Risk assessment of new psychoactive substances - EMCDDA - Europa

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Risk assessment of new psychoactive substances: operating guidelinesthe anticipated level of use, based on a comparison of the characteristics andaccessibility of the new psychoactive substance and the settings in which it isused with the characteristics, accessibility and settings of use of other well-knownsubstances.Based on these two approaches, the following matrix can be used to score‘prevalence’:PrevalencescorePrevalence of use in specific druguser groupsAnticipated level of usein general population0 Only a few individuals have been Only a few individualsreported1 (low) More than anecdotal reports, but last LYP < 0.2 %year prevalence (LYP) < 5 %2 (moderate) LYP ≥ 5 % LYP ≥ 0.2 %3 (high) LYP ≥ 20 % LYP ≥ 1 %Step 3The experts send their sheets with the scores (and remarks) by e-mail to the Chairof the Scientific Committee who makes an overall summary of the judgementsheets. This will contain:i) a copy of all judgement sheetsii) the mean value of the individual RLs given for the 19 subgroups, arrangedper subgroupiii) the average risk (AR) value of the five domainsiv) the list with subgroups on which there is agreement/consensus (similarscore by all experts; variation in score ≤ 1)v) the list with subgroups on which there is apparent disagreement (a rangeof different RLs given for a subgroup in which the variation > 1)vi) the list of all remarks arranged per subgroup.The overall summary is distributed to all members by e-mail.60
Step 4Delphi approach:On the day of decision, the Chair discusses with all members of the ScientificCommittee points v and vi of the overall summary.Step 5Following a Delphi approach/discussion, each expert is allowed to change his/hernumerical score on the second judgement sheet.Step 6The Chair produces the draft assessment report that includes:• a copy of all second judgement sheets• the mean value of the (revised) individual RLs for the 19 subgroups, arrangedper subgroup• the average risk (AR) value of the five domains.Step 7The EMCDDA’s Scientific Committee makes a final judgement on the risks of thenew psychoactive substance taking into account the draft assessment report,formulates a conclusion and produces the final Risk Assessment Report.61
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ContentsAcknowledgements 5Foreword
Page 13 and 14: IntroductionThese guidelines are a
Page 17 and 18: Chapter 1Legal basis and scope1.1 L
Page 19 and 20: factors that would warrant such act
Page 23 and 24: Chapter 2General considerations for
Page 25 and 26: 2.6 Quality of dataIn the final eva
Page 29 and 30: Chapter 3A conceptual framework for
Page 31 and 32: (family, neighbourhood and communit
Page 35 and 36: Chapter 4Headings for the Risk Asse
Page 37 and 38: Descriptive elements• Name of the
Page 39 and 40: (c) Social risksSome public health
Page 41 and 42: • Evidence that the same groups o
Page 43: Elements for examining the conseque
Page 47: Chapter 6ConclusionThe Risk Assessm
Page 51 and 52: Annex ITechnical reportThe EMCDDA i
Page 53 and 54: D1.1.D1.2.Animal dataHere, data reg
Page 55 and 56: E6. Possible appeal of the new psyc
Page 59 and 60: Annex IISemi-quantitative assessmen
Page 61: 8 subgroups. All members give numer
Page 66 and 67: Risk assessment of new psychoactive
Page 74: Risk assessment of new psychoactive
Page 90 and 91: European Monitoring Centre for Drug
Page 92: About the EMCDDAThe European Monito
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Risk assessment of new psychoactive substances - EMCDDA - Europa

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