患者和顾问对从原研生物制剂转向生物仿制药的看法和认知:定性研究。

IF 2 Q3 PHARMACOLOGY & PHARMACY
Pharmacy Pub Date : 2024-04-07 DOI:10.3390/pharmacy12020065
D. Rosembert, M. J. Twigg, D. Wright
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引用次数: 0

摘要

本研究旨在描述接受原研生物制剂治疗的患者和管理其病情的医疗顾问的意见,并确定从原研生物制剂过渡到同等生物仿制药的障碍和促进因素。这项研究是在英国一家大型教学医院进行生物仿制药转换之前进行的。我们采访了五位胃肠病学、风湿病学和皮肤病学顾问。还与开具英夫利西单抗(n = 2)和依那西普(etanercept)原研药(n = 7)处方的患者进行了两次焦点小组讨论。得出了以下四个主题(1) "对 NHS 的益处";(2) "疗效和安全性的证据";(3) "团队角色";(4) "转换过程中的有效沟通",以及(4a) "患者想知道什么 "和(4b) "应该如何沟通 "等副主题。对患者和顾问而言,认识到节省国家医疗服务系统资金的能力是一个促进因素,患者希望得到保证,节省下来的资金将用于造福其他患者。顾问们并不总是相信生物仿制药具有与原研药相似的疗效,或制造标准相同。需要采取有效的干预措施来解决这些问题。为患者提供在必要时重新使用原研药的机会被认为是一种促进因素,提供随时可用的机制以报告因转换而导致的可疑不良事件也是一种促进因素。药房在从原研生物制剂转为生物仿制药的过程中可以发挥的作用包括向顾问介绍生物仿制药的安全性和有效性、解释患者转药的理由以及提供报告不良事件的途径。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Patient's and Consultant's Views and Perceptions on Switching from an Originator Biologic to Biosimilar Medication: A Qualitative Study.
The aim of this study was to describe the opinions of patients undergoing treatment with originator biologics and medical consultants managing their conditions and identify the barriers and enablers to transitioning from originator biologics to equivalent biosimilars. This study was undertaken prior to biosimilar switching at a large teaching hospital in the United Kingdom. Five gastroenterology, rheumatology, and dermatology consultants were interviewed. Two focus groups were conducted with patients prescribed infliximab (n = 2) and etanercept originators (n = 7). Four main themes emerged, as follows: (1) 'Benefit to the NHS'; (2) 'Evidence for efficacy and safety'; (3) 'Team roles'; and (4) 'Effective communication during switching', with sub-themes such as (4a) 'What patients want to know' and (4b) 'How it should be communicated'. Recognition of the ability to save NHS money was an enabler for both patients and consultants, with patients wanting to be reassured that the money saved would be used to benefit other patients. Consultants did not always believe that biosimilars had similar efficacy as the originators or that the manufacturing standards were the same. Effective interventions to address these concerns are required. Offering patients the opportunity to revert back to their originator if necessary was seen as an enabler, as was the provision of readily available mechanisms for reporting suspected adverse events resulting from switching. The role of pharmacy in the process of switching from originator biologics to biosimilars can range from educating consultants regarding the safety and efficacy of biosimilars, explaining the rationale for switching patients, and providing a route for reporting adverse events.
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来源期刊
Pharmacy
Pharmacy PHARMACOLOGY & PHARMACY-
自引率
9.10%
发文量
141
审稿时长
11 weeks
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