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Drug Shortage in Italy: Retrospective Analysis from 2018 to 2024. 意大利的药物短缺问题:2018 年至 2024 年的回顾性分析。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-12 DOI: 10.1177/00185787241278142
Eleonora Castellana
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引用次数: 0
Rapid Desensitization to Antitumoral Agents. Result from a Retrospective Study, DESARCh. 抗肿瘤药物的快速脱敏。一项回顾性研究的结果,DESARCh.
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-05 DOI: 10.1177/00185787241278702
Roberto Tessari, Andrea Ossato, Francesca Realdon, Valentina Montresor, Giuseppe Giovagnoni, Michele Giannini, Debora Gandini, Alessandra Modena, Alessandro Inno, Stefania Gori

Antitumoral drugs (ADs) can induce drug hypersensitivity reactions (DHRs). Rapid drug desensitization (RDD) protocols represent an important option to mitigate recurrent DHRs thus allowing the safe administration of ADs at therapeutic doses. The aim of this retrospective study was to assess the effectiveness of the RDD protocols performed at our institution. The "DESARCh" study was a retrospective, observational study that included consecutive patients who underwent RDD protocols from January 2011 to December 2022 at IRCCS Ospedale Sacro Cuore Don Calabria in Negrar di Valpolicella, Verona, Italy. The RDD protocol consisted of a 5-step protocol with 5 different concentrations of the drugs at 1:1, 1:10, 1:100, 1:1,000 and 1:10,000 dilution given intravenously over a 1-hour infusion each, with concentrations increasing from the most diluted to the most concentrated form, preceded by a 30-min premedication regimen. A total of 66 RDD protocols were administered to 25 female patients with ovarian (64%; n = 16/25), breast (12%; n = 3/25), endometrium (8%; n = 2/25), cervix (8%; n = 2/25), uterine (4%; n = 1/25) and fallopian tubes (4%; n = 1/25) cancers. A known history of atopy/allergy was reported by 36% (n = 9/25) of patients. Patients received RDD protocols because of DHRs to carboplatin (n = 23/66, 34.85%), paclitaxel (n = 18/66, 27.27%), pegylated liposomal doxorubicin (n = 3/66, 4.55%), and trastuzumab (n = 22/66, 33.33%). DHRs were mild-moderate, severe and life-threatening in 60.72%, 28.57% and 10.71% of cases, respectively. The success rate of RDD protocols, defined as the rate of complete administration of full target dose with no breakthrough reactions, was 81.82% (n = 54/66). Success rate was lower for carboplatin compared to other drugs (65.22% vs 90.7%; P = .017678). The RDD protocol used in our institution was found to be safe, with a meaningful success rate. However, further research is needed to better understand the underlying mechanisms of DHRs and to enhance effectiveness, particularly for patients experiencing DHRs to platinum compounds. This study was approved by the ethics committee of Verona and Rovigo (Italy) with approval number 15476 on 10/03/2023 and it was registered with the Register of Observational Studies of the Italian Medicines Agency (AIFA) (available since 31 January 2023), with ID n. 109, on 28/02/2023 (https://www.aifa.gov.it/en/registro-studi-osservazionali).

抗肿瘤药物(ADs)可诱发药物超敏反应(DHRs)。快速药物脱敏(RDD)方案是缓解复发性药物过敏反应的重要选择,因此可以安全使用治疗剂量的抗肿瘤药物。这项回顾性研究旨在评估我院实施的 RDD 方案的有效性。DESARCh "研究是一项回顾性观察研究,纳入了2011年1月至2022年12月期间在意大利维罗纳Negrar di Valpolicella的IRCCS Ospedale Sacro Cuore Don Calabria接受RDD方案治疗的连续患者。RDD方案包括5个步骤,分别以1:1、1:10、1:100、1:1,000和1:10,000的比例稀释5种不同浓度的药物,每次静脉输注1小时,浓度从最稀释到最浓稠依次递增,输注前进行30分钟的预处理。25 名女性患者分别患有卵巢癌(64%;n = 16/25)、乳腺癌(12%;n = 3/25)、子宫内膜癌(8%;n = 2/25)、宫颈癌(8%;n = 2/25)、子宫癌(4%;n = 1/25)和输卵管癌(4%;n = 1/25),共使用了 66 个 RDD 方案。36%(n = 9/25)的患者有已知的过敏史。患者接受 RDD 方案是因为对卡铂(n = 23/66,34.85%)、紫杉醇(n = 18/66,27.27%)、聚乙二醇化脂质体多柔比星(n = 3/66,4.55%)和曲妥珠单抗(n = 22/66,33.33%)有 DHR。60.72%、28.57%和10.71%的病例出现轻-中度、重度和危及生命的 DHR。RDD方案的成功率为81.82%(n=54/66),成功率的定义是完全施用全部目标剂量且无突破性反应。与其他药物相比,卡铂的成功率较低(65.22% vs 90.7%; P = .017678)。我们医院采用的 RDD 方案是安全的,成功率也很高。然而,我们还需要进一步研究,以更好地了解DHRs的潜在机制并提高疗效,尤其是对铂类化合物产生DHRs的患者。本研究于2023年3月10日获得意大利维罗纳和罗维戈伦理委员会批准,批准号为15476,并于2023年2月28日在意大利药品管理局观察性研究登记处(AIFA)登记(自2023年1月31日起生效),登记号为109(https://www.aifa.gov.it/en/registro-studi-osservazionali)。
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引用次数: 0
Resmetirom. Resmetirom.
