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

scholtenw@who.int+41 22 79 15540

Access to Controlled Medicines