Person: Leape, Lucian
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Leape, Lucian
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Publication Effect of Computerized Physician Order Entry and a Team Intervention on Prevention of Serious Medication Errors(American Medical Association (AMA), 1998-10-21) Bates, David; Leape, Lucian; Cullen, David J; Laird, Nan; Petersen, Laura A; Teich, Jonathan; Burdick, Elizabeth; Hickey, Mairead; Kleefield, Sharon; Shea, Brian; Vander Vliet, Martha; Seger, Diane LContext: Adverse drug events (ADEs) are a significant and costly cause of injury during hospitalization. Objectives: To evaluate the efficacy of 2 interventions for preventing nonintercepted serious medication errors, defined as those that either resulted in or had potential to result in an ADE and were not intercepted before reaching the patient. Design: Before-after comparison between phase 1 (baseline) and phase 2 (after intervention was implemented) and, within phase 2, a randomized comparison between physician computer order entry (POE) and the combination of POE plus a team intervention. Setting: Large tertiary care hospital. Participants: For the comparison of phase 1 and 2, all patients admitted to a stratified random sample of 6 medical and surgical units in a tertiary care hospital over a 6-month period, and for the randomized comparison during phase 2, all patients admitted to the same units and 2 randomly selected additional units over a subsequent 9-month period. Interventions: A physician computer order entry system (POE) for all units and a team-based intervention that included changing the role of pharmacists, implemented for half the units. Main outcome measure: Nonintercepted serious medication errors. Results: Comparing identical units between phases 1 and 2, nonintercepted serious medication errors decreased 55%, from 10.7 events per 1000 patient-days to 4.86 events per 1000 (P=.01). The decline occurred for all stages of the medication-use process. Preventable ADEs declined 17% from 4.69 to 3.88 (P=.37), while nonintercepted potential ADEs declined 84% from 5.99 to 0.98 per 1000 patient-days (P=.002). When POE-only was compared with the POE plus team intervention combined, the team intervention conferred no additional benefit over POE. Conclusions: Physician computer order entry decreased the rate of nonintercepted serious medication errors by more than half, although this decrease was larger for potential ADEs than for errors that actually resulted in an ADE.Publication Incidence of Adverse Events and Negligence in Hospitalized Patients — Results of the Harvard Medical Practice Study I(Massachusetts Medical Society, 1991-02-07) Brennan, Troyen; Leape, Lucian; Laird, Nan; Hebert, Liesi; Localio, A. Russell; Lawthers, Ann G.; Newhouse, Joseph; Weiler, Paul; Hiatt, HowardMETHODS We reviewed 30,121 randomly selected records from 51 randomly selected acute care, nonpsychiatric hospitals in New York State in 1984. We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians. RESULTS Adverse events occurred in 3.7 percent of the hospitalizations (95 percent confidence interval, 3.2 to 4.2), and 27.6 percent of the adverse events were due to negligence (95 percent confidence interval, 22.5 to 32.6). Although 70.5 percent of the adverse events gave rise to disability lasting less than six months, 2.6 percent caused permanently disabling injuries and 13.6 percent led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test χ2 = 21.04, P<0.0001). Using weighted totals, we estimated that among the 2,671,863 patients discharged from New York hospitals in 1984 there were 98,609 adverse events and 27,179 adverse events involving negligence. Rates of adverse events rose with age (P<0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (P<0.01). There were significant differences in rates of adverse events among categories of clinical specialties (P<0.0001), but no differences in the percentage due to negligence. CONCLUSIONS There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.Publication The Nature of Adverse Events in Hospitalized Patients: Results of the Harvard Medical Practice Study II(Massachusetts Medical Society, 1991-02-07) Leape, Lucian; Brennan, Troyen; Laird, Nan; Lawthers, Ann G.; Localio, A. Russell; Barnes, Benjamin A.; Hebert, Liesi; Newhouse, Joseph; Weiler, Paul; Hiatt, HowardBackground: In a sample of 30,195 randomly selected hospital records, we identified 1133 patients (3.7 percent) with disabling injuries caused by medical treatment. We report here an analysis of these adverse events and their relation to error, negligence, and disability. Methods: Two physician-reviewers independently identified the adverse events and evaluated them with respect to negligence, errors in management, and extent of disability. One of the authors classified each event according to type of injury. We tested the significance of differences in rates of negligence and disability among categories with at least 30 adverse events. Results: Drug complications were the most common type of adverse event (19 percent), followed by wound infections (14 percent) and technical complications (13 percent). Nearly half the adverse events (48 percent) were associated with an operation. Adverse events during surgery were less likely to be caused by negligence (17 percent) than nonsurgical ones (37 percent). The proportion of adverse events due to negligence was highest for diagnostic mishaps (75 percent), noninvasive therapeutic mishaps ("errors of omission") (77 percent), and events occurring in the emergency room (70 percent). Errors in management were identified for 58 percent of the adverse events, among which nearly half were attributed to negligence. Conclusions: Although the prevention of many adverse events must await improvements in medical knowledge, the high proportion that are due to management errors suggests that many others are potentially preventable now. Reducing the incidence of these events will require identifying their causes and developing methods to prevent error or reduce its effects.Publication The Reproducibility of a Method to Identify the Overuse and Underuse of Medical Procedures(Massachusetts Medical Society, 1998-06-25) Shekelle, Paul G.; Kahan, James P.; Bernstein, Steven J.; Leape, Lucian; Kamberg, Caren J.; Park, R.E.BACKGROUND To assess the overuse and underuse of medical procedures, various methods have been developed, but their reproducibility has not been evaluated. This study estimates the reproducibility of one commonly used method. METHODS We performed a parallel, three-way replication of the RAND–University of California at Los Angeles appropriateness method as applied to two medical procedures, coronary revascularization and hysterectomy. Three nine-member multidisciplinary panels of experts were composed for each procedure by stratified random sampling from a list of experts nominated by the relevant specialty societies. Each panel independently rated the same set of clinical scenarios in terms of the appropriateness of the relevant procedure on a risk–benefit scale ranging from 1 to 9. Final ratings were used to classify the procedure in each scenario as necessary or not necessary (to evaluate underuse) and inappropriate or not inappropriate (to evaluate overuse). Reproducibility was measured by overall agreement and by the kappa statistic. The criteria for underuse and overuse derived from these ratings were then applied to real populations of patients who had undergone coronary revascularization or hysterectomy. RESULTS The rates of agreement among the three coronary-revascularization panels were 95, 94, and 96 percent for inappropriate-use scenarios and 93, 92, and 92 percent for necessary-use scenarios. Agreement among the three hysterectomy panels was 88, 70, and 74 percent for inappropriate-use scenarios. Scenarios involving necessary use of hysterectomy were not assessed. The three-way kappa statistic to detect overuse was 0.52 for coronary revascularization and 0.51 for hysterectomy. The three-way kappa statistic to detect underuse of coronary revascularization was 0.83. Application of individual panels' criteria to real populations of patients resulted in a 100 percent variation in the proportion of cases classified as inappropriate and a 20 percent variation in the proportion of cases classified as necessary. CONCLUSIONS The appropriateness method is far from perfect. Appropriateness criteria may be useful in comparing levels of appropriate procedures among populations but should not by themselves be used to direct care for individual patients.Publication Adverse Drug Events in Ambulatory Care(Massachusetts Medical Society, 2003-04-17) Gandhi, Tejal; Weingart, Saul N.; Borus, Joshua; Seger, Andrew; Peterson, Josh; Burdick, Elisabeth; Seger, Diane L.; Small, Kirstin; Federico, Frank; Leape, Lucian; Bates, DavidBackground: Adverse events related to drugs occur frequently among inpatients, and many of these events are preventable. However, few data are available on adverse drug events among outpatients. We conducted a study to determine the rates, types, severity, and preventability of such events among outpatients and to identify preventive strategies. Methods: We performed a prospective cohort study, including a survey of patients and a chart review, at four adult primary care practices in Boston (two hospital-based and two community-based), involving a total of 1202 outpatients who received at least one prescription during a four-week period. Prescriptions were computerized at two of the practices and handwritten at the other two. Results: Of the 661 patients who responded to the survey (response rate, 55 percent), 162 had adverse drug events (25 percent; 95 percent confidence interval, 20 to 29 percent), with a total of 181 events (27 per 100 patients). Twenty-four of the events (13 percent) were serious, 51 (28 percent) were ameliorable, and 20 (11 percent) were preventable. Of the 51 ameliorable events, 32 (63 percent) were attributed to the physician's failure to respond to medication-related symptoms and 19 (37 percent) to the patient's failure to inform the physician of the symptoms. The medication classes most frequently involved in adverse drug events were selective serotonin-reuptake inhibitors (10 percent), beta-blockers (9 percent), angiotensin-converting-enzyme inhibitors (8 percent), and nonsteroidal antiinflammatory agents (8 percent). On multivariate analysis, only the number of medications taken was significantly associated with adverse events. Conclusions: Adverse events related to drugs are common in primary care, and many are preventable or ameliorable. Monitoring for and acting on symptoms are important. Improving communication between outpatients and providers may help prevent adverse events related to drugs.Publication Regionalization and the Underuse of Angiography in the Veterans Affairs Health