The Pharmacy Research Support Facilities provide central storage and dispensing services as well as information support for investigators using pharmaceuticals or biologicals in clinical treatment protocols. Specifically, the aims are:
To maintain in a central area those investigational pharmaceuticals and biologicals that have Institutional Review Board approvals, and to dispense those agents under Hospital and FDA rules and regulations.
To provide a standardized mechanism that clinical investigators can use to order, maintain appropriate inventory levels, and return investigational agents to appropriate protocol sponsors.
To provide clinical investigators a standard and up-to-date method to maintain investigational drug dispensing logs.
To assist investigational drug sponsors by assuring that data on dispensing activities are complete, timely, and valid.
To assist clinical investigators by evaluating information on the chemistry, therapeutics, pharmacology, and technical issues of investigational agents and other drugs used in clinical protocols.
To provide clinical investigators with appropriate drug utilization review audits.
To provide a mechanism to dispense investigational drugs to patients in the ambulatory or home care setting.
To provide a mechanism for the appropriate disposal of investigational drugs.
To provide formal instruction to pharmacists and nurses on the proper method of handling and disposing of investigational drugs.
To maintain a computerized dispensing record as well as a manual drug profile to provide clinical and technical records to the facility.
Services to investigators include the provision of overall drug accountability required for investigational drugs. Each drug is stored separately for each protocol, and a separate drug accountability record is maintained for each drug, each strength, and each protocol. The accountability record documents receipt, dispensing, transfer, and return of drugs. Inventory of each investigational drug is performed weekly and requests for additional drugs are made when appropriate. All informed consents are checked prior to dispensing.
In addition, pertinent laboratory values are checked prior to drug preparation and the clinical investigator is notified of any problems. When the study is complete or discontinued, drugs are returned to the drug sponsor. Consultation is provided to clinical investigators regarding technical issues of drug stability, preparation, and dispensing.
Services to the Institution include the maintenance of a comprehensive, investigational quality assurance program, maintenance of patient profiles for all protocol patients, and numerous presentations for staff development programs.
Services to the patient and community include the dispensing of investigational medication doses, patient counseling, assistance with the monitoring of patient responses, and the provision of drug information to the patient and community.
