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의약품의 허가외사용 정보제공과 동의에 대한 일반인 인식

원문정보

Consumer Perspectives on the Informed Consent of Off-label Drug Use in South Korea

이인향, 계승희, 제남경, 이숙향

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초록

영어

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.

목차

Abstract
 연구 방법
 연구 결과
  응답자 특성
  일반인의 의약품의 허가외사용 인지여부
  일반인의 허가외사용 의약품 정보에 대한 수요
  허가외의약품 사용에 대한 일반인의 우려사항과 관리주체
 고찰
 감사의 말씀
 참고문헌
 설문참여 동의

저자정보

  • 이인향 Iyn-Hyang Lee. 영남대학교 약학대학
  • 계승희 Seunghee Kye. 아주대학교 의과대학 예방의학교실
  • 제남경 Nam Kyung Je. 부산대학교 약학대학
  • 이숙향 Sukhyang Lee. 아주대학교 약학대학

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