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Preventing Medication Errors (2007)

Chapter: 3 Medication Errors: Incidence and Cost

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Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
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3
Medication Errors: Incidence and Cost

CHAPTER SUMMARY

Medication error rates are important for gauging the scope of the problem, setting priorities for prevention strategies, and measuring the impact of those strategies. This chapter summarizes the evidence base on rates of medication errors; preventable adverse drug events; and failure to prescribe medications for which the evidence supports the ability to reduce morbidity and mortality in hospital, nursing home, and ambulatory settings. An understanding of the costs of medication errors is important as well to inform decisions about the implementation of strategies designed to reduce the risk of medication errors. This chapter also summarizes the evidence base on these costs.

As noted in Chapter 1, the committee’s charge encompassed developing estimates of the incidence, severity, and costs of medication errors and evaluating alternative approaches to reducing such errors in different settings. To this end, the committee commissioned papers summarizing the salient peer-reviewed literature in the areas of hospital care, nursing home care, ambulatory care, pediatric care, psychiatric care, and use of over-the-counter (OTC) and complementary and alternative medications.1 The au-

1

The authors of the papers are as follows: for hospital care, Harvey J. Murff, MD, MPH, Vanderbilt University; for nursing home care, Ginette A. Pepper, PhD, RN, FAAN, University of Utah College of Nursing; for ambulatory care, Grace M. Kuo, PharmD, MPH, Baylor

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

thors were asked to review this literature from the last 10 years2 (and earlier major studies if still relevant). Where possible, the five steps in the medication-use process were to be analyzed separately. Special attention was to be given to errors that arise during transfers between care settings, for example, from hospital to ambulatory care. In addition, the authors were asked to identify the approaches to reducing medication errors recommended by major health care organizations and to evaluate each approach in terms of the evidence/process used by these organizations to justify it. In addition, a paper was commissioned to review the non-peer-reviewed literature for approaches to reducing medication errors.3 The authors of the commissioned papers were encouraged to use a modified search strategy as described by Smeaton and colleagues (2002). They were also encouraged to search the following databases: MEDLINE, CINAHL (Cumulative Index to Nursing and Allied Health Literature), PsycINFO, IPA (International Pharmaceutical Abstracts), Science Citation Index, and Dissertation Abstracts. The authors tailored these suggestions to their own requirements. In summary, the study focused on English-language articles published in the period 1995–2005, augmented by earlier important studies and studies published after the literature reviews had been completed. The majority of studies reviewed were conducted in the United States. Where relevant, when there were no or few U.S. studies for a particular setting or study category, foreign studies are cited in the report, with the country of origin noted.

Drawing on these commissioned papers, this chapter summarizes the committee’s findings on the incidence and costs of medication errors (more detail on incidence is given Appendix C). Chapter 5 summarizes the committee’s findings on prevention strategies as part of the recommended action agendas for each care setting (more detail on these strategies is given in Appendix D).

INCIDENCE

The extent of the research on the incidence of medication errors and adverse drug events (ADEs) varies greatly across care settings (see Appendix C); Box 3-1 summarizes the difficulties encountered by the committee

College of Medicine; for pediatric care, Marlene R. Miller, MD, MSc, Karen A. Robinson, MSc, Lisa H. Lubornski, PhD, Michael L. Rinke, BA, and Peter J. Pronovost, MD, PhD, The Johns Hopkins University; for psychiatric care, Benjamin C. Grasso, MD, The Institute for Self-Directed Care; and for OTC and complementary and alternative medications, Albert I. Wertheimer, MBA, PhD and Thomas M. Santella, BS, Temple University.

2

The pediatric care paper examined peer-reviewed journals over the last 5 years.

3

Authored by Eta Berner, EdD, University of Alabama at Birmingham, and Richard Maisiak, PhD, MSPH, consultant.

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
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BOX 3-1

Difficulties in Synthesizing the Evidence on Incident Rates

Since the publication of To Err Is Human: Building a Safer Health System (IOM, 2000), there has been a rapid growth in contributions to the field of patient safety. As with any emerging discipline, synthesizing the results of this research is challenging because of the heterogeneity of study definitions and error identification methodologies.

Significant confusion exists about the most fundamental issue in quantifying medication errors. One broad definition of medication errors is any inappropriate use of a drug, regardless of whether that use resulted in harm (Nebeker et al., 2004). Other definitions include only medication errors that have the potential to produce harm, or “clinically significant medication errors” (Lesar et al., 1997). Thus a medication error that could never be executed, such as a prescription to give orally a medication that comes only in parenteral form, would be excluded. As discussed previously, medication use also involves various stages, including selecting and procuring the drug by the pharmacy, prescribing and selecting the drug for the patient, preparing and dispensing the drug, administering the drug, and monitoring the patient for effect, and many studies have focused on errors occurring during only one of these stages.

Contributing to the heterogeneity of the patient safety literature are the varying methodologies used to identify errors. The incidence rates found in the literature depend dramatically on the particular detection method used. Although many such methods exist, those most commonly employed include direct observation, chart review, computerized monitoring, and voluntary reporting (Murff et al., 2003) (see Chapter 5 for more detail). Many studies have established that voluntary reporting results in marked underestimation of rates of medication errors and ADEs (Allan and Barker, 1990; Cullen et al., 1995; Jha et al., 1998; Flynn et al., 2002). Voluntary reporting rates are generally low because of such factors as time pressures, fear of punishment, and lack of a perceived benefit (Cullen et al., 1995). Improvements in internal reporting have been achieved in nonpunitive reporting environments (Rozich and Resar, 2001), but these rates still vastly underestimate the true incidence.

A large study comparing direct observation, chart review, and incident reporting found that direct observation identified the greatest number of errors (Flynn et al., 2002). Earlier it had been established that automated surveillance could detect ADEs at a much higher rate than voluntary reporting. A comparison of automated surveillance, chart review, and voluntary reporting found that of the 617 ADEs detected, chart review identified 65 percent, automated surveillance 45 percent, and voluntary reporting 4 percent (Jha et al., 1998). In this study, only 12 percent of all ADEs detected were identified by both chart review and computerized surveillance (Jha et al., 1998).

Several studies have noted that different methods of detection appear more suited to identifying different types of medication-related problems (O’Neil et al., 1993; Jha et al., 1998), suggesting that the method selected should depend on the area of interest (again, see Chapter 5 for more detail). In conclusion, the incidence rates found in the patient safety literature depend dramatically on the particular detection method used.

A further confounding factor is that medication error rates are quoted in varying ways—errors per order/dose/opportunity, errors per 1,000 patient-days, and errors per 1,000 patient admissions. Rates of preventable ADEs are cited in a similar manner—preventable ADEs per 1,000 patient-days and per 1,000 patient admissions.

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

in synthesizing this heterogeneous evidence base. Hospital care is the setting with the most extensive research. Studies have estimated the rate of ADEs incurred in hospitals and error rates at each stage of the medication-use process. There is also an extensive literature on errors of omission in prescribing—failure to prescribe medications in appropriate situations.

Other care settings are much less well researched. For nursing home care, there are estimates of the rates of ADEs incurred while in a nursing home, plus a few studies on error rates at various stages of the medication-use process.4 Little attention has been paid to errors of omission in the nursing home population. For ambulatory care, a modest amount of research has been carried out, spread thinly over a large number of topics— ADE and error rates at various stages of the medication-use process, and omissions of effective therapies in specific populations. Similarly for pediatric care, a modest amount of research has been carried out, again thinly spread over a wide range of topics.

For the remaining care settings considered in this report, little or no research has been conducted on ADE and error rates. Of the limited number of studies relating to self-care, most addressed adherence issues. No study was found on medication error rates in the school setting. Just two studies were found on medication error rates in psychiatric care. Finally, there has been hardly any research on medication errors relating to OTC medications, and no study was found on error rates associated with complementary and alternative medications.

