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The Safety and Tolerability of High Dose Intravenous Push Levetiracetam. 大剂量左乙拉西坦静脉推注的安全性和耐受性。
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-12-01 Epub Date: 2025-02-14 DOI: 10.1177/08971900251320159
Melissa Brandes, Tara Flack, William B Hays

Objective: Levetiracetam (LEV) is a guideline-recommended antiepileptic that has been shown to be effective in the termination of status epilepticus. Traditionally, LEV is diluted in 100 mL of compatible fluid and administered as an intravenous (IV) piggyback over 15-60 minutes. Recent data supports the administration of LEV as an undiluted IV push. However, there is limited literature supporting the safety and tolerability of undiluted IV push administration of high dose LEV (2500 mg to 4500 mg). The purpose of this study was to further investigate safety and tolerability of IV push levetiracetam at doses 2500 mg and greater. Methods: A retrospective chart review was conducted to evaluate adverse drug reactions following IV push administration of levetiracetam at a dose of 2500 mg or greater between the dates 8/5/2021 to 6/30/2022. During chart review, each patient was evaluated for any adverse events that occurred utilizing provider documentation, significant event forms, and/or allergy list documentation following administration of IV push LEV. Results: Throughout the study period, 340 doses of LEV 2500 mg and greater were evaluated. Most common total dose was 3000 mg and weight-based dose was 50-59.99 mg/kg. 119 doses of 4000 mg or greater were evaluated. 338/340 (99.4%) doses were considered to be well-tolerated. One patient experienced erythema at the injection site and another patient was noted to have nystagmus. Significance: This study adds to the body of literature that rapid administration of undiluted LEV, including doses of 2500 mg to 4500 mg is safe and tolerable.

目的:左乙拉西坦(LEV)是一种指南推荐的抗癫痫药物,已被证明对终止癫痫持续状态有效。传统上,LEV在100ml相容液体中稀释,并作为静脉(IV)附带施用15-60分钟。最近的数据支持将LEV作为未稀释的静脉推注。然而,支持未稀释静脉推注高剂量LEV (2500 ~ 4500 mg)的安全性和耐受性的文献有限。本研究的目的是进一步研究静脉注射左乙拉西坦2500mg及以上剂量的安全性和耐受性。方法:回顾性回顾图表,评价2021年8月5日至2022年6月30日静脉推注左乙拉西坦2500mg及以上剂量的不良反应。在病历回顾过程中,利用供应商文件、重大事件表和/或过敏清单文件,评估每位患者在静脉滴注LEV后发生的任何不良事件。结果:在整个研究期间,评估了340剂量的2500 mg及以上的LEV。最常见的总剂量为3000 mg,体重剂量为50 ~ 59.99 mg/kg。评估了119次4000毫克或更大剂量的剂量。338/340(99.4%)剂量被认为耐受良好。一名患者在注射部位出现红斑,另一名患者出现眼球震颤。意义:本研究补充了大量文献,表明快速给药未稀释LEV(包括2500 ~ 4500 mg剂量)是安全且可耐受的。
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引用次数: 0
The Comparative Effectiveness and Safety of Ambulatory Care Warfarin Management by Non-physician Providers Versus Usual Medical Care: A Systematic Review and Meta-analysis. 非内科医生门诊华法林管理与常规医疗护理的有效性和安全性比较:一项系统回顾和荟萃分析。
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-12-01 Epub Date: 2025-06-02 DOI: 10.1177/08971900251347506
Anna Sharow, Joey Champigny, John-Michael Gamble, Sherilyn K D Houle, Caitlin Carter, Jeff Nagge