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-05 DOI: 10.1177/00185787241278571
Terri L Levien, Danial E Baker

Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy and Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433.

每月,《处方集专论服务》的订户都会收到 5 到 6 篇有据可查的专论,内容涉及新上市或处于 3 期试验后期的药物。这些专论主要针对药学和治疗学委员会。订户每月还会收到 1 页的药剂摘要专论,这些专论对议程和药学/护理培训很有用。此外,每月还提供一份综合目标药物使用评估/用药评估 (DUE/MUE)。订阅者可在线获取各论。各论可根据医疗机构的需求进行定制。通过与《处方集》的合作,医院药房在本专栏中发表了部分评论。有关《处方集》专论服务的更多信息,请致电 866-397-3433 联系 Wolters Kluwer 客户服务。
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引用次数: 0
Implementation of a Pharmacist-Driven Protocol to Improve Screening and Treatment of Iron Deficiency in Hospitalized Patients with Chronic Kidney Disease. 实施以药剂师为主导的方案,改善慢性肾病住院患者铁缺乏症的筛查和治疗。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-08-07 DOI: 10.1177/00185787241267730
Karissa Chow, Brandon Trollinger, Matthew Blum, Sami Alasfar, Jose Manuel Monroy-Trujillo, Dannielle Brown

Purpose: While intravenous (IV) iron repletion is an effective tool to treat anemia and improve outcomes in chronic kidney disease (CKD), guideline laboratory definitions of iron deficiency differ, resulting in variability in screening and repletion strategies. This study sought to describe current practices surrounding identification and treatment of iron deficiency in CKD and then implement a pharmacist-led protocol to optimize care at a tertiary medical center. Methods: This single center, retrospective, pre- and post-protocol implementation study of adults with CKD admitted to the inpatient setting first analyzed historic practices for iron deficiency screening and treatment, followed by deployment of a pharmacist-driven protocol for iron deficiency screening and treatment. Iron deficiency was defined as transferrin saturation of ≤30% and ferritin of ≤500 ng/mL. Improvement in screening and repletion rates was analyzed. Results: Historic pre-protocol practices were reviewed in 7155 admissions of which 2559 (35.8%) included screening for iron deficiency. Over the 2 months intervention (post-protocol) period, 315 admissions were included. The average age of patients in the post-protocol cohort was 64.1 years, 53.7% were female, and 26.4% were dialysis dependent. Compared to pre-protocol, patients were 2.33 (95% CI 2.20-2.47) times more likely to be screened and deficient patients were 2.05 (95% CI 1.46-2.86) times more likely to be treated, with most receiving IV iron therapy (85.4%), in the post-protocol cohort. Patients were 3.58 times (95% CI 1.97-6.48) more likely to receive IV iron versus oral alone in the post-protocol cohort compared to pre-protocol. Conclusion: The frequency of patients with CKD screened and treated with iron increased after implementation of a pharmacist-driven protocol. This study underscores the need for a systematic approach to identification/treatment of iron deficiency in this population.

