Abstracts 21st Annual Meeting Pediatric Pharmacy Advocacy Group

doi:10.5863/1551-6776-17.1.104

. 2012 Jan-Mar;17(1):104–138. doi: 10.5863/1551-6776-17.1.104

Abstracts 21^st Annual Meeting Pediatric Pharmacy Advocacy Group

PMCID: PMC3428183

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

ACETAZOLAMIDE DOSING IN CRITICALLY ILL NEONATES AND CHILDREN WITH METABOLIC ALKALOSIS

Megan Andrews ¹, Peter Johnson ¹, Erin Lammers ¹, Donald Harrison ¹, Jamie Miller ¹

INTRODUCTION Metabolic alkalosis (MA) is a common complication in critically ill patients. Acetazolamide has been used to treat hypochloremic MA, but there are limited reports in pediatric patients. The purpose of this study was to describe the acetazolamide dosage regimen and treatment outcomes in critically ill pediatric patients with hypochloremic MA.

METHODS This was a descriptive, retrospective study of patients <18 years of age who received ≥3 doses of acetazolamide between August 1, 2010, and July 31, 2011, for the treatment of hypochloremic MA. This was defined as a pH ≥7.45 and bicarbonate (HCO₃⁻) concentration of >26 mEq/L. Data collection included demographics, acetazolamide regimen, laboratory data (e.g., blood gases and electrolytes), urine output, and concomitant diuretic agents. The primary objective was to identify the mean dose and duration of acetazolamide. A secondary objective was to determine the number of patients with treatment success or failure. Treatment success was defined as a post-acetazolamide therapy HCO₃⁻ goal of 22 to 26 mEq/L. Between-group analysis was performed using Student t-test or chi-squared analysis as appropriate with a p value <0.05.

RESULTS A total of 131 patients were identified as receiving acetazolamide. Thirty-four patients were included for analysis; 18 of these children were female (53%); median age was 0.25 years (range, 0.05-12 years). Concomitant diuretic therapy was administered in 27 (79%) patients. The acetazolamide regimen included a mean dose of 4.98 ± 1.14 mg/kg with a mean number of 6.09 ± 5.29 (range, 3-24) doses used. The majority of patients (71%) received their acetazolamide every 8 hours, whereas 10 (29%) patients received it every 6 hours. Treatment success was achieved in 10 (29%) patients. Five (15%) patients required additional treatment within 24 hours of acetazolamide discontinuation. There was a statistically significant difference between the pre- and post-acetazolamide pH and HCO₃⁻, 7.51 ± 0.05 versus 7.37 ± 0.05 (p<0.001) and 39.3 ± 6.1 mEq/L versus 31.4 ± 7.5 mEq/L (p<0.001), respectively.

CONCLUSIONS Most patients received a mean dose of approximately 5 mg/kg, but there was a wide discrepancy in the total number of acetazolamide doses received. A statistically significant difference was observed between pre-acetazolamide and post-acetazolamide HCO₃⁻ therapy concentrations, but most patients did not achieve the post-acetazolamide HCO₃⁻ goal of 22 to 26 mEq/L. Future studies should elucidate the optimal duration of acetazolamide therapy to achieve this HCO₃⁻ goal.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

INVASIVE CANDIDIASIS IN A NEONATAL INTENSIVE CARE UNIT: FLUCONAZOLE PROPHYLAXIS IMPLEMENTATION

Neli Attas ¹, Diane McClure ¹, Linda Skroce ¹, Adel Zauk ¹

INTRODUCTION The rate of invasive candidiasis (IC) in very-low-birth weight (VLBW) infants had peaked at 12% between January 2007 and January 2009 in a 50-bed regional neonatal intensive care unit (NICU). The primary objective of this study was to review the incidence of IC in VLBW infants after implementation of a fluconazole prophylaxis (FP) protocol. A secondary objective was to monitor and report any adverse events in patients receiving FP.

METHODS Records of infants with IC admitted to the NICU revealed that most of these infants had a birth weight of less than 900 g, which was chosen as the therapy cutoff. Literature reviewed used FP doses ranging from 3 to 6 mg/kg with various frequencies and durations. A total of 9 doses of intravenous (IV) fluconazole, 3mg/kg twice weekly, was selected to be administered to these infants within the first 24 hours of life, providing they did not have liver failure. FP therapy was stopped early for those patients without IV access. Records were reviewed for IC, renal dysfunction, elevation of alkaline phosphatase, aspartate transaminase (AST), and alanine transaminase (ALT) values and direct bilirubin levels and eosinophil counts. These values were recorded as treatment-related laboratory abnormalities if they were twice normal standards while receiving FP therapy.

RESULTS A total of 111 infants were started on FP between March 2009 and December 2011. The median birth weight was 704 g (375-899 g) with a median gestational age of 25.7 weeks (22-32 weeks). Seventy-five of 111 infants received 9 doses of FP; of these, 50 (67%) infants received the first FP dose within 24 hours of birth, whereas 25 (33%) infants received their first dose between 24 and 72 hours of birth. Thirty-six of 111 infants received partial therapy only; of those, 28 infants died, having received 1 to 7 doses; 8 of the 36 infants received 5 to 8 doses of FP, which was stopped as they advanced to full feeds. None of the 83 infants taking FP developed IC. No associated serious adverse reactions necessitating discontinuation of FP occurred in these patients. Of the 83 infants, a total of 23 (27%) infants experienced cholestasis, and 5 (6%) infants experienced elevated transaminase levels, both of which were transient. None of the infants had elevated AST/ALT levels in the absence of cholestasis. Twelve (14%) infants experienced eosinophilia, and 5 (6%) infants experienced elevated creatinine levels, both were self-limited.

CONCLUSIONS FP decreased the incidence of IC from a peak of 12% to 0% in the period studied. FP therapy in select VLBW infants is a safe and cost-effective regimen in the prevention of IC.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

SUCCESSFUL USE OF PRESCRIBING RESTRICTIONS AND EXTENDED STABILITY DATA TO MINIMIZE COST IMPACT OF INTRAVENOUS ACETAMINOPHEN AT A PEDIATRIC TERTIARY MEDICAL CENTER

Allyson Berg ¹, Jennifer Hamner ¹, Paul Limberis ¹, Jeffrey Galinkin ¹

INTRODUCTION Intravenous acetaminophen therapy was approved for use in the United States by the Food and Drug Administration in November 2010. Acetaminophen is frequently used for the management of mild to moderate pain and as an antipyretic in pediatric patients. This project was designed to evaluate the pediatric literature for safety and efficacy of intravenous acetaminophen, to initiate the use of intravenous acetaminophen with appropriate restrictions to minimize the potentially negative cost impact, and to evaluate prescriber compliance with restrictions.

METHODS A pharmacy resident prepared a detailed intravenous acetaminophen drug monograph for presentation to the Pharmacy and Therapeutics Committee. The drug monograph reviewed safety and efficacy clinical trials in pediatric patients, recommendations for medication use from other pediatric institutions, and usage restrictions from the perspectives of surgeons, anesthesiologists, and oncologists. Drug samples were analyzed for the evaluation of chemical stability beyond the drug manufacturer's published stability information. Postimplementation, medication orders were analyzed for appropriateness according to patient characteristics and prescribing guidelines described in the drug monograph.

RESULTS The Pharmacy and Therapeutics Committee approved the use of intravenous acetaminophen in hospitalized pediatric patients. Medication orders were restricted to patients with a contraindication to alternate routes of acetaminophen administration and those receiving medical care from oncology or perioperative service. Duration of intravenous acetaminophen use was limited to the 48-hour perioperative period and scheduled at a 6-hour interval, with the exception of the oncology patient population. Drug stability testing resulted in an increased duration of stability from 6 to 72 hours.

CONCLUSIONS The use of intravenous acetaminophen with restrictions for medical specialty and duration of use was successfully initiated at a large pediatric medical center. The pharmacy department effectively assessed, designed, and implemented restrictions to minimize the cost impact of intravenous acetaminophen.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

IMPACT OF A CHANGE IN SEDATION BOLUS ADMINSTRATION IN A PEDIATRIC INTENSIVE CARE UNIT AT A LARGE CHILDREN'S HOSPTIAL: UTILIZATION OF A “SMART PUMP” BOLUS FEATURE

Shahnaz Zakeri ¹, Sara Bork ¹, Erin McDade ¹, Hilel Frankenthal ¹

INTRODUCTION At Texas Children's Hospital Pediatric Intensive Care Unit (PICU) sedation bolus doses for intubated patients historically required medication vial removal from the Omnicell and nurse manipulation and dose preparation away from the bedside prior to administration. Recently, TCH changed its practice to using the “smart” syringe pump for bolus doses, allowing bolus doses to be administered from a syringe running a continuous infusion.

OBJECTIVES The objective of this quality improvement study was to determine if this practice change would impact the time to bolus dose administration, the time the nurse was away from the patients' bedside, the frequency of central line access, and drug cost.

METHODS This was a nonrandomized observational quality improvement study. Data were collected via chart review and manual timing of nursing staff. The following data were collected pre- and post-implementation: time required for the nursing staff to be away from the bedside to retrieve and prepare the bolus dose; bolus dose drug cost; amount of drug wastage; and frequency of central line access for bolus dose administration.

RESULTS There were 20 patients evaluated during the 2 weeks prior to implementation, only 9 of whom were included in the time study. The total time for the nurse to leave the bedside, retrieve and prepare the medication, and then infuse the bolus dose was 3:17 ± 1:03 min. Nurses were administering the bolus over 38.4 ± 31.1 seconds, which is a much shorter time period than the recommended 2 to 3 minutes cited in the literature. The total wastage calculated during this period was 27.044 mcg of fentanyl (238.2 ± 162.4 mcg per patient day) and 186.5 mg of midazolam (1.43 ± 1.44 mg per patient day). This wastage was due to the single-dose vials retrieved from the Omnicell and used for bolus dosing. Delivery from the syringe pump eliminated this wastage. Only 28.6% of patients received boluses from a central line, and 14.3% of patients received boluses through a central or peripheral route. Bolus delivery from the pump reduced the potential for central line entries by 5.4 ± 2.9 entries per day. Additionally, to date, the nursing staff at TCH has been very pleased with the sedation bolus practice change. There have been no reported adverse events due to the change in practice.

CONCLUSIONS We implemented a change in practice to using “smart” intravenous pump technology to administer sedation boluses. Preliminary data indicate that this method can improve consistency in practice and adherence to medication administration recommendations and reduce time to bolus dose administration, time the nurse is away from the patients' bedside, frequency of central line access, and drug cost. Further data collection is underway to better determine the impact of this practice change on these outcomes.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

TRAINING PHARMACISTS FOR PARTICIPATION IN PEDIATRIC RESUSCITATION

Marcia Buck ¹, Amanda Williams ¹

INTRODUCTION Pharmacists at the University of Virginia participate in all cardiopulmonary resuscitation events (codes) to provide drug information and prepare medications. While comfortable with adult codes, they are often apprehensive about responding to pediatric codes due to lack of familiarity with the patients and drug doses.

OBJECTIVES To describe the development, implementation, and assessment of an institution-specific program to train pharmacists to participate in pediatric codes.

METHODS The project was divided into three components: a retrospective study of pediatric codes to determine frequency and location within the institution; an interactive 1-hour Accreditation Council for Pharmacy Education-accredited continuing education program; and a brief assessment tool. Four questions were included on the assessment tool: 2 questions rated the participant's comfort and confidence in their skills during pediatric code by using a 10-point Likert scale; 1 question required identification of the medication used most commonly during pediatric codes; and 1 question concerned the location of the institution's weight-based pediatric emergency drug dosage charts. The assessment tool was completed before and after the presentation. Results were analyzed with the Wilcoxon rank-sum test.

RESULTS A 2-year retrospective study revealed an average of 50 pediatric codes per year, with the majority (55%) occurring in the pediatric intensive care unit, followed by the neonatal intensive care unit (19%), and labor and delivery (13%). Fewer than 5% occurred on the pediatric wards. This information was incorporated into the program, along with the medications most frequently used during pediatric codes, the institution's code cart, and weight-based dosage charts. Participants also prepared an epinephrine dose for a 14-kg child, using expired supplies, allowing them to practice calculations and manipulation of the medication and equipment. All 61 participants completed the initial assessment; 58 participants completed the follow-up. Scores for comfort with participation in pediatric codes increased significantly after the presentation, with a median of 2 prior to and 5.5 following (p<0.001). Participants' confidence in their skills showed a similar increase, with an initial score of 3 and a follow-up score of 8 (p<0.001). Despite the lower scores prior to the program, 80% of participants correctly identified epinephrine as the medication most frequently used, and 84% of participants were able to identify the correct location of the dosage charts. All participants answered the questions correctly following the program.

CONCLUSIONS Use of an institution-specific interactive training program had a positive effect on attendees' knowledge and confidence. This program was useful in preparing our pharmacy staff for participation in pediatric codes. The program could easily be modified by other institutions in need of similar training.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

PEDIATRIC PARENTERAL NUTRITION COMPOUNDING SOFTWARE SAFETY LIMITS

Jared Cash ¹, Jared Olson ¹, Amber Tuckett ¹, Mark MacKay ¹

INTRODUCTION Independent risk factors for causing patient harm as a result of medication error include both pediatric patients and injectable sterile products. Ordering and producing pediatric parenteral nutrition (PN) involves the combination of over 20 injectable high-alert products. It is one of the most complex and risk-prone medication processes in the healthcare setting, as demonstrated in tragic publicized pediatric deaths. Abacus, the software most commonly used to compound PN, has basic built-in non-weight-based dose limits (for newborn, pediatric, and adult dosages) to help prevent error. This software relies on each institution defining specific weight- based limits that can result in arbitrary, absent, or abortive limits.

OBJECTIVES The goal of this project was to develop a set of weight-based safety limits for pediatric PN compounding and/or ordering software based on analysis of over 50,000 PN orders.

METHODS A database containing 52,679 PN orders from March 2007 to January 2011 at the Primary Children's Medical Center (Intermountain Healthcare) was used for analysis. No orders were excluded. The weight-based dosages for each PN component were grouped into 27 different weight categories (0 to 1.5 kg, 1.6 to 3 kg, and so forth) along with the maximum dose per kilogram. The 80th percentile for each group was also calculated in order to provide a soft alert (ie, a warning that can have an override). Hard alerts, also called catastrophic limits, were identified as the maximum dose-per-weight range. These data were then analyzed for natural breakpoints where weight categories could be combined for simplification.

RESULTS Hard alert limits are followed by soft alerts in parentheses: dextrose, 36 (23)percent, all weights; 36 (18) g/kg under 10 kg; 23 (13) g/kg, 10.1 to 40 kg; and 15 (7.5) g/kg over 40 kg. Amino acids, 5 (3) g/kg all weights; lipids, 7.5 (4) g/kg under 6 kg and 4 (2.5) g/kg over 6 kg; sodium, 11 (8) mEq/kg under 20 kg, and 11 (5) mEq/kg over 20 kg; potassium, 10 (4) mEq/kg under 20 kg and 6 (3) mEq/kg over 20 kg; magnesium, 3.5 (0.8) mEq/kg all weights; calcium, 6 (3.5) mEq/kg 0 to1.5 kg, 5.4 (2.9) mEq/kg 1.6 to 3 kg, 4.5 (2.5) mEq/kg, 3.1 kg to 6 kg, 3.3 (1.8) mEq/kg, 6.1 to 10 kg, 2.5 (1.3) mEq/kg 10.1 to 40 kg, and 1.1 (0.6) mEq/kg for weight greater than 40 kg; phosphate, 3.2 (1.5) mm/kg less than 30 kg, 2.4 (0.7) mm/kg 30.1 to 40 kg, and 1.1 (0.5) mm/kg over 40 kg; zinc is 800 (400) mcg/kg for less than 30 kg, 7.5 (5) mg 30 to 40 kg, and 10 (5) mg for over 40 kg; selenium, 5 mcg/kg for less than 30 kg and 40 mcg for over 40 kg; iodine, 2 mcg/kg all weights; iron, 0.2 (0.1) mg/kg for all weights; copper, 45 (30) mcg/kg for less than 30 kg, 700 (650) mcg for over 30 kg; manganese, 5 mcg/kg for less than 30kg and 150 mcg for over 30 kg; vitamin K, 2500 (500) mcg/kg for less than 30 kg and 5000 (500) mcg/kg for over 30 kg; vitamin C, 240 (100) mg/kg for less than 30 kg and 500 (300) mg/kg for over 30 kg; pediatric multivitamins, 7.5 mL for less than 10 kg and 10 mL for over 10 kg; adult multivitamins, 10 mL for less than 30 kg and 15 mL for above 30 kg.

