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Development of a collaborative pharmacy practice agreement to improve efficiency and management of prescribing in a renal transplant clinic 发展合作药房实践协议,以提高效率和管理处方在肾移植诊所
IF 2.4 Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658291
Rachel Chelewski, K. Johnson, A. Zuckerman, Joshua DeClercq, Leena Choi, Megan E. Peter, A. Langone
Abstract Background: Post-transplant patients require complex medication regimens to ensure the survival of the transplanted organ and patient overall well-being. These regimens are frequently adjusted, initiated, or discontinued after transplantation. Pharmacist (PharmD) expertise can be utilized to optimize post-transplant medication use. Aims: This study describes the creation and corresponding outcomes of a Collaborative Pharmacy Practice Agreements (CPPA) between PharmDs and physicians within a renal transplant clinic. Methods: After the Tennessee (TN) Pharmacist Association and TN Medical Association finalized legislation approving CPPAs for licensed PharmDs in TN (effective July 1, 2014), the Vanderbilt Renal Transplant Clinic and integrated health system pharmacy (IHSP) developed a CPPA, which was approved by the Vanderbilt University Medical Center (VUMC) Pharmaceutical, Diagnostics, and Therapeutics Committee and VUMC Medical Board. To evaluate the outcomes of the CPPA, we assessed the type of authorizer for immunosuppressant (IS) prescriptions (nurse, physician, or PharmD; measured as % of IS prescriptions) and the volume of IS prescriptions across three 7-month intervals: 1) before PharmD clinic integration (11/1/14–5/31/15), 2) with PharmD integration without a CPPA (12/1/15–6/30/16), and 3) with PharmD integration and a CPPA (4/1/17–10/31/17). Adult patients with at least one IS prescription generated in each time interval were included. Frequency of safety concerns and staffing requirements resulting from the CPPA were collected. Finally, we assessed the total volume of prescriptions filled by the IHSP. Results: Following PharmD prescription management under a CPPA, physician and nurse refill workload for IS prescriptions reduced from 42.7% and 57.3% to 8.7% and 5.9%, respectively. Overall prescription generation to the IHSP increased from 13,523 prior to PharmD integration to 45,320 after integration with a CPPA. No safety concerns were reported in any of seven quarterly reviews, and the IHSP has grown from a team of eight in 2015 to 23 team members in 2018. Conclusions: After implementing a CPPA, more IS and non-IS prescriptions were generated by pharmacists, which reduced physician and nurse burden and allowed pharmacy staff growth. Pharmacists in collaborative practice agreements are uniquely suited to closely monitor patients’ post-transplant medication regimens, ensuring safety and effectiveness of therapy.
背景:移植后患者需要复杂的药物治疗方案,以确保移植器官的存活和患者的整体健康。这些方案在移植后经常调整、开始或停止。药剂师(PharmD)的专业知识可以用来优化移植后药物的使用。目的:本研究描述了一个肾移植诊所的药学博士和医生之间的合作药学实践协议(CPPA)的创建和相应的结果。方法:在田纳西州(TN)药剂师协会和田纳西州医学协会最终通过立法批准田纳西州注册药房的CPPA(2014年7月1日生效)后,范德比尔特肾移植诊所和综合卫生系统药房(IHSP)制定了CPPA,该CPPA得到了范德比尔特大学医学中心(VUMC)制药、诊断和治疗委员会和VUMC医学委员会的批准。为了评估CPPA的结果,我们评估了免疫抑制剂(IS)处方的授权人类型(护士、医生或药学博士;以IS处方的百分比衡量)和三个7个月间隔的IS处方量:1)PharmD诊所整合之前(11/1/14-5/31/15),2)没有CPPA的PharmD整合(12/1/15-6/30/16),以及3)PharmD整合和CPPA(4/1/17-10/31/17)。在每个时间间隔内至少有一个IS处方的成年患者被纳入研究。收集了因CPPA而引起的安全问题和人员需求的频率。最后,我们评估了IHSP的处方总量。结果:在CPPA的药学处方管理下,医生和护士对IS处方的补药工作量分别从42.7%和57.3%降低到8.7%和5.9%。IHSP的处方总量从整合药学博士之前的13,523张增加到与CPPA整合后的45,320张。在七次季度评估中,没有任何一次报告存在安全问题,IHSP的团队从2015年的8人增加到2018年的23人。结论:实施CPPA后,药师开具了更多的IS和非IS处方,减轻了医师和护士的负担,促进了药学人员的增长。合作实践协议中的药剂师特别适合密切监测患者移植后的药物治疗方案,确保治疗的安全性和有效性。
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引用次数: 0
Understanding purchasing patterns and product access of newly launched specialty generics 了解新推出的专业仿制药的购买模式和产品获取途径
IF 2.4 Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658313
S. Ness, Ron Lucas
Abstract Background: Many specialty drugs have lost patent exclusivity and more specialty generics (SGs) are expected in the future. Payers continue to look for ways to manage health care costs in the specialty pharmacy space and SG products offer the opportunity for savings. Given increasing interest in SGs, manufacturers are expected to invest more than $100 billion in the development of SGs over the next five years. To remain competitive, pharmacies must have access to SG products and access to competitive pricing for SGs, which can be obtained by accessing pharmaceutical manufacturer agreements through MHA Specialty Pharmacy Solutions. Aims: Understand purchase patterns of newly launched SGs and see if increased access to product was facilitated by the entrance of a SG. Methods: To determine purchase patterns of newly launched SGs, the rate of change of both the brand and generic products were measured for five specialty drugs across MHA pharmacy members. When possible, the brand rate was measured by the units of brand product purchased the quarter prior to the generic launch compared to the number of units in first quarter 2019 (1Q19). The generic product rate was measured by the units of generic product in the quarter it launched compared to units in 1Q19. To detect changes in product access to SGs, the number of corporations dispensing the brand was measured in the quarter prior to the generic launch compared with the number of corporations dispensing the generic in 1Q19. Results: Brand imatinib (Gleevec1) number of units decreased 80% while generic imatinib units grew by 134%. The number of corporations dispensing generic imatinib increased 34%. Brand hydroxyprogesterone caproate (OHPC) (Makena2) number of units decreased 67% while generic OHPC units grew by 641%. The number of corporations dispensing generic OHPC increased 38%. Brand abiraterone acetate (Zytiga3) number of units decreased 63% while generic abiraterone units grew by 289%. The number of corporations dispensing generic abiraterone increased 60%. Brand tetrabenazine (Xenazine4) and brand dalfampridine ER (Ampyra5) could not be measured due to limited distribution. Generic tetrabenazine units increased 2967% and the number of corporations dispensing increased 2114%. Generic dalfampridine ER units increased 1451% and the number of corporations dispensing increased 463%. Conclusions: Pharmacies purchasing through MHA Specialty Pharmacy Solutions are able to expand their access to products and quickly adopt SGs in order to grow their businesses and serve patients.