目的:虽然静脉注射补铁是治疗慢性肾脏病(CKD)患者贫血和改善预后的有效手段,但实验室对缺铁的指导性定义各不相同,导致筛查和补铁策略存在差异。本研究旨在描述目前识别和治疗 CKD 缺铁症的方法,然后在一家三级医疗中心实施以药剂师为主导的方案,以优化护理。方法:这项针对住院成人 CKD 患者的单中心、回顾性、方案实施前后研究首先分析了缺铁筛查和治疗的历史做法,然后部署了药剂师主导的缺铁筛查和治疗方案。铁缺乏的定义是转铁蛋白饱和度≤30%,铁蛋白≤500 ng/mL。分析了筛查和补铁率的提高情况。结果:对 7155 例入院患者进行了协议前的历史回顾,其中 2559 例(35.8%)包括缺铁筛查。在为期 2 个月的干预(协议后)期间,共纳入 315 例入院患者。协议后组群中患者的平均年龄为 64.1 岁,53.7% 为女性,26.4% 依赖透析治疗。与方案实施前相比,方案实施后队列中患者接受筛查的几率是方案实施前的 2.33 倍(95% CI 2.20-2.47),缺乏铁质的患者接受治疗的几率是方案实施前的 2.05 倍(95% CI 1.46-2.86),其中大多数患者接受了静脉注射铁剂治疗(85.4%)。与方案实施前相比,方案实施后队列中患者接受静脉注射铁剂治疗的几率是方案实施前的 3.58 倍(95% CI 1.97-6.48)。结论在实施药剂师驱动的方案后,接受铁剂筛查和治疗的慢性肾脏病患者人数有所增加。这项研究强调,需要采用系统的方法来识别/治疗这类人群的铁缺乏症。
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引用次数: 0
A Pilot Study on the Drug Price Revision Strategy in Japan: A Comparison Among Fiscal Years 2018, 2020, and 2022. 日本药品价格修订战略试点研究:2018、2020 和 2022 财政年度的比较。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-08-06 DOI: 10.1177/00185787241267738
Naoto Nakagawa, Mizuha Konno, Masami Kashiwabara, Shinya Shimoji, Jun Mochimaru, Tadao Inoue, Leanne Lai

Objective: Japan has resumed its health technology assessment to decide how to reduce high-cost drug prices. While drug price rules in Japan are comprehensive, they do not necessarily capture differences in product characteristics. This study examined the drug price revision strategy in Japan using migraine treatment with triptans as an example. Cost data from fiscal years (FY) 2018, 2020, and 2022 were utilized. Methods: A cost-utility analysis was conducted from the perspective of healthcare payers, focusing on Japanese patients aged over 18 years experiencing migraines. The study employed a base-case model with probabilities derived from a network meta-analysis. Direct costs included medical and drug costs. Effectiveness was assessed using the European Quality of Life 5-dimensions-3-level questionnaire. Deterministic and probabilistic sensitivity analyses were conducted to examine the level of uncertainty. Results: In FY2018, sumatriptan and eletriptan were cost-effective; however, the other triptans were dominated by sumatriptan. In FY2020, sumatriptan and eletriptan were cost-effective, and rizatriptan was extended-dominated; nevertheless, the other triptans were dominated by sumatriptan. In FY2022, naratriptan and eletriptan were cost-effective; however, the other triptans were dominated by naratriptan. The hierarchy of triptan strategies varied in each fiscal year. Conclusions: This study provides valuable insights into the drug price revision strategy in Japan. The variations could be problematic because in Japan, formulary management of triptans, for example, those for migraine, may face revaluation every other year. Discussions regarding this issue will be further explored in the future.

目标:日本恢复了卫生技术评估,以决定如何降低高成本药品的价格。虽然日本的药品价格规则很全面,但并不一定能反映产品特性的差异。本研究以使用三苯氧胺治疗偏头痛为例,探讨了日本的药品价格修订策略。研究采用了 2018、2020 和 2022 财年的成本数据。研究方法从医疗支付方的角度进行了成本效用分析,重点关注 18 岁以上患有偏头痛的日本患者。研究采用了一个基础案例模型,其概率来自网络荟萃分析。直接成本包括医疗和药物成本。疗效采用欧洲生活质量 5 维-3 级问卷进行评估。进行了确定性和概率敏感性分析,以检查不确定性水平。结果:在2018财年,舒马曲普坦和依利普坦具有成本效益;但其他三普坦的成本效益被舒马曲普坦所取代。在 2020 财年,舒马曲普坦和依利普坦具有成本效益,利扎曲普坦以扩展为主;然而,其他三普坦以舒马曲普坦为主。在 2022 财政年度,那拉曲普坦和依来普坦具有成本效益;但其他三普坦以那拉曲普坦为主。在每个财政年度,三普坦策略的等级都有所不同。结论:这项研究为了解日本的药品价格调整策略提供了宝贵的资料。这些变化可能存在问题,因为在日本,三苯氧胺类药物(如治疗偏头痛的药物)的处方管理可能每隔一年就会面临一次重新评估。今后将进一步探讨这一问题。
{"title":"A Pilot Study on the Drug Price Revision Strategy in Japan: A Comparison Among Fiscal Years 2018, 2020, and 2022.","authors":"Naoto Nakagawa, Mizuha Konno, Masami Kashiwabara, Shinya Shimoji, Jun Mochimaru, Tadao Inoue, Leanne Lai","doi":"10.1177/00185787241267738","DOIUrl":"10.1177/00185787241267738","url":null,"abstract":"<p><p><b>Objective:</b> Japan has resumed its health technology assessment to decide how to reduce high-cost drug prices. While drug price rules in Japan are comprehensive, they do not necessarily capture differences in product characteristics. This study examined the drug price revision strategy in Japan using migraine treatment with triptans as an example. Cost data from fiscal years (FY) 2018, 2020, and 2022 were utilized. <b>Methods:</b> A cost-utility