Journal of Drug Assessment最新文献_第9页

Measuring the impact of integrating post-graduate year two ambulatory care pharmacy residents into specialty clinics 测量将研究生二年级门诊药房居民纳入专科诊所的影响

IF 2.4

Journal of Drug Assessment

Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658311

C. Spencer, M. Woosley, Amanda Brenske, Emily O’Reilly

Abstract Background: It is well established that integration of a pharmacist into specialty clinics increases access to medication, improves patient adherence and decreases financial burden on patients. As specialty clinics and the prescribing of specialty medications continues to exponentially grow, it is critical for pharmacy residents to be provided learning opportunities within these settings to maximize pharmacy services as well as to educate future pharmacists in this field. The University of Louisville Hospital is an academic medical center that currently trains two post-graduate year two (PGY-2) ambulatory care pharmacy residents annually. Aims: To measure the impact of utilizing PGY-2 ambulatory care pharmacy residents on increasing coverage and provider satisfaction in specialty clinics. Additionally, to evaluate the ability of the learning experience in meeting the residents’ educational objectives. Methods: PGY-2 residents were trained to provide ambulatory care pharmacy services in the Hepatitis C and Multiple Sclerosis (MS) Clinics. They then provided those services with peripheral support from a preceptor over a 6 month period. Outcomes collected to determine the impact of PGY-2 residents included hours of clinic coverage provided, number of patients served, number of patients that discontinued treatment and provider satisfaction with pharmacy services. To demonstrate the meaningfulness of this learning experience, the educational objectives met as defined by the American Society of Health System Pharmacists (ASHP) residency standards will be reported. Results: Over 6 months, pharmacist coverage was expanded by 104 hours in the Hepatitis C Clinic and 84 hours in the MS Clinic through utilization of PGY-2 residents. The total number of patients served during those hours was 114 in Hepatitis C and 102 in MS. During this 6 month period, only three patients discontinued hepatitis C treatment before completing therapy and two patients discontinued therapy in the MS clinic due to medication related issues. Of the providers surveyed, 100% were satisfied with the pharmacy services provided and agreed that the pharmacist took prompt action to resolve their needs and/or concerns. ASHP educational objectives met through this learning experience include R1.1.3, R1.1.4, R1.1.6, R1.1.7, R2.1.2, R3.3.1 and R3.3.2. Conclusions: These results and observations show that patients, providers and PGY-2 ambulatory care residents all benefit from integration of PGY-2 residents into the specialty clinic setting.

摘要背景：众所周知，将药剂师纳入专科诊所可以增加获得药物的机会，提高患者的依从性，并减轻患者的经济负担。随着专科诊所和专科药物的处方持续呈指数级增长，在这些环境中为药房居民提供学习机会，以最大限度地提供药房服务，并在该领域教育未来的药剂师，这一点至关重要。路易斯维尔大学医院是一个学术医疗中心，目前每年培训两名研究生二年级（PGY-2）门诊药房住院医师。目的：测量使用PGY-2门诊药房居民对提高专科诊所覆盖率和提供者满意度的影响。此外，评估学习体验在满足居民教育目标方面的能力。方法：对PGY-2住院医师在丙型肝炎和多发性硬化症（MS）诊所提供门诊药房服务进行培训。然后，他们在6岁以上的导师的外围支持下提供这些服务月份期间。为确定PGY-2居民的影响而收集的结果包括提供的诊所覆盖时间、服务的患者数量、停止治疗的患者数量以及提供者对药房服务的满意度。为了证明这种学习经历的意义，将报告美国卫生系统药剂师协会（ASHP）居住标准所定义的教育目标。结果：超过6 几个月后，药剂师的覆盖范围扩大了104 在丙型肝炎诊所的小时数和84 通过利用PGY-2居民在MS诊所的时间。在这几个小时内，丙型肝炎患者总数为114人，多发性硬化症患者总数为102人在一个月的时间里，只有三名患者在完成治疗前停止了丙型肝炎治疗，两名患者因药物相关问题在MS诊所停止了治疗。在接受调查的提供者中，100%的人对所提供的药房服务感到满意，并同意药剂师迅速采取行动解决他们的需求和/或担忧。通过此次学习经历达到的ASHP教育目标包括R1.1.3、R1.1.4、R1.1.6、R1.1.7、R2.1.2、R3.3.1和R3.3.2。结论：这些结果和观察结果表明，患者、提供者和PGY-2门诊护理住院医师都受益于PGY-2住院医师融入专科诊所环境。

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引用次数: 0

Appropriate prescribing of antiemetics with oral oncolytic therapy: a single center experience 合适的止吐药处方与口服溶瘤治疗：单中心经验

IF 2.4

Journal of Drug Assessment

Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658289

C. Suen, M. Hughes, C. Timlin, Christine Cambareri, Richard Kriska, Gregory Strong, Joseph Favatella, Richard Demers, D. Capozzi

