scholarly journals High-priority drug-drug interaction clinical decision support overrides in a newly implemented commercial computerized provider order-entry system: Override appropriateness and adverse drug events

2020 ◽  
Vol 27 (6) ◽  
pp. 893-900 ◽  
Author(s):  
Heba Edrees ◽  
Mary G Amato ◽  
Adrian Wong ◽  
Diane L Seger ◽  
David W Bates
Keyword(s):  
Drug Interaction ◽  
Adverse Drug Events ◽  
Clinical Decision ◽  
Medication Administration ◽  
Order Entry ◽  
Chi Square ◽  
Computerized Provider Order Entry ◽  
Chi Square Test ◽  
Drug Drug Interaction ◽  
Outpatient Settings

Abstract Objective The study sought to determine frequency and appropriateness of overrides of high-priority drug-drug interaction (DDI) alerts and whether adverse drug events (ADEs) were associated with overrides in a newly implemented electronic health record. Materials and Methods We conducted a retrospective study of overridden high-priority DDI alerts occurring from April 1, 2016, to March 31, 2017, from inpatient and outpatient settings at an academic health center. We studied highest-severity DDIs that were previously designated as “hard stops” and additional high-priority DDIs identified from clinical experience and literature review. All highest-severity alert overrides (n = 193) plus a stratified random sample of additional overrides (n = 371) were evaluated for override appropriateness, using predetermined criteria. Charts were reviewed to identify ADEs for overrides that resulted in medication administration. A chi-square test was used to compare ADE rate by override appropriateness. Results Of 16 011 alerts presented to providers, 15 318 (95.7%) were overridden, including 193 (87.3%) of the highest-severity DDIs and 15 125 (95.8%) of additional DDIs. Override appropriateness was 45.4% overall, 0.5% for highest-severity DDIs and 68.7% for additional DDIs. For alerts that resulted in medication administration (n = 423, 75.0%), 29 ADEs were identified (6.9%, 5.1 per 100 overrides). The rate of ADEs was higher with inappropriate vs appropriate overrides (9.4% vs 4.3%; P = .038). Conclusions The override rate was nearly 90% for even the highest-severity DDI alerts, indicating that stronger suggestions should be made for these alerts, while other alerts should be evaluated for potential suppression.

scholarly journals Appropriateness of Overridden Alerts in Computerized Physician Order Entry: Systematic Review (Preprint)

2019 ◽  
Author(s):  
Tahmina Nasrin Poly ◽  
Md.Mohaimenul Islam ◽  
Hsuan-Chia Yang ◽  
Yu-Chuan (Jack) Li
Keyword(s):  
Systematic Review ◽  
Drug Interaction ◽  
Drug Allergy ◽  
Adverse Drug Events ◽  
Clinical Decision ◽  
Drug Drug Interaction ◽  
Indispensable Tool ◽  
Physician Order Entry ◽  
Clear Information

BACKGROUND The clinical decision support system (CDSS) has become an indispensable tool for reducing medication errors and adverse drug events. However, numerous studies have reported that CDSS alerts are often overridden. The increase in override rates has raised questions about the appropriateness of CDSS application along with concerns about patient safety and quality of care. OBJECTIVE The aim of this study was to conduct a systematic review to examine the override rate, the reasons for the alert override at the time of prescribing, and evaluate the appropriateness of overrides. METHODS We searched electronic databases, including Google Scholar, PubMed, Embase, Scopus, and Web of Science, without language restrictions between January 1, 2000 and March 31, 2019. Two authors independently extracted data and crosschecked the extraction to avoid errors. The quality of the included studies was examined following Cochrane guidelines. RESULTS We included 23 articles in our systematic review. The range of average override alerts was 46.2%-96.2%. An average of 29.4%-100% of the overrides alerts were classified as appropriate, and the rate of appropriateness varied according to the alert type (drug-allergy interaction 63.4%-100%, drug-drug interaction 0%-95%, dose 43.9%-88.8%, geriatric 14.3%-57%, renal 27%-87.5%). The interrater reliability for the assessment of override alerts appropriateness was excellent (kappa=0.79-0.97). The most common reasons given for the override were “will monitor” and “patients have tolerated before.” CONCLUSIONS The findings of our study show that alert override rates are high, and certain categories of overrides such as drug-drug interaction, renal, and geriatric were classified as inappropriate. Nevertheless, large proportions of drug duplication, drug-allergy, and formulary alerts were appropriate, suggesting that these groups of alerts can be primary targets to revise and update the system for reducing alert fatigue. Future efforts should also focus on optimizing alert types, providing clear information, and explaining the rationale of the alert so that essential alerts are not inappropriately overridden.

