Practice Tip

According to the FDA's press release, the 'new format requires that prescription information for new and recently approved products meet specific graphical requirements and includes the reorganization of critical information so physicians can find the information they need quickly.' The rule is described by the agency as 'an effort to better manage the risks of medical product use and reduce medical errors associated with the use of prescription drug products.' (FDA Announces Final Rule on Requirements for Prescribing Information for Drug and Biological Products. FDA News, Jan. 18, 2006.) Health professionals and consumer advocacy groups have long urged the need for changes to the format in which prescription drug information is provided to physicians. Currently, package inserts are far from user friendly with agonizingly small print and hundreds of different pieces of information loosely organized under different subjects through numerous pages. The current format allows important information regarding adverse events and potential risks to become easily 'buried' within a tome of information.

With 300,000 preventable adverse events occurring last year in hospitals alone, the need for clear, effective communication of drug safety information must be made a top priority by regulators and drug manufacturers alike. A new package insert that provides health professionals with easily accessible risk information is critical to improving health care quality and protecting consumers from preventable serious injuries and even death. With the goal of communicating important information more efficiently and effectively, the new rule will require a table of contents to help guide health professionals to information within the package insert. It will also require an important new Highlightssection, which will be a half-page synopsis of the information the FDA feels is most pertinent to a prescribing physician such as any Boxed Warnings, Indications and Usage, dosage information and, crucially, a list of all changes that have occurred to the label within the last year. Other significant changes to the label also include a section of important issues doctors should discuss with a patient when a drug is being considered. It is easy to imagine how these changes to the package insert may indeed assist health practitioners to locate and analyze important drug safety information quickly before prescribing a drug to a patient. Any good attained by the new rule, however, has been severely threatened and undercut by a politically motivated addendum to the rule, which declares unprecedented and unnecessary pre-emption of failure to warn claims ' a fact not disclosed in the FDA's press release.