In This Edition

Literature at a Glance

A guide to this month’s studies

• Continuous insulin infusion in non-ICU patients
• How hospitalists spend their day
• Outcomes of patients leaving against medical advice
• Prediction rule for readmission
• Effects of high- vs. low-dose PPIs for peptic ulcer
• Hospital utilization by generalists before hospitalists
• Effect of hospitalist fragmentation on length of stay
• Medication errors at admissions in older patients

Continuous Insulin Infusion Provides Effective Glycemic Control in Non-ICU Patients

Clinical question: Is continuous insulin infusion (CII) a safe and effective option in the management of hyperglycemia in non-ICU patients?

Background: Hyperglycemia has been associated with worse outcomes in hospitalized patients. Prior research has demonstrated the benefit of CII in managing hyperglycemia in the ICU setting. However, outcomes have not been evaluated in the general medical (non-ICU) setting, where hyperglycemia is often inadequately addressed.

Study design: Retrospective chart review.

Setting: Urban tertiary-care medical center.

Synopsis: Charts of 200 adult patients treated with CII in non-ICU areas were reviewed with the primary outcomes including mean daily blood glucose (BG) levels and number of hyper- and hypoglycemic events occurring on CII. Mean BG dropped from 323 mg/dL to 182 mg/dL by day one, with a BG≤of 150 achieved in 67% of patients by day two of therapy. Twenty-two percent of patients suffered a hypoglycemic event (BG<60), reportedly similar to prior studies of insulin use in ICU and non-ICU settings. Eighty-two percent of patients received some form of nutritional support while on CII. In multivariate analyses, receiving oral nutrition (either a solid or liquid diet) was the only factor associated with increased risk of hyperglycemia and hypoglycemia.

This study was limited by its retrospective analysis in a single center. No comparison was made with basal-bolus or sliding-scale insulin therapy regarding efficacy or safety.

Bottom line: Non-ICU patients with hyperglycemia who received CII were able to achieve effective glycemic control within 48 hours of initiation, with rates of hypoglycemia comparable to those observed in ICU settings.

Citation: Smiley D, Rhee M, Peng L, et al. Safety and efficacy of continuous insulin infusion in noncritical care settings. J Hosp Med. 2010;5(4):212-217.

Hospitalists Spend More Time on Indirect, Rather Than Direct, Patient Care

Clinical question: What are the components of the daily workflow of hospitalists working on a non-housestaff service?

Background: The use of hospitalists is associated with increased efficiency in the hospital setting. However, it is not known how this efficiency is achieved. Prior literature has attempted to address this question, but with increasing demands and patient census, the representativeness of existing data is unclear.

Study design: Observational time-motion study.

Setting: Urban tertiary-care academic medical center.

Synopsis: Twenty-four hospitalists were directly observed for two weekday shifts. An electronic collection tool was developed using initial data on hospitalist activities and piloted prior to formal study data collection. Direct patient care was defined as involving face-to-face interaction between hospitalist and patient, while indirect patient care involved activities relevant to patient care but not performed in the patient’s presence.

Approximately 500 hours of observation were collected. Direct patient care comprised only a mean of 17.4% of the hospitalists’ daily workflow, while more was spent on indirect care, mainly electronic health record (EHR) documentation (mean 34.1%) and communication activities (mean 25.9%). Multitasking occurred 16% of the time, typically during communication or “critical documentation activities” (e.g. writing prescriptions). As patient volume increased, less time was spent in communication, and documentation was deferred to after hours.

These results were consistent with prior observational studies but were limited to a single center and might not represent the workflow of hospitalists in other settings, such as community hospitals, or nocturnists.

Bottom line: Hospitalists on non-housestaff services spend most of their time on indirect patient care and, with increasing patient census, communication is sacrificed. Multitasking is common during periods of communication and critical documentation.

Citation: Tipping MD, Forth VE, O’Leary KJ, et al. Where did the day go?—a time-motion study of hospitalists. J Hosp Med. 2010;5(6):323-328.

Patients Who Leave Against Medical Advice Have Higher Readmission, Mortality Rates

Clinical question: What are the 30-day hospital readmission and mortality rates for Veterans Administration (VA) patients discharged against medical advice (AMA) compared with those appropriately discharged from the hospital?

Background: Patients discharged AMA might be at increased risk of experiencing worse outcomes. Small studies have demonstrated that patients with asthma and acute myocardial infarction (MI) discharged AMA have increased risk of readmission and death. However, it is unclear whether these risks are generalizable to a wider medical population.

Study design: Five-year retrospective cohort study.

Setting: One hundred twenty-nine VA acute-care hospitals.

Synopsis: Of the nearly 2 million patients admitted to the VA from 2004 to 2008, 1.7% were discharged AMA. Patients discharged AMA generally were younger, had lower incomes, and were more likely to be black. Furthermore, patients discharged AMA had statistically significant higher rates of 30-day readmission (17.7% vs. 11%, P<0.001) and higher 30-day mortality rates (0.75% vs. 0.61%, P=0.001) compared with those who had been appropriately discharged. In hazard models, discharge AMA was a significant predictor of 30-day readmission and conferred a nonstatistically significant increase in 30-day mortality.

Because all patients were seen in VA facilities, the results might not be generalizable to other acute-care settings. Although VA patients differ from the general medical population, the characteristics of patients discharged AMA are similar to those in previously published studies. The study utilized administrative data, which are very reliable but limited by little information on clinical factors that could contribute to AMA discharges.

Bottom line: Patients discharged AMA are at increased risk of worse post-hospitalization outcomes, including hospital readmission and death.

Citation: Glasgow JM, Vaughn-Sarrazin M, Kaboli PJ. Leaving against medical advice (AMA): risk of 30-day mortality and hospital readmission. J Gen Intern Med. 2010;25(9): 926-929.

Simple Model Predicts Hospital Readmission

Clinical question: Which patient-level factors can be used in a simple model to predict hospital readmission of medicine patients?

Background: Hospital readmissions are common and costly. Previously published readmission prediction models have had limited utility because they focused on a specific condition, setting, or population, or were too cumbersome for practical use.

Study design: Prospective observational cohort study.

Setting: Six academic medical centers.

Synopsis: Data from nearly 11,000 general medicine patients were included in the analysis. Overall, almost 18% of patients were readmitted within 30 days of discharge.

In the prediction model derived and validated from the data, seven factors were significant predictors of readmission within 30 days of discharge: insurance status, marital status, having a regular healthcare provider, Charlson comorbidity index, SF 12 physical component score, one or more admissions within the last year, and current length of stay greater than two days. Points assigned from each significant predictor were used to create a risk score. The 5% of patients with risk scores of 25 and higher had 30-day readmission rates of approximately 30%, compared to readmission rates of approximately 16% in patients with scores of less than 25.

These results might not be generalizable to small, rural, nonacademic settings. Planned admissions could not be excluded from the data, and readmissions to nonstudy hospitals could not be ascertained. Despite these limitations, this model is easier to use than prior models and relevant to a broad population of patients.

Bottom line: A simple prediction model using patient-level factors can be used to identify patients at higher risk of readmission within 30 days of discharge to home.

Citation: Hasan O, Meltzer DO, Shaykevich SA, et al. Hospital readmission in general medicine patients: a prediction model. J Gen Intern Med. 2010;25(3):211-219.

No Difference in Outcomes Between High- and Non-High-Dose Proton Pump Inhibitors in Bleeding Peptic Ulcers

Clinical question: Do high-dose proton pump inhibitors (PPIs) decrease the rate of rebleeding, surgical intervention, or mortality in patients with bleeding peptic ulcers who have undergone endoscopic treatment?

Background: Previous studies have demonstrated superiority of both high- and low-dose PPIs to H2 receptor antagonists and placebo in reducing rebleeding rates in patients with peptic ulcers. However, no clear evidence is available to suggest that high-dose PPIs are more effective than non-high-dose PPIs for treatment of bleeding peptic ulcers.

Study design: Systematic review and meta-analysis.

Setting: Multicenter and single-site studies conducted in several countries.

Synopsis: Studies were included if they were randomized controlled trials, compared high- versus non-high-dose PPIs, evaluated endoscopically confirmed bleeding ulcers, gave PPIs after endoscopy, and documented outcomes regarding rates of rebleeding, surgical intervention, or mortality. High-dose PPIs were defined as equivalent to omeprazole 80 mg intravenous bolus followed by continuous intravenous infusion at 8 mg/hr for 72 hours.

Seven studies met inclusion criteria. The pooled odds ratios for rebleeding, surgical intervention, and mortality were 1.30 (95% CI, 0.88-1.91), 1.49 (95% CI, 0.66-3.37), and 0.89 (95% CI, 0.37-2.13), respectively, for high-dose versus non-high-dose PPIs. The authors concluded that high-dose PPIs were not superior to non-high-dose PPIs in reducing the rates of these adverse outcomes after endoscopic treatment of bleeding ulcers. Considering the cost of high-dose PPIs, further studies are indicated to help guide PPI dosing for patients with peptic ulcers.

Major limitations of this study were the small number of studies (1,157 patients in total) and their heterogeneity, and the lack of intention-to-treat analysis. The studies also included a high Asian predominance, and it has been shown that Asian populations have an enhanced PPI effect.

Bottom line: High-dose PPIs did not demonstrate reduced rates of ulcer rebleeding, surgical intervention, or mortality compared with non-high-dose PPIs in this meta-analysis, which included a small number of studies and patients.

Citation: Wang CH, Ma MH, Chou HC, et al. High-dose vs. non-high-dose proton pump inhibitors after endoscopic treatment in patients with bleeding peptic ulcer: a systematic review and meta-analysis of randomized controlled trials. Arch Intern Med. 2010;170(9):751-758.

Hospital Utilization by Practicing Generalists Declined before the Emergence of Hospitalists

Clinical question: What has been the pattern of hospital utilization by generalists before and after the emergence of hospitalists?

Background: It has been proposed that the emergence of hospitalists has “crowded out” generalist physicians from the U.S. hospital setting. This study evaluated the trends of inpatient practice by generalists both before and after the emergence of hospitalists.

Study design: Retrospective analysis of national databases.

Setting: U.S. data from 1980 to 2005.

Synopsis: Utilizing the National Hospital Discharge Survey and the American Medical Association’s Physician Characteristics and Distribution in the U.S., information was extracted to evaluate the average number of annual inpatient encounters relative to generalist workforce from 1980 to 2005. Total inpatient encounters for each year were calculated by multiplying the total number of hospital admissions by the average hospital length of stay. The emergence of hospitalists was defined as beginning in 1994.

Total inpatient encounters by generalists declined by 35% in the pre-hospitalist era but remained essentially unchanged in the hospitalist era. During the pre-hospitalist period, the number of generalists doubled, to more than 200,000 from approximately 100,000, while the number of hospital discharges remained relatively stable and the length of stay declined by a third. The decrease in average inpatient encounters in the pre-hospitalist era is thought to have been secondary to decreased length of stay and increased workforce.

Bottom line: Hospital utilization relative to generalist physician workforce was decreasing prior to the emergence of hospitalists mainly due to decreased length of hospital stay and increased numbers of physicians.

Citation: Meltzer DO, Chung JW. U.S. trends in hospitalization and generalist physician workforce and the emergence of hospitalists. J Gen Intern Med. 2010;25(5):453-459.

Fragmentation of Hospitalist Care Is Associated with Increased Length of Stay

Clinical question: Does fragmentation of care (FOC) by hospitalists affect length of stay (LOS)?

Background: Previous investigations have explored the impact of FOC provided by residency programs on LOS and quality of care. Results of these studies have been mixed. However, there have been no prior studies on the impact of the fragmentation of hospitalist care on LOS.

Study design: Concurrent control study.

Setting: Hospitalist practices all over the country managed by IPC: The Hospitalist Company.

Synopsis: Investigators looked at 10,977 patients admitted with diagnoses of pneumonia or heart failure. The primary endpoint was LOS. The independent variable of interest was a measure of FOC. The FOC was calculated as a quantitative index, by determining the percentage of hospitalist care delivered by a physician other than the primary hospitalist.

Multivariable analyses revealed a statistically significant increase in LOS of 0.39 days for each 10% increase in fragmentation level for pneumonia admissions. Similarly, for patients with heart failure, there was a significant increase in LOS of 0.30 days for each 10% increase in fragmentation level.

The study is a concurrent control study, so conclusions cannot be drawn about causality. Additionally, there are likely unmeasured differences between every hospital and hospitalist practice, which could further confound the relationships between hospitalist care and LOS.

Bottom line: Fragmentation of care provided by hospitalists is associated with an increased LOS in patients hospitalized for pneumonia or heart failure.

Citation: Epstein K, Juarez E, Epstein A, Loya K, Singer A. The impact of fragmentation of hospitalist care on length of stay. J Hosp Med. 2010;5(6):335-338.

Admission Medication Errors Are Common and Most Harmful in Older Patients Taking Many Medications

Clinical question: What are the risk factors and potential harm associated with medication errors at hospital admission?

Background: Obtaining a medication history from a hospitalized patient is an error-prone process. Several variables can affect the completeness and quality of medication histories, but existing data are limited regarding patient or medication risk factors associated with medication errors at admission.

Study design: Prospective cohort study.

Setting: Academic hospital in Chicago.

Synopsis: Pharmacist and admitting physician medication histories were compared with admission medication orders to identify any unexplained discrepancies. Discrepancies resulting in order changes were defined as medication errors.

Of the 651 adult medical inpatients studied, 234 (35.9%) had medication order errors identified at admission. Errors originated in the medication histories for 85% of these patients. The most frequent type of error was an omission (48.9%). An age of 65 or older (odds ratio [OR]=2.17, 95% confidence interval [CI], 1.09-4.30) and increased number of medications (OR=1.21, 95% CI, 1.14-1.29) were the only risk factors identified by multivariate analysis to be independently associated with increased risk of medication order errors potentially causing harm or requiring monitoring or intervention. Presenting a medication list upon admission was a significant protective factor (OR=0.35, 95% CI, 0.19-0.63).

Though this is the largest study to date evaluating admission medication errors in hospitalized medical patients, it remains limited by its single hospital site. Because the authors were unable to interview patients who were too ill or unwilling to participate and had no caregiver present, they might have underestimated the number of admission errors. Further, the harm assessment was based on potential and not actual harm.

Bottom line: Admission medication order errors are frequent, most commonly originate in the medication histories, and have increased potential to cause adverse outcomes in older patients and those taking higher numbers of medications.

Citation: Gleason KM, McDaniel MR, Feinglass J, et al. Results of the Medications At Transitions and Clinical Handoffs (MATCH) study: an analysis of medication reconciliation errors and risk factors at hospital admission. J Gen Intern Med. 2010;25(5):441-447.

In This Edition

Literature at a Glance

A guide to this month’s studies

• Continuous insulin infusion in non-ICU patients
• How hospitalists spend their day
• Outcomes of patients leaving against medical advice
• Prediction rule for readmission
• Effects of high- vs. low-dose PPIs for peptic ulcer
• Hospital utilization by generalists before hospitalists
• Effect of hospitalist fragmentation on length of stay
• Medication errors at admissions in older patients

Continuous Insulin Infusion Provides Effective Glycemic Control in Non-ICU Patients

Clinical question: Is continuous insulin infusion (CII) a safe and effective option in the management of hyperglycemia in non-ICU patients?

Background: Hyperglycemia has been associated with worse outcomes in hospitalized patients. Prior research has demonstrated the benefit of CII in managing hyperglycemia in the ICU setting. However, outcomes have not been evaluated in the general medical (non-ICU) setting, where hyperglycemia is often inadequately addressed.

Study design: Retrospective chart review.

Setting: Urban tertiary-care medical center.

Synopsis: Charts of 200 adult patients treated with CII in non-ICU areas were reviewed with the primary outcomes including mean daily blood glucose (BG) levels and number of hyper- and hypoglycemic events occurring on CII. Mean BG dropped from 323 mg/dL to 182 mg/dL by day one, with a BG≤of 150 achieved in 67% of patients by day two of therapy. Twenty-two percent of patients suffered a hypoglycemic event (BG<60), reportedly similar to prior studies of insulin use in ICU and non-ICU settings. Eighty-two percent of patients received some form of nutritional support while on CII. In multivariate analyses, receiving oral nutrition (either a solid or liquid diet) was the only factor associated with increased risk of hyperglycemia and hypoglycemia.

This study was limited by its retrospective analysis in a single center. No comparison was made with basal-bolus or sliding-scale insulin therapy regarding efficacy or safety.

Bottom line: Non-ICU patients with hyperglycemia who received CII were able to achieve effective glycemic control within 48 hours of initiation, with rates of hypoglycemia comparable to those observed in ICU settings.

Citation: Smiley D, Rhee M, Peng L, et al. Safety and efficacy of continuous insulin infusion in noncritical care settings. J Hosp Med. 2010;5(4):212-217.

Hospitalists Spend More Time on Indirect, Rather Than Direct, Patient Care

Clinical question: What are the components of the daily workflow of hospitalists working on a non-housestaff service?

Background: The use of hospitalists is associated with increased efficiency in the hospital setting. However, it is not known how this efficiency is achieved. Prior literature has attempted to address this question, but with increasing demands and patient census, the representativeness of existing data is unclear.

Study design: Observational time-motion study.

Setting: Urban tertiary-care academic medical center.

Synopsis: Twenty-four hospitalists were directly observed for two weekday shifts. An electronic collection tool was developed using initial data on hospitalist activities and piloted prior to formal study data collection. Direct patient care was defined as involving face-to-face interaction between hospitalist and patient, while indirect patient care involved activities relevant to patient care but not performed in the patient’s presence.

Approximately 500 hours of observation were collected. Direct patient care comprised only a mean of 17.4% of the hospitalists’ daily workflow, while more was spent on indirect care, mainly electronic health record (EHR) documentation (mean 34.1%) and communication activities (mean 25.9%). Multitasking occurred 16% of the time, typically during communication or “critical documentation activities” (e.g. writing prescriptions). As patient volume increased, less time was spent in communication, and documentation was deferred to after hours.

These results were consistent with prior observational studies but were limited to a single center and might not represent the workflow of hospitalists in other settings, such as community hospitals, or nocturnists.

Bottom line: Hospitalists on non-housestaff services spend most of their time on indirect patient care and, with increasing patient census, communication is sacrificed. Multitasking is common during periods of communication and critical documentation.

Citation: Tipping MD, Forth VE, O’Leary KJ, et al. Where did the day go?—a time-motion study of hospitalists. J Hosp Med. 2010;5(6):323-328.

Patients Who Leave Against Medical Advice Have Higher Readmission, Mortality Rates

Clinical question: What are the 30-day hospital readmission and mortality rates for Veterans Administration (VA) patients discharged against medical advice (AMA) compared with those appropriately discharged from the hospital?

Background: Patients discharged AMA might be at increased risk of experiencing worse outcomes. Small studies have demonstrated that patients with asthma and acute myocardial infarction (MI) discharged AMA have increased risk of readmission and death. However, it is unclear whether these risks are generalizable to a wider medical population.

Study design: Five-year retrospective cohort study.

Setting: One hundred twenty-nine VA acute-care hospitals.

Synopsis: Of the nearly 2 million patients admitted to the VA from 2004 to 2008, 1.7% were discharged AMA. Patients discharged AMA generally were younger, had lower incomes, and were more likely to be black. Furthermore, patients discharged AMA had statistically significant higher rates of 30-day readmission (17.7% vs. 11%, P<0.001) and higher 30-day mortality rates (0.75% vs. 0.61%, P=0.001) compared with those who had been appropriately discharged. In hazard models, discharge AMA was a significant predictor of 30-day readmission and conferred a nonstatistically significant increase in 30-day mortality.

Because all patients were seen in VA facilities, the results might not be generalizable to other acute-care settings. Although VA patients differ from the general medical population, the characteristics of patients discharged AMA are similar to those in previously published studies. The study utilized administrative data, which are very reliable but limited by little information on clinical factors that could contribute to AMA discharges.

Bottom line: Patients discharged AMA are at increased risk of worse post-hospitalization outcomes, including hospital readmission and death.

Citation: Glasgow JM, Vaughn-Sarrazin M, Kaboli PJ. Leaving against medical advice (AMA): risk of 30-day mortality and hospital readmission. J Gen Intern Med. 2010;25(9): 926-929.

Simple Model Predicts Hospital Readmission

Clinical question: Which patient-level factors can be used in a simple model to predict hospital readmission of medicine patients?

Background: Hospital readmissions are common and costly. Previously published readmission prediction models have had limited utility because they focused on a specific condition, setting, or population, or were too cumbersome for practical use.

Study design: Prospective observational cohort study.

Setting: Six academic medical centers.

Synopsis: Data from nearly 11,000 general medicine patients were included in the analysis. Overall, almost 18% of patients were readmitted within 30 days of discharge.

In the prediction model derived and validated from the data, seven factors were significant predictors of readmission within 30 days of discharge: insurance status, marital status, having a regular healthcare provider, Charlson comorbidity index, SF 12 physical component score, one or more admissions within the last year, and current length of stay greater than two days. Points assigned from each significant predictor were used to create a risk score. The 5% of patients with risk scores of 25 and higher had 30-day readmission rates of approximately 30%, compared to readmission rates of approximately 16% in patients with scores of less than 25.

These results might not be generalizable to small, rural, nonacademic settings. Planned admissions could not be excluded from the data, and readmissions to nonstudy hospitals could not be ascertained. Despite these limitations, this model is easier to use than prior models and relevant to a broad population of patients.

Bottom line: A simple prediction model using patient-level factors can be used to identify patients at higher risk of readmission within 30 days of discharge to home.

Citation: Hasan O, Meltzer DO, Shaykevich SA, et al. Hospital readmission in general medicine patients: a prediction model. J Gen Intern Med. 2010;25(3):211-219.

No Difference in Outcomes Between High- and Non-High-Dose Proton Pump Inhibitors in Bleeding Peptic Ulcers

Clinical question: Do high-dose proton pump inhibitors (PPIs) decrease the rate of rebleeding, surgical intervention, or mortality in patients with bleeding peptic ulcers who have undergone endoscopic treatment?

Background: Previous studies have demonstrated superiority of both high- and low-dose PPIs to H2 receptor antagonists and placebo in reducing rebleeding rates in patients with peptic ulcers. However, no clear evidence is available to suggest that high-dose PPIs are more effective than non-high-dose PPIs for treatment of bleeding peptic ulcers.

Study design: Systematic review and meta-analysis.

Setting: Multicenter and single-site studies conducted in several countries.

Synopsis: Studies were included if they were randomized controlled trials, compared high- versus non-high-dose PPIs, evaluated endoscopically confirmed bleeding ulcers, gave PPIs after endoscopy, and documented outcomes regarding rates of rebleeding, surgical intervention, or mortality. High-dose PPIs were defined as equivalent to omeprazole 80 mg intravenous bolus followed by continuous intravenous infusion at 8 mg/hr for 72 hours.

Seven studies met inclusion criteria. The pooled odds ratios for rebleeding, surgical intervention, and mortality were 1.30 (95% CI, 0.88-1.91), 1.49 (95% CI, 0.66-3.37), and 0.89 (95% CI, 0.37-2.13), respectively, for high-dose versus non-high-dose PPIs. The authors concluded that high-dose PPIs were not superior to non-high-dose PPIs in reducing the rates of these adverse outcomes after endoscopic treatment of bleeding ulcers. Considering the cost of high-dose PPIs, further studies are indicated to help guide PPI dosing for patients with peptic ulcers.

Major limitations of this study were the small number of studies (1,157 patients in total) and their heterogeneity, and the lack of intention-to-treat analysis. The studies also included a high Asian predominance, and it has been shown that Asian populations have an enhanced PPI effect.

Bottom line: High-dose PPIs did not demonstrate reduced rates of ulcer rebleeding, surgical intervention, or mortality compared with non-high-dose PPIs in this meta-analysis, which included a small number of studies and patients.

Citation: Wang CH, Ma MH, Chou HC, et al. High-dose vs. non-high-dose proton pump inhibitors after endoscopic treatment in patients with bleeding peptic ulcer: a systematic review and meta-analysis of randomized controlled trials. Arch Intern Med. 2010;170(9):751-758.

Hospital Utilization by Practicing Generalists Declined before the Emergence of Hospitalists

Clinical question: What has been the pattern of hospital utilization by generalists before and after the emergence of hospitalists?

Background: It has been proposed that the emergence of hospitalists has “crowded out” generalist physicians from the U.S. hospital setting. This study evaluated the trends of inpatient practice by generalists both before and after the emergence of hospitalists.

Study design: Retrospective analysis of national databases.

Setting: U.S. data from 1980 to 2005.

Synopsis: Utilizing the National Hospital Discharge Survey and the American Medical Association’s Physician Characteristics and Distribution in the U.S., information was extracted to evaluate the average number of annual inpatient encounters relative to generalist workforce from 1980 to 2005. Total inpatient encounters for each year were calculated by multiplying the total number of hospital admissions by the average hospital length of stay. The emergence of hospitalists was defined as beginning in 1994.

Total inpatient encounters by generalists declined by 35% in the pre-hospitalist era but remained essentially unchanged in the hospitalist era. During the pre-hospitalist period, the number of generalists doubled, to more than 200,000 from approximately 100,000, while the number of hospital discharges remained relatively stable and the length of stay declined by a third. The decrease in average inpatient encounters in the pre-hospitalist era is thought to have been secondary to decreased length of stay and increased workforce.

Bottom line: Hospital utilization relative to generalist physician workforce was decreasing prior to the emergence of hospitalists mainly due to decreased length of hospital stay and increased numbers of physicians.

Citation: Meltzer DO, Chung JW. U.S. trends in hospitalization and generalist physician workforce and the emergence of hospitalists. J Gen Intern Med. 2010;25(5):453-459.

Fragmentation of Hospitalist Care Is Associated with Increased Length of Stay

Clinical question: Does fragmentation of care (FOC) by hospitalists affect length of stay (LOS)?

Background: Previous investigations have explored the impact of FOC provided by residency programs on LOS and quality of care. Results of these studies have been mixed. However, there have been no prior studies on the impact of the fragmentation of hospitalist care on LOS.

Study design: Concurrent control study.

Setting: Hospitalist practices all over the country managed by IPC: The Hospitalist Company.

Synopsis: Investigators looked at 10,977 patients admitted with diagnoses of pneumonia or heart failure. The primary endpoint was LOS. The independent variable of interest was a measure of FOC. The FOC was calculated as a quantitative index, by determining the percentage of hospitalist care delivered by a physician other than the primary hospitalist.

Multivariable analyses revealed a statistically significant increase in LOS of 0.39 days for each 10% increase in fragmentation level for pneumonia admissions. Similarly, for patients with heart failure, there was a significant increase in LOS of 0.30 days for each 10% increase in fragmentation level.

