1. WHO Access to Controlled Medications Programme & Ensuring balance in national policies on controlled substances Barbara Milani, Technical Officer Department of Essential Medicines and Pharmaceutical Policies CENTRAL ASIAN PALLIATIVE CARE POLICY MEETING March 8-11, 2011, Barcelona, Spain

2. Layout of the presentation ● International drug control – Illicit drug market – International drug conventions – UN agencies' role ● Improving access to essential controlled medicines – ACMP background – Types of barriers – Tools to be used at country level including the WHO guidelines on Ensuring balance in national policies on controlled substances

3. Illicit drug use & International drug control Worldwide Problem drug users (severely dependent on drugs of abuse): 16-38 million 1 Injecting drug users: 16 million 2 World illicit drug market ● Over $ 332 billion 3 Protection against abuse and dependence is necessary 1.UNODC, World drug Report, 2010 2. Mathers, Global epidemiology of Injecting Drug Use and HIV, Lancet, 2008 3. UNODC, World drug Report, 2005

4. International Drug Control Conventions Currently 3: ● 1961 UN Single Convention on Narcotic Drugs ● 1971 UN Convention on Psychotropic Substances ● 1988 UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances

5. Conventions' Objectives 1961 and 1971 Conventions: Two goals: 1. Prevention of harm from drug dependence 2. 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 (concept of balance)

6. Narcotic substances: Ensuring availability for medical use 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)

7. Psychotropic Substances: Ensuring availability for medical use Recognizing that the use of psychotropic substances for medical and scientific purposes is indispensable and that their availability for such purposes should not be unduly restricted… (Preamble Psychotropic Substances Convention)

8. Implications of signing a treaty  Treaties are signed on behalf of the nation  Therefore:  Entire government is responsible, not one ministry or one officer only  All ministries should cooperate to achieve all public-health and other obligations from any treaty ● All countries that signed the conventions are obliged to implement them in their national legislation

9. Role of UN agencies in relation to the drug conventions International Narcotic Control Board (INCB) control organ monitoring implementation of the conventions UN Commission on Narcotic Drugs (CND) central drug policy-making body UN Office of Drugs and Crime (UNODC) research, prevention and treatment of drug abuse World Health Organization (WHO) medical and scientific advice

10. Role of WHO ● WHO nominates 3 out of 13 candidates to the INCB ● Since 1949, the WHO Expert Committee on Drug Dependence (ECDD): – Reviews substances – Recommends to add, to change scheduling, to delete a substance from the UN drug conventions considering the scientific and medical matters

11. On the WHO website: Guidelines on the WHO review of psychoactive substances for international control ECDD reports 1949 – 2006

12. WHO Access to Controlled Medications Programme (ACMP): the background

13. Morphine consumption per capita Graphic: New York Times

14. Lack of access to opioid analgesics "In 2003, six countries together accounted for 79 % of global consumption of morphine. Developing countries, which represent about 80 % of the world’s population, accounted for only about 6 % of global consumption of morphine." Source: INCB report, 2004

15. U.N. ECOSOC Resolution 2005/25 Treatment of pain using opioids (…) Calls upon Member States to remove barriers to the medical use of such analgesics, taking fully into account the need to prevent their diversion for illicit use

16. World Health Assembly Resolution 58.22 on Cancer Prevention and Control URGES Member States: ● (15) to ensure the medical availability of opioid analgesics according to international treaties and recommendations of WHO and the International Narcotics Control Board and subject to an efficient monitoring and control system

17. Both Resolutions ● REQUESTS the Director-General of WHO: "…..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"

18. Access to Controlled Medications Programme (ACMP) ● Response to Resolutions ECOSOC 2005/25 and WHA 58.22 ● WHO Programme to improve access to controlled medicines ● Launched in 2007 by WHO and INCB

19. Essential medicines in the drug conventions – Opioid analgesics: Morphine moderate to severe pain – Long-acting opioid agonists: methadone, buprenorphine treatment of opioid dependence – Ergometrine and ephedrine emergency obstetrics – Benzodiazepines anxiolytics, hypnotics, antiepileptics – Phenobarbital antiepileptic WHO recognized a number of controlled medicines as "essential" through its WHO model list of essential medicines

20. Opioid analgesics Used for moderate to Cancer AIDS/HIV Chronic pain Sickle cell anaemia Myocardial infarction severe pain due to: Traffic and other accidents Surgery Burns Neuropathic pain following amputation

21. Types of barriers to access opioid analgesics Attitudinal barriers ● Excessive fear for dependence ● Excessive fear for diversion Educational barriers ● Neglected medical needs ● Lack on knowledge on the rational medical use of opioid analgesics Supply barriers ● Unreliable estimates of narcotic annual needs to INCB ● Complex procurement procedures ● Unaffordable to patients Policy and legislative barriers ● No "concept of balance" in the national laws and regulations

22. Misconceptions on dependence from opioid analgesics ● Tolerance is unequal to dependence ● Withdrawal is unequal to dependence ● Medicines seeking behaviours due to inadequate treatment of pain with: – suboptimal doses / inadequate titration / no dose adjustment following increased tolerance are not to be confused with dependence "Dependence syndrome" is defined by WHO in ICD10 classification system

23. Overcoming attitudinal and educational barriers Guidelines on treatment of acute and chronic pain in adults and children WHO guidelines on the pharmacological treatment of persisting pain in children with medical illnesses (in press) Systematic review to investigate the incidence of dependence following treatment with opioid analgesics (expected by May 2011) It answers to clinical questions on risks and benefits for treatment in adults

24. Overcoming supply barriers Procurement procedures (complicated system of import/export authorizations) Step-by-step algorithm Estimates of annual requirements of narcotic substances to INCB WHO-INCB Manual (ongoing)

25. Overcoming policy and legislative barriers National situation assessment using the new WHO policy guidelines Ensuring balance in national policies on controlled substances, Guidance for availability and accessibility of controlled medicines Translations in 15 languages Include checklist and CD-ROM Update of: Achieving Balance in National Opioids Control Policy, guidelines for assessment (2000) – currently withdrawn

26. Operationalize "Ensuring balance.." Policy cycle approach: Assessment & evaluation Implementation Design new or adjust policy Decision making Country Assessment Checklist Guidelines Starting point

27. Suggestions to operationalize "Ensuring balance.." ● Create a taskforce at country level which includes all stakeholders – To collect information for national situation analysis – To agree on actions and priorities ● Create Sub-taskforces to work on specific aspects: (legal, policy, rational medical use, procurement, supply, affordability) ● Adopt a systematic approach (policy cycle approach incl. reassessment)

28. Thank you for your attention… Barbara Milani, Technical officer, ACMP milanib@who.int For additional information: www.who.int/medicines "Controlled medicines"