Abstract Background: Chemotherapy-induced nausea and vomiting (CINV) is a common and significant side-effect of chemotherapy that can impact a patient’s quality-of-life (QoL). As oral oncolytic therapies (OOT) become a common treatment option, they pose unique challenges for providers and patients. Unlike infusion therapies, a single-day administration, OOT may require daily dosing during a treatment cycle and, therefore, require patients to be proactive in terms of supportive care monitoring and prevention. The American Society of Clinical Oncology provides recommendations for appropriate emetic prophylaxis, however, due to limited data for OOT, only offer recommendations for single-day IV chemotherapy. Aims: The objective of this quality improvement study was to review the appropriate prescribing of antiemetics with OOT, in the specialty and ambulatory setting, and evaluate the opportunity to enhance medication safety and improve vigilance of concurrent prescribing with pharmacist involvement. Methods: All patients ordered for OOT between January and December 2018 to the Hospital of the University of Pennsylvania specialty pharmacy were reviewed for concurrent antiemetic prescriptions. Patients were excluded if prescriptions were sent to a satellite or outside institution pharmacy. Patients who were identified to have a discordant antiemetic:OOT prescribing ratio were evaluated for adverse events such as CINC-related office visits or hospitalization; as documented in the electronic medical record. Results: A total of 1,630 OOT prescriptions were written for 354 patients. Two hundred and sixty-eight patients were excluded for the following reasons; 117 (33.0%) were prescribed to a satellite or outside pharmacy and 151 (42%) had concordant antiemetics. Eighty-six patients were included based on initial discordance given that OOT and antiemetics were not ordered within the same office visit. Upon further evaluation, 60 were found to have active antiemetics ordered as part of a previous line of therapy and, therefore, had an adequate supply. Of the n = 26 without antiemetics, n = 4 were deemed to not require antiemetics, while n = 22 were confirmed to lack prescriptions. There were no reports of CINV that required urgent care or hospitalizations. Conclusions: OOT is becoming increasingly common, with unique risks such as CINV. The authors plan to increase the pharmacist involvement with the prescribing and counseling of new OOT to promote improved supportive care measures, communication between patients and providers, and potential avoidance of patient harm and improved QoL.

摘要背景：化疗引起的恶心呕吐（CINV）是化疗的一种常见且显著的副作用，可影响患者的生活质量。随着口服溶瘤疗法（OOT）成为一种常见的治疗选择，它们给提供者和患者带来了独特的挑战。与输液疗法不同，OOT可能需要在治疗周期内每天给药，因此需要患者在支持性护理监测和预防方面积极主动。美国临床肿瘤学会提供了适当的催吐预防建议，但由于OOT的数据有限，仅提供了单日IV化疗的建议。目的：本质量改进研究的目的是审查在专科和门诊环境中使用OOT止吐药的适当处方，并评估在药剂师参与的情况下提高药物安全性和提高对同时开处方的警惕性的机会。方法：对2018年1月至12月期间在宾夕法尼亚大学专科药房医院订购的所有OOT患者同时开具的止吐处方进行审查。如果处方被发送到附属机构或机构外药房，患者将被排除在外。对被确定具有不一致的止吐：OOT处方比率的患者进行不良事件评估，如CINC相关的办公室就诊或住院治疗；如电子医疗记录中所记录的。结果：共为354名患者开出1630张OOT处方。一百六十八名患者因以下原因被排除在外；117例（33.0%）是在卫星或外部药房开具的，151例（42%）有一致的止吐药。考虑到OOT和止吐药不是在同一次就诊中订购的，基于最初的不一致性，纳入了86名患者。经过进一步评估，发现有60人订购了作为前一系列治疗的一部分的活性止吐药，因此供应充足。在n = 26例无止吐药，n = 4人被认为不需要止吐药，而n = 22人被证实缺乏处方。没有需要紧急护理或住院治疗的CINV报告。结论：OOT正变得越来越普遍，具有独特的风险，如CINV。作者计划增加药剂师对新OOT处方和咨询的参与，以促进改善支持性护理措施、患者和提供者之间的沟通，以及潜在的避免患者伤害和改善生活质量。

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引用次数: 0

Implementation of an internal check of oral oncolytics: a single-center, specialty pharmacy safety initiative 口腔溶瘤药物内部检查的实施：一个单一的中心，专业药房安全倡议

IF 2.4

Journal of Drug Assessment

Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658303

M. Hughes, Richard Kriska, Gregory Strong, Jennifer Chung, Lily Nguyen, Daniel J. Rubin, M. Murphy, Joseph Favatella, D. Capozzi

