The world of pharmacy practice is constantly evolving and expanding. Dispensing medications for clinical trials adds another domain to the services that many pharmacies provide. Compliance with institutional regulations, study protocols, and practice standards is essential for pharmacies that provide clinical trial or investigational drug services (IDS). The Handbook of Investigational Drug Service Pharmacy is the only contemporary text that conveys the body of knowledge that pharmacists need to possess to ensure compliant IDS practices and processes. This comprehensive collection of best practices, fundamental knowledge, law, guidance documents, and literature on IDS pharmacy spans all areas of the profession. It will serve as a reference for pharmacies engaged in IDS functions, a manual for teaching IDS topics to pharmacy residents, students, and onboarding pharmacists and technicians.
KEY FEATURES:
• Details of compliant storage of investigational medications
• Description of the best practices for study medication information management
• Review of the medication approval process in the United States
• Practice-area specific best practices for handling investigational medications
• Managing the risk, personnel, and compliance functions of an investigational drug service
ABOUT THE EDITORS:
Randall J. Voytilla, PharmD, DSc, BCPS, FAPhA
Clinical Pharmacy Specialist, Investigational Drug Service
Cleveland Clinic Foundation
Cleveland, Ohio
Sapna R. Amin, PharmD, BCOP, RPh
Associate Director of Pharmacy, Investigational Pharmacy Services
MD Anderson Cancer Center
Houston, Texas