Pharmacovigilance in the field of addiction: challenges and emerging solutions.

INTRODUCTION

Monitoring the safety of drugs regarding their potential for misuse falls within the scope of international conventions on narcotic and psychotropic drugs. In the U.S. a surveillance approach based on multiple sources has been implemented for decades and identified the opioid epidemic in the early 2000s. In Europe, this monitoring is carried out by the European Union Drugs Agency (EUDA) for substance abuse and by the European Medicines Agency (EMA) through pharmacovigilance activities for substances for therapeutic use.

AREAS COVERED: Due to the hidden nature of prescription drug misuse, spontaneous pharmacovigilance reporting is rarely sufficient to quantify this complex phenomenon. This narrative review presents examples of a multisource approach based on a PubMed literature search using the terms 'pharmacovigilance' and 'addiction,' 'drug abuse,' or 'drug misuse.' These examples mainly concern the U.S. and the addictovigilance monitoring system in France.

EXPERT OPINION: Because of the constant changes in the drug misuse phenomenon and the effectiveness of addictovigilance in addressing it, other countries should strongly consider adapting this approach (with the necessary adaptations) into their national monitoring systems and adopting the addictovigilance terminology.