Publications by authors named "Jamie Miller"

97 Publications

Analysis of Fentanyl Pharmacokinetics, and its Sedative Effects and Tolerance in Critically-Ill Children.

Pharmacotherapy 2021 Feb 19. Epub 2021 Feb 19.

Department of Pharmacy, Clinical and Administrative Sciences, University of Oklahoma College of Pharmacy, Oklahoma City, Oklahoma, United States.

Introduction: Fentanyl pharmacokinetic and pharmacodynamic data are limited in mechanically ventilated children. This study aims to assess the fentanyl pharmacokinetics (PK), the sedation outcome, and the development of tolerance in children receiving fentanyl continuous infusion.

Methods: This study included children admitted to the pediatric or cardiovascular intensive care unit between January 1-October 31, 2016, who were >30 days to <18 years of age, receiving ventilatory support via endotracheal tube or tracheostomy, and receiving a fentanyl infusion. Population PK analysis was performed using a nonlinear mixed-effects model. The relationship between initial sedation outcome using State Behavioral Scale (SBS) and fentanyl exposure was assessed, and the observations consistent with tolerance were described.

Results: Seventeen children, with a median age of 0.83 years (range: 0.1-12) and weight of 8.7 kg (range: 3.4-52), were included. The fentanyl PK was adequately described by a weight-based allometry model with the power of 0.75 for clearance (CL=89.8 L/hr/70kg) and distributional CL, and 1 for volumes of distribution. In infants <6.6 months, age was an additional factor for CL (31.4 L/hr/70kg) to account for age-related maturation. Seven of twelve nonparalyzed patients achieved goal sedation, defined as >80% of SBS scores ≤0 per 24-hour, on the first day of fentanyl infusion with a median plasma concentration of 1.29 ng/mL (interquartile range: 0.78-2.05). Eight of the nine tolerant patients developed tolerance within a day of reaching goal sedation.

Conclusion: Different weight-based fentanyl dosing rates may be required for infants and children of different ages to achieve similar plasma concentrations. Using SBS scores may guide the dosing titration of fentanyl that resulted in plasma concentrations within the therapeutic range of 1-3 ng/mL. For those who developed tolerance to fentanyl and/or a sedative, it was noted one day after goal sedation was achieved.
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http://dx.doi.org/10.1002/phar.2515DOI Listing
February 2021

Publication Rates of Pediatric-Focused Resident Research Projects Presented at The Pediatric Pharmacy Association Bruce Parks Memorial Residency Showcase.

J Pediatr Pharmacol Ther 2021 15;26(2):163-171. Epub 2021 Feb 15.

Objectives: The primary objective was to identify the number of residency projects presented at the Pediatric Pharmacy Association (PPA) Bruce Parks Memorial Residency Showcase that were subsequently published. Secondary objectives included a comparison of subsequent publications after residency completion between those who did and did not publish their residency project and an analysis of factors associated with subsequent publications.

Methods: This was a descriptive study including all pediatric-focused resident projects presented at the PPA Bruce Parks Memorial Residency Showcase from 2006 to 2015. Literature searches for all the pediatric-focused residency projects and any subsequent publications were performed. Data collection included residency type (i.e., postgraduate year 1 [PGY1], postgraduate year 2 [PGY2]), project category, and initial position after residency. A zero-inflated Poisson regression was used to analyze subsequent publication status while controlling for other factors. Statistical analyses were performed using SAS/STAT, with a priori p value < 0.05.

Results: There were 434 projects presented by 401 residents. Seventy-four (17.1%) were published, with the majority being PGY2s (74.3%). Subsequent publications were identified for 162 residents (40.4%), with a higher percentage in those who published their pediatric-focused residency project versus those who did not, 59.5% versus 32.8%, p < 0.001. Factors associated with subsequent publications were those who published their residency project, initial position in academia, and PGY2s.

Conclusions: Of the residency projects presented at the showcase <20% were subsequently published. Those who published their residency research project were more likely to have subsequent publications. Future efforts should be taken to ensure that residents have the tools/confidence to independently publish their research/scholarship.
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http://dx.doi.org/10.5863/1551-6776-26.2.163DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7887887PMC
February 2021

Frequency and Severity of Chlorothiazide-Induced Hyponatremia in the Neonatal Intensive Care Unit.

Am J Perinatol 2021 Jan 6. Epub 2021 Jan 6.

Department of Pharmacy, Clinical and Administrative Sciences, University of Oklahoma College of Pharmacy, Oklahoma City, Oklahoma.

Objective:  Although thiazide diuretics are commonly used in the neonatal intensive care unit (NICU), the risk of thiazide-induced hyponatremia in infants has not been well documented. The primary objective of this study was to determine the frequency and severity of hyponatremia in neonates and infants receiving enteral chlorothiazide. Secondary objectives included identifying: (1) percent change in serum sodium from before chlorothiazide initiation to nadir, (2) time to reach nadir serum sodium concentration, and (3) percentage of patients on chlorothiazide receiving sodium supplementation.

Study Design:  This was a retrospective cohort study of NICU patients admitted between July 1, 2014 and July 31, 2019 who received ≥1 dose of enteral chlorothiazide. Mild, moderate, and severe hyponatremia were defined as serum sodium of 130 to 134 mEq/L, 120 to 129 mEq/L, and less than 120 mEq/L, respectively. Data including serum electrolytes, chlorothiazide dosing, and sodium supplementation were collected for the first 2 weeks of therapy. Descriptive and inferential statistics were performed in SAS software, Version 9.4.

Results:  One hundred and seven patients, receiving 127 chlorothiazide courses, were included. The median gestational age at birth and postmenstrual age at initiation were 26.0 and 35.9 weeks, respectively. The overall frequency of hyponatremia was 35.4% (45/127 courses). Mild, moderate, and severe hyponatremia were reported in 27 (21.3%), 16 (12.6%), and 2 (1.6%) courses. The median percent decrease in serum sodium from baseline to nadir was 2.9%, and the median time to nadir sodium was 5 days. Enteral sodium supplements were administered in 52 (40.9%) courses. Sixteen courses (12.6%) were discontinued within the first 14 days of therapy due to hyponatremia.

