The International Pain Policy Fellowship: The International Pain Policy Fellowship: Improving Opioid Availability and AccessImproving Opioid Availability and Access

SUPPORTSUPPORT::

Lance Armstrong FoundationLance Armstrong Foundation

Open Society Foundations, International Palliative Care InitiativeOpen Society Foundations, International Palliative Care Initiative

U.S. Cancer Pain Relief CommitteeU.S. Cancer Pain Relief Committee

International Renaissance Foundation (Ukraine)International Renaissance Foundation (Ukraine)

Open Society Foundation AlbaniaOpen Society Foundation Albania

Soros Foundation Kyrgyzstan Soros Foundation Kyrgyzstan

[NAME OF FELLOW(S) AND GOVERNMENT COLLEAGUE]

SPONSORSPONSOR::Pain & Policy Studies GroupPain & Policy Studies Group

World Health Organization Collaborating CenterWorld Health Organization Collaborating Center

University of Wisconsin Carbone Cancer CenterUniversity of Wisconsin Carbone Cancer Centerwww.painpolicy.wisc.edu

Madison, Wisconsin, USAMadison, Wisconsin, USA

Pain & Policy Studies Group (PPSG)Pain & Policy Studies Group (PPSG)(Founded 1996)(Founded 1996)

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 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.

World Health Organization Collaborating Center for Pain Policy and Palliative Care

Mission:

To improve global pain relief by achieving balanced access to opioids worldwide.

The International Pain Policy Fellowship (IPPF)The International Pain Policy Fellowship (IPPF)

The aim of the IPPF is to improve the availability The aim of the IPPF is to improve the availability of opioid analgesics in low- and middle-income of opioid analgesics in low- and middle-income countries by developing national leaders. countries by developing national leaders.

The PPSG, in cooperation with international The PPSG, in cooperation with international experts, provides training and technical experts, provides training and technical assistance to Fellows for the entire 2-year period assistance to Fellows for the entire 2-year period of the Fellowshipof the Fellowship

International Pain Policy Fellowship, International Pain Policy Fellowship, 20062006

Dr. Simbo Daisy Amanor-Boadu

Physician

Prof. Snežana Bošnjak Physician

Prof. Rosa BuitragoPharm Professor

Mrs. Nguyen Thi Phuong Cham Senior Pharmacist

Dr. Henry DdunguPhysician

Dr. Jorge Eisenchlas Physician

Dr. Marta Ximena León Physician

Mr. Gabriel Madiye Hospice Administrator

Vietnam

Republic of Panama

Serbia

Nigeria Uganda

Argentina

Colombia

Sierra Leone

Dr. Eva Duarte JuárezPhysician

Dr. Dingle SpenceDr. Dingle SpencePhysicianPhysician

Mrs. Verna Mrs. Verna Walker-EdwardsWalker-Edwards

PharmacistPharmacist

International Pain Policy Fellowship, 2008

Dr. Bishnu PaudelPhysician

Dr. Hrant KarapetyanPhysician

Dr. Irina KazaryanPharmacist

Armenia

Georgia

Dr. Pati DzotsenidzeDr. Pati DzotsenidzePhysicianPhysician

Guatemala

JamaicaJamaica

KenyaKenya

Nepal

Dr. Zippy AliDr. Zippy AliPhysicianPhysician

International Pain Policy Fellowship, 2012International Pain Policy Fellowship, 2012

UkraineUkraine

Ms. Nataliia DatsiukMs. Nataliia DatsiukResearcher Researcher 

Sri LankaSri Lanka Dr. Nadarajah JeyakumaranDr. Nadarajah JeyakumaranPhysicianPhysician

Dr. Suraj PereraDr. Suraj Perera PhysicianPhysician   

BangladeshBangladeshDr. Rumana DowlaDr. Rumana Dowla

PhysicianPhysician

Dr. Farzana KhanDr. Farzana Khan

PhysicianPhysician

IndiaIndia

Dr. Priyadarshini Kulkarni Dr. Priyadarshini Kulkarni PhysicianPhysician

Dr. Shalini VallabhanDr. Shalini Vallabhan Global Health Policy & Program Global Health Policy & Program

ConsultantConsultant

Dr. Nandini VallathDr. Nandini VallathPPhysicianhysician

AlbaniaAlbania

Dr. Kristo HutaDr. Kristo HutaPhysicianPhysician

KyrgyzstanKyrgyzstan

Dr. Taalaigul SabyrbekovaDr. Taalaigul Sabyrbekova P Physicianhysician

IPPF Training ProgramIPPF Training Program Madison, Wisconsin – 5 day programMadison, Wisconsin – 5 day program Provides framework to support the Fellow’s work over the Provides framework to support the Fellow’s work over the

next 2 yearsnext 2 years Presentations by expert faculty covering the relationships Presentations by expert faculty covering the relationships

between disease, pain, palliative care, and inadequate opioid between disease, pain, palliative care, and inadequate opioid availabilityavailability

Country reports that provide background information about Country reports that provide background information about the extent of cancer and AIDS, status of opioid availability, the extent of cancer and AIDS, status of opioid availability, Impediments, and potential resources to improve patient Impediments, and potential resources to improve patient access to pain relief in each country. access to pain relief in each country.