Introduction: Growing evidence suggests that non-physician providers (NPPs) can effectively and safely manage warfarin therapy. This systematic review and meta-analysis aimed to evaluate warfarin management by NPPs compared to usual medical care (UMC) in ambulatory patients. Methods: We conducted a systematic search of PubMed (MEDLINE), Ovid Embase, Ovid International Pharmaceutical Abstracts, Scopus, CINAHL (EBSCO), and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to January 2024. Studies were included if they were randomized controlled trials or quasi-experimental designs comparing warfarin management across professions. Two independent reviewers performed title and abstract screening, full-text review, data extraction, and risk of bias assessment. Results were pooled using random effects models. Results: Of 19 122 citations identified, 6 met the inclusion criteria. NPPs included pharmacists (4), nurse practitioners (1), and multidisciplinary teams (1). Meta-analysis showed no significant difference in time spent in therapeutic range (TTR) (mean difference [MD] 1.64%; 95% confidence interval [CI]-1.86 to 5.16, I2 = 0%)) for NPPs vs UMC. There were no differences in thrombosis (relative risk [RR] 1.23; 95% CI 0.36 to 4.23, I2 = 0%), hemorrhage (RR = 1.07; 95% CI 0.44 to 2.63, I2 = 0%), mortality (RR = 0.94; 95% CI 0.33 to 2.67, I2 = 0%), or patient satisfaction (standardized mean difference [SMD] 0.56; 95% CI -0.04 to 1.15, I2 = 85%). Conclusion: NPP management resulted in similar TTR as UMC. Due to few thromboembolic and hemorrhagic events, more studies are needed to determine the effects of NPP warfarin management on clinical outcomes.

越来越多的证据表明,非医师提供者(NPPs)可以有效和安全地管理华法林治疗。本系统综述和荟萃分析旨在评价非住院病人的华法林管理与常规医疗护理(UMC)的比较。方法:系统检索PubMed (MEDLINE)、Ovid Embase、Ovid International Pharmaceutical Abstracts、Scopus、CINAHL (EBSCO)和Cochrane Central Register of Controlled Trials (Central)自成立至2024年1月。如果研究是随机对照试验或准实验设计,比较不同职业的华法林管理,则纳入研究。两名独立审稿人进行标题和摘要筛选、全文审查、数据提取和偏倚风险评估。结果采用随机效应模型汇总。结果:19 122篇文献中,6篇符合纳入标准。npp包括药师(4名)、执业护士(1名)和多学科团队(1名)。meta分析显示,治疗范围内花费的时间(TTR)无显著差异(平均差异[MD] 1.64%;核电厂与联电的95%置信区间[CI]为-1.86至5.16,I2 = 0%)。两组在血栓形成方面无差异(相对危险度[RR] 1.23;95% CI 0.36 ~ 4.23, I2 = 0%),出血(RR = 1.07;95% CI 0.44 ~ 2.63, I2 = 0%),死亡率(RR = 0.94;95% CI 0.33 ~ 2.67, I2 = 0%)或患者满意度(标准化平均差[SMD] 0.56;95% CI -0.04 ~ 1.15, I2 = 85%)。结论:NPP管理导致的TTR与UMC相似。由于很少有血栓栓塞和出血事件,需要更多的研究来确定NPP华法林管理对临床结果的影响。
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引用次数: 0
CLIA-Waived Group a Streptococcal Pharyngitis Test and Treat Programs in Community Pharmacies. 社区药房中豁免的a组链球菌性咽炎检测和治疗项目。
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-12-01 Epub Date: 2025-05-23 DOI: 10.1177/08971900251345972
Renee R Koski, Michael Klepser, Hanna Bronz

Acute pharyngitis is mostly viral in origin, but antibiotics are commonly prescribed to cover group A streptococcus (GAS) which is the cause in 5%-30% of pharyngitis episodes. Patients are increasingly utilizing community pharmacy test and treat programs to diagnose and treat acute respiratory infections. There are several Clinical Laboratory Improvement Amendment (CLIA)-waived point-of-care tests (POCT) available to quickly identify GAS. The objective of this article is to explore the 11 antigen and two molecular CLIA-waived GAS POCTs currently available in the United States (U.S.) and the studies that assessed their use in pharmacy test and treat programs. Nine studies evaluated their use in community pharmacy test and treat programs and support their use, especially for decreasing unnecessary antibiotic prescriptions and providing access to care for patients without a primary care provider or after regular business hours. As medication dispensing margins continue to shrink, community pharmacists continue to seek additional ways to serve their patients and develop new revenue streams. Additionally, test and treat services are a means to improve access to care and promote outpatient antimicrobial stewardship. Recently, patients have expressed an increased willingness to receive care for various illnesses, including acute pharyngitis, at community pharmacies. Acute pharyngitis is well-suited for management in a community pharmacy since treatment recommendations are well established and straightforward. Overprescribing of antibiotics from traditional health care settings is higher than desired and pharmacy-based models have demonstrated the ability to decrease unwarranted antibiotic use. A pharmacy-based acute pharyngitis management model makes strong medical and business sense.

