의약품의 허가외사용 정보제공과 동의에 대한 일반인 인식 = Medicinal Chemistry : Consumer Perspectives on the Informed Consent of Off-label Drug Use in South Korea

다국어 초록 (Multilingual Abstract)

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.