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Additional Risk Minimisation Measures

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, the prescription status of product) or additional measures. Additional measures are used to improve the 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. These 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 those 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.

GVP Module XVI– Risk minimisation measures: selection of tools and effectiveness indicators

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GVP Module XVI Addendum I – Educational materials

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