Conclusion:  Hyponatremia occurred in over 35% of courses of enteral chlorothiazide in neonates and infants. Given the high frequency of hyponatremia, serum sodium should be monitored closely in infants receiving chlorothiazide. Providers should consider early initiation of sodium supplements if warranted.

Key Points: · One-third of infants on chlorothiazide develop hyponatremia.. · Nadir serum sodium typically occurs within 5 days.. · Monitor sodium closely after chlorothiazide initiation..
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http://dx.doi.org/10.1055/s-0040-1722598DOI Listing
January 2021

Infant Essential Fatty Acid Status Is Not Associated With Postoperative Wound Complication Severity.

J Surg Res 2021 02 23;258:435-442. Epub 2020 Oct 23.

Section of Neonatal-Perinatal Medicine, Department of Pediatrics, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.

Background: Neonates are susceptible to postoperative wound complications (POWCs), as prematurity, hypoxia, steroid use, immunosuppression, and malnutrition are all common comorbidities. Critically ill infants, dependent on parenteral nutrition, are at even further risk of developing essential fatty acid deficiency (EFAD). We hypothesized that POWC severity and EFAD were associated because of increased susceptibility to infections and impaired wound healing seen with EFAD.

Methods: Institutional review board-approved (OUHSC10554), retrospective review from our academic Level IV Neonatal Intensive Care Unit. Infants aged <1 y who underwent a fascial-compromising gastrointestinal surgery from June 1, 2015, to March 15, 2019, and who had essential fatty acids (EFAs) measured ±2 wk from surgery were included. Three blinded investigators independently categorized POWC using the World Union of Wound Healing Society Surgical Wound Grading System. Infants were categorized into three groups: no POWC, POWC Grades 1 and 2 (superficial tissue nonintegrity), and POWC Grades 3 and 4 (deep tissue nonintegrity and complete dehiscence). EFA status and other possible POWC-associated factors were analyzed to determine any association with wound severity.

Results: Fifty infants met the inclusion criteria. Half (25/50) had no POWC, 30% (15/50) had Grade 1 or 2, and 20% (10/50) had Grade 3 or 4. We found no association between EFAD and POWC severity.

Conclusions: In our cohort, EFA status did not predict POWC severity. At this time, we cannot suggest delaying elective surgical procedures to correct EFAD as an approach to preventing POWC.
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http://dx.doi.org/10.1016/j.jss.2020.08.046DOI Listing
February 2021

Massive spontaneous haemorrhage in a plexiform neurofibroma: A case report and discussion of the literature.

J Clin Neurosci 2020 Oct 28;80:229-231. Epub 2020 Aug 28.

Flinders Medical Centre, Australia.

Neurofibromatosis Type 1 (NF1) is a neurocutaneous tumour syndrome characterised by mutations in the NF1 gene and resultant neurofibromin protein. The condition is associated with several stigmata of variable penetrance, including various tumours. Massive and fatal haemorrhage arising from plexiform neurofibromas has been described in NF1 patients, though it is a rare clinical entity. The aetiology of massive haemorrhage in NF1 patients appears to be related to vasculopathy, including aneurysms and pseudoaneurysms, often arising within plexiform neurofibromas. There is currently no evidence-based consensus for managing this rare clinical emergency, likely as a result of its low incidence. We describe a case of massive haemorrhage in an NF1 patient managed via embolisation and discuss the literature.
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http://dx.doi.org/10.1016/j.jocn.2020.08.024DOI Listing
October 2020

Ampicillin Dose for Early and Late-Onset Group B Streptococcal Disease in Neonates.

Am J Perinatol 2020 Oct 22. Epub 2020 Oct 22.

Division of Pharmacy Practice, Department of Pharmacy, Clinical and Administrative Sciences, University of Oklahoma Health Sciences Center College of Pharmacy, Oklahoma City, Oklahoma.

Ampicillin is frequently used in neonates for early- and late-onset group B streptococcal (GBS) disease. In 2019, the American Academy of Pediatrics (AAP) published guidelines for GBS which included updated dosing recommendations for ampicillin for bacteremia and provided specific dosing recommendations for meningitis. The dosing recommendations in the guidelines were based off the 2018 Report of the Committee on Infectious Diseases (i.e., Red Book), which differed from the 2015 Red Book. For bacteremia, no dosing changes were recommended for ampicillin dosing in neonates ≤ 7 days of postnatal age (PNA), but less frequent dosing intervals were recommended for neonates > 7 days PNA. For meningitis, increased dosing recommendations were provided in the update. However, the rationale and supporting evidence for these changes were not provided. A literature search was performed to review articles pertaining to the pharmacokinetics (PK), pharmacodynamics (PD) and safety of ampicillin in neonates. The ampicillin dosing recommendations in the AAP guidelines were mainly supported by a 2014 publication that evaluated the PK and PD of ampicillin in neonates with gestational age (GA) of 24 to 41 weeks and PNA of 0 to 25 days. The proposed dosing from this study for bacteremia is included in the 2018 Red Book and 2019 guidelines. For meningitis, no supporting evidence was identified for the dosing recommendations in the 2018 Red Book and 2019 guidelines. Only one study has evaluated ampicillin concentrations in cerebrospinal fluid, but proposed dosing from this study was much lower than that included in the guidelines. The high ampicillin doses for GBS meningitis should be used with caution, as high ampicillin concentrations have been associated with seizures and no studies have evaluated efficacy of this dosing strategy. The purpose of this review is to identify key pieces of literature regarding dosing recommendations and safety of ampicillin in neonates. KEY POINTS: · Recent guidelines provide dosing recommendations for ampicillin, but the supporting evidence is not included.. · Literature supporting evidence for ampicillin dosing for bacteremia is available, but not for dosing for meningitis.. · Recommended meningitis dose may result in supratherapeutic concentrations and increase seizure risk..
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http://dx.doi.org/10.1055/s-0040-1718880DOI Listing
October 2020

Descriptive study of discharge medications in pediatric patients.

SAGE Open Med 2020 3;8:2050312120927945. Epub 2020 Jun 3.

