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To Err Is Human: Building a Safer Health System (2000)
Institute of Medicine (IOM)

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Page 215

C—
Literature Summary

This Appendix summarizes the literature described in Chapter 2. The references cited are at the end of Chapter 2.

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215

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Page 215 C— Literature Summary This Appendix summarizes the literature described in Chapter 2. The references cited are at the end of Chapter 2.

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Page 216 TABLE C-1 Literature Summary Reference Sample Description Data Source General studies of errors and adverse events     Thomas et al., forthcoming 2000 Randomly sampled 15,000 nonpsychiatric 1992 discharges from a representative sample of hospitals in Utah and Colorado. Chart review by trained nurses and board-certified family practitioners and internists. Bhasale et al., 1998 Analysing potential harm in Australian general practice A non-random sample of 324 general practitioners reporting incidents between October 1993 and June 1995. General practitioner-reported free-text descriptions of incidents and answered fixed-response questions. (table continued on next page)

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Page 217 (table continued from previous page) Reference Results Definition(s) Causes/Types of Error General studies of errors and adverse events       Thomas et al., forthcoming 2000 Adverse events occurred in 2.9% ± 0.2 of hospitalizations in each state. 32.6% ± 4 of adverse events were due to negligence in Utah and 27.4 ± 2.4 were due to negligence in Colorado. Death occurred in 6.6% ± 1.2 of adverse events and 8.8% ± 2.5 of negligent adverse events. The leading cause of nonoperative adverse events were adverse drug events (19.3% of all adverse events; 35.1% were negligent). Operative events comprised 44.9% of all adverse events and 16.9% were negligent. Adverse event—''an injury caused by medical management (rather than the disease process) that resulted in either a prolonged hospital stay or disability at discharge." Negligence was defined as "care that fell below the standard expected of physicians in their community." 46.1% of adverse events (22.3% negligent) were attributable to surgeons and 23.2% (44.9% negligent) were attributable to internists. Bhasale et al., 1998 Analysing potential harm in Australian general practice 805 incidents were reported. 76% were preventable and 27% had potential for severe harm. Incident—"an unintended event, no matter how seemingly trivial or commonplace, that could have harmed or did harm a patient." Pharmacological management related to 51 per 100 incidents. Poor communication between patients and healthcare professionals and actions of others contributed to 23 per 100 incidents each. Errors in judgment contributed to 22 per 100 incidents. Continued

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Page 218 TABLE C-1 Continued Reference Sample Description Data Source General studies of errors and adverse events (continued)     Leape et al., 1993 Preventing medical injury Record review of 1,133 patients who suffered from an adverse event (AE). Harvard Medical Practice Study. McGuire et al., 1992 Measuring and managing quality of surgery 44,603 consecutive major operations performed at a large medical center from 1977 to 1990. Resident reports giving name and procedure of each patient who suffered any complication. In a monthly conference, representatives of all specialties determined by consensus the category of each complication (inevitable, inherent risk, error, hospital deficit, coincidence, unknown). (table continued on next page)

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Page 219 (table continued from previous page) Reference Results Definition(s) Causes/Types of Error General studies of errors and adverse events (continued)       Leape et al., 1993 Preventing medical injury 70% of adverse events were found to be preventable, 24% unpreventable, and 6% potentially preventable. AE—per Leape (1991), AE is defined as "an unintended injury that was caused by medical management and that resulted in measurable disability." Preventable AE—an AE resulting from an error. Unpreventable AE—an AE resulting from a complication that cannot be prevented at the current state of knowledge. Potentially preventable AE—an AE where no error was identified but it is widely recognized that a high incidence of this type of complication reflects low standards of care or technical expertise. The most common types of preventable errors were technical errors (44%), errors in diagnosis (17%), failures to prevent injury (12%), and errors in the use of a drug (10%). Approximately 20% of technical errors, 71% of diagnostic errors, 50% of preventative errors, and 37% of errors in the use of a drug were judged to be negligent. McGuire et al., 1992 Measuring and managing quality of surgery 2,428 patients (5.4%) suffered 2,797 complications (6.3%). 49% of these complications were attributable to error. 749 patients (1.7%) died during the same hospitalization. 7.5% of these deaths were attributable to error.     Continued

