What is it about?
An important element of risk management is the planning and implementation of risk minimisation measures (RMMs) and the evaluation of their effectiveness by process or outcome indicators. The aim of this review is to summarize the characteristics of risk minimisation (RM) effectiveness studies in Europe and provide an overview of RMMs and their effectiveness.
Featured Image
Why is it important?
A review conducted by Gridchyna et al using MEDLINE and Embase, included published studies evaluating the effectiveness of RMMs worldwide up to 2013 which was before GVP XVI was adopted. However, a comprehensive review of studies assessing the effectiveness of RMMs in European countries using EU PAS register is lacking including the studies initiated after GVP XVI. Importance of this reivew is the use of EU PAS Register to review RM effectiveness studies and the availability of the detailed study reports. This review provides insights into RM effectiveness studies conducted in the EU with a good representation of potential study designs, target populations (physicians, nurses, pharmacists and patients), practice settings (general practice and secondary care), RMMs (DHPC, PPP, educational materials, label changes), countries, data sources and indicators (process and outcomes).
Perspectives
Evaluating the effectiveness of risk minimisation measures is an important area where further research is required and to stimulate further discussions in this field, this review provides valuable information to further define areas where guidance for the design, methods, interpretation, and use of data sources are required to conduct RM effectiveness studies with high quality Standards.
Pareen Vora
Bayer AG
Read the Original
This page is a summary of: A review of studies evaluating the effectiveness of risk minimisation measures in Europe using the European Union electronic Register of Post-Authorization Studies, Pharmacoepidemiology and Drug Safety, April 2018, Wiley,
DOI: 10.1002/pds.4434.
You can read the full text:
Contributors
The following have contributed to this page
