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In a subset analysis of the patients who failed primary guselkumab treatment, PGA*BSA was 20-3 before risankizumab treatment and 8-6 after treatment, demonstrating a 57-6% decrease. Although patients who failed primary guselkumab treatment seem to have a less effective response to risankizumab than the patients who failed secondary treatment with guselkumab, there was still a notable reduction in PGA*BSA. For the patients who failed secondary treatment, the PGA*BSA was 36-0 before risankizumab treatment and 3-6 after treatment, showing a 90% average decrease. [Extracted from the article]

Background: Bacillus cereus is a ubiquitous gram-positive rod-shaped bacterium that can cause sepsis and neuroinvasive disease in patients with acute leukemia or neutropenia., Methods: A single-center retrospective review was conducted to evaluate patients with acute leukemia, positive blood or cerebrospinal fluid test results for B cereus , and abnormal neuroradiographic findings between January 2018 and October 2022. Infection control practices were observed, environmental samples obtained, a dietary case-control study completed, and whole genome sequencing performed on environmental and clinical Bacillus isolates., Results: Five patients with B cereus neuroinvasive disease were identified. All patients had acute myeloid leukemia (AML), were receiving induction chemotherapy, and were neutropenic. Neurologic involvement included subarachnoid or intraparenchymal hemorrhage or brain abscess. All patients were treated with ciprofloxacin and survived with limited or no neurologic sequelae. B cereus was identified in 7 of 61 environmental samples and 1 of 19 dietary protein samples-these were unrelated to clinical isolates via sequencing. No point source was identified. Ciprofloxacin was added to the empiric antimicrobial regimen for patients with AML and prolonged or recurrent neutropenic fevers; no new cases were identified in the ensuing year., Conclusions: B cereus is ubiquitous in the hospital environment, at times leading to clusters with unrelated isolates. Fastidious infection control practices addressing a range of possible exposures are warranted, but their efficacy is unknown and they may not be sufficient to prevent all infections. Thus, including B cereus coverage in empiric regimens for patients with AML and persistent neutropenic fever may limit the morbidity of this pathogen., Competing Interests: Potential conflicts of interest. M. K.: royalties from UpToDate. All other authors report no potential conflicts., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Purpose: Anticoagulants often cause adverse drug events (ADEs), comprised of medication errors and adverse drug reactions, in patients. Our study objective was to determine the clinical characteristics, types, severity, cause, and outcomes of anticoagulation-associated ADEs from 2015-2020 (a contemporary period following implementation of an electronic health record, infusion device technology, and anticoagulant dosing nomograms) and to compare them with those of a historical period (2004-2009)., Methods: We reviewed all anticoagulant-associated ADEs reported as part of our hospital-wide safety system. Reviewers classified type, severity, root cause, and outcomes for each ADE according to standard definitions. Reviewers also assessed events for patient harm. Patients were followed up to 30 days after the event., Results: Despite implementation of enhanced patient safety technology and procedure, ADEs increased in the contemporary period. In the contemporary period, we found 925 patients who had 984 anticoagulation-associated ADEs, including 811 isolated medication errors (82.4%); 13 isolated adverse drug reactions (1.4%); and 160 combined medication errors, adverse drug reactions, or both (16.2%). Unfractionated heparin was the most frequent ADE-related anticoagulant (77.7%, contemporary period vs 58.3%, historical period). The most frequent anticoagulation-associated medication error in the contemporary period was wrong rate or frequency of administration (26.1%, n = 253), with the most frequent root cause being prescribing errors (21.3%, n = 207). The type, root cause, and harm from ADEs were similar between periods., Conclusions: We found that anticoagulation-associated ADEs occurred despite advances in patient safety technologies and practices. Events were common, suggesting marginal improvements in anticoagulant safety over time and ample opportunities for improvement., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Nontuberculous mycobacteria are water-avid pathogens that are associated with nosocomial infections., Objective: To describe the analysis and mitigation of a cluster of Mycobacterium abscessus infections in cardiac surgery patients., Design: Descriptive study., Setting: Brigham and Women's Hospital, Boston, Massachusetts., Participants: Four cardiac surgery patients., Intervention: Commonalities among cases were sought, potential sources were cultured, patient and environmental specimens were sequenced, and possible sources were abated., Measurements: Description of the cluster, investigation, and mitigation., Results: Whole-genome sequencing confirmed homology among clinical isolates. Patients were admitted during different periods to different rooms but on the same floor. There were no common operating rooms, ventilators, heater-cooler devices, or dialysis machines. Environmental cultures were notable for heavy mycobacterial growth in ice and water machines on the cluster unit but little or no growth in ice and water machines in the hospital's other 2 inpatient towers or in shower and sink faucet water in any of the hospital's 3 inpatient towers. Whole-genome sequencing confirmed the presence of a genetically identical element in ice and water machine and patient specimens. Investigation of the plumbing system revealed a commercial water purifier with charcoal filters and an ultraviolet irradiation unit leading to the ice and water machines in the cluster tower but not the hospital's other inpatient towers. Chlorine was present at normal levels in municipal source water but was undetectable downstream from the purification unit. There were no further cases after high-risk patients were switched to sterile and distilled water, ice and water machine maintenance was intensified, and the commercial purification system was decommissioned., Limitation: Transmission pathways were not clearly characterized., Conclusion: Well-intentioned efforts to modify water management systems may inadvertently increase infection risk for vulnerable patients., Primary Funding Source: National Institutes of Health.

