XVI.App2.1. Guides for risk minimisation for patients or healthcare professionals

A guide for risk minimisation may be intended to support the patient or healthcare professional by:

• Enhancing awareness of a specific risk of the medicinal product, risk factors and the actions for risk minimisation, including early recognition and management of adverse reactions during or after treatment;
• Guiding therapeutic decisions in applicable patients and supporting counselling of patients and shared therapeutic decision-making;
• Preparing and administering the medicinal product correctly; and/or
• Discussing the actions for risk minimisation between the healthcare professional and the patient, in particular when handing out the patient guide.

Specifically, guides for patients may:

• Advise the patient to inform the prescriber about a medical condition or concomitant medication before initiating treatment; or to not attempt self-treatment of signs or symptoms of a possible adverse reaction and/or stop treatment without consulting the healthcare professional, but to seek medical attention; and/or
• Provide guidance on the preparation or administration of the medicinal product where these processes are complex, e.g. in the case of a patient/caregiver-administered infusion at home.

For tailoring RMM materials (see XVI.B.4.1.), the purpose of the guide (e.g. “For the safe administration of the product”) may be specified in a sub-heading of the guide, below the name of the RMM tool as the main heading (see XVI.B.4.1.1.).