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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 SeminarNovember 2009Geneva, Switzerland
Overview of the presentation
Part I: International drug control – Illicit drug market– International drug conventions– UN agencies involved in prevention of drug
abuse
Part II: Improving access to controlled medicines – Medical uses – Access to Controlled Medications Programme
Part I
International drug control
Illicit drug use
Worldwide, 2008:
Problem drug users (severely dependent on drugs of abuse): 26 million1
Injecting drug users: 16 million2
Protection of populations against abuse and dependence is necessary
World illicit drug market ● Over $ 332 billion 3 or $ 45 - 280 billion4
1. UNODC, World Drug Report, 20081. 2. Bradley, Global epidemiology of Injecting Drug Use and HIV, Lancet, 20082. 3. UNODC, World drug Report, 2005 3. 4. Peter Reuter, unpublished.
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
Convention principles
1961 and 1971 Conventions:
● Both have 4 lists of substances "schedules"
● Each schedule is related to a set of control measures
Commentary, para 11 to Art 2, para 4(a)ii, 1972 Convention
"…That problem, however serious, therefore does not "warrant" the placing of tobacco under 'international control'…"
Intermezzo: exclusion of tobacco and alcohol
UN agencies involved in the drug conventions
Commission on Narcotic Drugs (CND) Assembly of the countries that are party to the
conventions
World Health Organization (WHO)Medical and scientific functions
International Narcotics Control Board (INCB)Control body monitoring implementation of the
conventions
UN Office of Drugs and Crime (UNODC)Research, prevention and treatment of drug abuse
Role of WHO
● Nominates 3 out of 13 candidates to the INCB● Recommends on the composition of the
schedules (lists) with substances in the conventions
WHO Expert Committee on Drug Dependence (ECDD; since 1949)
● Promoting access for medical use
Substance Review
● Pre-review, then critical review● Recommendation by ECDD● Note Verbale from Director-General WHO to
Secretary-General UN● Note Verbale from Secretary-General UN to
Member States● Decision by Commission on Narcotic Drugs
(CND) – on adding, changing of schedule/convention,
removing a substance
Critical Review
● Critical Review Report prepared by WHO Secretariat
● Questionnaire to Member States● Report on questionnaire outcome ● Peer review by two experts● Discussion in expert meeting ● Recommendation(s) and Expert Committee
Report
On the WHO website:
Guidelines for the WHO review of psychoactive substances for international control
ECDD reports 1949 – 2006
Part II
Improving access to controlled medicines
Millions have a drug problem
photo: WHO/Marko Kokic
They can't get any
Morphine consumption per capita
Graphic: New York Times
2007 Global Consumption of Morphine
0
20
40
60
80
100
120
140
160
160 Countries
Global mean, 5.9823 mg
United States of America
Canada
Austria
Source: Pain and Policy Study Group, University of Wisconsin, WHO Collaborating Center. Data received by the INCB.
India
Haiti
Palau
Sierra Leone
New Zealand
SudanPakistan
Kenya
Thailand
Ghana
Jordan
China
Egypt
Yemen
Australia
No data:AfghanistanNigeriaCameroon
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
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
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)
Reasons for low access to controlled medicines
● Excessive fear for dependence
● Excessive fear for diversion
● Neglected medical needs
Treatment with opioids
a. Pain
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
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
A myth: Dependence from opioid analgesics
● Very low incidence– Many doctors claim dependence from
treatment is non-existent
● Withdrawal is unequal to dependence
● Pain population very different from heroin user populations
Treatment with opioids
b. Opioid Dependence
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 less reinforcing then heroin● Normalization of body responses and
social life● Interruption of transmission of
– HIV – Hepatitis C Virus (HCV)– Other blood borne disease
WHO Treatment Guidelines
● WHO, 2009
● www.who.int: > Programmes and projects
> Substance abuse
> Treatment of opioid dependence
IDU mortality in Francebefore and after introduction of
LA Opioid Agonist treatment
0
100
200
300
400
500
600
1990 1992 1994 1996 1998 2000 2002
Year
0
10000
20000
30000
40000
50000
60000
70000
80000
90000
Heroin Overdoses Buprenorphine Patients Methadone Patients
With acknowledgement to Patrizia Carrieri, INSERM, Marseille, France
Access to Controlled Medications Programme
(ACMP)
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 supposed to be very
similar, giving opportunities – for finding allies– to prevent double work
ACMP Activities
Normative work● Guidelines● Technical standards
etcetera
Country support
mainly developing countries
Normative work
● Pain guidelines (all pain)● WHO/INCB Manual for estimates● Update of WHO Policy guidelines
"Achieving Balance in Nat. Opioid Control Policies"
● Model legislation● Guidelines treatment opioid dependence
Country support● Situational analysis and drafting a plan● 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
Example: analysing barriers
● Policy barriers
● Regulatory and administrative barriers
● Attitudinal and educational barriers
● Supply barriers
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
Other tools
– International Opioid Consumption Database• International Observatory End of Life Care,
Lancaster, UK and WHO ACMP– Collecting global figures on actual needs and
adequacy of opioid consumption• Article on figures for 2006 submitted• Working on 2007 and first trend analysis
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