Competing Interests: Conflicts of interest Dr Rosmarin has received honoraria as a consultant for AbbVie, Boehringer-Ingelheim, Bristol Meyers Squibb, Celgene, Concert, Dermavant, Dermira, Incyte, Janssen, Kyowa Kirin, Lilly, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharmaceuticals, UCB, and VielaBio. He has received research support from AbbVie, Amgen, Bristol Meyers Squibb, Celgene, Dermira, Galderma, Incyte, Janssen, Lilly, Merck, Novartis, Pfizer, and Regeneron Pharmaceuticals Inc. He has also served as a paid speaker for AbbVie, Amgen, Celgene, Janssen, Lilly, Novartis, Pfizer, Regeneron Pharmaceuticals Inc, and Sanofi. Authors Gao, Kahn, and Dumont and Drs Cohen, Fiumara, and Lam have no conflicts of interest to declare.

Objectives: The aims of the study were to assess a system-based approach to event investigation and analysis-collaborative case reviews (CCRs)-and to measure impact of clinical specialty on strength of action items prescribed., Methods: A fully integrated CCR process, co-led by radiology and an institutional patient safety program, was implemented on November 1, 2017, at our large academic medical center for evaluating adverse events involving radiology. Quality and safety teams performed reviews for events identified with other departments who maintained their existing processes. This institutional review board-approved study describes the program, including percentage of CCR from an institutional Electronic Safety Reporting System, percentage of CCR per specialty, and action item completion rates and strength (e.g., stronger) based on a Veterans Administration-designed hierarchy. χ2 analysis assessed impact of clinical specialty on strength of action prescribed., Results: Seventy-three CCR in 2018 generated 260 action items from 10 specialties. Seventy percent (51/73) were adverse events identified through Electronic Safety Reporting System. The specialty most frequently associated with CCR was radiology (16/73, 22%). Most action items (204/260, 78%) were completed in 1 year; stronger action items were completed in 71 (27%) of 260. Radiology was responsible for 61 action items; 25 (41%) of 61 were strong versus all other specialties with strong action items in 46 (23%) of 199 (P < 0.01)., Conclusions: An integrated multispecialty CCR co-led by the radiology department and an institutional patient safety program was associated with a higher proportion of CCR, stronger action items, and higher action item completion rate versus other hospital departments. Active engagement in CCR can provide insights into addressing adverse events and promote patient safety., Competing Interests: The authors disclose no conflict of interest., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

We interviewed 1,208 healthcare workers with positive SARS-CoV-2 tests between October 2020 and June 2021 to determine likely exposure sources. Overall, 689 (57.0%) had community exposures (479 from household members), 76 (6.3%) had hospital exposures (64 from other employees including 49 despite masking), 11 (0.9%) had community and hospital exposures, and 432 (35.8%) had no identifiable source of exposure., (© The Author(s) 2021.)

