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An ADR surveillance program: increasing quality, number of incidence reports. 不良反应监测规划:提高发生率报告的质量和数量。
Pub Date : 1995-08-01
M J Orsini, P A Orsini, D B Thorn, J N Gallina

An Adverse Drug Reaction Surveillance Program (ADRSP) was implemented by the pharmacy department of the University of Maryland Medical System to address the institution's underreporting of adverse drug reactions. The program aims were to increase the number and quality of significant adverse drug reaction (ADR) reports by facilitating and standardizing the reporting process, to more actively involve the pharmacy staff, and to create a comprehensive database, thus enabling the intervention of future untoward events. During the program's first 2 years, the number of ADR reports more than doubled, primarily due to increased pharmacists' participation. The ADRSP has facilitated the reporting process, enhanced the submission of ADR reports to the FDA, and helped prevent ADRs.

马里兰大学医学系统药学系实施了一项药物不良反应监测计划(ADRSP),以解决该机构对药物不良反应的少报问题。该项目的目的是通过促进和规范报告流程,提高重大药物不良反应(ADR)报告的数量和质量,使药学人员更积极地参与其中,并建立一个全面的数据库,从而能够对未来的不良事件进行干预。在项目的头两年,药品不良反应报告的数量增加了一倍多,这主要是由于药剂师参与的增加。ADRSP促进了报告过程,加强了向FDA提交ADR报告的工作,并帮助预防ADR。
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引用次数: 0
Increased adverse drug reaction reporting through wall-mounted ADR reporting cards. 通过壁挂式ADR报告卡增加药物不良反应报告。
Pub Date : 1995-08-01
B A Szymusiak-Mutnick, M B Ross

To increase adverse drug reaction reporting, the Pharmacy Department Quality Assessment and Improvement Committee at the University of Iowa Hospitals and Clinics created an abbreviated wall-mounted adverse drug reaction card on "tear-off" pads. This report discusses strategies the Committee identified in order to attain its goal.

为了增加药物不良反应报告,爱荷华大学医院和诊所的药学部门质量评估和改进委员会在“可撕下”的便笺上创建了一个简短的壁挂式药物不良反应卡。本报告讨论了委员会为实现其目标而确定的战略。
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引用次数: 0
Will politics sidetrack FDA reform? 政治会影响FDA的改革吗?
Pub Date : 1995-08-01
B Gatty
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引用次数: 0
Results of our national survey. Current formulary decision-making strategies and new factors influencing the process. 这是我们全国调查的结果。现行的公式决策策略和影响过程的新因素。
Pub Date : 1995-08-01

Formulary recently conducted a survey of 2,000 of its readers to uncover what forces are at play in their formulary decision-making processes. Topics included general philosophies toward formulary decision making, philosophies toward adding and deleting products, influences on the process, trends related to product reviews, formulary management strategies, drug information educational strategies, and new approaches to the formulary decision-making process. Some 295 surveys (14.75%) were returned. Highlights and analyses of the survey findings are presented for your review and comparison with your practice setting's approaches.

Formulary最近对2000名读者进行了一项调查,以揭示哪些力量在他们的配方决策过程中起作用。主题包括处方决策的一般理念,增加和删除产品的理念,对过程的影响,与产品评论相关的趋势,处方管理策略,药物信息教育策略,以及处方决策过程的新方法。共回收问卷295份(14.75%)。调查结果的重点和分析呈现给你回顾,并与你的实践设置的方法进行比较。
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引用次数: 0
FDA says 'Look at the facts' when judging its record on drug approvals. 美国食品药品监督管理局(FDA)说,在评判其药物批准记录时,要“看事实”。
Pub Date : 1995-07-01
B Gatty
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引用次数: 0
Use of decision analysis to evaluate the costs and benefits of filgrastim (G-CSF) therapy. 使用决策分析评估非格昔汀(G-CSF)治疗的成本和收益。
Pub Date : 1995-07-01
J A Peroutka, A H Mutnick

The FDA's approval of filgrastim (granulocyte colony-stimulating factor [G-CSF]) for accelerated recovery of neutrophil counts following chemotherapy has prompted discussions regarding the cost and benefits associated with such expensive new therapies. One method to evaluate the cost effectiveness of a therapy is decision analysis, which provides a quantitative method of cost analysis. Using the principles of decision analysis, we created a decision-analysis tree for evaluating the cost effectiveness of G-CSF therapy. Based on data gathered from a retrospective review of ambulatory oncology patients, we found that routine administration of G-CSF to all outpatients receiving chemotherapy is not cost effective, although it would be justifiable for some patients.

