An Evaluation of Risperidone Dosing for Pediatric Delirium in Children Less Than or Equal to 2 Years of Age.

Background: Risperidone dosing and safety data are limited in patients ≤2 years of age. Objective: To describe the dosing strategies, safety, and tolerability of risperidone in infants ≤2 years of age. Methods: An institutional review board-approved retrospective study was conducted in a 24-bed pediatric intensive care unit at an academic medical center in patients ≤2 years of age receiving risperidone for the management of ICU delirium. The primary outcome was mean initial daily dose of risperidone. Secondary outcomes included mean daily dose, dosing frequency, treatment duration, and adverse effects. Results: Seventeen patients who received at least 1 dose of risperidone were included in the study. The initial daily dose ranged from 0.1 to 0.25 mg (0.01-0.04 mg/kg), with a mean of 0.17 mg (0.02 mg/kg). Most patients were initiated on once-daily dosing (76.5%) versus twice-daily dosing (17.6%). More than 80% of patients required a dose increase during therapy. Median daily doses of fentanyl, morphine, ketamine, and midazolam were decreased following initiation of risperidone. No adverse events that led to discontinuation of risperidone were reported. Conclusion and Relevance: Risperidone was found to be safe and well tolerated at daily doses of risperidone of 0.1 to 0.25 mg in 1 or 2 doses per day in patients ≤2 years old for the management of ICU delirium. To our knowledge, these results provide the largest cohort describing dosing recommendations specific for risperidone in this age group. Further investigation on the effect of antipsychotic administration on other sedation and analgesic regimens is necessary.

New Inhaled Antimicrobial Formulations for Use in the Cystic Fibrosis Patient Population.

OBJECTIVE: To review the current literature on inhaled antibiotic therapies currently in clinical trials for cystic fibrosis (CF) patients. DATA SOURCES: A literature search was performed using PubMed (1975 to September 2015), International Pharmaceutical Abstracts (1970 to September 2015), and MEDLINE (1946 to September 2015) to identify studies for inclusion. The following search terms were used: cystic fibrosis, inhaled amikacin, inhaled liposomal amikacin, inhaled vancomycin, and/or inhaled levofloxacin. STUDY SELECTION AND DATA EXTRACTION: All English-language phase II to III studies evaluating efficacy and/or safety, case reports, and retrospective studies of inhaled amikacin, inhaled vancomycin, and inhaled levofloxacin in CF patients were included. DATA SYNTHESIS: Currently available inhaled antibiotics, tobramycin and aztreonam, have demonstrated improvement in respiratory function of CF patients. Newer agents have shown potentially similar efficacy, with improvement in ease of use. Limited data suggest that inhaled liposomal amikacin and levofloxacin are both noninferior to tobramycin in terms of improvements in respiratory function. Inhaled levofloxacin has a lower rate of hospitalizations secondary to respiratory exacerbations and a reduction in the Pseudomonas aeruginosa sputum density compared with inhaled tobramycin. Inhaled vancomycin use has been documented in case reports and 2 small retrospective eradication trials, although data are limited to support its use. CONCLUSIONS: The horizon of inhaled antibiotic choices for CF patients is promising. The introduction of different drug classes and formulations to treat resistant Gram-negative and Gram-positive organisms increases the number of options for patients for both eradication and treatment of chronic colonization.

Adrenocorticotropic hormone for the treatment of West Syndrome in children.

OBJECTIVE: To review the current literature on the efficacy and safety of low- versus high-dose adrenocorticotropic hormone (ACTH) regimens, low-dose ACTH regimens, and comparison of ACTH with oral corticosteroids or vigabatrin for the treatment of West syndrome. DATA SOURCES: A literature search was performed using MEDLINE, PubMed, and Inter national Pharmaceutical Abstracts (1975-November 2012) to identify studies for inclusion. In addition, reference citations from identified publications were reviewed. The following search terms were used: infantile spasms, West syndrome, adrenocorticotropic hormone, corticotropin, symptomatic West syndrome, cryptogenic West syndrome, pediatric, children, infant, adolescent, and neonate. STUDY SELECTION AND DATA EXTRACTION: Studies included in this article evaluated low-dose versus high-dose ACTH, low-dose ACTH, and ACTH compared with vigabatrin and oral corticosteroids. Data reporting the efficacy and adverse effects of ACTH, vigabatrin, and oral corticosteroids were extracted from each publication. Only English-language publications were included. We initially reviewed 20 studies, and 14 were included: 5 prospective randomized clinical trials and 9 chart reviews. DATA SYNTHESIS: West syndrome is an age-specific epileptic disorder that occurs in infancy and early childhood. It is characterized by the triad of infantile spasms, neurodevelopmental regression or delay, and hypsarrhythmia on electroencephalogram (EEG). The efficacy and adverse events of ACTH with different dosage regimens were reviewed and analyzed. ACTH compared with vigabatrin and oral corticosteroids was also evaluated. Based on this review, low-dose ACTH is probably as effective as high-dose ACTH. Compared with other agents, ACTH is suggested to be more effective than oral corticosteroids, and compared with vigabatrin, it has improved outcomes in the cessation of spasms. However, studies evaluating the efficacy of ACTH are limited by small sample size, inconsistent dosage regimens, and the use of synthetic or natural ACTH products. Serious adverse events, including intracranial hemorrhage, brain atrophy, Cushing syndrome, infection, weight gain, and hypertension, may deter the use of ACTH. Short-term therapy is recommended to reduce the risk of adverse effects. CONCLUSIONS: The current literature suggests that short-term, low-dose ACTH should be considered first-line treatment of infantile spasms.

