Risk assessment of new psychoactive substances - EMCDDA - Europa

Risk assessment of new psychoactive substances: operating guidelinesKey variables• Dose and frequency of use• Short-term and especially long-term effects• Interactions with other substances (including alcohol and medicines)• Individual characteristics (e.g. genetic susceptibility, presence of interacting riskfactors)• Characteristics of the social and cultural environment• Involvement of organised crimeThe information gathered during any risk-assessment process is likely to be basedon different types of evidence as outlined in the following box.Types of evidence• Laboratory evidence, either in vitro or in vivo (mainly animals)• Evidence of effects on humans (biological and psychological)• Epidemiological evidence• Sociological evidence• Criminological evidenceIn evaluating the consistency between laboratory-based and population-basedevidence, special account must be taken of social context factors, and of theselection of population groups and individual users as potential sources of biaswhen inferring the social and health risks of a specific substance.(a) Physical, chemical and pharmacological descriptionThe description of the new psychoactive substance should include its mechanism ofaction and its medical value. The description should include the elements set out inthe following box.34