Competing Interests: D.R. has received honoraria as a consultant for AbbVie, Abcuro, AltruBio, Boehringer-Ingelheim, Bristol Myers Squibb, Celgene, Concert, Dermavant, Dermira, Incyte, Janssen, Kyowa Kirin, Lilly, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharmaceuticals, UCB, and Viela Bio; has received research support from AbbVie, Amgen, Bristol Meyers Squibb, Celgene, Dermira, Galderma, Incyte, Janssen, Lilly, Merck, Novartis, Pfizer, and Regeneron Pharmaceuticals, Inc; and has served as a paid speaker for AbbVie, Amgen, Celgene, Janssen, Lilly, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc, and Sanofi. The remaining authors have no funding or conflicts of interest to declare.

Many patients are fearful of acquiring coronavirus disease 2019 (COVID-19) in hospitals and clinics. We characterized the risk of COVID-19 among 226 patients exposed to healthcare workers with confirmed COVID-19. One patient may have been infected, suggesting that the risk of COVID-19 transmission from healthcare workers to patients is generally low., (© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Introduction: Safety culture is defined as the product of individual and group values, attitudes, perceptions, competencies, and patterns of behavior that determine an organization's health and safety management. There is a lack of studies assessing patient safety culture in the perioperative setting., Objectives: We examined safety culture at a single tertiary care hospital, across all types of surgery, using previously collected data from a validated survey tool. We aim to understand how safety culture varies among perioperative staff., Methods: The Hospital Survey on Patient Safety Culture was administered at a single tertiary care hospital in 2014. We identified 431 respondents as perioperative healthcare workers: surgery attending physician, surgery trainee physician, anesthesia attending physician, anesthesia trainee physician, nurse, and technician. We calculated percent positive scores for each dimension of safety culture, as well as a composite score. Pairwise comparisons were calculated via analysis of variance., Results: The average response rate was 67%. The dimensions with the highest average percent positive scores were teamwork within hospital units (69%) and organizational learning and continuous improvement (57%). The dimensions with the lowest scores were feedback and communication about error (34%) and hospital handoffs and transitions (30%). Surgery attending physicians perceived the strongest safety climate overall, whereas nurses and surgical technicians perceived significantly worse safety climate., Conclusions: We observed significant variability in perioperative safety culture, across dimensions of safety climate, professional roles, and levels of training. These variations in safety culture should be addressed when implementing culture change programs in the perioperative setting., Competing Interests: The authors disclose no conflict of interest., (Copyright © 2017 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Little is known about clusters of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in acute care hospitals., Objective: To describe the detection, mitigation, and analysis of a large cluster of SARS-CoV-2 infections in an acute care hospital with mature infection control policies., Design: Descriptive study., Setting: Brigham and Women's Hospital, Boston, Massachusetts., Participants: Patients and staff with cluster-related SARS-CoV-2 infections., Intervention: Close contacts of infected patients and staff were identified and tested every 3 days, patients on affected units were preemptively isolated and repeatedly tested, affected units were cleaned, room ventilation was measured, and specimens were sent for whole-genome sequencing. A case-control study was done to compare clinical interactions, personal protective equipment use, and breakroom and workroom practices in SARS-CoV-2-positive versus negative staff., Measurements: Description of the cluster, mitigation activities, and risk factor analysis., Results: Fourteen patients and 38 staff members were included in the cluster per whole-genome sequencing and epidemiologic associations. The index case was a symptomatic patient in whom isolation was discontinued after 2 negative results on nasopharyngeal polymerase chain reaction testing. The patient subsequently infected multiple roommates and staff, who then infected others. Seven of 52 (13%) secondary infections were detected only on second or subsequent tests. Eight of 9 (89%) patients who shared rooms with potentially contagious patients became infected. Potential contributing factors included high viral loads, nebulization, and positive pressure in the index patient's room. Risk factors for transmission to staff included presence during nebulization, caring for patients with dyspnea or cough, lack of eye protection, at least 15 minutes of exposure to case patients, and interactions with SARS-CoV-2-positive staff in clinical areas. Whole-genome sequencing confirmed that 2 staff members were infected despite wearing surgical masks and eye protection., Limitation: Findings may not be generalizable., Conclusion: SARS-CoV-2 clusters can occur in hospitals despite robust infection control policies. Insights from this cluster may inform additional measures to protect patients and staff., Primary Funding Source: None.