Abstract Background: Oral oncolytic therapies (OOT) for patients with cancer continue to pose unique safety challenges. Unlike infusion therapies, there are few best practice recommendations for checking OOT. A multicenter review of four oncology clinics in the United States, estimated 8.1 errors in medications per 100 clinic visit identified. 1 The American Society of Health-System Pharmacists identify administration and ordering were the most common phases of the medication-use process where errors occur. 2 Despite the high-risk nature of OOT and high error-rate in these particular phases, with pharmacist surveillance, there continues to be little consensus for oral oncolytic safety to guide specialty pharmacists (SPs). Aims: The objectives of this single-center, quality improvement study was to review the quality metrics of the implementation of an oral oncolytic check process, in the specialty and ambulatory setting as a method to enhance medication safety and improve vigilance. Methods: The study was approved by the Institutional Review Board at the Hospital of the University of Pennsylvania. A standardized check process and documentation of capecitabine and temozolomide was implemented beginning in December 2016 for an adult oncology population. SPs have direct communication to pharmacy specialists and provider teams through the electronic medical record via Epic. Upon receipt of a new prescription, the SP reviews the prescription for: prescriber, chemotherapy regimen, indication, body surface area, dose verification, appropriate day supply/refills, laboratory values, allergy evaluation, drug interactions, and pre-medications. The SP documents this review as an intervention in Epic for every capecitabine and temozolomide prescriptions before processing. Intervention data between December 2016 and September 2018 was queried and quantified. Results: Over 22 months, a total of 1,619 intervention documents were reviewed with 551 intervention documents requiring intervention (34%). A total of 639 actionable interventions were identified. The top three categories were missing pre-medications (54.1%), missing/abnormal laboratory results (19.6%), and drug-drug interactions (13.6%). Rare interventions included dose clarification requests (3.6%), dose change requests (1.4%), and quantity supply requests (2.7%). A SP referred to a pharmacy specialist or provider outside of Epic communication in 21.2% of cases and 3.7% of cases respectively. The average time by the SP per intervention was 12.1 minutes (Range: 10-45 minutes). Conclusions: OOT is exponentially growing with unique risks associated when prescribing, with the SP being the last line of defense. Implementing an internal checking tool of oral oncolytics creates a standardized safety check and promotes active communication with oncology care teams. Addition of all OOT to incorporate mandatory documentation is ongoing.

摘要背景：癌症患者的口服溶瘤疗法（OOT）继续带来独特的安全性挑战。与输液疗法不同，很少有检查OOT的最佳实践建议。一项针对美国四家肿瘤诊所的多中心综述估计，每100次就诊中有8.1次药物错误。1美国卫生系统药剂师协会认为，用药和订购是用药过程中最常见的出错阶段。2尽管OOT具有高风险性，在这些特定阶段的错误率很高，但在药剂师监督下，对口腔溶瘤安全性指导专业药剂师（SP）的共识仍然很少。目的：这项单中心质量改进研究的目的是审查在专科和门诊环境中实施口腔溶瘤检查过程的质量指标，以此作为提高药物安全性和提高警惕性的方法。方法：该研究由宾夕法尼亚大学医院的机构审查委员会批准。从2016年12月开始，对成年肿瘤学人群实施了卡培他滨和替莫唑胺的标准化检查流程和文件记录。SP通过Epic通过电子病历与药房专家和供应商团队直接沟通。收到新处方后，SP会审查处方：处方医生、化疗方案、适应症、体表面积、剂量验证、适当的日供应/补充、实验室值、过敏评估、药物相互作用和用药前。SP将这一审查记录为Epic对每一个卡培他滨和替莫唑胺处方在处理前的干预。对2016年12月至2018年9月的干预数据进行了查询和量化。结果：超过22 月，共审查了1619份干预文件，其中551份干预文件需要干预（34%）。共确定了639项可采取行动的干预措施。前三类是用药前遗漏（54.1%）、实验室结果遗漏/异常（19.6%）和药物相互作用（13.6%）。罕见的干预措施包括剂量澄清请求（3.6%）、剂量更改请求（1.4%），和数量供应请求（2.7%）。SP分别在21.2%和3.7%的病例中转介给Epic通信之外的药房专家或供应商。SP每次干预的平均时间为12.1 分钟（范围：10-45 分钟）。结论：OOT呈指数级增长，处方时存在独特的风险，SP是最后一道防线。实施口腔肿瘤学的内部检查工具可以创建标准化的安全检查，并促进与肿瘤学护理团队的积极沟通。正在增加所有OOT以纳入强制性文件。

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引用次数: 0

Correlates and barriers to medication adherence in multiple sclerosis patients and their impact on clinical outcomes 多发性硬化症患者药物依从性的相关性和障碍及其对临床结果的影响

IF 2.4

Journal of Drug Assessment

Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658319

Jenna Lee, Danielle McPherson, Mark D'Ambrosi, Martha Stutsky

Abstract Background: Multiple sclerosis (MS), a debilitating, chronic disease of the central nervous system, is the most common cause of neurological defects in young adults. There are currently over a dozen disease-modifying therapies (DMTs) that reduce relapse rates and slow disease progression. Despite positive efficacy studies, there are many barriers to medication adherence, which may impact patient outcomes. Aims: The purpose of this study is to evaluate the correlation between medication adherence and clinical outcomes and to identify barriers to adherence in the MS patients filling DMT prescriptions at Yale New Haven Health Outpatient Pharmacy Services (OPS). Methods: This retrospective study was conducted with 138 adult patients filling MS medications at OPS between 1 January 2018 and 31 July 2018. Subjective adherence and outcomes data were obtained through semi-annual MS patient assessments. The following data were evaluated for correlation with medication adherence: age, gender, ethnicity, language, smoking status, alcohol dependency, PMH of depression, Charlson comorbidity index, medication frequency and route, insurance provider, and medication co-pay. Retrospective medication possession ratio (MPR) data were collected from the pharmacy dispensing system, and hospital admissions obtained through the electronic health record (EHR). Results: Adherence data demonstrated that 3.6% of patients had an MPR <80% and 15.2% had an MPR <90%. A statistically significant correlation (p < .05) was identified between patients with a diagnosis of depression and patients with an MPR <80%, suggesting a correlation between worsening adherence and increasing depressive symptoms. A statistically significant correlation (p < .05) was identified between patients with hospital admissions or ED visits due to MS symptoms and patients with an MPR <80% as well as the cumulative MPR results, suggesting a correlation between worsening adherence and increasing hospital admission or ED visits due to MS. Conclusions: Patients with lower adherence to DMTs were associated with a higher rate of hospital admissions or ED visits due to MS symptoms documented in the EHR indicating the importance of medication adherence for this patient population. The importance of mental health for patients should be emphasized in this population as increasing depression symptoms were correlated with decreasing medication adherence.