The discussion in this section is based on a large number of studies reviewed by the committee. It first addresses the incidence of medication errors in general, and then the incidence of three specific categories of medication errors—preventable ADEs, underutilization of medications, and overutilization of medications.

Incidence of Medication Errors
Hospitals

As noted, hospital care is the most researched setting for medication error incidence rates, although no study was identified that addressed medi-

4

There have been many studies of inappropriate prescribing for the elderly in nursing homes, ambulatory care, and home health care, based on such criteria as the Beers criteria (Beers et al., 1991) and subsequent updates/extensions (Beers, 1997). The committee did not include these studies in its synthesis since the causal link between inappropriate prescribing and poor health outcomes has not been documented.

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

cation errors in the selection and procurement of drugs by the hospital pharmacy.

Medication errors occur in all stages of the medication-use process, most frequently at the prescribing and administration stages. Several U.S. studies using differing definitions of error and methods of error identification found that rates of prescribing errors for adults in hospitals varied considerably (see Table 3-1). Prescribing errors occurred at rates of 12.3– 1,400.00 per 1,000 patient admissions (Bates et al., 1995a; Lesar et al., 1997; Lesar, 2002; LaPointe and Jollis, 2003; Winterstein et al., 2004). Such errors occurred at rates of 0.6–53.0 per 1,000 orders (Lesar et al., 1990; Bates et al., 1995a; Lesar et al., 1997; Lesar, 2002). And in studies that evaluated prescribing errors per opportunity for error, rates of 1.5–9.9 per 100 opportunities were found (Dean et al., 2002; van den Bemt et al., 2002; Bobb et al., 2004; Lisby et al., 2005).

Errors rates depend on the thoroughness of the error detection methods that are used (Gandhi et al., 2000). Most of the above studies used less comprehensive error detection methods, such as spontaneous reports by pharmacists after review of written orders (Lesar et al., 1997; Lesar, 2002), prompted reporting (Winterstein et al., 2004), and reporting by a clinical pharmacist participating in patient care (LaPointe and Jollis, 2003). The study that found by far the highest rate (Bates et al., 1995a) used much more comprehensive detection methods—chart review, including review of written medication orders by a dedicated trained reviewer, in addition to prompted reporting from nurses and pharmacists. This study found a rate of 1,400 prescribing errors per 1,000 patient admissions or 0.3 prescribing errors per patient per day. Of the errors identified, 7.5 percent were adjudged serious—preventable or potential ADEs. By comparison, a study (Kaushal et al., 2001) using similar error detection methods in pediatric units identified 405 prescribing errors per 1,000 patient admissions or 0.1

TABLE 3-1 Error Rates in Hospitals

Prescribing errors

Per 1,000 admissions

12.3–1,400 (5 studies)

 

Per 1,000 orders

0.61–53 (4 studies)

 

Per 100 opportunities for error

1.5–9.9 (4 studies)

Administration errors

Per 100 opportunities/doses

2.4–11.1 (5 studies)

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

prescribing error per patient per day. In this study, 19.5 percent of the errors were adjudged serious—preventable or potential ADEs.

Turning to medication administration errors, according to several international studies, administration errors (excluding wrong-time errors) are frequent, with error rates per dose ranging from 2.4 to 11.1 percent (Dean et al., 1995; Taxis et al., 1999; Barker et al., 2002; Tissot et al., 2003; Lisby et al., 2005). The U.S. study in this group found an administration error rate of 11 percent, excluding wrong-time errors (Barker et al., 2002). This study employed an observation-based method for detecting medication administration errors that has been used by the Centers for Medicare and Medicaid Services (CMS) for almost 20 years as a quality indicator for nursing homes. It was carried out in Colorado and Georgia in 36 different facilities (12 accredited hospitals, 12 nonaccredited hospitals, and 12 skilled nursing facilities). There was no significant difference in error rates (regardless of whether wrong-time errors were included) by type of facility. For the 36 facilities, the administration error rate (excluding wrong-time errors) ranged from 0 to 26 percent, with 8.3 percent as the median value. The 36 institutions studied were selected at random primarily from the Atlanta, Georgia, metropolitan statistical area and the Denver-Boulder-Greeley, Colorado, consolidated statistical area. Each facility had to agree to participate in the study. Twenty-six selected facilities declined to take part in the study. Most did not give reasons for not wishing to participate; of those that did, many expressed concerns about poor scores and wanting to improve their performance first (Barker et al., 2002). Thus the authors concluded that the error rates reported likely represent a lower bound.

A study in five intensive care units (ICUs) in U.S. tertiary teaching facilities (Calabrese et al., 2001) found an administration error rate of 3.3 percent—lower than that reported in the above study. The ICU study identified administration errors for a group of high-alert medications using a similar observational technique. The authors of this study commented that the rates they obtained were lower than those found in a comparable French ICU study (Tissot et al., 1999), and suggested that this difference might be due to varying methods of observation and pharmacist participation in patient care in the U.S. study. The committee believes these results—while the best available for large ICUs in the United States—are not generalizable to non-ICU hospital care and that the study by Barker and colleagues (2002) represents the best estimate of administration error rates in U.S. hospitals for non-ICU care.

Much higher rates of administration errors were observed in two studies that focused on intravenous medications—34 per 100 in a joint U.K./ German study (Wirtz et al., 2003) and 49 per 100 in a U.K. study (Taxis and Barber, 2003).

On the basis of the Barker et al. (2002) study and assuming a patient in

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

TABLE 3-2 Error Rates in Nursing Homes

Administration errors

Per 100 opportunities/doses

6 (Cooper et al., 1994)

12.2 (Barker et al., 1982)

14.7 (Barker et al., 2002)

20 (Baldwin, 1992)

the hospital receives 10 doses of medication per day,5 a typical patient would be subject to one administration medication error per day. These data, taken together with the results of the above studies, which identified 0.1 prescribing error per patient per day (Kaushal et al., 2001) and 0.3 prescribing error per patient per day (Bates et al., 1995a), as well as plus the fact that medication errors occur in other stages of the medication-use process (e.g., errors in the prescribing and administration stages accounted for 77 percent of medication errors [Leape et al., 1995]), suggest to the committee that about one medication error occurs per patient per day in hospital care.

Nursing Homes

There is little information on rates of dispensing errors in nursing homes, since this function generally is outsourced. According to the available data (see Table 3-2), medication administration errors appear to occur in nursing homes at a rate of 6–20 per 100 doses (Barker et al., 1982, 2002; Baldwin, 1992; Cooper et al., 1994). The two main studies in this area, published 20 years apart, both used the same error detection method (direct observation) and reported similar error rates—12 errors per 100 doses (Barker et al., 1982), and 15 errors per 100 doses (Barker et al., 2002) (in both cases excluding doses administered at the wrong time). Excluding wrong-time errors, omission of an ordered medication is generally the most common type of drug administration error in nursing homes. Given that administration error rates are higher in nursing homes than in hospitals, it

5

Rates of doses dispensed in hospital are rarely quoted in the literature. At MountainView Hospital, Las Vegas, Nevada, dose rates increased steadily at about 10 percent per year over the period 2002–2006 (Wood and Nam, 2005). During this period, the average numbers of doses dispensed per patient per day were 13.6 (January 2002), 13.3 (July 2002), 15.8 (January 2003), 15.1 (July 2003), 16.8 (January 2004), 16.3 (July 2004), 19.5 (January 2005), 18.0 (July 2005), and 22.1 (January 2006). The committee also carried out a small survey of eight community and teaching hospitals in Pennsylvania, Michigan, Ohio, and Minnesota. Based on 2005 or 2006 data, for the three community hospitals, the results were 24.4, 20.6, and 12.2 doses per patient per day; and for the teaching hospitals, the results were 25.8, 29.7, 32.8, 22.3, and 20.9 doses per patient per day. These data suggest that the assumption of 10 doses per patient per day is a conservative one.