FDA批准非格昔汀(粒细胞集落刺激因子[G-CSF])用于加速化疗后中性粒细胞计数的恢复,引发了关于这种昂贵的新疗法的成本和收益的讨论。评估治疗成本效益的一种方法是决策分析,它提供了成本分析的定量方法。利用决策分析的原则,我们创建了一个决策分析树来评估G-CSF治疗的成本效益。基于对门诊肿瘤患者的回顾性分析,我们发现对所有接受化疗的门诊患者常规给予G-CSF并不具有成本效益,尽管对某些患者来说是合理的。
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引用次数: 0
Pegaspargase versus asparaginase in adult ALL: a pharmacoeconomic assessment. Pegaspargase与天冬酰胺酶在成人ALL中的作用:药物经济学评估。
Pub Date : 1995-07-01
B G Peters, B J Goeckner, J J Ponzillo, W S Velasquez, A L Wilson

Asparaginase is an effective treatment for patients with acute lymphocytic leukemia (ALL). Unfortunately, asparaginase therapy is associated with a high incidence of hypersensitivity reactions (up to 73%), including life-threatening anaphylaxis, and its half-life of approximately 20 hours necessitates daily administration. Pegaspargase, a modification of L-asparaginase, has a longer half-life (357 hours), a decreased incidence of hypersensitivity reactions, and when doses every 14 days, provides comparable efficacy to asparaginase; however, it is much more expensive per single-dose vial ($980.00 vs $52.38). To determine the pharmacoeconomic impact of the two agents, we conducted a cost-minimization analysis for three common adult ALL protocols. Results showed that pegaspargase was significantly less costly to payers on an inpatient or outpatient basis and warranted addition to our formulary.

天冬酰胺酶是治疗急性淋巴细胞白血病(ALL)的有效药物。不幸的是,天冬酰胺酶治疗与高过敏反应发生率(高达73%)相关,包括危及生命的过敏反应,其半衰期约为20小时,需要每天给药。Pegaspargase是l -天冬酰胺酶的一种修饰物,其半衰期较长(357小时),超敏反应发生率较低,每14天服用一次,其疗效与天冬酰胺酶相当;然而,单剂量瓶要贵得多(980美元vs 52.38美元)。为了确定这两种药物的药物经济学影响,我们对三种常见的成人ALL方案进行了成本最小化分析。结果表明,pegaspargase在住院或门诊基础上对支付者的费用明显较低,并且有必要添加到我们的处方中。
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引用次数: 0
Dosing guidelines for foscarnet and trimetrexate. 氟膦酸酯和三甲氨蝶呤的剂量指南。
Pub Date : 1995-06-01
J M Wooten, K Chase, M C O'Connor, R B Henry

The P & T Committee at Trinity Lutheran Hospital, a 320-bed, community/teaching hospital in Kansas City, MO, has developed dosing and monitoring guidelines for foscarnet sodium (Foscavir) and trimetrexate glucuronate (Neutrexin)--two drugs used to treat patients with opportunistic infections associated with the human immunodeficiency virus (HIV). Presented in this Experience Brief is a short discussion of these drugs, the rationale for guideline development, and the actual dosing and monitoring protocols devised.

位于密苏里州堪萨斯城的三一路德医院(Trinity Lutheran Hospital)是一家拥有320个床位的社区/教学医院,该医院的医药委员会已经制定了Foscavir钠(Foscavir)和trimetrexate glucuronate (Neutrexin)的剂量和监测指南,这两种药物用于治疗与人类免疫缺陷病毒(HIV)相关的机会性感染患者。本文简要介绍了这些药物、指南制定的基本原理以及实际给药和制定的监测方案。
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引用次数: 0
Criteria-based antimicrobial i.v. to oral conversion program. 以标准为基础的抗菌素静脉注射到口服转化方案。
Pub Date : 1995-06-01
A U Okpara, J J Maswoswe, K Stewart

Collaborative efforts among several departments and the P & T Committee resulted in an IV to oral conversion program for select antimicrobials in our 580-bed county teaching hospital. This criteria-based program was designed to monitor and educate physicians on the appropriateness of parenteral antimicrobial prescribing, ensure rapid transition from IV to oral therapy, and contain costs. In the first 2 months of the program, 78 patients were converted from IV to oral administration with an estimated savings of $12,935. Of the ordering physicians, 66 (84.6%) accepted the interventions. All patients who switched administration routes were successfully treated with an oral agent. This program also has had a positive effect on patient outcomes and physician prescribing habits.

在几个部门和药检委员会的共同努力下,在我们拥有580张床位的县教学医院,选定了一种抗微生物药物的静脉注射到口服转换方案。这一基于标准的规划旨在监测和教育医生肠外抗菌药物处方的适当性,确保从静脉注射到口服治疗的快速过渡,并控制成本。在项目的前两个月,78名患者从静脉注射转为口服给药,估计节省了12,935美元。在订购医生中,66名(84.6%)接受了干预。所有改变给药途径的患者都成功地接受了口服药物治疗。这个项目也对病人的治疗结果和医生的处方习惯产生了积极的影响。
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引用次数: 0
Designing a disease management program: how to get started. 设计疾病管理程序:如何开始。
Pub Date : 1995-06-01
E R Gonzalez, V S Crane

To successfully design and implement disease management programs, clinicians must understand the disease's natural course and cost drivers, base the diagnosis and treatment on the disease process and not the reimbursement schedules, educate and reinforce compliance to improve treatment outcomes, and focus on commonly occurring and costly chronic diseases. This article describes a 7-step process for developing a disease management program based on those concepts. The changing role and functions of the P & T Committee in disease management programs are also presented.

为了成功地设计和实施疾病管理项目,临床医生必须了解疾病的自然过程和成本驱动因素,根据疾病过程而不是报销计划进行诊断和治疗,教育和加强依从性以改善治疗结果,并关注常见病和昂贵的慢性病。本文描述了基于这些概念制定疾病管理计划的7个步骤。在疾病管理计划的变化的角色和功能的P & T委员会也提出。
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引用次数: 0
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