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目前关于药物在给药辅助装置中稳定性的证据:对患者安全的影响。

Current evidence in the stability of medicines in dose administration aids: implications for patient safety.

机构信息

a Clinical Pharmacy and Pharmacotherapy Unit, Department of Pharmacy and Pharmaceutical Technology and Physical Chemistry, Faculty of Pharmacy and Food Sciences , University of Barcelona , Barcelona , Spain.

出版信息

Expert Opin Drug Deliv. 2018 Jun;15(6):577-587. doi: 10.1080/17425247.2018.1480610. Epub 2018 May 31.

DOI:10.1080/17425247.2018.1480610
PMID:29792364
Abstract

INTRODUCTION

As the elderly population and polypharmacy are increasing, it is predicted that interventions to enhance medication adherence, as dose administration aids (DAA), will grow. One of the limitations of repackaging medicines into DAA is to assure the stability of medicines, and, therefore, their quality, efficacy and safety.

AREAS COVERED

This article collects and summarises data of all the stability studies of repackaged medicines into DAAs. Computerized search in databases: PubMed, Google Scholar, SciELO, and reference texts related to the field (keywords: drug stability, DAAs, compliance aids, and repackaging), open access databases and guidelines. Also, it provides recommendations on the suitability of repackaging and compares them with those established.

EXPERT OPINION

Since medicines are removed from primary package, their stability can be compromised due to psychochemical characteristics of the drug substance and product, the dosage form, the type of DAA selected, the co-storage and splitting, the repackaging conditions, and the conditions of storage. This review reflects the need of more standardized stability studies to guarantee the quality of repackaged medicines. In addition, the importance of them to support the pharmacist to make the best decisions in order to maximize outcomes and minimize risks related to patients' medication when repackaging it.

摘要

简介

随着老年人口和多药治疗的增加,预计将增加以增强药物依从性的干预措施,如剂量给药辅助器(DAA)。将药物重新包装成 DAA 的一个限制是确保药物的稳定性,从而确保其质量、疗效和安全性。

涵盖领域

本文收集并总结了所有将药物重新包装成 DAA 的稳定性研究的数据。数据库中的计算机检索:PubMed、Google Scholar、SciELO 和与该领域相关的参考文本(关键词:药物稳定性、DAA、依从性辅助剂和重新包装)、开放获取数据库和指南。此外,它还就重新包装的适宜性提出了建议,并与既定建议进行了比较。

专家意见

由于药物已从原始包装中取出,其稳定性可能因药物物质和产品、剂型、所选 DAA 类型、共同储存和分割、重新包装条件以及储存条件的理化特性而受到影响。这篇综述反映了需要进行更标准化的稳定性研究,以保证重新包装药物的质量。此外,在重新包装药物时,这些研究对于支持药剂师做出最佳决策以最大程度地提高结果并最大程度地降低与患者用药相关的风险非常重要。

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