Serious Adverse Events / en Thu, 01 May 2025 22:47:29 -0500 Fri, 24 Aug 18 13:43:19 -0500 Study: Antibiotics are leading cause of ED visits for adverse drug events in kids /news/headline/2018-08-24-study-antibiotics-are-leading-cause-ed-visits-adverse-drug-events-kids <p>In children, antibiotics are the leading cause of emergency department visits for adverse drug events, according to a <a href="https://academic.oup.com/jpids/advance-article/doi/10.1093/jpids/piy066/5063274">Centers for Disease Control and Prevention study</a> published yesterday in the Journal of the Pediatric Infectious Diseases Society. The study estimates that 70,000 children 19 years or younger visited the ED for antibiotic-related adverse drug events each year from 2011–2015. Antibiotics save lives and are critical tools for treating infections, but they can lead to adverse drug events. AHA has compiled a number of resources on antibiotic stewardship, including a <a href="http://www.ahaphysicianforum.org/resources/appropriate-use/antimicrobial/index.shtml">toolkit</a> developed in collaboration with CDC and others. In addition, see the <a href="http://www.ahaphysicianforum.org/resources/appropriate-use/antimicrobial/content%20files%20pdf/CDC-Fact-Sheet.pdf">CDC factsheet</a> about antibiotic use.</p> Fri, 24 Aug 2018 13:43:19 -0500 Serious Adverse Events Case Study: Ochsner Health System - AI-powered Early-warning System Saves Lives /case-studies/2018-06-27-case-study-ochsner-health-system-ai-powered-early-warning-system-saves <div class="container row"> <div class="row"> <div class="col-md-9"> <h3 class="text-primary">Members in Action: Improve Quality and Patient Outcomes<br> Ochsner Health System – Jefferson, LA</h3> <hr> <p><img alt="doctor and nurse" class="hidden-xs pull-left" data-entity-type="file" data-entity-uuid="fc867071-b201-47b5-b7ba-5634705135a1" src="/sites/default/files/inline-images/ochsner-doctor-and-nurse-small.jpg" width="300" height="195">Ochsner Health System is breaking new ground by implementing an early-warning system aided by artificial intelligence (AI) designed to proactively prompt clinicians to intervene in a patient’s care. The goal is to identify patients at risk for “coding” and mitigate a deterioration of their health.</p> <p>Read the full case study below.</p> </div> </div> </div> Wed, 27 Jun 2018 13:26:42 -0500 Serious Adverse Events FDA announces drug compounding policy priorities, recall guidance /news/headline/2018-01-19-fda-announces-drug-compounding-policy-priorities-recall-guidance <p>The Food and Drug Administration yesterday issued a plan and <a href="https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm592610.htm?utm_campaign=2018%20Compounding%20Policy%20Priorities%20Plan&utm_medium=email&utm_source=Eloqua">related guidance</a> outlining how it will implement certain aspects of the Drug Quality and Security Act relevant to drug compounding outsourcing facilities and compounding pharmacies. The plan details how the FDA will address manufacturing standards for outsourcing facilities; regulate compounding from bulk drug substances; restrict compounding of drugs that are essentially copies of FDA-approved drugs; solidify the FDA’s partnership with state regulatory authorities; and provide guidance on other activities that compounders undertake. In other news yesterday, the FDA issued <a href="https://www.fda.gov/downloads/Safety/Recalls/IndustryGuidance/UCM592851.pdf">draft guidance</a> clarifying its policy on public warning and notification of recalled products, including drugs, medical devices and cosmetics. Specifically, the guidance outlines circumstances when a company should issue a public warning about a recall; describes the general timeline for companies to issue such a warning; discusses what information should be included in a public warning; and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient.</p> Fri, 19 Jan 2018 15:22:15 -0600 Serious Adverse Events Reducing the Risks of Wrong-Site Surgery: Safety Practices from The Joint Commission Center /ahahret-guides/2014-08-29-reducing-risks-wrong-site-surgery-safety-practices-joint-commission <p><img align="right" alt="Reducing the Risks of Wrong-Site Surgery: Safety Practices from The Joint Commission Center for Transforming Healthcare Project – August 2014" data-entity-type="file" data-entity-uuid="192a6b50-6a19-4ea4-a369-a55d9a5c3f27" src="/sites/default/files/inline-images/reducing-risks-wrong-site-surgery-safety-practices-joint-commission-center-transforming-healthcare-project-2014_tn.png" width="150" height="195">Although rare and difficult to study, wrong-site surgery is a serious risk recognized by health care organizations. Health care organizations in a variety of settings must manage the risks of wrong-site surgery to ensure the safety of patients. Preventing wrong-site surgery—which includes wrong-patient, wrong-procedure and wrong-side surgeries—is accomplished by creating a culture of safety and improving perioperative processes.</p> <p>As part of the <a href="http://www.centerfortransforminghealthcare.org/projects/detail.aspx?Project=2">Joint Commission Center for Transforming Healthcare wrong-site surgery project</a>, eight U.S. hospitals and ambulatory surgery centers measured the risk of wrong-site surgery in their perioperative processes, pinpointed the contributing causes and developed specific solutions targeted to each one. As a result, the health care organizations significantly reduced the number of surgical cases with risks for wrong-site surgery in four main areas: scheduling, pre-op/holding, operating room and organizational culture. Additional hospitals and ambulatory surgery centers that tested the work of the original organizations experienced the same improved results.</p> <p>The provider organziations are:</p> <ul> <li>AnMed Health, Anderson, S.C.</li> <li>Center for Health Ambulatory Surgery Center, Peoria, Ill.</li> <li>Holy Spirit Hospital, Harrisburg, Pa.</li> <li>La Veta Surgical Center, Orange, Calif.</li> <li>Mount Sinai Medical Center, New York, N.Y.</li> <li>Rhode Island Hospital, Providence, R.I.</li> <li>Seven Hills Surgery Center, Henderson, Nev.</li> <li>Thomas Jefferson University Hospital, Philadelphia, Pa.</li> </ul> <p>This report describes the types of risks for wrong-site surgery, their root causes and targeted solutions.</p> Fri, 29 Aug 2014 00:00:00 -0500 Serious Adverse Events