INVESTIGATIONAL DRUG SERVICES

Overview of Services

The Pharmacy Investigational Drug Services (IDS) supports clinical investigators conducting research on promising experimental therapies across medical specialties. The IDS coordinates investigational drug dispensing and storage with the clinical investigator for all clinical drug trials approved by the Committee on the Protection for Human Subjects (IRB). The IDS is available to principal investigators for the coordination and management of clinical drug trials, and provides the following services:

• Procurement and receipt of study drug, storage, or distribution, as appropriate. Shipments are inspected, contents verifed, and inventory logs updated. Secure investigational drug storage at frozen, refrigerated, and room temperatures, monitored continuously and recorded via a wireless electronic system.

• Maintenance and routine audits of perpetual inventory study drug logs.

• Return of unused or expired study drug to sponsor or destruction as either hazardous or nonhazardous waste in accordance with Pharmacy Services policy “Disposal of Unusable Drugs” (PH321).

• Establishment of procedures for randomization, documentation, preparation, labeling, and dispensing of the study drug per protocol. Maintenance of study records including, but not limited to, updated copy of the protocol and investigator brochure, accountability logs, shipping invoices, storage temperature records, name of the principal investigator and study contact.

• Provide clinical content to LifeChart analyst for build of medication entries (ERX) or order panels. Develop Beacon treatment plans and therapy plans as part of multidisciplinary team.

• Randomization/treatment assignment of patient. Pharmacists are experienced with interactive voice and web response systems, randomization logs and other randomization systems.

• Maintain integrity of blinded studies. IDS Pharmacists available for emergency un-blinding.

• Drug preparation, including but not limited to, sterile parenteral formulations for hazardous and nonhazardous medication and non-sterile study drug capsules with matching placebos.

• Design of randomization schedules, perform clinical review (e.g., patient profle, protocol, order validation), assess patient adherence, complete IVRS/IWRS transactions, and extract data to create custom reports.

While Rhode Island Hospital (RIH) has a strong oncology and memory disorders research group, the Miriam Hospital (TMH) focuses on infectious disease and immunologic research. The oncology clinical trials are offered to patients from all the Lifespan Cancer Institute locations. Other important research groups that are supported include the emergency department, nephrology, and cardiac research.

Hours of Operation

Monday-Friday: 7 a.m. – 3:30 p.m.

For off hours services, investigational drugs are dispensed by staff pharmacists. Study monitor visits, study meetings, and teleconference available by appointment.

Major Accomplishments

• Testing and implementation of nCOUP Software

» nCOUP is an accountability software system that increases accuracy and effciency in clinical trial pharmacy inventory management. The system integrates with electronic medical record (EMR) systems to eliminate the signifcant double entry of data related to patients and protocols, thus reducing the associated risk of entry errors. Some features of nCOUP include:

◊ Double signature verifcation

◊ Barcoded inventory labels

◊ Physical inventory monitoring

◊ Par level management

◊ Pharmacy billing