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Page 220 TABLE C-1 Continued Reference Sample Description Data Source General studies of errors and adverse events (continued)     Bedell et al., 1991 Incidence and characteristics of preventable iatrogenic cardiac arrests 203 patients who suffered from cardiac arrest at a teaching hospital during 1981. At least one of the authors evaluated patients who underwent CPR within 24 hours of arrest. Information from the medical record was also used. Leape et al., 1991 The nature of adverse events in hospitalized patients 30,195 randomly selected records in 51 hospitals in New York state (1984). Hospital records. DuBois et al., 1988 Preventable Deaths 182 deaths from 12 hospitals for 3 conditions (cerebrovascular accident, pneumonia, or myocardial infarction) Investigators prepared a dictated summary of each patient's hospital course. Panels of 3 physicians for each condition then independently reviewed each summary and independently judged whether the death was preventable. (table continued on next page)

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Page 221 (table continued from previous page) Reference Results Definition(s) Causes/Types of Error General studies of errors and adverse events (continued)       Bedell et al., 1991 Incidence and characteristics of preventable iatrogenic cardiac arrests 28 (14%) of arrests followed an iatrogenic complication. 17 (61%) of the 28 patients died. All 4 reviewers considered 18 (64%) of the iatrogenic arrests to have been preventable. latrogenic cardiac arrest—"an arrest that resulted from a therapy or procedure or from a clearly identified error of omission." The most common causes of potentially preventable arrest were medication errors and toxic effects (44%), and suboptimal response by physicians to clinical signs and symptoms (28%). Leape et al., 1991 The nature of adverse events in hospitalized patients 1,133 adverse events (AEs) occurred in 30,195 patients. AE—"an unintended injury that was caused by medical management and that resulted in measurable disability." Drug complications were the most common type of adverse event (19%), followed by wound infections (14%) and technical complications (13%). 58% of the adverse advents were errors in management, among which nearly half were attributable to negligence. DuBois et al., 1988 Preventable Deaths The physicians unanimously agreed that 14% of the deaths could have been prevented. 2 out of the 3 physicians found that 27% might have been prevented.   Preventable deaths from myocardial infarction reflected errors in management, from cerebrovascular accident reflected errors in diagnosis, and from pneumonia reflected errors in management and diagnosis. Continued

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Page 222 TABLE C-1 Continued Reference Sample Description Data Source General studies of errors and adverse events (continued)     Steel et al., 1981 latrogenic illness on a general medical service at a university hospital 815 consecutive patients on a university hospital's general medical service during a 5-month period in 1979 Record review, clinical personnel interviews, and information from utilization-review coordinators. Cooper et al., 1978 Preventable anesthesia mishaps 47 interviews regarding preventable mishaps between September 1975 and April 1977 including staff and resident anesthesiologists from a large urban teaching hospital. Interviewees selected at random from a list of departmental members. Dripps et al., 1961 The role of anesthesia in surgical mortality Records of 33,224 patients anesthetized in a 10-year period. Patient records (table continued on next page)

