Current View of Orphan Drug Usage in Tertiary Hospital and Rare Incurable Disease Hospital

상급종합병원과 희귀난치성질환 전문병원의 희귀의약품 사용현황

  • Choi, Kyung Suk (College of Pharmacy and Division of Life and Pharmaceutical Sciences Graduate School, Ewha Womans University) ;
  • Jeong, Young mi (College of Pharmacy and Division of Life and Pharmaceutical Sciences Graduate School, Ewha Womans University) ;
  • Kim, Yu Jeong (College of Pharmacy and Division of Life and Pharmaceutical Sciences Graduate School, Ewha Womans University) ;
  • Kim, Yoon Hee (College of Pharmacy and Division of Life and Pharmaceutical Sciences Graduate School, Ewha Womans University) ;
  • Gu, Hyunmin (Korea Orphan Drug Center) ;
  • Lee, Byung Koo (College of Pharmacy and Division of Life and Pharmaceutical Sciences Graduate School, Ewha Womans University) ;
  • Lee, Eunsook (Seoul National University Bundang Hospital) ;
  • Rhie, Sandy Jeong (College of Pharmacy and Division of Life and Pharmaceutical Sciences Graduate School, Ewha Womans University)
  • 최경숙 (이화여자대학교 생명약학부 약학대학) ;
  • 정영미 (이화여자대학교 생명약학부 약학대학) ;
  • 김유정 (이화여자대학교 생명약학부 약학대학) ;
  • 김윤희 (이화여자대학교 생명약학부 약학대학) ;
  • 구현민 (한국희귀의약품센터) ;
  • 이병구 (이화여자대학교 생명약학부 약학대학) ;
  • 이은숙 (분당서울대학교병원 약제부) ;
  • 이정연 (이화여자대학교 생명약학부 약학대학)
  • Received : 2016.04.28
  • Accepted : 2016.06.18
  • Published : 2016.06.30

Abstract

Objective: Until now, there is minimal number of research for overall domestic status of orphan drug use in Korea. The purpose of this study is to identify the list of orphan drugs available in Korea and to understand the status of orphan drug usage in tertiary Hospitals and rare incurable disease Hospital. Methods: We made domestic orphan drug lists based on available orphan drugs in Korea. Based on this lists, we conducted e-mail survey from August, 2014 to September, 2014 to identify domestic status of orphan drug usage including the availability and management of orphan drugs. Results: There are three hundred and eighteen orphan drugs (184 ingredients) registered in Ministry of Food and Drug Safety. Among the three hundred and eighteen orphan drugs, Two hundred and twenty-eight drugs (102 ingredients) were selected. Information on each item was collected and documented with generic and brand names, manufacturers, wholesalers, indications, FDA approval status and insurance coverage. Forty-three tertiary hospitals and thirty-two rare incurable hospitals responded to the survey questionnaire (57.3%). According to the survey result, the antineoplastics and immunomodulating agents group has the highest percentage (40%) usage in the hospital. Of fortythree tertiary hospitals, thirteen hospitals manage orphan drugs separately (30.2%). Based on the reply, most of the healthcare professionals commented the drug information related to efficacy and safety including medication counseling of orphan drugs is insufficient. Conclusion: Through this study we anticipate providing an understanding of orphan drug usage status in Korea. We found the limited resources to the information on orphan drugs and this information requires updating on a regular basis. This can be the basis for further studies about preparing drug information, educational resources for rare disease patients.

Keywords

References

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