Electronic Drug Labeling: No Consensus on the Advantages and Disadvantages of Its Exclusive Use

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A letter report issued by the Government Accountability Office with an abstract that begins "GAO found no consensus among stakeholders on the advantages and disadvantages of eliminating paper labeling and relying instead on electronic labeling as a complete substitute for the three types of drug labeling discussed in this report and approved by the Food and Drug Administration (FDA)--an agency within the Department of Health and Human Services (HHS). This report focuses on three types of prescription drug labeling: the prescribing information intended for health care practitioners, Medication Guides intended to inform patients about drugs FDA has determined pose a ... continued below

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United States. Government Accountability Office. July 8, 2013.

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This report is part of the collection entitled: Government Accountability Office Reports and was provided by UNT Libraries Government Documents Department to Digital Library, a digital repository hosted by the UNT Libraries. It has been viewed 45 times . More information about this report can be viewed below.

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Description

A letter report issued by the Government Accountability Office with an abstract that begins "GAO found no consensus among stakeholders on the advantages and disadvantages of eliminating paper labeling and relying instead on electronic labeling as a complete substitute for the three types of drug labeling discussed in this report and approved by the Food and Drug Administration (FDA)--an agency within the Department of Health and Human Services (HHS). This report focuses on three types of prescription drug labeling: the prescribing information intended for health care practitioners, Medication Guides intended to inform patients about drugs FDA has determined pose a serious and significant public health concern, and patient package inserts (PPI) required for oral contraceptives and estrogens. Stakeholders said an advantage of such a change would be that it could provide physicians, pharmacists, and patients with the most current drug information in a more user-friendly format, which would positively impact public health. For example, drug labeling could be made interactive to include hyperlinks to definitions of key terms or to additional information, enhancing patients' knowledge about the drugs they are using. However, stakeholders noted disadvantages that could offset any advantages gained from such a change. Relying on electronic labeling as a complete substitute for paper labeling could adversely impact public health by limiting 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. In addition, for electronic drug labeling to be successful, stakeholders said it is important to have a single data source that is reliable and unbiased for physicians, pharmacists, and patients to use, particularly given that there are multiple websites these groups can use to access information about prescription drugs. However, these websites that currently provide electronic labeling have limitations. For example, nongovernmental websites are not standardized, and one website can include information on a particular drug not included on another website."

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Government Accountability Office Reports

The U.S. Government Accountability Office (GAO) is an independent, nonpartisan agency that works for the U.S. Congress investigating how the federal government spends taxpayers' money. Its goal is to increase accountability and improve the performance of the federal government. The Government Accountability Office Reports Collection consists of over 13,000 documents on a variety of topics ranging from fiscal issues to international affairs.

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  • July 8, 2013

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  • June 12, 2014, 7:50 p.m.

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United States. Government Accountability Office. Electronic Drug Labeling: No Consensus on the Advantages and Disadvantages of Its Exclusive Use, report, July 8, 2013; Washington D.C.. (digital.library.unt.edu/ark:/67531/metadc301301/: accessed October 20, 2017), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Government Documents Department.