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Biomedical subjects

David W Bates

Publications and source records attributed to David W Bates.

At least 19 recordsLinked to original sources
PubMed2007

Implementation and use of an electronic health record within the Indian Health Service.

OBJECTIVES: There are limited data regarding implementing electronic health records (EHR) in underserved settings. We evaluated the implementation of an EHR within the Indian Health Service (IHS), a federally funded health system for Native Americans. DESIGN: We surveyed 223 primary care clinicians practicing at 26 IHS health centers that implemented an EHR between 2003 and 2005. METHODS: The survey instrument assessed clinician attitudes regarding EHR implementation, current utilization of individual EHR functions, and attitudes regarding the use of information technology to improve quality of care in underserved settings. We fit a multivariable logistic regression model to identify correlates of increased utilization of the EHR. RESULTS: The overall response rate was 56%. Of responding clinicians, 66% felt that the EHR implementation process was positive. One-third (35%) believed that the EHR improved overall quality of care, with many (39%) feeling that it decreased the quality of the patient-doctor interaction. One-third of clinicians (34%) reported consistent use of electronic reminders, and self-report that EHRs improve quality was strongly associated with increased utilization of the EHR (odds ratio 3.03, 95% confidence interval 1.05-8.8). The majority (87%) of clinicians felt that information technology could potentially improve quality of care in rural and underserved settings through the use of tools such as online information sources, telemedicine programs, and electronic health records. CONCLUSIONS: Clinicians support the use of information technology to improve quality in underserved settings, but many felt that it was not currently fulfilling its potential in the IHS, potentially due to limited use of key functions within the EHR.

Attitude of Health Personnel↗
PubMed2007

Mortality in Emergency Department Sepsis (MEDS) score predicts 1-year mortality.

OBJECTIVE: To assess the predictive performance for 1-yr mortality of the previously derived and validated Mortality in Emergency Department Sepsis (MEDS) score. DESIGN: Prospective cohort study. PATIENTS: Consecutive adult (aged > or =18 yrs) emergency department patients presenting to an urban, tertiary care, university hospital were eligible if they had a clinically suspected infection as indicated by the decision to obtain a blood culture. The enrollment period was between February 1, 2000, and February 1, 2001. Of 3,926 eligible patient visits, 3,762 (96%) were enrolled and 3,102 unique first visits were analyzed. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 667 patients (21.5%) died within 1 yr. The unadjusted 1-yr mortality rates for the MEDS risk groups were: very low risk, 7%; low risk, 20%; moderate risk, 37%; high risk, 64%; very high risk, 80%. Using a Cox proportional hazard model that controlled for age, sex, and Charlson co-morbidity index, the 1-yr hazard ratios compared with the baseline very low-risk group were: low risk, 2.2 (1.7-2.9); moderate risk, 3.5 (2.7-4.6); high risk, 6.7 (4.9-9.3); and very high risk, 10.5 (7.2-15.4). The groups were significantly different (p < .0001). CONCLUSIONS: Although the score was initially derived for 28-day in-hospital mortality, our results indicate that the MEDS score also predicts patient survival at 1 yr after index hospital visit with suspected infection. The score needs external validation before widespread use.

Adult↗
PubMed2006

Fluconazole for empiric antifungal therapy in cancer patients with fever and neutropenia.

BACKGROUND: Several clinical trials have demonstrated the efficacy of fluconazole as empiric antifungal therapy in cancer patients with fever and neutropenia. Our objective was to assess the frequency and resource utilization associated with treatment failure in cancer patients given empiric fluconazole antifungal therapy in routine inpatient care. METHODS: We performed a retrospective cohort study of cancer patients treated with oral or intravenous fluconazole between 7/97 and 6/01 in a tertiary care hospital. The final study cohort included cancer patients with neutropenia (an absolute neutrophil count below 500 cells/mm3) and fever (a temperature above 38 degrees C or 100.4 degrees F), who were receiving at least 96 hours of parenteral antibacterial therapy prior to initiating fluconazole. Patients' responses to empiric therapy were assessed by reviewing patient charts. RESULTS: Among 103 cancer admissions with fever and neutropenia, treatment failure after initiating empiric fluconazole antifungal therapy occurred in 41% (95% confidence interval (CI) 31%-50%) of admissions. Patients with a diagnosis of hematological malignancy had increased risk of treatment failure (OR = 4.6, 95% CI 1.5-14.8). When treatment failure occurred the mean adjusted increases in length of stay and total costs were 7.4 days (95% CI 3.3-11.5) and $18,925 (95% CI 3,289-34,563), respectively. CONCLUSION: Treatment failure occurred in more than one-third of neutropenic cancer patients on fluconazole as empiric antifungal treatment for fever in routine clinical treatment. The increase in costs when treatment failure occurs is substantial.

