2,728 research outputs found

    The Development of Practice Recommendations for Drug-Disease Interactions by Literature Review and Expert Opinion

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    Background: Drug-disease interactions negatively affect the benefit/risk ratio of drugs for specific populations. In these conditions drugs should be avoided, adjusted, or accompanied by extra monitoring. The motivation for many drug-disease interactions in the Summary of Product Characteristics (SmPC) is sometimes insufficiently supported by (accessible) evidence. As a consequence the translation of SmPC to clinical practice may lead to non-specific recommendations. For the translation of this information to the real world, it is necessary to evaluate the available knowledge about drug-disease interactions, and to formulate specific recommendations for prescribers and pharmacists. The aim of this paper is to describe a standardized method how to develop practice recommendations for drug-disease interactions by literature review and expert opinion. Methods: The development of recommendations for drug-disease interactions will follow a six-step plan involving a multidisciplinary expert panel (1). The scope of the drug-disease interaction will be specified by defining the disease and by describing relevant effects of this drug-disease interaction. Drugs possibly involved in this drug-disease interaction are selected by checking the official product information, literature, and expert opinion (2). Evidence will be collected from the official product information, guidelines, handbooks, and primary literature (3). Study characteristics and outcomes will be evaluated and presented in standardized reports, including preliminary conclusions on the clinical relevance and practice recommendations (4). The multidisciplinary expert panel will discuss the reports and will either adopt or adjust the conclusions (5). Practice recommendations will be integrated in clinical decision support systems and published (6). The results of the evaluated drug-disease interactions will remain up-to-date by screening new risk information, periodic literature review, and (re)assessments initiated by health care providers. Actionable Recommendations: The practice recommendations will result in advices for specific DDSI. The content and considerations of these DDSIs will be published and implemented in all Clinical Decision Support Systems in the Netherlands. Discussion: The recommendations result in professional guidance in the context of individual patient care. The professional will be supported in the decision making in concerning pharmacotherapy for the treatment of a medical problem, and the clinical risks of the proposed medication in combination with specific diseases

    The Development of Practice Recommendations for Drug-Disease Interactions by Literature Review and Expert Opinion

    Get PDF
    Background Drug-disease interactions negatively affect the benefit/risk ratio of drugs for specific populations. In these conditions drugs should be avoided, adjusted, or accompanied by extra monitoring. The motivation for many drug-disease interactions in the Summary of Product Characteristics (SmPC) is sometimes insufficiently supported by (accessible) evidence. As a consequence the translation of SmPC to clinical practice may lead to non-specific recommendations. For the translation of this information to the real world, it is necessary to evaluate the available knowledge about drug-disease interactions, and to formulate specific recommendations for prescribers and pharmacists. The aim of this paper is to describe a standardized method how to develop practice recommendations for drug-disease interactions by literature review and expert opinion. Methods The development of recommendations for drug-disease interactions will follow a six-step plan involving a multidisciplinary expert panel (1). The scope of the drug-disease interaction will be specified by defining the disease and by describing relevant effects of this drug-disease interaction. Drugs possibly involved in this drug-disease interaction are selected by checking the official product information, literature, and expert opinion (2). Evidence will be collected from the official product information, guidelines, handbooks, and primary literature (3). Study characteristics and outcomes will be evaluated and presented in standardized reports, including preliminary conclusions on the clinical relevance and practice recommendations (4). The multidisciplinary expert panel will discuss the reports and will either adopt or adjust the conclusions (5). Practice recommendations will be integrated in clinical decision support systems and published (6). The results of the evaluated drug-disease interactions will remain up-to-date by screening new risk information, periodic literature review, and (re)assessments initiated by health care providers. Actionable Recommendations The practice recommendations will result in advices for specific DDSI. The content and considerations of these DDSIs will be published and implemented in all Clinical Decision Support Systems in the Netherlands. Discussion The recommendations result in professional guidance in the context of individual patient care. The professional will be supported in the decision making in concerning pharmacotherapy for the treatment of a medical problem, and the clinical risks of the proposed medication in combination with specific diseases

    Factors Associated with Ordering and Completion of Laboratory Monitoring Tests for High-Risk Medications in the Ambulatory Setting: A Dissertation