Department of Pharmacy: Clinical and Administrative Sciences, The University of Oklahoma College of Pharmacy, Oklahoma City, OK, USA.

Background: Limited studies have evaluated medications in children discharged from hospitals. Knowledge of the number of medications and dosage forms could provide a baseline to establish a medication discharge prescription program.

Objectives: To identify the median number of discharge prescriptions per patient. Secondary objectives included an evaluation of the dosage formulations and frequency, and comparisons of the prevalence of unrounded medication doses between service type (medical vs surgical) and physician provider level (trainees vs attendings).

Methods: This retrospective study included children <18 years receiving >1 discharge prescription during 4 selected months over a 1-year time frame. Comparisons were made via Pearson's chi-square tests, Fisher's Exact tests, and Kruskal-Wallis nonparametric rank tests as appropriate with a priori value of <0.05.

Results: A total of 852 patients were evaluated, with most (78.8%) on a medical service. The median (interquartile range) number of new medications at discharge was 2 (1-3), with the median total number of discharge medications of 3 (2-6). There was no difference in the net change of the median number of home medications stopped and new medications started between service types. The majority (72.2%) received >1 oral liquid medications. There was no difference in prescribing rates per service type and provider level. There was a difference in the number of unrounded doses between trainees versus attendings, 17.8% versus 9.5%,  = 0.048.

Conclusion: Patients were discharged on a median of three medications, and most received >1 oral liquid medications. These data can be used to target children who would benefit from medication discharge prescription programs.
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http://dx.doi.org/10.1177/2050312120927945DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7271562PMC
June 2020

Which PGY1 Pharmacy Residency Is Right for Me? Advantages and Disadvantages of Pediatric-Focused and Traditional PGY1 Pharmacy Programs.

J Pediatr Pharmacol Ther 2020 ;25(4):273-277

Students interested in pediatric pharmacy may face difficulty choosing a postgraduate year 1 (PGY1) Pharmacy residency program. These students can complete their PGY1 Pharmacy residency in a traditional PGY1 Pharmacy program, a program with less than 50% of pediatric rotation experiences, or a pediatric-focused PGY1 Pharmacy program, a program with at least 50% of pediatric rotation experiences. These programs differ in rotational experiences, types of projects available, service commitment, and preceptor backgrounds. This article provides potential advantages and disadvantages that students may consider when selecting between these 2 different PGY1 Pharmacy residency programs. In addition, the article includes advice for students to consider when evaluating the best fit for themselves, and many of the recommendations were developed following a presentation that was given to students at the Pediatric Pharmacy Association's Annual Meeting in April 2019. Ultimately, the best residency program fit for a student interested in pediatrics should be based on each student's priorities, preferences, and career goals.
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http://dx.doi.org/10.5863/1551-6776-25.4.273DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7243907PMC
January 2020

Tips for writing pharmacy residency letters of intent.

Am J Health Syst Pharm 2020 04;77(8):605-607

Department of Pharmacy: Clinical and Administrative Sciences University of Oklahoma College of Pharmacy Oklahoma City, OK.

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http://dx.doi.org/10.1093/ajhp/zxaa026DOI Listing
April 2020

Antipsychotic Use in the Prevention and Treatment of Intensive Care Unit Delirium in Pediatric Patients.

J Pediatr Pharmacol Ther 2020 ;25(2):81-95

Objectives: To describe the antipsychotics, route of administration, dosage regimen, and outcomes reported to prevent or treat delirium in hospitalized children.

Methods: Medline, Embase, and International Pharmaceutical Abstracts were searched using the keywords "haloperidol," "olanzapine," "quetiapine," "risperidone," "ziprasidone," and "delirium." Articles evaluating the use of these agents to manage delirium in hospitalized children that were published between 1946 and August 2019 were included. Two authors independently screened each article for inclusion. Reports were excluded if they were published abstracts or included fewer than 3 patients in the report.

Results: Thirteen reports that included 370 children receiving haloperidol, quetiapine, olanzapine, and/or risperidone for delirium treatment were reviewed. Most children received haloperidol (n = 131) or olanzapine (n = 125). Significant variability in dosing was noted. A total of 23 patients (6.2%) had an adverse drug event, including 13 (56.5%) who experienced dystonia and 3 (13.0%) with a prolonged corrected QT interval. Most reports described improvement in delirium symptoms; however, only 5 reports used a validated screening tool for PICU delirium to evaluate antipsychotic response.

Conclusions: Most reports noted efficacy with antipsychotics, but these reports were limited by sample size and lacked a validated PICU delirium tool. Future research is needed to determine the optimal agent and dosage regimen to treat PICU delirium.
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http://dx.doi.org/10.5863/1551-6776-25.2.81DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7025750PMC
January 2020

A survey of pediatric degree option program graduates in a doctor of pharmacy curriculum: Confidence and initial employment position.

Curr Pharm Teach Learn 2019 Dec 7;11(12):1296-1302. Epub 2019 Nov 7.

Department of Pharmacy: Clinical and Administrative Sciences, University of Oklahoma College of Pharmacy, United States of America. Electronic address:

Background And Purpose: Graduates from the pediatric degree option program (PDOP) were tracked to identify confidence with pediatric pharmacotherapy and categorize initial employment following graduation.

Educational Activity And Setting: The PDOP was established in 2011 and requires 16 credits of pediatric-focused didactic coursework and advanced pharmacy practice experiences. Thirty PDOP graduates completed a 30-item questionnaire to assess confidence in pediatric pharmacotherapy knowledge and skill statements and employment position following graduation. Responses were compared between those completing post-graduate pediatric pharmacy training and those who did not.

Findings: Nineteen (63.3%) graduates responded. All expressed "very high" or "high" confidence with dose calculations, first-line treatment selection for otitis media, and counseling caregivers on medications. However, <75% expressed "very high" or "high" confidence with identification of pharmacokinetic differences in neonates vs. children, utilization of growth charts, and counseling children. Ten (52.6%) respondents completed post-graduate training, and the remainder had an initial position in community or hospital pharmacy. There were no significant differences in pharmacotherapy skill and knowledge statements between those completing residency vs. those who did not. The most beneficial experiences reported were gaining clinical experience in pediatric pharmacy and medication safety.

