This blog features:
- Understanding death as an adverse event
- Case scenarios involving death and fatal outcomes
- How death is represented and reported in pharmacovigilance cases
Table of Contents
Introduction
This comprehensive article explores how to handle fatal cases, which are classified under the serious criteria in pharmacovigilance. It also highlights special scenarios related to managing death cases during ICSR case processing.
Consider this your go-to guide to ensure you never overlook important pharmacovigilance conventions when handling such critical reports.
Death as an Adverse Event
As a pharmacovigilance case processor, you may encounter serious adverse events (SAEs) involving death from time to time.
Like other serious criteria, death as an adverse event has specific requirements and regulatory expectations that must be carefully followed during ICSR case processing.
Among the serious criteria—such as hospitalization, life-threatening conditions, and congenital anomalies—death is particularly significant due to its fatal outcome and the implications it carries in safety reporting.
According to ICH E2A guidelines, any untoward medical occurrence that results in death qualifies as a serious adverse event. Death is explicitly listed as one of the key seriousness criteria that require immediate attention and accurate documentation.
“In pharmacovigilance, every death reported is more than a number—it’s a call for clarity, compassion, and compliance. Understanding how to handle fatal outcomes is not just a regulatory duty, but a professional responsibility.”
Conventions to Follow When Death is Reported
- Death must be recorded as an adverse event, even if the patient has already passed away. It should still be assessed and reported with appropriate seriousness.
- In the event of a patient’s death, details such as the date and cause of death (including autopsy findings, if available) must be documented.
- If the death is unrelated to the suspected adverse reaction (e.g., due to disease progression), it should not be classified under the seriousness criterion “fatal.” Instead, the outcome of the event should be marked as death, not the seriousness criterion.
- When determining seriousness, assess the patient’s condition at the time of the reaction. For instance, “life-threatening” refers to an event where the patient was at risk of death at the time—not one that might hypothetically have caused death.
- If a marketing authorization holder becomes aware of a hospitalization or death without further clinical details, medical judgment should be applied to determine if the event qualifies as a suspected adverse reaction. For example, a report of sudden unexplained death generally warrants submission as a valid ICSR.
- Fetal deaths and spontaneous abortions are considered special scenarios and must be handled as serious adverse events.
- The term “fatal” should be used only when the death is possibly related to the adverse event/reaction. If the death is clearly unrelated (as per both reporter and sender), “fatal” should not be selected, although the death must still be documented.
- For any fatal outcome, the cause of death, its possible relationship to the suspected reaction, and any available post-mortem findings (e.g., autopsy or coroner’s report) should be included. Additionally, relevant context such as medical history, allergies, substance use, family history, and results from special investigations should be reported to support case assessment.
Handling Death Reports
- Date of death
- Reported cause(s) of death (list all applicable)
- Was an autopsy performed? (Yes/No/Unknown)
- Autopsy-confirmed cause(s) of death (if available)
- All fatal outcomes must be collected as adverse events. However, in specific study contexts—such as high-mortality diseases or when deaths are unrelated to study objectives—these may not require expedited ICSR reporting. The rationale should be clearly outlined in the study protocol.
Key Takeaways
Medical judgment and thorough analysis are essential when assessing death-related events.
Carefully evaluate whether death is the outcome of an existing condition or a direct adverse event.
Death cases must be followed diligently until the cause and relationship to the event are clearly established.
Certain death reports, such as fetal deaths, should be handled as special interest cases with appropriate attention.
Are you confident in handling death-related safety reports?
It is often possible, even the most experienced case processors can miss subtle yet critical details when dealing with fatal outcomes.
Are your team also facing the same handling ICSR cases?
No worries! We are here the expert of personnel to take care of your case processing workflow.
Conclusion
This comprehensive write-up has guided you on how to handle ICSRs involving death, including key conventions and special scenarios that require expedited processing.
Each case in ICSR management presents unique challenges, and when it comes to serious reports like death, they must be handled with particular care and significance, as they often require regulatory scrutiny and timely submission.
We aim to cover all essential aspects of such critical scenarios to support accurate and compliant case processing.
Did we miss anything in this discussion?
We’d love to hear your feedback!
If you found this content useful and informative, please share it with your colleagues and friends who may benefit from it.
Leave a Reply