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Search results for "Food and Drug Administration (FDA)"
- Food and Drug Administration (FDA)
- Legal and Policy Approaches
FDA Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 4, 2016.
This announcement alerts prescribers to differences in two oral formulations of the same medication that can lead to dosing errors. The FDA suggests that clinicians specify dosage form, strength, and frequency on prescriptions for this drug to reduce the risk of patient harm and recommend that pharmacists follow up with prescribers if such information is missing.
Journal Article > Study
Effect of US Drug Enforcement Administration's rescheduling of hydrocodone combination analgesic products on opioid analgesic prescribing.
Jones CM, Lurie PG, Throckmorton DC. JAMA Intern Med. 2016;176:399-402.
Improving the safety associated with opioid use is a major health policy priority. Investigators found that drug scheduling changes imposed by the US Drug Enforcement Administration (including tighter prescribing standards and prohibiting refills) led to major reductions in the prescribing and dispensing of hydrocodone combination analgesic products.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; February 25, 2015.
The practice of using multi-dose insulin pens, meant for single patient use only, among multiple patients has been linked to health care–associated infections. This announcement outlines federal labeling requirements to raise awareness of the risks associated with this practice to prevent misuse of the devices.
Advocate Redi-Code+ blood glucose test strips by Diabetic Supply of Suncoast: recall—labeling error.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; June 11, 2014.
This announcement describes a recall of blood glucose test strips due to missing information on the label that could result in accidental misuse of test strips and potential delays in diagnosis and treatment of hyper- or hypoglycemia.
Legislation/Regulation > Government Resource
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: Draft Guidance.
Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; April 24, 2013.
This draft guidance seeks to outline design elements that reduce errors associated with medication labels. The process for submitting public comments is now closed.
Hospira Carpuject pre-filled cartridges—drug alert: products may contain more than the intended fill volume.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; May 23, 2012.
This announcement raises awareness of pre-filled medication cartridges that may be overfilled, thereby increasing the risk of overdose. The FDA recommends that practitioners confirm the dosage prior to dispensing and administering the medication.
Web Resource > Government Resource
US Food and Drug Administration.
This Web site supports a coordinated effort to reduce preventable medication-related errors through cross-sector interventions.
Tools/Toolkit > Fact Sheet/FAQs
FDA Consumer Health Information. Rockville, MD: US Food and Drug Administration; February 20, 2009.
This fact sheet discusses the role of the Food and Drug Administration (FDA) in reducing medication errors and describes examples of such errors for consumers.