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).
ADVERSE DRUG REACTION REPORTING
IN THE 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). 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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