Summary: Overall, PDOP graduates noted high confidence in pediatric pharmacotherapy skills and knowledge. Most felt that the PDOP influenced their initial career plans and made them more competitive for their initial position following graduation. The PDOP was well received and provided an opportunity for additional knowledge and skill development for students interested in pediatrics.
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http://dx.doi.org/10.1016/j.cptl.2019.09.013DOI Listing
December 2019

Hyponatremia With Intravenous Sulfamethoxazole/Trimethoprim in Children.

Ann Pharmacother 2020 04 6;54(4):351-358. Epub 2019 Nov 6.

The University of Oklahoma College of Pharmacy, Oklahoma City, OK, USA.

Intravenous (IV) sulfamethoxazole/trimethoprim (SMX/TMP) has been associated with hyponatremia in adults. The primary objective was to identify the number of patients with a serum sodium <135 mEq/L. Secondary objectives between the hyponatremic versus nonhyponatremic groups included demographic comparisons, median serum sodium concentrations, SMX/TMP cumulative dose, number of diuretics, and other medications causing hyponatremia. This was a retrospective study of children <18 years receiving IV SMP/TMX. Comparisons were conducted via Mann-Whitney-Wilcoxon and Mantel-Haenszel χ tests with an a priori value <0.05. Sixty-one patients received 66 total courses; 20 courses (30.3%) were associated with hyponatremia with a decrease in the median nadir serum sodium concentration of 133 and 138 mEq/L in the hyponatremic and nonhyponatremic groups, respectively (<0.001). The median age (interquartile range) was lower in the hyponatremic versus nonhyponatremic group, but this was not statistically significant: 0.6 (0.1-5.5) versus 3.9 (0.3-11.0) years; =0.077. There was no significant difference in the median cumulative dose (mg/kg) between groups; =0.104. In addition, there was a significant difference in the number of children in the hyponatremic versus nonhyponatremic groups receiving diuretics (16 [80.0%] vs 23 [50.0%], =0.023) and other medications that cause hyponatremia (7 [35.0%] vs 5 [10.9%], =0.034), respectively. Furosemide was noted to be the medication most associated with hyponatremia. Approximately one-third administered IV SMX/TMP developed hyponatremia. Concomitant furosemide administration was one of the most common risk factors. Clinicians should be aware of this potential adverse event when initiating IV SMX/TMP in children.
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http://dx.doi.org/10.1177/1060028019887919DOI Listing
April 2020

Prescribing Patterns of Continuous Infusions in Nonobese versus Obese Children Admitted to the Pediatric Intensive Care Unit.

J Pediatr Intensive Care 2019 Dec 21;8(4):226-232. Epub 2019 Jun 21.

Department of Pharmacy: Clinical and Administrative Sciences, University of Oklahoma College of Pharmacy, Oklahoma City, Oklahoma, United States.

This retrospective study compared the continuous infusions prescribed for obese and nonobese children. Ninety-five (13.2%) received an infusion. A greater percentage of obese (  = 42/168) versus nonobese (53/552) children received infusions,  < 0.01. No difference was noted in the median number of infusions between the obese and nonobese groups, 2 versus 2,  = 0.975. The top 20 prescribed infusions included ten (50%) for sedation/analgesia or neuromuscular blockade and six (30%) for hemodynamic support. A literature search was performed for these 20 agents to determine pharmacokinetics, pharmacodynamics, and dosing in obese children and revealed six studies evaluating fentanyl (  = 2), midazolam (  = 1), and propofol (  = 3).
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http://dx.doi.org/10.1055/s-0039-1692669DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6821521PMC
December 2019

Disulfiram-like Reaction With Metronidazole: An Unsuspected Culprit.

J Pediatr Pharmacol Ther 2019 Sep-Oct;24(5):445-449

The association of disulfiram-like reaction with concomitant use of metronidazole and alcohol has been reported in the literature; however, alcohol containing oral liquids may not always be identified as a culprit. A case of a 14-year-old patient who experienced a possible disulfiram-like interaction while receiving metronidazole and Prednisone Intensol solution is reported. Metronidazole oral suspension was initiated for treatment of Clostridium difficile-associated diarrhea. Later, a 5-day course of oral Prednisone Intensol solution was initiated. On day 2 of concomitant metronidazole and steroid therapy, the patient experienced severe discomfort and abdominal distention accompanied by new onset tachycardia. A disulfiram-like reaction between the steroid solution and metronidazole was suspected; therefore, the Prednisone Intensol was discontinued. The patient's mother reported that, following discontinuation, the patient slept well for the first time in 2 days. Use of the Naranjo Adverse Drug Reaction Probability Scale indicated a possible relationship (score of 4) between the concomitant medication use and the gastrointestinal discomfort and tachycardia. If this interaction between metronidazole and alcohol containing medications occurs, it may be initially unrecognized, potentially resulting in patient discomfort or harm. It is important for healthcare professionals to identify these potential drug-drug interactions so that alternative medications may be utilized and offending agents can be avoided or replaced.
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http://dx.doi.org/10.5863/1551-6776-24.5.445DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6782120PMC
October 2019

Prediction and Comparison of Fentanyl Infusion Pharmacokinetics in Obese and Nonobese Children.

Pediatr Crit Care Med 2019 12;20(12):e556-e564

Department of Pharmacy, Clinical and Administrative Sciences, University of Oklahoma College of Pharmacy, Oklahoma City, OK.

Objectives: To compare fentanyl infusion pharmacokinetic variables in obese children and nonobese children.

Design: A pharmacokinetic simulation study.

Setting: We used a semi-physiologically based pharmacokinetic model to generate fentanyl pharmacokinetic variables.

Subjects: Simulations of pharmacokinetic variables were based on historical inpatient demographic data in less than 18-year-olds.

Interventions: Obese children were defined as children less than 2 years with weight-for-length greater than or equal to 97.7th percentile or body mass index-for-age greater than or equal to 95th percentile for greater than or equal to 2-17-year-olds.

