Managing Risk Management

Lisa Hughes shares her thoughts on Risk Management.

“All medicines have inherent risks in the form of side effects which are compounded by the complexity of the health and lifestyle of the population, however some products have specific risks due to their pharmacokinetic or pharmacodynamic actions. Many products will have a Risk Management Plan (RMP) which outlines the safety profile of the medicine including known, expected and unknown risks associated with it.

It is the products where the safety profile has identified a specific risk that include Risk Minimisation Measures (RMMs) including Education Materials as part of the product information.

I have noticed over the years I worked in the pharmaceutical industry the easier the access to information on medicines and the better-informed patients become the more important the profile of risk management has become, and dare I say it easier to disseminate. Whilst there is still the need for physical hard copies of the information to be provided the use of electronic platforms has changed how pharma distributes Risk Minimisation Measures. However, do not ignore all formats as the target audience will differ in their requirements and abilities, especially if the target population are elderly or unable to use technology.

The complexity of Risk Minimisation Measures range from a simple patient reminder card or Healthcare Professional checklist to a full Pregnancy Prevention Programme and everything in between. These are not promotional materials so cannot be overtly branded and the text is usually provided by the MHRA or based on the originator materials, however the format and distribution route is often left for the MAH to share with the MHRA for approval.

Jackie and I have a vast experience in risk management including the creation, introduction and maintenance of complex risk management plans and measures.

If PharmaGuard can help you with your risk management requirements then please do contact us, we would love to support you. Please contact us either via the website or by email at info@pharmaguard.co.uk”