The Situation
- The index case was reviewed during ICSR management of known risk of adrenal crisis; however, during medical review it was promoted as unexpected as the severity and seriousness was of higher degree.
- A potential signal was flagged to the client.
The Solution
- An ad hoc signal committee meeting was conducted where the validation, analysis and recommendation of action was confirmed for the signal of “adrenal crisis.”
- The signal was submitted to applicable health authorities with a plan of recommendation of action within timelines.
- Recommendation of action as to change USPI language and distribute training material to HCP to monitor the event closely and identify the development of adrenal crisis earlier and treat and prevent further complications.
The Results
- Better risk management.
- Compliance with regulations for monitoring and implementing risk minimization measures.
- Efficient product safety management by reducing risk of such events.
- Patient safety is at the core of all activities.