FDA weighs e-inserts or paperless labeling

June 4, 2007

The FDA is weighing whether to allow a system for electronic insert information for most prescription drugs, replacing paper Rx inserts.

Is it time to make prescribing information electronic and forgo paper package inserts for most prescription drugs? Manufacturers have long led an effort to move toward "paperless labeling," which they say could save millions of dollars. Now the Food & Drug Administration is exploring the idea with a call for comments and a recent hearing at its Rockville, Md., offices.

Douglas Scheckelhoff, M.S., R.Ph., director, pharmacy practice sections, for ASHP, testified, "Prescribers with access to electronic prescribing information would potentially have more drug information available and accessible, which might lead to fewer prescribing errors." He also said that for most routine questions, hospital pharmacists already use reference books or electronic resources.

The FDA, however, questions what happens when computer systems are down or electricity is off. Bough recommended, among other things, that 24-hour access to information be supplied in some form by manufacturers.

Should some products continue to have paper inserts after an electronic system is instituted? Bough said APhA is still gathering information, but Scheckelhoff urged that paper information be available for products such as injectable drugs or vaccines or any drugs requiring special compounding, preparation, dilution, or reconstitution and those that have been marketed for less than two years or have higher risks.

Karen Kistler, a packaging and development manager for Genentech Inc., said several of her company's inserts have exploded in size over the past year, due to increased indications and other information. Showing the FDA panel an insert that could, as she noted, cover a small picnic table, Kistler said it costs 35 cents per insert, and by next year some products may require two inserts glued together.

Some individual drug cartons are 300% larger due to inserts, she said, with the insert and empty space that accommodates the paper's length taking up most of the interior-a factor that adds greatly to costs for manufacturing, transportation, and storage, including cold storage. Even end users, including hospitals, must maintain significantly more cold storage space for some products, Kistler said, and sometimes new drug launches are delayed by the cumbersome process of printing the insert.

The FDA will take comments on electronic prescribing information until June 22, at http://www.fda.gov/, under "Dockets Management."

THE AUTHOR is a writer based in the Washington, D.C., area.