CONCLUSIONS The identified weight-based safety limits from over 50,000 pediatric PN orders may be used by the individual institution to program its pediatric PN compounding software.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

A NOVEL VANCOMYCIN DOSAGE RECOMMENDATION FOR PRETERM NEONATES

Hsiang-Ying Chang ¹, Ling-Yu Liu ¹, Fe-Lin Lin Wu ¹, Shu-Wen Lin ¹

INTRODUCTION Vancomycin dosage recommendation for preterm neonates <1200 g is decided based on weight and postnatal age (PNA). The literature recommends 15 mg/kg given once daily (OD), regardless of the patient's renal function. Recent guidelines advocate vancomycin trough of >10 mg/L to optimize outcome and prevent drug resistance. Therefore, the aim of this study was to evaluate the appropriateness of current dosage recommendation and to design a new dosage protocol for vancomycin for these patients.

METHODS A retrospective review was conducted of charts of preterm infants weighing ≤1200 g and treated with vancomycin for more than 3 days from July 2009 to January 2012 in the neonatal intensive care unit at National Taiwan University Hospital. Demographic characteristics, PNA, serum creatinine (Scr), vancomycin indication and dosing regimen, and subsequent serum trough concentrations were reviewed. Primary outcome was the likelihood of vancomycin troughs achieving target range of 10-20 mg/L. Secondary outcome was the correlation between Scr, vancomycin dose interval, and serum trough concentrations.

RESULTS A total of 45 preterm infants met study criteria, and their medical records were reviewed. Median values of PNA, body weight, and Scr were 19 days (range, 2-68 days), 850 g (460-1200 g), and 0.64 mg/dL (0.3-1.46 mg/dL), respectively. There were 75 vancomycin troughs monitored, but only 33.3% of them fell into the target range. The nonappropriate troughs in OD dosing accounted for 74.2%, with mean troughs of 5.93 mg/L in PNA of ≥7 days (n = 27) and 11.98 mg/L in the group with PNA of <7 days (n=4). A significant trend of correlation existed between Scr and vancomycin troughs. We further divided these troughs into 3 groups: group I had Scr of <0.6 mg/dL (n=23); group II had Scr of 0.6-0.89 mg/dL (n=37); and group III had Scr of ≥0.9 mg/dL (n=15). Median troughs were 2 mg/L with OD interval, 5.84 mg/L with 12-hour interval, and 11.88 mg/L in the 8-hour interval in group I; 3.24 mg/L with OD interval, 7.88 mg/L with 12-hour interval, and 13.01 mg/L in the 8-hour interval in group II; and 11.32 mg/L with OD interval, 14.01 mg/L with the 12-hour interval, and 17.79 mg/L in the 8-hour interval in group III.

CONCLUSIONS A significant trend of correlation was noted among Scr, vancomycin dose interval, and trough concentrations. Hence, we suggest that the current initial vancomycin dosage recommendation of 15 mg/kg OD for preterm infants weighing ≤1200 g should be reserved only for those with Scr of ≥0.9 mg/dL or PNA of <7 days with unknown Scr. More frequent dosage of 15 mg/kg every 12 hours is proposed for preterm infants with Scr of 0.6 to 0.89 mg/dL and 15 mg/kg every 8 hours for Scr of <0.6 mg/dL, regardless of PNA.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

PIPERACILLIN/TAZOBACTAM PHARMACOKINETICS IN CRITICALLY ILL CHILDREN RECEIVING EXTRACORPOREAL MEMBRANE OXYGENATION

Jeffrey Cies ¹, Arun Chopra ¹

INTRODUCTION There are adult data demonstrating that pharmacokinetic (PK) parameters such as volume of distribution (Vd) and clearance (Cl) can be significantly altered for individuals receiving extracorporeal membrane oxygenation (ECMO). Alterations of Vd and Cl of antibiotics in patients with sepsis and septic shock have also been documented in the literature. These data demonstrated lower-than-expected serum levels based on standard dosage regimens. Impaired antibiotic distribution into tissue, the target site where most infections occur, is a major concern for clinicians and may explain the high morbidity and mortality in this patient population. The PK alterations associated with sepsis can be further exacerbated by PK changes with ECMO. Therefore, an understanding of PK changes in critically ill children receiving ECMO is crucial to determining the most appropriate dosage of piperacillin/tazobactam (PTZ).

METHODS A retrospective chart review was conducted from January 1, 2009, through July 30, 2010, of children receiving ECMO who had obtained ≥2 PTZ serum concentration. PTZ serum concentrations were plotted against time, and individual PK parameters were determined by a one-compartmental analysis. Bayesian modeling was used to determine doses that would result in PTZ trough concentrations of ∼150 mg/L (>4× the highest sensitive minimum inhibitory concentration of 32 mg/L).

RESULTS Six patients met inclusion criteria. Ages ranged from 8 days to 7 months. The mean elimination rate constant was 0.22 hour⁻¹ and the mean half-life was 4.3 hours. The mean Vd was 0.397 L/kg. Different intermittent PTZ doses are shown in the Table, with the resulting peaks and troughs.

graphic file with name i1551-6776-17-1-104-t00.jpg

Open in a new tab

CONCLUSIONS Current neonatal and infant PTZ dosage recommendations are not intended to obtain serum PTZ trough concentrations of ∼150. These ECMO PK data suggest that an intravenous dosage regimen of 50 mg/kg/dose every 2 hours, 100 mg/kg/dose every 4 hours, or 200 mg/kg/dose every 6 hours would obtain a serum PTZ trough level of ∼150 mg/L to maximize PTZ efficacy for neonates and infants receiving ECMO. This method allows for rapid estimation of drug dose delivery in ECMO patients, where standard dosage regimens are likely to be inadequate and can be repeated for other important medications. These data need to be validated prospectively.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

PIPERACILLIN/TAZOBACTAM PHARMACOKINETICS IN CRITICALLY ILL CHILDREN

Jeffrey Cies ¹

INTRODUCTION Treatment of sepsis and septic shock remains a significant challenge. Current evidence suggests early and appropriate antimicrobial therapy reduces morbidity and mortality. Given the increasing incidence of sepsis, further research toward optimizing antibiotic therapy is paramount. Alterations in volume of distribution (Vd) and clearance (Cl) of antibiotics in patients with sepsis and septic shock have been documented in the literature. Adult data have shown significantly reduced concentrations of piperacillin in peripheral tissues in critically ill patients with septic shock. Impaired antibiotic distribution into tissue, the target site where most infections occur, is a major concern for clinicians and may explain the high morbidity and mortality in this patient population. Children between the ages of 6 months and 6 years typically have larger Vd values and faster drug Cl, which can impact dose and interval selection. Therefore, an understanding of pharmacokinetic (PK) and pharmacodynamic changes in critically ill children is crucial to determining the most appropriate dose and interval selection.

METHODS This was a retrospective chart review conducted from January 1, 2009, through July 30, 2010. Children between the ages of 6 months and 6 years, admitted to the intensive care unit with piperacillin/tazobactam (PTZ) serum concentrations ≥2 were eligible for inclusion. PTZ serum concentrations were plotted against time, and individual PK parameters were determined by a one-compartment analysis. Bayesian modeling was used to determine doses that would result in PTZ trough concentrations of ∼150 mg/L.

RESULTS Eight patients met inclusion criteria. Mean elimination rate constant was 0.59 hr⁻¹, and the mean half-life was 1.4 hours, which is similar to the values in the package insert for healthy volunteers. The mean Vd was 0.71 L/kg, compared with 0.24 L/kg as reported in the package insert. Intermittent doses of PTZ are shown in the Table with resultant troughs.

graphic file with name i1551-6776-17-1-104-t02.jpg

Open in a new tab

CONCLUSIONS Critically ill children have Vd that are significantly larger than currently published values for healthy volunteers. Appropriate PTZ serum concentrations may not be achieved in critically ill children based on current dosage recommendations. These data need to be further evaluated to determine if appropriate PK and pharmacodynamic targets are achieved.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

COMMUNITY PHARMACIST BEHAVIORS REGARDING PEDIATRIC PRESCRIPTIONS

Michelle Condren ¹, Shane Desselle ¹

INTRODUCTION Medication errors are prevalent in pediatric outpatient prescriptions, and community pharmacists are the final step in intervening in those errors. Little is known about the involvement of pharmacists in the actions recommended for ensuring that a medication is appropriately prescribed for a child.

METHODS The purpose of this study was to describe attitudes and behaviors of community pharmacists as they relate to pediatric prescriptions and to determine any effect of an educational intervention and provision of a dosage guide on those behaviors. The study also examined the effects of pharmacist demographic and pharmacy situational factors on pharmacists' behaviors and levels of confidence in performing recommended activities when dispensing medications for pediatric patients. The study used a self-administered survey of 3 groups of community pharmacists in a regional chain. The survey measured behaviors and attitudes of pharmacists related to their perceived ability to detect pediatric medication dosage errors and to promote medication safety in pediatric patients. The 3 groups consisted of 2 interventional groups and a control group. One interventional group attended a live continuing education session and was given a dosage guide. A second interventional group received a dosage guide in the mail. One month after the intervention, all 3 groups completed the survey.

RESULTS Sixty pharmacists participated, for a response rate of 61%. Due to the small number of participants in the education group, data for all groups were combined, and descriptive statistical analysis was performed. The construct validity and reliability of survey questions was shown with item analysis procedures. Only 32% of participants reported routinely calculating a dose if the weight was available. Obtaining a weight value for a pediatric prescription was reported as difficult by 58% of participants; 70% of participants stated that weight was rarely or never on the prescription, and 60% of participants rarely obtained a weight if one was not provided. In a 2-week period, 52% of respondents used a reference to check a pediatric prescription, the most common being Clinical Pharmacology (33%), followed by Epocrates (26%), and Lexi-Comp (16%) and the dosage guide provided for the study (16%). Only 8% of participants stated they were not confident in calculating an appropriate dose and detecting a dosage error for a child. While 85% of respondents reported high confidence in communicating with parents, only 22% reported this same level of confidence in communicating with children. The pharmacist's perception of the organizational culture correlated with their behaviors and level of confidence toward performing the activities surveyed (p<0.005).

CONCLUSIONS Pharmacists in this study rarely checked the accuracy of a weight-based dose on pediatric prescriptions, although they reported being confident in their ability to do so. A critical step toward reducing pediatric medication errors would be to integrate this activity into the pharmacist's workflow and inculcate a culture of patient safety.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

VITAMIN D SUPPLEMENTATION FOR PRETERM NEONATES

Danielle Coppola ¹, Gina Signorelli ¹, Melissa Lestini ¹

INTRODUCTION In 2008, the American Academy of Pediatrics (AAP) recommended that all infants and children have a minimum daily intake of 400 units of vitamin D beginning in the first few days of life to prevent vitamin D deficiency and rickets. The AAP also recommended that serum 25-hydroxy-vitamin D (25-OH-D) concentrations, used to assess vitamin D status, be maintained at ≥20 ng/mL. Premature infants may have vitamin D needs in excess of those recommended for other infants due to decreased stores and inability to produce cutaneous vitamin D due to hospitalization. Although the 2008 AAP guideline includes premature infants in its recommendations, it does not address these specific needs of the population. Since publication of the AAP guidelines, the Institute of Medicine (IOM), European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN), and the Endocrine Society have all published recommendations for vitamin D supplementation in infants. These groups have recommended both larger amounts of vitamin D supplementation and targeting higher 25-OH-D levels.

PURPOSE The purpose of this study was to determine baseline 25-OH-D levels in preterm neonatal patients (<35 weeks gestational age) and neonates >35 weeks gestational age who were small for gestational age (SGA). Subgroups included preterm neonates with gestational ages <28 weeks, 28 to 316 weeks, and 32 to 346 weeks. Patient response to exogenous vitamin D administration was also evaluated.

METHODS A retrospective review of patients admitted to the neonatal intensive care unit (NICU) at Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center was conducted. Preterm and SGA patients admitted between April 1, 2011, and September 30, 2011, were identified by querying the hospital's nutrition support database. Data collection included demographics and vitamin D dosage.

RESULTS The final analysis included 179 neonates eligible for vitamin D supplementation per institutional protocol. Levels were measured in 80.4% of the overall group. Levels were least frequently obtained in SGA neonates >35 weeks gestation (47.2%). In the overall group, 67.4% of patients were found to have 25-OH-D levels ≥20 ng/mL at baseline. However, only 19.4% of the overall group had baseline 25-OH-D levels ≥32 ng/mL. Levels increased by an average of 2.18 times (range, 1.18-4.2) when the vitamin D dosage was increased from 400 to 800 international units daily. All follow-up levels were found to be ≥20 ng/mL, and 61.5% of the group had a level of ≥32 ng/mL.

CONCLUSIONS Preterm neonates may benefit from vitamin D supplementation in excess of that recommended by AAP. Further studies are necessary to assess long-term benefits and toxicities.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

IMPLEMENTATION AND EVALUATION OF A CHEMOTHERAPY PRIMING PROCESS

Amy Davies ¹, Christopher Yuan ¹, Linh Nguyen ¹, Brooke Bernhardt ¹, Joy Hesselgrave ¹

INTRODUCTION Remarkable progress has been made in the protection of healthcare workers from occupational exposure to hazardous agents. The use of biologic safety cabinets, personal protective equipment, and closed transfer safety devices (CTSDs) help minimize exposure to hazardous agents during preparation and administration. Unfortunately, many pharmacies do not take the last step in protecting the nurse, specifically, priming of chemotherapy through the intravenous (IV) tubing set. The primary objective of this project was to examine the safety, feasibility, and cost of priming the IV tubing set for chemotherapy infusions. The secondary objective was to design and implement a process to prime chemotherapy.

METHODS An informal 4-question survey was conducted by phone and email during March 2010 to evaluate practice among 25 peer institutions. An evaluation of the literature and published guidelines was performed. In collaboration with the nursing department, a brainstorming session was conducted to explore potential configurations of a fully closed system from the point of preparation through administration. Variables used in the cost assessment included acquisition costs (ie, IV tubing and CTSD components) and personnel costs (ie, pharmacists' and technicians' salaries). An educational intervention was designed and administered to all staff members involved in chemotherapy preparation. A pilot study of the oncology floor was conducted. The Plan-Do-Study-Act (PDSA) Cycle was used to evaluate the pilot study prior to its hospital-wide implementation.

RESULTS The anticipated annualized cost of the new fully closed system was $82,064 for the preparation of 3668 chemotherapy infusions. A review of published literature and guidelines indicated the American Society of Health-System Pharmacists Guidelines on Handling Hazardous Drugs, the National Institutes for Occupational Safety and Health Guidelines, and Occupational Safety and Health Administration recommend priming with chemotherapy (as opposed to diluent). As a result, practice was changed to prime infusion bags of chemotherapy in the pharmacy with an Alaris PC 8015/8100 series pump by connecting the infusion set tubing with a Phaseal injector luer-lock to the Phaseal infusion adapter, resulting in a closed-loop system. Pharmacy staff members were educated about the new process. A pilot study of this revised practice was conducted over a 7-day period with hospital-wide implementation immediately following completion of the pilot study. After hospital-wide implementation, there were 4 reports of chemotherapy leakage from the Phaseal infusion adapter site. Our process was modified to disconnect the Phaseal injector luer lock from the Phaseal infusion adapter after priming. Following this modification there have been no reports of leakage.