Adult↗
PubMed2006

Evaluation and certification of computerized provider order entry systems.

Computerized physician order entry (CPOE) is an application that is used to electronically write physician orders either in the hospital or in the outpatient setting. It is used in about 15% of U.S. Hospitals and a smaller percentage of ambulatory clinics. It is linked with clinical decision support, which provides much of the value of implementing it. A number of studies have assessed the impact of CPOE with respect to a variety of parameters, including costs of care, medication safety, use of guidelines or protocols, and other measures of the effectiveness or quality of care. Most of these studies have been undertaken at CPOE exemplar sites with homegrown clinical information systems. With the increasing implementation of commercial CPOE systems in various settings of care has come evidence that some implementation approaches may not achieve previously published results or may actually cause new errors or even harm. This has lead to new initiatives to evaluate CPOE systems, which have been undertaken by both vendors and other groups who evaluate vendors, focused on CPOE vendor capabilities and effective approaches to implementation that can achieve benefits seen in published studies. In addition, an electronic health record (EHR) vendor certification process is ongoing under the province of the Certification Commission for Health Information Technology (CCHIT) (which includes CPOE) that will affect the purchase and use of these applications by hospitals and clinics and their participation in public and private health insurance programs. Large employers have also joined this focus by developing flight simulation tools to evaluate the capabilities of these CPOE systems once implemented, potentially linking the results of such programs to reimbursement through pay for performance programs. The increasing role of CPOE systems in health care has invited much more scrutiny about the effectiveness of these systems in actual practice which has the potential to improve their ultimate performance.

Certification↗
PubMed2006

Medication-related clinical decision support in computerized provider order entry systems: a review.

While medications can improve patients' health, the process of prescribing them is complex and error prone, and medication errors cause many preventable injuries. Computer provider order entry (CPOE) with clinical decision support (CDS), can improve patient safety and lower medication-related costs. To realize the medication-related benefits of CDS within CPOE, one must overcome significant challenges. Healthcare organizations implementing CPOE must understand what classes of CDS their CPOE systems can support, assure that clinical knowledge underlying their CDS systems is reasonable, and appropriately represent electronic patient data. These issues often influence to what extent an institution will succeed with its CPOE implementation and achieve its desired goals. Medication-related decision support is probably best introduced into healthcare organizations in two stages, basic and advanced. Basic decision support includes drug-allergy checking, basic dosing guidance, formulary decision support, duplicate therapy checking, and drug-drug interaction checking. Advanced decision support includes dosing support for renal insufficiency and geriatric patients, guidance for medication-related laboratory testing, drug-pregnancy checking, and drug-disease contraindication checking. In this paper, the authors outline some of the challenges associated with both basic and advanced decision support and discuss how those challenges might be addressed. The authors conclude with summary recommendations for delivering effective medication-related clinical decision support addressed to healthcare organizations, application and knowledge base vendors, policy makers, and researchers.

Contraindications↗
PubMed2006

A pragmatic approach to implementing best practices for clinical decision support systems in computerized provider order entry systems.

Incorporation of clinical decision support (CDS) capabilities is required to realize the greatest benefits from computerized provider order entry (CPOE) systems. Discussions at a conference on CDS in CPOE held in San Francisco, California, June 21-22, 2005 produced several papers in this issue of JAMIA. The first paper reviews CDS for electronic prescribing within CPOE systems; (1) the second describes current controversies regarding creation, maintenance, and uses of CPOE order sets for CDS; (2) and the third presents issues related to certification as a potential means of validating CPOE systems for widespread use. (3) This manuscript summarizes all of the discussions at the meeting and provides a pragmatically oriented view of how to implement CPOE with CDS.

Certification↗
PubMed2006

Correlates of electronic health record adoption in office practices: a statewide survey.

