Signal prioritisation is the process, continuously performed throughout signal management, which aims to identify those signals suggesting risks with a potential important patients’ or public health impact or which may significantly affect the risk-benefit balance of the medicinal product and thus require urgent attention and management without delay.
Below aspects to be consider while prioritizing:
- Impact on patients depending on the severity, reversibility, potential for prevention and clinical outcome of the association
- the patient exposure and the estimated frequency of the adverse reaction
- the patient exposure in vulnerable populations and/or in populations with different patterns of use, where appropriate
- Consequences on treatment discontinuation on the disease and the availability of other therapeutic options
- Strength and consistency of the evidence supporting the association as, for example, biological plausibility, a high number of cases reported in a short period of time, identification of the signal in different settings, data sources or countries
- Clinical context, that is, whether the association suggests a clinical syndrome that may include other reactions
- Public health impact, including the extent of utilization of the product in the general population and in special populations and the patterns of the medicinal product utilization
- If a marketing authorization application for a new medicinal product is still under evaluation
- The expected extent of the regulatory intervention (e.g. addition of adverse reactions, warnings, contraindications, additional risk minimisation measures, suspension, revocation)
The timeframe for further management of the signal will depend on the prioritisation. Appropriate measures should be considered at any stage if the information available suggests that there could be a risk that requires prevention or minimisation in a timely manner. Such measures may be required before a formal assessment of the signal is concluded. Clinical judgement and flexibility should be applied throughout the process.
The prioritised signal will be assessed to further evaluate the significance and potential risk of a validated signal so as to identify the need for additional data collection, risk mitigation or minimization activities in a timely manner, or for any regulatory action.