The study is a concurrent control study, so conclusions cannot be drawn about causality. Additionally, there are likely unmeasured differences between every hospital and hospitalist practice, which could further confound the relationships between hospitalist care and LOS.

Bottom line: Fragmentation of care provided by hospitalists is associated with an increased LOS in patients hospitalized for pneumonia or heart failure.

Citation: Epstein K, Juarez E, Epstein A, Loya K, Singer A. The impact of fragmentation of hospitalist care on length of stay. J Hosp Med. 2010;5(6):335-338.

Admission Medication Errors Are Common and Most Harmful in Older Patients Taking Many Medications

Clinical question: What are the risk factors and potential harm associated with medication errors at hospital admission?

Background: Obtaining a medication history from a hospitalized patient is an error-prone process. Several variables can affect the completeness and quality of medication histories, but existing data are limited regarding patient or medication risk factors associated with medication errors at admission.

Study design: Prospective cohort study.

Setting: Academic hospital in Chicago.

Synopsis: Pharmacist and admitting physician medication histories were compared with admission medication orders to identify any unexplained discrepancies. Discrepancies resulting in order changes were defined as medication errors.

Of the 651 adult medical inpatients studied, 234 (35.9%) had medication order errors identified at admission. Errors originated in the medication histories for 85% of these patients. The most frequent type of error was an omission (48.9%). An age of 65 or older (odds ratio [OR]=2.17, 95% confidence interval [CI], 1.09-4.30) and increased number of medications (OR=1.21, 95% CI, 1.14-1.29) were the only risk factors identified by multivariate analysis to be independently associated with increased risk of medication order errors potentially causing harm or requiring monitoring or intervention. Presenting a medication list upon admission was a significant protective factor (OR=0.35, 95% CI, 0.19-0.63).

Though this is the largest study to date evaluating admission medication errors in hospitalized medical patients, it remains limited by its single hospital site. Because the authors were unable to interview patients who were too ill or unwilling to participate and had no caregiver present, they might have underestimated the number of admission errors. Further, the harm assessment was based on potential and not actual harm.

Bottom line: Admission medication order errors are frequent, most commonly originate in the medication histories, and have increased potential to cause adverse outcomes in older patients and those taking higher numbers of medications.

Citation: Gleason KM, McDaniel MR, Feinglass J, et al. Results of the Medications At Transitions and Clinical Handoffs (MATCH) study: an analysis of medication reconciliation errors and risk factors at hospital admission. J Gen Intern Med. 2010;25(5):441-447.

In This Edition

Literature at a Glance

A guide to this month’s studies

• Continuous insulin infusion in non-ICU patients
• How hospitalists spend their day
• Outcomes of patients leaving against medical advice
• Prediction rule for readmission
• Effects of high- vs. low-dose PPIs for peptic ulcer
• Hospital utilization by generalists before hospitalists
• Effect of hospitalist fragmentation on length of stay
• Medication errors at admissions in older patients

Continuous Insulin Infusion Provides Effective Glycemic Control in Non-ICU Patients

Clinical question: Is continuous insulin infusion (CII) a safe and effective option in the management of hyperglycemia in non-ICU patients?

Background: Hyperglycemia has been associated with worse outcomes in hospitalized patients. Prior research has demonstrated the benefit of CII in managing hyperglycemia in the ICU setting. However, outcomes have not been evaluated in the general medical (non-ICU) setting, where hyperglycemia is often inadequately addressed.

Study design: Retrospective chart review.

Setting: Urban tertiary-care medical center.

Synopsis: Charts of 200 adult patients treated with CII in non-ICU areas were reviewed with the primary outcomes including mean daily blood glucose (BG) levels and number of hyper- and hypoglycemic events occurring on CII. Mean BG dropped from 323 mg/dL to 182 mg/dL by day one, with a BG≤of 150 achieved in 67% of patients by day two of therapy. Twenty-two percent of patients suffered a hypoglycemic event (BG<60), reportedly similar to prior studies of insulin use in ICU and non-ICU settings. Eighty-two percent of patients received some form of nutritional support while on CII. In multivariate analyses, receiving oral nutrition (either a solid or liquid diet) was the only factor associated with increased risk of hyperglycemia and hypoglycemia.

This study was limited by its retrospective analysis in a single center. No comparison was made with basal-bolus or sliding-scale insulin therapy regarding efficacy or safety.

Bottom line: Non-ICU patients with hyperglycemia who received CII were able to achieve effective glycemic control within 48 hours of initiation, with rates of hypoglycemia comparable to those observed in ICU settings.

Citation: Smiley D, Rhee M, Peng L, et al. Safety and efficacy of continuous insulin infusion in noncritical care settings. J Hosp Med. 2010;5(4):212-217.

Hospitalists Spend More Time on Indirect, Rather Than Direct, Patient Care

Clinical question: What are the components of the daily workflow of hospitalists working on a non-housestaff service?

Background: The use of hospitalists is associated with increased efficiency in the hospital setting. However, it is not known how this efficiency is achieved. Prior literature has attempted to address this question, but with increasing demands and patient census, the representativeness of existing data is unclear.

Study design: Observational time-motion study.

Setting: Urban tertiary-care academic medical center.

Synopsis: Twenty-four hospitalists were directly observed for two weekday shifts. An electronic collection tool was developed using initial data on hospitalist activities and piloted prior to formal study data collection. Direct patient care was defined as involving face-to-face interaction between hospitalist and patient, while indirect patient care involved activities relevant to patient care but not performed in the patient’s presence.

Approximately 500 hours of observation were collected. Direct patient care comprised only a mean of 17.4% of the hospitalists’ daily workflow, while more was spent on indirect care, mainly electronic health record (EHR) documentation (mean 34.1%) and communication activities (mean 25.9%). Multitasking occurred 16% of the time, typically during communication or “critical documentation activities” (e.g. writing prescriptions). As patient volume increased, less time was spent in communication, and documentation was deferred to after hours.

These results were consistent with prior observational studies but were limited to a single center and might not represent the workflow of hospitalists in other settings, such as community hospitals, or nocturnists.

Bottom line: Hospitalists on non-housestaff services spend most of their time on indirect patient care and, with increasing patient census, communication is sacrificed. Multitasking is common during periods of communication and critical documentation.

Citation: Tipping MD, Forth VE, O’Leary KJ, et al. Where did the day go?—a time-motion study of hospitalists. J Hosp Med. 2010;5(6):323-328.

Patients Who Leave Against Medical Advice Have Higher Readmission, Mortality Rates

Clinical question: What are the 30-day hospital readmission and mortality rates for Veterans Administration (VA) patients discharged against medical advice (AMA) compared with those appropriately discharged from the hospital?

Background: Patients discharged AMA might be at increased risk of experiencing worse outcomes. Small studies have demonstrated that patients with asthma and acute myocardial infarction (MI) discharged AMA have increased risk of readmission and death. However, it is unclear whether these risks are generalizable to a wider medical population.

Study design: Five-year retrospective cohort study.

Setting: One hundred twenty-nine VA acute-care hospitals.

Synopsis: Of the nearly 2 million patients admitted to the VA from 2004 to 2008, 1.7% were discharged AMA. Patients discharged AMA generally were younger, had lower incomes, and were more likely to be black. Furthermore, patients discharged AMA had statistically significant higher rates of 30-day readmission (17.7% vs. 11%, P<0.001) and higher 30-day mortality rates (0.75% vs. 0.61%, P=0.001) compared with those who had been appropriately discharged. In hazard models, discharge AMA was a significant predictor of 30-day readmission and conferred a nonstatistically significant increase in 30-day mortality.

Because all patients were seen in VA facilities, the results might not be generalizable to other acute-care settings. Although VA patients differ from the general medical population, the characteristics of patients discharged AMA are similar to those in previously published studies. The study utilized administrative data, which are very reliable but limited by little information on clinical factors that could contribute to AMA discharges.

Bottom line: Patients discharged AMA are at increased risk of worse post-hospitalization outcomes, including hospital readmission and death.

Citation: Glasgow JM, Vaughn-Sarrazin M, Kaboli PJ. Leaving against medical advice (AMA): risk of 30-day mortality and hospital readmission. J Gen Intern Med. 2010;25(9): 926-929.

Simple Model Predicts Hospital Readmission

Clinical question: Which patient-level factors can be used in a simple model to predict hospital readmission of medicine patients?

Background: Hospital readmissions are common and costly. Previously published readmission prediction models have had limited utility because they focused on a specific condition, setting, or population, or were too cumbersome for practical use.

Study design: Prospective observational cohort study.

Setting: Six academic medical centers.

Synopsis: Data from nearly 11,000 general medicine patients were included in the analysis. Overall, almost 18% of patients were readmitted within 30 days of discharge.

In the prediction model derived and validated from the data, seven factors were significant predictors of readmission within 30 days of discharge: insurance status, marital status, having a regular healthcare provider, Charlson comorbidity index, SF 12 physical component score, one or more admissions within the last year, and current length of stay greater than two days. Points assigned from each significant predictor were used to create a risk score. The 5% of patients with risk scores of 25 and higher had 30-day readmission rates of approximately 30%, compared to readmission rates of approximately 16% in patients with scores of less than 25.

These results might not be generalizable to small, rural, nonacademic settings. Planned admissions could not be excluded from the data, and readmissions to nonstudy hospitals could not be ascertained. Despite these limitations, this model is easier to use than prior models and relevant to a broad population of patients.

Bottom line: A simple prediction model using patient-level factors can be used to identify patients at higher risk of readmission within 30 days of discharge to home.

Citation: Hasan O, Meltzer DO, Shaykevich SA, et al. Hospital readmission in general medicine patients: a prediction model. J Gen Intern Med. 2010;25(3):211-219.

No Difference in Outcomes Between High- and Non-High-Dose Proton Pump Inhibitors in Bleeding Peptic Ulcers

Clinical question: Do high-dose proton pump inhibitors (PPIs) decrease the rate of rebleeding, surgical intervention, or mortality in patients with bleeding peptic ulcers who have undergone endoscopic treatment?

Background: Previous studies have demonstrated superiority of both high- and low-dose PPIs to H2 receptor antagonists and placebo in reducing rebleeding rates in patients with peptic ulcers. However, no clear evidence is available to suggest that high-dose PPIs are more effective than non-high-dose PPIs for treatment of bleeding peptic ulcers.

Study design: Systematic review and meta-analysis.

Setting: Multicenter and single-site studies conducted in several countries.

Synopsis: Studies were included if they were randomized controlled trials, compared high- versus non-high-dose PPIs, evaluated endoscopically confirmed bleeding ulcers, gave PPIs after endoscopy, and documented outcomes regarding rates of rebleeding, surgical intervention, or mortality. High-dose PPIs were defined as equivalent to omeprazole 80 mg intravenous bolus followed by continuous intravenous infusion at 8 mg/hr for 72 hours.

Seven studies met inclusion criteria. The pooled odds ratios for rebleeding, surgical intervention, and mortality were 1.30 (95% CI, 0.88-1.91), 1.49 (95% CI, 0.66-3.37), and 0.89 (95% CI, 0.37-2.13), respectively, for high-dose versus non-high-dose PPIs. The authors concluded that high-dose PPIs were not superior to non-high-dose PPIs in reducing the rates of these adverse outcomes after endoscopic treatment of bleeding ulcers. Considering the cost of high-dose PPIs, further studies are indicated to help guide PPI dosing for patients with peptic ulcers.

Major limitations of this study were the small number of studies (1,157 patients in total) and their heterogeneity, and the lack of intention-to-treat analysis. The studies also included a high Asian predominance, and it has been shown that Asian populations have an enhanced PPI effect.

Bottom line: High-dose PPIs did not demonstrate reduced rates of ulcer rebleeding, surgical intervention, or mortality compared with non-high-dose PPIs in this meta-analysis, which included a small number of studies and patients.

Citation: Wang CH, Ma MH, Chou HC, et al. High-dose vs. non-high-dose proton pump inhibitors after endoscopic treatment in patients with bleeding peptic ulcer: a systematic review and meta-analysis of randomized controlled trials. Arch Intern Med. 2010;170(9):751-758.

Hospital Utilization by Practicing Generalists Declined before the Emergence of Hospitalists

Clinical question: What has been the pattern of hospital utilization by generalists before and after the emergence of hospitalists?

Background: It has been proposed that the emergence of hospitalists has “crowded out” generalist physicians from the U.S. hospital setting. This study evaluated the trends of inpatient practice by generalists both before and after the emergence of hospitalists.

Study design: Retrospective analysis of national databases.

Setting: U.S. data from 1980 to 2005.

Synopsis: Utilizing the National Hospital Discharge Survey and the American Medical Association’s Physician Characteristics and Distribution in the U.S., information was extracted to evaluate the average number of annual inpatient encounters relative to generalist workforce from 1980 to 2005. Total inpatient encounters for each year were calculated by multiplying the total number of hospital admissions by the average hospital length of stay. The emergence of hospitalists was defined as beginning in 1994.

Total inpatient encounters by generalists declined by 35% in the pre-hospitalist era but remained essentially unchanged in the hospitalist era. During the pre-hospitalist period, the number of generalists doubled, to more than 200,000 from approximately 100,000, while the number of hospital discharges remained relatively stable and the length of stay declined by a third. The decrease in average inpatient encounters in the pre-hospitalist era is thought to have been secondary to decreased length of stay and increased workforce.

Bottom line: Hospital utilization relative to generalist physician workforce was decreasing prior to the emergence of hospitalists mainly due to decreased length of hospital stay and increased numbers of physicians.

Citation: Meltzer DO, Chung JW. U.S. trends in hospitalization and generalist physician workforce and the emergence of hospitalists. J Gen Intern Med. 2010;25(5):453-459.

Fragmentation of Hospitalist Care Is Associated with Increased Length of Stay

Clinical question: Does fragmentation of care (FOC) by hospitalists affect length of stay (LOS)?

Background: Previous investigations have explored the impact of FOC provided by residency programs on LOS and quality of care. Results of these studies have been mixed. However, there have been no prior studies on the impact of the fragmentation of hospitalist care on LOS.

Study design: Concurrent control study.

Setting: Hospitalist practices all over the country managed by IPC: The Hospitalist Company.

Synopsis: Investigators looked at 10,977 patients admitted with diagnoses of pneumonia or heart failure. The primary endpoint was LOS. The independent variable of interest was a measure of FOC. The FOC was calculated as a quantitative index, by determining the percentage of hospitalist care delivered by a physician other than the primary hospitalist.

Multivariable analyses revealed a statistically significant increase in LOS of 0.39 days for each 10% increase in fragmentation level for pneumonia admissions. Similarly, for patients with heart failure, there was a significant increase in LOS of 0.30 days for each 10% increase in fragmentation level.

The study is a concurrent control study, so conclusions cannot be drawn about causality. Additionally, there are likely unmeasured differences between every hospital and hospitalist practice, which could further confound the relationships between hospitalist care and LOS.

Bottom line: Fragmentation of care provided by hospitalists is associated with an increased LOS in patients hospitalized for pneumonia or heart failure.

Citation: Epstein K, Juarez E, Epstein A, Loya K, Singer A. The impact of fragmentation of hospitalist care on length of stay. J Hosp Med. 2010;5(6):335-338.

Admission Medication Errors Are Common and Most Harmful in Older Patients Taking Many Medications

Clinical question: What are the risk factors and potential harm associated with medication errors at hospital admission?

Background: Obtaining a medication history from a hospitalized patient is an error-prone process. Several variables can affect the completeness and quality of medication histories, but existing data are limited regarding patient or medication risk factors associated with medication errors at admission.

Study design: Prospective cohort study.

Setting: Academic hospital in Chicago.

Synopsis: Pharmacist and admitting physician medication histories were compared with admission medication orders to identify any unexplained discrepancies. Discrepancies resulting in order changes were defined as medication errors.

Of the 651 adult medical inpatients studied, 234 (35.9%) had medication order errors identified at admission. Errors originated in the medication histories for 85% of these patients. The most frequent type of error was an omission (48.9%). An age of 65 or older (odds ratio [OR]=2.17, 95% confidence interval [CI], 1.09-4.30) and increased number of medications (OR=1.21, 95% CI, 1.14-1.29) were the only risk factors identified by multivariate analysis to be independently associated with increased risk of medication order errors potentially causing harm or requiring monitoring or intervention. Presenting a medication list upon admission was a significant protective factor (OR=0.35, 95% CI, 0.19-0.63).

Though this is the largest study to date evaluating admission medication errors in hospitalized medical patients, it remains limited by its single hospital site. Because the authors were unable to interview patients who were too ill or unwilling to participate and had no caregiver present, they might have underestimated the number of admission errors. Further, the harm assessment was based on potential and not actual harm.

Bottom line: Admission medication order errors are frequent, most commonly originate in the medication histories, and have increased potential to cause adverse outcomes in older patients and those taking higher numbers of medications.

Citation: Gleason KM, McDaniel MR, Feinglass J, et al. Results of the Medications At Transitions and Clinical Handoffs (MATCH) study: an analysis of medication reconciliation errors and risk factors at hospital admission. J Gen Intern Med. 2010;25(5):441-447.

Clinical question: What is the relationship between duration of intravenous (IV) antibiotic therapy and treatment failure in infants <6 months of age hospitalized with urinary tract infections (UTIs)?

Background: There is an inadequate evidence base to drive decisions regarding duration of IV antibiotic therapy in young infants hospitalized with UTIs. Documented variability exists in length of stay (LOS) and resource utilization for these infants, which might be a direct result of practice variation with respect to IV therapy.

Study design: Retrospective cohort study.

Setting: Twenty-four freestanding children’s hospitals.

Synopsis: The Pediatric Health Information System (PHIS) administrative database was used to identify healthy infants <6 months of age admitted with a primary or secondary diagnosis of UTI or pyelonephritis from 1999 to 2004 to participating hospitals. Duration of IV therapy was defined as a dichotomous variable with three days (short course: three days) selected because it was the median length of therapy. Treatment failure was defined as readmission within 30 days.

More than 12,300 records were analyzed. Male gender, neonatal status, black race, Hispanic ethnicity, nonprivate insurance, severity of illness, known bacteremia, known genitourinary tract disorders, and specific hospital were independently associated with increased likelihood of long-course (four days) therapy.

Unadjusted analysis initially revealed that long-course therapy was significantly associated with a higher rate of treatment failure. After multivariate (to include propensity scores) adjustment, a significant association between treatment duration and failure was no longer identified. Treatment failure association with known genitourinary abnormalities and higher severity of illness remained.

A significant limitation of this study is the potential for multivariate analysis to fail to mitigate a bias toward sicker patients receiving longer duration of antibiotic therapy and, thus, having a higher likelihood of treatment failure. In addition, the greater question of when IV antibiotics (and hospital admission) are indicated in this population was not addressed by the study design.

Nonetheless, the data likely support a limited utility to long-course IV antibiotic therapy in this population. The study also adds to the evolving picture of considerable and widespread variation in physician practice.

Bottom line: Short-course IV therapy for infants with UTIs does not increase risk of treatment failure.

Citation: Brady PW, Conway PH, Goudie A. Length of intravenous antibiotic therapy and treatment failure in infants with urinary tract infections. Pediatrics. 2010;126(2):196-203.

Reviewed by Pediatric Editor Mark Shen, MD, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

Clinical question: What is the relationship between duration of intravenous (IV) antibiotic therapy and treatment failure in infants <6 months of age hospitalized with urinary tract infections (UTIs)?

Background: There is an inadequate evidence base to drive decisions regarding duration of IV antibiotic therapy in young infants hospitalized with UTIs. Documented variability exists in length of stay (LOS) and resource utilization for these infants, which might be a direct result of practice variation with respect to IV therapy.

Study design: Retrospective cohort study.

Setting: Twenty-four freestanding children’s hospitals.

Synopsis: The Pediatric Health Information System (PHIS) administrative database was used to identify healthy infants <6 months of age admitted with a primary or secondary diagnosis of UTI or pyelonephritis from 1999 to 2004 to participating hospitals. Duration of IV therapy was defined as a dichotomous variable with three days (short course: three days) selected because it was the median length of therapy. Treatment failure was defined as readmission within 30 days.

More than 12,300 records were analyzed. Male gender, neonatal status, black race, Hispanic ethnicity, nonprivate insurance, severity of illness, known bacteremia, known genitourinary tract disorders, and specific hospital were independently associated with increased likelihood of long-course (four days) therapy.

Unadjusted analysis initially revealed that long-course therapy was significantly associated with a higher rate of treatment failure. After multivariate (to include propensity scores) adjustment, a significant association between treatment duration and failure was no longer identified. Treatment failure association with known genitourinary abnormalities and higher severity of illness remained.

A significant limitation of this study is the potential for multivariate analysis to fail to mitigate a bias toward sicker patients receiving longer duration of antibiotic therapy and, thus, having a higher likelihood of treatment failure. In addition, the greater question of when IV antibiotics (and hospital admission) are indicated in this population was not addressed by the study design.

Nonetheless, the data likely support a limited utility to long-course IV antibiotic therapy in this population. The study also adds to the evolving picture of considerable and widespread variation in physician practice.

Bottom line: Short-course IV therapy for infants with UTIs does not increase risk of treatment failure.

Citation: Brady PW, Conway PH, Goudie A. Length of intravenous antibiotic therapy and treatment failure in infants with urinary tract infections. Pediatrics. 2010;126(2):196-203.

Reviewed by Pediatric Editor Mark Shen, MD, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

Clinical question: What is the relationship between duration of intravenous (IV) antibiotic therapy and treatment failure in infants <6 months of age hospitalized with urinary tract infections (UTIs)?

Background: There is an inadequate evidence base to drive decisions regarding duration of IV antibiotic therapy in young infants hospitalized with UTIs. Documented variability exists in length of stay (LOS) and resource utilization for these infants, which might be a direct result of practice variation with respect to IV therapy.

Study design: Retrospective cohort study.

Setting: Twenty-four freestanding children’s hospitals.

Synopsis: The Pediatric Health Information System (PHIS) administrative database was used to identify healthy infants <6 months of age admitted with a primary or secondary diagnosis of UTI or pyelonephritis from 1999 to 2004 to participating hospitals. Duration of IV therapy was defined as a dichotomous variable with three days (short course: three days) selected because it was the median length of therapy. Treatment failure was defined as readmission within 30 days.

More than 12,300 records were analyzed. Male gender, neonatal status, black race, Hispanic ethnicity, nonprivate insurance, severity of illness, known bacteremia, known genitourinary tract disorders, and specific hospital were independently associated with increased likelihood of long-course (four days) therapy.

Unadjusted analysis initially revealed that long-course therapy was significantly associated with a higher rate of treatment failure. After multivariate (to include propensity scores) adjustment, a significant association between treatment duration and failure was no longer identified. Treatment failure association with known genitourinary abnormalities and higher severity of illness remained.

A significant limitation of this study is the potential for multivariate analysis to fail to mitigate a bias toward sicker patients receiving longer duration of antibiotic therapy and, thus, having a higher likelihood of treatment failure. In addition, the greater question of when IV antibiotics (and hospital admission) are indicated in this population was not addressed by the study design.

Nonetheless, the data likely support a limited utility to long-course IV antibiotic therapy in this population. The study also adds to the evolving picture of considerable and widespread variation in physician practice.

Bottom line: Short-course IV therapy for infants with UTIs does not increase risk of treatment failure.

Citation: Brady PW, Conway PH, Goudie A. Length of intravenous antibiotic therapy and treatment failure in infants with urinary tract infections. Pediatrics. 2010;126(2):196-203.

Reviewed by Pediatric Editor Mark Shen, MD, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

New Generics

• Atomoxetine capsules (Strattera)¹
• Clonidine transdermal system USP (catapres-TTS)²
• Enoxaparin sodium injection (Lovenox)³
• Naratriptan hydrochloride 2.5-mg tablets (Amerge)⁴

New Drugs, Devices, Indications, and Dosage Forms

• A combination tablet containing both aliskiren and amlodipine (Tekamlo) has been approved by the FDA for the treatment of hypertension (HTN).⁵ Four strengths for once-daily dosing are available.
• Antihemophilic factor VIII (recombinant) injection (Xyntha) for treatment of hemophilia A has been approved by the FDA in a pre-filled, dual-chamber syringe for intravenous (IV) infusion following reconstitution of the freeze-dried powder with 0.9% sodium chloride diluent (both supplied in the dosage form).⁶ The first dose will be available in the 3,000 international units strength (4 mL). Other dosages will be available in 2011.
• Bimatoprost ophthalmic solution 0.01% (Lumigan) has been approved by the FDA as a first-line treatment for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.⁷
• Buprenorphine/naloxone sublingual film (Suboxone sublingual) has been approved by the FDA for the treatment of opioid dependence.⁸
• Coagulation factor VIIa room temperature stable (recombinant) (NovoSeven RT) has been approved by the FDA in an 8-mg vial.⁹ This larger size allows rapid initiation and administration of this product for patients who need a larger dose. Additionally, this product is approved for an extended shelf life, for all vial sizes, to 36 months at room temperature.
• Donepezil 21-mg tablets (Aricept) have been approved by the FDA for the treatment of moderate to severe Alzheimer’s disease.¹⁰
• Glycopyrrolate cherry-flavored oral solution (Cuvposa) has been approved by the FDA as an orphan drug for treating chronic severe drooling in patients ages 3 to 16 with neurological conditions such as cerebral palsy.¹¹
• Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA for a 24-month shelf life at room temperature when protected from light.¹²
• Miconazole 50-mg buccal tablets (Oravig) have been approved by the FDA to topically treat oropharyngeal candidiasis in patients 16 and older.¹³
• Niacin extended release/simvastatin tablets (Simcor) have been approved by the FDA in two new dosage strengths: 500 mg/40 mg and 1000 mg/40 mg.¹⁴
• Olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets (HCTZ) (Tribenzor) have been approved by the FDA in a single tablet to treat hypertension (not initial therapy).¹⁵ This combination should not be used in patients with a creatinine clearance <30 mL/minute, or in patients with renal artery stenosis.
• STX-100 has received orphan drug status for treating idiopathic pulmonary fibrosis (IPF) for which there currently are no FDA-approved treatments.¹⁶ STX-100 is a humanized, monoclonal antibody that targets integrin vb6, which exhibited major antifibrotic activity in preclinical animal models of the lung and other organs. The FDA previously granted orphan drug designation for STX-100 for chronic allograft nephropathy. A Phase 2 trial in IPF is planned for 2011.
• Docetaxel injection concentrate (Taxotere) has been approved by the FDA in a one-vial system, which eliminates the dilution step.¹⁷
• Valganciclovir injection (Valcyte) is FDA-approved for an increased therapy length (200 days) in adult renal transplant patients at high risk of developing cytomegalovirus disease (CMV).¹⁸ This extends the length of therapy from 100 days.

