Pharmacovigilance Overview Quiz

Pharmacovigilance Overview

• Pharmacovigilance covers various products including medicines, herbal supplements, biologics, blood products, vaccines, medical devices, cosmetics, veterinary products, and tobacco-related issues.

Current Practices in Pharmacovigilance

• Reporting Mechanism: Success relies heavily on reporting suspected adverse reactions (ADRs).
• Spontaneous Reporting: Involves voluntary submission of ADR reports by healthcare professionals and pharmaceutical companies to national centers.
• Active Surveillance Systems: Examples include Prescription Event Monitoring (PEM) in New Zealand and the UK, record linkage, and case-control studies.
• National Pharmacovigilance Centers: Tasked with promoting ADR reporting, collecting and evaluating case reports, analyzing trends, and informing stakeholders of new risks.
• WHO Program: Acts as a communication hub for international drug safety information and training.

Regulatory Aspects and Guidelines

• Company Core Data Sheet (CCDS): Prepared by Marketing Authorization Holders (MAHs) detailing safety information and other product-related data.
• Efficacy vs. Effectiveness: Efficacy pertains to drug performance in clinical trials; effectiveness refers to real-world performance.
• Off-label Use: Refers to the use of medicines for purposes not approved in their authorized product information.

Signal Management

• Triage System: Categorizes potential ADR reports into non-serious, serious, or invalid cases.
• Signal Types:
  • Confirmed signals indicate a causal link between a drug and an adverse event.
  • Refuted signals show no relationship after investigation.
  • Unconfirmed signals require further investigation.

Marketing Authorization Holder (MAH)

• Defined as any entity with marketing authorization from the European Medicines Agency (EMA) to sell medicinal products in EU member states.

ICH Guidelines

• Safety Guidelines (S): Focus on identifying potential risks (e.g., carcinogenicity).
• Efficacy Guidelines (E): Concern clinical trial conduct and reporting.
• Multidisciplinary Guidelines (M): Address cross-cutting topics like medical terminology and technical documents.

CIOMS and International Collaboration

• Established by WHO and UNESCO in 1949 to improve pharmacovigilance and standardize ADR reporting internationally.
• CIOMS launched its first Working Group on pharmacovigilance in 1986.

Good Pharmacovigilance Practices (GVP)

• GVP includes multiple modules addressing various aspects of pharmacovigilance such as systems quality, risk management, signal management, and safety communications.

Individual Case Safety Report (ICSR)

• A standardized document for reporting one or several suspected ADRs occurring in a single patient at a specific time.

WHO-UMC Causality Categories

• Categories: Certain, Probable/Likely, Possible, Unlikely, Conditional/Unclassified, Unassessable/Unclassifiable.
• Assessment Criteria:
  • Temporal relationship between drug administration and adverse event onset.
  • Abnormal lab test results that cannot be disregarded as related to the drug.
  • Outcomes of dechallenge and rechallenge tests.

Factors Affecting Adverse Event Attribution

• Medical Conditions: Pre-existing health issues may contribute to adverse events.
• Concomitant Medications: Other drugs being taken can also play a role in adverse reactions.