CONCLUSIONS Chemotherapy priming is feasible and was well accepted in a large, tertiary care facility and is considered indispensible at our institution despite the increased cost.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

INCIDENCE OF VANCOMYCIN SERUM CONCENTRATIONS IN PEDIATRIC PATIENTS WITHIN THE ASHP/IDSA/SIDP RECOMMENDED GOAL

Stephanie East ¹, Laura Bio ¹

INTRODUCTION The purpose of our study was to compare vancomycin serum trough concentrations in our pediatric cohort to the new ASHP/SIDP/IDSA-recommended target range. While pediatric dosage recommendations for intravenous (IV) vancomycin ranged from 40 to 60 mg/kg/day in divided doses to achieve the previous trough range of 5 to 15 mg/L, a modification in vancomycin dosage was required to achieve the new recommended trough range of 15 to 20 mg/L.

METHODS Retrospective chart review of pediatric patients 1-month-old full-term infants to 18 years of age admitted to our institution who received IV vancomycin therapy between January 2009 and January 2011 was conducted. Patients were required to have at least 1 serum vancomycin concentration to be included. Patients were excluded due to lack of data documentation. Each serum vancomycin concentration was reviewed for appropriate timing, and the incidence of troughs within the new recommended range was reviewed (15-20 mg/L). Of the supratherapeutic troughs, the renal function of the patients were reviewed for the presence of neprotoxicty, defined as a serum creatinine increase of >0.5 mg/dL or an increase of >50% from the patient's baseline serum creatinine concentration over 48 hours. For patients who achieved a trough level within goal range, a logistic regression analysis was performed to identify independent variables that effected achievement of the goal.

RESULTS Of the 127 patients screened for the study, 85 patients were included. Fifty-five (65%) patients were male, and the median age was 9 years (interquartile range [IQR], 1-16 years). Thirteen (20%) patients had a body mass index [BMI] >85th percentile for age and were at risk of obesity or were obese (IQR, 23.3-28). The median dosage for vancomycin was 14.9mg/kg (IQR 13 to 15). Fifty-three (62.4%) patients had a dosage frequency of every 6 hours, 17 (20%) patients every 8 hours, and 14 (16.5%) patients had every 12 hours. Forty (47%) patients had an appropriately drawn trough according to the study definition. Of the appropriately timed troughs, 15 patients were at goal (37.5%), 22 (55 %) patients were subtherapeutic , and 3 (7.5%) patients were supratherapeutic . Further descriptive and statistical analyses results for this study are pending.

CONCLUSIONS Approximately two-thirds of the cohort had an appropriately drawn trough, and of those patients, only one-third had a vancomycin serum trough concentration within goal range. The remaining outcome conclusions are pending further analysis.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

DEXMEDETOMIDINE (PRECEDEX) USE FOR PROLONGED SEDATION IN A PEDIATRIC BILATERAL NEPHRECTOMY PATIENT

Amanda Geist ¹, Manuel Caceres ¹

INTRODUCTION Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist with sedative and analgesic effects. Dexmedetomidine undergoes hepatic metabolism via glucuronidation and CYP2A6. The glucuronide and methyl conjugates are excreted in the urine. In adult patients with renal impairment. dexmedetomidine pharmacokinetics has not been shown to be significantly different; however, the pharmacokinetics of the metabolites have not been studied in either adult or pediatric patients. Given that most of metabolites are excreted in the urine, it is possible for metabolite accumulation. Current adult dosage recommendations advise caution and state that a dose reduction may be necessary. Specific guidelines for dose reduction are not provided, nor are there existing data regarding dexmedetomidine use in cases of renal impairment in pediatric patients. Dexmedetomidine is highly protein bound, therefore removal by dialysis is postulated to be unlikely. The objective of this case report was to add further detail to the use and management of dexmedetomidine in a pediatric patient status-post bilateral nephrectomy and receiving daily hemodialysis.

CASE REPORT A 3-year-old female presented to Charleston Area Medical Center with a 2-day history of grunting. The patient had a medical history of bilateral nephrectomy, end-stage renal disease, hypertension, and intermittent hemodialysis. On the day of admission, the patient required intubation for respiratory failure secondary to suspected sepsis and/or volume overload. Fentanyl, 1 mcg/kg/hr, and midazolam, 0.1 mg/kg/hr, infusions were initiated at the time of intubation for continuous sedation. By day 2 of admission, the patient required restraints, fentanyl, 5 mcg/kg/hr, and versed, 0.5 mg/kg/hr, with continued agitation, and was pulling at lines and tubing. The team then initiated dexmedetomidine at 0.1 mcg/kg/hr as an adjunctive agent to assist with sedation and ventilation and to conduct hemodialysis sessions. Dexmedetomidine was further increased to a maximal dosage of 0.3 mcg/kg/hr over the next 2 days with improvement in patient agitation and level of sedation with minimal further increases in fentanyl and midazolam doses. The patient received dexmedetomidine for a total of 15 days. The patient tolerated dexmedetomidine infusion well during all 15 days without incidence of adverse events.

DISCUSSION This case report may provide initial evidence that pharmacokinetic and pharmacodynamic profiles of dexmedetomidine are altered in pediatric patients who lack residual renal function and during hemodialysis. For example, it is postulated that dexmedetomidine is not likely dialyzable because it is highly protein bound. However, our case report demonstrates a lack of accumulation of drug and its metabolites as shown by a lack of adverse events.

CONCLUSIONS Although sedation with dexmedetomidine was successful in our patient, without incidence of adverse events, dosage and pharmacokinetic studies are necessary before it is routinely used in various forms of dialysis and before other pediatric patients with similar presentation can be recommended.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

RIFAXIMIN USE IN PEDIATRIC HEPATIC ENCEPHALOPATHY

Nathan Gorney ¹, Linda Book ¹, Emily Gish ¹

OBJECTIVES The efficacy of the nonabsorbable antibiotic rifaximin in pediatric patients with hepatic encephalopathy (HE) is unknown. The purpose of this study was to investigate the efficacy and dosage used for rifaximin in the treatment of HE in children, as well as the incidence of adverse effects.

METHODS This retrospective analysis included children ages 0 to 18 years admitted to any Intermountain Healthcare facility from June 1, 2004, to June 1, 2011, who received rifaximin and/or lactulose for the treatment of HE. Any patient who received rifaximin was included in the treatment group, and those receiving only lactulose served as the control group. All patients receiving rifaximin for any reason were included in the safety analysis. Patient demographics for comparison purposes (e.g., age, sex, admit diagnosis); laboratory values to assess liver function (aspartate transaminase, alanine transaminase, alkaline phosphatase, Tbili, albumin, and INR) dependent on patient's age; electrolytes and ammonia concentrations; rifaximin dosage; any adverse events; and evaluation of mental status according to physician notes were collected. The primary endpoint was to determine the efficacy of rifaximin compared to that of lactulose for the treatment of HE in pediatric patients, based on change in serum ammonia concentrations. Secondary measures were time to return to baseline mental status, assessment of the safety of rifaximin use in pediatric patients based on adverse effects and potential drug interactions, and to describe the dosage regimens of rifaximin for HE in children. Descriptive statistics were used primarily; however, chi-squared analyses and t-tests were used as appropriate to compare data between groups with an priori alpha of p ≤0.05.

RESULTS A total of 15 patients, consisting of 17 courses of rifaximin therapy, met inclusion criteria. Of these 17 courses, 12 courses were noted as complete response, 2 courses were noted as partial responders, and 3 courses were noted as treatment failures. Based on mental status, 9 patients had complete response, 1 patient failed to respond, and 7 patients had incomplete chart information or never deviated from baseline mental status. Dosages ranged from 75 to 826 mg/m²/day (average, 340 mg/m²/day). Reported adverse events were diarrhea (n=3), elevated amylase/lipase (n=2), bezoar formation (n=1), extremely elevated PT/INR (n=1), and death (n=3). Deaths were not attributed to rifaximin use. Complete results are to be presented.

CONCLUSIONS Based on these results, rifaximin may be a safe and effective treatment of pediatric HE. Approximately 82% of the courses produced at least a partial improvement in serum ammonia concentrations. It is unclear whether the adverse effects experienced by the patients were secondary to their underlying disease states or if the effects are attributable to rifaximin. The optimal dose of rifaximin is still unclear at this time.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

DEVELOPMENT AND IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR MANAGING CHEMOTHERAPY ORDERING AND ADMINISTRATION

Kevin Graner ¹, Darryl Grendahl ¹, Ronald Sieve ¹, Kent Johnson ¹, Amanda Kuper ¹, Matthew Baudoin ¹

INTRODUCTION As part of a continuous improvement, safety, and quality assurance initiative, the Mayo Clinic Cancer Center undertook a project to migrate from paper chemotherapy orders and medical records to an electronic format. Planning and development took 12 months, and actual implementation took 14 months.

BACKGROUND The scope of this effort encompassed inpatients and outpatients, adult medical oncology and hematology, pediatric oncology and hematology, radiation oncology, and gynecological oncology. Goals of the project included development of a comprehensive electronic system for ordering chemotherapy and supportive therapies, recording of multidisciplinary verification of appropriateness of chemotherapy, documentation of chemotherapy administration, and documentation of toxicities/adverse reactions. A Cancer Center Steering Committee was formed to review work flow and processes, design an electronic solution, create an implementation strategy, and direct institutional communication. Guiding principals included improvement in patient safety, enhanced data retrieval, elimination of the paper order, enhanced organization and display of data, enhanced practice efficiency, and Joint Commission compliance. Commercial chemotherapy ordering tools were considered; however, they fell far short of the necessary requirements. It was decided to develop an electronic solution internally.

METHODS The solution was designed to be protocol-driven. Web/CDM (a Web-based front end with the Clinical Document Management tool designed at Mayo Clinic) became the electronic solution, replacing the various paper ordering forms and documentation tools. A front end Windows application, Regimen Builder, was developed that allowed a clinical pharmacist to develop chemotherapy regimens with limited knowledge of Web-based programming. A clinical pharmacist constructs the chemotherapy regimens within the Regimen Builder tool, and a physician, oncology nurse, a second clinical pharmacist, and a study coordinator perform audits to ensure accuracy. The system generates HTML and JavaScript files that automatically calculate and order the appropriate chemotherapy based on the protocol and regimen selected by the prescriber. Once calculations are made, Web/CDM uses a JavaScript function to import the values of the chemotherapy regimen into the document browser for the clinician.

DISCUSSION Mayo Children's Hospital is a Children's Oncology Group (COG) member and most study regimens developed have been COG protocols. To date, 112 pediatric studies (484 regimens) have been developed in the system. A total of 307 non-study chemotherapy regimens have also been created. The average pharmacist's time required to build and audit each regimen is approximately 1.5 hours. Pharmacy dedicates approximately 0.25 FTE for ongoing development of new pediatric chemotherapy regimens.

CONCLUSIONS The benefits realized from the development of this system include reduction in ordering errors, increased legibility, a reduction in MD order entry time, and continuity of communication for what was given in the hospital and outpatient areas.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

IMPACT OF PHARMACISTS' INTERVENTIONS ON ADMISSION MEDICATION ORDERS IN A CHILDREN'S HOSPITAL

Sarah Hale ¹, Kelly Guza ¹, Leslie Taleroski ¹

PURPOSE To describe the impact of pharmacists' interventions on the review of admission medication orders for pediatric patients by evaluating the frequency, type, and clinical benefit of pharmacists' interventions.

METHODS This retrospective, observational, single-center study evaluated pharmacists' interventions on admission medication orders for patients admitted to a children's hospital over a four-week time frame. This project described the current pharmacist intervention program that is in place to ensure medication safety in pediatric patients, with a focus on interventions completed on admission medication orders. Pharmacist interventions completed at the time of the patient's admission were categorized as (a) dose adjustments, (b) duplicate therapy, (c) formulary conversions, (d) schedule (frequency) changes, (e) omissions, (f) concentration changes, and (g) wrong product selection.

RESULTS Pharmacists' interventions on admission orders occurred in 112 of 203 children admitted during the 4-week study period. A total of 1216 admission orders were processed, with 231 documented pharmacist interventions. Of the 231 interventions, 139 (60.2%) interventions were for new admission orders, and 92 (39.8%) interventions were for continuation of medications ordered prior-to-admission (PTA). The most common intervention was a dosage adjustment (24.7%). The clinical risk of the 231 interventions was categorized as minimal (40.3%), moderate (55.8%), or severe (3.9%).

CONCLUSIONS Over 50% of children had at least 1 admission medication order that required a pharmacist's intervention. Pharmacists' interventions occurred frequently, with almost 1 in 5 orders requiring clarification. Most interventions were completed for medications that were new on admission; however, 40% of interventions were for PTA medications that were being continued during the patient's hospital stay. Dose adjustments accounted for one-quarter of the pharmacists' interventions. Changes to the order due to product selection or formulary issues were also common, with both accounting for 18% of interventions. Most interventions were evaluated as contributing to a moderate patient impact. Overall, this retrospective review supports the significant role that pharmacists play in ensuring the safe and appropriate use of medications in pediatric patients.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

TOXICITY PROFILE OF RITUXIMAB AMONG PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED MATURE B-CELL NON-HODGKIN'S LYMPHOMA: A RETROSPECTIVE STUDY AT THE CHILDREN'S CANCER HOSPITAL EGYPT

Omneya Hassanain ¹, Mohamed Kamal ¹, Sherif Kamal ¹, Hany Abd El-Rahman ¹, Sherif Abouelnaga ¹

INTRODUCTION Almost all children with mature B-cell non-Hodgkin's lymphoma (NHL) express CD20, which makes rituximab, a chimeric monoclonal antibody that targets CD20, a treatment option. Rituximab added significantly to treatment outcome when used in aggressive mature B-cell NHL in adults. However, the role of rituximab in childhood NHL has not yet been defined.

PURPOSE We aimed to assess the toxicity profile of rituximab in children with mature B-cell NHL.

METHODS In our study, charts of 13 patients (11 males, 2 females; median age, 14 years) treated with rituximab from February 2010 to December 2011 were retrospectively reviewed and analyzed in order to report their clinical and pathological characteristics and documented toxicities. National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 was used for toxicity reporting. According to standard treatment at CCHE, mature B-cell NHL patients receive rituximab in combination with cyclophosphamide, hydroxydoxorubicin, prednisone, and vincristine (R-CHOP). Rituximab is given at 375 mg/m² as a slow IV infusion once weekly for 4 weeks at 50 mg/hour through a dedicated line and is then escalated in increments of 50 mg/hr every 30 min to a maximum of 400 mg/hr.

RESULTS The diagnosis of mature B-cell NHL was confirmed in all 13 patients. Ten patients (4 stage II, 6 stage III) had diffuse large B-cell NHL (5 common subtype, 3 mediastinal subtype, 1 anaplastic variant, 1 grade III pediatric follicular NHL mixed with the diffuse large subtype). These 10 patients received a total of 61 R-CHOP cycles, with the following toxicities recorded: 7 episodes of febrile neutropenia (FN), 24 of lymphopenia (11 grade II, 12 grade III, 1 grade IV), 5 of thrombocytopenia (4 grade III, 1 grade IV), and 25 of neutropenia (1 grade II, 5 grade III, 19 grade IV). Two patients had infusion-related reactions (flushing and rigors) and were treated with intravenous acetaminophen infusion and reduced rituximab infusion rate. One patient had tumor lysis syndrome (TLS) which resolved without complications. No cardiotoxicity or hepatotoxicity was noticed in this group. Three patients with ataxia telangiectasia (2 stage II, 1 stage III) received a total of 17 RCHOP cycles and had 7 episodes of febrile neutropenia, 9 of lymphopenia (1 grade II, 1 grade III, 7 grade IV), 4 of thrombocytopenia (2 grade II, 2 grade IV), and 12 of neutropenia (4 grade II, 1 grade III, 7 grade IV). One patient with TLS was admitted to the intensive care unit with impaired renal functions but recovered with no late effects. One patient had infusion-related reaction; and 1 instance of bacterial chest infection and 1 viral infection were documented in this group. No mortalities were documented in either group.

