Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

What defines an Unexpected Adverse Drug Reaction?

1. A reaction occurring without any prior evidence

2. A reaction consistently highlighted in product information

3. A reaction that is not consistent with product information

4. A general side effect likely to occur

The correct answer is: A reaction that is not consistent with product information

An Unexpected Adverse Drug Reaction is defined as a reaction that is not consistent with the information provided in the product's approved labeling or product information. This means that the reaction was not anticipated based on the known safety profile and clinical use of the drug. It can indicate new safety concerns and is crucial for patient safety and monitoring drug effects in post-marketing surveillance. In this context, the reason this choice is correct relates to the need for vigilance in pharmacovigilance practices, as healthcare providers must report and assess these unexpected reactions to ensure that any emerging safety issues are promptly identified. The other options describe reactions that either have prior evidence, are acknowledged in product labeling, or are expected general side effects. These do not fit the criteria for "unexpected," which specifically pertains to reactions that arise outside the documented experiences and expectations associated with the drug.