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A Global Policy Approach to Opioid Drug Availability Kathleen M. Foley, MD OSF Seminar 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 n IPCI OSF International Palliative Care Initiative Overarching goal: To advance palliative care globally n 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. n

Freedom From Cancer Pain “Nothing would have a greater impact than using the knowledge 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

WHO MONOGRAPHS World Health Organization WHO MONOGRAPHS World Health Organization

2002 WHO Definition of Palliative Care 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"

WHO Public Health Model Policy C o Drug Education n Availability t e x WHO Public Health Model Policy C o Drug Education n Availability t e x Implementation t O u t c o m e s

Ukraine 1. 78 mg / capita ≈ 81 kg Ukraine 1. 78 mg / capita ≈ 81 kg

WHO Public Health Model WHO Public Health Model

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

Global Cancer Mortality n 12. 7 million patients diagnosed each year with cancer n Global Cancer Mortality n 12. 7 million patients diagnosed each year with cancer n 7. 6 million who die from cancer n 29 million cancer survivors

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

UNAIDS Report n 40 million living with HIV/AIDS -28. 5 million in sub-saharan Africa UNAIDS Report n 40 million living with HIV/AIDS -28. 5 million in sub-saharan Africa n 14 million orphans worldwide -11 million in sub-saharan Africa n 20 million have died since 1981

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

The Global Burden of TB 2010 Estimated number of cases Estimated number of deaths The Global Burden of TB 2010 Estimated number of cases Estimated number of deaths All forms of TB 8. 8 million (range: 8. 5– 9. 2 million) 1. 45 million (range: 1. 2– 1. 6 million) HIV-associated TB 1. 1 million (13%) (range: 1. 0– 1. 2 million) 350, 000 (range: 320, 000– 390, 000) Multidrug-resistant TB (Prevalent) 650, 000 (460, 000 – 870, 000) Source: WHO Global Tuberculosis Control Report 2011. about 150, 000

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

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

Reasons for unavailability of opioids • Inadequate method for assessing needs • Unduly strict 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

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

A sense of urgency from UN Organizations § International Narcotics Control Board § World 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

WHO Criteria for Assessing Policy ü ü ü ü ü Opioids absolutely necessary Gov’t WHO Criteria for Assessing Policy ü ü ü ü ü 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

Main Parts to Achieving Balanced Policy WHO, 2000 WHO/ EDM/QSM/2000. 4 ENGLISH ONLY 1. Main Parts to Achieving Balanced Policy WHO, 2000 WHO/ EDM/QSM/2000. 4 ENGLISH ONLY 1. Evaluate national drug control policy 2. Estimate annual requirements; report consumption statistics 3. Administer an effective distribution system to patients DISTRIBUTION: GENERAL NARCOTIC & PSYCHOTROPIC DRUGS ACHIEVING BALANCE IN NATIONAL OPIOIDS CONTROL POLICY GUIDELINES FOR ASSESSMENT World Health Organization

www. who. int/medicines/areas/quality_safety/GLs_Ens_ Balance_NOCP www. who. int/medicines/areas/quality_safety/GLs_Ens_ Balance_NOCP

Old and New Policy in Romania 35 -year-old policies - - No independent prescribing Old and New Policy in Romania 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 - - 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

An introduction to ATOME The ATOME project aims to improve access to opioids across 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.

ATOME 12 Target Countries ATOME 12 Target Countries

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International Pain Policy Fellowship Pain and Policy Study Group University of Wisconsin 2006 Nigeria, International Pain Policy Fellowship Pain and Policy Study Group University 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

http: //www. hrw. org/sites/default/files/reports/health 1009 webwcover. pdf http: //www. hrw. org/sites/default/files/reports/health 1009 webwcover. pdf

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

People with debilitating illnesses are left to die in excruciating pain as a result 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 50 Milligrams is Not Enough 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/

Pain crippled me more than cancer…. . Pain crippled me more than cancer…. .

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

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

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