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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 - PowerPoint PPT Presentation
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Access to Controlled Medicines
Willem Scholten, Team Leader, Access to Controlled Medicines,Department of Essential Medicines and Pharmaceutical Policies
Technical Briefing Seminar2 November 2010Geneva, Switzerland
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?
Introduction
Controlled medicines on the WHO EML
– Opioid analgesics: Morphinemoderate to severe
pain
– Long-acting opioid agonists: methadone, buprenorphinetreatment of opioid
dependence
– Ergometrine and ephedrine emergency obstetrics
– Benzodiazepines anxiolytics, hypnotics,
antiepileptics
– Phenobarbital antiepileptic
Morphine consumption per capita
Graphic: New York Times
Patients affected (global figures, annually)
Cancer pain patients untreated 5.4 million
HIV pain patients untreated 1 million Lethal injuries
Surgery
0.8 million
8-40 million
Preventable HIV infections 130,000Mortality from post-partal haemorrhage
75,000
Background
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:1. Prevention of harm from drug dependence2. 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
Barriers for Access
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-dependencePrescription formalities
Attitudes
Examples:Thinking that opioid analgesia …
leads to dependenceleads to death (contrary was shown
recently)
Family or nurses not allowing patient to take medicines
Pain Treatment
Opioid analgesics
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
WHO Three step ladder on cancer pain (1986)
1. Non-opioid + adjuvant e.g. paracetamolIf pain persisting/increasing:
2. Weak acting opioid (e.g. codeine, tramadol)If pain persisting/increasing:
3. Strong acting opioid (e.g. morphine, methadone)Increase dosage until freedom from pain
Three Step Ladder
There is no maximum dose: the right dose is the dose that works
Adequacy of opioid consumption(x million people)*
AFRO AMRO EMRO EURO SEARO WPRO World
Adequate 0 335 0 129 0 0 464
Moderate 0 0 0 228 0 25 252
Low 0 0 0 127 0 128 255
Very low 1 206 77 94 0 79 457
No cons. 503 304 400 283 172 151 4718
No data 270 49 64 26 2 22 433
Total 774 895 540 887 1721 1763 6580
*People living in countries where opioid consumption is…
Adequacy as a function of Development
-5.00
-4.00
-3.00
-2.00
-1.00
0.00
1.00
0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0
HDI
log
(AC
M)
Data for 2006
ACM for selected countries for 2006
Adequate
cons in kg
ACM Adequate cons in kg
ACM
Top-20 HDI 1
(by definition)
Afghanistan 5 169 No data Nepal 4 466 0.0017
Austria 1 373 1.99 Pakistan 21 692 0.0005
Brasil 34 522 0.059 Sierra Leone 1 668 No data
China 245 892 0.0110 Sudan 8 020 0.001
Ethiopia 19 962 0.0001 Uganda 12 726 0.0019
Germany 15 039 2.08 Yemen 2 923 0.0012
Kenya 17 835 0.004
Seya MJ et al., J of Pain and Palliative CarePharmacotherapy, March 2011 (accepted)
ACM for selected countries (SADC) for 2006
Adequate
cons in kg
ACM Adequate cons in kg
ACM
Angola 6 104 0.0000 Namibia 1 692 0.002
Botswana 1 747 0.004 Seychelles 14 0.037
Dem Rep Congo
1 399 0.0002 South Africa 34 367 0.008
Lesotho 2 316 No data Swaziland 228 No data
Malawi 8 858 0.0000 Tanzania 18 509 No data
Mauritius 132 0.058 Zambia 9 342 0.001
Mozambique 14 654 0.0004 Zimbabwe 16 120 No data
Seya MJ et al., J of Pain and Palliative CarePharmacotherapy, 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
How to improve access to controlled medicines?
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 SudanEURO: 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 IndiaWPRO: 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:1. Non- opioids (paracetamol, NSAIDS)
2. 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 workerscan 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
Willem Scholten, PharmD., MPATeam Leader, Access to Controlled MedicinesEssential Medicines and Pharmaceutical PoliciesWorld Health OrganizationGeneva, Switzerland
[email protected]+41 22 79 15540
Access to Controlled Medicines