Each country completes an initial Action Plan to guide their Each country completes an initial Action Plan to guide their in-country project to improve opioid availability in-country project to improve opioid availability

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

CancerCancer• 22 Million in the world22 Million in the world• 10 Million diagnosed each year10 Million diagnosed each year• 6 Million die6 Million die

HIV/AIDSHIV/AIDS• 33 Million living with HIV/AIDS33 Million living with HIV/AIDS• 2.1 Million deaths2.1 Million deaths

Increasing, shifting to low and middle income Increasing, shifting to low and middle income countriescountries

Diagnosis often in late stage; severe painDiagnosis often in late stage; severe pain Drug regulatory and supply chain issues impede Drug regulatory and supply chain issues impede

accessaccess

Patient in South India presenting at a palliative care clinicPatient in South India presenting at a palliative care clinic

A picture of cancer and painA picture of cancer and pain

Patient after a dose of morphine sitting up and enjoying tea Patient after a dose of morphine sitting up and enjoying tea

EducationOf the public

Of health care professionals(doctors, nurses, pharmacists)

Of others(health care policy-makers,

administrators, drug regulators)

Drug availabilityChanges in health care regulations/ legislation to improve drug availability (especially of opioids)

Improvements in prescribing, distributing, dispensing, and administration of drugs

Government policyNational or state policy emphasizing the need to alleviate chronic cancer pain

World Health OrganizationWorld Health OrganizationThe PPSG, as a WHOCC, follows the WHO approach.The PPSG, as a WHOCC, follows the WHO approach.

World Health Organization World Health Organization RecommendationsRecommendations

Oral opioids Oral opioids • Morphine is an “Essential Morphine is an “Essential

Medicine” (since 1977)Medicine” (since 1977)• For relief of moderate to For relief of moderate to

severe painsevere pain• Cancer, HIV/AIDS, other Cancer, HIV/AIDS, other

conditions conditions

Cancer Pain Relief Cancer Pain Relief (1986)(1986)

Three-step Analgesic Three-step Analgesic ladderladder

Global Consumption of Morphine, Global Consumption of Morphine, 20102010

**Austria’s consumption includes use of morphine for substitution therapySources: International Narcotics Control Board; World Health Organization population dataBy: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2012

mg/capita

0

10

20

30

40

50

60

70

80

Global mean, 5.9912 mg/capita

**Austria122.5037

Bangladesh0.0502

Ukraine0.6418

India0.0913

Kyrgyzstan0.1048

Sri Lanka0.3872

Albania0.9429

152 countries

In 2010, eight countries together In 2010, eight countries together accounted for 85% of global accounted for 85% of global consumption of morphine. consumption of morphine. These countries represent less These countries represent less than 13% of the world’s than 13% of the world’s population.population.

Global disparities in accessGlobal disparities in access

Pain & Policy Studies Group, 2012. Based on 2010 INCB data.

“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 International Narcotics Control Board (INCB) to Governments:Governments:

Recommendation 35Recommendation 35: Large parts of the : Large parts of the world remain seriously undersupplied with world remain seriously undersupplied with medications that are necessary to alleviate medications that are necessary to alleviate patients’ pain and suffering. The Board patients’ pain and suffering. The Board urges the Governments of the countries urges the Governments of the countries concerned, in particular the Governments concerned, in particular the Governments of countries with consumption of opioids of countries with consumption of opioids below 100 defined daily doses for below 100 defined daily doses for statistical purposes (S-DDD) 46 per million statistical purposes (S-DDD) 46 per million inhabitants per day, to take appropriate inhabitants per day, to take appropriate action to ensure that their populations action to ensure that their populations have adequate access to opioid-based have adequate access to opioid-based medications, in line with the international medications, in line with the international drug control conventions. drug control conventions.

International Narcotics Control Board (INCB) to International Narcotics Control Board (INCB) to Governments:Governments:

(INCB 2010 Annual Report, p. 125)

Many Impediments to Pain Relief: Many Impediments to Pain Relief: Outdated Knowledge, Attitudes, and PoliciesOutdated Knowledge, Attitudes, and Policies

Why is opioid use so low?Why is opioid use so low?