摘要背景:许多特效药已经失去了专利排他性,预计未来会有更多的特效仿制药。付款人继续在专业药房寻找管理医疗保健成本的方法,SG产品提供了节约的机会。鉴于对SG的兴趣日益浓厚,预计制造商在未来五年将投资1000多亿美元开发SG。为了保持竞争力,药店必须能够获得SG产品和SG的有竞争力的定价,这可以通过MHA Specialty Pharmacy Solutions获得药品制造商协议来获得。目的:了解新推出的SG的购买模式,并了解SG的加入是否有助于增加对产品的获取。在可能的情况下,品牌率是通过在仿制药推出前一季度购买的品牌产品单位与2019年第一季度(2019年第1季度)的单位数量进行衡量的。非专利产品率是根据其推出的季度非专利产品的单位与2019年第一季度的单位进行衡量的。为了检测SGs产品访问的变化,与2019年第一季度发放仿制药的公司数量相比,在仿制药推出前的一个季度测量了发放该品牌的公司数量。结果:伊马替尼(格列卫1)品牌单位数量减少了80%,而伊马替尼非专利单位增加了134%。发放非专利伊马替尼的公司数量增加了34%。品牌己酸羟丙酯(OHPC)(Makena2)的单位数量减少了67%,而普通OHPC单位增加了641%。发放非专利OHPC的公司数量增加了38%。醋酸阿比特龙品牌(Zytiga3)的单位数量减少了63%,而普通阿比特龙单位增加了289%。发放非专利阿比特龙的公司数量增加了60%。由于分布有限,无法测量品牌的四苯那嗪(Xenazine4)和品牌的达法普利定ER(Ampyra5)。通用四苯并那嗪装置增加了2967%,配药公司数量增加了2114%。通用达法普啶ER单位增加了1451%,配药公司数量增加了463%。结论:通过MHA Specialty Pharmacy Solutions购买的药房能够扩大其产品的获取范围,并快速采用SG,以发展其业务并为患者服务。
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引用次数: 0
Patterns of on-demand medication use in patients with hereditary angioedema treated long-term with prophylactic subcutaneous C1-inhibitor 预防性皮下C1抑制剂长期治疗遗传性血管性水肿患者的按需用药模式
IF 2.4 Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658323
D. Levy, J. Chiao, J. Dang, C. Hood, D. Supina, H. Feuersenger
Abstract Background: Hereditary angioedema (HAE) is characterized by recurrent, debilitating attacks of angioedema that may require immediate (on-demand) treatment. HAE prophylactic therapy may reduce the need for on-demand treatment by decreasing the frequency and severity of attacks, which may in turn impact treatment costs. Subcutaneous C1-inhibitor (C1-INH [SC], HAEGARDA®, CSL Behring) at the FDA-approved dose of 60 IU/kg is indicated as routine prophylaxis to prevent attacks in patients with HAE. In the pivotal phase III COMPACT trial, the median reduction in attack rate relative to placebo was 95% with twice-weekly C1-INH (SC) 60 IU/kg, and the median reduction in on-demand medication use was >99%. Aims: We examined patterns of on-demand medication use in patients treated with C1-INH (SC) 60 IU/kg in a long-term, open-label extension (OLE) of the COMPACT trial. Methods: The OLE of the COMPACT trial was a multicenter, international, randomized, parallel-arm study that evaluated patients aged ≥6 years with ≥4 attacks over 2 consecutive months before enrollment. The trial included patients from the COMPACT trial and C1-INH (SC)-naïve patients. Patients were randomized to receive C1-INH (SC) 40 IU/kg or 60 IU/kg twice weekly for 52 weeks or up to 140 weeks (US patients only). The time-normalized number of uses of medication for treatment of HAE attacks was an exploratory endpoint. Results: Of the 63 patients in the 60 IU/kg group, 35 had a total of 371 attacks, of which 229 (61.7%) were treated with on-demand medication: 84% (192/229) were treated with 1 medication, 62% with C1-INH (IV), and 38% with icatibant. The majority of treated attacks (113/229) were severe. A total of 28 patients (44.4%) had no attacks, 11 (17.5%) had no treated attacks, and 24 (38.1%) had ≥1 treated attack. Post-hoc analysis of annualized on-demand medication use showed that 39 patients (61.9%) treated with C1-INH (SC) 60 IU/kg did not use any on-demand medication; 66.7% used it less than once per year (mean (SD): 3.8 (9.6) uses/year; median: 0.0 uses/year). Between months 25 and 30, 87% of patients (20/23) did not use any on-demand medication (mean: 0.08/month, or ∼1 use/year). Conclusions: On-demand medication use remained consistently low during prophylactic therapy with C1-INH (SC) in the OLE study, with two-thirds of patients using medication less than once per year. Reduction in on-demand medication use over time should be considered in cost-effectiveness analyses of HAE prophylactic therapies.
