주요국의 수급불안정 의약품 관리제도에 관한 고찰과한국에의 시사점

초록

Drug shortage is a persistent phenomenon that poses a public health risk worldwide and occurs due to a range of causes. The purpose of thisstudy is to review key policies to prepare for and respond to drug shortages in selected countries, such as the United States, Canada, and someEuropean countries in order to draw implications. This study reviewed the reports and articles derived from search engines and Google Scholarby using keywords such as drug shortage and stock-out. Over the last decade or so, the United States have strengthened requirements onadvance notification for disruption and interruption of drug manufacturing, established the Inter-agency Drug Shortages Task Force to promotethe 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 shortageproblem and released a detailed information guide on communication. In 2019, the joint task force between the European Medicines Agencyand the Heads of Medicines Agencies issued guidelines on drug shortage communication in the European Economic Area. The countriesreviewed in this paper focus on communication across different stakeholders for the monitoring of and timely response to drug shortages. Theefforts to protect public health from the negative impact of the drug shortage crisis would require multi-sectorial and multi-governmentalcoordination and development of guidelines.

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