Impact of adverse event reports from marketing authorization holder-sponsored patient support programs on the performance of signal detection in pharmacovigilance. Issue 10 (2nd October 2020)

• Record Type: Journal Article
• Authors: Lee, Inyoung; Lee, Todd A.; Crawford, Stephanie Y.; Kilpatrick, Ryan D.; Calip, Gregory S.; Jokinen, Jeremy D.
• Is Part Of: Expert opinion on drug safety. Volume 19:Issue 10(2020)
• Page Start: 1357
• Page End: 1366
• Publication Date: 2020-10-02
• Subjects: Adverse drug reaction reporting systems -- drug safety surveillance -- industry-sponsored programs -- multi-item Gamma Poisson Shrinker -- reference signals; Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1080/14740338.2020.1792883
• Languages: English
• ISSNs: 1474-0338

Abstract

ABSTRACT: Objectives: Marketing authorization holder (MAH)-sponsored patient support programs (PSPs) are a major source of adverse event (AE) reports. The impact of reports from PSPs on the ability to detect AE signals is unclear. We compared signal detection performance using data from PSPs vs. non-PSP sources, and between PSPs providing clinical services vs. PSPs not providing clinical services. Methods: Data were obtained from an internal safety database for a global pharmaceutical company 2015–2017. We assessed whether signals were detected for the reference drug-AE pairs using data from PSPs vs. non-PSP sources, and among different PSP services. The performance was evaluated by four measures including area under the receiver operating characteristic curve (AUC) and time-to-signal detection. Results: While the majority of reports were from PSPs, non-PSP sources were better and faster at detecting signals (AUC 0.63 vs. 0.41, p = 0.035; HR 3.52, p = 0.014) compared to PSPs. Within PSPs, PSPs providing clinical services were marginally better at detecting signals (AUC 0.60 vs. 0.41, p = 0.053) but not faster compared to PSPs not providing clinical services. Conclusion: Reports of AEs from PSPs had worse signal detection performance compared to non-PSP sources. Pharmacovigilance experts should be mindful when using databases that contain reports from PSPs for signal detection.