摘要背景：多发性硬化症（MS）是一种使人衰弱的慢性中枢神经系统疾病，是年轻人神经系统缺陷的最常见原因。目前有十几种疾病改良疗法（DMT）可以降低复发率并减缓疾病进展。尽管有积极的疗效研究，但药物依从性仍存在许多障碍，这可能会影响患者的预后。目的：本研究的目的是评估药物依从性与临床结果之间的相关性，并确定在耶鲁-纽黑文健康门诊药房服务（OPS）开具DMT处方的MS患者的依从性障碍。方法：这项回顾性研究对2018年1月1日至2018年7月31日期间138名在OPS服用MS药物的成年患者进行。通过半年一次的MS患者评估获得主观依从性和结果数据。评估了以下数据与药物依从性的相关性：年龄、性别、种族、语言、吸烟状况、酒精依赖性、抑郁症PMH、Charlson共病指数、用药频率和途径、保险提供商和药物共同支付。从药房配药系统收集回顾性药物占有率（MPR）数据，并通过电子健康记录（EHR）获得住院人数。结果：依从性数据显示，3.6%的患者MPR＜80%，15.2%的患者MPR<90%。统计学显著相关（p < .05）在诊断为抑郁症的患者和MPR<80%的患者之间被确定，这表明依从性恶化和抑郁症状增加之间存在相关性。统计学显著相关（p < .05）在因MS症状入院或ED就诊的患者和MPR<80%的患者以及累积MPR结果之间进行了鉴定，表明依从性恶化与因MS入院或ED访视增加之间存在相关性。结论：DMTs依从性较低的患者因EHR中记录的MS症状而入院或ED就诊率较高，这表明药物依从性对该患者群体的重要性。在这一人群中，应强调心理健康对患者的重要性，因为抑郁症状的增加与药物依从性的降低有关。

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引用次数: 0

Medication adherence and graft survival among kidney transplant recipients 肾移植受者的药物依从性和移植物存活率

IF 2.4

Journal of Drug Assessment

Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658328

Safia Boghani, H. Kirkham, E. Witt, N. Hira, W. Cherikh, A. Wilk, J. Maghirang, Glen Pietradoni

Abstract Background: Though medication adherence is essential for graft survival, non-adherence to immunosuppressants post kidney transplant is common (30–35%), potentially leading to poor quality of life and increased healthcare costs. Aims: The objective of this study was to examine the association between graft survival and adherence in kidney transplant recipients. Methods: This retrospective, observational cohort study used claims data from a single, large national pharmacy chain and post-transplant follow-up data from the OPTN Network database. The sample included adult deceased donor kidney transplant recipients (most recent transplant if more than one) who had: >2 pharmacy claims for any immunosuppressant >150 days apart in the 12 months after their first fill in the study period (2013–2016). Proportion of days covered (PDC) by any immunosuppressant for 12 months after first fill was calculated as a measure of adherence (defined as PDC >80%). Graft survival was defined as having a surviving graft at the end of the study period. Logistic regression was used to estimate the association between adherence and graft survival controlling for covariates (age at transplant, time since transplant, gender, race/ethnicity, copay, number of prescriptions for chronic conditions, pharmacy insurance plan, brand medication usage, digital fills, filling at a transplant specialized pharmacy, receiving financial assistance, the interaction between brand medication usage and receiving financial assistance, and the interaction between age and adherence). Results: Of the 14,703 kidney transplant recipients eligible for the study, 73% were adherent and 85% had a surviving graft (1 to 9780 post-transplant). After adjusting for covariates, the odds of having a surviving graft were higher for adherent patients than for non-adherent patients (OR = 2.75, [1.95, 3.87]; p < .001). Other notable factors associated with graft survival included having no post-index prescriptions for chronic conditions (OR = 3.48, [2.95, 4.11]; p < .001) and commercial insurance (vs. Medicare Part B) (OR = 1.35, [1.16, 1.56]; p < .001). Conclusions: This analysis suggests adherent patients were more likely to have a surviving graft than those who were not adherent to immunosuppressants. As medication adherence behaviors may vary across patient populations, future studies should aim to show which patient behaviors contribute to medication adherence.

