39 th Expert Committee on Drug Dependence Process and recommendations

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1 39 th Expert Committee on Drug Dependence Process and recommendations Dr Gilles Forte Essential Medicines and Health Products Department

2 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

- Independent expertise clear of COI not representing a country or an agency - Geographic and gender balance - Observers: UN

3 Expert Committee on Drug Dependence and 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 (1980); Revisions approved by WHO Exec. Board 2010

4 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(EMCDDA) Review of published data on toxicology, pharmacology, abuse and dependence Member States s data published/unpublished Uppsala Monitoring Center on adverse medicines reactions; Data search on specific websites e.g. Member States, User forums etc..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

5 Substances reviewed at 39 th 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)

6 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

7 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.

8 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.

9 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.

10 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

11 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

12 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

13 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

14 40 th ECDD on Cannabis Four substances will be subject to pre-review, as recommended by the 38 th ECDD in November 2016: cannabis plant and cannabis resin extracts and tinctures of cannabis delta-9-tetrahydrocannabinol (THC) stereoisomers of THC

15 40 th 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. )

16 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

3.5 Strengthen the prevention and treatment of substance abuse, including narcotic drugs and harmful use of alcohol 3.3 Ending the AIDS epidemic and

3.5 Strengthen the prevention and treatment of substance abuse, including narcotic drugs and harmful use of alcohol 3.3 Ending the AIDS epidemic and combating hepatitis, 3.4 Prevention and treatment of