RESUMO
BACKGROUND: There is concern that care provided in the Veterans Health Administration (VA) may be of poorer quality than non-VA health care. We compared use of medications after acute myocardial infarction in the VA with that in non-VA healthcare settings under fee-for-service (FFS) Medicare financing. METHODS AND RESULTS: We used clinical data from 2486 VA and 29 249 FFS men >65 years old discharged with a confirmed diagnosis of acute myocardial infarction from 81 VA hospitals and 1530 non-VA hospitals. We reported odds ratios (ORs) for use of thrombolytics, beta-blockers, ACE inhibitors, or aspirin among ideal candidates adjusted for age, sample design (hospital academic affiliation, availability of cardiac procedures, and volume), and within-hospital clustering. Ideal VA candidates were more likely to undergo thrombolytic therapy at arrival (OR [VA relative to Medicare] 1.40 [1.05, 1.74]) or to receive ACE inhibitors (OR 1.67 [1.12, 2.45]) or aspirin (OR 2.32 [1.81, 3.01]) at discharge and equally likely to receive beta-blockers (OR 1.09 [1.03, 1.40]) at discharge. CONCLUSIONS: Ideal candidates in VA were at least as likely as those in FFS to receive medical therapies of known benefit for acute myocardial infarction.
Assuntos
Hospitais de Veteranos , Medicare , Infarto do Miocárdio/tratamento farmacológico , Qualidade da Assistência à Saúde/normas , Antagonistas Adrenérgicos beta/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Inibidores da Enzima Conversora de Angiotensina/uso terapêutico , Aspirina/uso terapêutico , Estudos de Coortes , Planos de Pagamento por Serviço Prestado , Humanos , Masculino , Qualidade da Assistência à Saúde/estatística & dados numéricos , Terapia Trombolítica , Veteranos/estatística & dados numéricosRESUMO
BACKGROUND: Coronary artery bypass graft (CABG) surgery and percutaneous transluminal coronary angioplasty (PTCA) are well-established treatments for symptomatic coronary artery disease. Previous studies have documented racial differences in rates of use of these cardiac revascularization procedures. Other studies suggest that these procedures are overused: that is, they are done for patients with clinically inappropriate indications. OBJECTIVE: To test the hypothesis that the higher rate of cardiac revascularization among white patients is associated with a higher prevalence of overuse (revascularization for clinically inappropriate indications) among white patients than among African-American patients. DESIGN: Observational cohort study using Medicare claims and medical record review. SETTING: 173 hospitals in five U.S. states. PARTICIPANTS: A stratified, weighted, random sample of 3960 Medicare beneficiaries who underwent coronary angiography during 1991 and 1992; 1692 of these patients underwent 1711 revascularization procedures within 90 days. MEASUREMENTS: The proportion of CABG and PTCA procedures rated appropriate, uncertain, and inappropriate according to RAND criteria, and the multivariate odds of undergoing inappropriate revascularization among African-American patients and white patients. RESULTS: After angiography, rates of PTCA (23% vs. 19%) and CABG surgery (29% vs. 17%) were significantly higher among white patients than among African-American patients. The respective rates of inappropriate PTCA and CABG surgery were 14% and 10%. Among the study states, rates of inappropriate use ranged from 4% to 24% for PTCA and 0% to 14% for CABG surgery. White patients were more likely than African-American patients to receive inappropriate PTCA (15% vs. 9%; difference, 6 percentage points [95% CI, -0.4 to 12.7 percentage points]), and difference by race was statistically significant among men (20% vs. 8%; difference, 12 percentage points [CI, 1.2 to 21.7 percentage points]). Rates of inappropriate CABG surgery did not differ by race (10% in both groups). CONCLUSIONS: Among a large and diverse sample of Medicare beneficiaries in five U.S. states, overuse of PTCA was greater among white men than among other groups, but this difference did not fully account for racial disparities in revascularization. Overuse of cardiac revascularization varied significantly by geographic region.
