A review of the national adverse drug reaction (ADR) & medication errors reporting system of Malta

Abstract

The overall objectives of Pharmacovigilance include early identification of potential safety hazards, evaluation, monitoring and where appropriate, implementation of regulatory action to maximise benefits and minimise risks associated with medicinal products. Reporting of an ADR associated with use of a medicinal product as well as medication errors is an essential source of necessary information that is required to achieve these objectives. Safety concerns that arise from spontaneous reporting contribute to assessment of the risk benefit balance and hence lead to a regulatory action which could be suspension or revocation of marketing authorization of the product or change in the product information. Furthermore these safety concerns can be communicated to healthcare professionals through Direct Healthcare Professional Communications (DHPCs) and safety circulars and they form the basis of designing Risk Minimisation Measures (RMMs). The establishment of a functional ADR reporting system by law since 2004, not only facilitates participation in the national and EU regulatory process, but also enables Malta to participate in the WHO Programme for International Drug Monitoring, both by contributing to and obtaining data from this extensive information resource.