25th Annual Meeting Abstracts

doi:10.5863/1551-6776-21.3.263

. 2016 May-Jun;21(3):263–303. doi: 10.5863/1551-6776-21.3.263

25th Annual Meeting Abstracts

PMCID: PMC4956337

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

A COLLABORATIVE PRACTICE AGREEMENT FOR PHARMACIST TRIAGE OF MEDICATION RELATED CALLS FOLLOWING PATIENT DISCHARGE FROM A PEDIATRIC EMERGENCY DEPARTMENT

Ean Miller ¹, Alice Yeh ¹, Mike Bentley ¹, Ruthie Limo ¹, Kimberly Aaron ¹, Corwin Warmink ¹

Background: Emergency medicine pharmacists (EMPs) are uniquely positioned to affect pharmacotherapy choices for a wide variety of patients, ranging from the critically ill to those requiring only minor outpatient care. The beneficial impact of EMP prospective review of prescriptions written from the emergency department (ED) is well documented. This paper describes the impact of EMP triage of medication related phone calls from caregivers and community pharmacies after patient discharge from a pediatric ED.

Methods: In December 2014, a collaborative practice agreement (CPA) was implemented that authorized EMPs to triage all medication related calls received by the ED. The protocol was approved by the ED medical director and the medical center P&T committee. Under the CPA, EMPs may authorize specific changes to discharge prescriptions: limited rounding of doses; changes in dosage form; substitution of drug concentration or strength; and therapeutic substitutions due to cost or third-party payer formulary requirements. EMPs could also act as prescriber designated agents to communicate prescription information and clarifications to retail pharmacies. Any interventions not authorized by the protocol were discussed with an ED provider. EMP triaged calls were documented as interventions in the medical record, including reason for the call and actions taken. Interventions from December 2014 to January 2016 were tabulated for descriptive statistics of the quantity and nature of these calls, the number of calls handled independently by an EMP per protocol, and the number of secondary interventions made.

Results: A total of 1,515 unique calls were documented during the 14-month period: 1,052 from outpatient pharmacies; 446 from patients/caregivers; and 17 from other sources. The most common reasons for these calls were expected prescriptions not received by an outpatient pharmacy (n=323); insurance formulary or cost related issues (n=290); verification of prescription information (n=243); general questions (n=99); medication unavailability (n=64); requests to use an alternate pharmacy (n=63); requests to change dosage forms (n=33); and unclear or incorrect quantity/day supply (n=125), drug concentration/strength (n=58), or directions (n=54). The majority of the calls (n=1,154; 76%) were handled independently by EMPs through provision of information and order clarification (n=766) or protocol-based changes (n=391). Additionally, 49 secondary interventions were identified and addressed by EMP review of the original prescription.

Conclusions: A collaborative practice agreement was successfully implemented in a pediatric ED that allowed EMPs to continue positively impacting patient care even after discharge. This protocol has improved patient and community access to a qualified, knowledgeable care provider while reducing call burden on ED providers. Prior to this process change, all calls were triaged by unit secretaries and routed directly to the providers. The ED team is currently working with hospital information technology personnel to improve e-prescription transmission to address the most common cause for medication related calls.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

CURRICULAR PREFERENCES AND SUBSEQUENT EMPLOYMENT CHOICES OF PEDIATRIC DEGREE OPTION GRADUATES

Brooke Gildon ¹, Peter Johnson ¹, Michelle Condren ¹, Jamie Miller ¹, Tracy Hagemann ¹, Teresa Lewis ¹, Bob John ¹, Kevin Farmer ¹

A curricular degree option was created to improve competence in pediatric pharmacotherapy. The University of Oklahoma created the pediatric degree option program in 2010 with the first graduate in 2011. This abstract describes outcomes of pediatric curricular graduates over the first five years (2011–2016).

Objectives: The primary objective was to compare the number of advanced pharmacy practice experience (APPE) rotations five years pre- and post-degree option implementation. Secondary objectives were to determine the number and types of didactic electives and compare the number of faculty-based versus non-faculty APPEs. Additionally, the initial position after graduation was described.

Description/Methods: The goal of the program was to provide students with additional skills and experiences in pediatrics to translate into the hospital, community, and other pharmacy settings. The required pediatric coursework for completion of the degree option was accomplished by: 6 hrs of didactic coursework and 3 APPE rotations or 8 hrs of coursework and 2 rotations. Four didactic courses and 8 APPEs were available between two campuses.

Outcomes/Results: To date, the degree option has graduated 22 students and currently has 18 individuals completing coursework. There was a significant increase in the number of APPEs from pre- to post-degree option, 133 versus 259 (p<0.01). Graduates completed an average of 8.27 credit hrs/student in didactic coursework and 2.72 APPE rotations/student. Six (10%) rotations were precepted by non-faculty preceptors (Figure 3). Multiple positions were taken after graduation including eight (36%) as community pharmacists and seven (32%) completing a PGY1 residency.

Conclusions: The pediatric degree option has allowed for increased exposure of pediatric pharmacy content and experiential training to PharmD students. Providing formalized opportunities for training such as this curricular degree option will give students opportunities to enhance their skills in delivery of pediatric-focused pharmacotherapy to children and their caregivers.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

EFFICACY AND SAFETY OF INTRAVENOUS MAGNESIUM USE FOR STATUS ASTHMATICUS IN THE PEDIATRIC INTENSIVE CARE UNIT

Grace Lee ¹, Adam Schwarz ¹, Nick Anas ¹

Introduction: Intermittent, intravenous magnesium has been explored as an adjunctive treatment for status asthmaticus due to its pharmacologic effect as a smooth muscle relaxant and cofactor in energy production for respiratory muscles. Administration of intravenous magnesium in the emergency department, in addition to albuterol and steroids, has been shown to improve pulmonary function tests, decrease hospital admissions and reduce intubation rates, but its role in the management of patients admitted to the pediatric intensive care unit (PICU) for status asthmaticus is less well quantified, despite its widespread use in PICUs across the country.

Methods/Design: This observational study sought to gather efficacy and safety data on intravenous magnesium for the management of status asthmaticus in the PICU setting. All non-intubated patients aged 2–18 yrs old who failed first line therapy (short acting beta 2 agonist and steroids) but had not received any other second line agents upon PICU admission were eligible for inclusion. The decision to start magnesium was based on physician preference. Baseline severity and clinical improvement were measured using a six point pediatric asthma severity score (PASS). Eligible patients who did not receive intravenous magnesium in the PICU served as the control group. A linear regression model was used to evaluate the primary outcomes of interest including time to reach PASS<1 (equivalent to mild asthma symptoms) and PICU length of stay, while the need for therapy escalation (defined as the addition of other second line agents or intubation) was determined by a logistic regression model. Secondary objectives in patients who received magnesium included acute change in PASS score before and after the first dose of magnesium, and incidence of adverse effects.

Results: During an 11 month period, 54 patients were admitted to the PICU with status asthmaticus, 37% of which received at least 1 dose of magnesium in the PICU (average dose 58 mg/kg/dose over 20 min). Comparing subjects without or with magnesium use, there were no differences in time to PASS <1 (−12.5 hrs, 95% confidence interval (CI) −37.9–12.8 hrs, p=0.32), PICU length of stay (−20.4 hrs, 95% CI −43.1- 2.4 hrs, p=0.079), or the proportion of subjects requiring therapy escalation (OR= 2.5, 95% CI 0.38–16.8, p=0.34). Patients who received magnesium experienced an average acute drop in their PASS score by −0.4, with only 1 patient report of facial flushing.

Conclusion: Intermittent intravenous magnesium is well tolerated and acutely improves asthma scores but did not result in shorter time to asthma symptom resolution, PICU length of stay, or need for therapy escalation. More studies to determine which magnesium parameters should be optimized, such as dose, infusion duration, time between doses, and number of doses, are clearly needed.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

EVALUATION OF COMMON MEDICATIONS AND RISK OF NECROTIZING ENTEROCOLITIS IN VERY LOW BIRTH WEIGHT INFANTS

Katelyn Bull ¹, Nicole Corbin ¹, Christina Cox ¹, Jun Wu ¹

Purpose: Despite advances in identifying patients at an increased risk of necrotizing enterocolitis (NEC), the evaluation of the impact of medication use is still limited. The objectives of this study are to investigate the association between commonly used neonatal intensive care unit (NICU) medications and NEC in very low birth weight infants and to evaluate the accuracy of GutCheckNEC.

Methods: This institutional review board approved, single-center, retrospective study evaluated 924 neonates, weighing less than 1500 g, admitted to the NICU between January 1, 2010 and January 1, 2015. Patients transferred from another institution 72 hours after birth were excluded. Included patients were evaluated for their baseline NEC risk using GutCheckNEC. In addition to vasopressors, the use of caffeine, hydrocortisone, dexamethasone, prednisone/prednisolone, H2 blockers, proton pump inhibitors, iron, ibuprofen lysine, maternal cocaine, indomethacin, and antibiotics were evaluated. For NEC cases, medication use prior to diagnosis was evaluated. Chi-square tests assessed the association between NEC and medication use or GutCheckNEC. Time to NEC and adjusted risk for NEC associated with medication use were described using Kaplan-Meir curves and Cox regression analysis, respectively. Logistic regression assessed the association between early (≤ 21 days of life (DOL)) and late (>21 DOL) NEC and medication use.

Results: Data were analyzed for 899 patients. The average gestational age was 28.6 wks (range: 22–38.6 wks). The mean birthweight was 1018.5 g (range:330 to 1500 g). Diagnosis of NEC occurred in 46 patients (5.1%), with 55% as medical and 45% as surgical NEC. Early NEC occurred in 61% and late NEC in 39% of NEC cases. Non-iron use was the only medication associated with NEC (p<0.001), and remained significant after adjustment for sex, gestational age, race and birth-weight [HR=0.042, CI (0.020, 0.087)]. The overall time to NEC was significantly different between non-iron and iron users (p < 0.001), with a median time to NEC for non-iron users of 32 days. The association between GutCheckNEC risk category and development of NEC was not significant (p=0.128). In the low risk GutCheckNEC category, NEC patients received fewer medications than non-NEC patients (p=0.037). Further investigation revealed use of dopamine (p=0.032), caffeine (p=0.016), dexamethasone (p=0.041), indomethacin (p=0.004), and antibiotics (p=0.008 to <0.001) were associated with development of late NEC, but were not significant with adjusted analysis.

Conclusion: Incidence of NEC did not differ with the use of most medications. Exploration of the relationship between medication use and development of late NEC is warranted. The GutCheckNEC risk tool did not predict development of NEC.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

PREVALENCE OF ADVERSE EFFECTS AMONG CHILDREN RECEIVING PEGASPARAGINASE OR ERWINIA ASPARAGINASE BASED ON INTRAVENOUS VERSUS INTRAMUSCULAR ROUTES OF ADMINISTRATION

Megan Corsi ¹, Zachery Halford ¹, Cynthia Bender ¹, Whitney Leonard ¹

Purpose: Asparaginase is a vital component for treating patients with Acute Lymphoblastic Leukemia (ALL) and can be given either intravenously (IV) or intramuscularly (IM). A possible disparity in rates of hypersensitivity reaction and adverse events with asparaginase may depend on the route of administration. This study aims to identify if route adversely alters the rate of hypersensitivity reactions.

Methods: This single-center, retrospective analysis will evaluate patients receiving PEG-asparaginase or Erwinia asparaginase from January 1, 2008 through September 30, 2015. The primary outcome will measure the incidence of hypersensitivity reactions with either IV/IM PEG-asparaginase or IV/IM Erwinia asparaginase. Secondary outcomes will evaluate if administration route plays a role in the timing of these reactions and in the rates of other adverse drug events.

Results: A total of 386 patients were treated with PEG-asparaginase of which 199 patients received IV administration and 138 patients were given PEG-asparaginase intramuscularly. Thirty-one patients received both routes. Hypersensitivity reactions occurred in 18.6% of patients receiving IV and 13.8% receiving IM (p=0.242). For those patients receiving both routes, 9.7% experienced a reaction. Thirty-nine patients experienced hypersensitivity during consolidation, while interim maintenance and delayed intensification resulted in 4 reactions each. Alternately, of the 517 Erwinia doses administered, only one patient experienced a reaction. Increased antiemetic use was noted in 28 of 77 IV Erwinia doses (36.4%) compared to only 28 of 440 IM doses (6.4%).

Conclusion: Hypersensitivity reactions were more prevalent in those treated with IV PEG-asparaginase, though not statistically significant. Erwinia was associated with a low hypersensitivity rate. Giving Erwinia IV appears to be more emetogenic and should be a concern when choosing routes. Although administering IV PEG-asparaginase may be more convenient for patients, rates of hypersensitivity reactions may be higher. A prospective clinical trial would further clarify this issue.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

HSV PCR TESTING AND ACYCLOVIR USE IN CHILDREN: A FIVE YEAR REVIEW

Allison Stefanski ¹, Olivia Zalewski ¹, Christina R Hermos ¹, Kelly L Matson ¹

Purpose: Herpes Simplex Virus (HSV) is a viral infection that can lead to significant morbidity and mortality if acyclovir treatment for invasive disease is delayed. The gold standard for diagnosing invasive HSV is a blood or cerebral spinal fluid (CSF) Polymerase Chain Reaction (PCR), and currently UMass Memorial Medical Center (UMMC) sends this test to a referral laboratory. The objective of this study is 1) to measure the empiric use of acyclovir for suspected invasive HSV infection in the pediatric population at UMMC over 5 years; 2) to determine if having on-site HSV PCR testing, with a predicted turn-around time (TAT) of 36 hours, would significantly decrease acyclovir exposure and length of stay and 3) to document renal toxicity from acyclovir use.

Methods: We performed a retrospective chart review of patients ≤21 yrs of age admitted to the pediatric ward over 5 yrs with suspected invasive HSV infection (specimen submitted for HSV PCR) and acyclovir doses administered. The following data was collected: patient demographics, indication for acyclovir, TAT for HSV PCR, HSV PCR results, total length of stay, number of acyclovir doses received, and adverse drug effects. Empiric treatment was defined as patient acyclovir use with referral HSV PCR obtained and discontinuation of acyclovir following a negative PCR result within 24 hrs. Potential excess doses of acyclovir were calculated among the subset of patients receiving empiric treatment based on a 36-hr TAT for HSV PCR verses actual TAT. Excess length of stay was calculated among the subset of patients receiving empiric treatment and whose discharge occurred within 24 hrs of a negative HSV PCR results. Renal toxicity was determined by estimating creatinine clearance using the Bedside Schwartz calculation and the Pediatric RIFLE criteria for predicting acute kidney injury. Study protocol was submitted and approved by the Institutional Review Board.

Results: A total of 209 patients were reviewed and 107 patients met eligibility criteria. Subjects included 61 males (57%) and 46 females (43%), ages ranging from 1 day old to 21 yrs of age. Preliminary results show a mean TAT of 81.1 hrs, ranging from 20 to 548 hrs. Among the subset receiving empiric treatment, 448 doses of acyclovir would have been saved if all TAT had been 36 hrs. A total of 12 patients (11%) met pediatric RIFLE criteria during acyclovir use.

Conclusion: Our preliminary conclusions are that a modest number of excess acyclovir doses were given due to prolonged TAT of HSV PCRs sent to a referral laboratory. A larger cost saving of in-house HSV PCR testing may lie in earlier discharges after invasive HSV has been ruled out. Acyclovir is overall safe, leading to a small number of cases of negative renal effects.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

THE DEVELOPMENT OF AN EVIDENCE BASED, STANDARDIZED FORMULARY FOR THE PEDIATRIC EXTEMPORANEOUS ORAL LIQUID COMPOUNDS OF THE GATEWAY PEDIATRIC PHARMACY GROUP

Kyle Dillon ¹, Lisa Lubsch ¹, Kelly Burch ¹

Objectives: Standardization of the pediatric extemporaneous oral liquid formulations may help to decrease errors, improve patient care, and ease the transition from one institution to another. The five Gateway Pediatric Pharmacy Group (GPPG) hospitals currently do not have a formulary of oral liquids to reference for the pediatric population. Recently, the University of Michigan School of Pharmacy created a standardized list of pediatric oral formulations to ensure safety and consistency in the preparation of these medications. The objective of this study is to create a similar standard for pediatric hospitals in the St. Louis area.

Methods: This is a multicenter review of the pediatric oral liquid compounded formulations at Cardinal Glennon Children's Hospital, Children's Hospital of Illinois, Ranken Jordan Pediatric Bridge Hospital, St. Louis Children's Hospital, and Mercy Children's Hospital St. Louis. The most current oral extemporaneous formulations were collected from each institution and compared to the Michigan Pediatric Safety (MPSC) collaboration's formulary. After comparison, the most appropriate concentration, stability, storage, and diluent for each formulation were investigated, utilizing primary literature and published compounding guidelines. Formulations were divided into four separate groups based on therapeutic category for distribution to a team of 9 individuals, representing the five GPPG institutions. Members of the group included pharmacists from each institution with varying practices, including clinical staff, clinical specialists (NICU, Cardiology), and outpatient pharmacists. Formulations were distributed to the group and discussed via a series of four video conference calls. Group discussion was facilitated by the use of a common Microsoft Excel document, that allowed responses to be recorded for each formulation.

Results: Upon analysis, 36 of the 110 (33%) oral extemporaneous formulations currently used by the five GPPG hospitals matched completely in both concentration and stability. Of the remaining 74 formulations, 43 (39%) differed in either concentration, stability or both. The remaining 31 (28%) formulations were utilized only within the GPPG. After presentation to the group, 7 formulations were removed due to available commercial product. In total, 103 formulations were agreed upon by the group.

Conclusion: A standardized formulary of evidence based, oral extemporaneous formulations have been agreed upon by members of the GPPG for use at the five pediatric institutions. Currently, development of a website is ongoing to allow dissemination of the formulary to prescribers, community pharmacies, and insurers in the areas served.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

USE OF CHLORPROMAZINE TO ATTENUATE OPIOID TOLERANCE IN A PEDIATRIC PATIENT ON EXTRACORPOREAL MEMBRANOUS OXYGENATION (ECMO)

Kelvin Xu ¹, Serene Lim ¹

Case: A 16-mo-old Chinese boy was admitted to the pediatric intensive care unit (PICU) for hypoxic respiratory failure that was deduced to be secondary to graft versus host disease and underlying infection. He had a history of severe combined immunodeficiency and had undergone a bone marrow transplant 74 days ago. Extracorporeal membranous oxygenation (ECMO) was required for a viable outcome and he required sedo-analgesic infusions of fentanyl, midazolam and clonidine to facilitate this. The children's pain service received a referral to optimize his sedation, with the view to discontinuing his muscle relaxant. At that point of time, he had been rotated from a morphine infusion to a fentanyl infusion and also was also on concomitant infusions of midazolam and clonidine. However, despite optimising infusions of ketamine, midazolam, clonidine and fentanyl with additional fentanyl boluses, the patient continued to be agitated. Chlorpromazine was initiated intravenously (IV) on Day 24 of ECMO at 0.5 mg/kg/dose every 8 hrs and ECMO was discontinued the next day. The requirements for other sedatives and opioids were gradually reduced and tapered off. Chlorpromazine was converted to oral after 10 days of IV treatment and gradually tapered off over the course of one month after his transfer to a pediatric oncology ward. Chlorpromazine was initially developed for use as an antipsychotic and was found to be able to potentiate the effects of general anesthetics, sedatives and analgesics. It was also found to be useful in the treatment of neonatal abstinence syndrome as well as reducing postoperative opioid requirements in patients with a history of addiction. Critically ill children often require escalation of sedation due to drug tolerance as well as the need for adequate comfort while on ventilation and ECMO. Our case report illustrates that Chlorpromazine is a useful sedative that optimizes sedation and its weaning.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

PROLONGED EMPIRICAL ANTIBIOTIC THERAPY FOR PRESUMED EARLY-ONSET SEPSIS AND ADVERSE OUTCOMES OF LATE-ONSET SEPSIS, NECROTIZING ENTEROCOLITIS AND DEATH IN AN ASIAN VERY LOW BIRTH WEIGHT INFANT COHORT

Qi Chen ¹, Mee Ling Gan ¹, Yee Yin Tan ¹, Chinthala Jubal Pallavi ¹, Victor Samuel Rajadurai ¹, Sriram Bhavani ¹, Joseph Manuel Gomez ¹, Pei Shi Ong ¹

Objective: To evaluate the association between prolonged empirical antibiotic therapy for presumed early-onset sepsis (EOS) and the 3 composite outcomes of late-onset sepsis (LOS), necrotising enterocolitis (NEC) or death, LOS or death, and NEC or death in very low birth weight (VLBW) Asian infants.

