James F. Lloyd

Opioid-Related Adverse Drug Events in Surgical Hospitalizations: Impact on Costs and Length of Stay

Background: Opioid analgesics remain a mainstay in the treatment of pain associated with surgical procedures. Such use is associated with adverse drug events (ADEs). Objective: To investigate the impact of opioid-related ADEs on total hospital costs and length of stay (LOS) in adult surgical patients. Methods: This was a retrospective matched cohort study using data from computerized medical records. ADE cases were prospectively detected using computerized surveillance and verified by pharmacists. Surgical patients treated at LDS Hospital in Salt Lake City from January 1, 1998, to December 31, 2003, were included. The primary outcomes were costs and hospital LOS associated with opioid-related ADEs and the relationship of opioid dose to ADE events. Results: Patients experiencing opioid-related ADEs had significantly increased median total hospital costs (7.4% increase; 95% CI 3.83 to 10.96; p < 0.001) and increased median LOS (10.3% increase; 95% CI 6.5 to 14.2; p < 0.001) compared with matched non-ADE contrals. The increased costs attributable to ADEs, by surgery type, were general surgery (

Hospital Workload and Adverse Events

676.51; 95% CI 351.50 to 1001.50), orthopedics (

Risk of Symptomatic DVT Associated With Peripherally Inserted Central Catheters

861.50; 95% CI 448.20 to 1274.80), and obstetrics/gynecology (

Cost of Opioid-Related Adverse Drug Events in Surgical Patients

540.90; 95% CI 281.40 to 800.40). Similarly, increased LOS attributable to ADEs, by surgery type, were general surgery (0.64 days; 95% CI 0.40 to 0.88), orthopedics (0.52 days; 95% CI 0.33 to 0.71), and obstetrics/gynecology (0.53 days; 95% CI 0.33 to 0.72). Higher doses of opioids were associated with increased risk of experiencing ADEs (OR 1.3; 95% CI 1.07 to 1.60; p = 0.01). Conclusions: Opioid-related ADEs following surgery were associated with significantly increased LOS and hospitalization costs. These ADEs occurred more frequently in patients receiving higher doses of opioids.

Risk Factors for Adverse Drug Events: A 10-Year Analysis

Context:Hospitals are under pressure to increase revenue and lower costs, and at the same time, they face dramatic variation in clinical demand. Objective:We sought to determine the relationship between peak hospital workload and rates of adverse events (AEs). Methods:A random sample of 24,676 adult patients discharged from the medical/surgical services at 4 US hospitals (2 urban and 2 suburban teaching hospitals) from October 2000 to September 2001 were screened using administrative data, leaving 6841 cases to be reviewed for the presence of AEs. Daily workload for each hospital was characterized by volume, throughput (admissions and discharges), intensity (aggregate DRG weight), and staffing (patient-to-nurse ratios). For volume, we calculated an “enhanced” occupancy rate that accounted for same-day bed occupancy by more than 1 patient. We used Poisson regressions to predict the likelihood of an AE, with control for workload and individual patient complexity, and the effects of clustering. Results:One urban teaching hospital had enhanced occupancy rates more than 100% for much of the year. At that hospital, admissions and patients per nurse were significantly related to the likelihood of an AE (P < 0.05); occupancy rate, discharges, and DRG-weighted census were significant at P < 0.10. For example, a 0.1% increase in the patient-to-nurse ratio led to a 28% increase in the AE rate. Results at the other 3 hospitals varied and were mainly non significant. Conclusions:Hospitals that operate at or over capacity may experience heightened rates of patient safety events and might consider re-engineering the structures of care to respond better during periods of high stress.

Objective surveillance definitions for ventilator-associated pneumonia.

BACKGROUND Previous studies undertaken to identify risk factors for peripherally inserted central catheter (PICC)-associated DVT have yielded conflicting results. PICC insertion teams and other health-care providers need to understand the risk factors so that they can develop methods to prevent DVT. METHODS A 1-year prospective observational study of PICC insertions was conducted at a 456-bed, level I trauma center and tertiary referral hospital affiliated with a medical school. All patients with one or more PICC insertions were included to identify the incidence and risk factors for symptomatic DVT associated with catheters inserted by a facility-certified PICC team using a consistent and replicated approach for vein selection and insertion. RESULTS A total of 2,014 PICCs were inserted during 1,879 distinct hospitalizations in 1,728 distinct patients for a total of 15,115 days of PICC placement. Most PICCs were placed in the right arm (76.9%) and basilic vein (74%) and were double-lumen 5F (75.3%). Of the 2,014 PICC insertions, 60 (3.0%) in 57 distinct patients developed DVT in the cannulated or adjacent veins. The best-performing predictive model for DVT (area under the curve, 0.83) was prior DVT (odds ratio [OR], 9.92; P < .001), use of double-lumen 5F (OR, 7.54; P < .05) or triple-lumen 6F (OR, 19.50; P < .01) PICCs, and prior surgery duration of > 1 h (OR, 1.66; P = .10). CONCLUSIONS Prior DVT and surgery lasting > 1 h identify patients at increased risk for PICC-associated DVT. More importantly, increasing catheter size also is significantly associated with increased risk. Rates of PICC-associated DVT may be reduced by improved selection of patients and catheter size.

