From
Medscape PharmacistsMedication Errors: An Exposé of the Problem
Laurie L. Briceland, PharmD, FASHP, FCCP
[Medscape Pharmacists, 2000. © 2000 Medscape, Inc.]
The November 29, 1999, report issued by the Institute of Medicine (IOM), "To Err Is Human: Building a Safer Health System," has provided healthcare workers, policy makers, and the public with a comprehensive exposé of the pervasive and seemingly relentless problem of medication errors.[1] The salient features of the report, including data describing the vastness of the problem (Table 1), and numerous proposals for improvements in the medication use system (Table 2) are not likely to be a revelation to members of the healthcare industry. However, the IOM report did attract the attention of the media, the general public, and policy makers alike, and in so doing did satisfy one of its primary goals for publication: to expose and put into perspective the immensity of the problem of medication errors, a problem that had been largely unrecognized in the consumer world. Further intent of the report was to emphasize that inaction or "silence" toward finding solutions to this serious problem of medication errors will no longer be tolerable, and expert, expedient attention is required.
For the most part, patients or consumers have believed that when they enter the healthcare system, they are safe and protected from harm. The IOM report serves as a reminder that while not every medication error will result in harm to the patient, many will, and clearly enough data exist to suggest a serious concern for patient safety.
Analyses of the scope and extent of the consequences associated with medication errors are not new. In fact, some data that comprise the IOM report were extracted from studies conducted in 1984 and published in 1991.[2,3] Henri Manasse, Executive Vice President of the American Society for Health-System Pharmacists, forecast over a decade ago that drug-related morbidity and mortality, or "drug misadventuring," represented a serious medical problem and deserved consideration as an issue of public policy.[4,5] In addition, in an often cited probability pathway "cost-of-illness" model studied in an ambulatory care setting, Johnson and Bootman[6] further analyzed the scope of the medication-related problem. They report that the number of drug-related hospital admissions ranges from 3.5 million to 8.8 million annually, which corresponds to a hospitalization rate of 11.3% to 28.2%. According to this cost-of-illness model, the annual
national cost of drug-related morbidity and mortality is estimated to be $76.6 billion, of which $47 billion is due to hospitalizations associated with drug prescriptions or the lack thereof. To put these results in perspective, the cost of diabetes care is estimated to be $45.2 billion annually, while the costs for treatment of cardiovascular diseases range from $117 to $154 billion annually. Of interest, these same investigators subsequently assessed the impact to their cost-of-illness model of the introduction of pharmaceutical care,
which they defined as enhanced pharmacy services that are patient oriented and, in the opinion of their panel members inherent in the model, constitute pharmaceutical care.[7] With pharmaceutical care, they estimated a resultant number of reductions in negative therapeutic outcomes (eg, for treatment failures or new medical problems). In sum, more than 84% of patients were estimated to achieve an optimal outcome, as opposed to less than 60% of optimal outcomes attainable without pharmaceutical care services. This service could avoid $45.6 billion in direct healthcare costs, largely due to a reduction in hospital admissions.Further, Leape and colleagues,[3] in a study that constituted part of the IOM report, noted that 3.7% of hospitalized patients experienced clinically important adverse events, of which 20% are adverse drug events (ADEs), defined as injury resulting from medical intervention related to a drug. Subsequent studies by Bates and colleagues[8,9] discovered similar ADE rates and, on assessment, deemed that 28% of ADEs were preventable. This preventable subset of ADEs is of obvious importance when targeting corrective interventions. Bates and colleagues also determined for preventable ADEs the various stages of the medication use process during which the error occurred, as follows: ordering stage (56%), administration (34%), transcription (6%), and dispensing error (4%). These data further enhance our knowledge of the medication use system and might suggest that initial efforts be aimed at reducing medication prescribing errors.
