의약품의 허가외사용 정보제공과 동의에 대한 일반인 인식
Consumer Perspectives on the Informed Consent of Off-label Drug Use in South Korea
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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.
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.
참고문헌 (28)
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