背景:尽管药物依从性对移植肾存活至关重要，但肾移植后不坚持使用免疫抑制剂是常见的(30-35%)，这可能导致生活质量下降和医疗费用增加。目的:本研究的目的是检查肾移植受者移植存活与依从性之间的关系。方法:这项回顾性、观察性队列研究使用来自单一大型国家连锁药店的索赔数据和来自OPTN网络数据库的移植后随访数据。样本包括成年已故供体肾移植受者(最近一次移植，如果不止一次)，他们在研究期间(2013-2016年)第一次填写后的12个月内，间隔150天有:bbbb2次对任何免疫抑制剂>的药房索赔。计算首次填充后12个月内任何免疫抑制剂覆盖天数(PDC)的比例，作为依从性的衡量标准(定义为PDC >80%)。移植物存活被定义为在研究期结束时有一个存活的移植物。使用Logistic回归来估计依从性与移植物存活之间的关联，控制协变量(移植年龄、移植时间、性别、种族/民族、共付额、慢性病处方数量、药房保险计划、品牌药物使用、数字填充、在移植专业药房填充、接受财政援助、品牌药物使用与接受财政援助之间的相互作用)。年龄和依从性之间的相互作用)。结果:在14703名符合研究条件的肾移植受者中，73%的人粘附，85%的人移植后存活(移植后1 - 9780例)。在调整协变量后，粘附患者的移植物存活几率高于非粘附患者(OR = 2.75， [1.95, 3.87];p < 0.001)。其他与移植物存活相关的显著因素包括:没有慢性疾病的指数后处方(OR = 3.48， [2.95, 4.11];p < 0.001)和商业保险(与联邦医疗保险B部分相比)(OR = 1.35， [1.16, 1.56];p < 0.001)。结论:该分析表明，黏附患者比未黏附免疫抑制剂的患者更有可能存活移植物。由于药物依从性行为可能因患者群体而异，未来的研究应旨在表明哪些患者行为有助于药物依从性。

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引用次数: 1

Impact of specialty pharmacy taking ownership of the prior authorization process of multiple sclerosis specialty medications to increase access to infusible disease-modifying therapy (DMT) 专科药房拥有多发性硬化症专科药物的事先授权程序以增加可输注的疾病改良疗法（DMT）的影响

IF 2.4

Journal of Drug Assessment

Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658304

Miranda Whetstone, J. Reichard, Shelley Sigmon

Abstract Background: Multiple sclerosis (MS) is an autoimmune inflammatory demyelinating disease of the central nervous system (CNS) that is a leading cause of disability. Many disease-modifying therapies (DMT) with different routes of administration have been approved and introduced to the market to treat MS. These DMT are often costly and require Prior Authorizations (PA) which can lead to barriers in accessing DMT. This project was a response to the need for timely PA approval for patients needing infusible DMT. A previous project reviewed the impact of the specialty pharmacy taking ownership of all DMTs in regards to approved authorizations and timeliness of the approval. After this project highlighting the need and cost savings to the institution, an additional staff member was added to focus on infusible DMT PA. Aims: To increase the number of approved authorizations of infusible DMT and increase the timeliness of authorizations in order for patients to receive appropriate and timely DMT. Methods: The program was developed by a specialty pharmacy team and neurology team. The target audience were patients being initiated on a DMT for MS from September 2018–April 2019. A note was sent in the electronic medical record (EMR) to the pharmacy team to initiate the PA process when the neurologist prescribed a new DMT. Communication was made to the neurology team regarding the status of the DMT PA before scheduling a patient for their infusion. Results: A total of 92 patients had a new PA completed. Eighty-three (90%) authorizations were approved and three (3%) were denied. Of the three denials, additional appeals were done either by completing appeal letters or scheduling peer-to-peers. Two of the three patients then qualified to receive free medication through the manufacturer due to having two denials in place. One has applied for free medication and is currently pending. A total of 10 appeal letters were written, and seven peer-to-peers were set up for the attending physician. Five PAs were cancelled. Three of these required authorization through pharmacy benefits vs medical benefits, one received free medication through the manufacturer, thus the PA was cancelled, and one did not have a referral from the Veteran’s Association (VA) to be seen outside of the VA. One authorization was not covered due to the plan only covering preventative care. Overall, 89 (96.7%) patients received their DMT infusion. Conclusions: This program provides a new service to increase the number of approved infusible DMT to improve access and outcomes for MS patients.

摘要背景：多发性硬化症（MS）是一种自身免疫性炎症性中枢神经系统脱髓鞘疾病，是致残的主要原因。许多具有不同给药途径的疾病改良疗法（DMT）已被批准并推向市场，用于治疗MS。这些DMT通常成本高昂，需要事先授权（PA），这可能会导致获得DMT的障碍。该项目是对需要输液DMT的患者及时获得PA批准的需求的回应。之前的一个项目审查了专科药房拥有所有DMT对批准授权和批准及时性的影响。在该项目强调了该机构的需求和成本节约后，又增加了一名工作人员，专注于可输注DMT PA。目的：增加可输注DMT的批准授权数量，提高授权的及时性，以便患者及时获得适当的DMT。方法：该程序由专业药学团队和神经病学团队开发。目标受众是2018年9月至2019年4月期间接受多发性硬化症DMT的患者。当神经学家开具新的DMT处方时，电子病历（EMR）中的一张纸条被发送给药房团队，以启动PA流程。在安排患者输液之前，与神经病学团队就DMT PA的状态进行了沟通。结果：共有92名患者完成了新的PA。八十三（90%）项授权获得批准，三（3%）项授权被拒绝。在三次否认中，通过填写上诉信或安排同行对同行进行额外上诉。三名患者中的两名有资格通过制造商获得免费药物，因为有两项拒绝。其中一人申请了免费药物治疗，目前正在等待治疗。总共写了10封上诉信，并为主治医生设立了7封同行对同行的上诉信。五个PA被取消。其中三项需要通过药房福利和医疗福利获得授权，一项通过制造商获得免费药物，因此PA被取消，另一项没有退伍军人协会（VA）的转诊，无法在退伍军人协会之外就诊。一项授权不包括在内，因为该计划仅涵盖预防性护理。总体而言，89名（96.7%）患者接受了DMT输注。结论：该项目提供了一项新的服务，以增加批准的可输注DMT的数量，从而改善MS患者的获取和结果。