OBJECTIVE: Despite emerging evidence that electronic health records (EHRs) can improve the efficiency and quality of medical care, most physicians in office practice in the United States do not currently use an EHR. We sought to measure the correlates of EHR adoption. DESIGN: Mailed survey to a stratified random sample of all medical practices in Massachusetts in 2005, with one physician per practice randomly selected for survey. MEASUREMENTS: EHR adoption rates. RESULTS: The response rate was 71% (1345/1884). Overall, while 45% of physicians were using an EHR, EHRs were present in only 23% of practices. In multivariate analysis, practice size was strongly correlated with EHR adoption; 52% of practices with 7 or more physicians had an EHR, as compared with 14% of solo practices (adjusted odds ratio, 3.66; 95% confidence interval, 2.28-5.87). Hospital-based practices (adjusted odds ratio, 2.44; 95% confidence interval, 1.53-3.91) and practices that teach medical students or residents (adjusted odds ratio, 2.30; 95% confidence interval, 1.60-3.31) were more likely to have an EHR. The most frequently cited barriers to adoption were start-up financial costs (84%), ongoing financial costs (82%), and loss of productivity (81%). CONCLUSIONS: While almost half of physicians in Massachusetts are using an EHR, fewer than one in four practices in Massachusetts have adopted EHRs. Adoption rates are lower in smaller practices, those not affiliated with hospitals, and those that do not teach medical students or residents. Interventions to expand EHR use must address both financial and non-financial barriers, especially among smaller practices.

Attitude to Computers↗
PubMed2006

Medication dispensing errors and potential adverse drug events before and after implementing bar code technology in the pharmacy.

BACKGROUND: Many dispensing errors made in hospital pharmacies can harm patients. Some hospitals are investing in bar code technology to reduce these errors, but data about its efficacy are limited. OBJECTIVE: To evaluate whether implementation of bar code technology reduced dispensing errors and potential adverse drug events (ADEs). DESIGN: Before-and-after study using direct observations. SETTING: Hospital pharmacy at a 735-bed tertiary care academic medical center. INTERVENTION: A bar code-assisted dispensing system was implemented in 3 configurations. In 2 configurations, all doses were scanned once during the dispensing process. In the third configuration, only 1 dose was scanned if several doses of the same medication were being dispensed. MEASUREMENTS: Target dispensing errors, defined as dispensing errors that bar code technology was designed to address, and target potential ADEs, defined as target dispensing errors that can harm patients. RESULTS: In the pre- and post-bar code implementation periods, the authors observed 115,164 and 253,984 dispensed medication doses, respectively. Overall, the rates of target potential ADEs and all potential ADEs decreased by 74% and 63%, respectively. Of the 3 configurations of bar code technology studied, the 2 configurations that required staff to scan all doses had a 93% to 96% relative reduction in the incidence of target dispensing errors (P < 0.001) and 86% to 97% relative reduction in the incidence of potential ADEs (P < 0.001). However, the configuration that did not require scanning of every dose had only a 60% relative reduction in the incidence of target dispensing errors (P < 0.001) and an increased (by 2.4-fold) incidence of target potential ADEs (P = 0.014). There were several potentially life-threatening ADEs involving intravenous dopamine and intravenous heparin in that configuration. LIMITATIONS: The authors used surrogate outcomes; did not mask assessors to the purpose of study; and excluded the controlled substance fill process (a process with low error rates at baseline) from the study, which may bias the combined decrease in error rates toward a larger magnitude. CONCLUSIONS: The overall rates of dispensing errors and potential ADEs substantially decreased after implementing bar code technology. However, the technology should be configured to scan every dose during the dispensing process.

Drug Labeling↗
PubMed2006

Use and perceived benefits of handheld computer-based clinical references.

