Importance of Adverse Drug Reaction (ADR) Reporting:
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.