XV.B.6. Effectiveness of safety communication

Safety communication is considered effective when the message transmitted is received and understood by the target audience in the way it was intended, and appropriate action is taken by the target audience. Where possible, mechanisms should be introduced in order to measure the effectiveness of the communication. A research-based approach will normally be appropriate in order to establish that safety communications have met the standard of XV.B.2.. This approach may measure different outcomes, including behaviour, attitudes, and knowledge. When evaluating the effectiveness of safety communication, the scope of the evaluation may be broadened to include factors other than the performance of the individual tools used in the safety communication (see GVP Module XVI).

In the case of DHPCs, marketing authorisation holders should inform the relevant competent authorities about the number of healthcare professionals who received the DHPC and about any difficulty identified during the dissemination of the DHPCs (e.g. problems related to the list of recipients or the timing and mechanism of dissemination). Appropriate action should be taken as needed to correct the situation or prevent similar problems in the future.