Follow-Up Questions That Change the Assessment

Part of Pharmacovigilance and Drug Safety (PV) Training: Processing the Case.

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

Not all missing data is worth chasing

Follow-up costs the reporter's goodwill, which is finite. Spend it on the questions whose answers could change the assessment, the seriousness, the expectedness or the reportability.

The high-value questions

What happened when the drug was stopped? A positive dechallenge, where the event resolved on stopping, is one of the strongest pieces of causality evidence available.

Was it restarted, and what happened? A positive rechallenge is stronger still. Nobody should rechallenge deliberately to find out, but it happens for clinical reasons and when it does, the information is valuable.

What was the timing? Time from first dose to onset separates plausible from implausible.

What else could explain it? Underlying disease, another drug, an infection, a procedure. Alternative explanations are not a way of dismissing the case. They are part of the assessment and must be recorded whether or not they are convincing.

What was the outcome? Recovered, recovering, not recovered, recovered with sequelae, fatal, unknown. This drives seriousness and is frequently left as unknown when one question would have settled it.

Asking without leading

"Did the rash go away when he stopped taking it?" invites a yes. "What happened after he stopped taking it?" does not.

This matters more than it seems. A leading question that produces a positive dechallenge creates causality evidence that was never really there, and it will be counted.

When to stop

When further questions would not change anything you would write, or when the reporter has declined further contact. Record that you tried, and how many times.