High Direct Bilirubin Associated With Levoffoxacin Use in a Neonate.

Limited data exist regarding the use of fluoroquinolones in the neonatal population. Levofloxacin has some utility in this population because it is one of a very limited number of antibiotics with activity against Stenotrophomonas maltophilia. We describe the successful treatment of S maltophilia tracheitis in a premature neonate using levofloxacin 10 mg/kg every 24 hours and the subsequent unexpected sharp rise in the direct bilirubin. This case illustrates a previously unrecognized adverse drug effect associated with levofloxacin use in neonates.

Effectiveness of ledipasvir/sofosbuvir in real-world patients with chronic hepatitis C: a collaborative treatment approach.

The effectiveness of ledipasvir/sofosbuvir (LDV/SOF) in routine use in clinical practice for the management of chronic hepatitis C virus (HCV) has not been well described. Data with prior agents suggest that management of HCV using an interprofessional approach in clinical practice is associated with better outcomes. This single-centre, prospective, observational cohort study evaluated patients treated with LDV/SOF for 8, 12 or 24 weeks as part of the standardized interprofessional treatment protocol at Novant Health Infectious Diseases Specialists. Eighty-four patients treated with LDV/SOF were evaluated; of these, 97.5% and 91.7% of patients achieved a sustained virological response (SVR) in the per-protocol analysis and the intention-to-treat analysis, respectively. Two patients were not cured after relapse of HCV. No patients required LDV/SOF discontinuation and all patients completed the appropriate treatment duration. The majority (56%) of patients reported no adverse effects and all adverse effects that were reported were mild. The most commonly reported adverse effects were headache and fatigue. SVR and tolerability rates were similar to those seen in the clinical trials. LDV/SOF was associated with a successful translation from the clinical trial setting to clinical practice. A collaborative treatment approach should be considered in the management of HCV.

Use of specific indicators to detect warfarin-related adverse events.

PURPOSE: The use of specific indicators, or "triggers," to identify adverse drug events (ADEs) associated with warfarin therapy is described. SUMMARY: Automated triggers provided by laboratory and pharmacy data were used to identify potential ADEs associated with warfarin therapy among patients treated in the emergency room or admitted to six community hospitals between July 2002 and December 2003. The triggers consisted of an International Normalized Ratio (INR) of greater than 3.0 and pharmacy orders for vitamin K. Pharmacists reviewed the triggers monthly for clinical determination of ADEs during preintervention and postintervention periods. Interventions consisted of staff education and real-time adjustments in therapy. A 39% overall reduction in ADEs occurred between the preintervention and postintervention periods. Harmful ADEs declined by 70%. CONCLUSION: INRs of greater than 3.0 and vitamin K administration appeared to be reliable indicators of warfarin-associated ADEs, and detection with these indicators appeared to reduce ADEs when combined with appropriate interventions.

Safety and effectiveness of daptomycin across a hospitalized obese population: results of a multicenter investigation in the southeastern United States.

STUDY OBJECTIVE: Data are limited for antimicrobial outcomes in obese patients. This study investigated the safety and clinical outcomes of daptomycin therapy in a hospitalized obese population in the southeastern United States. DESIGN: Multicenter retrospective cohort study. SETTING: Thirteen hospitals in the southeastern United States. PATIENTS: A total of 126 hospitalized adult obese patients (body mass index [BMI] more than 30 kg/m(2) ) admitted from January 2005 through May 2010 who received daptomycin dosed on actual body weight for any indication for a minimum of 7 days. MEASUREMENTS AND MAIN RESULTS: Primary safety outcomes included incidence of creatine phosphokinase (CPK) elevations more than 1000 units/L, more than 500 units/L, myalgias, and discontinuation of therapy due to adverse drug events (ADEs). Patients were stratified by BMI class (I, II, or III) for analyses. The average weight was 121 kg, and 39% of patients were considered morbidly obese. Factors associated with an increased risk of primary safety outcomes were assessed through regression analysis. Clinical effectiveness was evaluated as a secondary outcome. CPK elevations more than 1000 units/L occurred in 8.4% of evaluable patients and specifically in 1 (3.6%), 3 (10.3%), and 4 (10.5%) patients in BMI class I, II, and III, respectively (p=0.554). CPK elevations more than 500 units/L occurred in 13.7% of patients with no statistically significant difference noted across BMI classes. Discontinuation due to ADEs occurred in 8 patients (6.3%). One patient developed rhabdomyolysis on day 9 of therapy. Clinical effectiveness was documented in 71% of patients and was consistent across BMI classes. CONCLUSION: Although elevations in CPK increased in high-risk obese patients on daptomycin, discontinuation rates due to ADEs remained low. Further evaluation in a prospective trial is warranted.

Postgraduate year one pharmacy residency program equivalency.

In 2006, the American College of Clinical Pharmacy (ACCP) charged the Task Force on Residency Equivalency to define the professional experience expected of a clinically mature practitioner that would meet or exceed the knowledge and skills of an accredited postgraduate year one residency-trained pharmacist. In this commentary, the Task Force discusses both the qualitative and quantitative components of documentation by means of a residency equivalency portfolio. The potential roles of academia, pharmacy professional organizations, and employers and the possible barriers to an equivalency process are addressed. This commentary lays the foundation for establishing a residency equivalency process that could promote the growth and development of existing and future residency programs and allow qualified practitioners to demonstrate their capabilities. The ACCP implores invested stakeholders to take an active part in this collaborative effort as the profession transitions toward residency training as a prerequisite for all pharmacists providing direct patient care by 2020.