A study by Classen and colleagues[10] was conducted with the purpose of evaluating attributable costs, mortality, and length of hospitalization due to ADEs. The study design was a matched case-control study at a 520-bed hospital, conducted during a 4-year period. The study hospital boasts sophisticated computerization that enables automated ADE detection based on predetermined "triggers" (use of antidotes, drug discontinuations, abnormal laboratory values, and so forth). The ADEs were voluntarily reported and assessed using standardized severity and causality assessment rating scales. There were 1580 case patients (those with ADEs) and more than 20,000 control patients (those without ADEs). The baseline ADE rate was 2.43 per 100 admissions. Causal drugs included an array of medications: morphine, digoxin, meperidine, oxycodone, imipenem, cefazolin, warfarin, and vancomycin. The types of ADEs observed and assessed are shown in Table 3, along with the attributable costs, and length of stay (LOS) in days, per patient, attributable to the ADE. This quantitative estimation of the costs associated with various ADEs provides useful information for a variety of applications, including incorporation in continuous quality improvement/risk reduction initiatives, formulary decision making, and individual patient care drug selection. The data collected by Classen and colleagues also demonstrated that case patients with ADEs had a statistically significant increase in LOS (7.69 days vs 4.46 days for controls), increased mortality (3.5% vs 1.05%), and increased cost of hospitalization ($10,010 vs $5,355, P < .001). These authors calculated that the costs attributed to 1 ADE exceed $2000.
A similar case-control study by Bates and coworkers,[11] which also assessed the LOS and costs associated with ADEs in hospitalized patients, reported during a 6-month study period that there were 190 ADEs (60 preventable) in the study hospital; based on hospital admissions, their ADE rate was approximately 2 per 100 admissions. Similarly, the LOS for any ADE and for preventable ADEs significantly exceeded the LOS for patients without ADEs (P < .04). The total costs for cases exceeded controls by more than $5000.
Annualized costs of preventable ADEs in this 700-bed study hospital were estimated at $2.8 million; extrapolation of this data nationally (based on hospitalization rates) would exceed $2 billion. This number is not inclusive of patients in other settings, such as ambulatory care, home care, and long-term care, where ADEs are every bit as prevalent as in hospitalized patients.Indeed, these extrapolated estimates are likely reflective of just the "tip of the iceberg" with respect to the actual scope or extent of ADEs. An exact or accurate monetary measure of the impact of medication misadventuring is not essential. What is essential is that the magnitude of this issue of medication errors is at last recognized, and that appropriate measures be positioned and operationalized expediently to meet the goal recommended in the IOM report and endorsed by President Clinton on February 23, 2000: that medication errors be reduced by 50% during the next 5 years. Future articles in this column will address proposed initiatives for medication error reduction.
Laurie L. Briceland, PharmD, FASHP, FCCP, is Professor of Pharmacy Practice, Albany College of
Pharmacy, Albany, New York.
References
1. Kohn LT, Corrigan JM, Donaldson MS, eds. Institute of Medicine Report: To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press; November 29, 1999. Available at http://bob.nap.edu/html/to_err_is_human/.
Accessed May 2, 2000.2. Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med. 1991;324:370-376.
3. Leape LL, Brennan TA, Laird N, et al. The nature of adverse events in hospitalized patients: results of the Harvard Medical Practice Study II. N Engl J Med. 1991;324:377-384.
4. Manasse HR Jr. Medication use in an imperfect world, I: drug misadventuring as an issue of public policy. Am J Hosp Pharm. 1989;46:1093-1097.
5. Manasse HR Jr. Medication use in an imperfect world, II: drug misadventuring as an issue of public policy. Am J Hosp Pharm. 1989;46:1141-11152.
6. Johnson JA, Bootman JL. Drug-related morbidity and mortality: a cost-of-illness model. Arch Intern Med. 1995;155:1949-1956.
7. Johnson JA Bootman JL. Drug-related morbidity and mortality and the economic impact of pharmaceutical care. Am J Health Syst Pharm. 1997;54:554-558.
8. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events: implications for preventions. JAMA. 1995;274:29-34.
9. Bates DW, Leape LL, Petrycki S. Incidence and preventability of adverse drug events in hospitalized adults. J Gen Intern Med. 1993;8:289-294.
10. Classen DC, Pestotnik SL, Evans RS, et al. Adverse drug events in hospitalized patients: excess length of stay, extra costs, and attributable mortality. JAMA. 1997;277:301-308.
11. Bates DW, Spell N, Cullen DJ, et al. The costs of adverse drug events in hospitalized patients. JAMA. 1997;277:307-311.
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