Pharmacovigilance

Pharmacovigilance - Drug Safety Watchdogs

• Science and activities for detecting, assessing, understanding, and preventing Adverse Drug Reactions (ADRs) and other drug-related problems.
• Primary goal: Continuously monitor and ensure drug safety in populations post-marketing.
• Key methods: Spontaneous Reporting Systems, active surveillance (e.g., cohort studies), signal detection.
• Pharmacovigilance Programme of India (PvPI) spearheads national efforts.

⭐ CDSCO, Ghaziabad, acts as the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI).

ADR Basics - Spotting Bad Reactions

• Adverse Drug Reaction (ADR): Any noxious, unintended, and undesired effect of a drug, which occurs at doses used in humans for prophylaxis, diagnosis, or therapy.
• Key characteristics:
  • Causality: Relationship to drug suspected.
  • Severity: Mild, moderate, severe, lethal.
  • Preventability: Some ADRs are preventable.
• Types:
  • Type A (Augmented): Dose-dependent, predictable (e.g., hypoglycemia with insulin).
  • Type B (Bizarre): Non-dose-dependent, unpredictable (e.g., anaphylaxis to penicillin).

⭐ Serious Adverse Event (SAE): Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. This definition is crucial for reporting.

• Signal: Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously. Usually more than a single report is required to generate a signal, depending upon the seriousness of the event and the quality of the information.
• 📌 Mnemonic for common ADR-causing drug classes: Antibiotics, NSAIDs, Thrombolytics, Insulin, Chemotherapy, Opioids, Anticoagulants, Glucocorticoids (ANTI COAGulants).

Reporting Systems - Sounding the Alarm

• Goal: Early ADR detection & signal generation.
• Spontaneous Reporting: Backbone; voluntary (HCPs, patients).
  • India: Pharmacovigilance Programme of India (PvPI).
  • NCC: IPC, Ghaziabad.
  • AMCs: Nationwide network.
  • Form: Suspected ADR Reporting Form (Red Form).
  • Software: VigiFlow (links to WHO VigiBase).
• Signal: New potential drug-ADR causal link.

⭐ PvPI's National Coordination Centre (NCC) is at the Indian Pharmacopoeia Commission (IPC), Ghaziabad.

Causality Check - WhoDunnit Drug Edition

• Systematic evaluation of the relationship between a drug and an Adverse Drug Reaction (ADR).
• Key Tools:
  • Naranjo Algorithm/Scale
  • WHO-UMC Causality Scale
• Assessment Factors:
  • Temporal sequence (drug admin → ADR onset)
  • Dechallenge: ADR ↓ on drug withdrawal?
  • Rechallenge (cautious/rare): ADR reappears on re-exposure?
  • Alternative causes excluded?
  • Biological plausibility/previous reports.
• Causality Categories: Certain, Probable, Possible, Unlikely.

⭐ The Naranjo algorithm uses a scoring system (≥9 = Definite, 5-8 = Probable, 1-4 = Possible, 0 = Doubtful) to assess ADR causality. This is a frequently tested concept for likelihood assessment of ADRs.

Signal & Action - Detecting Danger Signs

• Signal: Reported info on a possible new drug-Adverse Event (AE) causal link, or a new aspect of a known one. Requires careful assessment.
• Detection Methods: Analysis of Spontaneous Reporting Systems (SRS), statistical algorithms (e.g., Proportional Reporting Ratio - PRR, Reporting Odds Ratio - ROR).
• Regulatory Actions: May include label updates, warnings, risk communication (e.g., Dear Doctor letters), or rarely, market withdrawal.

⭐ A signal is not a confirmed Adverse Drug Reaction (ADR), but a hypothesis requiring further investigation and validation before action is taken.

High‑Yield Points - ⚡ Biggest Takeaways

• Pharmacovigilance (PV) is the science of ADR detection, assessment, understanding, and prevention.
• The Pharmacovigilance Programme of India (PvPI), coordinated by IPC Ghaziabad, spearheads national efforts.
• Spontaneous reporting by healthcare professionals is the cornerstone of ADR detection.
• Signal detection involves identifying new or changing ADR patterns from collected data.
• Causality assessment (e.g., WHO-UMC criteria, Naranjo algorithm) links a drug to an ADR.
• CDSCO is the primary regulatory body for pharmacovigilance activities in India.
• ADR reporting forms are crucial tools for data collection in PV practices.