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

is likely that per day, nursing home patients are more likely to experience a medication error than are hospital patients. Monitoring errors are probably the most common type of error in the nursing home setting, but are much more difficult to identify, and no study in this area was found. Because a typical medication pass in long-term care exceeds 2 hours, it is impossible for the nurse to deliver all medications within 1 hour of the scheduled time; thus wrong-time errors are predictably high in this setting. Finally, transitions from the nursing home to other settings are a time of high risk for adverse effects due to prescribing or transcription errors.

Ambulatory Care

For the purposes of this study, the committee examined medication error rates in six different settings within the ambulatory care domain: (1) the interface between care settings, for example, from hospital care to outpatient clinic; (2) the ambulatory clinic; (3) the community pharmacy; (4) the home care setting; (5) self-care; and (6) the school setting. In general, there is little or no understanding of incidence rates in all these areas.

Error rates in ambulatory clinics have been thinly researched (see Table 3-3). One study found that 21 percent of prescriptions in these settings

TABLE 3-3 Error Rates in Ambulatory Clinics

Prescription writing errors

Percentage of prescriptions containing at least one prescription writing error

21 (Shaughnessy and Nickel, 1989)

Errors in an ambulatory hemodialysis unit

Percentage of patients subject to prescribing errors

97.7 (Manley et al., 2003b)

 

Medication-related problems per patient per month

0.45 (Manley et al., 2003a)

Errors in an ambulatory chemotherapy unit

Percentage of doses containing an error

3 (Gandhi et al., 2005)

Errors in dispensing samples

Percentage of labels with usual dosage not present

12 (Dill and Generali, 2000)

 

Percentage of labels that referred user to enclosed prescribing information that was absent

17 (Dill and Generali, 2000)

Documentation errors

Current medications per patient missing from patient record

0.37 (Wagner and Hogan, 1996)

0.89 (Bedell et al., 2000)

 

Percentage of prescription renewals missing from patient record

15 (Ernst et al., 2001)

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

TABLE 3-4 Errors by Community and Mail Order Pharmacies

Community pharmacy: telephoned prescription errors

Percentage of telephoned prescriptions containing an error

12.4 (Camp et al., 2003)

Community pharmacy: dispensing errors

Percentage of prescriptions erroneously dispensed

1.7 (Flynn et al., 2003)

3.4 (Buchanan et al., 1991)

12.5 (Kistner et al., 1994)

24 (Allan et al., 1995)

Mail order pharmacy: dispensing errors

Percentage of prescriptions erroneously dispensed

0.075 (Teagarden et al., 2005)

contained at least one prescription writing error (Shaughnessy and Nickel, 1989). Two studies found high rates of medication errors in ambulatory hemodialysis units (Manley et al., 2003a,b). Extrapolating the findings of the study with the lower rate (Manley et al., 2003a) to the 246,000 U.S. hemodialysis patients, nearly 111,000 medication-related problems occur to these patients each month. In an ambulatory chemotherapy clinic, a medication error rate of 3.0 percent was found (Gandhi et al., 2005). Another study (Dill and Generali, 2000) found a lack of adequate documentation provided with drug samples available for administration to patients in an ambulatory clinic. Finally, three studies (Wagner and Hogan, 1996; Bedell et al., 2000; Ernst et al., 2001) found high rates of medication documentation errors.

Regarding community pharmacies (see Table 3-4), one study (Camp et al., 2003) found that 12.4 percent of telephoned prescriptions contained an error in the information provided by the person calling in the prescription. Four studies examining dispensing errors and using the same error detection method found a wide range of prescription dispensing error rates—1.7 to 24 percent. One study conducted in a hospital-based outpatient pharmacy found the rate of dispensing errors to be 12.5 percent (Kistner et al., 1994). Another small-scale study found a 24 percent dispensing error rate (Allan et al., 1995). In a study at a high-volume outpatient pharmacy, the error rate was found to be 3.4 percent (Buchanan et al., 1991). These three studies published in the period 1991–1995, reported much higher error rates than a more recent study reflecting the likely improvements in dispensing systems and technology over time. This more recent, large-scale study of both new prescriptions and prescription refills found an error rate of 1.7 percent (Flynn et al., 2003). This dispensing error rate translates to approximately 4 errors per 250 prescriptions per pharmacy per day, or an

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

estimated 51.5 million errors during the filling of 3 billion prescriptions each year. One study of medication errors at Medco Health Solutions, Inc., a large mail order pharmacy, carried out by Medco employees, found a dispensing error rate of 0.075 percent—16 dispensing errors among 21,252 prescriptions (Teagarden et al., 2005).

Self-care studies have focused mainly on adherence rates, which are generally low. An early study found adherence rates for prescribed medications of 50 percent (Sackett and Snow, 1979). A more recent meta-analysis of 328 studies reporting on adherence to medication regimens found an adherence rate of 79.4 percent (DiMatteo, 2004). Adherence rates appear to vary according to the number of doses taken per day (Cramer et al., 1989).

Pediatric Care

It has become clear that the prescription, dispensing, and administration of medications account for a substantial portion of the preventable medical errors that occur with children (Kaushal et al., 2001, 2004). Children are uniquely vulnerable to medication errors: all pediatric medication doses need to be based on body-size parameters (e.g., weight, body mass index) and the state of organ development; children are much less able than adults to double-check their own medications; and the wide range of appropriate doses for any given medication based on the child’s size gives the “average” dose little predictability for those doing the administering. Accurate pediatric medication administration requires knowledge of the child’s precise weight; proper conversion of pounds to kilograms; the correct choice of appropriate preparations and concentrations; and the ability to measure and administer doses properly, particularly for liquid medications.

An inpatient study covering all types of medications carried out at two urban teaching hospitals reported a rate of medication order errors of 4.2 percent, or 405 prescribing errors per 1,000 pediatric patients (Kaushal et al., 2001). Using a broader definition of medication error, a French study reported a higher rate—24.0 percent (Fontan et al., 2003). Also using a broader definition, a still higher rate was observed in a pediatric ICU—30.0 percent (Potts et al., 2004).

Rates of administration errors were estimated to be 0.72 per 100 orders (or 7.0 per 100 admissions, or 19.8 per 1,000 patient days) for all types of medication in a pediatric inpatient setting (Kaushal et al., 2001) and 23.0 per 100 opportunities for error in a pediatric nephrology ward (Fontan et al., 2003).

There have been two pediatric emergency department studies. One of these, conducted in a Canadian hospital, estimated that 100.0 prescribing

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

TABLE 3-5 Errors in Hospital Pediatric Care

Medication ordering errors

Percentage of prescriptions containing an error

4.2 (Kaushal et al., 2001)

24 (Fontan et al., 2003)

Medication ordering errors in pediatric intensive care

Percentage of prescriptions containing an error

30 (Potts et al., 2004)

Administration errors

Per 100 orders

0.72 (Kaushal et al., 2001)

Administration errors in pediatric nephrology units

Per 100 opportunities for error

23 (Fontan et al., 2003)

Emergency department prescribing errors

Per 1,000 patients

100 (Kozer et al., 2002)

Emergency department administration errors

Per 1,000 patients

39 (Kozer et al., 2002)

Emergency department acetaminophen doses ordered outside recommended range

Per 100 doses ordered

22 (Losek, 2004)

errors and 39.0 administration errors occurred in the emergency department per 1,000 pediatric patients (Kozer et al., 2002). The other study found that 22.0 percent of acetaminophen doses ordered were outside the recommended 10–15 milligrams/kilogram recommendation for these patients (Losek, 2004). (See Table 3-5 for a summary of errors in hospital pediatric care).

Finally, a recent study found that potential medication errors occur frequently in outpatient pediatric clinics (McPhillips et al., 2005). In a sample of new prescriptions for 22 common medications, approximately 15 percent of children were dispensed a medication with a potential dosing error.

