Guidelines for Conducting Pharmacovigilance Scientific Literature Review

1) Purpose

The purpose of this SOP is to outline the procedures for conducting a scientific literature review to identify relevant safety information related to pharmaceutical products and ensure compliance with pharmacovigilance requirements.

2) Scope

This SOP applies to all pharmacovigilance personnel responsible for conducting, reviewing, and reporting scientific literature relevant to drug safety.

3) Responsibilities

The Pharmacovigilance (PV) Team is responsible for conducting the scientific literature review. The PV Manager oversees the process to ensure accuracy, completeness, and compliance with regulatory requirements.

4) Procedure

4.1 Literature Search

1. Identify relevant databases and sources, including PubMed, Embase, Medline, and other scientific journals.
2. Develop search strategies using keywords, drug names, and safety-related terms.
3. Perform regular literature searches (e.g., weekly, monthly) to ensure up-to-date information is captured.

4.2 Literature Screening

1. Review search results to identify relevant articles, abstracts, and case reports.
2. Apply inclusion and exclusion criteria to select pertinent literature.
3. Document the screening process and maintain records of included and excluded studies.

4.3 Data Extraction

1. Extract relevant safety information from selected literature, including adverse event reports, clinical study results, and safety signals.
2. Document extracted data in a standardized format, ensuring consistency and accuracy.
3. Capture bibliographic details for each selected article, including title, authors, publication date, and journal name.

4.4 Data Analysis and Interpretation

1. Analyze extracted data to identify potential safety concerns, trends, and patterns.
2. Assess the significance of identified safety signals in the context of the product’s safety profile.
3. Document findings and interpretations in a literature review report.

4.5 Reporting and Communication

1. Prepare periodic literature review reports summarizing key findings and safety information.
2. Communicate significant safety findings to relevant stakeholders, including regulatory authorities, healthcare providers, and internal teams.
3. Ensure timely and transparent communication of critical safety information.

4.6 Documentation and Archiving

1. Maintain comprehensive records of all literature search activities, including search strategies, screening results, and data extraction forms.
2. Archive literature review reports and supporting documents in accordance with company policies and regulatory requirements.
3. Conduct periodic reviews of the literature review process to identify areas for improvement.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Search strategies, screening logs, data extraction forms, literature review reports.

7) Reference, if any

ICH Guideline for Good Clinical Practice, FDA Guidance for Industry – Good Pharmacovigilance Practices, EU Guidelines on Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products.

8) SOP Version

Version 1.0