Methods: This is a retrospective cohort study of 723 VLBW infants who received either short (<5 days) or prolonged (≥5 days) empirical antibiotic therapy for presumed EOS with sterile blood culture between January 2008 and December 2012 at the KK Women's and Children's Hospital, Singapore. Maternal and neonatal baseline characteristics, type and duration of empirical antibiotic therapy, and concomitant medications were documented. Univariate analyses and multivariate logistic regressions were conducted to identify association between prolonged empirical antibiotic and the 3 composite outcomes. Time to composite outcomes in the 2 groups were evaluated using Cox regression.

Results: Four hundred and eighty-two (66.7%) infants received prolonged empirical antibiotic therapy. These infants were more likely to have clinical presentation and risk factors of EOS than those who received short empirical antibiotic. The association of prolonged empirical antibiotic therapy with the 3 composite outcomes found in univariate analyses [unadjusted odds ratios (ORs) >3; p<0.001] became non-significant in multivariate analyses [adjusted OR= 1.28, 95% CI=0.65–2.54 for outcome of LOS, NEC or death; adjusted OR=0.93, 95% CI=0.42–2.07 for outcome of LOS or death; adjusted OR=1.98, 95% CI=0.77–5.10 for outcome of NEC or death; all p>0.05]. Times to the 3 composite outcomes were also not different between the groups (95% CI of all Hazard ratios included.

Conclusion: Prolonged empirical antibiotic therapy for presumed EOS was not found to be independently associated with incidence or shorter time to occurrence of the 3 composite outcomes in our Asian infant cohort.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

SPECIALISATION IN PEDIATRIC PHARMACY – RESULTS OF A SURVEY OF PHARMACISTS WORKING IN THE NEONATAL/PEDIATRIC SETTINGS IN SINGAPORE

Kelvin Xu ¹, Sok Hoon Lim ¹, Shyamala Narayanaswamy ¹, Irene Quay ¹

Introduction: In our journey to credential specialist pharmacists in Singapore, the Pharmacy Specialists Accreditation Board appointed a pro-tem committee for Pharmacy Specialisation in Paediatrics. As part of our report to the Board, pharmacists working in neonatal and pediatric settings were surveyed to study the expectations of the local pharmacy community regarding roles and responsibilities of a pediatric pharmacy specialist, as well as factors influencing the decision to pursue specialisation.

Methodology: A 10-question tool was developed. Data was collected on years of clinical practice, factors perceived as important in the recognition of a specialist, types of activities a specialist should be involved in, disease and drug treatments of especial concern, and aspects of care a specialist pharmacist should manage. Opinions on challenges and reasons for not pursuing specialisation were also sought.

Results: There were 36 respondents. Majority of respondents ranked clinical practice, formulation of protocols/guidelines, and education/training of pharmacists as the top 3 activities a specialist pharmacist should be involved in. A specialist was deemed to be most importantly determined by their years of experience. “Recognition” and “Additional job satisfaction” were highly ranked as top reasons for seeking specialist credentials. “Time spent on postgraduate studies, residency and/or board certification” was ranked as the largest challenge. Barriers to attaining credentials as a specialist in Singapore were “no substantial pay increment”, “difficulty balancing work, study and family”, and the bond period after completing required postgraduate studies (for candidates sponsored by their employers).

Discussion: Experience was ranked as most important in credentialing pediatric pharmacy specialists. Importance in aspects of care and mastery of specific pharmacotherapeutic categories differed between respondents. Professional recognition and job satisfaction are pull factors for specialisation, but the perception that is time-consuming with lack of immediate financial gain is a drawback.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

IMPROVING DISPENSING PRACTICES OF MEDICATIONS IN THE NEONATAL INTENSIVE CARE UNIT (NICU) THROUGH UNIT-DOSING AND EXTENDED STABILITY TESTING

Priya Patel ¹, Leshahn Mials ¹

Introduction/Objective: Dispensing and administration of medications in the neonatal population is a high-risk activity with a narrow margin of error between therapeutic benefits and fatal consequences. Medication dilutions often require complex calculations and references for storage, potency, or stability testing is limited. Further dilution of medications by nurses is contrary to patient safety recommendations that pharmacy prepare medications. Inappropriate aseptic technique, labeling, and miscalculations can lead to contamination and medication errors including overdose. Project goal was to evaluate extended stability dating for selected high-risk intravenous (IV) medications, and add unit-dose vials in automated dispensing cabinets (ADC) for nursing administration.

Methods: The process improvement project was conducted in a 125 bed Level 3 NICU. High-risk medication dilutions were previously loaded into ADCs daily in multi-dose vials for IV use. A multi-disciplinary team proposed unit-dosed vials with reduced volumes to minimize the severity of an overdose and ultimately improve medication safety. Targeted medications included intravenous insulin, fentanyl, lorazepam, morphine, methadone, pentobarbital, phenobarbital and vecuronium. Pharmacy evaluated IV dilution recipes and created standard operating procedures (SOPs) for compounding. Batches are quarantined and tested for sterility and potency.

Results: Vecuronium, phenobarbital, lorazepam and morphine were sequentially converted from multi-dose to unit-dose vials. Batch testing of these medications resulted in extended stability dating for 30–45 days. The short stability of diluted pentobarbital and the inability to test insulin potency prohibited extended dating. Fentanyl and methadone pre-filled syringes were obtained from an outsourced compounding company.

Conclusions: The NICU has converted from utilizing multi-dose vials to one time use unit-dose IV vials for high-risk medications. ADC generated reports are now reviewed by pharmacy for appropriate waste documentation and continuous discrepancy resolution. Through this new process and by limiting accessible volumes, patient safety has been improved while minimizing the potential for narcotic diversion.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

CLINICAL EXPERIENCE WITH INTRAVENOUS ACETAMINOPHEN FOR PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE

Roua El Kalach ¹, Ulfat Usta ¹

Introduction: Non-selective cyclooxygenase inhibitors, namely intravenous indomethacin and ibuprofen, are currently the standard therapies for closure of the hemodynamically significant patent ductus arteriosus (hs-PDA). Yet, the unavailability of the intravenous (IV) formulations is a setback in some developing countries including Lebanon where the only formulation available is oral ibuprofen which appears to be as effective as IV formulation. However, it remains prudent to resort to other therapies when contraindications such as active gastrointestinal bleeding, suspected or proven necrotizing enterocolitis, thrombocytopenia and severe renal impairment exist. The role of acetaminophen, an inhibitor of the peroxidase component of prostaglandin-H2 synthetase, has been proposed in several reports and trials for the treatment of patent ductus arteriosus.

Objective: To report our experience in using intravenous acetaminophen for pharmacological closure of hs-PDA

Methods: We report a series of four neonates with contraindications to oral ibuprofen therapy treated with intravenous acetaminophen for hs-PDA confirmed by echocardiogram at the American University of Beirut Medical Center Neonatal Intensive Care Unit in 2015. Therapy was initiated at a dose of 15 mg/kg/dose q 6 hr for a duration of three days. Primary outcome was successful PDA closure within the first week of therapy. Secondary outcome was persistent PDA closure beyond the first week and the subsequent months. Liver function tests were assessed at baseline and at the end of therapy to monitor for evidence of liver toxicity to acetaminophen.

Results: Four premature infants (mean gestational age: 28.6 ± 2.6 wks, mean birth weight 1014.6 ± 292 g) received intravenous acetaminophen. All infants (100%) were believed to have contraindications to oral ibuprofen therapy: coffee ground emesis and suspected gastrointestinal bleed (25%), pulmonary hemorrhage (25%), suspected intraventricular hemorrhage (IVH) (25%). All infants (100%) were on total parenteral nutrition and were not tolerating oral intake. None of the infants had previously received pharmacological therapy for PDA closure. Successful closure of the PDA was achieved in four infants (100%) as confirmed by echocardiogram within the first week of therapy. PDA remained closed in three infants (75%). Reopening occurred in one infant (25%) but that was hemodynamically insignificant and underwent spontaneous closure without pharmacological intervention. Liver function tests were normal at baseline and after therapy in all infants.

Conclusion: Based on our reports, acetaminophen appears to be a promising and safe alternative therapy for the pharmacological treatment of PDA in neonates having contraindications to oral ibuprofen.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

RISK OF POST-PROCEDURAL BLEEDING IN PATIENTS ON INTRAVENOUS FISH OIL. FACT VS. FICTION?

Kathleen Gura ¹, Mark Puder ¹, Lorenzo Anez-Bustillos ¹, Prathima Nandivada ¹, Paul Mitchell ¹, Alison O'Loughlin ¹, Meredith Baker ¹, Duy Dao ¹, Gillian Fell ¹, Bennett Cho ¹

Background: Omega-3 fatty acids (O3FA) are known to affect hemostatic pathways. There is little clinical evidence that translates these effects into an increased bleeding risk. Regardless, concerns about bleeding remain and many recommend discontinuing O3FA before invasive procedures. A fish-oil lipid emulsion (FOLE) is often used for management of intestinal failure-associated liver disease (IFALD) in parenteral nutrition (PN)-dependent patients. The objective of this study is to describe the incidence of clinically significant post-procedural bleeding (CSPPB) among a large cohort of patients with IFALD receiving FOLE.

Methods: A retrospective chart review of prospectively enrolled patients treated with FOLE for IFALD who underwent any type of invasive procedure between September 2004 and July 2015 was conducted. Clinically significant bleeding was defined as at least 1 of the following within 1 month post-procedure: 1) re-exploration/return to operating room for bleeding; 2) need for anti-bleeding therapy; 3) re-admission for bleeding; or 4) death due to bleeding. Pre-procedure data, including complete blood count, coagulation profile, liver function tests and duration of FOLE therapy prior to surgery was collected. As none were normally distribute, patient/procedure characteristics were presented as frequency (percentage) when categorical and median (inter-quartile range) when continuous. The incidence of clinically significant peri-procedural bleeding was analyzed as a percentage of all procedures occurring between the study period, bounded by Clopper-Pearson 95% confidence limits.

Results: Charts from 219 patients treated with FOLE were reviewed; 180 (82%) underwent at least 1 invasive procedure (total=728). Patients were 41.8% female (median age 10.1 mo). Forty-three percent of procedures were related to vascular access, 28% were abdominal surgery, and 14% were invasive endoscopic procedures. Only 4/728(0.55%) procedures resulted in CSPPB. Three were of gastrointestinal origin and required return to the operating room where the underlying cause of bleeding was corrected. A fourth case followed placement of a central venous catheter that required neck re-exploration due to an oozing defect in the sidewall of a small vessel feeding into the internal jugular vein that was repaired without difficulty. Of note, FOLE therapy was never interrupted in any of the events. No distinct pattern among those that developed CSPPB was observed. No deaths due to bleeding occurred. Pre-procedural fatty acid analyses reflected values typically seen in patients on FOLE, with a median omega 3:omega 6 ratio of 1.4 (IQR 1.0–1.9).

Conclusion: While hemostatic changes with FOLE therapy exist, our results suggest that these may not translate into an increased bleeding risk. Our data suggests that FOLE is safe, with a post-procedural bleeding risk not exceeding the 2%–8% that is generally reported for similar procedures in the general pediatric population. FOLE may be continued in PN-dependent children with IFALD and should not be held in preparation for invasive procedures or be interrupted in the event of CSPPB.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

CHARACTERISTICS OF PEDIATRIC CLINICAL INTERVENTIONS DOCUMENTED BY FACULTY AND STUDENTS

Lea Eiland ¹

Objectives: Pharmacists' interventions in pediatric practice settings for short periods of time have been reported in the literature. Only a single study has described faculty and student interventions in the pediatric setting. The objective of this study was to characterize four years of interventions by faculty and students of a school of pharmacy that occurred at various pediatric practice sites within the state.

Methods: In this school of pharmacy, practice faculty and fourth year student pharmacists are required to document clinical interventions during advanced pharmacy practice experiences. Interventions are documented in a single, commercially available, web-based system. Reports of interventions with cost avoidance at pediatric inpatient and outpatient practice sites from 2011–2014 were collected and data were analyzed quantitatively and qualitatively. Data was sorted based on year, practice site, type and number of interventions, and estimated cost avoidance.

Results: Two full-time faculty members practiced in the area of pediatrics and, on average, 25 students entered interventions at pediatric sites each year. A total of 12,779 interventions were documented by faculty and students over the 4 year period, with students entering 81.8% of the interventions and 69% occurring in the inpatient setting. Total cost avoidance for all 4 years was $1,623,844. The most frequent clinical interventions were patient medication history, patient counseling, allergy information clarified, drug information, and drug therapy adjusted. Seventeen adverse drug reactions were prevented or occurred with the most common cause of error being prescribing. Ninety-one percent of the student interventions were documented on a full-time faculty member's clerkship.

Conclusions: Pharmacy faculty and students documented various types of clinical interventions in the inpatient and outpatient pediatric settings and demonstrated a positive impact at pediatric practice sites within the state, as well as cost avoidance in the associated health care systems.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

IMPACT OF PHARMACISTS' ELECTRONIC MEDICATION THERAPY MANAGEMENT CONSULTS FOR PATIENTS ENROLLED IN A PEDIATRIC COMPLEX CARE COORDINATION PROGRAM

Michelle LoTurco ¹, Alexis Kuhn ¹

Background: Patients with complex health issues benefit from enrollment in multidisciplinary integrated care coordination programs, of which pharmacy has the potential to play a vital role. At our institution, adult patients enrolled in care coordination programs automatically receive medication therapy management (MTM) review by a pharmacist. For our pediatric care coordination patients, however, pediatric pharmacists are not currently consulted.

Methods: To evaluate the potential impact of a pediatric pharmacist in an MTM capacity, an e-Consult pilot program was established within the Pediatric Complex Care Coordination Program at our site. Patients were referred for an MTM e-Consult by a nurse care coordinator, based on nurse-perceived need of medication review. Components of the e-Consult included review of: medication and medication dose appropriateness, adherence to CDC-recommended immunization schedules, drug-drug or drug-supplement interactions, therapeutic duplications, and patient- or provider-specific concerns. One year after implementation of the pilot program, each completed e-Consult was evaluated to quantify the number of drug therapy problems (DTPs) identified and associated recommendations. Each recommendation was evaluated to establish if it was addressed, and, if addressed, if it was accepted (recommended action was taken).

Results: A total 24 e-Consults were reviewed with 166 DTPs/associated recommendations identified. DTPs fell into the following categories: 51% indication, 25% effectiveness, 22% safety, and 2% compliance. Of the 166 recommendations, 83 (50%) were addressed by a physician or nurse, as documented in the medical record. Of the 83 addressed recommendations, 57 (68.7%) were accepted with the recommended action undertaken. As a result, the average per-patient number of scheduled medications decreased from 8.5 before the consult to 7 after the consult (p=0.004).

Conclusions: Based on the aforementioned results, our institution is in the process of evaluating funds to formally place a pediatric pharmacist in the Pediatric Complex Care Coordination Program to provide MTM review.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

RETROSPECTIVE EVALUATION OF PROPHYLACTIC VALGANCICLOVIR DOSING FOR CYTOMEGALOVIRUS INFECTION PREVENTION IN PEDIATRIC RENAL TRANSPLANT RECIPIENTS

Gwen Egloff ¹, Maria Isabel Roberti ¹, Rachel Meyers ¹

Introduction/objective: Prophylactic therapy with the antiviral medication valganciclovir reduces the incidence of cytomegalovirus infection (CMV) following renal transplantation. The package insert provides dosing recommendations that require the use of a complex equation for the pediatric population. The objective of this retrospective evaluation is to assess the safety and efficacy of valganciclovir 10 mg/kg orally once daily in pediatric renal transplant recipients.

Methods/design: Patients aged 18 years of age and younger who underwent kidney transplantation between January 1, 2010 and January 1, 2014 and received valganciclovir for CMV prophylaxis were included in the study. Data collected included demographics, donor and recipient CMV serostatus, cold ischemic time, renal function, immunosuppression regimen, incidence of acute CMV, patient survival, graft survival, and adverse effects. Descriptive statistics were used to interpret results.

Results: All patients received prophylaxis for the appropriate duration and 90% of doses were in accordance with our hospital specific protocol. Three patients (12.5%) had acute CMV infection and of them, two (8%) had acute CMV disease. Anemia (67%, 33%, 29%, 29%, 13%) was the most common side effect, followed by leukocytopenia (0%, 21%, 25%, 8%, 0%) and thrombocytopenia (4%, 4%, 0%, 8%, 4%) at 0, 3, 6, 9 and 12 months respectively. Patient and graft survival were both 100% at one year following transplantation.

Conclusion: The pediatric renal transplant dosing protocol for valganciclovir at this institution is efficacious as evidenced by a low incidence of infection one-year post-transplant. The safety of this protocol is demonstrated by similar rates of adverse events compared with the currently available literature.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

CHARACTERIZATION OF CLINICAL OUTCOMES WITH CEFEPIME IN A NEONATAL INTENSIVE CARE UNIT: A RETROSPECTIVE COHORT STUDY

Chad Knoderer ¹, Meghan Toth ¹, Katherine Malloy ¹, Kristen Nichols ¹

Background: Neonates admitted to neonatal intensive care units (NICUs) face a significant risk of contracting nosocomial infections. Cefepime is a broad-spectrum fourth-generation cephalosporin being used in unstable, critically ill neonates. To date, no neonatal data describing clinical outcomes with cefepime exist. The objective of this study was to characterize the clinical outcomes with cefepime in a neonatal intensive care population.

Methods: Preterm and term neonates receiving cefepime for at least 48 hrs between January 1, 2010 and December 31, 2013 were included in the study. Cefepime courses could occur at any time between birth and 48 wks post-menstrual age. Demographic, cefepime regimen, culture and susceptibility, and documented adverse effect (AE) data were extracted from medical records. Courses were categorized as having positive clinical response if, while on cefepime, the patient experienced 1) normalization of a previously elevated leukocyte count and/or 2) negative follow-up cultures. Renal impairment was defined as a serum creatinine increase of 50 percent or greater above baseline or a urine output of less than 1 mL/kg/hr.

Results: Final analysis included 74 patients who received 105 cefepime treatment courses. Patients had a mean (SD) gestational age (weeks) of 29.7 (5.8), and 63.5% (47/74) were male. The mean (SD) empiric cefepime dose was 36 ± 12.9 mg/kg/dose every 12 hrs, and cefepime was most commonly used for late-onset sepsis (39%). Clinical response was evaluable in 49.5% (52/105) courses. In these courses, positive clinical response was observed in 73.1% (38/52). Overall patient mortality was 23% (17/74). There were 18 AE potentially attributable to cefepime occurring in 14.3% (15/105) of courses. Acute kidney injury was observed in 17.1% (18/105) of courses.