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    Since the Institute of Medicine highlighted the devastating impact of medical errors in their seminal report, “To Err is Human” (2000), efforts have been underway to improve patient safety. A portion of medical errors are due to medication errors, and a large portion of these can be attributed to inadequate laboratory monitoring. In this thesis, I attempt to address this small but important corner of this patient safety endeavor. Why are patients not getting their laboratory monitoring tests? Do they fail to complete them or do doctors not order the tests in the first place? Which prescribers and which patients are least likely to do what is needed for testing to happen and what interventions would be most promising? To address these questions, I conducted a systematic review of existing interventions. I then proceeded with three aims: 1) To identify reasons that patients give for missing monitoring tests; 2) To identify patient and provider factors associated with monitoring test ordering; and 3) To identify patient and provider factors associated with completion of ordered testing. To achieve these aims, I worked with patients and data at the Fallon Clinic. For aim 1, I conducted a qualitative analysis of their reasons for missing tests as well as reporting completion and ordering rates. For aims 2 and 3, I used electronic medical record data and conducted a regression with patient and provider characteristics as covariates to identify factors contributing to test ordering and completion. Interviews revealed that patients had few barriers to completion, with forgetting being the most common reason for missing a test. The quantitative studies showed that: older patients with more interactions with the health care system were more likely to have tests ordered and were more likely to complete them; providers who more frequently prescribe a drug were more likely to order testing for it; and drug-test combinations that were particularly dangerous, indicated by a black box warning, were more likely to have appropriate ordering, though for these combinations, primary care providers were less likely to order tests appropriately, and patients were less likely to complete tests. Taken together, my work can inform future interventions in laboratory monitoring and patient safety

    Contextualized Drug–Drug Interaction Management Improves Clinical Utility Compared With Basic Drug–Drug Interaction Management in Hospitalized Patients

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    Drug–drug interactions (DDIs) frequently trigger adverse drug events or reduced efficacy. Most DDI alerts, however, are overridden because of irrelevance for the specific patient. Basic DDI clinical decision support (CDS) systems offer limited possibilities for decreasing the number of irrelevant DDI alerts without missing relevant ones. Computerized decision tree rules were designed to context-dependently suppress irrelevant DDI alerts. A crossover study was performed to compare the clinical utility of contextualized and basic DDI management in hospitalized patients. First, a basic DDI-CDS system was used in clinical practice while contextualized DDI alerts were collected in the background. Next, this process was reversed. All medication orders (MOs) from hospitalized patients with at least one DDI alert were included. The following outcome measures were used to assess clinical utility: positive predictive value (PPV), negative predictive value (NPV), number of pharmacy interventions (PIs)/1,000 MOs, and the median time spent on DDI management/1,000 MOs. During the basic DDI management phase 1,919 MOs/day were included, triggering 220 DDI alerts/1,000 MOs; showing 57 basic DDI alerts/1,000 MOs to pharmacy staff; PPV was 2.8% with 1.6 PIs/1,000 MOs costing 37.2 minutes/1,000 MOs. No DDIs were missed by the contextualized CDS system (NPV 100%). During the contextualized DDI management phase 1,853 MOs/day were included, triggering 244 basic DDI alerts/1,000 MOs, showing 9.6 contextualized DDIs/1,000 MOs to pharmacy staff; PPV was 41.4% (P &lt; 0.01), with 4.0 PIs/1,000 MOs (P &lt; 0.01) and 13.7 minutes/1,000 MOs. The clinical utility of contextualized DDI management exceeds that of basic DDI management.</p

    Contextualized Drug–Drug Interaction Management Improves Clinical Utility Compared With Basic Drug–Drug Interaction Management in Hospitalized Patients

    Get PDF
    Drug–drug interactions (DDIs) frequently trigger adverse drug events or reduced efficacy. Most DDI alerts, however, are overridden because of irrelevance for the specific patient. Basic DDI clinical decision support (CDS) systems offer limited possibilities for decreasing the number of irrelevant DDI alerts without missing relevant ones. Computerized decision tree rules were designed to context-dependently suppress irrelevant DDI alerts. A crossover study was performed to compare the clinical utility of contextualized and basic DDI management in hospitalized patients. First, a basic DDI-CDS system was used in clinical practice while contextualized DDI alerts were collected in the background. Next, this process was reversed. All medication orders (MOs) from hospitalized patients with at least one DDI alert were included. The following outcome measures were used to assess clinical utility: positive predictive value (PPV), negative predictive value (NPV), number of pharmacy interventions (PIs)/1,000 MOs, and the median time spent on DDI management/1,000 MOs. During the basic DDI management phase 1,919 MOs/day were included, triggering 220 DDI alerts/1,000 MOs; showing 57 basic DDI alerts/1,000 MOs to pharmacy staff; PPV was 2.8% with 1.6 PIs/1,000 MOs costing 37.2 minutes/1,000 MOs. No DDIs were missed by the contextualized CDS system (NPV 100%). During the contextualized DDI management phase 1,853 MOs/day were included, triggering 244 basic DDI alerts/1,000 MOs, showing 9.6 contextualized DDIs/1,000 MOs to pharmacy staff; PPV was 41.4% (P &lt; 0.01), with 4.0 PIs/1,000 MOs (P &lt; 0.01) and 13.7 minutes/1,000 MOs. The clinical utility of contextualized DDI management exceeds that of basic DDI management.</p

    Timely follow-up of abnormal diagnostic imaging test results in an outpatient setting: are electronic medical records achieving their potential?

