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Obstacles to Opioid Availability and Use

Obstacles to Opioid Availability and Use. Thanks specifically to: Dave Joranson Dr. James Cleary Jody Garthwaite. Chennai, India December 13, 2005 Dr. Fraser Black. in collaboration with: Pain & Policy Studies Group University of Wisconsin Comprehensive Cancer Center

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Obstacles to Opioid Availability and Use

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  1. Obstacles to Opioid Availability and Use • Thanks specifically to: • Dave Joranson • Dr. James Cleary • Jody Garthwaite Chennai, India December 13, 2005 Dr. Fraser Black in collaboration with: Pain & Policy Studies Group University of Wisconsin Comprehensive Cancer Center World Health Organization Collaborating Center www.medsch.wisc.edu/painpolicy

  2. Demonstration Project in Calicut

  3. “…approximately 10 million people are diagnosed with cancer annually, and more than 6 million die of the disease every year; over 22 million people in the world are cancer patients…More than 50% of the world’s cancer burden, in terms of number of cases and deaths, occurs in developing countries.” WHO. World Cancer Report, IARC Press, 2003

  4. Cancer Pain Opioids Government • Increasing incidence • Shifting to less developed countries • Often painful • Diagnosed in late stage • Pain destroys quality of life • Cancer pain can be relieved • Opioid analgesics essential By: University of Wisconsin Pain & Policy Studies Group/WHO Collaborating Center, 2000

  5. Treatment gap exists however if there is inadequate availability of opioid analgesics.

  6. Need for Regular Dosing Half life of morphine is 3-4 hours. A 4 hourly schedule is logical with a double dose at bedtime (may help to sleep longer.

  7. Cancer Pain Opioids Government • Increasing incidence • Shifting to less developed countries • Often painful • Diagnosed in late stage • Pain destroys quality of life • Cancer pain can be relieved • Opioid analgesics essential • Governments have two responsibilities • - To control abuse of narcotics • - To ensure availability of opioid analgesics By: University of Wisconsin Pain & Policy Studies Group/WHO Collaborating Center, 2000

  8. “A palliative care program cannot exist unless it is based on a rational national drug policy…including regulations that allow ready access of suffering patients to opioids” World Health Organization, 2002

  9. WHO efforts to improve opioid availability • Recommends governments implement a three-part strategy. • WHO Collaborating Center for Policy and Communication in Cancer Care provides technical assistance to governments to evaluate impediments and monitor the progress. • WHO published “Achieving Balance in National Opioids Control Policy” in 2000.

  10. WHO Foundation Measures for Implementing Cancer Pain Relief Programs Education Of the public, healthcare professionals & others (policy makers, administrators, drug regulators) Drug Availability Changes in healthcare regulations/legislation to improve drug availability (especially of opioids) Government Policy National or state policy that supports pain relief and palliative care

  11. Global Consumption of Morphine 1981-2000 Stjernsward & Clark, 2004

  12. The RealityIn many countries, consumption of opioid analgesics remains extremely low in comparison to medical need, and many national governments have yet to address this important deficit. International Narcotics Control Board, 1996 Do patients in your country have adequate access to the opioids they need?

  13. Global Consumption of Morphinemg/capita, 2003 mg/capita In 2003, 6 countries accounted for 79 per cent of global consumption of morphine. Developing countries, which represent about 80 per cent of the world's population, accounted for only about 6 per cent of global consumption of morphine. - INCB Annual Report for 2004 The mean consumption of morphine for the African region was the lowest of all the WHO regions of the world, at 0.7 mg/capita (1999) Global mean, 5.85 mg Countries (152) Source: International Narcotics Control Board; United Nations Demographic YearbookBy: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2005 The global mean is calculated by adding the individual mg/capita statistics for all countries and then dividing by the number of countries

  14. Global Consumption of Morphinemg/capita, 2003 mg/capita Austria Canada United State of America France United Kingdom Tunisia China Ethiopia Brazil Egypt Mexico Global mean, 5.85 mg Countries Source: International Narcotics Control Board; United Nations Demographic YearbookBy: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2005 The global mean is calculated by adding the individual mg/capita statistics for all countries and then dividing by the number of countries

  15. Three types of barriers to pain management • Economic • Medical/Nursing • Regulatory

  16. Impediments to Availability • Low priority for pain management in health care systems. • Greatly exaggerated fears of addiction. • Overly restrictive national drug control policies. • Government policies that limit the quantity and duration of opioid prescriptions. • Problems in procurement, manufacture and distribution of opioids. • Cost to patients and families.