急性咽炎主要是由病毒引起的,但抗生素通常用于治疗A群链球菌(GAS),这是5%-30%咽炎发作的原因。患者越来越多地利用社区药房测试和治疗方案来诊断和治疗急性呼吸道感染。有几种临床实验室改进修正案(CLIA)豁免的护理点检测(POCT)可用于快速识别GAS。本文的目的是探讨目前在美国可获得的11抗原和两种免除clia的分子GAS POCTs,以及评估其在药学测试和治疗计划中的应用的研究。9项研究评估了它们在社区药房测试和治疗项目中的使用情况,并支持它们的使用,特别是在减少不必要的抗生素处方和为没有初级保健提供者或正常营业时间后的患者提供护理方面。由于药物配药利润不断缩水,社区药剂师继续寻求其他方式为患者服务并开发新的收入来源。此外,检测和治疗服务是改善获得护理和促进门诊抗菌药物管理的一种手段。最近,患者越来越愿意在社区药房接受包括急性咽炎在内的各种疾病的治疗。急性咽炎是非常适合管理的社区药房,因为治疗建议是建立良好的和直接的。传统卫生保健机构的抗生素过度处方高于预期,基于药物的模式已证明能够减少不必要的抗生素使用。以药物为基础的急性咽炎管理模式具有很强的医学和商业意义。
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引用次数: 0
Methemoglobinemia in the Setting of Hemolysis: A Case Report Suggesting Reflex Lab for Patients with Oxygen Saturation Gap for Early Detection and Diagnosis. 溶血背景下的高铁血红蛋白血症:建议对氧饱和度间隙患者进行反射实验室早期发现和诊断的病例报告。
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-12-01 Epub Date: 2025-02-16 DOI: 10.1177/08971900251321701
Christine Pham, Nicole Williams, Sarah Zavala

Methemoglobinemia typically presents as functional anemia and hypoxemia. It is often recognized by a discordance between the pulse oximeter reading and the oxygen saturation measured on arterial blood gas. Methemoglobinemia can be inherited or acquired, with some commonly-used medications recognized as causative agents. In patients with hemolytic anemia such as in glucose-6-phosphate dehydrogenase deficiency, hemolysis may be the main clinical presentation, with acquired methemoglobinemia after exposure to oxidizing agents. We present a case report of methemoglobinemia in the setting of hemolysis, with a new approach to coordinate with laboratory services to create a reflex lab to test for methemoglobinemia under certain conditions. This may improve time to recognition and treatment for patients with methemoglobinemia, as patient presentation as well as SpO2 and PaO2 discordance may be missed by less experienced providers.

高铁血红蛋白血症通常表现为功能性贫血和低氧血症。通常通过脉搏血氧计读数与动脉血气测量的氧饱和度之间的不一致来识别。高铁血红蛋白血症可遗传或获得,一些常用药物被认为是致病因子。溶血性贫血患者,如葡萄糖-6-磷酸脱氢酶缺乏症,溶血可能是主要的临床表现,暴露于氧化剂后出现获得性高铁血红蛋白血症。我们提出了一个病例报告在溶血设置高铁血红蛋白血症,与新的方法协调实验室服务创建反射实验室,以测试在某些条件下的高铁血红蛋白血症。这可能会缩短对高铁血红蛋白血症患者的识别和治疗时间,因为经验不足的医生可能会忽略患者的表现以及SpO2和PaO2的不一致。
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引用次数: 0
Intersecting Burdens: Type 2 Diabetes Diagnosis, Risk, and Pharmacological Management Among People Living With HIV. 交叉负担:2型糖尿病的诊断、风险和药物管理在HIV感染者中。
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-18 DOI: 10.1177/08971900251394121
Rachel Arnold, Briann Fischetti, Maria Longo

Many patients living with human immunodeficiency virus (HIV) may develop long-term metabolic complications due to various reasons, such as chronic inflammation and adverse effects from antiretrovirals (ARVs). A particularly significant metabolic complication is type 2 diabetes (T2DM); however, limited evidence is available regarding the management of this disease state among people living with HIV (PLWH). We review the available resources and evidence on the management of T2DM among PLWH. Diagnosis and monitoring of T2DM are slightly different from the general population as hemoglobin A1c may underestimate the level of glycemia PLWH experience. Although PLWH are typically not reported within landmark clinical trials for antidiabetic medications, treatment is likely similar to those without the virus. There are several drug-drug interactions to note between ARVs and antidiabetic medications with one of the most notable being between dolutegravir and metformin. This interaction requires the maximum daily dose of metformin to be reduced. Additionally, modifications may be considered to a patient's ARV regimen in order to reduce metabolic disturbances as these medications may affect fat redistribution, lipids, weight, and insulin resistance. This review article is intended to aide clinicians in clinical decision making when treating PLWH diagnosed with T2DM.