Impact of COVID-19 on Pharmacy Education and Practice: Strategies to Boost Advocacy and Unity among Health Care Organizations.

The global COVID-19 pandemic impacted pharmacy education and changed the pharmacists' scope of practice at the federal and state levels. Based on the Amended Public Readiness and Emergency Preparedness Act, pharmacists were authorized to provide essential services, including testing, treatments, and immunizations at various practice settings. Specifically, the United States Food and Drug Administration issued emergency use authorization for several medications, vaccines, and medical devices. The pandemic also affected the regulatory landscape for pharmacists, pharmacy education, access to care, and delivery of pharmacy services in-person and through telehealth. The pandemic's specific impact on pharmacy education heightened awareness of the well-being of the Academy. This commentary will highlight the impact of COVID-19 on both pharmacy education and practice. It will also provide strategies that educators, researchers, and practitioners can take into future research and action to help promote advocacy and unity among pharmacy organizations.

Continuous and extended infusions of ß-lactam antibiotics in the pediatric population.

OBJECTIVE: To conduct a systematic review of available data on the use of extended or continuous infusion of ß-lactam and monobactam therapy in the pediatric population (aged 0-18 years). DATA SOURCES: A literature search was performed using PubMed (1975-May 2012), International Pharmaceutical Abstracts (1970-May 2012), and Web of Science (1977-May 2012) to identify studies for inclusion. In addition, reference citations from identified publications were reviewed. The following search terms were used: pediatric, children, neonate, infant, adolescent, ß-lactam, cephalosporin, carbapenem, penicillin, monobactam, continuous infusion, extended infusion, and/or prolonged infusion. Individual names of drugs in each class of antibiotics were also included in the search. STUDY SELECTION AND DATA EXTRACTION: Randomized controlled clinical trials, pharmacokinetic/pharmacodynamic studies, observational studies, and case reports involving pediatric patients who received extended or continuous infusion of ß-lactam or monobactam antibiotics were reviewed. Only English-language publications were included. DATA SYNTHESIS: One randomized controlled clinical trial, 5 pharmacokinetic studies, 2 pharmacodynamic studies using Monte Carlo simulation, 1 case series, and 7 case reports were included in the analysis. The cephalosporin class has been studied the most and currently represents the only clinical trial using a continuous infusion dosing strategy in pediatric patients. There is limited clinical evidence available to support the use of extended or continuous infusion of ß-lactam antibiotics in the pediatric population. Pharmacodynamic studies conducted in this population mirror the current evidence in adults for cefepime and meropenem. The single prospective clinical trial using continuous infusion of ceftazidime failed to demonstrate any clinical benefit over traditional dosing; however, there was equal efficacy. CONCLUSIONS: More well-designed prospective clinical trials are required to determine the role of extended or continuous infusion of ß-lactam antibiotics in treatment of pediatric patients.

Identification of Factors Associated With the Desire to Participate in a Pediatric Pharmacy Practice-Based Research Network.

OBJECTIVES: To evaluate the practice-based research network (PBRN) potential within the Pediatric Pharmacy Advocacy Group (PPAG) membership and to identify characteristics associated with member willingness to join a PPAG PBRN. METHODS: In October 2016, a 21-question survey was sent by email to approximately 900 PPAG pharmacist members (excluding students) using contact information contained in the PPAG membership database. The survey elucidated information regarding training, clinical and research experience, practice site information, and willingness to participate in a PPAG PBRN. Descriptive statistics described the potential PBRN and multivariate logistic regression determined respondent characteristics associated with willingness to join the PBRN. RESULTS: Of 145 survey respondents (a 16% survey response rate), 92 selected "yes" regarding their willingness to participate in the PPAG PBRN. Acute care general pediatrics was the most common area where respondents desired to perform research (44.6% of "yes" respondents), with over 2500 patients/day collectively available. The most common selected limitations to research were time and size of available patient populations (59.8% and 47.8% of "yes" respondents, respectively). Cumulative hours/week members would be willing to devote to the PBRN was approximately 77 to 206. Publication of a retrospective study (OR 10.4, 95% CI 2.1-51.9, p = 0.004), research protected time (OR 4.9, 95% CI 1.4-17.8, p = 0.015), and affiliation with an academic medical center (OR 3.32, 95% CI 1.05-10.45, p = 0.04) were independently associated with willingness (a "yes" response) to join a PPAG PBRN. CONCLUSIONS: Within the PPAG membership, there is sufficient interest, expertise, patient exposure, and member time to develop a PBRN focused on pediatric pharmacotherapy. The identified characteristics associated with willingness to join the PBRN can help focus efforts for member involvement, education, and recruitment to ensure sustainability of the PPAG PBRN.