Psychiatric Care

Many studies of medication errors associated with psychotropic medications either were conducted as part of larger general medical–surgical studies or other ADE-reporting databases, or were restricted to geriatric populations in nonpsychiatric restricted settings, such as nursing homes and ambulatory clinics. The one major study devoted exclusively to medication errors in psychiatric care found a very high rate of errors in a state

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

psychiatric hospital—2,194 errors over 1,448 patient days, or an error rate of 1.5 errors per patient day (Grasso et al., 2003).

Use of Over-the-Counter and Complementary and Alternative Medications

The committee could only find three studies in the peer-reviewed literature addressing incidence rates for medication errors arising from the use of OTC drugs. These studies (Li et al., 2000; McErlean et al., 2001; Goldman and Scolnik, 2004) showed that parents using OTC medications to treat children with fever often administer an incorrect dosage. One study of 118 caregivers treating their children with a fever reducer revealed that incorrect doses were given 47 percent of the time; another study of 248 caregivers found that 12 percent gave an overdose and 41 percent an underdose; and a third study found that of 200 patients treated for fever by a parent, 51 percent received the wrong dose. Moreover, these studies indicated that a misdose often resulted in a continued fever and an eventual trip to the emergency department.

Despite the paucity of data on OTC-related error rates, there is a growing body of literature documenting adverse OTC drug–disease and OTC drug–drug interactions. Some examples are presented in Box 3-2.

The committee could find no studies of medication error rates associated with complementary and alternative medications. There is, however, an emerging literature indicating that these medications have the potential for adverse interactions with prescription drugs (D’Arcy, 1993; Calis and Young, 2004). In particular, these types of products can interfere with the metabolism and elimination of other drugs in the body. St. John’s Wort, an herbal product commonly used to treat depression, is an example. Studies have found that St. John’s Wort impacts an enzyme that ultimately increases the oxidation of drugs (Bailey and Dresser, 2004). This action limits the bioavailability of some drugs, resulting in serious adverse effects. Specifically, studies have shown that St. John’s Wort can increase organ rejection and increase the viral load in HIV patients by limiting the effects of prescription medications (Piscitelli et al., 2000; Ruschitzka et al., 2000).

Error Rates: Much More Needs to Be Done

Where incidence rates have been measured systematically, medication errors have been found to be common and to occur at unacceptably high levels. Reasonably well-researched stages of the medication-use process include prescribing, dispensing, and administering in hospitals; prescribing in ambulatory clinics; dispensing in community pharmacies; and medication adherence in self-care.

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

BOX 3-2

Examples of Adverse OTC Drug–Disease and OTC Drug–Drug Interactions

Drug–Disease Interactions

  • Cough syrup and diabetes. Because most OTC cough syrups contain large quantities of sugar, an unknowing diabetic patient could go into diabetic shock.

  • Ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs increase blood pressure in hypertensive individuals. Moreover, chronic NSAID use can counteract the effects of beta-blockers, thiazide diuretics, and other medications (Houston, 1991; Espino and Lancaster, 1992).

  • Acetaminophen and ibuprofen can result in kidney damage for those with congestive heart failure and renal impairment. Prostaglandins are critical to proper renal functioning in these individuals, and NSAIDs suppress prostaglandin synthesis (Bakris and Kern, 1989).

Drug–Drug Interactions

  • NSAIDs. These drugs can cause gastric bleeding. Many adults self-medicate with OTC NSAIDs to treat osteoarthritis, a practice known to cause gastric ulceration. When NSAIDs are combined with antacids or H2 antagonists, the risk of hospitalization for serious gastrointestinal bleeding is increased (Bradley et al., 1991; Singh et al., 1996).

  • Calcium supplements. When calcium supplements are combined with products such as aspirin, erythromycin, or bisacodyl (i.e., Dulcolax), gastric irritation results. Additionally, calcium supplements reduce the bioavailability of other medications, such as levothyroxine, ciproflaxin, phenytoin, and digoxin, and limit the absorption of such nutrients as iron, thiamin, zinc, and B12 (D’Arcy and McElnay, 1987).

  • Aspirin and coumadin. Because both aspirin and coumadin are blood thinners, there is an acute possibility of too much anticoagulation when they are taken together.

  • Too much acetaminophen. Many OTC and prescription medicines contain acetaminophen. An unassuming patient may self-treat a cold with both Advil Cold® or some other cough/cold medication and regular Tylenol without realizing that this constitutes a double dose of acetaminophen. It has been well documented that overuse of acetaminophen leads to hepatotoxicity (liver damage), which can lead to liver failure.

  • Antacids. These medications interfere with the effects of some HIV drugs (Piscitelli and Gallicano, 2001).

When it is possible to compare the results of more than one study, estimates of error rates vary greatly. Much but not all of this variation can be explained by differing definitions and identification methods. Even when the definition of error is standardized and the same identification method is used, substantial variation in administration error rates by institution are found (Barker et al., 2002). Taking this variability into account, however, the underlying error rates are unacceptably high.

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

Over the past decade, much scholarly activity and sizable government resources have been directed at determining the extent and scope of medication errors. Nonetheless, there remain broad aspects of the medication-use process for which we have little or no understanding of error rates. These include the selection and procurement of medications, monitoring of the effectiveness of medications in all care settings, medication use in schools, self-care, medication use in psychiatric care, and the use of OTC and complementary and alternative medications. The committee concludes that greater effort is needed to identify medication errors in most care settings, both to measure the extent and scope of such errors and to assess the impact of error prevention strategies.

Preventable Adverse Drug Events

ADEs, defined as any injury due to medication (Bates et al., 1995b), are common in hospitals, nursing homes, and ambulatory care. ADEs that are associated with a medication error are considered preventable (see the detailed discussion in Chapter 1). This section presents findings from the literature on the incidence of preventable ADEs.

Hospitals

Three major studies6 examined the incidence of preventable ADEs occurring during hospitalization (see Table 3-6). In chronological order, their findings are as follows:

  • 1.2 preventable ADEs per 100 admissions at LDS Hospital, Salt Lake City, Utah (Classen et al., 1997). Extrapolating these results nationally and assuming 32 million admissions annually, 380,000 hospital patients in America would experience a preventable ADE annually.

  • 1.8 preventable ADEs per 100 nonobstetric admissions at Brigham and Women’s Hospital, Boston, Massachusetts (Bates et al., 1995b). Extrapolating these results nationally and assuming 25 million nonobstetrical admissions annually, 450,000 hospital patients in America would experience a preventable ADE annually.

  • 5.7 preventable ADEs per 1,000 patient days at Brigham and Women’s Hospital, Boston, Massachusetts (Jha et al., 1998).

6

The committee also reviewed three other studies on the incidence of preventable ADEs occurring during hospitalization. In two studies the sample sizes were too small (Senst et al., 2001; Forster et al., 2004), and the third study used a much broader definition of preventable ADEs than that in other studies (Nebeker et al., 2005).

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

TABLE 3-6 Rates of Preventable ADEs in Hospitals

Study

Preventable ADE Rate

Proportion of ADEs Preventable (No. of ADEs in study)

ADE Rate

Classen et al., 1997

1.2 per 100 admissions

About 50% (2,227)

2.4 per 100 admissions

Bates et al., 1995b

1.8 per 100 admissions

28% (247)

6.5 per 100 admissions

 

3.2 per 1,000 patient-days

 

11.5 per 1,000 patient-days

Jha et al., 1998

5.7 per 1,000 patient-days

27% (617)

21 per 1,000 patient-days

NOTE: ADE rates usually are not reported in the medical literature by categories such as renal failure, hypotension, or bleeding. On the other hand, severity levels are often quoted— for example, mild (self-limited); moderate (requiring treatment); severe (life-threatening, disabling, or markedly prolonging hospitalization) (Classen et al., 1991); or fatal, life-threatening, serious, or significant (Bates et al., 1995b).

