Major clinical events and healthcare resource use among patients with long-chain fatty acid oxidation disorders in the United States: Results from LC-FAOD Odyssey program.

Major clinical events (MCEs) related to long-chain fatty acid oxidation disorders (LC-FAOD) in triheptanoin clinical trials include inpatient or emergency room (ER) visits for three major clinical manifestations: rhabdomyolysis, hypoglycemia, and cardiomyopathy. However, outcomes data outside of LC-FAOD clinical trials are limited. The non-interventional cohort LC-FAOD Odyssey study examines data derived from US medical records and patient reported outcomes to quantify LC-FAOD burden according to management strategy including MCE frequency and healthcare resource utilization (HRU). Thirty-four patients were analyzed of which 21 and 29 patients had received triheptanoin and/or medium chain triglycerides (MCT), respectively. 36% experienced MCEs while receiving triheptanoin versus 54% on MCT. Total mean annualized MCE rates on triheptanoin and MCT were 0.1 and 0.7, respectively. Annualized disease-related inpatient and ER events were lower on triheptanoin (0.2, 0.3, respectively) than MCT (1.2, 1.0, respectively). Patients were managed more in an outpatient setting on triheptanoin (8.9 annualized outpatient visits) vs MCT (7.9). Overall, this shows that those with LC-FAOD in the Odyssey program experienced fewer MCEs and less HRU in inpatient and ER settings during triheptanoin-treated periods compared with the MCT-treated periods. The MCE rate was lower after initiation of triheptanoin, consistent with clinical trials.

Major publications in the critical care pharmacotherapy literature: February 2012 through February 2013.

PURPOSE: Recent impactful additions to the professional literature on the role of pharmacotherapy in treating the critically ill are summarized. SUMMARY: An unusually large number of updated practice guidelines and other publications with broad critical care pharmacotherapy ramifications appeared in the primary biomedical literature during the designated review period (February 2012-February 2013). Hundreds of relevant articles were evaluated by the Critical Care Pharmacotherapy Literature Update group (CCPLU), a national group of pharmacists who routinely monitor 25 peer-reviewed journals for emerging evidence that pertains to rational medication use in the intensive care unit (ICU) setting. From among those articles, 64 were summarized for dissemination to CCPLU members; the 8 publications deemed to have the greatest utility for critical care practitioners, as determined by CCPLU through a voting process, were selected for inclusion in this review, with preference given to evidence meeting high standards of methodological quality. The summaries presented here include (1) important new recommendations on management of pain, agitation, and delirium in critically ill patients, (2) a comprehensive update of a practice guideline issued in 2008 by the Surviving Sepsis Campaign, (3) novel strategies for the prevention and/or treatment of hyperglycemia in critical care, and (4) reports on clinical trials of promising alternative methods of sedation for use in weaning patients from mechanical ventilation. CONCLUSION: This review provides synopses of practice guidelines and other recent additions to the professional literature pertaining to rational medication use in the ICU practice setting.

Bleeding-associated outcomes with preoperative clopidogrel use in on- and off-pump coronary artery bypass.

Clopidogrel use prior to coronary artery bypass graft surgery in patients presenting with acute coronary syndromes is associated with a greater incidence of procedural related morbidity. We studied the impact of clopidogrel pre-treatment in patients undergoing off-pump versus on-pump coronary revascularization. This report describes a post hoc analysis of 431 on-pump and 165 off-pump cases from a retrospective multicenter study of the impact of preoperative (within 5 days) clopidogrel use on bleeding related outcomes and surgical reintervention. Logistic regression was used to analyze the outcomes with respect to surgery type and clopidogrel exposure while using a propensity score risk adjustment for off-pump surgery. The hospital length of stay (9.3 ± 5.4 days vs. 8.9 ± 5.3 days, p = 0.35), major bleeding (21% vs. 20%, p = 0.74) and reoperation (3.7% vs. 4.8%, p = 0.53) were similar between on-pump and off-pump, respectively. In both surgical cohorts, recent clopidogrel use was associated with a greater incidence of major bleeding, reoperation, and transfusion. After multivariable adjustment, the odds ratio of major bleeding (1.76, 95% confidence interval 0.88-3.52 on-pump; 2.37, 95% confidence interval 1.06-5.30 off-pump) and reoperation (4.52, 95% confidence interval 0.58-36.6 in on-pump; 7.05, 95% confidence interval 0.82-60.5 in off-pump) was increased in clopidogrel-treated patients compared to no clopidogrel. Major bleeding and reoperation did not differ significantly between patients undergoing on- or off-pump surgery. Clopidogrel treatment within 5 days prior to surgery increased the risk of bleeding and reoperation in all CABG patients irrespective of whether surgery was performed on- or off-pump.

Impact of worsening renal function during hospital admission on resource utilization in patients with heart failure.

