XVI.App2.3. Risk awareness dialogue form/aid

A risk awareness dialogue form, or synonymously risk awareness dialogue aid, may be intended to support the prescribing healthcare professional in:

• Ensuring that all necessary information on the risks and the actions for risk minimisation are conveyed and discussed with the patient in the context of shared therapeutic decision-making and, if needed, at repeat prescribing in the case where e.g. the patient risk factors or situation may change over time (a paper version of the form should be handed over to the patient to take home);
• Ensuring that other RMM materials are applied and handed over to the patient if applicable; and/or
• Documenting in the patient’s health record that the patient has been made aware of the risk(s) during the discussion with the prescribing healthcare professional and understands the risk and actions to take for risk minimisation if such documentation is required in local healthcare systems.

Risk awareness dialogue forms/aids should clearly state that the patient does not waive any rights by acknowledging the risks. For clarity, risk awareness dialogue forms/aids do not transfer the physician’s responsibilities when treating a patient to the patient nor do they impact on the patient’s rights in relation to the marketing authorisation holder’s and healthcare professional’s liability. Also, risk awareness dialogue forms/aids are not informed consent forms as possibly required in local healthcare systems for specific medical procedures/treatments.