Conclusion: Cefepime was used safely with reasonable clinical response in this NICU cohort, but additional studies are needed to further determine cefepime-associated clinical outcomes.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

DECREASING THE TIME TO ORAL ANTIBIOTIC ADMINISTRATION IN A PEDIATRIC EMERGENCY DEPARTMENT

R Zachary Thompson ¹, Brian Gardner ¹, Thomas Carter ¹, Joye Allen ¹, Abby Bailey ¹

Background: Care in the pediatric emergency department (ED) commonly requires treatment for acute conditions, with high priority placed on timely administration of medications. A common practice to provide doses of oral antibiotics prior to discharge allows families the opportunity to later follow up at their local pharmacy to continue care. Providing pediatric specific dosing within the ED at large academic medical centers can be difficult due to the sometimes-limited availability of pediatric pharmacy services and necessity to provide patient specific dosing. In 2015, the practice of dispensing common oral antibiotic doses (amoxicillin, amoxicillin-clavulanate, azithromycin, cephalexin, cefdinir) from central pharmacy to patients in the pediatric ED changed to stocking them in automated dispensing cabinets (ADC).

Methods: This was a retrospective review of patients who received a one-time dose of oral antibiotics within the pediatric ED and were subsequently discharged home. Two three-month time periods were compared to determine the metrics of providing oral antibiotics before and after these medications were stocked in the pediatric ED ADC. The primary outcome was to compare the time to administration. Secondary outcomes were to assess wastage of stocked medications and time to ED discharge.

Results: In the ADC time period (n=74), the mean time to administration was 28.1 minutes versus 66.9 minutes in the central pharmacy time period (n=34) (p<0.001). The ED length of stay during the ADC time period was 211 minutes versus 232 minutes (p=0.25). 35.4% of doses from the ADC expired resulting in a wholesale acquisition cost of $53.14 wasted.

Conclusion: Stocking commonly used oral antibiotics in the pediatric ED led to a significant decrease in the time to medication administration. This decreased time to administration has the potential to lead to improved patient and nursing satisfaction. Routine surveillance is needed after implementation to ensure compliance and to minimize wastage.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

NEONATAL POSTMENSTRUAL AGE VS. WEIGHT-BASED GENTAMICIN DOSING STRATEGY COMPARISON

Emily Rodman ¹, Kimberly Dinh ¹, Jennifer Placencia ¹, Danielle Rios ¹

Objective: Popular gentamicin dosing strategies in the neonatal population have included postmenstrual age-based (NeoFax) and weight-based (Red Book) dosing. The concern with weight-based dosing is accounting for developmental pharmacology in premature infants.

Methods: An IRB approved, retrospective analysis of gentamicin levels was performed prior to and after the implementation of weight-based dosing in a quaternary-care children's hospital. Data collection occurred over a 6-month observation period (May–November 2015 with a washout during the conversion period in August). Patients were included in the analysis if they were admitted to the neonatal intensive care unit, received gentamicin, and had gentamicin levels obtained. Patients were excluded if they had known renal dysfunction. Gentamicin levels were assessed to determine if they met a goal trough value of <1.5 mg/L, or goal peak of 6–10 mg/L. Descriptive statistics and Fisher's exact test were used to compare the available levels. A subgroup analysis of patients greater than 28 days of life were reviewed as this is the age at which the weight-based dosing converted from neonatal to infant dosing.

Results: A total of 167 levels in 77 patients were obtained. Peak values were similar between the two groups (40% vs. 32%, p=0.58). Supratherapeutic troughs occurred more frequently in the weight-based dosing group (35.8% vs. 9%, p=0.0016). In patients less than 28 days of life, the weight-based group had 16% supratherapeutic troughs compared to 0% in the postmenstrual-age group (p=0.055). In patients greater than 28 days of life, the weight-based group had 54% supratherapeutic troughs compared to 25% in the postmenstrual-age group (p=0.071).

Conclusions: The weight-based dosing had a higher percentage of supratherapeutic troughs compared to the postmenstrual age-based dosing. This retrospective review shows that dosing schedules that do not account for postmenstrual age result in higher trough values which may result in renal and ototoxicity.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

RESOLUTION OF PARENTERAL NUTRITION-ASSOCIATED LIVER DISEASE WITH NEW LIPID EMULSION (SMOFLIPID): A LONG TERM CASE STUDY ON CHILDREN WITH SHORT BOWEL SYNDROME

Swee Lan Neo ¹, Christina Tjan Ong ¹, Yee Low ¹, Doris Mae Abear-Dimatatac ¹, Caroline Ong ¹, Anette Jacobsen ¹

Introduction: Parenteral nutrition-associated liver disease (PNALD) develops in 40% to 60% of infants with short bowel syndrome (SBS) who require long-term total parenteral nutrition (TPN). SMOFlipid, a new lipid emulsion containing soybean oil, medium-chain triglycerides, olive and fish oil, has been shown to be efficacious and safe for use in the short-term but little is known of its long-term effects on liver function.

Methods: Three infants (two female: one male) with SBS receiving long-term TPN were prescribed conventional lipid emulsion (Lipofundin 20%) for at least 28 days before changing to SMOFlipid. Lipids were administered at doses 1–3g/kg/day; rate <0.17 g/kg/hr. Liver function tests (LFTs) were analyzed at baseline, Day 28, 84, six months and one year.

Results: All patients completed two months of TPN with conventional lipids prior to changing to SMOFlipid due to deranged LFT: 57 days (Patient 1); 70 days (Patient 2) and 87 days (Patient 3). All patients had elevated total bilirubin (TB) at baseline: 161 umol/L (normal: 3–20 ummol/L) (Patient 1), 123 umol/L (Patient 2) and 33 umol/L (Patient3). All had normalization of TB after starting SMOFlipid. The time taken ranged from one month (Patient3), three months (Patient1) to five months (Patient2). Their TB remained normal after one year of SMOFlipid. Alanine transaminase (ALT) was also elevated in all patients at baseline: Patient 1=134 U/L (normal: 9–25 U/L), Patient 2= 151 U/L and Patient 3=57U/L. All had significant improvement of ALT after three months and one year.

Conclusion: SMOFlipid shows long-term beneficial effects on liver function status and may reverse PNALD in pediatric patients with SBS

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

GUIDELINE ADHERENCE AUDIT FOR TREATMENT OF PEDIATRIC OUTPATIENT URINARY TRACT INFECTION

Melanie MacInnis ¹, Shannon MacPhee ¹, Eleanor Fitzpatrick ¹, Katrina Hurley ¹, Emma Burns ¹, Ryan Lee ¹

Background: Our institution's Pediatric Emergency Department (ED) estimates approximately 2000 patients per year present with a urinary tract infection (UTI). ED physicians perceive that UTI treatment shows the greatest variation in antimicrobial prescribing. Several clinical and safety organizations recognize that antimicrobial stewardship is an important intervention in optimizing patient safety, reducing microbial resistance, and improving patient outcomes.

Objective: To obtain data regarding empiric antimicrobial selection for pediatric patients presenting with signs and symptoms of a UTI.

Methods: We conducted a randomized retrospective chart review of 100 patients aged 2 mo-16 yrs presenting to the ED from 1st April 2013 to 31st March 2014 from a convenience sample. Demographic data, choice of empiric antimicrobials and culture and sensitivity results were abstracted from patients' charts; obtained using a collection tool developed by the clinical investigators based on current Canadian guidelines for antimicrobial selection.

Results: There were 85 females and 20 males in the sample. Forty three percent (46) of patients were febrile in the ED. Patients presented with a previous history of urinary tract infections 5.7% (6) of the time, and antimicrobial use within the previous 3 months was documented in 2.9% (3) of cases. Urinalysis showed 78.1% (82) had white blood cells, 75.2% (79) had microscopic hematuria, 53.3% (56) had bacteriuria and 38.1% (40) had nitrites. Of 105 discharge prescriptions written, 47.6% (50) aligned with the 6 regimens that were predetermined by the clinical investigators to be in accordance with guideline adherence. Urine culture results obtained after patient discharge revealed 83% (71/86) of positive bacterial cultures were E. Coli.

Conclusions: The results of this audit confirm a broad variation in empiric prescribing selection by our ED physicians. This examination of practice is an important first step in providing feedback to the prescribers with the aim of improving empiric antimicrobial selection for treatment of UTIs.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

RETROSPECTIVE REVIEW OF PRAZOSIN USE FOR THE TREATMENT OF POST-TRAUMATIC STRESS DISORDER-RELATED NIGHTMARES IN PEDIATRIC AND ADOLESCENT PATIENTS

Katelyn Hood ¹, Kimberly Novak ¹

Objectives: Post-traumatic stress disorder (PTSD) is often characterized by central nervous system noradrenergic hyper-responsiveness, which can result in nightmares and sleep disturbances. In adult patients with PTSD, the α1-antagonist prazosin has been shown to reduce nightmares and sleep disturbances at doses of 3–15 mg/night. However, prazosin use in pediatric patients with PTSD is limited to a few brief case reports, and much less is known when prazosin is used amongst a larger pediatric population in a single center. The primary objective of this study was to determine which dose of prazosin has been associated with optimal efficacy and tolerability. The secondary objective was to determine the frequency of prazosin discontinuation due to side effects or lack of efficacy when used for the treatment of PTSD-related nightmares.

Methods: A retrospective electronic medical record review was performed to collect data on all pediatric patients < 18 years of age prescribed prazosin for the treatment of PTSD-related nightmares or sleep disturbances from December 1, 2014 through September 30, 2015. Data collected included patient demographics, prior therapies for PTSD, current therapies for PTSD at time of prazosin initiation, PTSD-related symptoms at time of prazosin initiation, starting prazosin dose, prazosin titration schedule, PTSD-related symptoms that improved, remained the same, and/or worsened during prazosin therapy, time to prazosin effect, and side effects related to prazosin therapy. The primary and secondary outcomes were evaluated using descriptive statistics.

Results: Eighty-five patients were included in this study, ranging in age from 6 to 17 yrs. The most common starting dose of prazosin was 1 mg, and the most common maintenance doses of prazosin were 1 mg and 2 mg. The time to prazosin effect was ≤ 2 months for 62% of patients (n=40), with 26% of patients (n=17) achieving benefit after only 1–2 doses. Prazosin was discontinued due to ineffectiveness, side effects, or resolution of nightmares in 9, 9, and 4 patients, respectively. The most common side effects documented with prazosin use were dizziness, anxiety, drowsiness, visual changes, behavioral changes, nausea, and syncope.

Conclusion: Prazosin appears to be safe and effective at decreasing the intensity and frequency of PTSD-related nightmares in pediatric patients. However, further studies are needed to prospectively evaluate the safety, efficacy, optimal dosing, and long-term effects or prazosin in this patient population.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

RITUXIMAB DESENSITIZATION IN PEDIATRIC PATIENTS

Hellauer ¹, James Dice ¹

Case Report: Rituximab is a monoclonal antibody targeted against the CD20 antigen in B cells that has been used as an off-label treatment option in several rheumatologic, renal, and neurologic diseases. However, hypersensitivity reactions to rituximab have been reported following both initial and subsequent infusions, which can prevent its use in some patients. In adults who have previously reacted, desensitization has been described as an alternative method of administering the drug when no therapeutic alternatives exist. The process involves gradually increasing the rate and concentration over several hours until the full prescribed dose has been administered. This method allows patients who have previously experienced hypersensitivity to receive the medication. A 12-step desensitization protocol has been described in the literature in adult patients. We report on 3 pediatric patients (age 13–17) who have received a total of 8 doses of rituximab via a similar desensitization protocol during a 10-month period. All doses were 1000 mg (750 mg/m²) and were administered in the pediatric intensive care unit. One patient did experience mild hypersensitivity symptoms during several of the infusions, but adjustments were made to the protocol that permitted the patient to receive the full prescribed dose. All other desensitization infusions were successfully completed without signs of hypersensitivity. From our experience, desensitization is a safe and effective method to administer rituximab in pediatric patients who have previously experienced a hypersensitivity reaction.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

INCREASING RATES OF INFLUENZA VACCINATION IN A PEDIATRIC EMERGENCY DEPARTMENT UTILIZING AUTOMATION IN AN ELECTRONIC MEDICAL RECORD (EMR)

Lauren Buenger ¹, John Peters ¹, Terry Stigdon ¹, Cara Willey ¹, Jennifer Walthall ¹, Cory Showalter ¹, Emily Webber ¹

Purpose: Vaccination against influenza has been shown to decrease the morbidity and mortality from the virus (1). Recommendations are for patients ≥ 6 mo of age to be vaccinated; however, rates remain below the Healthy People 2020 target of 70%, averaging 58.9% of pediatric patients nationally and 41.5% locally (2) in the 2013–14 influenza season. The emergency department (ED) provides a unique opportunity to administer influenza vaccines; however, incorporating preventative health interventions like vaccination must be efficient to be successful. A program for ED influenza vaccination for patients seen and discharged began at our institution in 2012, and in the 2014 season an electronic medical record (EMR) intervention was implemented in an effort to increase vaccination rates.

Methods: For patients > 6 months of age, two questions were added to the standard nursing triage assessment regarding influenza vaccination status and willingness to vaccinate. Upon completion of the primary assessment, embedded logic rules generate an age-specific influenza vaccination assessment task for the nurse. The task provides a secondary assessment to identify contraindications. Upon completion of the second assessment, an order for influenza vaccine is generated per protocol. Existing queries were utilized to identify total number of eligible patients who received the vaccine.

Results: In the 2013–2014 influenza season, the ED administered 42 doses of the vaccine, representing 0.3% of eligible visits. After implementation of the EMR tool, the ED administered 1,320 doses of influenza vaccine. This represents approximately 8.8% of qualified patients based on age group and eventual discharge from the ED. The distribution of the influenza vaccination administration was heavily weighted to the early part of the vaccination season.

Conclusion: The ED influenza vaccination program vaccinated approx. 20 times the number of eligible patients after automated EMR screening and ordering. Clinical decision support for vaccines can be a challenge. Utilizing knowledge of a multidisciplinary team, integration into the existing workflow, and visual cues in the EMR, we were able to increase the number of influenza vaccines administered substantially. Another key to success involved utilization of a protocol order, which removed the need for individual physician orders for each vaccine. Review of where patients screened out of this process and implementation of countermeasures could lead to higher vaccination rates in subsequent influenza seasons.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

PHARMACIST-LED MODEL TO REDUCE HOSPITAL READMISSIONS IN MEDICALLY COMPLEX CHILDREN

Alison DaCosta ¹, Courtney Sweet ¹, Lisa Biondo ¹, Francis Casey ¹, Jeffrey Lancaster ¹

Background: The medical home model is widely recognized for its ability to provide comprehensive, patient-centered, coordinated, accessible care with a high degree of quality and safety. A similar model based in the hospital rather than the community may be most beneficial for medically complex children who have special healthcare needs, are frequently hospitalized, and account for a disproportionate amount of healthcare costs. The role of the pharmacist in such a model should be considered as such patients are typically on multiple medications prescribed by various sub-specialists, and are at risk for medication errors, particularly at transitions of care. This pilot study investigated the feasibility and effect on healthcare utilization of medically complex children participating in a pharmacist-led model for care coordination. Quality of life and satisfaction with care were secondarily assessed for each patient.

Methods: Four medically complex children were enrolled and contacted by the pharmacist weekly for five consecutive months. The pharmacist also met with patients during hospitalizations and outpatient clinic visits to set specific goals related to their medical management and coordinated care between multiple providers. Time for each encounter with a patient was recorded. Each patient's hospital admissions, days of stay, emergency department visits, and clinic visits were recorded and compared from the five months prior to enrollment in this study to the five months during this study. At enrollment and at the end of the study, each caregiver completed the PedsQL 4.0^™ questionnaire to evaluate the child's quality of life and the Patient Assessment of Care for Chronic Conditions questionnaire to assess satisfaction with care. Patients age five and above completed an age appropriate version of the PedsQL 4.0^™ as well.

Results: The four patients enrolled in this study ranged in age from 4 to 15 years, were on 17 or more chronic medications, and each had between 7 and 17 admissions in the 12 months prior to enrollment. The pharmacist spent on average 60 to 80 min per patient per week. Hospital admissions and days of stay decreased for three patients and increased for one patient during this study. The total days of hospitalization for the four patients pooled decreased by 50 days, a 40% relative reduction. Quality of life increased for two patients and decreased for two patients and satisfaction with care increased for all four caregivers.

Conclusions: This model was feasible for a pharmacist to coordinate and required frequent physician involvement. Healthcare utilization varied between patients, but overall decreased for the four patients pooled. Changes in quality of life varied and may be attributed to using a survey that was not specific to medically complex children. Overall, caregivers were highly satisfied with this service and the healthcare their child received.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

VIRTUAL PEDIATRIC PATIENT CASES WITH RANDOMIZED SCENARIOS AS AN INSTRUCTIONAL TOOL FOR PHARMACY STUDENTS

Jeremy Stultz ¹, Michael Forder ¹, Amy Pakyz ¹

Objectives: We aimed to assess if student exam performance was impacted by the number of attempts of virtual pediatric clinical cases with randomized scenarios.

Methods: Two virtual cases (one meningitis and one asthma) that each randomly presented three scenarios were created. For the meningitis case only, students could only proceed to a second scenario (with three additional randomized outcomes) if the first scenario was correctly completed. Students were allowed unlimited attempts of the cases individually outside of class and as a group in class, with the highest group score being graded. Three exam questions were based on a fourth scenario of each randomized portion of the virtual cases. Characteristics of students who correctly versus incorrectly answered individual exam questions were compared using the Mann-Whitney U test or the T-test.

Results: In 132 students, the median number of group virtual case attempts was higher among students who correctly answered the exam question related to the first randomized scenario of the meningitis case (10.0, IQR 3.75–14.25, versus 4.0, IQR 2.0–14.0, p=0.015), despite no difference in prior mean grade point average (GPA) or individual attempts (all p>0.05). The number of case attempts was not different between students who correctly and incorrectly answered the other related meningitis and asthma exam questions (all p>0.05). Students who correctly answered the exam question related to the randomized portion of the asthma virtual case had a higher prior mean GPA (3.38, 95% CI 3.30–3.47, versus 3.23, 95% CI 3.15–3.32, p= 0.01).

Conclusions: When continuation of the virtual cases required correct randomized scenario completion, a higher number of group attempts may have increased the ability of students to apply knowledge and concepts to alternative exam scenarios. Prior GPA, not case attempts, impacted exam question performance when continuation of the virtual case was not dependent on correct randomized scenario completion.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

THE MINIMUM VOLUME OF PRE AND POST-MEDICATION FLUSHING FOR REDUCING INTRAVENOUS DRUG INCOMPATIBILITY IN PAEDIATRIC CRITICAL CARE

Suci Hanifah ¹, Ross Kennedy ¹, Patrick Ball ¹

Background: Pre and post- medication flushing with Normal Saline (NS) to overcome incompatibility may bring consequence to fluid overload and hypernatremia. The minimum volume of flushing is beneficiary for patients with restricted volume and Natrium. AIM: This study aims to examine minimum volume needed for pre and post medication flushing to prevent incompatibility.

Methods: This is a laboratory study, which mimic intravenous drug delivery in critical care. Various volumes (0.5 mL, 1 mL, 1.5 mL, 2 mL, 2.5 mL, 3 mL, 3.5 mL, 4 mL, 4.5 mL and 5 mL) of NS were flushed pre and post medication on simultaneous drug administrations, which were incompatible in previous studies. Those are meropenem with a co simultaneous infusion of morphine-midazolam-ketamine, phenytoin with a co simultaneous infusion of morphine-midazolam-ketamine, chloramphenicol with a co simultaneous infusion of morphine-fentanyl-dobutamine, cefotaxime with a co simultaneous infusion midazolam, norepinephrine and dobutamine, phenytoin with a co simultaneous infusion of morphine-fentanyl-midazolam and also furosemide with gentamycin. Samples were collected from the end of extension set. Precipitation was observed under dark field-optical microscopy.

