Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan
Background: Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. Methods: To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of c...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2015-09-01
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| Series: | EBioMedicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352396415300669 |
| _version_ | 1828520845535870976 |
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| author | Nobuhiro Handa Kensuke Ishii Yutaka Matsui Yuki Ando |
| author_facet | Nobuhiro Handa Kensuke Ishii Yutaka Matsui Yuki Ando |
| author_sort | Nobuhiro Handa |
| collection | DOAJ |
| description | Background: Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
Methods: To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of cardiovascular devices were retrieved. Two durations were calculated: (1) time from the date the AE occurred to that when the MAH captured it (DOC: days); and (2) time from the date of MAH capture to that of MAH report (DCR: days). Number of DOC > 15 days (DOC15) and delayed reports (DCR > 15 or 30 days) were also calculated.
Results: AEs included 9.2% deaths and 7.5% non-recoveries. DOC15 and delayed reports were 51.0% and 10.9%, respectively. By multivariate analysis, DOC15 was associated with foreign AE, device category, MAH, patient outcome, event category, and AE that had to be reported within 15 or 30 days (AE15/30). Delayed report was associated with device category, MAH, patient outcome, event category, and AE15/30.
Comments: Although Japanese MAHs complied with the obligation to report AEs, they often failed to share AEs with healthcare providers. Registry may be a potential solution, although the cooperation of healthcare providers to input data is essential. |
| first_indexed | 2024-12-11T19:38:12Z |
| format | Article |
| id | doaj.art-1985e17c7e524127be38d49a5d9126aa |
| institution | Directory Open Access Journal |
| issn | 2352-3964 |
| language | English |
| last_indexed | 2024-12-11T19:38:12Z |
| publishDate | 2015-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EBioMedicine |
| spelling | doaj.art-1985e17c7e524127be38d49a5d9126aa2022-12-22T00:53:06ZengElsevierEBioMedicine2352-39642015-09-01291211121610.1016/j.ebiom.2015.07.011Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, JapanNobuhiro HandaKensuke IshiiYutaka MatsuiYuki AndoBackground: Marketing authorization holders (MAHs) are obligated to report adverse events (AEs) within 15 days (some cases 30 days) to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. Methods: To analyze the timeliness of AE reporting to the PMDA, 6610 reports for five categories of cardiovascular devices were retrieved. Two durations were calculated: (1) time from the date the AE occurred to that when the MAH captured it (DOC: days); and (2) time from the date of MAH capture to that of MAH report (DCR: days). Number of DOC > 15 days (DOC15) and delayed reports (DCR > 15 or 30 days) were also calculated. Results: AEs included 9.2% deaths and 7.5% non-recoveries. DOC15 and delayed reports were 51.0% and 10.9%, respectively. By multivariate analysis, DOC15 was associated with foreign AE, device category, MAH, patient outcome, event category, and AE that had to be reported within 15 or 30 days (AE15/30). Delayed report was associated with device category, MAH, patient outcome, event category, and AE15/30. Comments: Although Japanese MAHs complied with the obligation to report AEs, they often failed to share AEs with healthcare providers. Registry may be a potential solution, although the cooperation of healthcare providers to input data is essential.http://www.sciencedirect.com/science/article/pii/S2352396415300669Adverse event reportCardiovascular deviceRegistryPharmaceuticals and Medical Devices Agency |
| spellingShingle | Nobuhiro Handa Kensuke Ishii Yutaka Matsui Yuki Ando Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan EBioMedicine Adverse event report Cardiovascular device Registry Pharmaceuticals and Medical Devices Agency |
| title | Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan |
| title_full | Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan |
| title_fullStr | Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan |
| title_full_unstemmed | Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan |
| title_short | Reporting of Cardiovascular Medical Device Adverse Events to Pharmaceuticals and Medical Devices Agency, Japan |
| title_sort | reporting of cardiovascular medical device adverse events to pharmaceuticals and medical devices agency japan |
| topic | Adverse event report Cardiovascular device Registry Pharmaceuticals and Medical Devices Agency |
| url | http://www.sciencedirect.com/science/article/pii/S2352396415300669 |
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