Technological Distractions (Part 2): A Summary of Approaches to Manage Clinical Alarms With Intent to Reduce Alarm Fatigue.

OBJECTIVE: Alarm fatigue is a widely recognized safety and quality problem where exposure to high rates of clinical alarms results in desensitization leading to dismissal of or slowed response to alarms. Nonactionable alarms are thought to be especially problematic. Despite these concerns, the number of clinical alarm signals has been increasing as an everincreasing number of medical technologies are added to the clinical care environment. DATA SOURCES: PubMed, SCOPUS, Embase, and CINAHL. STUDY SELECTION: We performed a systematic review of the literature focused on clinical alarms. We asked a primary key question; "what interventions have been attempted and resulted in the success of reducing alarm fatigue?" and 3-secondary key questions; "what are the negative effects on patients/families; what are the balancing outcomes (unintended consequences of interventions); and what human factor approaches apply to making an effective alarm?" DATA EXTRACTION: Articles relevant to the Key Questions were selected through an iterative review process and relevant data was extracted using a standardized tool. DATA SYNTHESIS: We found 62 articles that had relevant and usable data for at least one key question. We found that no study used/developed a clear definition of "alarm fatigue." For our primary key question 1, the relevant studies focused on three main areas: quality improvement/bundled activities; intervention comparisons; and analysis of algorithm-based false and total alarm suppression. All sought to reduce the number of total alarms and/or false alarms to improve the positive predictive value. Most studies were successful to varying degrees. None measured alarm fatigue directly. CONCLUSIONS: There is no agreed upon valid metric(s) for alarm fatigue, and the current methods are mostly indirect. Assuming that reducing the number of alarms and/or improving positive predictive value can reduce alarm fatigue, there are promising avenues to address patient safety and quality problem. Further investment is warranted not only in interventions that may reduce alarm fatigue but also in defining how to best measure it.

Changes in medical errors after implementation of a handoff program.

BACKGROUND: Miscommunications are a leading cause of serious medical errors. Data from multicenter studies assessing programs designed to improve handoff of information about patient care are lacking. METHODS: We conducted a prospective intervention study of a resident handoff-improvement program in nine hospitals, measuring rates of medical errors, preventable adverse events, and miscommunications, as well as resident workflow. The intervention included a mnemonic to standardize oral and written handoffs, handoff and communication training, a faculty development and observation program, and a sustainability campaign. Error rates were measured through active surveillance. Handoffs were assessed by means of evaluation of printed handoff documents and audio recordings. Workflow was assessed through time-motion observations. The primary outcome had two components: medical errors and preventable adverse events. RESULTS: In 10,740 patient admissions, the medical-error rate decreased by 23% from the preintervention period to the postintervention period (24.5 vs. 18.8 per 100 admissions, P<0.001), and the rate of preventable adverse events decreased by 30% (4.7 vs. 3.3 events per 100 admissions, P<0.001). The rate of nonpreventable adverse events did not change significantly (3.0 and 2.8 events per 100 admissions, P=0.79). Site-level analyses showed significant error reductions at six of nine sites. Across sites, significant increases were observed in the inclusion of all prespecified key elements in written documents and oral communication during handoff (nine written and five oral elements; P<0.001 for all 14 comparisons). There were no significant changes from the preintervention period to the postintervention period in the duration of oral handoffs (2.4 and 2.5 minutes per patient, respectively; P=0.55) or in resident workflow, including patient-family contact and computer time. CONCLUSIONS: Implementation of the handoff program was associated with reductions in medical errors and in preventable adverse events and with improvements in communication, without a negative effect on workflow. (Funded by the Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, and others.).

Technologic Distractions (Part 1): Summary of Approaches to Manage Alert Quantity With Intent to Reduce Alert Fatigue and Suggestions for Alert Fatigue Metrics.