Care System as Compared with a Fee-for-Service System(Massachusetts Medical Society, 2003-05-29) Petersen, Laura A.; Normand, Sharon-Lise; Leape, Lucian; McNeil, BarbaraBackground: Policies to concentrate or regionalize invasive procedures at high-volume medical centers are under active consideration. Such policies could improve outcomes among those who undergo procedures while increasing their underuse among those who never reach such centers. We compared the underuse of needed angiography after acute myocardial infarction in a traditional Medicare fee-for-service system with underuse in the regionalized Department of Veterans Affairs (VA) health care system. Methods: We studied 1665 veterans from 81 VA hospitals and 19,305 Medicare patients from 1530 non-VA hospitals, all of whom were elderly men. We compared adjusted angiography use and one-year mortality among patients for whom angiography was rated as clinically needed. We compared underuse in models before and after controlling for the on-site availability of cardiac procedures. Results: After adjustment for the need for angiography, underuse was present in both groups, but VA patients remained significantly less likely than Medicare patients to undergo angiography (43.9 percent vs. 51.0 percent; odds ratio, 0.75; 95 percent confidence interval, 0.57 to 0.96). After also controlling for on-site availability of cardiac procedures at the admitting hospital, we found no significant difference in the underuse of angiography among VA patients as compared with Medicare patients (odds ratio, 1.02; 95 percent confidence interval, 0.82 to 1.26) or in one-year mortality (odds ratio, 1.08; 95 percent confidence interval, 0.89 to 1.28). Conclusions: There is underuse of needed angiography after acute myocardial infarction in both the VA and Medicare systems, but the rate of underuse is significantly higher in the VA. These differences appear to be associated with limited on-site availability of cardiac procedures in the regionalized VA health care system. Further work should focus on how regionalization policies could be improved with effective referral and triage processes.Publication Assessing the level of healthcare information technology adoption in the United States: a snapshot(Springer Nature, 2006) Poon, Eric G; Jha, Ashish; Christino, Melissa; Honour, Melissa M; Fernandopulle, Rushika; Middleton, Blackford; Newhouse, Joseph; Leape, Lucian; Bates, David; Blumenthal, David; Kaushal, RainuBackground: Comprehensive knowledge about the level of healthcare information technology (HIT) adoption in the United States remains limited. We therefore performed a baseline assessment to address this knowledge gap. Methods: We segmented HIT into eight major stakeholder groups and identified major functionalities that should ideally exist for each, focusing on applications most likely to improve patient safety, quality of care and organizational efficiency. We then conducted a multi-site qualitative study in Boston and Denver by interviewing key informants from each stakeholder group. Interview transcripts were analyzed to assess the level of adoption and to document the major barriers to further adoption. Findings for Boston and Denver were then presented to an expert panel, which was then asked to estimate the national level of adoption using the modified Delphi approach. We measured adoption level in Boston and Denver was graded on Rogers' technology adoption curve by co-investigators. National estimates from our expert panel were expressed as percentages. Results: Adoption of functionalities with financial benefits far exceeds adoption of those with safety and quality benefits. Despite growing interest to adopt HIT to improve safety and quality, adoption remains limited, especially in the area of ambulatory electronic health records and physician-patient communication. Organizations, particularly physicians' practices, face enormous financial challenges in adopting HIT, and concerns remain about its impact on productivity. Conclusion: Adoption of HIT is limited and will likely remain slow unless significant financial resources are made available. Policy changes, such as financial incentivesto clinicians to use HIT or pay-for-performance reimbursement, may help health care providers defray upfront investment costs and initial productivity loss.Publication Implementing the 2009 Institute of Medicine recommendations on resident physician work hours, supervision, and safety(Dove Medical Press, 2011) Blum, Alexander B; Shea, Sandra; Czeisler, Charles; Landrigan, Christopher; Leape, LucianLong working hours and sleep deprivation have been a facet of physician training in the US since the advent of the modern residency system. However, the scientific evidence linking fatigue with deficits in human performance, accidents and errors in industries from aeronautics to medicine, nuclear power, and transportation has mounted over the last 40 years. This evidence has also spawned regulations to help ensure public safety across safety-sensitive industries, with the notable exception of medicine. In late 2007, at the behest of the US Congress, the Institute of Medicine embarked on a year-long examination of the scientific evidence linking resident physician sleep deprivation with clinical performance deficits and medical errors. The Institute of Medicine’s report, entitled “Resident duty hours: Enhancing sleep, supervision and safety”, published in January 