title: Agreement of label information of cardiovascular drugs in pregnancy among Korea, the USA, the UK, and Japan.
abstract: Drug label is a common source of information; however, the content varies widely. This study aims to evaluate label information on cardiovascular drugs regarding pregnancy for their similarities in Korea, USA, UK, and Japan. Study drugs were selected as following (1) cardiovascular drugs according to the WHO ATC code (C01-C09) and (2) drugs currently marketed in all four countries were included. Evidence level was classified into five categories ('Definite', 'Probable', 'Possible', 'Unlikely', and 'Unclassified') and recommendation level was classified into four categories ('Contraindicated', 'Cautious', 'Compatible', and 'Unclassified'). Frequency and proportion were presented. Percent agreement and kappa coefficient with 95% confidence interval (CI) were calculated using SAS ver. 9.3. Total of 50 cardiovascular drugs were included. 'Unclassified' was represented the most in Korea, followed by Japan and UK (58%, 54%, and 46%, p<0.05). For recommendation level, the majority of drugs in all four countries were classified as 'contraindicated' or 'cautious'. Japanese labels had the largest proportion of 'contraindicated' level (62%), and Korea and UK followed (58%, 44%, p<0.05). Only in the USA, 10.0% of the drugs were 'compatible' whereas, there were none in Korea, UK, and Japan (p<0.01). Korea and Japan showed a substantial agreement in evidence and recommendation level (kappa=0.69, 0.67). Labels of cardiovascular drugs in pregnancy differed widely. Reliable safety information in pregnancy should be provided through regular updates.
authors: Korea Institute of Drug Safety and Risk Management, 136 Changgyeonggung-ro, Jongno-gu, Seoul 110-750, Republic of Korea.
authors: Shin Haeng
authors: SH
authors: Lee
authors: Korea Institute of Drug Safety and Risk Management, 136 Changgyeonggung-ro, Jongno-gu, Seoul 110-750, Republic of Korea.
authors: Ju-Young
authors: JY
authors: Shin
authors: Korea Institute of Drug Safety and Risk Management, 136 Changgyeonggung-ro, Jongno-gu, Seoul 110-750, Republic of Korea.
authors: Mi-Ju
authors: MJ
authors: Park
authors: Korea Institute of Drug Safety and Risk Management, 136 Changgyeonggung-ro, Jongno-gu, Seoul 110-750, Republic of Korea; Department of Preventive Medicine, College of Medicine, Seoul National University, 103 Daehak-ro, Chongno-gu, Seoul 110-799, Republic of Korea. Electronic address: bjpark@snu.ac.kr.
authors: Byung-Joo
authors: BJ
authors: Park
mesh_terms: D002317:Cardiovascular Agents; D004348:Drug Labeling; D005260:Female; D006801:Humans; D007564:Japan; D011247:Pregnancy; D056910:Republic of Korea; D006113:United Kingdom; D014481:United States
chemical_list: D002317:Cardiovascular Agents
keywords: Cardiovascular drugs; Label; Pregnancy; Safety information