由于各种原因,如慢性炎症和抗逆转录病毒药物(ARVs)的不良反应,许多感染人类免疫缺陷病毒(HIV)的患者可能会出现长期的代谢并发症。特别重要的代谢并发症是2型糖尿病(T2DM);然而,关于艾滋病毒感染者(PLWH)中这种疾病状态的管理,现有证据有限。我们回顾了PLWH中T2DM管理的现有资源和证据。T2DM的诊断和监测与一般人群略有不同,因为糖化血红蛋白可能低估了PLWH的血糖水平。虽然在具有里程碑意义的抗糖尿病药物临床试验中通常没有报道PLWH,但治疗可能与没有病毒的治疗相似。在抗逆转录病毒药物和抗糖尿病药物之间有几种药物-药物相互作用值得注意,其中最值得注意的是多替格拉韦和二甲双胍之间的相互作用。这种相互作用要求降低二甲双胍的最大日剂量。此外,可以考虑修改患者的抗逆转录病毒治疗方案,以减少代谢紊乱,因为这些药物可能影响脂肪再分配、脂质、体重和胰岛素抵抗。这篇综述文章旨在帮助临床医生在治疗诊断为T2DM的PLWH时进行临床决策。
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引用次数: 0
Effectiveness of Pharmacist-Led Provider Education on Antimicrobial Discharge Prescriptions for Common Infections. 药师主导的提供者对常见感染抗菌药物出院处方教育的效果。
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-12 DOI: 10.1177/08971900251395191
Angela Basir, Ankit Gohel, Jason Brady, Michael Silver

Background: Several strategies described in the literature regarding the role of pharmacist-led educational interventions to healthcare providers, however, evidence available on the role of education in the Emergency Department (ED) setting on discharge prescriptions is limited. The purpose of this study was to evaluate the impact of pharmacist-led education on antimicrobial prescribing at discharge from the ED. Objective: To determine whether pharmacist-led provider education improves patient outcomes by reducing medication-related errors in the ED when prescribing antimicrobials at discharge for skin and soft tissue infections (SSTIs), urinary tract infections (UTIs), and community-acquired pneumonia (CAP). Methods: This was a retrospective pre-vs post-intervention cohort study at Maimonides Medical Center (MMC). A total of 192 patients in the pre-intervention period and 181 patients in the post-intervention period were included. The primary endpoint was appropriateness of antimicrobial discharge prescriptions pre- and post-intervention. Results: In the pre-intervention period, 17.7% of patients had an SSTI, 47.4% had a UTI, and 34.9% had CAP. In the post-intervention period, 15.5% of patients had an SSTI, 51.4% had a UTI, and 33.1% had CAP. After implementation of pharmacist-led provider education, there was a statistically significant increase in the number of appropriate antimicrobial discharge prescriptions in the post-intervention period, 86.7% vs 75.5% respectively (P = .008). While there was no statistically significant difference in recurrent infections, there was a trend towards improvement in post-intervention period, 3.9% vs 5.7% respectively (P = .473). Conclusion: Pharmacist-led provider education significantly improved prescribing patterns for antimicrobial discharge prescriptions.

