基于药学的综合临床试验药物服务:40年的更新。

IF 2.1 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Helen Karpov, Kevin Zinchuk, Jon Silverman
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引用次数: 0

摘要

免责声明:为了加快文章的发表,AJHP在接受稿件后将尽快在网上发布。被接受的稿件已经过同行评审和编辑,但在技术格式化和作者校对之前会在网上发布。这些手稿不是记录的最终版本,稍后将被最终文章(按照AJHP风格格式化并由作者校对)所取代。目的:回顾40年来的服务和发展,反映了马萨诸塞州波士顿一家拥有836张床位的教学医院在基于药物的研究药物服务(IDS)领域取得的重大进展。摘要:该机构的IDS成立于1980年,由于技术和监管要求的进步,已经发生了重大变化。对纸质系统的依赖已经转变为对电子和自动化系统的利用,如调查药物服务信息系统(IDSIS)、电子健康记录和电子温度监测。主要的更新包括条形码扫描和自动药房传送带系统的实施。新标准的法规遵从性推动了危险药物处理和复合程序的变化,而研究范围已扩大到包括基因和细胞疗法在内的复杂治疗。研究活动和技术一体化的增长导致了IDS管理的研究方案的数量和能力的增加。结论:该机构的IDS药房从一开始就有了显著的发展,反映了研究药学的更广泛趋势。技术进步和监管要求已经改变了IDS的做法,从而提高了研究药物管理的效率和安全性。IDS管理更广泛的研究的能力及其在研究中扩大的作用突出了它在推进临床试验方面的重要地位。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comprehensive pharmacy-based investigational drug service: A 40-year update.

Disclaimer: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

Purpose: A review of services and developments over a 40-year period will be included, reflecting significant advances in the field of pharmacy-based investigational drug services (IDS) at an 836-bed teaching hospital in Boston, MA.

Summary: The institution's IDS, established in 1980, has seen significant changes due to advancements in technology and regulatory requirements. Reliance on paper-based systems has shifted to utilization of electronic and automated systems such as the Investigation Drug Service Information System (IDSIS), electronic health records, and electronic temperature monitoring. Key updates have included barcode scanning and the implementation of an automated pharmacy carousel system. Regulatory compliance with new standards has driven changes in hazardous medication handling and compounding procedures while the scope of research has expanded to include complex treatments including gene and cell therapies. The growth in research activities and technological integration has led to an increase in both the volume and capacity of the study protocols managed by IDS.

Conclusion: The institution's IDS pharmacy has evolved significantly from its inception, reflecting broader trends in research pharmacy. Technological advancements and regulatory requirements have transformed IDS practices, leading to increased efficiency and safety in the management of investigational agents. IDS's capacity to manage a broader range of research studies and its expanded role in research highlight its vital position in advancing clinical trials.

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来源期刊
CiteScore
2.90
自引率
18.50%
发文量
341
审稿时长
3-8 weeks
期刊介绍: The American Journal of Health-System Pharmacy (AJHP) is the official publication of the American Society of Health-System Pharmacists (ASHP). It publishes peer-reviewed scientific papers on contemporary drug therapy and pharmacy practice innovations in hospitals and health systems. With a circulation of more than 43,000, AJHP is the most widely recognized and respected clinical pharmacy journal in the world.
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