Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Agreement of Label Information of Antihistamine, Anti-allergy Medications in Pregnancy among Korea, the USA, the UK, and Japan

임신부에서 항히스타민제와 알레르기용약의 국가별 안전정보 일치도 분석 : 한국, 미국, 영국, 일본 허가사항을 중심으로

  • Park, Mi-Ju (Korea Institute of Drug Safety and Risk Management) ;
  • Shin, Ju-Young (Korea Institute of Drug Safety and Risk Management) ;
  • Kim, Hong-Ah (Korea Institute of Drug Safety and Risk Management) ;
  • Park, Hyo-Ju (Korea Institute of Drug Safety and Risk Management) ;
  • Kim, Mi-Hee (Korea Institute of Drug Safety and Risk Management) ;
  • Shin, Sun-Mi (Korea Institute of Drug Safety and Risk Management) ;
  • Park, Byung-Joo (Korea Institute of Drug Safety and Risk Management)
  • Received : 2013.09.10
  • Accepted : 2013.12.18
  • Published : 2013.12.31
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Abstract

Background: Antihistamine and anti-allergy medications are widely used during pregnancy. Reading label information is one of the easiest ways to get safety information. But there are content gaps among countries. Objective: To compare the risk level and the recommendation level of antihistamine/anti-allergy drug's label information in pregnant women among Korea, the USA, the UK, and Japan. Method: Study drugs of antihistamine/anti-allergy medications were selected according to Korea drug classification codes. Based on the label information of selected product, risk level was classified into 5 categories 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 each category among 4 countries, percent agreement and kappa (k) coefficient were calculated. Results: Total 13 drug ingredients were selected for antihistamine/anti-allergy medications. In risk level, Korea (46%) and Japan (69%) were mostly classified in 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. In contrast, the category of 'Cautious' was 77%-85% in the USA, the UK, and Japan. The percent agreement for risk level was 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 provided by four different countries. 'Contraindicated' was more likely in Korea compared with other countries.

Keywords

References

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