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- Education and Training 3
- Error Reporting and Analysis 4
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- Technologic Approaches
- Device-related Complications 1
- Diagnostic Errors 1
- Medication Errors/Preventable Adverse Drug Events 6
- Surgical Complications 1
- Transfusion Complications 1
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- Non-Health Care Professionals 4
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Search results for "Food and Drug Administration (FDA)"
- Food and Drug Administration (FDA)
- Technologic Approaches
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.
FDA Safety Communication: caution when using robotically-assisted surgical devices in women's health including mastectomy and other cancer-related surgeries.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 28, 2019.
This announcement seeks to raise awareness of the potential risks associated with the use of robotic-assisted surgical devices in mastectomies or cancer-related care. Recommendations for patients who may seek to have robotically assisted surgery include asking about their surgeon's experience with these procedures and discussing benefits, risks, and alternatives regarding available treatment options with their health care provider. Suggestions for health care providers include completing specialized training on procedures they perform. A WebM&M commentary described the challenges and benefits associated with robotic surgery.
Journal Article > Commentary
U.S. Food and Drug Administration Precertification pilot program for digital health software: weighing the benefits and risks.
Lee TT, Kesselheim AS. Ann Intern Med. 2018;168:730-732.
Innovation is a valuable process in health care. However, when innovations are rapidly deployed, efforts to proactively identify and address safety concerns may fall short and lead to unintended consequences. This commentary describes a new program to expedite the review of digital health software and summarizes the benefits and potential harms that could result from the program.
Web Resource > Multi-use Website
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.
Journal Article > Study
Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.
Brajovic S, Piazza-Hepp T, Swartz L, Pan GD. Pharmacoepidemiol Drug Saf. 2012;21:565-570.
The Food and Drug Administration is piloting a new system that allows triggered reporting of suspected adverse drug events, with data automatically supplied from existing electronic medical record systems. This study evaluates the quality of such reports and identifies areas where the reports could be improved.
Web Resource > Government Resource
Bethesda, MD: National Library of Medicine, US Food and Drug Administration.
This Web site helps users to identify pills based on physical characteristics and includes links to additional drug information resources.
Potentially fatal errors with GDH-PQQ [glucose dehydrogenase pyrroloquinoline quinone] glucose monitoring technology.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 13, 2009.
This public health notification raises awareness of the potential for falsely elevated blood glucose readings in patients using therapeutic products containing certain non-glucose sugars.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; December 9, 2008.
This announcement recalls a particular lot of injectable potassium chloride solution due to incorrect barcode labeling, which could result in medication errors.
Shuren J. Federal Register. October 23, 2008;73:63153-63157.
This announcement invites field review of proposed information elements to be included in a Food and Drug Administration portal designed to collect drug- and product-related adverse event reports. The comment collection period is now closed.
Food and Drug Administration (FDA) Patient Safety News. Show #58. December 2006.
This video story reviews a high-profile medication error and suggests actions to prevent similar incidents from occurring.
Journal Article > Study
Follow-up study of medication errors reported to the Vaccine Adverse Event Reporting System (VAERS).
Varricchio F, Reed J, and the VAERS Working Group. South Med J. 2006;99:486-489.
The investigators analyzed medication errors submitted to a national database to assess whether they were true errors, the reasons for these errors, and responses to the errors.
Tools/Toolkit > Fact Sheet/FAQs
Frequently Asked Questions. Bethesda, MD: US Food and Drug Administration Center for Biologics Evaluation and Research; April 13, 2006.
This FAQ answers questions related to the FDA machine-readable bar-coding requirement for blood components.
Legislation/Regulation > Government Resource
US Food and Drug Administration, HHS. Final rule. Fed Regist. February 26, 2004;69(38):9119-9171.
The US Food and Drug Administration (FDA) requires certain human drug and biological product labels to contain bar codes. The rule aims to reduce the number of medication errors by allowing health care professionals to use bar code scanning equipment for necessary verification. This protects against an incorrect drug administration. Effective date: April 26, 2004.