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    Standardizing adverse drug event reporting data

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    Standardizing adverse drug event reporting data

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    Are We Making Smart Pumps Smarter?

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    Background: Medication errors comprise a significant proportion of medical errors, and are abundant, costly, and associated with causing harm to patients via adverse drug events. The most serious medication errors often involve IV medications. Smart pumps were developed to improve patient safety by reducing medication errors. While some studies have found that smart pumps do not decrease medication errors, most have found they are effective to some degree. It is believed that routinely analyzing data on smart pump alerts, making corresponding adjustments in the drug libraries, and analyzing those adjustments can reduce alarm fatigue, which may then decrease medication errors by resulting in less smart pump users overriding the alerts and utilizing workarounds of smart pump safety features. Objective: The objective of this study is to assess if changes made to the Indiana University Health system smart pump drug library decreased nuisance alerts by comparing the actions taken in response to alerts before and after the changes were made. Methods: For a given change made to the Indiana University Health smart pump drug library on April 1, 2016, actions taken in response to alerts corresponding to that change three months prior to and three months after the change were analyzed. The primary outcome was the percent of total alerts that were overrides. Using data from the smart pumps, the number of overrides, reprograms, cancels, and total alerts for each drug in the first and second quarter were recorded. The percentage of total alerts that were overrides, the percentage of total alerts that were reprograms, and the ratio of overrides to reprograms for each quarter were calculated. Results: Analysis was conducted on 8 drugs: carboplatin, fentanyl PCA, hydromorphone PCA, morphine PCA, morphine PCA 10-24kg, morphine PCA \u3e40kg, naloxone, and octreotide. From the first quarter to the second quarter, the percent of overrides increased for 3 drugs, but for all 3, the number of overrides and total alerts decreased. Of the 5 drugs that had a decrease in the percent of overrides, 3 had an increase in the number of overrides and total alerts. Only 2 drugs had a decrease in the percent of overrides and the number of overrides and total alerts. Statistical significance was achieved only for hydromorphone PCA and morphine PCA. The difference between the first and second quarters in the all the measured outcomes varied between the drugs. Conclusions: Forming any definitive conclusions was difficult due to the results containing a significant amount of variation. The literature suggests methods to improve smart pump usage, and improve medication safety by extension. These methods are interfacing smart pumps with computerized physician order entry, clinical decision support systems, electronic medical record/electronic medication administration record, pharmacy information systems, bar-coded medication administration, and laboratory data, as well as improving smart pump safety features compliance through education of smart pump users, leadership support, including/consulting smart pump users in drug library design, and routinely using the event log data as a component of a continuous quality improvement program. These methods are all in line with the current, trending belief that the best method for preventing medication errors is making changes to the medication use system as a whole to correct underlying systems failures instead of addressing a single point, such a smart pump alerts

    Improving the clinical value and utility of CGM systems: issues and recommendations : a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

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    The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionise the use of intensive insulin therapy in diabetes; however, progress towards that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardised format for displaying results and uncertainty on how best to use CGM data to make therapeutic decisions. This scientific statement makes recommendations for systemic improvements in clinical use and regulatory (pre- and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes

    Improving the clinical value and utility of CGM systems: issues and recommendations: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

    Get PDF
    The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionize the use of intensive insulin therapy in diabetes; however, progress toward that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardized format for displaying results, and uncertainty on how best to use CGM data to make therapeutic decisions. This Scientific Statement makes recommendations for systemic improvements in clinical use and regulatory (pre- and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes

    Committed to Safety: Ten Case Studies on Reducing Harm to Patients

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    Presents case studies of healthcare organizations, clinical teams, and learning collaborations to illustrate successful innovations for improving patient safety nationwide. Includes actions taken, results achieved, lessons learned, and recommendations

    Actionable Patient Safety Solution (APSS) #3D: Pediatric Adverse Drug Events

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    This report presents a plan of action for introducing a program to reduce the incidence of pediatric adverse drug events (pADEs) and harm ... [that] combine[s] leadership strategies, software (healthcare IT), hardware (drug compounding systems, drug delivery technology, and physiological monitoring systems), and most importantly people (changes in clinical practice, protocols and education) to protect pediatric patients

    Managing toxicities associated with immune checkpoint inhibitors: consensus recommendations from the Society for Immunotherapy of Cancer (SITC) Toxicity Management Working Group.

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    Cancer immunotherapy has transformed the treatment of cancer. However, increasing use of immune-based therapies, including the widely used class of agents known as immune checkpoint inhibitors, has exposed a discrete group of immune-related adverse events (irAEs). Many of these are driven by the same immunologic mechanisms responsible for the drugs\u27 therapeutic effects, namely blockade of inhibitory mechanisms that suppress the immune system and protect body tissues from an unconstrained acute or chronic immune response. Skin, gut, endocrine, lung and musculoskeletal irAEs are relatively common, whereas cardiovascular, hematologic, renal, neurologic and ophthalmologic irAEs occur much less frequently. The majority of irAEs are mild to moderate in severity; however, serious and occasionally life-threatening irAEs are reported in the literature, and treatment-related deaths occur in up to 2% of patients, varying by ICI. Immunotherapy-related irAEs typically have a delayed onset and prolonged duration compared to adverse events from chemotherapy, and effective management depends on early recognition and prompt intervention with immune suppression and/or immunomodulatory strategies. There is an urgent need for multidisciplinary guidance reflecting broad-based perspectives on how to recognize, report and manage organ-specific toxicities until evidence-based data are available to inform clinical decision-making. The Society for Immunotherapy of Cancer (SITC) established a multidisciplinary Toxicity Management Working Group, which met for a full-day workshop to develop recommendations to standardize management of irAEs. Here we present their consensus recommendations on managing toxicities associated with immune checkpoint inhibitor therapy

    Retrospective Evaluation of Clinical Experience With Intravenous Ascorbic Acid in Patients With Cancer.

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    BACKGROUND: Intravenous ascorbic acid (IV AA) has been used extensively in cancer patients throughout the United States. Currently, there are limited data on the safety and clinical effects of IV AA. The purpose of this study was to expand the current literature using a retrospective analysis of adverse events and symptomatic changes of IV AA in a large sample of cancer patients. METHODS: We conducted a retrospective chart review of all patients receiving IV AA for cancer at the Thomas Jefferson University Hospital over a 7-year period. We assessed all reports of adverse events, laboratory findings, and hospital or emergency department admissions. We also reviewed quality-of-life data, including fatigue, nausea, pain, appetite, and mood. RESULTS: There were 86 patients who received a total of 3034 doses of IV AA ranging from 50 to 150g. In all, 32 patients received only ascorbic acid as part of their cancer management (1197 doses), whereas 54 patients received ascorbic acid in conjunction with chemotherapy (1837 doses). The most common adverse events related to ascorbic acid were temporary nausea and discomfort at the injection site. All events reported in the ascorbic acid alone group were associated with less than 3% of the total number of infusions. Patients, overall, reported improvements in fatigue, pain, and mood while receiving ascorbic acid. CONCLUSIONS: The results of this retrospective analysis support the growing evidence that IV AA is generally safe and well tolerated in patients with cancer, and may be useful in symptom management and improving quality of life

    Clinical review: Medication errors in critical care

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    Medication errors in critical care are frequent, serious, and predictable. Critically ill patients are prescribed twice as many medications as patients outside of the intensive care unit (ICU) and nearly all will suffer a potentially life-threatening error at some point during their stay. The aim of this article is to provide a basic review of medication errors in the ICU, identify risk factors for medication errors, and suggest strategies to prevent errors and manage their consequences
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