Methodological Research in Pharmacovigilance

Evidence-Based Medicine (EBM) promotes the use of the best available evidence in clinical decision making, such as the use of randomised controlled trials when evaluating the efficacy of medications. There is a clear need to integrate the concepts of EBM into pharmacovigilance and it is important to recognise that the evidence for a drug safety issue may come from a number of study types and resources. Appropriate methods are therefore required to search relevant resources and identify suitable evidence.

The DSRU has conducted a number of studies in the area of evidence based medicine (EBM) using systematic searches of the medical literature and other pharmacovigilance resources (such as regulatory websites) to evaluate different issues relevant to the safety of medicines.

The studies completed so far include:

  • investigations into the evidence used for the withdrawal of products in the UK
  • a survey of the quality and conduct of systematic reviews of adverse effects of drug interventions
  • an evaluation of underreporting of adverse drug reactions
  • an investigation into the application of exclusion criteria in pharmacoepidemiological studies
  • an assessment of the use of the Bradford Hill criteria for the causal assessment of cisapride-induced arrhythmia

The DSRU hopes to develop this methodology further, as these studies can aid in the understanding of drug safety issues as well as identifying areas of additional research. We have expertise in the concept, design, implementation and completion of such studies, as well as a broad range of experience in pharmacovigilance and pharmacoepidemiology.