A randomized, double-blind study comparing the efficacy of selenium sulfide shampoo 1% and ciclopirox shampoo 1% as adjunctive treatments for tinea capitis in children.

Our objective was to compare the efficacy of selenium sulfide shampoo 1% and ciclopirox shampoo 1% as adjunctive treatments for tinea capitis in children. Forty children aged 1-11 years with clinically diagnosed tinea capitis were randomized to receive selenium sulfide shampoo 1% or ciclopirox shampoo 1% twice a week as adjuncts to an 8-week course of ultramicronized griseofulvin dosed at 10-12 mg/kg/day. At weeks 2, 4, and 8, subjects returned to the clinic for evaluation and scalp cultures. Subjects then returned for follow-up visits 4 weeks after completing treatment. Overall, by 8 weeks, 30 of 33 (90.9%) treated children demonstrated mycological cure. Selenium sulfide shampoo 1% and ciclopirox shampoo 1% were equally effective as adjunctive treatments for tinea capitis in children in our study.

Use of the Lean Manufacturing Principles to Improve Total Parenteral Nutrition Logistics and Clinical Outcomes in the Neonatal Patient Population.

Total parenteral nutrition (TPN) is one of the most frequently used pharmaceuticals administered to patients in our Neonatal Intensive Care Unit (NICU). Initially, the total interdepartmental processing time (ordering, manufacturing, and delivery between NICU and Pharmacy) averaged 15.2 hours. Inefficiencies in this process only allowed TPN to infuse 8.8 hours on average before labs were collected the next morning. Given the short administration-to-laboratory collection time, we hypothesized that laboratory samples would not adequately reflect the effect of the current TPN infusion. Furthermore, clinicians would be making decisions based on suboptimal data and ultimately nourish this patient population inadequately. METHODS: The project team and the frontline staff created an efficient process for the manufacture and delivery of TPN. They removed waste in the process associated with manufacturing TPN and created capacity for change upstream (ordering process) and downstream (TPN infusion process) of the internal pharmacy process. The use of selection criteria and new standard operating procedures allowed for controlled PDSA testing of changes on a subset of patients. After we attained proven, sustainable results, we scaled the improvement efforts to the entire NICU patient population. RESULTS: After 4 cycles of change, patients now receive TPN on average 14.2 hours before new labs are collected. The interventions over the continuum of this project yielded statistically significant results, increased infusion times to our patients by 61.4% (P < 0.001), improved glucose homeostasis, and decreased average length of stay. CONCLUSIONS: In conclusion, creating process capacity from incremental changes and iterative PDSA cycles has yielded sustained results.

Evaluation of Rapid vs Standard Infliximab Infusions in the Pediatric Population.

BACKGROUND: Rapid 1-hour infliximab infusions have been safely implemented in adults, but studies of these rapid infusions in pediatric patients are limited. This study's primary objective was to determine the safety of 1-hour infliximab infusions compared with standard 2- to 3-hour infusions in children with inflammatory bowel disease and other autoimmune disorders. METHODS: We conducted an institutional review board-approved prospective study using an unmatched historical control group at a freestanding children's hospital comparing rapid vs standard infusion rates of infliximab and the use of premedications and immunomodulatory agents on the frequency of early and delayed infusion reactions. RESULTS: There were 50 subjects with 540 total standard (2- to 3-hour) infusions in the retrospective group and 66 subjects with 545 total rapid (1-hour) infusions assessed in the prospective group. Although the prospective group received a significantly higher infliximab dose, was significantly less likely to receive premedication, and was significantly more likely to receive another immunomodulatory agent, only 2 instances of potential infusion reactions occurred in the 545 rapid infusions (0.36%; 95% confidence interval [CI], 0.22%-11.01%; 3% of patients) administered in the prospective group compared with 1 documented infusion reaction (0.19%; 95% CI, 0.0%-11.47%; 2% of patients) in the retrospective group (odds ratio, 0.65; 95% CI, 0.01-12.93; P = 0.99). CONCLUSIONS: This study suggests that rapid infusion of infliximab over 1 hour is not associated with an increased risk of infusion reactions when compared with standard 2- to 3-hour infusions and can be safely used in children with no previous reaction to standard infusions to treat inflammatory bowel disease and other autoimmune diseases.