Background: Patient safety has traditionally focused on the inpatient setting; however, there is an increased awareness of ambulatory safety risk. However, successful strategies and programs to mitigate risk in the ambulatory setting are lacking., Program: In 2012, we started building a multidisciplinary ambulatory safety program at an academic health system. Our team was composed of clinical, administrative, and patient safety membership. Based on organizational needs, our program initially focused on the following: (1) safety reporting, (2) safety culture measurement, (3) medication safety, and (4) test result management., What We Did: We were able to develop initiatives around safety reporting, safety culture survey administration, and medication safety and begin to work on test result management. Internal metrics were developed to measure performance and to drive improvement., Safety Reporting: When evaluating our ambulatory safety reports, we discovered that less than one-third of staff filing safety reports requested feedback. From 2013 to 2018, we tested various strategies to increase the rates of feedback to staff and ultimately found that a decentralized process that was supported by the ambulatory safety program could achieve rates of feedback of 90%., Safety Culture Measurement: We administered the Agency for Healthcare Research and Quality Medical Office Survey in 2012, 2014, and 2016, achieving a more than 70% response rate across 70 unique ambulatory areas. Data from these surveys were shared with senior hospital leadership, local departmental directors, and managers and ultimately with frontline staff focusing on two key survey areas: communication openness and communication about error., Medication Safety: From 2012 to 2014, our rates of ambulatory medication reconciliation increased to more than 90% in both primary care and specialty practices in our homegrown electronic medical record system. From 2015 to 2016, rates of ambulatory medication reconciliation in our new vendor-based electronic medical record were 73% as of August 2017., Conclusions: We were able to build an infrastructure to focus and support ambulatory safety efforts on safety reporting, safety culture change, and medication reconciliation with a team dedicated to ambulatory-focused safety risks and encountered many challenges along the way. Currently, we are expanding our program to concentrate on test result follow-up to prevent missed and delayed diagnosis and medication error reduction., Competing Interests: The authors disclose no conflict of interest., (Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.)

Background: High-sensitivity troponin assays (hs-Tn) detect lower serum concentrations than prior-generation assays and help guide acute coronary syndrome (ACS) evaluation in emergency departments. Outpatient hs-Tn utilization is not well described., Hypothesis: Outpatient providers use hs-TnT to triage patients with suspected ACS., Methods: We compared the volume of outpatient prior-generation troponin tests in the pre-hsTn implementation period (January 2015-March 2018) with outpatient hs-TnT volume in the post-implementation period (April 2018-January 2020). Triage patterns were compared between patients with hs-TnT≥99th vs <99th percentile, using two-sample t tests. In patients triaged home, adverse events were compared between patients with hs-TnT≥99th vs <99th percentile, using log-rank tests., Results: Across a large tertiary healthcare system, a mean of 80 prior-generation tests/month were ordered during the pre-hsTn implementation period compared with 12 hs-TnT tests/month in the post-implementation period. Prior-generation orders rose by 1.72 tests/month during pre-implementation, vs a decline of 2.74 hs-TnT tests/month during post-implementation (P < .001). Among 129 hs-TnT orders, most were placed by cardiologists (54%) and primary care providers (32%). Patient symptoms at the time of troponin ordering included dyspnea (34%) and chest pain (33%), although 25% were asymptomatic. Among symptomatic patients (n = 74), those with hs-TnT > 99th percentile were more likely to be sent to the ED (RR, 3.36; 95% CI, 1.22-9.25; P = .002). Among patients sent home (n = 66), those with hs-TnT > 99th percentile had more adverse events by 6 months (3.3% vs 22.2% RR, 6.67; 95% CI, 1.04-42.9; P = .026)., Conclusions: In this healthcare system, outpatient troponin utilization significantly declined since hs-TnT implementation. Some providers use hs-TnT to triage patients with suspected ACS to the ED; others test asymptomatic patients and some send patients home despite high hs-TnT values., (© 2020 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.)