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引用次数: 3

Clinical impact of pharmacist interventions on improving outcomes in patients receiving immune globulin therapy in a home setting 药师干预对改善患者在家庭环境中接受免疫球蛋白治疗结果的临床影响

IF 2.4

Journal of Drug Assessment

Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658294

J. DiStefano, L. Vaughan

Abstract Background: Immune globulin (IG) therapy is considered a safe and frequently used treatment in a wide range of disease states but has well known associated adverse drug reactions (ADRs) that may be problematic. Patients that receive IG in the home setting may be at higher risk for undertreated ADRs due to the limited number of immediate interventions in the home. Published literature indicate minor reactions are reported in up to 20% of IG infusions and serious ADRs in 2–6%. A pro-active approach to the prevention or reduction of known IG ADRs is critical for these patients. Pharmacists can have the greatest impact on ADRs due to their on-going and regular communication with the patients. Aims: To determine the frequency, type, and severity of ADRs associated with IG infusions and the impact of pharmacist intervention on reducing or eliminating the ADRs. Methods: An ADR Assessment tool was developed to track ADRs reported by patients during or after IG infusions, the severity of the ADR, interventions made by the pharmacist, acceptance of those interventions by the IG prescriber and the outcome of those interventions on reducing or preventing recurrence of the same ADRs. Results: ADRs tracked over a 2-year period show 98% of reported ADRs were mild or moderate in severity having limited impact on the patient’s normal activities. These were all able to be managed at home with simple and readily available therapeutic treatments. After the occurrence of an ADR, pharmacist interventions made to the IG prescriber on future IG infusions had an acceptance of 93%. Pharmacists suggested ADR interventions had a 90% success rate in the total or partial prevention of the same ADR during the next infusion cycle. During this same 2-year period, of the ADRs reported, 0.35% were categorized as serious. Review of these patients and reported serious ADRs showed events that were consistent with the FDA box warnings required on all IG products but did not result in discontinuation of IG therapy in half of these patients. Conclusions: Pharmacists can have a significant impact on preventing or reducing ADRs associated with IG therapy. In addition, the interventions suggested by the pharmacist have a high acceptance rate by prescribers and a positive effect on preventing recurrence of ADRs.

背景:免疫球蛋白(IG)治疗被认为是一种安全且经常用于多种疾病状态的治疗方法，但众所周知，相关的药物不良反应(adr)可能是有问题的。由于家中即时干预的数量有限，在家中接受IG治疗的患者发生不良反应的风险可能更高。已发表的文献表明，高达20%的IG输注报告轻微反应，2-6%报告严重不良反应。积极预防或减少已知IG不良反应对这些患者至关重要。由于药剂师与患者的持续和定期沟通，他们对adr的影响最大。目的:了解IG输注相关不良反应的发生频率、类型和严重程度，以及药师干预对减少或消除不良反应的影响。方法:开发ADR评估工具，跟踪患者在IG输注过程中或输注后报告的ADR、ADR的严重程度、药师采取的干预措施、IG处方方对这些干预措施的接受程度以及这些干预措施对减少或预防相同ADR复发的效果。结果:2年的adr追踪显示98%的adr报告为轻度或中度严重程度，对患者正常活动的影响有限。这些都可以在家里用简单易行的治疗方法进行治疗。发生不良反应后，药师对IG处方者今后IG输注的干预接受度为93%。药师建议ADR干预在下一个输液周期中对相同ADR的全部或部分预防成功率为90%。在同样的2年期间，报告的adr中，0.35%被归类为严重adr。对这些患者和报告的严重不良反应的审查显示，这些事件与所有IG产品要求的FDA框警告一致，但没有导致一半患者停止IG治疗。结论:药师可以在预防或减少IG治疗相关的不良反应方面发挥重要作用。此外，药师建议的干预措施被处方者接受率高，对预防adr再次发生有积极作用。

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引用次数: 0

Impact of specialty pharmacist integration on time to medication access for pimavanserin 专科药师整合对匹马西林用药可及性的影响

IF 2.4

Journal of Drug Assessment

Pub Date : 2019-09-03 DOI: 10.1080/21556660.2019.1658307

Sabrina Livezey, R. McCormick, Nisha B. Shah, Leena Choi, Joshua DeClercq, A. Zuckerman