Derivation and Validation of a Simple Model to Identify Venous Thromboembolism Risk in Medical Patients

Opioids have demonstrated efficacy and often are drugs of choice in the management of postoperative pain. However, their use is often limited by adverse drug events (ADEs). The objective of this study was to determine the ADE rate in adult surgical patients who received opioids and the impact of opioid ADEs on length of stay (LOS), costs, and mortality. A hospital-based computerized system detected potential ADEs. Adult patients were selected if they received at least one dose of opioid medication during a surgical hospitalization between 1 January 1990 and 31 December 1999. Control patients were matched based on matching length of stay ([LOS] at least as long as time to ADE), age (within 10 years), sex, admission year, major disease category (MDC), and without an ADE. Linear regression models were used to determine the predictors of increased LOS, total hospital costs, and log-transformed total hospital costs. 60,722 patients received opioid medication during their surgical hospitalization and 2.7% experienced an opioid-related ADE. The most common clinical manifestations were nausea and vomiting (67%), and rash, hives, or itching (33.5%). No statistically significant difference was seen in mortality between ADE/non-ADE patients. ADE patients had statistically significant increases in LOS (0.53 days) and in log-transformed cost (16%). The estimated log cost difference of 16%, if applied to the median cost patient in the non-ADE group, averaged US

Reduction of Peripherally Inserted Central Catheter-Associated DVT

840. Opioid-related ADEs are common in hospitalized patients and increase LOS and total hospital costs.

Apixaban for the Secondary Prevention of Thrombosis Among Patients With Antiphospholipid Syndrome: Study Rationale and Design (ASTRO-APS)

BACKGROUND Many adverse drug events (ADEs) are the result of known pharmacologic properties, and some result from medication errors. However, some are the result of patient-specific risk factors. OBJECTIVE To identify inpatient risk factors for ADEs. METHODS Conditional logistic regression was used to analyze all pharmacist-verified ADEs by therapeutic class of drugs and severity during a 10-year study period. All inpatients ≥18 years of age from a 520-bed tertiary teaching hospital were included. Each case patient was matched with up to 16 control patients. Odds ratios for patient factors associated with ADEs were calculated from different therapeutic classes of drugs. RESULTS Odds ratios for numerous risk factors were identified for 4376 ADEs and were found to vary depending on therapeutic classification. The risk factors for the different classifications were grouped by (1) patient characteristics—female (OR 1.5–1.7), age (0.7–0.9), weight (1.2–1.4), creatinine clearance (0.8–4.7), and number of comorbidities (1.1–12.6); (2) drug administration—dosage (1.2–3.7), administration route (1.4–149.9), and number of concomitant drugs (1.2–2.4); and (3) patient type—service (1.2–4.9), nursing division (1.5–3.8), and diagnosis-related group (1.5–5.7). CONCLUSIONS Some risk factors are consistent for all ADEs and across multiple therapeutic classes of drugs, while others are class specific. High-risk agents should be closely monitored based on patient characteristics (gender, age, weight, creatinine clearance, number of comorbidities) and drug administration (dosage, administration route, number of concomitant drugs).

Major bleeding with dabigatran and rivaroxaban in patients with atrial fibrillation: a real-world setting.

Objectives:The subjectivity and complexity of surveillance definitions for ventilator-associated pneumonia preclude meaningful internal or external benchmarking and therefore hamper quality improvement initiatives for ventilated patients. We explored the feasibility of creating objective surveillance definitions for ventilator-associated pneumonia. Design:We identified clinical signs suitable for inclusion in objective definitions, proposed candidate definitions incorporating these objective signs, and then applied these definitions to retrospective clinical data to measure their frequencies and associations with adverse outcomes using multivariate regression models for cases and matched controls. Setting:Medical and surgical intensive care units in eight U.S. hospitals (four tertiary centers, three community hospitals, and one Veterans Affairs institution). Patients:Eight thousand seven hundred thirty-five consecutive episodes of mechanical ventilation for adult patients. Interventions:We evaluated 32 different candidate definitions composed of different combinations of the following signs: three thresholds for respiratory deterioration defined by sustained increases in daily minimum positive end-expiratory pressure or FIO2 after either 2 or 3 days of stable or decreasing ventilator settings, abnormal temperature, abnormal white blood cell count, purulent pulmonary secretions defined by neutrophils on Gram stain, and positive cultures for pathogenic organisms. Measurements and Main Results:Ventilator-associated pneumonia incidence, attributable ventilator days, hospital days, and hospital mortality. All candidate definitions were significantly associated with increased ventilator days and hospital days, but only definitions requiring objective evidence of respiratory deterioration were significantly associated with increased hospital mortality. Significant odds ratios for hospital mortality ranged from 1.9 (95% confidence interval 1.2–2.9) to 6.1 (95% confidence interval 2.2–17). Requiring additional clinical signs beyond respiratory deterioration alone decreased event rates, had little impact on attributable lengths of stay, and diminished sensitivity and positive predictive values for hospital mortality. Conclusions:Objective surveillance definitions that include quantitative evidence of respiratory deterioration after a period of stability strongly predict increased length of stay and hospital mortality. These definitions merit further evaluation of their utility for hospital quality and safety improvement programs.