As can sometimes be the case, hospital facilities may undertake investigational studies on an ad hoc basis without a formalized system for managing the medications. While practicing in this manner can be tenable, the various regulatory requirements that govern investigational drugs are best served by a more formalized program for investigational drug services (IDS).
Prior to 2012, IDS were not formalized at Intermountain Medical Center (IMC), a 452-bed hospital that serves as the flagship medical center for Intermountain Healthcare System. Up to this point, the pharmacy’s primary role in any investigational drug program was to dispense study medications from the central pharmacy. During any given time, the pharmacy was servicing an average of three to four studies. Although this was not an aggressive number, it became clear that our facility needed to establish an IDS program in order to formally ensure compliance with regulatory requirements. Such a program would also provide structure for investigators conducting research at IMC.
Establish Core Service Expectations
In order to move forward in establishing a formal IDS, we proposed a proof-of-concept for this model with the intent of implementing the model throughout the entire, 23-hospital Intermountain Healthcare System. To begin with, the drug information service at IMC proposed a formalized IDS, the functions of which would include drug procurement, dispensing and preparation, accountability, storage and disposal; drug information; staff education and training; and pre-study site visit support (see FIGURE 1).
Under the new program, study records would be transferred from the assistant director of operations to the newly formed IDS and the first priority would be to take over billing for studies nearing completion. Other priorities included disposal of medications from completed studies, organizing records, establishing a standardized billing structure for future studies, securing appropriate storage space for medications and records, and promoting the service to investigators.
Program Implementation and Beneficial Results
Once the formalized proposal was presented to and approved by pharmacy administration, the service was established in January 2012. The standardized billing structure also was approved by the pharmacy director and has been well received by investigators (see FIGURE 2). In the first quarter of 2012 alone, the service billed $15,692. The total billing for 2012 and the first two quarters of 2013 was approximately $30,000.
As indicated in the initial proposal, the process for destruction and disposal of study medications was put into place. Investigational drug waste was classified as hazardous waste, and the IDS coordinated with waste management to secure appropriate disposal and removal of these drugs in accordance with study-specific instructions. Likewise, IDS has secured proper storage space for all investigational study medications, including outpatient medications, which were previously managed by investigators. Now there is a specific refrigerator that houses investigational drugs and we were able to rekey ID storage cabinets to ensure security. At last count, there were 20 ID studies under review and given the success of the program thus far, we have added an additional 0.5 FTE to support IDS.
The structuring and implementation of IDS at IMC has been successful in establishing effective processes covering the established key program functions of investigational drug procurement, preparation and dispensing, accountability, storage, and disposal, as well as enabling better drug information, staff education and training, and pre-study site visit support. Furthermore, the new billing practices ensure compliance with CMS regulations. The current intent is to maintain IDS and provide investigational study medications to patients in a safe manner, thus pharmacy will continue to dispense study medications. The billing structure has been finalized and statements are sent to the respective research teams once a quarter. Review and standardization of IDS within the health system is ongoing.
Elyse MacDonald, PharmD, MS, BCPS, is a drug information specialist at the University of Utah Drug Information Service. Her pharmacy interests include drug policy, drug information practice, medication safety, and research pharmacy.
Krystal Moorman, PharmD, holds an appointment as clinical assistant professor of pharmacotherapy at the University of Utah College of Pharmacy. She also maintains a practice site at the South Jordan Health Center Community Clinic. Her interests include drug information, medication safety, and collaborative drug management.