Lucian L. Leape

Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I.

BACKGROUND As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care. METHODS 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 chi 2 = 21.04, P less than 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 less than 0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (P less than 0.01). There were significant differences in rates of adverse events among categories of clinical specialties (P less than 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.

The Impact of Computerized Physician Order Entry on Medication Error Prevention

BACKGROUND Medication errors are common, and while most such errors have little potential for harm they cause substantial extra work in hospitals. A small proportion do have the potential to cause injury, and some cause preventable adverse drug events. OBJECTIVE To evaluate the impact of computerized physician order entry (POE) with decision support in reducing the number of medication errors. DESIGN Prospective time series analysis, with four periods. SETTING AND PARTICIPANTS All patients admitted to three medical units were studied for seven to ten-week periods in four different years. The baseline period was before implementation of POE, and the remaining three were after. Sophistication of POE increased with each successive period. INTERVENTION Physician order entry with decision support features such as drug allergy and drug-drug interaction warnings. MAIN OUTCOME MEASURE Medication errors, excluding missed dose errors. RESULTS During the study, the non-missed-dose medication error rate fell 81 percent, from 142 per 1,000 patient-days in the baseline period to 26.6 per 1,000 patient-days in the final period (P < 0.0001). Non-intercepted serious medication errors (those with the potential to cause injury) fell 86 percent from baseline to period 3, the final period (P = 0.0003). Large differences were seen for all main types of medication errors: dose errors, frequency errors, route errors, substitution errors, and allergies. For example, in the baseline period there were ten allergy errors, but only two in the following three periods combined (P < 0.0001). CONCLUSIONS Computerized POE substantially decreased the rate of non-missed-dose medication errors. A major reduction in errors was achieved with the initial version of the system, and further reductions were found with addition of decision support features.

Reducing the Frequency of Errors in Medicine Using Information Technology

BACKGROUND Increasing data suggest that error in medicine is frequent and results in substantial harm. The recent Institute of Medicine report (LT Kohn, JM Corrigan, MS Donaldson, eds: To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press, 1999) described the magnitude of the problem, and the public interest in this issue, which was already large, has grown. GOAL The goal of this white paper is to describe how the frequency and consequences of errors in medical care can be reduced (although in some instances they are potentiated) by the use of information technology in the provision of care, and to make general and specific recommendations regarding error reduction through the use of information technology. RESULTS General recommendations are to implement clinical decision support judiciously; to consider consequent actions when designing systems; to test existing systems to ensure they actually catch errors that injure patients; to promote adoption of standards for data and systems; to develop systems that communicate with each other; to use systems in new ways; to measure and prevent adverse consequences; to make existing quality structures meaningful; and to improve regulation and remove disincentives for vendors to provide clinical decision support. Specific recommendations are to implement provider order entry systems, especially computerized prescribing; to implement bar-coding for medications, blood, devices, and patients; and to utilize modern electronic systems to communicate key pieces of asynchronous data such as markedly abnormal laboratory values. CONCLUSIONS Appropriate increases in the use of information technology in health care- especially the introduction of clinical decision support and better linkages in and among systems, resulting in process simplification-could result in substantial improvement in patient safety.

Relationship between medication errors and adverse drug events

OBJECTIVE: To evaluate the frequency of medication errors using a multidisciplinary approach, to classify these errors by type, and to determine how often medication errors are associated with adverse drug events (ADEs) and potential ADEs.DESIGN: Medication errors were detected using self-report by pharmacists, nurse review of all patient charts, and review of all medication sheets. Incidents that were thought to represent ADEs or potential ADEs were identified through spontaneous reporting from nursing or pharmacy personnel, solicited reporting from nurses, and daily chart review by the study nurse. Incidents were subsequently classified by two independent reviewers as ADEs or potential ADEs.SETTING: Three medical units at an urban tertiary care hospital.PATIENTS: A cohort of 379 consecutive admissions during a 51-day period (1,704 patient-days).INTERVENTION: None.MEASUREMENTS AND MAIN RESULTS: Over the study period, 10,070 medication orders were written, and 530 medications errors were identified (5.3 errors/100 orders), for a mean of 0.3 medication errors per patient-day, or 1.4 per admission. Of the medication errors, 53% involved at least one missing dose of a medication; 15% involved other dose errors, 8% frequency errors, and 5% route errors. During the same period, 25 ADEs and 35 potential ADEs were found. Of the 25 ADEs, five (20%) were associated with medication errors; all were judged preventable. Thus, five of 530 medication errors (0.9%) resulted in ADEs. Physician computer order entry could have prevented 84% of non-missing dose medication errors, 86% of potential ADEs, and 60% of preventable ADEs.CONCLUSIONS: Medication errors are common, although relatively few result in ADEs. However, those that do are preventable, many through physician computer order entry.

