Beaney Alison M, Le Brun Paul, Ravera Silvia, Scheepers Henk
Consultant Quality Assurance Specialist, Stockton Quality Control Laboratory, University Hospital of North Tees, Stockton-on-Tees, UK.
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.
Eur J Hosp Pharm. 2020 Jul;27(4):216-221. doi: 10.1136/ejhpharm-2018-001723. Epub 2019 Feb 16.
This article focuses on the reconstitution of parenteral medicines and the work that has been carried out at the European level to improve patient safety. Reconstitution may occur in a clinical area, for example, ward, theatre and so on, or within pharmacy. The quality of reconstituted medicines should ideally be the same, regardless of where reconstitution takes place. However, in practice, risks are greater when reconstitution is carried out in clinical areas. Although ideally all reconstitutions should be carried out within pharmacy aseptic units, capacity is generally not available to allow this, so a risk assessment approach must be taken to enable the healthcare establishment to decide which products must be reconstituted in pharmacy and which, with appropriate safeguards, can be reconstituted in clinical areas. Although guidance on reconstitution has been established in some countries, this is not the case across much of Europe. The Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (Council of Europe) (hereafter: Committee of Experts) has undertaken work to develop quality and safety standards for reconstitution in the different locations within healthcare establishments, taking a risk-based approach. In June 2016, the Committee of Ministers of the Council of Europe adopted Resolution CM/Res(2016)2 on good reconstitution practices in healthcare establishments for medicinal products for parenteral use. Drafted by the Committee of Experts, the Resolution recommends implementation measures for best practices for the reconstitution of injectable medicines for administration to patients. This article summarises the rationale behind the Resolution, its drafting process and main chapters. There is no justification for patient safety with respect to reconstituted medicines to be variable across the Member States of the Council of Europe. Implementation of Resolution CM/Res(2016)2 will enable risk reduction in healthcare establishments and is a major contribution to patient safety from injectable medicines at the international level.
本文重点关注肠外用药的复溶以及在欧洲层面为提高患者安全所开展的工作。复溶可能发生在临床区域，例如病房、手术室等，也可能在药房内进行。理想情况下，无论在何处进行复溶，复溶后药品的质量都应相同。然而，在实际操作中，在临床区域进行复溶时风险更大。虽然理想情况下所有复溶都应在药房无菌单元内进行，但通常没有足够的能力来实现这一点，因此必须采用风险评估方法，以使医疗机构能够决定哪些产品必须在药房复溶，哪些在采取适当保障措施的情况下可以在临床区域复溶。尽管一些国家已制定了复溶指南，但欧洲大部分地区并非如此。药品实践和药学保健质量与安全标准专家委员会（欧洲委员会）（以下简称：专家委员会）已开展工作，采用基于风险的方法，为医疗机构内不同地点的复溶制定质量和安全标准。2016年6月，欧洲委员会部长委员会通过了关于医疗机构肠外用药复溶良好操作规范的CM/Res(2016)2号决议。该决议由专家委员会起草，建议对用于给患者注射的药品复溶的最佳实践采取实施措施。本文总结了该决议背后的基本原理、起草过程和主要章节。在欧洲委员会各成员国中，对于复溶药品的患者安全保障存在差异是没有道理的。实施CM/Res(2016)2号决议将有助于降低医疗机构的风险，是对国际层面注射用药品患者安全的一项重大贡献。
