The Four Things That Make It a Case

Part of Pharmacovigilance and Drug Safety (PV) Training: What the Safety Desk Is For.

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

Valid case criteria

A report becomes a valid case, and therefore something with a clock and an obligation attached, when four elements are present:

An identifiable patient. Not a name. Something that distinguishes one person from another: age, sex, initials, a patient number. "Several of my patients" is not identifiable.

An identifiable reporter. Someone who can be contacted for follow-up, or at least identified as a real source. Anonymous internet comment is not a reporter.

A suspect product. Your product, named or reasonably identifiable.

An event or outcome. Something happened. A patient who reports taking the wrong dose with no consequence is an important report, but it is not the same as an adverse event.

Why this matters more than it sounds

The four criteria decide whether a clock starts. Get this wrong in the permissive direction and you flood the system with reports that cannot be assessed. Get it wrong in the restrictive direction and you fail to report something you were obliged to report.

The common error is the second one, and it usually looks like a reasonable judgment at the time: the reporter did not give an age, so it was set aside pending follow-up, and the follow-up never came.

When one element is missing

Seek it. Do not discard the report. An incomplete report is held, followed up and recorded as incomplete. It is not deleted, and it is not treated as if it never arrived.

If the missing element is never obtained, the report remains on file. Several incomplete reports of the same unusual event are themselves worth noticing, which is a point the signal chapter returns to.

A note on consumer reports

A consumer report is a valid case. It does not require medical confirmation to exist, though whether it is medically confirmed affects how it is handled in some jurisdictions. Do not downgrade a report because the reporter is not a clinician.