Correction details clarify risks associated with drug management plans in Japan, indicating critical safety implications.
Correction on: Kameyama N, Hosaka A and Maeda H (2024) Current situation and issues regarding termination of risk management plans in Japan. Front. Med. 11:1387652. doi: 10.3389/fmed.2024.1387652 Wrong content There was a mistake in Tables 2 and3 as published. In Table 2, the number of drugs with important potential risks not listed in package inserts for RMP-terminated drugs was displayed as "16 (23.2)". The correct value is "15 (21.7)". The corrected )In Table 3, the total number and percentage of important potential risks not listed in package inserts were displayed as "24" and "14.6", respectively. The correct values are "23" and "14.0", respectively.The p-values in Table 3 were also recalculated accordingly. The p-values for malignant neoplasm, infectious disease, cerebral cardiovascular risks, antibody production, urinary system risks, medication error, disseminated intravascular coagulation, and suicide-related events were corrected from "0.0165", "0.4083", "0.1648", "0.1557", "0.2721", "0.2130", "0.1463", and "1.0000" to "0.0073", "0.3965", "0.1493", "0.1446", "0.2548", "0.1986", "0.1402", and "1.0000", respectively. The corrected Table 3 appears below. The original version of this article has been updated.Adding/removing text In the abstract, there was an error in the number and percentage of drugs with important potential risks not listed in package inserts in the Results section. The sentence was displayed as: "Upon RMP termination, 16 out of 69 drugs (23.2%) had important potential risks not listed in the package insert, with malignant neoplasm being the most common." This has been corrected to read: "Upon RMP termination, 15 out of 69 drugs (21.7%) had important potential risks not listed in the package insert, with malignant neoplasm being the most common."The original version of this article has been updated.Adding/removing textThe number and percentage of RMP-terminated drugs with important potential risks not listed in package inserts were incorrect. In the section Results, Paragraph 2, the sentence was displayed as: "However, 16 drugs (23.2%) had important potential risks, and 11 drugs (15.9%) had important missing information not listed." A correction has been made to the section Results, Paragraph 2: "However, 15 drugs (21.7%) had important potential risks, and 11 drugs (15.9%) had important missing information not listed."The original version of this article has been updated.The number and percentage of important potential risks not listed in package inserts and the p-value for malignant neoplasms were incorrect. In the section Results, Paragraph 3, the sentences were displayed as: "At the time of reexamination application of these drugs, we identified 164 important potential risks in the last RMPs, of which 24 risks (14.6%) were not included in the package inserts." "This was significantly higher than that for other important potential risks (p 0.0165)."Corrections have been made to the section Results, Paragraph 3:"At the time of reexamination application of these drugs, we identified 164 important potential risks in the last RMPs, of which 23 risks (14.0%) were not included in the package inserts." "This was significantly higher than that for other important potential risks (p = 0.0073)."The original version of this article has been updated.The percentage of important potential risks not listed in package inserts at the time of RMP termination was incorrect. In the section Discussion, Paragraph 2, the sentence was displayed as: "As for important potential risks, 14.6% of the potential risks were not listed in the package insert at the time of RMP termination." A correction has been made to the section Discussion, Paragraph 2:"As for important potential risks, 14.0% of the potential risks were not listed in the package insert at the time of RMP termination."The original version of this article has been updated.
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