PHARMACOVIGILANCE
Introduction to Pharmacovigilance:
- Science of monitoring the safety of medicines
- Derived from: Pharmacon (drug) + Vigilare (to keep watch)
- Focuses on detection, assessment, understanding, and prevention of adverse drug reactions
Aims of Pharmacovigilance:
- Improve patient safety
- Enhance public health
- Identify adverse drug effects
- Evaluate risk-benefit ratio
- Promote rational drug use
- Educate healthcare professionals and public
Scope of Pharmacovigilance:
- Herbal Medicines: Monitoring safety of herbal drugs
- Public Health Programs: Tuberculosis, HIV, malaria
- Ecopharmacovigilance: Drug effects on environment
- Blood Banks: Monitoring transfusion safety
- Immunization: Vaccine safety monitoring
- Dermatology: Skin-related adverse reactions
Overview of Pharmacovigilance:
- Systematic evaluation of drug safety
- Improves quality of life
- Balances risks and benefits
History and Development:
- 1848: Chloroform death case
- 1937: Sulfanilamide tragedy
- Aspirin: Identified GI side effects
- 1961: Thalidomide disaster (birth defects)
Pharmacovigilance in India:
- 1986: ADR monitoring started
- 1997: Joined WHO monitoring program
- 2004–2005: National Pharmacovigilance Program launched
- Multiple ADR monitoring centers established
- Coordinated by national regulatory bodies
Important Organizations:
- Central Drugs Standard Control Organization (CDSCO)
- National Pharmacovigilance Advisory Committee
These bodies monitor drug safety and collect adverse drug reaction reports.
Significance of Pharmacovigilance:
- Drug Surveillance: Continuous monitoring after approval
- ADR Monitoring: Detect harmful drug reactions
- ADR Reporting: Prevent future risks
- Post-Marketing Studies: Ensure long-term safety
Dr. Saint Paul is a pharmacy educator, Pharm.D graduate, and academic content creator from Jawaharlal Nehru Technological University Kakinada (JNTUK), where he completed his Doctor of Pharmacy (Pharm.D) degree between 2015 and 2021.
He has more than 7 years of experience creating pharmacy educational content, writing study materials, and reviewing academic articles for pharmacy students. He has also contributed guest articles to pharmacy education platforms, including PharmD Guru.
At D.PharmGuru, his work focuses on simplifying complex Diploma in Pharmacy (D.Pharmacy) subjects into easy-to-understand notes, practical explanations, and exam-oriented educational resources for students across India.
His areas of focus include Human Anatomy and Physiology, Pharmaceutics, Pharmacology, Pharmaceutical Chemistry, Hospital and Clinical Pharmacy, and other core D.Pharmacy subjects.
