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Knowledge, Attitudes, and Self-Reported Practices of South African Pharmacists Regarding Pediatric Pharmaceutical Care. 知识,态度,和自我报告的做法南非药剂师关于儿科药物护理。
Q2 Medicine Pub Date : 2025-12-01 Epub Date: 2025-12-08 DOI: 10.5863/JPPT-24-00139
Yasmine van Heerden

Objective: Evidence on South African pharmacists' pediatric knowledge is limited. This study explored the knowledge, attitudes, and self-reported practices of South African pharmacists regarding pediatric pharmaceutical care.

Methods: A descriptive cross-sectional online survey was conducted among registered South African pharmacists. The survey, which was developed by the researcher based on previous studies, consisted of 4 sections: demographics, knowledge, attitudes, and self-reported practices. Contact information of pharmacists was obtained from The South African Pharmacy Council. Pharmacists were invited to participate via email, and a reminder email was sent after 2 weeks. The study was closed 3 days thereafter. Quantitative data were analyzed using descriptive and inferential statistics (significance set at p < 0.05), and qualitative responses underwent thematic analysis.

Results: A total of 436 surveys were fully completed (response rate of 2.4%). The median knowledge score of pharmacists was 9 out of 12 (IQR, 8-10). Participants performed well (90% correct) in questions on basic pediatric medicine, but more poorly in questions on pediatric dose calculations (66% correct), formulation challenges (67% correct), and pharmacokinetics (55% correct). There was no significant correlation between knowledge scores and years of practice, sector of practice, highest qualification, or training in pediatrics. There was a statistically significant correlation between participant knowledge and attitude scores (p = 0.003).

Conclusion: The study sample possesses knowledge of basic pediatric principles; however, gaps in knowledge remain. Participants expressed a lack of perceived preparedness for pediatric care following undergraduate training, underscoring the need for further research and educational reform.

目的:关于南非药师儿科知识的证据有限。本研究探讨了知识,态度,和自我报告的做法,南非药剂师关于儿科药物护理。方法:对南非注册药师进行描述性横断面在线调查。该调查由研究人员在先前研究的基础上开发,包括4个部分:人口统计、知识、态度和自我报告的实践。药剂师的联络资料由南非药剂委员会提供。通过邮件邀请药师参与,2周后发送提醒邮件。试验结束3 d。定量资料采用描述性统计和推理统计(p < 0.05)进行分析,定性资料采用专题分析。结果:共完成问卷调查436份,回复率2.4%。药师知识得分中位数为9分(IQR, 8-10分)。参与者在基础儿科医学问题上表现良好(90%正确),但在儿科剂量计算(66%正确)、配方挑战(67%正确)和药代动力学(55%正确)问题上表现较差。知识得分与实习年数、实习部门、最高资格或儿科培训没有显著相关性。被试知识与态度得分有统计学意义(p = 0.003)。结论:研究样本具备儿科基本原理知识;然而,知识差距仍然存在。与会者表示缺乏对本科培训后儿科护理的感知准备,强调需要进一步研究和教育改革。
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引用次数: 0
Mistaken Administration of Hydroxyurea Instead of Tacrolimus in a Pediatric Kidney Transplant Recipient: A Case Report. 儿童肾移植受者误用羟基脲代替他克莫司:一例报告。
Q2 Medicine Pub Date : 2025-12-01 Epub Date: 2025-12-08 DOI: 10.5863/JPPT-24-00133
Sarah Lafond, Alethia Paulina Monserrat Guzman Nuñez, Mashael Abujabal, Emily Chen, Guido Filler

Tacrolimus is a core medication of anti-rejection regimens for pediatric kidney transplant recipients. It is well known to have a narrow therapeutic window, affected by multiple factors, including absorption differences that influence drug concentrations in the body. Genetic polymorphisms of metabolizing enzymes, drug interactions, and intercurrent illnesses can impact drug clearance. This case report discusses a unique situation where a 12-year-old kidney transplant recipient experienced undetectable concentrations of tacrolimus in whole blood that were initially thought to result from excessive clearance due to severe diarrhea. Our nurse case manager investigated potential pharmacy errors by recommending that we test the home medication bottle, which revealed the absence of tacrolimus. Instead, the patient was given hydroxyurea, an anti-metabolite commonly used for oncologic and hematologic indications and can cause diarrhea, thrombocytopenia, and neutropenia. The patient experienced borderline rejection. The cause of this pharmacy error was multifactorial. However, confusion and complexities in the compounding process of liquid formulations likely played a role. This report underscores the importance of considering pharmacy errors as a potential cause of variations in tacrolimus drug concentrations. It emphasizes the role of nurses and interdisciplinary collaboration in identifying and addressing medication errors. It also underscores the need for standardization in the pharmaceutical compounding process and advocates for pharmaceutical industries to produce pediatric-appropriate formulations to reduce such errors.