Safety, Warnings, and Label Changes

• Carbidopa/levodopa and entacapone tablets (Stalevo) are undergoing a safety review in relation to a possible increased cardiovascular event risk, including myocardial infarction, stroke, and cardiovascular death, compared with patients only taking carbidopa/levodopa.¹⁹ An FDA meta-analysis of 15 clinical trials found a small increased risk of cardiovascular events. However, this meta-analysis was not specifically designed to assess cardiovascular safety, and most patients had pre-existing cardiovascular disease risk factors, so even small differences in the level of these risks could significantly affect the study outcomes. Additionally, most negative cardiovascular events occurred in a single trial. The FDA recommends regular evaluation of patients’ cardiovascular status.
• Tigecycline IV injection (Tygacil) has undergone a label change in its “Warnings” and “Precautions” in relation to an increased mortality risk.²⁰ A pooled analysis compared tigecycline use to other similar antibacterials for managing different serious infections. Patients who had a greater increased risk of death were those with hospital-acquired pneumonia, ventilator-associated pneumonia, complicated skin and skin structure infections, diabetic foot infections, and complicated intra-abdominal infections.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Actavis receives FDA approval of atomoxetine HCI capsules. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/199692.php. Accessed Sept. 2, 2010.
2. Mylan receives approval for generic version of Catapres-TTS. Mylan Inc. website. Available at: http://investor.mylan.com/releasedetail.cfm?ReleaseID=489338. Accessed July 20, 2010.
3. Riley K. FDA approves first generic enoxaparin sodium injection. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm. Accessed Sept. 13, 2010.
4. First-time generic approvals August 2010. Formulary website. Available at: http://formularyjournal.modernmedicine.com/formulary/Modern+Medicine+Now/First-time-generic-approvals-Aug.-2010/ArticleStandard/Article/detail/683182?contextCategoryId=44276. Accessed Sept. 7, 2010.
5. Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure. Novartis Pharmaceuticals Corporation website. Available at: http://www.pharma.us.novartis.com/info/newsroom/press-release.jsp?PRID=2286. Accessed Sept. 13, 2010.
6. Xyntha prefilled dual-chamber syringe approved for hemophilia A treatment. Monthly Prescribing Reference website. Available at: http://www.empr.com/xyntha-pre-filled-dual-chamber-syringe-approved-for-hemophilia-a-treatment/article/176666/. Accessed Aug.18, 2010.
7. Allergan, Inc. receives FDA approval for Lumigan 0.01% as first-line therapy indicated for the reduction of elevated intraocular pressure in glaucoma patients. MarketWatch website. Available at: http://www.marketwatch.com/story/allergan-inc-receives-fda-approval-for-lumiganr-001-as-first-line-therapy-indicated-for-the-reduction-of-elevated-intraocular-pressure-in-glaucoma-patients-2010-08-31?reflink=MW_news_stmp. Accessed Sept. 2, 2010.
8. MonoSol Rx announces Reckitt Benckiser FDA approval of Suboxone sublingual film for treatment of opioid dependence. PR Newswire website. Available at: http://www.prnewswire.com/news-releases/monosol-rx-announces-reckitt-benckiser-fda-approval-of-suboxone-sublingual-film-for-treatment-of-opioid-dependence-101874388.html. Accessed Sept. 14, 2010.
9. NovoSeven RT 8mg vial approved for hemophilia A or B. Monthly Prescribing Reference website. Available at: http://www.empr.com/novoseven-rt-8mg-vial-approved-for-hemophilia-a-or-b/printarticle/176743/. Accessed Sept. 13, 2010.
10. Eisai announces U.S. FDA approval for new higher dose Aricept 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/196410.php. Accessed Sept. 13, 2010.
11. Cuvposa approved for chronic severe drooling associated with neurologic conditions. Monthly Prescribing Reference website. Available at: http://www.empr.com/cuvposa-approved-for-chronic-severe-drooling-associated-with-neurologic-conditions/article/175824/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 2, 2010.
12. Shelf life of Hizentra extended from 18 to 24 months. Monthly Prescribing Reference website. Available at: http://www.empr.com/shelf-life-of-hizentra-extended-from-18-to-24-months/article/177068/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 23, 2010.
13. Oravig available for oropharyngeal candidiasis. Monthly Prescribing Reference website. Available at: http://www.empr.com/oravig-available-for-oropharyngeal-candidiasis/article/177492/. Accessed Sept. 13, 2010.
14. Additional dosage strengths of Simcor approved. Monthly Prescribing Reference website. Available at: http://www.empr.com/additional-dosage-strengths-of-simcor-approved/article/175825/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Sept. 13, 2010.
15. Tribenzor 20/5/12.5mg. Monthly Prescribing Reference website. Available at: http://www.empr.com/tribenzor-205125mg/drugproduct/129/. Accessed Sept. 13, 2010.
16. Stromedix receives FDA orphan drug designation for STX-100 for the treatment of idiopathic pulmonary fibrosis. Stromedix website. Available at: http://www.stromedix.com/Stromedix_STX-100_Orphan_Drug_IPF.pdf. Accessed Sept. 13, 2010.
17. Dane L. Sanofi-Aventis garners FDA approval for one-vial formulation of Taxotere. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E0B4E517F06C4A9E94DC88EADBA079A8. Accessed Sept. 13, 2010.
18. FDA approves longer use of Valcyte for adult kidney transplant patients at high risk of developing cytomegalovirus (CMV) disease. Genentech website. Available at: http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=12907. Accessed Sept. 13, 2010.
19. FDA drug safety communication: ongoing safety review of Stalevo and possible increased cardiovascular risk. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm223060.htm. Accessed Sept. 13, 2010.
20. FDA drug safety communication: increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm. Accessed Sept. 13, 2010.

New Generics

• Atomoxetine capsules (Strattera)¹
• Clonidine transdermal system USP (catapres-TTS)²
• Enoxaparin sodium injection (Lovenox)³
• Naratriptan hydrochloride 2.5-mg tablets (Amerge)⁴

New Drugs, Devices, Indications, and Dosage Forms

• A combination tablet containing both aliskiren and amlodipine (Tekamlo) has been approved by the FDA for the treatment of hypertension (HTN).⁵ Four strengths for once-daily dosing are available.
• Antihemophilic factor VIII (recombinant) injection (Xyntha) for treatment of hemophilia A has been approved by the FDA in a pre-filled, dual-chamber syringe for intravenous (IV) infusion following reconstitution of the freeze-dried powder with 0.9% sodium chloride diluent (both supplied in the dosage form).⁶ The first dose will be available in the 3,000 international units strength (4 mL). Other dosages will be available in 2011.
• Bimatoprost ophthalmic solution 0.01% (Lumigan) has been approved by the FDA as a first-line treatment for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.⁷
• Buprenorphine/naloxone sublingual film (Suboxone sublingual) has been approved by the FDA for the treatment of opioid dependence.⁸
• Coagulation factor VIIa room temperature stable (recombinant) (NovoSeven RT) has been approved by the FDA in an 8-mg vial.⁹ This larger size allows rapid initiation and administration of this product for patients who need a larger dose. Additionally, this product is approved for an extended shelf life, for all vial sizes, to 36 months at room temperature.
• Donepezil 21-mg tablets (Aricept) have been approved by the FDA for the treatment of moderate to severe Alzheimer’s disease.¹⁰
• Glycopyrrolate cherry-flavored oral solution (Cuvposa) has been approved by the FDA as an orphan drug for treating chronic severe drooling in patients ages 3 to 16 with neurological conditions such as cerebral palsy.¹¹
• Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA for a 24-month shelf life at room temperature when protected from light.¹²
• Miconazole 50-mg buccal tablets (Oravig) have been approved by the FDA to topically treat oropharyngeal candidiasis in patients 16 and older.¹³
• Niacin extended release/simvastatin tablets (Simcor) have been approved by the FDA in two new dosage strengths: 500 mg/40 mg and 1000 mg/40 mg.¹⁴
• Olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets (HCTZ) (Tribenzor) have been approved by the FDA in a single tablet to treat hypertension (not initial therapy).¹⁵ This combination should not be used in patients with a creatinine clearance <30 mL/minute, or in patients with renal artery stenosis.
• STX-100 has received orphan drug status for treating idiopathic pulmonary fibrosis (IPF) for which there currently are no FDA-approved treatments.¹⁶ STX-100 is a humanized, monoclonal antibody that targets integrin vb6, which exhibited major antifibrotic activity in preclinical animal models of the lung and other organs. The FDA previously granted orphan drug designation for STX-100 for chronic allograft nephropathy. A Phase 2 trial in IPF is planned for 2011.
• Docetaxel injection concentrate (Taxotere) has been approved by the FDA in a one-vial system, which eliminates the dilution step.¹⁷
• Valganciclovir injection (Valcyte) is FDA-approved for an increased therapy length (200 days) in adult renal transplant patients at high risk of developing cytomegalovirus disease (CMV).¹⁸ This extends the length of therapy from 100 days.

Safety, Warnings, and Label Changes

• Carbidopa/levodopa and entacapone tablets (Stalevo) are undergoing a safety review in relation to a possible increased cardiovascular event risk, including myocardial infarction, stroke, and cardiovascular death, compared with patients only taking carbidopa/levodopa.¹⁹ An FDA meta-analysis of 15 clinical trials found a small increased risk of cardiovascular events. However, this meta-analysis was not specifically designed to assess cardiovascular safety, and most patients had pre-existing cardiovascular disease risk factors, so even small differences in the level of these risks could significantly affect the study outcomes. Additionally, most negative cardiovascular events occurred in a single trial. The FDA recommends regular evaluation of patients’ cardiovascular status.
• Tigecycline IV injection (Tygacil) has undergone a label change in its “Warnings” and “Precautions” in relation to an increased mortality risk.²⁰ A pooled analysis compared tigecycline use to other similar antibacterials for managing different serious infections. Patients who had a greater increased risk of death were those with hospital-acquired pneumonia, ventilator-associated pneumonia, complicated skin and skin structure infections, diabetic foot infections, and complicated intra-abdominal infections.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Actavis receives FDA approval of atomoxetine HCI capsules. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/199692.php. Accessed Sept. 2, 2010.
2. Mylan receives approval for generic version of Catapres-TTS. Mylan Inc. website. Available at: http://investor.mylan.com/releasedetail.cfm?ReleaseID=489338. Accessed July 20, 2010.
3. Riley K. FDA approves first generic enoxaparin sodium injection. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm. Accessed Sept. 13, 2010.
4. First-time generic approvals August 2010. Formulary website. Available at: http://formularyjournal.modernmedicine.com/formulary/Modern+Medicine+Now/First-time-generic-approvals-Aug.-2010/ArticleStandard/Article/detail/683182?contextCategoryId=44276. Accessed Sept. 7, 2010.
5. Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure. Novartis Pharmaceuticals Corporation website. Available at: http://www.pharma.us.novartis.com/info/newsroom/press-release.jsp?PRID=2286. Accessed Sept. 13, 2010.
6. Xyntha prefilled dual-chamber syringe approved for hemophilia A treatment. Monthly Prescribing Reference website. Available at: http://www.empr.com/xyntha-pre-filled-dual-chamber-syringe-approved-for-hemophilia-a-treatment/article/176666/. Accessed Aug.18, 2010.
7. Allergan, Inc. receives FDA approval for Lumigan 0.01% as first-line therapy indicated for the reduction of elevated intraocular pressure in glaucoma patients. MarketWatch website. Available at: http://www.marketwatch.com/story/allergan-inc-receives-fda-approval-for-lumiganr-001-as-first-line-therapy-indicated-for-the-reduction-of-elevated-intraocular-pressure-in-glaucoma-patients-2010-08-31?reflink=MW_news_stmp. Accessed Sept. 2, 2010.
8. MonoSol Rx announces Reckitt Benckiser FDA approval of Suboxone sublingual film for treatment of opioid dependence. PR Newswire website. Available at: http://www.prnewswire.com/news-releases/monosol-rx-announces-reckitt-benckiser-fda-approval-of-suboxone-sublingual-film-for-treatment-of-opioid-dependence-101874388.html. Accessed Sept. 14, 2010.
9. NovoSeven RT 8mg vial approved for hemophilia A or B. Monthly Prescribing Reference website. Available at: http://www.empr.com/novoseven-rt-8mg-vial-approved-for-hemophilia-a-or-b/printarticle/176743/. Accessed Sept. 13, 2010.
10. Eisai announces U.S. FDA approval for new higher dose Aricept 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/196410.php. Accessed Sept. 13, 2010.
11. Cuvposa approved for chronic severe drooling associated with neurologic conditions. Monthly Prescribing Reference website. Available at: http://www.empr.com/cuvposa-approved-for-chronic-severe-drooling-associated-with-neurologic-conditions/article/175824/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 2, 2010.
12. Shelf life of Hizentra extended from 18 to 24 months. Monthly Prescribing Reference website. Available at: http://www.empr.com/shelf-life-of-hizentra-extended-from-18-to-24-months/article/177068/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 23, 2010.
13. Oravig available for oropharyngeal candidiasis. Monthly Prescribing Reference website. Available at: http://www.empr.com/oravig-available-for-oropharyngeal-candidiasis/article/177492/. Accessed Sept. 13, 2010.
14. Additional dosage strengths of Simcor approved. Monthly Prescribing Reference website. Available at: http://www.empr.com/additional-dosage-strengths-of-simcor-approved/article/175825/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Sept. 13, 2010.
15. Tribenzor 20/5/12.5mg. Monthly Prescribing Reference website. Available at: http://www.empr.com/tribenzor-205125mg/drugproduct/129/. Accessed Sept. 13, 2010.
16. Stromedix receives FDA orphan drug designation for STX-100 for the treatment of idiopathic pulmonary fibrosis. Stromedix website. Available at: http://www.stromedix.com/Stromedix_STX-100_Orphan_Drug_IPF.pdf. Accessed Sept. 13, 2010.
17. Dane L. Sanofi-Aventis garners FDA approval for one-vial formulation of Taxotere. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E0B4E517F06C4A9E94DC88EADBA079A8. Accessed Sept. 13, 2010.
18. FDA approves longer use of Valcyte for adult kidney transplant patients at high risk of developing cytomegalovirus (CMV) disease. Genentech website. Available at: http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=12907. Accessed Sept. 13, 2010.
19. FDA drug safety communication: ongoing safety review of Stalevo and possible increased cardiovascular risk. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm223060.htm. Accessed Sept. 13, 2010.
20. FDA drug safety communication: increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm. Accessed Sept. 13, 2010.

New Generics

• Atomoxetine capsules (Strattera)¹
• Clonidine transdermal system USP (catapres-TTS)²
• Enoxaparin sodium injection (Lovenox)³
• Naratriptan hydrochloride 2.5-mg tablets (Amerge)⁴

New Drugs, Devices, Indications, and Dosage Forms

• A combination tablet containing both aliskiren and amlodipine (Tekamlo) has been approved by the FDA for the treatment of hypertension (HTN).⁵ Four strengths for once-daily dosing are available.
• Antihemophilic factor VIII (recombinant) injection (Xyntha) for treatment of hemophilia A has been approved by the FDA in a pre-filled, dual-chamber syringe for intravenous (IV) infusion following reconstitution of the freeze-dried powder with 0.9% sodium chloride diluent (both supplied in the dosage form).⁶ The first dose will be available in the 3,000 international units strength (4 mL). Other dosages will be available in 2011.
• Bimatoprost ophthalmic solution 0.01% (Lumigan) has been approved by the FDA as a first-line treatment for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.⁷
• Buprenorphine/naloxone sublingual film (Suboxone sublingual) has been approved by the FDA for the treatment of opioid dependence.⁸
• Coagulation factor VIIa room temperature stable (recombinant) (NovoSeven RT) has been approved by the FDA in an 8-mg vial.⁹ This larger size allows rapid initiation and administration of this product for patients who need a larger dose. Additionally, this product is approved for an extended shelf life, for all vial sizes, to 36 months at room temperature.
• Donepezil 21-mg tablets (Aricept) have been approved by the FDA for the treatment of moderate to severe Alzheimer’s disease.¹⁰
• Glycopyrrolate cherry-flavored oral solution (Cuvposa) has been approved by the FDA as an orphan drug for treating chronic severe drooling in patients ages 3 to 16 with neurological conditions such as cerebral palsy.¹¹
• Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA for a 24-month shelf life at room temperature when protected from light.¹²
• Miconazole 50-mg buccal tablets (Oravig) have been approved by the FDA to topically treat oropharyngeal candidiasis in patients 16 and older.¹³
• Niacin extended release/simvastatin tablets (Simcor) have been approved by the FDA in two new dosage strengths: 500 mg/40 mg and 1000 mg/40 mg.¹⁴
• Olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets (HCTZ) (Tribenzor) have been approved by the FDA in a single tablet to treat hypertension (not initial therapy).¹⁵ This combination should not be used in patients with a creatinine clearance <30 mL/minute, or in patients with renal artery stenosis.
• STX-100 has received orphan drug status for treating idiopathic pulmonary fibrosis (IPF) for which there currently are no FDA-approved treatments.¹⁶ STX-100 is a humanized, monoclonal antibody that targets integrin vb6, which exhibited major antifibrotic activity in preclinical animal models of the lung and other organs. The FDA previously granted orphan drug designation for STX-100 for chronic allograft nephropathy. A Phase 2 trial in IPF is planned for 2011.
• Docetaxel injection concentrate (Taxotere) has been approved by the FDA in a one-vial system, which eliminates the dilution step.¹⁷
• Valganciclovir injection (Valcyte) is FDA-approved for an increased therapy length (200 days) in adult renal transplant patients at high risk of developing cytomegalovirus disease (CMV).¹⁸ This extends the length of therapy from 100 days.

Safety, Warnings, and Label Changes

• Carbidopa/levodopa and entacapone tablets (Stalevo) are undergoing a safety review in relation to a possible increased cardiovascular event risk, including myocardial infarction, stroke, and cardiovascular death, compared with patients only taking carbidopa/levodopa.¹⁹ An FDA meta-analysis of 15 clinical trials found a small increased risk of cardiovascular events. However, this meta-analysis was not specifically designed to assess cardiovascular safety, and most patients had pre-existing cardiovascular disease risk factors, so even small differences in the level of these risks could significantly affect the study outcomes. Additionally, most negative cardiovascular events occurred in a single trial. The FDA recommends regular evaluation of patients’ cardiovascular status.
• Tigecycline IV injection (Tygacil) has undergone a label change in its “Warnings” and “Precautions” in relation to an increased mortality risk.²⁰ A pooled analysis compared tigecycline use to other similar antibacterials for managing different serious infections. Patients who had a greater increased risk of death were those with hospital-acquired pneumonia, ventilator-associated pneumonia, complicated skin and skin structure infections, diabetic foot infections, and complicated intra-abdominal infections.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Actavis receives FDA approval of atomoxetine HCI capsules. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/199692.php. Accessed Sept. 2, 2010.
2. Mylan receives approval for generic version of Catapres-TTS. Mylan Inc. website. Available at: http://investor.mylan.com/releasedetail.cfm?ReleaseID=489338. Accessed July 20, 2010.
3. Riley K. FDA approves first generic enoxaparin sodium injection. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm. Accessed Sept. 13, 2010.
4. First-time generic approvals August 2010. Formulary website. Available at: http://formularyjournal.modernmedicine.com/formulary/Modern+Medicine+Now/First-time-generic-approvals-Aug.-2010/ArticleStandard/Article/detail/683182?contextCategoryId=44276. Accessed Sept. 7, 2010.
5. Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure. Novartis Pharmaceuticals Corporation website. Available at: http://www.pharma.us.novartis.com/info/newsroom/press-release.jsp?PRID=2286. Accessed Sept. 13, 2010.
6. Xyntha prefilled dual-chamber syringe approved for hemophilia A treatment. Monthly Prescribing Reference website. Available at: http://www.empr.com/xyntha-pre-filled-dual-chamber-syringe-approved-for-hemophilia-a-treatment/article/176666/. Accessed Aug.18, 2010.
7. Allergan, Inc. receives FDA approval for Lumigan 0.01% as first-line therapy indicated for the reduction of elevated intraocular pressure in glaucoma patients. MarketWatch website. Available at: http://www.marketwatch.com/story/allergan-inc-receives-fda-approval-for-lumiganr-001-as-first-line-therapy-indicated-for-the-reduction-of-elevated-intraocular-pressure-in-glaucoma-patients-2010-08-31?reflink=MW_news_stmp. Accessed Sept. 2, 2010.
8. MonoSol Rx announces Reckitt Benckiser FDA approval of Suboxone sublingual film for treatment of opioid dependence. PR Newswire website. Available at: http://www.prnewswire.com/news-releases/monosol-rx-announces-reckitt-benckiser-fda-approval-of-suboxone-sublingual-film-for-treatment-of-opioid-dependence-101874388.html. Accessed Sept. 14, 2010.
9. NovoSeven RT 8mg vial approved for hemophilia A or B. Monthly Prescribing Reference website. Available at: http://www.empr.com/novoseven-rt-8mg-vial-approved-for-hemophilia-a-or-b/printarticle/176743/. Accessed Sept. 13, 2010.
10. Eisai announces U.S. FDA approval for new higher dose Aricept 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/196410.php. Accessed Sept. 13, 2010.
11. Cuvposa approved for chronic severe drooling associated with neurologic conditions. Monthly Prescribing Reference website. Available at: http://www.empr.com/cuvposa-approved-for-chronic-severe-drooling-associated-with-neurologic-conditions/article/175824/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 2, 2010.
12. Shelf life of Hizentra extended from 18 to 24 months. Monthly Prescribing Reference website. Available at: http://www.empr.com/shelf-life-of-hizentra-extended-from-18-to-24-months/article/177068/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 23, 2010.
13. Oravig available for oropharyngeal candidiasis. Monthly Prescribing Reference website. Available at: http://www.empr.com/oravig-available-for-oropharyngeal-candidiasis/article/177492/. Accessed Sept. 13, 2010.
14. Additional dosage strengths of Simcor approved. Monthly Prescribing Reference website. Available at: http://www.empr.com/additional-dosage-strengths-of-simcor-approved/article/175825/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Sept. 13, 2010.
15. Tribenzor 20/5/12.5mg. Monthly Prescribing Reference website. Available at: http://www.empr.com/tribenzor-205125mg/drugproduct/129/. Accessed Sept. 13, 2010.
16. Stromedix receives FDA orphan drug designation for STX-100 for the treatment of idiopathic pulmonary fibrosis. Stromedix website. Available at: http://www.stromedix.com/Stromedix_STX-100_Orphan_Drug_IPF.pdf. Accessed Sept. 13, 2010.
17. Dane L. Sanofi-Aventis garners FDA approval for one-vial formulation of Taxotere. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E0B4E517F06C4A9E94DC88EADBA079A8. Accessed Sept. 13, 2010.
18. FDA approves longer use of Valcyte for adult kidney transplant patients at high risk of developing cytomegalovirus (CMV) disease. Genentech website. Available at: http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=12907. Accessed Sept. 13, 2010.
19. FDA drug safety communication: ongoing safety review of Stalevo and possible increased cardiovascular risk. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm223060.htm. Accessed Sept. 13, 2010.
20. FDA drug safety communication: increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm. Accessed Sept. 13, 2010.

Kenneth G. Simone, DO, FHM, grew up as the son of a revered pediatrician. As a child, he often accompanied his father on hospital rounds and house calls, developing an appreciation for the “old-fashioned” medicine his father practiced.

Already inspired to follow in his father’s footsteps, Dr. Simone became even more convinced of his calling when the physician-patient roles were reversed: His dad developed a kidney disorder that cut his career—and ultimately his life—short. “His illness and my exposure to hospitals added to my desire to pursue medicine,” Dr. Simone says. “It instilled the drive to help others, to make a difference in someone’s or some family’s life.”

He has done that by developing multiple private medical practices, building the hospitalist program at St. Joseph Hospital in Bangor, Maine, and offering consulting services to more than 100 practices.

“It has always been my nature to challenge myself and put myself in situations that take me out of my comfort zone,” says Dr. Simone, president of Hospitalist and Practice Solutions, a practice-management consultancy in Veazie, Maine. “I enjoy building things from scratch, creating, rebuilding, thinking outside the box, and networking with other healthcare professionals.”

Question: What made you decide to start Hospitalist and Practice Solutions (HPS)?

Answer: HPS was established because of the demand for my services. Initially, word spread locally and then regionally about the work I did at St. Joseph Hospital. As a natural offshoot of my growing interest in helping other programs, HPS became a national consulting firm.

Q: Why did you think this venture could provide a valuable service?

A: I believed there were more effective healthcare delivery systems with which to provide both quality and cost-effective medical care. As time went on, I gained a very unique perspective working as both a hospitalist and referring PCP in private practice. This experience, coupled with my work as an administrative director for a hospitalist program, allowed me to develop applications to help hospitalist programs on a broader basis. I realized the advice I offered to other programs consistently rendered a positive effect.

Q: Which do you find more enjoyable: building a hospitalist program from the ground up or rebuilding a struggling program?

A: I truly enjoy the challenges of both equally. Projects that involve building a program de novo appeal to my creative side. These projects enable me to work with professionals to build a customized program that meets the needs of the community.

Q: What challenges are unique to each?

A: Rebuilding an established program involves critical analysis of the current program to identify what has gone wrong, what has been successful, and what will work in the future. It calls upon one’s skills to build consensus and instill trust in the process because the stakeholders may be apprehensive to have a consultant critically review their program and hospital. In many instances, conflict management is necessary.

In both the creation and rebuilding of an HM program, it is imperative to implement strategies that guide the program to future success. Both projects also require strategic planning and the development of tools and tactics that emphasize collaboration and collegiality.

Q: Do the failing programs you help to rebuild have characteristics in common?

A: Common themes include lack of planning and consensus-building before program start-up, inadequate tools and strategies to support effective practice management, and failure to align the hospitalist practice and sponsoring hospital’s goals and vision. Another common problem is the absence of a hospitalist recruitment and retention plan, which may lead to provider turnover and program instability.

Many programs experience problems due to ineffective leadership, poor implementation and follow-through, and lack of both a short- and long-term strategic plan. Some programs are victims of their own success. The program is not properly prepared to handle the demand for its services and grow accordingly.

Q: You help programs create effective recruitment and retention plans. You also wrote a book on the subject. Why are recruitment and retention challenging for so many programs?

A: The primary contributor is that [hospitalist] supply falls significantly short of physician demand. A secondary contributor is the generational expectations of the younger physician workforce. … In addition, leaders may not prioritize recruitment and retention because they lack an appreciation for the consequences of failed efforts.

