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AMCP Guidance for Submission of Clinical and Economic Evaluation Data to Support Formulary Listing in U.S. Health Plans and Pharmacy Benefits Management Organizations 提交临床和经济评估数据以支持美国健康计划和药房福利管理组织的处方清单的AMCP指南
Pub Date : 2015-09-15 DOI: 10.18553/JMCP.2001.7.4.272
S. Sullivan, A. Lyles, B. Luce, Joseph Grigar
This paper reports on the Academy of Managed Care Pharmacy's (AMCP's) suggested process for pharmaceutical manufacturers to submit a uniform, evidence-based dossier for each product submitted for formulary approval. The process requires that manufacturers provide clinical and economic evidence and an economic model that projects the potential economic consequences and impact of product coverage on health outcomes. This formulary-submission process is designed to achieve two main goals: (1) improve the timeliness, scope, quality, and relevance of information provided to pharmacy and therapeutics (PT and (2) streamline the process of acquiring data and reviewing products for health plan staff pharmacists. In time, it is hoped; this process will lead to progressive improvements in the quality of formulary submissions and provide P&T committees with evidence that previously was often unavailable.
本文报告了管理式医疗药房学会(AMCP)建议的流程,即制药商为提交处方批准的每种产品提交统一的、基于证据的档案。这一过程要求制造商提供临床和经济证据以及预测产品覆盖范围对健康结果的潜在经济后果和影响的经济模型。该处方提交流程旨在实现两个主要目标:(1)提高提供给药房和治疗学(PT)的信息的及时性、范围、质量和相关性;(2)简化健康计划工作人员药剂师获取数据和审查产品的过程。假以时日,这是有希望的;这一进程将导致提交的配方的质量逐步提高,并向药检委员会提供以前常常得不到的证据。
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引用次数: 9
Managing Natural Products 管理天然产品
Pub Date : 2015-09-15 DOI: 10.18553/JMCP.2001.7.5.414
M. Ferrill
Over the past ten years, natural products have become quite popular in the United States; about 60% of Americans use natural products daily. Herbs and other botanicals, vitamins, minerals, amino acids, and other natural products are sold as dietary supplements in the United States rather than as over-the-counter (OTC) or prescription products. Because they are sold and marketed as dietary supplements, they are not held to the same level of rigorous preapproval testing for safety and efficacy as pharmaceutical products. Although many of these products can be beneficial and there are few reported problems, the potential for serious health problems does exist. These potential problems can be due to allergic reactions, interactions between natural products, interactions between natural products and OTC or prescription medications, interactions between natural products and disease states, or even poor quality or contamination of the product. Because the potential for serious problems is real, as recently addressed by the Department of Health and Human Services, Office of the Inspector General, issues and information on managing natural products in a managed care environment are presented here. The goal of this continuing education program is to present information, options, and resources to help pharmacists in managed care settings manage the use of natural products in their patient populations.
