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A Risk-Based Approach for Safety Case Follow-up of Adverse Event Reports in Pharmacovigilance
Ganesh Kumar Vemula1, Pavan Badale2, Petros Mavrogenis3
1Patient Safety and Pharmacovigilance, Development, Novartis Pharma AG, Hyderabad, India. ganesh_kumar.vemula@novartis.com.
Advances in Therapy
|November 3, 2023
Summary
This study analyzed adverse event (AE) report follow-up by Marketing Authorization Holders (MAH), examining a risk-based approach for Individual Case Safety Reports (ICSRs) before the pandemic. Findings offer insights for optimizing safety data collection and regulatory discussions.
Area of Science:
- Pharmacovigilance and Drug Safety
- Regulatory Science
- Health Data Analysis
Background:
- Marketing Authorization Holders (MAHs) manage adverse event (AE) reporting, including Individual Case Safety Reports (ICSRs).
- Current follow-up strategies for ICSRs are often resource-intensive.
- A risk-based approach to ICSR follow-up is proposed to enhance efficiency and effectiveness.
Purpose of the Study:
- To analyze the characteristics and outcomes of follow-up attempts for AE reports.
- To evaluate the application of a risk-based approach to ICSR follow-up by MAHs.
- To provide data supporting industry and regulatory dialogue on ICSR follow-up procedures.
Main Methods:
- Descriptive statistical analysis of ICSR data from the European Economic Area (EEA) pre-pandemic.
- Examination of follow-up response rates over one year.
- Comparison of case types including Spontaneous Reports (SRs), Patient Support Programs (PSPs), and literature, across various ICSR features (e.g., serious, listed, suspected) and product categories (innovator, biological, generics, combinations).
Main Results:
- Analysis of response rates for different types of ICSRs (SR, PSP, literature) and case classifications (serious/non-serious, listed/unlisted, suspected/not-suspected).
- Comparative insights into follow-up effectiveness across innovator, biological, generic, and combination products.
- Characterization of follow-up attempts within a pre-pandemic European Economic Area (EEA) context.
Conclusions:
- The study provides empirical data on the effectiveness of different ICSR follow-up strategies.
- Findings highlight variations in follow-up success based on report source and case characteristics.
- The results aim to inform the development and adoption of more targeted, risk-based ICSR follow-up processes by MAHs and regulatory bodies.
Keywords:
Adverse drug reactionAdverse eventCausalityCouncil for International Organizations of Medical SciencesGood Pharmacovigilance PracticesListednessPharmacovigilanceSeriousnessMore Related Videos
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