他克莫司是儿童肾移植受者抗排斥治疗的核心药物。众所周知,它有一个狭窄的治疗窗口,受多种因素的影响,包括影响体内药物浓度的吸收差异。代谢酶的遗传多态性、药物相互作用和并发疾病可以影响药物清除。本病例报告讨论了一个独特的情况,一个12岁的肾移植受者在全血中检测不到他克莫司的浓度,最初认为是由于严重腹泻引起的过度清除。我们的病例管理护士调查了潜在的药房错误,建议我们测试家用药瓶,结果发现没有他克莫司。相反,患者被给予羟基脲,这是一种抗代谢物,通常用于肿瘤和血液学适应症,可引起腹泻、血小板减少和中性粒细胞减少。病人经历了边缘性排斥。造成用药错误的原因是多方面的。然而,液体配方配制过程中的混乱和复杂性可能起了作用。本报告强调了考虑药房错误作为他克莫司药物浓度变化的潜在原因的重要性。它强调护士和跨学科合作在识别和解决药物错误中的作用。它还强调了在药物配制过程中标准化的必要性,并倡导制药工业生产适合儿科的配方,以减少此类错误。
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引用次数: 0
Time to Stop Correcting Total Calcium. 是时候停止校正总钙了。
Q2 Medicine Pub Date : 2025-12-01 Epub Date: 2025-12-08 DOI: 10.5863/JPPT-25-00100
Michael L Christensen
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引用次数: 0
Indicators of Antibiotic Use in Pediatric Care: A Prospective Observational Study. 儿科护理中抗生素使用指标:一项前瞻性观察研究。
Q2 Medicine Pub Date : 2025-10-01 Epub Date: 2025-10-17 DOI: 10.5863/JPPT-24-00138
Midhun Mathew K, Vineeta Pande, Renuka Jadhav, Aanya Verma, Godwin Geo Gigi, Harsh Patil
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引用次数: 0
Continuing as Partners in Immunization: Updates to Practice and Legislation for Pediatric Pharmacy Immunizations. 继续作为免疫合作伙伴:儿科药学免疫实践和立法的更新。
Q2 Medicine Pub Date : 2025-10-01 Epub Date: 2025-10-17 DOI: 10.5863/JPPT-25-01216
Jennifer E Girotto, Selena Warminski, Tamara Oz, J Hunter Fly
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引用次数: 0
High Anion Gap Metabolic Acidosis (HAGMA) After Levetiracetam Administration in an 11-Year-Old Boy With Laminin-α2-Deficiency-Associated Muscular Dystrophy and Epilepsy. 左乙拉西坦给药后高阴离子间隙代谢性酸中毒(HAGMA) 1例伴有层粘连蛋白-α2缺乏相关肌营养不良和癫痫的11岁男孩
Q2 Medicine Pub Date : 2025-10-01 Epub Date: 2025-10-17 DOI: 10.5863/JPPT-24-00127
Piet Erik Beusker, Doortje Marieke Mehrtens, Eckard Hamelmann, Georg Classen