Improving Palivizumab Compliance rough a Pharmacist-Managed RSV Prevention Clinic.

OBJECTIVES: Palivizumab is a monoclonal antibody approved for the prevention of serious lower respiratory tract infections caused by respiratory syncytial virus (RSV) in high-risk pediatric patients. While palivizumab is more effective if used correctly, compliance with the monthly dosing is suboptimal. We established a pharmacist-managed RSV prevention clinic in an effort to improve compliance. The primary objective of this study was to determine the impact of a pharmacist-managed RSV prevention clinic on palivizumab compliance. METHODS: A chart review was performed. Patients who received palivizumab between September 2009 and April 2012 were identified. Compliance was determined as the number of patients who received eligible doses at 28- to 30-day intervals, consecutively. RESULTS: One hundred seventy-two patients received at least 1 dose of palivizumab. An average of 92% of patients who received at least 1 dose subsequently received all doses of palivizumab during the RSV season. Of those, 88% received all eligible doses in consecutive 28-to 30-day intervals. CONCLUSION: A pharmacist-managed RSV prevention clinic can assist physicians in the prevention of RSV by increasing compliance with palivizumab dosing.

Sevelamer therapy for pediatric end-stage renal disease.

Sevelamer, a non-calcium-containing, non-aluminum-containing phosphate binder, is frequently prescribed for treatment in adults with hyperphosphatemia secondary to end-stage renal disease (ESRD). However, published information regarding sevelamer use in children younger than 11 years is lacking. We report the use of sevelamer as a phosphate binder in a 19-month-old girl with ESRD who was receiving calcium carbonate 1250 mg 3 times/day for hyperphosphatemia. The patient's initial serum phosphorus concentration was 8.6 mg/dl, and the calcium-phosphorus product was 75 mg(2)/dl(2). This was well above the level that places patients at risk for complications such as joint, vessel, and soft-tissue calcification. An aluminum-containing phosphate binder was not an option given the patient's renal disease and the concern for neurotoxicity. Sevelamer was considered, but a MEDLINE search revealed no pediatric dosing information. An initial dosage of 100 mg/kg/day divided every 8 hours was administered, as extrapolated from adult data, and then titrated to 130 mg/kg/day divided every 8 hours based on the patient's response. The child's dietary phosphorus intake remained constant throughout her hospital stay. During sevelamer therapy, her serum phosphorus concentration dropped as low as 5.2 mg/dl; at discharge it was 6.5 mg/dl, with a corresponding calcium-phosphorus product in the upper 50s. No adverse effects associated with sevelamer were observed. In the dosages we used, sevelamer resulted in an acceptable calcium-phosphorus product and returned the patient's serum phosphorus concentration to near normal. Sevelamer appears to be a viable option as a phosphate binder in children with ESRD.

Patent ductus arteriosus: an overview.

Patent ductus arteriosus (PDA) is one of the most common congenital heart defects, accounting for 5%-10% of all congenital heart disease in term infants. The occurrence of PDA is inversely related to gestational age and weight, with an even greater incidence in preterm infants. The maintenance of ductal patency is essential for the normal development of the fetus. In the neonate, however, persistent patency of the ductus arteriosus (DA) is associated with significant morbidity and mortality. Normally, at birth, the DA constricts, resulting in intraluminal ischemic hypoxia, which eventually leads to closure and remodeling of the ductus. PDA in term infants is usually associated with a functional defect, whereas in preterm infants it is associated with immaturity. Normal physiologic mechanisms contributing to closure - oxygen tension and decreased prostaglandins-are altered in prematurity. Clinical signs of ductal patency include murmur, tachycardia, bounding peripheral pulses, and congestive heart failure and associated symptoms. Symptoms are not always present; therefore, diagnostic imaging is critical if a PDA is suspected on clinical grounds. Three management strategies are currently available for PDA: fluid restriction and diuretics (as clinically appropriate), medical intervention, and surgical ligation. Pharmacologic closure can be achieved via administration of intravenous indomethacin or ibuprofen lysine. While both agents have shown similar efficacy, ibuprofen lysine has demonstrated an improved safety profile, particularly in terms of renal effects, compared to indomethacin.

