XV.B.2. Principles of safety communication

The following principles of safety communication should be applied:

• Safety communication should deliver relevant, clear, accurate and consistent messages and reach the right audiences at the right time for them to take appropriate action.
• Safety communication should be tailored to the appropriate audiences (e.g. patients and healthcare professionals) by using appropriate language and taking account of the different levels of knowledge and information needs whilst maintaining the accuracy and consistency of the information conveyed.
• The need for communicating safety information should be considered throughout the pharmacovigilance and risk management process, and should be part of the risk assessment and risk minimisation measures.
• There should be adequate coordination and cooperation between the different parties involved in issuing safety communications (e.g. competent authorities, other public bodies and marketing authorisation holders).
• Information on risks should be presented in the context of the benefits of the medicine and include available and relevant information on the seriousness, severity, frequency, risk factors, time to onset, reversibility of potential adverse reactions and expected time to recovery.
• Safety communication should address the uncertainties related to a safety concern. This is of particular relevance for new information which is often communicated while competent authorities are conducting their evaluations; the usefulness of communication at this stage needs to be balanced against the potential for confusion if uncertainties are not properly represented.
• Information on competing risks such as the risk of non-treatment should be included where appropriate.
• The most appropriate quantitative measures should be used when describing and comparing risks, e.g. the use of absolute risks and not just relative risks; when comparing risks, denominators should be the same in size. The use of other tools such as graphical presentation of the risk and/or the risk-benefit balance may also be considered.
• Patients and healthcare professionals should, where possible, be consulted and messages pretested early in the preparation of safety communication, particularly on complex safety concerns.
• Where relevant safety communication should be complemented at a later stage with follow-up communication e.g. on the resolution of a safety concern or updated recommendations.
• The effectiveness of safety communication should be evaluated where appropriate and possible (see XV.B.7.).
• Safety communications should comply with relevant requirements relating to individual data protection and confidentiality