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- Communication Improvement 2
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- Error Reporting and Analysis
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- Legal and Policy Approaches 1
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- Device-related Complications 11
- Medical Complications 3
- Medication Errors/Preventable Adverse Drug Events 13
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Health Care Providers
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Search results for "Food and Drug Administration (FDA)"
- Error Reporting and Analysis
- Food and Drug Administration (FDA)
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 identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.
Silver Spring, MD: US Food and Drug Administration; April 9, 2019.
Efforts to address the opioid epidemic range from regulation to changes in pain management. This safety announcement raises awareness of potential harms associated with rapidly decreasing the dose of or discontinuing opioids for patients who may be physically dependent on the medication. It also announces a requirement regarding changes to prescribing information for opioids to provide expanded guidance on how to safely taper doses. Health care providers should discuss tapering plans with patients and provide ongoing monitoring and support.
US Food and Drug Administration. March 8, 2019.
Errors of commission during complex procedures can contribute to patient harm. Drawing from an analysis of medical device reports submitted to the Food and Drug Administration, this announcement seeks to raise awareness of common adverse events associated with surgical staplers and implantable staples. User-related problems include opening of the staple line, misapplied staples, and staple gun difficulties. Recommendations include ensuring availability of various staple sizes and avoiding use of staples on large blood vessels.
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.
FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; November 14, 2018.
This safety announcement raises awareness of pump failures, dosing errors, and other potential safety issues associated with implanted pumps. Recommendations to enhance safety include review of medication labeling to select appropriate medicines and concentrations as well as open discussions with patients about risks associated with pump and medication options.
Journal Article > Study
Magill SS, O'Leary E, Janelle SJ, et al; Emerging Infections Program Hospital Prevalence Survey Team. N Engl J Med. 2018;379:1732-1744.
Health care–associated infections (HAIs) are a key cause of preventable harm in hospitals. Successful programs to avert HAIs include the comprehensive unit-based safety program to reduce catheter-related bloodstream infections and the AHRQ Safety Program for Surgery to prevent surgical site infections. This survey of 12,299 patients at 199 hospitals on a single day enabled researchers to estimate the prevalence of HAIs in the United States. In 2015, 3.2% of hospitalized patients experienced an HAI, a 16% decrease compared to a similarly derived estimate in 2011. The most common HAIs were pneumonia and Clostridium difficile infections, while the biggest reductions were in urinary tract and surgical site infections. This data emphasizes the importance of identifying strategies to combat pneumonia in nonventilated patients, which remains common and less well-studied than other HAIs. A past PSNet perspective discussed the history around efforts to address preventable HAIs, including federal initiatives.
Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Silver Spring, MD: US Food and Drug Administration; September 29, 2018.
Silver Spring, MD: US Food and Drug Administration; April 2018.
Reliable use of medical devices is an important contributor to safe health care delivery. This report describes the US Food and Drug Administration's plan to raise awareness of problems with devices in the field, develop new devices with better safety and cybersecurity protections, and enhance innovation and the product life cycle through regulation.
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.
Tavernise S. New York Times. January 15, 2015.
This newspaper article discusses an investigation into how a saline solution that had been manufactured specifically for training purposes was inadvertently distributed and used for actual care and led to patient harm and death.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 21, 2011.
This announcement reports the recall of several mislabeled products, including the commonly used anticoagulant warfarin.
Journal Article > Commentary
Kaufman D, Weick-Brady M. Home Healthc Nurse. 2009;27:300-307.
This article surveys the main concerns in using medical devices at home and focuses on two initiatives by the US Center for Devices and Radiologic Health that help home health care workers report medical device failures and near misses.
Tools/Toolkit > Fact Sheet/FAQs
FDA Consumer Health Information. Silver Spring, MD: US Food and Drug Administration; February 27, 2009.
This fact sheet provides information for consumers about how to report adverse drug events and product complaints to the US Food and Drug Administration (FDA) through the Consumer Complaint Reporting system and MedWatch.
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.
Audiovisual > Audiovisual Presentation
Silver Spring, MD: US Food and Drug Administration; October 2008.
This tutorial and slide set for medical residents and students will introduce viewers to the FDA's MedWatch system, its drug safety information collection, and its dissemination effort.
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.
Tools/Toolkit > Fact Sheet/FAQs
Center for Drug Evaluation and Research, US Food and Drug Administration.
This Web site provides information on and access to quarterly reports and an interactive dashboard of medication-related incidents culled from FDA's Adverse Event Reporting System (FAERS) database and identifies potential safety issues.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 13, 2007.
This announcement describes a fatal overdose of a protease inhibitor in an infant and discusses how to prevent such occurrences.
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.
Roxane Laboratories Initiates a Nationwide Voluntary Recall of a Single Manufacturing Lot of Azathioprine Tablets in the U.S. and Puerto Rico.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; July 13, 2006.
This news release announces the recall of a manufacturing lot of Azathioprine. Bottles may have been erroneously filled with another medication, which could lead to serious health effects for those taking the drug.