XVI.App2.2. Healthcare professional checklist for risk minimisation

A healthcare professional checklist for risk minimisation may be intended to support the healthcare professional in:

• Checking and recording before first or repeat prescribing or dispensing (which may include patient counselling by a pharmacist for a medicinal product not subject to medical prescription) whether the medicinal product is (still) appropriate for a given patient by checking whether e.g. contraindications, interacting concomitant medication or risk factors for adverse reactions are present in the patient (which may require conducting a medical test), whether the patient has received the necessary vaccination(s) before start of treatment with the medicinal product, and/or whether signs or symptoms of adverse reactions have emerged during treatment;
• Avoiding medication errors by e.g. selecting the pharmaceutical form, strength and dosing of the medicinal product which are appropriate for the patient and the indication; and/or
• Advising the patient about the risk and the intended actions for risk minimisation and, if applicable,handing out to the patient educational materials.

In contrast to guides for risk minimisation (see XVI.App2.1.), a checklist is presented as a series of questions which can generally be answered in a ‘yes’/’no’/’not applicable’-manner or with a very short answer.

For tailoring RMM materials (see XVI.B.4.1.), the purpose of the checklist (e.g. “For correct dosing of the product”) may be specified in a sub-heading of the checklist, below the name of the RMM tool as the main heading (see XVI.B.4.1.1.). The tailoring may also include presenting the checklist in a poster format for use in healthcare facilities.