Advanced Pharmacovigilance Study Material

Introduction to Pharmacovigilance

• Pharmacovigilance (PV) is essential for ensuring drug safety post-market.
• It starts with drug discovery and continues through phases of clinical research and FDA review.
• Key phases include preclinical research, clinical trials (Phase 1, 2, and 3), and post-marketing surveillance.

PV Process

• Drug development involves drug discovery, testing for safety and efficacy, regulatory review, and continuous monitoring after market release.
• The FDA evaluates submitted data, ensuring safety before drugs are approved for public use.

Adverse Drug Reaction (ADR) Assessment

• The Naranjo Scale is a tool used to assess ADR causality, consisting of 10 questions with different scoring.
• Scores range from -4 to +13; classifications include:
  • Definite: Score of 9 or higher
  • Probable: Score between 5 and 8
  • Possible: Score between 1 and 4
  • Doubtful: Score of 0 or less

Key Guidelines in Pharmacovigilance

• ICH E2A established standards for clinical safety data management.
• ICH E2B focuses on the electronic transmission of individual case safety reports.
• EU Good Pharmacovigilance Practices (GVP) provide comprehensive guidance for monitoring drug safety in Europe.
• FDA Title 21 outlines requirements for post-marketing reporting in the U.S.

Clinical Trials Overview

• Clinical trials compare a treatment to a placebo or standard treatment to assess safety and efficacy.
• Investigational drug effects and potential adverse reactions are key focuses during trials.
• Studies can be single-blind (participant unaware) or double-blind (both participant and investigator unaware).

Pharmacovigilance Programme of India (PvPI)

• Launched by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health.
• Coordinated by the Indian Pharmacopoeia Commission with guidelines for regulatory interventions from a Steering Committee.

Handling Fraudulent Reports

• Verify and consult with peers before concluding on report accuracy.
• Address discrepancies professionally to maintain pharmacovigilance integrity and ensure patient safety.

Social and Risk Factors in ADRs

• Factors influencing ADRs include alcohol use, smoking, obesity, diet, age, and organ impairments (hepatic and renal).
• Identification of risk factors is crucial for accurate causality assessments in ADR cases.

Continuous Monitoring

• Ongoing surveillance is vital for maintaining drug efficacy and safety in the broader clinical population.
• Regular updates on product information and communication of risks is essential for healthcare providers and patients.

This quiz covers advanced topics in pharmacovigilance, including its history, guidelines, and key concepts. It is designed for those seeking an in-depth understanding of pharmacovigilance processes and causal assessments. Ideal for students and professionals in the field of medicine and healthcare.