XVI.App2.5. Patient diary for risk minimisation

A patient diary for risk minimisation may be intended to support the patient in:

• Recording specific information in situations where it is considered important that, when using the medicinal product, such information is regularly exchanged between the patient and the healthcare professional for the purpose of risk minimisation, e.g. dates and results of tests at (other) healthcare facilities or at home needed to identify emerging risk factors, or signs and symptoms indicative of a possible adverse reaction;
• Administering the medicinal product at the prescribed dose and time intervals through recording the dose and dates of administration in situations where it is considered that specific potential for medication errors exist; and/or
• Seeking immediate medical attention should the recorded information indicate that a risk factor, adverse reaction or medication error may have emerged.

Where an adverse reaction on the basis of the patient’s entries in the diary is suspected, the healthcare professional or patient should report this by using the applicable spontaneous reporting system