This blog covers:
- What defines serious adverse events?
- Key characteristics of serious adverse events.
- Guidelines for upgrading and downgrading the severity of adverse events.
Table of Contents
Introduction
As life experiences both serious and joyful moments, health condition involves as well. Within this context, some adverse events are of such severity that they need attention.
In this blog, we explains what makes up an adverse event serious including the criteria that determine its seriousness.
How do you identify serious cases? Is it possible to downgrade a serious event to non-serious?
“Serious adverse events demand our utmost attention, as their impact goes beyond immediate symptoms; they shape the course of a patient’s health and require careful assessment, intervention, and sometimes, a shift in perspective.”
Seriousness: Definition
According to ICH-E2A, a serious adverse event or reaction is any undesirable medical occurrence that, at any dose:
- Results in death;
- Is life-threatening;
- Requires hospitalization or extends an existing hospitalization;
- Leads to abortion, premature delivery, or congenital anomalies/birth defects;
- Results in persistent or significant disability or incapacity; or
- Is considered a medically significant or important event or reaction.
The seriousness of a report should always be assessed based on the characteristics and consequences at the time of the report.
Medical judgment is always essential when decision making, where other situations should be classified as serious or not.
What Defines a Serious Event? Criteria Explained
Here’s a concise and brief overview of each scenario:
Death
Report: If the death is suspected to be a result (outcome) of the adverse event, and include the date if known.
Life-threatening
Report: If the patient was at significant risk of death at the time of the adverse event, or if continued use of the product could have led to death. “Life-threatening” refers to an immediate risk of death, not a hypothetical outcome.
Hospitalization (Initial or Prolonged)
Report: If the adverse event led to hospitalization or extended an existing hospital stay. A hospitalization of at least 24 hours due to the event should be clearly indicated. Emergency room visits without admission should be evaluated for other serious outcomes.
Disability or Permanent Damage
Report: If the adverse event caused substantial disruption in normal life functions, leading to a significant, lasting change, impairment, or damage to the patient’s physical abilities or quality of life.
Congenital Anomaly/Birth Defect
Report: If exposure to a medical product before conception or during pregnancy may have caused adverse outcomes in the child.
Required Intervention to Prevent Permanent Impairment or Damage (Devices)
Report: If medical or surgical intervention was necessary to prevent permanent impairment or damage to a body function or structure, suspected to be due to the use of a medical product.
Other Serious (Important Medical Events)
Report: If the event doesn’t fit the above categories but is serious enough to potentially jeopardize the patient, requiring medical or surgical intervention. Examples include allergic reactions requiring emergency treatment, serious blood disorders, or seizures not leading to hospitalization.
Upgrading and Downgrading: Explained
Can a serious adverse event be downgraded to non-serious?
Yes, but only in rare instances.
The decision is based on the specifics of the report. It’s common to have doubts when a previously serious event is later reported as non-serious.
This can happen, especially in cases where lab investigation results are updated.
Even if the condition appears normal later, the serious criteria may still apply initially. However, if the report clearly states that the event should be considered non-serious or acknowledges that the earlier classification was a mistake, downgrading is possible.
Regardless of the situation, medical expertise is always required when reviewing serious cases and making decisions. Whether downgrading or upgrading, all changes should be documented and submitted accordingly.
Key Takeaways
- The term “severe” refers to the intensity or severity of a specific event.
- Medical intervention is always necessary to reach a final conclusion about events.
- Serious events should only be downgraded if the report specifically mentions such a change.
- The seriousness of a report must be evaluated based on the characteristics and consequences at the time of the report.
How can we assist you in case management?
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Conclusion
In conclusion, this blog has provided a clear explanation to help you better understand how to handle serious adverse events. Managing serious cases is critical and requires more immediate attention than other events. It is essential to never overlook the seriousness of a case.
Do you think we’ve missed any important points? Feel free to comment below and bring it to our attention.
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References:
- ‘Guidelines on Good Pharmacovigilance Practices: Module VI – Management and reporting of adverse reactions to medicinal products’ (no date).
- Serious Adverse Events: Discussion from FDA.
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