scholarly journals Appropriateness of Overridden Alerts in Computerized Physician Order Entry: Systematic Review

10.2196/15653 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e15653 ◽  
Author(s):  
Tahmina Nasrin Poly ◽  
Md.Mohaimenul Islam ◽  
Hsuan-Chia Yang ◽  
Yu-Chuan (Jack) Li
Keyword(s):  
Systematic Review ◽  
Drug Interaction ◽  
Drug Allergy ◽  
Adverse Drug Events ◽  
Clinical Decision ◽  
Drug Drug Interaction ◽  
Indispensable Tool ◽  
Physician Order Entry ◽  
Clear Information

Background The clinical decision support system (CDSS) has become an indispensable tool for reducing medication errors and adverse drug events. However, numerous studies have reported that CDSS alerts are often overridden. The increase in override rates has raised questions about the appropriateness of CDSS application along with concerns about patient safety and quality of care. Objective The aim of this study was to conduct a systematic review to examine the override rate, the reasons for the alert override at the time of prescribing, and evaluate the appropriateness of overrides. Methods We searched electronic databases, including Google Scholar, PubMed, Embase, Scopus, and Web of Science, without language restrictions between January 1, 2000 and March 31, 2019. Two authors independently extracted data and crosschecked the extraction to avoid errors. The quality of the included studies was examined following Cochrane guidelines. Results We included 23 articles in our systematic review. The range of average override alerts was 46.2%-96.2%. An average of 29.4%-100% of the overrides alerts were classified as appropriate, and the rate of appropriateness varied according to the alert type (drug-allergy interaction 63.4%-100%, drug-drug interaction 0%-95%, dose 43.9%-88.8%, geriatric 14.3%-57%, renal 27%-87.5%). The interrater reliability for the assessment of override alerts appropriateness was excellent (kappa=0.79-0.97). The most common reasons given for the override were “will monitor” and “patients have tolerated before.” Conclusions The findings of our study show that alert override rates are high, and certain categories of overrides such as drug-drug interaction, renal, and geriatric were classified as inappropriate. Nevertheless, large proportions of drug duplication, drug-allergy, and formulary alerts were appropriate, suggesting that these groups of alerts can be primary targets to revise and update the system for reducing alert fatigue. Future efforts should also focus on optimizing alert types, providing clear information, and explaining the rationale of the alert so that essential alerts are not inappropriately overridden.

scholarly journals Implementation Strategies of a Quality Improvement Initiative for Hospital-Acquired Clostridioides difficile Infection Prevention

2020 ◽  
Vol 41 (S1) ◽  
pp. s279-s280
Author(s):  
Nicole Lamont ◽  
Lauren Bresee ◽  
Kathryn Bush ◽  
Blanda Chow ◽  
Bruce Dalton ◽  
...  
Keyword(s):  
Decision Support ◽  
Focus Groups ◽  
Clinical Decision Support ◽  
Implementation Strategy ◽  
Clinical Decision ◽  
Medication Administration ◽  
Quality Improvement Initiative ◽  
Order Entry ◽  
Clostridioides Difficile ◽  
Number Of Patients

