Adverse Drug Reaction Reporting in the United States

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Chapter: Pharmacovigilance: Spontaneous Reporting - United States

The FDA continues to assess the benefit–risk profile of approved drugs throughout the life of the drug, primarily on the basis of ADR case reports (GAO/ HEHS, 2000).


The FDA continues to assess the benefit–risk profile of approved drugs throughout the life of the drug, primarily on the basis of ADR case reports (GAO/ HEHS, 2000). In the United States, ADR case reports are voluntarily sent to the FDA or the drug’s manu-facturer by healthcare professionals and consumers (Ahmad, Goetsch and Marks, 2005). Drug manufac-turers are legally required to submit all ADR reports they receive to the FDA. Under current US regula-tions (21 CFR 314.80), reports of ‘serious’ ADRs not presently listed in the drug product’s labeling must be submitted to the FDA within 15 calendar days of the company’s receipt of them. For regulatory purposes, a ‘serious’ report is defined as one describing an ADR that is life threatening or that leads to death, hospi-talization (initial or prolonged), disability, congenital anomaly or required intervention to prevent perma-nent impairment/damage. Reports meeting the regula-tory definition of ‘serious’ but describing events already listed in product labeling as well as all reports with non-serious outcomes are submitted to the FDA on a periodic basis that varies depending on the market age of the product.

The FDA has maintained a computerized reposi-tory of these voluntarily reported ADRs since 1969 (Ahmad, Goetsch and Marks, 2005; Wysowski and Swartz, 2005). This repository and the system to manage it have grown and changed since then. In 2004, the FDA received approximately 425 000 reports, and the total number of reports in the database now exceeds 3 million, covering all marketed prescription drug and therapeutic biological products in the United States. For most over-the-counter (non-prescription) products, manufacturers are not required to submit ADR case reports to the FDA.

The ADR database has evolved over the years as computer and information technologies have improved. The most recent modification occurred in 1997 when the FDA redesigned the database, now referred to as the Adverse Event Reporting System (AERS), and shifted from using Coding Symbols for Thesaurus of Adverse Reaction Terms (COST-ART) to Medical Dictionary for Regulatory Activi-ties (MedDRA) coding terminology (Brown, Wood and Wood, 1999). These changes were implemented for several reasons. Agreements reached through the International Conference on Harmonization (ICH) necessitated a restructuring of the database to meet international standards for electronic submission of ADR reports. This ‘ICH compatibility’ should facil-itate information exchange with industry and with other national pharmacovigilance centers (Green, 1998). Furthermore, electronic submission of ADR reports has greatly enhanced the efficiency and accu-racy of the data entry process. In 2004, manufac-turers submitted over 80 000 reports electronically to the FDA. From a pharmacovigilance perspec-tive, electronic submission should result in higher quality data and greater immediate access to this data by those who review or work with the case reports.

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