임신부에서 항히스타민제와 알레르기용약의 국가별 안전정보 일치도 분석 : 한국, 미국, 영국, 일본 허가사항을 중심으로
Agreement of Label Information of Antihistamine, Anti-allergy Medications in Pregnancy among Korea, the USA, the UK, and Japan
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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.
Abstract
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.
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