We report on COVID-19 risk among HCWs exposed to a patient diagnosed with COVID-19 on day 13 of hospitalization. There were 44 HCWs exposed to the patient before contact and droplet precautions were implemented: of these, 2 of 44 (5%) developed COVID-19 potentially attributable to the exposure.

Importance: Death due to preventable medical error is a leading cause of death, with varying estimates of preventable death rates (14%-56% of total deaths based on national extrapolated estimates, 3%-11% based on single-centre estimates). Yet, how best to reduce preventable mortality in hospitals remains unknown., Objective: In this article, we detail lessons learnt from implementing a hospital-wide, automated, real-time, electronic mortality reporting system that relies on the opinions of front-line clinicians to identify opportunities for improvement. We also summarise data obtained regarding possible preventability, systems issues identified and addressed, and challenges with implementation. We outline our process of survey, evaluation, escalation and tracking of opportunities identified through the review process., Methods: We aggregated and analysed 7 years of review data regarding deaths, review responses categorised by ratings of possible preventability and inter-rater reliability of possible preventability. A qualitative analysis of reviews was performed to identify care delivery opportunities and institutional response., Results: Over the course of 7 years, 7856 inpatient deaths occurred, and 91% had at least one review completed. 5.2% were rated by front-line clinicians as potentially being preventable (likely or possibly), and this rate was consistent over time. However, there was only slight inter-rater agreement regarding potential preventability (Cohen's kappa=0.185). Nevertheless, several major systems-level opportunities were identified that facilitated care delivery improvements, such as communication challenges, need for improved end-of-life care and interhospital transfer safety., Conclusions: Through implementation, we found that a hospital-wide mortality review process that elicits feedback from front-line providers is feasible, and provides valuable insights regarding potential preventable mortality and prioritising actionable opportunities for care delivery improvements., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: A commonly cited reason among nurses and physicians for not reporting safety events is a perceived lack of feedback from management on filed safety reports. This suggests that the value of a safety reporting system could be improved with a closed-loop feedback system between management and frontline staff on filed safety reports in which feedback was requested., Methods: Ambulatory staff were surveyed on barriers to reporting to assess this challenge at an academic medical center. In response, system changes were implemented to the electronic safety reporting system, gained leadership buy-in, incorporated managers into a work group tasked with enhancing feedback to staff, established project management support, and developed a safety star manager recognition program. Ultimately, a process was developed to measure and ensure that feedback was provided to staff who requested it through a series of Plan-Do-Study-Act cycles termed the Feedback to Reporter program., Results: At baseline in 2013, the team found that staff who indicated they wanted feedback on safety reports received it less than 50% of the time. By the end of fiscal year 2018, the monthly feedback to reporter rate was consistently 90% or higher. The percentage of safety reports in which feedback was requested ranged from 35.0% to 49.7% of all safety reports submitted., Conclusion: Ultimately, a multidimensional approach improved closed-loop communication from local managers to frontline staff and between managers of different departments on ambulatory safety reports when feedback was requested. Improvements were sustained for more than one year., (Copyright © 2019 The Joint Commission. Published by Elsevier Inc. All rights reserved.)

Background: Incomplete medication reconciliation has been identified as a source of adverse drug events and a threat to patient safety. How best to measure and improve rates of medication reconciliation in ambulatory care remains unknown., Methods: An institutional collaborative improvement effort to develop and implement medication reconciliation processes was designed and facilitated across all 148 Brigham and Women's Hospital (Boston) ambulatory specialty practices: 63 underwent a more rigorous approach, a modified approach was undertaken in another 71 specialty practices, and a less intensive approach took place in the 14 primary care practices. The level of intervention varied on the basis of preexisting improvement infrastructure and practice prescription rates. Two electronically measured metrics were created to evaluate ambulatory visits to a provider in which there was a medication change: (1) Measure 1: the percentage of active medications prescribed by that provider that were reconciled; and (2) Measure 2: how often all the medications prescribed by that provider were reconciled. After the collaborative was completed, performance data were routinely shared with frontline staff and hospital leadership, and medication reconciliation rates became part of an institutional financial incentive program., Results: For Measure 1, specialty practices improved from 71% to 90% (September 2012-August 2014; 24-month period). Primary care practice performance improved from 62% to 91% (December 2012-August 2014; 20-month period). For Measure 2, overall performance across all ambulatory practices increased from 81% to 90% during the first 12 months of the financial incentive program (October 2013- September 2014)., Conclusion: A collaborative model of process improvement paired with financial incentives can successfully increase rates of ambulatory medication reconciliation.

