ASPEN Lipid Injectable Emulsion Safety Recommendations, Part 1: Background and Adult Considerations.

Lipid injectable emulsions (ILEs) are complex pharmaceutical formulations used as a source of energy and essential fatty acids in parenteral nutrition. Issues associated with ILE use are distinctly different from oral fat and arise from emulsion stability, dose, and infusion tolerance. Since 1975, soybean oil has been the consistent source oil used in ILE formulations in the US. Partly because of safety concerns with the soybean-based ILE and frequent and long-standing problems with product inventory shortages, new ILE products have become available. Gaps in ILE best practices create a risk for ILE safety errors in prescribing, compounding, and administration of these products. This paper provides information on appropriate indications, dosing, and methods to avoid potential errors with ILE products in the US. This paper (Part 1) will focus on ILE background, information, and recommendations for adult patients, whereas Part 2 of this series will focus on neonatal and pediatric patient-specific information.

New and Emerging Antibiotics for Complicated Intra-Abdominal Infections.

The purpose of this review is to evaluate the efficacy and safety of ceftazidime/avibactam and ceftolozane/tazobactam in patients with complicated intra-abdominal infections (cIAI), and review eravacycline and other agents in the pipeline for management of cIAI. The increasing incidence of multidrug resistant strains of bacteria has led to the need for additional antibiotics with activity against these organisms. There are 2 newly approved antibiotics, ceftazidime/avibactam and ceftolazane/tazobactam for treatment of cIAI. Both agents have been shown to exert activity against resistant bacteria, including extended-spectrum beta-lactamase-producing organisms. Several other antibiotics are currently under investigation for this indication. Included in the pipeline of agents is a new tetracycline, an aminoglycoside, 2 new fluroquinolones, and 2 new beta-lactamase inhibitor combinations with carbapenems. Although the mechanisms for these new agents are not novel, promising data have shown their ability to overcome class resistance. The passing of the Generating Antibiotic Incentives Now Act has led to an increasing number of fast tracked antibiotic approvals. In addition to recent approval of ceftazidime/avibactam and ceftolazane/tazobactam, several other emerging antibiotics are under investigation which will aid in the management of resistant cIAI.

Dosing of enoxaparin for venous thromboembolism prophylaxis in obese patients.

OBJECTIVE: To evaluate the appropriate dosing of enoxaparin as a venous thromboembolism (VTE) prophylaxis in hospitalized obese patients. DATA SOURCES: Literature articles were accessed through MEDLINE (1946 to August week 1, 2013) and EMBASE (1980 to 2013 week 33) searches using the terms enoxaparin, obesity, and thromboprophylaxis. STUDY SELECTION AND DATA EXTRACTION: All articles that involved human subjects and were published in the English language, evaluating the appropriate dose of enoxaparin for VTE prophylaxis in hospitalized, obese patients were included. DATA SYNTHESIS: Appropriate enoxaparin dosing for thromboprophylaxis in adult patients is 40 mg subcutaneously daily or 30 mg subcutaneously twice daily. Although obesity is considered one of the risk factors for thromboembolism, morbidly obese patients were excluded from most clinical trials; therefore, the appropriate enoxaparin preventive dose is not clear in this population. In recent years, the appropriate dose of enoxaparin for VTE prophylaxis in obese patients has been evaluated in 3 clinical studies. All studies enrolled patients with various risk factors for thromboembolism and evaluated different enoxaparin dosing regimens. End point analyses were all based on anti-Xa levels. CONCLUSIONS: Due to a lack of well-designed prospective, randomized control studies, varying doses of enoxaparin are used for VTE prophylaxis in hospitalized, obese patients. All doses studied were monitored using anti-Xa levels. Patient follow-up was of short duration in all studies and did not show long-term effectiveness of enoxaparin. Prospective, randomized controlled studies are warranted to show efficacy and safety of one dosage regimen over another.