Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

Development of Drug Exposure Registries on Pregnant Women

임부의 약물 노출 관련 등록지침 개발 연구

  • Received : 2010.05.14
  • Accepted : 2010.06.18
  • Published : 2010.09.30
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Abstract

Objectives: We developed a registry guidance to provide a standard for data collection, analysis and methodical management of information on the influence of drug exposure on pregnant women and fetus. Methods: We surveyed guidances and regulations of clinical trials and the pharmaceutical affairs law, compared them with Pregnancy Exposure Registry of other countries and in addition, investigated related references. We found the flaws of the present registry and supplemented it based on better results from other countries. Results: We developed a concrete and detailed report that included pregnancy drug exposure cases necessary for close monitoring, types and characteristics of data on pregnancy drug exposure, the requirements of registry data, and essential items needed to be researched. Conclusions: Information on pregnancy drug exposure in Korea can be effectively collected by using this report which provides a comprehensive assess to drug's influence on pregnant women and fetus, and in addition, accurate information about safety and effectiveness of drug use in pregnant women and fetus can be obtained by sharing data globally and managing it synthetically and systematically.

Keywords

References

  1. Guidance for Industry, Establishing Pregnancy Exposure Registries, U.S. Department of Health and Human Services, FDA/CDER/CEBR, August 2002.
  2. Ward RM. Difficulties in the Study of Adverse Fetal and Neonatal Effects of Drug Therapy During Pregnancy. In: Seminars in Perinatology: proceedings of the NIH workshop to label drugs during pregnancy, 2001, 25(3): 191-5.
  3. 신약등의 재심사기준, 식품의약품안전청, 고시 제2004-21호
  4. 신약등의 재심사 업무 지침서, 식품의약품안전청 의약품안전국, 2004
  5. 식품의약품안전청. http://www.kfda.go.kr/ 2005년 9월 6일 접속
  6. U.S. Food and Drug Administration. http://www.fda.gov/. 2005년 8월 14일 접속
  7. Evaluation of Human Pregnancy Outcome Data, U.S. Department of Health and Human Services, FDA/CDER/CEBR, June 1999.
  8. European Medicines Agency, EMEA. http://www.emea.eu.int/. 2005년 8월 16일 접속
  9. Note for guidance on the exposure to medicinal products during pregnancy, London, 23 June 2004, EMEA/CHMP/1889/04/Consultation
  10. Vol. 9 of the Rules Governing Medicinal Products in the European Union (Pharmacovigilance - Medicinal Products for Human Use).
  11. ICH E2E: Note for Guidance for Pharmacovigilance Planning (CPMP/ICH/5716/03, released for 6 month consultation in November 2003)
  12. ICH E2D: Note for Guidance on Post-Approval Safety Data Management: Definitions and Standards for expedited reporting(CPMP/ICH/3945/03, adopted in November 2003)
  13. ICH topic E1A : The Extent of Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions(CPMP/ICH/375/95, adopted in November 1994)
  14. ICH topic E2A: Note for Guidance on Clinical Safety Data Management: Definitions and Standards for expedited reporting(CPMP/ICH/377/95, adopted in November 1994)
  15. ICH topic E2C - Note for Guidance on Clinical Safety Data Management : Periodic Safety Update Reports for Marketed Drugs(CPMP/ICH/288/95, adopted in December 1996).
  16. ICH topic E2B(M): Note for Guidance on Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (CPMP/ICH/387/95, adopted in November 2000).
  17. Shields KE, Wiholm BE, Hostelley LS, et al. Monitoring outcomes of pregnancy following drug exposure: a company-based pregnancy registry program. Drug Saf 2004; 27(6): 353-67. https://doi.org/10.2165/00002018-200427060-00001
  18. Reiff-Eldridge R, Heffner CR, Ephross SA, et al. Monitoring pregnancy outcomes after prenatal drug exposure through prospective pregnancy registries: a pharmaceutical company commitment. Am J Obstet Gynecol 2000; 182(1 Pt 1): 159-63. https://doi.org/10.1016/S0002-9378(00)70506-0
  19. 약사법 일부개정 2005.7.29 법률 7635호.
  20. 약사법 시행규칙[일부개정 2005.6.8 보건복지부령 317호].
  21. 의약품임상시험관리기준(제19999-67호), 식품의약품안전청, 고시 제1999-67호.
  22. 의약품임상시험계획승인지침제정안, (식품의약품안전청, 고시 제 2002-65호).
  23. 모자보건법 제2조 1항[일부개정 1999.2.8 법률 제5859호].
  24. 마약류관리에관한법률[일부개정 2004.1.20 법률 제07098호].
  25. 의약품등안전성정보관리규정, (식품의약품안전청고시, 제 2004-30호).
  26. Mastroianni AC, Faden RR, Federman DD. Risks to Reproduction and Offspring, In: Women and Health Research, Ethical and Legal Issues of Including Women in Clinical Studies. Washington, DC: Natl Acad Sci Press, 1994: 175-202.