摘要背景:遗传性血管性水肿(HAE)的特点是血管性水肿的复发性、衰弱性发作,可能需要立即(按需)治疗。HAE预防性治疗可以通过降低发作的频率和严重程度来减少对按需治疗的需求,这反过来可能会影响治疗成本。经美国食品药品监督管理局批准剂量为60的皮下C1抑制剂(C1-INH[SC]、HAEGARDA®、CSL Behring) IU/kg被认为是预防HAE患者发作的常规预防措施。在关键的III期COMPACT试验中,与安慰剂相比,每周两次C1-INH(SC)60的发病率中位数降低了95% IU/kg,按需用药的中位减少率>99%。目的:我们研究了接受C1-INH(SC)60治疗的患者的按需用药模式 COMPACT试验的长期开放标签扩展(OLE)中的IU/kg。方法:COMPACT试验的OLE是一项多中心、国际、随机、平行臂研究,评估年龄≥6岁的患者 在入组前连续2个月内有≥4次发作的年。该试验包括COMPACT试验的患者和C1-INH(SC)-幼稚患者。患者随机接受C1-INH(SC)40 IU/kg或60 IU/kg,每周两次,每次52 周或最多140 周(仅限美国患者)。HAE发作药物使用的时间标准化次数是一个探索性终点。结果:在60名患者中的63名患者中 IU/kg组,35例共371次发作,其中229例(61.7%)接受按需药物治疗:84%(192/229)接受1种药物治疗,62%接受C1-INH(IV)治疗,38%接受艾替班治疗。大多数接受治疗的发作(113/229)是严重的。共有28名患者(44.4%)没有发作,11名患者(17.5%)没有治疗发作,24名患者(38.1%)有≥1次治疗发作。对年度按需用药的事后分析显示,接受C1-INH(SC)60治疗的39名患者(61.9%) IU/kg未使用任何按需用药;66.7%的人每年使用少于一次(平均(SD):3.8(9.6)次/年;中位数:0.0次/年)。在第25个月至第30个月期间,87%的患者(20/23)没有使用任何按需用药(平均值:0.08/月,或~1次使用/年)。结论:在OLE研究中,C1-INH(SC)预防性治疗期间,随需应变的药物使用率一直很低,三分之二的患者每年用药少于一次。在HAE预防性治疗的成本效益分析中,应考虑随时间减少按需用药。
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引用次数: 0
A targeted approach to reducing rates of discontinuation and dose reduction in patients receiving sorafenib or regorafenib 降低索拉非尼或瑞戈非尼患者停药率和剂量减少的靶向方法
IF 2.4 Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658310
Ryan Nix, Brooke Looney, Carson Lamb, Megan E. Peter, A. Zuckerman
Abstract Background: Sorafenib and regorafenib are oral multikinase inhibitors used to treat some cancers, but adverse events for both drugs are common and often cause patients to discontinue therapy or reduce their dose within several months of initiating therapy. Pharmacists have the potential to prevent discontinuation by closely monitoring and addressing patients’ adverse reactions. Aims: To assess whether a pharmacist-initiated tailored intervention reduced patient discontinuations and dose reductions due to adverse reactions from sorafenib and regorafenib. Methods: We conducted a historically controlled intervention (initiated Aug 2017) to detect and address adverse events in patients prescribed sorafenib and regorafenib. All patients who initiated therapy after August 2017 were in the intervention group (IG); at treatment initiation, IG patients received initial pharmacist counseling and a welcome kit containing educational materials, urea based creams, therapeutic socks and pill container (sorafenib only). During the 90 days after initiating treatment, pharmacists called IG patients six times to conduct assessment questionnaires, designed to detect common adverse reactions at each interval. Pharmacists addressed adverse events by providing additional counseling, referring patients for clinic appointment or requesting ancillary medications. The comparison group (CG) patients initiated therapy between September 2016 and August 2017. CG patients only received pharmacist counseling at treatment initiation. We collected patient demographics and treatment indication, and compared how many patients discontinued or reduced dose in the IG vs the CG. Results: We assessed 33 patients (16 IG vs 17 CG). Most were female (61%) and White (88%); median age 53 years. Common indications were hepatocellular carcinoma (36%), acute myeloid leukemia (30%) and desmoid tumor (21%). In the 90 day follow-up, IG had lower rates of treatment discontinuation (13% vs 29%) and dose reduction due to side effects (13% vs 18%) than CG. Combined events of either discontinuation or dose reduction due to side effects were less frequent in the patients in the IG than the CG (25% vs 65%). Conclusions: Patients treated with sorafenib or regorafenib were less likely to discontinue therapy or reduce doses due to adverse reactions after receiving a pharmacist-led phone intervention. Findings suggest tailored phone assessments are effective in detecting and treating adverse reactions, thus enabling patients to remain on therapy longer and without dose modification.
摘要背景:索拉非尼和瑞戈非尼是用于治疗某些癌症的口服多激酶抑制剂,但这两种药物的不良事件很常见,通常会导致患者在开始治疗后的几个月内停止治疗或减少剂量。药剂师有可能通过密切监测和处理患者的不良反应来防止停药。目的:评估药剂师启动的量身定制的干预措施是否减少了索拉非尼和瑞戈非尼不良反应导致的患者停药和剂量减少。方法:我们进行了一项历史对照干预(始于2017年8月),以检测和解决索拉非尼和瑞戈非尼处方患者的不良事件。2017年8月后开始治疗的所有患者均属于干预组(IG);在治疗开始时,IG患者接受了最初的药剂师咨询和欢迎试剂盒,其中包含教育材料、尿素乳膏、治疗袜和药丸容器(仅索拉非尼)。90年代 在开始治疗几天后,药剂师给IG患者打了六次电话,进行评估问卷,旨在检测每个间隔的常见不良反应。药剂师通过提供额外的咨询、转诊患者预约诊所或要求辅助药物来解决不良事件。对照组(CG)患者于2016年9月至2017年8月开始接受治疗。CG患者仅在治疗开始时接受药剂师咨询。我们收集了患者的人口统计数据和治疗指征,并比较了有多少患者停用或减少了IG和CG的剂量。结果:我们评估了33例患者(16例IG vs 17例CG)。大多数是女性(61%)和白人(88%);中位年龄53 年。常见的适应症为肝细胞癌(36%)、急性髓系白血病(30%)和硬纤维瘤(21%)。在90年代 在第二天的随访中,IG的停药率(13%对29%)和因副作用而减少的剂量(13%对18%)低于CG。IG组患者因副作用而停药或减少剂量的联合事件发生率低于CG组(25%对65%)。结论:接受索拉非尼或瑞戈非尼治疗的患者在接受药剂师主导的电话干预后,不太可能因不良反应而停止治疗或减少剂量。研究结果表明,量身定制的电话评估在检测和治疗不良反应方面是有效的,从而使患者能够在不改变剂量的情况下更长时间地接受治疗。
{"title":"A targeted approach to reducing rates of discontinuation and dose reduction in patients receiving sorafenib or regorafenib","authors":"Ryan Nix, Brooke Looney, Carson Lamb, Megan E. Peter, A. Zuckerman","doi":"10.1080/21556660.2019.1658310","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658310","url":null,"abstract":"Abstract Background: Sorafenib and regorafenib are oral multikinase inhibitors used to treat some cancers, but adverse events for both drugs are common and often cause patients to discontinue therapy or reduce their dose within several months of initiating therapy. Pharmacists have the potential to prevent discontinuation by closely monitoring and addressing patients’ adverse reactions. Aims: To assess whether a pharmacist-initiated tailored intervention reduced patient discontinuations and dose reductions due to adverse reactions from sorafenib and regorafenib. Methods: We conducted a historically controlled intervention (initiated Aug 2017) to detect and address adverse events in patients prescribed sorafenib and regorafenib. All patients who initiated therapy after August 2017 were in the intervention group (IG); at treatment initiation, IG patients received initial pharmacist counseling and a welcome kit containing educational materials, urea based creams, therapeutic socks and pill container (sorafenib only). During the 90 days after initiating treatment, pharmacists called IG patients six times to conduct assessment questionnaires, designed to detect common adverse reactions at each interval. Pharmacists addressed adverse events by providing additional counseling, referring patients for clinic appointment or requesting ancillary medications. The comparison group (CG) patients initiated therapy between September 2016 and August 2017. CG patients only received pharmacist counseling at treatment initiation. We collected patient demographics and treatment indication, and compared how many patients discontinued or reduced dose in the IG vs the CG. Results: We assessed 33 patients (16 IG vs 17 CG). Most were female (61%) and White (88%); median age 53 years. Common indications were hepatocellular carcinoma (36%), acute myeloid leukemia (30%) and desmoid tumor (21%). In the 90 day follow-up, IG had lower rates of treatment discontinuation (13% vs 29%) and dose reduction due to side effects (13% vs 18%) than CG. Combined events of either discontinuation or dose reduction due to side effects were less frequent in the patients in the IG than the CG (25% vs 65%). Conclusions: Patients treated with sorafenib or regorafenib were less likely to discontinue therapy or reduce doses due to adverse reactions after receiving a pharmacist-led phone intervention. Findings suggest tailored phone assessments are effective in detecting and treating adverse reactions, thus enabling patients to remain on therapy longer and without dose modification.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658310","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49098517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of a high-touch, collaborative, patient-centric, hepatitis C specialty clinical program on completion of glecaprevir/pibrentasvir therapy 高接触、协作、以患者为中心的丙型肝炎专科临床项目对完成格列卡韦/皮布伦他韦治疗的影响
