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- Title
Designing a national combined reporting form for adverse drug reactions and medication errors.
- Authors
Tanti, A.; Serracino-Inglott, A.; Borg, J. J.
- Abstract
The Maltese Medicines Authority was tasked with developing a reporting form that captures highquality 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.
- Subjects
ISLANDS of the Mediterranean; DRUGS; EXPERIMENTAL design; RESEARCH methodology; MEDICATION errors; QUESTIONNAIRES
- Publication
Eastern Mediterranean Health Journal, 2015, Vol 21, Issue 4, p246
- ISSN
1020-3397
- Publication type
Article
- DOI
10.26719/2015.21.4.246