2009, recommended new limits on resident physician work hours and workload, increased supervision, a heightened focus on resident physician safety, training in structured handovers and quality improvement, more rigorous external oversight of work hours and other aspects of residency training, and the identification of expanded funding sources necessary to implement the recommended reforms successfully and protect the public and resident physicians themselves from preventable harm. Given that resident physicians comprise almost a quarter of all physicians who work in hospitals, and that taxpayers, through Medicare and Medicaid, fund graduate medical education, the public has a deep investment in physician training. Patients expect to receive safe, high-quality care in the nation’s teaching hospitals. Because it is their safety that is at issue, their voices should be central in policy decisions affecting patient safety. It is likewise important to integrate the perspectives of resident physicians, policy makers, and other constituencies in designing new policies. However, since its release, discussion of the Institute of Medicine report has been largely confined to the medical education community, led by the Accreditation Council for Graduate Medical Education (ACGME). To begin gathering these perspectives and developing a plan to implement safer work hours for resident physicians, a conference entitled “Enhancing sleep, supervision and safety: What will it take to implement the Institute of Medicine recommendations?” was held at Harvard Medical School on June 17–18, 2010. This White Paper is a product of a diverse group of 26 representative stakeholders bringing relevant new information and innovative practices to bear on a critical patient safety problem. Given that our conference included experts from across disciplines with diverse perspectives and interests, not every recommendation was endorsed by each invited conference participant. However, every recommendation made here was endorsed by the majority of the group, and many were endorsed unanimously. Conference members participated in the process, reviewed the final product, and provided input before publication. Participants provided their individual perspectives, which do not necessarily represent the formal views of any organization. In September 2010 the ACGME issued new rules to go into effect on July 1, 2011. Unfortunately, they stop considerably short of the Institute of Medicine’s recommendations and those endorsed by this conference. In particular, the ACGME only applied the limitation of 16 hours to first-year resident physicans. Thus, it is clear that policymakers, hospital administrators, and residency program directors who wish to implement safer health care systems must go far beyond what the ACGME will require. We hope this White Paper will serve as a guide and provide encouragement for that effort. Resident physician workload and supervision By the end of training, a resident physician should be able to practice independently. Yet much of resident physicians’ time is dominated by tasks with little educational value. The caseload can be so great that inadequate reflective time is left for learning based on clinical experiences. In addition, supervision is often vaguely defined and discontinuous. Medical malpractice data indicate that resident physicians are frequently named in lawsuits, most often for lack of supervision. The recommendations are: The ACGME should adjust resident physicians workload requirements to optimize educational value. Resident physicians as well as faculty should be involved in work redesign that eliminates nonessential and noneducational activity from resident physician dutiesMechanisms should be developed for identifying in real time when a resident physician’s workload is excessive, and processes developed to activate additional providersTeamwork should be actively encouraged in delivery of patient care. Historically, much of medical training has focused on individual knowledge, skills, and responsibility. As health care delivery has become more complex, it will be essential to train resident and attending physicians in effective teamwork that emphasizes collective responsibility for patient care and recognizes the signs, both individual and systemic, of a schedule and working conditions that are too demanding to be safeHospitals should embrace the opportunities that resident physician training redesign offers. Hospitals should recognize and act on the potential benefits of work redesign, eg, increased efficiency, reduced costs, improved quality of care, and resident physician and attending job satisfactionAttending physicians should supervise all hospital admissions. Resident physicians should directly discuss all admissions with attending physicians. Attending physicians should be both cognizant of and have input into the care patients are to receive upon admission to the hospitalInhouse supervision should be required for all critical care services, including emergency rooms, intensive care units, and trauma services. Resident physicians should not be left unsupervised to care for critically ill patients. In settings in which the acuity is high, physicians who have completed residency should provide direct supervision for resident physicians. Supervising physicians should always be physically in the hospital for supervision of resident physicians who care for critically ill patientsThe ACGME