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Paperless Labeling ––>

The FDA recently published a proposed rule that would convert the manufacturer’s paper labeling, either on or in a product from which the drug is being dispensed, to electronic media. This would provide for far more timely information on warnings, adverse reactions, and contraindications that, in paper form, may take several months to work its way through the supply chain. Manufacturers are now required to update their labeling every six months with changes that have taken place. Moving to electronic labeling would give pharmacists access to changes within a few days — close to real time — by going to labels.fda.gov. I went to this site, and it is easy to select the drug in question and go right to the section of the labeling that would be of interest to you.
For pharmacies without Internet access (and these are in the minority), manufacturers would be required to have a toll-free number to request that the labeling be emailed or faxed, or a paper copy be mailed to the pharmacy. This toll-free number would be operational 24/7 and printed on the container label. So would a note that the prescribing information is available at the FDA’s website.

Moving from paper to electronic media will save the pharma companies a bundle. But the FDA anticipates that pharmacies would incur setup costs associated with this changeover and with the expense of printer and paper use when someone asked for a printed copy. On the other hand, pharmacists could refer the patient to the FDA’s website.

In a survey with pharmacists the FDA found overwhelming support for electronic access because it would increase patient safety. While they can go to the manufacturer’s website to access the labeling, having it all in one place simplifies the process. Moreover, pharmacists would no longer have to contend with the small print on paper that makes the information difficult to read. The FDA also found that pharmacists have access to other electronic drug compendia, so the labeling accompanying the product into the pharmacy is rarely referenced and often ends up in the trash. And the FDA is aware that patients are receiving drug monographs with their prescriptions and, where required, medication guides, so a copy of the manufacturer’s labeling isn’t really essential.

I doubt that when the final rule is published it is going to deviate very much from the proposed rule, since all the issues with the conversion to electronic media are addressed in the proposed rule.

was involved with a PhRMA task force on this subject a few years ago that started us down this road. It seemed to me that this was a natural Web application. There was a lot of discussion at the time as to where the information would be stored. This has now been answered with labels.fda.gov. CT


Bill Lockwood, chairman/publisher, can be reached at wal@computertalk.com.