WHO Access to Controlled Medications Programme & Ensuring balance in national policies on controlled substancesBarbara Milani, Technical Officer

Department of Essential Medicines and Pharmaceutical Policies

CENTRAL ASIAN PALLIATIVE CARE POLICY MEETINGMarch 8-11, 2011, Barcelona, Spain

Layout of the presentation

● International drug control – Illicit drug market– International drug conventions– UN agencies' role

● Improving access to essential controlled medicines – ACMP background– Types of barriers – Tools to be used at country level including the WHO guidelines on Ensuring

balance in national policies on controlled substances

Illicit drug use & International drug control

Worldwide

Problem drug users (severely dependent on drugs of abuse): 16-38 million1

Injecting drug users: 16 million2

World illicit drug market ● Over $ 332 billion 3

Protection against abuse and dependence is necessary

1.UNODC, World drug Report, 20102. Mathers, Global epidemiology of Injecting Drug

Use and HIV, Lancet, 20083. UNODC, World drug Report, 2005

International Drug Control Conventions

Currently 3:

● 1961 UN Single Convention on Narcotic Drugs

● 1971 UN Convention on Psychotropic Substances

● 1988 UN Convention against Illicit

Traffic in Narcotic Drugs and Psychotropic Substances

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 abuse prevention (concept of balance)

Narcotic substances: Ensuring availability for medical use

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)

Psychotropic Substances: Ensuring availability for medical use

Recognizing that the use of psychotropic substances for medical and scientific purposes is indispensable and that their availability for such purposes should not be unduly restricted…

(Preamble Psychotropic Substances Convention)

Implications of signing a treaty

Treaties are signed on behalf of the nation

Therefore: Entire government is responsible, not one

ministry or one officer only All ministries should cooperate to achieve

all public-health and other obligations from any treaty

● All countries that signed the conventions are obliged to implement them in their national legislation

Role of UN agencies in relation to the drug conventions

International Narcotic Control Board (INCB)control organ monitoring implementation of the

conventions

UN Commission on Narcotic Drugs (CND)central drug policy-making body

UN Office of Drugs and Crime (UNODC)research, prevention and treatment of drug abuse

World Health Organization (WHO)medical and scientific advice

Role of WHO

● WHO nominates 3 out of 13 candidates to the INCB

● Since 1949, the WHO Expert Committee on Drug Dependence (ECDD):– Reviews substances– Recommends to add, to change scheduling, to

delete a substance from the UN drug conventions

considering the scientific and medical matters

On the WHO website:

Guidelines on the WHO review of psychoactive substances for international control

ECDD reports 1949 – 2006

WHO Access to Controlled Medications Programme

(ACMP): the background

Morphine consumption per capita

Graphic: New York Times

Lack of access to opioid analgesics

"In 2003, six countries together accounted for79 % of global consumption of morphine.Developing countries, which represent about 80 % of the world’s population, accounted for only about 6 % of global consumption of morphine."

Source: INCB report, 2004

U.N. ECOSOC Resolution 2005/25Treatment of pain using opioids

(…) Calls upon Member States to remove barriers to the medical use of such analgesics, taking fully into account the need to prevent their diversion for illicit use

World Health Assembly Resolution 58.22

on Cancer Prevention and Control

URGES Member States:● (15) to ensure the medical

availability of opioid analgesics according to international treaties and recommendations of WHO and the International Narcotics Control Board and subject to an efficient monitoring and control system

Both Resolutions

● REQUESTS the Director-General of WHO:

"…..to examine jointly with the International Narcotics Control Board the feasibility of a possible assistance mechanism that would facilitate the adequate treatment of pain using opioid analgesics"

Access to Controlled Medications Programme (ACMP)

● Response to Resolutions ECOSOC 2005/25 and WHA 58.22

● WHO Programme to improve access to controlled medicines

● Launched in 2007 by WHO and INCB

Essential medicines in the drug conventions

– 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

WHO recognized a number of controlled medicines as "essential" through its WHO model list of essential medicines

Opioid analgesics

Used for moderate to

• Cancer• AIDS/HIV• Chronic pain• Sickle cell anaemia• Myocardial

infarction

severe pain due to:

• Traffic and other accidents

• Surgery• Burns• Neuropathic pain

following amputation

Types of barriers to access opioid analgesics

Attitudinal barriers ● Excessive fear for dependence● Excessive fear for diversionEducational barriers● Neglected medical needs● Lack on knowledge on the rational medical use of

opioid analgesicsSupply barriers● Unreliable estimates of narcotic annual needs to INCB● Complex procurement procedures● Unaffordable to patients Policy and legislative barriers● No "concept of balance" in the national laws and

regulations

Misconceptions on dependence from opioid analgesics

● Tolerance is unequal to dependence

● Withdrawal is unequal to dependence

● Medicines seeking behaviours due to inadequate treatment of pain with:

– suboptimal doses / inadequate titration / no dose adjustment following increased tolerance

are not to be confused with dependence

"Dependence syndrome" is defined by WHO in ICD10 classification system

Overcoming attitudinal and educational barriers

Guidelines on treatment of acute and chronic pain in adults and children

WHO guidelines on the pharmacological treatment of persisting pain in children with medical illnesses (in press)

Systematic review to investigate the incidence of dependence following treatment with opioid analgesics (expected by May 2011)It answers to clinical questions on risks and benefits for treatment in adults

Overcoming supply barriers

Procurement procedures (complicated system of import/export authorizations)

Step-by-step algorithm

Estimates of annual requirements of narcotic substances to INCB WHO-INCB Manual (ongoing)

Overcoming policy and legislative barriers

National situation assessment using the new WHO policy guidelines

Ensuring balance in national policies on controlled substances, Guidance for availability and accessibility of controlled medicinesTranslations in 15 languagesInclude checklist and CD-ROM

Update of: Achieving Balance in National Opioids Control Policy, guidelines for assessment (2000)

– currently withdrawn

Operationalize "Ensuring balance.."

Policy cycle approach:

Assessment &

evaluation

Implementation Design new or adjust policy

Decision making

Country Assessment Checklist

Guidelines

Starting point

Suggestions to operationalize "Ensuring

balance.."

● Create a taskforce at country level which includes all stakeholders– To collect information for national situation

analysis– To agree on actions and priorities

● Create Sub-taskforces to work on specific aspects:(legal, policy, rational medical use, procurement,

supply, affordability)

● Adopt a systematic approach (policy cycle approach incl. reassessment)

Thank you for your attention…

Barbara Milani, Technical officer, ACMPmilanib@who.int

For additional information: www.who.int/medicines

" Controlled medicines"