CONCLUSIONS Rituximab is well tolerated and can be given in outpatient settings, taking into consideration the infusion rate, premedication, and proper supportive care. Follow-up of a larger group of patients over a longer period will help in defining the role of rituximab in treatment of B-cell NHL in children.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

DESCRIPTION OF A PEDIATRIC PHARMACOTHERAPY TRACK FOR DOCTOR OF PHARMACY STUDENTS

Brooke Honey ¹, Peter Johnson ¹, Michelle Condren ¹, Jamie Miller ¹, Tracy Hagemann ¹, Teresa Lewis ¹, Mark Britton ¹, Nancy Brahm ¹, Susan Conway ¹, Jane Wilson ¹

INTRODUCTION Approximately 27% of the US population is <18 years old. Many PharmD curricula do not incorporate sufficient coverage of pediatric topics or opportunities for skill development. Faculty with advanced pediatric training in collaboration with college administrators developed a specialized pediatric curricular track to improve competence in pediatric pharmacotherapy for graduates interested in additional training in pediatrics for use in pharmacy practice.

DESCRIPTION In 2009, the College of Pharmacy approved a policy for development of specialty curricular tracks. In this program, interested students apply to complete 16 credit hours in didactic and experiential settings. Students receive a transcript designation specifying they completed track requirements. In 2010, pediatric faculty developed a curricular track. The goal of the program is to provide students with additional skills and experiences in the pediatric population to translate into the hospital, community, and other pharmacy settings. The required coursework is accomplished by completing 6 hours of didactic coursework and 3 advanced pharmacy practice experience (APPE) rotations or 8 hours of coursework and 2 rotations. Students apply during the fall of their second professional year. The track allows up to 6 students per class between the college's two campuses. Students applying must submit an application, curriculum vitae, letter of intent, and reference letters. Following review of application materials, interviews are offered. Candidates begin during the spring of their second professional year. Once accepted, students are assigned a faculty mentor to facilitate their growth and provide direction through their remaining coursework. The track is individually tailored to meet the needs of each student. Furthermore, track students and pediatric faculty meet every semester as a group to discuss student development and areas for track growth.

RESULTS To date, the track has graduated 1 student and currently has 12 individuals completing coursework. The graduate is a postgraduate first year pharmacy practice resident and plans to pursue a career in pediatrics. Current students have career goals that include postgraduate residency training and hospital and community pharmacy practices. Since track creation, these 13 students have published 2 manuscripts, have 3 manuscripts under review, are actively working on 8 research or quality improvement projects, have presented 7 posters at national meetings, presented 1 podium presentation, provided local in-services, and volunteered in the community. Additionally, track students have voiced a desire for a pediatric organization/student Pediatric Pharmacy Advocae Group chapter. The goal of the student organization is to help children in the community and promote pediatric pharmacy. Students are currently working to make this a reality.

CONCLUSIONS The introduction of a pediatric curricular track for PharmD students appears to be successful. Providing formalized opportunities for training such as this curricular track will give students opportunities to enhance their skills in delivery of pediatric-focused pharmacotherapy to children and their caregivers.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

MEDICATION THERAPY MANAGEMENT IN A PEDIATRIC MEDICAL HOME

Jill Johnson ¹, James McCord ¹

INTRODUCTION Children's Hospitals and Clinics launched a pilot Medication Therapy Management (MTM) program in December 2009. The purpose of the pilot progarm was to evaluate the effectiveness of a pediatric pharmacotherapist in improving MTM. In this model, a pharmacist prospectively reviews patient care data and medications, conducts one-on-one interviews, gathers medication histories, and provides medication education to families. A pharmacist-run MTM program can identify medication therapy problems, improve care coordination, and reduce unnecessary medication cost. Experience with MTM has been limited largely to the adult population. This review describes experience with MTM in a pediatric medical home for special needs patients.

METHODS The pharmacist plays an integral role in managing patient's medications; the positive outcomes have led to an increased demand for MTM. The pharmacist is responsible for meeting with each patient's family, reviewing the patient's medications, looking for medication therapy problems, and finding ways to improve the medication regimens. The pharmacist then meets with the physician after each appointment to make recommendations. Examples of interventions include improvement of compliance, recommending dosage corrections, education of families about medications, coordination of care with other providers, and provision of cost reduction alternatives. Families receive a letter summarizing the medication recommendations along with a laminated medication list. The pharmacist also updates the patient's medication list and writes a note describing all interventions in the patient's electronic medical record. The pilot program began with a pharmacist working one-half day per week in the “Special Needs Clinic.” It has since expanded to 3 mornings a week.

RESULTS Many patients had drug therapy problems that were identified by the pharmacist. During the first 15 months after the pilot phase, 82 children received MTM over 34 days between August 31, 2010 and December 31, 2011. In this patient group, the pharmacist identified 112 medication therapy problems. The most common problems were lack of adherence to medications (32 of 112), medication dosage that was too low (23 of 112), additional medications needed (13 of 112), and different medication needed (12 of 112). Other interventions included recommendations for additional laboratory tests, identification of adverse medication reactions, and removal of unnecessary medications.

CONCLUSIONS Pediatric MTM is a novel service that has the potential to develop into a larger role. Approximately 200 pharmacists are registered to conduct MTM in Minnesota; no others practice in the pediatric settings. Not all pediatric patients need MTM, and pharmacist's time is costly. It is most cost effective for the clinic to have patients with complex medication issues scheduled on the same day to optimize the pharmacist's time. Third parties that are paying for this service include Minnesota Medical Assistance. Reimbursement from government and private insurance coverage for MTM services will help increase the potential for developing practice roles within this area.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

MEDICATION THERAPY MANAGEMENT IN A PEDIATRIC MEDICAL HOME

Jill Johnson ¹, James McCord ¹

INTRODUCTION Children's Hospitals and Clinics launched a pilot Medication Therapy Management (MTM) program in December 2009. The purpose of the pilot progarm was to evaluate the effectiveness of a pediatric pharmacotherapist in improving MTM. In this model, a pharmacist prospectively reviews patient care data and medications, conducts one-on-one interviews, gathers medication histories, and provides medication education to families. A pharmacist-run MTM program can identify medication therapy problems, improve care coordination, and reduce unnecessary medication cost. Experience with MTM has been limited largely to the adult population. This review describes experience with MTM in a pediatric medical home for special needs patients.

METHODS The pharmacist plays an integral role in managing patient's medications; the positive outcomes have led to an increased demand for MTM. The pharmacist is responsible for meeting with each patient's family, reviewing the patient's medications, looking for medication therapy problems, and finding ways to improve the medication regimens. The pharmacist then meets with the physician after each appointment to make recommendations. Examples of interventions include improvement of compliance, recommending dosage corrections, education of families about medications, coordination of care with other providers, and provision of cost reduction alternatives. Families receive a letter summarizing the medication recommendations along with a laminated medication list. The pharmacist also updates the patient's medication list and writes a note describing all interventions in the patient's electronic medical record. The pilot program began with a pharmacist working one-half day per week in the “Special Needs Clinic.” It has since expanded to 3 mornings a week.

RESULTS Many patients had drug therapy problems that were identified by the pharmacist. During the first 15 months after the pilot phase, 82 children received MTM over 34 days between August 31, 2010 and December 31, 2011. In this patient group, the pharmacist identified 112 medication therapy problems. The most common problems were lack of adherence to medications (32 of 112), medication dosage that was too low (23 of 112), additional medications needed (13 of 112), and different medication needed (12 of 112). Other interventions included recommendations for additional laboratory tests, identification of adverse medication reactions, and removal of unnecessary medications.

CONCLUSIONS Pediatric MTM is a novel service that has the potential to develop into a larger role. Approximately 200 pharmacists are registered to conduct MTM in Minnesota; no others practice in the pediatric settings. Not all pediatric patients need MTM, and pharmacist's time is costly. It is most cost effective for the clinic to have patients with complex medication issues scheduled on the same day to optimize the pharmacist's time. Third parties that are paying for this service include Minnesota Medical Assistance. Reimbursement from government and private insurance coverage for MTM services will help increase the potential for developing practice roles within this area.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

INCIDENCE OF PSEDUOHYPERPHOSPHATEMIA IN CHILDREN PRESCRIBED LIPOSOMAL AMPHOTERICIN

Misty Miller ¹, Peter Johnson ¹, Tracy Hagemann ¹, Ryan Webb ¹, Jamie Miller ¹

INTRODUCTION Liposomal amphotericin B (L-AMB) is a commonly used antifungal agent that has been associated with hyperphosphatemia. Some reports describe this elevation in serum phosphorus as an adverse event related to L-AMB administration, while others call it “pseudohyperphosphatemia” and attribute the elevation to an error in the laboratory assay. The purpose of this study was to evaluate the incidence of pseudohyperphosphatemia in children receiving L-AMB to determine whether it is a true elevation or a simple laboratory error.

METHODS This was a retrospective study of patients <18 years of age who received >5 L-AMB doses and had phosphorus and calcium concentrations at baseline and during treatment from April 1, 2009, through April 30, 2011. Data collection included patient demographics, L-AMB regimen, laboratory data, concomitant medications, and total parenteral nutrition (TPN) constituents. The primary objective was the incidence of pseudohyperphosphatemia, defined as elevated phosphorus concentration and normal calcium concentration for age-adjusted values. The secondary objective was to compare the incidence of pseudohyperphosphatemia in patients receiving a maximum L-AMB dose ≤5 mg/kg/day versus that in patients receiving >5 mg/kg/day. Chi-squared or Fisher's exact tests were used as appropriate, with a p value of <0.05.

RESULTS One hundred and forty patients were identified as receiving L-AMB. Seventy-two patients were included for analysis. Forty-two children were females (58%); the median age was 2.5 years (range, 0.02-16). Fifty-three children (74%) received TPN therapy. Thirty-six children (50%) exhibited pseudohyperphosphatemia. Documentation for pseudohyperphosphatemia within provider notes was noted in 4 (11%) of these children. The L-AMB regimen consisted of a maximum dose of 5.95 plus 2.29 mg/kg/dose, median total cumulative dose of 69.3 (range, 9.73-837.6) mg/kg, and a median duration of 12.5 (range, 5-89) days. Thirty-nine (54%) children had a maximum L-AMB dose of <5 mg/kg, while thirty-three (46%) children had >5 mg/kg/dose. There was no significant difference in pseudohyperphosphatemia between children receiving ≤5 and those receiving >5 mg/kg/dose, 19 versus 17 (p=0.18), respectively. The development of pseudohyperphosphatemia was not different between those with and without TPN therapy (p=0.15).

CONCLUSIONS Half of children in this cohort receiving L-AMB met the criteria for pseudohyperphosphatemia. Documentation for this adverse event was noted in only 4 children. This preliminary study suggests that pseudohyperphosphatemia should be included in the differential for elevated phosphorus concentrations in children receiving L-AMB. Future work should further define the true frequency of this adverse event.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

TREATMENT PROTOCOLS' MONITORING SOLUTION FOR REAL-TIME TRACKING OF PEDIATRIC CANCER PATIENTS: A RESEARCH-ORIENTED SYSTEM

Mohamed Kamal ¹, Omneya Hassanain ¹, Sherif Abouelnaga ¹, Hatem Hosny ¹, Ahmad Samir ¹

INTRODUCTION Pediatric oncology has evolved into a multidisciplinary specialty. At the Children's Cancer Hospital Egypt (CCHE) 57357, each subtype of pediatric oncology is managed through a treatment strategy team. These teams provide essential components of comprehensive patient care. The complexity of care and the interdependence of different disciplines mandate a tailored information system. CCHE implemented a world-level hospital information system that served the clinical needs of the patients and treatment teams. The remaining challenge was real-time monitoring of treatment protocols.

PURPOSE The aim of the study was to assess the role of CCHE treatment protocol monitoring system, ensuring that patients are accurately receiving their assigned protocols, and reducing medication errors and protocol violations in addition to minimizing loss to follow-up.

METHODS The real-time protocol monitoring and patient follow-up system at CCHE was innovated and built at the research department. The need to accurately manage clinical data of patients in a hospital-wide scope over long periods while keeping a simple user-friendly interface was the motive to develop the software. The system represents a collection of Web-based subsystems, each customized to a specific pediatric oncology subtype. The authors deployed department-level Web applications, following the Analyze, Design, Develop, Implement and Evaluate (ADDIE) model. The team took into consideration Health Insurance Portability and Accountability Act (HIPAA) recommendations and Food and Drug Administration Code of Federal Regulations (CFR) Title 21-part 11 requirements.

RESULTS The system improved the quality of clinical treatment by allowing treatment management teams and researchers to concurrently view, analyze, and evaluate the standard treatment protocol milestones. Moreover, the proposed patient follow-up system facilitated interactions between the treatment team members by providing ease of access to patient data from any terminal, including hand-held devices, or smart phones. It was a means for accurately creating and accessing each patient's history and for tracking patients' progress. It helped the facility to provide the highest quality of care and save resources by minimizing medication errors and unnecessary investigations. Because it was developed in-house, the system was tailored to CCHE's needs; however, it was a cost effective solution that enabled our development team to build capacity and gain experience.

CONCLUSIONS This study demonstrated the advantages of using patient oriented follow-up and protocol monitoring information systems. The information system helped in effective management of patients and providing better patient care. We recommend using a web based information system, with the advantages of mobility, ease of accessibility and maintenance. The developed system can be easily applied in the course of management of other chronic diseases.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

IMPROVING PEDIATRIC PATIENT CARE THROUGH PHARMACIST-LED MEDICATION RECONCILIATION DOCUMENTATION

Armine Khachatryan ¹, Gerald Lee ¹

INTRODUCTION Medication reconciliation as defined by Institute for Healthcare Improvement is the process of obtaining a “complete and accurate list of each patient's current home medications-including name, dosage, frequency, route and comparing the physician's admission, transfer, and/or discharge orders to that list.” The underlying intent of medication reconciliation is the use of a formal process to prevent the occurrence of medication errors including omissions, duplications, dosing errors, and/or drug interactions when an individual is hospitalized, transferred, and discharged. Errors related to ordering medications upon admission to a hospital are a major source of preventable harm. By obtaining and documenting an accurate medication history upon admission, healthcare professionals are empowered to provide consistent and quality patient care.

METHODS At Children's Hospital Los Angeles (CHLA), pharmacists recently instituted medication reconciliation processes through major portals of entry: the emergency department (ED) and the operating room (OR). These portals account for 80% of all CHLA admissions. Prior to the implementation of the medication reconciliation process, a baseline house audit showed that less than 40% of medication lists were complete. Furthermore, previous to the process improvements, errors contributed to loss of continuity of care due to omission, dosage errors, and duplications. These errors were often compounded as the admitting team copied the incomplete medication lists from the patient's ED chart or used outdated medication lists from the patient's medical record. Through quality improvement, the surgery pharmacist, surgical nurse practitioners, and emergency department pharmacists began to obtain and document patient medication histories into the patient's electronic medication record.

RESULTS After 6 months of project trial, an audit demonstrated that pharmacists' entries of medication documentation into the electronic medical record resulted in more complete and accurate medication lists for greater than 90% of inpatient admissions.

CONCLUSIONS This project intervention has reduced medication errors related to missing medication, wrong dose, wrong frequency, wrong route, and wrong medication. Since the medication reconciliation process has been implemented and conducted by pharmacists, a significant improvement in patient care has been noted.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

DEVELOPMENT AND IMPLEMENTATION OF A PEDIATRIC DOSE RANGE CHECKING PROGRAM

Rhonda Kurz ¹, Vanessa Holton ¹, Christine Sanchez ¹

INTRODUCTION Many pediatric hospitals have implemented computerized physician order-entry (CPOE) systems. A benefit of these systems should be to detect and prevent medication errors. The goal of our CPOE dose range project was to prevent medication dosage errors from propagating downstream by alerting the prescriber at the point of order entry.