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    BACKGROUND: Given the fragmentation of outpatient care, timely follow-up of abnormal diagnostic imaging results remains a challenge. We hypothesized that an electronic medical record (EMR) that facilitates the transmission and availability of critical imaging results through either automated notification (alerting) or direct access to the primary report would eliminate this problem. METHODS: We studied critical imaging alert notifications in the outpatient setting of a tertiary care Department of Veterans Affairs facility from November 2007 to June 2008. Tracking software determined whether the alert was acknowledged (ie, health care practitioner/provider [HCP] opened the message for viewing) within 2 weeks of transmission; acknowledged alerts were considered read. We reviewed medical records and contacted HCPs to determine timely follow-up actions (eg, ordering a follow-up test or consultation) within 4 weeks of transmission. Multivariable logistic regression models accounting for clustering effect by HCPs analyzed predictors for 2 outcomes: lack of acknowledgment and lack of timely follow-up. RESULTS: Of 123 638 studies (including radiographs, computed tomographic scans, ultrasonograms, magnetic resonance images, and mammograms), 1196 images (0.97%) generated alerts; 217 (18.1%) of these were unacknowledged. Alerts had a higher risk of being unacknowledged when the ordering HCPs were trainees (odds ratio [OR], 5.58; 95% confidence interval [CI], 2.86-10.89) and when dual-alert (\u3e1 HCP alerted) as opposed to single-alert communication was used (OR, 2.02; 95% CI, 1.22-3.36). Timely follow-up was lacking in 92 (7.7% of all alerts) and was similar for acknowledged and unacknowledged alerts (7.3% vs 9.7%; P = .22). Risk for lack of timely follow-up was higher with dual-alert communication (OR, 1.99; 95% CI, 1.06-3.48) but lower when additional verbal communication was used by the radiologist (OR, 0.12; 95% CI, 0.04-0.38). Nearly all abnormal results lacking timely follow-up at 4 weeks were eventually found to have measurable clinical impact in terms of further diagnostic testing or treatment. CONCLUSIONS: Critical imaging results may not receive timely follow-up actions even when HCPs receive and read results in an advanced, integrated electronic medical record system. A multidisciplinary approach is needed to improve patient safety in this area

    Unlocking therapeutic symphonies:Innovations in clinical decision support for drug-disease interactions in kidney transplantation

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    Introduction: Drug-disease interactions (DDSIs) are associated with increasing morbidity, mortality, and healthcare costs. These interactions are preventable if recognized and managed properly. Medication safety is critical in kidney transplant patients due to polypharmacy, co-morbidities, and susceptibility to adverse events. Clinical decision support systems (CDSSs) can play a key role therein. Therefore, this study aims to report on the process of developing an innovative, patient-centered, context-aware CDSS for managing DDSIs in kidney recipients. Material and Methods: Clinically important DDSIs were identified in the medications of patients at a kidney transplant outpatient clinic. Subsequently, rules for their detection and management were extracted based on pharmacology references and clinical expertise. A CDSS was developed and piloted following recommendations on medication CDSS design principles. Results: The knowledge base for this CDSS was developed with clinical context sensitivity. We defined priority levels for alerts, established associated display rules, and determined necessary actions based on the transplantation clinical workflow. The DDSI-CDSS correctly detected 37 DDSIs and displayed nine warnings and 28 cautionary alerts for the medications of 113 study patients (32.7% DDSI rate). The system fired three warnings for diltiazem in bradyarrhythmia, and two for each of the following medications and underlying diseases: aspirin in asthma, erythropoietin alfa in hypertension, and gemfibrozil in gall bladder disease. The potential consequences of the identified DDSIs were GI complications (17%), deterioration of the existing disease/condition (6.1%), and an increased risk of arrhythmias (2.6%), thrombosis (2.6%), and hypertension (1.7%). Complying with system alerts and recommendations would potentially prevent all these DDSIs. Conclusion: This study delineates the process of developing an evidence-based DDSI-CDSS for kidney transplantation, laying the groundwork for future advancements. Our results underscore the clinical significance of these interactions and emphasize the imperative for their accurate and timely detection, particularly in these vulnerable patients.</p
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