Impact of adverse event reports from marketing authorization holder-sponsored patient support programs on the performance of signal detection in pharmacovigilance

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.

KEYWORDS:

• Adverse drug reaction reporting systems
• drug safety surveillance
• industry-sponsored programs
• multi-item Gamma Poisson Shrinker
• reference signals

Author contributions

All authors contributed to the study conception and design. Material preparation and data analysis were performed by I Lee. I Lee wrote the first draft of the manuscript and all authors commented on previous versions of the manuscript. All authors read and approved the final version.

Declaration of interest

I Lee was supported by the UIC-AbbVie Fellowship in Pharmacovigilance and Patient Safety. RD Kilpatrick is an employee of AbbVie, Inc. and may own stocks of the company. GS Calip received grants from AbbVie, Inc. and Pfizer, Inc. outside the submitted work; and at the time of publication, reports current employment with Flatiron Health, Inc., which is an independent subsidiary of the Roche group. JD Jokinen was employed by AbbVie, Inc. and owned stocks of the company while the submitted work was conducted; and currently is an employee and shareholder of Bristol-Myers Squibb Company. All other authors have no conflict of interest to disclose. 

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This paper was not funded.