{"title":"基于药学的综合临床试验药物服务:40年的更新。","authors":"Helen Karpov, Kevin Zinchuk, Jon Silverman","doi":"10.1093/ajhp/zxaf104","DOIUrl":null,"url":null,"abstract":"<p><strong>Disclaimer: </strong>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.</p><p><strong>Purpose: </strong>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.</p><p><strong>Summary: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":7577,"journal":{"name":"American Journal of Health-System Pharmacy","volume":" ","pages":""},"PeriodicalIF":2.1000,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comprehensive pharmacy-based investigational drug service: A 40-year update.\",\"authors\":\"Helen Karpov, Kevin Zinchuk, Jon Silverman\",\"doi\":\"10.1093/ajhp/zxaf104\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Disclaimer: </strong>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.</p><p><strong>Purpose: </strong>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.</p><p><strong>Summary: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":7577,\"journal\":{\"name\":\"American Journal of Health-System Pharmacy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2025-05-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American Journal of Health-System Pharmacy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/ajhp/zxaf104\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American Journal of Health-System Pharmacy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ajhp/zxaf104","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
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.
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.