Results: Flushing 2 mL decreases precipitation of all groups' combination, but it cannot eliminate the overall precipitation of phenytoin with a co simultaneous infusion of morphine-midazolam-ketamine. Flushing post dose needs more volume (2 mL) than flushing pre dose (1.5 ml). The volume of flushing found to be effective (i.e., 3.5 mL total) was far lower from the common practice (i.e. 5 mL). Based on this simulation, this volume of fluid injected would be reduced by 45–195 mL per day. This represents a reduction of between 4.4% and 25.7% in fluid intake. Meanwhile, that volume would reduce 7.5 mEq-30 mEq sodium intake. These number will be significant for patient weighing 10 kg.

Conclusions: Flushing 2 mL post dose and 1.5 mL pre-dose are minimum volume to avoid precipitation of most IV drug incompatibility. However, volume up to 5 mL is not adequate to prevent phenytoin precipitation.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

EVALUATION OF RAPID VERSUS STANDARD INFLIXIMAB INFUSIONS IN THE PEDIATRIC POPULATION

Nicole Rozette ¹, Christina Hellauer ¹, Chephra McKee ¹, James Dice ¹, Nancy Yokois ¹

Background: Infliximab is used in the pediatric population to induce and maintain remission of inflammatory bowel disease (IBD) and rheumatologic disorders. The manufacturer recommends administering infusions over at least two hours to reduce the risk of infusion reactions. Several studies have been conducted in the adult population evaluating the safety of infusing infliximab more rapidly than the manufacturer's recommendation, most commonly over 30 minutes to 1 hour. However, there is only one retrospective report evaluating the safety of rapid infliximab infusions in children and adolescents. With this paucity of literature, the aim of this study was to determine the safety of one-hour rapid infliximab infusions in the pediatric population. Secondary objectives were to evaluate the impact of immunomodulator medications and premedication on the occurrence of infusion reactions.

Study Design: This was an IRB-approved prospective study with an unmatched historical control group conducted at a free-standing children's hospital. Data for the retrospective portion of this study was collected from subjects' electronic medical records to evaluate the incidence of infusion reactions occurring with the standard 2- to 3-hr infliximab infusions. The prospective arm included patients 6–21 yrs of age with IBD or a rheumatologic indication who had successfully completed induction plus two standard infliximab infusions without experiencing infusion reactions. Once enrolled, subjects received rapid infliximab infusions over 1 hr. Monitoring continued per the standard practice and 2 wks following each infusion to evaluate for potential delayed infusion reactions.

Results: Fifty subjects were included in the retrospective portion, receiving 540 standard infusions during the evaluation period. Two of the 50 subjects (4%) each experienced 1 potential infusion reaction (0.37%) with the standard 2- to 3-hour infusions. Sixty-six patients were enrolled in the prospective arm of the study, receiving 545 rapid infliximab infusions. Four instances of potential infusion reactions (0.73%) were reported in the 66 subjects (6%). Only 2 of these 4 instances required patients to stop receiving the rapid infusions. Use of immunomodulator medications and premedication prior to infliximab infusion was inconsistent among the subjects experiencing potential infusion reactions in both groups.

Conclusion: This study suggests that rapid infusion of infliximab over 1 hour is not associated with an increased risk of infusion reactions when compared to standard 2- to 3-hr infusions and can be safely used in the pediatric population to treat IBD and rheumatologic disorders.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

COMPARISON OF AMIKACIN PHARMACOKINETICS IN NEONATES AND INFANTS WITH AND WITHOUT CONGENITAL HEART DISEASE

Lauren Lees ¹, Katie Hughes ¹, Pete Johnson ¹, Michael Anderson ¹, Kris Sekar ¹, Robert Welliver ¹, Jamie Miller ¹

Introduction: There are no studies evaluating use of amikacin in neonates and infants with congenital heart disease (CHD). The purpose was to compare amikacin pharmacokinetics and acute kidney injury (AKI) in neonates and infants with and without CHD.

Methods: This was a descriptive, retrospective study of neonates and infants who received amikacin from January 1, 2013 through December 31, 2014. CHD was classified as cyanotic or acyanotic. Controls were matched in a 2:1 fashion according to postmenstrual age (PMA). Data collection included demographics, amikacin regimen, renal function, and pharmacokinetic parameters. The primary objective was to compare the volume of distribution (Vd) and clearance (CL) in neonates and infants with CHD versus controls. Secondary objectives included comparison of elimination rate Ke and half-life (t1/2) between groups. The incidence of AKI was compared between groups. AKI was defined as a reduction in urine output < 0.5 mL/kg/hr for > 8 hours, an absolute increase in SCr by 0.3 mg/dL, or an increase in SCr > 50% from baseline. Between-group analysis were performed using Wilcoxon-Mann-Whitney test, Student's t-test or Chi-square, or Fisher's exact analysis as appropriate with a p< 0.05.

Results: Thirty-two CHD and 64 controls were included. There was no difference in the PMA between the CHD and controls, 34.1+4.7 vs 34.2+4.8 wks (p=0.84). There was no difference in the Vd (0.46+0.10 vs 0.45+0.12 L/kg, p=0.58) or CL (0.047+0.014 vs 0.045+0.014 L/kg/hr, p=0.39) between the CHD and controls. A greater incidence of AKI was noted in the CHD group, but this was not significantly different, 5 (15.6%) versus 5 (7.8%) (p=0.29).

Conclusions: No difference in pharmacokinetic parameters was noted between groups. There was a greater percentage of neonates and infants with CHD with AKI. Future studies should focus pharmacokinetic analysis of neonates and infants with CHD on amikacin post-cardiac surgery.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

HYPERTENSION RISK IN PEDIATRIC PATIENTS RECEIVING ADHD THERAPY

Shirin Madzhidova ¹, Genevieve Hale ¹, Jane Clare Miller ¹

Introduction: Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder of children and adolescents. The majority of these patients are successfully treated with stimulant medications; however, these agents are known to cause cardiovascular risks including increased risk of hypertension. Prevalence of developing hypertension in pediatrics being treated with stimulants compared to non-stimulants or serotonin-norepinephrine reuptake inhibitors (SNRI) is not well described.

Objective: To assess and evaluate the incidence of hypertension risk associated with stimulant versus non-stimulant ADHD therapy among US children and adolescents ages 2–19 years.

Methods: In our secondary database analysis, the National Health and Nutrition Examination Survey (NHANES) database was utilized to attain population data. The NHANES survey examines a representative sample of 5000 people each year across the country. Our population included two sample cohorts from the years 2009–2010 and 2011–2012. Our inclusion criterion includes individuals aged 2 to 19-yrs-old who are taking at least one ADHD treatment medication at the time of the survey. Our exclusion criterion includes individuals with a past medical history of hypertension. Correlation analysis, Chi-square test, and descriptive statistics have been utilized to carry out the analysis of data.

Results: Our initial sample size included 183 subjects. Upon applying the exclusion criteria and eliminating missing or incomplete data, 147 subjects remained. Our preliminary results have shown our population to encompass 72.1% males, 42.2% Caucasian, and mean age of 11.8 years. Most patients (83%) were on 1 ADHD agent, 15% were on 2 ADHD agents, 2% were on 3 ADHD agents, and 0.6% was on 4 ADHD agents. Of these 76.5% of patients were treated with stimulants, 34.9% with non-stimulants, and 0.7% with serotonin-norepinephrine reuptake inhibitors (SNRI). Chi-squared analysis has shown that there is no significant difference in hypertension risk at any stage in relation to the number of agents used to treat ADHD (p=0.252).

Conclusion: The results of our secondary database analysis have shown that there is no significant increase in hypertension risk among three different classes of agents used to treat pediatric patients with ADHD. Further observational studies are needed to make conclusive recommendations on reducing the risk of hypertension among pediatric patients receiving ADHD medications.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

NALOXONE FOR MANAGEMENT OF PEDIATRIC CLONIDINE INGESTIONS

Ashley Lindstrom ¹, Jenny Mason ¹

Background: There is no antidote for clonidine overdose; therefore treatment primarily involves supportive care measures. Naloxone is used as an adjunct therapy to manage respiratory depression, bradycardia and hypotension. However, case reports and retrospective studies demonstrate conflicting efficacy, making the use of naloxone in this setting controversial.

Objectives: Evaluate the effects of naloxone in the setting of clonidine ingestion by assessing vital signs before and after naloxone administration. Additionally, gather information on length of stay, need for intubation and frequency of admission to an intensive care unit (ICU) after naloxone is given.

Methods: This evaluation was approved by the Institutional Review Board. A list of all naloxone doses administered in the emergency room between July 1, 2013 and June 30, 2015 was generated from the electronic medical record. A retrospective chart for all patients was performed. Patients were included if they were <18 yrs of age and received >1 dose of naloxone after clonidine overdose. Patients with polypharmacy overdose were excluded from review. During chart review the following data was collected: sex, age, weight, number of naloxone doses, time to first naloxone dose, dose of naloxone, duration of naloxone infusion, vital signs (HR, BP, RR) before and after naloxone administration, length of stay, need for intubation, and need for admission to an ICU. Descriptive statistics were performed.

Results: A total of 13 patients were included in the evaluation. Eighteen bolus naloxone doses were administered. The median naloxone bolus dose was 98.6 mcg/kg/dose. Continuous infusions were only used on two occasions and ranged greatly in terms of rate and duration. Patients received between one and four doses of naloxone. The median time between presentation to the emergency department and first naloxone dose was 0.9 hours. Half of the patients who receive naloxone experienced improvement in HR, RR, systolic BP or diastolic BP. Despite naloxone therapy, two patients required intubation and nine needed admitted to ICU for further management. Mean length of stay for the study population was 1.5 days.

Conclusion: Half of the patients demonstrated improvement in vital signs after naloxone administration. Comparative studies are needed to determine if patients who receive naloxone have better outcomes than those who do not receive naloxone.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

CURRENT ORAL MEDICATION DOSING DEVICE DISPENSING PRACTICES FOR PEDIATRIC PATIENTS AMONG COMMUNITY PHARMACISTS

Jessica Frye ¹, Christine A Robinson ¹, Katelin Kimler ¹, Pooja Shah ¹, Anita Siu ¹, Rachel Meyers ¹

Background: The Institute for Safe Medication Practices (ISMP) has identified errors associated with medication administration using household measuring devices and therefore recommends doses be conveyed using only metric weights or volumes. Community pharmacists and pharmacy technicians are frequently involved in the care of pediatric patients and can play a significant role in the prevention of medication errors related to improper medication administration in this patient population. The purpose of this study was to identify trends among community pharmacists regarding their practice of dispensing and counseling on the use of oral dosing devices and to highlight areas for improvement in the care of pediatric patients.

Methods: A 10-question, online, IRB-approved survey was developed to collect baseline demographic data and information regarding oral dosing device dispensing and counseling practices among community pharmacists. All pharmacists currently registered as community practice preceptors with Ernest Mario School of Pharmacy (Piscataway, New Jersey) were contacted via electronic mail and considered for inclusion in this study. Baseline demographics collected included years of experience, community practice site, as well as county of current practice. Questions regarding dispensing practices were asked using a reference prescription for amoxicillin. Participants were also asked to comment on the dose-checking capabilities of their pharmacy computer systems for pediatric patients. Descriptive statistics were utilized to summarize and evaluate response trends.

Results: A total of 25 out of a potential 299 responses were received. Of the 25 respondents, 22 (88%) identified New Jersey as their primary state of practice. Twenty respondents (80%) described their employer as a national chain pharmacy. Device availability was noted to have the largest impact on oral dosing device selection followed by personal experience (46.3% and 26.8%, respectively). All surveyed pharmacists recommended the use of an oral dosing device with the provided reference prescription; however, 18 (72%) utilized the word “teaspoon” on the prescription label. When asked which pharmacy employee counsels patients or caregivers on the proper utilization of dosing devices, 48% participants indicated that the pharmacist was always responsible. Only 8 participants (32%) stated that their pharmacy's computer system had a place to enter a patient weight and of these eight, five (62.5%) stated that their computer system had weight-based dosing capabilities.

Conclusions: While this study was limited by both its location and low response rate, important trends in community dispensing were identified. The use of non-metric terminology remains prevalent despite ISMP recommendations and, although all respondents recommended the use of an oral dosing device, device availability may impact community dispensing practices. The provision of dosing devices and pharmacist counseling to caregivers on their use in pediatric patients requires additional research and improvement.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

VARIATION IN DETERMINING AUC FOR VANCOMYCIN IN PHARMACOKINETIC ANALYSIS IN PEDIATRIC PATIENTS

Breanna Moody ¹, Brian Gardner ¹, Karen Garlitz ¹, Robert Kuhn ¹

Background: Vancomycin therapy is commonly monitored by measuring and assessing steady-state trough levels. Adult data indicates trough levels of 15–20 mg/L correspond with an AUC/MIC ratio of ≥400 mg*h/L. Increasing pediatric information suggests lower levels may yield the targeted ratio. Using a single drug level, there currently are multiple different methods to estimate vancomycin clearance in pediatric patients and calculate AUC. Differences in these methods may complicate determination of dosing adjustments in pediatric patients.

Methods: A retrospective chart review of patients 0–17 years that had a vancomycin steady-state vancomycin trough level over a consecutive 10-week period in the fall of 2015 was conducted. Demographic data collected included: height, weight, age in days, vancomycin daily dose and trough concentration, MIC of the organism if reported, and serum creatinine. If an MIC was not reported for the patient, an MIC of 1 mg/L was assumed. Vancomycin clearance and AUC were calculated using each method. Per Ploessl et al, clearance equaled 0.248 * Wt0.75 * (0.48/SrCr)0.361 * [ln(age)/7.8]0.995. Dividing the total daily dose by the calculated clearance yielded AUC. Per Rainke et al, the AUC equaled daily Vancomycin dose/(((Cl*0.79)+15.7)*0.06) [Cl = 0.413*Height)/SCr]. Each AUC value was divided by the reported or assumed MIC to calculate the AUC/MIC ratio for both formulas.

Results: A total of 64 patients were included in the analysis. The average age, weight, and height were 7.7 yrs, 32.9 kg, and 135.8 cm, respectively. The average vancomycin dose was 52.9 mg/kg/day. The mean trough was 15.33 mg/L with an average serum creatinine of 0.65 mg/dL. The average calculated AUC/MIC ratio found by the Ploessl equation was 176.6 mg*hr/L, compared to an average of 531.6 mg*hr/L when using the Rainkie equation. This resulted in an average AUC/MIC ratio difference of 355 mg*hr/L, or 67%. 56% of the patients had more than a 300 mg*hr/L difference between the two calculations.

Conclusion: An extremely large disparity was found between the two population-based equations to calculate vancomycin clearance and AUC. This potentially causes uncertainly in adjustment of pediatric vancomycin regimens based on single trough levels. For serious gram-positive infections, two steady-state concentrations could be considered to calculate patient-specific parameters.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

EFFECTS OF PHARMACIST INTERVENTION ON MONITORING OF MICRONUTRIENTS IN PEDIATRIC PARENTERAL NUTRITION

Chelsea Williams ¹, Jake Luke ¹, Mark MacKay ¹, Collin Anderson ¹, Jared Olson ¹, Sabrina Boehme ¹, Susan Sorenson ¹

Objective: Monitoring pediatric patients receiving parenteral nutrition (PN) is necessary to confirm that the patient is receiving adequate nutrition. Pharmacists play a vital role in writing and monitoring PN. The purpose of this study was to assess the frequency with which pharmacists' recommendations for monitoring or dose adjustments of micronutrients were accepted by the medical team compared to other members of the nutrition support team.

Methods: An interdisciplinary nutrition support team has consistently made recommendations for monitoring and adjusting micronutrients for pediatric PN. In 2015, pharmacists became the primary source of micronutrient monitoring and dosage adjustments, a role that had previously been held by other members of the interdisciplinary nutrition support team. Data from patients receiving PN at Primary Children's Hospital between January 1 and December 31, 2015 was retrospectively reviewed. Micronutrients monitored and adjusted include zinc, carnitine, copper, aluminum, selenium, iodine, and multivitamins. Data collected included: number of patients receiving PN monthly, number of patients monitored monthly, recommendations made to the medical team, and acceptance of those recommendations. Macronutrients and electrolytes were not assessed. The primary outcome was the percentage of recommendations accepted by the medical team. Secondary outcomes measured included the percent of accepted monthly recommendations as well as all micronutrient dose adjustments. Measures of central tendency were utilized to analyze the data.

Results: Data was obtained from 923 patients that received PN during 2015, of which 562 received specific recommendations regarding monitoring of micronutrients during therapy. Prior to pharmacist intervention, the acceptance rate of recommendations was 61%. After implementation of the pharmacist interventions, approvals rose to 83.5%. Nine hundred eighty-three total recommendations were made in 2015 (zinc 304, carnitine 202, copper 260, aluminum 24, selenium 81, iodine 52, vitamin A 13, vitamin D 15, and other 32). Iodine had the highest rate of acceptance with 88.5% of the recommendations being implemented.

Conclusions: Pharmacists have an important role on both the interdisciplinary nutrition support team as well as the medical team. Acceptance and implementation of recommendations made by nutritional support team members rose from 61% to 83.5% with pharmacist involvement. Improved monitoring and dose customization may lead to optimized nutritional supplementation for patients receiving parenteral nutrition.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

DEVELOPMENT AND EVALUATION OF A PEDIATRIC INPATIENT INSULIN PEN SAFETY INITIATIVE AT A COMMUNITY TEACHING HOSPITAL

Jessica Frye ¹, Suzannah Kokotajlo ¹, Christine Robinson ¹

Background: Because of the potential for inadvertent multipatient pen use, the Institute for Safe Medication Practices has called hospitals to closely reexamine all policies related to insulin pen utilization. Insulin pens were previously available for adult critical care and all pediatric patients at our institution; however, in July 2014, pens were removed from the adult intensive care units. Insulin pens were retained for pediatric use because of their role in comprehensive diabetes education for both patients and their families prior to discharge. In an effort to develop a safer practice model, we participated in an improvement activity sponsored by the American Society of Health-System Pharmacists and developed a double scanning procedure to ensure each insulin pen utilized is patient specific.

Methods: An insulin pen double scanning policy was initiated in 2014 for all pediatric inpatients. The double scanning procedure requires the pharmacist to create an entry for the patient's insulin order along with an order for the pen itself, generating a patient-specific barcode at the time of order entry. Prior to dispensing, the patient-specific barcode is affixed to the barrel of the insulin pen. Upon administration, the nurse is required to scan both the manufacturer barcode and the hospital-generated patient label. Pharmacy and nursing education was provided and visual references were placed in the pediatric pharmacy satellite and medication rooms. Pen labeling and double scanning compliance was trended from August 2014 through January 2016 for patients admitted to the pediatric intensive care unit or general pediatric floor with a goal compliance rate of greater than 90%.

Results: A total of 1372 insulin doses were administered to pediatric inpatients during the study period. During the first 10 months of data collection, double scanning compliance was 62%. Due to an unsatisfactory compliance rate, process improvements were initiated. Weekly scanning audits were conducted and misses were presented to pediatric nursing coordinators. Individual nurses were re-educated and information about the double scanning procedure was presented in morning nursing huddles. Following an increase in audit frequency and nursing re-education, compliance increased to 93%. Compliance dropped once again in November and December of 2015 to 85% and 84%, respectively leading to the inclusion of a labeled bag dispensed from the pharmacy depicting which barcodes must be scanned prior to insulin pen administration. Following further process improvements, compliance increased to 100% in the month of January.

