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Ken Margolin
Ken Margolin
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New FDA Drug Information Rules

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Earlier this year, the federal Food and Drug Administration passed new rules designed to make it easier for doctors to get essential information from the inserts inside packages of prescription drugs. The rules change reflected an understanding that the growing complexity of information presented in package inserts, was becoming confusing even to physicians. Serious medication errors were a too-frequent result.

The new rules apply to all drugs approved by the FDA since January 2001, and will be phased in gradually. Some of the most important requirements for package inserts are: (1) a new section on every one called Highlights, that will provide immediate access to the most important information about the drug’s risks and benefits, as well as important prescribing information; (2) a Table of Contents so that all safety information in the package insert can be readily found; (3) the date the product was initially approved by the FDA (so the doctor can know how long the drug has been in use); (4) a toll-free number and internet reporting information, to encourage doctors to report suspected “adverse events” (i.e., medication injury to the patient) from the medication; (5) a “Patient Counseling Information” section containing information about uses and risks of the medication, with the expectation that doctors will communicate the information to patients. The FDA package insert rule changes are promising. Time will be needed to see if they have a significant impact on medication errors.