Access to Controlled
Medicines
Technical Briefing Seminar
November 2009
Geneva, Switzerland
Willem Scholten, Team Leader,
Access to Controlled Medicines,
Department of Essential Medicines
and Pharmaceutical Policies
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.
2.
3.
1. UNODC, World Drug Report, 2008
2. Bradley, Global epidemiology of Injecting Drug Use and HIV, Lancet, 2008
3. UNODC, World drug Report, 2005
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 Peter Reuter, unpublished.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 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 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
Intermezzo: exclusion of
tobacco and alcohol
"…That problem, however
serious, therefore does not
"warrant" the placing of
tobacco under 'international
control'…"
Commentary, para 11 to Art 2, para
4(a)ii, 1972 Convention
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
160
2007 Global Consumption of
Morphine
Global mean, 5.9823 mg
No data:
Afghanistan
Nigeria
Cameroon
140
Austria
120
100
80
United States of America
Canada
Yemen
60
Australia
Pakistan
Ghana
New Zealand
Haiti
Kenya
40
Egypt
Jordan
20
Sudan
India
Thailand
Sierra Leone
China
Palau
0
160 Countries
Source: Pain and Policy Study Group, University of Wisconsin, WHO Collaborating
Center. Data received by the INCB.
Controlled medicines on
the WHO EML
– 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
Patients affected
(global figures, annually)
Cancer pain patients untreated
HIV pain patients untreated
Lethal injuries
Surgery
Preventable HIV infections
Mortality from post-partal haemorrhage
5.4 million
1 million
0.8 million
8-40 million
130,000
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
Three Step Ladder
WHO Three step ladder on cancer pain (1986)
1.
Non-opioid + adjuvant e.g. paracetamol
If 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
There is no maximum dose: the right dose
is the dose that works
Opioid analgesics
Used for all moderate to severe pain due to:
• Cancer
• Traffic and other
accidents
• AIDS/HIV
• Myocardial infarction
• Chronic pain
– Some exceptions • 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 France
before and after introduction of
LA Opioid Agonist treatment
600
90000
80000
500
70000
400
60000
50000
300
40000
200
30000
20000
100
0
1990
10000
0
1992
1994
1996
1998
2000
2002
Year
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 workers
can 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
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