Guidelines for Conducting Pharmacovigilance Literature Review

1) Purpose

The purpose of this SOP is to establish standardized procedures for conducting literature reviews to identify and evaluate safety information on medicinal products.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in the literature review process, including safety specialists, medical writers, and managers.

3) Responsibilities

The Literature Review Team is responsible for performing comprehensive literature reviews and extracting relevant safety information. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Preparation for Literature Review

1. Identify the scope and objectives of the literature review.
2. Define the search criteria, including keywords, databases, and timeframes.
3. Document the search strategy in a literature review plan.

4.2 Conducting the Literature Search

1. Perform literature searches using relevant databases (e.g., PubMed, Embase, Google Scholar).
2. Use predefined keywords and filters to retrieve relevant articles.
3. Save and document the search results, including the search date, databases used, and total number of articles retrieved.

4.3 Screening and Selection of Articles

1. Review the titles and abstracts of the retrieved articles to determine their relevance to pharmacovigilance.
2. Include articles that contain safety information on the medicinal products of interest.
3. Exclude articles that do not meet the relevance criteria, documenting the reasons for exclusion.

4.4 Detailed Review and Data Extraction

1. Perform a detailed review of the full text of the selected relevant articles.
2. Extract relevant safety information, including adverse events, risk factors, and benefit-risk assessments.
3. Summarize the findings and document them in a literature review report.

4.5 Evaluation and Interpretation

1. Evaluate the extracted data to determine its impact on the safety profile of the medicinal product.
2. Interpret the findings in the context of existing safety information and regulatory requirements.
3. Document the evaluation and interpretation in the literature review report.

4.6 Documentation and Record Keeping

1. Maintain detailed records of all literature searches, including search strategies, results, and review notes.
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 literature 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. Communicate literature review procedures and updates to all relevant staff members.
2. Provide training on literature search tools and techniques to ensure consistency and quality.
3. Report any issues or challenges encountered during the literature review process to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Search strategies, search results, review notes, literature review reports.

7) Reference, if any

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

8) SOP Version

Version 1.0