상급종합병원과 희귀난치성질환 전문병원의 희귀의약품 사용현황

다국어 초록 (Multilingual 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.

목차 (Table of Contents)

• ABSTRACT
• 연구방법
• 국내 희귀의약품 등록 현황
• 국내 희귀의약품 사용실태 및 교육현황 설문조사
• 연구결과
• 국내 희귀의약품 등록 현황
• 국내 희귀의약품 사용현황 관련 설문조사
• 희귀의약품에 대한 인지도
• 희귀의약품 사용 및 관리현황
• 희귀의약품관련 정보의 필요성
• 희귀의약품 관련 의료진 및 환자교육현황
• 고찰
• 결론
• 감사의 말씀
• 참고문헌
• 별첨 1. 국내 희귀의약품 사용실태 및 교육현황 설문문항

참고문헌 (Reference)

1 박실비아, "희귀의약품 제도의 국가별 비교 연구" 한국보건사회연구원 33 (33): 525-548, 2013

2 곽혜선, "국내 희귀의약품의 현황 및 과제 -희귀질환에 대한 의약품 공급을 중심으로" 한국임상약학회 16 (16): 107-112, 2006

3 "The Portal for rare diseases and orphan drugs"

4 Park S, "Policy measures to enhance access to drugs for rare diseases" Korea Institute for Health and Social Affairs 2010

5 "National health Insurance service"

6 "MINISTRY OF FOOD AND DRUG SAFETY"

7 "Korea Orphan Drug Center"

8 Hong EJ, "Analysis of Orphan Drug Use in Seoul National University Hospital" 21 (21): 142-148, 2004

9 KOREA HEALTH INDUSTRY DEVELOPMENT INSTITUTE, "A study of promotion in the R&D for orphan drug and biomarker" Korea Health Ind Develop Inst 7-83, 2012

10 Hadjivasiliou A, "2014 Orphan Drug Report" Evalu Pharma 7-19, 2014