In the study at LDS Hospital (Classen et al., 1997), ADEs were identified using computerized surveillance of medical records through the use of various automated signals (for example, drug stop orders, antidote orders) plus voluntary reporting. Among the 2,227 ADE patients, 42 percent of the ADEs arose from excessive dosage of a drug for a patient’s weight and calculated renal function, 4.6 percent from drug interactions, and 1.5 percent from known drug allergies. All these ADEs were thought to be potentially preventable, particularly through the application of computer-based programs that monitor drug use for appropriate selection and dosage.

In the first Brigham and Women’s Hospital study (Bates et al., 1995b), ADEs were identified by stimulated self-reports by nurses and pharmacists and daily review of charts by nurse investigators. Relative to the LDS Hospital study, this study reported a higher ADE incidence rate (6.5 ADEs per 100 nonobstetric admissions versus 2.4 ADEs per 100 admissions) and a lower proportion of ADEs identified as preventable (28 percent versus almost 50 percent). Among the preventable events (preventable ADEs and potential ADEs) in the first study at Brigham and Women’s Hospital (Bates et al., 1995b), 49 percent of primary errors occurred in the ordering stage, 11 percent in the transcription stage, 14 percent in the dispensing stage, and 26 percent in the administration stage. The leading types of ordering errors—wrong dose, known allergy, wrong frequency, and drug–drug interactions—were all thought to be potentially preventable by computer-

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

ized order checking. The data in this study were analyzed further. For the 70 preventable ADEs and 194 potential ADEs, a systems analysis group found 334 errors associated with these 264 events. The group identified the proximal causes of these errors (Leape et al., 1995) (see Table 3-7). These proximal causes cut across multiple stages; most errors occurred in the ordering (39 percent) and drug administration (38 percent) stages. Lack of knowledge of the drug was the most common proximal cause (22 percent), followed by lack of knowledge of the patient (14 percent) and rule violations (10 percent).

The systems group then identified the system failures that led to the proximal causes (see Table 3-8). The seven most common system failures (defects in drug knowledge dissemination, dose and identity checking, the availability of patient information, order transcription, the allergy defense system, medication order tracking, and interservice communications) all have in common impaired access to information. This group of system failures accounted for 78 percent of the errors identified.

In the second Brigham and Women’s Hospital study (Jha et al., 1998), ADEs were identified using a combination of the methods of the LDS Hospital study and the first Brigham and Women’s Hospital study— computerized surveillance of medical records, chart review, and voluntary reporting. Relative to the first Brigham and Women’s Hospital study, this second study reported a higher preventable ADE incidence rate (5.7 per 1,000 patient days versus 3.2 per 1,000 patient days) and a similar proportion of ADEs identified as preventable (27 percent versus 28 percent). This study demonstrated that the types of ADEs found by chart review and computer surveillance are different despite some overlap, with the chart-based approach also finding 45 percent more ADEs. In this study, 25 percent of the ADEs identified by the computer monitor were preventable; for chart review, this proportion was 27 percent. Moreover, the computer monitor used in the second Brigham and Women’s Hospital study found ADEs at a higher rate than the computer monitor used in the LDS Hospital study because it was more sensitive (i.e., able to detect milder ADEs) and contained rules for identifying a wider range of ADEs. A key insight from the second Brigham and Women’s Hospital study was that the three detection methods used in the study—computerized surveillance of medical records, chart review, and voluntary reporting—complemented each other in identifying preventable and potential ADEs.

The committee believes the key messages from this series of studies are as follows:

  • The estimates of about 400,000 preventable ADEs occurring annually in U.S hospitals, derived from the LDS Hospital study (Classen et al., 1997) and the first Brigham and Women’s study (Bates et al., 1995b), are likely

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

TABLE 3-7 Distribution of Errors by Proximal Cause and Stage

Proximal Cause

Ordering % (No.)

Transcription and Verification % (No.)

Dispensing % (No.)

Administration % (No.)

All % (No.)

Lack of knowledge of the drug

36

(47)

15

(6)

0

(0)

15

(19)

22

(72)

Lack of information about the patient

24

(31)

10

(4)

0

(0)

10

(13)

14

(48)

Rule violations

19

(25)

0

(0)

16

(6)

2

(2)

10

(33)

Slips and memory lapses

11

(14)

0

(0)

0

(0)

12

(15)

9

(29)

Transcription errors

0

(0)

73

(29)

0

(0)

0

(0)

9

(29)

Faulty drug identity checking

0

(0)

0

(0)

29

(11)

10

(13)

7

(24)

Faulty interaction with other services

1

(1)

0

(0)

8

(3)

10

(13)

5

(17)

Faulty dose checking

0

(0)

0

(0)

8

(3)

10

(13)

5

(16)

Infusion pump and parenteral delivery problems

0

(0)

0

(0)

0

(0)

13

(16)

5

(16)

Inadequate monitoring

8

(11)

0

(0)

0

(0)

3

(4)

4

(15)

Drug stocking and delivery problems

0

(0)

0

(0)

29

(11)

0

(0)

3

(11)

Preparation errors

0

(0)

0

(0)

11

(4)

5

(6)

3

(10)

Lack of standardization

0

(0)

0

(0)

0

(0)

6

(8)

2

(8)

Unclassified

1

(1)

3

(1)

0

(0)

3

(4)

2

(6)

TOTALS*

100

(130)

100

(40)

100

(38)

100

(126)

100

(334)

  

*Percentages do not add to 100% due to rounding.

SOURCE: Leape etal., 1995.

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

TABLE 3-8 Distribution of Errors by System Failure

 

Errors Attributed

System Failure

%

No.

Drug knowledge dissemination

29

98

Dose and identity checking

12

40

Patient information availability

11

37

Order transcription

9

29

Allergy defense

7

24

Medication order tracking

5

18

Interservice communication

5

17

Device use

4

12

Standardization of doses and frequencies

4

12

Standardization of drug distribution within unit

3

11

Standardization of procedures

3

10

Preparation of intravenous medications

2

6

Transfer/transition procedures

1

4

Conflict resolution

1

4

Others

4

12

TOTALS

100

334

SOURCE: Leape et al., 1995.

lower bounds since the second Brigham and Women’s study (Jha et al., 1998), using more comprehensive detection methods, reported higher rates.

  • A high proportion of preventable ADEs are caused by system errors that could be eliminated by computerized provider order entry (CPOE).

  • Sophisticated decision-support tools that address dosing, prophylaxis, and patient monitoring, among other issues, must be built into CPOE systems.

Nursing Homes

Two studies estimated the incidence of preventable ADEs in long-term care (see Table 3-9). Their findings were as follows:

TABLE 3-9 Rates of Preventable ADEs in Nursing Homes

Study

Preventable ADE Rate per Patient Month

Proportion of ADEs Preventable (No. of ADEs in study)

ADEs per 100 Admissions

Gurwitz et al., 2000

0.01

51% (546)

0.02

Gurwitz et al., 2005

0.04

42% (815)

0.1

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×
  • 0.01 preventable ADE per resident-month (Gurwitz et al., 2000).

  • 0.04 preventable ADE per resident-month (Gurwitz et al., 2005).

In the first study, carried out in 18 community-based nursing homes in Massachusetts, ADEs were identified by voluntary reporting and review of the record of each nursing home resident by two nurses and one pharmacist, performed every 6 weeks. In the second study, carried out in two large academic long-term care facilities, one in Connecticut and one in Ontario, Canada, ADEs were identified by a pharmacist’s monthly review of patient records. Medical records were also targeted for review using computer-generated signals (for example, abnormal serum levels), and administrative incident reports were reviewed as well for any indication of an ADE. This second study identified a much higher rate of ADEs than the first study. The authors suggested this difference could be attributed to the enhanced approach to identification of ADEs in the second study, although they thought the estimates from this study were still conservative since the study relied solely on information in medical records; there was no direct assessment of residents, which likely would have led to the identification of additional events.

