ABSTRACT
In order to improve patient safety in cases of drug recall, we studied drug recall data disclosed by the Food and Drug Administration (FDA). Since the FDA does not disclose data in the form of a database, we focused on enforcement reports published by the FDA, which are less structured and contain less information. This suggests that it is difficult to identify necessary information from the reports. For this reason, we constructed a database storing drug recall data in the appropriate format. The data sources are enforcement reports and press releases, the latter of which are published by pharmaceutical companies. In this paper, we discuss the problems faced during construction of the database.
