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A Global Policy Approach to Opioid Drug Availability

A Global Policy Approach to Opioid Drug Availability. Kathleen M. Foley, MD OSF Seminar Vienna March 5-6, 2013. OSF International Palliative Care Initiative. Overarching goal: To advance palliative care globally

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A Global Policy Approach to Opioid Drug Availability

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  1. A Global Policy Approach to Opioid Drug Availability Kathleen M. Foley, MD OSF Seminar Vienna March 5-6, 2013

  2. OSF International Palliative Care Initiative Overarching goal: • To advance palliative care globally • IPCI works to integrate palliative care into national health plans, policies, financing, legislation, delivery systems, professional and public education and to ensure the availability of essential drugs for pain relief and symptom management.

  3. Freedom From Cancer Pain “Nothing would have a greater impact than using the knowledge we have now to improve the care of the patient with cancer pain” Dr. Jan Stjernsward Chief, Cancer Unit, WHO,1986

  4. WHO MONOGRAPHS World Health Organization

  5. 2002 WHO Definition of Palliative Care "Palliative care is an approach which improves quality of life of patients and their families facing life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual"

  6. WHO Public Health Model Policy O utcomes Context DrugAvailability Education Implementation

  7. Ukraine 1.78 mg / capita≈ 81 kg

  8. WHO Public Health Model

  9. The continuum of palliative care Life Closure Therapies to modify disease(curative, restorative intent) Actively Dying Death Diagnosis 6m BereavementCare Therapies to relieve suffering, improve quality of life

  10. Global Cancer Mortality • 12.7 million patients diagnosed each year with cancer • 7.6 million who die from cancer • 29 million cancer survivors

  11. Global Cancer Mortality (millions/yr) Data Source: World Bank

  12. UNAIDS Report • 40 million living with HIV/AIDS -28.5 million in sub-saharan Africa • 14 million orphans worldwide -11 million in sub-saharan Africa • 20 million have died since 1981

  13. Pediatric Palliative Care • Worldwide there are 7-9 million children with life-limiting and life-threatening conditions requiring palliative care • 80% live in resource-limited countries

  14. The Global Burden of TB 2010 Estimated number of cases Estimated number of deaths 8.8 million (range: 8.5–9.2 million) 1.45 million (range: 1.2–1.6 million) All forms of TB 1.1 million (13%) (range: 1.0–1.2 million) 350,000 (range: 320,000– 390,000) HIV-associated TB Multidrug-resistant TB (Prevalent) about 150,000 650,000 (460,000 – 870,000) Source: WHO Global Tuberculosis Control Report 2011.

  15. Palliative Care Roadmap • Identify National Champions • Complete a Country Needs Assessment • Hold a National Stakeholders Meeting • Create Various Government Task Forces • Development of a Palliative Care Concept

  16. Elements of Policy Work • International documents with symbolic language • International documents to guide policy development • Passionate committed champions • Financial support for technical expertise

  17. Reasons for unavailability of opioids Inadequate method for assessing needs Unduly strict drug regulations Burdensome administrative procedures Exaggerated fears of addiction Fear of investigation, penalties Lack of training in pain management PPSG 2007 INCB, 2002

  18. Meeting the Challenge • Unquestioned need to relieve pain • Solid scientific and medical basis • Clear Guidelines from UN Bodies • International Narcotic Control Board • World Health Assembly -Economic, Social and Cultural Council -UN Human Rights Rapporteurs for Health and Torture -Committee on Narcotic Drugs • Acceptance of pain relief and palliative as human rights issues

  19. A sense of urgency from UN Organizations International Narcotics Control Board World Health Organization World Health Assembly UN Economic and Social Council Commission on Narcotic Drugs

  20. WHO Criteria for Assessing Policy • Opioids absolutely necessary • Gov’t obligation to ensure availability • Designate Competent Authority • Estimate requirements; report statistics • Address fear of legal sanctions • Use correct terminology regarding addiction • Avoid restrictions that limit medical decisions • Avoid unduly strict prescription requirements • Cooperation to ensure availability

  21. Main Parts to Achieving Balanced PolicyWHO, 2000 WHO/ EDM/QSM/2000.4 ENGLISH ONLY DISTRIBUTION: GENERAL  • Evaluate national drug control policy • Estimate annual requirements; report consumption statistics • 3. Administer an effective distribution system to patients NARCOTIC & PSYCHOTROPIC DRUGS ACHIEVING BALANCE IN NATIONAL OPIOIDS CONTROL POLICY GUIDELINES FOR ASSESSMENT World Health Organization

  22. www.who.int/medicines/areas/quality_safety/GLs_Ens_Balance_NOCPwww.who.int/medicines/areas/quality_safety/GLs_Ens_Balance_NOCP

  23. Old and New Policy in Romania New policies • Prescribing authority granted for 30-day period • (for physicians with specific specialties or who have received training) • Not limited by patient diagnosis • No limit of daily dose • Less burdensome for physicians and patient family 35-year-old policies • No independent prescribing authority beyond 3-day period • Opioid analgesics limited by patient diagnosis (3) • Limit of 60 mg per day of morphine • 10-day prescription possible, but with very complex authorization process (expires in 90 days). • Burdensome for physicians and patient family

  24. An introduction to ATOME The ATOME project aims to improve access to opioids across Europe. A consortium of academic institutions and public health organizations is working to help governments, particularly in Eastern Europe, identify and remove barriers that prevent people from accessing medicines that could improve end of life care, alleviate debilitating pain and treat heroin dependence.

  25. ATOME 12 Target Countries

  26. International Pain Policy FellowshipPain and Policy Study GroupUniversity of Wisconsin 2006 Nigeria, Serbia, Panama, Uganda, Argentina, Columbia Sierra Leone 2008 Kenya, Moldova, Guatemala, Georgia, Armenia, Nepal, Jamaica 2012 India, Bangladesh, Sri lanka, Albania, Kyrgyzstan, Ukraine

  27. http://www.hrw.org/sites/default/files/reports/health1009webwcover.pdfhttp://www.hrw.org/sites/default/files/reports/health1009webwcover.pdf

  28. Uncontrolled Pain Ukraine’s Obligation to Ensure Evidence-Based Palliative Care http://www.hrw.org/reports/2011/05/12/uncontrolled-pain

  29. 50 Milligrams is Not Enough People with debilitating illnesses are left to die in excruciating pain as a result of restrictions on pain medicines. Health care workers must be allowed to provide patients with relief from severe pain Vlad is suffering from incurable brain cancer. Despite his chronic pain, doctors in Ukraine are only allowed to prescribe 50 mg of pain medicine. In another country, doctors would typically prescribe more than 2,000 mg for a patient like Vlad. http://www.stoptortureinhealthcare.org/

  30. Pain crippled me more than cancer…..

  31. Seeing my patients’ suffering and not being able to help … killing me

  32. Unlike to my illness, my pain could be treated

  33. Pain relief lasts only for 4 hours. The rest of the day I live in hell

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