Annex E Terms of Reference: Therapeutic use

Transcription

1 Annex E Terms f Reference: Therapeutic use The purpse f the pre-review reprt is t synthesize existing scientific evidence abut the therapeutic use and ptential fr dependence and abuse f cannabisrelated cmpunds Any recmmendatins n the scheduling f the substances are t be made by the Expert Cmmittee, and shuld nt be included in the pre-review The WHO pre-review reprt template 1 fr substances under review by the Expert Cmmittee n Drug Dependence cmprises five scientific tpics: Chemistry Pharmaclgy Txiclgy/ Adverse Effects Epidemilgy Therapeutic Use The authr will cmplete the Pre-Review reprt fr the scientific tpic f therapeutic use based n the template fund n Annex Page 7 The authr will prepare fur separate Pre-Review reprts n the therapeutic use f the fllwing cannabis related cmpunds: Reprt 1: Cannabis plant and cannabis resin Reprt 2: Extracts and tinctures f cannabis Reprt 3: Delta-9-tetrahydrcannabinl (THC) Reprt 4: Ismers f THC Where authrs refer t a specific cmpund (e.g. type f cannabis plant, extract, r ismer), they are asked t clearly indicate this in the reprt The Pre-Review reprts will be prepared in accrdance with the specific inclusin and exclusin criteria t minimise verlap and repetitin f infrmatin (Annex Pages 3-6). The Pre-Review reprts shuld include infrmatin, where feasible, in all the required sectins f the template in accrdance with the Guidance n the WHO review f psychactive substances fr internatinal cntrl dcument. The guidance dcument is available nline at the WHO Expert Cmmittee n Drug Dependence website: The Pre-Review reprts shuld be presented in a manner that will facilitate an evidencebased assessment by the Expert Cmmittee. The Pre-Review reprts shuld be written in an bjective manner withut bias r pinins. 1 Pre-review: An initial review t determine whether a critical review is warranted. If the Expert Cmmittee finds the infrmatin may justify scheduling r a change in the scheduling f the substance they can recmmend a Critical Review. A critical review is t cnsider whether the Expert Cmmittee shuld advise the Directr-General t recmmend the scheduling f, r amending f the scheduling status f, a substance. 1

2 The Pre-Review reprts shuld summarise the literature in a manner that presents the relevant infrmatin, withut necessarily prducing an exhaustive reprt. The use f existing reviews is encuraged, prvided adequate referencing is utilised. Preliminary drafts shuld be submitted t the WHO ECDD Secretariat fr assessment f quality and suitability fr the Expert Cmmittee. The Secretariat may request editrial changes and fllw up drafts, if deemed necessary. The final draft f the Pre-Review reprts will be peer-reviewed by experts frm WHO s Expert Advisry Panels. This will include an evaluatin f the strength f evidence presented. If there are data limitatins r missins, they will be discussed with, and adapted as needed, by the authr. Examples f previus pre-reviews are available n the WHO Expert Cmmittee n Drug Dependence website. Fr example, tw pre-reviews (phenazepam and etizlam) were prepared fr the 37 th ECDD in Authrs shuld include a cmprehensive list f references, and specify the methdlgy used in the reprt 2

3 Inclusin and Exclusin Criteria fr Pre-Review reprts Reprt 1: Cannabis plant and Cannabis Resin Pre-Review Inclusin Criteria Cannabis as defined by the Internatinal Drug Cntrl Cnventins as the flwering tps f the cannabis plant frm which the resin has nt been extracted 2. The term cannabis generally refers t a dried preparatin f the flwering tps r ther parts f the cannabis plant. Cannabis resin which is defined as the separated resin, whether crude r purified, btained frm the cannabis plant. It is nrmally in slid frm and is smetimes knwn as hashish. Exclusin Criteria Tinctures and extracts f cannabis including preparatins r mixtures f cannabis substances (e.g. nabiximls) Pure delta-9-tetrahydrcannabinl (THC) and its fur sterechemical variants (-)-trans-delta-9-tetrahydrcannabinl Pure cannabidil (CBD) Ismers f tetrahydrcannabinl (THC) 7,8,9,10-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d] pyran-1-l (9R,10aR)-8,9,10,10a-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d]pyran-1-l (6aR,9R,10aR)-6a,9,10,10a-tetrahydr-6,6,9-trimethyl-3-pentyl- 6H-dibenz[b,d]pyran-1-l (6aR,10aR)-6a,7,10,10a-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d]pyran-1-l 6a,7,8,9-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d] pyran-1-l (6aR,10aR)-6a,7,8,9,10,10a-hexahydr-6,6-dimethyl-9-methylene-3-pentyl-6Hdibenz[b,d]pyran- 1-l 2 _Drug_Cntrl_Cnventins_E.pdf 3