Congenital muscular dystrophy type 1A (MDC1A), an autosomal recessive disorder, is one of the most prevalent forms of congenital muscular dystrophy, characterized by the loss of Laminin-α2 subunit (Merosin). Approximately one-third of affected patients experience epileptic seizures, typically manifesting around 8 years of age, with focal onset and secondary generalization, often with tonic-clonic semiology. Most reported cases show limited or no response to conventional treatment, though a subset responds to valproate or lamotrigine. The efficacy of levetiracetam in these patients remains insufficiently studied. Metabolic acidosis is not listed as a known adverse effect of levetiracetam in the medication's technical information. In this case, an 11-year-old male with MDC1A presented with nocturnal seizure equivalents and was started on levetiracetam therapy. Approximately 24 hours after receiving the loading dose, the patient's condition deteriorated significantly, and severe metabolic acidosis with an elevated anion gap was observed. The patient required transfer to the pediatric intensive care unit and received intensive intravenous hydration and potassium supplementation. Upon discontinuation of levetiracetam, the patient stabilized, and metabolic normalization was achieved within approximately 24 hours. There are very few reports in the literature that also point to the development of a high anion gap metabolic acidosis after levetiracetam administration. The underlying mechanism is hypothesized but not experimentally verified, and a causal relationship remains unproven. Nevertheless, this observation represents a potentially serious adverse event associated with a commonly used medication, warranting heightened clinical awareness. We therefore recommend actively highlighting this and considering safety monitoring based on the individual risk of the patients being treated.

先天性肌营养不良1A型(MDC1A)是一种常染色体隐性遗传病,是先天性肌营养不良最常见的一种形式,其特征是层粘连蛋白-α2亚基(Merosin)的缺失。大约三分之一的受影响患者经历癫痫发作,通常在8岁左右表现出来,有局灶性发作和继发性泛化,通常具有强直-阵挛的符号。大多数报告的病例对常规治疗反应有限或无反应,尽管有一部分对丙戊酸盐或拉莫三嗪有反应。左乙拉西坦对这些患者的疗效研究尚不充分。代谢性酸中毒在药物的技术信息中没有被列为左乙拉西坦的已知不良反应。在本病例中,一名患有MDC1A的11岁男性表现为夜间癫痫发作,并开始接受左乙拉西坦治疗。在接受负荷剂量约24小时后,患者病情明显恶化,出现严重代谢性酸中毒,阴离子间隙升高。患者需要转到儿科重症监护室,并接受了强化静脉补水和补充钾。停用左乙拉西坦后,患者病情稳定,代谢在大约24小时内恢复正常。文献中很少有报道指出左乙乙坦给药后发生高阴离子间隙代谢性酸中毒。潜在的机制是假设的,但没有实验验证,因果关系仍未得到证实。尽管如此,这一观察结果表明与常用药物相关的潜在严重不良事件,需要提高临床意识。因此,我们建议积极强调这一点,并考虑根据接受治疗的患者的个体风险进行安全监测。
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引用次数: 0
Real-World Tocilizumab Use in Pediatric Inpatients. Tocilizumab在儿科住院患者中的实际应用。
Q2 Medicine Pub Date : 2025-10-01 Epub Date: 2025-10-17 DOI: 10.5863/JPPT-24-00130
Gideon A Stitt, Mark W Hall, Mary Ann Diliberto, Athena F Zuppa

Objectives: Primary objective: to quantify tocilizumab (TCZ) use in pediatric inpatients. Secondary objectives: to explore safety and clinical outcomes.

Methods: This retrospective cohort study took place in a free-standing, 564-bed children's hospital. Pediatric inpatients who received intravenous TCZ from January 2016 to May 2021 were included. Data collected included demographics, indication, dose, number of administrations, safety events on days 0 to 7 after TCZ, use of extracorporeal support (ES), presence of concurrent infection, and survival to discharge. Exploratory analyses assessed characteristics associated with mortality.

Results: A total of 103 TCZ courses (n = 87 patients) were analyzed. Median age was 14 years. Tocilizumab indications included cytokine release syndrome (CRS; 56%), autoimmune disease (27%), graft-versus-host disease (GVHD; 5%), and COVID-19 (4%). The median TCZ dose was 8 mg/kg (IQR, 7.9-11.9), 18% of courses were administered during active infection, and ES was used in 15% of courses. New-onset alanine transaminase (ALT) or aspartate transaminase (AST) levels >3 times upper limit of normal (ULN) occurred in 53% and 60% of courses, respectively. Of 29 courses with evaluable hematologic data, 10% resulted in new-onset neutropenia and 3% in severe thrombocytopenia. Overall survival to discharge was 83%. In multivariable analyses, independent associations with mortality were found for the use of ES (OR, 8.68; 95% CI, 1.85-4.87), oncologic diagnosis (OR, 7.07; 95% CI, 1.14-89.29), and post-TCZ infection (OR, 11.17; 95% CI, 1.50-138.13).