Background:Clostridioides difficile infection (CDI) is the most common cause of infectious diarrhea in hospitalized patients. Probiotics have been studied as a measure to prevent CDI. Timely probiotic administration to at-risk patients receiving systemic antimicrobials presents significant challenges. We sought to determine optimal implementation methods to administer probiotics to all adult inpatients aged 55 years receiving a course of systemic antimicrobials across an entire health region. Methods: Using a randomized stepped-wedge design across 4 acute-care hospitals (n = 2,490 beds), the probiotic Bio-K+ was prescribed daily to patients receiving systemic antimicrobials and was continued for 5 days after antimicrobial discontinuation. Focus groups and interviews were conducted to identify barriers, and the implementation strategy was adapted to address the key identified barriers. The implementation strategy included clinical decision support involving a linked flag on antibiotic ordering and a 1-click order entry within the electronic medical record (EMR), provider and patient education (written/videos/in-person), and local site champions. Protocol adherence was measured by tracking the number of patients on therapeutic antimicrobials that received BioK+ based on the bedside nursing EMR medication administration records. Adherence rates were sorted by hospital and unit in 48- and 72-hour intervals with recording of percentile distribution of time (days) to receipt of the first antimicrobial. Results: In total, 340 education sessions with >1,800 key stakeholders occurred before and during implementation across the 4 involved hospitals. The overall adherence of probiotic ordering for wards with antimicrobial orders was 78% and 80% at 48 and 72 hours, respectively over 72 patient months. Individual hospital adherence rates varied between 77% and 80% at 48 hours and between 79% and 83% at 72 hours. Of 246,144 scheduled probiotic orders, 94% were administered at the bedside within a median of 0.61 days (75th percentile, 0.88), 0.47 days (75th percentile, 0.86), 0.71 days (75th percentile, 0.92) and 0.67 days (75th percentile, 0.93), respectively, at the 4 sites after receipt of first antimicrobial. The key themes from the focus groups emphasized the usefulness of the linked flag alert for probiotics on antibiotic ordering, the ease of the EMR 1-click order entry, and the importance of the education sessions. Conclusions: Electronic clinical decision support, education, and local champion support achieved a high implementation rate consistent across all sites. Use of a 1-click order entry in the EMR was considered a key component of the success of the implementation and should be considered for any implementation strategy for a stewardship initiative. Achieving high prescribing adherence allows more precision in evaluating the effectiveness of the probiotic strategy.Funding: Partnerships for Research and Innovation in the Health System, Alberta Innovates/Health Solutions Funding: AwardDisclosures: None

Prevalence and trend of potential drug–drug interaction among children with depression in U.S. outpatient settings

2019 ◽  
Vol 10 (4) ◽  
pp. 393-399
Author(s):  
L. Leanne Lai ◽  
Goar Alvarez ◽  
Linh Dang ◽  
Dung Vuong ◽  
Vy Ngo ◽  
...  
Keyword(s):  
Drug Interaction ◽  
Potential Drug ◽  
Drug Drug Interaction ◽  
Outpatient Settings

scholarly journals An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period

2021 ◽  
pp. 01-06
Author(s):  
Unnati Saxena ◽  
Debdipta Bose ◽  
Shruti Saha ◽  
Nithya J Gogtay ◽  
Urmila M Thatte
Keyword(s):  
Adverse Drug Events ◽  
The United States ◽  
Institutional Review Boards ◽  
Chi Square ◽  
Institutional Review ◽  
United States Food ◽  
Post Marketing ◽  
Chi Square Test ◽  
Us Fda ◽  
Review Boards

The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits. WLs were reviewed and classified as per stakeholders and further categorised as per predefined violation themes. The chi-square test was performed for trend analysis of WLs. A total of 62 WLs were issued to the three stakeholders. The maximum number of WLs were issued to the clinical investigators (36/62, 58.06%), followed by sponsors (19/62, 30.64%), and least to the IRBs (7/62, 11.29%). Among sponsors, lack of standard operating procedures for the monitoring, receipt, evaluation and reporting of post-marketing adverse drug events was the most common violation theme (8/19, 42.1%). Among clinical investigators, deviation from investigational plan was the most common violation theme (31/36, 86.11%.). For IRBs, inadequate documentation was the most common violation theme (6/7, 85.71%). We saw an overall reduction in the number of WLs issued to the stakeholders. Thus, we identified multiple areas on which each stakeholder should work for improvement.

