A Medical Device Daily

The FDA yesterday issued a statement describing its effort to create electronic health records (EHRs) for Americans within the next decade by making it easier to share drug information electronically.

The 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, it said, will allow healthcare professionals nationwide to access and share critical health and treatment information electronically, and therefore 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 EHRs and other computerized methods for managing healthcare data, the issues around electronic data standards and standardized terminologies will become increasingly important,“ said Dr. Andrew von Eschenbach, 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, 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 for recently approved (within the last five 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, the FDA said. 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.

The FDA said its adoption of SNOMED is consistent with the May 2005 Department of Health and Human Services 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.

“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 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.“

Guidelines for treating severe injuries

If someone is injured in an automobile collision or is severely burned, emergency room physicians across the country would probably take similar steps to stabilize each condition. But subsequent treatment in the intensive care unit or operating room is less well established and may vary significantly, according to a statement by the National Institutes of Health (NIH).

It said this is likely to change, based on the work of an interdisciplinary team of scientists and physicians funded by the National Institute of General Medical Sciences (NIGMS), part of the NIH. The team is developing a series of standard procedures for the care of severely injured patients. The guidelines will describe how to implement the most successful treatment protocols in the clinic and will include summaries of each procedure ready to print – not on a computer program or some complex med-tech system – but on 3 x 5 index cards for quick bedside reference.

The team's first article – on mechanical ventilation – appeared in the September 2005 issue of the Journal of Trauma: Injury, Infection, and Critical Care. Planned future topics will cover resuscitation, prevention and treatment of venous blood clots, diagnosis of ventilator-associated pneumonia, blood sugar control, nutritional support, transfusion thresholds, and sedation.

The team chose to cover aspects of care for which practices vary the most and those that have the greatest potential to influence patient outcomes.

The scientific team is part of a collaborative, NIGMS-supported initiative called the Inflammation and Host Response to Injury “glue grant“ program. Glue grants bring together scientists with diverse expertise to address major biomedical questions that are beyond the scope of any one research group – in this case, to uncover why patients who experience comparable traumatic injuries can have dramatically different outcomes.

This project was launched in 2001 with a five-year award totaling $37 million.

“Establishing standard treatment procedures is an important first step in improving patient care,“ said Jeremy Berg, PhD, director of NIGMS. “But we expect the real breakthrough to come when genetic data from the project helps physicians tailor treatments for each critically injured patient.“