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Page 223 (table continued from previous page) Reference Results Definition(s) Causes/Types of Error General studies of errors and adverse events (continued)       Steel et al., 1981 latrogenic illness on a general med 36% of patients had an iatrogenic illness. 9% of the patients had an iatrogenic illness that threatened life or produced considerable disability while, in another 2%, the illness was believed to contribute to the death of the patient. latrogenic illness—"any illness that resulted from a diagnostic procedure or from any form of therapy." In addition, the authors included harmful occurrences (e.g., injuries from a fall or decubitus ulcers) that were not natural consequences of the patient's disease.   Cooper et al., 1978 Preventable anesthesia mishaps 359 preventable critical incidents were identified and coded. Critical incident—a mishap that "was clearly an occurrence that could have led (if not discovered or corrected in time) or did lead to an undesirable outcome, ranging from increased length of hospital stay to death or permanent disability." 82% of the preventable incidents reported involved human error and 14% involved equipment error. Dripps et al., 1961 The role of anesthesia in surgical mortality 12 of the 18,737 patients who received spinal anesthesia died from causes definitely related to the anesthetic (1:1,560). 27 of the 14,487 patients who received general anesthesia supplemented with a muscle relaxant died from causes directly related to the anesthetic (1:536).     Continued

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Page 224 TABLE C-1 Continued Reference Sample Description Data Source General studies of errors and adverse events (continued)     Beecher and Todd, 1954 A study of the deaths associated with anesthesia and surgery based on a study of 599,548 anesthesias in ten institutions All deaths from January 1, 1948, through December 31, 1952, occurring on the surgical services of 10 university hospitals. 1 team, consisting of an anesthesiologist, a surgeon, and a secretary, worked in each of the 10 hospitals and appraised the causes of all deaths on the surgical services. Medication-related studies     Knox, 1999 Prescription errors tied to lack of advice Globe article Analysis of medication errors by 51 Massachusetts pharmacists.   Leape, 1999 Pharmacist participation on physician rounds and adverse drug events in the intensive care unit 75 patients randomly selected from each of 3 groups: all admissions to the study unit (2 medical ICUs at Massachusetts General Hospital) from February 1, 1993, through July 31, 1993 (baseline), and all admissions to the study unit (postintervention) and control unit from October 1, 1994, through July 7, 1995.50 patients were also selected at random from the control unit during the baseline period. Review of medical records and pharmacist recommendations. (table continued on next page)

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Page 225 (table continued from previous page) Reference Results Definition(s) Causes/Types of Error General studies of errors and adverse events (continued)       Beecher and Todd, 1954 A study of the deaths associated with anesthesia and surgery based on a study of 599,548 anesthesias in ten institutions 7,977 of the 599,548 patients who received anesthesia died. Gross errors in anesthetic management occurred in 29 of the 384 (7.6%) deaths caused by anesthesia.     Medication-related studies       Knox, 1999 Prescription errors tied to lack of advice Globe article 88% of medication errors involved the wrong drug or the wrong dose and 63% involved first-time prescriptions rather than refills.   Pharmacists cited factors that led to mistakes. 62% cited "too many telephone calls," 59% "unusually busy day," 53% ''too many customers," 41% "lack of concentration," and 32% "staff shortage." Leape, 1999 Pharmacist participation on physician rounds and adverse drug events in the intensive care unit The rate of preventable adverse drug events (ADEs) due to ordering decreased by 66% from 10.4 per 1,000 patient days before the intervention to 3.5 per 1,000 patient days after the intervention. The rate was essentially unchanged during the same time periods in the control unit: 10.9 and 12.4 per 1,000 patient days. ADE—per Bates (1993), ADE is defined as "an injury resulting from the administration of a drug."   Continued

