Additional Risk Minimisation

Pregnancy prevention plans, Educational materials, DHPCs

Risk minimisation measures are interventions intended to prevent or reduce the occurrence of adverse reactions. Risk minimisation measures can either be routine measures (e.g. SmPC, PIL, prescription status of product) or additional measures. Additional measures are used to improve benefit-risk profile of medicines.

Additional risk minimisation measures can vary in nature and may guide patient selection, either to maximise the benefit-risk balance or exclude patients where use is contraindicated, or educate a target audience about the safe and effective use of a product. Here are some of the more common types of measures used:

Educational tools: Educational tools can be directed either at healthcare professionals or at patients and/or carers. The provide information about one (or more) safety concerns associated with a medicinal product, in order to minimise the risk associated with that safety concern.

Controlled access programme: This type of programme is used for a product with a known benefit that may cause a risk to public health. Conditions such as specialist prescribers or dispensers or a patient registry may be used.

Pregnancy prevention programme: These programmes are used for products that have known or potential teratogenic effects. The programme aims to ensure that female patients are not pregnant when they begin therapy and do not become pregnant during the course of treatment.

Direct Healthcare Professional Communications (DHPC): DHPCs are used to deliver important safety information directly to a healthcare professional. These communications will inform of a safety concern and advise on what action needs to be taken to minimise the concern.

Additional risk minimisation measures will be identified in the risk management plan for a particular product. Information on risk minimisation measures can be found in the Guideline on Good Pharmacovigilance Practices (GVP) Module XVI– Risk minimisation measures: selection of tools and effectiveness indicators.