should explicitly define “good” supervision by specialty and by year of training. Explicit requirements for intensity and level of training for supervision of specific clinical scenarios should be providedCenters for Medicare and Medicaid Services (CMS) should use graduate medical education funding to provide incentives to programs with proven, effective levels of supervision. Although this action would require federal legislation, reimbursement rules would help to ensure that hospitals pay attention to the importance of good supervision and require it from their training programs Resident physician work hours Although the IOM “Sleep, supervision and safety” report provides a comprehensive review and discussion of all aspects of graduate medical education training, the report’s focal point is its recommendations regarding the hours that resident physicians are currently required to work. A considerable body of scientific evidence, much of it cited by the Institute of Medicine report, describes deteriorating performance in fatigued humans, as well as specific studies on resident physician fatigue and preventable medical errors. The question before this conference was what work redesign and cultural changes are needed to reform work hours as recommended by the Institute of Medicine’s evidence-based report? Extensive scientific data demonstrate that shifts exceeding 12–16 hours without sleep are unsafe. Several principles should be followed in efforts to reduce consecutive hours below this level and achieve safer work schedules. The recommendations are: Limit resident physician work hours to 12–16 hour maximum shiftsA minimum of 10 hours off duty should be scheduled between shiftsResident physician input into work redesign should be actively solicitedSchedules should be designed that adhere to principles of sleep and circadian science; this includes careful consideration of the effects of multiple consecutive night shifts, and provision of adequate time off after night work, as specified in the IOM reportResident physicians should not be scheduled up to the maximum permissible limits; emergencies frequently occur that require resident physicians to stay longer than their scheduled shifts, and this should be anticipated in scheduling resident physicians’ work shiftsHospitals should anticipate the need for iterative improvement as new schedules are initiated; be prepared to learn from the initial phase-in, and change the plan as neededAs resident physician work hours are redesigned, attending physicians should also be considered; a potential consequence of resident physician work hour reduction and increased supervisory requirements may be an increase in work for attending physicians; this should be carefully monitored, and adjustments to attending physician work schedules made as needed to prevent unsafe work hours or working conditions for this group“Home call” should be brought under the overall limits of working hours; work load and hours should be monitored in each residency program to ensure that resident physicians and fellows on home call are getting sufficient sleepMedicare funding for graduate medical education in each hospital should be linked with adherence to the Institute of Medicine limits on resident physician work hours Moonlighting by resident physicians The Institute of Medicine report recommended including external as well as internal moonlighting in working hour limits. The recommendation is: All moonlighting work hours should be included in the ACGME working hour limits and actively monitored. Hospitals should formalize a moonlighting policy and establish systems for actively monitoring resident physician moonlighting Safety of resident physicians The “Sleep, supervision and safety” report also addresses fatigue-related harm done to resident physicians themselves. The report focuses on two main sources of physical injury to resident physicians impaired by fatigue, ie, needle-stick exposure to blood-borne pathogens and motor vehicle crashes. Providing safe transportation home for resident physicians is a logistical and financial challenge for hospitals. Educating physicians at all levels on the dangers of fatigue is clearly required to change driving behavior so that safe hospital-funded transport home is used effectively. Fatigue-related injury prevention (including not driving while drowsy) should be taught in medical school and during residency, and reinforced with attending physicians; hospitals and residency programs must be informed that resident physicians’ ability to judge their own level of impairment is impaired when they are sleep deprived; hence, leaving decisions about the capacity to drive to impaired resident physicians is not recommendedHospitals should provide transportation to all resident physicians who report feeling too tired to drive safely; in addition, although consecutive work should not exceed 16 hours, hospitals should provide transportation for all resident physicians who, because of unforeseen reasons or emergencies, work for longer than consecutive 24 hours; transportation under these circumstances should be automatically provided to house staff, and should not rely on self-identification or request Training in effective handovers and quality improvement Handover practice for resident physicians, attendings, and other health care providers has long been identified as a weak link in patient safety throughout health care settings. Policies to