Journal of Pediatric Pharmacology and Therapeutics最新文献

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Racial and Ethnic Disparities in the Use of Expensive Medications: A Focus on Sugammadex in the Pediatric Perioperative Setting. 昂贵药物使用中的种族和民族差异:对儿科围手术期Sugammadex的关注。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-25-00017
Ralph J Beltran, Christian Mpody, Joseph D Tobias, Olubukola O Nafiu
{"title":"Racial and Ethnic Disparities in the Use of Expensive Medications: A Focus on Sugammadex in the Pediatric Perioperative Setting.","authors":"Ralph J Beltran, Christian Mpody, Joseph D Tobias, Olubukola O Nafiu","doi":"10.5863/JPPT-25-00017","DOIUrl":"10.5863/JPPT-25-00017","url":null,"abstract":"<p><strong>Introduction: </strong>Avoiding residual neuromuscular blockade in the postoperative period sparked interest in the use of sugammadex as a reversal agent. However, because sugammadex was considered more expensive than other commonly used medications for this purpose, it was crucial to investigate potential disparities in its use.</p><p><strong>Methods: </strong>A retrospective cohort study of children (<18 years) was performed, who underwent general anesthesia and received neuromuscular blockade, in hospitals reporting to the Pediatric Health Information System between January 1, 2018, and December 31, 2023 was performed. Multivariable log-binomial regression was used to estimate the adjusted relative risk (RRAdj) of sugammadex administration across racial and ethnic groups, while adjusting for baseline covariates.</p><p><strong>Results: </strong>The study included 246,171 children. The overall use of sugammadex steadily increased among all groups throughout the study period from 2018 to 2023. The adjusted rate of sugammadex administration trended consistently lower for Black children compared with White children throughout the study period (54.5% vs 62.7%, RRAdj: 0.86 [95% CI, 0.84-0.87]), p < 0.01). A less pronounced lower rate of receiving sugammadex was noted for Hispanic children compared with White children (60.7% vs 62.7%, RRAdj 0.97 [95% CI, 0.95-0.98], p < 0.01). Asian children were also less likely to receive sugammadex, compared with White children (58.7% vs 62.7%, RRAdj 0.94 [95% CI, 0.91-0.96], p < 0.01). Within insurance group comparisons mirrored the disparities observed in the main model.</p><p><strong>Conclusions: </strong>Despite increased use of sugammadex among children who underwent elective surgery, racial and ethnic disparities in its use remained. These differences persisted regardless of insurance status.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"43-49"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12888980/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167143","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Duration Dilemma: With and Without Definitive Diagnostics. 持续时间的困境:有和没有明确的诊断。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-26-00106
Andi L Shane
{"title":"The Duration Dilemma: With and Without Definitive Diagnostics.","authors":"Andi L Shane","doi":"10.5863/JPPT-26-00106","DOIUrl":"10.5863/JPPT-26-00106","url":null,"abstract":"","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"120-122"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12888981/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146165938","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Tranexamic Acid in Pediatric Care: A Comprehensive Overview. 氨甲环酸在儿科护理:全面概述。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-25-00027
Mohammed Alsabri, Mayar M Aziz, Karim Fahmy, Alaa Zayed, Mohamed Tawfik Elkefl, Ebraheem A Ebraheem, Menna S Nabawy
{"title":"Tranexamic Acid in Pediatric Care: A Comprehensive Overview.","authors":"Mohammed Alsabri, Mayar M Aziz, Karim Fahmy, Alaa Zayed, Mohamed Tawfik Elkefl, Ebraheem A Ebraheem, Menna S Nabawy","doi":"10.5863/JPPT-25-00027","DOIUrl":"10.5863/JPPT-25-00027","url":null,"abstract":"<p><strong>Objective: </strong>Tranexamic acid (TXA) is a vital hemostatic agent in pediatric medicine, demonstrating substantial efficacy in managing both traumatic and nontraumatic hemorrhage. Although TXA has been widely adopted in adult trauma and surgical care, reducing mortality, minimizing transfusion requirements, and controlling perioperative and emergency-related bleeding, its pediatric use remains under researched, with knowledge gaps in optimal dosing, long-term safety, and thromboembolic risks. Pediatric-specific clinical guidelines remain inconsistent, necessitating further research on their role in pediatric emergency and perioperative care.