Conclusions: Tocilizumab is used for many pediatric inpatient indications, most commonly CRS. Newly identified transaminitis was common following TCZ administration. Risk factors for mortality are likely confounded by illness severity. Administration during active infection was not independently associated with increased mortality.

目的:主要目的:量化tocilizumab (TCZ)在儿科住院患者中的使用。次要目标:探讨安全性和临床结果。方法:本回顾性队列研究在一家独立的564张床位的儿童医院进行。纳入了2016年1月至2021年5月接受静脉注射TCZ的儿科住院患者。收集的数据包括人口统计学、适应症、剂量、给药次数、TCZ后0至7天的安全事件、体外支持(ES)的使用、并发感染的存在以及存活至出院。探索性分析评估了与死亡率相关的特征。结果:共分析103个TCZ疗程(n = 87例)。中位年龄为14岁。Tocilizumab适应症包括细胞因子释放综合征(CRS, 56%)、自身免疫性疾病(27%)、移植物抗宿主病(GVHD, 5%)和COVID-19(4%)。中位TCZ剂量为8 mg/kg (IQR, 7.9-11.9), 18%的疗程在活动性感染期间使用,15%的疗程使用ES。新发丙氨酸转氨酶(ALT)和天冬氨酸转氨酶(AST)水平分别为正常上限(ULN)的53%和60%。在具有可评估血液学数据的29个疗程中,10%导致新发中性粒细胞减少,3%导致严重血小板减少。总生存率为83%。在多变量分析中,发现ES的使用(OR, 8.68; 95% CI, 1.85-4.87)、肿瘤学诊断(OR, 7.07; 95% CI, 1.14-89.29)和tcz后感染(OR, 11.17; 95% CI, 1.50-138.13)与死亡率存在独立关联。结论:Tocilizumab用于许多儿科住院指征,最常见的是CRS。新发现的转氨炎在TCZ治疗后很常见。死亡率的危险因素可能与疾病严重程度相混淆。活动性感染期间给药与死亡率增加没有独立的相关性。
{"title":"Real-World Tocilizumab Use in Pediatric Inpatients.","authors":"Gideon A Stitt, Mark W Hall, Mary Ann Diliberto, Athena F Zuppa","doi":"10.5863/JPPT-24-00130","DOIUrl":"10.5863/JPPT-24-00130","url":null,"abstract":"<p><strong>Objectives: </strong>Primary objective: to quantify tocilizumab (TCZ) use in pediatric inpatients. Secondary objectives: to explore safety and clinical outcomes.</p><p><strong>Methods: </strong>This retrospective cohort study took place in a free-standing, 564-bed children's hospital. Pediatric inpatients who received intravenous TCZ from January 2016 to May 2021 were included. Data collected included demographics, indication, dose, number of administrations, safety events on days 0 to 7 after TCZ, use of extracorporeal support (ES), presence of concurrent infection, and survival to discharge. Exploratory analyses assessed characteristics associated with mortality.</p><p><strong>Results: </strong>A total of 103 TCZ courses (n = 87 patients) were analyzed. Median age was 14 years. Tocilizumab indications included cytokine release syndrome (CRS; 56%), autoimmune disease (27%), graft-versus-host disease (GVHD; 5%), and COVID-19 (4%). The median TCZ dose was 8 mg/kg (IQR, 7.9-11.9), 18% of courses were administered during active infection, and ES was used in 15% of courses. New-onset alanine transaminase (ALT) or aspartate transaminase (AST) levels >3 times upper limit of normal (ULN) occurred in 53% and 60% of courses, respectively. Of 29 courses with evaluable hematologic data, 10% resulted in new-onset neutropenia and 3% in severe thrombocytopenia. Overall survival to discharge was 83%. In multivariable analyses, independent associations with mortality were found for the use of ES (OR, 8.68; 95% CI, 1.85-4.87), oncologic diagnosis (OR, 7.07; 95% CI, 1.14-89.29), and post-TCZ infection (OR, 11.17; 95% CI, 1.50-138.13).</p><p><strong>Conclusions: </strong>Tocilizumab is used for many pediatric inpatient indications, most commonly CRS. Newly identified transaminitis was common following TCZ administration. Risk factors for mortality are likely confounded by illness severity. Administration during active infection was not independently associated with increased mortality.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 5","pages":"638-644"},"PeriodicalIF":0.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12533711/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145330365","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
Knowledge and Awareness of Caregivers About Using Paracetamol in Children in Al-Baha Region: a Cross-sectional Study. Al-Baha地区儿童护理人员使用扑热息痛的知识和意识:一项横断面研究。
Q2 Medicine Pub Date : 2025-10-01 Epub Date: 2025-10-17 DOI: 10.5863/JPPT-24-00126
Salah Eldin Abdel Hag Abdel Haleem, Hashim Abdullah S Alghamdi, Adham Mohammed H Alghamdi, Amer Khaled S Alghamdi, Hassan Saleh H Alzhrani, Faris Abdulrahman M Alzahrani, Basim Ibrahim B Alzahrani

