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Recognition of pharmaceutical prescriptions across the European Union: A comparison of five Member States' policies and practices

机译:整个欧盟对药品处方的认可:五个成员国政策和做法的比较

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Background: In 2011, the EU Directive on Patients' Rights in Cross Border Healthcare was approved, including a regulation on mutual recognition of prescriptions. Objective: To compare current national policies and practices on prescribing and dispensing, prescription-only medicines (POMs) in European countries in order to identify differences which could, challenge acceptance across borders. Methods: Semi-structured interviews with 37 national stakeholders were carried out. Furthermore, data on policies for prescribing and dispensing POMs were gathered based on desk research, and, contacts with relevant authorities via a purposely designed questionnaire. Results: Important differences exist regarding: (1) information requirements for prescriptions to be, legally valid, (2) generic and international non-proprietary name (INN) policies and (3) professionals, legally allowed to prescribe POMs. Moreover, there is a lack of EU-wide access to key information for, validating prescriptions, recognizing the equivalence of products or identifying authorised prescribers. Conclusion: Differences in legislation and its application across Europe pose important challenges to be, addressed by policy makers with appropriate actions: (1) a prescribed product may not be dispensed, to a patient who needs it, (2) an inappropriate product (or inappropriate instructions) could be, provided and (3) POMs could be dispensed and consumed or sold, based on false prescriptions.
机译:背景:2011年,欧盟批准了《关于跨境医疗保健中患者权利的指令》,其中包括关于相互认可处方的规定。目的:比较欧洲国家目前在处方药和配药,仅处方药(POM)方面的国家政策和做法,以识别可能挑战跨国接受的差异。方法:与37个国家利益相关者进行了半结构化访谈。此外,在案头研究的基础上,收集了有关POM处方和分发政策的数据,并通过有针对性的设计问卷与有关当局进行了联系。结果:在以下方面存在重大差异:(1)合法有效的处方信息要求;(2)通用和国际非专有名称(INN)政策;以及(3)合法允许开具POM的专业人员。此外,在欧盟范围内,缺乏用于获取关键信息以验证处方,识别产品的等效性或确定授权处方者的途径。结论:整个欧洲的立法及其适用方面的差异提出了重要的挑战,需要政策制定者采取适当的行动来解决:(1)可能无法将处方产品分发给需要它的患者,(2)不适当的产品(或可能会提供,提供不当的指示,并且(3)基于错误的处方,可能会分发,消费或出售POM。

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