39th expert committee on drug dependence · expert committee on drug dependence and guidance for...
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HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
39th Expert Committee on Drug DependenceProcess and recommendations
Dr Gilles Forte
Essential Medicines and Health Products Department
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
WHO role within the International Drug Conventions
• To recommend placement of a psychoactive substance under international control or change its level of control
• Recommendations are made through an evidence-based assessment process
– Assessing risks for abuse, dependence and harm to health
– Considering therapeutic usefulness of the substance
• This assessment process is carried out by the Expert Committee on Drug Dependence (ECDD) and is reinforced by UNGASS and resolutions of the CND
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
Expert Committee on Drug Dependenceand guidance for the review of substances
• ECDD composition:
- Selected experts - recognised expertise on substance
evaluation e.g. toxicology, addiction, pharmacology etc.
- Independent expertise – clear of COI
not representing a country or an agency
- Geographic and gender balance
- Observers: UN agencies e.g. INCB, UNODC
• ECDD rules: 'Guidance on WHO review of psychoactive substances for international control‘
– WHA 33.27 (1980);
– Revisions approved by WHO Exec. Board 2010
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
Prioritization of substances for review at the ECDD
The ECDD reviews the most prevalent, persistent and harmful psychoactive substances
• Data from UNODC (EWA), European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) –
• Review of published data on toxicology, pharmacology, abuse and dependence
• Member States’s data published/unpublished
• Uppsala Monitoring Center on adverse medicines reactions;
• Data search on specific websites e.g. Member States, User forums etc..
Scientific evidence is central to the role of ECDD
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
Substances reviewed at 39th ECDD
• Ocfentanil
• Furanyl fentanyl
• Acryloylfentanyl
• Carfentanil
• 4-fluoroisobutyrfentanyl
• Tetrahydrofuranylfentanyl
• 4-fluoroamphetamine
• AB-PINACA • AB-CHMINACA • 5F-PB-22 • UR-144 • 5F-ADB
• Etizolam• Pregabalin• Tramadol • Cannabidiol (CBD)
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
Fentanyl analogues
• Carfentanil• Similar effects to other opioids analgesics, 100 times more potent
than fentanyl and 1000 times than morphine
• Carfentanil has been associated with hundreds of deaths and nonfatal intoxications globally
• Carfentanil is used in veterinary medicine primarily for immobilizing large animals
• Similar abuse and similar ill effects to controlled opioids such as fentanyl that are included in Schedule I of the Single Convention on Narcotic Drugs of 1961
• The Committee was particularly concerned by the extreme potency of the substance and serious risk to public health and recommended to be also placed in Schedule I & Schedule IV of the UN Single Convention on Narcotic Drugs, 1961
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
Fentanyl analogues
• Ocfentanil
• Furanyl fentanyl
• Acryloylfentanyl
• fluoroisobutyrfentanyl
• (4-FIBF)
• Tetrahydrofuranylfentanyl(THF-F)
• Synthetic opioids, clandestinely manufactured
• Severe intoxications: serious respiratory depression and deaths
• No recorded therapeutic use
• Similar abuse and similar ill effects to controlled opioids such as fentanyl that are included in Schedule I of the Single Convention on Narcotic Drugs of 1961.
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
Synthetic cannabinoids
• AB-PINACA
• AB-CHMINACA
• 5F-PB-22
• UR-144
• 5F-ADB
• Clandestinely manufactured
• 2 to 60 times more potent than THC
• Severe intoxications: hallucinations, tachycardia and deaths.
• No recorded therapeutic use
• Similar abuse and similar ill effects as other substances already scheduled in Schedule II of the 1971 Convention.
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
Amphetamine-type stimulants
• 4- fluoramphetamine (4-FA)
• Derivative of amphetamine
• Severe intoxications: cardiovascular and cerebrovascular complications & deaths
• No recorded therapeutic use
• Similar abuse and similar ill-effects to substances in Schedule II of the UN Convention on Psychotropic Substances of 1971.
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
Substances under surveillance
• Etizolam • Effects similar to those of the model benzodiazepine, diazepam, that is in Schedule IV of the Convention on Psychotropic Substances of 1971
• Etizolam used to treat psychiatric conditions including anxiety disorders
• Data on the misuse and abuse of etizolam are increasing but still are minimal
• The Committee recommended that etizolam be kept under surveillance
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
Substances proposed for critical review
• Pregabalin • Pregabalin, is an analogue of gamma amino butyric acid (GABA)
• Increasing evidence of misuse and abuse in many countries
• Has the capacity to produce a state of dependence.
• Pregabalin has approved indications for the treatment of diabetic neuropathy, neuropathic pain, and of drug and alcohol withdrawal
• Proceed to a future critical review to next ECDD
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
Substances proposed for critical review
• Tramadol • Opioid analgesic with mild opioid-like effect by oral administration and low potential for abuse compared to morphine
• Intoxication with symptoms such as coma, cardiovascular collapse, respiratory depression up to respiratory arrest ; Few cases of fatal poisoning due to tramadol alone with most intoxications involving co‐ingestion of other drugs or alcohol.
• Growing evidence of abuse of tramadol in some African and Asian countries, in several Middle Eastern countries.
• Used to treat both acute and chronic pain of moderate to severe intensity. Important in low income countries and emergency situations.
• Proceed to a critical review to next ECDD
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
Substances proposed for critical review
• Cannabidiol • No case reports of abuse or dependence relating to the use of CBD.
• No public health problems (e.g. impaired driving) associated with the use of CBD.
• No evidence that CBD as a substance is liable to similar abuse and similar ill-effects as substances in the 1961 or 1971 Conventions (including cannabis and dronabinol (THC), respectively).
• CBD is being actively explored for a range of therapeutic indications and has demonstrated effectiveness for some forms of epilepsy
• CBD is produced for pharmaceutical purposes as an extract of cannabis & cannabis extracts and tinctures are included in the 1961 UN Single Convention on Narcotic Drugs.
• It is recommended that extracts or preparations containing almost exclusively CBD be subject to critical review at the next ECDD meeting on Cannabis
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
40th ECDD on Cannabis
• Four substances will be subject to pre-review, as recommended by the 38th ECDD in November 2016:
• cannabis plant and cannabis resin
• extracts and tinctures of cannabis
• delta-9-tetrahydrocannabinol (THC)
• stereoisomers of THC
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
40th ECDD on Cannabis
• Public call for proposals for authors of pre-reviews was issued – Chemistry– Pharmacology– Toxicology– Epidemiology– Therapeutic Use
• Applications now closed
• 44 expressions of interest across all 5 scientific topics for the cannabis reviews. Of those, a total of 31 applications were received.
• Starting preparation of meeting in accordance with ECDD guidance (e.g. Note Verbale, country questionnaires etc. )
HIS/EMP | Communications PlanningWHO/HIS/EMP | December 15, 2017
ECDD assessment processes
• Pre-review– Initiated by ECDD Secretary, ECDD Member, or ECDD Observer– Does the current evidence justify a critical review?
• Critical review– Initiated by:
• Positive pre-review• Notification from Treaty Party• Request from CND• Information on clandestine manufacture with no therapeutic use
– Does the current evidence justify scheduling according to international drug conventions?
• ECDD recommendations presented to the CND