Clinical Pharmacy Services and Patient Safety in US Hospitals
Adverse drug reactions (ADRs) were examined in 1,960,059 hospitalized Medicare patients in 584 United States hospitals in 1998. A database was constructed from the MedPAR database and the National Clinical Pharmacy Services survey. The 584 hospitals were selected because they provided specific information on 14 clinical pharmacy services and on pharmacy staffing; they also had functional ADR reporting systems. The study population consisted of 35,193 Medicare patients who experienced an ADR (rate of 1.8%). Of the 14 clinical pharmacy services, 12 were associated with reduced ADR rates. The most significant reductions occurred in hospitals offering pharmacist-provided admission drug histories (odds ratio [OR] 1.864, 95% confidence interval [CI] 1.765-1.968), drug protocol management (OR 1.365, 95% CI 1.335-1.395), and ADR management (OR 1.360, 95% CI 1.328-1.392). Multivariate analysis, performed to further evaluate these findings, showed that nine variables were associated with ADR rate: pharmacist-provided in-service education (slope -0.469, p=0.018), drug information (slope -0.488, p=0.005), ADR management (slope -0.424, p=0.021), drug protocol management (slope -0.732, p=0.002), participation on the total parenteral nutrition team (slope 0.384, p=0.04), participation on the cardiopulmonary resuscitation team (slope -0.506, p=0.008), medical round participation (slope -0.422, p=0.037), admission drug histories (slope -0.712, p=0.008), and increased clinical pharmacist staffing (slope -4.345, p=0.009). As clinical pharmacist staffing increased from the 20th to the 100th percentile (from 0.93 ± 0.77/100 to 5.16 ± 4.11/100 occupied beds), ADRs decreased by 47.88%. In hospitals without pharmacist-provided ADR management, the following increases were noted: mean number of ADRs/100 admissions by 34.90% (OR 1.360, 95% CI 1.328-1.392), length of stay 13.64% (Mann-Whitney U test [U]=11047367, p=0.017), death rate 53.64% (OR 1.574, 95% CI 1.423-1.731), total Medicare charges 6.88% (U=111298871, p=0.018), and drug charges 8.16% (U=108979074, p<0.001). Patients in hospitals without pharmacist-provided ADR management had an excess of 4266 ADRs, 443 deaths, 85,554 patient-days, $11,745,342 in total Medicare charges, and $1,857,744 in drug charges. The implications of these findings are significant for our health care system, especially considering that the study population represented 15.55% of 12,261,737 Medicare patients and 5.71% of the 34,345,436 patients admitted to all U.S. hospitals.
Numerous studies document the benefits of pharmacists, pharmacy staffing, and clinical pharmacy services, but no studies specify which clinical pharmacy services can reduce adverse drug reactions (ADRs) in a large number of hospitals or in a large population of patients. Studies involving large patient populations are critical because they are not subject to bias of patient populations, physical facilities, structure, and process that may confound studies conducted at single sites. Studies with large patient populations also significantly reduce the observer's bias, which occurs when investigators evaluate the impact of pharmacists on patient care outcomes at individual sites (the pharmacists know they are being evaluated and thus are more diligent). Large-population studies also provide objective data that are most likely to influence physicians, hospital administrators, health care policy experts, and government officials. These studies are more effective in objectively supporting provider status for pharmacists, and are more useful in helping the profession gain reimbursement for clinical services.
Even though few studies evaluate pharmacist interventions in reducing ADRs, some excellent studies document the value of pharmacists in reducing adverse drug events (ADEs). Adverse drug events more inclusively define virtually everything that can go wrong with drugs, such as errors in prescribing, dosage, administration, and dosage form; negligence; and ADRs. One study found that when pharmacists were included on a pediatric rounds team, they prevented 94% of ADEs. Another study found that 66% of ADEs could be prevented when pharmacists were included on rounding teams in a medical intensive care unit. Similar results were observed in other studies documenting the value of pharmacists in reducing ADEs. In the last 10-15 years, most studies evaluating patient safety used ADEs, of which ADRs are one component. Since the withdrawal of rofecoxib and valdecoxib due to increased risk of cardiovascular events, health care professionals and the public have focused on the adverse effects of drugs. As such, our focus was to evaluate the impact of clinical pharmacy services and staffing on the frequency of ADRs and associated clinical and economic outcomes.