The committee believes the second Gurwitz et al. study provides a better estimate of preventable ADE rates in the long-term care population. Applying the findings of this study to an average nursing home in the United States (bed size 105), 50 preventable ADEs (Gurwitz et al., 2005) would occur annually in the nursing home setting; applying the findings to the entire 1.6 million nursing home population in the United States, 800,000 (Gurwitz et al., 2005) preventable ADEs would occur each year in these settings. These figures are likely conservative, however, given the much higher ADE incident rates published in two other studies—0.44 ADEs per patient-month or 115 ADEs per 100 admissions (Gerety et al., 1993) and 134 ADEs per 100 admissions (Cooper, 1999). (Neither of these studies quoted the proportion of ADEs considered preventable.)

In one of the two nursing home studies by Gurwitz and colleagues (2000), of the 464 preventable ADEs and potential ADEs identified, 315 occurred in the ordering stage. Among those 315 errors, wrong dose (for example, excessive dose for an elderly patient) occurred in 63 percent of cases, followed by prescription of a drug for which there was a well-established interaction with another drug, which occurred in 22 percent of cases. The other Gurwitz et al. (2005) nursing home study found similar results. Among the 338 preventable ADEs identified, 198 occurred in the ordering stage. Of these prescribing errors, the most common were wrong dose (48 percent), wrong drug choice (38 percent), and known interaction (12 percent).

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×
Ambulatory Care

In a large study of Medicare enrollees, Gurwitz and colleagues (2003) found 5 ADEs per 100 patient-years and 1.4 preventable ADEs per 100 patient-years. The study took place in a large New England multispecialty ambulatory practice providing health care for more than 30,000 persons aged 65 and over. In total, 1,523 ADEs were identified, 421 of which were adjudged preventable (28 percent). ADEs were identified using multiple methods: reporting from health care providers, review of hospital discharge summaries, review of emergency department notes, computer-generated signals, free-text review of electronic clinical notes, and review of administrative incident reports of medication errors. Generalizing these results to the population of all Medicare enrollees, the authors estimated that 530,000 preventable ADEs occur among the 38 million enrollees (Gurwitz et al., 2003).

Another study, which contacted patients directly, found a much higher rate of ADEs but a lower proportion adjudged preventable. In a study (Gandhi et al., 2003) carried out in four primary care practices in Boston, of the 661 patients who had received at least one prescription during a 4-week period and who responded to a survey, 181 ADEs were identified (27 per 100 patients). Many more ADEs were identified by surveying the patients than by reviewing charts: of the 181 ADEs, 166 (92 percent) were identified by surveying patients, 50 (28 percent) by reviewing charts, and 35 (19 percent) by both means. Of the 181 ADEs identified, 20 were considered preventable (11 percent).

In a study on ADEs in ambulatory care (Gandhi et al., 2003), of the 20 preventable ADEs identified, 9 were due to the selection of an inappropriate dose, 2 to wrong dose, and 2 to wrong frequency of dose. It was considered that CPOE, including checking of dosages, interactions with other drugs, and allergies to the drug, could have prevented 7 of the 20 preventable ADEs. In a study of ADEs among elderly patients in the ambulatory setting (Gurwitz et al., 2003), of the 421 preventable ADEs identified, 246 were found in the prescribing stage. Among these prescribing errors, 46 percent involved wrong drug/wrong therapeutic choice and 41 percent wrong dose. (See Table 3-10 for rates of preventable ADEs in ambulatory care.)

Summary

In total, the committee estimates that at least 1.5 million preventable ADEs occur each year in the United States:

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

TABLE 3-10 Rates of Preventable ADEs in Ambulatory Care

Study

Preventable ADE Rate

Proportion of ADEs Preventable (No. of ADEs in study)

ADE Rate

Gurwitz et al., 2003

1.4 per 100 patient-years

28% (1,523)

5 per 100 patient-years

Gandhi et al., 2003

5.4 per 100 patients

20% (181)

27 per 100 patients

  • Preventable ADEs occurring in hospitals—Classen and colleagues (1997) projected 380,000 occurring annually and Bates and colleagues (1995b) 450,000. These are likely underestimates given the higher preventable ADE rate found in another study using more comprehensive ADE identification methods (Jha et al., 1998).

  • Preventable ADEs occurring in long-term care—Gurwitz and colleagues (2005) projected 800,000—again likely an underestimate given the higher ADEs rates of other studies (Gerety et al., 1993; Cooper, 1999).

  • Preventable ADEs among outpatient Medicare patients—Gurwitz and colleagues (2003) projected 530,000.

Underutilization and Overutilization of Medications

Both underutilization of medications (the failure to prescribe medications for which there is an evidence base for reduction in morbidity and mortality) and overutilization of medications (prescribing of medications for which there is no evidence base for reduction in morbidity and mortality) are common in hospitals, nursing homes, and the ambulatory setting. The committee found well-documented evidence of inadequate treatment for acute coronary syndromes, heart failure, chronic coronary disease, atrial fibrillation, bacterial infection prophylaxis, and thrombosis prophylaxis in hospitals. Underutilization of medications in nursing homes and assisted-living facilities relative to national standards is best documented for pain management, congestive heart failure, and use of anticoagulants in stroke prevention and atrial fibrillation, but there is also limited evidence for deficits in use of medications for depression, myocardial infarction prophylaxis, and treatment of osteoporosis. Overutilization of medication is best documented in the treatment of colds, upper respiratory infections, and bronchitis by antibiotics.

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×
Underutilization of Medications in Hospitals

For hospital care, three broad classifications of studies were identified: on treatment of acute coronary syndromes, on antibiotic prophylaxis for surgical patients, and on thromboembolic prophylaxis for surgical patients (see Table 3-11). Seven studies addressed acute myocardial infarction. Within the first 24 hours of hospitalization for a myocardial infarction, 85–93 percent had received aspirin (Sanborn et al., 2004; Granger et al., 2005; Roe et al., 2005), and 66–78 percent beta-blockers (Sanborn et al., 2004; Granger et al., 2005; Roe et al., 2005). Among patients discharged with a diagnosis of acute myocardial infarction, aspirin was prescribed for 53–93 percent of ideal candidates (those with no known contraindication), beta-blockers for 53–83 percent of ideal candidates, and angiotensin converting enzyme (ACE) inhibitors for 59–83 percent of ideal candidates (Alexander et al., 1998; Petersen et al., 2001, 2003; Krumholz et al., 2003; Sanborn et al., 2004; Granger et al., 2005; Roe et al., 2005). Rates of prophylaxis for bacterial infections among surgical patients ranged from 70 to 98 percent (Heineck et al., 1999; Vaisbrud et al., 1999; Gupta et al., 2003; van Kasteren et al., 2003; Bedouch et al., 2004; Quenon et al., 2004). Rates of thromboembolic prophylaxis varied greatly—from 5 to 81 percent (Ageno et al., 2002; Ahmad et al., 2002; Aujesky et al., 2002; Campbell et

TABLE 3-11 Underutilization of Medications in Hospitals

Patients discharged with diagnosis of acute myocardial infarction

Percentage of patients given aspirin within 24 hours of hospitalization

85–93 (3 studies)

 

Percentage of patients prescribed aspirin at discharge

53–93 (6 studies)

 

Percentage of patients given beta-blockers within 24 hours of hospitalization

66–78 (3 studies)

 

Percentage of patients prescribed beta-blockers at discharge

53–83 (6 studies)

 

Percentage of patients prescribed angiotensin converting enzyme (ACE) inhibitors at discharge

51–73 (6 studies)

Rates of antibiotic prophylaxis in surgical studies

Percentage of procedures for which patients prescribed antibiotics

70–98 (6 studies)

Rates of thromboembolic prophylaxis in surgical studies

Percentage of procedures for which thromboembolic prophylaxis carried out

5–90 (9 studies)

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

al., 2001; Freeman et al., 2002; Learhinan and Alderman, 2003; Scott et al., 2003; Tan and Tan, 2004; Chopard et al., 2005).