Conclusions: Pharmacy and nursing collaboration led to the development of an improved process for the dispensing and administration of insulin pens to pediatric patients at our institution. Fluctuating insulin order frequency provided the greatest challenge to compliance. Policy reinforcement, nursing education and process improvements ultimately led to a 100% double scanning compliance rate which will continue to be monitored.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

PHARMACIST-MANAGED SHORT-ACTING BETA AGONIST REFILL SERVICE FACILITATES ASTHMA CARE AND EDUCATION IN A GENERAL PEDIATRICS CLINIC

Brooke Gildon ¹, Michelle Condren ¹, Barnabas John ¹, Roxanne Naanos ¹, Shellie Keast ¹, Christopher Robertson ¹

Background: Overuse of short-acting beta agonist (SABA) medication is a marker of asthma morbidity in pediatric patients. SABA refill algorithms can regulate SABA use and assist in identifying patients with uncontrolled asthma. This study evaluates the effects of a pharmacist-managed SABA refill phone service in a pediatric clinic.

Objective: To identify the reason for requesting SABA refills and the pharmacist's clinical assessment, recommendations, and interventions.

Methods: Secondary to concerns regarding excessive SABA refill requests, a pharmacist-managed refill service was initiated. Over 12-wks, pharmacists contacted caregivers requesting a SABA refill to determine reasons for request, whether the request met criteria for refill per a clinic-wide refill algorithm, asthma control, controller medication adherence, and spacer use. Patient demographics and pharmacist interventions (e.g., refill provided, education provided, follow-up scheduled) were also collected. Service effectiveness was evaluated by retrospective chart review. Data was analyzed using Chi-Square, Fisher's Exact, or multivariate logistic regression, as appropriate.

Results: Eighty-four patients were included in the study. Primary reasons for SABA refill request were for 1) current symptom management and 2) no refills remaining on a current prescription in the absence of symptoms. Fifty percent of SABA refill requests were eligible to refill per the clinic algorithm. Asthma control was assessed as well controlled (26%), not well controlled (38%), and very poorly controlled (36%). Forty-eight percent of patients prescribed daily controller medications were deemed adherent. Spacers use was reported in 56% of patients using metered-dose inhalers. Education was provided to 82% of caregivers contacted. Pharmacists facilitated asthma follow-up visits in 49% of patients contacted and 61% of those appointments were kept.

Conclusions: Pharmacist management of a SABA refill phone service provides an additional means for delivery of healthcare provider asthma education between patient clinic visits, and facilitates follow-up asthma care for those without adequate asthma control.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

COMMUNITY PHARMACISTS' KNOWLEDGE OF CODEINE USE IN CHILDREN

Ting He ¹, Allison Lardieri ¹, Jill Morgan ¹

Introduction: In 2011, approximately 1.7 million pediatric patients had a codeine containing prescription filled at US retail pharmacies. However, numerous cases involving serious adverse effects or fatalities have been reported in children who have been prescribed codeine. In 2013, the FDA added a black box warning to avoid codeine in children after a tonsillectomy. However, it is unknown how the current warnings surrounding codeine have impacted pharmacy practice. Therefore, the purpose of this study is to determine pharmacists' knowledge of the black box warning for codeine in children.

Methods: A 16-item survey was administered via survey monkey to community pharmacists in Maryland. The survey consisted of questions regarding knowledge of the black box warning for codeine in children and which conditions are appropriate for codeine use. Participants were recruited using emails and professional meetings. Descriptive statistics were used to analyze results.

Results: There were 47 responses to the survey, which was a response rate of 35%. Of those, 6 were inpatient pharmacists and 8 did not complete the entire survey. The majority of the responders were male (64%), Caucasian (60%), and practicing for 6 or more years (63.1%). 38% (14/37) of respondents were aware of the black box warning; however, only 4/14 respondents (29%) were able to correctly describe the warning in an open ended question. Only 29% (10/35) knew the concern occurred in ultra-rapid metabolizers. Respondents noted it was appropriate to use codeine in a child for pain (41%), cough (32%), and not at all (27%).

Conclusions: The majority of respondents do not know about the codeine black box warning in children. Therefore, more education is needed for community pharmacists in the future.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

LONG TERM STABILITY OF PEG 3350 AND LACTULOSE IN COMMON LIQUIDS

Allison Lardieri ¹, Jill Morgan ¹, Soundarya Vaithianathan ¹, Claire Carter ¹, Maureen Kane ¹, James Polli ¹

Introduction: Constipation is common problem in pediatric patients. Polyethylene glycol (PEG 3350) and lactulose are commonly used to treat children with constipation, but adherence rates have been reported as <40%. To increase adherence, PEG 3350 or lactulose can be mixed with liquids a child may be more likely to drink. However, there is no stability information for PEG 3350 or lactulose in liquids other than water. The objective of this study was to determine is lactulose (Kristalose^®) and PEG 3350 (Miralax^®) can be mixed with water, juices, soda, and milk and maintain stability for up to 72 hrs.

Design/Methods: Commercially available lactulose and PEG 3350 were prepared with water according to their respective package insert directions, as well as prepared with 4 common liquids: soda, orange juice, apple juice, milk. Physical characteristics of the solutions were evaluated at time of preparation (time 0) and at 24 hr intervals for 3 days. At each time point, the samples were examined for obvious changes in color and odor. Immediately after the visual/odor observations, the samples were analyzed using Matrix Assisted Laser Desorption Ionization (MALDI) mass spectrometry. Stability of PEG 3350 was assessed by monitoring for its sustained presence as well as formation of degradation products. Since there are no known degradants of lactulose, stability was assessed by monitoring only for its sustained presence.

Results: There were no significant differences in the profiles for 0hr and 72hr, suggesting the stability of both PEG 3350 and lactulose.

Conclusions: Both Miralax and Lactulose were stable for 72 hrs in water, juice, soda, and milk. Clinicians can counsel families to mix both of these products in common liquids, which may be more preferable to children, thus potentially increasing adherence.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

IMPACT OF A PEDIATRIC DEGREE OPTION ON STUDENT PARTICIPATION IN SCHOLARLY ACTIVITIES

Pete Johnson ¹, Brooke Gildon ¹, Michelle Condren ¹, Jamie Miller ¹, Tracy Hagemann ¹, Teresa Lewis ¹, Bob John ¹, Kevin Farmer ¹

Introduction: A curricular degree option was created at the University of Oklahoma in 2010 to improve competence in pediatrics, with the first graduate in 2011. Students have to complete 6–8 hrs of didactic coursework and 2–3 advanced pharmacy practice experience (APPE) rotations. This abstract quantifies student participation in scholarly activities pre- and post-degree option implementation.

Methods: This was a retrospective, IRB-exempt study comparing student participation in scholarly activities 5 years pre- (2005–2010) and 5 years post-degree option (2011–2016) implementation. Data collection included number of APPEs per faculty per year and number of quality improvement (QI) and scholarship projects. The primary objective was to compare the number of students participating in scholarship and QI projects pre- and post-degree option implementation. Secondary objectives included comparison of the mean number of projects per student between groups. Descriptive and inferential statistics were utilized.

Results: Forty students have been enrolled in the program, including 22 graduates. Thirty-three (82.5%) have participated in a project to date. There were 37 APPEs offered per faculty member pre-, and 41 APPEs offered post-degree option. There was a significant difference in the number of students completing projects pre- versus post-implementation per faculty member, 17 (45.9%) versus 33 (80.5%) (p<0.01). There was a significant difference in the mean number of projects per student pre- versus post-implementation, 3.0+1.5 vs 5.1+3.7 (p=0.03). There were noticeable though not statistically significant differences between the mean QI and IRB projects, presentations, and manuscripts between groups.

Conclusions: The pediatric degree option allowed for a significant increase in the number of students per faculty member to participate in scholarly activities. These projects have resulted in a sizeable number of manuscripts and presentations. These data suggest that this program increases students' clinical pediatric experience but also scholarly activities in pediatrics.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

VORICONAZOLE THERAPEUTIC DRUG MONITORING IN PEDIATRIC HEMATOPOIETIC CELL TRANSPLANT PATIENTS

Keito Hoshitsuki ¹, Raman Venkataramanan ¹, Denise Howrie ¹

Introduction: Voriconazole (VORI) is used frequently in patients undergoing hematopoietic cell transplant (HCT) as prophylaxis against opportunistic fungal infections by both Candida and Aspergillus species. At the Children's Hospital of Pittsburgh of UPMC (CHP), patients receive oral VORI after allogenic HCT. Survival benefits and treatment failure have been demonstrated in the pediatric population with trough concentrations above and below 1 μg/ml respectively. VORI demonstrates large inter- and intra-patient pharmacokinetic variability, thus therapeutic drug monitoring (TDM) is recommended. As a quality initiative under the CHP Antimicrobial Stewardship Program, our objectives were to review the VORI dosing and TDM practices at CHP following HCT; characterize the relationship between dose, age, and concentrations; and formulate recommendations for VORI dosing and monitoring for pediatric HCT patients.

Methods: Allogenic HCT patients at CHP from January 2013 to September 2015 that received VORI as primary antifungal prophylaxis were identified retrospectively through review of the electronic medical record. Patients on VORI research protocols or receiving VORI for treatment of suspected or documented fungal infection were excluded.

Results: Of the 37 patients that met the inclusion criteria, 33 patients had at least one trough measurement in the 60 days following VORI prophylaxis initiation. Only 9 patients achieved a trough concentration ≥1 mg/L on the first trough draw. For all patients, 140 total trough measurements were obtained in the 60 days post-VORI initiation with 116 troughs <1 mg/L. Despite the lower than desired levels, only 6 dosage modifications were performed. In pediatric patients ≤21-yrs-old, no significant associations between trough concentration ≥1 mg/L and dose or age were observed. Findings were similar in analyses in patients < 12-yrs-old.

Conclusions: These results are consistent with the large inter- and intra-patient variability described with VORI use in small case studies in children. From these results, use of higher initial VORI doses and more structured serum concentration monitoring and dose adjustments is needed to maximize care in pediatric HCT patient population. Additional planned study in this population includes prospective study of VORI dosing and TDM practices following interventions and analysis of the magnitude of drug-drug interaction between VORI and calcineurin inhibitors administered for graft-versus-host disease prophylaxis.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

RECURRENT FOCAL SEGMENTAL GLOMERULOSCLEROSIS AFTER PEDIATRIC RENAL TRANSPLANT – A SINGLE CENTER EXPERIENCE

Anastacia Glumova ¹, Rochelle Liverman ¹, Roshan George ¹

Introduction: Focal Segmental Glomerulosclerosis (FSGS) recurrence after renal transplantation is an important cause of patient morbidity and allograft loss. The aim was to review the management and outcomes of recurrent FSGS in pediatric renal transplant recipients at a large pediatric center.

Methods: A retrospective review was done of pediatric renal transplant recipients from 1/1/2002–12/31/2014 who had FSGS recurrence post-transplant at our institution.

Results: A total of 351 pediatric patients received a renal transplant at our institution during the study period. Of these, 39 (11%) had a primary diagnosis of FSGS. In that cohort, 17/39 patients (44%) developed nephrotic-range proteinuria and/or had histological evidence of recurrent FSGS on biopsy within 1–10 days post-transplant. All patients with FSGS recurrence received our standard induction regimen (basiliximab and methylprednisolone) and maintenance immunosuppression (tacrolimus, mycophenolate or azathioprine, and prednisone). All patients with FSGS recurrence received early plasmapheresis (PP) as their initial treatment. The median number of PP sessions was 27 (range: 9–119). Nine patients received treatment with PP alone; additional therapies included oral cyclophosphamide (n=5), rituximab (n=4), intravenous (IV) methylprednisolone (n=4), IV cyclophosphamide (n=2), and abatacept (n=1). Complete remission as defined by urine protein to creatinine ratio (UPCR) <0.2 mg/mg was achieved in 10/17 patients (59%) and sustained partial remission (UPCR 0.2–2 mg/mg) in 1 additional patient. Six of 10 patients (60%) who achieved complete remission received PP only; the median number of PP sessions was 16 (range: 9–55 sessions) in patients who achieved complete remission with PP alone or in combination with other therapies. In the recurrent FSGS cohort, 4 patients lost their renal allograft, 1 secondary to recurrent FSGS and 3 patients due to other causes (rejection [n=2] and thrombosis [n=1]).

Conclusions: Early initiation of PP is effective in managing recurrent FSGS in pediatric renal transplant recipients. Cytotoxic agents and corticosteroids may provide additional benefit in those who are not able to achieve remission with PP alone. Unfortunately, data at our center indicates that as many as 40% may not achieve complete remission with currently available therapies and are at increased risk for graft loss.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

EXAMINING THE IMPACT OF USING SMARTPHONES WITH PEDIATRIC PATIENTS: A SYSTEMATIC REVIEW

Katrina D'Souza ¹, Mehdi Namil ¹, Natalie Weltman ¹, Annesha White ¹, Jason Trinh ¹, Pamela Carter ¹, Cassidy Loving ¹, Chloe Dang ¹, Stephanie Jacobs ¹

Introduction/Objective: Many babies and toddlers absolutely love playing with touch-screen technology. The touch screen provides instant gratification with its cool images, movements, and sounds appealing to their senses. Many parents are also thrilled with this interactive technology because the objective of this study was to identify examples of pediatric patient use of smartphones to improve health outcomes and to discuss the costs associated with use.

Methods/Design: A systematic review was conducted using Pubmed, Medline, Cinahl Plus, Cochrane Library, Scopus, Trip and PsychInfo databases to identify studies regarding smartphone use in pediatrics conducted between 2005 and 2015. Key search terms included “mhealth”, “telehealth”, “smartphone”, “mobile applications”, “cost savings”, “pediatric”, and “patient health outcomes”. Abstracts were screened against inclusion criteria and selected based upon relevance and quality. The most significant eligibility criteria required was that a smartphone be provided to the patient/parent. Risk of bias was assessed using the Cochrane Risk of Bias Tool. Use of Covidence facilitated the summary of selected articles. Notable characteristics were summarized in tables.

Results: The search yielded a total of 80 articles for review. Nineteen articles were included in the analysis that pertained to pediatric patients. Several disease states were presented in papers that matched inclusion criteria including childhood obesity and weight management, hearing loss, immunization adherence, cardiovascular issues as well as asthma and COPD. Smartphones have been very useful in improving the engagement in treatment and reducing dropout rates in clinical studies. The use of smartphones has sufficiently bridged gaps in healthcare in rural areas. In certain functions, further research is needed to validate the effectiveness of smartphone use, specifically in patients less than 2 years old.

Conclusions: Providing smartphones to pediatric patients (or parents of pediatric patients) can improve disease state management and lower overall healthcare costs. Several studies point toward decreases in readmissions, but more research is needed to explore future implications.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

PEDIATRIC INDIVIDUALIZED PEDIATRIC THERAPEUTICS CLINIC: ACTION IN PRACTICE

Tracy Sandritter ¹, Cristy Eidelman ¹, Kelly Hodges ¹, Jennifer Lowry ¹

Background: A goal of an Individualized Pediatric Therapeutics (IPT) Clinic is to find the right medication without a trial and error process. Personalizing medicine incorporates knowledge related to medication therapy (pharmacokinetics, formulation options, pharmacology) with several laboratory technologies to individualize medicine. The IPT Clinic at Children's Mercy was established in 2010 as part of our initiative to integrate the advancements of genomic technologies into patient care. We utilize a multidisciplinary team approach to solve clinically significant medication-related problems. Our team includes physicians, pharmacists, clinical pharmacologists, basic scientists, and nurses. We meet one week prior to the clinic visit to review a patient's medical history. On the day of the clinic visit, a physician and pharmacist meet with the patient and family to complete a medication history. If necessary, pharmacogentic or other clinical tests are ordered. If tests are ordered, a second visit occurs to review the results with the patient's family. Recommendations are provided to the referring physician after each appointment. Rational: The reason for reviewing our experience is to understand which patients are referred and determine which tools have been of assistance. We hypothesized that referrals made to an IPT Clinic are frequently related to difficult to explain adverse responses or lack of clinical response to medications and that laboratory tests, including pharmacogenomics, provide guidance for recommendations in drug therapy.

Objectives: were two-fold: to describe the referrals made to an IPT Clinic and to describe the laboratory evaluation completed to provide therapy recommendations.

Results: The first patient was seen in July 2010. We have seen 279 patients. Demographics: 236 Caucasian, 15 Black, 9 Asian, 1 Pacific Islander, 15 other (11 multiracial). 36 were adopted (5 China, 1 Korean, 27 USA). 213 patients referred by Sub-specialists (Top 3: Psychiatry, Gastroenterology, Neurology), 43 patients by Primary Care Providers (182 and 7 patients, respectively referred by internal providers). The greater majority of our patients have behavioral and developmental diagnosis. The next most common diagnoses were gastrointestinal and neurologic. Reasons for referral: 127 ADR, 152 poor medication response, 6 family provided genotype results, 19 genotype requested by family / physician, 17 other. At the time of the first visit, patients were on an average of 5.4 ± 3.72 medications. Common genotyping tests performed include CYP2D6, CYP2C19, CYP2C9, Serotonin 2A/2C receptor, serotonin transporter, DRD3 Receptor, and the DRD4 Receptor. Genotyping was performed in 163 patients (58.4%). For patients whose referring physician was an internal provider, recommendations were accepted 70 patients, partly accepted in 23 patients (49% full/partial acceptance rate).

Conclusions: Referrals to our IPT Clinic are frequently related to difficult to explain adverse responses or lack of clinical response to medications. Pharmacogenetic results have helped provide guidance for recommendations in drug therapy.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

RETROSPECTIVE REVIEW OF THE RISK FACTORS ASSOCIATED WITH ADVERSE EFFECTS ASSOCIATED WITH CHRONIC SYSTEMIC GLUCOCORTICOID USE

Kin Yin Jennifer Ng ¹, Celeste LY Ewig ¹

Introduction: The anti-inflammatory and immunosuppressive properties of glucocorticoids have prompted their extensive use in the management of myriad diseases. The diverse actions of glucocorticoids however also result in a diverse adverse effect profile affecting multiple organ systems. This often leads to fear among parents with the use of systemic glucocorticoids and possible non- compliance

Objective: To determine the incidence of chronic glucocorticoid-associated adverse events and the medication usage pattern associated with such adverse events in a local ambulatory pediatric population

Methods: Patients receiving ≥30 day supply of systemic glucocorticoids were identified from dispensing records of the outpatient pediatric clinic at a local regional tertiary care institution from January 1 to December 31, 2013. A retrospective review of selected patients' medical record was conducted. The primary outcome measured was the presence of a glucocorticoid associated adverse event. Our secondary outcome measured was the dose and duration of exposure of systemic glucocorticoids in each patient. The odds ratio (OR) for known glucocorticoid adverse events was calculated to determine the likelihood of such event to occur.

Results: A total of 67 patients met the criteria for inclusion in our study. The two most commonly identified adverse effects were the development of the cushingoid appearance and skin changes. Cushingoid appearance was found among 52 (78%) patients with an adjusted OR=0.898 (CI 0.815–0.999 p<0.28) taking into consideration the duration of continuous use; and an adjusted OR = 3.125 (CI 1.349–7.241 p=0.008) for cumulative dose. Skin changes were reported among 38 (57%) patients and corresponded to an adjusted OR= 0.926 (CI 0.863–0.993 p=0.031) with duration of continuous use and adjusted OR= 2.003 (CI 1.307–3.069 p=0.001). Total cumulative dose was also found to be an important predictor of eye conditions, while the duration of use appears to be a stronger predictor of growth suppression. No significant difference in bone development or occurrence of fractures was noted between patients on calcium and/or vitamin D supplements since glucocorticoid initiation and those who were not. Serum phosphate levels were found to be higher in children who were not initially supplemented at certain time points, i.e. after 1 yr, 2.5 yrs and 3.5 yrs of treatment.

