Risk minimisation measures (RMM) are intended to ensure the safe and effective use of a medicinal product. Routine risk minimisation measures apply to all medicinal products and include Summary of product characteristics, Package leaflet, Labelling of inner and outer packaging, and legal status.
However, for certain medicinal products, in addition to routine RMM, additional risk minimisation measures (aRMM) are required and are described in the Risk management plan (RMP). aRMM constitute a condition for the marketing authorisation of the medicinal product and are required when further support is needed to ensure the safe and appropriate use of the medicinal product in clinical practice. In particular, they are intended to reduce specific safety risks that cannot be sufficiently controlled through routine measures alone.

The objectives of aRMM are to:

• increase awareness of risks;
• facilitate the early recognition of adverse events;
• promote appropriate prescribing, monitoring and use of the medicinal product;
• reduce the probability or severity of important adverse reactions.

aRMM include Educational/Safety advice tools and Risk minimisation control tools. Depending on specific needs, aRMM may include, among others, the following measures:

• Patient card;
• Guides for risk minimisation for patients or healthcare professionals;
• Healthcare professional checklist for risk minimisation;
• Patient diary for risk minimisation;
• •Pregnancy prevention programme.

The effectiveness of aRMM is subject to monitoring and evaluation.

Patient Card (PAC)
 

The Patient card (previously referred to as Alert Card) is an additional risk minimisation measure (aRMM) intended to support the safe and correct use of a medicinal product that requires specific precautions for use. It generally consists of a paper card provided by the healthcare professional to the patient (or their guardian/caregiver) at the time of prescribing or dispensing the medicinal product or, in some cases, forms an integral part of the medicinal product package.

Typically, the Patient Card contains essential information on:

• the need for the patient to carry the Patient card at all times;
• the medicinal product administered;
• important risks associated with the treatment;
• symptoms requiring prompt recognition;
• actions or behaviours to adopt or avoid;
• the need for laboratory and/or clinical monitoring;
• the need to show the Patient Card to all healthcare professionals involved in routine care or emergency treatment;
• contact details of the prescribing physician or clinical centre.

The information contained in the Patient card is of particular importance and should be carefully considered before, during and after treatment with a given medicinal product.

To ensure the correct implementation of the Patient card, the healthcare professional, when communicating with the patient (or guardian), shall provide the information necessary for completing the card, explain the purpose of the measure and recommend its proper use. The patient should carry the Patient card at all times and present it to all healthcare professionals involved in their routine care or emergency treatment.

The list published in this section contains the medicinal products for which a Patient card is required. The most up-to-date version may be viewed and, where appropriate, downloaded and printed. For Patient cards included in the package of medicinal products authorised through the centralised procedure, reference should be made to the EMA website (https://www.ema.europa.eu/en/medicines).

List of medicinal products for which a Patient card is required as an aRMM