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, [email protected]
For additional information: www.who.int/medicines
" Controlled medicines"