背景:文献中描述了几种关于药剂师主导的教育干预对医疗保健提供者的作用的策略,然而,关于教育在急诊科(ED)出院处方设置中的作用的证据有限。本研究的目的是评估药师主导的教育对急诊科出院时抗菌药物处方的影响。目的:确定药师主导的提供者教育是否可以通过减少急诊科在皮肤和软组织感染(SSTIs)、尿路感染(uti)和社区获得性肺炎(CAP)出院时开具抗菌药物处方时的药物相关错误来改善患者的预后。方法:这是一项在迈蒙尼德医学中心(MMC)进行的回顾性干预前和干预后队列研究。干预前192例,干预后181例。主要终点是干预前后抗菌出院处方的适宜性。结果:干预前发生SSTI的占17.7%,发生UTI的占47.4%,发生CAP的占34.9%。干预后发生SSTI的占15.5%,发生UTI的占51.4%,发生CAP的占33.1%。实施药师主导的提供者教育后,干预后适当的抗菌出院处方数量增加,分别为86.7%和75.5% (P = 0.008)。两组复发感染发生率无统计学差异,干预后有改善趋势,分别为3.9% vs 5.7% (P = .473)。结论:药师主导的提供者教育显著改善了抗菌药物出院处方的处方模式。
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引用次数: 0
Oral Ibuprofen Versus Intramuscular Ketorolac for Acute Musculoskeletal Back Pain in the Emergency Department: A Prospective Analysis. 急诊科口服布洛芬与肌内注射酮乐酸治疗急性肌肉骨骼性背痛的前瞻性分析
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-06 DOI: 10.1177/08971900251394098
Myroslava Sharabun, Robert O'Connell, Howard Greller, Andrew P Smith

Ibuprofen and ketorolac are nonsteroidal anti-inflammatory drugs (NSAIDs) commonly used to treat acute back pain in the Emergency Department (ED). Data comparing pain relief between oral and intramuscular administration at their proposed ceiling doses is lacking. The aim of this study was to compare oral (PO) ibuprofen 400 mg to intramuscular (IM) ketorolac 10 mg for the treatment of acute, atraumatic, musculoskeletal back pain. This single-center, double-blind, double-placebo, randomized study compared PO ibuprofen 400 mg to IM ketorolac 10 mg for acute, atraumatic musculoskeletal back pain in adult patients presenting to an urban ED. Subjects were randomized to receive PO ibuprofen 400 mg suspension plus IM placebo injection or IM ketorolac 10 mg plus PO placebo suspension. The primary outcome was absolute reduction in pain score 1 hour after medication administration, as measured by visual analog scale (VAS). Secondary outcomes included rescue analgesia administration at 60 minutes and adverse drug reactions. The author's enrolled 93 patients; 47 in the ibuprofen group and 46 in the ketorolac group. VAS score reduction from baseline to 1 hour with ibuprofen or ketorolac was 35 vs 32, respectively (95% Confidence Interval: -8.03 to 15.03). Rescue analgesia administration at 60 minutes was similar between both groups; adverse reactions were reported in the ketorolac group only as pain at injection site in two patients. In this prospective analysis, PO ibuprofen 400 mg and IM ketorolac 10 mg provide comparable pain relief for the treatment of acute, atraumatic, musculoskeletal back pain.

布洛芬和酮酸是非甾体抗炎药(NSAIDs),通常用于治疗急诊科(ED)的急性背痛。比较口服和肌肉注射在其建议的上限剂量下缓解疼痛的数据是缺乏的。本研究的目的是比较口服(PO)布洛芬400mg与肌注(IM)酮罗拉酸10mg治疗急性、非创伤性、肌肉骨骼性背痛的效果。这项单中心、双盲、双安慰剂、随机研究比较了PO布洛芬400mg和IM酮洛拉酸10mg治疗急性、非创伤性肌肉骨骼性背痛的城市ED成年患者。受试者被随机分配接受PO布洛芬400mg混悬液加IM安慰剂注射或IM酮洛拉酸10mg加PO安慰剂混悬液。主要结局是在给药后1小时疼痛评分的绝对减少,用视觉模拟量表(VAS)测量。次要结局包括60分钟镇痛抢救和药物不良反应。作者入组了93例患者;布洛芬组47例,酮咯酸组46例。布洛芬或酮乐酸从基线到1小时的VAS评分降低分别为35 vs 32(95%置信区间:-8.03至15.03)。两组60分钟抢救镇痛给药效果相似;酮咯酸组仅有2例患者出现注射部位疼痛的不良反应。在这项前瞻性分析中,PO布洛芬400mg和IM酮洛酸10mg对急性、非创伤性、肌肉骨骼性背痛的治疗提供了相当的疼痛缓解。
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引用次数: 0
Appropriateness of Empiric Antimicrobial Therapy for Community Onset Sepsis With Bacteremia in the Emergency Department: A Multidisciplinary Approach. 急诊社区发病脓毒症伴菌血症的经验性抗菌治疗的适宜性:一项多学科方法。
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-06 DOI: 10.1177/08971900251394125
Salma Abdelwahab, Yanina Dubrovskaya, Kassandra Marsh, Cristian Merchan, Samantha Smalley, Justin Siegfried, John Papadopoulos