The aim of our study was to assess hospital budget implications of substituting dabigatran for warfarin in patients enrolled in a large anticoagulation service. The study population was identified using criteria from randomized controlled trials of dabigatran. We obtained labor costs ($483 per patient) from the hospital's anticoagulation service budget, laboratory costs of international normalized ratio (INR) tests ($267 per patient), and wholesale costs of warfarin 5 mg tablets ($31 per patient) and dabigatran 150 mg capsules ($2464 per patient). A total of 1774 (93.5%) of 1898 patients were eligible to substitute dabigatran for warfarin. The annual projected hospital expense for anticoagulation with dabigatran was $4,371,136, attributable to drug cost alone. The annual projected cost of warfarin management was $1,385,494. This was comprised of $856,842 for labor, $473,658 for INR testing, and $54,994 for the drug cost of warfarin. Substitution will result in increased expense due to drug cost.

Purpose: Anticoagulant drugs are among the most common medications that cause adverse drug events (ADEs) in hospitalized patients. We performed a 5-year retrospective study at Brigham and Women's Hospital to determine clinical characteristics, types, root causes, and outcomes of anticoagulant-associated ADEs., Methods: We reviewed all inpatient anticoagulant-associated ADEs, including adverse drug reactions (ADRs) and medication errors, reported at Brigham and Women's Hospital through the Safety Reporting System from May 2004 to May 2009. We also collected data about the cost associated with hospitalizations in which ADRs occurred., Results: Of 463 anticoagulant-associated ADEs, 226 were medication errors (48.8%), 141 were ADRs (30.5%), and 96 (20.7%) involved both a medication error and ADR. Seventy percent of anticoagulant-associated ADEs were potentially preventable. Transcription errors (48%) were the most frequent root cause of anticoagulant-associated medication errors, while medication errors (40%) were a common root cause of anticoagulant-associated ADRs. Death within 30 days of anticoagulant-associated ADEs occurred in 11% of patients. After an anticoagulant-associated ADR, most hospitalization expenditures were attributable to nursing costs (mean $33,189 per ADR), followed by pharmacy costs (mean $7451 per ADR)., Conclusion: Most anticoagulant-associated ADEs among inpatients result from medication errors and are, therefore, potentially preventable. We observed an elevated 30-day mortality rate among patients who suffered an anticoagulant-associated ADE and high hospitalization costs following ADRs. Further quality improvement efforts to reduce anticoagulant-associated medication errors are warranted to improve patient safety and decrease health care expenditures., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Venous thromboembolism (VTE) prophylaxis in high-risk patients is frequently underutilised. We previously devised a one-screen computer alert program that identified hospitalised patients at high risk for VTE who were not receiving prophylaxis and advised their physicians to prescribe prophylaxis. While this strategy reduced the 90-day incidence of symptomatic VTE by 41%, the majority of electronic alerts were ignored. We have now developed a serial three-screen alert computer program designed to educate physicians who initially declined to order prophylaxis after a single screen alert. Of a total cohort of 880, the responsible physicians for 425 patients received a single electronic alert, whereas 455 who declined prophylaxis after the first screen received the second and third screens of the novel three-screen alert. Our enhanced serial three-screen alert program generated VTE prophylaxis orders for 58.4% of the 455 patients whose physicians initially declined to order prophylaxis following the one-screen alert. There was no significant difference in symptomatic 90-day VTE rates between the two cohorts (2.8% for the one-screen vs. 2.2% for the three-screen, p=0.55). We conclude that our three-screen computer alert program can markedly increase prophylaxis among physicians who decline an initial single screen alert.

