New US prescription drug information format to improve safety

The U.S. Food and Drug Administration (FDA) announced in January a major revision to the format of prescription drug information, including drugs to treat HIV/AIDS, commonly called the package insert or drug label, to make information for healthcare professionals clear and concise to help ensure safe and optimal use of drugs.

Part of an effort to manage the risks of medication use and reduce medical errors, the newly designed package insert will provide the most up-to-date information in an easy-to-read format that draws attention to the most important pieces of drug information, thus reducing the complexity of information on prescription drug labels. The new format will also make prescription information more accessible for use with electronic prescribing tools and other electronic information resources.

The new drug labeling requirements will be phased in gradually, and initially will apply to newly and recently approved prescription drugs and drugs that receive approval for new uses. The agency is encouraging drug makers to consider complying with the new labeling requirements earlier on a voluntary basis. All drugs approved within the past five years are included, and they will gradually be converted to the new prescribing information format.

The new format requires that the prescription information for newly approved products, and those approved within the last five years, meet specific graphical requirements, including the reorganisation of critical information so medical professionals can find the information they need quickly.

As prescription information is updated in this new format it will be added to a new online health information clearinghouse called DailyMed that will provide up-to-date medication information free to consumers, healthcare professionals and healthcare information providers. This information can be accessed through the National Library of Medicine at:

Comment

None of the ten drugs listed on the site when HTB went to press were HIV-related. Although the EMEA website contains product information in all European languages it is cumbersome and difficult to use. A Similar approach in Europe would therefore be welcomed.