METHODS Our free-standing pediatric hospital, with a level I pediatric trauma center and 465 licensed beds, developed an innovative approach that allowed implementation of a dose range checking program within 4 months. A multidisciplinary team that included pharmacists, IT clinical analysts, and physicians retrospectively analyzed over 750,000 medication orders. We were able to target high-risk drugs and those most frequently ordered that account for 80% of pharmacy orders. The logic for this alerting process was developed to include a check of each dose on a total (flat dose) as well as weight (per kg) basis. This approach provides safety while accommodating the wide pediatric weight ranges of obese adolescents down to preterm infants. Thresholds alerts were developed with soft and hard limits on both parameters by using historical analysis as a guide to minimize nuisance alerts. Similarly, care was taken to consider the workflow to accommodate situations when nurses, pharmacists, or specialized physicians might be entering orders. Depending upon those roles, the alert was modified to alert differently. Soft stops require an acknowledgement with comments on the override reason by the prescriber. To enhance pharmacist workflow, those comments are sent electronically to the pharmacy verification system. The override reason is displayed prior to pharmacist verification of the order. An order that encounters a hard stop cannot be submitted by the prescriber. If a hard stop order is clinically appropriate in a given situation, a call from the attending physician must be placed to a pharmacist. Following discussion and agreement, the pharmacist enters the order. These clinical acknowledgement reasons are saved and are retrievable in both systems. Alerts are sent to clinical pharmacists for review and follow-up. Hard stop orders that are verified create a pharmacist consult.

RESULTS The pediatric dose range checking program made a substantial impact on pediatric medication safety at our institution. The greatest being, 80% of all medication orders are being checked for dose appropriateness on a per-kg and a flat dose basis. Of those checks, 3% result in either a hard or soft stop being triggered. In more than 50% of the cases, the alert results in a modification or cancellation of the order by the prescriber. Modifications ranged from 2-fold to 100-fold reduction in the dose. This workflow has reduced follow-up phone calls from pharmacists to prescribers. Our customized program decreases prescribing errors that are submitted to pharmacy and potential for adverse medication related events.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

HYDROCORTISONE PROPHYLAXIS FOR REDUCTION OF INTRAVENOUS IMMUNOGLOBULIN-RELATED ADVERSE EVENTS IN PEDIATRIC PATIENTS

Weng Man Lam ¹, Kelley Norris ¹, Kalen Manasco ¹, Reda Bassali ¹

INTRODUCTION To our knowledge, there is limited evidence evaluating the premedication regimen prior to the administration of intravenous immunoglobulin (IVIG) therapy in pediatric patients. The standard premedication regimen for the administration of IVIG at our institution is acetaminophen and diphenhydramine. The purpose of this project was to compare the incidence of Ig-related adverse events in patients receiving 1 dose of hydrocortisone in addition to the standard premedications to those receiving the standard premedications alone.

METHODS This was a prospective, randomized, double-blind, placebo-controlled study. Children between the ages of 1 and 18 years receiving IVIG included. Patients were excluded if they had a history of IVIG-related adverse events, were receiving steroid medications, or had a serious infection in the previous 30 days. The IVIG infusion rate is standardized, and the anticipated number of subjects is 30. All patients and parents were provided with research informed consent documents and children's assent documents before study enrollment. Data collection included incidence of adverse events, premedications, IVIG infusion rate, and demographic data.

RESULTS This is a preliminary analysis of our current study from January 2009 to February 2012. Fourteen patients requiring IVIG therapy have been enrolled in the study. The majority of patients (78%) had a diagnosis of Kawasaki disease. All patients received appropriate doses of acetaminophen and diphenhydramine with or without hydrocortisone (2 mg/kg/dose) prior to the Ig therapy (mean dose, 1.8 g/kg/dose). Overall, 11 (85%) patients did not experience any Ig-related adverse events, and 1 patient was withdrawn from the study. Two patients, 1 in the placebo group and 1 in the hydrocortisone group, experienced IVIG related adverse events, and they were managed with supportive care.

CONCLUSIONS This interim analysis did not demonstrate any differences between the premedication regimens. Because most patients in the study did not experience any adverse reactions, the standardized infusion rate rather than the premedications used might have played a significant role in the prevention of IVIG related adverse events. Our goal is to continue to enroll more patients to reach our target sample size of 30 patients.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

COMPREHENSIVE STANDARDIZATION OF INTRAVENOUS CONCENTRATIONS IN THE NEONATAL INTENSIVE CARE UNIT OF A PEDIATRIC HOSPITAL

Shirley Lee ¹, Sarah Scarpace Lucas ¹, Lisa Musick ¹, Julie Wilson-Ganz ¹

BACKGROUND Medication errors with the potential to cause harm are significantly more likely to occur in the neonatal intensive care unit (NICU) than in the adult patient care areas in the hospital. The ICN setting offers unique challenges when attempting to standardize drug concentrations because of the diverse range of neonates' weights and various fluid requirements.

OBJECTIVES This project was designed to assess the use of intravenous (IV) medications in the ICN of a pediatric hospital and to standardize concentrations of these medications.

METHODS In a retrospective data analysis, 6 months of data (May 1, 2010-October 31, 2010) was collected from the hospital's pharmacist order-entry system, WORx. Medications were evaluated, and those that needed to be updated, deleted, or added were identified. Each medication was standardized based on the current best standards of practice, current concentration references, and purchasing capabilities. For each IV medication, references that were used during the review were incorporated into the hospital's final list of standardized concentrations.

RESULTS Our data, consisting of intravenous continuous infusions, intermittent infusions, and intermittent bolus injections, included 16,364 IV medications dispensed to the ICN from May 1 through October 31, 2010. There were 1594 doses (9.7%) representing 29 different drugs that were administered with an unmeasurable volume of less than 0.2 mL, resulting in the proposed addition of 25 new standard concentrations. Proposing to change 7, delete 40, and add 31 concentrations, we standardized 127 different IV medications, which were built into the development of infusion libraries for Smart-Pump technology that was implemented throughout the pediatric hospital in January 2012.

CONCLUSIONS Standardizing concentrations of IV medications used in the ICN decreased the potential for medication errors and promoted patient safety. Additionally, establishing standard concentrations will identify potential outsourcing opportunities, minimize calculations and required double-checks, and optimize the safety features of Smart-Pump technology.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

GENTAMICIN PHARMACOKINETICS IN NEONATES UNDERGOING THERAPEUTIC HYPOTHERMIA

Liana Mark ¹, Addishiwot Solomon ¹, Frances Northington ¹, Carlton Lee ¹

PURPOSE To identify whether therapeutic hypothermia in newborns with hypoxic ischemic encephalopathy (HIE) affects the pharmacokinetic parameters and subsequent peak and trough serum concentrations of gentamicin.

METHODS This was a retrospective case-controlled study consisting of 16 neonates who underwent therapeutic hypothermia, received gentamicin, and had interpretable gentamicin peak and trough serum levels drawn during the period of cooling and around or after the third gentamicin dose; a comparator group consisted of 7 neonates who met criteria but did not undergo therapeutic hypothermia.

RESULTS Significant differences in gentamicin pharmacokinetics were noted between the therapeutic hypothermia group and the comparator group in elimination rate constant (ke) (0.08 ± 0.02 vs. 0.11 ± 0.03, p<0.01), half-life (t_½) (9.16 ± 2.08 vs. 6.56 ± 1.81, p<0.01), and clearance (Cl; 0.04 ± 0.01 vs. 0.05 ± 0.01, p<0.01), respectively. No difference in volume distribution (Vd) was found between groups. A significant difference was found in gentamicin trough concentrations, where the group that underwent therapeutic hypothermia had higher trough serum concentration (1.68 ± 0.69 vs. 0.77 ± 0.53, p<0.01).

CONCLUSIONS Therapeutic hypothermia is associated with alterations in gentamicin pharmacokinetics, reduction of gentamicin Cl by 25.5% in neonates with HIE, which may result in increased trough serum concentrations.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

IMPLEMENTATION OF PEDIATRIC PHARMACY DRUG SHORTAGE MANAGEMENT TEAM

Steve Martin ¹, Carmen Gerkovich ¹, Meredith Mulvanity ¹, Juana Real ¹, Jennifer Shenk ¹, Susanna Holmes ¹

INTRODUCTION Treating pediatric patients presents its own challenges with limited evidence-based literature, pharmacokinetic differences, and so forth. However, one of the most challenging aspects in treating our patients today comes with the ever-increasing number of drug shortages. With drug shortages reaching an alarming level, both safety and efficacy have been threatened. However, managing drug shortages in pediatric patients exposes additional challenges not experienced in the adult setting. Alternative agents from which to select are more limited, and package sizes may require compounding, reducing sterility or leading to medication errors. Therefore, a drug shortage database program and pharmacy team were created to improve our ability to provide medications for our patients.

METHODS The drug shortage pharmacy team consisted of team members representing all levels within the department. The team consisted of pharmacy manager, operational managers, buyer, pharmacist specialists, staff pharmacist, and technicians. Meetings were held on a biweekly basis to discuss new shortages and update ongoing shortages. A drug shortage database program was created and used to provide accurate, up-to-date information regarding shortages directly affecting our patient population. A drug shortage is entered into the database and categorized as either a critical or pending/moderate shortage status. Critical shortages are defined as medications with either no release date, an on-hand supply of <1 month with release date beyond 1 month, or an on-hand supply of >1 month but no alternative agent available. Drug shortage memos are created and attached to each individual drug shortage and can be printed/emailed to the pharmacy department. Drug shortage status reports can also be emailed to physicians directly from the database, providing succinct information about selected medications. Information is obtained from the biweekly meetings and entered into the database and also placed into a drug shortage binder kept in the main pharmacy for quick retrieval. Drug identification cards of critical or pending/moderate shortages are placed on the bins of each shortage item as a visual cue to the pharmacy personnel retrieving the item. Last, a cost analysis feature, included in the database, can determine the extent of the pharmacy budget spent on drug shortages purchased via drop shipment or the gray market.

CONCLUSIONS The database and drug shortage team allows continuation of a high level of care to be provided to our patients during these difficult times. We are able to more quickly identify shortages and develop strategic plans for restrictions and/or alternatives. This ability to monitor and forecast has limited the number of medications we have been unable to dispense. A survey was completed before the creation of the drug shortage team. Results will be compared to the same survey, to be performed post- implementation, to assess the program's impact on the pharmacy department.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

RETROSPECTIVE ANALYSIS OF VANCOMYCIN-ASSOCIATED NEPHROTOXICITY IN PEDIATRIC PATIENTS

Kelly Matson ¹, Barbara Maas ¹

INTRODUCTION Methicillin-resistant Staphylococcus aureus (MRSA) infections have increased among pediatric patients recently, and vancomycin remains the drug of choice for treatment of these invasive infections. Concerns of emerging resistant strains due to exposure to low serum vancomycin concentrations have prompted updated adult treatment guidelines recommending target trough concentrations of >10 mg/L and 15 to 20 mg/L for empiric or definitive treatment of noncomplicated and complicated MRSA infections. Literature pertaining to the adult population has reported an association of vancomycin serum trough concentrations of >10 mg/L and aggressive dosages with renal toxicity; however, pediatric literature is limited. The purpose of this study was to assess the effect of vancomycin serum trough concentrations on the occurrence of nephrotoxicity in pediatric patients.

METHODS Pediatric patients who received >3 doses of vancomycin for presumed or confirmed infection with S. aureus and who had at least 1 trough vancomycin level drawn from January 2008 to July 2010 were evaluated in a retrospective, observational study at an academic medical center. Patients were excluded if they were >18 years old, had documented infection with another organism, or had acute renal injury or received dialysis in the previous year. Data collected included demographics, vancomycin indication and dosage regimen, laboratory and microbiology results, and nephrotoxicity risk factors. Serial serum creatinine (SCr) measurements were collected to determine nephrotoxicity, defined as 0.5 mg/dL or >50% increase from baseline in SCr. The primary study objectives were to determine the rate of nephrotoxicity in pediatric patients treated with vancomycin for presumed or confirmed S. aureus infections and whether higher trough concentrations were associated with a greater risk for nephrotoxicity. Secondary objectives were to compare renal toxicity rates by trough subgroups and to determine concomitant nephrotoxicity risk factors. Between-group analysis was performed using the chi-squared test.

RESULTS A total of 169 patients were assessed for eligibility, and 134 patients met criteria. The study population consisted of 51% males with a median patient age of 8.1 years (range, 0.03-18 years). Nephrotoxicity was determined in 20.9% of 143 patients (95% confidence interval [CI], 0.15-0.2]. Of the patients who developed nephrotoxicity, 60% had higher vancomycin trough concentrations (p<0.0001). Renal toxicity rates by trough subgroups were 40% with <10 mg/L, 23% with 10 to 15 mg/L, and 37% with >15 mg/L. Nephrotoxicity risk factors included complicated infection (83.3%), >1 nephrotoxic agent (76.7%), and a blood-urea-nitrogen (BUN):SCr ratio elevation to >20:1 (70%), p<0.002 and p<0.05, p <0.01, respectively.

CONCLUSIONS Over 20% of patients who received vancomycin treatment for presumed or confirmed S. aureus infection had documented nephrotoxicity, and of those patients, 60% of patients had nephrotoxicity with vancomycin serum concentrations at the currently desired levels. Monitoring for nephrotoxicity and its risk factors is essential given the extrapolation of trough recommendations to the pediatric population.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

THE USE OF INTRAPLEURAL CISPLATIN FOR TREATMENT OF MALIGNANT PLEURAL EFFUSION

Tara McCabe ¹, Joanne Lagmay ¹

INTRODUCTION An alternative method of treatment of localized cancer e with low long-term risk to the patient is intracavitary (IC) instillation of chemotherapy. There have been limited pediatric studies using IC chemotherapy, and due to sample size and retrospective design, it is difficult to truly assess the efficacy of this therapy. In order to add to the literature pertaining to IC cisplatin therapy in pediatric patients, we report a case in which intrapleural cisplatin was used in a pediatric patient with malignant pleural effusion due to metastatic osteosarcoma.

CASE REPORT Patient 1 is a 16-year-old caucasian female weighing 70.1 kg, with a history of chondroblastic osteosarcoma of the left distal femur that metastasized to the L2 vertebra. She presented 16 months after treatment with a solitary pulmonary nodule which was resected. Follow-up imaging 4 months after metastectomy showed multiple left-sided lung relapse with diffuse pleural involvement associated with a large pleural effusion. Due to the degree of involvement of the left lung, local control with surgery or radiation therapy was not possible. A chest tube was placed, and after continued build up of malignant pleural effusion, it was decided to administer IC cisplatin. Prior to the procedure, the patient was given intravenous (IV) fluids and antiemetics and placed on morphine patient-controlled analgesia. She was then given sodium thiosulfate IV over 1 hour prior to cisplatin administration. Cisplatin was allowed to dwell for 4 hours, and then the chest tube was put to suction. Patient was then started on post-chemotherapy IV fluids containing mannitol and was given an infusion of sodium thiosfulfate over 6 hours. After receiving IC cisplatin, the patient received ifosfamide and etoposide systemically. The patient tolerated the IC administration of chemotherapy well with minor toxicities, which included reversible electrolyte disturbances and mild renal dysfunction, neutropenia, and nausea and vomiting. The patient's malignant pleural effusion resolved completely and she did not experience reaccumulation. She also improved and stabilization of her lung disease continued 4 months after IC cisplatin.

DISCUSSION Despite randomized trials in adults, the efficacy and role of IC chemotherapy remain controversial. Pediatric tumors confined to body cavities such as pleural or peritoneal spaces are rare, thus clinical trials to statistically evaluate efficacy have not been performed to date. The patient discussed in this case report tolerated this procedure well and had side-effect profile similar to those in previous reports.

CONCLUSIONS Intapleural cisplatin therapy has been demonstrated to be a safe option for patients with malignant pleural effusions, but without prospective trials of IC cisplatin in pediatrics this will continue to be a controversial therapy. Pharmacists' knowledge and understanding of the IC cisplatin process will contribute to improve the safety of administration of IC cisplatin.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

PRESCRIBING ERRORS IN ADULT CONGENITAL HEART DISEASE PATIENTS ADMITTED TO A PEDIATRIC CARDIAC INTENSIVE CARE UNIT

Genevieve Echeta ¹, Brady Moffett ¹, Paul Checchia ¹, Mary Kay Benton ¹, Leda Kloudas ¹, Fred Rodriguez ¹, Wayne Franklin ¹

INTRODUCTION Adults with congenital heart disease (CHD) are often cared for at pediatric hospitals. There are no data describing the incidence or type of medication errors in adult patients with CHD admitted to a pediatric cardiac intensive care unit (CICU). Additionally, there are no data to suggest the impact of weight versus age of the patient as contributing factors to any errors.

