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항불안약물과 항우울약물의 허가사항 내 임신부 안전성정보에 대한 일치도 분석: 한국, 미국, 영국, 일본 허가사항을 중심으로Agreement of Label Information on Anxiolytics and Antidepressants for Pregnant Women: Comparison among Korea,the USA, the UK and Japan

Other Titles
Agreement of Label Information on Anxiolytics and Antidepressants for Pregnant Women: Comparison among Korea,the USA, the UK and Japan
Authors
박효주신주영김홍아박미주김미희이신행신선미홍순철이상열박병주
Issue Date
Sep-2013
Publisher
대한정신약물학회
Keywords
항불안약물; 항우울약물; 임신부; 약물 정보; 허가사항 Anxiolytic; Antidepressant; Pregnancy; Drug information; Label information
Citation
대한정신약물학회지, v.24, no.4, pp 172 - 179
Pages
8
Indexed
KCI
Journal Title
대한정신약물학회지
Volume
24
Number
4
Start Page
172
End Page
179
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/10368
ISSN
1017-5717
2092-5700
Abstract
Objective Anxiolytics and antidepressants are commonly used to treat depressive disorders in pregnant women. Specific and clear evidence is required when managing pregnant patients with such medications to ensure safety. However, information provided by approval label information is insufficient and often different among many countries. By analyzing label information of approval label and other references, this study aims to show the limitations and suggest appropriate directions for retrieving safety information. Methods We selected five anxiolytics and eleven antidepressants, which belongs to Korea drug classification codes 117 (psychotropic agents). We chose four countries, Korea, the United States of America (USA), the United Kingdom, Japan and collected safety information for pregnant women in label information. We evaluated the safety information based on recommendation level and evidence level. Then, kappa value and overall agreement were calculated using SAS 9.3. to assess data homogeneity. We further searched Reprotox and a textbook about contraindicated drugs in label information. Results Recommendation level and evidence level was different in each country. The number of commonly contraindicated drug in label information of four countries was none, and contraindicated drugs in labels were different respectively. Kappa value of evidence level between label information of Korea and Japan, the USA and Japan was 0.61, 0.43 respectively, corresponding to ‘substantial agreement’ and ‘moderate agreement’. The overall agreement was 75%, 62.5% respectively. The information of label was different from that of other references, Reprotox and a textbook in terms of the clinical evidences and recommendation levels. Conclusion Safety information of anxiolytics and antidepressants in label information needs to be updated on a regular basis both for health professionals and patients. With the implication of the inconsistent guidance for the safety information in pregnant women, reliable safety information in pregnant women would be needed.
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Hong, Soon Cheol
Anam Hospital (Department of Obstetrics and Gynecology, Anam Hospital)
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