Abstract Background: Patient access to pimavanserin treatment, an antipsychotic agent used to treat Parkinson’s disease-related psychosis, is limited by insurance approval and navigating a limited distribution network. Once initiated, safety and efficacy monitoring is needed to ensure adherence and clinical benefit. Aims: To determine the impact of specialty pharmacist integration on time to pimavanserin access. A secondary objective is to describe pharmacist interventions related to pimavanserin. Methods: This was a single-center, retrospective cohort study with a pre–post design. Patients prescribed pimavanserin through the center’s neurology clinic during May 2016 through July 2018 were included. An electronic chart review was performed to collect data for patient demographics (age, race, gender), insurance information (type, prior authorization process), and pharmacist interventions. The primary outcome was defined as time to medication access (in days) between the initial intent to treat and insurance approval. Univariate analysis and multiple logistic regression were performed to assess the associations between medication access time and pharmacist integration. Results: Ninety-four patients met inclusion criteria. Patients were mostly male (80%) and Caucasian (96%). Median age was 74 years. Baseline demographics between the pre- and post-integration cohorts were similar. Pre-integration, 33 patients were prescribed pimavanserin, with 82% attaining insurance approval and 79% starting therapy. Post-integration, 61 patients were prescribed pimavanserin, with 95% attaining insurance approval and 93% starting therapy. Median time to access decreased following integration (3 days compared to 24.5 days). Patients prescribed pimavanserin pre-integration had a 23-fold increase in odds of experiencing a longer time to access compared to post-integration (OR = 23; 95% CI = 8–69; p < 0.001). In addition, patients with non-commercial insurance were more likely to have a shorter medication access time compared to patients with commercial insurance. The pharmacist performed at least one intervention for 85% of patients, including medication counseling (n = 58) and interventions to improve clinical care (n = 120) and medication access (n = 135). Conclusions: Integration of a specialty pharmacist decreased time to pimavanserin access and facilitated pharmacy interventions to ensure safety and efficacy of use. Additional research is needed to evaluate the impact of faster medication access on clinical outcomes.

背景:匹马万色林是一种用于治疗帕金森病相关精神病的抗精神病药物，患者获得匹马万色林治疗受到保险批准和有限分销网络的限制。一旦启动，需要进行安全性和有效性监测，以确保依从性和临床获益。目的:探讨专业药师整合对匹马西林及时获取的影响。第二个目标是描述与匹马西林相关的药剂师干预措施。方法:这是一项单中心、回顾性队列研究，采用前后设计。包括2016年5月至2018年7月期间通过该中心神经病学诊所处方匹马万塞林的患者。进行电子图表回顾，收集患者人口统计(年龄、种族、性别)、保险信息(类型、事先授权程序)和药剂师干预措施的数据。主要结局被定义为从最初的治疗意图到保险批准之间获得药物的时间(以天为单位)。采用单因素分析和多元逻辑回归评估用药可及时间与药师整合的关系。结果:94例患者符合纳入标准。患者以男性(80%)和白人(96%)居多。中位年龄为74岁。整合前和整合后队列的基线人口统计数据相似。整合前，33名患者开了匹马瑟林，82%获得保险批准，79%开始治疗。整合后，61例患者处方匹马万塞林，95%获得保险批准，93%开始治疗。中位就诊时间在整合后减少(3天相比于24.5天)。与整合后相比，处方匹马万塞林的患者经历更长的就诊时间的几率增加了23倍(OR = 23;95% ci = 8-69;p < 0.001)。此外，与商业保险患者相比，非商业保险患者更有可能有更短的药物获取时间。药剂师对85%的患者至少进行了一项干预，包括药物咨询(n = 58)和改善临床护理(n = 120)和药物获取(n = 135)的干预。结论:专业药师的整合缩短了获得匹马西林的时间，促进了药学干预，确保了使用的安全性和有效性。需要进一步的研究来评估更快获得药物对临床结果的影响。

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引用次数: 4

Hepatitis C virus genotype analysis in patients with chronic hepatitis in North Eastern Bulgaria. 保加利亚东北部慢性肝炎患者丙型肝炎病毒基因型分析

IF 2.4

Journal of Drug Assessment

Pub Date : 2019-08-08 eCollection Date: 2019-01-01 DOI: 10.1080/21556660.2019.1654484

Zarina Brady, Zhivka Stoykova

Background: The main objective of this study was to analyse the spread of hepatitis C virus (HCV) genotype in patients with chronic liver disease; commenting on the molecular characterization of HCV and gender and age in Varna, Bulgaria. Across Europe and the world, HCV is a significant economic concern and public health crisis. Defined by genotype variations, HCV is the leading cause of chronic liver disease, liver related morbidity, and mortality worldwide. Active examination for asymptomatic patients is essential, initiating early treatment aimed at the specific HCV genotype, effective outcomes, and reducing transmission and mortality in Bulgaria. Methods and materials: Nucleic acid extraction and amplification were performed with commercially available test kits on 115 patients blood samples collected from March 2018 to October 2018. Male (n = 58) (50.43%, 95% CI = 41.29%-59.57%) and female (n = 57) (49.57%, 95% CI = 41.29%-59.57%) samples were equally distributed (mean age = 51.4 years; SD = ±16.5 years; range = 17-87 years old). Results: Genotype 1b predominated (73%, 95% CI = 64.89%-81.11%), followed by high prevalence of 1a (13.9%, 95% CI = 7.58%-20.22%) and 3 genotypes (11.3%, 95% CI = 5.51%-17.09%). Genotypes 2 and 4 were equally the least prevalent (0.9%, 95% CI = -0.83%-2.63%). In genotype 1b, 60.7% were women and 39.3% were men; in genotype 1a, 25% were women and 75% were men; and in genotype 3, only 7.7% were women and 92.3% were men. Males were most prevalent in genotypes 1a (75%) and 3 (92.3%), while women were most prevalent in genotype 1b (60.7%). Conclusions: HCV genotype lb is the predominant variant within the epidemiological pattern of HCV genotypes in patients with chronic liver diseases in North Eastern Bulgaria.

