The FDA recently began requiring drug manufacturers to submit certain prescription human drug label information in the structured product labeling (SPL) format to make the data in agency-approved package inserts more accessible to healthcare providers and consumers. The SPL initiative, which was dependent on the agency's implementation of its new electronic labeling information processing system (ELIPS), had been scheduled to begin Oct. 31. The SPL mandate applies to content for new drug applications, abbreviated new drug applications and biologics license applications submitted to the Center for Drug Evaluation and Research.
ELIPS received the first XML-based submission from a pharmaceutical company Nov. 1, which enabled the FDA to make the final switch to SPL, said Ron Celeste, CEO of ThinSpring, which developed SPL Server, the software behind the new system.
The new electronic product labels - which replace the traditional PDF submissions -- will provide data for DailyMed, a new interagency online health information clearinghouse for consumers, healthcare providers and healthcare information providers, the FDA said.
SPL "provides accurate, up-to-date drug information using standardized medical terminology in a readable, accessible format," the agency said. "Using embedded computer tags, the prescribing and product information in the 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, description of drug product, active and inactive ingredients, and how the drug is supplied."
This online data will enable physicians to quickly search and access specific information about a drug before prescribing it, which will result in fewer prescribing errors and better treatment decisions, the FDA said. SPL also will improve the FDA review process, enabling the agency to quickly provide important medication information to doctors and patients.
"Updated product labels will be posted on the [DailyMed] 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 FDA said.
The DailyMed system was developed in collaboration with the National Library of Medicine, the Agency for Healthcare Research and Quality, the National Cancer Institute and the Veterans Health Administration to make the most current medication information available on the Internet free to patients and providers, the FDA said. Product labels for most approved prescription medications will be posted on DailyMed within a year, the FDA said.
DailyMed is accessible through the National Library of Medicine at http://dailymed.nlm.nih.gov (http://dailymed.nlm.nih.gov).