Medically Important Events

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

About 1 minutes. Free, in your language, no account needed.

The sixth criterion exists for a reason

The first five seriousness criteria are largely mechanical. Death, hospitalization and congenital anomaly are facts you can establish from a report.

The sixth is judgment: an event that did not cause any of the first five but which jeopardized the patient, or required intervention to prevent one of them.

Why it is not a loophole

Without it, an event that was caught in time would be classified as non-serious precisely because the intervention worked. Anaphylaxis treated promptly at a clinic, where the patient went home the same day, meets no other criterion. It is plainly serious.

Similarly: a seizure, agranulocytosis found on a routine blood test, a drug dependence, an intensive treatment for bronchospasm, the development of a malignancy.

How to apply it

Ask whether, without the intervention that happened, one of the other five outcomes was a realistic prospect. If the answer is yes, it is medically important.

Many organizations maintain a list of terms always treated as medically important. Use it. It exists so that this judgment is consistent between case processors rather than varying with who picked up the case.

Escalate rather than guess

This criterion is where medical judgment properly belongs. If you are not medically qualified and the case is genuinely borderline, the escalation to a physician reviewer is the correct action, not a failure to decide.

What is not acceptable is classifying a borderline case as non-serious because the escalation would be inconvenient, or because the deadline for a serious case is short.