Adverse Drug Reaction (ADR) Reporting
Adverse Drug Reaction (ADR) Reporting helps identify, document, and prevent harmful drug effects in patients.
Importance:
- Detecting New ADRs: Identifying previously unrecognized reactions.
- Monitoring Drug Safety: Tracking known ADRs for frequency and severity.
- Regulatory Actions: Informing updates to drug labels or withdrawal.
Reporting Systems:
- National Pharmacovigilance Programs: Agencies like the FDA’s MedWatch in the USA.
- International Collaboration: WHO’s Programme for International Drug Monitoring.
Who Should Report:
- Healthcare Professionals: Physicians, pharmacists, nurses.
- Patients and Caregivers: Encouraged to report suspected ADRs.
What to Report:
- Serious ADRs: Resulting in death, hospitalization, disability.
- Unexpected ADRs: Not listed in the product information.
- All ADRs for New Drugs: During the initial years after approval.