Conclusion: The high prevalence of cushingoid appearance and skin changes is of concern especially among children who require long-term treatment with systemic glucocorticoids. Pharmacists may play an important role in alerting physicians regarding the increase risk for such adverse effects through vigilant monitoring of a patient's cumulative dose and duration of exposure and suggest options to decrease the patient's risk and educate parents and caregivers to minimize potential non-compliance.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

ASSESSMENT OF INITIAL VANCOMYCIN DOSE REGIMENS AND ACHIEVEMENT OF TARGET VANCOMYCIN TROUGHS IN A PICU POPULATION

Allison Chung ¹, Rosa Vidal ¹, Fadi Alaas ¹

Introduction/Objective: The latest vancomycin monitoring guidelines in adults advocate goal trough levels of 15–20 mg/L. However, there are no specific guidelines for children especially critically ill children. Oftentimes, achieving goal troughs can be difficult in the critically ill pediatric population using standard vancomycin dosing. The objective of this study was to assess the frequency and time period which vancomycin dosing regimens of <60 mg/kg/day versus ≥60mg/kg/day achieved target serum concentration levels of 15–20 mg/L in critically ill pediatric patients.

Methods/Design: This was a retrospective review of pediatric patients admitted to the Pediatric Intensive Care Unit (PICU) between 2011 and 2015. Inclusion criteria included PICU patients between 3 mo-18 yrs, who received vancomycin for >3 days with appropriately obtained troughs after initial regimen (obtained 30 minutes prior to 4th dose), and had a creatinine clearance >70 mL/min. Patients were compared based on initial vancomycin dosages with Group 1 consisting of patient who received doses < 60mg/kg/day and Group 2 receiving ≥60 mg/kg/day. Groups were also analyzed based on clinical status (critical versus non-critical). The time to achieve target trough concentrations were determined to fall in one of three time periods: <48 hrs, ≥48 hrs, or never achieved.

Results: A total of 87 encounters were evaluated with 54% male (n=47). The age range was 3 months-2 years (n=23), 3–10 years (n=26), and 10–18 years (n=38). For all encounters, the goal trough was achieved within 24 hours in 12.6%, 48 hrs in 11.4%, 72 hrs in 9.1%, >96 hrs in 20.7% and not achieved in 46%. Group 1 was 34% of the encounters whereas Group 2 was 65.5%. Achievement of target trough concentration at <48hrs was 20% and 26% for Group 1 and Group 2 (p=0,5), respectively, 30% for both Groups at ≥48 hrs (p=0.9) and not achieved in 50% and 44% (p=0.5). In Group 2, 69% were defined as critical and 39% were non critical. Critical encounters achieved goal troughs 24% at <48 hrs, 31% at ≥48 hrs and 45% did not achieve goal. When critical versus non-critical encounters was compared, there was no statistically significant difference between these groups for target troughs < 48 hrs (p=0.3). However, there was a statistically significant difference at ≥48 hrs (p=0.05) and for goals not achieved (p=0.04).

Conclusion: Overall, target troughs were obtained in about half of the occurrences with most of these occurring after 96 hrs. There was no statistically significant difference in obtaining the goal trough when < 60 mg/kg/dose was compared to ≥60 mg/kg/dose. There was no difference in time to obtaining target troughs in PICU patients receiving doses <60 mg/kg/day versus those receiving ≥60 mg/kg/day. It appears that the level of acuity may negatively affect achieving target trough concentrations.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

POPULATION PHARMACOKINETICS (PK) OF VANCOMYCIN (VAN) IN NEONATES ON EXTRA-CORPOREAL LIFE SUPPORT (ECLS)

Jeffrey Cies ¹, Wayne Moore ¹, Kristen Nichols ¹, Chad Knoderer ¹, Dominick Carella ¹, Jason Parker ¹, Paul Shea ², Arun Chopra ¹

Introduction: VAN remains first line therapy for the treatment of life-threatening infections caused by methicillin resistant Staphylococcus aureus (MRSA) and ampicillin resistant Enterococci. Current evidence suggests that VAN trough levels of 15–20 mg/L or an AUC:MIC ratio of 400:1 are needed to maximize outcomes. Many factors can affect VAN PK in the pediatric ICU including sepsis and ECLS. Currently, no VAN PK data exists for children on ECLS with the current ECLS equipment. The purpose of this study was to describe VAN PK in children with a contemporary ECLS operation, including the Quadrox oxygenator

Methods: During the ECLS run, routine blood samples were collected from 14 neonates who received VAN for prophylaxis or empiric therapy. VAN concentrations were measured by fluorescent polarization and the population PK was determined using PMetrics. Multiple compartmental and covariate models were explored to determine the best fit of the data.

Results: 13 neonates with a median gestational age of 36 weeks accounted for 16 VAN treatment courses. Each course contributed a median of 8 VAN levels (3–27) to the model. A 2 compartment model with weight as a covariate fit the VAN concentration data the best. Mean (SD) population estimates for clearance (CL), volume of the central compartment (Vc), total volume of distribution (Vd), and intercompartment transfer constants were 1.93 (5.11) mL/min/kg, 0.27 (0.25) L/kg, 0.49 (0.38) L/kg, 2.49 (1.4) hr-1, and 2.64(1.1) hr-1, respectively. This resulted in a mean (SD) elimination half-life of 4.9 (6.6) hr. The CL estimate in this population of ECLS patients is significantly higher than previous estimates (0.5–1 mL/kg/min) with older oxygenators with a similar Vd with a contemporary ECLS arrangement.

Conclusion: These are the first VAN PK data in neonates with a contemporary ECLS operation utilizing the Quadrox oxygenator demonstrating significantly higher CL values with a similar Vd.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

POPULATION PHARMACOKINETICS (PK) OF VANCOMYCIN (VAN) IN CHILDREN ON EXTRA-CORPOREAL LIFE SUPPORT (ECLS)

Jeffrey Cies ¹, Kristen Nichols ¹, Chad Knoderer ¹, Wayne Moore ¹, Dominick Carella ¹, Jason Parker ¹, Pau Shea ¹, Arun Chopra ¹

Introduction: VAN remains first line therapy for the treatment of life-threatening infections caused by methicillin resistant Staphylococcus aureus (MRSA) and ampicillin resistant Enterococci. Current evidence suggests that VAN trough levels of 15–20 mg/L or an AUC:MIC ratio of 400:1 are needed to maximize outcomes. Many factors can affect VAN PK in the pediatric ICU including sepsis and ECLS. Currently, no VAN PK data exists for children on ECLS with the current ECLS equipment. The purpose of this study was to describe VAN PK in children with a contemporary ECLS operation, including the Quadrox oxygenator

Methods: During the ECLS run, routine blood samples were collected from 26 children who received VAN for prophylaxis or empiric therapy. VAN concentrations were measured by fluorescent polarization and the population PK was determined using PMetrics. Multiple compartmental and covariate models were explored to determine the best fit of the data.

Results: 26 children with a median age of 1.8 yrs (3 mo-7 yrs) accounted for 33 VAN treatment courses. Each child contributed a median of 2 VAN levels (1–14) to the model. A 2 compartment model with weight as a covariate fit the VAN concentration data the best. Mean (SD) population estimates for clearance (CL), volume of the central compartment (Vc), total volume of distribution (Vd), and intercompartment transfer constants were 2.02(2.79) mL/min/kg, 0.05 (0.05) L/kg, 0.12 (0.17) L/kg, 1.63 (1.31) hr-1, and 2.34 (1.55) hr-1, respectively. This resulted in a mean (SD) elimination half-life of 2.03 (2.47) hr. The CL estimate in this population of ECLS patients is significantly higher than previous estimates (1 mL/kg/min) with older oxygenators yet the Vd appears to be smaller with a contemporary ECLS arrangement.

Conclusion: These are the first VAN PK data in critically ill children with a contemporary ECLS operation utilizing the Quadrox oxygenator. These data demonstrate significantly higher CL estimate than previous data which needs to be recognized when selecting a dosing regimen.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

CEFEPIME PHARMACOKINETICS IN PEDIATRIC CYSTIC FIBROSIS PATIENTS

Jeffrey Cies ¹, Wayne Moore ¹, Arun Chopra ¹, Adela Enache ¹, Laurie Varlotta ¹

Introduction: The treatment of acute pulmonary exacerbations (APEs) in Cystic Fibrosis (CF) requires dual therapy, typically with regimens containing an anti-pseudomonal β-lactam. Optimal β-lactam dosing regimens in pediatric CF patients are not well described. We aimed to evaluate the pharmacokinetics (PK) of cefepime (CEF) in pediatric CF patients admitted for the treatment of an APE.

Methods: This was a PK study of hospitalized pediatric CF patients that received CEF either as a 0.5 hr intermittent infusion (II) or 18 hr continuous infusion (CI) for treatment of an APE from November 2014-March 2015. Patients contributed 2–3 blood samples for CEF concentration determination. CEF concentrations were determined by liquid chromatography/tandem mass spectroscopy. A non-compartmental PK analysis was conducted to determine the elimination rate constant (ke), half-life (t1/2), and volume of distribution (Vd). The % of the dosing interval with free drug concentrations above the MIC (fT>MIC) was calculated using an MIC of 8 and 16 mg/L. Bactericidal exposure was defined as ≥ 50% fT>MIC. The probability of target attainment (PTA) > 90% for each MIC was defined as optimal.

Results: 7 patients contributed 16 CEF concentrations. The median age was 4 yrs (range 2–9 yrs). Mean weight was 20.5 ± 0.94 kg. 4 of 7 patients received CEF as II of 50 mg/kg/dose IV q 6 hr and 3 of 7 patients received 200 mg/kg/day 18-hr CI. The mean ± SD ke was 0.46 ± 0.2 hr-1. The mean ± SD t1/2 was 1.8 ± 0.9 hrs as compared to a reported t1/2 of 2–4 hrs in non-CF pediatric patients. Of the 4 patients receiving II, none had an appropriate PTA at the MICs of 8 and 16 mg/L. Of the 3 patients receiving 18-hr CIs, all achieved target PTA at the MICs of 8 and 16. Using the mean PK parameters from this cohort, an 18-hr CI of 175 mg/kg/day is needed is needed to achieve a serum level 8x the intermediate breakpoint of 16 mg/L and 350 mg/kg/day for the resistant breakpoint of 32 mg/L. If 24-hr CIs were used, the total daily doses needed would increase to 240 and 470 mg/kg/day, respectively.

Conclusion: These data suggest the CEF PK in pediatric CF patients is different than non-CF pediatric patients. Standard intermittent dosing regimens do not result in serum concentrations that achieve a 90% PTA for a bactericidal exposure. 18 and 24-hr CI regimens of do provide for an appropriate PTA with doses ranging from 175–470 mg/kg/day depending on the MIC.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

CEFEPIME PHARMACOKINETICS IN ADOLESCENT AND YOUNG ADULT CYSTIC FIBROSIS PATIENTS

Jeffrey Cies ¹, Wayne Moore ¹, Arun Chopra ¹, Adela Enache ¹, Laurie Varlotta ¹

Introduction: The treatment of acute pulmonary exacerbations (APEs) in Cystic Fibrosis (CF) requires dual therapy, typically with regimens containing an anti-pseudomonal β-lactam. Optimal β-lactam dosing regimens in pediatric CF patients are not well described. We aimed to evaluate the pharmacokinetics (PK) of cefepime (CEF) in adolescent CF patients admitted for the treatment of an APE.

Methods: This was a PK study of hospitalized adolescent CF patients that received CEF either as a 0.5 hr intermittent infusion (II) or 18 hr continuous infusion (CI) for treatment of an APE from November 2014-March 2015. Patients contributed 2–3 blood samples for CEF concentration determination. CEF concentrations were determined by liquid chromatography/tandem mass spectroscopy. A non-compartmental PK analysis was conducted to determine the elimination rate constant (ke), half-life (t1/2), and volume of distribution (Vd). The % of the dosing interval with free drug concentrations above the MIC (fT>MIC) was calculated using an MIC of 8 and 16 mg/L. Bactericidal exposure was defined as ≥50% fT>MIC. The probability of target attainment (PTA) > 90% for each MIC was defined as optimal.

Results: 7 patients contributed 16 CEF concentrations. The median age was 15 yrs (range 15–22). Mean weight was 53.1 ±8.9 kg. 3 of 7 patients received CEF as II of 2000 mg IV q 6 hr and 4 of 7 patients received 8000 mg 18-hr CI. The mean ± SD ke was 0.63 ± 0.13 hr⁻¹. The mean ± SD t1/2 was 1.1 ± 0.3 hrs as compared to a reported t1/2 of 2–4 hrs in non-CF adolescent patients. Of the 3 patients receiving II, each had an appropriate PTA at the MICs of 8 and 16 mg/L with the q 6 hr dosing regimen. Of the 4 patients receiving 18-hr CIs, all achieved target PTA at the MICs of 8 and 16.

Conclusion: These data suggest the CEF PK in adolescent and young adult CF patients is different than non-CF patients. Standard intermittent dosing regimens do not result in serum concentrations that achieve a 90% PTA for a bactericidal exposure but a q 6 hr dosing regimen did. 18 and 24-hr CI regimens also provided for an appropriate PTA.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

CONTINUOUS INFUSION OF ROCURONIUM IN CRITICALLY ILL INFANTS AND CHILDREN

Weng Man Lam ¹, Courtney Kain ¹

Introduction: Rocuronium, an intermediate-acting neuromuscular blocking agent, is typically used intermittently for temporary paralysis. Fluctuating medication shortages of vecuronium has prompted the use of rocuronium as a continuous infusion despite limited published literature in the pediatric population. The objective of this study was to evaluate the efficacy and safety of continuous infusion rocuronium for facilitation of mechanical ventilation in pediatric critically ill patients.

Methods: This retrospective study included pediatric patients less than 18 years of age admitted to the pediatric intensive care unit and started on continuous rocuronium infusion between March 1, 2014 to June 30, 2015. Patients initiated on extracorporeal membrane oxygenation during PICU stay were excluded. Patient demographic information, including admitting diagnosis, age, weight, blood pressure, heart rate, mean arterial pressure, concurrent sedation and analgesic agents at time of rocuronium infusion were collected. Rocuronium infusion doses to maintain a train of four at 2 of 4 twitches (approximate 85% blockade) were also documented as well as any potential complications of neuromuscular blockade. Statistical analysis included t-test to compare dosage of different age and paired t-test to compare the initial rocuronium dose with blood pressure, mean arterial pressure, heart rate at baseline and one hour after the initiation of the continuous infusion. All analyses were considered significant with p values < 0.05.

Results: Forty-six patients with a total of fifty encounters met inclusion criteria. Admitting diagnoses included respiratory failure, sepsis, trauma, congenital heart or cardiac disease, and other. The mean initial rocuronium dose was 0.58 mg/kg/hr ± 0.176 (range: 0.1 –1 mg/kg/hour) with a mean infusion dose of 0.68 mg/kg/hr ± 0.179. On average, each patient was on the continuous infusion for 2.7 days, but the duration of each rocuronium infusion rate varied from 8 to 189 hrs. The average highest dose of rocuronium administered at any time was 0.824 mg/kg/hr ± 0.27 (range: 0.5 to 1.5 mg/kg/hr) and the number of dose adjustments per day to maintain the required train of four varied from 0 to 6 times. Four patients did not achieve adequate paralysis using rocuronium and had to be changed to vecuronium. Average dose requirements for patients less than one year of age and those greater than one year were not significantly different (p-value: 0.1799). Cardiovascular effects of rocuronium at baseline and one hour after rocuronium infusion were also not statistically significant. No additional adverse effects were reported.

Conclusions: Continuous infusion rocuronium for neuromuscular blockade may be a viable option for critically ill infants and children. Based on this study, a recommended rocuronium starting dose of 0.6 mg/kg/hr is appropriate for adequate blockade in most patients while titrating the medication for neuromuscular effect.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

PENTAMIDINE IS EFFECTIVE PROPHYLAXIS AGAINST PNEUMOCYSTIS JIROVECII PNEUMONIA (PCP) IN PEDIATRIC ONCOLOGY PATIENTS

JT Fannin ¹, Melissa Quinn ¹, Joseph Sciasci ¹, Hope Swanson ¹, Allison Bragg ¹, Jennifer L Pauley ¹, Kristine Crews ¹, Delia Carias ¹, David Gregornik ¹, Joshua Wolf ¹, Patrick Campbell ¹, Sima Jeha ¹, Gabriela Maron ¹, William Greene ¹

Background: PCP is a potentially life-threatening opportunistic infection in children receiving immunosuppressive chemotherapy. Trimethoprim-sulfamethoxazole is the preferred agent for PCP prophylaxis. An optimal alternative agent has not been clearly identified for use in pediatric patients unable to tolerate trimethoprim-sulfamethoxazole.

Objective: This study describes the success rates for aerosolized and IV pentamidine for PCP prophylaxis in children receiving immunosuppressive chemotherapy at our institution.

Methods: A retrospective chart review was conducted of pediatric oncology patients who received at least one dose of pentamidine for PCP prophylaxis between January 2007 and August 2014. The objective was to determine the rate of breakthrough PCP infection. Breakthrough infections were classified as possible, probable or proven PCP. Possible cases were identified by review of ICD-9 codes, pharmacy and pathology records, and death summaries using a surveillance definition comprising any compatible illness resulting in death or treatment for pneumocystis.

Results: A total of 754 patients, median age 8 years (range 1 month-24 years), were evaluated. Routes of pentamidine administration: aerosolized (n=158), IV (n=508), and both (n=88). Five children (0.66% of 754), including one infant less than one year of age (1.7% of 60 infants evaluated), developed possible PCP, but none had probable or proven PCP. All five cases had received only IV pentamidine.

Conclusions: Both aerosolized and IV pentamidine have acceptably low failure rates in pediatric oncology patients, including in children less than 1 year of age, and may be an acceptable alternative for PCP prophylaxis.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

IM TRIAMCINOLONE IN PEDIATRIC ASTHMA PATIENTS: A RETROSPECTIVE CASE SERIES

Carmen Echols ¹, Samantha Atwood ¹, Abla Bennani ¹

Introduction: Triamcinolone given intra-muscularly to adults and children has been shown in small studies to have positive results with a minimal side effect profile. Patients in previous studies were treated over a short time period at varying doses. The purpose of this case series is to report the benefits seen with using IM triamcinolone over multiple months in three pediatric asthmatic patients.

Methods: The retrospective data was collected with an approval from the Children's Healthcare of Atlanta IRB. Data was collected on three asthma patients who were started on monthly IM triamcinolone at the Hughes Spalding Asthma Clinic in 2014. Data was collected on patient demographics, triamcinolone dose and duration, asthma related ED visits and inpatient admissions, other asthma therapies, pulmonary function tests and adverse events.

Results: Three patients were reviewed for this series; ages 7, 12 and 17. After initiating monthly IM triamcinolone therapy (dose range 0.01 to 1.5 mg/kg), compliant patients were noted to have decreased missed school days, ED visits and inpatient admissions. Each patient reported symptomatic improvement following initiation of the intervention. Patients did not require concomitant oral steroid therapy while on IM triamcinolone. No reported adverse events.

Conclusion: Adding IM triamcinolone to non-compliant and/or severe pediatric asthma patients may show a reduction in asthma symptoms, decrease need for oral steroids and decrease missed school days, ED visits and inpatient admissions. Further studies are needed confirm these findings.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

THE IMPACT OF THE MEDICAL EDUCATION PROVIDED BY A CLINICAL PHARMACIST PARTICIPATING AS A MEMBER OF CHILDREN'S SPECIALIZED HOSPITAL'S INPATIENT PEDIATRIC CHRONIC ILLNESS MANAGEMENT PROGRAM (CIMP) TEAM – A CASE REPORT

Nidhi Jain ¹, Karen Kisty ¹, Colin O'Reilly ¹, Christine Tricarico ¹, Christopher Haines ¹

Introduction: Children's Specialized Hospital, the nation's leading provider of care for children facing special health challenges, offers a four week Chronic Illness Management Program (CIMP) specifically tailored for the needs of the pediatric population up to age 21. It is the only program of its kind in the New York Tri-State area specifically designed to treat young patients with chronic illnesses who have demonstrated poor adherence to their prescribed regimen. Utilizing a multi-disciplinary team approach in an acute inpatient rehabilitation hospital setting, the program targets the medical, nutritional, physical, and psychosocial needs of each patient. The role of the clinical pharmacist within the CIMP team is unique in that she provides the medical education to the patient on a scheduled 1:1 basis for a total of twenty hours during their admission. The clinical pharmacist is able to evaluate the patient and customize their teaching approach according to their age and individual need. Innovative methods such as games, podcasts, age- appropriate visual aids and handouts are all used during daily education sessions. In addition, the parents are also provided 1:1 education to help the collaborative efforts enabling supportive continuity of care from facility to home.

