Enhance the FDA's Postmarketing Drug Surveillance System of Adverse Effects through the Electronic Healthcare Data

In Drug Administration (FDA), a Federal Agency of the United States Department of Health and Human Services, before marketing (open to the public use). The FDA has a systematic premarketing risk identification and assessment system and makes decisions to approve or not approve a drug to treat a specific condition, based on a benefit-risk analysis for the intended population. Once approved,drugs move swiftly into the market place for use by prescribers and patients. 

The FDA also has a postmarketing drug surveillance and risk assessment system with intention to identify unexpected short- and long-term risks of approved drugs or products, which currently relies primarily on two methods of adverse event reporting to the FDA. One is the direct, voluntary reporting by health professionals and consumers. The other is a mandated reporting by pharmaceutical manufacturers that is mainly based on the voluntary submission of reports from medical facilities, health professionals, and consumers, so-called MedWatch program. The spontaneous case reports from health professionals like the MedWatch program are important, but may miss over 90% of all cases with rare toxic events. Read more.....................