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血浆制品的安全问题会限制自给自足吗?

Do safety issues of plasma products constrain self-sufficiency?

作者信息

Savidge G F

机构信息

Haemophilia Reference Centre, Guy's & St Thomas' Hospital NHS Trust, St Thomas' Hospital, London, UK.

出版信息

Blood Coagul Fibrinolysis. 1994 Dec;5 Suppl 4:S67-70. doi: 10.1097/00001721-199412004-00018.

DOI:10.1097/00001721-199412004-00018
PMID:7795142
Abstract

The ultimate responsibility for selecting and administering plasma products to patients rests with the prescribing physician, and it is for him/her to choose the safest product available. However, liability for a product with a full licence rests exclusively with the licence holder. After the problems of HIV and hepatitis C the safety of plasma-derived products has become of paramount importance. Particularly in the public sector, financial, strategic and political obstacles may adversely influence the quantity, quality and safety of plasma collection. The safety of blood products can be substantially enhanced by the harmonization of technical standards across both public and private sectors, thus supporting EC Directive 89/381. Additionally, the goal of European rather than national self-sufficiency should be encouraged.

摘要

为患者选择和管理血浆制品的最终责任在于开处方的医生,应由其选择可获得的最安全的产品。然而,具有完整许可证的产品的责任完全由许可证持有者承担。在出现艾滋病毒和丙型肝炎问题之后,血浆衍生产品的安全性已变得至关重要。特别是在公共部门,财政、战略和政治障碍可能会对血浆采集的数量、质量和安全性产生不利影响。通过统一公共和私营部门的技术标准,可以大幅提高血液制品的安全性,从而支持欧共体第89/381号指令。此外,应鼓励实现欧洲而非国家自给自足的目标。

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