Risk assessment of new psychoactive substances - EMCDDA - Europa

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Risk assessment of new psychoactive substances: operating guidelinesAlso, prevalence of use of the new psychoactive substance among specific groupscould be indicative. Such groups may be drug users familiar with the use of similarpsychoactive substances, e.g. stimulant users or users of opioids.2.3 Potential benefits of the substanceIn addition, and where feasible, the beneficial use of a new substance also needsto be considered to assess the risk-benefit ratio of each new substance. When newpsychoactive substances have a therapeutic value, they will in some cases not besubjected to a risk assessment since such substances may, in line with Article 7.3of the Council Decision, be exempted from risk assessment. Furthermore, otherfactors such as economic value and industrial use may imply a benefit of thesubstance that also needs to be considered.2.4 Risks of a substance, independently of its legal statusThe scientific risk assessment of a particular substance should be carried outindependently of its legal status in one or more of the European Union MemberStates.2.5 Scientific evidence in relation to better-known substancesSince scientific evidence on new psychoactive substances will, by definition,often be limited, it will thus be necessary to evaluate the possible risks of thesesubstances with reference to similar known substances. Such comparisonsneed not be restricted to illicit substances but may include licit substances withsimilar chemical characteristics, pharmacological actions or psychological andbehavioural effects, or which offer relevant insights into the social risks presentedby the substance. Similarly, when assessing the possible consequences of controlmeasures, as presented in Chapter 4, it may be appropriate to examine relevantexamples of control models involving licit or illicit substances.22
2.6 Quality of dataIn the final evaluation, the reliability of information (quality) needs to be weighed.As implied by the very nature of the assignment at hand, it will often be impossibleto base the risk assessment of a new psychoactive substance on the evaluationof sound (reliable and valid) scientific knowledge. Pharmacological and socioscientificknowledge will accumulate over time and will therefore be compiled associal experience with the drug phenomenon in question develops. In the interim,risk assessments will have to be based on a broad range of available evidence.The quality of this evidence should be appraised according to the two followingcriteria:2.6.1 Methodological characteristics of the available evidenceFrom a methodological point of view, evidence for risk assessment may beproduced by more or less rigorous scientific procedures. Detailed biomedicaldata, based on systematic pharmacological and toxicological studies, will rarelybe available for new psychoactive substances. In the case of socio-scientific data,evidence from preliminary, impressionistic accounts may be more available thanevidence from more methodologically rigorous and objective studies, such assurveys or panel studies.2.6.2 Sources of available evidenceThe risk-assessment procedure should include a strategy for using data fromsources of different quality. Evidence is likely to originate from sources with awide range of reliability from peer-reviewed publications in prominent scientificjournals, through, for example, reports by youth workers or psycho-medicalinstitutions, to unsubstantiated media or Internet reports. A possible method ofclassifying this information is to use the type of ranking listed in the box below.Adopting a differential strategy when accepting information may be the mostsensible approach. In the first instance, the identification and collection ofavailable data will involve accepting a wide range of information — includinginformation that may be useful for signalling phenomena of possible relevance —and then applying different weights based on a hierarchy of data quality whenscreening the evidence to be considered in the final evaluation process.23
Page 5: 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: Chapter 2General considerations for
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
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Risk assessment of new psychoactive
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European Monitoring Centre for Drug
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About the EMCDDAThe European Monito
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Risk assessment of new psychoactive substances - EMCDDA - Europa

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