The Follow-Up Dilemma

Manage follow-up information and determine when new reports are needed

Role: Drug Safety Case Processor

Context: Several cases in your queue have received follow-up information. You need to determine how this new information affects each case's reporting requirements.

Task: Assess the impact of follow-up information on reporting obligations.

Step 1 of 3

Case 1: The Escalation

case

Original report (received 10 days ago): 65-year-old male developed mild rash after starting Dermaclear. Non-serious case processed in periodic reporting. Follow-up received today: The patient was hospitalized yesterday. The rash progressed to erythema multiforme with mucosal involvement. Dermaclear was discontinued.

What action is required?