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 Peter Reuter, unpublished.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

scholtenw@who.int+41 22 79 15540

Access to Controlled Medicines