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英国的非专利药和通用名药替代:这是好事吗?

Generic and therapeutic substitutions in the UK: are they a good thing?

机构信息

Betsi Cadwaladr University Health Board, Cardiff University, Princes Park, Princes Drive, Colwyn Bay, Conwy, North Wales, LL29 8 PL, UK.

出版信息

Br J Clin Pharmacol. 2010 Sep;70(3):335-41. doi: 10.1111/j.1365-2125.2010.03718.x.

Abstract

There is considerable interest and debate concerning the place of generic substitution (switching from a brand to generic product); and on therapeutic substitution, that is, switching to a cheaper, but apparently equivalent, product, usually within the drug class. Generic substitution by pharmacists is standard practice in UK hospital settings, and is being proposed for implementation in primary care. Although most prescriptions are already written generically (83% in the community in England in 2008), there are still cost savings that could be made if generic medicines are substituted against prescriptions written by branded name or by getting prescribers to adhere to advice to prescribe generically. Therapeutic substitution is more contentious, as direct evidence to support equivalence is normally lacking. However, the price differential between established drugs whose patents have expired and for which generics are available and newer, branded medicines within the same therapeutic class, makes therapeutic substitution an attractive application of cost-minimization analysis for the more efficient use of healthcare resources. Here we explore the tension that exists between the clinical appropriateness and safety of switching from an individual patient perspective and the consideration of value for money which is required to maximize population health from a health service perspective. Although substitution may affect individual patients (such as, for instance, reduced adherence, increased potential for medication error), it might be a price worth paying given the opportunity cost associated with the use of medicines that are clinically no better than cheaper alternatives.

摘要

人们对替代药物(从品牌药物转换为仿制药)和治疗性替代药物(即改用更便宜但显然等效的药物,通常在同一药物类别内)的应用非常关注,并展开了激烈的讨论。药剂师替代药物在英国医院环境中是标准做法,目前正在考虑在初级保健中实施。尽管大多数处方已经以通用名开具(2008 年在英格兰社区中占 83%),但如果可以用仿制药替代品牌名或让开处方者遵循开通用名药物的建议,仍可节省成本。治疗性替代药物更具争议性,因为通常缺乏支持等效性的直接证据。然而,对于已过专利期且有仿制药可用的已上市药物与同一治疗类别内的较新品牌药物之间的价格差异,使得治疗性替代药物成为成本最小化分析的一个有吸引力的应用,以更有效地利用医疗资源。在这里,我们从个体患者角度探讨了从临床适宜性和安全性的角度转换的紧张局面,以及从卫生服务角度考虑物有所值,以最大化人群健康的必要性。尽管替代药物可能会影响个别患者(例如,降低依从性,增加药物错误的潜在风险),但如果与使用临床效果并不优于更便宜替代品相关的机会成本相比,这可能是值得付出的代价。

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