OBJECTIVE: Clinicians are increasingly using handheld computers (HC) during patient care. We sought to assess the role of HC-based clinical reference software in medical practice by conducting a survey and assessing actual usage behavior. DESIGN: During a 2-week period in February 2005, 3600 users of a HC-based clinical reference application were asked by e-mail to complete a survey and permit analysis of their usage patterns. The software includes a pharmacopeia, an infectious disease reference, a medical diagnostic and therapeutic reference and transmits medical alerts and other notifications during HC synchronizations. Software usage data were captured during HC synchronization for the 4 weeks prior to survey completion. MEASUREMENTS: Survey responses and software usage data. RESULTS: The survey response rate was 42% (n = 1501). Physicians reported using the clinical reference software for a mean of 4 years and 39% reported using the software during more than half of patient encounters. Physicians who synchronized their HC during the data collection period (n = 1249; 83%) used the pharmacopeia for unique drug lookups a mean of 6.3 times per day (SD 12.4). The majority of users (61%) believed that in the prior 4 weeks, use of the clinical reference prevented adverse drug events or medication errors 3 or more times. Physicians also believed that alerts and other notifications improved patient care if they were public health warnings (e.g. about influenza), new immunization guidelines or drug alert warnings (e.g. rofecoxib withdrawal). CONCLUSION: Current adopters of HC-based medical references use these tools frequently, and found them to improve patient care and be valuable in learning of recent alerts and warnings.

Adult↗
PubMed2006

Evaluation and treatment of pharyngitis in primary care practice: the difference between guidelines is largely academic.

BACKGROUND: The guidelines from the American College of Physicians and the Infectious Diseases Society of America differ with respect to the use of clinical criteria and microbiologic testing to identify adults with pharyngitis who are likely to have group A beta-hemolytic streptococci. METHODS: To measure the rate of adherence to 3 strategies, we performed a retrospective analysis of visits to Boston, Mass, area primary care clinics by adults with a diagnosis of pharyngitis (n = 2097). RESULTS: The 4-point Centor criteria recommended by the American College of Physicians and Infectious Diseases Society of America were not predictive of streptococcal testing (results for 0, 1, 2, 3, and 4 criteria were 79%, 81%, 79%, 80%, and 74%, respectively; P = .63) but were predictive of a positive streptococcal test (8%, 13%, 22%, 31%, and 30%, respectively; P<.001) and of antibiotic prescribing (25%, 34%, 63%, 80%, and 89%, respectively; P<.001). Clinicians were adherent to the American College of Physicians' empirical strategy in 12% of visits, the American College of Physicians' test strategy in 30% of visits, the Infectious Diseases Society of America's strategy in 30% of visits, and adherent to none of these strategies in 66% of visits. The most common reason for nonadherence to any strategy was testing or antibiotic prescribing to patients at low risk of streptococcal pharyngitis (1076 visits; 78% of the visits in which physicians were nonadherent to any strategy), patients for whom the guidelines agree. CONCLUSIONS: The major problem in the testing and treatment of adults with pharyngitis is not which guideline to follow, but that clinicians usually fail to follow any guideline. Interventions should focus on an area where the guidelines agree: avoiding testing and antibiotic prescribing to patients at low risk for streptococcal pharyngitis.

Adult↗
PubMed2006

Ability of practitioners to identify solid oral dosage tablets.

PURPOSE: Physicians' and pharmacists' ability to correctly identify three commonly used oral dosage forms was assessed. METHODS: A list of physicians and pharmacists was obtained from two urban teaching hospitals. A total of 100 pharmacists and physicians were randomly selected and their ability to correctly identify three commonly used tablets was tested. Participants were also asked about their experiences and views on current resources and alternatives for identifying oral dosage forms. Tablet-identification exercises were performed by physicians and pharmacists in their usual practice settings. Participants could consult the resources usually available to them for the identification of unknown medications. RESULTS: A total of 300 observations were made in the tablet-identification exercise (100 participants, three tablets per participant). The tablet was correctly identified in 190 of the observations (63%). The brand-name tablet, the generic tablet, and the nonprescription generic tablet were correctly identified in 78%, 64%, and 48% of the observations, respectively. Only 18 physicians (36%) and 24 pharmacists (48%) correctly identified all three tablets, whereas 10 physicians (20%) and 5 pharmacists (10%) could not correctly identify any of the tablets. The mean time required to identify a tablet was 3.65 minutes. Pharmacists most often used electronic resources (52%), while physicians relied on print resources. Overall, 77% expressed dissatisfaction with the current system and 91% favored a universal imprint coding system for oral dosage forms. CONCLUSION: Physicians and pharmacists failed to correctly identify three commonly prescribed tablets more than a third of the time. The brand-name tablet was correctly identified more often than were the prescription generic and nonprescription generic products.