METHODS We retrospectively reviewed patients >18 years of age with CHD admitted to the pediatric CICU at our institution from 2009 to 2011. Patients were excluded if they spent less than 24 hours in the CICU. A comparator group of patients <18 years of age but >70 kg (a typical adult weight) was identified from the same study criteria. Patient demographics, disease state, surgical procedure, and length of hospital stay were collected. Medication errors were determined by comparing patient medication profiles to a commonly used adult drug reference (Lexi-Drugs, Hudson, OH). Medication orders were classified as appropriate, under dose, over dose, or nonstandard (dosed per weight instead of standard adult dosing). An independent panel consisting of a physician specializing in the care of adult CHD patients, a nurse, and a pharmacist evaluated all orders initially identified.

RESULTS Eight-six admissions (74 adult patients) and 33 pediatric admissions (32 patients) met study criteria (mean age, 27.4 ± 9.4 years, 53% male vs 14.9 ± 1.8 years, 85% male). A cardiothoracic surgical procedure was performed in 80.6% of admissions. Adult admissions weighed less than pediatric admissions (72.8 ± 22.4 vs. 85.6 ± 14.9 kg, p<0.01), and hospital lengths of stay were similar between groups (adult, 6 days [range, 1-216 days); pediatric, 5 days [range, 2-123 days] p=0.52). Prescribing errors trended toward lower frequency in adults than pediatric admissions (40.7% vs 67%, p=0.06), and adults were lower in number of errors per admission (1.48 errors per adult admission vs 2.41 errors per pediatric admission, p<0.01). Underdose was the most common category of prescribing error, followed by nonstandard and overdose in adults (32 underdose, 16 nonstandard, 4 overdose) and pediatric admissions (19 underdose, 11 nonstandard, 3 overdose). Overdoses occurred with vancomycin, morphine, ondansetron, intravenous acetaminophen, escitalopram, fentanyl, and cefazolin. Prescribing errors by medication order occurred most commonly with antibiotics (n=26), followed by antiemetics and gastrointestinal medications (n=24), analgesics (n=23), and cardiovascular medications (n=19).

CONCLUSIONS Prescribing errors occur frequently in adult patients with CHD admitted to a pediatric CICU. Most prescribing errors in this setting are underdoses and are likely due to weight-based dosages in patients who should receive standard adult doses.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

CONTINUOUS ESOMEPRAZOLE INFUSION FOR ACUTE GASTROINTESTINAL BLEEDING IN CHILDREN: A CASE SERIES

Jennifer W Chow ¹, SB Ng ¹, Michael F Chicella ¹

INTRODUCTION Continuous proton pump inhibitor (PPI) infusions are commonly used to treat adults with acute gastrointestinal (GI) bleeding. Most adult literature recommends an initial bolus plus a low-dose continuous infusion. The most frequently studied PPI is omeprazole. Typically, the adult loading dose is 80 mg of intravenous omeprazole, followed by a continuous infusion of 8 mg/hour for 72 hours. Currently, at our hospital, esomeprazole is the PPI on formulary. There are few data establishing the dose of continuous PPI infusions in the pediatric population, and there are no data regarding the use of esomeprazole by continuous infusion.

PURPOSE The purpose of this study was to establish preliminary dosage recommendations for continuous infusion of esomeprazole in pediatric patients with acute GI bleeding.

METHODS !!We conducted a retrospective review of all children younger than 18 years of age who received esomeprazole by continuous infusion for at least 24 hours. All patients were receiving esomeprazole for acute GI bleeding. From the adult data, we extrapolated a dose for pediatric patients. All patients were given 1mg/kg/dose bolus and then started on 0.1mg/kg/hr continuous esomeprazole infusion. The goal was to maintain a gastric pH greater than or equal to 6. Data collection included patient age, weight, initial hemoglobin and hematocrit, initial platelet count, initial prothrombin time (PT) and international normalized ratio, diagnostic criteria, esomeprazole dose, duration of therapy, and gastric pH. All potential adverse drug effects associated with esomeprazole were also evaluated.

RESULTS Six patients were identified who were treated for acute GI bleeding and received continuous infusion esomeprazole. The mean age of the patients was 6.4 years (range, 8 months-19 years). Mean patient weight was 28.2 kg (range, 14.6-79 kg). Mean initial hemoglobin and hematocrit levels were 11.5 mg/dL (range, 7.1-15.8 mg/dL) and 33.9% (range, 20.4%-48.2%), respectively. Mean initial bolus dose of esomeprazole was 0.8 mg/kg, 22 mg (range, 0.5-1 mg/kg/dose). Initially patients received a continuous infusion of esomeprazole at 0.1 to 0.2 mg/kg/hr. Infusion rates were adjusted to maintain a gastric pH >6. The mean gastric pH achieved during continuous infusion was >7.0 (range, 5.0-8.0). Mean duration of infusion was 2.2 days (range, 1-3 days). No adverse drug effects associated with esomeprazole were found.

CONCLUSIONS An intravenous bolus of 1mg/kg/dose of esomeprazole followed by a continuous infusion of 0.1 to 0.2 mg/kg/hr is effective in achieving gastric pH greater than or equal to 6 in pediatric patients with acute GI bleeding.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

INITIATION OF EARLY INTENSIVE INSULIN REGIMEN: EFFECT ON MAINTENANCE INSULIN THERAPY IN CHILDREN AND ADOLESCENTS WITH TYPE 2 DIABETES

Ying-Tang Ng ¹, Thomas Parker ¹, Sherry Luedtke ¹

INTRODUCTION Scarce information exists on the effective management of type 2 diabetes mellitus (T2DM) in children and adolescents. Children and adolescents with T2DM can present with ketoacidosis and symptoms of hyperglycemia. The course of the disease may be more aggressive, requiring the need for intensive treatment especially if the patient is symptomatic. Early introduction of insulin therapy has been shown to be beneficial for the long-term control of glucose in adults with T2DM. The purpose of this retrospective study was to assess the effects of early intensive insulin therapy in children and adolescents newly diagnosed with T2DM on insulin requirements for stabilization.

METHODS A retrospective chart review of insulin requirements at stabilization for children and adolescents with T2DM was performed to compare the impact of intensive insulin therapy versus nonintensive therapies at diagnosis. Charts of pediatric patients (0-18 years old) with T2DM who were diagnosed over a 6-year time period and managed by a pediatric diabetes specialty clinic were evaluated . Insulin requirements at 6 months post- diagnosis were compared in each group. Secondary comparisons evaluated influence of age, severity at diagnosis, insulin dosage requirements, and concomitant antidiabetes medication use on the efficacy of intensive insulin therapy; determined incidence of acute complications with intensive insulin therapy; evaluated the effect of intensive insulin therapy on hemoglobin A1c (HbA1c) and average fasting plasma glucose. Data collection included patient demographics, diabetes severity indicators at diagnosis, indicators of diabetes control (e.g., HbA1c), insulin regimens, concomitant diabetes medication use, and adverse events (e.g., hypoglycemia).

RESULTS Seventeen patients were identified with T2DM based on International Classificatin of Disease (ICD)-9 codes at the pediatric specialty clinic. Results showed a decrease in total insulin dose of at least 40% at 6 months after diagnosis in approximately 40% of patients given intensive insulin therapy at diagnosis. All patients had over 20% decreases in total daily insulin dose in the intensive insulin group by 6 months post-diagnosis. Average daily dose at diagnosis and at 6 months was 0.7 units/kg/day and 0.39 units/kg/day, respectively. At 6 months post- diagnosis, 70% of patients given intensive insulin therapy (n=10) were at the HgA1c goal level versus 100% in the nonintensive insulin group (n=1). All patients diagnosed with T2DM regardless of insulin therapy began taking metformin at diagnosis. Further statistical analysis will be conducted upon completion of patient enrollment.

CONCLUSIONS Most patients had a decrease in insulin need by 6 months post-diagnosis. Some patients had a decrease of greater than 40% in total insulin requirement. All patients reached HbA1c goal by three months. Based on preliminary results, initiating T2DM patients presenting in DKA on intensive insulin therapy reduces maintenance insulin dose.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

Y-SITE COMPATIBILITY OF VANCOMYCIN AND PIPERACILLIN/TAZOBACTAM AT CONCENTRATIONS USED IN PEDIATRIC POPULATIONS

Kristen Nichols ¹, Michael DeMarco ¹, Michael Vertin ¹, Chad Knoderer ¹

INTRODUCTION Vancomycin and piperacillin/tazobactam are mainstays in empiric antibacterial regimens in hospitalized pediatric patients. Both agents are administered via intravenous (IV) infusion; however, there are limited data demonstrating IV compatibility at concentrations commonly used in pediatric institutions. Children often have limited IV access and may require simultaneous infusions of the two antibacterials. The objective of this study was to determine the y-site compatibility of vancomycin and piperacillin/tazobactam.

METHODS Vancomycin (10-g vial) was reconstituted using sterile water for injection (SWFI) and diluted with 5% dextrose in water to a final concentration of 10 mg/mL in an evacuated IV bag. Piperacillin/tazobactam (40.5-g vial) was reconstituted and diluted with SWFI to a final concentration of 112.5 mg/mL (100 mg/mL piperacillin) in an evacuated IV bag. Both of the antibacterial stock solutions were then stored in a refrigerator. Initial solution appearances, including color, clarity, and particulates were documented. Diluted solutions were mixed in a quantity of 3 mL of each vancomycin and piperacillin/tazobactam vancomycin in glass test tubes. Subsequent evaluation included pH assessment and visual evaluation with unaided eye, magnifying glass, high-beam light, and Spec-20 turbidimeter. Solution mixtures were evaluated upon mixing and again at 30 minutes, 1 hour, and 4 hours after mixing.

RESULTS Initial visual evaluation following combination of vancomycin and piperacillin/tazobactam resulted in a milky precipitate that dissipated approximately 15 seconds after mixing. No precipitate was visualized via any method at any time point following initial mixing. Turbidimetry and pH readings did not demonstrate differences from baseline measurements.

CONCLUSIONS A combination of vancomycin, 10 mg/mL, and piperacillin/tazobactam, 112.5 mg/mL, demonstrated precipitation immediately upon mixing. Co-infusion of vancomycin and piperacillin/tazobactam via y-site should be considered incompatible.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

PREDICTORS OF HEPATOTOXICITY IN PEDIATRIC PATIENTS RECEIVING VORICONAZOLE

Nicole Even ¹, Kathryn Matthias ¹, Hanna Phan ¹

INTRODUCTION Current data describing hepatoxicity as the result of voriconazole therapy have been focused on adult patients. However, given the differences in pharmacokinetics and pharmacodynamics of drug therapy in pediatric patients and potential vulnerability of this population to adverse drug effects, additional data regarding voriconazole specific to this population is needed. The objectives of this study were (1) to evaluate patient-specific parameters associated with hepatotoxicity, defined as liver function tests (LFT) results 2 times the upper limit of normal during voriconazole therapy and (2) to evaluate the incidence of and reasons for discontinuation due to hepatotoxicity and adverse effects.

METHODS This was a retrospective cohort study. Patients under the age of 18 years admitted to an academic medical center who received voriconazole between August 2006 and July 2010 were included in this study. Patients were excluded if no LFT had been obtained within 1 week of starting and during treatment. General linear model analyses were performed to assess predictors of elevated LFT results greater than 2 times the upper limit of normal based on age. Predictors tested including demographic data, baseline LFTs, comorbidities, potential drug interactions, daily and cumulative dose by body weight, duration, and reason for use. Descriptive statistical analyses were performed to examine incidence, causality, and timing of other adverse effects as well as reasons for therapy discontinuation. Adverse drug events were assessed using the Naranjo scale.

RESULTS Of the 85 patients included, 50.6% were male, and 83.5% were white (51.4% Hispanic), with median age of 4 (0.03-16) years. Mean cumulative voriconazole dose was 1400 ± 1959 mg/kg, mean daily dose was 11.7 ± 8.9 mg/kg, and median duration was 33 (1-578) days. Known reasons for discontinuation included completed course or discharge (34.1%), culture negative result (5.9%), increased LFTs (3.5%), change to alterative antifungal therapy (17.6%), and death (22%, unrelated to voriconazole). One adverse drug event was reported as rash, classified as a probable association based on Naranjo score. Of patients who received voriconazole therapy, 76% received medication that potentially affected CYP P450 3A4. Based on general linear models between incidence of 2 times or greater than the upper limit of normal LFTs with 1) each patient specific factor and 2) combined in a multivariate model revealed no significant association (all p>0.05). However, in total, cumulative voriconazole dose by body weight was associated with incidence of elevated alanine aminotransferase (p=0.045) in a multivariate analysis with confounding variables.

CONCLUSIONS Significant association between elevations in LFTs while taking voriconzole therapy and patient-specific factors were not found in the given pediatric population. However, a trend may exist for total cumulative dose by weight and elevated alanine amintransferase. Additional studies are needed to further investigate the possible association between these factors and their effects on liver function during voriconazole therapy.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

TOLERABILITY OF HIGH DOSE VORICONAZOLE IN CHILDREN: A SINGLE-CENTER EXPERIENCE

Kristine Phansana ¹, Ngoc-Yen Nguyen ¹

INTRODUCTION Voriconazole (VCN) is a broad-spectrum triazole antifungal agent with activity against Aspergillus, Fusarium, or Scedosporium species. Use of VCN is increasing in pediatrics due to its activity against aspergillosis, safe side-effect profile, and availability in different dosage forms. However, published reports of VCN use in pediatrics are still limited. A number of these reports demonstrated that children have a higher capacity for VCN elimination than healthy adults and suggested higher doses are needed to ensure therapeutic drug exposure. In 2010, based on further pharmacokinetics data, the European Union approved the use of VCN at 7 mg/kg IV twice daily or 200 mg orally twice daily in young children. In the same year, Texas Children's Hospital implemented the above-described dosing guidelines. This study examined the safety and tolerability of high-dose VCN in children 2 to 11 years old.

METHODS Using the institution's electronic record, we performed a retrospective chart review of children aged 2 to 11 years who received VCN at >7 mg/kg/dose for at least 7 days from October 2010 to January 2012. Information collected include patient demographics, liver function panel results and serum creatinine, bilirubin, and VCN levels (when available), concomitant potentially hepatotoxic medications, incidents of ocular complications, and rationale for discontinuation of VCN therapy. Critically ill patients who received vasopressors and those who had baseline hepatic transaminases of >5× upper limit of normal prior to initiation of therapy were excluded.

RESULTS Forty-eight patients were evaluated. Twelve patients received VCN for treatment of active fungal disease, and the remaining patients received it as prophylactic therapy. Duration of therapy ranged from 7 days to 1 year. Dose ranged from 7 to 20 mg/kg. Forty-eight VCN levels were available, ranging from undetected to 12.51 mg/mL. Six (12.5%) patients experienced a total of 3 treatment-related adverse events (AE). Treatment was discontinued in 4 patients due to hepatic AE. One patient reported visual disturbance, while 1 patient experienced nausea and vomiting. No treatment failure of VCN was reported.

CONCLUSIONS High-dose VCN at 7 mg/kg/dose twice daily appears to be safe and well tolerated. Occurrences of gastrointestinal, hepatic, and visual AE were consistent with the known safety profile of VCN in adults. However, close monitoring for AE is recommended in patients with organ dysfunction. VCN level should be monitored to assure therapeutic drug concentration in patients with active fungal infection.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

DEVELOPMENT OF A MEDICATION SAFETY SCORECARD FOR EVALUATION OF THE MEDICATION USE PROCESS IN A PEDIATRIC HOSPITAL

Amy Potts ¹, J Autumne Bailey ¹, Jennifer Slayton ¹, Paul Hain ¹

INTRODUCTION Medication errors occur commonly, are costly, and may result in significant morbidity and mortality. An estimated 1.5 million medication errors harm patients annually. This is equivalent to 1 medication error per patient day. Pediatric patients are at higher risk and are more vulnerable due to unique differences from adults. Pediatric patients are 3 times more likely to experience a medication error. More than a decade has passed since the Institute of Medicine published its initial report To Err is Human, which served as the catalyst for health care reform and patient safety. Since then, several recommendations to promote safe use of medications have been established. These include national patient safety goals, medication management standards, improved communication and education, standardization, and implementation of technology with advanced decision support. However, there are very few benchmarks or standard performance indicators for measuring medication safety.

