title: The use of observational health-care data to identify and report on off-label use of biopharmaceutical products.
abstract: Significant efforts are under way to develop analytic surveillance systems that can leverage observational health-care data to monitor biopharmaceutical products. The systems are being designed to identify safety-related events in a post-approval setting, when the products are already on the market.An additional application of such a system would be the use of observational data to help identify and track off-label use of marketed biopharmaceutical products in specific populations.The opportunities and challenges associated with such a system, as well as the underlying data sources themselves, are reviewed in this article.
authors.affiliation: Scientific Affairs, United BioSource Corporation/Medco Health Solutions Inc., Blue Bell, Pennsylvania, USA. jon.morris@unitedbiosource.com
authors.forename: J
authors.initials: J
authors.lastname: Morris
mesh_terms: D000328:Adult; D001688:Biological Products / Q000627:therapeutic use*; D003695:Delivery of Health Care; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use
chemical_list: D001688:Biological Products