4 Reprt 2: Extracts and Tinctures f Cannabis Inclusin criteria Cannabis extracts: this term refers t a plant extract mixture frm the leaves and flwers f Cannabis sativa Cannabis tinctures: this term refers t specific alchl extractins f the flwering tps r ther parts f Cannabis sativa. Cannabis ils e.g. Butane Hash Oil, Hemp Seed Oil Aqueus extracts e.g. marijuana tea Nabiximls (e.g. Sativex ) Exclusin criteria Cannabis plant (dried preparatins f the flwering tps r ther parts f the cannabis plant) and cannabis resin (separated resin btained frm the plant) Pure delta-9-tetrahydrcannabinl (THC) and its fur sterechemical variants except when delta-9-thc is extracted frm the cannabis plant. (-)-trans-delta-9-tetrahydrcannabinl Pure cannabidil (CBD) when nt in a preparatin with ther cannabis related ingredients Ismers f tetrahydrcannabinl (THC) 7,8,9,10-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d] pyran-1-l (9R,10aR)-8,9,10,10a-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d]pyran-1-l (6aR,9R,10aR)-6a,9,10,10a-tetrahydr-6,6,9-trimethyl-3-pentyl- 6H-dibenz[b,d]pyran-1-l (6aR,10aR)-6a,7,10,10a-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d]pyran-1-l 6a,7,8,9-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d] pyran-1-l (6aR,10aR)-6a,7,8,9,10,10a-hexahydr-6,6-dimethyl-9-methylene-3-pentyl-6Hdibenz[b,d]pyran- 1-l 4

5 Reprt 3: Delta-9-tetrahydrcannabinl Inclusin criteria Pure delta-9-tetrahydrcannabinl that is btained either directly frm the cannabis plant r synthesised. The sterechemical variants f delta-9-tetrahydrcannabinl: (-)-trans-delta-9-tetrahydrcannabinl (als knwn as drnabinl) Exclusin criteria Cannabis plant (dried preparatins f the flwering tps r ther parts f the cannabis plant) and cannabis resin (separated resin btained frm the plant) Tinctures and extracts f cannabis including preparatins r mixtures f cannabis substances (e.g. nabiximls), except thse that are pure delta-9-thc Pure cannabidil Ismers and sterechemical variants f tetrahydrcannabinl as listed in Schedule 1 f the 1971 Cnventin n Psychtrpic Substances 7,8,9,10-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d] pyran-1-l (9R,10aR)-8,9,10,10a-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d]pyran-1-l (6aR,9R,10aR)-6a,9,10,10a-tetrahydr-6,6,9-trimethyl-3-pentyl- 6H-dibenz[b,d]pyran-1-l (6aR,10aR)-6a,7,10,10a-tetrahydr-6,6,9-trimethyl-3-pentyl-6H- dibenz[b,d]pyran -1- l 6a,7,8,9-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d] pyran-1-l (6aR,10aR)-6a,7,8,9,10,10a-hexahydr-6,6-dimethyl-9-methylene- 3-pentyl- 6Hdibenz[b,d]pyran-1-l 5

6 Reprt 4: Ismers f THC Inclusin criteria Ismers and sterechemical variants f tetrahydrcannabinl as listed in Schedule 1 f the 1971 Cnventin n Psychtrpic Substances: 7,8,9,10-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d] pyran-1-l (9R,10aR)-8,9,10,10a-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d]pyran-1-l (6aR,9R,10aR)-6a,9,10,10a-tetrahydr-6,6,9-trimethyl-3-pentyl- 6H-dibenz[b,d]pyran-1-l (6aR,10aR)-6a,7,10,10a-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d]pyran-1-l 6a,7,8,9-tetrahydr-6,6,9-trimethyl-3-pentyl-6H-dibenz[b,d] pyran-1-l (6aR,10aR)-6a,7,8,9,10,10a-hexahydr-6,6-dimethyl-9-methylene-3-pentyl-6Hdibenz[b,d]pyran- 1-l Exclusin criteria Cannabis plant (dried preparatins f the flwering tps r ther parts f the cannabis plant) and cannabis resin (separated resin btained frm the plant) Tinctures and extracts f cannabis including preparatins r mixtures f cannabis substances (e.g. nabiximls) Delta-9-tetrahydrcannabinl (THC) and its fur sterechemical variants (-)-trans-delta-9-tetrahydrcannabinl (als knwn as Drnabinl) Cannabidil 6

7 Template fr the each pre-review reprt Therapeutic Use Pre-Review Reprt: Therapeutic Use f (insert substance name/s) I. Marketing Authrizatins (as a Medicinal Prduct) (11) 3 (Fr example: cmpany names and cuntries which hld authrity t prduce substance as a medicinal prduct. Name f medicinal prduct can be included) II. Listing n the WHO Mdel List f Essential Medicines (10) III. Therapeutic Applicatins (9) Extent f Therapeutic Use Epidemilgy f Medical Use Effectiveness f Therapeutic Uses Systematic reviews and meta-analysis RCTs Quasi-experimental studies Chrt studies Case cntrl studies Crss-sectinal surveys Case Pre-Review reprts IV. Adverse reactins in humans (6) V. Other medical and scientific matters relevant fr a recmmendatin n the scheduling f the substance (19) 3 () indicates crrespnding reprt sectin in Paragraph 23: Guidance n the WHO Review f psychactive substances fr internatinal cntrl 7