Background: Despite existing consensus guidelines, venous thromboembolism (VTE) prophylaxis is underused in high-risk hospitalized patients. The present study evaluated the effects of an electronic alert to the responsible physician in a cohort of hospitalized high-risk patients not receiving VTE prophylaxis., Methods: The absence of VTE prophylaxis orders in hospitalized patients at high-risk for VTE triggered an electronic alert to the responsible physician. We studied a cohort of 866 patients whose physicians were alerted that their patients were at high-risk but receiving no VTE prophylaxis. The electronic alert recommended that the responsible physician order preventive measures. We followed each patient for 90 days to determine whether imaging-confirmed symptomatic VTE occurred., Results: 9,527 patients were identified as high-risk for VTE. 9% (866) were not receiving prophylaxis, compared with 18% in the intervention arm of a previous randomized trial (P < 0.001). In our current cohort study, 82% (713) of patients were Medical Service patients. Physician response to alerts resulted in prophylactic measures for 37.7% of those alerted. Symptomatic VTE at 90 days occurred in 5.1% of patients in the present cohort group., Conclusion: Implementation of a computer alert program increased prophylaxis rates. However, the majority of alerted physicians in the cohort study did not order VTE prophylaxis despite the alerts. Therefore, novel strategies must be employed to further improve the use of VTE prophylaxis in hospitalized high-risk patients, especially in Medical Service patients.

Little information is available concerning adverse drug events (ADEs) in cardiac patients. Therefore, the investigators report the results of cardiac patients in an ADE surveillance program, with the intent of reducing the frequency of future events. All reported adverse drug reactions and medication errors in cardiac patients over a 5-year period at Brigham and Women's Hospital were reviewed. There were 547 ADEs in cardiac patients, a rate of 1.9 events for every 100 patient admissions. Preventable ADEs most often occurred during medication administration (34.2%), with wrong rate or frequency of medication administration the most widespread event. Cardiovascular agents (29.8%), anticoagulants (28.5%), and antimicrobial agents (10.8%) were the most common drug classes associated with ADEs. Injury or prolonged hospitalization occurred in 5.3% of patients. ADEs occurred most frequently on the admission day, on weekdays, and in the early morning hours. Peak frequencies of ADEs coincided with nursing shift changes. In conclusion, ADEs occur often in hospitalized cardiac patients and affect 2 of every 100 patient admissions. Given the high percentage of ADEs associated with drug administration, more resources should be directed at this step of medication use. Focusing interventions around nursing shift changes may further enhance preventive strategies.

This study reviewed 863 alerts generated from the infusion of anticoagulants in 355 patients from October 2003 to January 2005. Alerts were generated by smart infusion technology pumps and recorded in the devices' memory. The most common alerts were underdose alerts (59.8%), followed by overdose alerts (31.3%) and duplicate drug therapy alerts (8.9%). In response to the alerts, users' most frequent action was to cancel (46.5%) or reprogram (43.1%) the infusions. The highest percentage of alerts occurred from 2 to 4 p.m. During the study, there were 4 infusion rate errors, compared with 15 in the immediately preceding 16-month period. In conclusion, smart infusion technology intercepted keypad entry errors, thereby reducing the likelihood of intravenous anticoagulant overdose or underdose. Dose or infusion rate programming during intravenous anticoagulation is an important targets for medication safety interventions.

Background: Alemtuzumab is an emerging therapy for refractory lymphoproliferative disorders. The associated long-term risks of infection remain poorly defined., Methods: From July 2001 through December 2003, all patients who received alemtuzumab for the treatment of lymphoproliferative disorders at 1 institution underwent a retrospective evaluation to document infectious complications until death or end of follow-up in October 2004. Alemtuzumab recipients who underwent allogeneic hematopoietic stem cell transplantation were compared with a concurrent cohort who also underwent allogeneic hematopoietic stem cell transplantation but did not receive alemtuzumab., Results: Twenty-seven patients were identified (21 with chronic lymphocytic leukemia and 6 with plasma cell disorders). The overall mortality was 37%, with 7 of 10 deaths being related to infection. Significant opportunistic infections occurred in 9 patients (43%) with chronic lymphocytic leukemia, including cytomegalovirus, progressive multifocal leukoencephalopathy, adenovirus, toxoplasmosis, and acanthamaebiasis. Thirty nonopportunistic infections in 22 patients (82%) were also identified. The 3 deaths related to nonopportunistic infections all involved Enterococcus species bacteremia. When compared with a concurrent chronic lymphocytic leukemia cohort that underwent allogeneic hematopoietic stem cell transplantation, alemtuzumab recipients had an incidence of cytomegalovirus reactivation of 66.7% (6 of 9 patients), compared with 37% in the non-alemtuzumab group (10 of 27 patients; P = .15), and an incidence of post-transplant opportunistic infections (excluding herpesviruses) of 44.4% (compared with 29.6% in the non-alemtuzumab group; P = .41)., Conclusions: Despite the use of herpesvirus and Pneumocystis pneumonia prophylaxis, serious infectious complications occur in patients receiving alemtuzumab for lymphoproliferative disorders. Infectious complications are more varied and diverse in patients receiving alemtuzumab than has been reported in trials to date.

