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복합성분제 중 병용금기 성분의 추가지정 필요성에 관한 연구
A Study on the Necessity of Additional Designation of Contraindications in Fixed-Dose Combination Drugs

2021년 Vol.7 No.01

이은주1,3, 방준석2*
1숙명여자대학교 임상약학대학원, 2숙명여자대학교 약학대학, 3건강나누리약국
Eun-Joo Lee1,3 and Joon Seok Bang2*
1Graduate School of Clinical Pharmacy, Sookmyung Women’s University
2College of Pharmacy, Sookmyung Women’s University
3Geongang-Nanoori Pharmacy
Abstract

Purpose: Recently, combination drugs (CDs) are steadily increasing in the proportion of production, sales and prescription drug claims. However, as the CDs containing single drug with contraindication combinations are excluded often from the contraindication schedule, safety of the patients are greatly threatened. Methods: In this study, we compared the drug efficacies and side effects of each single drug with CDs which contain single drug with contraindication combinations. Also, we examined the reasons for the low contraindication in combination drugs in terms of content of active ingredient, timing of product launch, number of products, specificity of combination drug, and applicable range of contraindications. Results: The combination drugs are more likely to interact with the active ingredients that make up the combination drugs than single drug, the release timing is late, and the number of products is small, so it is thought that there will be fewer contraindications. Conclusion: The additional contraindications should be designated as soon as possible in CDs to enable safer use of CDs for patients with chronic diseases taking multiple drugs concurrently.



KeyWord
Contraindication, Combination drug, Single agent, DUR, Korean FDA, Notification
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