Q: What advice would you offer hospitalist program leaders about how they can improve those aspects of their programs?

A: No. 1, create an effective recruitment and retention plan and execute the plan with precision. No. 2, approach recruitment and retention with the same attention to detail as you approach patient care.

Q: You’re offering best-practice advice to help your clients develop and sustain effective programs. What advice do you find yourself giving to your clients that you wish someone gave to you early in your career?

A: From my perspective as a hospitalist administrative director, the advice I would offer is for individuals to believe in themselves and stay engaged. If you feel you have something to offer to the practice or healthcare system as a whole, share it with the appropriate parties. If you experience problems within the workplace, seek resolution in a timely manner. Stay positive and be part of the solution, not part of the problem.

Q: You have written two hospitalist books and coauthored two others. Do you have plans to write another?

A: I wouldn’t say I have immediate plans, but I am always thinking about topics and other projects that would provide value to readers. I’ve got some exciting ideas for future projects, but they are in a very early stage of development.

Q: How would you compare the feeling you get from finishing a book with the satisfaction you derive from other aspects of your career?

A: Writing a book is a highly personal accomplishment for me, while caring for patients is more of a team accomplishment that involves the patient, family, and other healthcare professionals. Typically, the completion of a book is a finite event, while caring for a patient is a long-term commitment.

Q: What is your biggest professional reward?

A: Helping people, whether they are patients in my role as physician, or other professionals—physicians, practice administrators, and hospital administrators—in my role as a practice management consultant. Whenever I reflect on my career, I tell myself how lucky I am. There are not many professions or individuals who have an opportunity to close the door behind them and have other human beings entrust them with their most intimate information. Also, there are very few individuals who are able to impact the delivery of medical care from a systems perspective. I get to do both, and for that I am most grateful.

Q: What is your biggest professional challenge?

A: Saying “no” when someone asks for help. There is nothing more rewarding for me than to help others. With that said, I try not to overextend myself, because that wouldn’t be fair to my family, colleagues, friends, or clients.

Q: What’s next for you professionally?

A: I will continue to concentrate my effort on building my hospitalist consultative practice and expanding the services I offer. In addition, I’m always tempted to explore the valley of the unknown. What excites me is venturing into new areas and to challenge myself to grow as both an individual and professional. TH

Mark Leiser is a freelance writer based in New Jersey.

Kenneth G. Simone, DO, FHM, grew up as the son of a revered pediatrician. As a child, he often accompanied his father on hospital rounds and house calls, developing an appreciation for the “old-fashioned” medicine his father practiced.

Already inspired to follow in his father’s footsteps, Dr. Simone became even more convinced of his calling when the physician-patient roles were reversed: His dad developed a kidney disorder that cut his career—and ultimately his life—short. “His illness and my exposure to hospitals added to my desire to pursue medicine,” Dr. Simone says. “It instilled the drive to help others, to make a difference in someone’s or some family’s life.”

He has done that by developing multiple private medical practices, building the hospitalist program at St. Joseph Hospital in Bangor, Maine, and offering consulting services to more than 100 practices.

“It has always been my nature to challenge myself and put myself in situations that take me out of my comfort zone,” says Dr. Simone, president of Hospitalist and Practice Solutions, a practice-management consultancy in Veazie, Maine. “I enjoy building things from scratch, creating, rebuilding, thinking outside the box, and networking with other healthcare professionals.”

Question: What made you decide to start Hospitalist and Practice Solutions (HPS)?

Answer: HPS was established because of the demand for my services. Initially, word spread locally and then regionally about the work I did at St. Joseph Hospital. As a natural offshoot of my growing interest in helping other programs, HPS became a national consulting firm.

Q: Why did you think this venture could provide a valuable service?

A: I believed there were more effective healthcare delivery systems with which to provide both quality and cost-effective medical care. As time went on, I gained a very unique perspective working as both a hospitalist and referring PCP in private practice. This experience, coupled with my work as an administrative director for a hospitalist program, allowed me to develop applications to help hospitalist programs on a broader basis. I realized the advice I offered to other programs consistently rendered a positive effect.

Q: Which do you find more enjoyable: building a hospitalist program from the ground up or rebuilding a struggling program?

A: I truly enjoy the challenges of both equally. Projects that involve building a program de novo appeal to my creative side. These projects enable me to work with professionals to build a customized program that meets the needs of the community.

Q: What challenges are unique to each?

A: Rebuilding an established program involves critical analysis of the current program to identify what has gone wrong, what has been successful, and what will work in the future. It calls upon one’s skills to build consensus and instill trust in the process because the stakeholders may be apprehensive to have a consultant critically review their program and hospital. In many instances, conflict management is necessary.

In both the creation and rebuilding of an HM program, it is imperative to implement strategies that guide the program to future success. Both projects also require strategic planning and the development of tools and tactics that emphasize collaboration and collegiality.

Q: Do the failing programs you help to rebuild have characteristics in common?

A: Common themes include lack of planning and consensus-building before program start-up, inadequate tools and strategies to support effective practice management, and failure to align the hospitalist practice and sponsoring hospital’s goals and vision. Another common problem is the absence of a hospitalist recruitment and retention plan, which may lead to provider turnover and program instability.

Many programs experience problems due to ineffective leadership, poor implementation and follow-through, and lack of both a short- and long-term strategic plan. Some programs are victims of their own success. The program is not properly prepared to handle the demand for its services and grow accordingly.

Q: You help programs create effective recruitment and retention plans. You also wrote a book on the subject. Why are recruitment and retention challenging for so many programs?

A: The primary contributor is that [hospitalist] supply falls significantly short of physician demand. A secondary contributor is the generational expectations of the younger physician workforce. … In addition, leaders may not prioritize recruitment and retention because they lack an appreciation for the consequences of failed efforts.

Q: What advice would you offer hospitalist program leaders about how they can improve those aspects of their programs?

A: No. 1, create an effective recruitment and retention plan and execute the plan with precision. No. 2, approach recruitment and retention with the same attention to detail as you approach patient care.

Q: You’re offering best-practice advice to help your clients develop and sustain effective programs. What advice do you find yourself giving to your clients that you wish someone gave to you early in your career?

A: From my perspective as a hospitalist administrative director, the advice I would offer is for individuals to believe in themselves and stay engaged. If you feel you have something to offer to the practice or healthcare system as a whole, share it with the appropriate parties. If you experience problems within the workplace, seek resolution in a timely manner. Stay positive and be part of the solution, not part of the problem.

Q: You have written two hospitalist books and coauthored two others. Do you have plans to write another?

A: I wouldn’t say I have immediate plans, but I am always thinking about topics and other projects that would provide value to readers. I’ve got some exciting ideas for future projects, but they are in a very early stage of development.

Q: How would you compare the feeling you get from finishing a book with the satisfaction you derive from other aspects of your career?

A: Writing a book is a highly personal accomplishment for me, while caring for patients is more of a team accomplishment that involves the patient, family, and other healthcare professionals. Typically, the completion of a book is a finite event, while caring for a patient is a long-term commitment.

Q: What is your biggest professional reward?

A: Helping people, whether they are patients in my role as physician, or other professionals—physicians, practice administrators, and hospital administrators—in my role as a practice management consultant. Whenever I reflect on my career, I tell myself how lucky I am. There are not many professions or individuals who have an opportunity to close the door behind them and have other human beings entrust them with their most intimate information. Also, there are very few individuals who are able to impact the delivery of medical care from a systems perspective. I get to do both, and for that I am most grateful.

Q: What is your biggest professional challenge?

A: Saying “no” when someone asks for help. There is nothing more rewarding for me than to help others. With that said, I try not to overextend myself, because that wouldn’t be fair to my family, colleagues, friends, or clients.

Q: What’s next for you professionally?

A: I will continue to concentrate my effort on building my hospitalist consultative practice and expanding the services I offer. In addition, I’m always tempted to explore the valley of the unknown. What excites me is venturing into new areas and to challenge myself to grow as both an individual and professional. TH

Mark Leiser is a freelance writer based in New Jersey.

Kenneth G. Simone, DO, FHM, grew up as the son of a revered pediatrician. As a child, he often accompanied his father on hospital rounds and house calls, developing an appreciation for the “old-fashioned” medicine his father practiced.

Already inspired to follow in his father’s footsteps, Dr. Simone became even more convinced of his calling when the physician-patient roles were reversed: His dad developed a kidney disorder that cut his career—and ultimately his life—short. “His illness and my exposure to hospitals added to my desire to pursue medicine,” Dr. Simone says. “It instilled the drive to help others, to make a difference in someone’s or some family’s life.”

He has done that by developing multiple private medical practices, building the hospitalist program at St. Joseph Hospital in Bangor, Maine, and offering consulting services to more than 100 practices.

“It has always been my nature to challenge myself and put myself in situations that take me out of my comfort zone,” says Dr. Simone, president of Hospitalist and Practice Solutions, a practice-management consultancy in Veazie, Maine. “I enjoy building things from scratch, creating, rebuilding, thinking outside the box, and networking with other healthcare professionals.”

Question: What made you decide to start Hospitalist and Practice Solutions (HPS)?

Answer: HPS was established because of the demand for my services. Initially, word spread locally and then regionally about the work I did at St. Joseph Hospital. As a natural offshoot of my growing interest in helping other programs, HPS became a national consulting firm.

Q: Why did you think this venture could provide a valuable service?

A: I believed there were more effective healthcare delivery systems with which to provide both quality and cost-effective medical care. As time went on, I gained a very unique perspective working as both a hospitalist and referring PCP in private practice. This experience, coupled with my work as an administrative director for a hospitalist program, allowed me to develop applications to help hospitalist programs on a broader basis. I realized the advice I offered to other programs consistently rendered a positive effect.

Q: Which do you find more enjoyable: building a hospitalist program from the ground up or rebuilding a struggling program?

A: I truly enjoy the challenges of both equally. Projects that involve building a program de novo appeal to my creative side. These projects enable me to work with professionals to build a customized program that meets the needs of the community.

Q: What challenges are unique to each?

A: Rebuilding an established program involves critical analysis of the current program to identify what has gone wrong, what has been successful, and what will work in the future. It calls upon one’s skills to build consensus and instill trust in the process because the stakeholders may be apprehensive to have a consultant critically review their program and hospital. In many instances, conflict management is necessary.

In both the creation and rebuilding of an HM program, it is imperative to implement strategies that guide the program to future success. Both projects also require strategic planning and the development of tools and tactics that emphasize collaboration and collegiality.

Q: Do the failing programs you help to rebuild have characteristics in common?

A: Common themes include lack of planning and consensus-building before program start-up, inadequate tools and strategies to support effective practice management, and failure to align the hospitalist practice and sponsoring hospital’s goals and vision. Another common problem is the absence of a hospitalist recruitment and retention plan, which may lead to provider turnover and program instability.

Many programs experience problems due to ineffective leadership, poor implementation and follow-through, and lack of both a short- and long-term strategic plan. Some programs are victims of their own success. The program is not properly prepared to handle the demand for its services and grow accordingly.

Q: You help programs create effective recruitment and retention plans. You also wrote a book on the subject. Why are recruitment and retention challenging for so many programs?

A: The primary contributor is that [hospitalist] supply falls significantly short of physician demand. A secondary contributor is the generational expectations of the younger physician workforce. … In addition, leaders may not prioritize recruitment and retention because they lack an appreciation for the consequences of failed efforts.

Q: What advice would you offer hospitalist program leaders about how they can improve those aspects of their programs?

A: No. 1, create an effective recruitment and retention plan and execute the plan with precision. No. 2, approach recruitment and retention with the same attention to detail as you approach patient care.

Q: You’re offering best-practice advice to help your clients develop and sustain effective programs. What advice do you find yourself giving to your clients that you wish someone gave to you early in your career?

A: From my perspective as a hospitalist administrative director, the advice I would offer is for individuals to believe in themselves and stay engaged. If you feel you have something to offer to the practice or healthcare system as a whole, share it with the appropriate parties. If you experience problems within the workplace, seek resolution in a timely manner. Stay positive and be part of the solution, not part of the problem.

Q: You have written two hospitalist books and coauthored two others. Do you have plans to write another?

A: I wouldn’t say I have immediate plans, but I am always thinking about topics and other projects that would provide value to readers. I’ve got some exciting ideas for future projects, but they are in a very early stage of development.

Q: How would you compare the feeling you get from finishing a book with the satisfaction you derive from other aspects of your career?

A: Writing a book is a highly personal accomplishment for me, while caring for patients is more of a team accomplishment that involves the patient, family, and other healthcare professionals. Typically, the completion of a book is a finite event, while caring for a patient is a long-term commitment.

Q: What is your biggest professional reward?

A: Helping people, whether they are patients in my role as physician, or other professionals—physicians, practice administrators, and hospital administrators—in my role as a practice management consultant. Whenever I reflect on my career, I tell myself how lucky I am. There are not many professions or individuals who have an opportunity to close the door behind them and have other human beings entrust them with their most intimate information. Also, there are very few individuals who are able to impact the delivery of medical care from a systems perspective. I get to do both, and for that I am most grateful.

Q: What is your biggest professional challenge?

A: Saying “no” when someone asks for help. There is nothing more rewarding for me than to help others. With that said, I try not to overextend myself, because that wouldn’t be fair to my family, colleagues, friends, or clients.

Q: What’s next for you professionally?

A: I will continue to concentrate my effort on building my hospitalist consultative practice and expanding the services I offer. In addition, I’m always tempted to explore the valley of the unknown. What excites me is venturing into new areas and to challenge myself to grow as both an individual and professional. TH

Mark Leiser is a freelance writer based in New Jersey.

Case

A 46-year-old woman with Addison’s disease and type II diabetes presents with one day of right leg pain, swelling, and redness. She has had mild nausea and vomiting over the past week, with an episode of diarrhea three days prior. She takes hydrocortisone 30mg in the morning and 10mg at bedtime, as well as fludrocortisone 0.2mg in the morning. She is afebrile with a pulse of 108 beats per minute. Her initial blood pressure was 74/49 mmHg, which improved to 84/45 mmHg following one liter of normal saline. She is mentating appropriately. The physical exam is significant for a large, tender area of erythema and warmth from the right ankle to mid-calf. She is admitted for cellulitis and intravenous antibiotics are initiated.

Does she require an increase in her glucocorticoid dose during her acute illness?

Overview

Adrenal insufficiency occurs in approximately 5 out of every 10,000 people and results from primary failure of the adrenal gland, or secondary impairment of the hypothalamic-pituitary-adrenal (HPA) axis, which regulates cortisol secretion.1 In developed countries, 90% of primary adrenal insufficiency (Addison’s disease) cases are due to autoimmune adrenalitis, which might occur in isolation or as part of an autoimmune polyglandular syndrome.^1,2 Secondary adrenal insufficiency is most commonly the result of chronic glucocorticoid therapy, though lesions involving the hypothalamus or pituitary gland might be implicated.^2,3

In a healthy individual, cortisol is secreted in a diurnal pattern from the adrenal glands under the control of corticotropin (ACTH) produced by the pituitary gland and corticotropin-releasing hormone (CRH) produced by the hypothalamus (see Figure 1, p. 19). In the normal state, during periods of such systemic stress as illness, trauma, burns, or surgery, cortisol production increases to a degree roughly proportional to the degree of illness (as much as sixfold).^4,5 Patients with adrenal insufficiency are unable to mount an appropriate cortisol response and, therefore, are at risk for adrenal crisis—a life-threatening condition characterized by hypotension and hypovolemic shock.

Although recommendations for high-dose intravenous steroids in adrenally insufficient patients who are critically ill or undergoing surgery have been extensively discussed in the literature, there are relatively few data regarding the appropriate management of adrenal insufficiency in patients hospitalized for noncritical illness.

Several recent studies have investigated the patient characteristics, situations, and conditions most likely to provoke adrenal crisis in order to establish guidelines dictating the use of supra-physiologic steroid dosing.

Review of the Data

Studies have estimated the prevalence of adrenal crisis in patients with underlying insufficiency at 3.3 to 6.3 events per 100 patient years, with 42% of patients reporting at least one crisis.^2,5,6 A recent survey of 982 patients with Addison’s disease in the United Kingdom reported an 8% annual frequency.⁷

A retrospective Japanese study reviewed the medical charts of 137 adult patients receiving steroid replacement for established primary or secondary adrenal insufficiency. The authors noted a significant positive association between adrenal crisis and long-term steroid replacement (>4 years), concomitant mental disorder, and sex hormone deficiency. A combination of any of these factors further increased the risk.⁸

A more recent survey of 444 patients ages 17-81 assessed independent risk factors for adrenal crisis in the setting of primary (N=254) or secondary (N=190) adrenal insufficiency. The incidence of crisis was higher in primary versus secondary insufficiency. In patients with primary insufficiency, concomitant, non-endocrine disorders increased the risk of adrenal crisis, whereas diabetes insipidus and female gender increased risk in patients with secondary insufficiency. This same study also investigated events leading to a crisis and found gastrointestinal infection to be the most frequent factor, followed by other infectious or febrile illnesses. Overall, infection comprised 45% of all identified triggers.⁶

A similar study conducted by White and Arlt evaluated 841 Addison’s patients in the United Kingdom, Canada, Australia, and New Zealand.⁷ Again, gastrointestinal illness was the most common provoking factor, responsible for 56% of all reported crises. Flulike illness followed at 11%, followed by infections and surgical procedures at 6% each. This study found a higher risk of crisis in patients with diabetes (type I or II), premature ovarian failure, and asthma; the presence of multiple comorbidities further increased risk.

click for large version

Medications. Glucocorticoid therapy is known to suppress the HPA axis. Although it was once believed that the duration and dose of therapy correlated directly with the degree of HPA suppression, more recent studies have failed to find any definite relationship.⁹ Patients taking the equivalent of 5mg of prednisone per day should continue to have an intact HPA axis, as this dose mimics physiologic secretion of cortisol in a healthy individual.³

However, the dose and duration of therapy at which suppression occurs is highly variable between patients. In general, patients on 7.5mg of prednisone or more per day for at least three weeks should be considered to be suppressed.^3,9 Additionally, progesterone derivatives (i.e., megestrol) have glucocorticoid activity and might suppress HPA function. Other medications that might have related effects are those that inhibit enzymes involved in cortisol synthesis; ketoconazole and etomidate are common examples. Rifampin and several classes of anti-epileptic drugs induce enzymes, which increase hepatic metabolism of cortisol (see Table 1, p. 18).

Hyperthyroidism. Thyroid hormone is involved in the metabolism of cortisol, thus an increase in T4 correlates with lower levels. Adrenal insufficiency and thyroid disease might coexist within the autoimmune polyglandular syndrome. Initiation or uptitration of thyroid replacement should be avoided if acute adrenal insufficiency is suspected, as this might provoke an adrenal crisis. Conversely, any patient with adrenal insufficiency who has uncontrolled hyperthyroidism should receive two to three times their usual glucocorticoid replacement.^1,2

Pregnancy. Levels of cortisol-binding globulin increase throughout pregnancy. In women with intact adrenal function, free cortisol levels also rise during the third trimester. Therefore, glucocorticoid replacement should be increased by 50% during the last three months of pregnancy.²

click for large version

Acute illness. The cortisol response to stress is highly variable and dependent on a number of factors, including age, underlying health, and genetics. In general, most experts recommend doubling or tripling the daily replacement dose during mild to moderate illness until recovery (often referred to as the “sick-day rules”). What constitutes “recovery” is not clearly defined. When oral intake is compromised, as with vomiting or diarrhea, parenteral administration of steroids is recommended.^1-5,9,10 Patients with adrenal insufficiency should be provided an emergency injection kit to use and further counseled to seek medical attention. Injection kits typically consist of 100mg of hydrocortisone or 4mg of dexamethasone, although other glucocorticoids may be used (see Table 2, above left, for conversions).

Limited data are available to support guidelines for glucocorticoid adjustment during acute, non-critical illness. Published guidelines vary both in illness categorization and category-specific recommendations (see Table 3, below).

click for large version

Coursin and Wood devised a set of guidelines based on a literature review and consultation with experts, categorizing medical illness as minor, moderate, severe, and critical (see Table 3).³ For noncritical illness, they recommended continuation of standard replacement therapy with an additional, once-daily dose, which varied according to illness severity.

Cooper and Stewart conducted a similar review, basing their guidelines on a categorization of mild, moderate, severe/critical, or septic shock. These guidelines recommended a total daily dose of glucocorticoid supplementation, rather than an addition of a single dose to current therapy. They also stated that the least severe category of illness (defined as mild) did not require any change to a patient’s regular therapy.⁴

Jung et al classified illness as minimal, minor, moderate, severe, and critical.⁹ Under these guidelines, supplemental therapy was not advised for minimal (nonfebrile) illness. Moderate illness, including cellulitis, warranted a doubling or tripling of the outpatient dose until recovery, which was consistent with prior expert recommendation. More severe illness warranted intravenous administration of steroids.

Back to the Case

The patient had a mild case of cellulitis, classified by most experts as moderate illness, which responded well to vancomycin. Her outpatient glucocorticoid dose was doubled on admission and administered orally for the duration of her hospitalization, as she had no further episodes of vomiting or diarrhea.

Review of the patient’s records from prior hospitalizations and ambulatory visits revealed that her systolic blood pressure typically ran in the 80 mmHg to 100 mmHg range. Following initial volume resuscitation, her systolic blood pressure remained in the 90-100 mmHg range.

She was discharged home in stable condition, with instructions to complete a course of oral trimethoprim/sulfamethoxazole, resume her baseline dose of hydrocortisone the day after discharge, and follow up with her PCP for further monitoring and adjustment of her adrenal replacement therapy.

Bottom Line

For adults with adrenal insufficiency hospitalized with noncritical, nonsurgical illness, the expert recommendation is to double or triple the usual outpatient dose of glucocorticoid; however, data to support this is limited, and each patient should be assessed carefully and monitored to determine the optimal dose adjustment. TH

Dr. Shaw is a resident in the Department of Medicine at the University of Washington School of Medicine in Seattle. Dr. Best is an assistant professor of medicine in the division of general internal medicine, University of Washington School of Medicine.

References

1. Arlt W. The approach to the adult with newly diagnosed adrenal insufficiency. J Clin Endocrinol Metab. 2009;94(4):1059-1067.
2. Arlt W, Allolio B. Adrenal insufficiency. Lancet. 2003; 361:1881-1893.
3. Coursin DB, Wood KE. Corticosteroid supplementation for adrenal insufficiency. JAMA. 2002;287:236-240.
4. Cooper MS, Stewart PM. Corticosteroid insufficiency in acutely ill patients. N Engl J Med. 2003;348:727-734.
5. Hahner S, Allolio B. Therapeutic management of adrenal insufficiency. Best Pract Res Clin Endocrinol Metab. 2009;23:167-179.
6. Hahner S, Loeffler M, Bleicken B, et al. Epidemiology of adrenal crisis in chronic adrenal insufficiency: the need for new prevention strategies. Eur J Endocrinol. 2010;162:597:602.
7. White K, Arlt W. Adrenal crisis in treated Addison’s disease: a predictable but under-managed event. Eur J Endocrinol. 2010;162:115-120.
8. Omori K, Nomura K, Shimizu S, Omori N, Takano K. Risk factors for adrenal crises in patients with adrenal insufficiency. Endocr J. 2003;50:745-752.
9. Jung C, Inder WJ. Management of adrenal insufficiency during the stress of medical illness and surgery. Med J Aust. 2008;188:409-413.
10. Crown A, Lightman S. Why is the management of glucocorticoid deficiency still controversial: a review of the literature. Clin Endocrinol. 2005;63:483-492.

Case

A 46-year-old woman with Addison’s disease and type II diabetes presents with one day of right leg pain, swelling, and redness. She has had mild nausea and vomiting over the past week, with an episode of diarrhea three days prior. She takes hydrocortisone 30mg in the morning and 10mg at bedtime, as well as fludrocortisone 0.2mg in the morning. She is afebrile with a pulse of 108 beats per minute. Her initial blood pressure was 74/49 mmHg, which improved to 84/45 mmHg following one liter of normal saline. She is mentating appropriately. The physical exam is significant for a large, tender area of erythema and warmth from the right ankle to mid-calf. She is admitted for cellulitis and intravenous antibiotics are initiated.

Does she require an increase in her glucocorticoid dose during her acute illness?

Overview

Adrenal insufficiency occurs in approximately 5 out of every 10,000 people and results from primary failure of the adrenal gland, or secondary impairment of the hypothalamic-pituitary-adrenal (HPA) axis, which regulates cortisol secretion.1 In developed countries, 90% of primary adrenal insufficiency (Addison’s disease) cases are due to autoimmune adrenalitis, which might occur in isolation or as part of an autoimmune polyglandular syndrome.^1,2 Secondary adrenal insufficiency is most commonly the result of chronic glucocorticoid therapy, though lesions involving the hypothalamus or pituitary gland might be implicated.^2,3

In a healthy individual, cortisol is secreted in a diurnal pattern from the adrenal glands under the control of corticotropin (ACTH) produced by the pituitary gland and corticotropin-releasing hormone (CRH) produced by the hypothalamus (see Figure 1, p. 19). In the normal state, during periods of such systemic stress as illness, trauma, burns, or surgery, cortisol production increases to a degree roughly proportional to the degree of illness (as much as sixfold).^4,5 Patients with adrenal insufficiency are unable to mount an appropriate cortisol response and, therefore, are at risk for adrenal crisis—a life-threatening condition characterized by hypotension and hypovolemic shock.

Although recommendations for high-dose intravenous steroids in adrenally insufficient patients who are critically ill or undergoing surgery have been extensively discussed in the literature, there are relatively few data regarding the appropriate management of adrenal insufficiency in patients hospitalized for noncritical illness.

Several recent studies have investigated the patient characteristics, situations, and conditions most likely to provoke adrenal crisis in order to establish guidelines dictating the use of supra-physiologic steroid dosing.