Renal impairment frequently accompanies heart failure (HF) and is a recognized independent risk factor for morbidity and mortality. Few data are available assessing the impact of worsening renal function (WRF) during hospitalization on health care resource use in patients with HF. Health Insurance Portability and Accountability Act-compliant, de-identified, clinical, laboratory, and economic data for patients admitted to a tertiary care medical center with a primary diagnosis of HF were extracted by MedMining and reviewed retrospectively by the authors. Patients were excluded if they had no previous HF or were admitted for acute coronary syndrome or coronary artery bypass grafting within 30 days of index hospitalization. WRF was defined as ≥ 0.3 mg/dl increase in serum creatinine from baseline at any time during hospitalization. Of 5,803 hospitalized patients with primary HF diagnosis, 827 patients (14%) fulfilled all prespecified inclusion and exclusion criteria (74 ± 14 years of age, 43% men, 98% white, admission serum creatinine 1.4 ± 0.9 mg/dl, estimated glomerular filtration rate < 90 ml/min/1.73 m(2) at admission in 83%). During index hospitalization, WRF was identified in nearly 33%. Compared to patients without WRF, those with WRF had greater prevalence of diabetes (54% vs 43%), lower estimated glomerular filtration rate (44 ± 30 vs 62 ± 35 ml/min/1.73 m(2)), higher serum potassium (4.3 ± 0.7 vs 4.2 ± 0.7 mEq/L), and higher B-type natriuretic peptide (845 ± 821 vs 795 ± 947 pg/ml) at baseline (all p values < 0.05). Patients developing WRF incurred higher total inpatient costs ($10,977, range 671 to 212,819, vs $7,820, range 697 to 269,797, p < 0.001) and longer hospital stay (8.2 ± 6.8 vs 5.7 ± 5.5 days, p < 0.001). In conclusion, occurrence of WRF during HF-related hospitalization is associated with higher hospitalization costs and longer hospital stay.

Implementing an intravenous insulin infusion protocol in the intensive care unit.

PURPOSE: The implementation of three different insulin protocols in intensive care unit (ICU) settings in two community hospitals and one academic hospital is described. SUMMARY: Each institution possessed a commitment to improve the existing insulin protocols in order to achieve tighter glycemic control for ICU patients. Studies have shown that the maintenance of tight glycemic control provides improved patient outcomes. Obstacles to implementation of the insulin protocols at the institutions were increased staff workload, difficulties in interpreting algorithms, and lack of perceived benefit. In comparing details of the insulin protocols at the academic and community hospitals, it was found that differences were influenced by the type of institution. The differences among the institutions in the implementation of the protocols included the initial physician response to the protocol, the details of each protocol, nursing staff autonomy, and the involvement of the nursing staff in early protocol development. All three institutions had a dedicated pharmacist in the ICU who committed time toward insulin protocol implementation. For an increased likelihood of successful insulin protocol implementation, a full-time dedicated ICU pharmacist should be assigned to participate on multidisciplinary rounds, provide nursing support and education, and collect process measures to monitor and improve the protocol. CONCLUSION: The i.v. insulin infusion protocols developed and implemented in the ICUs at three institutions successfully achieved acceptance and compliance by physicians and nurses. The factors attributed to the success were multidisciplinary involvement, the continuous education of nursing staff, the vigilant involvement of a pharmacist, and flexibility in revising the protocol.

Medication errors involving continuously infused medications in a surgical intensive care unit.

OBJECTIVE: To document the incidence of medication errors related to medications administered by continuous infusion. DESIGN: Observational study. SETTING: Sixteen-bed surgical intensive care unit. MEASUREMENTS AND MAIN RESULTS: All continuous infusions in the surgical intensive care unit were evaluated at least once daily for correct flow-sheet charting, concentration, infusion rate, and dose administered, as well as patients' heights and weights (actual, ideal, and "dry"). Collected information was examined to determine the error rate, types of errors occurring, and weight used for dose calculation. Variations inpatient weight measures were compared. Seventy-one patients with 202 total infusions were observed. Errors involving continuously infused medications in our surgical intensive care unit occurred at a rate of 105.9 per 1,000 patient days. For nonweight-based infusions, 94% of doses were delivered correctly. Slightly >10% of the doses administered for weight-based infusions (dose based on dry body weight) were incorrect. Significant differences were found between the weight measurements recorded, but this did not translate into statistically significant differences in the apparent calculated doses delivered. CONCLUSIONS: Medications delivered by continuous infusion, particularly those that are weight based, can contribute to medication errors in the intensive care unit. A large proportion (87.6%) of doses for weight-based infusions was calculated based on estimated or unreliable admission weights. There were no severe consequences resulting from the errors observed in this 1 month investigation; however, depending on the pharmacokinetic characteristics of the drug being administered, there is a potential to deliver artificially low or high doses resulting in subtherapeutic or adverse effects.