Earticle

초록

영어

Background: Antihistamine and anti-allergy medications are widely used during pregnancy. Reading label information isone of the easiest ways to get safety information. But there are content gaps among countries. Objective: To compare therisk level and the recommendation level of antihistamine/anti-allergy drug’s label information in pregnant women amongKorea, the USA, the UK, and Japan. Method: Study drugs of antihistamine/anti-allergy medications were selected accordingto Korea drug classification codes. Based on the label information of selected product, risk level was classified into 5categories as follows: ‘Definite’, ‘Probable’, ‘Possible’, and ‘Unlikely’, ‘Unclassified’ according to the level of evidence. Recommendation level was classified into 4 categories as follows: ‘Contraindicated’, ‘Cautious’, ‘Compatible’, and‘Unclassified’. Frequency and proportion were presented according to the each category. To estimate agreement of eachcategory among 4 countries, percent agreement and kappa (k) coefficient were calculated. Results: Total 13 drug ingredientswere selected for antihistamine/anti-allergy medications. In risk level, Korea (46%) and Japan (69%) were mostly classifiedin the category of ‘Unclassified’, but ‘Unlikely’ category was more frequent in the UK (62%) and the USA (46%). In recommendation level, the proportion of ‘Contraindicated’ was highest in Korea (46%) compared to other countries. Incontrast, the category of ‘Cautious’ was 77%-85% in the USA, the UK, and Japan. The percent agreement for risk levelwas highest in the USA-UK (54%). The recommendation level of Korea-USA showed lowest agreement for percent agreement(46%) and kappa coefficient (k=0.02). Conclusion: We confirmed the differences among safety information providedby four different countries. ‘Contraindicated’ was more likely in Korea compared with other countries.

목차

Abstract
 연구 방법
  연구대상약물
  허가사항 조사
  자료구축
  위험수준 등급 분류
  권고수준 등급 분류
  통계분석
 연구 결과
 고찰
 결론
 참고문헌

키워드

저자

• 박미주 [ Mi-Ju Park | 한국의약품안전관리원 ]
• 신주영 [ Ju-Young Shin | 한국의약품안전관리원 ]
• 김홍아 [ Hong-Ah Kim | 한국의약품안전관리원 ]
• 박효주 [ Hyo-Ju Park | 한국의약품안전관리원 ]
• 김미희 [ Mi-Hee Kim | 한국의약품안전관리원 ]
• 신선미 [ Sun-Mi Shin | 한국의약품안전관리원 ]
• 박병주 [ Byung-Joo Park | 한국의약품안전관리원, 서울대학교 의과대학 예방의학교실 ] Correspondence to

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국임상약학회지 [Korean Journal of Clinical Pharmacy]

• 간기

  계간

• pISSN

  1226-6051

• 수록기간

  1991~2026

• 등재여부

  KCI 등재

• 십진분류

  KDC 518 DDC 615