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Search results for "Press Release/Announcement"
- Press Release/Announcement
- Medication Safety
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.
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.
Washington DC: National Academy of Medicine and the Aspen Institute.
Despite increased awareness regarding the public health impacts of opioid misuse and overdose in the United States, the complexity of the problem has hindered the effectiveness of improvement efforts. This website highlights the work of a multiorganizational collaborative to explore systemic solutions to address the opioid crisis. An Annual Perspective discussed the impact of the opioid epidemic on patient safety.
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.
Institute for Safe Medication Practices.
Horsham, PA: Institute for Safe Medication Practices; 2018.
Results from this survey will inform the revision of a high-alert medication list used to raise awareness about drugs that have heightened potential to cause patient harm if used incorrectly.
Safe handling of concentrated electrolyte products from outsourcing facilities during critical drug shortages.
National Alert Network. Horsham, PA: Institute for Safe Medication Practices; Bethesda, MD: American Society of Health-System Pharmacists. May 24, 2018.
Drug shortages can necessitate hospitals to find alternative sources for important medications. This alert raises awareness of risks associated with potassium chloride use due to variations in labeling, packaging, or concentration of outsourced medications. Recommendations include use of barcode scanning and communicating with staff regarding drug shortages.
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.
The Institute for Safe Medication Practices.
Structured interaction with a wide variety of experts and environments enables medication safety improvement. This 2-week educational program provides international clinicians with the opportunity to work with leaders based in the United States to engage in incident analysis, project design, and strategic planning to enhance medication safety efforts in their home countries.
Food and Drug Administration, Institute for Safe Medication Practices.
This fellowship program provides clinicians with learning opportunities at the Institute for Safe Medication Practices and the US Food and Drug Administration. The appointment consists of a pair of successive 6-month positions designed to provide experience in both system improvement and regulatory approaches to enhance medication safety. The process for submitting applications is now closed.
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.
National Alert Network. Horsham, PA: Institute for Safe Medication Practices; Bethesda, MD: American Society of Health-System Pharmacists. October 12, 2017.
Care devices that enable patients to administer medicines at home can have unintended consequences. This alert raises awareness of hazards related to insulin pen misuse and offers recommendations to reduce risks, such as training patients to properly use pen needles and engaging community pharmacists in verifying that patients understand appropriate administration techniques.
Horsham, PA: Institute for Safe Medication Practices; 2017.
High-alert medications have the potential to cause substantial patient harm if administration mistakes occur. This assessment tool will enable organizations across a range of care environments to determine opportunities for improvement in 11 high-alert medication categories. In addition, the tool provides an opportunity for organizations to submit their data anonymously to a national data collection effort led by the Institute for Safe Medication Practices to define the current state of high-alert medication practices in health care. The data submission process is now closed.
Institute for Safe Medication Practices.
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.
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 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.