A patient recently started on a newly licensed biologic therapy for rheumatoid arthritis reports only mild injection-site redness. What is the most appropriate action regarding adverse drug reaction reporting under the MHRA Yellow Card Scheme?

• A. Only report severe adverse reactions
• B. Do not report mild adverse reactions
• C. Report all adverse reactions, regardless of severity
• D. Only report after 12 months

Answer: (C)

The main idea here is pharmacovigilance and the purpose of spontaneous adverse drug reaction reporting. The MHRA Yellow Card Scheme is the UK system that collects reports of suspected adverse reactions to medicines, and reporters are encouraged to submit any suspected ADRs, not just the severe ones or those with a clear causal link.

Reporting all adverse reactions, regardless of severity, is important because even mild events provide real-world information that helps regulators assess a drug’s safety profile, especially for a newly licensed biologic where long-term data are still accumulating. A mild injection-site redness after starting a biologic can still contribute to detecting patterns or signals when combined with other reports, which might lead to updates in guidance, patient information, or risk management measures.

Patients and health professionals can both report to the Yellow Card Scheme, and the report should include relevant details (drug name, reaction, onset, outcome, patient factors) to support accurate assessment. This collective data is what underpins ongoing safety monitoring and protects public health.