Preventable adverse drug events in hospitalized patients: a comparative study of intensive care and general care units.

OBJECTIVES To compare the frequency and preventability of adverse drug events and potential adverse drug events in intensive care units (ICUs) and non-ICUs. To evaluate systems factors involving the individual caregivers, care unit teams, and patients involved in each adverse drug event by comparing ICUs with non-ICUs and medical ICUs with surgical ICUs. DESIGN Prospective cohort study. Participants included all 4,031 adult admissions to a stratified, random sample of 11 medical and surgical units in two tertiary care hospitals over a 6-month period. Units included two medical and three surgical ICUs and four medical and two surgical general care units. SETTING Two tertiary care hospitals: Eleven medical and surgical units, including two medical and three surgical ICUs. PATIENTS Adult admissions (n = 4,031). INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS Rate of preventable adverse drug events and potential adverse drug events, length of stay, charges, costs, and measures of the units environment. Incidents were detected by stimulated self-report by nurses and pharmacists and by daily review of all charts by nurse investigators. Incidents were subsequently classified by two independent reviewers as to whether they represented adverse drug events or potential adverse drug events and as to severity and preventability. Those individuals involved in the preventable adverse drug event and potential adverse drug event underwent detailed interviews by peer case-investigators. The rate of preventable adverse drug events and potential adverse drug events in ICUs was 19 events per 1000 patient days, nearly twice that rate of non-ICUs (p <.01). The medical ICU rate (25 events per 1000 patient days) was significantly (p <.05) higher than the surgical ICU rate (14 events per 1000 patient days). When adjusted for the number of drugs used in the previous 24 hrs or ordered since admission, there were no differences in rates between ICUs and non-ICUs. ICU acuity, length of stay, and severity of the adverse drug event were greater in ICUs than non-ICUs, but there were no differences between medical ICU and surgical ICU patients. Structured interviews indicated almost no differences between ICUs and non-ICUs for many characteristics of the patient, patient care team, systems, and individual caregivers. CONCLUSIONS The rate of preventable and potential adverse drug events was twice as high in ICUs compared with non-ICUs. However, when adjusted for the number of drugs ordered, there was no greater likelihood for preventable adverse drug events and potential adverse drug events to occur in ICUs than in non-ICUs. Preventable adverse drug events and potential adverse drug events occurred in units that functioned normally and involved caregivers who were working under reasonably normal circumstances, not at the extremes of workload, stress, or a difficult environment.

The Incident Reporting System Does Not Detect Adverse Drug Events: A Problem for Quality Improvement

OBJECTIVES The objectives of this study were 1) to determine the frequency with which adverse drug events result in an incident report (IR) in hospitalized patients; and 2) to determine if there were differences between quality assurance administrators, nurse leaders in quality assurance, and staff nurses as to whether an incident report should or would be filed for each adverse drug event. STUDY DESIGN All patients admitted to five patient care units (one medical intensive care unit, two surgical intensive care units, and two medical general care units) in one academic tertiary care hospital were studied between February and July 1993. The main outcome measures used were adverse drug events (ADEs) and IRs. Consensus voting was used by senior hospital administrators, nursing leaders, and staff nurses to determine whether an adverse drug event should have been reported and would have been reported. RESULTS Of 54 adverse drug events identified by the study, only 3 patients (6%) had a corresponding incident report submitted to the hospitals quality assurance program or called into the pharmacy hotline. One additional ADE was identified by an IR, but not by the ADE study. Of the 55 ADEs, 15 were preventable, and 26 were serious or life-threatening, yet only 2 of the 26 led to an incident report. The three voting groups agreed that most ADEs justified an IR, but judged that in actual practice, an IR would infrequently have been filed. CONCLUSIONS Voluntary reporting identified only a small fraction of ADEs. Using IRs for quality assurance/quality improvement will lead to significant bias when assessing quality of care.

Patient participation: current knowledge and applicability to patient safety.

