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KMID : 0941820140240040265
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Korean Journal of Clinical Pharmacy
2014 Volume.24 No. 4 p.265 ~ p.271
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Consumer Perspectives on the Informed Consent of Off-label Drug Use in South Korea
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Lee Iyn-Hyang
Kye Seung-Hee
Je Nam-Kyung
Lee Suk-Hyang
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Abstract
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Objective: This study aims to explore the perception of off-label use of medications and the provision of informed consents
from the general public’s perspective.
Methods: The study subjects (n=291) were recruited from 7 cities in Korea through a convenience sampling method. The self-administered questionnaire with 13 items was issued and collected. The study subjects who have had a pharmaceutical job were excluded.
Results: The total of 231 respondents was included. Only 23% of respondents were familiar with the concept of off-label use of medications. Eighty five percent of respondents (n=196) stated that the prescribers should explain the off-label use of a medication to their patients. The preferred method for delivering the message was the oral explanation (n=122, 53%), followed by oral explanation plus a pamphlet (n=94, 41%). The safety issue is the most concerned aspect regarding the off-label drug use, also effectiveness and insurance coverage. The majority of respondents (n=217, 94%) agreed that the prescriber should get a consent from patients before prescribing medications for off-label use. They preferred written consent to oral consent (140 vs. 77).
Conclusion: This study demonstrated general publics are infrequently aware of off-label use of medications. It is important to raise public awareness of the off-label use of medications and to openly discuss its pros and cons for safe and effective drug therapy.
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KEYWORD
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off-label drugs, informed consent, safety, risk management
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