FDA to Require Standard Language on Electronic Drug Labels

The FDA's requirement of a standard vocabulary for electronic prescription drug labels is expected to help prevent medical errors.

To find drug information about heart attacks, a physician should remember to search not just for "heart attack" but also for "MI," "infarct" and "myocardial infarction."

Automated, electronic ways to access drug information can miss or misclassify information because there are myriad medical terms.

Now, the U.S. Food and Drug Administration is moving to standardize drug information.

It will require a standard vocabulary for electronic prescription drug labels starting June 30.

The move is expected to prevent medical errors by helping doctors and physicians get better information about how drugs should be prescribed.

SNOMED (the Systematized Nomenclature of Medicine) will be used to electronically code important terms in prescription drug labeling, an officially approved description of what a prescription drug can be used for.

"The FDAs adoption of SNOMED 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, M.D., Kaiser Permanente.

However, a leading provider of clinical reference tools contacted by eWEEK declined comment on the move, saying it wasnt relevant for the company.

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The FDA is billing the move as a means to support widespread electronic health records because consistent use of SNOMED should allow electronic systems at different health care facilities to exchange FDA-approved labeling information to describe patient treatments.

Acting FDA Commissioner Andrew C. von Eschenbach described the policy as "an important step toward creating an electronic environment for drug information exchange that can provide American patients and health care professionals with critical information at the point of care."

The FDA is adopting the "Problem List" Subset of SNOMED, which was developed through a partnership between the Department of Veterans Affairs and Kaiser Permanente.

Drugs approved within the past five years as well as any newly approved drugs will electronically code certain terms in the Highlights data elements for prescription drug information.

In May 2005, Department of Health and Human Services announced that SNOMED CT will be used by federal agencies for the exchange of clinical information across the federal government.

The new labeling format will be used in DailyMed, an interagency health information clearinghouse sponsored by the National Library of Medicine.

The Problem List Subset of SNOMED is one of several terminologies being used with SPL (structured product labeling), such as LOINC, the NCI Thesaurus and NDF-RT.

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