在过去的十年里,天然产品在美国变得相当流行;大约60%的美国人每天使用天然产品。在美国,草药和其他植物、维生素、矿物质、氨基酸和其他天然产品作为膳食补充剂出售,而不是作为非处方(OTC)或处方产品出售。因为它们是作为膳食补充剂销售和营销的,所以它们没有像药品那样经过严格的安全性和有效性预先批准测试。虽然这些产品中有许多是有益的,而且几乎没有报道的问题,但严重的健康问题确实存在。这些潜在的问题可能是由于过敏反应、天然产物之间的相互作用、天然产物与非处方药或处方药之间的相互作用、天然产物与疾病状态之间的相互作用,甚至是产品的质量差或污染。正如卫生与公众服务部监察长办公室最近所指出的那样,严重问题的潜在可能性是真实存在的,因此,在这里提出了在管理式护理环境中管理天然产品的问题和信息。这个继续教育计划的目标是提供信息,选项和资源,以帮助管理护理设置的药剂师在他们的病人群体中管理天然产品的使用。
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引用次数: 0
Professional Opportunities in Managed Care 管理式医疗的职业机会
Pub Date : 2015-09-15 DOI: 10.18553/JMCP.1995.1.2.80
M. Gore
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引用次数: 0
Looking Back, Glancing Ahead: State and Federal Legislative Fronts 回顾过去,展望未来:州和联邦立法战线
Pub Date : 2015-09-15 DOI: 10.18553/JMCP.1997.3.2.125
E. Zablocki
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引用次数: 0
Pharmaceutical Privatization and Reform Program in Kazakhstan 哈萨克斯坦药品私有化和改革方案
Pub Date : 2015-09-15 DOI: 10.18553/JMCP.1997.3.4.415
Larry Barenbaum
dened a rather poor government in its attempt to resurrect some sort of systematic structure from the previous dominance of Soviet health care. AMCP board member Larry Barenbaum was hired by. BHM Consulting to review the technical assistance provided by an American agency aiding the Kazakhstan Ministry of Health in its monumental move toward privatization. At the 1993 Vancouver Summit by President Bill Clinton and Russian President Boris Yeltsin, the u.s. agreed to send professional and
在试图从之前苏联医疗保健的主导地位中恢复某种系统结构的过程中,一个相当糟糕的政府被击败了。AMCP董事会成员拉里·巴伦鲍姆受雇于。BHM咨询公司审查一家美国机构为哈萨克斯坦卫生部私有化大业提供的技术援助。在1993年比尔·克林顿总统和俄罗斯总统鲍里斯·叶利钦举行的温哥华峰会上,美国同意派遣专业人员和专家
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引用次数: 0
Examining the Managed Health Care Continuum 检查管理医疗保健连续体
Pub Date : 2015-09-15 DOI: 10.18553/JMCP.1997.3.5.511
M. Indritz
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引用次数: 0
Pharmacoeconomics of NSAIDs: Beyond Bleeds 非甾体抗炎药的药物经济学:超越出血
Pub Date : 2015-09-15 DOI: 10.18553/jmcp.1997.3.4.425
C. Mullins
OBJECTIVE: To determine the marginal effect of including a minor, yet common, gastrointestinal (GI) side effect in a cost effectiveness analysis of NSAID therapy. DESIGN: Base economic model of cost effectiveness analysis (CEA) developed using data from a randomized controlled trial of two formulations of an NSAID therapy (conventional versus extended release etodolac) for the treatment of osteoarthritis (OA) of the knee. SETTING: Outpatient. PARTICIPANTS: 225 patients with osteoarthritis of the knee. INTERVENTIONS: Patients were randomized to receive either conventional or extended release etodolac with primary endpoints evaluated at four weeks. Cost effectiveness was calculated from a managed care perspective as dollars spent per OA patient treated, focusing on the marginal dollar value of reduced side effects. Costs included in the analysis were initial ($64 or $71) and subsequent ($64) prescriptions for NSAID therapy, pharmacological treatment of side effects ($79) and physician office visits ($50). M...
目的:确定在非甾体抗炎药治疗的成本-效果分析中纳入轻微但常见的胃肠道(GI)副作用的边际效应。设计:采用随机对照试验的数据,对两种非甾体抗炎药(常规与缓释依托度酸)治疗膝关节骨关节炎(OA)的处方进行成本-效果分析(CEA)的基础经济模型。设置:门诊。参与者:225例膝关节骨关节炎患者。干预措施:患者随机接受常规或缓释依托度酸,主要终点在四周评估。成本效益是从管理护理的角度计算的,即每个OA患者治疗花费的美元,重点关注减少副作用的边际美元价值。分析中包含的费用包括初始(64美元或71美元)和后续(64美元)非甾体抗炎药治疗处方、药物治疗副作用(79美元)和医生就诊(50美元)。米……
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引用次数: 0
The Changing Face of Managed Care Pharmacy and the Role of PBMs 管理式护理药房的变化面貌和药品福利管理机构的作用
Pub Date : 2015-09-15 DOI: 10.18553/jmcp.1997.3.5.494
L. Epstein
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引用次数: 0
Use of Glycosylated Hemoglobin Testing Among Patients with Diabetes Mellitus 糖化血红蛋白检测在糖尿病患者中的应用
Pub Date : 2015-09-15 DOI: 10.18553/JMCP.1997.3.6.691
B. Else
OBJECTIVE: To estimate the likelihood of the use of glycosylated hemoglobin testing (HbA1c) among a cohort of patients with diabetes mellitus in a managed care setting. DESIGN: A retrospective, cross-sectional analysis of managed care claims data obtained from the private business claims (PSC) files of the Hawaii Medical Service Association for the calendar year 1995. A probit model was used to estimate the probability of the dependent variable (HbA1c). Independent variables specified in the model included age, gender, presence of common comorbidities, use of insulin and oral anti-diabetic agents, and type of insurance plan. The probit model was run for an n of 6,841 patients. SETTING: Health insurer in the state of Hawaii. Includes managed care and indemnity products. PATIENTS: 6,841 patients under 65 years old were identified by paid claims with ICD-9-CM codes of 250.xx. PARTICIPANTS: Not applicable. INTERVENTION: Not applicable. MAIN OUTCOME MEASURES: Use of HbA1c testing. RESULTS: Age and gender are n...
