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Record the duration of increased temperature exposure. For example, the temperature of the freezer was 0 degrees Fahrenheit at noon on day 1 when the power failed; 15 degrees Fahrenheit at 6 PM on day 2 when the power was restored; 10 degrees Fahrenheit at 10 PM on day 2; and 0 degrees Fahrenheit at 7 AM on day 3. This information about time/temperature duration can enable calculations to be made by the product manufacturer, in consultation with FDA as necessary, about the continued potency of the involved products.
The DMEPA includes a medication error prevention program staffed with healthcare professionals. Among their many duties, program staff review medication error reports sent to MedWatch, evaluate causality, and analyze the data to provide solutions to reduce the risk of medication errors to industry and others at FDA.
Jack E. Fincham, Ph.D., R.Ph. Professor University of Missouri � Kansas City School of Pharmacy Division of Pharmacy Practice and Administration 2464 Charlotte Street Room 4246 Health Sciences Building Kansas City, Missouri 64108 USA 816-235-5909 Phone 816-235-6008 Fax finchamj@umkc.edu Professor of Health Policy and Management The University of Georgia College of Public Health Athens, Georgia 30602 USA
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