Guidelines for Pharmacovigilance Medical Review

1) Purpose

The purpose of this SOP is to establish standardized procedures for conducting medical review of adverse event reports and other safety data in pharmacovigilance.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the medical review process, including medical reviewers, safety physicians, and pharmacovigilance managers.

3) Responsibilities

The Medical Review Team is responsible for evaluating the medical aspects of adverse event reports, assessing causality, and providing medical insights into safety issues. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Receipt and Initial Assessment of Adverse Event Reports

1. Receive adverse event reports from healthcare professionals, consumers, and clinical trials.
2. Conduct an initial assessment to ensure completeness and clarity of the reported information.
3. Verify the presence of all required data elements, including patient demographics, medical history, and event description.

4.2 Medical Review and Causality Assessment

1. Assign cases to qualified medical reviewers for detailed medical assessment.
2. Review the medical history, concomitant medications, and clinical course of the adverse event.
3. Assess the causal relationship between the adverse event and the medicinal product using standardized causality assessment tools (e.g., WHO-UMC criteria).

4.3 Documentation of Medical Review Findings

1. Document the medical review findings, including the assessment of causality and any medical opinions or recommendations.
2. Record all relevant information in the adverse event case report.
3. Ensure consistency and accuracy in documenting medical review outcomes.

4.4 Collaboration and Consultation

1. Collaborate with other members of the pharmacovigilance team, including safety scientists and regulatory affairs, for comprehensive review and decision-making.
2. Consult with medical experts or advisory committees as needed to address complex medical issues or uncertainties.
3. Document all consultations and their outcomes in the adverse event case file.

4.5 Risk Management Recommendations

1. Based on the medical review findings, provide recommendations for risk minimization measures, product labeling updates, or additional safety studies.
2. Communicate risk management recommendations to the PV Manager and relevant stakeholders.
3. Implement approved risk management measures and monitor their effectiveness.

4.6 Documentation and Record Keeping

1. Maintain detailed records of all medical reviews and causality assessments.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.

4.7 Quality Control

1. Conduct regular quality control checks on the medical review process to ensure accuracy and consistency.
2. Address any discrepancies or errors identified during quality control checks promptly.
3. Document all quality control activities and any corrective actions taken.

4.8 Training and Communication

1. Provide training to medical reviewers on adverse event assessment and causality determination.
2. Communicate updates to medical review procedures and guidelines to ensure consistency in practices.
3. Report any issues or challenges encountered during the medical review process to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Adverse event case reports, medical review findings, causality assessment reports.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module VIII.

8) SOP Version

Version 1.0