Improving patient access to opioid analgesics through consensus building with government

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

3. U.S. Pain Policy University of Wisconsin Consensus of pain groups, DEA: “Balance” Website “Pain policy” Full text data base of federal and state policies Medical Board guidelines Evaluation of federal and state policies Profile of individual states Report card for state pain policies* Update of trends in use, abuse of opioids*

4. Making opioids available requires work with governments Opioids are essential pain medications Opioids have a potential for abuse Opioids are controlled substances Opioids are controlled by governments Policy Administration Enforcement

5. 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

6. Global Per Capita Consumption of Morphine1999 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

7. 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

8. Barriers identified by governments

9. www.medsch.wisc.edu/painpolicy

10. 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

11. WHO guidance to governmentsfor addressing barriers

12. 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

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 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 • Endorsed by the INCB • - 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. Main Elements of WHO’s “Achieving Balance” Guidelines 1. Evaluate narcotics policies for barriers • Evaluate needs--estimate requirements 3. Effective distribution system to the patient 4. Government and health professionals should communicate

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

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

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

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

24. 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

25. Why no oral morphine? - Fear of respiratory depression - Fear of addiction - Excessive licensing requirements • 1985 Narcotic Drugs Act • Low demand

26. National opioid policy project: Diagnosis Key informants, workshops (1992-94) - Analysis of policies for barriers (1995-96) Treatment - Model regulation to simplify state regulation of narcotics (1997-98) 11 workshops (1998-2001) Evaluation - Consumption - Misuse, diversion 3. Proposal to simplify national policy (1997)

27. Regulatory barriers in India • Several state agencies are involved in the morphine licensing process. • Multiple licenses are needed • Possession • Import • Export • Transport

28. Workshops to adopt model rule

32. Consumption of Morphine in India Kilograms

33. Evaluation: Morphine use, misuse and diversion 1999-2000 • Pain and Palliative Care Clinic, Calicut, Kerala • 4,057 patients • 1723 received oral morphine (43%)

34. Results • Patient access 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

35. 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

36. Take-home messages Government cooperation is essential Unduly restrictive regulatory requirements barriers can be identified and changed Adequate controls are necessary Training of health professionals is essential Opioids can be made safely available Pain relief with limited resources is possible Patient access to pain relief can be achieved

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