Measurements And Main Results: Overall, 4,376 patients were included, with 807 (18.4%) classified as obese children. The majority (52.9%) were male, with a median age of 8.1 years (interquartile range, 4.3-13.0 yr). The differences in total clearance (CLS), volume of distribution at steady-state values, weight-normalized CLS, and weight-normalized volume of distribution at steady state were assessed in obese children and nonobese children. Multivariable analyses indicated that obesity was significantly associated with a higher CLS in obese children greater than 6-year-olds (p < 0.0375). However, there was an 11-30% decrease in weight-normalized CLS in obese children versus nonobese children in all age groups (p < 0.05). Both volume of distribution at steady state and weight-normalized volume of distribution at steady state increased significantly in obese children compared with nonobese children (p < 0.05). Fentanyl plasma concentration-time profiles of obese children and nonobese children pairs (ages 4, 9, and 15) receiving 1 µg/kg/hr using total body weight were also compared. Steady-state concentrations of the obese children using similar weight-based dosing increased by 25%, 77%, and 44% in comparison to nonobese children 4-, 9-, and 15-year-olds, respectively. Time to steady state and elimination half-lives were two- to four-fold longer in obese children. An additional simulation was conducted for 15-year-old obese children and nonobese children using a fixed dose of 50 µg/hr and it provided similar pharmacokinetic profiles.

Conclusions: CLS may increase less than proportional to weight in obese children greater than 6-year-olds, while volume of distribution at steady state increases more than proportional to weight in all obese children compared with nonobese children. Weight-based dosing in obese children may cause an increase in steady-state concentration while prolonging the time to steady state. Exploring alternative dosing strategies for obese children is warranted.
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http://dx.doi.org/10.1097/PCC.0000000000002125DOI Listing
December 2019

Small patients, big problems? Pediatric primer for the nonpediatric pharmacist.

Am J Health Syst Pharm 2019 09;76(19):1451-1452

Department of Pharmacy University of Oklahoma College of Pharmacy Oklahoma City, OK.

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http://dx.doi.org/10.1093/ajhp/zxz170DOI Listing
September 2019

Off-Label Medication use in Children, More Common than We Think: A Systematic Review of the Literature.

J Okla State Med Assoc 2018 Oct;111(8):776-783

Department of Pediatrics: Section of General and Community Pediatrics, University of Oklahoma College of Medicine, Oklahoma City, OK.

Content: Clinician prescribing of off-label medications is common due to a lack of pediatric-specific data regarding the dosing, efficacy and safety of medications regularly prescribed to children.

Objective: This systematic review summarizes the published incidence of off-label medication use in children from the past 10 years. We also performed a retrospective chart review to determine the incidence of off-label prescriptions for children seen in the OU Physicians clinics.

Data Sources: We conducted a literature search of PubMed and OVID Medline from 2007 to 2017. Search terms included off-label use of medications and all child. For the local review, the outpatient electronic medical record (EMR) was queried.

Study Selection: Studies were eligible for inclusion if the study included children < 18 years of age, defined off-label use in the paper, and included the incidence of off-label drug use.

Data Extraction: Each review author extracted the study data from their assigned studies. For the retrospective chart review, the EMR was queried for patients <21 years of age who had a clinic visit and received a new prescription during 2017.

Results: We identified 31 studies, with off-label prescription rates from 3.2 % to 95%. The local retrospective chart review included 1,323 prescriptions; 504 were off-label (38.1%) and 819 were approved. The frequency of off-label prescriptions does not differ significantly between the meta-analysis from the systematic review and the local retrospective chart review (30.9% vs 38.1%).

Conclusions: The use of off-label medications in children remains a common practice for pediatric providers.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6677268PMC
October 2018

Low-dose versus high-dose methadone for the management of neonatal abstinence syndrome.

J Opioid Manag 2019 Mar/Apr;15(2):159-167

Associate Professor, Department of Pharmacy: Clinical and Administrative Sciences, University of Oklahoma College of Pharmacy, Oklahoma City, Oklahoma.

Objectives: The primary objective was to compare median time to symptom relief (time from methadone initiation until two consecutive modified Finnegan [neonatal abstinence syndrome, NAS] scores < 8) between neonates receiving low-dose (≤0.275 mg/kg/day) versus high-dose (>0.275 mg/kg/day) methadone. Secondary objectives included assessment of factors associated with symptom relief.

Design: Retrospective cross-sectional study.

Setting: Ninety-nine bed neonatal intensive care unit within a tertiary-care academic hospital.

Participants: Seventy-two neonates who received methadone for NAS over a 7.5-year period.

Main Outcome Measures(s): Kaplan-Meier curves with a log-rank test and a stepwise Cox proportional-hazard model were used to analyze outcomes.

Results: The median dose for the low-dose (n = 40) and high-dose (n = 32) groups were 0.19 mg/kg/day (interquartile range [IQR], 0.12-0.24) divided every 6-12 hours and 0.4 mg/kg/day (0.3-0.44) divided every 6-8 hours, respectively. The median time to symptom relief was higher in the low-dose versus high-dose groups, 9.3 (5.8-24.6) versus 6.0 (5.4-12.5) hours, respectively (p = 0.014). Low-dose males had a longer time to symptom resolution than other groups (p = 0.008). Female premature neonates (<37 weeks gestation) had a shorter time to symptom relief than term neonates [adjusted hazard ratio = 2.96 (1.02-8.62)]. The median total duration of methadone was shorter but not statistically significant between high- versus low-dose groups, 17.5 (IQR: 11.0-25.0) versus 21.0 days (IQR: 10.0-28.0), respectively (p = 0.483).

Conclusions: Neonates receiving high-dose methadone had a significantly shorter time to symptom relief. Differences in sex were noted in response to therapy with low-dose males having a longer time to symptom relief and premature neonates a shorter time to symptom relief.
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http://dx.doi.org/10.5055/jom.2019.0497DOI Listing
September 2019

Assessing psychosocial risk in pediatric cystic fibrosis.

Pediatr Pulmonol 2019 09 25;54(9):1391-1397. Epub 2019 Jun 25.

Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.