OBJECTIVE: To provide ICU clinicians with evidence-based guidance on tested interventions that reduce or prevent alert fatigue within clinical decision support systems. DESIGN: Systematic review of PubMed, Embase, SCOPUS, and CINAHL for relevant literature from 1966 to February 2017. PATIENTS: Focus on critically ill patients and included evaluations in other patient care settings, as well. INTERVENTIONS: Identified interventions designed to reduce or prevent alert fatigue within clinical decision support systems. MEASUREMENTS AND MAIN RESULTS: Study selection was based on one primary key question to identify effective interventions that attempted to reduce alert fatigue and three secondary key questions that covered the negative effects of alert fatigue, potential unintended consequences of efforts to reduce alert fatigue, and ideal alert quantity. Data were abstracted by two reviewers independently using a standardized abstraction tool. Surveys, meeting abstracts, "gray" literature, studies not available in English, and studies with non-original data were excluded. For the primary key question, articles were excluded if they did not provide a comparator as key question 1 was designed as a problem, intervention, comparison, and outcome question. We anticipated that reduction in alert fatigue, including the concept of desensitization may not be directly measured and thus considered interventions that reduced alert quantity as a surrogate marker for alert fatigue. Twenty-six articles met the inclusion criteria. CONCLUSION: Approaches for managing alert fatigue in the ICU are provided as a result of reviewing tested interventions that reduced alert quantity with the anticipated effect of reducing fatigue. Suggested alert management strategies include prioritizing alerts, developing sophisticated alerts, customizing commercially available alerts, and including end user opinion in alert selection. Alert fatigue itself is studied less frequently, as an outcome, and there is a need for more precise evaluation. Standardized metrics for alert fatigue is needed to advance the field. Suggestions for standardized metrics are provided in this document.

Effect of bar-code technology on the safety of medication administration.

BACKGROUND: Serious medication errors are common in hospitals and often occur during order transcription or administration of medication. To help prevent such errors, technology has been developed to verify medications by incorporating bar-code verification technology within an electronic medication-administration system (bar-code eMAR). METHODS: We conducted a before-and-after, quasi-experimental study in an academic medical center that was implementing the bar-code eMAR. We assessed rates of errors in order transcription and medication administration on units before and after implementation of the bar-code eMAR. Errors that involved early or late administration of medications were classified as timing errors and all others as nontiming errors. Two clinicians reviewed the errors to determine their potential to harm patients and classified those that could be harmful as potential adverse drug events. RESULTS: We observed 14,041 medication administrations and reviewed 3082 order transcriptions. Observers noted 776 nontiming errors in medication administration on units that did not use the bar-code eMAR (an 11.5% error rate) versus 495 such errors on units that did use it (a 6.8% error rate)--a 41.4% relative reduction in errors (P<0.001). The rate of potential adverse drug events (other than those associated with timing errors) fell from 3.1% without the use of the bar-code eMAR to 1.6% with its use, representing a 50.8% relative reduction (P<0.001). The rate of timing errors in medication administration fell by 27.3% (P<0.001), but the rate of potential adverse drug events associated with timing errors did not change significantly. Transcription errors occurred at a rate of 6.1% on units that did not use the bar-code eMAR but were completely eliminated on units that did use it. CONCLUSIONS: Use of the bar-code eMAR substantially reduced the rate of errors in order transcription and in medication administration as well as potential adverse drug events, although it did not eliminate such errors. Our data show that the bar-code eMAR is an important intervention to improve medication safety. (ClinicalTrials.gov number, NCT00243373.)

An initiative to improve the management of clinically significant test results in a large health care network.

