A Drug Safety Glossary has been developed to help overcome some of the difficulties in understanding and using the various terms and phrases used in pharmacovigilance. Many of the terms can vary in how they are interpreted and used - this guide largely draws from relevant ICH (www.ich.org) and/or European regulatory agency definitions. Take a look and let us know if you have any other suggestions!
Research in pregnant and breastfeeding women is a complex area, with both the wellbeing of the mother and child paramount. Careful monitoring of any intervention to treat, or prevent, illness is required to ensure the benefits outweigh any harms. Read this article to find out more and download some of the safety tools developed by experts from the Malaria in Pregnancy Consortium.
A novel application utilising data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) has been developed by a Biomedical Informatics team at the Cincinnati Children’s Hospital Medical Center.
A recently published paper in PLOS Medicine has investigated how adverse event data from clinical trials are summarised and consequently reported in published papers.
Although there is now a good research pipeline of antimalarial drugs in response to the rapid spread of drug resistant malaria, there is very little evidence on how these drugs should best be deployed. The ACT Consortium is a global research partnership of a number of eminent public health and academic institutions in Africa, Asia, Europe and the United States where our projects' Principal Investigators are based. Research focuses around four major themes relating to artemisinin-based combination therapies (ACTs), the first-line treatment recommended by the World Health Organisation for malaria - in Africa and Asia: targeting, access, quality and safety. Including safety as a theme was important as, despite the wide scale use of ACTs, little is known about their long-term effects and their use in vulnerable populations, such as those co-infected with HIV. Moreover, it is clear that there is a need to work towards the pooling of safety data from multiple studies to understand uncommon adverse drug reactions that may not be detected by individual studies.
If you take two different medications for two different reasons, here's a sobering thought: your doctor may not fully understand what happens when they're combined, because drug interactions are incredibly hard to study. In this fascinating and accessible talk, Russ Altman shows how doctors are studying unexpected drug interactions using a surprising resource: search engine queries.