Background: Optimizing early antimicrobial therapy and incorporating clinical pharmacists into sepsis treatment strategies are essential for improving patient outcomes. Objective: To examine the appropriateness of empiric antimicrobial selection for patients presenting with community onset sepsis with confirmed bacteremia, to characterize de-escalation practices, and to evaluate pharmacy involvement throughout the sepsis care process. Methods: We conducted a retrospective review of adult patients with community-onset sepsis and confirmed bacteremia who presented to the Emergency Department (ED) between 9/2022 and 5/2023 at our hospital. The primary outcome was the percent of patients with ineffective empiric antimicrobials. Secondary outcomes included time to de-escalation, sepsis outcomes, sepsis guidelines adherence, and pharmacy interventions. Results: 109 patients were included. Median Charlson Comorbidity Index (CCI) was 6 (IQR 3-8) and Pitt bacteremia score 0 (IQR 0-1). Median time to first antibiotic administration was 29 minutes (IQR 15-50). Ineffective empiric antimicrobials occurred in 13.7% of cases, with median time to effective antibiotics at 24 h. De-escalation occurred in 84% of cases. The median time for discontinuation was 2 days for antimicrobial coverage against MRSA and atypical organisms and 4 days for coverage against P. aeruginosa. Initial therapy adhered to guidelines in 70.6% of cases, with deviation primarily due to vancomycin administration in the absence of MRSA risk factors. Antibiotic-related pharmacy recommendations were made in 40% (n = 44/109) of ED patients and 96% (n = 105/109) of hospitalized patients. In-hospital mortality, ICU admission, 30-day infection related re-admission and C. difficile infection within 6 months were 8.3% (n = 9), 42.2% (n = 46), 8.3% (n = 9), and 1.8% (n = 2), respectively. Conclusion: Pharmacist involvement led to appropriate antimicrobial selection in the ED, effective de-escalation, and favorable sepsis outcomes.

