Micó-Pérez R M, Payares-Herrera C, Palomo-Jiménez P I, Sánchez-Fierro J, Avendaño-Solá C, Llisterri-Caro J L
Consultorio Fontanars dels Alforins, EAP Ontinyent, Valencia, España.
Servicio de Farmacología Clínica, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, España.
Semergen. 2018 Sep;44(6):380-388. doi: 10.1016/j.semerg.2018.01.002. Epub 2018 Feb 17.
The objective of this study was to evaluate the awareness and training needs on biosimilar drugs in Primary Care (PC) physicians.
Descriptive cross-sectional study based on an on-line questionnaire with a total of 34 multiple choice questions, published on the SEMERGEN website. The main Knowledge areas were: biosimilar definition; regulatory and legal framework; prescription, traceability, interchangeability and pharmacovigilance; availability of biosimilars in the PC setting, and the biosimilars contribution to sustainability. The software used for the analysis and data processing was the Barbwin 7.5.
An analysis was performed on the responses from 701 questionnaires completed. There was a slight majority (57%) of women participants. The majority of participant worked in urban centres (60.91%). The definition of biosimilar was not known by 58% of those that responded, and 73% were unaware that the management of biosimilars and generics was not comparable. Most (84%) of those that responded were not aware that the studies required for the approval of biosimilars is different from reference biological medicines. Around two-thirds (66%) those that responded did not know of any biosimilars available in PC setting, and the 94% were also unaware of the Spanish legal framework for the management of biosimilar medicines.
The current knowledge about biosimilars among PC physicians is low. The critical areas in need of further training include specific information on biosimilars currently available in PC setting, as well as key aspects regarding prescription, interchangeability and pharmacovigilance requirements. Six out of ten doctors do not know of any biosimilar used in PC in Spain.
本研究的目的是评估基层医疗(PC)医生对生物类似药的认知及培训需求。
基于在SEMERGEN网站上发布的一份包含34个多项选择题的在线问卷进行描述性横断面研究。主要知识领域包括:生物类似药的定义;监管和法律框架;处方、可追溯性、可互换性及药物警戒;基层医疗环境中生物类似药的可获得性,以及生物类似药对可持续性的贡献。用于分析和数据处理的软件是Barbwin 7.5。
对701份完成的问卷回复进行了分析。女性参与者略占多数(57%)。大多数参与者在城市中心工作(60.91%)。58%的回复者不知道生物类似药的定义,73%的人不知道生物类似药和仿制药的管理不可相提并论。大多数(84%)回复者不知道生物类似药获批所需的研究与参比生物药不同。约三分之二(66%)的回复者不知道基层医疗环境中有任何生物类似药可用,94%的人也不知道西班牙生物类似药管理的法律框架。
基层医疗医生目前对生物类似药的了解程度较低。需要进一步培训的关键领域包括基层医疗环境中现有生物类似药的具体信息,以及处方、可互换性和药物警戒要求等关键方面。十分之六的医生不知道西班牙基层医疗中使用的任何生物类似药。