BACKGROUND: The failure of providers to communicate and follow up clinically significant test results (CSTR) is an important threat to patient safety. The Massachusetts Coalition for the Prevention of Medical Errors has endorsed the creation of systems to ensure that results can be received and acknowledged. METHODS: In 2008 a task force was convened that represented clinicians, laboratories, radiology, patient safety, risk management, and information systems in a large health care network with the goals of providing recommendations and a road map for improvement in the management of CSTR and of implementing this improvement plan during the sub-force sequent five years. In drafting its charter, the task broadened the scope from "critical" results to "clinically significant" ones; clinically significant was defined as any result that requires further clinical action to avoid morbidity or mortality, regardless of the urgency of that action. RESULTS: The task force recommended four key areas for improvement--(1) standardization of policies and definitions, (2) robust identification of the patient's care team, (3) enhanced results management/tracking systems, and (4) centralized quality reporting and metrics. The task force faced many challenges in implementing these recommendations, including disagreements on definitions of CSTR and on who should have responsibility for CSTR, changes to established work flows, limitations of resources and of existing information systems, and definition of metrics. CONCLUSIONS: This large-scale effort to improve the communication and follow-up of CSTR in a health care network continues with ongoing work to address implementation challenges, refine policies, prepare for a new clinical information system platform, and identify new ways to measure the extent of this important safety problem.

Analysis of risk factors for adverse drug events in critically ill patients*.

OBJECTIVES: An evaluation of risk factors for adverse drug events in critically ill patients has not been previously studied. The purpose of this original study was to determine risk factors for adverse drug events in critically ill adult patients. DESIGN: This retrospective case-control study includes patients who were admitted to the intensive care unit during a 7.5-yr period. SETTING: Academic medical center with 647 beds that contains approximately 120 intensive care unit beds. PATIENTS: Patients in the case group experienced an adverse drug event as documented in the hospital's database. The control group comprised the next two patients admitted to the same intensive care unit by the same admitting service. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Twenty-nine suspected risk factors identified from the literature were evaluated, including patient characteristics, drug characteristics, and laboratory values using a multiple logistic regression. A sample of 1101 cases and controls (54% male), with a mean age of 59.4 ± 17.5 yrs, were identified. In 367 cases, there was a total of 499 documented adverse drug events. Patients with kidney injury, thrombocytopenia, and those admitted emergently were 16-times, 3-times, and 2-times more likely to have an adverse drug event, respectively. Patients who were administered intravenous medications had a 3% higher risk of having an adverse drug event for each drug dispensed. Overall, the case group received more drugs per intensive care unit day and more drugs per intensive care unit stay. CONCLUSIONS: Several patient and drug-related characteristics contribute to the risk of adverse drug events in critically ill patients. Diligent monitoring of factors that can influence the pharmacokinetic properties for existing drug therapies is necessary. Drug regimens should be evaluated daily for minimization. Based on previous studies, pharmacists as part of the interdisciplinary team could help to manage these risks.

Adverse drug events in intensive care units: risk factors, impact, and the role of team care.

Advances in diagnostic tests, technological interventions, and pharmacotherapy have resulted in spectacular results for many intensive care unit (ICU) patients who, in earlier generations, would have succumbed to their critical illness. At the same time, the complexity and intensity of care required for ICU patients is also associated with greater risks for harm resulting from care. As in other inpatient areas, medications are the most common type of therapy in ICUs and are also associated with the most frequent type of ICU adverse events. Critically ill patients are at high risk for adverse drug events for many reasons, including the complexity of their disease that creates challenges in drug dosing, their vulnerability to rapid changes in pharmacotherapy, the intensive care environment providing ample distractions and opportunity for error, the administration of complex drug regimens, the numerous high-alert medications that they receive, and the mode of drug administration. The clinical outcomes of adverse drug events can result in end-organ damage and even death. The costs of an adverse drug event can be substantial to healthcare systems with an additional $6,000-$9,000 for each event. The multiprofessional patient care team is one approach to promoting patient safety in the ICU.

Medication errors recovered by emergency department pharmacists.