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Page 243 (table continued from previous page) Reference Results Definition(s) Causes/Types of Error Medication-related studies (continued)       Raju et al., 1989 Medication errors in neonatal and paediatric intensivecare units 315 iatrogenic medication errors were reported among the 2,147 neonatal and pediatric care admissions, an error rate of 1 per 6.8 admissions (14.7%). The frequency of iatrogenic injury of any sort due to a medication error was 3.1%, or 1 for each 33 intensive care admissions. 66 errors resulted in injury, 33 were potentially serious, 32 caused mild injuries, and 1 patient suffered acute aminophylline poisoning. Medication error—"a dose of medication that deviates from the physicians' order as written in the medical record.... Except for error of omission, the medication dose must actually reach the patient ... a wrong dose (or other type of error) that is detected and corrected before administration will not constitute a medication error.... Prescription errors (not dispensed and administered to the patient) ... are excluded from this definition ..." 60.3% of the 315 errors were attributable to nurses and 29.6% to pharmacists. Only 2.9% were attributable to physicians (because prescription errors detected before drug administration were not counted). Blum et al., 1988 Medication error prevention by pharmacists 123,367 medication orders were written. Riley Hospital for Children had 1,277 errors out of the 48,034 (2.7%) orders written and University Hospital had 1,012 errors out of 75,333 (1.3%) orders written. 90.4% of the overall orders questioned by pharmacists were confirmed by the physician as being in error. 0.2% of the 2289 errors were classified as potentially lethal, 13.7% were serious, 34.2% were significant, and 51.9% were minor. The number of errors that pharmacists prevent each year approaches 9,000. Order with a potential medication error—"if any aspect of the order was not in accordance with information in standard reference text, an approved protocol, or dosing guidelines approved by the pharmacy and therapeutics committee of the hospitals."   Continued

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Page 244 TABLE C-1 Continued Reference Sample Description Data Source Medication-related studies (continued)     Nolan and O'Malley, 1988 Prescribing for the elderly, part I 21 hospital inpatient studies conducted in the United States, United Kingdom, Israel, New Zealand, Switzerland, Canada, and India published between 1964 and 1981. Review of published studies on adverse drug reactions (ADRs). Folli et al., 1987 Medication error prevention by clinical pharmacists in two children's hospitals 101,022 medication orders prescribed in two children's teaching hospitals (Miller Children's Hospital of Memorial Medical Center [MMC] and Stanford University Medical Center [SUMC]) during a six-month period (February through July 1985). Copies of errant chart orders reviewed by a member of the pediatric faculty or attending physician and by two pediatric clinical pharmacist practitioners. Perlstein et al., 1979 Errors in drug computations during newborn intensive care 43 nursing, pharmacy, and medical personnel tested for accuracy in calculating drug doses to be administered to newborn infants. (27 registered nurses, 5 registered pharmacists, and 11 pediatricians.)   (table continued on next page)

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Page 245 (table continued from previous page) Reference Results Definition(s) Causes/Types of Error Medication-related studies (continued)       Nolan and O'Malley, 1988 Prescribing for the elderly, part I Rates of patients experiencing ADRs ranged from 1.5% to 43.5%. A majority of the studies documented ADR rates between 10% and 25%.     Folli et al., 1987 Medication error prevention by clinical pharmacists in two children's hospitals A combined total of 479 errant medication orders were identified at the two institutions. MMC and SUMC had similar frequency of error, 4.9 and 4.5 errors per 1,000 medication orders, or 1.37 and 1.79 per 100-patient days, respectively. Involving pharmacists in the reviewing of drug orders reduced the potential harm resulting from errant medication orders significantly. Errant medication order—"An order was considered to be potentially in error if it was not in accordance with standard pediatric references, current published literature, or dosing guidelines approved by the pharmacy and therapeutics committees of each hospital." The most common type of error was incorrect dosage. The most prevalent type of error was overdosage. Perlstein et al., 1979 Errors in drug computations during newborn intensive care The mean test score for nurses was 75.6%. 56% of the errors would have resulted in administered doses ten times greater or less than the ordered dose. The mean test score was 96% for pharmacists and none of the errors would have resulted in the administration of doses over 1% greater or less than the dose ordered. Pediatricians averaged a score of 89.1%. 38.5% of the errors would have resulted in the administration of doses ten times higher or lower than the dose ordered.     Continued

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Page 246 TABLE C-1 Continued Reference Sample Description Data Source Medication-related studies (continued)     Miller, 1977 Interpretation of studies on adverse drug reactions   Boston Collaborative Drug Surveillance Program Burnum, 1976 Preventability of adverse drug reactions 1,000 adult medical patients drawn from a community, office-based practice of general internal medicine. Physician observation. Jick, 1974 Drugs: remarkably nontoxic 19,000 inpatients admitted to medical wards. Boston Collaborative Drug Surveillance Program (table continued on next page)

