Electronic labels might improve patient safety

December 1, 2005

Washington-- In an effort to meet President George W. Bush's Management Agenda goal of expanded electronic government, FDA is requiring drug manufacturers to submit prescription drug label information to the agency in a new electronic format. This electronic format will allow healthcare providers and consumers to more easily access the product information found in package inserts for all approved medications in the United States.

WASHINGTON, D.C.- In an effort to meet President George W. Bush's Management Agenda goal of expanded electronic government, FDA is requiring drug manufacturers to submit prescription drug label information to the agency in a new electronic format. This electronic format will allow healthcare providers and consumers to more easily access the product information found in package inserts for all approved medications in the United States.

Structured Product Labeling (SPL) is an XML-based format that allows the electronic management of medication information, resulting in more accurate and complete information that can be provided directly to the healthcare community and the public in a timely manner, according to FDA. "A standardized, electronic format allows for efficient dissemination of risk information to a broad audience," an FDA spokesperson says.

Using embedded computer tags, the content of prescribing information in SPL format can be electronically managed, allowing a user to search for specific information. These tags can instruct computers to read specific sections of a drug label, including product names, indications, dosage and administration, warnings, descriptions of a drug product, active and inactive ingredients, and how the drug is supplied.

FDA leaders say that the SPL format will result in improvement in the quality of healthcare by:

These new electronic product labels will be the key element and primary source of medication information for "DailyMed," a new interagency online health information clearinghouse provided by the National Library of Medicine (NLM). The information can be accessed through NLM at http://dailymed.nlm.nih.gov/. In the future, this new product information also will be provided through FACTS@FDA, an FDA Internet resource designed to give one-stop access for information about all FDA-regulated products.

Within one year, product labels for most approved prescription medications will be posted on DailyMed. The SPL project, led by FDA's Center for Drug Evaluation and Research (CDER), is the first in an agency-wide initiative regarding the public provision of electronic information. In the future, DailyMed also will include labels for biologics, medical devices, veterinary drugs, and some food products. The goal is for updated product labels to be posted on the site within one business day of an approval action by FDA or submission to FDA of a product label change that does not require prior approval.

The DailyMed system was developed in collaboration with federal agencies including: FDA, NLM, Agency for Healthcare Research and Quality (AHRQ), the National Cancer Institute (NCI) in HHS, and the Veterans Health Administration in the Department of Veteran Affairs (VA).

"This . . . format will help all of the 'Ps' in healthcare-physicians, providers, pharmacists, payers, pharmaceutical industry and, above all, patients," says MHE Editorial Advisor Joel V. Brill, MD, chief medical officer for Predictive Health. "With rising healthcare costs and the calls for value-based purchasing, initiatives such as these will help all meet the quality objective of doing the right thing right, the first time, for patients."