背景:优化早期抗菌药物治疗并将临床药师纳入脓毒症治疗策略对改善患者预后至关重要。目的:探讨确诊菌血症的社区发病脓毒症患者经验性抗菌药物选择的适宜性,描述降级做法的特征,并评估整个脓毒症护理过程中药房的参与情况。方法:我们对2022年9月至2023年5月在我院急诊科(ED)就诊的社区发病脓毒症和确诊菌血症的成年患者进行了回顾性分析。主要结果是使用无效经验性抗菌素的患者百分比。次要结局包括降级时间、败血症结局、败血症指南依从性和药物干预。结果:纳入109例患者。Charlson合并症指数(CCI)中位数为6 (IQR 3-8), Pitt菌血症评分为0 (IQR 0-1)。至首次给药的中位时间为29分钟(IQR 15-50)。13.7%的病例使用了无效的经验性抗菌素,获得有效抗生素的中位数时间为24小时。84%的病例出现了药物降级。停药的中位时间为耐甲氧西林金黄色葡萄球菌和非典型微生物2天,铜绿假单胞菌4天。在70.6%的病例中,初始治疗遵循指南,偏差主要是由于在没有MRSA危险因素的情况下使用万古霉素。40%的ED患者(n = 44/109)和96%的住院患者(n = 105/109)提出了抗生素相关的用药建议。住院死亡率为8.3% (n = 9), ICU住院率为42.2% (n = 46), 30天感染相关再入院率为8.3% (n = 9), 6个月内艰难梭菌感染率为1.8% (n = 2)。结论:药师的参与导致了急诊科中适当的抗菌药物选择、有效的降级和良好的败血症结局。
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引用次数: 0
Assessing the Value of Biosimilars: A Cost-Effectiveness Approach for Managed Care Organizations. 评估生物仿制药的价值:管理式医疗组织的成本效益方法。
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-03 DOI: 10.1177/08971900251394782
Vishwanauth Persaud, Reanne Bernstein, Albert Wertheimer
<p><p>Biologic medications are essential for treating chronic diseases but come with high costs, prompting interest in biosimilars as more affordable alternatives. Biosimilars are highly similar to FDA-approved biologics in terms of safety and efficacy, though not identical. Managed Care Organizations (MCOs), especially those contracted by Medicaid in New York, play a key role in formulary management and cost containment. Despite over 600 approved biologics, only approximately 69 biosimilars are available, and their adoption varies widely. This study evaluates cost and clinical outcomes across three disease states-Rheumatoid Arthritis (RA), Crohn's Disease (CD), and Type 1 Diabetes Mellitus (DM)-using biologic-biosimilar pairs: Adalimumab (Cyltezo), Infliximab (Avsola), and Insulin Glargine (Semglee). We aim to understand pricing discrepancies and the lag in biosimilar uptake within MCO formularies through cost-effectiveness analysis. Findings will inform whether clinical equivalence translates into formulary preference and support efficient resource allocation while maintaining patient access and treatment outcomes. A formulary review identified high-cost biologics with FDA-approved biosimilars used in managed care. RA, CD, and T1DM were selected based on prevalence and cost impact. Biologics included Humira, Remicade, and Lantus, with biosimilars Cyltezo, Avsola, and Semglee. Selection was based on FDA approval, formulary access, and clinical relevance. Efficacy and safety were confirmed through trial review and real-world data. Cost-effectiveness was assessed using ICER, calculated from annual treatment costs and clinical outcomes, with a $50,000 willingness-to-pay threshold. Biosimilars demonstrated strong cost-effectiveness compared to their reference biologics. Cyltezo showed better clinical response than Humira (69% vs 64.5%) at a much lower annual cost ($6600 vs $107,992.82), yielding an ICER of -$2.25 million. Avsola was also more effective than Remicade (68.1% vs 59.1%) and significantly cheaper ($24,000 vs $50,500), with an ICER of -$297,752.81. Semglee and Lantus had equivalent outcomes, but Semglee cost less ($1775.76 vs $4896), supporting a cost-minimization approach. Despite favorable outcomes, biosimilars were often placed on equal or higher formulary tiers than reference biologics due to rebate contracts, limited interchangeability, and provider hesitancy. Biosimilars offer equal or better clinical outcomes at much lower costs in RA, CD, and T1DM. Cyltezo and Avsola were dominant in both efficacy and cost, yet their formulary placement remains inconsistent due to rebate-driven incentives, provider hesitancy, and administrative barriers. To improve adoption, MCOs and PBMs should prioritize value-based formulary decisions, enhance transparency, and support provider and patient education. Pharmacists can help lead biosimilar use through counseling and substitution protocols. Greater alignment between clinical evidence and formulary
生物药物对于治疗慢性疾病至关重要,但成本高昂,这促使人们对生物仿制药的兴趣,因为它是更实惠的替代品。生物仿制药在安全性和有效性方面与fda批准的生物制剂高度相似,尽管不完全相同。管理式医疗组织(MCOs),特别是那些与纽约医疗补助计划签约的组织,在处方管理和成本控制方面发挥着关键作用。尽管批准的生物制剂超过600种,但只有大约69种生物仿制药可用,而且它们的采用情况差别很大。本研究评估了三种疾病状态的成本和临床结果-类风湿关节炎(RA),克罗恩病(CD)和1型糖尿病(DM)-使用生物-生物类似药对:阿达木单抗(Cyltezo),英夫利昔单抗(Avsola)和甘精胰岛素(Semglee)。我们的目标是通过成本效益分析了解定价差异和MCO处方中生物类似药吸收的滞后。研究结果将告知临床等效是否转化为处方偏好,并支持有效的资源分配,同时保持患者可及性和治疗结果。处方审查确定了高成本生物制剂与fda批准的生物仿制药用于管理式医疗。RA、CD和T1DM是根据患病率和成本影响来选择的。生物制剂包括Humira、Remicade和Lantus,以及生物仿制药Cyltezo、Avsola和Semglee。选择基于FDA批准、处方可及性和临床相关性。通过试验回顾和实际数据证实了有效性和安全性。使用ICER评估成本效益,根据年度治疗费用和临床结果计算,支付意愿阈值为50,000美元。与参考生物制剂相比,生物仿制药具有很强的成本效益。Cyltezo表现出比Humira更好的临床反应(69%对64.5%),且年成本(6600美元对107,992.82美元)低得多,ICER为- 225万美元。Avsola也比Remicade更有效(68.1% vs 59.1%),并且明显更便宜(24,000美元vs 50,500美元),ICER为- 297,752.81美元。Semglee和Lantus的效果相当,但Semglee的成本更低(1775.76美元对4896美元),支持成本最小化的方法。尽管结果良好,但由于回扣合同、有限的互换性和供应商的犹豫,生物仿制药往往被置于与参考生物药相同或更高的处方级别。生物仿制药在类风湿关节炎、CD和T1DM中以更低的成本提供相同或更好的临床结果。Cyltezo和Avsola在疗效和成本上都占主导地位,但由于回扣驱动的激励、供应商的犹豫和行政障碍,它们的处方位置仍然不一致。为了提高采用率,mco和pbm应优先考虑基于价值的处方决策,提高透明度并支持提供者和患者教育。药剂师可以通过咨询和替代协议帮助引导生物仿制药的使用。临床证据与处方实践之间的更大一致性可以降低成本,改善可及性并促进可持续护理。
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引用次数: 0
Evaluation of Antibiotic Selection in the Emergency Department Following the Implementation of an Infectious Source-Specific Order Set. 实施传染源特异性医嘱集后急诊科抗生素选择评估
IF 1.1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-03 DOI: 10.1177/08971900251394123
Jon Derringer, Cody Null, Jared Heiles, Katherine Lusardi, Amanda Novack, Ryan Dare

