Improving investigational drug service operations through development of an innovative computer system.
OBJECTIVE
The development of a computerized system for protocol management, dispensing, inventory accountability, and billing by the investigational drug service (IDS) of a university health system is described.


CONCLUSIONS
After an unsuccessful search for a commercial system that would accommodate the variation among investigational protocols and meet regulatory requirements, the IDS worked with the health-system pharmacy's information technology staff and informatics pharmacists to develop its own system. The informatics pharmacists observed work-flow and information capture in the IDS and identified opportunities for improved efficiency with an automated system. An iterative build-test-design process was used to provide the flexibility needed for individual protocols. The intent was to design a system that would support most IDS processes, using components that would allow automated backup and redundancies. A browser-based system was chosen to allow remote access. Servers, bar-code scanners, and printers were integrated into the final system design. Initial implementation involved 10 investigational protocols chosen on the basis of dispensing volume and complexity of study design. Other protocols were added over a two-year period; all studies whose drugs were dispensed from the IDS were added, followed by those for which the drugs were dispensed from decentralized pharmacy areas. The IDS briefly used temporary staff to free pharmacist and technician time for system implementation. Decentralized pharmacy areas that rarely dispense investigational drugs continue to use manual processes, with subsequent data transcription into the system. Through the university's technology transfer division, the system was licensed by an external company for sale to other IDSs.


CONCLUSIONS
The WebIDS system has improved daily operations, enhanced safety and efficiency, and helped meet regulatory requirements for investigational drugs.
Sweet
Burgunda V
BV
Department of Pharmacy Services, University of Michigan Health System, UH B2D301/5008, 1500 East Medical Center Drive, Ann Arbor, MI 48109-5008, USA. gsweet@med.umich.edu
Tamer
Helen R
HR
Siden
Rivka
R
McCreadie
Scott R
SR
McGregory
Michael E
ME
Benner
Todd
T
Tankanow
Roberta M
RM
D016303:Clinical Pharmacy Information Systems; D002986:Clinical Trials as Topic; D003199:Computer Systems; D004360:Drug Therapy, Computer-Assisted; D015507:Drugs, Investigational; D006785:Hospitals, University; D006801:Humans; D010607:Pharmacy Service, Hospital
D015507:Drugs, Investigational