{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T05:57:06Z","timestamp":1790575026347,"version":"4.1.0"},"reference-count":40,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T00:00:00Z","timestamp":1790553600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Drug shortages threaten treatment continuity and health-system resilience, yet empirical evidence from South Korea remains limited.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a nationwide, retrospective descriptive analysis of 868 drug products (1,054 shortage reports) officially reported to the Ministry of Food and Drug Safety (MFDS) between January 2018 and February 2024. Shortages were characterized by frequency, reported cause (six categories), and duration, and compared between reportable and non-reportable drugs. Duration analyses were restricted to 360 temporary supply disruptions. To examine COVID-19-related temporal patterns, temporary supply disruptions during 2018\u20132023 were grouped into pre-COVID-19 (2018\u20132019), COVID-19 (2020\u20132021), and later COVID-19 (2022\u20132023) periods, defined a priori around the WHO pandemic declaration. Continuous variables were summarized as median (interquartile range, IQR) and categorical variables as counts (%). Analyses were descriptive; no causal inference was intended.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A directly substitutable product with the same active ingredient, strength, and dosage form was available for only 269 of 868 drugs (31.0%). Cause structures differed by event type: internal supply issues predominated among temporary supply disruptions (183\/396 cause attributions, 46.2%) and business decisions among permanent discontinuations (418\/720, 58.1%). Among temporary supply disruptions, regulatory constraints showed the longest durations (median 104 days; IQR 63.3\u2013328) and the largest share lasting \u2265366 days (25.0%). Products with \u22652 reported drug shortages were more frequent among orphan drugs (23.3%) and withdrawal-prevention drugs (21.1%), whereas Korean essential drugs showed a widely dispersed duration distribution (median 48 days; IQR 29.8\u2013233.8; 25.6% &amp;gt; 180 days). The numbers of temporary supply disruptions were 53, 106, and 178 in the pre-COVID-19, COVID-19, and later COVID-19\/recovery periods, respectively. While internal supply issues remained the leading reported cause throughout (69.8%, 53.4%, and 39.5%), the relative contribution of raw-material supply disruptions (11.3%\u201326.7%) and increased demand (9.4%\u201323.1%) grew.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The patterns observed are consistent with structural vulnerabilities related to market incentives, regulatory processes, and API import dependence, with raw-material and demand-related causes becoming more prominent in the later study periods. Potential policy responses, each requiring separate evaluation, include supply diversification, domestic API production, cost-compensation for economically vulnerable essential medicines, and a risk-based early-warning system with severity-tiered responses.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fphar.2026.1931826","type":"journal-article","created":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T05:43:54Z","timestamp":1790574234000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Frequency, causes, and duration of drug shortages in South Korea, 2018\u20132024: a nationwide descriptive analysis of regulatory reporting data and temporal patterns across the COVID-19 pandemic"],"prefix":"10.3389","volume":"17","author":[{"given":"Ji Young","family":"Kim","sequence":"first","affiliation":[{"name":"College of Pharmacy, Chung-Ang University","place":["Seoul, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eun Young","family":"Shin","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Chung-Ang University","place":["Seoul, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ju Won","family":"Park","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Chung-Ang University","place":["Seoul, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seung Soo","family":"Lee","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Chung-Ang University","place":["Seoul, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoo Jin","family":"Lee","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Chung-Ang University","place":["Seoul, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yun Jae","family":"Jung","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Chung-Ang University","place":["Seoul, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min Ji","family":"Kim","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Chung-Ang University","place":["Seoul, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu Kyoung","family":"Song","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Chung-Ang University","place":["Seoul, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chae