Administration, Oral↗
PubMed2006

Prescribers' responses to alerts during medication ordering in the long term care setting.

OBJECTIVE: Computerized physician order entry with clinical decision support has been shown to improve medication safety in adult inpatients, but few data are available regarding its usefulness in the long-term care setting. The objective of this study was to examine opportunities for improving medication safety in that clinical setting by determining the proportion of medication orders that would generate a warning message to the prescriber via a computerized clinical decision support system and assessing the extent to which these alerts would affect prescribers' actions. DESIGN: The study was set within a randomized controlled trial of computerized clinical decision support conducted in the long-stay units of a large, academically-affiliated long-term care facility. In March 2002, a computer-based clinical decision support system (CDSS) was added to an existing computerized physician order entry (CPOE) system. Over a subsequent one-year study period, prescribers ordering drugs for residents on three resident-care units of the facility were presented with alerts; these alerts were not displayed to prescribers in the four control units. MEASUREMENTS: We assessed the frequency of drug orders associated with various categories of alerts across all participating units of the facility. To assess the impact of actually receiving an alert on prescriber behavior during drug ordering, we calculated separately for the intervention and control units the proportion of the alerts, within each category, that were followed by an appropriate action and estimated the relative risk of an appropriate action in the intervention units compared to the control units. RESULTS: During the 12 months of the study, there were 445 residents on the participating units of the facility, contributing 3,726 resident-months of observation time. During this period, 47,997 medication orders were entered through the CPOE system-approximately 9 medication orders per resident per month. 9,414 alerts were triggered (2.5 alerts per resident-month). The alert categories most often triggered were related to risks of central nervous system side-effects such as over-sedation (20%). Alerts for risk of drug-associated constipation (13%) or renal insufficiency/electrolyte imbalance (12%) were also common. Twelve percent of the alerts were related to orders for warfarin. Overall, prescribers who received alerts were only slightly more likely to take an appropriate action (relative risk 1.11, 95% confidence interval 1.00, 1.22). Alerts related to orders for warfarin or central nervous system side effects were most likely to engender an appropriate action, such as ordering a recommended laboratory test or canceling an ordered drug. CONCLUSION: Long-term care facilities must implement new system-level approaches with the potential to improve medication safety for their residents. The number of medication orders that triggered a warning message in this study suggests that CPOE with a clinical decision support system may represent one such tool. However, the relatively low rate of response to these alerts suggests that further refinements to such systems are required, and that their impact on medication errors and adverse drug events must be carefully assessed.

Decision Support Systems, Clinical↗
PubMed2006

Charlson Index is associated with one-year mortality in emergency department patients with suspected infection.

OBJECTIVES: A patient's baseline health status may affect the ability to survive an acute illness. Emergency medicine research requires tools to adjust for confounders such as comorbid illnesses. The Charlson Comorbidity Index has been validated in many settings but not extensively in the emergency department (ED). The purpose of this study was to examine the utility of the Charlson Index as a predictor of one-year mortality in a population of ED patients with suspected infection. METHODS: The comorbid illness components of the Charlson Index were prospectively abstracted from the medical records of adult (age older than 18 years) ED patients at risk for infection (indicated by the clinical decision to obtain a blood culture) and weighted. Charlson scores were grouped into four previously established indices: 0 points (none), 1-2 points (low), 3-4 points (moderate), and > or =5 points (high). The primary outcome was one-year mortality assessed using the National Death Index and medical records. Cox proportional-hazards ratios were calculated, adjusting for age, gender, and markers of 28-day in-hospital mortality. RESULTS: Between February 1, 2000, and February 1, 2001, 3,102 unique patients (96% of eligible patients) were enrolled at an urban teaching hospital. Overall one-year mortality was 22% (667/3,102). Mortality rates increased with increasing Charlson scores: none, 7% (95% confidence interval [CI] = 5.4% to 8.5%); low, 22% (95% CI = 19% to 24%); moderate, 31% (95% CI = 27% to 35%); and high, 40% (95% CI = 36% to 44%). Controlling for age, gender, and factors associated with 28-day mortality, and using the "none" group as a reference group, the Charlson Index predicted mortality as follows: low, odds ratio of 2.0; moderate, odds ratio of 2.5; and high, odds ratio of 4.7. CONCLUSIONS: This study suggests that the Charlson Index predicts one-year mortality among ED patients with suspected infection.