</p><p><strong>Methods: </strong>A targeted literature search using a combination of MeSH terms and keywords was conducted using PubMed and Google Scholar, covering relevant studies focusing on the efficacy, pharmacokinetics, dosing strategies, and safety profile of TXA in children (ages 0-18 years) published between 1995 and February 2025.</p><p><strong>Results: </strong>Evidence supports the efficacy of TXA in reducing blood loss, minimizing transfusion needs, and improving survival outcomes in pediatric trauma, surgery, and emergency settings. Alternative administration routes, such as nebulized TXA, show promise for post-tonsillectomy hemorrhage and refractory epistaxis, potentially reducing the need for invasive interventions. However, gaps persist regarding age-specific pharmacokinetics, long-term safety, and potential thromboembolic and seizure risks. Inconsistent clinical practice, limited provider familiarity, and a lack of standardized pediatric protocols further hinder the use of TXA in pediatric settings.</p><p><strong>Conclusion: </strong>TXA remains a critical intervention for improving survival and clinical outcomes in pediatric hemorrhagic emergencies. However, its full potential depends on further interdisciplinary research, the development of standardized pediatric-specific guidelines, and enhanced provider training. Addressing knowledge gaps will be essential to ensuring safe implementation of TXA across diverse pediatric clinical scenarios.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"18-29"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12889008/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146166549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
External Pharmacokinetic Model Evaluation of Caffeine in Critically Ill Neonates With Heart Disease Using Data Collected From a Pragmatic Platform Trial. 使用实用平台试验收集的数据评估咖啡因在危重新生儿心脏病中的外部药代动力学模型
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-25-00144
Courtney Hallock, Annalisa Hawk, Calla Castro, Jessminda DiCello, Andrea L Storer, Rachel Sielaty, Henry P Foote, Daniel K Benjamin, Victoria E Helfer, Daniel Gonzalez, Kanecia O Zimmerman, Christoph P Hornik, Elizabeth J Thompson
{"title":"External Pharmacokinetic Model Evaluation of Caffeine in Critically Ill Neonates With Heart Disease Using Data Collected From a Pragmatic Platform Trial.","authors":"Courtney Hallock, Annalisa Hawk, Calla Castro, Jessminda DiCello, Andrea L Storer, Rachel Sielaty, Henry P Foote, Daniel K Benjamin, Victoria E Helfer, Daniel Gonzalez, Kanecia O Zimmerman, Christoph P Hornik, Elizabeth J Thompson","doi":"10.5863/JPPT-25-00144","DOIUrl":"10.5863/JPPT-25-00144","url":null,"abstract":"<p><strong>Objective: </strong>While most population pharmacokinetic (PopPK) models undergo internal validation, few pediatric PopPK models undergo external evaluation. We aimed to externally evaluate a previously developed PopPK model of caffeine in neonates with congenital heart disease using data collected from a pragmatic platform trial.</p><p><strong>Methods: </strong>We prospectively enrolled neonates with congenital heart disease who received caffeine per standard of care for prostaglandin-associated apnea and collected opportunistic or scavenged pharmacokinetic samples in a pragmatic platform trial. The predictive performance of the PopPK model was evaluated using model prediction error (PE), mean prediction error (MPE), mean absolute prediction error (MAPE), proportion of predicted values within 20% (F20) and 30% (F30) of observed values, prediction-corrected visual predictive checks, and normalized prediction distribution errors. Dosing simulations were conducted to match exposures seen in preterm infants.</p><p><strong>Results: </strong>Fourteen neonates contributed 37 pharmacokinetic samples to the validation cohort. The model demonstrated strong quantitative predictive performance (PE -0.18 mg/L, MPE -1.3%, and MAPE 13.3%, F20 79%, and F30 88%), meeting predefined thresholds. Graphical diagnostics supported model accuracy. Dosing simulations revealed lower caffeine exposures in neonates with congenital heart disease, particularly after cardiopulmonary bypass, than in preterm neonates without heart disease.</p><p><strong>Conclusions: </strong>External evaluation of a pediatric PopPK model using data from a pragmatic platform trial was successful. Our external evaluation supports broader adoption of pragmatic platform trials for pediatric model development and evaluation. These studies can inform starting doses for future trials, which cannot necessarily be extrapolated from other populations due to variability in drug disposition.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"170-179"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12888983/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prevention of Subsequent L-Asparaginase Hypersensitivity in Children Through Premedication: A Single-Center Experience. 通过用药前预防儿童l -天冬酰胺酶过敏:单中心经验。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-25-00031