Underutilization of Medications in Nursing Homes

In a study of residents over age 65 in assisted-living facilities, 62 percent of those with congestive heart failure were not receiving an ACE inhibitor; of those with a history of myocardial infarction, 60.5 percent were not receiving aspirin, and 76 percent were not receiving beta-blockers; of those with a history of stroke, 37.5 percent were not receiving an anti-coagulant or antiplatelet product; and of those with osteoporosis, 61 percent were not receiving calcium supplements (Sloane et al., 2004). In a second study of nursing home residents, only 53 percent of ideal candidates with atrial fibrillation were receiving warfarin (McCormick et al., 2001). A third study showed that only 25 percent of nursing home residents with congestive heart failure had been prescribed an ACE inhibitor (Gambassi et al., 2000). A fourth study showed that only 55 percent of residents identified as depressed had received antidepressants (Brown et al., 2002).

Inadequate pain management is well documented in nursing homes, with 45–80 percent of residents experiencing unrelieved pain (AGS, 2002). Results of cross-sectional studies indicate that 26 percent of nursing home residents overall and 30 percent of those with a cancer diagnosis have daily pain, and approximately 25 percent of these patients receive no analgesics (Bernabei et al., 1998; Won et al., 1999, 2004).

Underutilization of Medications in Ambulatory Care

A number of studies have examined underutilization of medications in ambulatory care. A major U.S. study of both inpatient and outpatient care carried out during 1998–2000 found high levels of errors of omission generally: across a wide range of acute and chronic conditions, patients received 55 percent of recommended care (McGlynn et al., 2003). Regarding the use of medications in particular, 69 percent of patients received recommended care; of those presenting with myocardial infarction, however, only 45 percent of ideal candidates received beta-blockers and 61 percent aspirin.

Analysis of the results of three phases of the National Health and Nutrition Examination Survey shows that rates of hypertension control, although improving, continue to be low (Hajjar and Kotchen, 2003). Of those with hypertension in the 1988–1991 phase of the survey, 52 percent received treatment, and 25 percent achieved control of their hypertension; in the 1991–1994 phase, 52 percent received treatment, and 23 percent achieved control; and in the 1999–2000 phase, 58 percent received treatment, and 31 percent achieved control.

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

One study found that the outpatient use of evidence-based therapies for coronary artery disease is increasing, but remains suboptimal (Newby et al., 2006). The proportion of patients reporting use (consistently or inconsistently) of aspirin, beta-blockers, and lipid-lowering agents increased over time, and in the last year (2002) of the study, the use of aspirin was 83 percent, of beta-blockers 61 percent, and of lipid-lowering agents 63 percent. Rates of consistent use were, however, much lower: for aspirin 71 percent of patients, for beta-blockers 46 percent, and for lipid-lowering agents 43 percent.

Overutilization of Medications

Overutilization of medications represents an important problem and is best documented in the treatment of colds, upper respiratory infections, and bronchitis by antibiotics. These infections are common diagnoses in the ambulatory care setting. Such infections are overwhelmingly viral in origin and do not respond to antibiotics (Arroll and Kenealy, 2002; Thomas and Arroll, 2000). Nevertheless, patients are often prescribed antibiotics for these diseases, thereby being exposed to ADEs; increased antibiotic resistance results as well. Although prescribing of unnecessary drugs has not always been considered a medication error (but rather overuse), clearly the problem exists and represents a major opportunity for improvement.

For example, using National Ambulatory Medical Care Survey data for 1992, a study found that 51 percent of adult patients diagnosed as having colds, 52 percent of adult patients diagnosed as having upper respiratory tract infections, and 66 percent of adult patients diagnosed as having bronchitis were treated with antibiotics (Gonzales et al., 1997). A parallel study on antibiotic prescribing for children using the same dataset found similar results: antibiotics were prescribed for 44 percent of patients with colds, 46 percent of patients with upper respiratory tract infections, and 75 percent of patients with bronchitis (Nyquist et al., 1998). A third study, using National Ambulatory Medical Care Survey data for 1996, found that in the emergency department, antibiotics were prescribed for 24 percent of patients with common colds and upper respiratory tract infections and 42 percent of patients with bronchitis (Stone et al., 2000).

Results of later studies indicate that the prescribing of antimicrobials for respiratory tract infections has declined somewhat. Again using National Ambulatory Medical Care Survey data for the period 1989–1990 to 1999–2000 for respiratory tract infections, the prescribing of antimicrobials for children and adolescents decreased from 67 to 38 prescriptions per 100 office visits, and the visit-based prescription rate decreased from 72 to 61 per 100 visits (McCaig et al., 2002). Similarly for adults, the prescribing of antibiotics for acute respiratory infections fell from 60 percent of outpa-

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

tient office visits during 1995–1996 to 49 percent of office visits during the 2001–2002 (Roumie et al., 2005). The general issue of overuse of medications in patients with other conditions is also undoubtedly important, but this is perhaps the best-documented case.

Impact of Formularies on Medication Safety

In an effort to control the costs of pharmaceuticals, managed care organizations have established formularies—schedules of prescription drugs that will be paid for by a health insurance plan and dispensed through participating pharmacies. Often patients taking prescription drugs switch from one managed care organization to another, resulting in the need to switch to another formulary. This sometimes involves patients changing their medications. Moreover, there can be difficulties in the handoffs between managed care organizations, which can result in patients having periods of time off their medications. Formulary changes may also be required when a patient moves from an outpatient to an inpatient and then back to an outpatient setting. In this situation, a recent study found a minimal effect of the hospital formulary on postadmission use of proton pump inhibitors and statins as compared with pre-admission use in a privately insured managed care population (Sun et al., 2005).

Limited research has been carried out on the impact of the use of formularies and formulary switching on medication safety. A major review of studies of interventions to improve drug use in managed care organizations found evidence for the effectiveness of several interventions but little understanding of longer-term efficacy and safety issues (Pearson et al., 2003). An editorial in a psychiatric journal commented that Medicaid preferred drug lists had been rapidly implemented across the nation, but studies analyzing the impact of these lists on patients had not kept pace (Elam et al., 2005). In the case of psychotropic drugs, however, concerns have been raised about the use of overly restrictive formularies. Studies have shown that the failure to respond to one selective serotonin reuptake inhibitor or the occurrence of severe side effects does not mean the patient will have the same experience with another such drug (Huskamp, 2003). The committee believes the impact of the use of formularies and formulary switching on medication safety is an area that requires further research.

COSTS

The costs of medication errors have been much less well researched than incidence rates. The committee could find no studies on the costs of ADEs relating to pediatric and psychiatric care or to the use of OTC and

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

complementary and alternative medications. Most of the cost studies that have been carried out relate to ADEs associated with hospital care. This group of studies has examined both the costs of ADEs experienced in hospitals and the costs of emergency room visits or hospital admissions that are attributable to an earlier ADE. A few studies have examined the costs of ADEs in nursing home and ambulatory care. Some studies have used cost models of the health care delivery system to estimate annual national costs attributable to drug-related morbidity and mortality in ambulatory care.

Hospitals

As noted, hospital-related studies fall into two categories—those addressing the costs of ADEs experienced while in the hospital, and those addressing the costs of emergency room visits and hospital admissions that can be attributable to earlier ADEs.

Costs of ADEs Experienced in Hospitals

Only one study was found that estimated the extra hospital costs of a preventable ADE occurring in a hospital. This study, carried out in 1993 within the Adverse Drug Events Prevention Study, found that after adjusting7 for patient comorbidities and case mix, the additional length of stay associated with a preventable ADE was 4.6 days, with an increase in total cost of $5,857 (Bates et al., 1997). From these data, the authors estimated that in a 700-bed teaching hospital, preventable ADEs resulted in an additional cost of $2.8 million per year (Bates et al., 1997).

Costs of Emergency Room Visits and Hospital Admissions Attributable to Prior ADEs

A few studies have estimated the hospital/emergency room costs and the proportion of hospital admissions and emergency room visits attributable to an earlier preventable ADE.