Review of the Data

Studies have estimated the prevalence of adrenal crisis in patients with underlying insufficiency at 3.3 to 6.3 events per 100 patient years, with 42% of patients reporting at least one crisis.^2,5,6 A recent survey of 982 patients with Addison’s disease in the United Kingdom reported an 8% annual frequency.⁷

A retrospective Japanese study reviewed the medical charts of 137 adult patients receiving steroid replacement for established primary or secondary adrenal insufficiency. The authors noted a significant positive association between adrenal crisis and long-term steroid replacement (>4 years), concomitant mental disorder, and sex hormone deficiency. A combination of any of these factors further increased the risk.⁸

A more recent survey of 444 patients ages 17-81 assessed independent risk factors for adrenal crisis in the setting of primary (N=254) or secondary (N=190) adrenal insufficiency. The incidence of crisis was higher in primary versus secondary insufficiency. In patients with primary insufficiency, concomitant, non-endocrine disorders increased the risk of adrenal crisis, whereas diabetes insipidus and female gender increased risk in patients with secondary insufficiency. This same study also investigated events leading to a crisis and found gastrointestinal infection to be the most frequent factor, followed by other infectious or febrile illnesses. Overall, infection comprised 45% of all identified triggers.⁶

A similar study conducted by White and Arlt evaluated 841 Addison’s patients in the United Kingdom, Canada, Australia, and New Zealand.⁷ Again, gastrointestinal illness was the most common provoking factor, responsible for 56% of all reported crises. Flulike illness followed at 11%, followed by infections and surgical procedures at 6% each. This study found a higher risk of crisis in patients with diabetes (type I or II), premature ovarian failure, and asthma; the presence of multiple comorbidities further increased risk.

click for large version

Medications. Glucocorticoid therapy is known to suppress the HPA axis. Although it was once believed that the duration and dose of therapy correlated directly with the degree of HPA suppression, more recent studies have failed to find any definite relationship.⁹ Patients taking the equivalent of 5mg of prednisone per day should continue to have an intact HPA axis, as this dose mimics physiologic secretion of cortisol in a healthy individual.³

However, the dose and duration of therapy at which suppression occurs is highly variable between patients. In general, patients on 7.5mg of prednisone or more per day for at least three weeks should be considered to be suppressed.^3,9 Additionally, progesterone derivatives (i.e., megestrol) have glucocorticoid activity and might suppress HPA function. Other medications that might have related effects are those that inhibit enzymes involved in cortisol synthesis; ketoconazole and etomidate are common examples. Rifampin and several classes of anti-epileptic drugs induce enzymes, which increase hepatic metabolism of cortisol (see Table 1, p. 18).

Hyperthyroidism. Thyroid hormone is involved in the metabolism of cortisol, thus an increase in T4 correlates with lower levels. Adrenal insufficiency and thyroid disease might coexist within the autoimmune polyglandular syndrome. Initiation or uptitration of thyroid replacement should be avoided if acute adrenal insufficiency is suspected, as this might provoke an adrenal crisis. Conversely, any patient with adrenal insufficiency who has uncontrolled hyperthyroidism should receive two to three times their usual glucocorticoid replacement.^1,2

Pregnancy. Levels of cortisol-binding globulin increase throughout pregnancy. In women with intact adrenal function, free cortisol levels also rise during the third trimester. Therefore, glucocorticoid replacement should be increased by 50% during the last three months of pregnancy.²

click for large version

Acute illness. The cortisol response to stress is highly variable and dependent on a number of factors, including age, underlying health, and genetics. In general, most experts recommend doubling or tripling the daily replacement dose during mild to moderate illness until recovery (often referred to as the “sick-day rules”). What constitutes “recovery” is not clearly defined. When oral intake is compromised, as with vomiting or diarrhea, parenteral administration of steroids is recommended.^1-5,9,10 Patients with adrenal insufficiency should be provided an emergency injection kit to use and further counseled to seek medical attention. Injection kits typically consist of 100mg of hydrocortisone or 4mg of dexamethasone, although other glucocorticoids may be used (see Table 2, above left, for conversions).

Limited data are available to support guidelines for glucocorticoid adjustment during acute, non-critical illness. Published guidelines vary both in illness categorization and category-specific recommendations (see Table 3, below).

click for large version

Coursin and Wood devised a set of guidelines based on a literature review and consultation with experts, categorizing medical illness as minor, moderate, severe, and critical (see Table 3).³ For noncritical illness, they recommended continuation of standard replacement therapy with an additional, once-daily dose, which varied according to illness severity.

Cooper and Stewart conducted a similar review, basing their guidelines on a categorization of mild, moderate, severe/critical, or septic shock. These guidelines recommended a total daily dose of glucocorticoid supplementation, rather than an addition of a single dose to current therapy. They also stated that the least severe category of illness (defined as mild) did not require any change to a patient’s regular therapy.⁴

Jung et al classified illness as minimal, minor, moderate, severe, and critical.⁹ Under these guidelines, supplemental therapy was not advised for minimal (nonfebrile) illness. Moderate illness, including cellulitis, warranted a doubling or tripling of the outpatient dose until recovery, which was consistent with prior expert recommendation. More severe illness warranted intravenous administration of steroids.

Back to the Case

The patient had a mild case of cellulitis, classified by most experts as moderate illness, which responded well to vancomycin. Her outpatient glucocorticoid dose was doubled on admission and administered orally for the duration of her hospitalization, as she had no further episodes of vomiting or diarrhea.

Review of the patient’s records from prior hospitalizations and ambulatory visits revealed that her systolic blood pressure typically ran in the 80 mmHg to 100 mmHg range. Following initial volume resuscitation, her systolic blood pressure remained in the 90-100 mmHg range.

She was discharged home in stable condition, with instructions to complete a course of oral trimethoprim/sulfamethoxazole, resume her baseline dose of hydrocortisone the day after discharge, and follow up with her PCP for further monitoring and adjustment of her adrenal replacement therapy.

Bottom Line

For adults with adrenal insufficiency hospitalized with noncritical, nonsurgical illness, the expert recommendation is to double or triple the usual outpatient dose of glucocorticoid; however, data to support this is limited, and each patient should be assessed carefully and monitored to determine the optimal dose adjustment. TH

Dr. Shaw is a resident in the Department of Medicine at the University of Washington School of Medicine in Seattle. Dr. Best is an assistant professor of medicine in the division of general internal medicine, University of Washington School of Medicine.

References

1. Arlt W. The approach to the adult with newly diagnosed adrenal insufficiency. J Clin Endocrinol Metab. 2009;94(4):1059-1067.
2. Arlt W, Allolio B. Adrenal insufficiency. Lancet. 2003; 361:1881-1893.
3. Coursin DB, Wood KE. Corticosteroid supplementation for adrenal insufficiency. JAMA. 2002;287:236-240.
4. Cooper MS, Stewart PM. Corticosteroid insufficiency in acutely ill patients. N Engl J Med. 2003;348:727-734.
5. Hahner S, Allolio B. Therapeutic management of adrenal insufficiency. Best Pract Res Clin Endocrinol Metab. 2009;23:167-179.
6. Hahner S, Loeffler M, Bleicken B, et al. Epidemiology of adrenal crisis in chronic adrenal insufficiency: the need for new prevention strategies. Eur J Endocrinol. 2010;162:597:602.
7. White K, Arlt W. Adrenal crisis in treated Addison’s disease: a predictable but under-managed event. Eur J Endocrinol. 2010;162:115-120.
8. Omori K, Nomura K, Shimizu S, Omori N, Takano K. Risk factors for adrenal crises in patients with adrenal insufficiency. Endocr J. 2003;50:745-752.
9. Jung C, Inder WJ. Management of adrenal insufficiency during the stress of medical illness and surgery. Med J Aust. 2008;188:409-413.
10. Crown A, Lightman S. Why is the management of glucocorticoid deficiency still controversial: a review of the literature. Clin Endocrinol. 2005;63:483-492.

Case

A 46-year-old woman with Addison’s disease and type II diabetes presents with one day of right leg pain, swelling, and redness. She has had mild nausea and vomiting over the past week, with an episode of diarrhea three days prior. She takes hydrocortisone 30mg in the morning and 10mg at bedtime, as well as fludrocortisone 0.2mg in the morning. She is afebrile with a pulse of 108 beats per minute. Her initial blood pressure was 74/49 mmHg, which improved to 84/45 mmHg following one liter of normal saline. She is mentating appropriately. The physical exam is significant for a large, tender area of erythema and warmth from the right ankle to mid-calf. She is admitted for cellulitis and intravenous antibiotics are initiated.

Does she require an increase in her glucocorticoid dose during her acute illness?

Overview

Adrenal insufficiency occurs in approximately 5 out of every 10,000 people and results from primary failure of the adrenal gland, or secondary impairment of the hypothalamic-pituitary-adrenal (HPA) axis, which regulates cortisol secretion.1 In developed countries, 90% of primary adrenal insufficiency (Addison’s disease) cases are due to autoimmune adrenalitis, which might occur in isolation or as part of an autoimmune polyglandular syndrome.^1,2 Secondary adrenal insufficiency is most commonly the result of chronic glucocorticoid therapy, though lesions involving the hypothalamus or pituitary gland might be implicated.^2,3

In a healthy individual, cortisol is secreted in a diurnal pattern from the adrenal glands under the control of corticotropin (ACTH) produced by the pituitary gland and corticotropin-releasing hormone (CRH) produced by the hypothalamus (see Figure 1, p. 19). In the normal state, during periods of such systemic stress as illness, trauma, burns, or surgery, cortisol production increases to a degree roughly proportional to the degree of illness (as much as sixfold).^4,5 Patients with adrenal insufficiency are unable to mount an appropriate cortisol response and, therefore, are at risk for adrenal crisis—a life-threatening condition characterized by hypotension and hypovolemic shock.

Although recommendations for high-dose intravenous steroids in adrenally insufficient patients who are critically ill or undergoing surgery have been extensively discussed in the literature, there are relatively few data regarding the appropriate management of adrenal insufficiency in patients hospitalized for noncritical illness.

Several recent studies have investigated the patient characteristics, situations, and conditions most likely to provoke adrenal crisis in order to establish guidelines dictating the use of supra-physiologic steroid dosing.

Review of the Data

Studies have estimated the prevalence of adrenal crisis in patients with underlying insufficiency at 3.3 to 6.3 events per 100 patient years, with 42% of patients reporting at least one crisis.^2,5,6 A recent survey of 982 patients with Addison’s disease in the United Kingdom reported an 8% annual frequency.⁷

A retrospective Japanese study reviewed the medical charts of 137 adult patients receiving steroid replacement for established primary or secondary adrenal insufficiency. The authors noted a significant positive association between adrenal crisis and long-term steroid replacement (>4 years), concomitant mental disorder, and sex hormone deficiency. A combination of any of these factors further increased the risk.⁸

A more recent survey of 444 patients ages 17-81 assessed independent risk factors for adrenal crisis in the setting of primary (N=254) or secondary (N=190) adrenal insufficiency. The incidence of crisis was higher in primary versus secondary insufficiency. In patients with primary insufficiency, concomitant, non-endocrine disorders increased the risk of adrenal crisis, whereas diabetes insipidus and female gender increased risk in patients with secondary insufficiency. This same study also investigated events leading to a crisis and found gastrointestinal infection to be the most frequent factor, followed by other infectious or febrile illnesses. Overall, infection comprised 45% of all identified triggers.⁶

A similar study conducted by White and Arlt evaluated 841 Addison’s patients in the United Kingdom, Canada, Australia, and New Zealand.⁷ Again, gastrointestinal illness was the most common provoking factor, responsible for 56% of all reported crises. Flulike illness followed at 11%, followed by infections and surgical procedures at 6% each. This study found a higher risk of crisis in patients with diabetes (type I or II), premature ovarian failure, and asthma; the presence of multiple comorbidities further increased risk.

click for large version

Medications. Glucocorticoid therapy is known to suppress the HPA axis. Although it was once believed that the duration and dose of therapy correlated directly with the degree of HPA suppression, more recent studies have failed to find any definite relationship.⁹ Patients taking the equivalent of 5mg of prednisone per day should continue to have an intact HPA axis, as this dose mimics physiologic secretion of cortisol in a healthy individual.³

However, the dose and duration of therapy at which suppression occurs is highly variable between patients. In general, patients on 7.5mg of prednisone or more per day for at least three weeks should be considered to be suppressed.^3,9 Additionally, progesterone derivatives (i.e., megestrol) have glucocorticoid activity and might suppress HPA function. Other medications that might have related effects are those that inhibit enzymes involved in cortisol synthesis; ketoconazole and etomidate are common examples. Rifampin and several classes of anti-epileptic drugs induce enzymes, which increase hepatic metabolism of cortisol (see Table 1, p. 18).

Hyperthyroidism. Thyroid hormone is involved in the metabolism of cortisol, thus an increase in T4 correlates with lower levels. Adrenal insufficiency and thyroid disease might coexist within the autoimmune polyglandular syndrome. Initiation or uptitration of thyroid replacement should be avoided if acute adrenal insufficiency is suspected, as this might provoke an adrenal crisis. Conversely, any patient with adrenal insufficiency who has uncontrolled hyperthyroidism should receive two to three times their usual glucocorticoid replacement.^1,2

Pregnancy. Levels of cortisol-binding globulin increase throughout pregnancy. In women with intact adrenal function, free cortisol levels also rise during the third trimester. Therefore, glucocorticoid replacement should be increased by 50% during the last three months of pregnancy.²

click for large version

Acute illness. The cortisol response to stress is highly variable and dependent on a number of factors, including age, underlying health, and genetics. In general, most experts recommend doubling or tripling the daily replacement dose during mild to moderate illness until recovery (often referred to as the “sick-day rules”). What constitutes “recovery” is not clearly defined. When oral intake is compromised, as with vomiting or diarrhea, parenteral administration of steroids is recommended.^1-5,9,10 Patients with adrenal insufficiency should be provided an emergency injection kit to use and further counseled to seek medical attention. Injection kits typically consist of 100mg of hydrocortisone or 4mg of dexamethasone, although other glucocorticoids may be used (see Table 2, above left, for conversions).

Limited data are available to support guidelines for glucocorticoid adjustment during acute, non-critical illness. Published guidelines vary both in illness categorization and category-specific recommendations (see Table 3, below).

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Coursin and Wood devised a set of guidelines based on a literature review and consultation with experts, categorizing medical illness as minor, moderate, severe, and critical (see Table 3).³ For noncritical illness, they recommended continuation of standard replacement therapy with an additional, once-daily dose, which varied according to illness severity.

Cooper and Stewart conducted a similar review, basing their guidelines on a categorization of mild, moderate, severe/critical, or septic shock. These guidelines recommended a total daily dose of glucocorticoid supplementation, rather than an addition of a single dose to current therapy. They also stated that the least severe category of illness (defined as mild) did not require any change to a patient’s regular therapy.⁴

Jung et al classified illness as minimal, minor, moderate, severe, and critical.⁹ Under these guidelines, supplemental therapy was not advised for minimal (nonfebrile) illness. Moderate illness, including cellulitis, warranted a doubling or tripling of the outpatient dose until recovery, which was consistent with prior expert recommendation. More severe illness warranted intravenous administration of steroids.

Back to the Case

The patient had a mild case of cellulitis, classified by most experts as moderate illness, which responded well to vancomycin. Her outpatient glucocorticoid dose was doubled on admission and administered orally for the duration of her hospitalization, as she had no further episodes of vomiting or diarrhea.

Review of the patient’s records from prior hospitalizations and ambulatory visits revealed that her systolic blood pressure typically ran in the 80 mmHg to 100 mmHg range. Following initial volume resuscitation, her systolic blood pressure remained in the 90-100 mmHg range.

She was discharged home in stable condition, with instructions to complete a course of oral trimethoprim/sulfamethoxazole, resume her baseline dose of hydrocortisone the day after discharge, and follow up with her PCP for further monitoring and adjustment of her adrenal replacement therapy.

Bottom Line

For adults with adrenal insufficiency hospitalized with noncritical, nonsurgical illness, the expert recommendation is to double or triple the usual outpatient dose of glucocorticoid; however, data to support this is limited, and each patient should be assessed carefully and monitored to determine the optimal dose adjustment. TH

Dr. Shaw is a resident in the Department of Medicine at the University of Washington School of Medicine in Seattle. Dr. Best is an assistant professor of medicine in the division of general internal medicine, University of Washington School of Medicine.

References

1. Arlt W. The approach to the adult with newly diagnosed adrenal insufficiency. J Clin Endocrinol Metab. 2009;94(4):1059-1067.
2. Arlt W, Allolio B. Adrenal insufficiency. Lancet. 2003; 361:1881-1893.
3. Coursin DB, Wood KE. Corticosteroid supplementation for adrenal insufficiency. JAMA. 2002;287:236-240.
4. Cooper MS, Stewart PM. Corticosteroid insufficiency in acutely ill patients. N Engl J Med. 2003;348:727-734.
5. Hahner S, Allolio B. Therapeutic management of adrenal insufficiency. Best Pract Res Clin Endocrinol Metab. 2009;23:167-179.
6. Hahner S, Loeffler M, Bleicken B, et al. Epidemiology of adrenal crisis in chronic adrenal insufficiency: the need for new prevention strategies. Eur J Endocrinol. 2010;162:597:602.
7. White K, Arlt W. Adrenal crisis in treated Addison’s disease: a predictable but under-managed event. Eur J Endocrinol. 2010;162:115-120.
8. Omori K, Nomura K, Shimizu S, Omori N, Takano K. Risk factors for adrenal crises in patients with adrenal insufficiency. Endocr J. 2003;50:745-752.
9. Jung C, Inder WJ. Management of adrenal insufficiency during the stress of medical illness and surgery. Med J Aust. 2008;188:409-413.
10. Crown A, Lightman S. Why is the management of glucocorticoid deficiency still controversial: a review of the literature. Clin Endocrinol. 2005;63:483-492.

Although the term “hospitalist” was coined in 1996 in a New England Journal of Medicine article, the field of HM grew organically from pressure to optimize hospital economics and improve efficiency in economically pressed healthcare markets.¹

Scholarship in HM has also grown and now includes regular publications of investigations exploring optimization of efficiency and quality, many with an emphasis on patient safety. In this way, HM is a unique field, with tools for approaching problems that aren’t commonly used in other branches of medicine.

In parallel to the emergence of HM as a field distinct from general internal medicine (IM), the HM fellowship is similar but distinct. Such fellowships serve multiple purposes.

HM fellowships can add clinical expertise and scholarship skills for a career in HM. While early HM research focused on proving the value of the hospitalist model, the field has expanded greatly for those interested in an academic career. The molding of a safer, more efficient hospital of the future depends on the creativity and scholarship of HM leaders. Further, experts suggest that with its unique emphasis on quality, safety, and efficiency, the field will be a key player in healthcare reform.² Its strength lies in traditional clinical research, as well as further adoption of lessons from other fields including industry, ethnography, and public health.³ As such, fellowships to train future leaders and researchers is essential.

SHM’s website (www.hospitalmedicine.org/fellowships) lists dozens of IM hospitalist fellowships, as well as programs in family practice, pediatrics, and psychiatry. These programs last from one to three years, accept from one to six fellows per year, and exist in locations throughout the U.S. and Canada.

An excellent description of the nature and scope of pediatric HM fellowships was published last year in the Journal of Hospital Medicine.⁴ Descriptions of IM and HM fellowships also have been published.^3,5

Hospitalist fellowships, like IM fellowships, aren’t credentialed by a governing body. In contrast to subspecialty fellowships, no separate specialty board exam is required for admittance to the field after completion of fellowship. HM positions do not require training after residency, and HM job opportunities continue to outpace the available workforce. This is the basis for the most important question confronting anyone considering such a fellowship: How is a fellowship of benefit to a career as a hospitalist?

Program Types

Ranji and colleagues wrote that the “goal of hospital medicine fellowship training is to produce clinicians who are trained explicitly in studying and optimizing medical care of the hospitalized patient and in disseminating that knowledge for the advancement of patient care.”³ A review of information available for the different programs reveals two distinct approaches to this goal, with much overlap but distinct emphases:

Clinical programs usually last one year with a majority of time spent filling clinical responsibilities. In addition to providing focused exposure to HM with an emphasis on the Core Competencies in Hospital Medicine as outlined by SHM, such a program generally expands a trainee’s clinical scope. Additional training in palliative care, the management of neurologic emergencies, and comanagement of surgical patients are likely to be a part of clinical practice but often are underemphasized during residency. Research expectations vary, but most clinical programs allot some time for quality-improvement (QI) projects.

Clinical fellowships also afford more leadership training than most jobs would offer in the period immediately following residency. It also offers the possibility of refining clinical skills and developing a clinical niche.

Academic programs last two years and are characterized by two to four months of clinical responsibility per year. They offer a formal teaching curriculum and provide dedicated training in research, health policy, or health economics.³ Research training varies from program to program. Most include basic biostatistics and research-method coursework at a minimum; others offer the option to pursue a graduate degree in clinical research or public health.

Academic programs also offer dedicated research mentorship.

Other Considerations

The value of an HM fellowship lies in career development. The decision to commit to a relatively low-paying fellowship can be a difficult one, especially given the debt burden most graduating residents bear and the abundance of high-paying HM jobs. It also is important for those interested in a career as an academic hospitalist to consider not only HM fellowships, but other programs as well, such as the Robert Wood Johnson Clinical Scholars Program (rwjcsp.unc.edu/about/index.html).

While all of the fellowship programs aren’t geared specifically toward the hospitalist, they often incorporate faculty with expertise that would benefit a future academic hospitalist. Of course, the best fit for an individual depends on their particular interests and needs.

Fellowship in HM can offer training in clinical skills, clinical research, teaching, and quality and patient safety. Anyone interested in an HM career should consider a fellowship an opportunity for career development in a young specialty entrenched in revolutionizing the care of hospitalized patients. Academic HM fellowships hold the promise of empowering tomorrow’s academic leaders with the tools to continue to move the field forward. TH

Dr. Mann is a fellow in the division of hospital medicine, Department of Medicine, at Mount Sinai School of Medicine in New York City. Dr. Markoff is associate division chief and fellowship director in the division of hospital medicine, Department of Medicine, at Mount Sinai School of Medicine in New York City.

References

1. Wachter RM. Reflections: the hospitalist movement a decade later. J Hosp Med. 2006;1(4):248-252.
2. Wachter RM. Keynote presentation. SHM national meeting. National Harbor, Md.: May 2010.
3. Ranji SR, Rosenman DJ, Amin AN, Kripalani S. Hospital medicine fellowships: works in progress. Am J Med. 2006;119(1):72.e1-e7.
4. Freed GL, Dunham KM, Research advisory committee of the American Board of Pediatrics. Characteristics of pediatric hospital medicine fellowships and training programs. J Hosp Med. 2009;4:157-163.
5. Arora V, Fang MC, Kripalani S, Amin AN. Preparing for “diastole”: advanced training opportunities for academic hospitalists. J Hosp Med. 2006;1(6):368-377.

Although the term “hospitalist” was coined in 1996 in a New England Journal of Medicine article, the field of HM grew organically from pressure to optimize hospital economics and improve efficiency in economically pressed healthcare markets.¹

Scholarship in HM has also grown and now includes regular publications of investigations exploring optimization of efficiency and quality, many with an emphasis on patient safety. In this way, HM is a unique field, with tools for approaching problems that aren’t commonly used in other branches of medicine.

In parallel to the emergence of HM as a field distinct from general internal medicine (IM), the HM fellowship is similar but distinct. Such fellowships serve multiple purposes.

HM fellowships can add clinical expertise and scholarship skills for a career in HM. While early HM research focused on proving the value of the hospitalist model, the field has expanded greatly for those interested in an academic career. The molding of a safer, more efficient hospital of the future depends on the creativity and scholarship of HM leaders. Further, experts suggest that with its unique emphasis on quality, safety, and efficiency, the field will be a key player in healthcare reform.² Its strength lies in traditional clinical research, as well as further adoption of lessons from other fields including industry, ethnography, and public health.³ As such, fellowships to train future leaders and researchers is essential.

SHM’s website (www.hospitalmedicine.org/fellowships) lists dozens of IM hospitalist fellowships, as well as programs in family practice, pediatrics, and psychiatry. These programs last from one to three years, accept from one to six fellows per year, and exist in locations throughout the U.S. and Canada.

An excellent description of the nature and scope of pediatric HM fellowships was published last year in the Journal of Hospital Medicine.⁴ Descriptions of IM and HM fellowships also have been published.^3,5

Hospitalist fellowships, like IM fellowships, aren’t credentialed by a governing body. In contrast to subspecialty fellowships, no separate specialty board exam is required for admittance to the field after completion of fellowship. HM positions do not require training after residency, and HM job opportunities continue to outpace the available workforce. This is the basis for the most important question confronting anyone considering such a fellowship: How is a fellowship of benefit to a career as a hospitalist?

Program Types

Ranji and colleagues wrote that the “goal of hospital medicine fellowship training is to produce clinicians who are trained explicitly in studying and optimizing medical care of the hospitalized patient and in disseminating that knowledge for the advancement of patient care.”³ A review of information available for the different programs reveals two distinct approaches to this goal, with much overlap but distinct emphases:

Clinical programs usually last one year with a majority of time spent filling clinical responsibilities. In addition to providing focused exposure to HM with an emphasis on the Core Competencies in Hospital Medicine as outlined by SHM, such a program generally expands a trainee’s clinical scope. Additional training in palliative care, the management of neurologic emergencies, and comanagement of surgical patients are likely to be a part of clinical practice but often are underemphasized during residency. Research expectations vary, but most clinical programs allot some time for quality-improvement (QI) projects.

Clinical fellowships also afford more leadership training than most jobs would offer in the period immediately following residency. It also offers the possibility of refining clinical skills and developing a clinical niche.

Academic programs last two years and are characterized by two to four months of clinical responsibility per year. They offer a formal teaching curriculum and provide dedicated training in research, health policy, or health economics.³ Research training varies from program to program. Most include basic biostatistics and research-method coursework at a minimum; others offer the option to pursue a graduate degree in clinical research or public health.

Academic programs also offer dedicated research mentorship.

Other Considerations

The value of an HM fellowship lies in career development. The decision to commit to a relatively low-paying fellowship can be a difficult one, especially given the debt burden most graduating residents bear and the abundance of high-paying HM jobs. It also is important for those interested in a career as an academic hospitalist to consider not only HM fellowships, but other programs as well, such as the Robert Wood Johnson Clinical Scholars Program (rwjcsp.unc.edu/about/index.html).

While all of the fellowship programs aren’t geared specifically toward the hospitalist, they often incorporate faculty with expertise that would benefit a future academic hospitalist. Of course, the best fit for an individual depends on their particular interests and needs.

Fellowship in HM can offer training in clinical skills, clinical research, teaching, and quality and patient safety. Anyone interested in an HM career should consider a fellowship an opportunity for career development in a young specialty entrenched in revolutionizing the care of hospitalized patients. Academic HM fellowships hold the promise of empowering tomorrow’s academic leaders with the tools to continue to move the field forward. TH

Dr. Mann is a fellow in the division of hospital medicine, Department of Medicine, at Mount Sinai School of Medicine in New York City. Dr. Markoff is associate division chief and fellowship director in the division of hospital medicine, Department of Medicine, at Mount Sinai School of Medicine in New York City.

