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Pharmacists’ Perspectives of Biosimilars: A Systematic Review
BioDrugs ( IF 6.8 ) Pub Date : 2022-07-01 , DOI: 10.1007/s40259-022-00541-x
Noraisyah Mohd Sani 1, 2 , Zoriah Aziz 1, 3 , Rema Panickar 1, 2 , Adeeba Kamarulzaman 1
Affiliation  

Background and Objective

While biosimilars are less expensive than their originator biologics, various factors are known to impede their uptake in clinical practice including concerns regarding their interchangeability, efficacy, and safety. Pharmacists are well positioned to promote the adoption of biosimilars, thus, the aim of the review was to assess pharmacists’ knowledge and perceptions of biosimilars to identify the need for pharmacist-directed biosimilar education.

Methods

We conducted a systematic literature search for published articles indexed in MEDLINE via EBSCOHOST, Web of Science, Scopus, Cochrane Library, Dimensions, and Google Scholar databases. We included studies written in English from their earliest publication dates until December 2021. Only studies concerning pharmacists’ perspectives on biosimilars were included. Two reviewers extracted data from the studies that included pharmacists’ knowledge, perceptions, and opinions about interchangeability and automatic substitution of biosimilars. We also assessed the methodological quality of the included studies using the Joanna Briggs Institute Analytical Cross-Sectional Studies Assessment (JBI-ACSSA) for quantitative studies and the Critical Appraisal Skills Programme (CASP) for qualitative studies.

Results

Out of the 22 studies included in the review, 19 were cross-sectional quantitative studies, and the other three were qualitative studies. The sample size of the included studies ranged from 19 to 1500 participants. The level of knowledge of biosimilars graded as good, considerable, above average, or excellent among pharmacists varied from study to study, with a range of 47–86%. Only 22–51% of pharmacists were comfortable if biosimilars were prescribed for all of the indications previously used for the originator products. Pharmacists’ acceptability of switching from the originator to a biosimilar also varied, with a range of 26–84%. However, most pharmacists viewed the substitution of the originator with a biosimilar without physicians’ permission as unacceptable. Data from three studies reported that 22–74% of pharmacists had attended biosimilar training. They obtained information about biosimilars from scientific publications, pharmaceutical companies, and continuing education. Based on the criteria of JBI-ACSSA and CASP, the overall methodological quality of the studies ranged from moderate to high. The majority of the studies did not describe the sampling methods used and the strategies to deal with confounding factors.

Conclusions

Pharmacists’ knowledge and perception about biosimilars varied and were limited, especially about interchangeability and substitution, efficacy, safety, and indication extrapolation. A better understanding of biosimilars amongst pharmacists could help them to encourage prescribers’ acceptance of biosimilars.



中文翻译:

药剂师对生物仿制药的看法:系统评价

背景与目的

虽然生物仿制药比其原始生物制剂便宜,但已知有多种因素会阻碍其在临床实践中的应用,包括对其可互换性、有效性和安全性的担忧。药剂师在促进生物仿制药的采用方面处于有利地位,因此,审查的目的是评估药剂师对生物仿制药的知识和看法,以确定药剂师指导的生物仿制药教育的必要性。

方法

我们通过 EBSCOHOST、Web of Science、Scopus、Cochrane 图书馆、Dimensions 和谷歌学术数据库对 MEDLINE 中已发表的文章进行了系统的文献检索。我们纳入了从最早发表日期到 2021 年 12 月的英文研究。仅纳入了关于药剂师对生物仿制药观点的研究。两名审查员从研究中提取数据,其中包括药剂师对生物仿制药的可互换性和自动替代的知识、看法和意见。我们还使用 Joanna Briggs Institute 分析性横截面研究评估 (JBI-ACSSA) 进行定量研究和关键评估技能计划 (CASP) 进行定性研究来评估纳入研究的方法学质量。

结果

在纳入评价的 22 项研究中,19 项为横断面定量研究,另外 3 项为定性研究。纳入研究的样本量从 19 到 1500 名参与者不等。药剂师对生物仿制药的知识水平被评为良好、相当、高于平均水平或优秀,因研究而异,范围为 47-86%。如果为之前用于原研产品的所有适应症开具生物仿制药处方,只有 22-51% 的药剂师感到满意。药剂师对从原研药转向生物仿制药的接受程度也各不相同,范围为 26-84%。然而,大多数药剂师认为未经医生许可用生物仿制药替代原研药是不可接受的。三项研究的数据报告称,22-74% 的药剂师参加过生物仿制药培训。他们从科学出版物、制药公司和继续教育中获得了有关生物仿制药的信息。根据 JBI-ACSSA 和 CASP 的标准,研究的总体方法学质量介于中等到高之间。大多数研究没有描述使用的抽样方法和处理混杂因素的策略。

结论

药剂师对生物仿制药的知识和认知各不相同且有限,尤其是在互换性和替代性、疗效、安全性和适应症外推方面。药剂师更好地了解生物仿制药可以帮助他们鼓励开处方者接受生物仿制药。

更新日期:2022-07-01
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