Background: Psychosocial risk factors are known to impact quality of life, treatment adherence, and health outcomes. No standardized comprehensive psychosocial risk screener is routinely utilized in cystic fibrosis (CF) care. The objectives of the study were to describe the range and severity of psychosocial risk within this CF population, investigate the reliability of a comprehensive psychosocial screener in pediatric CF clinical care, and explore relationships between psychosocial risk and key factors affecting health outcomes. It was hypothesized that the PAT-CF total and subscale α coefficients would be similar to those found in other pediatric medical populations.

Method: Parents of 154 children with CF completed a CF-specific version of the Psychosocial Assessment Tool_All-lit (PAT-CF), an empirically-based psychosocial risk assessment, during routine CF clinical care.

Results: The internal consistency of the PAT-CF Total score was 0.71. Total score and subscale reliabilities reflect findings in other pediatric populations. Total risk scores fell in the following categories: 7% (Clinical-highest risk), 41% (Targeted), and 52% (Universal-lowest risk), respectively. Increased psychosocial risk was associated with Medicaid status and lower parent education, whereas having private insurance was associated with decreased psychosocial risk.

Conclusions: The PAT-CF can feasibly be used as an empirically-based comprehensive psychosocial risk tool in routine CF care and is acceptable by parents. In addition to providing universal anticipatory guidance regarding child and family wellness, early identification of risk factors allows care teams to proactively provide targeted support and intervention for specific psychosocial risk factors to promote improved quality of life and ability to sustain daily care.
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http://dx.doi.org/10.1002/ppul.24414DOI Listing
September 2019

Pilot Study Comparing Modified Finnegan Scoring Versus Adjusted Scoring System for Infants With Iatrogenic Opioid Abstinence Syndrome After Cardiothoracic Surgery.

J Pediatr Pharmacol Ther 2019 Mar-Apr;24(2):148-155

Objectives: To compare the modified Finnegan Scoring System (modified Finnegan) with an Adjusted Scoring System Criteria (adjusted Finnegan) for infants after cardiothoracic surgery with iatrogenic opioid abstinence syndrome (IOAS).

Methods: This was a retrospective, observational pilot study. This study was conducted in a tertiary care academic hospital. Infants after cardiothoracic surgery with IOAS transferred between the pediatric intensive care unit and neonatal intensive care unit between January 1, 2014, and January 31, 2016, were included retrospectively. The main outcome variable was to compare the area under the curve for the mean modified Finnegan versus adjusted Finnegan.

Results: Twenty-five patients were included in the study. Twenty patients with at least 30 scores were included in the final analysis. Overall, the modified Finnegan scores were at least 2 points higher than the adjusted Finnegan. The difference in area under the curve was 34.6 (p < 0.001).

Conclusions: Use of the modified Finnegan tool for older infants with IOAS could overestimate withdrawal, leading to unnecessary interventions.
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http://dx.doi.org/10.5863/1551-6776-24.2.148DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478355PMC
April 2019

Impact of Ceftazidime Use on Susceptibility Patterns in the Neonatal Intensive Care Unit.

Pediatr Infect Dis J 2019 06;38(6):605-607

University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.

Background: Ceftazidime use in the neonatal intensive care unit (NICU) has increased after a cefotaxime shortage. The impact of this change is unknown. The purpose was to assess the effect of increased ceftazidime use on susceptibilities of Gram-negative organisms in the NICU.

Methods: Retrospective study of Gram-negative isolates identified in blood, urine, cerebrospinal fluid, tracheostomy, abdominal fluid and pleural fluid cultures from a single-center NICU over a 5-year period. Duplicate cultures that occurred within 90 days were noted. Pre- and postshortage periods were defined based on cessation of cefotaxime. Third- and fourth-generation cephalosporin susceptibility rates were compared between periods, as well as rates of extended-spectrum beta-lactamase (ESBL) Escherichia coli and Klebsiella species.

Results: Analysis included 666 isolates. Twelve (1.8%) were duplicate isolates that occurred after a 90-day period. The preshortage period included 464 (69.7%) isolates, and the postshortage included 202 (30.3%). No significant differences in susceptibility rates were noted when excluding duplicates. No difference in ESBL rates for E. coli were noted between periods (3.8% vs. 4.9%, P =1.000). No ESBL-positive Klebsiella species were identified. A post-hoc analysis of duplicate isolates demonstrated significant lower susceptibility rates for Pseudomonas aeruginosa to ceftazidime (risk ratio 0.58; 95% CI: 0.43-0.79) and cefepime (risk ratio 0.66; 95% CI: 0.51-0.86).

Conclusions: Ceftazidime use did not appear to affect susceptibility rates for third- and fourth-generation cephalosporins for most Gram-negative organisms in the short-term of 1.5 years. However, susceptibility rates for P. aeruginosa decreased when evaluating duplicate isolates. Long-term monitoring is needed to assess the true impact.
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http://dx.doi.org/10.1097/INF.0000000000002255DOI Listing
June 2019

Assessment of Outcomes With a Sedation Protocol During Laser Photocoagulation in Preterm Infants With Retinopathy of Prematurity.

J Pediatr Pharmacol Ther 2018 Sep-Oct;23(5):410-416

Objectives: To evaluate the success of a sedation protocol of fentanyl and midazolam infusions for infants undergoing laser photocoagulation for retinopathy of prematurity.

Methods: This retrospective study included infants receiving a sedation protocol for laser photocoagulation during a 4-year period. The primary objective was protocol success, defined as completion without interruption, absence of protocol dose deviations, and absence of interventions. Secondary objectives compared outcomes between those with and without opioid/benzodiazepine exposure. A logistic regression was used to assess the effect of prior opioid/benzodiazepine exposure on requirement for fentanyl infusion increases.

Results: Twenty-six infants were included. Seven (26.9%) had protocol success. Sixteen (61.5%) had protocol success, excluding dose deviations. Seventeen (65.4%) experienced ≥1 cardiopulmonary adverse events. Photocoagulation was completed in all cases.

Conclusions: Most achieved protocol success, when eliminating dosing deviations. These data indicate that flexibility is needed in fentanyl and midazolam infusion titration, based on clinical response.
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http://dx.doi.org/10.5863/1551-6776-23.5.410DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6213621PMC
November 2018

Optimal Medical Therapy Prescribing Patterns and Disparities Identified in Patients with Acute Coronary Syndromes at an Academic Medical Center in an Area with High Coronary Heart Disease-Related Mortality.

