The reason to develop and distribute Patient Alert Cards is to inform the doctor and other healthcare professionals about the medicinal products taken by the patient, the procedure(s) completed by the patient in association with the use of the medicinal products, and situations that could imply safety risks (e.g. potential interactions, teratogenic nature of the active substance, an increased risk of adverse reaction incidence, etc.).
The content of the communication must include:
- the necessity to carry the Patient Alert Card with oneself at all times and to present it on any visit to a doctor or a therapeutic or diagnostic procedure;
- key information regarding diagnosis and treatment that could affect any urgent as well as non-urgent medical decisions;
- contact details of the patient or their carer, if appropriate;
- contact details of the treating doctor or workplace where the patient is treated.
Where no other materials for patients have been created, the content of the Patient Alert Card shall also include a description of the adverse reaction reporting method (an abbreviated version may be used), an invitation to study the SmPC or PIL, according to the purpose of the card in question, and the symbol of inverted black triangle together with the declaration of additional monitoring, if relevant for the concerned medicinal product.
The size and quality of material of the Patient Alert Card must be adequate to ensure that the Card may be easily carried by the patient (e.g. in a purse) in the long run.