analysis was conducted from the perspective of healthcare payers, focusing on Japanese patients aged over 18 years experiencing migraines. The study employed a base-case model with probabilities derived from a network meta-analysis. Direct costs included medical and drug costs. Effectiveness was assessed using the European Quality of Life 5-dimensions-3-level questionnaire. Deterministic and probabilistic sensitivity analyses were conducted to examine the level of uncertainty. <b>Results:</b> In FY2018, sumatriptan and eletriptan were cost-effective; however, the other triptans were dominated by sumatriptan. In FY2020, sumatriptan and eletriptan were cost-effective, and rizatriptan was extended-dominated; nevertheless, the other triptans were dominated by sumatriptan. In FY2022, naratriptan and eletriptan were cost-effective; however, the other triptans were dominated by naratriptan. The hierarchy of triptan strategies varied in each fiscal year. <b>Conclusions:</b> This study provides valuable insights into the drug price revision strategy in Japan. The variations could be problematic because in Japan, formulary management of triptans, for example, those for migraine, may face revaluation every other year. Discussions regarding this issue will be further explored in the future.</p>","PeriodicalId":13002,"journal":{"name":"Hospital Pharmacy","volume":" ","pages":"00185787241267738"},"PeriodicalIF":0.8,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11569764/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142667348","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
When Antimicrobial Treatment and Surgical Prophylaxis Collide: A Stewardship Opportunity. 当抗菌治疗和手术预防发生冲突时:管理机会。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-08-01 Epub Date: 2024-04-27 DOI: 10.1177/00185787241230079
Priscila Fiallo, Timothy Williams, Larry M Bush
<p><p><b>Background:</b> In 2002, the Centers for Medicare and Medicaid Services (CMS) in collaboration with the Centers for Disease Control and Prevention (CDC) established the <i>Surgical Infection Prevention</i> (SIP) project for the purposes of developing and standardizing quality improvement measures known to reduce the rates of post-operative surgical site infections (SSIs). Four years later the <i>Surgical Care Improvement Project</i> (SCIP), an expansion of SIP, was published in governmental <i>Specifications Manual for National Inpatient Quality Measures and</i> provided several additional initiatives applicable to the perioperative period. Central to both projects are the assurance of the timeliness, selection, and duration of peri-operative surgical prophylactic antibiotics. In support of this objective, various medical associations, such as the American Society of Health-System Pharmacists (ASHP) and the Infectious Diseases Society of America (IDSA), have developed the <i>Clinical Practice Guidelines for Antimicrobial Prophylaxis in Surgery</i>. To ensure compliance with quality measures, hospitals are required to report data to the <i>Physicians Quality Reporting System</i>, which is then reviewed by CMS for reimbursement purposes and to measure hospital performance. To maintain optimal standards of care and satisfy all core measures, it is expected that patients undergoing most categories of surgical procedures receive prophylactic antibiotics. We recognized that patients already being administered antimicrobial therapy as treatment for the condition requiring the surgery not uncommonly also were prescribed unwarranted and redundant pre-operative antibiotics. Our study was meant to quantify such antibiotic redundancy, which only risks the development of antimicrobial resistance and adverse events, to bolster our and other hospitals antimicrobial stewardship programs. <b>Methods:</b> A retrospective analysis of computerized hospital records over a one-month period of time (November 2022) was conducted focusing on hospital admissions that involved surgical operative procedures. Only those patients who had received a pre-operative surgical prophylactic antibiotic were included in the