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Access to Controlled Medications Programme

Access to Controlled Medications Programme. NPO Meeting 20 – 24 October 2008, Delhi, India. Zafar Mirza EM/RGO/DHS Willem Scholten HQ/EMP/QSM/ACMP. Drug Control. Currently 3 UN drug conventions: Single Convention on Narcotic Drugs (1961) Convention on Psychotropic Substances (1971)

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Access to Controlled Medications Programme

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  1. Access to Controlled Medications Programme NPO Meeting 20 – 24 October 2008, Delhi, India Zafar Mirza EM/RGO/DHS Willem Scholten HQ/EMP/QSM/ACMP

  2. Drug Control Currently 3 UN drug conventions: • Single Convention on Narcotic Drugs (1961) • Convention on Psychotropic Substances (1971) • Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988)

  3. Drug conventions are public health law 1961 and 1971 Conventions: Two objectives: • Prevention of harm from drug dependence • Availability for rational medical use Public health interests are best served if all control measures aim at the optimum between medical availability and abuse prevention

  4. Opioid analgesics moderate to severe pain Opioids for substitution treatment opioid dependence Ergometrine and ephedrine emergency obstetrics Benzodiazepines anxiolytics, hypnotics, anti-epileptics Phenobarbital anti-epileptic Controlled medicines on the WHO EML

  5. Morphine consumption per capita Graphic: New York Times

  6. Drug conventions

  7. Millions have a drug problem photo: WHO/Marko Kokic They can't get any

  8. Why does drug control impede medical access? - Excessive fear for dependence - Excessive fear for diversion - Attention for medical needs neglected

  9. Drug conventions Recognizing that the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic drugs for such purposes … (Preamble Single Conv. on Narcotic Drugs)

  10. Conventions are a minimum • Countries may apply stricter measures Examples: • Licence requirement for community and hospital pharmacies • Dispensing restricted to major hospitals • Government monopoly on morphine trade • Special prescription forms • Stricter measures usually decrease medical availability

  11. International Covenant on Economic Social and Cultural Rights (ICESCR) Article 12: 1. The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. 2. The steps to be taken by the States Parties to the present Covenant to achieve the full realization of this right shall include those necessary for: (…) the creation of conditions which would assure to all medical service and medical attention in the event of sickness.

  12. Right to Health includes: • Access to Essential Medicines • Chronically and terminally ill • Spare avoidable pain • Die with dignity • Non-discrimination • Women, children, prisoners, HIV-patients, people with heroin dependence et cetera • Protection against drug abuse • States, treaties and UN-bodies should promote right to health internationally General Comment 14 to the International Covenant on Economic, Social and Cultural Rights

  13. Undue medical effectsof drug control (first three: annual prevalence)

  14. Untreated pain patients(annually, globally) All avoidable with controlled medications

  15. Substitution therapyeffects • Prevents transmission of HIV and Hepatitis C • Reduction HIV seroconversion in IDU's: 55% - 85% (= 230,000 – 360,000) • Reduces death rate of dependence patients to about normal • Reduction 90 – 95% • Reduces public nuisance and petty crime • $ 1 investment yields $ 5 for society

  16. Resolutions • ECOSOC 2005/25 • On treatment of pain using opioid analgesics • World Health Assembly 58.22 (25-05-2005) • on Cancer Prevention and Control "…..to examine jointly with the International Narcotics Control Board the feasibility of a possible assistance mechanism that would facilitate the adequate treatment of pain using opioid analgesics"

  17. Access to Controlled Medications Programme (ACMP) • To assist countries to improve access to controlled essential medicines • Developed in consultation with the International Narcotics Control Board (INCB) • Operated by WHO

  18. Access to Controlled Medications Programme (ACMP) Programme info on www.who.int/medicines: - Framework - Briefing notes - Pain guideline development

  19. ACMP Activities (1) Step 1: Developing tools Monitoring and planning tools - International Opioid Consumption Database (interactive on-line database) (on-line by end of 2009) - methods for need estimation (ready for publication) WHO Treatment Guidelines for all types of pain Focussed on opioid availability ongoing; available by 2010-2012 Update of Guidelines on Opioid availability ("Achieving balance in national opioid control policies") available by 2010

  20. ACMP Activities (2) Step 2: Direct country support Policy analysis Analysis of legislation and support for amendment process Procurement of controlled substances (advice) Estimates training Support for training of health care professionals

  21. ACMP Methods 6-country workshops - policies analysed by 3 government officials and 3 health care workers - lectures - national plans drafted National workshops 50 – 200 stakeholders invited Estimates training workshops for civil servants responsible for estimates and statistics submission to INCB Counselling

  22. Other areas of work involved Not a pharmaceutical topic exclusively: - HIV - Palliative care/cancer care - Surgery and emergency care - Child and adolescent health - Substance abuse

  23. ACMP priority countries AFRO • Cameroon, Ethiopia, Ghana, Ivory Coast, Kenya, Malawi, Nigeria, Rwanda, Senegal, Sierra Leone, Tanzania, Zambia. EMRO • Egypt, Iran, Morocco, Oman, Pakistan, Sudan. EURO • Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Moldova, Poland, Romania, Serbia & Montenegro, Slovenia, Slovakia. PAHO • Argentina, Colombia, Panama. SEARO • Indonesia, Bangladesh, India WPRO • Vietnam, China, Philippines

  24. Programme Duration and Cost • Over 150 countries to go to • Expected to take over 15 years • Action Plan Phase I (2008 -2013) • Needed budget: US$ 55.5 million • Funds to be raised from Members States and donor organizations

  25. ATOME Project • Funded by European Commission • Consortium: 10 organizations from 7 EU countries, including WHO (HQ/EMP, EURO) • "ACMP-like" activities in 12 Eastern European countries • 2009 - 2014

  26. More information: Willem Scholten Manager Access to Controlled Medications Programme Quality Assurance and Safety: Medicines Department of Essential Medicines and Pharmaceutical Policies scholtenw@who.int +41 22 79 15540

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