STUDY OBJECTIVE: We assess the impact of emergency department (ED) pharmacists on reducing potentially harmful medication errors. METHODS: We conducted this observational study in 4 academic EDs. Trained pharmacy residents observed a convenience sample of ED pharmacists' activities. The primary outcome was medication errors recovered by pharmacists, including errors intercepted before reaching the patient (near miss or potential adverse drug event), caught after reaching the patient but before causing harm (mitigated adverse drug event), or caught after some harm but before further or worsening harm (ameliorated adverse drug event). Pairs of physician and pharmacist reviewers confirmed recovered medication errors and assessed their potential for harm. Observers were unblinded and clinical outcomes were not evaluated. RESULTS: We conducted 226 observation sessions spanning 787 hours and observed pharmacists reviewing 17,320 medications ordered or administered to 6,471 patients. We identified 504 recovered medication errors, or 7.8 per 100 patients and 2.9 per 100 medications. Most of the recovered medication errors were intercepted potential adverse drug events (90.3%), with fewer mitigated adverse drug events (3.9%) and ameliorated adverse drug events (0.2%). The potential severities of the recovered errors were most often serious (47.8%) or significant (36.2%). The most common medication classes associated with recovered medication errors were antimicrobial agents (32.1%), central nervous system agents (16.2%), and anticoagulant and thrombolytic agents (14.1%). The most common error types were dosing errors, drug omission, and wrong frequency errors. CONCLUSION: ED pharmacists can identify and prevent potentially harmful medication errors. Controlled trials are necessary to determine the net costs and benefits of ED pharmacist staffing on safety, quality, and costs, especially important considerations for smaller EDs and pharmacy departments.

Recovered Medical Error Inventory.

PURPOSE: To describe the development and psychometric testing of the Recovered Medical Error Inventory (RMEI). DESIGN AND METHODS: Content analysis of structured interviews with expert critical care registered nurses (CCRNs) was used to empirically derive a 25-item RMEI. The RMEI was pilot tested with 345 CCRNs. The data set was randomly divided to use the first half for reliability testing and the second half for validation. A principal components analysis with Varimax rotation was conducted. Cronbach's alpha values were examined. A t test and Pearson correlation were used to compare scores of the two samples. FINDINGS: The RMEI consists of 25 items and two subscales. Evidence for initial reliability includes a total scale alpha of .9 and subscale alpha coefficients of .88 (mistake) and .75 (poor judgment). CONCLUSIONS: The RMEI subscales have satisfactory internal consistency reliability and evidence for construct validity. Additional testing is warranted. CLINICAL RELEVANCE: A tool to measure CCRNs' experiences with recovering medical errors allows quantification of nurse surveillance in promoting safe care and preventing unreimbursed hospital costs for treating nosocomial events.

Medical errors recovered by critical care nurses.

OBJECTIVE: : The frequency and types of medical errors are well documented, but less is known about potential errors that were intercepted by nurses. We studied the type, frequency, and potential harm of recovered medical errors reported by critical care registered nurses (CCRNs) during the previous year. BACKGROUND: : Nurses are known to protect patients from harm. Several studies on medical errors found that there would have been more medical errors reaching the patient had not potential errors been caught earlier by nurses. METHODS: : The Recovered Medical Error Inventory, a 25-item empirically derived and internally consistent (alpha =.90) list of medical errors, was posted on the Internet. Participants were recruited via e-mail and healthcare-related listservs using a nonprobability snowball sampling technique. Investigators e-mailed contacts working in hospitals or who managed healthcare-related listservs and asked the contacts to pass the link on to others with contacts in acute care settings. RESULTS: : During 1 year, 345 CCRNs reported that they recovered 18,578 medical errors, of which they rated 4,183 as potentially lethal. CONCLUSION: : Surveillance, clinical judgment, and interventions by CCRNs to identify, interrupt, and correct medical errors protected seriously ill patients from harm.

Risks of complications by attending physicians after performing nighttime procedures.