  17. History of Drug Regulatory Systems • Systems regulating the distribution and prescription of opioid drugs were often designed before the value of oral opioid drugs in cancer pain management was recognized. • The systems were developed to prevent the social misuse of strong opioids. • There was no intention to prevent the use of opioids for pain relief.

  18. “Morphine Myths” • Addiction will occur • Respiratory depression will occur • The patient will be sedated all the time • The patient will be euphoric • The patient will confused • The patient will rapidly build tolerance

  19. International Narcotics Control Board (INCB) • Independent, quasi-judicial monitoring body • Established in 1968 in accordance with the Single Convention on Narcotic Drugs, 1961 • Implementation of the United Nations international drug control conventions • Based in Viena • 13 members from different countries • Madan Mohan BHATNAGAR (India)

  20. International Narcotics Control Board (INCB) – Broad Mandate • Ensure that adequate supplies of drugs are available for medical and scientific uses and that the diversion of drugs from licit sources to illicit channels does not occur. • Identifies weaknesses in national and international control systems regarding the illicit manufacture of, trafficking in and use of drugs.

  21. INCB has requested all national governments • Re-evaluate their medical needs for opioids. • Identify and address impediments. • Communicate with health professionals to determine the unmet medical need for opioid analgesics.

  22. INCB Survey of Governments • Injectable morphine more available than oral morphine (which is recommended by WHO). • About ½ of governments reported that morphine was not available in all hospitals that treat cancer. • 43% of governments that responded require the physician to report to the government those patients who are prescribed opioid analgesia.

  23. INCB Annual Report for 2004March 2005 “In view of the continued inadequate global consumption of opiates for the treatment of pain, the Board reiterates that it would welcome a further increase in global demand for opiates. The Board encourages governments to take steps to increase the medical use of opiates in their countries in order to meet their real needs for the treatment of pain.”

  24. The distribution system for opioid analgesics is as strong as its weakest link By: University of Wisconsin Pain & Policy Studies Group/WHO Collaborating Center, 2000

  25. Health Ministry/Licensing Manufacturers/Distributors/Importers Hospitals/Pharmacies/Hospice/PC Programs Physicians/Nurses Patients Opioid Distribution System Pain & Policy Studies Group

  26. Common characteristics of countries that improve opioid policy 1. Recognition that regulations interfere with patient access to pain relief 2. Leadership • Specialists; NGOs • Cancer survivors, family members, politicians 3. Gov’t willingness to study needs and barriers • Commission; Task Force; study • Public report and recommendations

  27. Demonstration Project India Objective: To overcome regulatory barriers and to improve availability and access to opioid analgesics for Indian patients with painful conditions such as cancer and, increasingly, HIV/AIDS. Pain and Palliative Care Society (PPCS), Calicut designated as WHODP for a source of national expertise and leadership in opioid availability

  28. Uganda Experience • First African country to recognize palliative care as an essential clinical service • Changed its national legislation to make opioids more available • In 2004 further modified its policy to permit nurses prescribe morphine • Programs of morphine “sensitization”

  29. www.medsch.wisc.edu/painpolicy WHO/EDM/QSM/2000.4 ENGLISH ONLY DISTRIBUTION: GENERAL  NARCOTIC & PSYCHOTROPIC DRUGS ACHIEVING BALANCE IN NATIONAL OPIOIDS CONTROL POLICY GUIDELINES FOR ASSESSMENT World Health Organization

  30. Achieving Balance in National Opioids Control Policy: Guidelines for Assessment (WHO, 2000) • Guidelines to evaluate policy in any country • Approved by international pain and regulatory experts, and the INCB • Explains regulatory barriers and the imperative to achieve “Balance” • 16 criteria for evaluating national drug control policy and administration • Simplified Checklist • For use by governments and health professionals

  31. How to evaluate drug policy … • Identify person or committee to study the guidelines – include the National Competent Authority. • Obtain additional information from key resources. • Obtain up-to-date copies of your national drug control policies and study them. • Use the self-assessment checklist to assess the policies. • Establish dialogue with policy-makers to make the necessary changes.

  32. Assessment Guidelines • Total of 16 areas of reflection and assessment • Six relate to national laws and regulations • Ten relate to administrative policies, directives and practices that implement national laws and regulations.

  33. 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.

  34. The work ahead for palliative care: Ensure your patients have access • Study guidance documents • Present your situation to govt • Establish government study commission • Examine needs, policies, barriers • Make realistic recommendations • share with media • Educate, evaluate, communicate

  35. Final Words …. “Freedom from pain should be seen as a right of every cancer patient and access to pain therapy as a measure of respect for this right” WHO Expert Committee on Cancer Pain Relief and Active Supportive Care

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