Emergency department (ED) practitioners frequently prescribe antibiotics for sepsis and other infections, with quality and performance metrics often influencing broad-spectrum antibiotic selection. This study objective was to evaluate improvements in antibiotic selection in the ED following implementation and revision of sepsis order sets designed to adhere to Centers for Medicare and Medicaid Services sepsis performance measure bundle across time periods. This single-center, retrospective analysis assessed antibiotic orders in the ED across three periods of order set availability: no sepsis order set (period 1), general broad-spectrum order set (period 2), and infectious-source specific order set (period 3). Order rates of narrow-spectrum β-lactams, extended-spectrum cephalosporins, antipseudomonal β-lactams, fluoroquinolones, clindamycin, and other agents were assessed. Individual patient encounters with antibiotic orders for period 1 (n = 4228), period 2 (n = 4407), and period 3 (n = 5129) were assessed. Order set use for antibiotic ordering increased across time periods (4% vs 20.6% vs 53.3%; P < 0.001). Period 3 was associated with an increase in narrow spectrum β-lactam use (3% vs 3% vs 15.2%; P < 0.001), a decrease in antipseudomonal β-lactam use (30.1% vs 36.1% vs 27.7%; P < 0.001), and a decrease in targeted antibiotics associated with high risk for adverse effects (28% vs 16% vs 6.9%; P < 0.001). The creation and utilization of an infectious source-specific sepsis antibiotic order set was associated with improved antibiotic ordering trends in the emergency department. This intervention should be considered by hospital antimicrobial stewardship programs.

急诊科(ED)从业者经常开抗生素治疗败血症和其他感染,质量和性能指标往往影响广谱抗生素的选择。本研究的目的是评估在实施和修订脓毒症医单集后,急诊科抗生素选择的改善,这些医单集旨在遵守医疗保险和医疗补助服务中心跨时期的脓毒症表现测量包。本单中心回顾性分析评估了急诊科三个阶段的抗生素订单:无脓毒症订单集(第1期)、一般广谱订单集(第2期)和传染源特定订单集(第3期)。评估窄谱β-内酰胺类药物、广谱头孢菌素、抗假单胞菌β-内酰胺类药物、氟喹诺酮类药物、克林霉素等药物的订购率。评估了第1期(n = 4228)、第2期(n = 4407)和第3期(n = 5129)患者的抗生素处方。抗生素订购的订单集使用在不同时期有所增加(4% vs 20.6% vs 53.3%; P < 0.001)。第3期与窄谱β-内酰胺使用增加(3% vs 3% vs 15.2%, P < 0.001)、抗假单胞菌β-内酰胺使用减少(30.1% vs 36.1% vs 27.7%, P < 0.001)以及与高危不良反应相关的靶向抗生素使用减少(28% vs 16% vs 6.9%, P < 0.001)相关。感染性源特异性脓毒症抗生素订购集的创建和使用与急诊科抗生素订购趋势的改善有关。医院抗菌药物管理方案应考虑这种干预措施。
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引用次数: 0
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Journal of pharmacy practice
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