INCB Survey of government drug INCB Survey of government drug control authorities control authorities 19951995 (65 (65 countries) and countries) and 20072007 (144 (144 countries)countries)

Impediments to opioid availability:Impediments to opioid availability:1)1) Fear of addictionFear of addiction2)2) Lack of training of health Lack of training of health

care providerscare providers3)3) Excessively restrictive laws Excessively restrictive laws

and regulationsand regulations4)4) Fear of legal consequencesFear of legal consequences5)5) Insufficient supply of opioidsInsufficient supply of opioids6)6) Cost of opioidsCost of opioids7)7) Reluctance to Rx or stockReluctance to Rx or stock8)8) Lack of national policy, Lack of national policy,

guidelinesguidelines

Why is opioid use so low?Why is opioid use so low? 2006 Survey of Health 2006 Survey of Health

care workers, and care workers, and hospice/PC staff in Asia, hospice/PC staff in Asia, Africa and Latin AmericaAfrica and Latin America

Impediments to accessing Impediments to accessing oral morphine: oral morphine:

1)1) Excessively strict Excessively strict national drug laws national drug laws and regulations; and regulations;

2)2) Fear of addiction;Fear of addiction;3)3) Poorly developed Poorly developed

health care health care systems;systems;

4)4) Lack of knowledgeLack 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:Impediments can be found in:

1) Opioid Regulatory Policy

2) Drug Distribution System

3) Cost of Opioid Analgesics

4) Knowledge & Attitudes

Summary of Impediments inSummary of Impediments in { {Country nameCountry 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

International Narcotics Control BoardInternational Narcotics Control Board World Health AssemblyWorld Health Assembly UN Economic and Social CouncilUN Economic and Social Council World Health OrganizationWorld Health Organization Commission on Narcotic DrugsCommission on Narcotic Drugs

Resolution in 2010: “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 Report on DIVERSION

International Narcotics Control Board, 2009 report

“The system of control measures laid down in the1961 Convention provides effective protection ofinternational 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)

World Health AssemblyWorld Health Assembly Cancer Prevention and Control 58.22Cancer Prevention and Control 58.22

25 May 200525 May 2005

Urges member states to ensure the medical Urges member states to ensure the medical availability of opioid analgesicsavailability of opioid analgesics

Requests the WHO Director General: Requests the WHO Director General:

(1) to explore mechanisms for funding cancer (1) to explore mechanisms for funding cancer prevention, control and palliative-care, prevention, control and palliative-care, especially in developing countries.especially in developing countries.

(2) to examine with the International Narcotics (2) to examine with the International Narcotics Control Board how to facilitate the adequate Control Board how to facilitate the adequate treatment of pain using opioid analgesics.treatment of pain using opioid analgesics.

ECOSOC Resolution 2005/25 ECOSOC Resolution 2005/25 Treatment of Pain Using Opioid AnalgesicsTreatment of Pain Using Opioid Analgesics

22 July 200522 July 2005

Urges member states to remove impediments to Urges member states to remove impediments to the medical use of opioid analgesics, taking into the medical use of opioid analgesics, taking into account the need to prevent their diversion for account the need to prevent their diversion for illicit use;illicit use;

Invites the INCB and WHO to examine the Invites the INCB and WHO to examine the feasibility of a possible assistance mechanism to feasibility of a possible assistance mechanism to facilitate adequate treatment of pain using opioid facilitate adequate treatment of pain using opioid analgesics;analgesics;

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

Ensuring Balance in National Policies on Controlled Substances, Guidance for Availability and Accessibility of

Controlled Medicines (2011)

Armenian

Bulgarian

English

French

Georgian

Greek

Hungarian

Khmer

Polish

Russian

Serbian

Slovak

Slovenian

Turkish

““Balance” is the Fundamental PrincipleBalance” 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 DrugsCommission on Narcotic Drugs 2010 Resolution: “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 pertinentrecommendations of the World Health Organization and in line with theinternational drug control conventions;”

Commission on Narcotic DrugsCommission on Narcotic Drugs 2010 Resolution: “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 InternationalNarcotics 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 ControlBoard 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 FoundationBuilding on a Strong Foundation

Unquestioned need to relieve sufferingUnquestioned need to relieve suffering Solid medical and scientific basisSolid medical and scientific basis Strong leadership from governments & Strong leadership from governments &

expertsexperts Clear policy guidance from UN bodiesClear policy guidance from UN bodies

• Single Convention on Narcotic DrugsSingle Convention on Narcotic Drugs• Economic and Social CouncilEconomic and Social Council• International Narcotics Control BoardInternational Narcotics Control Board• World Health OrganizationWorld Health Organization• Commission on Narcotic DrugsCommission on Narcotic Drugs

Summary of Action Plan for Summary of Action Plan for {{Country nameCountry name}}

Summary of the 3-5 problems that lead to inadequate patient Summary of the 3-5 problems that lead to inadequate patient access to opioid analgesics in {access to opioid analgesics in {Fellow’s CountryFellow’s Country}}

Problem 1:

Problem 2:

Problem 3:

Problem 4:

Problem 5:

ConclusionsConclusions

Unrelieved pain is a great unmet human needUnrelieved pain is a great unmet human need Pain Pain cancan be relieved be relieved Requires a national responseRequires a national response Strong foundationStrong foundation

• Medicine and scienceMedicine and science• Ethical and legal Ethical and legal

Leadership from drug regulator authoritiesLeadership from drug regulator authorities Drug control policy should be examinedDrug control policy should be examined Achieving a better “Balance” is the goalAchieving a better “Balance” is the goal

• Not giving up controlNot giving up control Methods and experience are availableMethods and experience are available