Adverse drug reactions (ADRs) were examined in 1,960,059 hospitalized Medicare patients in 584 United States hospitals in 1998. A database was constructed from the MedPAR database and the National Clinical Pharmacy Services survey. The 584 hospitals were selected because they provided specific information on 14 clinical pharmacy services and on pharmacy staffing; they also had functional ADR reporting systems. The study population consisted of 35,193 Medicare patients who experienced an ADR (rate of 1.8%). Of the 14 clinical pharmacy services, 12 were associated with reduced ADR rates. The most significant reductions occurred in hospitals offering pharmacist-provided admission drug histories (odds ratio [OR] 1.864, 95% confidence interval [CI] 1.765-1.968), drug protocol management (OR 1.365, 95% CI 1.335-1.395), and ADR management (OR 1.360, 95% CI 1.328-1.392). Multivariate analysis, performed to further evaluate these findings, showed that nine variables were associated with ADR rate: pharmacist-provided in-service education (slope -0.469, p=0.018), drug information (slope -0.488, p=0.005), ADR management (slope -0.424, p=0.021), drug protocol management (slope -0.732, p=0.002), participation on the total parenteral nutrition team (slope 0.384, p=0.04), participation on the cardiopulmonary resuscitation team (slope -0.506, p=0.008), medical round participation (slope -0.422, p=0.037), admission drug histories (slope -0.712, p=0.008), and increased clinical pharmacist staffing (slope -4.345, p=0.009). As clinical pharmacist staffing increased from the 20th to the 100th percentile (from 0.93 ± 0.77/100 to 5.16 ± 4.11/100 occupied beds), ADRs decreased by 47.88%. In hospitals without pharmacist-provided ADR management, the following increases were noted: mean number of ADRs/100 admissions by 34.90% (OR 1.360, 95% CI 1.328-1.392), length of stay 13.64% (Mann-Whitney U test [U]=11047367, p=0.017), death rate 53.64% (OR 1.574, 95% CI 1.423-1.731), total Medicare charges 6.88% (U=111298871, p=0.018), and drug charges 8.16% (U=108979074, p<0.001). Patients in hospitals without pharmacist-provided ADR management had an excess of 4266 ADRs, 443 deaths, 85,554 patient-days, $11,745,342 in total Medicare charges, and $1,857,744 in drug charges. The implications of these findings are significant for our health care system, especially considering that the study population represented 15.55% of 12,261,737 Medicare patients and 5.71% of the 34,345,436 patients admitted to all U.S. hospitals.
Numerous studies document the benefits of pharmacists, pharmacy staffing, and clinical pharmacy services, but no studies specify which clinical pharmacy services can reduce adverse drug reactions (ADRs) in a large number of hospitals or in a large population of patients. Studies involving large patient populations are critical because they are not subject to bias of patient populations, physical facilities, structure, and process that may confound studies conducted at single sites. Studies with large patient populations also significantly reduce the observer's bias, which occurs when investigators evaluate the impact of pharmacists on patient care outcomes at individual sites (the pharmacists know they are being evaluated and thus are more diligent). Large-population studies also provide objective data that are most likely to influence physicians, hospital administrators, health care policy experts, and government officials. These studies are more effective in objectively supporting provider status for pharmacists, and are more useful in helping the profession gain reimbursement for clinical services.
Even though few studies evaluate pharmacist interventions in reducing ADRs, some excellent studies document the value of pharmacists in reducing adverse drug events (ADEs). Adverse drug events more inclusively define virtually everything that can go wrong with drugs, such as errors in prescribing, dosage, administration, and dosage form; negligence; and ADRs. One study found that when pharmacists were included on a pediatric rounds team, they prevented 94% of ADEs. Another study found that 66% of ADEs could be prevented when pharmacists were included on rounding teams in a medical intensive care unit. Similar results were observed in other studies documenting the value of pharmacists in reducing ADEs. In the last 10-15 years, most studies evaluating patient safety used ADEs, of which ADRs are one component. Since the withdrawal of rofecoxib and valdecoxib due to increased risk of cardiovascular events, health care professionals and the public have focused on the adverse effects of drugs. As such, our focus was to evaluate the impact of clinical pharmacy services and staffing on the frequency of ADRs and associated clinical and economic outcomes.
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