FDA Requires Use of SNOMED Problem List

Pharmaceutical manufacturers face a new FDA mandate to incorporate the “Problem List” subset of the Systematized Nomenclature of Medicine (SNOMED) into their electronic labeling as of June 30, although many are more familiar with the international Medical Dictionary for Regulatory Activities (MedDRA).

The mandate applies to newly approved prescription drug products, as well as products approved within the last five years. The Problem List will have to be used to code important terms in the “Highlights” section of the FDA-approved package inserts that accompany prescription drugs, a part of structured product labeling (SPL).

Uniform Coding

The agency is touting this change as part of “the federal effort to create electronic health records for Americans within the next decade by making it easier to share drug information electronically.” More modestly, the imposition of the SNOMED Problem List as a standard is meant to “allow healthcare professionals nationwide [to] electronically access and share critical health and treatment information more easily and efficiently.”

The uniform coding in this list means, for example, that one term replaces the varying use of the terms “heart attack,” “myocardial infarction,” “infarct” and “MI.” This is supposed to ease the electronic exchange of important health information from system to system and improve the interoperability of electronic systems exchanging FDA-approved labeling information.

“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 Acting FDA Commissioner Andrew von Eschenbach.

“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,” von Eschenbach added.

SNOMED was developed by the College of American Pathologists (CAP) and made available royalty-free in late 2004 to the government, which is using it “as part of the health information technology infrastructure for clinical language.” The FDA says it will integrate the new labeling format into its other e-Health efforts, such as the provision of medication information for DailyMed — an interagency online health information clearinghouse sponsored by the National Library of Medicine.

SNOMED is used “for direct communications with physicians,” Alan Goldhammer, associate vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), told PIR. The new Problem List subset was jointly created by the Department of Veterans Affairs and Kaiser Permanente.

No Privacy Concerns

Creating a national system of electronic medical records is certain to raise privacy concerns, but not at this stage. “This issue currently only involves products frompharmaceutical companies that are covered by the recent changes in thelabeling rule for providing Highlights,” Randy Levin, director for health and regulatory data standards at the FDA’s Center for Drug Evaluation and Research (CDER), told PIR.“The terminology is used for coding a small number of terms used in the labeling, and there are technical issues of incorporating this information into the electronic labeling file, but I would not consider these obstacles. There are no privacy issues because this only involves labeling.”

The new FDA mandate raises some complex issues, as the pharma industry currently uses MedDRA to list adverse reactions, according to Goldhammer. “The industry is largely unfamiliar with the use of SNOMED,” he said, adding that the FDA’s choice of this standard does help clarify matters. “We are uncertain at this stage what the full impact will be on the pharmaceutical industry,” said Goldhammer. — Martin Gidron