ADVERSE DRUG REACTIONS AND FAMILY PAEDIATRICIANS

Key words: ADR, Pharmacovigilance, Family paediatricians

Pre-marketing trials cannot define the safety of drugs introduced into the market sufficiently. Therefore, the spontaneous signalling of suspected adverse drug reactions (ADRs) becomes an important tool to promote justified safety alerts. FIMP has formed a pharmcovigilance team whose aim consists in: a) organizing trainings; b) setting up a pharmacovigilance network of family paediatricians; c) setting up a territorial survey (drug and/or disease registers); d) active participation in independent research tenders to assess risks/ benefits of drugs in paediatrics; e) inviting drug producers to insert a link in their programmes for spontaneous signalling; f) enhancing a strict collaboration with the national regulatory action.