Designing a national combined reporting form for adverse drug reactions and medication errors/Elaboration d'un formulaire de notification national combinant les reactions indesirables aux medicaments et les erreurs de medication

The Maltese Medicines Authority was tasked with developing a reporting form that captures high quality case information on adverse drug reactions (ADRs) and medication errors in order to fulfil its public-health obligations set by the European Union (EU) legislation on pharmacovigilance. This paper describes the process of introducing the first combined ADR/medication error reporting form in the EU for health-care professionals, the analysis of reports generated by it and the promotion of the system. A review of existing ADR forms was carried out and recommendations from the European Medicines Agency and World Health Organization audits integrated. A new, combined ADR/medication error reporting form was developed and pilot tested based on case studies. The Authority's quality system (ISO 9001 certified) was redesigned and a promotion strategy was deployed. The process used in Malta can be useful for countries that need to develop systems relative to ADR/ medication error reporting and to improve the quality of data capture within their systems. [TEXT NOT REPRODUCIBLE IN ASCII] L'Autorite maltaise pour les medicaments (Maltese Medicines Authority) a ete chargee d'elaborer un formulaire de notification visant a recueillir des informations de haute qualite sur les reactions indesirables aux medicaments et les erreurs de medication afin de satisfaire a ses obligations de sante publique definies par la legislation de l'Union europeenne sur la pharmacovigilance. Le present article decrit le processus d'introduction du premier formulaire de notification combinant les reactions indesirables aux medicaments et les erreurs de medication pour les professionnels des soins de sante dans l'Union europeenne, l'analyse des rapports issus de ce processus et la promotion de ce systeme. Les formulaires de notification des reactions indesirables aux medicaments existants ont ete passes en revue et les recommandations de l'Agence europeenne des medicaments ainsi que des audits de l'Organisation mondiale de la Sante ont ete integres. Un nouveau formulaire de notification combinant les reactions indesirables aux medicaments et les erreurs de medication a ete elabore puis soumis a un essai pilote dans des etudes de cas. Le systeme qualite de l'Autorite maltaise (certifie ISO 9001) a ete remanie et une strategie de promotion a ete deployee. Le processus applique a Malte peut etre utile a d'autres pays qui ont besoin de mettre au point des systemes de notification des reactions ind