Actual-Use Study Awareness Of Physician Influence Urged In Poster
This article was originally published in The Tan Sheet
Executive Summary
Physician guidance to consumers on potential Rx-to-OTC switch drugs should be considered when designing an actual-use study, Bernard Schachtel, MD, Yale University School of Medicine, et al., suggest.
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Physician guidance to consumers on potential Rx-to-OTC switch drugs should be considered when designing an actual-use study, Bernard Schachtel, MD, Yale University School of Medicine, et al., suggest. The "definition and determination of compliance for OTC drugs require the consideration and examination of many factors which may directly influence OTC drug consumption," the researchers note. In an actual-use study on omeprazole magnesium for episodic heartburn, "we found that a high proportion of consumers were complying with the label and listening to their doctors, too." Schachtel et al. presented their findings in a poster session at the American Society for Clinical Pharmacology & Therapeutics annual meeting in Orlando March 6-10. The 488-person study was submitted to FDA as part of AstraZeneca/Procter & Gamble's switch NDA for Prilosec I (1 (Also see "Prilosec GERD Treatment Behavior Shown In Actual Use Studies - FDA" - Pink Sheet, 30 Oct, 2000.)). Speculating that actual-use studies for OTC switches typically do not take into account several "naturally occurring extra study factors," such as physicians' influence on consumer behavior, Schachtel and colleagues incorporated into the exit interview of their study a questionnaire geared toward "whether, when and how" subjects had received counseling on heartburn treatment. Interview questions included: "While you were in the study, did you speak with a doctor about how to use the study medication for your heartburn?"; "Thinking back over the past year prior to the study, did you speak with a doctor about your heartburn?"; and "It seems that you used the study medication for more than 10 days in a row. Can you tell me why?" According to the researchers, "56%-72% of the consumers who disregarded specific label dosing instructions had received other advice from health professionals (predominantly physicians) or were under the care of a physician for their heartburn." Inclusion of such a late-stage questionnaire allows an investigator, without fear of bias, to "document explanations for a drug consumption pattern which otherwise might appear to be non-compliant with the labeled directions for use," the researchers state. |