Serious Is Not Severe

Part of Pharmacovigilance and Drug Safety (PV) Training: Seriousness.

About 2 minutes. Free, in your language, no account needed.

Two words that are not synonyms

Severe describes intensity. A severe headache is a bad headache.

Serious is a regulatory category with a fixed definition. It has nothing to do with how unpleasant the event was.

A severe headache that resolves with paracetamol is not serious. A mild rash that required an overnight hospital admission is serious. Confusing these two is the most common error in this part of the work, and it goes in both directions.

The criteria

An event is serious if it:

• Results in death
• Is life-threatening, meaning the patient was at risk of death at the time of the event
• Requires inpatient hospitalization or prolongs an existing hospitalization
• Results in persistent or significant disability or incapacity
• Is a congenital anomaly or birth defect
• Is another medically important event that may jeopardize the patient or require intervention to prevent one of the outcomes above

Life-threatening means at the time

Life-threatening does not mean the event could hypothetically have been fatal if it had been worse. It means the patient was, in the reporter's view, at risk of dying at the time it happened. Almost any event could be fatal if severe enough. That is not the test.

Hospitalization is about admission, not the building

An emergency department visit that does not result in admission is not, by itself, hospitalization. An admission for a planned procedure that was scheduled before the event is not a hospitalization caused by the event. A social admission because the patient could not be cared for at home may or may not be, and this is the kind of question to escalate rather than decide alone.