Am J Cardiovasc Drugs 2019 Apr;19(2):185-193

TRC Healthcare, Pharmacist's Letter, Oklahoma City, OK, USA.

Background: Coronary heart disease (CHD)-related mortality is high in the southern United States. A five-drug pharmacotherapy regimen for acute coronary syndromes (ACS), defined as optimal medical therapy (OMT), can decrease CHD-related mortality. Studies have indicated that OMT is prescribed 50-60% of the time. Assessment of prescribing could provide insight into the potential etiology of disparate mortality.

Objective: The aim was to evaluate prescribing of OMT at discharge in patients presenting with an ACS event at an academic medical center and identify patients at risk of not receiving OMT.

Methods: A single-center, retrospective cohort of patients with ACS diagnosis between July 2013 and July 2015 was investigated, and a multivariable regression analysis conducted to identify populations at risk of not receiving OMT.

Results: A total of 864 patients were identified by International Classification of Diseases, Ninth Revision (ICD-9) codes, with 533 excluded and 331 analyzed. OMT was prescribed in 69.79%. Patients ≥ 75 years of age [p = 0.003; odds ratio (OR) 0.30; 95% confidence interval (CI) 0.136-0.673], unstable angina presentation (p = 0.042; OR 0.55; 95% CI 0.307-0.977), and surgical management (p = 0.001; OR 0.22; 95% CI 0.095-0.519) were less likely to receive OMT.

Conclusions: The percentage of patients prescribed OMT exceeded the reported global percentage of prescribed OMT. However, disparities exist among specific populations.
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http://dx.doi.org/10.1007/s40256-018-0308-xDOI Listing
April 2019

Career Skills Assessment in a Doctor of Pharmacy Curriculum.

Am J Pharm Educ 2018 09;82(7):6300

The University of Oklahoma College of Pharmacy, Oklahoma City, Oklahoma.

To assess students' knowledge of, perceived importance of, and confidence in six career skills areas (curriculum vitae/resume writing, interviewing skills/business attire, phone interviews, thank you notes, business/dining etiquette, and networking) before, immediately after, and six months after participating in a career skills workshop. All students in a senior-level seminar course participated in the same simulation/performance-based workshop that was coupled with verbal or rubric-based feedback for each of the areas. Ninety-one students participated in the study and all students' knowledge significantly increased over the study as determined by study baseline, conclusion, and six-month follow-up assessments. At study follow-up, knowledge increased an average of +7.1 percentage points from baseline. Multivariate analysis indicated significant increases in confidence from baseline to follow-up ranging from +0.15 to +0.29 across the six workshop areas, with resume/CV preparation having the highest increase. From study onset to follow-up, students perceived that the six career skills areas were above the average importance midpoint (3.0). The workshop was effective in increasing students' knowledge and confidence of essential career skills vital to pursuing post-graduate employment. These career skills are important for helping students distinguish themselves in a competitive job market.
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http://dx.doi.org/10.5688/ajpe6300DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6181174PMC
September 2018

Description of a pediatric degree option program in a doctorate of pharmacy curriculum and its impact on pediatric-focused advanced pharmacy practice experience rotations and faculty scholarly productivity.

Curr Pharm Teach Learn 2018 05 13;10(5):627-636. Epub 2018 Mar 13.

Department of Pharmacy, Clinical and Administrative Sciences, University of Oklahoma College of Pharmacy, United States. Electronic address:

Purpose: To describe the development of a Pediatric Degree Option program and its impact on pediatric-focused advanced pharmacy practice experiences (APPEs) and faculty scholarly productivity.

Educational Activity: The Pediatric Degree Option program was established in 2011 and requires 16 h of didactic coursework and APPEs. The number of pediatric-focused APPEs and mean number of APPEs per pediatric faculty per year was compared pre- (2005-2010) and post-implementation (2011-2016). In addition, the median number of scholarship activities per student pre- and post-implementation was compared. The initial position obtained by graduates completing the degree option was collected.

Findings: Thirty students have completed the program. There were 146 pediatric-focused APPEs for the pre-implementation period and 259 post-implementation. However, there was an increase in pediatric faculty during the post-implementation, so there was no difference in the mean number of pediatric-focused APPEs per pediatric faculty in the pre- versus post-implementation period, 8.4 + 2.7 versus 6.9 +1.0, p = .224. A significant increase in the median number of pediatric-focused scholarly activities per student was observed pre-versus post-implementation, 3 (2-5) versus 5 (3-7), p = .005. Twenty-six (86.7%) students in the post-implementation period participated as a research assistant or coauthor in an original research or manuscript writing project. Students accepted a variety of positions after graduation including twelve (40%) accepting a PGY1 residency and eight (36.7%) as community pharmacists.

Summary: Although the number of pediatric-focused APPEs increased in the post-implementation, this did not result in an increase in the mean number of mean pediatric-focused APPEs per pediatric faculty member. However, it did allow a unique opportunity for 30 students with interest in pediatrics and allowed for content and skill development. The Pediatric Degree Option program allowed students to gain experience with pediatric-focused scholarly activities that also enhanced faculty productivity in scholarship and research.
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http://dx.doi.org/10.1016/j.cptl.2018.01.002DOI Listing
May 2018

Ascending Aorta and Myocardial Mechanics in Patients with "Clinically Normal" Bicuspid Aortic Valve.

Int Heart J 2018 Jul 6;59(4):741-749. Epub 2018 Jun 6.

Department of Heart Health, South Australian Health & Medical Research Institute.

