Faculty of Pharmacy in Hradec Kralove, Department of Social and Clinical Pharmacy, Charles University, Akademika Heyrovskeho 1203, 500 05, Hradec Kralove, Czech Republic.
Faculty of Pharmacy in Hradec Kralove, Czech Pharmaceutical Museum, Charles University, Akademika Heyrovskeho 1203, 500 05, Hradec Kralove, Czech Republic.
BMC Health Serv Res. 2019 Oct 30;19(1):777. doi: 10.1186/s12913-019-4631-y.
Generic drugs and generic substitution belong to the tools by which healthcare costs may be reduced. However, low awareness and reluctance among healthcare professionals towards generic drugs may negatively affect the rational use of generic substitution.
The study aimed to analyze opinions and attitudes towards generic drugs and generic substitution among Czech physicians including their understanding of generic substitution legislative rules and the physicians´ previous experience in this field. Using random allocation, 1551 physicians practicing in the Czech Republic were asked to participate in the sociological representative survey conducted from November to December 2016, through face-to-face structured interviews comprising 19 items. Factor analysis as well as reliability analysis of items focused on legal rules in the context of physicians' awareness were applied with p-value of < 0.05 as statistically significant.
Of a total of 1237 (79.8%) physicians (43.7% males; mean age 47.5 ± 11.6 years, 46.3% general practitioners) 24.8% considered generic drugs to be less safe, especially those with specialized qualification (p < 0.01). However, only 4.4% of the physicians noticed any drug-related problems, including adverse drug reactions associated with generic substitution. The majority of physicians felt neutrally about performing generic substitution in pharmacies, nor they expressed any opinion on characteristics of generics, even though a better understanding of the legislation and higher need of accordance of substituted drugs were associated with more positive attitudes towards generic substitution (p < 0.05). Physicians showed low knowledge score of legislative rules (mean 3.9 ± 1.6 from maximum 9), nevertheless they overestimated the law, as they considered some rules valid, even if the law does not require them. Cronbach alpha of all legislative rules that regulate generic substitution increased from 0.318 to 0.553 if two optional rules (physician consent and strength equivalence) would be taken into account.
There is no sufficient awareness of generic drugs and generic substitution related issues among Czech physicians, although a deeper knowledge of legislation improves their perception about providing generic substitution.
仿制药和仿制药替代属于降低医疗保健成本的工具。然而，医护人员对仿制药的认识不足和不愿意可能会对仿制药替代的合理使用产生负面影响。
本研究旨在分析捷克医生对仿制药和仿制药替代的意见和态度，包括他们对仿制药替代立法规则的理解以及他们在这一领域的以往经验。研究采用随机分配的方式，邀请了 1551 名在捷克共和国执业的医生参加了 2016 年 11 月至 12 月期间进行的一项社会学代表性调查，通过面对面的结构化访谈，共包含 19 个项目。应用因子分析和项目可靠性分析来关注医生意识方面的法律规则，p 值<0.05 为统计学显著。
在总共 1237 名医生中（79.8%）（43.7%为男性；平均年龄 47.5±11.6 岁，46.3%为全科医生），24.8%的医生认为仿制药安全性较低，特别是那些具有专业资格的医生（p<0.01）。然而，只有 4.4%的医生注意到任何与药物相关的问题，包括与仿制药替代相关的不良反应。大多数医生对在药店进行仿制药替代持中立态度，也没有对仿制药的特征发表任何意见，尽管对立法的更好理解和对替代药物的更高需求与对仿制药替代的更积极态度相关（p<0.05）。医生对立法规则的知识得分较低（最高分为 9 分，平均得分为 3.9±1.6），但他们高估了法律，因为他们认为一些规则是有效的，即使法律没有要求他们这样做。如果考虑到两项可选规则（医生同意和强度等效性），则调节仿制药替代的所有立法规则的克朗巴赫阿尔法从 0.318 增加到 0.553。
捷克医生对仿制药和仿制药替代相关问题的认识不足，尽管对立法的深入了解改善了他们对提供仿制药替代的看法。
