Woerdenbag Herman J, van Basten Boy, Oussoren Christien, Smeets Oscar S N M, Annaciri-Donkers Astrid, Crul Mirjam, Maurer J Marina, Schimmel Kirsten J M, Kemper E Marleen, Hooge Marjolijn N Lub-de, Schreuder Nanno, Eikmann Melissa, Ramcharan Arwin S, Lantink Richard B, Quodbach Julian, Boersma Hendrikus H, Kelder Oscar, Larmené-Beld Karin H M, Le Brun Paul P H, Kok Robbert Jan, Schellekens Reinout C A, Breukels Oscar, Frijlink Henderik W, Gareb Bahez
Department of Pharmaceutical Technology and Biopharmacy, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands.
Department of Pharmaceutical Technology and Biopharmacy, School of Science and Engineering (SSE), University of Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands.
Pharmaceutics. 2025 Jul 31;17(8):1005. doi: 10.3390/pharmaceutics17081005.
: In many parts of the world, pharmacists hold the primary responsibility for providing safe and effective pharmacotherapy. A key aspect is the availability of appropriate medicines for each individual patient. When industrially manufactured medicines are unsuitable or unavailable, pharmacists can prepare tailor-made medicines. While this principle applies globally, practices vary between countries. In the Netherlands, the preparation of medicines in pharmacies is well-established and integrated into routine healthcare. This narrative review explores the role and significance of extemporaneous compounding, pharmacy preparations and related product care in the Netherlands. : Pharmacists involved in pharmacy preparations across various professional sectors, including community and hospital pharmacies, central compounding facilities, academia, and the professional pharmacists' organisation, provided detailed and expert insights based on the literature and policy documents while also sharing their critical perspectives. : We present arguments supporting the need for pharmacy preparations and examine their position and role in community and hospital pharmacies in the Netherlands. Additional topics are discussed, including the regulatory and legal framework, outsourcing, quality assurance, standardisation, education, and international context. Specific pharmacy preparation topics, often with a research component and a strong focus on product care, are highlighted, including paediatric dosage forms, swallowing difficulties and feeding tubes, hospital-at-home care, reconstitution of oncolytic drugs and biologicals, total parenteral nutrition (TPN), advanced therapy medicinal products (ATMPs), radiopharmaceuticals and optical tracers, clinical trial medication, robotisation in reconstitution, and patient-centric solid oral dosage forms. : The widespread acceptance of pharmacy preparations in the Netherlands is the result of a unique combination of strict adherence to tailored regulations that ensure quality and safety, and patient-oriented flexibility in design, formulation, and production. This approach is further reinforced by the standardisation of a broad range of formulations and procedures across primary, secondary and tertiary care, as well as by continuous research-driven innovation to develop new medicines, formulations, and production methods.
在世界许多地方,药剂师承担着提供安全有效药物治疗的主要责任。一个关键方面是为每个患者提供合适的药物。当工业生产的药物不合适或无法获得时,药剂师可以配制量身定制的药物。虽然这一原则在全球适用,但各国的做法有所不同。在荷兰,药房配制药物的做法由来已久,并已融入日常医疗保健之中。本叙述性综述探讨了荷兰临时调配、药房制剂及相关产品护理的作用和意义。
参与药房制剂工作的药剂师来自各个专业领域,包括社区和医院药房、中央配药设施、学术界以及专业药剂师组织,他们根据文献和政策文件提供了详细而专业的见解,同时也分享了他们的批判性观点。
我们提出支持药房制剂必要性的论据,并审视其在荷兰社区和医院药房中的地位和作用。还讨论了其他主题,包括监管和法律框架、外包、质量保证、标准化、教育以及国际背景。突出了一些特定的药房制剂主题,这些主题通常包含研究内容且非常注重产品护理,包括儿科剂型、吞咽困难与喂食管、居家医院护理、溶瘤药物和生物制品的复溶、全胃肠外营养(TPN)、高级治疗药品(ATMPs)、放射性药物和光学示踪剂、临床试验用药、复溶过程中的自动化以及以患者为中心的固体口服剂型。
荷兰药房制剂的广泛接受是严格遵守确保质量和安全的定制法规与在设计、配方和生产中以患者为导向的灵活性这一独特组合的结果。广泛的制剂和程序在初级、二级和三级护理中的标准化,以及持续的研究驱动创新以开发新药、新配方和新生产方法,进一步强化了这种方法。