Improving investigational drug service operations through development of an innovative computer system.

PURPOSE: 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. SUMMARY: 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. CONCLUSION: The WebIDS system has improved daily operations, enhanced safety and efficiency, and helped meet regulatory requirements for investigational drugs.

Dietary supplement use in a pediatric inpatient population.

OBJECTIVES: Patients are assuming responsibility for their own health by self-medicating with dietary supplements, often without physician knowledge or oversight. The objectives of this study were to determine: 1) pediatric dietary supplement use by surveying parents of children who were hospitalized in a university institution; 2) if any health care professional inquired about supplement use at the time the child was hospitalized; 3) whether the use of a supplement was documented in the patient's medical record; and 4) parents' attitudes about dietary supplements. STUDY DESIGN: Parents of 100 hospitalized pediatric patients (<18 years of age) were randomly selected to complete a survey about their child's use of dietary supplements prior to and during hospitalization. They were also asked if they intended to use these products after hospitalization. The purpose of the study was explained, informed consent was obtained, and parents were given ample time to complete the survey. RESULTS: Fifty percent of parents reported giving their child a dietary supplement prior to hospitalization; 17% reported use of an herbal supplement. Only 24% of parents reported being asked about supplement use by a health care professional upon admission or during the hospital stay. The response to only five of these queries was documented in the child's medical record. CONCLUSIONS: Increasing dietary supplement use mandates that all health care professionals elicit this information as part of the routine History and Physical Examination at the time a child is hospitalized. This information should also be documented in the patient's medical record. Likewise, parents should be encouraged to discuss the use of these products with their physician and pharmacist.