Development and implementation of a writing program to improve resident authorship rates.

PURPOSE: The development, implementation, and evaluation of a writing program with a formalized writing project as a component of postgraduate year 1 (PGY1) and postgraduate year 2 (PGY2) pharmacy residencies are described. SUMMARY: The writing program at Georgia Regents Medical Center/University of Georgia College of Pharmacy, a collaborative and jointly funded program, was initiated in the 2010-11 residency year. The goals of the program are to teach residents to communicate effectively, apply leadership skills, employ project management skills, and provide medication- and practice- related education and training. The program combines both writing experiences and mentorship. At the beginning of the residency year, trainees are presented with opportunities to participate in both research projects and writing projects. Specifically, opportunities within the writing program include involvement in review articles, case reports, drug information rounds, book chapters, letters to the editor, and high-quality medication-use evaluations for potential publication. The writing project is highly encouraged, and completion of a manuscript to be submitted for publication is expected by graduation. Nine papers were published by 8 of 18 PGY1 and PGY2 residents in the four years before program implementation. A total of 23 publications were published by 18 (72%) of the 25 PGY1 and PGY2 residents in the four years after implementation of the writing program. CONCLUSION: Implementation of a formal writing program increased the overall publication rate of residents.

Systemic effects of ophthalmic cyclopentolate on body weight in neonatal mice.

BACKGROUND: Cyclopentolate is standardly used in ophthalmologic examinations of neonates to facilitate screening for retinopathy of prematurity. Reports of systemic effects have raised concerns of an increased risk of feeding intolerance after the examinations. OBJECTIVES: The goal of this study was to evaluate systemic concentrations of cyclopentolate after ophthalmic administration, as well as assess changes in weight as an indirect measure of alteration in feeding. METHODS: Neonatal mice were randomized into three groups to simulate a neonatal model for ophthalmic medication administration. The cyclopentolate group received a one-time administration of tetracaine, cyclopentolate, and phenylephrine ophthalmologic solutions in accordance with the protocol used at the children's hospital. The placebo group received the same ophthalmic drop administration, except for normal saline in place of cyclopentolate, and the control group received no ophthalmic drops and minimal handling. Daily weights and serum samples to measure systemic concentrations of cyclopentolate post-ophthalmic administration were assessed at baseline and for 7 days following drop administration. RESULTS: Analysis of serum levels demonstrated detectability of systemic cyclopentolate after ophthalmic administration as early as 30 min (86 ng/ml), 1 h (60 ng/ml), and 24 h (6.2 ng/ml). There were also differences in weight gained on following ophthalmic administration observed between the cyclopentolate group and placebo group, with the cyclopentolate group weighing significantly less on days 3 and 7 (p = 0.02). CONCLUSIONS: RESULTS indicate cyclopentolate is absorbed systemically and instillation of cyclopentolate decreases weight gain in neonatal mice compared to placebo. These preclinical findings provide rationale for further studies in neonatal patients.

Survey of learning opportunities in academia for pharmacy residents.

PURPOSE: The types of teaching experiences offered in academia in pharmacy residency programs affiliated with or offered through colleges of pharmacy throughout the United States were evaluated. METHODS: Two 15-item questionnaires were developed, one for programs that offer a concentrated rotation in academia and one for programs that offer longitudinal opportunities in academia. These questionnaires were developed to assess the activities incorporated into the different learning experiences, the number of residents completing concentrated rotations, the residency director's perception of the benefit to the residents, and barriers that exist for institutions that do not offer concentrated rotations. The questionnaires were distributed electronically to pharmacy residency directors at academic medical centers and colleges of pharmacy in the University HealthSystem Consortium listserver. The responses were analyzed with descriptive statistics. RESULTS: Of the 154 institutions identified for survey distribution, 86 were academic medical centers and 68 were colleges of pharmacy and affiliated programs. Program directors from 99 institutions completed a questionnaire (response rate, 64.3%), representing 434 postgraduate year 1 (PGY1) and 290 postgraduate year 2 (PGY2) residency positions. Thirty-six percent (n = 36) of respondents offered a concentrated rotation in academia, and 64% (n = 63) offered longitudinal opportunities in academia. Sixty-six institutions offered a teaching certificate program; however, it was mandatory in only 42% of programs. CONCLUSION: The majority of PGY1 and PGY2 residency programs surveyed did not offer concentrated rotations in academia but did offer longitudinal opportunities for residents to gain teaching experience. The majority of programs that did not offer these experiences did want formal training on how to provide these opportunities.