FDA Weighs E-Inserts or Paperless Labeling

Article excerpt

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.

Pharmacists support the idea in general, but with some specific recommendations, said Marcie A. Bough, Pharm.D., federal regulatory affairs director of the American Pharmacists Association, at the hearing. Paper inserts are easily separated from the product, she said, and there is often a lag time between FDA approval of a labeling change and the change on the insert. On the other hand, she said, APhA is concerned that a switch to electronic distribution may shift costs from manufacturers to pharmacies, for example, for paper and ink for printing the insert on-site.

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.

APhA recommends a transition period during which the inserts would be both on paper and available electronically, Bough said. Like several other witnesses, she called for a central, free Internet site to contain all information for prescription drugs, similar to "Daily Medical" from the National Library of Medicine.

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? …