References

1. Wachter RM. Reflections: the hospitalist movement a decade later. J Hosp Med. 2006;1(4):248-252.
2. Wachter RM. Keynote presentation. SHM national meeting. National Harbor, Md.: May 2010.
3. Ranji SR, Rosenman DJ, Amin AN, Kripalani S. Hospital medicine fellowships: works in progress. Am J Med. 2006;119(1):72.e1-e7.
4. Freed GL, Dunham KM, Research advisory committee of the American Board of Pediatrics. Characteristics of pediatric hospital medicine fellowships and training programs. J Hosp Med. 2009;4:157-163.
5. Arora V, Fang MC, Kripalani S, Amin AN. Preparing for “diastole”: advanced training opportunities for academic hospitalists. J Hosp Med. 2006;1(6):368-377.

Although the term “hospitalist” was coined in 1996 in a New England Journal of Medicine article, the field of HM grew organically from pressure to optimize hospital economics and improve efficiency in economically pressed healthcare markets.¹

Scholarship in HM has also grown and now includes regular publications of investigations exploring optimization of efficiency and quality, many with an emphasis on patient safety. In this way, HM is a unique field, with tools for approaching problems that aren’t commonly used in other branches of medicine.

In parallel to the emergence of HM as a field distinct from general internal medicine (IM), the HM fellowship is similar but distinct. Such fellowships serve multiple purposes.

HM fellowships can add clinical expertise and scholarship skills for a career in HM. While early HM research focused on proving the value of the hospitalist model, the field has expanded greatly for those interested in an academic career. The molding of a safer, more efficient hospital of the future depends on the creativity and scholarship of HM leaders. Further, experts suggest that with its unique emphasis on quality, safety, and efficiency, the field will be a key player in healthcare reform.² Its strength lies in traditional clinical research, as well as further adoption of lessons from other fields including industry, ethnography, and public health.³ As such, fellowships to train future leaders and researchers is essential.

SHM’s website (www.hospitalmedicine.org/fellowships) lists dozens of IM hospitalist fellowships, as well as programs in family practice, pediatrics, and psychiatry. These programs last from one to three years, accept from one to six fellows per year, and exist in locations throughout the U.S. and Canada.

An excellent description of the nature and scope of pediatric HM fellowships was published last year in the Journal of Hospital Medicine.⁴ Descriptions of IM and HM fellowships also have been published.^3,5

Hospitalist fellowships, like IM fellowships, aren’t credentialed by a governing body. In contrast to subspecialty fellowships, no separate specialty board exam is required for admittance to the field after completion of fellowship. HM positions do not require training after residency, and HM job opportunities continue to outpace the available workforce. This is the basis for the most important question confronting anyone considering such a fellowship: How is a fellowship of benefit to a career as a hospitalist?

Program Types

Ranji and colleagues wrote that the “goal of hospital medicine fellowship training is to produce clinicians who are trained explicitly in studying and optimizing medical care of the hospitalized patient and in disseminating that knowledge for the advancement of patient care.”³ A review of information available for the different programs reveals two distinct approaches to this goal, with much overlap but distinct emphases:

Clinical programs usually last one year with a majority of time spent filling clinical responsibilities. In addition to providing focused exposure to HM with an emphasis on the Core Competencies in Hospital Medicine as outlined by SHM, such a program generally expands a trainee’s clinical scope. Additional training in palliative care, the management of neurologic emergencies, and comanagement of surgical patients are likely to be a part of clinical practice but often are underemphasized during residency. Research expectations vary, but most clinical programs allot some time for quality-improvement (QI) projects.

Clinical fellowships also afford more leadership training than most jobs would offer in the period immediately following residency. It also offers the possibility of refining clinical skills and developing a clinical niche.

Academic programs last two years and are characterized by two to four months of clinical responsibility per year. They offer a formal teaching curriculum and provide dedicated training in research, health policy, or health economics.³ Research training varies from program to program. Most include basic biostatistics and research-method coursework at a minimum; others offer the option to pursue a graduate degree in clinical research or public health.

Academic programs also offer dedicated research mentorship.

Other Considerations

The value of an HM fellowship lies in career development. The decision to commit to a relatively low-paying fellowship can be a difficult one, especially given the debt burden most graduating residents bear and the abundance of high-paying HM jobs. It also is important for those interested in a career as an academic hospitalist to consider not only HM fellowships, but other programs as well, such as the Robert Wood Johnson Clinical Scholars Program (rwjcsp.unc.edu/about/index.html).

While all of the fellowship programs aren’t geared specifically toward the hospitalist, they often incorporate faculty with expertise that would benefit a future academic hospitalist. Of course, the best fit for an individual depends on their particular interests and needs.

Fellowship in HM can offer training in clinical skills, clinical research, teaching, and quality and patient safety. Anyone interested in an HM career should consider a fellowship an opportunity for career development in a young specialty entrenched in revolutionizing the care of hospitalized patients. Academic HM fellowships hold the promise of empowering tomorrow’s academic leaders with the tools to continue to move the field forward. TH

Dr. Mann is a fellow in the division of hospital medicine, Department of Medicine, at Mount Sinai School of Medicine in New York City. Dr. Markoff is associate division chief and fellowship director in the division of hospital medicine, Department of Medicine, at Mount Sinai School of Medicine in New York City.

References

1. Wachter RM. Reflections: the hospitalist movement a decade later. J Hosp Med. 2006;1(4):248-252.
2. Wachter RM. Keynote presentation. SHM national meeting. National Harbor, Md.: May 2010.
3. Ranji SR, Rosenman DJ, Amin AN, Kripalani S. Hospital medicine fellowships: works in progress. Am J Med. 2006;119(1):72.e1-e7.
4. Freed GL, Dunham KM, Research advisory committee of the American Board of Pediatrics. Characteristics of pediatric hospital medicine fellowships and training programs. J Hosp Med. 2009;4:157-163.
5. Arora V, Fang MC, Kripalani S, Amin AN. Preparing for “diastole”: advanced training opportunities for academic hospitalists. J Hosp Med. 2006;1(6):368-377.

Recent media reports about the dangers surrounding unused prescription medications, including abuse by teens and medications finding their way into the water supply, have prompted an increase in inquiries to healthcare providers about disposing of unused medication. These issues are complicated when controlled substances are involved.

Often, providers are unsure how to respond to patient questions about medication disposal. For example, what would you do if a patient requests an alternative medication because of an unwanted side effect and brings the originally prescribed medication back to you? What if the family of a recently expired patient brings unused medication to you and asks you to donate it to other patients? What if you have a colleague who performs mission work; could you accept and donate unused medication for use in another country?

Unfortunately, the Controlled Substances Act (CSA) does not provide a readily available mechanism to accomplish efficient, secure, and environmentally sound methods to collect and use or dispose of unwanted controlled substances. This article explains the rules physicians must adhere to and guidelines for “taking back” controlled substances.

The Legislation

Enacted in 1970, the CSA combined all existing federal drug laws into a single statute. It created five “schedules” in which certain drugs are classified. These “scheduled” drugs are commonly referred to as controlled substances. A drug’s classification depends on its potential for abuse and its currently accepted medical use in the U.S. Additionally, provisions of international treaties impact classification.

Under the classification system, Schedule I drugs have a high potential for abuse and have no currently accepted medical use in treatment in the U.S. In contrast, Schedule V drugs have a low potential for abuse and do have a currently accepted medical use in treatment in the U.S.

The CSA governs the manufacture, import, export, possession, use, and distribution of controlled substances. In doing so, the CSA established a system to register those authorized to handle controlled substances. Manufacturers, dispensers, distributors, and individual practitioners who prescribe controlled substances must be registered with the Drug Enforcement Administration (DEA).

The CSA requires registrants to keep certain records for at least two years related to their handling of controlled substances. For example, physician registrants must keep records of controlled substances in Schedules II, III, IV, and V that are dispensed via methods other than prescribing or administering (e.g., industry samples). Inventories of controlled substances are required. Most notably, physicians generally are not required to keep records of prescribed medications; however, records must be kept if drugs are dispensed or administered. Moreover, there are heightened recordkeeping responsibilities for providers who prescribe, dispense, or administer for maintenance or detoxification.

Controlled Substance “Takeback”

The system of registration established by the CSA prohibits a DEA registrant from acquiring controlled substances from nonregistered entities and, in turn, bars an end-user from distributing pharmaceutical controlled substances to a DEA registrant. In other words, physicians cannot receive controlled substances from anyone who does not also have a registration. Thus, physicians may not “take back” prescribed medications from patients or their family members. Similarly, except in cases of a drug being recalled or a dispensing error, patients are not allowed to return controlled medications to a pharmacy.

Information on how a patient or family member should properly dispose of medication is commonly misunderstood. DEA regulations provide a process for nonregistrants to dispose of unused medication; however, it is cumbersome and meant to be used only when dealing with large quantities of controlled substances (e.g., large quantities of abandoned drugs). In such cases, the DEA special agent in charge (SAC) may instruct on disposal, which may include transfer of the substance to a DEA registrant, delivery to a DEA agent or office, destruction in the presence of an agent of the administration or other authorized person, or by other means. The person must submit a letter to the local SAC, which includes:

• Name and address of the person;
• Name and quantity of each controlled substance to be disposed of;
• Explanation of how the applicant obtained the controlled substance, if known; and
• Name, address, and registration number, if known, of the person who possessed the controlled substances prior to the applicant.

Federal legislation also provides a way for the DEA to grant approval to law-enforcement agencies to operate “takeback” programs. The regulation states that “any person in possession of a controlled substance and desiring to dispose of such substance may request assistance from the SAC in the area in which the person is located.” The regulation allows the SAC to authorize and specify the means of disposal to assure that the controlled substances do not become available to unauthorized persons.

State and local government agencies and community associations might hold takeback programs only if law enforcement makes the request, takes custody of the controlled substances, and is responsible for the disposal.

The U.S. Office of National Drug Control Policy has published guidelines for medication disposal. These guidelines advise flushing medications only if the prescription label or accompanying patient information specifically states to do so. Instead of flushing, the guidelines recommend that medications be disposed of through a takeback program or by:

• Taking the prescription drugs out of their original containers;
• Mixing the drugs with an undesirable substance, such as cat litter or used coffee grounds;
• Placing the mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag;
• Concealing or removing personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off; and
• Placing the sealed container with the mixture, and the empty drug containers, in the trash.

Unused Medication Donation

The rising cost of prescription medication leaves many questioning whether there is a need for a safe method to allow unused medication to be donated to others. At least 10 states have passed laws allowing or encouraging the donation of unused pharmaceutical drugs. Many of these programs involve healthcare facilities, nursing homes, or pharmacies. The CSA and current DEA regulations, however, prohibit patients from delivering or distributing controlled substances to a DEA registrant, even if it is for the purpose of a donation. Moreover, the Food and Drug Administration (FDA) does not permit redistribution of medications, except under limited circumstances.

Consequently, state law may be inconsistent with federal law for donation and reuse of controlled substances.

Conclusion

Physicians who fail to comply with CSA handling requirements are subject to criminal charges, discipline against their DEA registration, and discipline against their license to practice medicine. Consequently, physicians should use caution whenever handling unused medication.

The application of various aspects of the CSA and implementing rules is situation-specific. Moreover, the DEA may issue additional regulations. Accordingly, if you have a question about a specific situation, consult an attorney, or contact your local DEA field division office and ask for the diversion duty agent. TH

Patrick O’Rourke works in the Office of University Counsel, Department of Litigation, University of Colorado Denver.

Recent media reports about the dangers surrounding unused prescription medications, including abuse by teens and medications finding their way into the water supply, have prompted an increase in inquiries to healthcare providers about disposing of unused medication. These issues are complicated when controlled substances are involved.

Often, providers are unsure how to respond to patient questions about medication disposal. For example, what would you do if a patient requests an alternative medication because of an unwanted side effect and brings the originally prescribed medication back to you? What if the family of a recently expired patient brings unused medication to you and asks you to donate it to other patients? What if you have a colleague who performs mission work; could you accept and donate unused medication for use in another country?

Unfortunately, the Controlled Substances Act (CSA) does not provide a readily available mechanism to accomplish efficient, secure, and environmentally sound methods to collect and use or dispose of unwanted controlled substances. This article explains the rules physicians must adhere to and guidelines for “taking back” controlled substances.

The Legislation

Enacted in 1970, the CSA combined all existing federal drug laws into a single statute. It created five “schedules” in which certain drugs are classified. These “scheduled” drugs are commonly referred to as controlled substances. A drug’s classification depends on its potential for abuse and its currently accepted medical use in the U.S. Additionally, provisions of international treaties impact classification.

Under the classification system, Schedule I drugs have a high potential for abuse and have no currently accepted medical use in treatment in the U.S. In contrast, Schedule V drugs have a low potential for abuse and do have a currently accepted medical use in treatment in the U.S.

The CSA governs the manufacture, import, export, possession, use, and distribution of controlled substances. In doing so, the CSA established a system to register those authorized to handle controlled substances. Manufacturers, dispensers, distributors, and individual practitioners who prescribe controlled substances must be registered with the Drug Enforcement Administration (DEA).

The CSA requires registrants to keep certain records for at least two years related to their handling of controlled substances. For example, physician registrants must keep records of controlled substances in Schedules II, III, IV, and V that are dispensed via methods other than prescribing or administering (e.g., industry samples). Inventories of controlled substances are required. Most notably, physicians generally are not required to keep records of prescribed medications; however, records must be kept if drugs are dispensed or administered. Moreover, there are heightened recordkeeping responsibilities for providers who prescribe, dispense, or administer for maintenance or detoxification.

Controlled Substance “Takeback”

The system of registration established by the CSA prohibits a DEA registrant from acquiring controlled substances from nonregistered entities and, in turn, bars an end-user from distributing pharmaceutical controlled substances to a DEA registrant. In other words, physicians cannot receive controlled substances from anyone who does not also have a registration. Thus, physicians may not “take back” prescribed medications from patients or their family members. Similarly, except in cases of a drug being recalled or a dispensing error, patients are not allowed to return controlled medications to a pharmacy.

Information on how a patient or family member should properly dispose of medication is commonly misunderstood. DEA regulations provide a process for nonregistrants to dispose of unused medication; however, it is cumbersome and meant to be used only when dealing with large quantities of controlled substances (e.g., large quantities of abandoned drugs). In such cases, the DEA special agent in charge (SAC) may instruct on disposal, which may include transfer of the substance to a DEA registrant, delivery to a DEA agent or office, destruction in the presence of an agent of the administration or other authorized person, or by other means. The person must submit a letter to the local SAC, which includes:

• Name and address of the person;
• Name and quantity of each controlled substance to be disposed of;
• Explanation of how the applicant obtained the controlled substance, if known; and
• Name, address, and registration number, if known, of the person who possessed the controlled substances prior to the applicant.

Federal legislation also provides a way for the DEA to grant approval to law-enforcement agencies to operate “takeback” programs. The regulation states that “any person in possession of a controlled substance and desiring to dispose of such substance may request assistance from the SAC in the area in which the person is located.” The regulation allows the SAC to authorize and specify the means of disposal to assure that the controlled substances do not become available to unauthorized persons.

State and local government agencies and community associations might hold takeback programs only if law enforcement makes the request, takes custody of the controlled substances, and is responsible for the disposal.

The U.S. Office of National Drug Control Policy has published guidelines for medication disposal. These guidelines advise flushing medications only if the prescription label or accompanying patient information specifically states to do so. Instead of flushing, the guidelines recommend that medications be disposed of through a takeback program or by:

• Taking the prescription drugs out of their original containers;
• Mixing the drugs with an undesirable substance, such as cat litter or used coffee grounds;
• Placing the mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag;
• Concealing or removing personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off; and
• Placing the sealed container with the mixture, and the empty drug containers, in the trash.

Unused Medication Donation

The rising cost of prescription medication leaves many questioning whether there is a need for a safe method to allow unused medication to be donated to others. At least 10 states have passed laws allowing or encouraging the donation of unused pharmaceutical drugs. Many of these programs involve healthcare facilities, nursing homes, or pharmacies. The CSA and current DEA regulations, however, prohibit patients from delivering or distributing controlled substances to a DEA registrant, even if it is for the purpose of a donation. Moreover, the Food and Drug Administration (FDA) does not permit redistribution of medications, except under limited circumstances.

Consequently, state law may be inconsistent with federal law for donation and reuse of controlled substances.

Conclusion

Physicians who fail to comply with CSA handling requirements are subject to criminal charges, discipline against their DEA registration, and discipline against their license to practice medicine. Consequently, physicians should use caution whenever handling unused medication.

The application of various aspects of the CSA and implementing rules is situation-specific. Moreover, the DEA may issue additional regulations. Accordingly, if you have a question about a specific situation, consult an attorney, or contact your local DEA field division office and ask for the diversion duty agent. TH

Patrick O’Rourke works in the Office of University Counsel, Department of Litigation, University of Colorado Denver.

Recent media reports about the dangers surrounding unused prescription medications, including abuse by teens and medications finding their way into the water supply, have prompted an increase in inquiries to healthcare providers about disposing of unused medication. These issues are complicated when controlled substances are involved.

Often, providers are unsure how to respond to patient questions about medication disposal. For example, what would you do if a patient requests an alternative medication because of an unwanted side effect and brings the originally prescribed medication back to you? What if the family of a recently expired patient brings unused medication to you and asks you to donate it to other patients? What if you have a colleague who performs mission work; could you accept and donate unused medication for use in another country?

Unfortunately, the Controlled Substances Act (CSA) does not provide a readily available mechanism to accomplish efficient, secure, and environmentally sound methods to collect and use or dispose of unwanted controlled substances. This article explains the rules physicians must adhere to and guidelines for “taking back” controlled substances.

The Legislation

Enacted in 1970, the CSA combined all existing federal drug laws into a single statute. It created five “schedules” in which certain drugs are classified. These “scheduled” drugs are commonly referred to as controlled substances. A drug’s classification depends on its potential for abuse and its currently accepted medical use in the U.S. Additionally, provisions of international treaties impact classification.

Under the classification system, Schedule I drugs have a high potential for abuse and have no currently accepted medical use in treatment in the U.S. In contrast, Schedule V drugs have a low potential for abuse and do have a currently accepted medical use in treatment in the U.S.

The CSA governs the manufacture, import, export, possession, use, and distribution of controlled substances. In doing so, the CSA established a system to register those authorized to handle controlled substances. Manufacturers, dispensers, distributors, and individual practitioners who prescribe controlled substances must be registered with the Drug Enforcement Administration (DEA).

The CSA requires registrants to keep certain records for at least two years related to their handling of controlled substances. For example, physician registrants must keep records of controlled substances in Schedules II, III, IV, and V that are dispensed via methods other than prescribing or administering (e.g., industry samples). Inventories of controlled substances are required. Most notably, physicians generally are not required to keep records of prescribed medications; however, records must be kept if drugs are dispensed or administered. Moreover, there are heightened recordkeeping responsibilities for providers who prescribe, dispense, or administer for maintenance or detoxification.

Controlled Substance “Takeback”

The system of registration established by the CSA prohibits a DEA registrant from acquiring controlled substances from nonregistered entities and, in turn, bars an end-user from distributing pharmaceutical controlled substances to a DEA registrant. In other words, physicians cannot receive controlled substances from anyone who does not also have a registration. Thus, physicians may not “take back” prescribed medications from patients or their family members. Similarly, except in cases of a drug being recalled or a dispensing error, patients are not allowed to return controlled medications to a pharmacy.

Information on how a patient or family member should properly dispose of medication is commonly misunderstood. DEA regulations provide a process for nonregistrants to dispose of unused medication; however, it is cumbersome and meant to be used only when dealing with large quantities of controlled substances (e.g., large quantities of abandoned drugs). In such cases, the DEA special agent in charge (SAC) may instruct on disposal, which may include transfer of the substance to a DEA registrant, delivery to a DEA agent or office, destruction in the presence of an agent of the administration or other authorized person, or by other means. The person must submit a letter to the local SAC, which includes:

• Name and address of the person;
• Name and quantity of each controlled substance to be disposed of;
• Explanation of how the applicant obtained the controlled substance, if known; and
• Name, address, and registration number, if known, of the person who possessed the controlled substances prior to the applicant.

Federal legislation also provides a way for the DEA to grant approval to law-enforcement agencies to operate “takeback” programs. The regulation states that “any person in possession of a controlled substance and desiring to dispose of such substance may request assistance from the SAC in the area in which the person is located.” The regulation allows the SAC to authorize and specify the means of disposal to assure that the controlled substances do not become available to unauthorized persons.

State and local government agencies and community associations might hold takeback programs only if law enforcement makes the request, takes custody of the controlled substances, and is responsible for the disposal.

The U.S. Office of National Drug Control Policy has published guidelines for medication disposal. These guidelines advise flushing medications only if the prescription label or accompanying patient information specifically states to do so. Instead of flushing, the guidelines recommend that medications be disposed of through a takeback program or by:

• Taking the prescription drugs out of their original containers;
• Mixing the drugs with an undesirable substance, such as cat litter or used coffee grounds;
• Placing the mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag;
• Concealing or removing personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off; and
• Placing the sealed container with the mixture, and the empty drug containers, in the trash.

Unused Medication Donation

The rising cost of prescription medication leaves many questioning whether there is a need for a safe method to allow unused medication to be donated to others. At least 10 states have passed laws allowing or encouraging the donation of unused pharmaceutical drugs. Many of these programs involve healthcare facilities, nursing homes, or pharmacies. The CSA and current DEA regulations, however, prohibit patients from delivering or distributing controlled substances to a DEA registrant, even if it is for the purpose of a donation. Moreover, the Food and Drug Administration (FDA) does not permit redistribution of medications, except under limited circumstances.

Consequently, state law may be inconsistent with federal law for donation and reuse of controlled substances.

Conclusion

Physicians who fail to comply with CSA handling requirements are subject to criminal charges, discipline against their DEA registration, and discipline against their license to practice medicine. Consequently, physicians should use caution whenever handling unused medication.

The application of various aspects of the CSA and implementing rules is situation-specific. Moreover, the DEA may issue additional regulations. Accordingly, if you have a question about a specific situation, consult an attorney, or contact your local DEA field division office and ask for the diversion duty agent. TH

Patrick O’Rourke works in the Office of University Counsel, Department of Litigation, University of Colorado Denver.

From the outset, HM has been about efficiency. And there was nothing wrong with that, for value is quality divided by cost. But in our story, we found that mere efficiency was not enough: The lowering of the denominator (cost) had to be met with an escalation of the numerator (quality) to ensure value.

And see us as being born in the right place at the right time. For with the national focus turning to the need for quality and patient safety, hospital medicine was in the right place and the right time to heed the call to action: appropriately stepping up to enact efforts to make the slope of the line (on a chart of quality vs. cost) “STEEEPER” … finding systems innovations to make care Safe, Timely, Efficient, Effective, Equitable, and Patient-centered.

Of course, the story continued with the Affordable Care Act and healthcare reform, greatly accelerating our evolution as change agents. And now we find ourselves fully invested in a “change the system” mentality, perfectly positioned to meaningfully change healthcare for millions of people. But threats loom—specifically, the “R” in the STEEEPER mnemonic: the risks to quality in the face of healthcare reform.

So in the next chapter of our story, I present to you our challenge: how to overcome the threats to quality in the context of healthcare reform. The first three are presented here; in subsequent articles, I will address the remainder. Overcoming all threats will hinge on mastering the four truisms of cultural change:

1. Systems drive function;
2. Every system is perfectly designed to produce the outcomes that it does;
3. This is not an issue of people needing to try harder; and
4. The “no blame” culture begins with a paradigm shift from the “person at fault” to the “system at fault.”

Threat 1: Failure to Fund Quality

SHM elected to merge its annual State of Hospital Medicine survey with the MGMA. Though not without risk, this has resulted in the anticipated benefits. The MGMA collaboration brings greater leverage in working with the C-suite, which is pre-programmed to react to MGMA surveys. From the most recent MGMA survey comes good news: The financial compensation for hospitalists has increased. A sobering insight, however, is that this increase in compensation has been met with a corresponding increase in work intensity—RVUs. Further, the link between RVUs and compensation appears to be tightening, quantifying what has long been of concern: The time devoted to the nonclinical “value added” duties of the hospitalist is shrinking.

The threat to the culture of quality is captured in the single question: How many RVUs is a quality-improvement (QI) project worth? I’m not sure we have that answer. But without an answer, it is difficult to believe that meaningful QI can be expected without time to do so. And again, as the gap between compensation and RVUs narrows, one is left wondering if there will soon be a day where there is no value-added time remaining to perform QI at all.

Fortunately, the Affordable Care Act might provide some movement in the right direction via value-based purchasing. Linking quality outcomes to financial reimbursement is a big step forward in the hospitalist’s quest to leverage the C-suite in trading RVUs for devoted QI time. Although we still are left asking the question of how many RVUs a QI project is worth, value-based purchasing at least sets the stage for the conversation. But in the interim, it is still upon hospitalists to design these QI projects, and to learn the skills necessary to see the design to its fruition.

Threat 2: Quality Stops at Core Measures

It is hard to argue that fulfilling “core measures” is a bad thing. Nonetheless, the core measures were not meant to be quality; instead, they were meant as surrogate measures of quality. The presumption of the core-measures initiative is that the system would exist without direct attention to the core measures, operating as it ordinarily would with generic attention to meeting all standards of quality for all diseases. And at some point in time, the core measures would be assessed to give an overall assessment of the system’s quality.

What has evolved, however, is a concerted attention to meeting the core measures, with little regard to the overall culture of quality.

Let’s say you were tasked with improving the public school system in your state. As a measure of the improvement, you choose five of the 1,000 schools as “core measure” schools. The state board of education is told that the performance of these five sample schools will be assessed at the end of the year, and financial support for the system as a whole will hinge on their performance. The intended result is that attention would be paid to improving the performance of every school in the system, and this improvement would be reflected in the performance of the five sample schools. The board of education could take the route of improving all schools, but the more pragmatic route would be to funnel all resources into these five schools, to the detriment of resources for the other 995 schools. The performance of the core measure schools would dramatically improve, and funding would be secured. But ask yourself: Did the performance of the school system as a whole actually improve?

Such is the risk of the core measures in healthcare. The original intent of the core measures was to instill a culture of QI for all points of care. And this has been a valuable contribution to changing the consciousness of the healthcare system. The presumption was that the core measures would be “seeds,” and that by emphasizing these select measures, the QI culture eventually would spread to all aspects of patient care. But this plan hinged on the presumption that that there is an unlimited amount of mental energy and resources to be devoted to all tasks within healthcare. The reality is that there is a fixed amount of intellectual energy and resources to be devoted to the various aspects of healthcare. One wonders if the overemphasis on meeting the core measures might actually have taken the wind out of the sails for QI in other non-core-measure patient care.

