title: Designing a national combined reporting form for adverse drug reactions and medication errors.
abstract: 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.
authors.affiliation: Medicines Authority, Gzira, Malta.
authors.forename: A
authors.initials: A
authors.lastname: Tanti
authors.affiliation: Medicines Authority, Gzira, Malta.|Department of Pharmacy, University of Malta, Msida, Malta.
authors.forename: A
authors.initials: A
authors.lastname: Serracino-Inglott
authors.affiliation: Medicines Authority, Gzira, Malta.|Department of Biology, School of Pharmacy, University of Tor Vergata, Rome, Italy. John-joseph.borg@gov.mt.
authors.forename: J J
authors.initials: JJ
authors.lastname: Borg
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008319:Malta; D008508:Medication Errors; D016730:Program Development