analysis. <b>Results:</b> Of the 92 surgeries that fulfilled the inclusion criteria, 38 (41.3%) were performed on patients who were already receiving therapeutic antibiotics for more than 24 hours targeted to treat the infection for which they were undergoing surgery. These included laparoscopic cholecystectomy (24), appendectomy (12), wound debridement (12), and soft tissue incision and drainage procedures (9), comprising nearly 50% of each type of these operations performed during the study time period. <b>Conclusion:</b> These findings demonstrate a clear opportunity to strengthen both our, and presumably other, hospitals antimicrobial stewardship programs. Together with physician education, granting the pharmacy the ability to cancel unnecessary and re
背景:2002 年,美国医疗保险和医疗补助服务中心 (CMS) 与美国疾病控制和预防中心 (CDC) 合作建立了外科感染预防 (SIP) 项目,目的是制定和规范已知可降低术后手术部位感染 (SSI) 率的质量改进措施。四年后,SIP 的扩展项目--外科护理改进项目(SCIP)在《国家住院病人质量措施规范手册》(Governmental Specifications Manual for National Inpatient Quality Measures)中发布,并提供了几项适用于围术期的额外措施。这两个项目的核心都是确保围手术期手术预防性抗生素的及时性、选择和持续时间。为实现这一目标,美国卫生系统药剂师协会 (ASHP) 和美国传染病协会 (IDSA) 等多个医学协会制定了《外科抗菌预防临床实践指南》。为确保符合质量标准,医院必须向 "医生质量报告系统 "报告数据,然后由 CMS 进行审核,以用于报销和衡量医院绩效。为了保持最佳的护理标准并满足所有核心指标的要求,接受大多数类别外科手术的患者都应接受预防性抗生素治疗。我们认识到,已经接受抗菌治疗的患者在治疗需要手术的疾病时,也会被开具不必要和多余的术前抗生素,这种情况并不少见。我们的研究旨在量化这种抗生素重复使用的情况(这种情况只会导致抗菌药耐药性的产生和不良事件的发生),以加强我们和其他医院的抗菌药物管理计划。方法对一个月内(2022 年 11 月)的计算机化医院记录进行回顾性分析,重点是涉及外科手术程序的入院患者。只有术前接受过手术预防性抗生素治疗的患者才被纳入分析范围。分析结果在符合纳入标准的 92 例手术中,有 38 例(41.3%)的患者在接受手术时已经接受了 24 小时以上的抗生素治疗,以治疗感染。这些手术包括腹腔镜胆囊切除术(24 例)、阑尾切除术(12 例)、伤口清创术(12 例)和软组织切开引流术(9 例),占研究期间所进行的各类手术的近 50%。结论这些研究结果表明,我们的抗菌药物管理计划以及其他医院的抗菌药物管理计划都有明显的加强机会。在对医生进行教育的同时,赋予药房取消不必要和多余的手术预防性抗生素的能力将大有裨益。
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引用次数: 0
Case Report: Cefepime Induced Neurotoxicity Following a Change in Infusion Time. 病例报告:改变输注时间后头孢吡肟引发的神经毒性。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-08-01 Epub Date: 2024-03-07 DOI: 10.1177/00185787241237142
Kendall Stratton, Kelly W Davis

Purpose: Cefepime is an antibiotic associated with cefepime induced neurotoxicity (CIN), particularly in those with reduced renal function, or in cases of inappropriate medication dosing. This report describes a case of CIN associated with a change in infusion duration from 180 to30 minutes, which to the best of our knowledge has not been previously reported in the literature. Summary: A 73-year old male was treated with extended infusion cefepime over 180 minutes while hospitalized with recurrent pneumonia. On discharge, cefepime was continued as outpatient parenteral antimicrobial therapy (OPAT) administered over 30 minutes. The patient began to experience symptoms of neurotoxicity after 1 day of receiving OPAT, which subsequently led to a readmission as neurological symptoms worsened. Cefepime was discontinued and symptoms resolved within 48 hours. Renal function was stable throughout treatment and no other causes for neurotoxicity were noted. Conclusion: This is a unique case of CIN secondary to shortened infusion time, which is clinically relevant, particularly during transitions of care. Further investigation, including more widespread use of therapeutic drug monitoring will be beneficial to further elucidate the relationship between infusion time and CIN development.

目的:头孢吡肟是一种与头孢吡肟诱导神经毒性(CIN)相关的抗生素,尤其是在肾功能减退或用药剂量不当的情况下。本报告描述了一例与输液时间从 180 分钟缩短至 30 分钟有关的 CIN 病例,据我们所知,以前的文献中从未报道过此类病例。摘要:一名 73 岁的男性患者因反复肺炎住院,在住院期间接受了超过 180 分钟的头孢吡肟延长输注治疗。出院后,患者继续接受头孢吡肟门诊肠外抗菌治疗(OPAT),用药时间为 30 分钟。接受 OPAT 治疗 1 天后,患者开始出现神经中毒症状,随后因神经症状恶化而再次入院。停用头孢吡肟后,症状在 48 小时内缓解。在整个治疗过程中,患者肾功能稳定,未发现其他导致神经中毒的原因。结论这是一例因输液时间缩短而继发 CIN 的独特病例,具有临床意义,尤其是在护理过渡期间。进一步调查,包括更广泛地使用治疗药物监测,将有助于进一步阐明输液时间与 CIN 发生之间的关系。
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引用次数: 0
Methicillin-Resistant Staphylococcus aureus Bacteremia Treated With Vancomycin Calculated by Area-Under-the-Curve in Patients With Elevated Vancomycin Minimum Inhibitory Concentrations. 用万古霉素治疗耐甲氧西林金黄色葡萄球菌菌血症,按万古霉素最低抑制浓度升高患者的曲线下面积计算。
IF 0.7 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-06-01 Epub Date: 2023-12-21 DOI: 10.1177/00185787231218922