IF 2.4 Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658325
Melissa Swoope, C. Bertram, Randi Krouskos, G. Peeler, C. Wood
Abstract Background: Hepatitis C (Hep C) is a liver infection caused by the Hep C virus. It is the most common, chronic, blood-borne infection in the US. It is estimated to affect as many as 3 million Americans and is the leading cause of liver transplants in the US. Hep C is often curable with newer antiviral therapy that is short in duration of treatment and more tolerable than traditional therapies. Aims: To measure the impact of a high-touch, specialty clinical program on driving therapy completion of glecaprevir/pibrentasvir in Hep C patients. Methods: This study was performed from a single center specialty pharmacy (SP). We evaluated patients initiating glecaprevir/pibrentasvir from February to March 2019. The outreach strategy included onboarding new-to-therapy patients by pharmacy technician specialists through the completion of a “Welcome Call”. The technician specialists determined the best time with every patient’s input for the pharmacist to follow up with a “New Start Pharmacist Initial Counseling Call”. A clinical pharmacist completed the Hep C counseling call. Afterward, a nursing refill reminder call was completed. Also, a “Patient Care Coordinator Refill Reminder Call” was coordinated to set up the shipment of the medication. After the patient completed their final refill, a nurse generated an “End of Therapy Call” to determine whether completion of therapy occurred. Results: Of the 46 patients managed by the SP, 44 patients received the cumulative days’ supply required to complete therapy. The SP had a 100% completion rate of therapy for the patients that were eligible to continue therapy. Two patients, due to allergic reactions, were not eligible to complete therapy. As such, this resulted in an overall completion rate of 96%. All patients received an initial counseling call. Thirty of the 46 patients received refill reminder calls from a nurse; 16 patients were not eligible for this call due to the patient reaching out to the pharmacy prior to the refill reminder call for their shipment, refill not applicable or allergies to the medication. Forty-four patients had end-of-therapy calls completed. Conclusions: A collaborative, high-touch SP, managing Hep C patients, drove a high rate of completion of glecaprevir/pibrentasvir Hep C therapy (100% of patients eligible). Specialty pharmacies that demonstrate improved Hep C completion rate outcomes with robust, coordinated care processes can be more confident in building future value-based reimbursement models with payers and pharmaceutical manufacturers.
摘要背景:丙型肝炎是由丙型肝炎病毒引起的肝脏感染。它是美国最常见的慢性血源性感染。据估计,它影响了多达300万美国人,是美国肝移植的主要原因。丙型肝炎通常可以通过较新的抗病毒疗法治愈,这种疗法治疗时间短,比传统疗法更耐受。目的:测量高接触度、专业临床项目对丙型肝炎患者完成格列卡韦/皮布伦他韦治疗的影响。方法:本研究在一家单中心专业药房(SP)进行。我们评估了2019年2月至3月期间开始使用格列卡韦/皮布伦他韦的患者。外联战略包括通过完成“欢迎电话”,由药学技术专家为新的治疗患者提供服务。技术专家根据每位患者的意见确定最佳时间,让药剂师跟进“新起点药剂师初始咨询电话”。一位临床药剂师完成了丙型肝炎咨询电话。之后,完成了护理补充提醒电话。此外,还协调了“患者护理协调员补充提醒电话”,以安排药物的装运。在患者完成最后一次补充后,护士发出“治疗结束电话”,以确定是否完成了治疗。结果:在SP管理的46名患者中,44名患者获得了完成治疗所需的累计天数供应。对于有资格继续治疗的患者,SP的治疗完成率为100%。两名患者由于过敏反应,没有资格完成治疗。因此,这导致了96%的总体完成率。所有患者都接到了初步咨询电话。46名患者中有30人接到了护士打来的补充提醒电话;16名患者不符合此电话的资格,因为患者在重新填充提醒电话之前联系了药房,要求他们发货、重新填充不适用或对药物过敏。44名患者完成了治疗结束电话。结论:一个协作的、高接触的SP,管理丙型肝炎患者,推动了高完成率的格列卡韦/皮布伦他韦丙型肝炎治疗(100%符合条件的患者)。通过稳健、协调的护理流程,证明丙型肝炎完成率提高的专业药房可以更有信心与付款人和制药商建立未来基于价值的报销模式。
{"title":"Impact of a high-touch, collaborative, patient-centric, hepatitis C specialty clinical program on completion of glecaprevir/pibrentasvir therapy","authors":"Melissa Swoope, C. Bertram, Randi Krouskos, G. Peeler, C. Wood","doi":"10.1080/21556660.2019.1658325","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658325","url":null,"abstract":"Abstract Background: Hepatitis C (Hep C) is a liver infection caused by the Hep C virus. It is the most common, chronic, blood-borne infection in the US. It is estimated to affect as many as 3 million Americans and is the leading cause of liver transplants in the US. Hep C is often curable with newer antiviral therapy that is short in duration of treatment and more tolerable than traditional therapies. Aims: To measure the impact of a high-touch, specialty clinical program on driving therapy completion of glecaprevir/pibrentasvir in Hep C patients. Methods: This study was performed from a single center specialty pharmacy (SP). We evaluated patients initiating glecaprevir/pibrentasvir from February to March 2019. The outreach strategy included onboarding new-to-therapy patients by pharmacy technician specialists through the completion of a “Welcome Call”. The technician specialists determined the best time with every patient’s input for the pharmacist to follow up with a “New Start Pharmacist Initial Counseling Call”. A clinical pharmacist completed the Hep C counseling call. Afterward, a nursing refill reminder call was completed. Also, a “Patient Care Coordinator Refill Reminder Call” was coordinated to set up the shipment of the medication. After the patient completed their final refill, a nurse generated an “End of Therapy Call” to determine whether completion of therapy occurred. Results: Of the 46 patients managed by the SP, 44 patients received the cumulative days’ supply required to complete therapy. The SP had a 100% completion rate of therapy for the patients that were eligible to continue therapy. Two patients, due to allergic reactions, were not eligible to complete therapy. As such, this resulted in an overall completion rate of 96%. All patients received an initial counseling call. Thirty of the 46 patients received refill reminder calls from a nurse; 16 patients were not eligible for this call due to the patient reaching out to the pharmacy prior to the refill reminder call for their shipment, refill not applicable or allergies to the medication. Forty-four patients had end-of-therapy calls completed. Conclusions: A collaborative, high-touch SP, managing Hep C patients, drove a high rate of completion of glecaprevir/pibrentasvir Hep C therapy (100% of patients eligible). Specialty pharmacies that demonstrate improved Hep C completion rate outcomes with robust, coordinated care processes can be more confident in building future value-based reimbursement models with payers and pharmaceutical manufacturers.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658325","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47931668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Determining specialty pharmacy FTEs (full-time equivalents) needed in a clinical practice 确定临床实践所需的专业药学专职人员(相当于全职人员)