Assuntos
Angioplastia Coronária com Balão/estatística & dados numéricos , População Negra , Ponte de Artéria Coronária/estatística & dados numéricos , Doença das Coronárias/etnologia , Doença das Coronárias/terapia , Mau Uso de Serviços de Saúde/estatística & dados numéricos , População Branca , Idoso , Estudos de Coortes , Feminino , Humanos , Renda , Masculino , Medicare , Razão de Chances , Fatores Sexuais , Estados UnidosRESUMO
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.
Assuntos
Sistemas de Apoio a Decisões Clínicas , Erros Médicos/prevenção & controle , Sistemas de Apoio a Decisões Clínicas/estatística & dados numéricos , Prescrições de Medicamentos , Humanos , Sistemas Computadorizados de Registros Médicos , Qualidade da Assistência à Saúde , Integração de SistemasRESUMO
BACKGROUND: In January 1996, 38 hospitals and health care organizations (for a total of 40 hospitals) in the United States came together in an Institute for Healthcare Improvement (IHI; Boston) Breakthrough Series collaborative to reduce adverse drug events-injuries related to the use or nonuse of medications. METHODS: The participants were taught the Model for Improvement, a method for rapid-cycle change and evaluation, and were then coached on how to identify their own problem areas and develop changes in practice for rapid-cycle testing. These changes could be implementation of one or more known medication error prevention practices or new practices developed. RESULTS: During a 15-month period the 40 hospitals conducted a total of 739 tests of changes. Process changes accounted for 63% of the cycles; the remainder consisted of preliminary data gathering, consensus-building, or education cycles. Eight types of changes were implemented by seven or more hospitals, with a success rate of 70%. These changes included non-punitive reporting, ensuring documentation of allergy information, standardizing medication administration times, and implementing chemotherapy protocols. DISCUSSION: Success in making significant changes was associated with strong leadership, effective processes, and appropriate choice of intervention. Successful teams were able to define, clearly state, and relentlessly pursue their aims, and then chose practical interventions and moved early into changing a process. They did not spend months collecting data before beginning a change. Changes that were most successful were those that attempted to change processes, not people. Health care organizations committed to patient safety need not regard current performance limits as inevitable.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Erros de Medicação/prevenção & controle , Sistemas de Medicação no Hospital/normas , Gestão de Riscos/métodos , Gestão da Qualidade Total/organização & administração , Sistemas de Notificação de Reações Adversas a Medicamentos , Benchmarking , Sistemas de Informação em Farmácia Clínica , Estudos de Avaliação como Assunto , Humanos , Participação nas Decisões , Notificação de Abuso , Avaliação de Processos em Cuidados de Saúde , Gestão de Riscos/organização & administração , Estados UnidosAssuntos
Doença Iatrogênica , Defesa do Paciente , Gestão de Riscos , Competência Clínica , Administração Hospitalar , Hospitais/normas , Humanos , Doença Iatrogênica/prevenção & controle , Legislação Médica , Responsabilidade Legal , Imperícia , Privilégios do Corpo Clínico , Revisão por Pares , Inabilitação do Médico , Qualidade da Assistência à SaúdeAssuntos
Medicina de Emergência/organização & administração , Serviço Hospitalar de Emergência/organização & administração , Erros Médicos/prevenção & controle , Erros Médicos/estatística & dados numéricos , Tomada de Decisões Gerenciais , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Equipe de Assistência ao Paciente/organização & administração , Gestão de Riscos/métodos , Análise de Sistemas , Estados UnidosRESUMO
PURPOSE: To determine the extent of overuse and underuse of diagnostic testing for coronary artery disease and whether the socioeconomic status, health insurance, gender, and race/ethnicity of a patient influences the use of diagnostic tests. SUBJECTS AND METHODS: We identified patients who presented with new-onset chest pain not due to myocardial infarction at one of five Los Angeles-area hospital emergency departments between October 1994 and April 1996. Explicit criteria for diagnostic testing were developed using the RAND/University of California, Los Angeles, expert panel method. They were applied to data collected by medical record review and patient questionnaire. RESULTS: Of the 356 patients, 181 met necessity criteria for diagnostic cardiac testing. Of these, 40 (22%) failed to receive necessary tests. Only 7 (3%) of the 215 patients who received some form of cardiac testing had tests that were judged to be inappropriate. Underuse was significantly more common in patients with only a high school education (30% vs 15% for those with some college, P = 0.02) and those without health insurance (34% vs 15% of insured patients, P = 0.01). In a multivariate logistic regression model, only the lack of a post-high school education was a significant predictor of underuse (odds ratio 2.2, 95% confidence interval 1.0 to 4.4). CONCLUSION: Among patients with new-onset chest pain, underuse of diagnostic testing for coronary artery disease was much more common than overuse. Underuse was primarily associated with lower levels of patient education.