CONTEXT: Few data exist on the relationships between experienced physicians' work hours and sleep, and patient safety. OBJECTIVE: To determine if sleep opportunities for attending surgeons and obstetricians/gynecologists are associated with the risk of complications. DESIGN, SETTING, AND PATIENTS: Matched retrospective cohort study of procedures performed from January 1999 through June 2008 by attending physicians (86 surgeons and 134 obstetricians/gynecologists) who had been in the hospital performing another procedure involving adult patients for at least part of the preceding night (12 am-6 am, postnighttime procedures). Sleep opportunity was calculated as the time between end of the overnight procedure and start of the first procedure the following day. Matched control procedures included as many as 5 procedures of the same type performed by the same physician on days without preceding overnight procedures. Complications were identified and classified by a blinded 3-step process that included administrative screening, medical record reviews, and clinician ratings. MAIN OUTCOME MEASURES: Rates of complications in postnighttime procedures as compared with controls; rates of complications in postnighttime procedures among physicians with more than 6-hour sleep opportunities vs those with sleep opportunities of 6 hours or less. RESULTS: A total of 919 surgical and 957 obstetrical postnighttime procedures were matched with 3552 and 3945 control procedures, respectively. Complications occurred in 101 postnighttime procedures (5.4%) and 365 control procedures (4.9%) (odds ratio, 1.09; 95% confidence interval [CI], 0.84-1.41). Complications occurred in 82 of 1317 postnighttime procedures with sleep opportunities of 6 hours or less (6.2%) vs 19 of 559 postnighttime procedures with sleep opportunities of more than 6 hours (3.4%) (odds ratio, 1.72; 95% CI, 1.02-2.89). Postnighttime procedures completed after working more than 12 hours (n = 958) compared with 12 hours or less (n = 918) had nonsignificantly higher complication rates (6.5% vs 4.3%; odds ratio, 1.47; 95% CI, 0.96-2.27). CONCLUSION: Overall, procedures performed the day after attending physicians worked overnight were not associated with significantly increased complication rates, although there was an increased rate of complications among postnighttime surgical procedures performed by physicians with sleep opportunities of less than 6 hours.

Programmable infusion pumps in ICUs: an analysis of corresponding adverse drug events.

BACKGROUND: Patients in intensive care units (ICUs) frequently experience adverse drug events involving intravenous medications (IV-ADEs), which are often preventable. OBJECTIVES: To determine how frequently preventable IV-ADEs in ICUs match the safety features of a programmable infusion pump with safety software ("smart pump") and to suggest potential improvements in smart-pump design. DESIGN: Using retrospective medical-record review, we examined preventable IV-ADEs in ICUs before and after 2 hospitals replaced conventional pumps with smart pumps. The smart pumps alerted users when programmed to deliver duplicate infusions or continuous-infusion doses outside hospital-defined ranges. PARTICIPANTS: 4,604 critically ill adults at 1 academic and 1 nonacademic hospital. MEASUREMENTS: Preventable IV-ADEs matching smart-pump features and errors involved in preventable IV-ADEs. RESULTS: Of 100 preventable IV-ADEs identified, 4 involved errors matching smart-pump features. Two occurred before and 2 after smart-pump implementation. Overall, 29% of preventable IV-ADEs involved overdoses; 37%, failures to monitor for potential problems; and 45%, failures to intervene when problems appeared. Error descriptions suggested that expanding smart pumps' capabilities might enable them to prevent more IV-ADEs. CONCLUSION: The smart pumps we evaluated are unlikely to reduce preventable IV-ADEs in ICUs because they address only 4% of them. Expanding smart-pump capabilities might prevent more IV-ADEs.

Adverse drug events and medication errors in psychiatry: methodological issues regarding identification and classification.