The implications are twofold. By definition, a core measure has to be applicable to all healthcare systems, and with a fixed amount of mental energy and resources, there is a real risk that what portion is reserved for QI finds its way only to the core indicators, especially if they are overemphasized in the system. The second implication is captured in our experience with time to antibiotics. With meeting the core indicator as the priority, many systems instituted the “work-around”: Give antibiotics to every patient presenting to the ED, and you will be sure to have met the four-hour window in the core indicator. The result was an exponential increase in inappropriate antibiotic administration and radiographic tests, all because meeting the indicator became more important than the overall goal.

As stewards of the hospital system, it is upon us to ensure that the original intent of core measures remains secure: The core measures seed a culture of quality, but do not become ends in and of themselves. QI apart from the core measures must remain an equal priority, and it is the hospitalist who will be central in ensuring this comes to fruition.

Threat 3: Misplaced Incentives

There is an interesting anecdote in Steven Levitt and Stephen Dubner’s book Freakonomics.¹ The story begins with a daycare center struggling with a problem: Some parents are showing up late to pick up their children at the end of the day, and this is costing the center in the way of overtime charges for the staff. To solve the problem, the center elects to institute a financial disincentive: Those showing up late to pick up their children will pay a modest financial penalty.

Fast-forward to months after the policy was put in place. The result? An exponential increase in the number of parents showing up late to pick up their children.

How do you explain worsening performance in spite of a financial disincentive? The answer resides in understanding human behavior. According to the authors, there are three primary motivations in life: financial, social, and moral. As ugly as it sounds, the decisions people make in life are driven by one of these three motivations. There is nothing wrong with providing incentives for behavior; incentives work.

But the danger arises when incentives are mismatched to behaviors. For example, if a financial outcome is the goal, then financial incentives make sense. If a social outcome (people should play better as a team) is the goal, the social incentives make sense (public recognition). But when the incentives get misaligned with their respective goals, trouble results.

What went wrong with the daycare’s plan is simple—most of the parents were motivated to pick up their children on time out of moral (“I gave my word”) or social (“I don’t want to be talked about by other parents”) incentives. But once a financial incentive was offered, the daycare center had essentially given the parents a way out in absolving their social and moral obligations. The parents had essentially cost-adjusted their behavior.

If you think this couldn’t happen to the healthcare system, let me ask you this. As a hospitalist, I see all of my patients early in the morning, because I see it as part of my obligation to the hospital team to discharge patients by 11 a.m. (social motivation).

But what if the CEO released this directive: “You will see all of your patients early in the morning, or you will take a $1,000 a year pay cut.” Is it possible that I might cost-adjust the $1,000 in exchange for sleeping in a little later and not having to deal with the morning traffic? I don’t know.

When it comes to financial incentives, there is a valley in the U-shaped curve. When the financial incentive is trivial, it is disregarded and the social/moral motivations of behavior persist (the kids are picked up on time; I persist in seeing patients early in the morning). When the financial incentive is huge, the financial incentive trumps all social/moral motivations, ensuring compliance with the goal behavior (every kid is picked up on time to avoid a penalty; I see all patients early in the day to avoid a larger penalty).

But in between is the risk zone: When the person feels they are paying an appropriate penance for not complying with the goal behavior, the financial disincentive absolves any social/moral guilt.

Healthcare reform is about incentives—and there is nothing wrong with that. But as the stewards of the inpatient healthcare system, it is upon us as hospitalists to ensure that the incentives remain matched to their intended goals, and that the untoward consequences of the incentives do not adversely affect the quality and safety of a patient’s care.

It is safe to say that the Affordable Care Act of 2010 moves us closer to a true environment of quality and patient safety. But it is equally safe to say that meaningful change will require more than what the law can provide. As stewards of the inpatient system, we have a responsibility to ensure that the healthcare system, particularly in how it responds to incentives, evolves to remain patient-centered, effective, and safe.

The next chapter in our story—the hospitalists’ story—will be one of accountability and responsibility. While there are things the government can do, the majority of what needs to be done will come directly from us. TH

Dr. Wiese is president of SHM.

Reference

1. Levitt SD, Dubner SJ. Freakonomics: A Rogue Economist Explores the Hidden Side of Everything. New York City: William Morrow; 2005.

From the outset, HM has been about efficiency. And there was nothing wrong with that, for value is quality divided by cost. But in our story, we found that mere efficiency was not enough: The lowering of the denominator (cost) had to be met with an escalation of the numerator (quality) to ensure value.

And see us as being born in the right place at the right time. For with the national focus turning to the need for quality and patient safety, hospital medicine was in the right place and the right time to heed the call to action: appropriately stepping up to enact efforts to make the slope of the line (on a chart of quality vs. cost) “STEEEPER” … finding systems innovations to make care Safe, Timely, Efficient, Effective, Equitable, and Patient-centered.

Of course, the story continued with the Affordable Care Act and healthcare reform, greatly accelerating our evolution as change agents. And now we find ourselves fully invested in a “change the system” mentality, perfectly positioned to meaningfully change healthcare for millions of people. But threats loom—specifically, the “R” in the STEEEPER mnemonic: the risks to quality in the face of healthcare reform.

So in the next chapter of our story, I present to you our challenge: how to overcome the threats to quality in the context of healthcare reform. The first three are presented here; in subsequent articles, I will address the remainder. Overcoming all threats will hinge on mastering the four truisms of cultural change:

1. Systems drive function;
2. Every system is perfectly designed to produce the outcomes that it does;
3. This is not an issue of people needing to try harder; and
4. The “no blame” culture begins with a paradigm shift from the “person at fault” to the “system at fault.”

Threat 1: Failure to Fund Quality

SHM elected to merge its annual State of Hospital Medicine survey with the MGMA. Though not without risk, this has resulted in the anticipated benefits. The MGMA collaboration brings greater leverage in working with the C-suite, which is pre-programmed to react to MGMA surveys. From the most recent MGMA survey comes good news: The financial compensation for hospitalists has increased. A sobering insight, however, is that this increase in compensation has been met with a corresponding increase in work intensity—RVUs. Further, the link between RVUs and compensation appears to be tightening, quantifying what has long been of concern: The time devoted to the nonclinical “value added” duties of the hospitalist is shrinking.

The threat to the culture of quality is captured in the single question: How many RVUs is a quality-improvement (QI) project worth? I’m not sure we have that answer. But without an answer, it is difficult to believe that meaningful QI can be expected without time to do so. And again, as the gap between compensation and RVUs narrows, one is left wondering if there will soon be a day where there is no value-added time remaining to perform QI at all.

Fortunately, the Affordable Care Act might provide some movement in the right direction via value-based purchasing. Linking quality outcomes to financial reimbursement is a big step forward in the hospitalist’s quest to leverage the C-suite in trading RVUs for devoted QI time. Although we still are left asking the question of how many RVUs a QI project is worth, value-based purchasing at least sets the stage for the conversation. But in the interim, it is still upon hospitalists to design these QI projects, and to learn the skills necessary to see the design to its fruition.

Threat 2: Quality Stops at Core Measures

It is hard to argue that fulfilling “core measures” is a bad thing. Nonetheless, the core measures were not meant to be quality; instead, they were meant as surrogate measures of quality. The presumption of the core-measures initiative is that the system would exist without direct attention to the core measures, operating as it ordinarily would with generic attention to meeting all standards of quality for all diseases. And at some point in time, the core measures would be assessed to give an overall assessment of the system’s quality.

What has evolved, however, is a concerted attention to meeting the core measures, with little regard to the overall culture of quality.

Let’s say you were tasked with improving the public school system in your state. As a measure of the improvement, you choose five of the 1,000 schools as “core measure” schools. The state board of education is told that the performance of these five sample schools will be assessed at the end of the year, and financial support for the system as a whole will hinge on their performance. The intended result is that attention would be paid to improving the performance of every school in the system, and this improvement would be reflected in the performance of the five sample schools. The board of education could take the route of improving all schools, but the more pragmatic route would be to funnel all resources into these five schools, to the detriment of resources for the other 995 schools. The performance of the core measure schools would dramatically improve, and funding would be secured. But ask yourself: Did the performance of the school system as a whole actually improve?

Such is the risk of the core measures in healthcare. The original intent of the core measures was to instill a culture of QI for all points of care. And this has been a valuable contribution to changing the consciousness of the healthcare system. The presumption was that the core measures would be “seeds,” and that by emphasizing these select measures, the QI culture eventually would spread to all aspects of patient care. But this plan hinged on the presumption that that there is an unlimited amount of mental energy and resources to be devoted to all tasks within healthcare. The reality is that there is a fixed amount of intellectual energy and resources to be devoted to the various aspects of healthcare. One wonders if the overemphasis on meeting the core measures might actually have taken the wind out of the sails for QI in other non-core-measure patient care.

The implications are twofold. By definition, a core measure has to be applicable to all healthcare systems, and with a fixed amount of mental energy and resources, there is a real risk that what portion is reserved for QI finds its way only to the core indicators, especially if they are overemphasized in the system. The second implication is captured in our experience with time to antibiotics. With meeting the core indicator as the priority, many systems instituted the “work-around”: Give antibiotics to every patient presenting to the ED, and you will be sure to have met the four-hour window in the core indicator. The result was an exponential increase in inappropriate antibiotic administration and radiographic tests, all because meeting the indicator became more important than the overall goal.

As stewards of the hospital system, it is upon us to ensure that the original intent of core measures remains secure: The core measures seed a culture of quality, but do not become ends in and of themselves. QI apart from the core measures must remain an equal priority, and it is the hospitalist who will be central in ensuring this comes to fruition.

Threat 3: Misplaced Incentives

There is an interesting anecdote in Steven Levitt and Stephen Dubner’s book Freakonomics.¹ The story begins with a daycare center struggling with a problem: Some parents are showing up late to pick up their children at the end of the day, and this is costing the center in the way of overtime charges for the staff. To solve the problem, the center elects to institute a financial disincentive: Those showing up late to pick up their children will pay a modest financial penalty.

Fast-forward to months after the policy was put in place. The result? An exponential increase in the number of parents showing up late to pick up their children.

How do you explain worsening performance in spite of a financial disincentive? The answer resides in understanding human behavior. According to the authors, there are three primary motivations in life: financial, social, and moral. As ugly as it sounds, the decisions people make in life are driven by one of these three motivations. There is nothing wrong with providing incentives for behavior; incentives work.

But the danger arises when incentives are mismatched to behaviors. For example, if a financial outcome is the goal, then financial incentives make sense. If a social outcome (people should play better as a team) is the goal, the social incentives make sense (public recognition). But when the incentives get misaligned with their respective goals, trouble results.

What went wrong with the daycare’s plan is simple—most of the parents were motivated to pick up their children on time out of moral (“I gave my word”) or social (“I don’t want to be talked about by other parents”) incentives. But once a financial incentive was offered, the daycare center had essentially given the parents a way out in absolving their social and moral obligations. The parents had essentially cost-adjusted their behavior.

If you think this couldn’t happen to the healthcare system, let me ask you this. As a hospitalist, I see all of my patients early in the morning, because I see it as part of my obligation to the hospital team to discharge patients by 11 a.m. (social motivation).

But what if the CEO released this directive: “You will see all of your patients early in the morning, or you will take a $1,000 a year pay cut.” Is it possible that I might cost-adjust the $1,000 in exchange for sleeping in a little later and not having to deal with the morning traffic? I don’t know.

When it comes to financial incentives, there is a valley in the U-shaped curve. When the financial incentive is trivial, it is disregarded and the social/moral motivations of behavior persist (the kids are picked up on time; I persist in seeing patients early in the morning). When the financial incentive is huge, the financial incentive trumps all social/moral motivations, ensuring compliance with the goal behavior (every kid is picked up on time to avoid a penalty; I see all patients early in the day to avoid a larger penalty).

But in between is the risk zone: When the person feels they are paying an appropriate penance for not complying with the goal behavior, the financial disincentive absolves any social/moral guilt.

Healthcare reform is about incentives—and there is nothing wrong with that. But as the stewards of the inpatient healthcare system, it is upon us as hospitalists to ensure that the incentives remain matched to their intended goals, and that the untoward consequences of the incentives do not adversely affect the quality and safety of a patient’s care.

It is safe to say that the Affordable Care Act of 2010 moves us closer to a true environment of quality and patient safety. But it is equally safe to say that meaningful change will require more than what the law can provide. As stewards of the inpatient system, we have a responsibility to ensure that the healthcare system, particularly in how it responds to incentives, evolves to remain patient-centered, effective, and safe.

The next chapter in our story—the hospitalists’ story—will be one of accountability and responsibility. While there are things the government can do, the majority of what needs to be done will come directly from us. TH

Dr. Wiese is president of SHM.

Reference

1. Levitt SD, Dubner SJ. Freakonomics: A Rogue Economist Explores the Hidden Side of Everything. New York City: William Morrow; 2005.

From the outset, HM has been about efficiency. And there was nothing wrong with that, for value is quality divided by cost. But in our story, we found that mere efficiency was not enough: The lowering of the denominator (cost) had to be met with an escalation of the numerator (quality) to ensure value.

And see us as being born in the right place at the right time. For with the national focus turning to the need for quality and patient safety, hospital medicine was in the right place and the right time to heed the call to action: appropriately stepping up to enact efforts to make the slope of the line (on a chart of quality vs. cost) “STEEEPER” … finding systems innovations to make care Safe, Timely, Efficient, Effective, Equitable, and Patient-centered.

Of course, the story continued with the Affordable Care Act and healthcare reform, greatly accelerating our evolution as change agents. And now we find ourselves fully invested in a “change the system” mentality, perfectly positioned to meaningfully change healthcare for millions of people. But threats loom—specifically, the “R” in the STEEEPER mnemonic: the risks to quality in the face of healthcare reform.

So in the next chapter of our story, I present to you our challenge: how to overcome the threats to quality in the context of healthcare reform. The first three are presented here; in subsequent articles, I will address the remainder. Overcoming all threats will hinge on mastering the four truisms of cultural change:

1. Systems drive function;
2. Every system is perfectly designed to produce the outcomes that it does;
3. This is not an issue of people needing to try harder; and
4. The “no blame” culture begins with a paradigm shift from the “person at fault” to the “system at fault.”

Threat 1: Failure to Fund Quality

SHM elected to merge its annual State of Hospital Medicine survey with the MGMA. Though not without risk, this has resulted in the anticipated benefits. The MGMA collaboration brings greater leverage in working with the C-suite, which is pre-programmed to react to MGMA surveys. From the most recent MGMA survey comes good news: The financial compensation for hospitalists has increased. A sobering insight, however, is that this increase in compensation has been met with a corresponding increase in work intensity—RVUs. Further, the link between RVUs and compensation appears to be tightening, quantifying what has long been of concern: The time devoted to the nonclinical “value added” duties of the hospitalist is shrinking.

The threat to the culture of quality is captured in the single question: How many RVUs is a quality-improvement (QI) project worth? I’m not sure we have that answer. But without an answer, it is difficult to believe that meaningful QI can be expected without time to do so. And again, as the gap between compensation and RVUs narrows, one is left wondering if there will soon be a day where there is no value-added time remaining to perform QI at all.

Fortunately, the Affordable Care Act might provide some movement in the right direction via value-based purchasing. Linking quality outcomes to financial reimbursement is a big step forward in the hospitalist’s quest to leverage the C-suite in trading RVUs for devoted QI time. Although we still are left asking the question of how many RVUs a QI project is worth, value-based purchasing at least sets the stage for the conversation. But in the interim, it is still upon hospitalists to design these QI projects, and to learn the skills necessary to see the design to its fruition.

Threat 2: Quality Stops at Core Measures

It is hard to argue that fulfilling “core measures” is a bad thing. Nonetheless, the core measures were not meant to be quality; instead, they were meant as surrogate measures of quality. The presumption of the core-measures initiative is that the system would exist without direct attention to the core measures, operating as it ordinarily would with generic attention to meeting all standards of quality for all diseases. And at some point in time, the core measures would be assessed to give an overall assessment of the system’s quality.

What has evolved, however, is a concerted attention to meeting the core measures, with little regard to the overall culture of quality.

Let’s say you were tasked with improving the public school system in your state. As a measure of the improvement, you choose five of the 1,000 schools as “core measure” schools. The state board of education is told that the performance of these five sample schools will be assessed at the end of the year, and financial support for the system as a whole will hinge on their performance. The intended result is that attention would be paid to improving the performance of every school in the system, and this improvement would be reflected in the performance of the five sample schools. The board of education could take the route of improving all schools, but the more pragmatic route would be to funnel all resources into these five schools, to the detriment of resources for the other 995 schools. The performance of the core measure schools would dramatically improve, and funding would be secured. But ask yourself: Did the performance of the school system as a whole actually improve?

Such is the risk of the core measures in healthcare. The original intent of the core measures was to instill a culture of QI for all points of care. And this has been a valuable contribution to changing the consciousness of the healthcare system. The presumption was that the core measures would be “seeds,” and that by emphasizing these select measures, the QI culture eventually would spread to all aspects of patient care. But this plan hinged on the presumption that that there is an unlimited amount of mental energy and resources to be devoted to all tasks within healthcare. The reality is that there is a fixed amount of intellectual energy and resources to be devoted to the various aspects of healthcare. One wonders if the overemphasis on meeting the core measures might actually have taken the wind out of the sails for QI in other non-core-measure patient care.

The implications are twofold. By definition, a core measure has to be applicable to all healthcare systems, and with a fixed amount of mental energy and resources, there is a real risk that what portion is reserved for QI finds its way only to the core indicators, especially if they are overemphasized in the system. The second implication is captured in our experience with time to antibiotics. With meeting the core indicator as the priority, many systems instituted the “work-around”: Give antibiotics to every patient presenting to the ED, and you will be sure to have met the four-hour window in the core indicator. The result was an exponential increase in inappropriate antibiotic administration and radiographic tests, all because meeting the indicator became more important than the overall goal.

As stewards of the hospital system, it is upon us to ensure that the original intent of core measures remains secure: The core measures seed a culture of quality, but do not become ends in and of themselves. QI apart from the core measures must remain an equal priority, and it is the hospitalist who will be central in ensuring this comes to fruition.

Threat 3: Misplaced Incentives

There is an interesting anecdote in Steven Levitt and Stephen Dubner’s book Freakonomics.¹ The story begins with a daycare center struggling with a problem: Some parents are showing up late to pick up their children at the end of the day, and this is costing the center in the way of overtime charges for the staff. To solve the problem, the center elects to institute a financial disincentive: Those showing up late to pick up their children will pay a modest financial penalty.

Fast-forward to months after the policy was put in place. The result? An exponential increase in the number of parents showing up late to pick up their children.

How do you explain worsening performance in spite of a financial disincentive? The answer resides in understanding human behavior. According to the authors, there are three primary motivations in life: financial, social, and moral. As ugly as it sounds, the decisions people make in life are driven by one of these three motivations. There is nothing wrong with providing incentives for behavior; incentives work.

But the danger arises when incentives are mismatched to behaviors. For example, if a financial outcome is the goal, then financial incentives make sense. If a social outcome (people should play better as a team) is the goal, the social incentives make sense (public recognition). But when the incentives get misaligned with their respective goals, trouble results.

What went wrong with the daycare’s plan is simple—most of the parents were motivated to pick up their children on time out of moral (“I gave my word”) or social (“I don’t want to be talked about by other parents”) incentives. But once a financial incentive was offered, the daycare center had essentially given the parents a way out in absolving their social and moral obligations. The parents had essentially cost-adjusted their behavior.

If you think this couldn’t happen to the healthcare system, let me ask you this. As a hospitalist, I see all of my patients early in the morning, because I see it as part of my obligation to the hospital team to discharge patients by 11 a.m. (social motivation).

But what if the CEO released this directive: “You will see all of your patients early in the morning, or you will take a $1,000 a year pay cut.” Is it possible that I might cost-adjust the $1,000 in exchange for sleeping in a little later and not having to deal with the morning traffic? I don’t know.

When it comes to financial incentives, there is a valley in the U-shaped curve. When the financial incentive is trivial, it is disregarded and the social/moral motivations of behavior persist (the kids are picked up on time; I persist in seeing patients early in the morning). When the financial incentive is huge, the financial incentive trumps all social/moral motivations, ensuring compliance with the goal behavior (every kid is picked up on time to avoid a penalty; I see all patients early in the day to avoid a larger penalty).

But in between is the risk zone: When the person feels they are paying an appropriate penance for not complying with the goal behavior, the financial disincentive absolves any social/moral guilt.

Healthcare reform is about incentives—and there is nothing wrong with that. But as the stewards of the inpatient healthcare system, it is upon us as hospitalists to ensure that the incentives remain matched to their intended goals, and that the untoward consequences of the incentives do not adversely affect the quality and safety of a patient’s care.

It is safe to say that the Affordable Care Act of 2010 moves us closer to a true environment of quality and patient safety. But it is equally safe to say that meaningful change will require more than what the law can provide. As stewards of the inpatient system, we have a responsibility to ensure that the healthcare system, particularly in how it responds to incentives, evolves to remain patient-centered, effective, and safe.

The next chapter in our story—the hospitalists’ story—will be one of accountability and responsibility. While there are things the government can do, the majority of what needs to be done will come directly from us. TH

Dr. Wiese is president of SHM.

Reference

1. Levitt SD, Dubner SJ. Freakonomics: A Rogue Economist Explores the Hidden Side of Everything. New York City: William Morrow; 2005.

Several months ago, my toilet broke. You should also know that I’m not particularly handy. So when I first realized that the toilet bowl seemed to fill constantly, I got a little stressed out.

How much was it going cost to call in a plumber on the weekend?

What kind of a water bill was I going to have?

Was this a serious problem?

I took a quick peek in the tank, but that just made me more confused. I was paralyzed by a lack of know-how.

Normally, I would have just Googled a local plumber. But that day, I decided to do something different. Maybe it was because it was the fantasy football offseason. Maybe it was because my wife had started to ask my father-in-law to change light bulbs around the house. Or, maybe, I wanted to learn to actually fix the problem. A few hours later, after an Internet lesson in toilet physiology, a $4.12 trip to Home Depot, and a wet pair of hands, I had replaced my first toilet flapper.

This wasn’t the rebuilding of a car engine, but it was a clear DIY step toward self-improvement. Easily the most memorable moment here was my sense of accomplishment.

I felt empowered.

One Part Science, One Part Art

It’s taken me a while to realize this, but I’ve begun to take advantage of improvement opportunities at work as well. No, I haven’t been moonlighting as a plumber for my hospital. I’ve just been fortunate to be part of a trifecta of rewarding quality-improvement (QI) projects over the past year. Before I’d gotten my hands dirty with these, my understanding of QI was fairly naive. I’d heard about Plan-Do-Study-Act many times. I had listened to a talk at a national conference. And I had kept up with the general medical literature on the subject.

But none of those activities had truly prepared me for experience of actually doing the work on my own.

By taking on a project, an ambitious attempt to reduce continuous pulse oximetry use, I experienced a crash course in both the science and the art of process improvement. I was forced to overcome my “I don’t know how” inertia. And with expert guidance in the form of a clinical safety and effectiveness class, I learned the importance of run charts (science) and a well-crafted multidisciplinary team (art) in changing established but inefficient behavior.

Our rates of continuous pulse oximetry usage dropped by 50%, and cost savings were $12,000 per year on one unit. These results made my prior attempts at change—years of complaining about ingrained nursing culture—look infantile. (OK, maybe it was ineffective, but who hasn’t complained about the overuse of continuous monitoring?)

I haven’t met a pediatric hospitalist who wouldn’t understand the symbolic importance of this success. But I know of many hospitalists who have not yet participated in meaningful QI project. Imagine calling a plumber who grasped the flush and fill mechanism of a toilet but had never touched real porcelain. Here’s an even better analogy: What if doctors could get licensed without having touched real patients?

If pediatric hospitalists are to transform the care delivery of hospitalized children, and quality learning only comes through hands-on training, then we need some more hands in the pot.

Discharge Improvement

On the heels of my first project, I was fortunate enough to augment my education through another effort—this time with a cohort of fellow pediatric hospitalists. This was a national collaborative to improve discharge handoffs, and I will admit that, at the outset, I was as puzzled as the first time I pulled the lid off the tank of the toilet. There were just too many permutations on PCP communication at the participating institutions, and some felt our aim of timely discharge handoffs was unattainable.

What carried me through, however, was the collective and infectious DIY—no, QIY (Quality Improve-it-Yourself) attitude of the group. We were all learning, and regular participation in the collaborative essentially guaranteed improvement. We achieved our aim of 90% communication with PCPs within two days of discharge. The secret was simple: The more you do, the more you learn.

Pediatric hospitalists can transform care delivery through a focus on safe and quality care, but the tools to accomplish this must come through post-residency, on-the-job learning. This QI know-how must efficiently spread among our ranks through practical and project-based educational efforts. It’s “see one, do one, teach one,” but we’re not talking about lumbar punctures anymore.

This is a journey in which we all take on the responsibility of rolling up our sleeves and simply learn by doing. And here is where the third leg of my as-yet-unfinished QI course unfolds.

Through my involvement with the Value in Inpatient Pediatrics (VIP) Network, I’ve gained a newfound vision for what the future might hold. VIP has evolved from a benchmarking project focused on bronchiolitis to an improvement network that will incorporate projects similar to the discharge handoff collaborative above.

In the process, a model for how to rapidly spread QI learning has emerged. The capacity lies in the network’s rapidly growing connectivity. The power comes from the individuals: motivated, card-carrying pediatric hospitalists from a wide array of sites. Collaborative learning harbors the potential to exponentially increase the pace at which we improve.

The future of our quality care is bright. I see an open network of improvement doers and learners. I see collaboration on quality and safety initiatives in all manner of hospitals and communities. I see that this will all be built upon a foundation of hard work and a QIY attitude.

You, too, will play a role.

Just don’t be afraid to get your hands a little dirty. TH

Dr. Shen is medical director of hospital medicine at Dell Children’s Medical Center in Austin, Texas. He is pediatric editor of The Hospitalist.

Several months ago, my toilet broke. You should also know that I’m not particularly handy. So when I first realized that the toilet bowl seemed to fill constantly, I got a little stressed out.

How much was it going cost to call in a plumber on the weekend?

What kind of a water bill was I going to have?

Was this a serious problem?

I took a quick peek in the tank, but that just made me more confused. I was paralyzed by a lack of know-how.

Normally, I would have just Googled a local plumber. But that day, I decided to do something different. Maybe it was because it was the fantasy football offseason. Maybe it was because my wife had started to ask my father-in-law to change light bulbs around the house. Or, maybe, I wanted to learn to actually fix the problem. A few hours later, after an Internet lesson in toilet physiology, a $4.12 trip to Home Depot, and a wet pair of hands, I had replaced my first toilet flapper.

