“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.
Additional risk minimisation measures are required for a wide range of products.
DSRU Risk minimisation service
The DSRU both undertakes risk minimisation activities and monitors the effectiveness of risk minimisation measures.
At the DSRU you don’t just get a single specialist to work on risk minimisation and monitoring its effectiveness, but a whole team. The DSRU team of medics, epidemiologists and scientists led by Professor Saad Shakir has enormous combined experience in all areas of risk minimisation.
As the UK’s premier pharmacovigilance unit, we have an in-depth understanding of the UK healthcare system and established links with prescribers in primary and secondary care, which is key to implementing additional risk minimisation measures.
The experienced DSRU team provides a risk minimisation service, including the following:
• Interpreting regulatory requirements to decide on the most suitable risk minimisation measures to use
• Designing risk minimisation activities.
• Implementing or working with the marketing authorisation holder (MAH) to implement the risk minimisation measures
• Designing and undertaking studies to monitor the effectiveness of risk minimisation measures
• We can write the proposal for submission to the medicines regulator, covering risk minimisation and monitoring effectiveness of risk minimisation measures.
• We make use of our unique links with prescribers both in primary and secondary care to understand use of the medicine in real world conditions.
Risk minimisation measures fall into two categories: “routine” and “additional” measures:
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 MAH. The requirements for additional risk minimisation measures are detailed in Good Pharmacovigilance Practice (GVP) Module XIV. As there is no restrictive list of additional risk minimisation measures, they are decided upon depending on the need for each product and issue. 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)