- Palabras clave > adverse drug reactions (ADRs)
- Palabras clave > adverse reactions and medication errors
- Palabras clave > drug side effects
- Palabras clave > medicine surveillance systems
- Palabras clave > national reporting systems - adverse reactions to medicines
- Palabras clave > pharmacovigilance reporting system
(2015; 10 pages)
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 fulfill 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.