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Improving patient access to opioids through consensus building with government

Improving patient access to opioids through consensus building with government. David E. Joranson Pain & Policy Studies Group World Health Organization Collaborating Center www.medsch.wisc.edu/painpolicy. Global Consumption of Morphine 1972-2000. Kilograms.

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Improving patient access to opioids through consensus building with government

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  1. Improving patient access to opioids through consensus building with government David E. Joranson Pain & Policy Studies Group World Health Organization Collaborating Center www.medsch.wisc.edu/painpolicy

  2. Global Consumption of Morphine1972-2000 Kilograms Source: International Narcotics Control Board By: Pain & Policy Studies Group/WHO Collaborating Center, 2001 Top 10 countries = Australia, Canada, Denmark, Iceland, Ireland, New Zealand, Norway, Sweden, the United Kingdom, and the United States

  3. Global Per Capita Consumption of Morphine, 1999 mg/capita GLOBAL MEAN 5.93 mg Source: International Narcotics Control Board; United Nations “Demographic Yearbook,” 1999 By: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2002

  4. Morphine Consumption vs. Development Status, 1998 104 Countries Source: (1) International Narcotics Control Board, (2) CIA population data, (3) Human Development Index By: University of Wisconsin Pain & Policy Studies Group/WHO Collaborating Center, 1999

  5. Factors influencing “diffusion” of innovations • Observable? • Simple? • Demonstrable? • Relative advantage? • Compatible?

  6. Factors influencing “compatibility”(i.e., the barriers) • Knowledge, attitudes • Health care system policies, priorities, resources • Policies governing opioids, professional practice

  7. Barriers perceived by government

  8. www.medsch.wisc.edu/painpolicy

  9. INCB Survey of National Governments Purpose: To identify barriers to improving availability of opioids for relief of pain 48% national policies recognize medical necessity of narcotics/opioids 59% excessively strict narcotic laws and regulations 72% concern about drug abuse and addiction • INCB, 1996

  10. Reasons for unavailability(INCB, 2002) -Inadequate method, personnel to assess needs -Unduly restrictive regulations -Burdensome administrative procedures -Concerns about addiction, dependence -Physicians’ fear of investigation, penalties -Lack of medical training in pain relief

  11. Guidance to governmentsfor addressing barriers

  12. 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

  13. The goal is a “balanced” national policy • National narcotics control system should ensure availability for medical use and patient care, while preventing diversion • Efforts to prevent diversion must not interfere with availability of opioid analgesics to the patient Source: World Health Organization. Achieving balance in national opioids control policy: Guidelines for Assessment. Geneva, Switzerland: WHO; 2000.

  14. Achieving Balance in National Opioids Control Policy: Guidelines for Assessment (WHO, 2000) - For governments and health professionals - Explains need, rationale and imperative for “balanced” national drug control policy - 16 criteria for evaluating national drug control policy and administration - Simplified Checklist www.medsch.wisc.edu/painpolicy

  15. Working Group on WHO Guidelines for Achieving Balance in National Opioid Control Policy Mr. T. Yoshida: WHO Geneva– Sponsor Mr. D. Joranson: WHOCC USA– Chair Mr. R. Bhattacharji: India Dr. C. Blengini: Italy Dra. L. De Lima: PAHO/Colombia Dr. P. Emafo: Nigeria Ms. Gu Wei-ping: China Dr. A. Nixon: Saudi Arabia Ms. C. Selva: INCB Secretariat- Vienna

  16. “Achieving Balance in National Opioids Control Policy”WHO, 2000 1. Estimate annual requirements 2. Administer an effective distribution system to the patient 3. Evaluate national narcotics control policy 4. Communication between government and health professionals

  17. Putting WHO Guidelines into action • Chinese regulators and physicians (2000) • Regulators from Asian countries (JICWELS 2001-02) • WHO workshops with government teams • 6 Andean countries (2000) • 6 Central European Countries (2002) • 5 African countries (2002) • WHOCC project in India

  18. * * Population: 273 million Population: 1.03 billion

  19. Consumption of Morphine in India Kilograms Source: International Narcotics Control Board

  20. “As the domestic consumption of morphine has decreased to an extremely low level over the last few years, the Government of India should take effective measures to ensure its adequate availability for medical purposes.” INCB, 1999

  21. What does low and declining use of morphine mean for people in India?

  22. 1994-1996: Morphine shortages Measures taken by doctors - Rationing of morphine • Use less effective drugs: codeine, buprenorphine • Invasive procedures With these measures - only 10% received adequate pain relief

  23. The paradox India grows poppy to supply much of the world’s pain medications, yet a million Indians with cancer and pain have no access to morphine

  24. Why no oral morphine? - Fear of respiratory depression - Fear of addiction - Excessive licensing requirements - 1985 Narcotic Drugs Act

  25. National opioid policy project Analysis of regulatory problem • 1. Key informants, focus workshops (1992-94) • 2. Review of national and state policies (1995) 3. Proposal to simplify national policy (1997) • 4. Model state regulation (1997) • 5. 11 Implementation workshops (1998- 2001)

  26. Present morphine licensing system in India ??

  27. WHOCC proposal to Government of India

  28. Workshops to adopt model rule

  29. KERALA 32 million                             Pain & Palliative Care Society Link Centres

  30. Consumption of Morphine in India Kilograms

  31. Project to evaluate morphine use, misuse and diversion 1999-2000 • Study conducted in Pain and Palliative Care Clinic, Calicut, Kerala • Supported by - PPSG/WHOCC, Madison-Wisconsin - United States Cancer Pain Relief Committee • 4,057 patients treated • 1723 received oral morphine (43%)

  32. Pain & Palliative Care ClinicCalicut, India • 80% patients have cancer - 1/3 head and neck - 2/3 cervix, lung, breast, other • 20% non cancer • Peripheral vascular disease • Neuralgias

  33. Results of 2 Year Evaluation • Availability to patients ensured • No shortages • No evidence of misuse or diversion • Increases in dose related to disease • Lack of stock discrepancies • No reports of loss or theft - No reports from law enforcement The Lancet 2001; 358:139-143

  34. But what if…“…misuse or diversion of opioid analgesics should take place, the sources of diversion should be identified quickly and directly, without affecting opioid availability or patient care.”The Lancet 2001; 358:139-143

  35. “The Board notes with satisfaction that several governments have taken steps to improve the availability of narcotic drugs. For example, in India, model regulations aimed at simplifying access to morphine for use in palliative care were developed by the Government, in cooperation with WHO, in 1998 and have since been introduced in several states in that country.” INCB, 2001

  36. Take-home messages Government cooperation is essential Unduly restrictive regulatory requirements barriers can be changed Training of health professionals is essential Opioids can be made safely available Pain relief with limited resources is possible Patient access to pain relief is the bottom line

  37. Thank you! Univ of Wisconsin Pain & Policy Studies Group WHO Collaborating Center for Policy and Communications www.medsch.wisc.edu/painpolicy

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