Pongsathorn Saligupta, Chane Choed-Amphai, Lalita Sathitsamitphong, Mongkol Lao-Araya
{"title":"Prevention of Subsequent L-Asparaginase Hypersensitivity in Children Through Premedication: A Single-Center Experience.","authors":"Pongsathorn Saligupta, Chane Choed-Amphai, Lalita Sathitsamitphong, Mongkol Lao-Araya","doi":"10.5863/JPPT-25-00031","DOIUrl":"10.5863/JPPT-25-00031","url":null,"abstract":"<p><strong>Objective: </strong>L-asparaginase is an essential component of pediatric acute lymphoblastic leukemia (ALL) treatment. However, hypersensitivity reactions can occur, necessitating a switch to alternative asparaginase formulations. In resource-limited settings, access to pegylated asparaginase and <i>Erwinia</i> asparaginase may be limited. This study aimed to evaluate the safety and feasibility of a premedication protocol in preventing subsequent L-asparaginase hypersensitivity reactions in children with a history of severe reactions to native <i>Escherichia coli</i> L-asparaginase.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted in 119 children with ALL treated with L-asparaginase at Chiang Mai University Hospital. Ten patients (8.4%) developed severe systemic hypersensitivity reactions. Subsequent intramuscular L-asparaginase doses were preceded by a standardized premedication protocol comprising oral prednisolone, cetirizine, and montelukast, along with preinfusion intravenous hydrocortisone.</p><p><strong>Results: </strong>A total of 76 subsequent L-asparaginase doses were administered following premedication. Seven episodes (9.2%) of recurrent hypersensitivity reactions occurring within 5 to 40 minutes of L-asparaginase dosing occurred in 6 patients. Most reactions were mild and managed with additional antihistamines and corticosteroids. One episode required treatment with intramuscular epinephrine. All patients successfully completed their prescribed course of L-asparaginase therapy.</p><p><strong>Conclusion: </strong>In resource-limited settings, our premedication protocol demonstrated potential for safely enabling continued native <i>E. coli</i> L-asparaginase therapy in children with a history of severe hypersensitivity reactions, thus potentially improving access to chemotherapy treatment.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"62-69"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12889000/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167122","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Duration of Antibiotic Therapy for Escherichia coli Bacteremia in Infants With Normal Cerebrospinal Fluid Studies and Without Meningitis. 脑脊液检查正常且无脑膜炎的婴儿中大肠杆菌血症的抗生素治疗持续时间
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-25-00150
Ashley Stark, Veronica Quiett, Thomas Roberts, Rachel Rockwell, Veeral N Tolia, Melissa Campbell, Kanecia O Zimmerman, Daniel K Benjamin, Rachel G Greenberg, Angelique E Boutzoukas
{"title":"Duration of Antibiotic Therapy for <i>Escherichia coli</i> Bacteremia in Infants With Normal Cerebrospinal Fluid Studies and Without Meningitis.","authors":"Ashley Stark, Veronica Quiett, Thomas Roberts, Rachel Rockwell, Veeral N Tolia, Melissa Campbell, Kanecia O Zimmerman, Daniel K Benjamin, Rachel G Greenberg, Angelique E Boutzoukas","doi":"10.5863/JPPT-25-00150","DOIUrl":"10.5863/JPPT-25-00150","url":null,"abstract":"<p><strong>Objective: </strong>The optimal antibiotic duration for infants with <i>Escherichia coli</i> bacteremia with reliable, normal cerebrospinal fluid (CSF) studies and without meningitis is unknown. We evaluated whether treatment duration is associated with infection recurrence or mortality in these infants.</p><p><strong>Methods: </strong>This cohort study included infants discharged from Pediatrix Medical Group neonatal intensive care units between 2003-2022 with first instance of <i>E coli</i> bacteremia. Exclusion criteria included absence of CSF test results, CSF pleocytosis, positive culture or Gram stain from the CSF, delayed antimicrobial initiation (>2 days), or death/discharge during therapy. Antibiotic duration was categorized as <10, 10 to 14, or >14 days. Univariable analysis and multivariable logistic regression were used to assess associations between antibiotic duration and 30-day and in-hospital mortality, recurrence of infection, and the combined outcome of recurrence of infection or 30-day mortality. Sensitivity analysis excluded courses <5 days.