The U.S. Food and Drug Administration (FDA) is advancing the federal effort to create electronic health records for Americans within the next decade by making it easier to share drug information electronically. FDA is moving the effort forward by adopting the Systematized Nomenclature of Medicine (SNOMED) as the standard computerized medical vocabulary system to be used to electronically code important terms in the Highlights section of prescription drug labeling. This move will allow healthcare professionals nationwide electronically to access and share critical health and treatment information more easily and efficiently.

"Today's action moves us closer to our goal of establishing electronic medical records for most Americans within 10 years. With the increasing use of electronic medical records and other computerized methods for managing healthcare data, the issues around electronic data standards and standardized terminologies will become increasingly important," said Dr. Andrew C. von Eschenbach, the Acting Commissioner of the FDA. "Once we have implemented a national e-health record, health professionals will have quick, reliable, and secure access to patient information that can be cross-referenced with critical treatment information, including the information in the Highlights section of drug labeling."

Specifically, FDA is adopting the "Problem List" Subset of SNOMED for use in this electronic labeling initiative for prescription drug products. SNOMED (Systematized Nomenclature of Medicine), developed by the College of American Pathologists (CAP), is one of the terminologies chosen by the U. S. Government as part of the health information technology infrastructure for clinical language. The Problem List Subset was created through a health technology partnership between the Department of Veterans Affairs (VA) and Kaiser Permanente. This use of SNOMED for medical product labeling will improve the domestic exchange of product information in FDA-approved package inserts.
The Problem List Subset of SNOMED can electronically code certain terms in the Highlights data elements of the new format for prescription drug information. This format will be required beginning June 30, 2006, for recently approved (within the last 5 years) and newly approved drug products. The SNOMED system has been developed to provide coding for clinical terminology to make it computer readable across systems. For example, what is commonly known as a heart attack can also be called a myocardial infarction, infarct, or an MI . SNOMED provides one code for all of these terms for use in product labeling, enabling the electronic exchange of important health information from system to system. The use of SNOMED in the Highlights section of prescription drug labeling will enhance the interoperability of electronic systems exchanging FDA approved labeling information in the care of patients.

More Industry Headlines