Assuntos
Dor no Peito/etiologia , Doença das Coronárias/diagnóstico , Testes Diagnósticos de Rotina/estatística & dados numéricos , Mau Uso de Serviços de Saúde/estatística & dados numéricos , Adulto , Distribuição por Idade , Idoso , Doença das Coronárias/complicações , Diagnóstico Diferencial , Etnicidade/estatística & dados numéricos , Feminino , Pesquisa sobre Serviços de Saúde , Hospitais Urbanos/estatística & dados numéricos , Humanos , Seguro Saúde/estatística & dados numéricos , Los Angeles/epidemiologia , Masculino , Prontuários Médicos , Pessoa de Meia-Idade , Estudos Retrospectivos , Distribuição por Sexo , Classe Social , Fatores Socioeconômicos , Inquéritos e Questionários , Procedimentos Desnecessários/estatística & dados numéricosAssuntos
Erros Médicos/prevenção & controle , Qualidade da Assistência à Saúde , Gestão de Riscos , Gestão da Segurança , American Medical Association , Humanos , Joint Commission on Accreditation of Healthcare Organizations , Risco Ajustado , Estados Unidos , United States Department of Veterans AffairsRESUMO
Little is known about physicians' exposure to managed care techniques that affect clinical practice. In 1995, we conducted a survey of 2,003 U.S. physicians asking them about their share of patients subject to a variety of managed care techniques. Nationally, 24% of physicians received some form of capitation payment for their patients. The two most widely used techniques were utilization review (UR), applied to an average of 59% of patients, and discounted fees, applied to an average of 38% of patients. Although UR was common, ultimate denial rates of coverage were very low: at most 3% for the types of care studied. Use of managed care techniques varied more within states than between states. Conventional measures of HMO market penetration revealed little about how managed care affects physicians.
Assuntos
Capitação/estatística & dados numéricos , Programas de Assistência Gerenciada/organização & administração , Médicos/economia , Revisão da Utilização de Recursos de Saúde/estatística & dados numéricos , Coleta de Dados , Honorários Médicos , Humanos , Cobertura do Seguro , Programas de Assistência Gerenciada/economia , Programas de Assistência Gerenciada/estatística & dados numéricos , Assistência ao Paciente/economia , Assistência ao Paciente/normas , Médicos/estatística & dados numéricos , Guias de Prática Clínica como Assunto , Recusa em Tratar , Estados UnidosRESUMO
The transformation of the medical marketplace has major implications for the physician workforce. Findings are reported here from national surveys of physicians, hospitals, health maintenance organizations (HMOs), preferred provider organizations (PPOs), and medical group practices conducted in 1995 to measure the impact of those changes. Physicians in higher HMO penetration states were more likely to report serious problems with several aspects of medical practice and patient care and were more likely to perceived oversupply in their specialty areas and changes in their practice arrangements. Some divergence is noted in views of supply between physicians and those that employ them. The majority of physicians would still recommend medicine and their specialty as a career.
