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- Device-related Complications 20
- Diagnostic Errors 4
- Discontinuities, Gaps, and Hand-Off Problems 2
- Identification Errors 1
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- Medication Errors/Preventable Adverse Drug Events 36
- MRI safety 2
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- Transfusion Complications 1
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Health Care Providers
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United States of America
United States Federal Government
- Department of Health and Human Services (HHS) 86
- United States Federal Government
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Search results for "Press Release/Announcement"
- Press Release/Announcement
- United States Federal Government
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.
Notice of Intent to Publish Funding Opportunity Announcement to Improve Care Transitions Through the Use of Interoperable Health Information Technology (R01).
Rockville, MD: Agency for Healthcare Research and Quality; January 28, 2019. AHRQ Publication No. NOT-HS-19-009.
The introduction of information technology has transformed health care. This notice of intent from AHRQ announces an upcoming funding opportunity to support research exploring the adoption of interoperable information technologies to improve communication during transitions. The pending funding will help to refine and develop methods to assess implementation success.
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.
Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs.
Washington, DC: Office of the National Coordinator for Health Information Technology; November 28, 2018.
Clinician burnout is a persistent threat to patient safety, and electronic health records have been identified as a high-profile contributor to the problem. This call for public comments on a draft report seeks insights on specific goals and recommended strategies to address the issue. The approaches outlined focus on reducing the time burden associated with frontline electronic health record use. The option for submitting comments is closed.
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.
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.
Rockville, MD: Agency for Healthcare Research and Quality. Special Emphasis Notice. August 2, 2018. Publication No. NOT-HS-18-015.
This announcement highlights Agency for Healthcare Research and Quality funding opportunities for health services research to assess local, state, and system-level policy to address the opioid crisis, evaluate interventions to minimize opioid misuse, and understand the rapid increase in opioid-related hospitalizations.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration. May 29, 2018.
Surgical fires can result in patient harm. This announcement provides information about causes of surgical fires and reviews FDA recommendations to prevent them, such as presurgery fire risk assessment, promoting team communication, and fire management planning. A WebM&M commentary discussed common sources of operating room fires and how to reduce risks.
Bethesda, MD: Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health. May 21, 2018. PA-18-790; PA-18-791.
Drug Enforcement Administration. April 28, 2018.
Removing unused medications from the home can help prevent accidental exposure to unneeded medications and limit their availability for misuse. This annual program provides patients with an opportunity to discard medications safely. The sponsors also provide education to highlight the importance of appropriate disposal of unused prescription drugs as a medication safety activity.
FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 11, 2018.
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.
Notice of Intent to Publish Funding Opportunity Announcements to Promote Implementation Science (R01) and Dissemination and Implementation Studies (R18).
Rockville, MD: Agency for Healthcare Research and Quality; October 25, 2016. AHRQ Publication No. NOT-HS-17-002.
Implementation science has been highlighted as a key component to achieve progress. This notice of intent from AHRQ provides information about two upcoming funding opportunities to support the adoption of implementation science in safety and quality improvement work. One (RO1) will help to refine and develop methods to assess implementation success and the other (R18) will support the dissemination of evidence-based patient-centered improvements.
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.
Rockville, MD: Agency for Healthcare Research and Quality. Special Emphasis Notice. March 9, 2016. Publication No.NOT-HS-16-009.
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.
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.
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.
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.