The International Pain Policy Fellowship: Improving Opioid Availability and Access 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 [NAME OF FELLOW(S) AND GOVERNMENT COLLEAGUE] SPONSOR: Pain & Policy Studies Group World Health Organization Collaborating Center University of Wisconsin Carbone Cancer Center Madison, Wisconsin, USA

Pain & Policy Studies Group (PPSG) (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 aim of the IPPF is to improve the availability of opioid analgesics in low- and middle-income countries by developing national leaders. 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 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 Dr. Simbo Daisy Amanor-Boadu Physician Prof. Snežana Bošnjak Physician Prof. Rosa Buitrago Pharm Professor Mrs. Nguyen Thi Phuong Cham Senior Pharmacist Dr. Henry Ddungu Physician Dr. Jorge Eisenchlas Physician Dr. Marta Ximena León Physician Mr. Gabriel Madiye Hospice Administrator Vietnam Republic of Panama Serbia NigeriaUganda Argentina Colombia Sierra Leone

Dr. Eva Duarte Juárez Physician Dr. Dingle Spence Physician Mrs. Verna Walker-EdwardsPharmacist International Pain Policy Fellowship, 2008 Dr. Bishnu Paudel Physician Dr. Hrant Karapetyan Physician Dr. Irina Kazaryan Pharmacist Armenia Georgia Dr. Pati Dzotsenidze Physician Guatemala Jamaica Kenya Nepal Dr. Zippy Ali Physician

International Pain Policy Fellowship, 2012 Ukraine Ms. Nataliia Datsiuk Researcher Sri Lanka Dr. Nadarajah Jeyakumaran Physician Dr. Suraj Perera Physician Dr. Suraj Perera Physician Bangladesh Dr. Rumana Dowla Physician Dr. Farzana Khan PhysicianIndia Dr. Priyadarshini Kulkarni Physician Dr. Shalini Vallabhan Global Health Policy & Program Consultant Dr. Nandini Vallath Physician Albania Dr. Kristo Huta PhysicianKyrgyzstan Dr. Taalaigul Sabyrbekova Physician

IPPF Training Program Madison, Wisconsin – 5 day program Madison, Wisconsin – 5 day program Provides framework to support the Fellow’s work over the next 2 years 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 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. 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 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 Cancer Cancer 22 Million in the world22 Million in the world 10 Million diagnosed each year10 Million diagnosed each year 6 Million die6 Million die HIV/AIDS HIV/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 countries Increasing, shifting to low and middle income countries Diagnosis often in late stage; severe pain Diagnosis often in late stage; severe pain Drug regulatory and supply chain issues impede access 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

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 The PPSG, as a WHOCC, follows the WHO approach.

World Health Organization Recommendations Oral opioids Oral opioids Morphine is an “Essential Medicine” (since 1977)Morphine is an “Essential Medicine” (since 1977) For relief of moderate to severe painFor relief of moderate to severe pain Cancer, HIV/AIDS, other conditionsCancer, HIV/AIDS, other conditions Cancer Pain Relief (1986) Cancer Pain Relief (1986) Three-step Analgesic ladder Three-step Analgesic ladder

Global Consumption of Morphine, 2010 **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 mg/capita 152 countries

In 2010, eight countries together accounted for 85% of global consumption of morphine. These countries represent less than 13% of the world’s population. Global disparities in access Pain & Policy Studies Group, 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 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. International Narcotics Control Board (INCB) to Governments: (INCB 2010 Annual Report, p. 125)

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

Why is opioid use so low?  INCB Survey of government drug control authorities 1995 (65 countries) and 2007 (144 countries)  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?  2006 Survey of Health care workers, and hospice/PC staff in Asia, Africa and Latin America  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  International Narcotics Control Board  World Health Assembly  UN Economic and Social Council  World Health Organization  Commission 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 International Narcotics Control Board, 2009 report “ 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)

World Health Assembly Cancer Prevention and Control May 2005 Urges member states to ensure the medical availability of opioid analgesics Urges member states to ensure the medical availability of opioid analgesics Requests the WHO Director General: 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 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; 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; Invites the INCB and WHO to examine the feasibility of a possible assistance mechanism to facilitate adequate treatment of pain using opioid 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 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: “ 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;”

Commission on Narcotic Drugs 2010 Resolution: “ 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 Unquestioned need to relieve suffering Unquestioned need to relieve suffering Solid medical and scientific basis Solid medical and scientific basis Strong leadership from governments & experts Strong leadership from governments & experts Clear policy guidance from UN bodies Clear 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 {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 Unrelieved pain is a great unmet human need Unrelieved pain is a great unmet human need Pain can be relieved Pain can be relieved Requires a national response Requires a national response Strong foundation Strong foundation Medicine and scienceMedicine and science Ethical and legalEthical and legal Leadership from drug regulator authorities Leadership from drug regulator authorities Drug control policy should be examined Drug control policy should be examined Achieving a better “Balance” is the goal Achieving a better “Balance” is the goal Not giving up controlNot giving up control Methods and experience are available Methods and experience are available