Adult↗
PubMed2006

Role of pharmacist counseling in preventing adverse drug events after hospitalization.

BACKGROUND: Hospitalization and subsequent discharge home often involve discontinuity of care, multiple changes in medication regimens, and inadequate patient education, which can lead to adverse drug events (ADEs) and avoidable health care utilization. Our objectives were to identify drug-related problems during and after hospitalization and to determine the effect of patient counseling and follow-up by pharmacists on preventable ADEs. METHODS: We conducted a randomized trial of 178 patients being discharged home from the general medicine service at a large teaching hospital. Patients in the intervention group received pharmacist counseling at discharge and a follow-up telephone call 3 to 5 days later. Interventions focused on clarifying medication regimens; reviewing indications, directions, and potential side effects of medications; screening for barriers to adherence and early side effects; and providing patient counseling and/or physician feedback when appropriate. The primary outcome was rate of preventable ADEs. RESULTS: Pharmacists observed the following drug-related problems in the intervention group: unexplained discrepancies between patients' preadmission medication regimens and discharge medication orders in 49% of patients, unexplained discrepancies between discharge medication lists and postdischarge regimens in 29% of patients, and medication nonadherence in 23%. Comparing trial outcomes 30 days after discharge, preventable ADEs were detected in 11% of patients in the control group and 1% of patients in the intervention group (P = .01). No differences were found between groups in total ADEs or total health care utilization. CONCLUSIONS: Pharmacist medication review, patient counseling, and telephone follow-up were associated with a lower rate of preventable ADEs 30 days after hospital discharge. Medication discrepancies before and after discharge were common targets of intervention.

Directive Counseling↗
PubMed2006

Return on investment for a computerized physician order entry system.

OBJECTIVE: Although computerized physician order entry (CPOE) may decrease errors and improve quality, hospital adoption has been slow. The high costs and limited data on financial benefits of CPOE systems are a major barrier to adoption. The authors assessed the costs and financial benefits of the CPOE system at Brigham and Women's Hospital over ten years. DESIGN: Cost and benefit estimates of a hospital CPOE system at Brigham and Women's Hospital (BWH), a 720-adult bed, tertiary care, academic hospital in Boston. MEASUREMENTS: Institutional experts provided data about the costs of the CPOE system. Benefits were determined from published studies of the BWH CPOE system, interviews with hospital experts, and relevant internal documents. Net overall savings to the institution and operating budget savings were determined. All data are presented as value figures represented in 2002 dollars. RESULTS: Between 1993 and 2002, the BWH spent $11.8 million to develop, implement, and operate CPOE. Over ten years, the system saved BWH $28.5 million for cumulative net savings of $16.7 million and net operating budget savings of $9.5 million given the institutional 80% prospective reimbursement rate. The CPOE system elements that resulted in the greatest cumulative savings were renal dosing guidance, nursing time utilization, specific drug guidance, and adverse drug event prevention. The CPOE system at BWH has resulted in substantial savings, including operating budget savings, to the institution over ten years. CONCLUSION: Other hospitals may be able to save money and improve patient safety by investing in CPOE systems.

Academic Medical Centers↗
PubMed2006

E-Prescribing collaboration in Massachusetts: early experiences from regional prescribing projects.

Massachusetts payers and providers have encouraged clinician usage of e-Prescribing technology to improve patient safety, enhance office practice efficiencies, and reduce medical costs. This report describes three early pilot e-Prescribing projects as case studies. These projects identified the e-Prescribing needs of clinicians, illustrated key issues that made implementation difficult, and clarified the impact of various types of functionality. The authors identified ten key barriers: (1) previous negative technology experiences, (2) initial and long-term cost, (3) lost productivity, (4) competing priorities, (5) change management issues, (6) interoperability limitations, (7) information technology (IT) requirements, (8) standards limitations, (9) waiting for an "all-in-one solution," and (10) confusion about competing product offerings including hospital/Integrated Delivery System (IDN)-sponsored projects. In Massachusetts, regional projects have helped to address these barriers, and e-Prescribing activities are accelerating rapidly within the state.

Drug Prescriptions↗
PubMed2006

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.

Adolescent↗