Please use this identifier to cite or link to this item:
Title: Designing a national combined reporting form for adverse drug reactions and medication errors
Authors: Tanti, Amy
Serracino-Inglott, Anthony
Borg, John-Joseph
Keywords: Drug receptors -- Research -- Methodology
Medication errors -- Malta
Pharmacovigilance -- Malta
Medical personnel -- Malta
Issue Date: 2015
Publisher: World Health Organization. Regional Office for the Eastern Mediterranean
Citation: Tanti, A., Serracino Inglott, A., & Borg, J. J. (2015). Designing a national combined reporting form for adverse drug reactions and medication errors. EMHJ-Eastern Mediterranean Health Journal, 21(4), 246-255.
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.
ISSN: 1687-1634
Appears in Collections:Scholarly Works - FacM&SPha

Files in This Item:
File Description SizeFormat 
  Restricted Access
755.02 kBAdobe PDFView/Open Request a copy

Items in OAR@UM are protected by copyright, with all rights reserved, unless otherwise indicated.