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- Press Release/Announcement
Request for comments on the proposed measures and 2020 targets for the National Action Plan for Adverse Drug Event Prevention: inpatient and outpatient measures for reduction of adverse drug events from anticoagulants, diabetes agents, and opioid analgesics.
Federal Register. Washington, DC: Office of Disease Prevention and Health Promotion, US Department of Health and Human Services. October 20, 2016;81:72594-72595.
National attention has focused on efforts to address adverse drug events. This call for comments seeks insights regarding revisions to a 2014 action plan that highlighted how to reduce adverse drug events associated with anticoagulants, diabetes agents, and opioids. These proposed updates involve measures to apply in both the inpatient and outpatient environments to track adverse drug events. The opportunity to submit written comments is now closed.
Heparin-containing medical devices and combination products: recommendations for labeling and safety testing. Draft guidance for industry and Food and Drug Administration staff.
Federal Register. Washington, DC: US Department of Health and Human Services. Baltimore, MD: Food and Drug Administration. July 9, 2015;80:39440-39441.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; December 6, 2012.
FDA Public Health Advisory [US Food and Drug Administration Web site]. February 28, 2008.
This announcement update alerts providers to a recall of certain heparin sodium injection vials, in response to a series of serious adverse events associated with heparin sodium injections, especially those in multiple-dose vials.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 18, 2008.
This announcement provides information on a recall of heparin vials due to negative reactions reported with certain batches of the medication.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 6, 2007.
This announcement alerts health care providers to the potential for life-threatening errors involving two heparin products and provides recommendations to minimize mistakes.