Good Clinical Practice (GCP) Practice Exam

What indicates an Unexpected Adverse Drug Reaction?

1. Consistency with product information

2. A reaction with known side effects

3. A severity inconsistent with product labeling

4. A reaction expected by participants

The correct answer is: A severity inconsistent with product labeling

An Unexpected Adverse Drug Reaction (ADR) is characterized by its severity or nature being inconsistent with what is described in the product labeling or package insert. When a reaction is deemed unexpected, it typically means that the severity, frequency, or type of reaction was not anticipated based on existing knowledge of the drug's safety profile. In this context, when a reaction is described as having a severity that is inconsistent with product labeling, it raises concerns as it may indicate that the drug has effects that were not adequately disclosed and thus not anticipated by healthcare providers or patients. This inconsistency suggests a need for further investigation, as it could indicate potential risks that were not previously recognized during clinical trials. In contrast, reactions consistent with product information or known side effects are expected and therefore do not fall under the category of unexpected. Similarly, reactions that are anticipated by participants or clearly outlined in the product's labeling would not be considered unexpected, as they are already foreseen risks associated with taking the medication.