Physical Compatibility of Alprostadil with Commonly Used IV Solutions and Medications in the Neonatal Intensive Care Unit.

OBJECTIVE: To determine the physical compatibility of alprostadil with intravenous (IV) solutions, a parenteral nutrition (PN) solution, and other intravenous medications commonly used in the neonatal intensive care unit (NICU). METHODS: To simulate y-site administration, each IV solution and the PN solution were slowly mixed 1:1 with alprostadil 15 µg/mL at 25°C. The mixtures were gently shaken and visually examined at 1, 15, 30, 45, and 60 minutes for physical incompatibility (gross precipitation, color change, haze, separation or gas production). In addition, each test tube was touched to assess for gross temperature change. The above mixtures were made a second time and each mixture was slowly mixed 1:1 with each of the test medications at 25°C. The ampicillin-parenteral nutrition and the chlorothiazide-parenteral nutrition solution mixtures were not tested with alprostadil. The mixtures were examined for physical incompatibility as described above. RESULTS: Alprostadil was visually compatible with D5W 0.45% NaCl, D5W 0.45% NaCl with 20 mEq KCl/L, D10W 0.45% NaCl, D10W 0.45% NaCl with 20mEq KCl/L, and a PN solution. Alprostadil was visually compatible with ampicillin, cefazolin, cefotaxime, chlorothiazide, dobutamine, dopamine, fentanyl, furosemide, gentamicin, methylprednisolone, tobramycin, vancomycin and vecuronium when mixed in D5W 0.45% NaCl, D5W 0.45% NaCl with 20mEq KCl/L, D10W 0.45% NaCl, and D10W 0.45% NaCl with 20mEq KCl/L. Alprostadil was visually compatible with cefazolin, cefotaxime, dobutamine, dopamine, fentanyl, furosemide, gentamicin, methylprednisolone, tobramycin, vancomycin and vecuronium when mixed in a PN solution. In addition, no gross temperature change was detected in any mixture. CONCLUSIONS: Based on the results, alprostadil is physically compatible with the tested IV solutions and a PN solution, as well as commonly prescribed IV medications used in the NICU when mixed with the tested IV solutions and a PN solution.

Prokinetic drug therapy in children: a review of current options.

OBJECTIVE: To review the pharmacology, safety, and efficacy of the prokinetic agents metoclopramide and erythromycin in children. DATA SOURCES: English-language literature was accessed using MEDLINE (1970-June 2004) with metoclopramide, erythromycin, macrolides, gastroesophageal reflux, and gastrointestinal motility as the search terms. STUDY SELECTION AND DATA EXTRACTION: Abstracts and original research articles were included. Preference was given to published controlled trials. Articles providing descriptions of pharmacology, safety, and effectiveness of metoclopramide and erythromycin for the treatment of gastroesophageal reflux (GER) were also used in this review. DATA SYNTHESIS: Some authors advocate using a prokinetic agent along with acid suppression for treatment of GER in children. The 2 prokinetic agents most commonly used are erythromycin and metoclopramide. Erythromycin has numerous observational reports and controlled trials demonstrating its efficacy in improving feeding tolerance in children. Adverse drug reactions associated with its use were uncommon in prospective controlled trials. Few data support the use of metoclopramide for management of GER, and the potential adverse effects associated with its use need to be considered before prescribing. CONCLUSIONS: The literature supports the use of erythromycin as a prokinetic agent. Many children with GER are adequately controlled with acid suppression alone; however, if use of a prokinetic agent is warranted, erythromycin in combination with acid suppression should be considered. Given the lack of prospective controlled studies demonstrating metoclopramide's efficacy and safety in the treatment of GER in children, metoclopramide should not be considered a treatment option.