improve handovers of care must be tailored to fit the appropriate clinical scenario, recognizing that information overload can also be a problem. At the heart of improving handovers is the organizational effort to improve quality, an effort in which resident physicians have typically been insufficiently engaged. The recommendations are: Hospitals should train attending and resident physicians in effective handovers of careHospitals should create uniform processes for handovers that are tailored to meet each clinical setting; all handovers should be done verbally and face-to-face, but should also utilize written toolsWhen possible, hospitals should integrate hand-over tools into their electronic medical records (EMR) systems; these systems should be standardized to the extent possible across residency programs in a hospital, but may be tailored to the needs of specific programs and services; federal government should help subsidize adoption of electronic medical records by hospitals to improve signoutWhen feasible, handovers should be a team effort including nurses, patients, and familiesHospitals should include residents in their quality improvement and patient safety efforts; the ACGME should specify in their core competency requirements that resident physicians work on quality improvement projects; likewise, the Joint Commission should require that resident physicians be included in quality improvement and patient safety programs at teaching hospitals; hospital administrators and residency program directors should create opportunities for resident physicians to become involved in ongoing quality improvement projects and root cause analysis teams; feedback on successful quality improvement interventions should be shared with resident physicians and broadly disseminatedQuality improvement/patient safety concepts should be integral to the medical school curriculum; medical school deans should elevate the topics of patient safety, quality improvement, and teamwork; these concepts should be integrated throughout the medical school curriculum and reinforced throughout residency; mastery of these concepts by medical students should be tested on the United States Medical Licensing Examination (USMLE) stepsFederal government should support involvement of resident physicians in quality improvement efforts; initiatives to improve quality by including resident physicians in quality improvement projects should be financially supported by the Department of Health and Human Services Monitoring and oversight of the ACGME While the ACGME is a key stakeholder in residency training, external voices are essential to ensure that public interests are heard in the development and monitoring of standards. Consequently, the Institute of Medicine report recommended external oversight and monitoring through the Joint Commission and Centers for Medicare and Medicaid Services (CMS). The recommendations are: Make comprehensive fatigue management a Joint Commission National Patient Safety Goal; fatigue is a safety concern not only for resident physicians, but also for nurses, attending physicians, and other health care workers; the Joint Commission should seek to ensure that all health care workers, not just resident physicians, are working as safely as possibleFederal government, including the Centers for Medicare and Medicaid Services and the Agency for Healthcare Research and Quality, should encourage development of comprehensive fatigue management programs which all health systems would eventually be required to implementMake ACGME compliance with working hours a “ condition of participation” for reimbursement of direct and indirect graduate medical education costs; financial incentives will greatly increase the adoption of and compliance with ACGME standards Future financial support for implementation The Institute of Medicine’s report estimates that $1.7 billion (in 2008 dollars) would be needed to implement its recommendations. Twenty-five percent of that amount ($376 million) will be required just to bring hospitals into compliance with the existing 2003 ACGME rules. Downstream savings to the health care system could potentially result from safer care, but these benefits typically do not accrue to hospitals and residency programs, who have been asked historically to bear the burden of residency reform costs. The recommendations are: The Institute of Medicine should convene a panel of stakeholders, including private and public funders of health care and graduate medical education, to lay down the concrete steps necessary to identify and allocate the resources needed to implement the recommendations contained in the IOM “Resident duty hours: Enhancing sleep, supervision and safety” report. Conference participants suggested several approaches to engage public and private support for this initiativeEfforts to find additional funding to implement the Institute of Medicine recommendations should focus more broadly on patient safety and health care delivery reform; policy efforts focused narrowly upon resident physician work hours are less likely to succeed than broad patient safety initiatives that include residency redesign as a key componentHospitals should view the Institute of Medicine recommendations as an opportunity to begin resident physician work redesign projects as the core of a business model that embraces safety and ultimately saves resourcesBoth the Secretary of Health and Human Services and the