...
首页> 外文期刊>GaBi journal. >European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution
【24h】

European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution

机译:欧洲公务员对生物制定和自动替代的态度和信仰

获取原文
           

摘要

The European Union (EU) and the European Medicines Agency (EMA) have led the development of a regulatory framework for biosimilars since 2004. By end of December 2019, 64 biosimilars of 15 originator biological medicines have a marketing authorization in Europe. Now, for the second time, the Alliance for Safe Biologic Medicines (ASBM) asked European prescribers for their views on the prescribing, adverse drug reaction reporting, automatic substitution and switching of biologicals and biosimilars. Methods: In March 2019, the ASBM surveyed 579 prescribers in France, Germany, Italy, Spain, Switzerland and the UK. Prescribers were asked for their views on authority over prescribing and dispensing of biologicals/biosimilars, reporting biological/biosimilar use and adverse drug reactions (ADR) and switching. There were also questions related to their familiarity with, knowledge of, attitudes to, and beliefs in, biosimilars. Results: Since the previous European prescriber study conducted in 2013, the percentage of respondents considering themselves highly familiar with biosimilar medicines has increased from 76% to 90%. Four out of five prescribers said they are legally required to report ADR that are brought to their attention and they file detailed ADR reports taking 10–20 minutes. Four out of five prescribers feel very strongly about having control over what is prescribed and dispensed to their patients. While highly comfortable prescribing biosimilars to na?ve patients, physician comfort level decreased when switching a stable patient to a biosimilar. Comfort level decreased further when prescribers were asked about switching a patient to a biosimilar for non-medical reasons, e.g. cost, and further still if the switch is initiated by a third party. Conclusion: European physicians have increased their familiarity with biosimilars since the 2013 survey. Physicians increasingly believe they should always have control of treatment decisions including the decision to switch to a biosimilar. It was also highlighted that governments should make multiple therapeutic options available through tenders.
机译:欧洲联盟(欧盟)和欧洲药物局(EMA)已从2004年以来一直致力于发展生物仿制率的监管框架。到2019年12月底,欧洲的营销授权有64个生物仿制物。现在,第二次,安全生物药物(ASBM)联盟要求欧洲规定对处方,不良药物反应报告,自动取代和生物仿制性和生物仿制物切换的看法。方法:2019年3月,ASBM调查了法国,德国,意大利,西班牙,瑞士和英国的579例规定。要求处方人对授权的看法,以便对生物学/生物仿制率的处方和分配,报告生物/生物仿水和药物反应(ADR)和转换。还有与他们熟悉,知识,态度和信仰的知识有关的问题,BioSimilars。结果:自2013年进行的以前进行的欧洲处方试验研究以来,考虑到自己高度熟悉的生物仿生药物的受访者的百分比增加到了76%至90%。五个公章中的四个表示,他们有法律要求报告其引起的ADR,他们提出详细的ADR报告需要10-20分钟。五个公章中的四个患有对患者的规定和分配的东西的控制感到非常强烈。虽然对Na ve患者的高度舒适的生物纤维单模,但在将稳定的患者切换到生物纤维单体时,医生舒适程度降低。当要求处方人询问患者以获得非医疗原因的生物拖模时,舒适程度进一步降低,例如,成本,并进一步仍然是交换机由第三方发起。结论:自2013年调查以来,欧洲医师提高了熟悉生物素质。医生越来越多地认为,他们应该始终控制治疗决策,包括切换到生物素质的决定。它还强调政府应通过投标制定多种治疗选择。

著录项

获取原文

客服邮箱:kefu@zhangqiaokeyan.com

京公网安备:11010802029741号 ICP备案号:京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有
  • 客服微信

  • 服务号