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德瑞社区药剂师对生物制剂和生物类似药的认知和态度 - 新冠疫情前后的前瞻性调查。

Knowledge and attitudes of German and Swiss community pharmacists towards biologicals and biosimilars - a prospective survey before and after the COVID-19 pandemic.

机构信息

Pharmaceutical Care Research Group, University of Basel, Basel, Switzerland.

Department of Medicine, ABDA - Federal Union of German Associations of Pharmacists, Berlin, Germany.

出版信息

BMC Health Serv Res. 2023 Dec 18;23(1):1432. doi: 10.1186/s12913-023-10475-x.

Abstract

BACKGROUND

Knowledge, attitudes and substitution laws of biosimilars are not consistent across countries. Biosimilar acceptance among patients and healthcare professionals may be suffering from gaps in knowledge and understanding about biosimilars and their regulatory approval process. Pharmacists' roles and responsibilities changed considerably during the COVID-19 pandemic. Thus, they might have gained new skills and self-confidence in counseling and substitution of biosimilars.

AIMS

To examine and compare the knowledge, perceptions and information needs of German and Swiss pharmacists regarding original biologicals and biosimilars in 2020 and 2022.

METHODS

We conducted an online survey among Swiss and German community pharmacies in February 2020 (before) and August 2022 (after the COVID-19 pandemic). Descriptive statistics were calculated and the Chi-Square test was used for comparisons among categorical variables.

RESULTS

A total of 764 pharmacists took part in the survey (390 in 2020 and 374 in 2022) with comparable demographics. The frequency of dispensing biologicals remained similar between German and Swiss pharmacists in 2020 and 2022, but the Swiss dispensation of biosimilars increased significantly in 2022 compared to 2020. Concerning the understanding of the term biosimilars, knowledge remained moderate in both countries in both years. Participants were equally familiar with the term and most felt sufficiently informed. In both countries, substitution with a biosimilar showed the least confidence of all attitudes. A third of the participants indicated correct substitution rules in their country. In both years, around 85% of the participants were highly interested in additional training on this topic.

DISCUSSION/CONCLUSION: The results indicate that similarities and differences between Germany and Switzerland regarding knowledge and attitudes towards biologicals and biosimilars remained unchanged before and after the COVID-19 pandemic. An influence of the pandemic is unlikely. There is still a clear lack of knowledge among community pharmacists on biosimilars, especially regarding the substitution rules. Due to a rising market with many benefits but also big challenges to overcome, the topic of biosimilars should receive more attention in the future. This requires additional training for pharmacists.

摘要

背景

知识、态度和生物类似药的替代法规在各国之间并不一致。患者和医疗保健专业人员对生物类似药的接受程度可能受到对生物类似药及其监管审批过程的知识和理解差距的影响。药剂师在 COVID-19 大流行期间的角色和责任发生了重大变化。因此,他们可能在咨询和替代生物类似药方面获得了新的技能和自信。

目的

在 2020 年和 2022 年,检查和比较德国和瑞士药剂师对原生物制剂和生物类似药的知识、看法和信息需求。

方法

我们在 2020 年 2 月(大流行前)和 2022 年 8 月(大流行后)对瑞士和德国社区药房进行了在线调查。计算了描述性统计数据,并使用卡方检验比较了分类变量之间的差异。

结果

共有 764 名药剂师参加了调查(2020 年 390 名,2022 年 374 名),他们的人口统计学特征相似。2020 年和 2022 年,德国和瑞士药剂师生物制剂的配发频率相似,但瑞士 2022 年生物类似药的配发量明显高于 2020 年。关于对生物类似药术语的理解,两国药剂师在这两年的知识水平都处于中等水平。参与者对该术语同样熟悉,大多数人都觉得自己得到了充分的信息。在两国,与生物类似药的替代相比,信心最低。有三分之一的参与者表示他们所在国家有正确的替代规则。在这两年中,约 85%的参与者对这个话题的额外培训非常感兴趣。

讨论/结论:结果表明,德国和瑞士在生物制剂和生物类似药的知识和态度方面的相似性和差异在 COVID-19 大流行前后没有改变。大流行的影响不太可能。社区药剂师在生物类似药方面的知识仍然明显不足,特别是在替代规则方面。由于市场庞大,有许多好处,但也有许多挑战需要克服,生物类似药的话题在未来应该得到更多关注。这需要为药剂师提供额外的培训。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d7c7/10726545/010f49f1b3d0/12913_2023_10475_Fig1_HTML.jpg

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