Sarah Arnold, Dustin Orvin, Malay Patel, Katie Schoen, Jamie Wagner, Bruce M Jones

Purpose: Vancomycin is recommended as first-line treatment of methicillin-resistant Staphylococcus aureus (MRSA) bacteremia, dosed by area-under-the-curve (AUC) with an assumed minimum inhibitory concentration (MIC) of 1 mcg/mL via broth microdilution. The purpose of this study was to compare effectiveness of AUC-based and trough-based dosing in MRSA bacteremia with an MIC > 1 mcg/mL via Etest. Methods: This was a retrospective, observational cohort that compared vancomycin dosed by AUC or trough between January 1, 2017 and September 1, 2022. The primary outcome was a composite of treatment failure defined as peristent bacteremia ≥ 7 days, inpatient mortality within 90 days, or microbiologic relapse or readmission within 30 days. Secondary outcomes compared nephrotoxicity, hospital and ICU length of stay, MIC differences, and difference in exposure measured by AUC. Results: Twenty-four patients in each group met inclusion criteria. For the primary outcome, there was no statistical difference in treatment failure between trough and AUC groups, respectively [10 (41.7%) vs 10 (41.7%), P = 1.000]. There was no statistical difference in secondary outcomes, with incidence of nephrotoxicity [3 (12.5%) trough vs 2 (8.33%) AUC, P = 1.000] and median AUC exposure over treatment course [502.9 mcg.h/mL (454.1-599.9) vs 474 mcg.h/mL (435.3-533), P = .312] similar between groups. Conclusion: There was no statistically significant difference in treatment failure for vancomycin by AUC or trough with an Etest MIC > 1 mcg/mL. Overall exposure to vancomycin and incidence of nephrotoxicty were numerically higher in the trough group, suggesting that dosing by AUC may limit exposure without impact on treatment failure.

目的:万古霉素被推荐作为耐甲氧西林金黄色葡萄球菌(MRSA)菌血症的一线治疗药物,通过肉汤微量稀释法按曲线下面积(AUC)给药,假定最低抑菌浓度(MIC)为 1 mcg/mL。本研究的目的是比较基于 AUC 和基于谷值的剂量在通过 Etest 测定 MIC > 1 mcg/mL 的 MRSA 菌血症中的有效性。研究方法这是一项回顾性、观察性队列研究,比较了 2017 年 1 月 1 日至 2022 年 9 月 1 日期间按 AUC 或谷值给药的万古霉素。主要结果是治疗失败的复合结果,即持续菌血症≥7天、90天内住院死亡率或30天内微生物复发或再入院。次要结果比较了肾毒性、住院时间和重症监护室住院时间、MIC差异以及以AUC衡量的暴露差异。结果每组有 24 名患者符合纳入标准。就主要结果而言,谷值组和 AUC 组的治疗失败率没有统计学差异[10(41.7%) vs 10(41.7%),P = 1.000]。在次要结果方面,两组间无统计学差异,肾毒性发生率[谷值组 3 (12.5%) vs AUC 组 2 (8.33%),P = 1.000]和治疗过程中 AUC 暴露中位数[502.9 mcg.h/mL (454.1-599.9) vs 474 mcg.h/mL (435.3-533),P = .312]相似。结论按AUC或谷值计算,当Etest MIC > 1 mcg/mL时,万古霉素治疗失败的差异无统计学意义。谷值组的万古霉素总暴露量和肾毒性发生率在数量上更高,这表明按AUC给药可能会限制暴露量,但不会对治疗失败产生影响。
{"title":"Methicillin-Resistant <i>Staphylococcus aureus</i> Bacteremia Treated With Vancomycin Calculated by Area-Under-the-Curve in Patients With Elevated Vancomycin Minimum Inhibitory Concentrations.","authors":"Sarah Arnold, Dustin Orvin, Malay Patel, Katie Schoen, Jamie Wagner, Bruce M Jones","doi":"10.1177/00185787231218922","DOIUrl":"10.1177/00185787231218922","url":null,"abstract":"<p><p><b>Purpose:</b> Vancomycin is recommended as first-line treatment of methicillin-resistant <i>Staphylococcus aureus</i> (MRSA) bacteremia, dosed by area-under-the-curve (AUC) with an assumed minimum inhibitory concentration (MIC) of 1 mcg/mL via broth microdilution. The purpose of this study was to compare effectiveness of AUC-based and trough-based dosing in MRSA bacteremia with an MIC > 1 mcg/mL via Etest. <b>Methods:</b> This was a retrospective, observational cohort that compared vancomycin dosed by AUC or trough between January 1, 2017 and September 1, 2022. The primary outcome was a composite of treatment failure defined as peristent bacteremia ≥ 7 days, inpatient mortality within 90 days, or microbiologic relapse or readmission within 30 days. Secondary outcomes compared nephrotoxicity, hospital and ICU length of stay, MIC differences, and difference in exposure measured by AUC. <b>Results:</b> Twenty-four patients in each group met inclusion criteria. For the primary outcome, there was no statistical difference in treatment failure between trough and AUC groups, respectively [10 (41.7%) vs 10 (41.7%), <i>P</i> = 1.000]. There was no statistical difference in secondary outcomes, with incidence of nephrotoxicity [3 (12.5%) trough vs 2 (8.33%) AUC, <i>P</i> = 1.000] and median AUC exposure over treatment course [502.9 mcg.h/mL (454.1-599.9) vs 474 mcg.h/mL (435.3-533), <i>P</i> = .312] similar between groups. <b>Conclusion:</b> There was no statistically significant difference in treatment failure for vancomycin by AUC or trough with an Etest MIC > 1 mcg/mL. Overall exposure to vancomycin and incidence of nephrotoxicty were numerically higher in the trough group, suggesting that dosing by AUC may limit exposure without impact on treatment failure.