Director of the Centers for Medicare and Medicaid Services should take the Institute of Medicine recommendations into consideration when promulgating rules for innovation grantsThe National Health Care Workforce Commission should consider the Institute of Medicine recommendations when analyzing the nation’s physician workforce needs Recommendations for future research Conference participants concurred that convening the stakeholders and agreeing on a research agenda was key. Some observed that some sectors within the medical education community have been reluctant to act on the data. Several logical funders for future research were identified. But above all agencies, Centers for Medicare and Medicaid Services is the only stakeholder that funds graduate medical education upstream and will reap savings downstream if preventable medical errors are reduced as a result of reform of resident physician work hours.Publication Adverse Drug Events in Ambulatory Care(Massachusetts Medical Society, 2003-04-17) Gandhi, Tejal; Weingart, Saul N.; Borus, Joshua; Seger, Andrew C.; Peterson, Josh; Burdick, Elisabeth; Seger, Diane L.; Small, Kirstin; Federico, Frank; Leape, Lucian; Bates, DavidBACKGROUND Adverse events related to drugs occur frequently among inpatients, and many of these events are preventable. However, few data are available on adverse drug events among outpatients. We conducted a study to determine the rates, types, severity, and preventability of such events among outpatients and to identify preventive strategies. METHODS We performed a prospective cohort study, including a survey of patients and a chart review, at four adult primary care practices in Boston (two hospital-based and two community-based), involving a total of 1202 outpatients who received at least one prescription during a four-week period. Prescriptions were computerized at two of the practices and handwritten at the other two. RESULTS Of the 661 patients who responded to the survey (response rate, 55 percent), 162 had adverse drug events (25 percent; 95 percent confidence interval, 20 to 29 percent), with a total of 181 events (27 per 100 patients). Twenty-four of the events (13 percent) were serious, 51 (28 percent) were ameliorable, and 20 (11 percent) were preventable. Of the 51 ameliorable events, 32 (63 percent) were attributed to the physician's failure to respond to medication-related symptoms and 19 (37 percent) to the patient's failure to inform the physician of the symptoms. The medication classes most frequently involved in adverse drug events were selective serotonin-reuptake inhibitors (10 percent), beta-blockers (9 percent), angiotensin-converting–enzyme inhibitors (8 percent), and nonsteroidal antiinflammatory agents (8 percent). On multivariate analysis, only the number of medications taken was significantly associated with adverse events. CONCLUSIONS Adverse events related to drugs are common in primary care, and many are preventable or ameliorable. Monitoring for and acting on symptoms are important. Improving communication between outpatients and providers may help prevent adverse events related to drugs.Publication The Costs of Adverse Drug Events in Hospitalized Patients(American Medical Association (AMA), 1997-01-22) Bates, David; Spell, Nathan; Cullen, David J.; Burdick, Elisabeth; Laird, Nan; Petersen, Laura A.; Small, Stephen D.; Sweitzer, Bobbie J.; Leape, LucianObjective: To assess the additional resource utilization associated with an adverse drug event (ADE). Design: Nested case-control study within a prospective cohort study. Participants: The cohort included 4108 admissions to a stratified random sample of 11 medical and surgical units in 2 tertiary-care hospitals over a 6-month period. Cases were patients with an ADE, and the control for each case was the patient on the same unit as the case with the most similar pre-event length of stay. Main outcome measures: Postevent length of stay and total costs. Methods: Incidents were detected by self-report stimulated by nurses and pharmacists and by daily chart review, and were classified as to whether they represented ADEs. Information on length of stay and charges was obtained from billing data, and costs were estimated by multiplying components of charges times hospital-specific ratios of costs to charges. Results: During the study period, there were 247 ADEs among 207 admissions. After outliers and multiple episodes were excluded, there were 190 ADEs, of which 60 were preventable. In paired regression analyses adjusting for multiple factors, including severity, comorbidity, and case mix, the additional length of stay associated with an ADE was 2.2 days (P=.04), and the increase in cost associated with an ADE was USD3244 (P=.04). For preventable ADEs, the increases were 4.6 days in length of stay (P=.03) and USD5857 in total cost (P=.07). After adjusting for our sampling strategy, the estimated postevent costs attributable to an ADE were USD2595 for all ADEs and USD4685 for preventable ADEs. Based on these costs and data about the incidence of ADEs, we estimate that the annual costs attributable to all ADEs and preventable ADEs for a 700-bed teaching hospital are USD5.6 million and USD2.8 million, respectively. Conclusions: The substantial costs of ADEs to hospitals justify investment in efforts to prevent these events. Moreover, these estimates are conservative because they do not include the costs of injuries to patients or malpractice costs.