IF 2.4 Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658295
J. Holton, Joseph Favatella, D. Capozzi, Richard Demers
Abstract Background: The Hospital of the University of Pennsylvania (HUP) created the Penn Specialty Pharmacy Program in 2014 to establish a pharmacy presence in clinics, with a patient focus on specialty medication access and adherence. The program utilizes both pharmacists and technicians to assist the clinics with medication counseling, prior authorizations, and copay assistance. As the program expands to more clinics throughout Penn, there is a growing need to employ more pharmacists and technicians, without a method in place to determine exactly how many FTEs are needed in clinic. Aims: To determine the number of clinical pharmacist and technician FTEs required in a clinical practice for maximum efficacy and patient care. Methods: Calculations were obtained by recording duties handled by the pharmacist (including those for which time does not allow), and determining if the task requires handling by a pharmacist, or if it could be delegated to a tech. This pilot program was first tested in the Dermatology Clinic at HUP, with the intent of launching throughout Penn, if successful. Once assignments were determined as either pharmacist or tech-appropriate, the recommended number of FTEs needed in the practice was calculated based on data obtained during an average 8-h work day: Duration of all tasks (in hours) × 5 days = ___ RPh/Tech Hours, and RPh/Tech Hours/40 = ___ RPh/Tech FTE. Results: The Dermatology pharmacist was observed over the course of 4 h as they completed several tasks, such as sending electronic rxs, patient calls, filling out paperwork for drug manufacturer programs, and responding to patient and provider cost-related concerns. Using the formula, and including roughly 7 h of assistance a pharmacist cannot currently provide (clinic/photopheresis rounds, appeals, etc.), this study was able to determine that the clinic would require ∼1.5 Pharmacist FTE and 0.39 Tech FTE. Conclusions: Many of the duties categorized as tech-specific were clerical or cost-related issues that did not require clinical intervention from a pharmacist. Addition of the 0.39 Tech FTEs would provide the RPh with additional resources to delegate duties to a tech, maximizing focus on patient care. This would also give the clinic an opportunity to include the pharmacist in other areas of the practice. More data may be needed to make a final decision on the needs of the clinic; however, this will be a helpful tool in validating departmental needs in other clinical settings for broad use in FTE determinations.
背景:宾夕法尼亚大学医院(HUP)于2014年创建了宾夕法尼亚大学专科药房项目,在诊所建立药房,让患者关注专科药物的获取和依从性。该计划利用药剂师和技术人员协助诊所进行药物咨询,事先授权和共同支付援助。随着该计划扩展到整个宾夕法尼亚的更多诊所,越来越需要雇用更多的药剂师和技术人员,而没有适当的方法来确定诊所需要多少全职员工。目的:确定临床实践中临床药师和技术员fte的数量,以达到最大的疗效和患者护理。方法:通过记录药剂师处理的任务(包括那些时间不允许的任务),并确定该任务是否需要药剂师处理,或者是否可以委托给技术人员来处理,从而获得计算结果。该试点项目首先在HUP的皮肤科诊所进行了测试,如果成功,打算在整个宾夕法尼亚开展。一旦任务被确定为药剂师或技术合适,根据平均8小时工作日获得的数据计算实践中所需的推荐FTE数量:所有任务的持续时间(小时)× 5天= ___ RPh/技术小时,RPh/技术小时/40 = ___ RPh/技术FTE。结果:在4小时的观察过程中,皮肤科药剂师完成了几项任务,如发送电子病历,患者电话,填写药品制造商计划的文书工作,以及回应患者和供应商与成本相关的问题。使用该公式,并包括药剂师目前无法提供的大约7小时的帮助(诊所/光镜检查,申诉等),本研究能够确定诊所将需要约1.5药剂师FTE和0.39技术FTE。结论:许多被归类为技术特定的职责是文书或与成本相关的问题,不需要药剂师的临床干预。增加0.39名技术全职员工将为注册医院提供额外的资源,将职责委派给技术人员,最大限度地集中精力照顾病人。这也将给诊所一个机会,包括药剂师在其他领域的做法。可能需要更多的数据来对诊所的需求做出最终决定;然而,这将是一个有用的工具,在其他临床环境中验证部门需要,广泛用于FTE测定。
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引用次数: 0
Integrating high touch specialty pharmacy services within a neurology clinic to improve medication access and affordability 在神经病学诊所内整合高质量的专业药房服务,以改善药物获取和负担能力
IF 2.4 Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658302
Brandon Newman, A. Hickman, Kathryn M. Edwards
Abstract Background: The cost of medications has been an upfront topic in the public, with 24% of patients reporting difficulty with affordable access, and specialty medications contribute to those concerns through an increase in price by 57% since 2014. Specialty pharmacy services (SPS) were implemented into a neurology clinic to assist with medication coverage and affordability. Aims: To assess the impact of integrating high touch SPS within a neurology clinic by measuring migraine medication affordability. Methods: The dispensing data for patients (1) filling a Calcitonin Gene-Related Peptide (CGRP) receptor antagonist (CGRPra) and/or onabotulinumtoxin A (Ona A) for migraine through the onsite specialty pharmacy, and (2) being treated through the SPS-affiliated neurology clinic was gathered and analyzed for medication cost coverage and patient financial responsibility. The study endpoints were to observe a minimized patient copay and assess the amount of $0 copays after the initiation of the clinic-based SPS. Results: For the CGRPra group, the SPS were able to reduce the patient responsibility to 2% of the medication cost, and more than 25% of the CGRPra dispenses had a $0 copay. For the Ona A group, comparing January 2018 to January 2019 showed a 185% increase in vials dispensed on pharmacy benefits and a patient responsibility of < 1% medication cost in January 2019 vs 19% in January 2018. The median copay went from $150 in January 2018 to $0 in January 2019. No vials in January 2018 had $0 copays, 20 did in January 2019. Measuring 6 months before SPS were started and 6 months after, the Ona A had similar results as the January comparison, with an increase of 188% dispensed through the pharmacy and the same median copays, $150 vs $0. The number of vials with $0 copay increased from four before SPS to 112 6 months after SPS was integrated. In addition, through the SPS reimbursement audits and benefit verification for Ona A billing, the Ona A reimbursement is projected to increase by $325,000 over 3 years due to switching Medicaid Ona A patients to bill through pharmacy benefits. Conclusions: The implementation of high touch SPS in a clinic can benefit patients through prescription coordination and price mitigation. Through the SPS, patients were responsible for only 2% of the CGRPra cost and < 1% of the Ona A cost. The SPS were able to verify which insurance branch was preferred for Ona A, which helped mitigate patient copays and improved facility financials for Ona A through upfront reimbursement through the preferred method of pharmacy benefits.