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Page 247 (table continued from previous page) Reference Results Definition(s) Causes/Types of Error Medication-related studies (continued)       Miller, 1977 Interpretation of studies on adverse drug reactions Adverse drug reactions (ADRs) occur in approximately 30% of hospitalized patients and after about 5% of drug exposures. The rate per patient of life-threatening ADRs in 3% and the rate per course of drug therapy is 0.4%.     Burnum, 1976 Preventability of adverse drug reactions Adverse drug reactions (ADRs) occurred in 42 of the individual patients. 23 (55%) were judged unnecessary and potentially preventable.   23% of the 42 ADRs were attributable to physician error (10 out of 42; 6 because of giving a drug that was not indicated and 4 because of improper drug administration), 17% to patient or pharmacist error, and 14% to errors shared by the physician, patient and pharmacist. Jick, 1974 Drugs: remarkably nontoxic 30% of hospitalized medical patients have at least 1 adverse drug reaction (ADR) while hospitalized. An estimated 3 million hospital patients have an ADR in medical units each year.     Continued

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Page 248 TABLE C-1 Continued Reference Sample Description Data Source Medication-related studies (continued)     Phillips et al., 1974 Increase in U.S. Medicationerror deaths between 1983 and 1993   All United States death certificates between 1983 and 1993. Talley and Laventurier, 1974 Drug-induced illness   Boston Collaborative Drug Surveillance Program and an Israeli study. Cost     Thomas et al., 1999 Medical records of 14,732 randomly selected 1992 discharges from 28 hospitals in Utah and Colorado Two-stage chart review by trained nurses and board-certified family practitioners and internists. (table continued on next page)

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Page 249 (table continued from previous page) Reference Results Definition(s) Causes/Types of Error Medication-related studies (continued)       Phillips et al., 1974 Increase in U.S. Medicationerror deaths between 1983 and 1993 In 1983, 2,876 people died from medication errors. By 1993, this number had risen to 7,391, a 2.57-told increase. Between 1983 and 1993, outpatient medication error deaths rose 8.48-fold (from 172 to 1,459) and inpatient medical error deaths rose 2.37-fold (504 to 1,195). Medication errors— "'accidental poisoning by drugs, medicaments, and biologicals' and have resulted from acknowledged errors, by patients or medical personnel."   Talley and Laventurier, 1974 Drug-induced illness An estimated incidence of lethal adverse drug reactions ranges from a low of 60,000 (.18% incidence) to a high of 140,000 (.44% incidence) for hospitalized patients in the U.S.     Cost       Thomas et al., 1999 459 adverse events were detected, of which 265 were preventable. Death occurred in 6.6% of adverse events and 6.9% of preventable adverse events. The total costs were $661,889,000 for adverse events and $308,382,000 for preventable adverse events. Health care costs were $348,081,000 for all adverse events and $159,245,000 for preventable adverse events. 57% of the adverse event health care costs and 46% of the preventable adverse event costs were attributable to outpatient medical care. Adverse event—"an injury caused by medical management (rather than the disease process) that resulted in either prolonged hospital stay or disability at time of discharge."   Continued

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Page 250 TABLE C-1 Continued Reference Sample Description Data Source Cost (continued)     Bates et al., 1997 The costs of adverse drug events in hospitalized patients 4,108 admissions to a stratified random sample of 11 medical and surgical units in Brigham and Women's Hospital (726 beds) and Massachusetts General Hospital (846 beds) in Boston over a 6-month period between February and July 1993. Cases were patients with an adverse drug event (ADE), and the control for each case was a patient on the same unit as the case with the most similar pre-event length of stay. Stimulated self-reports by nurses and pharmacists and daily chart review. 2 independent reviewers classified the incidents. Bootman et al., 1997 The health care cost of drug-related morbidity and mortality in nursing facilities To estimate the cost of drug-related problems (DRPs) within nursing facilities, a decision analysis technique was used to develop a probability pathway model. Survey of an expert panel consisting of consultant pharmacists and physicians with practice experience in nursing facilities and geriatric care. (table continued on next page)

