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Access to Controlled Medicines. Technical Briefing Seminar 2 November 2010 Geneva, Switzerland. Willem Scholten, Team Leader, Access to Controlled Medicines, Department of Essential Medicines and Pharmaceutical Policies. Overview of the presentation. Introduction Background
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Access to Controlled Medicines Technical Briefing Seminar 2 November 2010 Geneva, Switzerland Willem Scholten, Team Leader, Access to Controlled Medicines, Department of Essential Medicines and Pharmaceutical Policies
Overview of the presentation • Introduction • Background • Barriers for Access • Pain treatment • Treatment of Dependence and Prevention of HIV Transmission • How to improve access to controlled medicines?
Ergometrine and ephedrine emergency obstetrics Benzodiazepines anxiolytics, hypnotics, antiepileptics Phenobarbital antiepileptic Controlled medicines on the WHO EML • Opioid analgesics: Morphine moderate to severe pain • Long-acting opioid agonists: methadone, buprenorphine treatment of opioid dependence
Morphine consumption per capita Graphic: New York Times
International Drug Control Conventions • Single Convention on Narcotic Drugs (1961) • United Nations Convention on Psychotropic Substances (1971) • United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988)
Conventions' Objectives 1961 and 1971 Conventions: Two goals: • 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 prevention of abuse
Reasons for low access to controlled medicines • Excessive fear for dependence • Excessive fear for diversion • Neglected medical needs
Policy and Legislation I Examples: Prescribing limitations • Who can prescribe • Dosage and duration • Disease (e.g. cancer only) Dispensing limitations • Hospital pharmacy only • Police offices only
Policy and Legislation II Examples: Functioning of the estimates system Non-medical authorities taking medical decisions Exclusion of certain patient groups from pain treatment, e.g. people who were dependent on drugs
Knowledge Examples: Dosage regimen - how to start? - how to titrate? - how to stop? - recognizing overdosage - treatment of overdosage Pseudo-dependence Prescription formalities
Attitudes Examples: Thinking that opioid analgesia … leads to dependence leads to death (contrary was shown recently) Family or nurses not allowing patient to take medicines
Used for all moderate Cancer AIDS/HIV Chronic pain Some exceptions to severe pain due to: Traffic and other accidents Myocardial infarction Sickle cell anaemia Surgery Opioid analgesics
Three Step Ladder WHO Three step ladder on cancer pain (1986) • Non-opioid + adjuvant e.g. paracetamol If pain persisting/increasing: • Weak acting opioid (e.g. codeine, tramadol) If pain persisting/increasing: • Strong acting opioid (e.g. morphine, methadone) Increase dosage until freedom from pain There is no maximum dose: the right dose is the dose that works
Adequacy of opioid consumption(x million people)* * People living in countries where opioid consumption is …
Adequacy as a function of Development Data for 2006
ACM for selected countries for 2006 Seya MJ et al., J of Pain and Palliative Care Pharmacotherapy, March 2011 (accepted)
ACM for selected countries (SADC) for 2006 Seya MJ et al., J of Pain and Palliative Care Pharmacotherapy, March 2011 (accepted)
Treatment of Dependence and Prevention of HIV Transmission
Long-Acting Opioid Agonist Therapy • Methadone Maintenance Therapy (MMT) • Supervised administration of Methadone oral solution • Dosage level high enough to stop heroin use • Continuously • Other modalities (e.g. buprenorphine: BMT)
Long-Acting Opioid Agonist Therapy • To treat opioid dependence (which is a disease) • Methadone/buprenorphine less reinforcing then heroin • Normalization of body responses and social life • Interruption of transmission of • HIV • Hepatitis C Virus (HCV) • Other blood borne disease
Access to Controlled Medications Programme • Response to Resolutions ECOSOC 2005/25 and WHA 58.22 • WHO Programme to improve access to controlled medicines • Launched in 2007 by WHO and the INCB
Access to Controlled Medications Programme • Addresses all medicines controlled under the international drug conventions • Essential Medicines in particular • Problems and solutions for various medicines supposed to be very similar, giving opportunities • for finding allies • to prevent duplication of work
ACMP Priority Countries AFRO: Cameroon, Ethiopia, Ghana, Ivory Coast, Kenya, Malawi, Nigeria, Rwanda, Senegal, Sierra Leone, Tanzania and Zambia EMRO: Egypt, Iran, Morocco, Oman, Pakistan and Sudan EURO: Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Finland, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Romania, Serbia, Slovenia, Slovakia and Turkey AMRO: Argentina, Colombia and Panama SEARO: Indonesia, Bangladesh and India WPRO: Vietnam, China and the Philippines
ACMP Activities Normative work • Guidelines • Technical standards etcetera Country support
Normative work • Pain treatment guidelines – next slide • Policy guidelines"Ensuring Balance in Opioid Control Policies" (2011) • WHO/INCB Manual for estimates • Model legislation • Guidelines treatment opioid dependence (Dept of MSD; 2009)
Pain Treatment Guidelines WHO Treatment Guidelines on • Persisting Pain in Children with Medical Illness (early 2011) • Chronic Pain in Adults • Acute Pain
Persisting Pain in Childrenwith Medical Illness • Transparent, evidence based • Guidelines Development Group meeting (March 2010) • Currently under review (worldwide) • Publication main document (as pdf): Spring 2010
Persisting Pain in Childrenwith Medical Illness • All moderate to severe pain in children needs addressing • Two step pain treatment • Codeine – obsolete • Tramadol – insufficient safety data • Steps: • Non- opioids (paracetamol, NSAIDS) • Strong opioids (oral morphine etc)
Country support • Situational analysis and drafting a plan • E.g. review of legislation and policies • Introduction of balanced policy • optimum for accessibility for medical use and prevention of dependence and abuse Model plan drafted with involvement of MoH Ghana, APCA and health care workers can easily be adapted to local needs elsewhere
Country support • Update of national essential medicines list • Oral morphine • Oral methadone • Update of National Medicines Policy Plan • Training of civil servants • Estimates/statistics • Support to health education institutions
Access to Controlled Medicines Willem Scholten, PharmD., MPA Team Leader, Access to Controlled Medicines Essential Medicines and Pharmaceutical Policies World Health Organization Geneva, Switzerland scholtenw@who.int +41 22 79 15540