Aortic valve dysfunction and aortic wall changes are well-known complications of bicuspid aortic valve (BAV) disease. The aim of the present study was to investigate whether a remodeling process of the left ventricle (LV) is present in patients with isolated BAV. Twenty-two consecutive patients (39 ± 15 years, 9 males) with clinically normal BAV and 18 age- and gender-matched control subjects (37 ± 10 years, 9 males) were included. Cardiovascular magnetic resonance (CMR) imaging was performed to evaluate LV function, aortic valve morphology, aortic orifice area, and ascending aorta (AA) dimensions. Tissue-tracking analysis was applied to assess LV systolic and diastolic myocardial mechanics in the longitudinal, circumferential, and radial direction and AA circumferential strain (CS). No significant difference was observed between BAV and controls regarding LV ejection fraction and LV mass index. Tissue-tracking analysis demonstrated that BAV patients had significantly impaired LV systolic and diastolic myocardial mechanics. BAV patients had also significantly lower AA CS compared with controls. At multivariate analysis, the presence of BAV was the only variable significantly and independently related to the impaired AA and LV systolic myocardial mechanics. In conclusion, LV myocardial deformation properties are impaired among BAV patients. The impairment of LV systolic mechanics observed in BAV patients appears to be related only to the congenital abnormality of the aortic valve itself.
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http://dx.doi.org/10.1536/ihj.17-230DOI Listing
July 2018

Sedation and Analgesia Using Medications Delivered via the Extravascular Route in Children Undergoing Laceration Repair.

J Pediatr Pharmacol Ther 2018 Mar-Apr;23(2):72-83

Objectives: To describe the method of delivery, dosage regimens, and outcomes of sedatives and analgesics administered via the extravascular route for laceration repair in children.

Methods: Medline, Embase, and International Pharmaceutical Abstracts were searched using the keywords "child," "midazolam," "ketamine," dexmedetomidine," "fentanyl," "nitrous oxide" (NO), and "laceration repair." Articles evaluating the use of extravascular sedation in children for laceration repair published in the English language between 1946 and June 2017 were included. Two authors independently screened each article for inclusion. Reports were excluded if they did not contain sufficient details on dosage regimen and outcomes.

Results: A total of 16 reports representing 953 children receiving sedatives and analgesics via the extravascular route were included for analyses. A statistical analysis was not performed because of heterogeneity in dosing and types of analyses conducted. Midazolam and NO were the most common agents, with oral (PO) midazolam being the most common agent. Other agents that have supporting data were intranasal (IN) dexmedetomidine, IN ketamine, IN midazolam, PO diazepam, PO ketamine, transmucosal (TM) midazolam, and TM fentanyl.

Conclusions: Most of the agents administered through the extravascular route were efficacious. Selection of the agents should be based on perceived need for analgesia versus sedation, patient accessibility, and adverse drug events. Future research is needed to determine the optimal agent and route for laceration repair.
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http://dx.doi.org/10.5863/1551-6776-23.2.72DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5916449PMC
May 2018

Sedation Protocol During Bevacizumab Intravitreal Injection in Preterm Infants With Retinopathy of Prematurity.

J Pediatr Pharmacol Ther 2018 Jan-Feb;23(1):34-40

Objectives: This study describes outcomes of intravenous (IV) analgesics and sedatives for bedside intravitreal bevacizumab injections for retinopathy of prematurity.

Methods: This retrospective study included infants receiving intravitreal bevacizumab injections between January 2012 and May 2016. Infants were excluded if bevacizumab was administered under general anesthesia or for incomplete records. Data collection included demographics, sedation and analgesia regimen, and cardiopulmonary adverse events (AEs). The primary objective was to identify the median doses of the IV analgesics and sedatives. The secondary objectives included the number of patients with cardiopulmonary AEs and those with procedure success, defined as procedure completion without interruption and absence of interventions.

Results: Fifteen infants were included. Fourteen (93.3%) were initiated on a fentanyl infusion at a median of 2 mcg/kg/hr (IQR, 2-3.6), and 12 (80%) received midazolam infusions at a median of 0.06 mg/kg/hr. All patients received at least 1 IV neuromuscular blocker dose just prior to the procedure. Only 2 patients (13.3%) required an increase in their fentanyl or midazolam infusions. Procedure success was achieved in 13 patients (86.7%). Five patients (33.3%) experienced 1 cardiopulmonary AE. One patient (6.7%) had a delay in the procedure, and 1 patient (6.7%) required naloxone. Despite this, the procedure was completed in all patients.

Conclusions: Most received fentanyl and midazolam infusions with a dose of vecuronium just prior to the procedure. Thirteen (86.7%) met the criteria for procedure success. One-third experienced a cardiopulmonary AE. Future studies are needed to identify the optimal agents and route of administration for this procedure.
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http://dx.doi.org/10.5863/1551-6776-23.1.34DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5823490PMC
March 2018

Detectable Concentrations of Inhaled Tobramycin in Critically Ill Children Without Cystic Fibrosis: Should Routine Monitoring Be Recommended?

Pediatr Crit Care Med 2017 Dec;18(12):e615-e620

Department of Pharmacy: Clinical and Administrative Science, University of Oklahoma College of Pharmacy, Oklahoma City, OK.

Objectives: To determine the percentage of detectable tobramycin troughs and acute kidney injury in critically ill children without cystic fibrosis on inhaled therapy.

Design: Historic cohort.

Setting: Academic hospital.

Patients: Forty children less than 18 years receiving inhaled tobramycin across 6.5 years.

Interventions: None.

Measurements And Main Results: The primary objective was to determine the percentage of detectable tobramycin troughs greater than or equal to 0.5 µg/mL. Secondary objectives included a comparison of acute kidney injury in children with and without detectable troughs. Twenty-two (55%) had trough concentrations obtained. Ten of these (45.5%) had detectable concentrations, with a median of 0.85 µg/mL (interquartile range, 0.5-2.0). There was no statistical significance between the detectable and nondetectable groups in age, gender, and method of administration. However, patients in the detectable group tended to be younger than nondetectable group and more likely to have a tracheotomy. There was a clinically significant decrease in estimated glomerular filtration rate in the detectable trough group.

Conclusions: Detectable troughs were noted in almost half of patients with concentrations obtained. A clinically significant decrease in estimated glomerular filtration rate was noted in patients with detectable concentrations. Continued work should be directed to better understand outcomes and monitoring in children requiring inhaled tobramycin.
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http://dx.doi.org/10.1097/PCC.0000000000001362DOI Listing
December 2017