| アブストラクト | INTRODUCTION: On 4 February, 2020, the Secretary of the Department of Health and Human Services declared a public health emergency related to coronavirus disease 2019 (COVID-19), and on 27 March, 2020 declared circumstances existed to justify the authorization of the emergency use of drug and biological products (hereafter, "drugs") for COVID-19. At the outset of the pandemic with uncertainty relating to the virus, many drugs were being used to treat or prevent COVID-19, resulting in the US Food and Drug Administration's (FDA's) need to initiate heightened surveillance across these drugs. OBJECTIVE: We aimed to describe the FDA's approach to monitoring the safety of drugs to treat or prevent COVID-19 across multiple data sources and the subsequent actions taken by the FDA to protect public health. METHODS: The FDA conducted surveillance of adverse event and medication error data using the FDA Adverse Event Reporting System, biomedical literature, FDA-American College of Medical Toxicology COVID-19 Toxicology Investigators Consortium Pharmacovigilance Project Sub-registry, and the American Association of Poison Control Centers National Poison Data System. RESULTS: From 4 February, 2020, through 31 January, 2022, we identified 22,944 unique adverse event cases worldwide and 1052 unique medication error cases domestically with drugs to treat or prevent COVID-19. These were from the FDA Adverse Event Reporting System (22,219), biomedical literature (1107), FDA-American College of Medical Toxicology COVID-19 Toxicology Investigator's Consortium Sub-registry (638), and the National Poison Data System (32), resulting in the detection of several important safety issues. CONCLUSIONS: Safety surveillance using near real-time data was critical during the COVID-19 pandemic because the FDA monitored an unprecedented number of drugs to treat or prevent COVID-19. Additionally, the pandemic prompted the FDA to accelerate innovation, forging new collaborations and leveraging data sources to conduct safety surveillance to respond to the pandemic. |
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| ジャーナル名 | Drug safety |
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| 投稿日 | 2022/12/3 |
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| 投稿者 | Diak, Ida-Lina; Swank, Kimberley; McCartan, Kate; Beganovic, Maya; Kidd, James; Gada, Neha; Kapoor, Rachna; Wolf, Lisa; Kangas, Laura; Wyeth, Jo; Salvatore, Toni; Fanari, Melina; LeBoeuf, Andrew A; Mishra, Poonam; Blum, Michael D; Dal Pan, Gerald |
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| 組織名 | Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research,;US Food and Drug Administration, Silver Spring, MD, USA.;Ida-Lina.Diak@fda.hhs.gov.;Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug;Administration, Silver Spring, MD, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36460854/ |
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