Prescription drug label information goes electronic

In an effort to meet the administration's 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 format that allows for 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 said.

Currently, healthcare providers could be accessing information that is as much as a year out-of-date, "thereby potentially impacting the safety of patients," the FDA spokesperson said.

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 will also be provided through FACTS@FDA, an FDA Internet resource designed to give one-stop access for information about all FDA-regulated products. FACTS@FDA is a section of the FDA website, http://www.fda.gov/.

Within 1 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 will also 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 1 business day of an approval action by FDA or submission to FDA of a product label change that does not require prior approval.

"This unprecedented health technology partnership builds a solid foundation for enhanced e-health initiatives to be realized in the very near future," said acting FDA commissioner Andrew C. von Eschenbach, MD. "The electronic standards established with structured product labeling pave the way for future health information innovations in areas such as electronic prescribing and electronic health record keeping, that can transform the way we gather, use, and share medication information from bench to bedside."

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

"This proposed standardized electronic format will help all of the 'P's' in the healthcare system-physicians, providers, pharmacists, payors, pharmaceutical industry, and, above all, patients," said Joel V. Brill, MD, chief medical officer for Predictive Health (Dr Brill also serves as a peer reviewer for Formulary). "With rising healthcare costs and the calls for value-based purchasing, initiatives such as these will help all to meet the quality objective of doing the right thing right, the first time, for patients."