In a study at a tertiary hospital, a computer-based monitoring program was used to identify admissions that may have been associated with an ADE. Among 3,238 admissions, 1.4 percent were found to be due to an ADE (Jha et al., 2001). Of these ADEs, 28 percent were preventable. Estimated costs were $10,375 per preventable ADE; annual costs to the hospital were $1.2 million per year for all preventable ADEs.

7

Adjusting for patient comorbidities and case mix is rarely completely successful, but it is the best possible approach since patients cannot be randomized to have or not have an ADE.

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

Based on data on patients who presented in 1994 at the emergency department of a 560-bed teaching hospital, the costs of treating those with a preventable ADE experienced previously were $308 for those who were not hospitalized and $2,752 for those who were (Dennehy et al., 1996). The study found that 4 percent of all emergency department visits (50 of 1,260) were due to prior ADEs; of these ADEs, 66 percent were judged preventable.

In one study of 253 patients presenting to an emergency department, 71 (28 percent) made their visit because of an ADE (Tafreshi et al., 1999). Of these 71 visits, 50 (70.4 percent) were judged to be due to a preventable ADE. The average cost to the institution was approximately $1,444 for each preventable medication-related visit.

Costs of Medication Errors in Nursing Homes

A study of medication problems in one nursing home provided information on the costs of ADEs in the nursing home setting (Cooper, 1987). That study reported two cases of antibiotic-related errors (omission and known drug allergy) that resulted in hospitalizations costing $3,923 and more than $5,000, respectively. It was further reported (GAO, 2000) that preventable errors in that nursing home cost up to $340,942 over a 2-year period.

Costs of Medication Errors in Ambulatory Care

Only one study was found that addressed the cost of ADEs in ambulatory care. In a study carried out from July 1999 to June 2000, the estimated increased costs (relative to costs incurred in a matched comparison group) associated with ADEs and preventable ADEs among older adults in the ambulatory care setting were $1,310 and $1,983, respectively. Inpatient stays accounted for 71 percent of the additional costs for ADEs and 62 percent of the additional cost for preventable ADEs. Based on the study’s cost estimates and rates of ADEs, the annual costs related to ADEs and preventable ADEs in 1,000 older adults would be $65,631 and $27,365, respectively (Field et al., 2005).

Overall Costs of Preventable Medication Errors

In summary, our understanding of the cost of medication errors is very incomplete. Most of what we know relates to additional health care costs associated with preventable ADEs, which represent the injuries caused by errors:

  • Hospitals—Classen and colleagues (1997) projected 380,000 preventable ADEs occurring annually and Bates and colleagues (1995b)

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
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450,000; these are likely underestimates given the higher rates of another study (Jha et al., 1998). There is one estimate of the extra costs of inpatient care for a preventable ADE—$5,857 (Bates et al., 1997); this figure excludes health care costs outside the hospital and is derived from 1993 cost data. Assuming conservatively an annual incidence of 400,000 preventable ADEs, each incurring extra hospital costs of $5,857, gives a total cost of $2.3 billion (1993 dollars) or $3.5 billion8 (2006 dollars).

  • Long-term care—Gurwitz and colleagues (2005) projected an annual incidence of 800,000 preventable ADEs—again likely an underestimate given the higher ADE rates of earlier studies (Gerety et al., 1993; Cooper, 1999). However, there is no estimate of the health care costs for this group of preventable ADEs.

  • Ambulatory care—The best estimate derives from a study (Field et al., 2005) of the costs of ADEs in older adults, which estimated the annual cost of preventable ADEs for all Medicare enrollees aged 65 and older. The cost per preventable ADE was $1,983, and the national annual costs were estimated to be $887 million in 2000. These figures include the costs of inpatient stays (62 percent of the total cost), emergency department visits (6 percent), outpatient care and physician fees (28 percent), and prescribed medicines (4 percent). The national estimate is almost certainly conservative because the detection approach used did not include direct patient contact, which identifies many more ADEs than other approaches.

In addition to the likelihood of being underestimates, the above estimates have some important omissions. First, the costs of some highly common medication errors, such as drug use without a medically valid indication and failure to receive drugs that should have been prescribed, were excluded from the Medicare study of ambulatory ADEs (Field et al., 2005). Moreover, the costs of morbidity and mortality arising from the lack of adherence to the drug regimen were not assessed. Second, all the cost studies omitted other important costs—lost earnings, the costs of not being able to carry out household duties (lost household production), and compensation for pain and suffering. Third, few data are available for any setting regarding the costs of medication errors that do not result in harm. While no injury is involved, these errors often create extra work, and the costs involved may be substantial. For example, one estimate suggested that a 700-bed hospital has 300,000 medication errors per year, each of which creates approximately 20 minutes of extra work for providers—mainly nurses and pharmacists (Bates et al., 1995a). Near-misses may also cost

8

The producer price index for general medical and surgical hospitals increased by 49.4 percent between 1993 and 2006 (BLS, 2006).

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
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more than medication errors with little potential for harm, although this possibility has not been assessed formally.

Limited Understanding of the Costs of Medication Errors

Very few studies have examined the costs of medication errors in individual care settings; rather, studies have focused mainly on the additional hospital costs of ADEs. One study (Bates et al., 1997) used cost data that are now more than 10 years old. There has been one study of the health care costs of treating preventable ADEs occurring in ambulatory care.

There are large gaps in our understanding of the costs of medication errors. No studies have been conducted on (1) the costs of medication errors in pediatric and psychiatric care, (2) the costs associated with errors involving OTC and complementary and alternative medications, (3) the costs of medication errors not considered ADEs, (4) the costs of the failure to receive drugs that should have been prescribed, (5) the costs of over-utilization of drugs (for example, antibiotics), and (6) the costs associated with nonadherence to prescribed drugs in the ambulatory setting. Finally, we have limited understanding of the economic and social costs of medication errors borne by patients and their families.

CONCLUSION

On the basis of the information currently available about the various types of medication errors, the committee acknowledges that it is impossible to formulate a fully comprehensive set of corrective medication error strategies. For example, there is a need to better define the impact on the incidence of errors in the medication-use stage of system problems in the research and development, regulatory review, and distribution/marketing stages (for example, inadequate information about dosages for special populations, look-alike/sound-alike drug names). In addition, the impact of underutilization of medications for the treatment of acute coronary syndromes, for antibiotic prophylaxis, and for thrombosis prophylaxis is not well understood. The area best understood is the incidence of preventable ADEs in various care settings—especially in the hospital, but also in nursing homes and in ambulatory care for adults—where significant problems and their causes have been identified. More research is needed to evaluate the impact of upstream problems on the incidence of errors in the use of medications, as well as the impact of the underutilization of medications.

Suggested Citation:"3 Medication Errors: Incidence and Cost ." Institute of Medicine. 2007. Preventing Medication Errors. Washington, DC: The National Academies Press. doi: 10.17226/11623.
×

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Next: Part II Moving Toward a Patient-Centered, Integrated Medication-Use System »
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In 1996 the Institute of Medicine launched the Quality Chasm Series, a series of reports focused on assessing and improving the nation’s quality of health care. Preventing Medication Errors is the newest volume in the series. Responding to the key messages in earlier volumes of the series—To Err Is Human (2000), Crossing the Quality Chasm (2001), and Patient Safety (2004)—this book sets forth an agenda for improving the safety of medication use. It begins by providing an overview of the system for drug development, regulation, distribution, and use. Preventing Medication Errors also examines the peer-reviewed literature on the incidence and the cost of medication errors and the effectiveness of error prevention strategies. Presenting data that will foster the reduction of medication errors, the book provides action agendas detailing the measures needed to improve the safety of medication use in both the short- and long-term. Patients, primary health care providers, health care organizations, purchasers of group health care, legislators, and those affiliated with providing medications and medication- related products and services will benefit from this guide to reducing medication errors.

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