</p><p><strong>Results: </strong>In 682 infants with <i>E coli</i> bacteremia, recurrence of infection or death following antibiotics occurred in 3% and was not associated with antibiotic duration (p = 0.82). After adjusting for gestational age and severe disease (defined as 1 or more of the following: mechanical ventilation, inotropic administration, or extracorporeal support) on the first day of bacteremia, antibiotic durations of 10 to 14 days were associated with lower odds of 30-day mortality (OR 0.18; 95% CI: 0.03-0.99) than antibiotic durations of <10 days. In the sensitivity analysis (N = 667), antibiotic duration was not predictive of any outcomes.</p><p><strong>Conclusions: </strong>A 10-day course of antibiotics for <i>E coli</i> bacteremia with normal CSF results is likely sufficient for term and preterm infants.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"131-137"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12888993/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Policy Failure, Not "Hesitancy": Lessons From Recent Measles and Pertussis Outbreaks in the United States. 政策失败,而不是“犹豫”:美国最近麻疹和百日咳爆发的教训。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-25-01224
Gregory L Kearns, Ellie Whitney, James D Marshall
{"title":"Policy Failure, Not \"Hesitancy\": Lessons From Recent Measles and Pertussis Outbreaks in the United States.","authors":"Gregory L Kearns, Ellie Whitney, James D Marshall","doi":"10.5863/JPPT-25-01224","DOIUrl":"10.5863/JPPT-25-01224","url":null,"abstract":"","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"115-117"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12888995/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Implementation and Evaluation of a Pediatric Behavioral Health Medication Reconciliation Program in a Regional Tertiary Care Pediatric Emergency Department. 在地区三级护理儿科急诊科实施和评估儿科行为健康药物和解计划。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2026-02-01 Epub Date: 2026-02-09 DOI: 10.5863/JPPT-24-00098
Taylor Norris, Robert Davis, Steve Willis, Morgan Wynes, Alexis Duncan, Karen Nolan, Frank Overly, Sarah John, Patrick H Lee
{"title":"Implementation and Evaluation of a Pediatric Behavioral Health Medication Reconciliation Program in a Regional Tertiary Care Pediatric Emergency Department.","authors":"Taylor Norris, Robert Davis, Steve Willis, Morgan Wynes, Alexis Duncan, Karen Nolan, Frank Overly, Sarah John, Patrick H Lee","doi":"10.5863/JPPT-24-00098","DOIUrl":"10.5863/JPPT-24-00098","url":null,"abstract":"<p><strong>Objective: </strong>Currently, there is limited information regarding the effect of a pharmacy-managed medication reconciliation program for pediatric behavioral health patients admitted to an inpatient service through a pediatric emergency department. This research aimed to determine the impact of a pediatric behavioral health medication reconciliation program in a regional tertiary care pediatric emergency department.</p><p><strong>Methods: </strong>This retrospective, single-center analysis evaluated the implementation of a medication reconciliation program in the pediatric behavioral health population using a pre-post design. We compared the quantity of pharmacy-initiated admission medication reconciliation interventions, the time to completion of admission medication reconciliations, and the trends in completion rates for a 2-month period before (October 1, 2022, to November 30, 2022) and after implementation (October 1, 2023, to November 30, 2023).</p><p><strong>Results: </strong>A total of 107 patients were included, 59 in the pre-intervention group and 48 in the post-intervention group. Between the pre-intervention and post-intervention groups, the post-intervention group had a statistically significantly higher number of interventions by pharmacists (61 vs 129, p < 0.0001). The most common pharmacy intervention made in the post-intervention group was discontinuation of the medication order. The average time to completion of admission medication reconciliation increased from 16.33 hours in the pre-intervention group to 38.47 hours in the post-intervention group (p = 0.002).</p><p><strong>Conclusions: </strong>Implementing a medication reconciliation program in the pediatric behavioral health population admitted through a pediatric emergency department has the potential to increase the quantity of medication discrepancies identified. Time to completion of medication reconciliation increased significantly in the post-intervention group.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"31 1","pages":"77-82"},"PeriodicalIF":0.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12888985/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Coming of Age of Model-Informed Precision Therapeutics for Children. 儿童模型信息精确治疗时代的到来。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2025-12-01 Epub Date: 2025-12-08 DOI: 10.5863/JPPT-25-01219
