Overview
“The right medicine, at the right dose, at the right time, to the right patient” – GVP, Module XVI
Risk minimisation measures are actions taken to prevent or reduce the occurrence of adverse drug reactions, or to reduce the severity or impact on the patient of adverse reactions that do occur.
The multidisciplinary DSRU team is experienced in advising on additional risk minimisation measures and measuring the effectiveness of risk minimisation activities.
Reasons to use the DSRU for risk minimisation:
- Our world class pharmacoepidemiologists are experienced in conducting risk minimisation studies
- Our team includes medics, epidemiologists, pharmacists and biomedical scientists
- We have innate understanding of the UK health system which is important in implementing and measuring risk minimisation measures (both the process and outcomes)
- We have an in depth understanding of European pharmacovigilance regulations
Our risk minimisation service can include:
- Interpreting regulatory requirements to decide on the most suitable risk minimisation measure to use
- Designing risk minimisation activities
- Designing studies to monitor the effectiveness of risk minimisation measures
- We offer a full study package, including writing the protocol, conducting the study, analysing the data, writing the report and publishing the results
- We make use of our unique links with prescribers in both primary and secondary care
- We also have access to secondary data sources, such as CPRD should this be required
Routine risk minimisation measures
All medicinal products are subject to routine risk minimisation measures, which should be detailed in the Risk Management Plan for the product, in accordance with Good Pharmacovigilance Practice (GVP) Module V. Routine risk minimisation activities relate to the Summary of Product Characteristics, the labelling, the pack size, the package leaflet and the product’s legal status.
Additional risk minimisation measures
In some cases, routine risk minimisation measures are not sufficient to ensure safe and effective use of the medicinal product, in which case additional risk minimisation measures may be proposed by the Marketing Authorisation Holder. Such measures may include:
- Educational tools aimed at health care professionals
- Educational tools aimed at patients or carers
- Controlled access programmes
- Pregnancy prevention programmes
- Direct health care professional communications (DHPC)
