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October 23, 1996

FDA Focuses on Drug and Device Errors

JAMA. 1996;276(16):1287. doi:10.1001/jama.1996.03540160009003

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"EVERY DAY in the United States a hospital patient dies because someone made a mistake in his or her prescribed medication."

With these words, Sharon Smith Holston, JD, the Food and Drug Administration's (FDA) deputy commissioner for external affairs, opened what was described—surprisingly—as the first meeting the agency has ever convened on preventing errors in the use of medications and other medical products.

The gathering, which brought together FDA officials and groups representing physicians, pharmacists, and nurses, was an effort to move beyond finger-pointing at perpetrators of drug- and device-related errors to the development of strategies for preventing such mistakes.

Underscoring the need for such strategies are the 150 new reports each month to the agency's database of medication errors. To date, the FDA has received approximately 4500 reports of medication mistakes, resulting in 250 deaths and 525 serious injuries, explained Jerry Phillips, RPh, director of the FDA's Division of