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KMID : 0941820130230040327
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Korean Journal of Clinical Pharmacy
2013 Volume.23 No. 4 p.327 ~ p.333
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Agreement of Label Information of Antihistamine, Anti-allergy Medications in Pregnancy among Korea, the USA, the UK, and Japan
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Park Mi-Ju
Shin Ju-Young
Kim Hong-Ah
Park Hyo-Ju
Kim Mi-Hee
Shin Sun-Mi
Park Byung-Joo
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Abstract
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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: ‘Con raindicated’, ‘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.
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KEYWORD
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Pregnancy, Antihistamine, Anti-allergy, Label Information
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FullTexts / Linksout information
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Listed journal information
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