NEW REQUIREMENTS FOR PRESCRIPTION DRUG LABELING: A PRELIMINARY EVALUATION OF EFFECTIVENESS

Abstract

Medication errors and their role in patient safety have recently become a widely publicized issue in public health. In an attempt to lower medication errors, the FDA implemented new requirements for prescription drug labeling in June 2006. The new regulations modify the format and content requirements for prescription drug labeling, or package inserts, used by prescribing professionals. The main purposes of the new format are to make it easier for physicians to use the package insert and to make it easier for them to find specific information at the time of prescribing. A package insert that is easier to use will be referenced more frequently, which should lead to fewer medication errors. This study utilized 12 volunteers to evaluate a total of 50 package inserts, in both the old and new format, to see if the new format is easier to use than the old format. The results of the study show that the new format is a statistically significant improvement upon the old format for all evaluated characteristics. However, while the new prescription drug labeling requirements will likely reduce medication errors, public health is a complex issue and an improvement in prescription drug labeling is only one step toward a larger goal of protecting patient safety.