Abstract Adverse drug events and medication errors have received extensive study recently in a variety of clinical populations, though compared to many other areas relatively little work has focused on this area in psychiatry, especially with respect to the contribution of error to harm. The goal of this paper is to discuss methodological issues around measurement of medication safety in psychiatric patients. Against the background of a systems approach, a modern perspective of error management is discussed, and a multidimensional procedure for detection and classification of incidents related to the medication process is presented. This method has proven successful in non-psychiatric settings yielding the current best estimate of error rates and providing insight into the underlying causes. While this general approach can be adapted to the psychiatric setting, a number of issues make measurement especially challenging in psychiatry. These include the fluctuating course of psychiatric disorders, reduced patient adherence to the medication process, adverse effects which are often similar to symptoms of the underlying disorder, the frequent use of wide dose intervals depending on the clinical situation, and the presence of many drug-drug interactions. Data collected by means of the presented approach provide a basis for the development of effective strategies to reduce the risk of medication errors and thus improve patient safety in psychiatric care.

A controlled trial of a rapid response system in an academic medical center.

A medical emergency team composed of house staff and existing float-pool nurses was successfully implemented on the general medical floor of an academic medical center without increasing personnel. The intervention had little noticeable impact, although the number of cardiac arrests and deaths were low both before and after the intervention.

Effect of reducing interns' weekly work hours on sleep and attentional failures.

BACKGROUND: Knowledge of the physiological effects of extended (24 hours or more) work shifts in postgraduate medical training is limited. We aimed to quantify work hours, sleep, and attentional failures among first-year residents (postgraduate year 1) during a traditional rotation schedule that included extended work shifts and during an intervention schedule that limited scheduled work hours to 16 or fewer consecutive hours. METHODS: Twenty interns were studied during two three-week rotations in intensive care units, each during both the traditional and the intervention schedule. Subjects completed daily sleep logs that were validated with regular weekly episodes (72 to 96 hours) of continuous polysomnography (r=0.94) and work logs that were validated by means of direct observation by study staff (r=0.98). RESULTS: Seventeen of 20 interns worked more than 80 hours per week during the traditional schedule (mean, 84.9; range, 74.2 to 92.1). All interns worked less than 80 hours per week during the intervention schedule (mean, 65.4; range, 57.6 to 76.3). On average, interns worked 19.5 hours per week less (P<0.001), slept 5.8 hours per week more (P<0.001), slept more in the 24 hours preceding each working hour (P<0.001), and had less than half the rate of attentional failures while working during on-call nights (P=0.02) on the intervention schedule as compared with the traditional schedule. CONCLUSIONS: Eliminating interns' extended work shifts in an intensive care unit significantly increased sleep and decreased attentional failures during night work hours.

Effect of reducing interns' work hours on serious medical errors in intensive care units.

BACKGROUND: Although sleep deprivation has been shown to impair neurobehavioral performance, few studies have measured its effects on medical errors. METHODS: We conducted a prospective, randomized study comparing the rates of serious medical errors made by interns while they were working according to a traditional schedule with extended (24 hours or more) work shifts every other shift (an "every third night" call schedule) and while they were working according to an intervention schedule that eliminated extended work shifts and reduced the number of hours worked per week. Incidents were identified by means of a multidisciplinary, four-pronged approach that included direct, continuous observation. Two physicians who were unaware of the interns' schedule assignments independently rated each incident. RESULTS: During a total of 2203 patient-days involving 634 admissions, interns made 35.9 percent more serious medical errors during the traditional schedule than during the intervention schedule (136.0 vs. 100.1 per 1000 patient-days, P<0.001), including 56.6 percent more nonintercepted serious errors (P<0.001). The total rate of serious errors on the critical care units was 22.0 percent higher during the traditional schedule than during the intervention schedule (193.2 vs. 158.4 per 1000 patient-days, P<0.001). Interns made 20.8 percent more serious medication errors during the traditional schedule than during the intervention schedule (99.7 vs. 82.5 per 1000 patient-days, P=0.03). Interns also made 5.6 times as many serious diagnostic errors during the traditional schedule as during the intervention schedule (18.6 vs. 3.3 per 1000 patient-days, P<0.001). CONCLUSIONS: Interns made substantially more serious medical errors when they worked frequent shifts of 24 hours or more than when they worked shorter shifts. Eliminating extended work shifts and reducing the number of hours interns work per week can reduce serious medical errors in the intensive care unit.

