This is set to make it easier to share drug information electronically, allowing healthcare professionals nationwide to access and share critical health and treatment information more efficiently.
The FDA's adoption of the Systematized Nomenclature of Medicine (SNOMED) codes to encode the highlights section of drug labelling could be one of the most significant advances in patient care since the introduction of automated drug-drug and drug-allergy checking software.
SNOMED aims to become the standard computerised medical vocabulary system, and has been designed as part of an overall healthcare system within the US, which aspires to standardise terminologies and technology, limiting the number of standards currently being used.
"With the increasing use of electronic medical records and other computerised methods for managing healthcare data, the issues around electronic data standards and standardised terminologies will become increasingly important," said Andrew 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."
Central to the system is the "Problem List" Subset of SNOMED, which has been implemented to electronically code certain terms in the Highlights data elements of the new format for prescription drug information.
The format - required at the beginning June 30, 2006 - is for recently (within the last 5 years) and newly approved drug products and has been developed to provide coding for clinical terminology to make it computer readable across systems.
For example, the term for 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 this way opens the door to establishing another key element in building a unified electronic health information infrastructure in the US," said von Eschenbach.
"We are committed to electronic exchange of safety information on prescription drug products globally," he added.
The >FDA's adoption of SNOMED comes into line 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.
Additionally, the FDA will also be working with the federal Health IT Standards Panel as SNOMED is implemented. 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.
The new labelling format will be integrated into the FDA's other e-Health efforts. As prescription information is updated in this new format it will be used to provide medication information for DailyMed - an online health information clearing house, which maintains the most up-to-date medication information free.