Good Clinical Practice (GCP) Practice Exam

What does an Adverse Drug Reaction (ADR) entail?

1. Noxious and unintended responses to medicinal products

2. Only allergic reactions to medications

3. Positive responses to therapeutic treatments

4. Interactions with food while taking medications

The correct answer is: Noxious and unintended responses to medicinal products

An Adverse Drug Reaction (ADR) refers to noxious and unintended responses to medicinal products that occur at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. This definition encompasses a wide range of reactions that can occur with medications, including but not limited to side effects, unexpected effects that are harmful, or events that are indirectly related to the medication’s primary indication. Choosing this option captures the essence of what ADRs are, as they highlight the adverse nature of the reactions without narrowing the scope to any particular type of reaction, such as allergic responses or interactions. The other options do not accurately represent ADRs. For example, allergic reactions constitute a subset of ADRs but do not encompass all possible adverse effects, as ADRs can occur without any allergic response. Positive responses to therapeutic treatments do not reflect an adverse reaction at all, and interactions with food, while relevant to medication administration, do not specifically define ADRs either. Thus, the option emphasizing noxious and unintended responses most comprehensively covers the concept of an ADR.