Comprehensive pharmacy-based investigational drug service: A 40-year update.

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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.