Which term describes an unpleasant and unintended response to any dose of a drug or biologic product where there is a possibility that the product caused the response?

Which term describes an unpleasant and unintended response to any dose of a drug or biologic product where there is a possibility that the product caused the response?

• A. Adverse event
• B. Adverse reaction
• C. Suspected adverse drug reaction
• D. Medication error

Answer: (C)

In pharmacovigilance, we separate events based on how likely it is that the drug caused them. When someone has an unpleasant and unintended response after taking a drug, and there’s a reasonable possibility that the drug caused it but it's not proven, we call that a suspected adverse drug reaction. The word “suspected” communicates that causality is plausible but not established, so the event should be reported and investigated further. Adverse events are any unfavorable medical occurrences in a person taking a product, whether or not the drug caused them. Adverse reactions (ADR) are harmful effects with a plausible relationship to the drug, implying some level of proven or established causality. Medication error refers to harm that results from mistakes in prescribing, dispensing, or administering the drug, not from a reaction to the drug itself.

In pharmacovigilance, we separate events based on how likely it is that the drug caused them. When someone has an unpleasant and unintended response after taking a drug, and there’s a reasonable possibility that the drug caused it but it's not proven, we call that a suspected adverse drug reaction. The word “suspected” communicates that causality is plausible but not established, so the event should be reported and investigated further.

Adverse events are any unfavorable medical occurrences in a person taking a product, whether or not the drug caused them. Adverse reactions (ADR) are harmful effects with a plausible relationship to the drug, implying some level of proven or established causality. Medication error refers to harm that results from mistakes in prescribing, dispensing, or administering the drug, not from a reaction to the drug itself.