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.

Effect of pharmacy practice residency training on residents' knowledge of and interest in clinical research.

PURPOSE: The effect of pharmacy practice residency training on subjectively and objectively assessed research knowledge, skills, and interests of residents was studied. METHODS: A preintervention versus post-intervention design was used. Residency year 2004- 05 residents were administered a validated Web-based survey at the beginning of residency and again at the end of residency. The survey collected resident responses to questions regarding resident and residency characteristics, subjective assessments of specific professional skills and research skills and knowledge, and objective assessments of basic research knowledge. For residents who completed beginning and end of residency surveys, results were linked when possible to allow for paired and unpaired statistical analyses. RESULTS: Totals of 346 (33.2% response rate) and 222 (21.3% response rate) surveys were completed at the beginning and the end of the residency, respectively, with 129 respondents completing both. Statistically significant improvements were observed for the total and paired population in subjectively assessed research-related skills and abilities and general professional skills. Subjectively assessed understanding of specific statistical tests revealed a significant improvement. Total population analysis and paired population analysis revealed no changes in objectively assessed research-related knowledge from the beginning of the residency to the end of the residency. CONCLUSION: Although there was improvement from the beginning to the end of residency in subjectively assessed research-related skills and abilities and in self-assessed understanding of most statistical tests, the end of residency objectively assessed research-related knowledge scores were unchanged. Residents' expectations that the residency would increase research knowledge, skills, and desire for research involvement were unmet. These results suggest that training based on residency program standards may not increase residents' interest or provide them with the skills necessary to participate in clinical research.

Developing dashboards to measure and manage inpatient pharmacy costs.

PURPOSE: A pharmacy dashboard was developed and implemented to identify trends in drug use; normalize data for patient volumes; allow the user to determine whether changes were due to cost increases, actual use changes, or both; permit evaluation of drug use within key diagnoses for individual services; and allow multiple formats and layers of analysis. SUMMARY: At the University of Michigan, a drug cost and drug-use database had been developed, and an enterprise data warehouse had been implemented. The data warehouse served as the core data source for the pharmacy dashboard effort. The department of pharmacy services worked with the clinical information and decision support services (CIDSS) unit to develop and promote the use of the pharmacy dashboard. On the basis of the core data in the data warehouse, the dashboard was designed to harness these data for the useful and actionable presentation to service chiefs, individual house officers, and administration for a better understanding of drug costs and use within the institution. In addition to the drug cost and drug-use trend data, the dashboard included help features such as access to the Drugdex database for detailed clinical information about specific drugs, including indications, adverse effects, and drug interactions. CONCLUSION: The cost reports that were developed through the collaboration between the CIDSS and the department of pharmacy services have permitted a more robust understanding of drug-use trends by a wider audience of physician leaders and clinical pharmacists at the institution. These data are critical in formulating strategies to control drug expenses by each service.

Evaluation of clinical research knowledge and interest among pharmacy residents: survey design and validation.

PURPOSE: The development and validation of a survey to describe the research knowledge, attitudes, and skills of pharmacy practice residents are described. SUMMARY: A survey was drafted to determine if pharmacy practice residency experience and the American Society of Health-System Pharmacists (ASHP)-required project improve the residents' objectively and subjectively assessed research knowledge, to determine if the residency experience and the ASHP-required project affect the residents' attitudes regarding research as a component of their future professional practice, and to subjectively assess the effect of the residency experience and the ASHP-required project on other essential skills, such as problem solving, critical thinking, and time management. An initial questionnaire was developed and underwent content validation testing by clinical pharmacists and faculty, residents, and research fellows. Following content validation, the questionnaire underwent construct validity testing (for discriminative validity and responsiveness) in students, residents, and clinical pharmacists and faculty. Reliability was tested in a subgroup of subjects who completed the questionnaire twice within two to four weeks. From the content validation phase, average scores for individual questions ranged from 1.00 to 2.00. Discriminative validity testing of the revised questionnaire demonstrated the instrument's ability to discriminate between groups expected to differ. Effect-size and mean-knowledge score differences indicated high levels of responsiveness, signifying the instrument's ability to detect change over time or after an intervention. CONCLUSION: A survey questionnaire developed to measure research knowledge and interest among pharmacy practice residents demonstrated its validity and reliability with significant sensitivity and responsiveness.

Experiences incorporating Tablet PCcs into clinical pharmacists' workflow.

Tablet PCs are portable computers that combine the power of a laptop with an intuitive pendriven interface that have been heavily promoted for vertical industries such as healthcare. The authors describe their experiences with tablet PCs used by clinical pharmacists in a large academic medical center. A slate tablet with a large screen and wireless networking capability was chosen. Tablet PCs were issued to users with a customized 'pen-friendly" clinical application and secure access to the majority of available electronic patient information. In general, the feedback from the pilot users was positive. Users reported increased efficiency on patient care rounds; they say they reduced or eliminated paper notes and shadow charts from their daily routine. However, researchers also observed that some clinical practice workflow models or clinicians did not benefit from or were hindered by the mobile devices. The department plans to expand the use of tablet PCs through desktop replacement and is developing solutions to increase the applicability of tablet PCs for all clinical models and clinicians.

Building a better online formulary.

The history of and improvements made to the University of Michigan Health System (UMHS) inpatient online formulary are described. The current formulary at UMHS is the third version of the Web-based formulary. The original effort in 1997 consisted of converting word-processing documents to HTML format and exporting this information to the university's intranet. There was no mechanism to search for formulary items, no therapeutic class cross-referencing, and no cost information. Documents and their conversion had to be manually maintained. The second version incorporated a series of automatic daily computer downloads from the inpatient pharmacy computer system. Web pages were built to dynamically display the formulary information from the database based on users' requests. The formulary enabled searching by brand or generic names, provided therapeutic category cross-references, listed the location of products within automated dispensing cabinets, provided accurate cost information, and was always up-to-date. Maintenance efforts drastically decreased. The current version has incorporated additional logic to meet users' needs. If no matches are found, the system expands its search by automatically linking to UMHS's inpatient pharmacy system repository of all drugs, finding matches to what the user entered, and then returning the names of therapeutically similar formulary agents to the user. A cross-index feature allows the system to return all the drugs that fall under the searched therapeutic category. Dramatic improvements have been made to UMHS's inpatient online formulary in the past two years. The current formulary provides a very low-cost, easily maintainable, and effective means to access the formulary and clinically relevant and timely information specific to each medication.

Using personal digital assistants to access drug information.

The use of personal digital assistants (PDAs) to access drug information in a health system is described. Given the widespread use of PDAs at an 872-bed university health system, an opportunity existed to provide current drug information to physicians via these devices. As part of the health system's intranet, extensive online content had been made available through a browser; extension to PDAs was a natural next step. There were two primary requirements: the ability to synchronize information with the database server when a PDA was used and the development of content and applications by using existing staff. Mobile enterprise software was chosen that supports multiple PDA platforms, is easy to use, and does not require programming skills. The software works through customized "channels," or collections of information from a content provider. The customized channel service works over the Internet. Two channels of content were created, an ambulatory care channel and an inpatient care channel. The ambulatory care channel contains a list of preferred ambulatory care agents, poison control information, the locations of outpatient pharmacies, drug information, and safety tips for prescribing. The inpatient channel contains the inpatient formulary, current news and events, information on currrent drug shortages and recalls, pharmacy contact information, and medication safety tips. When a user synchronizes his or her PDA, the software contacts the department's intranet servers and processes the request. The data are compressed and downloaded to the user's PDA. A university health system successfully used PDAs to access drug and other information.