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

Area of Science:

• Pharmacy Practice
• Clinical Research Management
• Drug Development

Background:

• The field of pharmacy-based investigational drug services (IDS) has undergone substantial transformation.
• A 40-year review highlights key developments in IDS at a major teaching hospital.

Purpose of the Study:

• To review the evolution of pharmacy-based investigational drug services (IDS) over four decades.
• To reflect on significant advances driven by technology and regulatory changes.

Main Methods:

• Historical review of services and developments within an institutional IDS.
• Analysis of shifts from paper-based to electronic and automated systems.
• Examination of adaptations to new regulatory standards and expanding research scope.

Main Results:

• Transition from paper records to electronic systems like Investigation Drug Service Information System (IDSIS), electronic health records, and automated temperature monitoring.
• Implementation of barcode scanning and automated pharmacy carousel systems.
• Adaptation to new regulations for hazardous medication handling and compounding, supporting complex therapies like gene and cell therapies.

Conclusions:

• The institutional IDS has evolved significantly, mirroring broader trends in research pharmacy.
• Technological integration and regulatory compliance have improved efficiency and safety in managing investigational agents.
• The expanded capacity and role of IDS are crucial for advancing clinical trials and research.