</p>","PeriodicalId":13002,"journal":{"name":"Hospital Pharmacy","volume":"59 3","pages":"329-333"},"PeriodicalIF":0.7,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11097929/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141064817","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
Evaluation of an Automated, Pharmacist-Driven, Antimicrobial Patient Acuity Scoring System for Hospitalized Bacteremic Patients. 药剂师驱动的住院细菌患者抗菌能力自动评分系统的评估
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-02-01 Epub Date: 2023-07-06 DOI: 10.1177/00185787231182567
Riley Karpen, Claire Murphy, Erica Reed, Anthony T Gerlach, Kari Cape, John Mellett, Sara A Atyia

Purpose: The implementation of an automated, pharmacist-driven, scoring system within the EMR has been shown to improve patient care in patients with Staphylococcus aureus bacteremia by increasing the adherence to disease specific quality-of-care measures. However, there are a lack of studies evaluating the incorporation of blood culture review into standard, non-antimicrobial stewardship pharmacist workflow. Our institution implemented an automated, pharmacist-driven, antimicrobial scoring system in the electronic medical record (EMR) on August 6, 2019. Methods: This was a retrospective, single-center, quasi-experimental study of hospitalized, non-critically ill adult (18-89 years of age) patients with bacteremia between July 6, 2018 and July 5, 2019 (pre-implementation group) and September 6, 2019 and September 5, 2020 (post-implementation group). The primary outcome was time to directed antibiotic therapy in patients with positive blood cultures. Secondary outcomes included hospital length-of-stay, days of therapy (DOT) while inpatient, time to effective therapy, 30-day all-cause mortality, and rates of Clostridioides difficile infections documented within 3 months of positive culture results. Results: Implementation of the antimicrobial scoring system did not result in a significant change in time to directed antibiotic therapy (32.5 hours vs 37.4 hours; P = .757). There was also no difference found for time to effective antibiotic therapy (-12.6 hours vs -14.2 hours; P =.905) and no difference found for all other secondary outcomes. Conclusion: The implementation of the antimicrobial scoring system did not lead to an improvement in clinical outcomes. Further research is needed to better define a patient population that may benefit from this system.

目的:在电子病历中实施自动化、药剂师驱动的评分系统已被证明可以通过提高对特定疾病护理质量措施的依从性来改善金黄色葡萄球菌菌血症患者的护理。然而,缺乏评估将血液培养审查纳入标准、非抗菌药物管理药剂师工作流程的研究。我们机构于2019年8月6日在电子病历(EMR)中实施了一个自动化、药剂师驱动的抗菌评分系统。方法:这是一项回顾性、单中心、准实验性研究,研究对象为住院的非危重成人(18-89岁) 2018年7月6日至2019年7月5日期间(实施前组)以及2019年9月6日和2020年9月5日(实施后组)的菌血症患者。主要结果是对血液培养呈阳性的患者进行定向抗生素治疗的时间。次要结果包括住院时间、住院治疗天数、有效治疗时间、30天全因死亡率和3年内记录的艰难梭菌感染率 数月的阳性培养结果。结果:抗菌评分系统的实施没有导致直接抗生素治疗时间的显著变化(32.5小时vs 37.4小时;P = .757)。有效抗生素治疗的时间也没有发现差异(−12.6 小时vs−14.2 小时;P =.905),并且对于所有其他次要结果没有发现差异。结论:抗菌药物评分系统的实施并没有改善临床结果。需要进一步的研究来更好地定义可能从该系统中受益的患者群体。
{"title":"Evaluation of an Automated, Pharmacist-Driven, Antimicrobial Patient Acuity Scoring System for Hospitalized Bacteremic Patients.","authors":"Riley Karpen, Claire Murphy, Erica Reed, Anthony T Gerlach, Kari Cape, John Mellett, Sara A Atyia","doi":"10.1177/00185787231182567","DOIUrl":"10.1177/00185787231182567","url":null,"abstract":"<p><p><b>Purpose:</b> The implementation of an automated, pharmacist-driven, scoring system within the EMR has been shown to improve patient care in patients with <i>Staphylococcus aureus</i> bacteremia by increasing the adherence to disease specific quality-of-care measures. However, there