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Single-Patient Trials, Extemporaneously Compounded Products and Pharmaceutical Care

Author(s):  Fassett William E

Issue:  Nov/Dec 2003 - Compounding for Investigational Studies
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Abstract:  Documentation of the achievement of desired outcomes is a key element of pharmaceutical care, and an important tool is assessing outcome is the use of single-patient trials, controlled trials of drug therapies in individual patients. This article discusses the philosophical and practical basis for including the preparation of extemporaneously compounded dosage forms as a component of pharmaceutical care and discusses how single-patient trials are conducted. The main topics of discussion include pharmaceutical care and the pharmaceutical-care process, the alternative-therapies compromise, documentation, the role of single-patient trials, requirements for single-patient trials, a primer on the conduct of single-patient trials, study designs and analysis (with three figures illustrating different designs) and establishing a single-patient-trial service. References provide a list of useful resources for pharmacists who wish to conduct single-patient trials. The author concludes that a well-designed single-patient trial can provide the crucial evidence needed to support therapeutic decision making when marketed products are not available to meet the needs of a specific patient and that a pharmacist’s ability to provide such services is a useful contribution to delivery of pharmaceutical care.

Related Keywords: Alternative therapies, in drug-related care, Extemporaneously compounded products, Fassett, PhD, RPh, William E., Single-patient trials, Single-patient trial service, establishing, Trials, single-patient, designing, conducting, and analyzing

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