Objective: This study aimed to assess parents' knowledge, attitudes, and practices regarding the use of paracetamol in children.

Methods: A cross-sectional study was conducted in the in Al-Baha region. A self-administered electronic questionnaire was constructed and distributed by the research team using a simple random sampling method. The questionnaire included sections regarding the sociodemographic data, knowledge, practices and attitudes regarding pediatrics' paracetamol use. Parents or children's caregivers were targeted by the study.

Results: 41.9% of 1000 survey respondents reported administering paracetamol to their children. Parents reported administering paracetamol based on experience with similar symptoms in their children (27.2%). One-third of the respondents (33.3%) believes that the maximum amount to be administered in 1 time is a single dose, 58.8% are aware that overdose of paracetamol can harm the child, 60.8% had never administered adults' paracetamol to their children, 26% measure doses using a graded cup or a teaspoon, 61.3% preferred paracetamol syrup, and 56.9% store the drugs in the refrigerator. Re-administration of pediatric paracetamol, as per instructions of the manufacturer, is practiced by 40%. Physicians are the source of drug information in 48.1% of cases. Physician's prescriptions are the source of obtaining paracetamol in 51.1% of cases.

Conclusion: A parental knowledge gap exists regarding the correct use of paracetamol for children in Al-Baha region. Educational programs should focus on the risks of overdose and the importance of following recommended dosages. Educational programs should also recommend limiting OTC dispensing of pediatric medications. Health care professionals should educate parents during clinical visits. Social media can be utilized to disseminate correct drug information. Narrowing of these gaps in parents' knowledge and practices improves safety and efficacy of paracetamol yielding better health outcomes.

目的:本研究旨在评估家长对儿童使用扑热息痛的知识、态度和做法。方法:在Al-Baha地区进行横断面研究。研究小组采用简单的随机抽样方法,编制并发放了一份自我管理的电子问卷。问卷内容包括社会人口学数据、儿科对扑热息痛使用的知识、实践和态度。这项研究的目标人群是父母或儿童看护人。结果:1000名调查对象中有41.9%的人报告给他们的孩子服用扑热息痛。父母报告说,他们的孩子出现类似症状时,他们会使用扑热息痛(27.2%)。三分之一(33.3%)的受访者认为一次最大剂量为一次剂量,58.8%的人知道过量服用扑热息痛会对儿童造成伤害,60.8%的人从未给孩子服用过成人扑热息痛,26%的人使用分级杯或茶匙测量剂量,61.3%的人喜欢使用扑热息痛糖浆,56.9%的人将药物存放在冰箱中。根据制造商的说明,儿科扑热息痛的重新给药率为40%。在48.1%的病例中,医生是药物信息的来源。51.1%的病例通过医生处方获得扑热息痛。结论:Al-Baha地区儿童对扑热息痛的正确使用存在家长知识差距。教育项目应侧重于过量用药的风险和遵循推荐剂量的重要性。教育项目也应该建议限制儿科药物的OTC配药。卫生保健专业人员应在临床访问期间教育家长。可以利用社交媒体传播正确的药物信息。缩小父母在知识和实践方面的差距可以提高扑热息痛的安全性和有效性,从而产生更好的健康结果。
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引用次数: 0
Evaluation of Institution-Specific Strategy for Converting Dexmedetomidine to Clonidine in a Pediatric Cardiac Intensive Care Unit. 儿科心脏重症监护病房将右美托咪定转化为可乐定的机构特定策略评估。
Q2 Medicine Pub Date : 2025-10-01 Epub Date: 2025-10-17 DOI: 10.5863/JPPT-24-00084
Christopher Phillips, Andrew Sweigart, Hailey Collier, Elizabeth Herrup, Evan Zachary Ramsey

Objective: This study aimed to evaluate the success and safety of an institution-specific strategy for converting dexmedetomidine to clonidine in the cardiac intensive care unit at a tertiary care pediatric hospital.