Assuntos
Atitude do Pessoal de Saúde , Setor de Assistência à Saúde/tendências , Programas de Assistência Gerenciada , Médicos/psicologia , Educação Médica , Feminino , Humanos , Satisfação no Emprego , Masculino , Programas de Assistência Gerenciada/organização & administração , Médicos/provisão & distribuição , Atenção Primária à Saúde , Estados Unidos , Recursos HumanosRESUMO
OBJECTIVE: To compare waiting times for percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass graft (CABG) surgery in New York State, the Netherlands and Sweden and to determine whether queuing adversely affects patients' health. METHODS: We reviewed the medical records of 4487 chronic stable angina patients who underwent PTCA or CABG in one of 15 New York State hospitals (n = 1021) or were referred for PTCA or CABG to one of ten hospitals in the Netherlands (n = 1980) or to one of seven hospitals in Sweden (n = 1486). We measured the median waiting time between coronary angiography and PTCA or CABG. RESULTS: The median waiting time for PTCA in New York was 13 days compared with 35 and 42 days, respectively, in the Netherlands and Sweden (P < 0.001). For CABG, New York patients waited 17 days, while Dutch and Swedish patients waited 72 and 59 days, respectively (P < 0.001). The Swedish and Dutch waiting list mortality rate was 0.8% for CABG candidates and 0.15% for PTCA candidates. CONCLUSIONS: There were large variations in waiting time for coronary revascularization among these three sites. Patients waiting for CABG were at greatest risk of experiencing an adverse event. In both the Netherlands and Sweden, the capacity to perform coronary revascularization has been expanded since this study began. Further international cooperation may identify other areas where quality of care can be improved.
Assuntos
Angina Pectoris/cirurgia , Angioplastia Coronária com Balão/estatística & dados numéricos , Ponte de Artéria Coronária/estatística & dados numéricos , Alocação de Recursos para a Atenção à Saúde/estatística & dados numéricos , Listas de Espera , Angina Pectoris/complicações , Angioplastia Coronária com Balão/efeitos adversos , Ponte de Artéria Coronária/efeitos adversos , Humanos , Auditoria Médica , Prontuários Médicos , Países Baixos/epidemiologia , Seleção de Pacientes , Suécia/epidemiologia , Estados Unidos/epidemiologiaRESUMO
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 unit's 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.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Unidades Hospitalares/normas , Unidades de Terapia Intensiva/normas , Erros de Medicação/estatística & dados numéricos , Adulto , Preços Hospitalares , Custos Hospitalares , Humanos , Tempo de Internação , Erros de Medicação/economia , Revisão dos Cuidados de Saúde por Pares , Estudos Prospectivos , Fatores de Risco , Gestão de Riscos , Índice de Gravidade de Doença , Inquéritos e Questionários , Análise de SistemasRESUMO
PURPOSE: To assess the data that support the use of coronary angiography and angioplasty after acute myocardial infarction, that identify the risks of these procedures, and that analyze their use and costs. DATA SOURCES: English-language articles published between 1970 and June 1995 identified through a search of the MEDLINE database. STUDY SELECTION: Studies that contained information about benefits, risks, use, and costs of coronary angiography and angioplasty after acute myocardial infarction. DATA EXTRACTION: Descriptive and analytic data from each study were collected. DATA SYNTHESIS: The outcome for patients who have complications of myocardial infarction (such as shock) is poor. Such patients usually undergo angiography, although the evidence that supports this practice is weak. Preliminary data suggest that patients who immediately have angiography and angioplasty after acute myocardial infarction have better outcomes than do patients who receive thrombolytic therapy with angioplasty only for specific indications in experienced centers. After the acute phase of myocardial infarction, patients who have noninvasive evidence of persistent or recurrent ischemia are believed to benefit from angiography. In the remaining patients, however, angiography after myocardial infarction has not been shown to be beneficial. Coronary angiography is done in 30% to 81% of patients after acute myocardial infarction in different settings and regions; for many of these patients, the benefit is questionable. Better outcomes are not always associated with more frequent use of the procedure. In the United States, catheterizations after myocardial infarction cost approximately $1 billion per year. CONCLUSIONS: Although many patients benefit from angiography and angioplasty after myocardial infarction, others probably do not. Substantial resources are at stake.
