Control Board how to facilitate the adequate
treatment of pain using opioid analgesics.
ECOSOC Resolution 2005/25
Treatment of Pain Using Opioid Analgesics
22 July 2005
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Urges member states to remove impediments to
the medical use of opioid analgesics, taking into
account the need to prevent their diversion for
illicit use;
Invites the INCB and WHO to examine the
feasibility of a possible assistance mechanism to
facilitate adequate treatment of pain using opioid
analgesics;
Ensuring Balance in National Policies on Controlled
Substances, Guidance for Availability and Accessibility of
Controlled Medicines (2011)
 policy-makers, regulators and
politicians; academia and civil
society; healthcare
professionals and their
organizations; individuals and
organizations whose area of
work or interest is drug control
or public health.
 Explains need, rationale and
imperative
 21 guidelines
 Country Assessment Checklist
 14 Languages
Armenian
Khmer
Bulgarian
Polish
English
Russian
French
Serbian
Georgian
Slovak
Greek
Slovenian
Hungarian
Turkish
“Balance” is the Fundamental Principle
• National policy should establish a
drug control system that prevents
diversion and ensures adequate
availability for medical use
• Drug control measures should not
interfere with medical access to
opioid
Commission on Narcotic Drugs
2010 Resolution: “Promoting adequate availability of internationally controlled licit
drugs for medical and scientific purposes while preventing their diversion and abuse”
•Calls upon Member States to fulfill in a timely manner their reporting
obligations to the International Narcotics Control Board and the
Secretary-General, as appropriate, on the use of internationally
controlled substances for medical and scientific purposes and on the
diversion of, trafficking in and abuse of those substances, as required
under the international drug control treaties;
•“Encourages Member States, where necessary, to educate regulators
and health-care professionals, including through targeted awarenessraising campaigns, to recognize that the medical use of narcotic drugs
continues to be indispensable for the relief of pain and suffering and
that adequate provision must be made to ensure the availability of
narcotic drugs for such purposes, taking into account the pertinent
recommendations of the World Health Organization and in line with the
international drug control conventions;”
Commission on Narcotic Drugs
2010 Resolution: “Promoting adequate availability of internationally controlled licit
drugs for medical and scientific purposes while preventing their diversion and abuse”
•Encourages Member States to consider working with the International
Narcotics Control Board and the United Nations Office on Drugs and Crime to
update policies and legislative frameworks, as appropriate, to ensure adequate
availability of internationally controlled substances and to prevent the diversion
and abuse of those substances, in line with the provisions of the international
drug control treaties;
•Supports recommendation 39 of the International Narcotics Control
Board contained in its annual report for 2009, in which the Board called on
Governments to promote access to and rational use of narcotic drugs and
psychotropic substances, to adopt measures against unlawful medical practice
and to ensure that domestic distribution channels are adequately controlled, and
its recommendation 40, in which the Board requested Governments of countries
in which factors such as knowledge limitations and administrative barriers
stricter than the control measures required under the 1961 Convention affect the
availability of opioid analgesics to identify the impediments in their countries to
the access and adequate use of opioid analgesics for the treatment of pain and
to take steps to improve the availability of those narcotic drugs for medical
purposes, in accordance with pertinent recommendations of the World Health
Organization;
Building on a Strong Foundation
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Unquestioned need to relieve suffering
Solid medical and scientific basis
Strong leadership from governments &
experts
Clear policy guidance from UN bodies
• Single Convention on Narcotic Drugs
• Economic and Social Council
• International Narcotics Control Board
• World Health Organization
• Commission on Narcotic Drugs
Summary of Action Plan for
{Country name}
Summary of the 3-5 problems that lead to inadequate patient
access to opioid analgesics in {Fellow’s Country}
Problem 1:
Problem 2:
Problem 3:
Problem 4:
Problem 5:
Conclusions
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Unrelieved pain is a great unmet human need
Pain can be relieved
Requires a national response
Strong foundation
• Medicine and science
• Ethical and legal
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Leadership from drug regulator authorities
Drug control policy should be examined
Achieving a better “Balance” is the goal
• Not giving up control
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Methods and experience are available