Risk Minimisation2019-07-04T16:56:59+00:00

Project Description

Risk Minimisation 

“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 DSRU both undertakes risk minimisation activities and monitors the effectiveness of risk minimisation 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 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)

The experienced DSRU team provides a risk minimisation service, including the following:

  • 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 CPRD should this be required

For more information or to arrange a no obligation chat, please contact Dr Liz Lynn, Head of Scientific and Educational Development.

Email: elizabeth.lynn@dsru.org

Tel: +44 (0) 23 8040 8600

Contact Info

Drug Safety Research Unit Bursledon Hall, Blundell Lane, Southampton, SO31 1AA, U.K.

Phone: +44 (0)23 80 40 86 00

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