Health Policy and Management (보건행정학회지)

Korean Academy of Health Policy and Management (한국보건행정학회)
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Policies to Manage Drug Shortages in Selected Countries: A Review and Implications

주요국의 수급불안정 의약품 관리제도에 관한 고찰과 한국에의 시사점

  • Inmyung Song (Department of Health Administration, Kongju National University) ;
  • Sang Jun Jung (Department of Health Administration, Kongju National University) ;
  • Eunja Park (Research Center for Food and Drug Policy, Korea Institute for Health and Social Affairs) ;
  • Sang-Eun Choi (Department of Pharmacy, College of Pharmacy, Korea University) ;
  • Eun-A Lim (Department of Pharmacy, College of Pharmacy, Korea University) ;
  • Sanghyun Kim (Department of Pharmacy, College of Pharmacy, Korea University) ;
  • Dongsook Kim (Department of Health Administration, Kongju National University)
  • 송인명 (국립공주대학교 보건행정학과) ;
  • 정상준 (국립공주대학교 보건행정학과) ;
  • 박은자 (한국보건사회연구원 식품의약품정책연구센터) ;
  • 최상은 (고려대학교 약학대학 약학과) ;
  • 임은아 (고려대학교 약학대학 약학과) ;
  • 김상현 (고려대학교 약학대학 약학과) ;
  • 김동숙 (국립공주대학교 보건행정학과)
  • Received : 2024.03.02
  • Accepted : 2024.05.24
  • Published : 2024.06.30
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Abstract

Drug shortage is a persistent phenomenon that poses a public health risk worldwide and occurs due to a range of causes. The purpose of this study is to review key policies to prepare for and respond to drug shortages in selected countries, such as the United States, Canada, and some European countries in order to draw implications. This study reviewed the reports and articles derived from search engines and Google Scholar by using keywords such as drug shortage and stock-out. Over the last decade or so, the United States have strengthened requirements on advance notification for disruption and interruption of drug manufacturing, established the Inter-agency Drug Shortages Task Force to promote the communication and coordination of responses, and expedited drug regulatory processes. Similarly, Canada established the Multi-Stakeholder Steering Committee on drug shortages by involving representatives from central and local governments and private sectors. Canada also adopted a tiered approach to the communication of drug shortages based on the assessment of the severity of the shortage problem and released a detailed information guide on communication. In 2019, the joint task force between the European Medicines Agency and the Heads of Medicines Agencies issued guidelines on drug shortage communication in the European Economic Area. The countries reviewed in this paper focus on communication across different stakeholders for the monitoring of and timely response to drug shortages. The efforts to protect public health from the negative impact of the drug shortage crisis would require multi-sectorial and multi-governmental coordination and development of guidelines.

의약품 부족은 전 세계적으로 보건학적 위험을 초래할 수 있는 문제이다. 본 연구의 목적은 미국, 캐나다, 일부 유럽 국가에서 국가의 의약품 부족에 대응하는 정책을 비교하고, 시사점을 도출하고자 하였다. 본 연구는 'drug shortage'와 'stock-out'와 같은 키워드를 사용하여 검색엔진과 구글학술검색을 통해 검색된 보고서 및 논문들을 검토하였다. 미국은 의약품 제조 중단에 대한 보고시스템을 구축하고, 의약품 공급망 관리의 중요성을 강조하고 있다. 또한 의약품 부족에 대한 대응체계를 마련하고자, 정부부처와 민간기관 간 의약품 부족 테스크포스를 설립했다. 캐나다는 중앙 및 지방 정부, 민간 부문의 대표를 참여시켜 의약품 부족에 관한 이해관계자 운영위원회를 설립하고, 의약품 부족 문제에 대해 단계적 접근방식을 채택하고 있다. 유럽의약품청(European Medicines Agency)은 2019년 유럽 경제 지역(European Economic Area)의 의약품 부족 커뮤니케이션에 대한 지침을 발표하였다. 외국에서는 의약품 부족을 모니터링하고 적시에 대응하기 위해 다양한 이해관계자 간의 의사소통에 중점을 두고 있다는 점을 확인하였다. 국내에서도 의약품 수급불안정 문제가 지속되는 만큼, 전담조직을 구성하고 가이드라인을 마련하며, 정부, 제약사, 의약품 유통사 등 민간부문의 협의와 조정을 통해 문제를 개선하는 것이 필요하다.

Keywords

Acknowledgement

이 연구는 2023년도 건강보험심사평가원 연구개발비로 수행된 연구의 일부를 보완하였고, 연구지원에 감사드린다.

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