OBJECTIVE To develop a comprehensive medication safety scorecard with defined performance indicators for evaluation of the medication use process at a pediatric hospital with closed-loop technology and advanced clinical decision support.

METHODS Since1994, our institution has implemented computerized practitioner order entry with advanced clinical decision support with an integrated pharmacy system, automated dispensing cabinets, and an electronic medical record. More recently, bar-code medication administration (BCMA) and smart pump technology have been implemented, making our medication use process a closed-loop system with technology advances. In 2010, a multidisciplinary workgroup, the Medication Use Safety Improvement Committee (MUSIC), was implemented to evaluate safe medication use across the continuum. This was the initial step of the overall medication safety program for pediatric patients. After 1 year, the committee implemented performance indicators for culture, safety, compliance, work-arounds, and unintended consequences of technology and medication-related process improvement.

RESULTS A scorecard was implemented to document performance indicators for medication safety. Measures on the scorecard were number of reported adverse drug events, overrides, compliance, BCMA scanning, dispensing delays, number of doses dispensed ready to administer, clinical interventions, and self-assessment scores. Progress toward achieving each defined threshold, target, and goal is indicated using yellow, gold, or green. A goal that was not met is indicated using red. A performance indicator that is being validated and currently does not have a value is indicated using gray.

CONCLUSIONS A medication safety scorecard was established through a multidisciplinary approach to measure important safety strategies in quality and compliance and realign organizational goals. These metrics serve as an internal benchmark for our institution to evaluate the medication use process and overall success of the medication safety program. This also creates a sustainment model for improvement as well as a venue to develop more reliable approaches to monitoring/tracking medication safety.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

IMPACT OF PHARMACY INTERN INVOLVEMENT IN MEDICATION RECONCILIATION: A FOCUS ON THE HOME MEDICATION LIST

Andrew Rakers ¹, Lisa Lubsch ¹, Gerald Krausz ¹, Eric Armbrecht ¹, Christopher Sallee ¹

INTRODUCTION An accurate home medication list can enhance treatment in the hospital as well as ensure accuracy of medications upon discharge. An area of current opportunity at Cardinal Glennon Children's Medical Center (CGCMC) is ensuring that the home medication list is accurate, and this system needs to be evaluated. The specific aims of this study were 1) to identify common errors made during the current medication reconciliation process at CGCMC and 2) to evaluate the safety and effectiveness of using a pharmacy intern to obtain home medication lists at CGCMC.

METHODS This was a retrospective chart review comparing the current medication reconciliation process at CGCMC with the current medication reconciliation process plus the addition of a medication history conducted by a pharmacy intern. Patients admitted to non-intensive care units were included in the study if they were receiving at least 1 home medication. A pharmacy intern interviewed the caregivers of patients admitted the day before (intervention group) for 1 month. The interview involved discussion of the home medication list currently in the electronic medical record (EMR) at CGCMC for the patient. Each medication was reviewed for completeness and accuracy with the family. The pharmacy intern asked about further prescription, nonprescription, and complementary therapies. After the interview, the pharmacy intern discussed discrepancies of the medication lists with the pharmacist on duty and updated the home medications in the EMR. The patients' discharge medication lists were compared to discharge medication lists of patients who were not interviewed by a pharmacy intern (control group). The primary outcome was to compare the number of medications with errors at discharge between intervention and control groups. Other endpoints included total number of discharge errors and errors found during the interview process.

RESULTS Over 100 medication histories were conducted. Of these, 90 patients met inclusion/exclusion criteria. In the intervention month, there were a total of 8 of 300 discharge medications that were in error. Of these 8 medications, there was a total of 13 medication errors. There were 90 patients in the control group with 20 medications with errors of 258 discharge medications. From these 20 medications, there were 37 total medication errors. The overall discharge medication error rate was 0.04 in the intervention group compared to 0.14 in the control group. There was a total of 156 medications with errors found on the patients' home medication lists during the interviews, of 393 medications.

CONCLUSIONS There was a lower number of discharge errors that occurred with pharmacy involvement during the initial medication reconciliation process. Secondary outcomes also favored pharmacy involvement. This study showed that a pharmacy intern might help improve patient safety through obtaining complete and accurate home medication lists.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

EFFECTS OF CONTINUOUS KETAMINE INFUSION FOR SEDATION IN PEDIATRIC PATIENTS: A RETROSPECTIVE CASE REVIEW

Joseph Sciasci ¹, Laura Bio ¹

INTRODUCTION The primary objective of this study was to determine whether the use of ketamine as a continuous intravenous (IV) infusion would provide effective sedation in pediatric patients. Ketamine is an anesthetic commonly used for induction and maintenance of general anesthesia for short-term, painful procedures. This review was performed to evaluate the use ketamine for extended sedation purposes in the event of continued nationwide manufacturer shortages of current first-line agents.

METHODS A retrospective chart review of children between the ages of 1 month and 18 years of age who received continuous ketamine IV infusion while admitted between May 1, 2009, and December 31, 2011, to the pediatric intensive care unit was performed. The primary outcome of this review was the change in total sedative requirements while using continuous ketamine IV infusion. Changes in dose and duration of any concurrent sedatives during ketamine therapy were evaluated. Secondary outcomes were to evaluate changes in patients' heart rates, blood pressure, and ventilator settings at time points before, during, and after the use of ketamine. Changes in dose and/or duration of concurrent medications such as vasopressors, antihypertensives, and/or anticholinergic medications indicating an adverse effect were also evaluated.

RESULTS Eight patients were identified as receiving continuous ketamine IV infusion while being treated in the pediatric intensive care unit during our study period: a 6-week-old male, 5-month-old female, 8-month-old male, 17-month-old male, 24-month-old male, 27-month-old male, 3-year-old female, and a 10-year-old male. Reason for admission varied from asthma to respiratory infection. Due to respiratory distress, all patients were intubated and sedated with continuous midazolam infusion. Six of the 8 patients received continuous fentanyl IV infusion concurrently. Median initial ketamine infusion was 0.3 mg/kg/hr, and median maximum infusion was 1.2 mg/kg/hr (interquartile range [IQR], 0.8-1.6 mg/kg/hr). Median infusion length was 3.5 days (IQR, 1.7-4.17 days). During ketamine therapy, there was no change in concurrent sedation with midazolam infusion. Of the 6 patients who were receiving fentanyl upon ketamine initiation, 3 patients were titrated off fentanyl continuous infusion, and 1 patient had a reduction in the fentanyl infusion dose by 1 mcg/kg/hr. One patient who initially appeared normotensive prior to continuous ketamine infusion experienced hypertension during therapy that persisted after ketamine was discontinued. Continuous ketamine also resulted in a heart rate that was increased from normal to tachycardic in 1 patient during therapy. One patient required both atropine and glycopyrrolate during therapy for hypersecretion. No emergence reactions were documented among the patients reviewed.

CONCLUSIONS The use of continuous ketamine IV infusion may allow for the reduction of total sedative requirements. The incidence of adverse effects associated with continuous ketamine such as tachycardia, hypertension, and emergence reactions were not observed in this study cohort.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

STANDARD DOSE DEVELOPMENT FOR MEDICATIONS COMMONLY USED IN THE NEONATAL INTENSIVE CARE UNIT

Christine A Robinson ¹, Anita Siu ¹, Rachel Meyers ¹, Lisa Degnan ¹, Yitin Huang ¹, Suzannah Cox ¹, Christopher McPherson ¹, Dawn Butler ¹, Charla Miller ¹, Katherine Pham ¹, Amy L Potts ¹, Brian Winther ¹, Heather M Monk ¹, Ben H Lee ¹, Jared Cash ¹

INTRODUCTION A universal challenge in pediatric pharmacology is the mandatory use of weight and body surface area calculations for individualized drug dosages; this is particularly true for neonatology, where weight differences as small as 50 g can result in significantly different dosage regimens. Unfortunately, such calculations are error prone and are a significant source of medication error in this population. Furthermore, pediatric medication references and electronic-prescribing systems often require detailed calculations such as 0.1 mg per kilogram, and the wide range of pediatric weights creates an equally large number of potential final dosages. “Standard doses,” “dose banding,” or “rounding tolerance” are terms used to describe the limitation of doses to a smaller subset to simplify medication processes without altering clinically desired effects. To our knowledge, however, the use of such standardized doses has not been described in the neonatal population.

OBJECTIVES The goal of this project was to establish standardized, rounded doses of medications for neonates in the neonatal intensive care unit (NICU) through a multi-institutional peer-reviewed process.

METHODS Pediatric faculty and pediatric pharmacy residents from the Ernest Mario School of Pharmacy (Piscataway, NJ) conducted a systematic review of rounded, weight-based medication information for neonatal patients from September 2010 to April 2011. After initial review, an expanded workgroup of expert pediatric pharmacy clinicians from academic institutions throughout the United States were invited to conduct a final review. The workgroup identified 74 commonly prescribed medications in the NICU for the first phase of the review. Recommended standardized doses were established for discrete weight categories at workgroup consensus Web meetings conducted from June 2011 to December 2011. Workgroup recommendations were cross-referenced with published neonatal pharmacology resources (primary literature, national guidelines: Neofax, Thomson-Reuters; and Pediatric Dosage Handbook, Lexi-Comp).

RESULTS Standardized dosing was determined for each of the 74 reviewed medications. Three drug categories were used: oral medication (4), intermittent intravenous medication (64), and other modes of administration (e.g., intratracheal or intramuscular administration) (6). Seventeen weight categories of increasing ranges in 10-g increments were used, from 50 g for the lowest weights (e.g., 350-400 g) to 850 g for the highest weights (e.g., 3650-4500 g). Most doses were rounded to within 15% of the calculated dose: one less than 5%, none between 5% and 10%, 61 from 10% to 15%, and 12 between 15% and 20%. Final recommendations for each drug were determined through workgroup peer review. Consensus was obtained when references provided insufficient information on medication information.

CONCLUSIONS Standardized, rounded doses of medications commonly used in the NICU were feasibly established by a multi-institutional peer review process. All standardized doses varied less than 20%, with most differing less than 15%, from calculated doses.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

ADVERSE DRUG EVENTS IN CHILDREN: USING VOLUNTARY REPORTS TO MEASURE THE IMPACT OF MEDICATION SAFETY INITIATIVES IN AN AUSTRALIAN PEDIATRIC HOSPITAL

Sonya Stacey ¹, Karen Whitfield ¹, Claire Wainwright ¹

PURPOSE To review reported adverse drug events (ADEs) in children in an Australian pediatric hospital to determine the impact of successive preventative initiatives.

METHODS The study was undertaken in a 170-bed quaternary-level pediatric hospital. Clinical pharmacist interventions, voluntary medication incident reports, medication chart audits, and purchasing data from 2005 to 2011 were linked. Reports were examined to remove duplications and those unrelated to ADEs. Events were categorized by stage of medication pathway, potential or actual error or harm. Specific trends regarding chemotherapy prescribing, potassium administration, and narcotics were reviewed to determine the effectiveness of a series of preventative initiatives implemented from 2006, including introduction of a Medication Safety Committee; mandatory chemotherapy prescribing competencies; preprinted chemotherapy medication charts; an electronic oncology medical record; restriction of access to concentrated potassium ampoules; introduction of premixed IV bags; alert signs on controlled drug safes; staff education; and annotation of formulation choice on the medication chart by pharmacists.

RESULTS A total of 9500 individual reports were reviewed to identify 8500 separate ADEs from 2005 to 2011, with a range from 34 ADEs/1000 bed days in 2007 to 18 ADEs/1000 bed days in 2011. Incident types most associated with harm were intravenous fluids, antibiotics, narcotics, and extravasation injuries. Chemotherapy prescribing errors were reduced from 45 chemotherapy prescribing errors/1000 oncology separations in 2005 (31% total oncology prescribing pharmacy interventions) to 12 errors/1000 separations in 2011 (23% of oncology prescribing pharmacy interventions) in 2011. Potassium-related events were reduced from 7 errors/10,000 bed days in 2007 to 4 errors/10,000 bed days in 2011. Potassium-related events remained at approximately 2% of the total reported events. Events changed from errors with reconstitution of potassium into intravenous fluid bags to errors in monitoring of hyper-/hypokalemia and infusion rates. ADEs related to confusion among OxyContin, oxycodone, and MSContin increased from 2006 to 2008 with the introduction of OxyContin brand into the market and increase in use of oxycodone. ADEs were reduced from a peak of 6 reported events in 2008 to 1 in 2011 after a series of interventions, despite continued high use. Ongoing errors with narcotic use involved programming of intravenous pumps and patient monitoring. Medication chart audits have shown improvement in documentation such as adverse drug reaction and medication histories, attributed improved resourcing and training of pharmacy staff.

CONCLUSIONS Voluntary reporting identifies only a small proportion of ADEs; however, this study shows that a strong reporting culture can produce valuable information to determine the impact of quality improvement initiatives. Strategies that include multidisciplinary input and “forcing functions” have been the most effective, with education and clinical guidelines essential but not effective alone.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

ADVANCED PRACTICE IN PEDIATRIC PHARMACY: THE AUSTRALIAN EXPERIENCE

Sonya Stacey ¹, Karen Whitfield ¹

INTRODUCTION Pediatric pharmacy is a relatively newly recognized specialty for pharmacists, with professional organizations introduced in the 1980s in the United States, the 1990s in the United Kingdom, and 2000s in Australia. A definition of what it means to be a pediatric pharmacist and the evolution of advanced practice is ongoing.

PURPOSE To describe the development of an advanced practice competency framework for pediatric pharmacy in Australia and a proposed direction for the future.

METHODS In 2007, a grant was obtained from the Queensland government to develop an advanced level competency framework for pediatric pharmacy (Pediatric ALF). This involved input from a multidisciplinary expert reference group of pediatric pharmacists and other health professionals and was initially based on the framework developed by the Competency Development and Evaluation Group (CoDEG) in the United Kingdom. The ALF was designed as a tool for professional development and included detailed curricula for expected knowledge, skills, attitudes, and behaviors for pharmacists working with children. The ALF was piloted by pediatric pharmacists across 5 regional and metropolitan sites in Queensland. It was used as a formative assessment tool, using individual self-reflection and mentors observing practice and then providing structured feedback. Three workshops were held to introduce the concept to pharmacists from Queensland and interstate in 2008, 2009, and 2010, with the first national “Pediatric ALF Clinic” held in 2011.

RESULTS Nineteen pharmacists were involved in the initial pilot of the tool. Feedback from the participants was positive, with an average score of 6 on a 7-point Likert scale (with 7 the highest) for fairness, positive experience, and helpful and evaluation of skills. The lowest average scores (average 5) were for the experience being nontaxing versus taxing and practical versus theoretical. Feedback from the initial pilot and subsequent participants was used to further clarify descriptors and develop a writeable portable document file (PDF) format. Individual competency gaps informed professional development plans for the individual pharmacists and to target educational activities (seminars and workshops) provided by professional organizations. Curricula derived from the ALF are used by tertiary institutions offering postgraduate training in pediatric pharmacy and in electronic learning resources developed by professional organizations. The framework was adapted for other hospital pharmacy specialties, including cancer care, cardiology, and emergency medicine and in development of a generic advanced practice framework for pharmacists in direct patient care roles in varied practice settings across Australia.

CONCLUSIONS The evolution of pediatric pharmacy as a defined speciality with recognition of advanced skills is occurring in parallel across a number of countries. The Pediatric ALF has been a valuable tool to define the required competencies of pediatric pharmacist who work at an advanced practice level and will assist in future opportunities for formal accreditation.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

J-TIP UTILIZATION IN A PEDIATRIC POPULATION

Christine Steffensen ¹, Kimberly Wittmayer ¹

INTRODUCTION It is often necessary to emergently insert an intravenous (IV) line or draw blood from a patient, especially upon admission to the hospital. Poor pain management upon introduction to the health system has been shown to have detrimental effects on the child's response to future procedures1. However, there are very few options that provide immediate anesthesia of the skin. The J-tip is a device used to administer a pressurized dose of lidocaine, thus numbing the skin for a needle stick. We hypothesized that use of the J-tip would significantly improve patient satisfaction scores as measured with Press Ganey post-discharge surveys.