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Page 251 (table continued from previous page) Reference Results Definition(s) Causes/Types of Error Cost (continued)       Bates et al., 1997 The costs of adverse drug events in hospitalized patients 247 ADEs occurred among 207 admissions and 60 were preventable. The additional length of stay was 2.2 days with an ADE and 4.6 days with a preventable ADE. The estimated post-event costs attributable to an ADE were $2,595 for all ADEs and $4,685 for preventable ADEs. The estimated annual costs for a 700-bed teaching hospital attributable to all ADEs are $5.6 million and to preventable ADEs are $2.8 million. The national hospital costs of ADEs was estimated at $4 billion; preventable ADEs alone would cost $2 billion. ADE—''an injury resulting from medical intervention related to a drug." Potential ADE—"incidents in which an error was made but no harm occurred."   Bootman et al., 1997 The health care cost of drug-related morbidity and mortality in nursing facilities The cost of drug-related morbidity and mortality with the services of consultant pharmacists was $4 billion compared with $7.6 billion without services of consultant pharmacists. For every dollar spent on drugs in nursing facilities, $1.33 is consumed in the treatment of DRPs. DRPs—"an event of circumstance involving a patient's drug treatment that actually or potentially interferes with the achievement of an optimal outcome."   Continued

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Page 252 TABLE C-1 Continued Reference Sample Description Data Source Cost (continued)     Johnson and Bootman, 1995 Drug-related morbidity and mortality A probability pathway model was developed for drug-related morbidity and mortality based primarily on drug-related problems (DRPs). A panel of experts gave estimates on the numbers of patients affected by DRPs and monetary value data were taken from published reports and statistical reports. Telephone survey of 15 expert practicing pharmacists. Schneider et al., 1995 Cost of medication-related problems at a university hospital 109 patients at a universityaffiliated medical center hospital who were known to have had clinical consequences from an adverse drug reaction (ADR) or medication error. Retrospective chart review. Bloom, 1988 Cost of treating arthritis and NSAID-related gastrointestinal side-effects Retrospective analysis of all direct costs related to the care of 527 Medicaid recipients treated for arthritis with non-steroidal anti-inflammatory drugs (NSAIDs) between December 1,1981 and November 30, 1983. Medicaid Management Information System of Washington, D.C. (table continued on next page)

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Page 253 (table continued from previous page) Reference Results Definition(s) Causes/Types of Error Cost (continued)       Johnson and Bootman, 1995 Drug-related morbidity and mortality Drug-related morbidity and mortality costs an estimated $76.6 billion in the ambulatory setting in the United States. The panel members estimated that 40% of patients who receive drug therapy would have some form of DRP. Drug-related problem—"an event or circumstance that involves a patient's drug treatment that actually, or potentially, interferes with the achievement of an optimal outcome."   Schneider et al., 1995 Cost of medication-related problems at a university hospital 349 clinical outcomes associated with medical related problems (MRPs) (average of approximately 3 outcomes per patient) were detected. For the 1,911 ADRs and medication errors reported through the voluntary reporting system in 1994, the estimated annual cost was just under $1.5 million.     Bloom, 1988 Cost of treating arthritis and NSAID-related gastrointestinal side-effects In 1983, an estimated $3.9 million was spent on treating preventable gastrointestinal adverse drug reactions to NSAIDs. Gastrointestinal adverse drug reaction—"any claim for payment accompanied by a diagnosis of peptic ulcer, gastritis/duodenitis, other disorders of the stomach or duodenum, gastrointestinal symptoms, or a pharmacy claim for an H2-recepter antagonist, sucralfate or antacid, which occurred during the arthritis treatment study period.  

Representative terms from entire chapter:

adverse events