药品短缺对制药实践的影响

A. Focșa, M. Bîrsan, M. Dragan, Ruxandra Teodora Stan, C. Mircea, C. Stan
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引用次数: 0

摘要

获得药品是一项基本人权,也是卫生保健的重要组成部分。在过去10年中,全球药品供应中断已成为一个主要问题,这一现象在欧洲联盟日益加剧,由于多种原因(生产问题、药品定价政策、平行出口等),对患者保健产生了潜在的负面影响。罗马尼亚国家药品和医疗器械管理局(NAMMDR)与欧洲药品管理局完全同意,认为在这种情况下,需要各利益攸关方和监管机构之间的有效合作,也需要制造商、分销商和当局之间的良好沟通。NAMMDR在与上市许可持有人/制造商、批发分销、患者协会代表的工作会议上支持这一观点。据药剂师说,已经报告了病人倾向于囤积药品的情况,这对现有库存造成了额外的压力。在这项工作中,我们打算引起人们对药品短缺问题的关注,这对国家卫生系统、患者安全、公共卫生和医疗保健专业人员产生了巨大影响。
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The impact of medicines shortages on pharmaceutical practice
Access to medicines is a fundamental human right and is a vital element of health care. Over the last 10 years, there has been a tendency for the global discontinuation of drug supply to become a major problem, with an increasing exacerbation of this phenomenon in the European Union, with a potential negative impact on patient health care due to multiple causes (manufacturing problems, drug pricing policy, parallel export etc.). National Agency for Medicines and Medical Devices of Romania (NAMMDR) argues, in full agreement with European Medicines Agency, that in this situation effective collaboration between the various stakeholders and regulators is required, and also a good communication between manufacturers, distributors and authorities. It is a point of view that NAMMDR supported in the working meetings with the representatives of the marketing authorization holders/ manufacturers, wholesale distribution, patient associations. According to pharmacists, situations have been reported in which patients tend to stock up on medicines, and this puts additional pressure on existing stocks. In this work, we intended to draw attention to the medicine shortages issue which has a huge impact on national health systems, on patients′ safety, on public health and healthcare professionals.
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