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.
Paul Seligman, M.D., MPH, director of FDA's Office of Pharmacoepidemiology and Statistical Sciences, examines one of Genentech's
small tablecloth-sized package inserts.
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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 in-formation 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? 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.
Douglas Scheckelhoff, R.Ph., of ASHP testifies before the FDA panel on Electronic Distribution of Prescribing Information.
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Thomson Healthcare has worked for seven years with the Paperless Labeling Taskforce led by the Pharmaceutical Research & Manufacturers
of America (PhRMA). According to company VP Mukesh Mehta, dispensers taking part in a field trial that concluded in 2005 said
that an electronic system was fast and easy to use and that they appreciated being able to bookmark parts of the information.
Trials have included expedited access to a specific drug's information with use of a bar-code scanner.
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.
