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

被引：1

作者：

Vemula, Ganesh Kumar ^{[1
]}

Badale, Pavan ^{[1
]}

Mavrogenis, Petros ^{[2
]}

Lalande-Luesink, Isabelle ^{[2
]}

Borkowski, Michal ^{[2
]}

Lewis, David John ^{[2
]}

机构：

[1] Novartis Pharm AG, Patient Safety & Pharmacovigilance, Dev, Hyderabad, India

[2] Novartis Pharm AG, Patient Safety & Pharmacovigilance, Dev, Basel, Switzerland

来源：

ADVANCES IN THERAPY | 2024年 / 41卷 / 01期

关键词：

Adverse drug reaction; Adverse event; Causality; Council for International Organizations of Medical Sciences; Good Pharmacovigilance Practices; Listedness; Pharmacovigilance; Seriousness;

D O I：

10.1007/s12325-023-02699-4

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页码：82 / 91

页数：10

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