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Search results for "Food and Drug Administration (FDA)"

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Book/Report

Safety Considerations for Product Design to Minimize Medication Errors: Guidance for Industry.

Rockville, MD: Center for Drug Evaluation and Research, US Food and Drug Administration; April 2016.

Strategies to prevent medication errors are a continuing focus of ongoing safety initiatives. This guidance outlines factors to consider when creating drug products to reduce design-associated medication errors.

Press Release/Announcement

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.

Book/Report

Computerized Prescriber Order Entry Medication Safety (CPOEMS): Uncovering and Learning From Issues and Errors.

Brigham and Women's Hospital, Harvard Medical School, Partners HealthCare. Silver Spring, MD: US Food and Drug Administration; December 15, 2015.

Electronic prescribing, considered an opportunity to reduce medication errors, has been linked to problems unique to technology use. This white paper discusses the results of a multi-hospital effort to develop a process and tools to collect and analyze data related to search, display, and workflow issues associated with computerized provider order entry. The authors offer recommendations to enhance the safety of electronic prescribing, including standardizing drug names, minimizing the number of alerts, and designing better search functions.

Web Resource > Government Resource

Drug Shortages.

US Food and Drug Administration.

Medication shortages are emerging as a patient safety issue. This Web site helps hospitals and practitioners monitor drug availability and design processes to manage shortages in daily care.

Press Release/Announcement

Implantable infusion pumps in the magnetic resonance (MR) environment: FDA safety communication—important safety precautions.

MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 11, 2017.

Hazards in the magnetic resonance imaging environment can result in patient harm. This announcement raises awareness of inaccuracies and disruptions that may affect the safety of patients with implantable infusion devices who undergo an MRI exam. The statement recommends that patients inform their care team and carry an implant card with information about the implanted device to prevent these problems.

Tools/Toolkit > Fact Sheet/FAQs

Four Medication Safety Tips for Older Adults.

FDA Consumer Health Information. Silver Spring, MD: US Food and Drug Administration; September 20, 2016.

Highlighting how aging affects medication absorption that may lead to complications, this fact sheet offers recommendations for older patients to follow instructions, maintain a medication list, be aware of drug interaction potential, and perform an annual review of medications with clinicians to help them take prescriptions safely.

Web Resource > Government Resource

Interference between CT and Electronic Medical Devices.

Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration. April 12, 2016.

This website alerts clinicians and patients to risks for patient harm associated with implanted electronic medical devices, such as insulin infusion pump and pacemakers, when x-rays are used during CT examinations.

Press Release/Announcement

Infections associated with reprocessed flexible bronchoscopes.

FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; September 17, 2015.

Use of incompletely cleaned medical devices has been linked to health care–associated infections. Drawing from reports submitted to the FDA regarding infections related to reprocessed flexible bronchoscopes, this announcement offers recommendations to enhance the reliability of scope sterilization methods.

Press Release/Announcement

FDA Drug Safety Communication: FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor).

MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; July 30, 2015.

Look-alike and sound-alike drug names can contribute to confusion and result in medication errors. To raise awareness of potential wrong-patient errors due to similarity between two proprietary names, this announcement describes near misses with the drugs at the prescribing and dispensing stage and suggests clinicians use the generic names for the medications to reduce risk of patient harm.

Legislation/Regulation

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.

Heparin is a high-alert anticoagulant that has been associated with patient harm due to issues with administration and contamination. This draft guidance seeks to engage insights from the field to help improve labeling practices. The deadline for officially submitting comments was October 7, 2015.

Press Release/Announcement

FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam).

FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; May 20, 2015.

Dosing information on drug labels should be clearly articulated to prevent confusion. This announcement raises awareness of a drug strength labeling change regarding active ingredients in the antibacterial drug Zerbaxa to improve dosing accuracy.

Press Release/Announcement

FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients.

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.

Press Release/Announcement

Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning.

FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; February 23, 2015.

Design limitations and production pressure may contribute to insufficient sterilization of complicated medical devices between uses. This announcement raises awareness of risks associated with inadequate cleaning of duodenoscopes that surfaced after a cluster of nosocomial infections at Ronald Reagan UCLA Medical Center.

Legislation/Regulation > Government Resource

Safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications.

Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; February 11, 2015.

Mistakes due to small-bore Luer connector similarities can contribute to patient harm. This guidance provides ways for manufacturers, policy makers, and product designers to prevent misconnections, including recommendations regarding improvements for labeling, user testing, and risk assessment.

Tools/Toolkit > Fact Sheet/FAQs

FDA Pharmacists Help Consumers Use Medicines Safely.

Silver Spring, MD: United States Food and Drug Administration; October 31, 2014.

Studies have shown that pharmacist involvement can prevent medication errors. To help patients take their medications safely, this consumer update discusses pharmacists as participants in a government drug information center and reveals the top five questions submitted along with their corresponding answers.

Tools/Toolkit

My Medicines.

Silver Spring, MD: US Food and Drug Administration. Office of Women's Health and National Association of Chain Drug Stores.

This toolkit offers tips for patients to prevent adverse drug events and provides a way to record important medication information such as a list of allergies, prescriptions, dosages, and conditions being treated.

Press Release/Announcement

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.

Web Resource > Multi-use Website

OpenFDA.

Silverspring, MD: US Food and Drug Administration.

This Web site provides access to large publicly available datasets for adverse drug events to enable developers, researchers, and consumers to use this information when designing medication safety improvement plans or projects. Planned updates to this site include data on recalls and product documentation.

Tools/Toolkit > Fact Sheet/FAQs

Be an Active Member of Your Health Care Team.

Silver Spring, MD: US Food and Drug Administration; April 2014.

This fact sheet describes five ways patients can contribute to and ensure safe medication use, including speaking up about medical history, asking questions, and following directions on prescription labels. A question guide is also provided to help consumers become informed about their medications.

Book/Report

Strategic Plan for Preventing and Mitigating Drug Shortages.

Silver Spring, MD: Food and Drug Administration; October 2013.

This report outlines the FDA's plans to address drug shortages, including streamlining tracking processes and developing early warning signals to identify potential shortages.

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