July 25, 2013
GAO Finds No Consensus on Move to Exclusive Electronic Drug Labeling
Washington, D.C.—The General Accountability Office (GAO) found no consensus from involved parties on the advantages and disadvantages of eliminating paper labeling and instead exclusively relying on electronic labeling for prescribing information, medication guides, or patient inserts required for oral contraceptives and estrogens.
The issue is of significant concern to pharmacists because, according to the GAO report, if drug manufacturers no longer supply paper labeling for patients, “it would shift the costs of printing to the pharmacies.” That would be a lot of printer paper, with the report further noting that retail pharmacists filled about 3.8 billion prescriptions in 2011.
The GAO points out that the FDA reviews manufacturer-developed drug labeling, which, while generally available in paper form, is also publicly available in electronic form on government-operated Web sites.
The report states that drug manufacturers have supported eliminating paper labeling, instead using electronic drug labeling. Other groups, including drug labeling manufacturers and patient advocates, have warned the move could have a detrimental effect on public health.
Supporters of electronic-only labels argue that it would provide physicians, pharmacists, and patients with the most current drug information in a more user-friendly format. On the other hand, opponents argue that shift could limit the availability of drug labeling for some physicians, pharmacists, and patients “by requiring them to access drug labeling through a medium with which they might be uncomfortable, that they might find inconvenient, or that might be unavailable,” the GAO report states.
The report cites data from the Federal Communications Commission that about 14 million Americans have inadequate access or no access to adequate broadband capabilities, especially in less-populated areas.
Furthermore, while multiple Web sites exist to provide information about prescription drugs, those provided by nongovernmental entities are not standardized, according to the report. Stakeholders, it says, emphasize the importance of “a single data source that is reliable and unbiased for physicians, pharmacists, and patients to use.”
FDA officials say that changing to an exclusively electronic version would require the agency to amend or review regulations for two of the three types of FDA-approved drug labeling that are the focus of this report.
The GAO also raises questions about the shift of some responsibilities from drug manufacturers to pharmacies. “If pharmacists’ workflow is disrupted because they need to print drug labeling for patients, it could reduce the time available for patient consultations. Interruptions to pharmacists' workflow have been shown to increase the risk for errors made when dispensing a drug.”
The report was created for the Senate Committee on Health, Education, Labor, & Pensions and the House Committee on Energy & Commerce.
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