의약품의 허가외사용 정보제공과 동의에 대한 일반인 인식

Title
의약품의 허가외사용 정보제공과 동의에 대한 일반인 인식
Other Titles
Consumer Perspectives on the Informed Consent of Off-label Drug Use in South Korea
Author(s)
이인향계승희[계승희]제남경[제남경]이숙향[이숙향]
Keywords
off-label drugs; informed consent; safety; risk management
Issue Date
201412
Publisher
한국임상약학회
Citation
한국임상약학회지, v.24, no.4, pp.265 - 271
Abstract
Objective: This study aims to explore the perception of off-label use of medications and the provision of informed consentsfrom the general public’s perspective. Methods: The study subjects (n=291) were recruited from 7 cities in Koreathrough 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 wasincluded. Only 23% of respondents were familiar with the concept of off-label use of medications. Eighty five percentof respondents (n=196) stated that the prescribers should explain the off-label use of a medication to their patients. Thepreferred method for delivering the message was the oral explanation (n=122, 53%), followed by oral explanation plusa pamphlet (n=94, 41%). The safety issue is the most concerned aspect regarding the off-label drug use, also effectivenessand insurance coverage. The majority of respondents (n=217, 94%) agreed that the prescriber should get a consentfrom patients before prescribing medications for off-label use. They preferred written consent to oral consent (140vs. 77). Conclusion: This study demonstrated general publics are infrequently aware of off-label use of medications. Itis important to raise public awareness of the off-label use of medications and to openly discuss its pros and cons forsafe and effective drug therapy.
URI
http://hdl.handle.net/YU.REPOSITORY/30267
ISSN
1226-6051
Appears in Collections:
약학대학 > 약학부 > Articles
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