Alexander A Vinks
{"title":"The Coming of Age of Model-Informed Precision Therapeutics for Children.","authors":"Alexander A Vinks","doi":"10.5863/JPPT-25-01219","DOIUrl":"10.5863/JPPT-25-01219","url":null,"abstract":"<p><p>This article provides a summary of the Sumner Yaffe Award lecture presented at the annual meeting of the Pediatric Pharmacy Association in Portland, Oregon, on April 10, 2025. The article provides a short history of pediatric clinical pharmacology and elaborates on the ongoing paradox of precision medicine and the drug development process that is still geared toward the labeling of doses for the average patient. The article highlights contemporary clinical decision support approaches that integrate model-informed precision dosing (MIPD) to improve treatment outcomes in children. A series of case studies of successful implementation of model-informed clinical decision support tools is described including examples of full integration of such platforms into the electronic health record at Cincinnati Children's Hospital Medical Center. These studies show that pediatric precision dosing is progressing beyond the conceptual and proof-of-concept stages toward implementation into clinical workflows. The evidence provided indicates that model-informed therapeutic drug management for children is clinically feasible, with an increasing number of studies documenting improved clinical outcomes as compared with standard of care.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 6","pages":"719-730"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710491/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145782909","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cytomegalovirus Breakthrough in Pediatric Cardiac Transplant Recipients Receiving Weight-Based Dosing Valganciclovir Prophylaxis. 小儿心脏移植受者接受基于体重剂量的缬更昔洛韦预防的巨细胞病毒突破。
Journal of Pediatric Pharmacology and Therapeutics Pub Date : 2025-12-01 Epub Date: 2025-12-08 DOI: 10.5863/JPPT-24-00148
Nicole Poirier, Alyssa Miles, Alfred Asante-Korang, Asma Khan, Jessica Laks, Amy L Kiskaddon
{"title":"Cytomegalovirus Breakthrough in Pediatric Cardiac Transplant Recipients Receiving Weight-Based Dosing Valganciclovir Prophylaxis.","authors":"Nicole Poirier, Alyssa Miles, Alfred Asante-Korang, Asma Khan, Jessica Laks, Amy L Kiskaddon","doi":"10.5863/JPPT-24-00148","DOIUrl":"10.5863/JPPT-24-00148","url":null,"abstract":"<p><strong>Objective: </strong>Valganciclovir is an antiviral used to prevent CMV infection. The optimal dosing strategy remains uncertain as manufacturer and weight-based dosing strategies exist. This study aims to define the risk of CMV breakthrough using a weight-based dosing approach for valganciclovir.</p><p><strong>Methods: </strong>This is a retrospective, single-center study. All patients who received a heart transplant at <18 years of age from January 2011 to August 2022 and were initiated on valganciclovir prophylaxis were eligible for inclusion. Patients were excluded if they required cardiac re-transplantation. The primary outcome was the incidence of CMV breakthrough on a weight-based dose. Secondary outcomes included median difference in daily dose between 2 dosing strategies, incidence of CMV disease, and adverse events.</p><p><strong>Results: </strong>Thirty-four patients met eligibility for inclusion. The median age at transplant was 3.45 years (range, 0.07-16.87). Thirty-three patients were high- or intermediate-risk for CMV infection. There was no difference in initial valganciclovir dose in patients with CMV breakthrough compared with those without (median: 23.9 mg/kg vs 23.6 mg/kg, p = 0.238). The median weight-based total daily dose (23.9 mg/kg) was found to be significantly lower than the median manufacturer-recommended dose (34.3 mg/kg) (p < 0.001). This study found no significant difference in the daily dose of valganciclovir in patients with and without CMV breakthrough. Use of the manufacturer's equation for the initial dosing regimen produced significantly higher daily doses.</p><p><strong>Conclusions: </strong>This study's findings suggest implementation of a standard dosing procedure may be useful in optimizing prophylaxis with valganciclovir.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 6","pages":"767-772"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710495/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145783096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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