Yun","family":"Kim","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Chung-Ang University","place":["Seoul, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Se Hee","family":"Lee","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Sookmyung Women\u2019s University","place":["Seoul, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jong Hyuk","family":"Lee","sequence":"additional","affiliation":[{"name":"College of Pharmacy, Chung-Ang University","place":["Seoul, Republic of Korea"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,28]]},"reference":[{"key":"B1","volume-title":"Addressing the Root Causes of Medicines Shortages: Supply Chain Stakeholders\u2019 Views on Root Causes and Solutions","author":"AESGP","year":"2019"},{"key":"B2","doi-asserted-by":"publisher","first-page":"e244246","DOI":"10.1001\/jamanetworkopen.2024.4246","article-title":"Drug shortages prior to and during the COVID-19 pandemic","volume":"7","author":"Callaway Kim","year":"2024","journal-title":"JAMA Netw. Open"},{"key":"B3","doi-asserted-by":"publisher","first-page":"102271","DOI":"10.1016\/j.tre.2021.102271","article-title":"COVID-19 pandemic related supply chain studies: a systematic review","volume":"148","author":"Chowdhury","year":"2021","journal-title":"Transp. Res. E Logist. Transp. Rev."},{"key":"B4","unstructured":"Communication from the commission to the european parliament, the council, the european economic and social committee and the committee of the regions: addressing medicine shortages in the EU. COM(2023) 672 final. Brussels:"},{"key":"B5","unstructured":"Proposal for a regulation of the european parliament and of the council laying down union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the european medicines agency. COM(2023) 193 final. Brussels:"},{"key":"B6","volume-title":"Directorate-General for Health and Food Safety; Technopolis Group; Ecorys; Milieu Ltd. Future-proofing Pharmaceutical Legislation: Study on Medicine Shortages \u2014 Final Report (Revised)","year":"2021"},{"key":"B7","volume-title":"Proposal for a Regulation of the European Parliament and of the Council Laying a Framework for Strengthening the Availability and Security of Supply of Critical Medicinal Products as Well as the Availability Of, and Accessibility Of, Medicinal Products of Common Interest, and Amending Regulation (EU) 2024\/795 (Critical Medicines Act). COM(2025) 102 Final","year":"2025"},{"key":"B8","volume-title":"European Medicines Shortages Research Network\u2014Addressing Supply Problems to Patients. Brussels: COST","year":"2018"},{"key":"B9","unstructured":"Critical shortages of medicines: EU measures were of added value, but structural problems remain. Special report 19\/2025\n          \n          \n          2025"},{"key":"B10","unstructured":"Guidance on detection and notification of shortages of medicinal products for marketing authorisation holders (MAHs) in the Union (EEA)\n          \n          \n          2019"},{"key":"B11","volume-title":"Union List of Critical Medicines","year":"2026"},{"key":"B12","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1111\/ijpp.12063","article-title":"European drug shortages: a call for action","volume":"21","author":"Huys","year":"2013","journal-title":"Int. J. Pharm. Pract."},{"key":"B13","first-page":"150","article-title":"A study for identifying current drug shortages of public hospitals and improving the drug shortage information delivery system","volume":"57","author":"Kim","year":"2013","journal-title":"J. Pharm. Soc. 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Policy"},{"key":"B17","unstructured":"Regulation on the designation of orphan drugs (MFDS notice no. 2018-41)\n          \n          \n          2018"},{"key":"B18","volume-title":"Status of Domestic self-sufficiency in Active Pharmaceutical Ingredients","year":"2022"},{"key":"B19","volume-title":"2022 Drug and quasi-drug Production, Export and Import Statistics","year":"2023"},{"key":"B20","unstructured":"Regulation on the reporting of medicinal products subject to notification of suspension of production, importation, or supply (MFDS notification no. 2025-33)\n          \n          \n          2025"},{"key":"B21","unstructured":"National drug information portal\n          \n          \n          2026"},{"key":"B22","article-title":"Notification on medicinal products subject to reporting of suspension of production","volume-title":"Importation, or Supply (MOHW Notification No. 2022-269, Effective 1 December 2022)","year":"2022"},{"key":"B23","volume-title":"Protocol for the Notification and Communication of Drug Shortages","year":"2017"},{"key":"B24","volume-title":"Dossier Pharmaceutique","year":"2024"},{"key":"B25","doi-asserted-by":"publisher","first-page":"1608843","DOI":"10.3389\/fphar.2025.1608843","article-title":"Drug shortage in South Korea: machine learning-based prediction models and analysis of duration and causal factors","volume":"16","author":"Roe","year":"2025","journal-title":"Front. 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