Sirolimus is increasingly used in transplantation for prevention and treatment of graft-versus-host disease and organ rejection. Voriconazole is contraindicated when used concomitantly with sirolimus because of a substantial increase in sirolimus drug exposure with unadjusted dosing, but voriconazole is also considered the best initial treatment of invasive aspergillosis and other fungal infections. Patients who received voriconazole and sirolimus concomitantly were identified by a review of the medical records of all allogeneic hematopoietic stem cell recipients at our institution from September 1, 2002, to June 1, 2005. Data including baseline characteristics, indications for both drugs, and potential adverse effects were evaluated. Eleven patients received voriconazole and sirolimus concomitantly for a median of 33 days (range, 3-100 days). In 8 patients whose sirolimus dose was initially reduced by 90%, trough sirolimus levels were similar to those obtained before the administration of voriconazole; no obvious significant toxicity from either drug was observed during coadministration. Serious adverse events were observed in 2 patients in whom sirolimus dosing was not adjusted during voriconazole administration. Sirolimus and voriconazole may be safely coadministered if there is an empiric initial 90% sirolimus dose reduction combined with systematic monitoring of trough levels.

One hundred four patients at Brigham and Women's Hospital who received alteplase for acute pulmonary embolism were evaluated. Major bleeding occurred in 20 patients (19.2%). The principal site of bleeding was unknown in 9 (45.0%), gastrointestinal in 6 (30.0%), retroperitoneal in 3 (15.0%), intracranial in 1 (5.0%), and splenic in 1 (5.0%). Independent predictors of major hemorrhage were the administration of catecholamines for systemic arterial hypotension (odds ratio [OR] 115, 95% confidence interval [CI] 9.4 to 1,410.9, p < 0.001), cancer (OR 16.0, 95% CI 3.2 to 80, p = 0.004), diabetes mellitus (OR 9.6, 95% CI 1.7 to 54, p = 0.010), and elevated international normalized ratio before fibrinolysis (OR 5.8, 95% CI 1.5 to 22, p = 0.012).

Objective: To investigate the pattern of use of infliximab with an emphasis on treatment escalation and the durability of infliximab use in the management of rheumatoid arthritis (RA) in an academic setting., Methods: We conducted a retrospective review of pharmacy and medical records of 183 patients with RA who received at least 1 infliximab infusion at the infusion centers of the Brigham and Women's Hospital. Treatment escalation was defined as an increase in the dosage of infliximab to >3 mg/kg and/or a decrease in the dosing interval to <7 weeks between infusions., Results: A total of 183 patients with RA received infliximab infusions for a mean +/- SD duration of 58.2 +/- 56.6 weeks. Infliximab was discontinued in 48% of the patients during the first year of therapy and in 67% of the patients overall. A total of 126 patients had a treatment escalation, including 25 patients with a dose increase, 35 patients with a decrease in the interval, and 66 patients with both. Infliximab treatment was associated with a decrease in corticosteroid and methotrexate doses. Patients who had a treatment escalation were more likely to continue infliximab infusions compared with patients without a treatment escalation (odds ratio 2.0, 95% confidence interval 1.0-4.1)., Conclusion: The use of infliximab may be an effective treatment for RA; however, a substantial number of patients will discontinue its use. Treatment escalation is commonly used in the management of RA with infliximab and is associated with longer duration of infliximab use.