QT shortening: a proarrhythmic safety surrogate measure or an inappropriate indicator of it?

Objective: To examine whether QT interval shortening is an overlooked adverse event as compared to QT prolongation through a review of preclinical, clinical and post-marketing adverse event data available to the regulator for centrally and nationally authorized medicinal products.

Methods: Potential safety signals of QT shortening related to authorized medicinal products were detected from Eudravigilance using proportional reporting ratios. Active substances identified as having unexpected signals of QT shortening were assessed in depth using the Bradford-Hill criteria for causation.

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.

Changing paradigms in bioequivalence trials submitted to the EMA for evaluation - A clinical and regulatory perspective.

Background: The selection of a robust bioequivalence (BE) study designs for registering a generic product remains still a hard task. This task is still challenging despite the fact that generic products are much needed by health care providers in economical terms. Thus, BE study designs could be a means to allow companies to reduce costs and reach the market earlier.

A review of the National pharmacovigilance system in Malta - implementing and operating a pharmacovigilance management system.

Regulatory authorities have a legal mandate to implement and maintain a Pharmacovigilance System designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. Areas covered: This review maps the implementation of pharmacovigilance activities in Malta since accession in the EU in mid 2004 and discusses the challenges the Maltese Regulator encountered while setting up adequate and effective systems to fulfil its legal mandate. Areas reviewed are those around ADR reporting, promotion and safety communications including rapid alerts and recalls, direct healthcare professional communications, risk minimisation measures and safety circulars and quality systems.

European Union pharmacovigilance capabilities: potential for the new legislation.

European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU.

Medication errors through a national pharmacovigilance database approach: a study for Malta.

Aim: To identify medication errors in the Maltese pharmacovigilance database and describe the frequency and characteristics of these events.

Method: A retrospective analysis of the Adverse Drug Events (ADEs) reported over 5 years in Malta was conducted. Medication errors were identified by comparing use against the product's Summary of Product Characteristics (SmPC) and then classified by type of medication error, seriousness and the stage of the medication use chain at which they occurred.