Methods: This retrospective descriptive study included pediatric patients under 18 years of age receiving at least 7 days of dexmedetomidine infusion before conversion to clonidine between January 1, 2018, and October 1, 2023. A successful conversion was defined as dexmedetomidine infusion discontinuation in the absence of therapy reinitiation within 36 hours after the initial enteral clonidine dose; no dose increases greater than 15% within 36 hours of initial clonidine dose, and no requirement for supplemental doses. Patients with dexmedetomidine discontinuation before completing stepwise conversion were evaluated for adverse drug events (ADEs). Descriptive statistics were used to analyze the data.

Results: A total of 148 episodes of conversion from dexmedetomidine to clonidine were evaluated for 134 patients. Patient demographics and treatment characteristics included a median age at conversion of 4.6 months (IQR, 1.5-7.1), a median duration of dexmedetomidine exposure of 19 days (IQR, 12-34), a median initial clonidine dose of 9.3 mcg/kg/day (IQR, 7.2-10), and a median time to discontinuation of 19 hours (IQR, 17-36) after the first dose of clonidine. Successful conversion occurred in 99 (67%) of episodes evaluated, and no ADEs were identified.

Conclusion: The conversion allowed for most patients to tolerate the conversion to clonidine, and no ADEs were identified.

目的:本研究旨在评估三级儿科医院心脏重症监护病房将右美托咪定转换为可乐定的机构特定策略的成功和安全性。方法:本回顾性描述性研究纳入2018年1月1日至2023年10月1日期间接受至少7天右美托咪定输注后转为可乐定的18岁以下儿科患者。成功转换的定义是在初始肠内可乐定剂量后36小时内没有重新开始治疗的情况下停止右美托咪定输注;在初始可乐定剂量的36小时内,剂量增加不超过15%,也不需要补充剂量。在完成逐步转换前停用右美托咪定的患者进行药物不良事件(ADEs)评估。采用描述性统计对数据进行分析。结果:134例患者共148次右美托咪定转换为可乐定。患者人口统计学和治疗特征包括转换时的中位年龄为4.6个月(IQR, 1.5-7.1),右美托咪定暴露的中位持续时间为19天(IQR, 12-34),可乐定初始剂量中位为9.3微克/千克/天(IQR, 7.2-10),以及首次给药后的中位停药时间为19小时(IQR, 17-36)。99例(67%)的评估发作成功转化,未发现不良事件。结论:大多数患者改用可乐定耐受,未发现不良反应。
{"title":"Evaluation of Institution-Specific Strategy for Converting Dexmedetomidine to Clonidine in a Pediatric Cardiac Intensive Care Unit.","authors":"Christopher Phillips, Andrew Sweigart, Hailey Collier, Elizabeth Herrup, Evan Zachary Ramsey","doi":"10.5863/JPPT-24-00084","DOIUrl":"10.5863/JPPT-24-00084","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to evaluate the success and safety of an institution-specific strategy for converting dexmedetomidine to clonidine in the cardiac intensive care unit at a tertiary care pediatric hospital.</p><p><strong>Methods: </strong>This retrospective descriptive study included pediatric patients under 18 years of age receiving at least 7 days of dexmedetomidine infusion before conversion to clonidine between January 1, 2018, and October 1, 2023. A successful conversion was defined as dexmedetomidine infusion discontinuation in the absence of therapy reinitiation within 36 hours after the initial enteral clonidine dose; no dose increases greater than 15% within 36 hours of initial clonidine dose, and no requirement for supplemental doses. Patients with dexmedetomidine discontinuation before completing stepwise conversion were evaluated for adverse drug events (ADEs). Descriptive statistics were used to analyze the data.</p><p><strong>Results: </strong>A total of 148 episodes of conversion from dexmedetomidine to clonidine were evaluated for 134 patients. Patient demographics and treatment characteristics included a median age at conversion of 4.6 months (IQR, 1.5-7.1), a median duration of dexmedetomidine exposure of 19 days (IQR, 12-34), a median initial clonidine dose of 9.3 mcg/kg/day (IQR, 7.2-10), and a median time to discontinuation of 19 hours (IQR, 17-36) after the first dose of clonidine. Successful conversion occurred in 99 (67%) of episodes evaluated, and no ADEs were identified.</p><p><strong>Conclusion: </strong>The conversion allowed for most patients to tolerate the conversion to clonidine, and no ADEs were identified.</p>","PeriodicalId":37484,"journal":{"name":"Journal of Pediatric Pharmacology and Therapeutics","volume":"30 5","pages":"623-629"},"PeriodicalIF":0.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12533707/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145330239","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
Stability Study of Lorazepam Oral Solution Repackaged in Amber Colored ENFit Oral Syringes. 琥珀色ENFit口腔注射器重新包装劳拉西泮口服液的稳定性研究。
Q2 Medicine Pub Date : 2025-10-01 Epub Date: 2025-10-17 DOI: 10.5863/JPPT-24-00147
Collin Owczarzak, Sara Woytowicz, Fang Zhao, Ankit Rochani