scholarly journals Influenza With and Without Fever: Clinical Predictors and Impact on Outcomes in Patients Requiring Hospitalization

2020 ◽  
Vol 7 (7) ◽  
Author(s):  
Benjamin J Smith ◽  
David J Price ◽  
Douglas Johnson ◽  
Bruce Garbutt ◽  
Michelle Thompson ◽  
...  
Keyword(s):  
Clinical Decision Making ◽  
Antiviral Treatment ◽  
Delayed Diagnosis ◽  
Clinical Decision ◽  
Case Definition ◽  
Influenza B ◽  
Clinical Predictors ◽  
Chi Square ◽  
Chi Square Test ◽  
The Impact

Abstract Background The Infectious Diseases Society of America influenza guidelines no longer require fever as part of their influenza case definition in patients requiring hospitalization. However, the impact of fever or lack of fever on clinical decision-making and patient outcomes has not been studied. Methods We conducted a retrospective review of adult patients admitted to our tertiary health service between April 2016 and June 2019 with laboratory-confirmed influenza, with and without fever (≥37.8ºC). Patient demographics, presenting features, and outcomes were analyzed using Pearson’s chi-square test, the Wilcoxon rank-sum test, and logistic regression. Results Of 578 influenza inpatients, 219 (37.9%) had no fever at presentation. Fever was less likely in individuals with a nonrespiratory syndrome (adjusted odds ratio [aOR], 0.44; 95% CI, 0.26–0.77), symptoms for ≥3 days (aOR, 0.53; 95% CI, 0.36–0.78), influenza B infection (aOR, 0.45; 95% CI, 0.29–0.70), chronic lung disease (aOR, 0.55; 95% CI, 0.37–0.81), age ≥65 (aOR, 0.36; 95% CI, 0.23–0.54), and female sex (aOR, 0.69; 95% CI, 0.48–0.99). Patients without fever had lower rates of testing for influenza in the emergency department (64.8% vs 77.2%; P = .002) and longer inpatient stays (median, 2.4 vs 1.9 days; P = .015). These patients were less likely to receive antiviral treatment (55.7% vs 65.6%; P = .024) and more likely die in the hospital (3.2% vs 0.6%; P = .031), and these differences persisted after adjustment for potential confounders. Conclusions Absence of fever in influenza is associated with delayed diagnosis, longer length of stay, and higher mortality.

scholarly journals Patient safety in nursing care during medication administration

2018 ◽  
Vol 26 (0) ◽  
Author(s):  
Júlian Katrin Albuquerque de Oliveira ◽  
Eliana Ofélia Llapa-Rodriguez ◽  
Iza Maria Fraga Lobo ◽  
Luciana de Santana Lôbo Silva ◽  
Simone de Godoy ◽  
...  
Keyword(s):  
Hand Hygiene ◽  
Medication Administration ◽  
Test Results ◽  
Chi Square ◽  
Exact Test ◽  
Direct Observations ◽  
Nursing Team ◽  
Chi Square Test ◽  
Vascular Catheters ◽  
Multidose Vial

ABSTRACT Objective: to evaluate the conformity of care practices of the nursing team during the administration of drugs through central vascular catheter. Method: a descriptive, prospective, observational study conducted in an Intensive Care Unit. The non-probabilistic intentional sample consisted of 3402 observations of drug administrations in patients with central vascular catheters. The previously validated collection instrument was constructed based on the Guideline for Prevention of Intravascular catheter-related infections. Data was collected through direct observations of nursing practices performed by the nursing team. The analysis used analytical, descriptive and inferential statistics (Chi-square test and Fisher’s exact test). Results: a total of 3402 procedures of drug administrations were observed. Female nursing technicians performed the highest number of actions. In none of the procedures did the professional perform all necessary actions. 0.2% of drug administrations were preceded by hand hygiene and 1.3% by disinfection of the multidose vial, ampoule or injectors. Conclusion: the practice evaluated was classified as undesirable. Failure to achieve the desired conformity was probably due to the low adherence of professionals to the practice of hand hygiene and disinfection of materials, injectors and connectors.

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