Identification and International Comparison of Drugs Contraindicated for Pregnant Women in the Package Inserts
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- Sakai Takamasa
- Drug Informatics, Faculty of Pharmacy, Meijo University
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- Sato Yuri
- KTS Plan Inc.
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- Hatakeyama Shiro
- Division of Pharmacy, Yamagata University Hospital
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- Kikuchi Daisuke
- Department of Pharmacy, Tohoku Medical and Pharmaceutical University Hospital
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- Tsuchiya Masami
- Department of Pharmacy, Miyagi Cancer Center
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- Kondo Yuki
- Department of Clinical Chemistry and Informatics, Graduate School of Pharmaceutical Sciences, Kumamoto University
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- Sato Izumi
- Department of Clinical Epidemiology, Graduate School of Biomedical Sciences, Nagasaki University
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- Okada Yuko
- Faculty of Pharmacy, Takasaki University of Health and Welfare
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- Obara Taku
- Department of Pharmaceutical Sciences, Tohoku University Hospital
Bibliographic Information
- Other Title
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- 添付文書で妊婦に対して禁忌に設定されている医薬品の特定と国際比較
Abstract
<p>Objective: The package inserts are official clinical decision-making documents that provide pharmacological treatment information. However, it has been noted that package inserts on perinatal drug usage differ greatly from expert opinions. This study identified Japanese package insert drugs that are contraindicated for pregnant women and compared them to foreign risk categories.</p><p>Methods: The survey included 19,022 drugs on the drug pricing list as of April 2022, with package inserts available on the Pharmaceuticals and Medical Devices Agency website. We retrieved the package inserts with the word “pregnant” in the “Contraindications” section and reviewed the descriptions to exclude those that satisfied the exclusion criteria. We also checked the foreign risk categories of contraindicated ingredients for pregnant women. This study used the Australian Therapeutic Goods Administration’s categorization for prescribing medicines in pregnancy (the TGA classification).</p><p>Results: Of the 19,022 medicines studied, 4,111 (21.6%) were contraindicated for pregnant women. Conversely, 19 (5.1%) ingredients categorized under the relatively safe TGA classifications A, B1, and B2 were also contraindicated for pregnant Japanese women.</p><p>Conclusion: This study revealed that Japanese package inserts contraindicate over 20% of drugs for pregnant women. On the other hand, some forbidden ingredients did not match the foreign risk categories. Therefore, healthcare professionals should be aware of the limitations of Japanese package inserts concerning pregnant women and make careful decisions based on both package inserts and additional drug information.</p>
Journal
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- Japanese Journal of Drug Informatics
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Japanese Journal of Drug Informatics 25 (4), 211-219, 2024-02-29
Japanese Society of Drug Informatics
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Keywords
Details 詳細情報について
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- CRID
- 1390299595850062976
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- ISSN
- 1883423X
- 13451464
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- Text Lang
- ja
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- Data Source
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- JaLC
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- Abstract License Flag
- Disallowed