Patient participation is increasingly recognized as a key component in the redesign of health care processes and is advocated as a means to improve patient safety. The concept has been successfully applied to various areas of patient care, such as decision making and the management of chronic diseases. We review the origins of patient participation, discuss the published evidence on its efficacy, and summarize the factors influencing its implementation. Patient-related factors, such as acceptance of the new patient role, lack of medical knowledge, lack of confidence, comorbidity, and various sociodemographic parameters, all affect willingness to participate in the health care process. Among health care workers, the acceptance and promotion of patient participation are influenced by other issues, including the desire to maintain control, lack of time, personal beliefs, type of illness, and training in patient-caregiver relationships. Social status, specialty, ethnic origin, and the stakes involved also influence patient and health care worker acceptance. The London Declaration, endorsed by the World Health Organization World Alliance for Patient Safety, calls for a greater role for patients to improve the safety of health care worldwide. Patient participation in hand hygiene promotion among staff to prevent health care-associated infection is discussed as an illustrative example. A conceptual model including key factors that influence participation and invite patients to contribute to error prevention is proposed. Further research is essential to establish key determinants for the success of patient participation in reducing medical errors and in improving patient safety.

Transforming healthcare: a safety imperative

Ten years ago, the Institute of Medicine reported alarming data on the scope and impact of medical errors in the US and called for national efforts to address this problem. While efforts to improve patient safety have proliferated during the past decade, progress toward improvement has been frustratingly slow. Some of this lack of progress may be attributable to the persistence of a medical ethos, institutionalized in the hierarchical structure of academic medicine and healthcare organizations, that discourages teamwork and transparency and undermines the establishment of clear systems of accountability for safe care. The Lucian Leape Institute, established by the US National Patient Safety Foundation to provide vision and strategic direction for the patient safety work, has identified five concepts as fundamental to the endeavor of achieving meaningful improvement in healthcare system safety. These five concepts are transparency, care integration, patient/consumer engagement, restoration of joy and meaning in work, and medical education reform. This paper introduces the five concepts and illustrates the meaning and implications of each as a component of a vision for healthcare safety improvement. In future roundtable sessions, the Institute will further elaborate on the meaning of each concept, identify the challenges to implementation, and issue recommendations for policy makers, organizations, and healthcare professionals.

Preventing medical injury.

Although adverse events (AEs) are not uncommon in hospitalized patients, they are by no means inevitable. A review of records from a population-based study in New York revealed that nearly 4% of hospitalized patients suffered AEs. Two-thirds of those events were considered to be caused by errors in management, most of which were not because of negligence. A large part of the reason preventable AEs occur is that todays medical care is extremely complex, involving a variety of personnel, equipment, and procedures. By seeking to eliminate errors in the system of providing care and raising the awareness of health care providers about the potential for AEs, programs can be established to address and possibly remedy this serious problem.

Incidence and preventability of adverse drug events in hospitalized adults

Objective: To evaluate the incidence and preventability of adverse drug events (ADEs) and to determine the yield of several strategies for identifying them.Design: Prospective cohort study.Setting: Seven units, including two medical, two surgical, and two obstetric general care units and a coronary intensive care unit in an urban tertiary care hospital.Patients: All patients on these units over a 37-day period (2,967 patient-days).Interventions: None.Methods: Events were identified in three ways: 1) logs were placed on each unit and satellite pharmacy for nurses and pharmacists to record incidents; 2) a research nurse solicited reports of incidents twice daily on each unit; and 3) the nurse reviewed all charts at least daily. Incidents were classified by two independent reviewers as ADEs or potential ADEs.Results: The rate of drug-related incidents was 73 in 2,967 patient-days; 27 incidents were judged ADEs, 34 potential ADEs, and 12 problem orders. Fifty different drugs were involved. Physicians were primarily responsible for 72% of the incidents, with the remainder divided evenly between nursing, pharmacy, and clerical personnel. Of the 27 ADEs, five were life-threatening, nine were serious, and 13 were significant. Fifteen (56%) of the 27 were judged definitely or probably preventable. Incidents were discovered about equally often from the logs and by chart review. However, when the incidents in which an ADE was present were compared with the remainder of incidents, the authors found that 67% (18 of 27) of the ADEs were identified only by chart review (p<0.001), and physicians were more often judged responsible than other personnel (p<0.001).Conclusions: The authors conclude that ADEs are not infrequent, often preventable, and usually caused by physician decisions. In this study, solicited reporting by nurses and pharmacists was inferior to chart review for identifying ADEs, but was effective for identifying potential ADEs. Optimal prevention strategies should cover many types of drugs and target physicians’ ordering practices.