Monitoring the quality of pharmaceutical products is one of the key roles of a regulatory agency, including FDA.

The FDA’s Sentinel Initiative – an electronic monitoring system based on real-world data – is one way by which the Administration ensures its approved products, including small-molecule and biological drugs (innovator and generic/biosimilar), vaccines and medical devices, are safe for use.

The initiative was launched in 2008 and is currently the largest multi-site distributed database for medical product safety.

In a recently published research letter [1], a representative of the Center for Drug Evaluation and Safety at the University of Florida outlines the importance of tracking the quality of generic drugs using tools such as the Sentinel Initiative.

The letter explains how FDA uses a site-selection model to prioritize facilities for inspection. This model is based on factors such as site characteristics, inspection history and hazard signals, which may include inspection reports, previous drug recalls, or signals from the FDA Adverse Event Reporting System (FAERS).

In the post-marketing phase, real-world data is invaluable for monitoring drug quality. The letter details studies demonstrating the use of real-world data to monitor generic drug quality, including one study [2] which used the Sentinel Initiative to track switching patterns. This study found that among patients who switched from brand-name drug to generic, 80% remained on the generic version after two years.

Another study [3] tracked clinical events related to metoprolol succinate, a treatment for high blood pressure. The study compared the brand-name drug to two generic versions, which were recalled during the marketing period. This study also found that it was easier to capture data related to specific side-effects, such as low blood pressure, than data on usage.

The author concludes that the use of real-world data, and specifically claims data, are important to enhance the surveillance of generic drug quality. They recommend that FDA (in particular the Offices of Generic Drugs and of Pharmaceutical Quality) makes adequate use of the Sentinel Initiative, and that other organizations with access to patient data use their own resources for similar purposes. Doing so could protect both drug supply and public health in the US, the author says.

Finally, the article recommends that healthcare providers – including physicians and pharmacists – report both their observations and patient concerns on generic drug quality.

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References
1. Brown JD. A Call to action to track generic drug quality using real-world data and the FDA’s Sentinel Initiative. Manag Care Spec Pharm. 2020;26(8):1050.
2. Gagne JJ, Popovic Jr, Nguyen M, et al. Evaluation of switching patterns in FDA’s Sentinel System: a new tool to assess generic drugs. Drug Safety. 2018;41(12):1313-23.
3. Brown JD, Henriksen C, Vozmediano V, et al. Real‐world data approaches for early detection of potential safety and effectiveness signals for generic substitution: a metoprolol extended‐release case study. J Clin Pharmacol. 2019;59(9):1275-84.

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