Assuntos
Angioplastia , Angiografia Coronária , Infarto do Miocárdio/diagnóstico por imagem , Infarto do Miocárdio/cirurgia , Angioplastia/efeitos adversos , Angioplastia/economia , Angiografia Coronária/efeitos adversos , Angiografia Coronária/economia , Custos de Cuidados de Saúde , Humanos , Infarto do Miocárdio/complicações , Fatores de Risco , Terapia Trombolítica , Fatores de TempoRESUMO
OBJECTIVE: 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 $3244 (P=.04). For preventable ADEs, the increases were 4.6 days in length of stay (P=.03) and $5857 in total cost (P=.07). After adjusting for our sampling strategy, the estimated postevent costs attributable to an ADE were $2595 for all ADEs and $4685 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 $5.6 million and $2.8 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.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Preços Hospitalares/estatística & dados numéricos , Custos Hospitalares/estatística & dados numéricos , Hospitais Urbanos/economia , Tempo de Internação/economia , Boston , Estudos de Casos e Controles , Custos e Análise de Custo , Tratamento Farmacológico/economia , Feminino , Hospitais com mais de 500 Leitos , Hospitais Urbanos/estatística & dados numéricos , Humanos , Tempo de Internação/estatística & dados numéricos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Preparações Farmacêuticas/economia , Estudos ProspectivosAssuntos
Administração Hospitalar/normas , Erros Médicos , Sistemas de Notificação de Reações Adversas a Medicamentos , Embalagem de Medicamentos/normas , Prescrições de Medicamentos/normas , Humanos , Sistemas de Medicação no Hospital/normas , Inovação Organizacional , Gestão de Riscos/métodos , Estados Unidos , Carga de TrabalhoRESUMO
The authors compare the appropriateness ratings and mutual influence of panelists from different specialties rating a comprehensive set of indications for six surgical procedures. Nine-member panels rated each procedure: abdominal aortic aneurysm surgery, carotid endarterectomy, cataract surgery, coronary angiography, and coronary artery bypass graft surgery/percutaneous transluminal coronary angioplasty (common panel). Panelists individually rated the appropriateness of indications at home and then discussed and re-rated the indications during a 2-day meeting. Subsequently, they rated the necessity of those indications scored by the group as appropriate. There were 45 panelists, including specialists (either performers of the procedure or members of a related specialty) and primary care providers, all drawn from nominations by their respective specialty societies. Main outcome measures included: individual panelists' mean ratings over all indications, mean change and conformity scores between rounds of ratings, and the percentage of audited actual procedures rated appropriate or necessary. Performers had the highest mean ratings, followed by physicians in related specialties, trailed by primary care providers. One fifth of all actual procedures were for indications rated appropriate by performers and less than appropriate by primary care providers. At the panel meetings, primary care providers and related specialists showed no greater tendency to be influenced by other panelists than did performers. Multispecialty panels provide more divergent viewpoints than panels composed entirely of performers. This divergence means that fewer actual procedures are deemed performed for appropriate or necessary indications.
Assuntos
Medicina/estatística & dados numéricos , Seleção de Pacientes , Revisão dos Cuidados de Saúde por Pares , Padrões de Prática Médica/estatística & dados numéricos , Especialização , Procedimentos Cirúrgicos Operatórios/estatística & dados numéricos , Angioplastia Coronária com Balão , Aneurisma da Aorta Abdominal/cirurgia , Extração de Catarata , Angiografia Coronária , Ponte de Artéria Coronária , Endarterectomia das Carótidas , Necessidades e Demandas de Serviços de Saúde , Pesquisa sobre Serviços de Saúde , Humanos , Medicina/normas , Médicos de Família , Padrões de Prática Médica/normas , Resultado do Tratamento , Estados UnidosRESUMO
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 hospital's 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.