Case: DD is a 16 yo male diagnosed with Type 1 DM as an infant, initially well controlled until age 13, admitted with non-adherence to his medical regimen, an elevated HbA1c of 9%, and two episodes of DKA. Improved outcomes measured at six months following discharge included decreased HbA1c of 7.6%, no hospitalizations due to DKA, and increased self-reported and family member disease knowledge base, quality of life for patient and family, compliance with prescribed medical regimen, exercise regimen, and knowledge of nutrition.

Conclusions: These results are indicative of the positive impact of a clinical pharmacist-driven, disease specific educational program within an interdisciplinary pediatric chronic illness team.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

ORGANIZATION AND PROGRAMMING OF PEDIATRIC PHARMACY ADVOCACY GROUP-AFFILIATED STUDENT CHAPTERS

Lauren Karmire ¹, Courtney Cox ¹, Stephanie O'Brien ¹, Kristen Nichols ¹, Ashley Crumby ¹, Chad Knoderer ¹

Background: Following recognition of the first pediatric pharmacy student chapter by the Pediatric Pharmacy Advocacy Group (PPAG) in February 2011, the number of PPAG-affiliated student chapters has grown to 31 as of January 2016. Currently, there is limited information on chapter sponsored outreach and service opportunities or professional development of student members. The objective of this study is to characterize and share outreach and service programming sponsored by PPAG-affiliated student chapters.

Methods: An email invitation with a request for one student member and one faculty advisor from each PPAG-affiliated student chapter to participate in an online survey was distributed to a list of PPAG-affiliated student chapters on February 4, 2016. The survey asked multiple choice and free response questions about the demographics of the respondent, chapter structure, as well as chapter outreach, service, and professional opportunities. Responses were collected from February 4, 2016 to February 20, 2016.

Results: A total of 29 participants responded, with 18 unique respondents (14 students and 4 faculty) completing the entire survey for a chapter response rate of 45% (14/31). Student respondents indicated that chapters most commonly participated in fundraisers (78.6%), collaboration (64.3%) with pediatric advocacy groups (i.e., College Mentors for Kids) and professional organizations (i.e., ASHP), or health fair participation (50%). Twelve chapters (86%) reported interactions with pediatric health care practitioners, most commonly through meeting presentations (83.3%, 10/12) and professional panels (75%, 9/12). Student chapter representation at the PPAG annual meeting increased 700% from 2013 (1 chapter) to 2015 (8 chapters).

Conclusion: Student chapters affiliated with PPAG are offering and participating in varying outreach, service, and development experiences aimed at promoting optimal pediatric medication utilization and developing student members. Sharing the results of this study may encourage more student chapter growth and increased PPAG student engagement and annual meeting attendance.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

PROPYLENE GLYCOL TOXICITY ASSOCIATED WITH INTERMITTENT INTRAVENOUS LORAZEPAM IN A PEDIATRIC INTENSIVE CARE PATIENT

Kari Ausherman ¹, Michael Chicella ¹, Aline Branca ¹

Introduction: Propylene glycol is added during formulation to improve solubility of medications that are insoluble in water. Although considered innocuous, its accumulation has been associated with toxicity. Potential for propylene glycol toxicity is described with continuous infusion of lorazepam; however, information describing propylene glycol toxicity with intermittent boluses is lacking. We present the case of a 12-mo-old female with possible propylene glycol toxicity secondary to intermittent intravenous lorazepam administration.

Case: BB is a 12-mo-old female with Trisomy 21, atrioventricular septal defect and partial anomalous pulmonary venous return. She was admitted to the PICU in May 2015 after complete repair. She was intubated in the OR during her heart surgery and she remained mechanically ventilated until discharge from the PICU to a long term care facility in October. While intubated, she was sedated with a combination of fentanyl, midazolam and dexmedetomidine. These infusions were increased to keep her sedated and comfortable; however, in June she was transitioned from fentanyl and midazolam to intravenous methadone and lorazepam. Her lorazepam was started at 0.5 mg (0.05 mg/kg/dose) every 6 hrs and over time was increased to 12 mg IV every 6 hrs (1 mg/kg/dose). In September, her tracheal aspirate grew methicillin-sensitive S. Aureus and she was started on oxacillin. After 7days, she developed fever again, and was re-cultured. This time her tracheal aspirate grew both methicillin-sensitive S. Aureus and C. Freundii, so she was started on a 10 day course of oxacillin and gentamicin (baseline BUN=16 mg/dL, SCr=0.3 mg/dL). Despite having therapeutic gentamicin serum concentrations, her BUN and SCr began to rise (BUN= 64 mg/dL, SCr= 0.9 mg/dL). Due to this, her furosemide and chlorothiazide were discontinued; however, her BUN and SCr continued to rise and reached a high of 97 mg/dL and 1.3 mg/dL, respectively. Additionally, her anion gap was noted to be 15 mmol/L. BB's serum albumin was 2.6 mg/dL, so her corrected anion gap was 19 mmol/L. There was concern for propylene glycol accumulation due to lorazepam administration, so a serum osmolarity was obtained. The serum osmolarity was 372 mOsm/kg, her calculated serum osmolarity was 302 mOsm/kg, which resulted in an osmolar gap of 70 mOsm/kg. At that time lorazepam was discontinued, and a midazolam drip was initiated. Over the next 7 days her serum osmolarity normalized (298 mOsm/kg). Additionally, her BUN and SCr improved to 20 mg/dL and 0.6 mg/dL, respectively.

Conclusions: We concluded that BB experienced propylene glycol toxicity secondary to the use of intermittent intravenous lorazepam. Propylene glycol toxicity was indicated by increased serum osmolarity and increased osmolar gap. The accumulation of propylene glycol was likely due in part to her acute kidney injury.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

FLUCONAZOLE IN EXTREMELY LOW BIRTH WEIGHT INFANTS: EVALUATION OF INSTITUTIONAL PROPHYLAXIS MEASURES

Allison Jones ¹, Madeline O'Bryan ¹

Objective: To evaluate the impact of fluconazole prophylaxis in ELBW infants for the prevention of invasive candidiasis. Secondary objectives were to determine the incidence of non-albicans isolates and to ensure compliance with both national recommendations and hospital specific protocol.

Methods: Retrospective chart review of ELBW infants (<1000 grams) born between 1/01/2014 and 12/27/2015 and treated in the level IV NICU at Kosair Children's Hospital. Exclusion criteria included birth weight (BW) >1000 g, transfer from an outside facility on day of life >10, and the use of fluconazole for any other condition. Noncompliance with hospital prophylaxis guidelines was defined as no fluconazole prophylaxis by day of life 10.

Results: 285 patient records were analyzed and 151 patients met inclusion criteria. Baseline characteristics included 60% male patients, mean gestational age of 26 weeks (range 22–31), and mean BW of 746 g (range 400–995). Day to initiation of fluconazole prophylaxis was 0.9 (mean, range 0–46). Compliance with hospital fluconazole prophylaxis recommendations was 96.7%, with 5 of 151 eligible patients not receiving prophylaxis. Total length of fluconazole prophylaxis course was 28 days (mean, range 1–43). A 4% fungal infection rate (6/151 patients) was observed with no deaths attributed to fungal infections. Only 2 of these were bloodstream infections. Of the candida isolates obtained, 4 were non-albicans (80%, 4/5 patients).

Conclusions: The results from this review show an overall fungal infection incidence of 4% with 1.3% incidence of bloodstream infections. Both incidences are below documented national averages. Overall compliance of the institutional specific fluconazole prophylaxis policy was high, at 97%. With hospital-wide trends of increased non-albican fungal isolates, eighty percent of the isolates observed in the NICU during this study were non-albicans. While the incidence was alarming, no deaths were attributed to fungal infections during this time.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

PHARMACIST'S ROLE IN AN INTERPROFESSIONAL PEDIATRIC SEPSIS ALERT INITIATIVE

Emily Chen ¹, Marcia Buck ¹

Introduction: The 2012 Surviving Sepsis Campaign recommends the administration of antibiotics within one hour of identification of severe sepsis. This study describes the impact of a pharmacist as part of an interprofessional team in reducing the time to antibiotic administration during a pediatric sepsis alert (PSA).

Methods: A pilot study was conducted between June 1, 2015 and December 31, 2015 at a 144-bed children's hospital. An algorithm developed based on vital signs and change in pediatric early warning scores (PEWS) was built into the electronic medical record to identify early sepsis in patients admitted to non-ICU wards meeting sepsis criteria. Once identified, a page was sent to the interprofessional PSA response team, which facilitated timely evaluation, order verification, and antibiotic delivery. The PSA pharmacist reviewed the patient chart for allergies, previous antibiotic exposures, and possible sources of infection. A documentation tool created in the medical record guided the pharmacist on drug selection and provided a means of capturing data. The pharmacist collaborated with the prescriber and the bedside nurse regarding antibiotic selection and administration whenever possible.

Results: Twenty hospital encounters triggered twenty-six PSAs. Seventeen antibiotics were ordered, prepared, and delivered following ten PSAs. The mean time from PSA page to antibiotic order entry was 6 ± 4 minutes, mean time from order entry to verification was 4 ± 3 min, and mean time from PSA page to order verification was 10 ± 6 min. The mean time from alert page to first antibiotic administration was 44 ± 22 min. The mean time from alert page to second antibiotic administration was 70 ± 36 min, which decreased from 175 min based upon historical data. During seven events, nine (52%) antibiotics were administered more than sixty minutes after the PSA was triggered. There were nine female and ten male patients with the median age being 3.5 yrs (range, 2 mo to 16 yrs). Hematology/Oncology patients comprised the majority of PSAs. One patient triggered four PSAs during two separate hospital encounters. Three patients triggered two PSAs each during their hospital encounters. Five patients were treated with 48 hrs of antibiotics. Pharmacists were able to respond to the bedside during eight events (30%) and typically spent less than thirty minutes evaluating the patients in collaboration with the prescriber. Thirteen PSAs occurred between 0800–1630, seven PSAs occurred between 1630–2230, and six PSAs occurred between 2230–0800.

Conclusion: Pharmacist involvement in the PSA initiative resulted in rapid order verification times, as well as timely antibiotic delivery and administration.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

CASE STUDY IN MULTIDISCIPLINARY COLLABORATION: ORAL CANDIDIASIS IN NICU AFTER FEEDING TEAM PRACTICE CHANGE

Kelly Burch ¹, Warren (Gil) Diesel ¹

We noted an increase in oral candidiasis in convalescing NICU infants after a change in practice related to improving oral feeding transition. A multidisciplinary team of nurses, occupational therapists, and speech pathologists implemented a carefully designed oral feeding transition pathway. One aspect of the pathway was increased access to an air venting nipple/bottle assembly (Dr. Brown's). The previous feeding system used largely disposable components. The new system did not use disposable components and required soap and water cleaning at the bedside, as well as a daily microwave sterilization process. At around this time, we noted an increase in both the frequency and the refractory nature of oral candidiasis at around the same time. We wished to characterize the frequency of cases, and searched the pharmacy system for patients receiving oral fluconazole, oral nystatin, or gentian violet. The baseline incidence of oral candidiasis in NICU infants was 0.84 cases/1000 patient*days (Jan 2014–Nov 2014). For six months during early implementation of the feeding protocol, the rate increased to 2 cases/1000 patient*days (Dec 2014–May 2015). We increased the frequency of microwave sterilization to twice daily, and provided education on the possible relationship of overuse of oral sucrose to the incidence of oral candidiasis. Lessons for pharmacists are threefold: NICU projects that might seem to have little or no drug therapy impact may have unintended consequences; drug use records can be valuable sources of data in case finding; collaboration with all disciplines, including therapy services and infection prevention, can lead to improvements in the quality of care.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

IMPACT OF INITIATING ORKAMBI THERAPY IN A CYSTIC FIBROSIS CENTER

Michelle Condren ¹, Landry Volz ¹, Richelle Nowlin ¹

Background: Lumacaftor/ivacaftor, a novel therapy for cystic fibrosis patients 12 and older that are delF508homozygous,became available in July 2015.

Objective: The goals of this study are to determine the safety and efficacy of lumacaftor/ivacaftor therapy; determine the nature and prevalence of adverse effects reported; and determine the number of patients requiring dose adjustment or discontinuation in a single cystic fibrosis care center.

Methods: This is a retrospective chart review of patients at the Tulsa Cystic Fibrosis Center who were eligible for therapy between July 2015 and January 2016. Pulmonary exacerbations, FEV1, and BMI, will be collected for 1 year prior to starting lumacaftor/ivacaftor and for months 3, 6, 9, and 12 after. Frequency of adverse effects, dose adjustments, liver function testing, and medication discontinuation will also be recorded.

Results: Thirty-four patients were eligible to receive therapy with lumacaftor/ivacaftor. Of these 34 patients, 19 have started therapy and 3 have been excluded. The starting dose was decreased for 4 patients based on risk for adverse effects. Eleven patients (58%) reported adverse effects including: dyspnea, heartburn, nausea/vomiting, elevated INR, sedation, and diarrhea. Of these adverse effects, diarrhea and dyspnea were most common. At 3 months, no patients have had significant elevations in AST, ALT or bilirubin. Two patients received dose adjustments due to adverse effects. Three patients (19%) discontinued therapy, one of which has since restarted. Five patients have been hospitalized for exacerbations since starting therapy. Data will continue to be collected to assess lung function, BMI and exacerbations before and after therapy.

Conclusion: Adverse effects have been common and have prompted the center to create a dose titration schedule for new patients. Many eligible patients are not receiving lumacaftor/ivacaftor after 7 months of availability, which will be further explored. Data collection will continue to assess efficacy.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

CLONIDINE USE FOR DEXMEDETOMIDINE WITHDRAWAL IN THE PEDIATRIC INTENSIVE CARE UNIT

Savannah Gulley ¹, R Zachary Thompson ¹, Brian Gardner ¹, Elizabeth Autry ¹, Aric Schadler ¹, Ashwin Krishna ¹

Introduction: Dexmedetomidine usage has increased in the pediatric population for sedation in critically ill children. With prolonged infusion times, case reports and retrospective reviews have described a withdrawal phenomenon. Clonidine has been stated as an agent to assist with dexmedetomidine withdrawal symptoms in patients who received extended infusions. The primary objective of this study is to characterize withdrawal in patients receiving dexmedetomidine infusions of greater than five days, and describe management of withdrawal symptoms with clonidine.

Methods: This is a retrospective chart review evaluating the use of dexmedetomidine in the pediatric intensive care unit and the utilization of clonidine for withdrawal symptoms in patients aged one month to 17 years old from January 1, 2013 to August 31, 2015. Data included patient demographics, dexmedetomidine dosing, withdrawal scores and symptoms, and clonidine use.

Results: Forty-seven treatment courses met study inclusion. Patients who received clonidine for withdrawal had significantly higher mean doses (0.846 vs 0.602 mcg/kg/hr; p<0.001), larger cumulative doses (268.9 vs 128.8 mcg/kg; p=0.003), and longer durations (307.5 vs 206.3 hrs; p=0.013) of dexmedetomidine. Of the 47 courses, 30 received clonidine for management or prevention of withdrawal symptoms. Withdrawal scores of ≥ 3 were seen in 12 patients in the clonidine group versus 0 patients in the no clonidine group (p=0.002). Expanded analysis is ongoing.

Conclusions: Patients who received clonidine, compared to those who did not, were administered dexmedetomidine at significantly higher mean doses, larger cumulative doses, and longer durations. Results showed various clonidine initiation timelines, including both anticipation of withdrawal and treatment after symptoms presented. This data suggests that future studies are needed to determine the dexmedetomidine dose suspected of leading to withdrawal, and optimal use of enteral/transdermal alpha-2 agonist therapy to prevent withdrawal symptoms in patients receiving that prolonged exposure.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

RISK FACTORS ASSOCIATED WITH OPIOID- INDUCED ADVERSE EFFECTS: A REVIEW OF NALOXONE UTILIZATION IN A PEDIATRIC HOSPITAL

Kaysie Jackson ¹, Amy Potts ¹

Background: Opioids are used routinely for the treatment of moderate to severe pain. High doses of opioids may lead to adverse effects. Naloxone is routinely used as a reversal agent for opioid induced adverse effects and has been identified as a potential trigger to identify patients at greater risk. Previous literature has suggested that possible risk factors include: age < 1 year, obstructive sleep apnea, obesity, underweight, prematurity, and developmental delay. Our objective is to evaluate naloxone administration data to identify possible risk factors of opioid induced adverse effects and potential process improvement strategies.

Methods: Naloxone administration data was collected from the electronic medical record for inpatients at a pediatric hospital from January 2015 to July 2015. Inclusion criteria included any patient that received naloxone for respiratory depression. We excluded patients that were given naloxone in the emergency department, naloxone use for pruritis, and patients receiving naloxone infusions. Data recorded included: adverse event, drug name, dose, route, frequency, concomitant medications, past medical history, and outcome following naloxone administration.

Results: Naloxone was effective in reversal of respiratory adverse effects in 15 of our 22 patients. Seven patients in the immediate post-operative period and 8 patients with a past medical history that included heart defects experienced respiratory depression. Five patients that experienced respiratory depression were patients that also had a past medical history including a heart defect and were post-operative when they received the naloxone administration. Opioids used were similar and within standard dosing recommendations. Naloxone reversed adverse drug events in 68% of patients. Forty-one percent of our patients received patient controlled analgesia of hydromorphone, morphine or fentanyl prior to naloxone administration. This may suggest patient controlled analgesia as a risk factor for opioid induced respiratory depression. Patients receiving PCA hydromorphone had a 57% chance of requiring the use of naloxone administration than when compared to other opioids. Two out of the four patients on hydromorphone patient controlled analgesia triggered a rapid response.

Conclusions: Sample size was a limitation for this analysis and was not powered to show statistical significance. The results showed that 16 of the 22 patients that triggered naloxone administration had previous comorbid conditions or were receiving opioids via a PCA pump. Overall, the risk factors that we observed included patients coming from post-operative procedures and children with comorbidities (heart problems, pulmonary, neuromuscular, prematurity). Additionally, there also may be a higher risk with the use of hydromorphone over other opioids. We recommend increasing monitoring parameters for respiratory status (i.e. pulse oximetry, saturation monitor) for patients with these potential risk factors in an effort to prevent adverse drug events with opioids.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

ASSESSMENT OF OUTCOMES WITH A SEDATION PROTOCOL DURING LASER SURGERY IN PRETERM INFANTS WITH RETINOPATHY OF PREMATURITY

Jennifer Dannelley ¹, Peter Johnson ¹, Michael Anderson ¹, Kari Harkey ¹, Jamie Miller ¹

Introduction: Laser surgery is the standard of care for retinopathy of prematurity (ROP), yet there is a paucity of data regarding sedation during this procedure. The purpose was to evaluate a sedation protocol for ROP laser surgery.

