Opinions of Maltese doctors and pharmacists on medication errors.

Background: Pharmacovigilance directive 2010/84/EU focused attention on medication errors and encouraged regulators to identify causing and contributing factors.

Objectives: (1) To study opinions of doctors/pharmacists on factors bearing a causal link to MEs as well as ways to minimise MEs (2) to test whether differences in opinion exist between subgroups of doctors and pharmacists working in community, hospital or office settings.

Methods: Different questionnaires were circulated to doctors and pharmacists.

Pharmaceutical issues during the review of European Marketing Authorisation Applications in Malta.

The aim of this study was to identify pharmaceutical issues encountered during regulatory review in European Procedures. A database of issues from Day 70 assessment reports of 150 EU procedures was compiled; most procedures were for generics (108). Frequencies of common deficiencies have been calculated and summarised for use of all stakeholders.