The International Pain Policy Fellowship: Improving Opioid Availability and Access

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The International Pain Policy Fellowship
Improving Opioid Availability and Access
NAME OF FELLOW(S) AND GOVERNMENT COLLEAGUE
SPONSOR Pain Policy Studies GroupWorld Health
Organization Collaborating Center University of
Wisconsin Carbone Cancer Center www.painpolicy.wis
c.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

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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
• 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.
• 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 tonational 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
  tocountry projects regarding palliative care,
  especially those concerning advocacy for
  availability of controlled medicines and
  development of pain policy.

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The International Pain Policy Fellowship (IPPF)

• 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

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International Pain Policy Fellowship, 2006
Nigeria
Uganda
Dr. Simbo Daisy Amanor-Boadu Physician
Dr. Henry Ddungu Physician
Serbia
Argentina
Prof. Snežana Bošnjak Physician
Dr. Jorge Eisenchlas Physician
Republic of Panama

• Colombia

Prof. Rosa Buitrago Pharm Professor
Dr. Marta Ximena León Physician

• Vietnam

Sierra Leone
Mrs. Nguyen Thi Phuong Cham Senior Pharmacist
Mr. Gabriel Madiye Hospice Administrator
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International Pain Policy Fellowship, 2008
Dr. Dingle Spence Physician Mrs. Verna
Walker-Edwards Pharmacist
Dr. Hrant Karapetyan Physician Dr. Irina
Kazaryan Pharmacist
Jamaica
Armenia

• Georgia

Kenya
Dr. Pati Dzotsenidze Physician
Dr. Zippy AliPhysician
Guatemala
Nepal
Dr. Eva Duarte Juárez Physician
Dr. Bishnu Paudel Physician
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International Pain Policy Fellowship, 2012
Ukraine Ms. Nataliia Datsiuk Researcher  Sri Lanka Dr. Nadarajah Jeyakumaran Physician Dr. Suraj Perera Physician  
Bangladesh Dr. Rumana Dowla Physician Dr. Farzana Khan Physician India Dr. Priyadarshini Kulkarni Physician Dr. Shalini Vallabhan Global Health Policy Program Consultant Dr. Nandini VallathPhysician
Albania Dr. Kristo Huta Physician Kyrgyzstan Dr. Taalaigul Sabyrbekova Physician
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IPPF Training Program

• Madison, Wisconsin 5 day program
• Provides framework to support the Fellows 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

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The need for pain relief, palliative care, and
opioid analgesics

• Cancer
• 22 Million in the world
• 10 Million diagnosed each year
• 6 Million die
• HIV/AIDS
• 33 Million living with HIV/AIDS
• 2.1 Million deaths
• Increasing, shifting to low and middle income
  countries
• Diagnosis often in late stage severe pain
• Drug regulatory and supply chain issues impede
  access

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Patient in South India presenting at a palliative
care clinic A picture of cancer and pain
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Patient after a dose of morphine sitting up and
enjoying tea
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World Health OrganizationThe 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
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World Health Organization Recommendations

• Oral opioids
• Morphine is an Essential Medicine (since 1977)
• For relief of moderate to severe pain
• Cancer, HIV/AIDS, other conditions
• Cancer Pain Relief (1986)
• Three-step Analgesic ladder

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Global Consumption of Morphine, 2010
mg/capita
152 countries
Austrias 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
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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 worlds
population.
Pain Policy Studies Group, 2012. Based on 2010
INCB data.
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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)
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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)
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Many Impediments to Pain Relief Outdated
Knowledge, Attitudes, and Policies
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Why is opioid use so low?

• INCB Survey of government drug control
  authorities 1995 (65 countries) and 2007 (144
  countries)
• Impediments to opioid availability
• Fear of addiction
• Lack of training of health care providers
• Excessively restrictive laws and regulations
• Fear of legal consequences
• Insufficient supply of opioids
• Cost of opioids
• Reluctance to Rx or stock
• Lack of national policy, guidelines

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Why is opioid use so low?

• 2006 Survey of Health care workers, and
  hospice/PC staff in Asia, Africa and Latin
  America
• Impediments to accessing oral morphine
• Excessively strict national drug laws and
  regulations
• Fear of addiction
• Poorly developed health care systems
• Lack of knowledge

Adams, V. (2007). Access to Pain Relief an
essential human right. Help the Hospices,
Worldwide Palliative Care Alliance.
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Impediments can be found in
1) Opioid Regulatory Policy 2) Drug Distribution
System 3) Cost of Opioid Analgesics 4) Knowledge
Attitudes
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Summary of Impediments in Country name
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• Establishes a balanced legal framework to
• Prevent abuse and diversion, and
• Ensure the adequate availability of drugs for
  medical purposes

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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)
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A sense of urgency from UN Organizations

• 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

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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
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World Health Assembly Cancer Prevention and
Control 58.2225 May 2005

• 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.

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ECOSOC Resolution 2005/25 Treatment of Pain
Using Opioid Analgesics22 July 2005

• 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

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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

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Khmer Polish Russian Serbian Slovak Slovenian
Turkish
Armenian Bulgarian English French Georgian Gr
eek Hungarian
Available in 14 languages
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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

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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 awareness-raising
  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

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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

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Building on a Strong Foundation

• 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

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Summary of Action Plan for Country name
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Summary of the 3-5 problems that lead to
inadequate patient access to opioid analgesics in
Fellows Country
Problem 1
Problem 2
Problem 3
Problem 4
Problem 5
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Conclusions

• Unrelieved pain is a great unmet human need
• Pain can be relieved
• Requires a national response
• Strong foundation
• Medicine and science
• Ethical and legal
• Leadership from drug regulator authorities
• Drug control policy should be examined
• Achieving a better Balance is the goal
• Not giving up control
• Methods and experience are available