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Necessity of Research for Safe Drug use in Pregnant Women

임신부에서 약물의 안전사용을 위한 연구의 필요성

  • Han, Jung Yeol (Department of Obstetrics and Gynecology, Cheil General Hospital and Women's Healthcare Center, Dankook University, College of Medicine) ;
  • Cho, Geum Joon (Department of Obstetrics and Gynecology, Korea University College of Medicine) ;
  • Oh, Jung Mi (College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University)
  • 한정열 (단국대학교 의과대학 제일병원 산부인과) ;
  • 조금준 (고려대학교 의과대학 구로병원 산부인과) ;
  • 오정미 (서울대학교 약학대학)
  • Received : 2017.08.28
  • Accepted : 2017.09.15
  • Published : 2017.07.30

Abstract

The thalidomide tragedy in the 1960s has resulted in a perpetuation of a certain perception amongst physicians and pregnant women that the use of medication during pregnancy is a potential teratogen. Consequently, physicians hesitate in prescribing medication to pregnant women. In addition, pregnant women often refuse medication despite therapeutic necessity because of this existing perception. Recently there have been frequent adverse pregnancy outcomes related to the recurrence of chronic diseases, such as hypertension and diabetes, following pregnancy in older women. And there are lots of unnecessary termination of pregnancy due to the of information of medication exposed to medication following over 50% of unintended pregnancy. In light of this, better dissemination of information regarding the safe usage of medication for pregnant women is required. This would not only be cost-effective in terms of medical expenditure, but also prove beneficial for the treatment of diseases. In addition, Korea needs to adapt to the increasing changes of the international information system regarding supporting the safe usage of medication during pregnancy. An example of this is shown by the recent changes to the labeling of medication by the United States Food and Drug Administration. The new labeling includes information on the risk of usage, rather than just an arbitrary alphabetic classification of B, C, D, or X. Furthermore, this information is limited in Korea because of the lack of research, which in turn is due to several limitations on ethics and methodology, as well as present regulations on the research of pregnant women. From this, we can learn that government support is critical for the establishment of research so that we can alter the perception that all medication is harmful to pregnant women.

Keywords

Acknowledgement

Supported by : 식품의약품안전처

Cited by

  1. Korean Mothersafe Center 10th Anniversary: Outcome and Future Prospects vol.23, pp.4, 2017, https://doi.org/10.21896/jksmch.2019.23.4.209