摘要背景:药物成本一直是公众关注的一个前沿话题,24%的患者表示难以负担得起,而专业药物自2014年以来价格上涨了57%,加剧了这些担忧。专科药房服务(SPS)被纳入一家神经科诊所,以帮助提高药物覆盖率和可负担性。目的:通过测量偏头痛药物的可负担性,评估在神经病学诊所内整合高接触SPS的影响。方法:收集(1)通过现场专业药房填充降钙素基因相关肽(CGRP)受体拮抗剂(CGRPra)和/或肉毒杆菌毒素a(Ona a)治疗偏头痛的患者和(2)通过SPS附属神经科诊所接受治疗的患者的配药数据,并分析药物费用覆盖率和患者经济责任。研究终点是观察最小化的患者自付垫底费,并评估开始基于临床的SPS后的0美元自付垫垫底费金额。结果:对于CGRPra组,SPS能够将患者的责任降低到药物成本的2%,超过25%的CGRPra配药者的自付额为0美元。对于Ona A组,与2018年1月和2019年1月相比,2019年1月份,药房福利配药的药瓶增加了185%,患者承担的药物费用<1%,而2018年1月份为19%。自付垫底费中位数从2018年1月的150美元上升到2019年1月为0美元。2018年1月,没有一个小瓶有0美元的自付垫底费,2019年1月有20个。测量6 SPS开始前的几个月和6 几个月后,Ona A的结果与1月份的比较相似,通过药房配药的人数增加了188%,自付垫底费中位数相同,分别为150美元和0美元。共付0美元的小瓶数量从SPS前的4个增加到1126个 SPS整合后数月。此外,通过SPS报销审计和对Ona A账单的福利验证,Ona A报销预计将比3年增加325000美元 由于将医疗补助Ona A患者改为通过药房福利计费。结论:在诊所实施高接触SPS可以通过处方协调和价格降低使患者受益。通过SPS,患者仅承担CGRPra费用的2%,而Ona A费用的<1%。SPS能够验证哪家保险分支机构更适合Ona A,这有助于减少患者自付垫底费,并通过首选的药房福利方法提前报销,改善Ona A的设施财务状况。
{"title":"Integrating high touch specialty pharmacy services within a neurology clinic to improve medication access and affordability","authors":"Brandon Newman, A. Hickman, Kathryn M. Edwards","doi":"10.1080/21556660.2019.1658302","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658302","url":null,"abstract":"Abstract Background: The cost of medications has been an upfront topic in the public, with 24% of patients reporting difficulty with affordable access, and specialty medications contribute to those concerns through an increase in price by 57% since 2014. Specialty pharmacy services (SPS) were implemented into a neurology clinic to assist with medication coverage and affordability. Aims: To assess the impact of integrating high touch SPS within a neurology clinic by measuring migraine medication affordability. Methods: The dispensing data for patients (1) filling a Calcitonin Gene-Related Peptide (CGRP) receptor antagonist (CGRPra) and/or onabotulinumtoxin A (Ona A) for migraine through the onsite specialty pharmacy, and (2) being treated through the SPS-affiliated neurology clinic was gathered and analyzed for medication cost coverage and patient financial responsibility. The study endpoints were to observe a minimized patient copay and assess the amount of $0 copays after the initiation of the clinic-based SPS. Results: For the CGRPra group, the SPS were able to reduce the patient responsibility to 2% of the medication cost, and more than 25% of the CGRPra dispenses had a $0 copay. For the Ona A group, comparing January 2018 to January 2019 showed a 185% increase in vials dispensed on pharmacy benefits and a patient responsibility of < 1% medication cost in January 2019 vs 19% in January 2018. The median copay went from $150 in January 2018 to $0 in January 2019. No vials in January 2018 had $0 copays, 20 did in January 2019. Measuring 6 months before SPS were started and 6 months after, the Ona A had similar results as the January comparison, with an increase of 188% dispensed through the pharmacy and the same median copays, $150 vs $0. The number of vials with $0 copay increased from four before SPS to 112 6 months after SPS was integrated. In addition, through the SPS reimbursement audits and benefit verification for Ona A billing, the Ona A reimbursement is projected to increase by $325,000 over 3 years due to switching Medicaid Ona A patients to bill through pharmacy benefits. Conclusions: The implementation of high touch SPS in a clinic can benefit patients through prescription coordination and price mitigation. Through the SPS, patients were responsible for only 2% of the CGRPra cost and < 1% of the Ona A cost. The SPS were able to verify which insurance branch was preferred for Ona A, which helped mitigate patient copays and improved facility financials for Ona A through upfront reimbursement through the preferred method of pharmacy benefits.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658302","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45958277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Variation in health plan specialty drug coverage: an empirical analysis 健康计划中特殊药品覆盖率的变化:一个实证分析
IF 2.4 Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658290
N. Margaretos, Rachel C. Lai, A. Panzer, J. Chambers
Abstract Background: Patients’ access to specialty drugs is determined in part by their health plan. Because health plans develop their own coverage policies, coverage of specialty drugs can vary, which in turn may affect their members’ access to care. Aims: Our objective was to examine variation in how commercial health plans cover specialty drugs. Methods: We used the Specialty Drug Evidence and Coverage (SPEC) Database for this research. SPEC contains 6,139 specialty drug coverage decisions current as of December 2018 issued by 17 of the largest US commercial health plans. SPEC includes 239 drugs and 484 drug-indication pairs (when a drug is approved for multiple indications, each drug-indication pair is represented separately in the database). We compared each plan’s publicly available coverage policies with the drugs’ FDA labels and categorized coverage as follows: (i) broader coverage than the FDA label (the plan provided coverage for populations not included in the FDA label indication), (ii) coverage with no restrictions, (iii) coverage with restrictions (the plan applies restrictions beyond the FDA label to their coverage decision, e.g., step edits or patient subgroup restrictions), (iv) mixed restrictiveness (coverage was more restrictive than the FDA label in one way but broader in another) (v), or not covered. We examined the consistency in coverage of the drug-indication pairs across the included health plans. Results: Overall, 10% of coverage decisions were broader than the FDA label, 43% covered with no restrictions, 40% covered with restrictions, 5% “mixed” restrictiveness, and 3% not covered. We found substantial variation between health plans, with the proportion of the included plans’ coverage decisions including restrictions ranging from 14% to 85%. We also found notable variation in how the included health plans covered the included drug-indication pairs, with only 5% of drug-indication pairs covered the same way by all included plans. Conclusions: Health plans applied restrictions in roughly half of their coverage policies. We found notable inconsistency between plans, with the proportion of restricted coverage decisions varying widely. All plans covered few drug-indication pairs the same way, indicating that a patient’s plan may have a large influence on their access to specialty medications.
