Disproportionality and Clinical Review

Interpret PRR and decide next step (validate vs dismiss).

Role: Signal Detection Lead

Context: Quarterly run: drug X vs 'hepatic failure' — PRR 4.2, 8 cases. Hepatic failure is not in the label.

Task: Recommend next step.

Step 1 of 2

Interpretation

case

PRR 4.2, 8 cases, unlisted.

What do you do?