FDA Announces New Prescription Drug Information Format

The Food and Drug Administration (FDA) unveiled a major revision to the format of prescription drug information, commonly called the package insert (PI), to give healthcare professionals clear and concise prescribing information. In an effort to manage the risks of medication use and reduce medical errors, the newly designed PI will provide the most up-to-date information in an easy-to-read format that draws physician and patient attention to the most important pieces of drug information before a product is prescribed. The new format will also make prescription information more accessible for use with electronic prescribing tools and other electronic information resources. Each year, approximately 300,000 preventable adverse events occur in hospitals in this country, many as a result of confusing medical information. Research shows that prioritizing the warning information has a greater impact on reducing such events. Therefore, the new prescription label format provides the most important information about a prescription product in a format that is better understood, more easily accessible and more memorable for physicians. By making these changes, FDA is seeking to reduce the complexity of information on prescription drug labels, making them more useful for physicians and their patients. The new prescription information format will be integrated into FDA’s other e- Health initiatives and standards-setting efforts through a variety of ongoing initiatives at the agency. As prescription information is updated in this new format it will be used to provide medication information for DailyMed — a new interagency online health information clearinghouse that will provide the most up- to-date medication information free to consumers, healthcare professionals and healthcare information providers. The DailyMed is now making up-to-date information about FDA-regulated products widely available on the Internet free of charge. This information can be accessed through the National Library of Medicine. In the future, this new information will also be provided through a website called facts@fda, a comprehensive Internet resource designed to give one-stop access for information about all FDA-regulated products.