Medication safety in a psychiatric hospital.

OBJECTIVE: We sought to assess the epidemiology of medication errors (MEs) and adverse drug events (ADEs) in a psychiatric hospital. METHODS: We conducted a 6-month prospective observational study in a 172-bed academic psychiatric hospital. Errors and ADEs were found by way of chart review, staff reports and pharmacy intervention reports. Physicians rated incidents as to the presence of injury, preventability and severity of an injury. Serious MEs were nonintercepted MEs with potential for harm (near misses) and preventable ADEs. RESULTS: We studied 1871 admissions with 19,180 patient-days. The rate of ADEs and serious MEs were 10 and 6.3 per 1000 patient-days, respectively. Preventable ADEs accounted for 13% of all ADEs (25/191). The most common classes of drugs associated with ADEs were atypical antipsychotics (37%). Nonpsychiatric drugs accounted for only 4% of nonpreventable ADEs but were associated with nearly one third of all preventable ADEs and near misses. MEs were most frequently associated with physician orders (68%), but there was also a high rate of nursing transcription errors (20%). CONCLUSIONS: ADEs and serious MEs were common among psychiatric inpatients and similar to rates in studies of general hospital inpatients. Medication safety interventions targeting psychiatric care need further study.

Adherence to black box warnings for prescription medications in outpatients.

BACKGROUND: Few data are available regarding the prevalence of potentially dangerous drug-drug, drug-laboratory, and drug-disease interactions among outpatients. Our objectives were to determine how frequently clinicians prescribe drugs in violation of black box warnings for these issues and to determine how frequently such prescribing results in harm. METHODS: In an observational study of 51 outpatient practices using an electronic health record, we measured the frequency with which patients received prescriptions in violation of black box warnings for drug-drug, drug-laboratory, and/or drug-disease interactions. We performed medical record reviews in a sample of patients to detect adverse drug events. Multivariate analysis was conducted to assess the relationship of prescribing in violation of black box warnings to patient and clinician characteristics, adjusting for potential confounders and clustering. RESULTS: Of 324 548 outpatients who received a medication in 2002, 2354 (0.7%) received a prescription in violation of a black box warning. After adjustment, receipt of medication in violation of a black box warning was more likely when patients were 75 years or older or female. The number of medications taken, the number of medical problems, and the site of care were also associated with violations. Less than 1% of patients who received a drug in violation of a black box warning had an adverse drug event as a result. CONCLUSIONS: About 7 in 1000 outpatients received a prescription violating a black box warning. Few incidents resulted in detectable harm.

Effects of health care provider work hours and sleep deprivation on safety and performance.

BACKGROUND: There has been increasing interest in the impact of resident-physician and nurse work hours on patient safety. The evidence demonstrates that work schedules have a profound effect on providers' sleep and performance, as well as on their safety and that of their patients. Nurses working shifts greater than 12.5 hours are at significantly increased risk of experiencing decreased vigilance on the job, suffering an occupational injury, or making a medical error. Physicians-in-training working traditional > 24-hour on-call shifts are at greatly increased risk of experiencing an occupational sharps injury or a motor vehicle crash on the drive home from work and of making a serious or even fatal medical error. As compared to when working 16-hours shifts, on-call residents have twice as many attentional failures when working overnight and commit 36% more serious medical errors. They also report making 300% more fatigue-related medical errors that lead to a patient's death. CONCLUSION: The weight of evidence strongly suggests that extended-duration work shifts significantly increase fatigue and impair performance and safety. From the standpoint of both providers and patients, the hours routinely worked by health care providers in the United States are unsafe. To reduce the unacceptably high rate of preventable fatigue-related medical error and injuries among health care workers, the United States must establish and enforce safe work-hour limits.