Objective: Lorazepam is a benzodiazepine drug that hospital pharmacies commonly dispense to treat patients with severe anxiety and seizure disorders. Lorazepam oral concentrate, a marketed oral formulation of lorazepam, contains polyethylene glycol and propylene glycol in a solution (2 mg/mL). At Strong Memorial Hospital nurses draw patient-specific doses from a 30mL bulk bottle of lorazepam oral concentrate for administration. This study aims to investigate the stability of lorazepam when stored in repackaged amber-colored ENFit Oral syringes under typical hospital pharmacy conditions (stored at ambient temperature), to reduce waste.

Methods: Stability indicating HPLC assay was established to investigate the degradation profile of lorazepam treated at ambient temperature (∼25°C) and hot conditions (60°C) under acidic (1N HCL), basic (1N NaOH), and oxidative (H2O2) stress conditions. This HPLC assay established a robust calibration curve to check the stability of the repackaged lorazepam ENFit Oral Syringes. The repackaged syringes were stored at Strong Memorial Hospital's Inpatient Pharmacy at ambient temperature (72 ± 4°F) for 182 days and samples were taken to investigate the stability of the repackaged formulation.

Results: After 182 days, both volumes (0.25 mL and 0.5 mL) of lorazepam repackaged formulation in the ENFit oral syringes, exhibited no visible changes and remained within the acceptable concentration range (100 ± 10%) when stored at ambient temperature (72 ± 4°F). The stability data demonstrated that lorazepam repackaged in amber-colored ENFit Oral Syringes remained stable at room temperature for up to 90 days.

Conclusion: This study represents a 30-day extension in the stability compared with the previously reported 60-day stability period for the repackaged lorazepam oral syringes.

目的:劳拉西泮是医院药房常用的一种苯二氮卓类药物,用于治疗严重焦虑和癫痫患者。劳拉西泮口服浓缩物是一种已上市的劳拉西泮口服制剂,其溶液中含有聚乙二醇和丙二醇(2mg /mL)。在斯特朗纪念医院,护士从30毫升的散装瓶中抽取患者特定剂量的劳拉西泮口服浓缩物进行管理。本研究旨在考察劳拉西泮在典型医院药房条件下(常温下储存)重新包装的琥珀色ENFit口服注射器中的稳定性,以减少浪费。方法:建立稳定性指示高效液相色谱法,研究劳拉西泮在常温(~ 25℃)和高温(60℃)下酸性(1N HCL)、碱性(1N NaOH)和氧化(H2O2)应激条件下的降解情况。该方法建立了可靠的校准曲线,用于检查重新包装的劳拉西泮ENFit口服注射器的稳定性。将重新包装的注射器在环境温度(72±4°F)下存放在Strong Memorial医院的住院药房182天,并取样以研究重新包装的配方的稳定性。结果:在ENFit口腔注射器中,重新包装的劳拉西泮在182天后(0.25 mL和0.5 mL)的体积均无明显变化,在环境温度(72±4°F)下保存,其浓度均在可接受的浓度范围(100±10%)内。稳定性数据表明,琥珀色ENFit口服注射器中重新包装的劳拉西泮在室温下保持稳定长达90天。结论:与先前报道的重新包装的劳拉西泮口服注射器的60天稳定期相比,本研究代表了30天的稳定性延长。
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引用次数: 0
期刊
Journal of Pediatric Pharmacology and Therapeutics
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