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New Rules For Patient Package Inserts

In June, new Food and Drug Administration rules for the format and content of patient package inserts in prescription drugs became effective. The new format emphasizes "highlights" of the label information, provides a table of contents, requires the information to appear in a different order, and sets forth specified graphic requirements. That goes along with a requirement put in place late last year calling for drug makers to submit labeling information in electronic format, for easier searching and cross-referencing. Says the FDA, "These revisions will make it easier for healthcare professionals to access, read, and use prescribing information, and will enhance the safe and effective use of prescription drug products."

The FDA is even attacking that old stereotypical medical hazard, doctors with bad handwriting. Yes, the FDA and an agency called the Institute for Safe Medication Practices have started an education campaign attacking unclear medical abbreviations, symbols, and dose designations.

In fairness to doctors, the campaign is aimed at not just handwritten orders but also "computer-generated labels, medication administration records, pharmacy or prescriber computer order-entry screens and commercial medication labeling, packaging, and advertising," says the FDA. Mixups over these designations can lead to medication errors. Errors with medicines cause more than 7,000 deaths a year, says the Institute of Medicine. The new campaign will establish standardized abbreviations, symbols and dose designations so that a "U" won't get mistaken for a zero or a 4, "IU" won't be taken for "IV," and so on. [HCP]

By Eric F. Greenberg,
Attorney at Law

Eric F. Greenberg is attorney at law in his own law firm, Eric F. Greenberg, P.C., where he practices food and drug law, packaging law, and commercial litigation.
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