Drug and medical device product failures and the stability of the pharmaceutical supply chain

Abstract

Objective: Our objective was to review recent drug and medical device recalls, categorize recall types based on the free text descriptions posted within the recall announcements, and conduct exploratory analyses for researchers interested in pharmaceutical supply chain challenges.

Methods: A cross-sectional study of all current recalls, market withdrawals, and safety alerts published by the United States Food and Drug Administration pertaining to drugs was conducted. A manual review of all the recalls was also conducted to extract additional information including company details, recall type (labeling or quality), and location of failure in the pharmaceutical supply chain (manufacturing or distribution). Descriptive statistics and exploratory bivariate analyses were conducted to test any potential differences between drug and device recalls.

Results: Most recalls issued between January 2017 and September 2019 were pharmaceutical drug recalls (85.2%), while 34 (14.8%) medical device recalls were issued for the same period. For drug recalls, 85.1% (166/195) were because of quality, while 14.9% (29/195) were because of labeling issues. Of the quality issues for drug recalls, lack of sterility was the most frequent issue (139/166, 83.7%). There was no difference between drug or device recalls based on recall type (P = 0.16), top 20 pharmaceutical company (P = 0.62), or location of the supply chain failure (P = 0.20).

Conclusions: This study provides a process to categorize and evaluate drug and device recalls by recall type and location of the supply chain. By categorizing the free text provided in public recall data it would be easier to monitor trends over time.