This wasn’t the rebuilding of a car engine, but it was a clear DIY step toward self-improvement. Easily the most memorable moment here was my sense of accomplishment.

I felt empowered.

One Part Science, One Part Art

It’s taken me a while to realize this, but I’ve begun to take advantage of improvement opportunities at work as well. No, I haven’t been moonlighting as a plumber for my hospital. I’ve just been fortunate to be part of a trifecta of rewarding quality-improvement (QI) projects over the past year. Before I’d gotten my hands dirty with these, my understanding of QI was fairly naive. I’d heard about Plan-Do-Study-Act many times. I had listened to a talk at a national conference. And I had kept up with the general medical literature on the subject.

But none of those activities had truly prepared me for experience of actually doing the work on my own.

By taking on a project, an ambitious attempt to reduce continuous pulse oximetry use, I experienced a crash course in both the science and the art of process improvement. I was forced to overcome my “I don’t know how” inertia. And with expert guidance in the form of a clinical safety and effectiveness class, I learned the importance of run charts (science) and a well-crafted multidisciplinary team (art) in changing established but inefficient behavior.

Our rates of continuous pulse oximetry usage dropped by 50%, and cost savings were $12,000 per year on one unit. These results made my prior attempts at change—years of complaining about ingrained nursing culture—look infantile. (OK, maybe it was ineffective, but who hasn’t complained about the overuse of continuous monitoring?)

I haven’t met a pediatric hospitalist who wouldn’t understand the symbolic importance of this success. But I know of many hospitalists who have not yet participated in meaningful QI project. Imagine calling a plumber who grasped the flush and fill mechanism of a toilet but had never touched real porcelain. Here’s an even better analogy: What if doctors could get licensed without having touched real patients?

If pediatric hospitalists are to transform the care delivery of hospitalized children, and quality learning only comes through hands-on training, then we need some more hands in the pot.

Discharge Improvement

On the heels of my first project, I was fortunate enough to augment my education through another effort—this time with a cohort of fellow pediatric hospitalists. This was a national collaborative to improve discharge handoffs, and I will admit that, at the outset, I was as puzzled as the first time I pulled the lid off the tank of the toilet. There were just too many permutations on PCP communication at the participating institutions, and some felt our aim of timely discharge handoffs was unattainable.

What carried me through, however, was the collective and infectious DIY—no, QIY (Quality Improve-it-Yourself) attitude of the group. We were all learning, and regular participation in the collaborative essentially guaranteed improvement. We achieved our aim of 90% communication with PCPs within two days of discharge. The secret was simple: The more you do, the more you learn.

Pediatric hospitalists can transform care delivery through a focus on safe and quality care, but the tools to accomplish this must come through post-residency, on-the-job learning. This QI know-how must efficiently spread among our ranks through practical and project-based educational efforts. It’s “see one, do one, teach one,” but we’re not talking about lumbar punctures anymore.

This is a journey in which we all take on the responsibility of rolling up our sleeves and simply learn by doing. And here is where the third leg of my as-yet-unfinished QI course unfolds.

Through my involvement with the Value in Inpatient Pediatrics (VIP) Network, I’ve gained a newfound vision for what the future might hold. VIP has evolved from a benchmarking project focused on bronchiolitis to an improvement network that will incorporate projects similar to the discharge handoff collaborative above.

In the process, a model for how to rapidly spread QI learning has emerged. The capacity lies in the network’s rapidly growing connectivity. The power comes from the individuals: motivated, card-carrying pediatric hospitalists from a wide array of sites. Collaborative learning harbors the potential to exponentially increase the pace at which we improve.

The future of our quality care is bright. I see an open network of improvement doers and learners. I see collaboration on quality and safety initiatives in all manner of hospitals and communities. I see that this will all be built upon a foundation of hard work and a QIY attitude.

You, too, will play a role.

Just don’t be afraid to get your hands a little dirty. TH

Dr. Shen is medical director of hospital medicine at Dell Children’s Medical Center in Austin, Texas. He is pediatric editor of The Hospitalist.

Several months ago, my toilet broke. You should also know that I’m not particularly handy. So when I first realized that the toilet bowl seemed to fill constantly, I got a little stressed out.

How much was it going cost to call in a plumber on the weekend?

What kind of a water bill was I going to have?

Was this a serious problem?

I took a quick peek in the tank, but that just made me more confused. I was paralyzed by a lack of know-how.

Normally, I would have just Googled a local plumber. But that day, I decided to do something different. Maybe it was because it was the fantasy football offseason. Maybe it was because my wife had started to ask my father-in-law to change light bulbs around the house. Or, maybe, I wanted to learn to actually fix the problem. A few hours later, after an Internet lesson in toilet physiology, a $4.12 trip to Home Depot, and a wet pair of hands, I had replaced my first toilet flapper.

This wasn’t the rebuilding of a car engine, but it was a clear DIY step toward self-improvement. Easily the most memorable moment here was my sense of accomplishment.

I felt empowered.

One Part Science, One Part Art

It’s taken me a while to realize this, but I’ve begun to take advantage of improvement opportunities at work as well. No, I haven’t been moonlighting as a plumber for my hospital. I’ve just been fortunate to be part of a trifecta of rewarding quality-improvement (QI) projects over the past year. Before I’d gotten my hands dirty with these, my understanding of QI was fairly naive. I’d heard about Plan-Do-Study-Act many times. I had listened to a talk at a national conference. And I had kept up with the general medical literature on the subject.

But none of those activities had truly prepared me for experience of actually doing the work on my own.

By taking on a project, an ambitious attempt to reduce continuous pulse oximetry use, I experienced a crash course in both the science and the art of process improvement. I was forced to overcome my “I don’t know how” inertia. And with expert guidance in the form of a clinical safety and effectiveness class, I learned the importance of run charts (science) and a well-crafted multidisciplinary team (art) in changing established but inefficient behavior.

Our rates of continuous pulse oximetry usage dropped by 50%, and cost savings were $12,000 per year on one unit. These results made my prior attempts at change—years of complaining about ingrained nursing culture—look infantile. (OK, maybe it was ineffective, but who hasn’t complained about the overuse of continuous monitoring?)

I haven’t met a pediatric hospitalist who wouldn’t understand the symbolic importance of this success. But I know of many hospitalists who have not yet participated in meaningful QI project. Imagine calling a plumber who grasped the flush and fill mechanism of a toilet but had never touched real porcelain. Here’s an even better analogy: What if doctors could get licensed without having touched real patients?

If pediatric hospitalists are to transform the care delivery of hospitalized children, and quality learning only comes through hands-on training, then we need some more hands in the pot.

Discharge Improvement

On the heels of my first project, I was fortunate enough to augment my education through another effort—this time with a cohort of fellow pediatric hospitalists. This was a national collaborative to improve discharge handoffs, and I will admit that, at the outset, I was as puzzled as the first time I pulled the lid off the tank of the toilet. There were just too many permutations on PCP communication at the participating institutions, and some felt our aim of timely discharge handoffs was unattainable.

What carried me through, however, was the collective and infectious DIY—no, QIY (Quality Improve-it-Yourself) attitude of the group. We were all learning, and regular participation in the collaborative essentially guaranteed improvement. We achieved our aim of 90% communication with PCPs within two days of discharge. The secret was simple: The more you do, the more you learn.

Pediatric hospitalists can transform care delivery through a focus on safe and quality care, but the tools to accomplish this must come through post-residency, on-the-job learning. This QI know-how must efficiently spread among our ranks through practical and project-based educational efforts. It’s “see one, do one, teach one,” but we’re not talking about lumbar punctures anymore.

This is a journey in which we all take on the responsibility of rolling up our sleeves and simply learn by doing. And here is where the third leg of my as-yet-unfinished QI course unfolds.

Through my involvement with the Value in Inpatient Pediatrics (VIP) Network, I’ve gained a newfound vision for what the future might hold. VIP has evolved from a benchmarking project focused on bronchiolitis to an improvement network that will incorporate projects similar to the discharge handoff collaborative above.

In the process, a model for how to rapidly spread QI learning has emerged. The capacity lies in the network’s rapidly growing connectivity. The power comes from the individuals: motivated, card-carrying pediatric hospitalists from a wide array of sites. Collaborative learning harbors the potential to exponentially increase the pace at which we improve.

The future of our quality care is bright. I see an open network of improvement doers and learners. I see collaboration on quality and safety initiatives in all manner of hospitals and communities. I see that this will all be built upon a foundation of hard work and a QIY attitude.

You, too, will play a role.

Just don’t be afraid to get your hands a little dirty. TH

Dr. Shen is medical director of hospital medicine at Dell Children’s Medical Center in Austin, Texas. He is pediatric editor of The Hospitalist.

Despite never advancing his musical tastes beyond the arena bands of the 1970s and ’80s (think Def Leppard), Mark Williams, MD, FACP, FHM, editor-in-chief of the Journal of Hospital Medicine, has done a great job in securing informative and meaningful research and opinion for the journal. Did you see read the July/August 2010 issue of JHM? It is a great example of content uniquely relevant to hospitalists: several original research articles documenting how hospitalists spend their time. Anyone thinking about the best way to organize and operate a hospitalist practice should read through these studies, along with one published by Kevin O’Leary, MD, and colleagues in the March/April 2006 issue.¹ But as a service, I’ll provide a CliffsNotes version of them, along with some comments here.

Time-Motion Studies

What all the studies demonstrate is that academic hospitalists spend only about 15% to 20% of their time in direct patient care, generally defined as time spent taking a patient’s history and examination, meeting with families, etc. Indirect patient care, such as time spent reviewing records, documenting, and communicating with consultants and other patient care staff, consumes about 60% to 70% of their time. The remainder of time is spent in transit (around 7% of each day) and in personal activities.

Remember, all these studies reported on academic hospitalists in large academic medical centers. As noted in the discussion sections, the results in nonteaching community hospitals might be different. My guess is that community hospitalists spend about the same portion of time in the broad categories above, but the individual activities within each category might differ. So I’m willing to believe that these studies tell us something about the majority of hospitalists who practice outside of academia.

90 Minutes of Doctoring?

While the JHM studies assess hospitalist time in a number of different categories, I think it makes the most sense to divide our time into just two categories: “real doctoring” and other. We’ll probably never see a study that divides hospitalists’ time that way, as there would be endless debate about what is and isn’t real doctoring. But it is worth thinking about your work this way.

A lot of what the studies generally defined as indirect patient care is still “real doctoring.” Things like reviewing old records are critically important and typically can’t be done adequately by a nonclinician. But the 10 minutes you spent to get the CD of outside X-rays to show up on your computer, and rearranging the faxed pages so they’re all oriented the same way and in order, are not a good use of your time; a clerical person could do it.

I periodically have an experience that makes me think I spend too much time on patients’ social issues (e.g. long conversations about why Medicare won’t pay for a patient’s skilled nursing facility stay) and too little on “real doctoring.” One such experience is when I have a patient with an unusual pulmonary infiltrate and the radiologist is able to generate a much more comprehensive differential diagnosis than I can. This is embarrassing. Maybe the radiologist is just smarter than I am, but I think it could be because, compared to me, he spends more of his time every day thinking about “real medicine,” such as pulmonary diseases, and less time dealing with nonclinical issues.

Even though we’re paid for a full day’s work, I suspect many hospitalists might spend only about 90 minutes a day immersed in thought about “real medicine,” while doctors in most other specialties probably spend a lot more. If I’m right, then it shouldn’t be a surprise that after practicing for many years, the radiologist who spends several hours a day exercising his fund of medical knowledge probably has more command of some clinical things than a hospitalist who does so only 90 minutes a day. Actively practicing as a hospitalist might not be as effective a method of maintaining proficiency as it is in other specialties. More than many other specialties, we need to rely on self-study and continuing education courses to prevent erosion of our knowledge base.

I’ve just made up this 90-minute figure. I have no idea how accurate it might be, and, the JHM studies don’t offer a lot of insight either. Clearly, it varies a lot by individual doctor and practice setting. How much of your day do you think you spend on “real doctoring” vs. other activities?

What really matters is whether we’ve ended up with too much work that isn’t “real doctoring.” Sure, all of the work needs to be done, but the system isn’t served best when paying a doctor to do work a less expensive person could do.

Max “Doctoring” Time

I think most hospitalists, including me, are stuck spending too much time on activities that don’t add value. For example, while complete and informative documentation is essential, most of us probably spend too much time on it, in part because we’re trying to immunize against lawsuits and ensure our documentation matches the relevant coding regulations.

I think hospitalists have a communication burden that is higher than that of most other specialties. The JHM article by Tipping and colleagues notes that a time-motion study of ED doctors (Ann Emerg Med. 1998:31(1):87-91) found that they spent 13% of their time communicating with other providers and staff, compared with their finding that hospitalists spent 26% of their time communicating.² Only a portion of this communication is real doctoring. Discussing patient management with a surgeon is, but spending 20 minutes figuring out which surgeon is on call and how to reach her isn’t.

Tipping’s study also found that when patient census was above average, hospitalists spent less time communicating and documenting in the electronic record, even though the total time spent working on those days increased. Of course, it is possible that when the patient census is below average, we just work more slowly and let work fill the time available, and the reduced time spent documenting and communicating when busy simply reflects working more efficiently. But I suspect that when our patient census climbs above a certain point, or we’re made less efficient by things like implementing a new technology, we compensate in part by relying on consultants more to do the real doctoring we would otherwise be doing and communicating with them less.

All of us should be thinking about ways to make communication as efficient as possible so that we can spend less time doing it. I’m hopeful that we will figure out new ways to communicate (e-mail, text, IM, etc.) that are quicker and just as effective in certain situations.

Coda

I try to write most of my columns in a way that minimizes the editorializing and maximizes the practical advice. This month is an exception; it’s all editorializing. But I do have some advice for Dr. Williams: Investigate music options other than the arena bands of the 1980s. Try something like Alison Krauss’ live album or Puccini’s opera Gianni Schicchi, which has the beautiful aria O mio babbino caro.

Or do what I do: Ask former SHM board member Brad Flansbaum, MD, SFHM, for advice. TH

Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson Flores Hospital Medicine Consultants, a national hospitalist practice management consulting firm (www.nelsonflores.com). He is course co-director and faculty for SHM’s “Best Practices in Managing a Hospital Medicine Program.” This column represents his views and is not intended to reflect an official position of SHM.

References

1. O’Leary KJ, Liebovitz DM, Baker DW. How hospitalists spend their time: insights on efficiency and safety. J Hosp Med. 2006;1(2):88-93.
2. Tipping MD, Forth VE, O’Leary KJ, et al. Where did the day go? A time-motion study of hospitalists. J Hosp Med. 2010;5(6):323-328.

Despite never advancing his musical tastes beyond the arena bands of the 1970s and ’80s (think Def Leppard), Mark Williams, MD, FACP, FHM, editor-in-chief of the Journal of Hospital Medicine, has done a great job in securing informative and meaningful research and opinion for the journal. Did you see read the July/August 2010 issue of JHM? It is a great example of content uniquely relevant to hospitalists: several original research articles documenting how hospitalists spend their time. Anyone thinking about the best way to organize and operate a hospitalist practice should read through these studies, along with one published by Kevin O’Leary, MD, and colleagues in the March/April 2006 issue.¹ But as a service, I’ll provide a CliffsNotes version of them, along with some comments here.

Time-Motion Studies

What all the studies demonstrate is that academic hospitalists spend only about 15% to 20% of their time in direct patient care, generally defined as time spent taking a patient’s history and examination, meeting with families, etc. Indirect patient care, such as time spent reviewing records, documenting, and communicating with consultants and other patient care staff, consumes about 60% to 70% of their time. The remainder of time is spent in transit (around 7% of each day) and in personal activities.

Remember, all these studies reported on academic hospitalists in large academic medical centers. As noted in the discussion sections, the results in nonteaching community hospitals might be different. My guess is that community hospitalists spend about the same portion of time in the broad categories above, but the individual activities within each category might differ. So I’m willing to believe that these studies tell us something about the majority of hospitalists who practice outside of academia.

90 Minutes of Doctoring?

While the JHM studies assess hospitalist time in a number of different categories, I think it makes the most sense to divide our time into just two categories: “real doctoring” and other. We’ll probably never see a study that divides hospitalists’ time that way, as there would be endless debate about what is and isn’t real doctoring. But it is worth thinking about your work this way.

A lot of what the studies generally defined as indirect patient care is still “real doctoring.” Things like reviewing old records are critically important and typically can’t be done adequately by a nonclinician. But the 10 minutes you spent to get the CD of outside X-rays to show up on your computer, and rearranging the faxed pages so they’re all oriented the same way and in order, are not a good use of your time; a clerical person could do it.

I periodically have an experience that makes me think I spend too much time on patients’ social issues (e.g. long conversations about why Medicare won’t pay for a patient’s skilled nursing facility stay) and too little on “real doctoring.” One such experience is when I have a patient with an unusual pulmonary infiltrate and the radiologist is able to generate a much more comprehensive differential diagnosis than I can. This is embarrassing. Maybe the radiologist is just smarter than I am, but I think it could be because, compared to me, he spends more of his time every day thinking about “real medicine,” such as pulmonary diseases, and less time dealing with nonclinical issues.

Even though we’re paid for a full day’s work, I suspect many hospitalists might spend only about 90 minutes a day immersed in thought about “real medicine,” while doctors in most other specialties probably spend a lot more. If I’m right, then it shouldn’t be a surprise that after practicing for many years, the radiologist who spends several hours a day exercising his fund of medical knowledge probably has more command of some clinical things than a hospitalist who does so only 90 minutes a day. Actively practicing as a hospitalist might not be as effective a method of maintaining proficiency as it is in other specialties. More than many other specialties, we need to rely on self-study and continuing education courses to prevent erosion of our knowledge base.

I’ve just made up this 90-minute figure. I have no idea how accurate it might be, and, the JHM studies don’t offer a lot of insight either. Clearly, it varies a lot by individual doctor and practice setting. How much of your day do you think you spend on “real doctoring” vs. other activities?

What really matters is whether we’ve ended up with too much work that isn’t “real doctoring.” Sure, all of the work needs to be done, but the system isn’t served best when paying a doctor to do work a less expensive person could do.

Max “Doctoring” Time

I think most hospitalists, including me, are stuck spending too much time on activities that don’t add value. For example, while complete and informative documentation is essential, most of us probably spend too much time on it, in part because we’re trying to immunize against lawsuits and ensure our documentation matches the relevant coding regulations.

I think hospitalists have a communication burden that is higher than that of most other specialties. The JHM article by Tipping and colleagues notes that a time-motion study of ED doctors (Ann Emerg Med. 1998:31(1):87-91) found that they spent 13% of their time communicating with other providers and staff, compared with their finding that hospitalists spent 26% of their time communicating.² Only a portion of this communication is real doctoring. Discussing patient management with a surgeon is, but spending 20 minutes figuring out which surgeon is on call and how to reach her isn’t.

Tipping’s study also found that when patient census was above average, hospitalists spent less time communicating and documenting in the electronic record, even though the total time spent working on those days increased. Of course, it is possible that when the patient census is below average, we just work more slowly and let work fill the time available, and the reduced time spent documenting and communicating when busy simply reflects working more efficiently. But I suspect that when our patient census climbs above a certain point, or we’re made less efficient by things like implementing a new technology, we compensate in part by relying on consultants more to do the real doctoring we would otherwise be doing and communicating with them less.

All of us should be thinking about ways to make communication as efficient as possible so that we can spend less time doing it. I’m hopeful that we will figure out new ways to communicate (e-mail, text, IM, etc.) that are quicker and just as effective in certain situations.

Coda

I try to write most of my columns in a way that minimizes the editorializing and maximizes the practical advice. This month is an exception; it’s all editorializing. But I do have some advice for Dr. Williams: Investigate music options other than the arena bands of the 1980s. Try something like Alison Krauss’ live album or Puccini’s opera Gianni Schicchi, which has the beautiful aria O mio babbino caro.

Or do what I do: Ask former SHM board member Brad Flansbaum, MD, SFHM, for advice. TH

Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson Flores Hospital Medicine Consultants, a national hospitalist practice management consulting firm (www.nelsonflores.com). He is course co-director and faculty for SHM’s “Best Practices in Managing a Hospital Medicine Program.” This column represents his views and is not intended to reflect an official position of SHM.

References

1. O’Leary KJ, Liebovitz DM, Baker DW. How hospitalists spend their time: insights on efficiency and safety. J Hosp Med. 2006;1(2):88-93.
2. Tipping MD, Forth VE, O’Leary KJ, et al. Where did the day go? A time-motion study of hospitalists. J Hosp Med. 2010;5(6):323-328.

Despite never advancing his musical tastes beyond the arena bands of the 1970s and ’80s (think Def Leppard), Mark Williams, MD, FACP, FHM, editor-in-chief of the Journal of Hospital Medicine, has done a great job in securing informative and meaningful research and opinion for the journal. Did you see read the July/August 2010 issue of JHM? It is a great example of content uniquely relevant to hospitalists: several original research articles documenting how hospitalists spend their time. Anyone thinking about the best way to organize and operate a hospitalist practice should read through these studies, along with one published by Kevin O’Leary, MD, and colleagues in the March/April 2006 issue.¹ But as a service, I’ll provide a CliffsNotes version of them, along with some comments here.

Time-Motion Studies

What all the studies demonstrate is that academic hospitalists spend only about 15% to 20% of their time in direct patient care, generally defined as time spent taking a patient’s history and examination, meeting with families, etc. Indirect patient care, such as time spent reviewing records, documenting, and communicating with consultants and other patient care staff, consumes about 60% to 70% of their time. The remainder of time is spent in transit (around 7% of each day) and in personal activities.

Remember, all these studies reported on academic hospitalists in large academic medical centers. As noted in the discussion sections, the results in nonteaching community hospitals might be different. My guess is that community hospitalists spend about the same portion of time in the broad categories above, but the individual activities within each category might differ. So I’m willing to believe that these studies tell us something about the majority of hospitalists who practice outside of academia.

90 Minutes of Doctoring?

While the JHM studies assess hospitalist time in a number of different categories, I think it makes the most sense to divide our time into just two categories: “real doctoring” and other. We’ll probably never see a study that divides hospitalists’ time that way, as there would be endless debate about what is and isn’t real doctoring. But it is worth thinking about your work this way.

A lot of what the studies generally defined as indirect patient care is still “real doctoring.” Things like reviewing old records are critically important and typically can’t be done adequately by a nonclinician. But the 10 minutes you spent to get the CD of outside X-rays to show up on your computer, and rearranging the faxed pages so they’re all oriented the same way and in order, are not a good use of your time; a clerical person could do it.

I periodically have an experience that makes me think I spend too much time on patients’ social issues (e.g. long conversations about why Medicare won’t pay for a patient’s skilled nursing facility stay) and too little on “real doctoring.” One such experience is when I have a patient with an unusual pulmonary infiltrate and the radiologist is able to generate a much more comprehensive differential diagnosis than I can. This is embarrassing. Maybe the radiologist is just smarter than I am, but I think it could be because, compared to me, he spends more of his time every day thinking about “real medicine,” such as pulmonary diseases, and less time dealing with nonclinical issues.

Even though we’re paid for a full day’s work, I suspect many hospitalists might spend only about 90 minutes a day immersed in thought about “real medicine,” while doctors in most other specialties probably spend a lot more. If I’m right, then it shouldn’t be a surprise that after practicing for many years, the radiologist who spends several hours a day exercising his fund of medical knowledge probably has more command of some clinical things than a hospitalist who does so only 90 minutes a day. Actively practicing as a hospitalist might not be as effective a method of maintaining proficiency as it is in other specialties. More than many other specialties, we need to rely on self-study and continuing education courses to prevent erosion of our knowledge base.

I’ve just made up this 90-minute figure. I have no idea how accurate it might be, and, the JHM studies don’t offer a lot of insight either. Clearly, it varies a lot by individual doctor and practice setting. How much of your day do you think you spend on “real doctoring” vs. other activities?

What really matters is whether we’ve ended up with too much work that isn’t “real doctoring.” Sure, all of the work needs to be done, but the system isn’t served best when paying a doctor to do work a less expensive person could do.

Max “Doctoring” Time

I think most hospitalists, including me, are stuck spending too much time on activities that don’t add value. For example, while complete and informative documentation is essential, most of us probably spend too much time on it, in part because we’re trying to immunize against lawsuits and ensure our documentation matches the relevant coding regulations.

I think hospitalists have a communication burden that is higher than that of most other specialties. The JHM article by Tipping and colleagues notes that a time-motion study of ED doctors (Ann Emerg Med. 1998:31(1):87-91) found that they spent 13% of their time communicating with other providers and staff, compared with their finding that hospitalists spent 26% of their time communicating.² Only a portion of this communication is real doctoring. Discussing patient management with a surgeon is, but spending 20 minutes figuring out which surgeon is on call and how to reach her isn’t.

Tipping’s study also found that when patient census was above average, hospitalists spent less time communicating and documenting in the electronic record, even though the total time spent working on those days increased. Of course, it is possible that when the patient census is below average, we just work more slowly and let work fill the time available, and the reduced time spent documenting and communicating when busy simply reflects working more efficiently. But I suspect that when our patient census climbs above a certain point, or we’re made less efficient by things like implementing a new technology, we compensate in part by relying on consultants more to do the real doctoring we would otherwise be doing and communicating with them less.

All of us should be thinking about ways to make communication as efficient as possible so that we can spend less time doing it. I’m hopeful that we will figure out new ways to communicate (e-mail, text, IM, etc.) that are quicker and just as effective in certain situations.

Coda

I try to write most of my columns in a way that minimizes the editorializing and maximizes the practical advice. This month is an exception; it’s all editorializing. But I do have some advice for Dr. Williams: Investigate music options other than the arena bands of the 1980s. Try something like Alison Krauss’ live album or Puccini’s opera Gianni Schicchi, which has the beautiful aria O mio babbino caro.

Or do what I do: Ask former SHM board member Brad Flansbaum, MD, SFHM, for advice. TH

Dr. Nelson has been a practicing hospitalist since 1988 and is co-founder and past president of SHM. He is a principal in Nelson Flores Hospital Medicine Consultants, a national hospitalist practice management consulting firm (www.nelsonflores.com). He is course co-director and faculty for SHM’s “Best Practices in Managing a Hospital Medicine Program.” This column represents his views and is not intended to reflect an official position of SHM.

References

1. O’Leary KJ, Liebovitz DM, Baker DW. How hospitalists spend their time: insights on efficiency and safety. J Hosp Med. 2006;1(2):88-93.
2. Tipping MD, Forth VE, O’Leary KJ, et al. Where did the day go? A time-motion study of hospitalists. J Hosp Med. 2010;5(6):323-328.