目的:评估在管理医疗机构中糖尿病患者队列中使用糖化血红蛋白检测(HbA1c)的可能性。设计:对从夏威夷医疗服务协会1995年私人商业索赔(PSC)档案中获得的管理式医疗索赔数据进行回顾性、横断面分析。probit模型用于估计因变量(HbA1c)的概率。模型中指定的独立变量包括年龄、性别、常见合并症的存在、胰岛素和口服抗糖尿病药物的使用以及保险计划的类型。概率模型以6,841例患者为例进行运行。单位:夏威夷州医疗保险公司。包括管理护理和赔偿产品。患者:6841例65岁以下患者通过支付理赔确认,ICD-9-CM代码为250.xx。参与者:不适用。干预:不适用。主要观察指标:HbA1c检测的使用。结果:年龄、性别差异无统计学意义。
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引用次数: 1
Evaluating the Operational Performance and Financial Effects of a Drug Prior Authorization Program 评估药品预先批准程序的运营绩效和财务影响
Pub Date : 2015-09-15 DOI: 10.18553/JMCP.1997.3.6.699
Charles R. Phillips
OBJECTIVE: To present a managerial approach for evaluating the performance of a drug prior authorization (PA) program, illustrated through an evaluation of the Iowa Medicaid drug PA program. DESIGN: A before-and-after comparison without a control group. SETTING: State of Iowa Medicaid Program. PATIENTS: Iowa Medicaid enrollees (approximately 250,000). INTERVENTION: Medicaid Drug Prior Authorization (PA) Program. MAIN OUTCOME MEASURES: Operational and economic performance, including volume of prior authorization requests, PA program response times, PA approval rates by therapeutic category, medication utilization, and PA program savings and administrative costs. RESULTS: Overall, 82.9% of new and extension PA requests were approved for coverage. Of the new PA requests, 74.4% were approved for coverage, while 92.5% of PA extensions were approved. The average response time for new requests and extensions was 52.4 (s.d.=1 01.8) minutes. New PA responses averaged 73.2 (s.d.=119.6) minutes, while extensions ave...
目的:提出一种评估药物事先授权(PA)计划绩效的管理方法,通过对爱荷华州医疗补助药物PA计划的评估来说明。设计:前后比较,不设对照组。地点:爱荷华州医疗补助计划。患者:爱荷华州医疗补助计划参保者(约25万人)。干预:医疗补助药物预先授权(PA)计划。主要结果测量:操作和经济绩效,包括事先授权请求的数量、PA项目响应时间、按治疗类别划分的PA批准率、药物利用率、PA项目节约和管理成本。结果:总体而言,82.9%的新的和延长的PA请求被批准覆盖。在新的保险申请中,74.4%的保险申请获得批准,而92.5%的保险延期申请获得批准。新请求和扩展的平均响应时间为52.4分钟(sd = 101.8分钟)。新的PA响应平均为73.2分钟(s.d =119.6),而延长的PA响应平均为…
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引用次数: 5
期刊
Journal of Managed Care Pharmacy
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