Retour programme
Congrès annuel SFT - Paris, 23-24 octobre 2006
"Toxicologie de la pharmacodépendance aux médicaments et aux drogues"

Évaluation du risque des nouvelles substances psycho-actives non médicamenteuses
Role of non-clinical data in risk assessment of new psychoactive substances

Dr. Leon A.G.J.M. van Aerts
National Institute of Public Health and the Environment
Bilthoven, The Netherlands


New psychoactive substances (NPS) are new narcotic or psychotropic drugs used non-medically, for recreational purposes that may pose a threat to public health. MDMA (3,4-methylenedioxymethamphetamine) is a well-known example, but phenylethylamine and tryptamine derivatives have been around now for many decades. In the EU a mechanism has been put in place to tackle the appearnace of NPS, basically consisting of an early warning system and a risk assessment followed by a decision which control measures should be implemented. Although the prevalance of use for individual NPS may be low, the potential for a rapid spread is always present, taking account of a last year prevalence for amphetamine use or ecstasy use in most European Member States between 1 and 5%. Up to 30 NPS have been reported to the European Monitoring Centre for Drugs and Drugs Addiction (EMCDDA). Of these substances, nine have been subject of a formal risk assessment. Part of a risk assessment is a review of all pharmacological and toxicological data of a NPS. The number of cited sources containing non-clinical safety data for these substances is astonishing low.Obviously, and in contrast to substances developed for medical use, no one feels the responsibility to investigate the toxicological properties of NPS, despite their human consumption. Safety pharmacology, acute and subacute toxicity, genotoxicity and dependence potential might be considered as areas were non-clinical safety data may substantially contribute to the risk assessment of NPS.

Key words : new psychoactive substances, risk assessment.