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

Access to Controlled Medications
Programme
NPO Meeting
20 – 24 October 2008, Delhi, India
Zafar Mirza
EM/RGO/DHS
Willem Scholten
HQ/EMP/QSM/ACMP
Drug Control
Currently 3 UN drug conventions:
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Single Convention on Narcotic Drugs (1961)
Convention on Psychotropic Substances
(1971)
Convention against Illicit Traffic in Narcotic
Drugs and Psychotropic Substances (1988)
Drug conventions are public
health law
1961 and 1971 Conventions:
Two objectives:
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
Controlled medicines on the
WHO EML
– Opioid analgesics
moderate to severe pain
– Opioids for substitution
treatment
opioid dependence
– Ergometrine and
ephedrine
emergency obstetrics
– Benzodiazepines
anxiolytics, hypnotics,
anti-epileptics
– Phenobarbital
anti-epileptic
Morphine consumption per
capita
Graphic: New York Times
Drug conventions
Millions have a drug problem
photo: WHO/Marko Kokic
They can't get any
Why does drug control
impede medical access?
- Excessive fear for dependence
- Excessive fear for diversion
- Attention for medical needs neglected
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)
Conventions are a minimum
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Countries may apply stricter measures
Examples:
– Licence requirement for community and hospital
pharmacies
– Dispensing restricted to major hospitals
– Government monopoly on morphine trade
– Special prescription forms
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Stricter measures usually decrease medical
availability
International Covenant on
Economic Social and Cultural
Rights (ICESCR)
Article 12:
1. The States Parties to the present Covenant
recognize the right of everyone to the enjoyment of
the highest attainable standard of physical and
mental health.
2. The steps to be taken by the States Parties to the
present Covenant to achieve the full realization of
this right shall include those necessary for:
(…) the creation of conditions which would assure
to all medical service and medical attention in the
event of sickness.
Right to Health includes:
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Access to Essential Medicines
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Chronically and terminally ill
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Non-discrimination
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Spare avoidable pain
Die with dignity
Women, children, prisoners, HIV-patients, people with heroin
dependence et cetera
Protection against drug abuse
States, treaties and UN-bodies should promote right to
health internationally
General Comment 14 to the International
Covenant on Economic, Social and Cultural
Rights
Undue medical effects
of drug control
Untreated pain patients
Preventable HIV infections
tens of millions
> 250,000
Mortality from post-partal
75,000
haemorrhage
Effect on mortality among
2-3%  0.2–0.3%
patients with opioid dependence
Antiepileptics, anxiolytics
(first three: annual prevalence)
?
Untreated pain patients
(annually, globally)
Cause
Number of untreated pain patients
Cancer
around 4 million
HIV/Aids
0.8 million
Emergencies
8 - 40 million
Surgery
8 - 40 million (overlap with emergencies)
Other
10 million (estimated)
Total
All avoidable with controlled
medications
30 – 86 million
Substitution therapy
effects
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Prevents transmission of HIV and Hepatitis C
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Reduces death rate of dependence patients
to about normal
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Reduction HIV seroconversion in IDU's:
55% - 85% (= 230,000 – 360,000)
Reduction 90 – 95%
Reduces public nuisance and petty crime
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$ 1 investment yields $ 5 for society
Resolutions
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ECOSOC 2005/25
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On treatment of pain using opioid analgesics
World Health Assembly 58.22 (25-05-2005)
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on Cancer Prevention and Control
"…..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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To assist countries to improve access to
controlled essential medicines
Developed in consultation with the
International Narcotics Control Board (INCB)
Operated by WHO
Access to Controlled Medications
Programme (ACMP)
Programme info on
www.who.int/medicines:
- Framework
- Briefing notes
- Pain guideline
development
ACMP Activities (1)
Step 1:
Developing tools
Monitoring and planning tools
- International Opioid Consumption Database
(interactive on-line database) (on-line by end of 2009)
- methods for need estimation (ready for publication)
WHO Treatment Guidelines for all types of pain
Focussed on opioid availability
ongoing; available by 2010-2012
Update of Guidelines on Opioid availability
("Achieving balance in national opioid control policies")
available by 2010
ACMP Activities (2)
Step 2: Direct country support
Policy analysis
Analysis of legislation and support for amendment process
Procurement of controlled substances (advice)
Estimates training
Support for training of health care professionals
ACMP Methods
6-country workshops
- policies analysed by 3 government officials and 3 health
care workers
- lectures
- national plans drafted
National workshops
50 – 200 stakeholders invited
Estimates training
workshops for civil servants responsible for estimates
and statistics submission to INCB
Counselling
Other areas of work involved
Not a pharmaceutical topic exclusively:
- HIV
- Palliative care/cancer care
- Surgery and emergency care
- Child and adolescent health
- Substance abuse
ACMP priority countries
AFRO
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Cameroon, Ethiopia, Ghana, Ivory Coast, Kenya, Malawi,
Nigeria, Rwanda, Senegal, Sierra Leone, Tanzania, Zambia.
EMRO
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Egypt, Iran, Morocco, Oman, Pakistan, Sudan.
EURO
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Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, Czech
Republic, Estonia, Finland, Greece, Hungary, Italy, Latvia,
Lithuania, Malta, Moldova, Poland, Romania, Serbia &
Montenegro, Slovenia, Slovakia.
PAHO
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Argentina, Colombia, Panama.
SEARO
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Indonesia, Bangladesh, India
WPRO
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Vietnam, China, Philippines
Programme Duration and Cost
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Over 150 countries to go to
Expected to take over 15 years
Action Plan Phase I (2008 -2013)
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Needed budget: US$ 55.5 million
Funds to be raised from Members States and
donor organizations
ATOME Project
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Funded by European Commission
Consortium: 10 organizations from 7 EU
countries, including WHO (HQ/EMP, EURO)
"ACMP-like" activities in 12 Eastern
European countries
2009 - 2014
More information:
Willem Scholten
Manager Access to Controlled Medications
Programme
Quality Assurance and Safety: Medicines
Department of Essential Medicines and
Pharmaceutical Policies
[email protected]
+41 22 79 15540