A new package insert rule from the federal Food and Drug Administration is designed to better manage the risks of medication use and reduce medication errors, according to the agency.
Under the rule, package inserts must include a new highlights section that summarizes the most important information required to ensure patient safety. The section must list safety warnings, summarize recent revisions to the warnings, provide information on how to use and dose the medication, and offer advice to physicians on instructions for patients.
The rule is the first proposed revision to prescription drug packages in 25 years. It will not require new information in the package inserts. Pharmaceutical companies must revise package inserts for new prescription drugs by June 30 and must revise the inserts for medications between one and five years old within seven years.
Each year, approximately 300,000 preventable adverse events occur in hospitals in this country, many as a result of confusing medical information, according to the FDA.