A Risk-Based Approach for Safety Case Follow-up of Adverse Event Reports in Pharmacovigilance

• Published in: Advances in therapy Vol. 41; no. 1; pp. 82 - 91
• Main Authors: Vemula, Ganesh Kumar, Badale, Pavan, Mavrogenis, Petros, Lalande-Luesink, Isabelle, Borkowski, Michal, Lewis, David John
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 2024
• Subjects: Adverse Drug Reaction Reporting Systems; Cardiology; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Endocrinology; Follow-Up Studies; Humans; Internal Medicine; Medicine; Medicine & Public Health; Oncology; Patients; Pharmacology/Toxicology; Pharmacovigilance; Review; Rheumatology; Listedness; Good Pharmacovigilance Practices; Adverse event; Adverse drug reaction; Pharmacovigilance; Causality; Seriousness; Council for International Organizations of Medical Sciences
• ISSN: 0741-238X; 1865-8652; 1865-8652
• DOI: 10.1007/s12325-023-02699-4

This study presents an analysis of follow-up attempts for adverse event (AE) reports, shedding light on the characteristics of a risk-based approach to Individual Case Safety Report (ICSR) follow-up by Marketing Authorization Holders (MAH). The analysis primarily focuses on Spontaneous Reports (SR), reports from Patient Support Programs (PSPs), and literature, utilizing data from safety reports sourced from the European Economic Area (EEA) during the pre-pandemic period. Through descriptive statistics, we examine response rates spanning 1 year and compare various types of cases based on distinct ICSR features, including serious vs non-serious, listed vs unlisted, suspected vs not-suspected, SR vs PSP vs literature, as well as comparisons between different product categories (innovator, biological, generics, and combinations). The objective of this report is to stimulate further dialogue within the industry and regulatory authorities regarding the adoption of a risk-based approach to ICSR follow-up procedures.