Event Reporting Procedures (Medication errors, Adverse effects, MedWatch, Near miss, Root-cause analysis)

Event Reporting Procedures in Healthcare

Pharmacists and healthcare providers must report medication errors, adverse drug reactions (ADRs), product defects, and near misses to improve patient safety.

Who Can Report Medication Errors, Adverse Events & Product Issues?

Anyone can report safety concerns, including:

1. Healthcare Professionals
  • Pharmacists (dispensing errors, adverse drug reactions)
  • Doctors/Nurses (prescribing/administration errors, side effects)
  • Dentists/Veterinarians (drug reactions in humans/animals)
2. Patients & Caregivers
  • Patients experiencing side effects or medication errors
  • Family members reporting suspected harm
3. Manufacturers & Distributors
  • Drug/device makers reporting product defects or recalls
4. Public Health Agencies
  • Hospitals, clinics, and pharmacies reporting sentinel events (e.g., fatal errors)

What Types of Products get Reported in Healthcare

1. Pharmaceuticals (Drugs & Biologics)

2. Vaccines

3. Medical Devices

4. Dietary Supplements & Herbal Products

5. Blood & Blood Products

6. Compounded Medications

7. Over-the-Counter (OTC) Products

8. Controlled Substances

9. Parenteral (IV) & Sterile Products