Which of the following best describes ADRs (adverse drug reactions) in pharmacovigilance?

• A. Adverse Drug Reactions; must be reported
• B. Adverse Drug Reactions; are optional to report
• C. Adverse Drug Reactions; are never reported
• D. Adverse Drug Reactions; reported only for hospital patients

Answer: (A)

In pharmacovigilance, spotting and collecting reports of suspected adverse drug reactions is essential to protect patient safety. This process relies on clinicians, patients, and manufacturers submitting ADR reports to safety authorities so regulators can detect new risks and take action, such as updating labels or issuing warnings. Because of its role in safeguarding the public, reporting ADRs is expected and often legally required in many jurisdictions, not optional. ADRs can occur in any care setting, not just in hospital, so reports come from a variety of sources. Therefore, ADRs are described as something that must be reported to pharmacovigilance authorities.