Abstract

An innovative conference on the general principles of recognition and management of drug-induced disease was developed for healthcare professionals (particularly primary care). The full-day conference used a clinical therapeutic approach and was a cooperative effort of the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Staff College and Georgetown University Medical Center (GUMC). Linked with the FDA MedWatch postmarketing surveillance initiative, the conference used multiple formats, including didactic presentations, panel discussions, and case discussions led by faculty from various disciplines (e.g., internal and family medicine, psychiatry, clinical pharmacology, dentistry, clinical pharmacy, nursing, epidemiology). Conference topics included new drug approval, pharmacokinetic/pharmacodynamic considerations, and clinical assessment of adverse drug events. Tests were administered to participants before and after the conference, and participants completed a conference evaluation. Mean scores for the pre- and posttests were compared globally and by professional discipline. Conference evaluations were assessed for responses to eight standardized statements and elicited comments. After the conference, mean and median test scores were improved both globally and by discipline in comparison to protest results, with improvement on almost all individual test questions. Comparison of median scores for the pre- and posttests showed small differences between physicians and pharmacists. Evaluations showed markedly positive response to standardized statements, including enhancement of professional growth; elicited comments were supportive of conference effectiveness and attendee acceptance. This conference, which utilized a combination of educational formats, was designed to present material of an innovative nature. Results indicate that the conference was well-received and fulfilled specified learning objectives, including recognition of populations particularly vulnerable to adverse drug events and understanding of how individual providers can contribute to FDA postmarketing surveillance. Continuing educational efforts using this approach are encouraged.

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