UPCI Investigation Drug Service (IDS) is directed by Rowena Schwartz, Pharm.D., BCOP and managed by Carol L. Matthews, R.Ph. The UPCI IDS oversees all pharmacy procedures and processes for IDS and clinical sites where UPCI sponsored studies are implemented. The service is responsible for coordinating and managing the investigational drug inventory, storage, distribution, and record keeping for UPCI clinical research studies. The IDS has moved into the Hillman Cancer Center and three additional UPMC cancer centers have opened in the Western Pennsylvania region increasing off site locations requiring additional efforts and time for implementation and ongoing coordination and monitoring of studies. The IDS will be working closely with the UPCI efforts in the recently funded NCI grant for overcoming barriers to participation in early clinical trials at community-based locations. The IDS will continue to facilitate the conduct of early phase clinical trials throughout the network sites by developing strategies for drug preparation and delivery in sites that are not currently involved in clinical trials. All protocols are reviewed by Ms. Matthews early in the developmental phase to identify any IDS related issues including the pharmaceutical and clinical pharmacy requirements. This review includes an assessment of drug handling issues, implementation requirements, development of procedures for drug preparation at each treatment site and study related drug costs on the impact of protocol development and implementation. The IDS is also responsible for the education of pharmacists throughout the network who will be handling the drugs or agents for each protocol. The IDS is responsible for working with new clinical sites to develop appropriate processes for drug handling and preparation. The IDS is responsible for drug management, investigational drug supply including development of protocol specific pharmacy procedures for drug management that can be adapted to each participating clinical site, development and/or adaptation of protocol specific guidelines for written medication or medications used in the clinical studies, maintaining all investigational medications in secured areas of clinical sites, maintaining drug accountability records for invesfigational medications, coordination of medication distribution of the clinical sites involved in clinical studies, and routine quality assurance of drug handling. Quality assurance includes monitoring of drug accountability records, a coding system, and a form to calculate dose for specific protocols. The IDS will provide important infrastructure support for the coordination of studies within the UPMC cancer's network and will work with each clinical site to develop the appropriate implementation plan on a protocol by protocol basis.
Showing the most recent 10 out of 1187 publications
