Survey to assess the role of pharmacy technicians and nonpharmacist staff in the operation of research pharmacies.

PURPOSE: Results of a survey assessing trends and innovations in the use of pharmacy technicians and other nonpharmacist staff in the research pharmacy setting are reported. METHODS: A Web-based survey was distributed to Internet communities of members of the American Society of Health-System Pharmacists and the University Health-System Consortium involved in investigational drug research and related practice areas. The survey collected data on the characteristics of institutions with pharmacy department staff dedicated to such research activities and the participation of pharmacists, technicians, and other staff in key areas of research pharmacy operations. RESULTS: Survey responses from 51 institutions were included in the data analysis. Overall, the reported distribution of assigned responsibility for most evaluated research pharmacy tasks reflected traditional divisions of pharmacist and technician duties, with technicians performing tasks subject to a pharmacist check or pharmacists completing tasks alone. However, some institutions reported allowing technicians to perform a number of key tasks without direct pharmacist supervision, primarily in the areas of inventory management and sponsor monitoring and auditing; almost half of the surveyed institutions reported technician involvement in teaching activities. In general, the reported use of "tech-check-tech" arrangements in research pharmacies was very limited. Some responding institutions reported the innovative use of nonpharmacist staff (e.g., paid interns, students and residents on rotation). CONCLUSION: Although the majority of research pharmacy tasks related to direct patient care are performed by or under the direct supervision of pharmacists, a variety of other essential tasks are typically assigned to pharmacy technicians and other nonpharmacist staff.

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.

Interaction study between digoxin and a preparation of hawthorn (Crataegus oxyacantha).

Hawthorn, an herbal supplement, is currently being evaluated for the treatment of heart failure. The flavonoid components of hawthorn may be responsible for hawthorn's beneficial effects in the treatment of heart failure. However, these components may also affect P-glycoprotein function and cause interactions with drugs that are P-glycoprotein substrates, such as digoxin, which is also used to treat heart failure. Therefore, the purpose of this study was to determine the effect of hawthorn on digoxin pharmacokinetic parameters. A randomized, crossover trial with 8 healthy volunteers was performed evaluating digoxin 0.25 mg alone (D) for 10 days and digoxin 0.25 mg with Crataegus special extract WS 1442 (hawthorn leaves with flowers; Dr. Willmar Schwabe Pharmaceuticals) 450 mg twice daily (D + H) for 21 days. Pharmacokinetic studies were performed for 72 hours. There were no statistically significant differences in any measured pharmacokinetic parameters. The AUC0-infinity, Cmax-Cmin, Cmin, and renal clearance for the D group were 79 +/- 26 mcg.h/L, 1.4 +/- 0.7 mcg/L, 0.84 +/- 0.2 mcg/L, and 74 +/- 10 mL/min versus 73 +/- 20 mcg.h/L, 1.1 +/- 0.1 mcg/L, 0.65 +/- 0.2 mcg/L, and 81 +/- 22 mL/min for the D + H group, respectively (p > 0.05). Following 3 weeks of concomitant therapy, hawthorn did not significantly alter the pharmacokinetic parameters for digoxin. This suggests that both hawthorn and digoxin, in the doses and dosage form studied, may be coadministered safely.