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FDA should rescind switch to electronic drug labeling

When Hurricane Sandy made landfall in October 2012, it caused more than 8.5 million power outages across 17 states. More than 1.5 million businesses were impacted by the storm, including hundreds of community pharmacies that were still without power more than a week later. Power outages such as these can severely compromise pharmacy operations, putting the delivery of vital medicines – and countless patient lives – at risk. 

Yet instead of preparing for disasters like Sandy and inevitable Internet connectivity issues, the U.S. Food and Drug Administration (FDA) is actually considering a rule that would make it nearly impossible for some pharmacists to safely serve customers.

{mosads}Some background: when a consumer picks up a prescription, the pharmacist often flags important dosing information, potential side effects, and drug interactions. The pharmacist often obtains this information from printed “pharmaceutical inserts” that are manufactured with medications.

In their paper form, these inserts reliably deliver vital safety information from the manufacturers that make the medications to the pharmacists who communicate them to patients, but the FDA is moving to eliminate these inserts. Instead, the agency would require e-labeling, mandating that this critical information be provided solely online instead of on paper.

Currently, a dual system is in place to provide health care professionals with access to prescribing information through both an online portal and paper inserts, which are an important fail-safe in the case of unexpected power outages or poor Internet connectivity.

The reasoning behind printed pharmaceutical inserts goes beyond the impact of natural disasters or routine power outages. Even when skies are blue, many pharmacies across the country are without reliable Internet access. In the FDA’s own national survey, an alarming 27 percent of pharmacists indicated that their pharmacy either does not have Internet access or that they are unable to browse the Internet.

And the FDA’s new proposal doesn’t just compromise consumer wellbeing; it could also bankrupt many community pharmacies, which will bear the brunt of the transition. By the FDA’s own estimations, the transition to an exclusively web-based labeling system could cost pharmacies anywhere from $45 to $90 million. As a result, this rule proposal would likely hurt businesses in rural and economically disadvantaged communities, which can least afford the switch.

Paper is the only method that we can be sure will provide pharmacists with the prescribing information they need at all times.

For decades, the National Consumers League has worked to improve the delivery of information to consumers about the drugs they take. Effective and reliable communication between pharmacists and their patients is paramount to safely managing prescriptions and avoiding potentially harmful consequences.

Whether in the wake of a natural disaster, or in rural towns lacking steady Internet access, connectivity issues mean the U.S. is simply not ready for an all-electronic drug labeling system. The FDA should rescind its new proposal and support the continued use of printed inserts. Pharmacists need unfettered access to the prescribing guidelines that are so critical to patient safety.

Greenberg is executive director of the National Consumers League, a private, nonprofit advocacy group dedicated to protecting and promoting social and economic justice for consumers and workers in the United States and abroad.


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