摘要背景：本研究的主要目的是分析丙型肝炎病毒（HCV）基因型在慢性肝病患者中的传播；对保加利亚瓦尔纳丙型肝炎病毒的分子特征以及性别和年龄进行评论。在整个欧洲和世界范围内，丙型肝炎病毒是一个重大的经济问题和公共卫生危机。根据基因型变异的定义，HCV是全球慢性肝病、肝脏相关发病率和死亡率的主要原因。在保加利亚，对无症状患者进行积极检查至关重要，可以针对特定的HCV基因型进行早期治疗，取得有效的结果，并降低传播和死亡率。方法和材料：使用市售检测试剂盒对2018年3月至2018年10月采集的115名患者血样进行核酸提取和扩增。男性（n = 58）（50.43%，95%CI = 41.29%–59.57%）和女性（n = 57）（49.57%，95%置信区间 = 41.29%–59.57%）样本分布均匀（平均年龄 = 51.4 年；SD = ±16.5 年；范围 = 17–87 岁）。结果：基因型1b占主导地位（73%，95%CI = 64.89%–81.11%），其次是1a的高患病率（13.9%，95%CI = 7.58%-20.22%）和3种基因型（11.3%，95%CI = 5.51%-17.09%）。基因型2和4同样是最不流行的（0.9%，95%CI = −在基因型1b中，60.7%为女性，39.3%为男性；基因型1a中，女性占25%，男性占75%；在基因型3中，女性仅占7.7%，男性仅占92.3%。男性在基因型1a（75%）和3（92.3%）中最为普遍，而女性在基因型1b（60.7%）中最普遍。结论：在保加利亚东北部的慢性肝病患者中，HCV基因型lb是HCV基因型流行病学模式中的主要变异。

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引用次数: 0

Effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in patients with Crohn's disease or ulcerative colitis. 生物仿制药英夫利昔单抗(CT-P13)在克罗恩病或溃疡性结肠炎患者中的有效性和安全性

IF 2.4

Journal of Drug Assessment

Pub Date : 2019-06-18 eCollection Date: 2019-01-01 DOI: 10.1080/21556660.2019.1626735

Cristian Gheorghe, Pavel Svoboda, Bogdan Mateescu

Objective: To assess the effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting in adults with moderate-to-severe active Crohn's disease (CD) or ulcerative colitis (UC). Methods: This multi-centre, observational cohort study was conducted at medical centres in Romania, Czech Republic, and Bulgaria. Effectiveness was measured using the Crohn's Disease Activity Index (CDAI) for CD or partial Clinical Activity Index (pCAI) for UC. Quality-of-life (QoL) was measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ). Safety was assessed according to treatment withdrawals and adverse events (AEs) monitoring. Analyses were performed in the safety population and were reported based on the observed case (OC) or last observation carried forward (LOCF) method. Results: Altogether, 85 patients with CD (n = 38) or UC (n = 47) received biosimilar infliximab for up to 30 weeks. Most patients (n = 68; 80.0%) had no prior exposure to infliximab. At the end of treatment, 65.8% (95% CI = 49.8-78.9) of CD patients and 55.3% (95% CI = 41.2-68.6) of UC patients showed a clinical response, and 47.4% (95% CI = 32.5-62.7) and 48.9% (95% CI = 35.3-62.8), respectively, were in remission. Statistically significant (p < 0.0001) improvements from baseline were observed in CDAI and pCAI scores (both LOCF). In the combined CD and UC population, SIBDQ was significantly improved (p < 0.0001) from baseline to end of treatment (OC). Two AEs (moderately severe infusion reactions) were judged by investigators to be definitely related to treatment, one of which led to treatment withdrawal. Conclusion: Results align with those of previous studies demonstrating the effectiveness and safety of biosimilar infliximab in CD and UC.

目的:评估生物仿制药英夫利昔单抗(CT-P13)在现实生活中治疗中度至重度活动性克罗恩病(CD)或溃疡性结肠炎(UC)成人的有效性和安全性。方法:这项多中心、观察性队列研究在罗马尼亚、捷克共和国和保加利亚的医疗中心进行。使用克罗恩病活动性指数(CDAI)测量CD或部分临床活动性指数(pCAI)测量UC的有效性。生活质量(QoL)采用短期炎症性肠病问卷(SIBDQ)进行测量。根据停药和不良事件(ae)监测评估安全性。在安全人群中进行分析，并根据观察病例(OC)或最后观察结转(LOCF)方法进行报告。结果:总共有85例CD (n = 38)或UC (n = 47)患者接受了生物仿制药英夫利昔单抗治疗，治疗时间长达30周。大多数患者(n = 68;80.0%)既往未接触过英夫利昔单抗。治疗结束时，65.8% (95% CI = 49.8-78.9)的CD患者和55.3% (95% CI = 41.2-68.6)的UC患者表现出临床反应，47.4% (95% CI = 32.5-62.7)和48.9% (95% CI = 35.3-62.8)的UC患者分别出现缓解。结论:结果与先前的研究结果一致，证明了生物仿制药英夫利昔单抗治疗CD和UC的有效性和安全性。

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引用次数: 6