METHODS J-tip was approved for use in our institution. Treatment was limited to pediatric patients ranging from 3 months to 18 years of age. Because its use is very technique-dependent, staff education was completed. To ensure proper administration and acceptability, an initial patient cohort (N=30) was treated with J-tip. Each nurse completed a survey after administration of J-tip. After staff successfully completed this trial period, the J-tip was provided for all “STAT” IV attempts or blood draws. A drug use evaluation was performed to determine that J-tip use was limited to STAT procedures. Last, Press Ganey results were collected from 2010 and compared to 2011 results after J-tip was initiated.

RESULTS The trial period of 30 patients elicited an overall positive reception to J-tip. Survey responses (based on a 1-5-point Likert scale, with 5 being “strongly agree”) were collated. The median scores regarding ease of administration and pain relief were 4.6 and 4.03, respectively. When asked “Did J-tip frighten the child?” the Likert score was 2.1, correlating with the “disagree” response. Perceived vasoconstriction did not occur with any of the doses. Thereafter, 520 doses of J-tip were administered from July to December 2011. Doses were used appropriately for “STAT” procedures in 95% of the cases. Press Ganey scores were used to measure parental satisfaction. A total of 689 surveys were received, 353 surveys prior to J-tip use (January-June 2011) and 336 surveys after J-tip initiation (July-December 2011). The mean Press Ganey survey response to the question “How well was your child's pain controlled?” increased from 90.1 to 90.7. However, Press Ganey survey scores related to the “admission” process and “tests and treatments” decreased from 70% to 62.5% and 64% to 60%, respectively.

CONCLUSIONS J-tip can be used to provide immediate anesthesia of the skin in children 3 months to 18 years of age. Nurses and parents perceive the child's pain to be decreased with its use. Despite this finding, patient satisfaction scores did not improve in regard to the admission or testing processes. Other variables may be involved in these two activities that contribute to patient dissatisfaction.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

DECREASING TIME TO FIRST DOSE OF ANTIBIOTICS FOR PEDIATRIC ONCOLOGY PATIENTS WITH FEVER AND NEUTROPENIA: A QUALITY IMPROVEMENT PROJECT UTILIZING SIX SIGMA METHODOLOGY

Christine Steffensen ¹, Kimberly Arvidson ¹, Larry Roy ¹, Joanne Joslyn ¹, Chris Conrady ¹

INTRODUCTION Febrile neutropenia (FN) is the most common complication encountered by children undergoing treatment for cancer and is a major risk factor for the development of infection. Mortality untreated patients with severe neutropenia exceeds 50%. Literature fails to specifically define prompt antibiotic therapy for this indication. Based on the “Surviving Sepsis Guidelines,” an institutional objective to administer the first dose of antibiotics within 1 hour of arrival at the hospital was established.

METHODS A quality improvement project using Six Sigma methodology by a collaborative interdisciplinary team was initiated to assess current performance and correct deficiencies in the process. First, a retrospective review of electronic patient charts from 2009 to 2010 was conducted to determine median time to first dose of antibiotics. Next, a detailed algorithm of the entire process was formulated. Data from the chart review was used to determine the time consumed at each step of the algorithm. Last, a critical pathway was designed to ensure the first dose of antibiotics would be administered with 1 hour of arrival at the hospital for patients with FN. The impact of implementing this pathway was measured.

RESULTS The median time to first dose of antibiotics in 2009 was 154 minutes, and 12% reached patients in less than 1 hour (N=25). In 2010, median time was 136 minute and 23.8% of doses were administered in less than 1 hour (N=21). The steps that consumed inordinate amounts of time included resident assessment of the patient and antibiotic ordering (50 min), pharmacist order verification (31 min), medication delivery (18 min), and receipt of drug by the nurse (32 min). These steps were further broken down to determine the precise barriers to expeditious care. These barriers included patient admission into the computer system, obtaining weight/allergy information, notifying the resident of the patient's needs, antibiotic choice, pharmacist order verification, delivery of dose to the patient care area, and delivery of the dose to the nurse. The interdisciplinary team reviewed these barriers and attempted to remedy each one. A critical pathway for the management of FN was defined and implemented. In 2011, after the implementation of the pathway, the time to first dose of antibiotics was decreased to 45 minutes, with 100% of the patients receiving the dose in less than 60 minutes (N=30).

CONCLUSIONS Institutions should consider measuring time to first dose of antibiotics for their FN patients. If the time is not less than 1 hour, several processes can be changed or improved to decrease this response time.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

A DESCRIPTIVE PILOT FOR CLINICAL PHARMACY SERVICES IN A PEDIATRIC CLINIC FOR CHILDREN WITH MEDICAL COMPLEXITY

James Tjon ¹, Lori Chen ¹, Marina Strzelecki ¹, Jennifer Poh ¹, Michael Pe ¹

INTRODUCTION According to the literature, children with special health care needs (CSHCN) have been defined as “those who have or at increased risk for a chronic, physical, developmental, behavioral or emotional condition and who also require health and related services of a type or amount beyond that required by children generally.” A subset of CSHCN have been identified in the literature as children with medical complexity (CMC). CMC require a level of care that may include 1) need for intensive hospital- and community-based service, 2) dependence on multiple medications, technology, and home care to maintain a basic quality of life, 3) risk of frequent and prolonged hospitalizations, and 4) a need for care coordination. Because most CMC are on numerous chronic medications, there is high risk for potential and actual drug therapy problems (DTPs) that can be challenging to manage for practitioners. Pharmacists possess the knowledge base, skills, and training required to identify DTPs and are well suited to help optimize drug therapy and minimize the occurrence of medication discrepancies for this unique patient population. Clinical pharmacists are funded to support and provide pharmaceutical services to the Pediatric Medicine inpatient Complex Care team at SickKids Hospital. Funding is not allocated to support this service in the outpatient Complex Care clinics servicing the identical population. The continued shift of health care delivery to the ambulatory setting coupled with the increased emphasis on medication safety and errors has underscored the need to extend provision of clinical pharmacy services to this population in the ambulatory setting.

METHODS The Department of Pharmacy at SickKids made the decision to temporarily allow a pharmacist to staff the Complex Care clinic for a period of 11 weeks. This arrangement allowed for the collection of baseline data in the form of a pilot study. The objectives of the pilot study were to identify and characterize the drug-related needs of ambulatory Complex Care patients and to describe and develop the role of the pharmacist in the Complex Care clinic.

RESULTS Overall, 46 CMC patients were seen in clinic, with an average of 7 medical conditions and 9 medications per patient. Pharmacists identified 43 DTPs (35 actual and 7 potential), performed medication teaching for 4 families of patients, competed 22 medication reconciliations, developed 7 medication administration calendars, answered 38 drug information questions, and assisted with 12 drug access queries.

CONCLUSIONS The pilot study demonstrates that CMC are at higher risk for medication errors and that the presence of a clinic pharmacist helps in the identification, prevention, and resolution of DTPs while ensuring continuity of care. Partly as a result, the Complex Care program at SickKids has currently received tentative approval to support a part-time clinic pharmacist position.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

INCREASED Tdap IMMUNIZATION RATES IN POSTPARTUM WOMEN AFTER IMPLEMENTATION OF A FOCUSED VACCINE ADMINISTRATION PROGRAM

Christina Victor ¹, Lisa Owens ¹

INTRODUCTION Both the Centers for Disease Control and Prevention (CDC) and the Advisory Committee on Immunization Practices (ACIP) recommend administration of tetanus toxoid, reduced diphtheria, and acellular pertussis (Tdap) vaccine to postpartum women at or before discharge. In addition to this recommendation, ACIP recommends vaccinating all caregivers of infants less than 1 year of age with Tdap to prevent pertussis. The infant population at highest risk for development of severe complications from pertussis are infants less than 2 months of age who are not yet immunized. Due to the resurgence of pertussis in both Oklahoma and the nation, we implemented a program to increase Tdap vaccination rates in our postpartum population.

METHODS Our hospital implemented a program to automatically vaccinate all postpartum women prior to discharge. The program included staff and patient education stressing the value of immunization and implementation of a vaccine declination form that patients were required to sign if vaccine administration was refused. All staff were involved in the education process including obstetricians, nurses, and pharmacists. Pharmacists actively monitored all eligible patients for either administration of vaccine or signed declination by the patient. Data were collected from all patients who received Tdap vaccine during calendar year 2011. Results excluded those patients younger than 12 or older than 45 years of age, male patients who received Tdap, and all patients who received Tdap in the ER to identify the postpartum population of women.

RESULTS After implementation of the education program and aggressive education of hospital staff, Tdap vaccination rates increased from a baseline of 55% to greater than 90% of eligible patients in every month following the implementation of the new program.

CONCLUSIONS Eleven months into the program, vaccination rates continued to be greater than 90% in this population. Instituting a program that requires automatic vaccination of eligible postpartum women coupled with focused staff and patient education can significantly reduce the risk of pertussis in all infants.

J Pediatr Pharmacol Ther. 2012 Jan-Mar;17(1):104–138.

EVALUATION OF NORMAL SALINE FLUSH TO MAINTAIN CENTRAL VENOUS ACCESS PATENCY IN A PEDIATRIC INTENSIVE CARE UNIT

Maria Whitmore ¹, Soni Bahri ¹, Mindy Closser ¹, Anthony Coddington ¹, Rachael Smock ¹, Kay Sichting ¹, Julie Hawkins ¹

INTRODUCTION Use of heparin holding solution for maintaining central vascular access device (CVAD) patency remains standard practice in the pediatric population, despite little evidence supporting this practice. However, heparin use in routine CVAD flushing protocols has been eliminated for adult and many neonatal patients due to the concern of heparin-induced thrombocytopenia (HIT) and incorrect heparin concentrations that have led to permanent disabilities and death. The primary objective of this study was to determine the effectiveness of normal saline at maintaining CVAD patency in our pediatric intensive care unit (PICU). Patency was defined as the ability to either flush or aspirate blood from CVADs. Secondary objectives were to compare the amount of alteplase (Cathflo) needed and the number of CVADs requiring replacement between devices flushed with heparin versus normal saline.

METHODS Infants and children admitted to PICU who required placement of a nontunneled CVAD were included in this retrospective 3-phase analysis. The pre-implementation phase occurred between October 2009 and September 2010, in which CVADs were flushed with heparin (10 units/mL) intravenously every 8 hours by using various flushing techniques. Nurses were educated in September 2010 on a standardized push-pause flushing technique, and the method was implemented in October 2010. The post-implementation phase occurred between October 2010 and September 2011 in which CVADs were flushed with normal saline, 2 mL (for children <10 kg) and 5 mL (for children >10 kg), intravenously, using the push-pause technique every 6 hours. Demographics and catheter characteristic data were collected. Additionally, for nonpatent CVADs, data for the number of alteplase (Cathflo) doses required to restore patency and whether the CVAD required replacement were collected. Data were analyzed using descriptive statistics.

RESULTS A total of 391 CVADs were analyzed in 188 children. The pre-group was older (median 11.2 vs 7.3 months; p=0.007) and heavier (8.4 vs 6.2 kg; p=0.001) compared to the post- group. There was not a statistically significant difference in patency between the pre- (127/176, 72.2%) and post- groups (138/215, 64.2%; p=0.103). Patency was not affected by patient age (p=0.589), patient weight (p=0.943), catheter size (p=0.323), or line length (p=0.926). Only 1 of 176 patients in the pre- group and 4 of 215 patients in the post- group required their CVAD to be replaced due to occlusion (p=0.348).

CONCLUSIONS Results of this retrospective analysis suggest that routine standardized saline flushing of nontunneled CVADs in the PICU is effective at maintaining CVAD patency. Elimination of routine heparin flushing may reduce the risk of iatrogenic anticoagulation and the development of HIT and improve the safety by reducing medication errors in the pediatric intensive care population.

PERMALINK

Abstracts 21st Annual Meeting Pediatric Pharmacy Advocacy Group

ACETAZOLAMIDE DOSING IN CRITICALLY ILL NEONATES AND CHILDREN WITH METABOLIC ALKALOSIS

Megan Andrews

Peter Johnson

Erin Lammers

Donald Harrison

Jamie Miller

INVASIVE CANDIDIASIS IN A NEONATAL INTENSIVE CARE UNIT: FLUCONAZOLE PROPHYLAXIS IMPLEMENTATION

Neli Attas

Diane McClure

Linda Skroce

Adel Zauk

SUCCESSFUL USE OF PRESCRIBING RESTRICTIONS AND EXTENDED STABILITY DATA TO MINIMIZE COST IMPACT OF INTRAVENOUS ACETAMINOPHEN AT A PEDIATRIC TERTIARY MEDICAL CENTER

Allyson Berg

Jennifer Hamner

Paul Limberis

Jeffrey Galinkin

IMPACT OF A CHANGE IN SEDATION BOLUS ADMINSTRATION IN A PEDIATRIC INTENSIVE CARE UNIT AT A LARGE CHILDREN'S HOSPTIAL: UTILIZATION OF A “SMART PUMP” BOLUS FEATURE

Shahnaz Zakeri

Sara Bork

Erin McDade

Hilel Frankenthal

TRAINING PHARMACISTS FOR PARTICIPATION IN PEDIATRIC RESUSCITATION

Marcia Buck

Amanda Williams

PEDIATRIC PARENTERAL NUTRITION COMPOUNDING SOFTWARE SAFETY LIMITS

Jared Cash

Jared Olson

Amber Tuckett

Mark MacKay

A NOVEL VANCOMYCIN DOSAGE RECOMMENDATION FOR PRETERM NEONATES

Hsiang-Ying Chang

Ling-Yu Liu

Fe-Lin Lin Wu

Shu-Wen Lin

PIPERACILLIN/TAZOBACTAM PHARMACOKINETICS IN CRITICALLY ILL CHILDREN RECEIVING EXTRACORPOREAL MEMBRANE OXYGENATION

Jeffrey Cies

Arun Chopra

PIPERACILLIN/TAZOBACTAM PHARMACOKINETICS IN CRITICALLY ILL CHILDREN

Jeffrey Cies

COMMUNITY PHARMACIST BEHAVIORS REGARDING PEDIATRIC PRESCRIPTIONS

Michelle Condren

Shane Desselle

VITAMIN D SUPPLEMENTATION FOR PRETERM NEONATES

Danielle Coppola

Gina Signorelli

Melissa Lestini

IMPLEMENTATION AND EVALUATION OF A CHEMOTHERAPY PRIMING PROCESS

Amy Davies

Christopher Yuan

Linh Nguyen

Brooke Bernhardt

Joy Hesselgrave

INCIDENCE OF VANCOMYCIN SERUM CONCENTRATIONS IN PEDIATRIC PATIENTS WITHIN THE ASHP/IDSA/SIDP RECOMMENDED GOAL

Stephanie East

Laura Bio

DEXMEDETOMIDINE (PRECEDEX) USE FOR PROLONGED SEDATION IN A PEDIATRIC BILATERAL NEPHRECTOMY PATIENT

Amanda Geist

Manuel Caceres

RIFAXIMIN USE IN PEDIATRIC HEPATIC ENCEPHALOPATHY

Nathan Gorney

Linda Book

Emily Gish

DEVELOPMENT AND IMPLEMENTATION OF AN ELECTRONIC SYSTEM FOR MANAGING CHEMOTHERAPY ORDERING AND ADMINISTRATION

Kevin Graner

Darryl Grendahl

Ronald Sieve

Kent Johnson

Amanda Kuper

Matthew Baudoin

IMPACT OF PHARMACISTS' INTERVENTIONS ON ADMISSION MEDICATION ORDERS IN A CHILDREN'S HOSPITAL

Sarah Hale

Kelly Guza

Leslie Taleroski

TOXICITY PROFILE OF RITUXIMAB AMONG PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED MATURE B-CELL NON-HODGKIN'S LYMPHOMA: A RETROSPECTIVE STUDY AT THE CHILDREN'S CANCER HOSPITAL EGYPT

Omneya Hassanain

Mohamed Kamal

Sherif Kamal

Hany Abd El-Rahman

Abstracts 21^st Annual Meeting Pediatric Pharmacy Advocacy Group