The IDS is a resource for UPCI investigators during the developmental phase of clinical protocols. A pharmacy specialist in drug preparation, handling, and stability meets with the Principal Investigator (PI) and other investigators to assist in the development of clinical protocols to ensure from the outset that arrangements for handling of drug products or biological agents that require special handling are identified and dealt with appropriately. Additionally, the oncology pharmacy specialist provides expertise and assistance with development of drug therapy-related issues that need to be considered in the protocol, including but not limited to prevention or management of drug-related side effects.
All protocols are reviewed by IDS pharmacists early in the developmental phase to identify any IDS-related issues, including the pharmaceutics 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 that may impact protocol development and implementation. Emphasis is placed on the resources required for each location throughout all clinical sites to ensure that studies are successfully managed at locations throughout the UPMC CancerCenter network. This initial review during the protocol development helps to facilitate the rapid implementation of the protocol once it has been approved by the IRB and other regulatory bodies.
All clinical research studies are reviewed in detail by an IDS pharmacist after the protocol has been approved by the UPCI Protocol Review Committee. A pharmacist is part of the interdisciplinary team that reviews the protocol to determine requirements (equipment needs, procedure needs within individual practice sites, personnel requirements) for effective study implementation. Implementation includes preparation of a protocol-specific pharmacotherapy plan that can be adapted without compromise of quality within the UPCI network. If required, educational materials for health care professionals and for patients and patient-caregivers are developed during this time.
The IDS is responsible for development of appropriate processes for drug handling and preparation at new clinical sites. This includes an on-site review of each study location by an investigational pharmacist to assure appropriate storage, drug accountability, and staff knowledge. The IDS works with each site to determine the need for additional equipment (refrigeration, secure storage) prior to the implementation of protocols.
IDS is responsible for drug management of investigational drug supply. This includes the following:
- Development and/or adaptation of protocol-specific guidelines for written medication orders used in the clinical study.
- Maintenance of all investigational medications in secured areas of clinical site(s). The UPMC CancerCenter Outpatient Services coordinates the storage and transfer of investigational agents to clinical areas within the network. Transfer of medication is done on an individual patient basis as patients are placed on clinical study, with a minimum of drug supply stored at locations other than the IDS facility in the Hillman Cancer Center.
- Coordination of medication distribution for the clinical site(s) involved in clinical studies. Medications are distributed to each clinical site on an individual patient basis.
- Routine quality assurance of drug handling (preparation, storage, and transfer) for clinical site(s) where each research study will be conducted.
The IDS is responsible for the integrity of drug management for clinical studies. Routine monitoring of drug accountability records is done for all sites. Drug accountability records are reviewed before new supplies of drug are sent to a site.
A coding system has been developed within UPCI to assure that the appropriate drug is used for each trial. Each drug vial is labeled with number/letter/color that corresponds to the number/letter/color on the drug accountability record to assure that the appropriate drug is used for the appropriate trial. This system was developed based on a quality assurance effort of the IDS.
The IDS has also implemented a system to assure proper labeling and monitoring of investigational agents that receive a new expiration date. Once a new expiration is received, all drugs related to the notice are adequately labeled, and the notice is placed with the agents, protocol, and drug accountability records.
UPCI Community Network Participation in Clinical Trials
IDS provides important infrastructure support for the coordination of studies within the UPMC CancerCenter network. The IDS works with the pharmacy departments at institutions throughout the network to assure that adequate quality of service is set up prior to clinical protocol implementation. This includes the development of protocol resources, preparation resources, and drug accountability processes.