摘要背景:患者获得特殊药物的机会在一定程度上取决于他们的健康计划。由于健康计划制定了自己的覆盖政策,特殊药物的覆盖范围可能会有所不同,这反过来可能会影响其成员获得护理的机会。目的:我们的目的是研究商业健康计划如何涵盖特殊药物的差异。方法:我们使用特殊药物证据和覆盖率(SPEC)数据库进行本研究。SPEC包含截至2018年12月由17个美国最大的商业健康计划发布的6139项特殊药物覆盖决定。SPEC包括239种药物和484对药物适应症(当一种药物被批准用于多种适应症时,每个药物适应症对在数据库中单独表示)。我们将每个计划的公开覆盖政策与药物的FDA标签进行了比较,并将覆盖范围分类如下:(i)比FDA标签更广泛的覆盖范围(该计划为未纳入FDA标签适应症的人群提供了覆盖范围),(ii)无限制的覆盖范围,(iii)有限制的覆盖范围(该计划将超出美国食品药品监督管理局标签的限制应用于其覆盖决定,例如,步骤编辑或患者亚组限制),(iv)混合限制性(覆盖范围在一方面比美国食品药品管理局标签更严格,但在另一方面更广泛)(v),或未覆盖。我们检查了纳入的健康计划中药物适应症对覆盖范围的一致性。结果:总体而言,10%的覆盖范围决定比美国食品药品监督管理局的标签更广,43%的覆盖范围没有限制,40%的覆盖范围有限制,5%的“混合”限制,3%没有覆盖。我们发现,健康计划之间存在很大差异,包括限制在内的纳入计划的覆盖决定比例从14%到85%不等。我们还发现,纳入的健康计划覆盖纳入的药物适应症对的方式存在显著差异,只有5%的药物适应证对以相同的方式覆盖所有纳入的计划。结论:健康计划在大约一半的覆盖政策中实施了限制。我们发现计划之间存在明显的不一致性,限制覆盖决定的比例差异很大。所有计划都以相同的方式涵盖了少数药物适应症对,这表明患者的计划可能会对他们获得专业药物产生很大影响。
{"title":"Variation in health plan specialty drug coverage: an empirical analysis","authors":"N. Margaretos, Rachel C. Lai, A. Panzer, J. Chambers","doi":"10.1080/21556660.2019.1658290","DOIUrl":"https://doi.org/10.1080/21556660.2019.1658290","url":null,"abstract":"Abstract Background: Patients’ access to specialty drugs is determined in part by their health plan. Because health plans develop their own coverage policies, coverage of specialty drugs can vary, which in turn may affect their members’ access to care. Aims: Our objective was to examine variation in how commercial health plans cover specialty drugs. Methods: We used the Specialty Drug Evidence and Coverage (SPEC) Database for this research. SPEC contains 6,139 specialty drug coverage decisions current as of December 2018 issued by 17 of the largest US commercial health plans. SPEC includes 239 drugs and 484 drug-indication pairs (when a drug is approved for multiple indications, each drug-indication pair is represented separately in the database). We compared each plan’s publicly available coverage policies with the drugs’ FDA labels and categorized coverage as follows: (i) broader coverage than the FDA label (the plan provided coverage for populations not included in the FDA label indication), (ii) coverage with no restrictions, (iii) coverage with restrictions (the plan applies restrictions beyond the FDA label to their coverage decision, e.g., step edits or patient subgroup restrictions), (iv) mixed restrictiveness (coverage was more restrictive than the FDA label in one way but broader in another) (v), or not covered. We examined the consistency in coverage of the drug-indication pairs across the included health plans. Results: Overall, 10% of coverage decisions were broader than the FDA label, 43% covered with no restrictions, 40% covered with restrictions, 5% “mixed” restrictiveness, and 3% not covered. We found substantial variation between health plans, with the proportion of the included plans’ coverage decisions including restrictions ranging from 14% to 85%. We also found notable variation in how the included health plans covered the included drug-indication pairs, with only 5% of drug-indication pairs covered the same way by all included plans. Conclusions: Health plans applied restrictions in roughly half of their coverage policies. We found notable inconsistency between plans, with the proportion of restricted coverage decisions varying widely. All plans covered few drug-indication pairs the same way, indicating that a patient’s plan may have a large influence on their access to specialty medications.","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2019-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2019.1658290","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42490315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Patiromer and maintenance of RAASi therapy in hyperkalemic medicare patients 高钾血症患者RAASi治疗的临床应用和维持
IF 2.4 Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658287
N. Desai, C. Rowan, Paula J. Alvarez, J. Fogli, R. Toto
Abstract Background: Renin angiotensin aldosterone system inhibitor (RAASi) therapy is part of the cornerstone of therapy for patients (pts) with cardiovascular disease including hypertension, CHF, and/or CAD, but use is often limited by the development of hyperkalemia. Patiromer (PAT) is a sodium (Na)-free non-absorbed potassium (K+) binder approved for hyperkalemia (HK) treatment. Patiromer has been shown to reduce recurrent HK and allow pts to maintain RAASi. Aims: This retrospective cohort study evaluated RAASi utilization among Medicare Advantage pts with HK. Methods: RAASi utilization was evaluated from a large, de-identified national health insurance claims database, Optum Clinformatics Datamart, from Janaury 1, 2016 to December 31, 2017. Three HK cohorts were identified: (1) patiromer (PAT cohort) or (2) sodium polystyrene sulfonate (SPS cohort), or (3) HK diagnosis code without K+-binder prescription (NoKb cohort). Pts were included who had a pre-index serum K+ ≥5.0 mEq/L and were continuously exposed to RAASi for ≥6 months pre-index (i.e. index date is date of first K + binder dispensing or HK diagnosis). Exposure during follow-up was classified as intent to treat (ITT) and continuous exposure (CE). ITT follow-up began on the index date and ended at the first censoring event (i.e. plan disenrollment, death, December 31, 2017) or 6 months post-index while CE also included censoring for discontinuation or switching of binder therapy (i.e. PAT or SPS). RAASi continuation and down-titration (the latter assessed for lisinopril, losartan, and valsartan) were assessed at 6 months post-index. Results: The study population included: 214 PAT pts, 2371 SPS pts, and 8531 NoKb pts. Overall, the mean age was 75 years and 50% were male. Pt comorbidities (all cohorts): CKD (48%), ESRD (1%), CHF (23%), and DM (54%). At 6 months post-index, 102 (ITT)/36 (CE) PAT pts, 1,627 (ITT)/35 (CE) SPS pts, 5,543 (ITT)/5,127 (CE) NoKb pts were evaluated. RAASi continuation rates for CE were 78%, 57%, and 57% and for ITT were 63%, 52%, and 56% in the PAT, SPS, and NoKb cohorts, respectively. Down-titration rates for the CE/ITT groups were 13/9%, 6/7%, and 7/8% in the PAT, SPS, and NoKb cohorts, respectively. Conclusions: At 6 months post-index, among continuously exposed patiromer pts, a high RAASi continuation of ∼80% was observed. RAASi continuation for pts in the SPS and NoKb cohorts was <60%. Down-titration rates of RAASi in all three cohorts were low (∼10%). Further study is warranted to fully elucidate these findings.
