부산대학교 도서관

Drug supply chain stabilization is important to ensure the treatment quality and medication safety. To protect the rights to obtain essential drugs, the drug shortage management has been developed since 2012 in Taiwan, including establishing an assessment mechanism for shortage cases, strengthening the regulatory management, and building the online shortage reporting system to allow the clinical side to master the supplying status of the shortage drugs and their substitutes. If concerned of any insufficient supply of drugs, the authority may post on a public platform, and grant special permission to manufacture or import the drug to ensure the drug supply. During 2019 to 2021, 2,470 shortage cases were reported, while most of them were repeatedly reported or cases with no shortage after investigation, and 717 (29%) cases needed to be further assessed for their clinical necessities and alternatives. By evaluating the shortage reports, most cases had alternative drugs, and only 62 (8.6%) cases were in shortage and needed to grant special permission for manufacturing or importing the alternatives. Due to the outbreak of the COVID-19 in 2020, the shortage cases were widely increased, the main reasons of the shortages included drug raw material issues (such as shortage of active pharmaceutical ingredients), manufacturing issues (such as city lockdown or employee infection, resulting in reduced productivity), and distribution issues (such as uneven distribution of domestic drugsor international transportation issues). TFDA continued to take relevant actions, including enhancing domestic drug distribution, strengthening drug supply monitoring and active pharmaceutical ingredients storage, and accelerating drug supply information transmission in order to reduce the impact of pandemic on supply chain. With the globalization, many factors could fluctuate drug supply chain. How to avoid drug shortage is still a big issue among countries, and we still need to improve the drug shortage management system to ensure the continuity of patient care.