The US Food and Drug Administration (FDA) advanced 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 labelling. This move will allow healthcare professionals nationwide electronically to access and share critical health and treatment information more easily and efficiently, an NIH release stated.
"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 labelling."
Specifically, FDA is adopting the "Problem List" Subset of SNOMED for use in this electronic labelling 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 US 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 labelling 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 labelling, enabling the electronic exchange of important health information from system to system. The use of SNOMED in the Highlights section of prescription drug labelling will enhance the interoperability of electronic systems exchanging FDA approved labeling information in the care of patients.
FDA's adoption of SNOMED is consistent with the May 2005 Department of Health and Human Services (HHS ) announcement that SNOMED CT will be used by federal agencies for the exchange of clinical information across the federal government for laboratory result contents, non-laboratory interventions and procedures, anatomy, diagnoses and problems, and nursing, and FDA will be working with the federal Health IT Standards Panel as SNOMED is implemented. A licensing agreement with the CAP, administered through the National Library of Medicine (NLM) a component of HHS ' National Institutes of Health (NIH), is making it possible for U.S. healthcare professionals, hospitals, insurance companies, public health departments, medical research facilities, and others to easily incorporate this uniform terminology system into their information systems. The Problem List Subset of codes to be used within labelling will be made available free of charge through the National Cancer Institute (NCI) Web site.
"We have today announced an important step toward creating an electronic environment for drug information exchange that can provide American patients and healthcare professionals with critical information at the point of care," said Dr. von Eschenbach. "The use of SNOMED in this way opens the door to establishing another key element in building a unified electronic health information infrastructure in the United States. We likewise are committed to electronic exchange of safety information on prescription drug products globally, and we will continue to support our ICH agreements in this regard."
"The FDA's adoption of SMOMED codes to encode the highlights section of drug labeling is one of the most significant advances in patient care since the introduction of automated drug-drug and drug-allergy checking software," said Bob Dolin, MD, Kaiser Permanente.
The Problem List Subset of SNOMED is one of several terminologies being used with structured product labelling (SPL) (e.g., LOINC, the NCI Thesaurus, NDF-RT) in the new physician labelling design announced in January 2006, which is providing accurate, up-to-date drug information in an accessible, computer readable format.
The new labeling format will be integrated into FDA's other e-Health efforts through a variety of ongoing initiatives. As prescription information is updated in this new format it will be used to provide medication information for DailyMed - an interagency online health information clearinghouse, sponsored by the National Library of Medicine, which is maintaining the most up-to-date medication information free to consumers, healthcare professionals, and healthcare information providers. The DailyMed is making up-to-date information about FDA-regulated products widely available on the Internet at no cost. (http://dailymed.nlm.nih.gov.)
"VA will use the FDA DailyMed messages to increase the quality of its pharmacy terminology, used to deliver over 110 million outpatient prescriptions per year to our nation's Veterans. SPL and DailyMed will also support VA's electronic Problem List and related administrative applications. VA is excited to be collaborating with Kaiser, FDA, and others to provide up- to- date medical information that improves patient safety and care quality," said Michael J. Lincoln, MD, Chief Terminologist, Department of Veterans Affairs Office of Information.