Signal detection and validation by Marketing Authorization Holders is an integral pharmacovigilance activity and should be carried out intermittently because ‘Signal’ may pop up out of the blue necessitating appropriate evaluation or justification, as the case may be.
Things You Should know to Manage a ‘Safety Signal’
Does the Safety Signal warrant further investigation or should be refuted ? Who is going to decide and document?
Have an SOP that is clear and indicative of ‘Signal’ activities.
Frequency of occurrence of adverse event: Is it more than the threshold value? If yes, do you have the safety plan of action ready? Even a single case can trigger a potential signal which needs evaluation.
Additional monitoring: Does the drug come under Additional monitoring list of the European Medicines Agency? Or has posed serious risks in the past!
If so, keeping vigilance and deciding timelines for monitoring would be important for periodic safety profile monitoring
Periodic Safety data from database: Have you listed out the time for periodic database run that might pull out a statistical signal?
It could be in the form of line listings and summary reports.
Safety Crisis: Do you have a system in place for Safety crisis management?
For example, temporary suspension of product from market owing to Regulatory recommendation (eg: Vaccine recall due to manufacturing defect!).
You may have a well-documented plan but without mock drills (wherever feasible), practical aspect is still very dubious!
CMEs for the Safety Signal team esp. the medical experts for analyzing Safety Signal warning criteria!
The latter includes the causality association, positive dechallenge/rechallenge, higher frequency, biological plausibility, novel information not known or documented previously etc. along with other signal validation factors as per applicable guidelines.
Dealing with each Signal experience is unique in itself and there has to be a common platform or forum to share ultimate outcomes (respecting confidentiality and privacy of case(s)) that would help in designing future Signal management strategies
Signal Indicators: Do you have indicators such as number of false signals per specific time period or number of potential safety issues discussed and reviewed by the medical experts in a specific duration.
This is important in a voluminous database where there are all chances that a safety signal may be unknowingly ignored due to less effectivity of method employed for signal detection.
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