背景:肾素血管紧张素醛固酮系统抑制剂(RAASi)治疗是心血管疾病(包括高血压、心力衰竭和/或CAD)患者治疗的基石之一,但其使用往往受到高钾血症的限制。patromer (PAT)是一种无钠(Na)非吸收钾(K+)结合剂,被批准用于治疗高钾血症(HK)。parromer已被证明可减少复发性HK并使患者维持RAASi。目的:本回顾性队列研究评估了RAASi在医疗优势患者中的应用。方法:从2016年1月1日至2017年12月31日的大型、去识别的国家健康保险索赔数据库Optum Clinformatics Datamart中评估RAASi的使用情况。确定了三个HK队列:(1)patiromer (PAT队列)或(2)聚苯乙烯磺酸钠(SPS队列)或(3)无K+结合剂处方的HK诊断代码(NoKb队列)。纳入指数前血清K+≥5.0 mEq/L且指数前连续暴露于RAASi≥6个月的患者(即指数日期为首次K+黏结剂分配日期或HK诊断日期)。随访期间暴露分为意图治疗(ITT)和持续暴露(CE)。ITT随访从索引日期开始,并在第一次审查事件(即计划退出,死亡,2017年12月31日)或索引后6个月结束,而CE还包括审查停止或切换粘合剂治疗(即PAT或SPS)。RAASi的继续和下降(后评估赖诺普利,氯沙坦和缬沙坦)在指数后6个月进行评估。结果:研究人群包括:214名PAT患者,2371名SPS患者和8531名NoKb患者。总体而言,平均年龄为75岁,其中50%为男性。Pt合并症(所有队列):CKD (48%), ESRD (1%), CHF(23%)和DM(54%)。6个月后,评估102 (ITT)/36 (CE) PAT点,1627 (ITT)/35 (CE) SPS点,5543 (ITT)/ 5127 (CE) NoKb点。在PAT、SPS和NoKb组中,CE的RAASi持续率分别为78%、57%和57%,ITT的RAASi持续率分别为63%、52%和56%。在PAT、SPS和NoKb组中,CE/ITT组的降滴定率分别为13/9%、6/7%和7/8%。结论:在指数后6个月,在持续暴露的患者中,观察到高RAASi延续率为80%。在SPS和NoKb队列中,患者的RAASi延续率<60%。在所有三个队列中,RAASi的下降滴定率都很低(约10%)。有必要进一步研究以充分阐明这些发现。
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引用次数: 1
Development of a palivizumab specialty pharmacy management program 开发帕利珠单抗专业药房管理程序
IF 2.4 Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658299
Lana Harlan, Katlyn Benskin, C. Gatzke, A. Majors
Abstract Background: Palivizumab is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in high risk pediatric patients. Due to the high cost, handling requirements, administration route, and importance of adherence, palivizumab is best managed by specialty pharmacies able to provide robust clinical services. In collaboration with the health system and surrounding pediatric clinics, a specialty pharmacy management program was established to serve patients receiving palivizumab. Aims: To develop a relationship with local pediatric clinics to provide specialty pharmacy services for patients receiving palivizumab. Methods: The patient medication liaison (PML) completed a query of the internal electronic medical record based on diagnosis code to target high risk infants and newborns meeting approval criteria for palivizumab. Providers were notified and palivizumab was prescribed if warranted. During RSV season, internal referrals were also received from the transition of care team directly from the neonatal intensive care unit. An intake form was created for outside clinic/institutions referring pediatrics meeting criteria. The form included: patient, insurance, prescriber, clinical, and prescription information. The PML initiated contact with the parent/guardian and proceeded with benefits investigation. The PML coordinated refills, clinic visits, and nurse visits. The clinical pharmacist provided education on dosing, administration, side-effects, warnings/precautions, importance of adherence, goals of therapy, and RSV prevention strategies. The outcomes of the project include: number of approved prior authorizations, number of prescription fills for Mizzou Specialty Pharmacy, and the number of patients enrolled in patient assistance. Results: From October 2016 through April 2019, the specialty pharmacy worked with two local pediatric clinics. Two hundred and thirty-nine patients were referred to the pharmacy for benefits investigation; 172 prior authorizations (PAs) were approved: 34 triaged to an outside specialty pharmacy, 129 managed by Mizzou Specialty Pharmacy, 18 chose not to pursue. Finally, 48 PAs were denied and 19 patients were approved for patient assistance. Conclusions: Mizzou Specialty Pharmacy successfully developed relationships with local pediatric clinics to serve their patients receiving palivizumab.
背景:帕利珠单抗适用于预防高危儿童呼吸道合胞病毒(RSV)所致的严重下呼吸道疾病。由于高成本、处理要求、给药途径和依从性的重要性,帕利珠单抗最好由能够提供强大临床服务的专业药房管理。与卫生系统和周边儿科诊所合作,建立了一个专业药房管理项目,为接受帕利珠单抗的患者提供服务。目的:与当地儿科诊所建立合作关系,为接受帕利珠单抗的患者提供专业药学服务。方法:患者用药联络员(PML)基于诊断代码完成内部电子病历查询,针对符合帕利珠单抗审批标准的高危婴儿和新生儿。通知了供应商,并在必要时开了帕利珠单抗。在呼吸道合胞病毒流行季节,还从新生儿重症监护室直接接收了过渡护理小组的内部转诊。为符合标准的门诊/机构外的儿科推荐创建了一份摄入表。表单包括:患者、保险、处方、临床和处方信息。PML开始与父母/监护人联系,并进行福利调查。PML协调补充、诊所访问和护士访问。临床药师提供了有关剂量、给药、副作用、警告/注意事项、依从性的重要性、治疗目标和RSV预防策略的教育。该项目的结果包括:批准的事先授权数量,Mizzou Specialty Pharmacy的处方填充数量,以及患者援助登记的患者数量。结果:2016年10月至2019年4月,该专业药房与当地两家儿科诊所合作。239例患者转介到药房进行福利调查;172个预先授权(PAs)被批准:34个分类到外部专业药房,129个由Mizzou专业药房管理,18个选择不追求。最后,48例PAs被拒绝,19例患者被批准患者援助。结论:Mizzou Specialty Pharmacy成功地与当地儿科诊所建立了关系,为接受帕利珠单抗的患者提供服务。
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Journal of Drug Assessment
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