Transcript Dronabinol (INN) - syn.Δ-9-THC

CENTRAL ASIAN PALLIATIVE CARE POLICY MEETING
March 8-11, 2011, Barcelona, Spain
WHO Access to Controlled
Medications Programme
Ensuring balance in national
policies on controlled substances
&
Barbara Milani, Technical Officer
Department of Essential Medicines
and Pharmaceutical Policies
Layout of the presentation
●
International drug control
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–
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●
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
3
● Over $ 332 billion
Protection against abuse and dependence is
necessary
1.UNODC, World drug Report, 2010
2. Mathers, Global epidemiology of Injecting Drug Use
and HIV, Lancet, 2008
3. UNODC, World drug Report, 2005
International Drug Control Conventions
Currently 3:
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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 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 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:
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
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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
●
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WHO nominates 3 out of 13 candidates to the
INCB
Since 1949, the WHO Expert Committee on Drug
Dependence (ECDD):
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–
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 for
79 % 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 2005/25
Treatment 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)
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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:
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
WHO recognized a number of controlled medicines as
"essential" through its WHO model list of essential
medicines
Opioid analgesics
Used for moderate to severe pain due to:
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•
•
•
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Cancer
AIDS/HIV
Chronic pain
Sickle cell anaemia
Myocardial
infarction
• Traffic and other
accidents
• Surgery
• Burns
• Neuropathic pain
following amputation
Types of barriers to access opioid
analgesics
Attitudinal barriers
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Excessive fear for dependence
Excessive fear for diversion
Educational barriers
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Neglected medical needs
Lack on knowledge on the rational medical use of opioid
analgesics
Supply barriers
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Unreliable estimates of narcotic annual needs to INCB
Complex procurement procedures
Unaffordable to patients
Policy and legislative barriers
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No "concept of balance" in the national laws and regulations
Misconceptions on dependence from
opioid analgesics
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Tolerance is unequal to dependence
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Withdrawal is unequal to dependence
Medicines seeking behaviours due to
inadequate treatment of pain with:
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–
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 medicines
Translations in 15 languages
Include 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:
Starting point
Country Assessment Checklist
Assessment &
evaluation
Guidelines
Implementation
Design new or
adjust policy
Decision making
Suggestions to operationalize
"Ensuring balance.."
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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…
For additional information: www.who.int/medicines
"Controlled medicines"
Barbara Milani, Technical
officer, ACMP
[email protected]