Methods: This retrospective, descriptive study included infants receiving a sedation protocol for ROP laser surgery between 2012–2015. The protocol consisted of IV midazolam 0.1 mg/kg and fentanyl 2 mcg/kg boluses and midazolam 0.06–0.12 mg/kg/hr and fentanyl 2 mcg/kg/hr infusions initiated 2 hours pre-procedure. Infants were excluded if surgery was performed under general anesthesia or had incomplete records. Baseline demographics were collected. Additional data included baseline ventilation status and opioid/benzodiazepine exposure two weeks prior to surgery. The fentanyl and midazolam regimens were collected. Sedation Rating Scale (SRS) scores and vital signs were collected throughout the infusions pre-, during and post-procedure. Additional data included termination or delay of surgery, dosage deviations from protocol, and interventions. The primary objective was to assess protocol success. Success was defined as procedure completion without interruption, absence of a protocol dose deviation, and absence of interventions. Secondary objectives compared outcomes between those patients with and without opioid/benzodiazepine exposure. Additionally, risk factors for sedation failure were assessed and occurrence of cardiopulmonary adverse events (ADEs). Descriptive statistics were employed.

Results: Twenty-five were included with a median postmenstrual age of 36.4 weeks (range: 33.7–40.6) and a median weight of 1.97 kg (range: 1.36–3.075.) Eight (32%) had prior opioid/benzodiazepine. Three (12%) required a procedure delay. 7 (28%) required a fentanyl dose increase. 13 (52%) required a lower dose of fentanyl, midazolam, or both. Nine (36%) required intubation. One (4%) received naloxone. Ten (40%) had protocol success. Sixteen (64%) experienced cardiopulmonary ADEs; 11 (44%) of these experienced hypotension.

Conclusion: The protocol appeared to achieve adequate sedation for most patients, but not without ADEs.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

SECONDHAND MARIJUANA SMOKE RESULTING IN CLINICAL INTOXICATION

Ferras Bashoqy ¹, Justin Heizer ¹, Pam Reiter ¹, Laura Borgelt ¹

Introduction: The number of pediatric intoxication cases has increased since legalization of marijuana in Colorado. Exposure to marijuana can cause euphoria, impaired motor and mental skills, tachycardia, and in extreme cases, respiratory depression. Individuals exposed to marijuana through passive inhalation in unventilated environments may produce positive urine test results and experience drug effects. Marijuana potency has increased over the past 20 years from an average 4% delta-9 tetrahydrocannabinol (THC) in 1995 to 15% in 2012 and 20–30% in 2016. It is possible that passive inhalation from present-day marijuana may produce more profound clinical effects; especially in small children with higher minute ventilation. We report two cases of THC intoxication in children exposed to marijuana through secondhand smoke.

Case 1: A 2.8 yo male (weight= 14.2 kg) with a history of prematurity and asthma was brought to an outside hospital with complaints of extreme lethargy. Examination revealed a temperature of 35 degrees, blood pressure of 128/49mmHg, heart rate of 143 beats/min and oxygen saturation of 86% on room air. Initial Glasgow Coma Scale (GCS) was 9. A peripheral IV was placed and blood was collected for complete blood count (CBC) and electrolytes. Urine was obtained for toxicology and culture. An electrocardiogram (EKG) revealed sinus tachycardia. Urine toxicology results were positive for THC and the child was transferred to CHCO. Upon arrival to our hospital, he remained altered with a GCS of 9. After further investigation, the babysitter admitted to smoking marijuana in the same room as the child earlier that day. The child was observed for an additional 11 hrs and was discharged after neurological status improved.

Case 2: A 1.4 yo female (weight= 10.6 kg) was brought to the emergency department with features of altered mental status, lethargy, fever, tachycardia and abnormal eye exam. Due to initial denials of possible toxin exposure, IV access was obtained and an EKG was performed. Blood was collected for culture, electrolytes and CBC. Urine was obtained for culture and toxicology. After urine toxicology revealed THC, her father admitted to smoking marijuana in his car in the presence of his daughter. The child required hospital admission and was monitored for 48 hrs until symptoms resolved and she was discharged.

Discussion: Passive THC exposure in young children can have serious consequences. Previous reports in healthy adults, exposed to controlled conditions of passive marijuana smoke containing 2.8% THC, have demonstrated features consistent with active smoking. Since the concentration of present-day marijuana in Colorado is more than ten-times that previously studied, it is plausible that contact with today's marijuana would be more profound.

Conclusion: These cases highlight health consequences of unintentional passive THC exposure in children and should alert the public to heed caution when smoking in confined areas.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

EVALUATION OF WORKUP AND TREATMENT OF URINARY TRACT INFECTION IN PEDIATRIC PATIENTS IN THE EMERGENCY DEPARTMENT

Carly Heyrend ¹, Emily Thorell ¹, Jared Olson ¹

Introduction: Urinary tract infections (UTI) are one of the most common bacterial infections encountered in pediatrics. The purpose of this study was to examine prescriber practices before implementation of an emergency department (ED) algorithm for the treatment of UTI at Primary Children's Hospital and to determine anticipated efficacy of various empiric antibiotics.

Methods: Primary Children's Hospital is a 289 bed facility in Salt Lake City, UT. The ED cared for 43,471 visits in 2015. We identified patients between the ages of 3 months and 18 years presenting to the ED with urinalysis and urine culture from the Intermountain clinical data repository from 1/1/2015 through 12/31/2015. We included only the first visit meeting entry criteria per unique patient. Patient age, sex, urinalysis, culture results, and prescribed drug therapy were collected.

Results: A total of 3,274 patient visits were identified; 26% of patients were between 3 months and 24 months and 72% of patients were female. Of the 2583 patients with negative leukocyte esterase and negative nitrites, 10 (0.4%) of urine cultures had a single uropathogen between 50,000 CFU/mL and 100,000 CFU/mL, 28 (1%) or urine cultures had single uropathogen greater than 100,000 CFU/ml and 1420 (55%) were negative. Of the patients evaluated for UTI, 713 (21%) of patients were prescribed at least one antibiotic. Cefdinir was the most frequent antibiotic prescribed for this cohort of patients (57%).

Conclusions: The value of urine culture for patients with urinalysis negative for leukocyte esterase and nitrites is questionable. Cefdinir appears to be frequently prescribed to children evaluated for UTI.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

EFFICIENCY OF ACETAMINOPHEN DOSE STANDARDIZATION IN THE NEONATAL PATIENT CARE AREAS

Katelin Kimler ¹, Pooja Shah ¹

Introduction: The Institute of Safe Medicine Practices encourages pediatric patients' medications to be prepared by pharmacy in patient-specific unit doses and recommends implementing standardized processes for medication doses. Due to weight-based dosing of acetaminophen liquid, it is difficult to provide readily-available yet patient-specific doses to administer immediately post-operatively after circumcision.

Aim: In an effort to facilitate timely medication administration, improve pharmacy workflow, and reduce the potential for error, the dosing of acetaminophen was standardized in the newborn nursey and neonatal intensive care unit.

Methods: Utilizing the weight range present in these patient care areas, the minimum and maximum dose that can be administered was evaluated based on the accepted dosing range for acetaminophen of 10 to 15 mg/kg/dose. Seven doses were chosen as standards that best fit the acceptable dosing range (25, 30, 35, 40, 45, 50, 55 mg). The standardization was facilitated through ordering 12 mg/kg/dose. The CPOE system would then automatically round to the nearest standardized dose. Ordering providers have the option of overriding the standardization as necessary. Pre-drawn standardized doses were stored in the automated dispensing machines in each of the units to facilitate timely administration. To determine whether standardization improved efficiency, a retrospective review was conducted of all acetaminophen orders administered from Oct 2014 to Oct 2015. The mean time to administration, the mean percent variance of each standardized dose to the ordered dose of 12 mg/kg/dose, and the number of times the standardized dosing was overridden was evaluated.

Results: There were 1926 orders of acetaminophen placed in this timeframe. The mean time to administration was 3449 min; however 359 doses were administered within an hr of ordering with an average time of 27.6 min. The mean percent variance from 12 mg/kg to the administered dose was 3.27% with a maximum variance of 9.02%. There were 113 unique doses referenced and rounded to 7 standardized doses, with one exception for a 36 mg dose that was electively not rounded. This was a reduction of 93% through standardization with 99.9% compliance.

Discussion: Standardized dosing has demonstrated efficiency in the pharmacy workflow and timely administration of acetaminophen. There was also observed compliance with the standardization by ordering providers. Weight based dosing in the pediatric patient population utilizing oral formulations fit for adult patients makes safe and timely administration difficult. The ordering, preparation, and dispensing of numerous doses on a daily basis increase the potential of an error and are minimized by standardization. Standardized dosing will be expanded to all pediatric patient care units and can easily be duplicated in other institutions faced with similar problems related to timely delivery of pediatric oral liquids.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

COMPARISON OF ANTIBIOTIC DOSING BEFORE AND AFTER IMPLEMENTATION OF AN ELECTRONIC ORDER SET

Allison Gritzman ¹, Chad Knoderer ¹, Kristen Nichols ¹

Background: Hospitalized children frequently receive antibiotics, and clinical decision support can improve dosing accuracy. Paper ordersets with dosing guidance may improve the ordering accuracy but the impact of electronic ordersets on accuracy has not been evaluated. The objective of this study was to compare antibiotic dosing appropriateness before and after electronic orderset implementation.

Methods: This was a retrospective cohort study of patients less than 18 years of age who received IV cefepime, piperacillin-tazobactam, tobramycin, or gentamicin at 12 hospitals within a health system. Use of the ordersets and antibiotic dosing were evaluated in patients who received the specified antibiotics during the 6 months before and after electronic orderset implementation. Orders were excluded if initiated during the perioperative period, received via a verbal or telephone order, or administered as a one-time dose without a specified frequency. The primary outcome was comparison of appropriate antibiotic dosing before and after implementation.

Results: Seven hundred and forty seven antibiotic orders (n=747) were eligible for inclusion with 360 and 387 included in the before and after study periods, respectively. Gentamicin, piperacillin-tazobactam, cefepime, and tobramycin comprised 55.2%, 22.4%, 13.7%, and 8.8% of total orders, respectively. There was no difference in antibiotic order appropriateness in the before or after implementation periods (47.7% vs. 52.3%, p=0.415). Appropriateness did not differ when the electronic orderset was utilized vs. any other order format (90.5 % vs. 87.9 %, p=0.285). More orders were appropriate when the electronic orderset was utilized as compared to blank orders (90.5% vs. 82.8%, p=0.024).

Conclusions: No difference in antibiotic appropriateness was found based on during which study period the order occurred or the type of order format utilized. There was a significant difference in antibiotic appropriateness when comparing the use of a blank order form vs. the antibiotic electronic ordersets.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% LIQUID (GAMUNEX^®)

Jeffrey Butler ¹, Ada Koch ¹, Jennifer Hamner ¹

Introduction: Intravenous immune globulin (IVIG) has been traditionally used in the pediatric population for the treatment of patients with a primary immunodeficiency, Kawasaki disease, and various autoimmune diseases. This role continues to expand to a wider variety of disease states owing to its multiple mechanisms of action. At Children's Hospital Colorado (CHCO) it was discovered that a significant fraction of IVIG was used for indications deemed “questionable” or “inappropriate”. An indication field was incorporated into the IVIG drug file in Epic^™ in order to gain an understanding of “questionable” and “inappropriate” use. It was also discovered that a significant amount of IVIG was being wasted due to not rounding doses to the nearest vial size. This medication utilization evaluation (MUE) is a follow up to previous recommendations based on these discoveries to assess the appropriateness of IVIG use..

Methods: A list of all patients who received IVIG at CHCO from Nov. 1st, 2014 through Nov. 1st, 2015 was generated.. The dose, net number of dispenses, and indication for each order was collected. All doses dispensed were included in this evaluation. These data were compared to data collected from a previous MUE completed in January 2014. Doses that could be rounded up to the nearest vial size and remain within 20% of the ordered dose were included in the assessment of dose rounding.

Results: There was a total of 27,197 gms of IVIG was dispensed at CHCO with the majority (8,378 grams) dispensed in the main hospital infusion center51% dispensed on an outpatient basis. There was an 11% and 73% reduction in the total number of grams of IVIG dispensed for uses deemed “questionable” and “inappropriate”, respectively. Fourteen percent of doses were dispensed for indications deemed “questionable” compared to 24.3% of doses-revealed in the previous MUE, which lead to an estimated cost savings (based on GPO pricing) of $93,233. 390 (1.4%) were dispensed for “inappropriate” uses compared to 1446 g (8.2%) previously, leading to a cost savings of roughly $93,105. The dose rounding analysis showed estimated only 0.27% 74.01 g were of IVIG was wasted as a result of not rounding to the nearest vial size, which was associated with a cost of $5,107. 0.32% of the total cost of IVIG.

Conclusion: The implementation of the indication field in the IVIG drug field in Epic^™ resulted in a reduction in doses of IVIG being dispensed for “questionable” and “inappropriate” uses. Our results confirmed that the interventions from the previous MUE achieved desired (if not better than expected/desired) results. There was no change in practice with regards to rounding IVIG doses, Previous recommendations regarding dose rounding of IVIG were not implemented by CHCO. However, with the availability of 1 g vials of IVIG dose rounding may no longer be necessary.

J Pediatr Pharmacol Ther. 2016 May-Jun;21(3):263–303.

PEDIATRIC CODE COMPETENCY FOR PHARMACISTS USING SIMULATION LAB INTEGRATION AT A FREESTANDING CHILDREN'S HOSPITAL

Christopher Sommer ¹, Jennifer Hamner ¹

Introduction: Historically, Children's Hospital Colorado (CHCO) has only required Pediatric Advanced Life Support (PALS) certification for pharmacists routinely expected to respond to codes. In an effort to define clear expectations and expand code competency opportunities a policy was implemented in January 2016 utilizing high fidelity simulation lab integration. High fidelity simulations include participation in two mock code scenarios with a multidisciplinary team in the areas of general medicine, pediatric/neonatal/cardiac intensive care (PICU/NICU/CICU), emergency department (ED), or trauma. Scenarios are followed by a video-based debriefing focusing on interdisciplinary communication and team-building. Simulations were incorporated due to requests from the simulation lab staff to increase pharmacist involvement to improve the multidisciplinary approach.

Methodology: This was a Department of Pharmacy policy implemented for all pharmacists. Competencies were outlined for three categories of pharmacists with documentation of compliance due by December 31st of each year: Non-Resident Pharmacists Working in Direct Patient Care Areas: Direct patient care area = any pharmacist expected to respond to a code as part of their shift description; Participate in one high fidelity simulation annually; PALS certification and recertification is required every two years; Completion of Department of Pharmacy written code competency or institution-wide code online module is required annually Non-Resident Pharmacists Working in Non-Direct Patient Care Areas: Non-direct patient care area = any pharmacist not expected to respond to a code as part of their shift description; Basic Life Support or PALS certification and recertification is required every two years Resident Pharmacists; Participate in one high fidelity simulation lab every quarter (3 months); One in general medicine, one in PICU, one in ED/trauma/CICU, one in area of choice; PALS certification required within first half of residency year; Completion of Department of Pharmacy written code competency or institution-wide code online module is required within first half of residency year.

Results and Conclusions: In May 2015 a survey of pharmacists at CHCO identified that 83% of pharmacists expected to respond to codes were certified in PALS. Data will be collected pre- and post-implementation of this policy examining PALS certification rates and participation in high fidelity simulations annually. We hypothesize that an increase in pharmacist involvement in multidisciplinary simulation labs/mock codes will occur as well as an increased compliance rate with PALS certification.

PERMALINK

25th Annual Meeting Abstracts

A COLLABORATIVE PRACTICE AGREEMENT FOR PHARMACIST TRIAGE OF MEDICATION RELATED CALLS FOLLOWING PATIENT DISCHARGE FROM A PEDIATRIC EMERGENCY DEPARTMENT

Ean Miller

Alice Yeh

Mike Bentley

Ruthie Limo

Kimberly Aaron

Corwin Warmink

CURRICULAR PREFERENCES AND SUBSEQUENT EMPLOYMENT CHOICES OF PEDIATRIC DEGREE OPTION GRADUATES

Brooke Gildon

Peter Johnson

Michelle Condren

Jamie Miller

Tracy Hagemann

Teresa Lewis

Bob John

Kevin Farmer

EFFICACY AND SAFETY OF INTRAVENOUS MAGNESIUM USE FOR STATUS ASTHMATICUS IN THE PEDIATRIC INTENSIVE CARE UNIT

Grace Lee

Adam Schwarz

Nick Anas

EVALUATION OF COMMON MEDICATIONS AND RISK OF NECROTIZING ENTEROCOLITIS IN VERY LOW BIRTH WEIGHT INFANTS

Katelyn Bull

Nicole Corbin

Christina Cox

Jun Wu

PREVALENCE OF ADVERSE EFFECTS AMONG CHILDREN RECEIVING PEGASPARAGINASE OR ERWINIA ASPARAGINASE BASED ON INTRAVENOUS VERSUS INTRAMUSCULAR ROUTES OF ADMINISTRATION

Megan Corsi

Zachery Halford

Cynthia Bender

Whitney Leonard

HSV PCR TESTING AND ACYCLOVIR USE IN CHILDREN: A FIVE YEAR REVIEW

Allison Stefanski

Olivia Zalewski

Christina R Hermos

Kelly L Matson

THE DEVELOPMENT OF AN EVIDENCE BASED, STANDARDIZED FORMULARY FOR THE PEDIATRIC EXTEMPORANEOUS ORAL LIQUID COMPOUNDS OF THE GATEWAY PEDIATRIC PHARMACY GROUP

Kyle Dillon

Lisa Lubsch

Kelly Burch

USE OF CHLORPROMAZINE TO ATTENUATE OPIOID TOLERANCE IN A PEDIATRIC PATIENT ON EXTRACORPOREAL MEMBRANOUS OXYGENATION (ECMO)

Kelvin Xu

Serene Lim

PROLONGED EMPIRICAL ANTIBIOTIC THERAPY FOR PRESUMED EARLY-ONSET SEPSIS AND ADVERSE OUTCOMES OF LATE-ONSET SEPSIS, NECROTIZING ENTEROCOLITIS AND DEATH IN AN ASIAN VERY LOW BIRTH WEIGHT INFANT COHORT

Qi Chen

Mee Ling Gan

Yee Yin Tan

Chinthala Jubal Pallavi

Victor Samuel Rajadurai

Sriram Bhavani

Joseph Manuel Gomez

Pei Shi Ong

SPECIALISATION IN PEDIATRIC PHARMACY – RESULTS OF A SURVEY OF PHARMACISTS WORKING IN THE NEONATAL/PEDIATRIC SETTINGS IN SINGAPORE

Kelvin Xu

Sok Hoon Lim

Shyamala Narayanaswamy

Irene Quay

IMPROVING DISPENSING PRACTICES OF MEDICATIONS IN THE NEONATAL INTENSIVE CARE UNIT (NICU) THROUGH UNIT-DOSING AND EXTENDED STABILITY TESTING

Priya Patel

Leshahn Mials

CLINICAL EXPERIENCE WITH INTRAVENOUS ACETAMINOPHEN FOR PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE

Roua El Kalach

Ulfat Usta

RISK OF POST-PROCEDURAL BLEEDING IN PATIENTS ON INTRAVENOUS FISH OIL. FACT VS. FICTION?

Kathleen Gura

Mark Puder

Lorenzo Anez-Bustillos

Prathima Nandivada

Paul Mitchell

Alison O'Loughlin

Meredith Baker

Duy Dao

Gillian Fell

Bennett Cho

CHARACTERISTICS OF PEDIATRIC CLINICAL INTERVENTIONS DOCUMENTED BY FACULTY AND STUDENTS

Lea Eiland

IMPACT OF PHARMACISTS' ELECTRONIC MEDICATION THERAPY MANAGEMENT CONSULTS FOR PATIENTS ENROLLED IN A PEDIATRIC COMPLEX CARE COORDINATION PROGRAM

Michelle LoTurco

Alexis Kuhn