are a lack of studies evaluating the incorporation of blood culture review into standard, non-antimicrobial stewardship pharmacist workflow. Our institution implemented an automated, pharmacist-driven, antimicrobial scoring system in the electronic medical record (EMR) on August 6, 2019. <b>Methods:</b> This was a retrospective, single-center, quasi-experimental study of hospitalized, non-critically ill adult (18-89 years of age) patients with bacteremia between July 6, 2018 and July 5, 2019 (pre-implementation group) and September 6, 2019 and September 5, 2020 (post-implementation group). The primary outcome was time to directed antibiotic therapy in patients with positive blood cultures. Secondary outcomes included hospital length-of-stay, days of therapy (DOT) while inpatient, time to effective therapy, 30-day all-cause mortality, and rates of <i>Clostridioides difficile</i> infections documented within 3 months of positive culture results. <b>Results:</b> Implementation of the antimicrobial scoring system did not result in a significant change in time to directed antibiotic therapy (32.5 hours vs 37.4 hours; <i>P</i> = .757). There was also no difference found for time to effective antibiotic therapy (-12.6 hours vs -14.2 hours; <i>P</i> =.905) and no difference found for all other secondary outcomes. <b>Conclusion:</b> The implementation of the antimicrobial scoring system did not lead to an improvement in clinical outcomes. Further research is needed to better define a patient population that may benefit from this system.</p>","PeriodicalId":13002,"journal":{"name":"Hospital Pharmacy","volume":"1 1","pages":"32-38"},"PeriodicalIF":0.8,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10786048/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41262553","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
Estimating Tiotropium Wasted Doses After Adding Revefenacin to an Inpatient Formulary: A Single-Center Cross-Sectional Study 在住院病人处方中添加瑞维那新后的噻托溴铵浪费剂量估算:单中心横断面研究
IF 0.7 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-01-04 DOI: 10.1177/00185787231222274
Paul M. Boylan, Jordan A. Fuller, Corey M Guidry, Stephen Neely
Introduction: Revefenacin is a once-daily nebulized long-acting muscarinic antagonist (LAMA). Revefenacin is supplied as single-use nebulized vials, which may be preferable and less costly for hospital and health-system pharmacies to dispense versus multidose tiotropium inhalers. Estimates of LAMA multidose inhaler wasted doses remains unknown. Methods: This was a single-center descriptive cross-sectional study conducted between January 1 2021 and December 31 2021. Adult patients 18 years and older admitted to a 500-bed academic medical center in the southern United States and were ordered multidose tiotropium packages or single-use revefenacin vials during the study period were included. Results: Among 602 inpatients, there were 705 LAMA orders: 541 tiotropium (76.7%) and 164 revefenacin (23.3%). Four hundred ninety-five tiotropium orders (91.5%) wasted between 20% and 90% of multidose packages. Approximately $24,000 tiotropium doses were wasted versus single-use revefenacin vials. Conclusion: Multidose inhalers of tiotropium dispensed to hospitalized patients contributed to wasted doses compared to nebulized single-use revefenacin vials. Opportunities exist to minimize wasted doses of multidose long-acting inhalers dispensed to hospitalized patients.
简介瑞维那新是一种每日一次的雾化长效毒蕈碱拮抗剂(LAMA)。瑞芬那新以一次性雾化小瓶的形式供应,与多剂量噻托溴铵吸入剂相比,医院和医疗系统药房配药时可能更喜欢使用这种小瓶,而且成本更低。对 LAMA 多剂量吸入器浪费剂量的估计仍不清楚。方法:这是一项单中心描述性横断面研究,研究时间为 2021 年 1 月 1 日至 2021 年 12 月 31 日。研究对象包括美国南部一家拥有 500 张病床的学术医疗中心收治的 18 岁及以上成人患者,他们在研究期间订购了多剂量噻托溴铵包装或一次性使用的瑞芬那新小瓶。研究结果在 602 名住院患者中,有 705 份 LAMA 订单:其中噻托溴铵 541 份(占 76.7%),利芬那新 164 份(占 23.3%)。495 份噻托溴铵订单(91.5%)浪费了 20% 至 90% 的多剂量包装。与一次性使用的利芬那新小瓶相比,浪费了约 24,000 美元的噻托溴铵剂量。结论与雾化单次使用的瑞芬那新小瓶相比,分配给住院患者的噻托溴铵多剂量吸入剂造成了剂量浪费。在减少住院患者使用多剂量长效吸入剂时的剂量浪费方面存在机会。
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引用次数: 0
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Hospital Pharmacy
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