Quality evaluation of the Japanese Adverse Drug Event Report database (JADER)

Tsuchiya, Masami; Obara, Taku; Sakai, Takamasa; Nomura, Kaori; Takamura, Chizuko; Mano, Nariyasu

doi:10.1002/pds.4944

Cited by 26 publications

(20 citation statements)

References 17 publications

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“…Given that signal detection is a hypothesis-generating study, future efforts to accumulate cases and confirm/refute hypotheses are desirable. In addition, information available on individual case safety reports is limited [ 23 ]. In particular, spontaneous reports do not include information on which term of pregnancy the drug was used, which is essential for assessing the causal relationship between drug exposure and pregnancy outcome.…”

Section: Discussionmentioning

confidence: 99%

Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Disproportionality Analysis Using Japanese and US Spontaneous Reporting Databases

Sakai

Mori

Koshiba

et al. 2021

Drugs - Real World Outcomes

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Background There is limited research regarding the use of glaucoma medicines during pregnancy. Prostaglandins contract uterine smooth muscle; however, it is not clear whether prostaglandin eye drops are associated with pregnancy loss in pregnant women. Objectives We conducted a pharmacovigilance study using spontaneous report databases from Japan and the USA to evaluate the association between pregnancy loss and the use of prostaglandin eye drops during pregnancy. Methods The Japanese Adverse Drug Event Report database and the Food and Drug Administration Adverse Event Reporting System were used for analysis. Disproportionality analyses and a review of individual case safety reports were conducted. Results As for prostaglandin eye drops in pregnancy-related reports, there were eight reports involving latanoprost in the Japanese Adverse Drug Event Report database and no reports of pregnant women using other prostaglandin eye drops. In the Food and Drug Administration Adverse Event Reporting System, there were 25 reports involving latanoprost, 23 involving bimatoprost, 13 involving travoprost, and three involving tafluprost. The drug safety signal was detected during latanoprost usage and pregnancy loss. In the Japanese Adverse Drug Event Report database, there were five reports of pregnancy loss related to latanoprost, with a reporting odds ratio of 12.84 (95% confidence interval 3.06–53.86), and in the Food and Drug Administration Adverse Event Reporting System, pregnancy loss was reported in 12 cases of latanoprost usage with a reporting odds ratio of 4.35 (95% confidence interval 1.98–9.54). Uterine contractions were observed as concomitant adverse events in one case. Conclusions Although a disproportionality analysis cannot determine causality, we need to keep an eye on the signal detected in this study. This signal should be validated using a causal design study.

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Section: Discussionmentioning

confidence: 99%

Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Disproportionality Analysis Using Japanese and US Spontaneous Reporting Databases

Sakai

Mori

Koshiba

et al. 2021

Drugs - Real World Outcomes

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“…Completeness assessment tools include: the WHO's documentation grading scheme (8); vigiGrade (9), which was created to assess the quality of the information in VigiBase; the ATHE score (10); amongst other methods of calculating completeness scores (11)(12)(13). Here, we have analyzed the quality and characteristics of the JADER, using the WHO documentation grading scheme (14) and the vigiGrade (15). The WHO's documentation grading scheme, which was noted if essential elements (e.g., date of onset of ADR, duration of administration of suspected drugs, dose, and frequency of administration, rechallenge information) were given in the reports, could divide ADR reports into four grades.…”

Section: Introductionmentioning

confidence: 99%

High-quality reports and their characteristics in the Japanese Adverse Drug Event Report database (JADER)

Tsuchiya

Obara²,

Miyazaki³

et al. 2021

J Pharm Pharm Sci

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Purpose: Spontaneous adverse drug reaction reporting is the foundation of postmarketing drug safety monitoring. The present study aimed to analyze and clarify the quality and characteristics of the Japanese Adverse Drug Event Report database (JADER) using the World Health Organization (WHO) documentation grading scheme and the vigiGrade completeness score. The characteristics of reports were described using both schemes simultaneously. The way of proper use of these two schemes was explored. Methods: The WHO documentation grading scheme and the vigiGrade completeness score were applied to the same dataset (JADER202001 dataset). Reports classified as high-quality under both assessment criteria were extracted, and the characteristics of these reports were analyzed. Results: Of the 607,361 adverse drug reaction reports analyzed, 52.8% were ‘well-documented reports’ with a vigiGrade completeness score >0.8. Under the WHO documentation grading scheme, 328,702 reports (54.1%) were Grade 2 and 5,178 (0.9%) were Grade 3 (including rechallenge information). Among well-documented Grade 3 reports, classified as the highest quality, a high proportion of the adverse drug reaction reports were related to disorders of hematopoietic function resulting from anticancer drugs. Because a high proportion of the reports with rechallenge information were for anticancer drugs as suspect drugs, the WHO documentation grading scheme tended to extract reports regarding anticancer drugs as high quality. Conclusions: We conclude that the two schemes need to be used appropriately, depending on the purpose of analysis, the target adverse drug reactions, and suspect drugs.

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“…Small sample sizes may increase these biases. Second, a previous study showed that the quality of reports differed depending on the facilities or occupations in the JADER database [ 34 ], and the quality of the reports was not evenly distributed. Third, although ROR is suggested to be less biased than the proportional reporting ratio, which is a ratio of reporting proportions, there are still various biases [ 35 ].…”

Section: Discussionmentioning

confidence: 99%

Analysis of adverse drug events in pulmonary Mycobacterium avium complex disease using spontaneous reporting system

et al. 2022

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Background In Japan, Mycobacterium avium complex lung disease (MAC-LD) is the most common in nontuberculous mycobacterial lung disease. Patients often experience adverse events, resulting in the discontinuation of treatment, which causes treatment failure. The JADER (Japanese Adverse Drug Event Report) database is a database of adverse events that allows us to collect real-world data on adverse events. We can collect large-scale data cost-effectively and detect signals of potential adverse events such as reporting odds ratio (ROR) by using spontaneous reporting systems. In this study, we aimed to elucidate the adverse events of clarithromycin (CAM), ethambutol (EB), and rifampicin (RFP) using the JADER database. Methods We included cases of MAC-LD between April 2004 and June 2017. We investigated sex, age, and medications that may have caused the adverse events, outcomes, and time of onset. We calculated the safety signal index as the ROR. Time-to-event analysis was performed using the Weibull distribution. Results The total number of adverse events of CAM, EB, and RFP was 2780, with 806 patients. In the overall adverse events, hematologic and lymphatic disorders were the most common adverse events, with 17.3%, followed by eye disorders (16.6%), and hepatobiliary disorders (14.0%). The outcomes were as follows: recovery, 40.0%; remission, 27.1%; non-recovery, 11.2%; and death, 7.1%. Regarding the most common onset time of CAM, EB, and RFP was within 120 days at 40%, 181–300 days at 43.6%, and within 120 days at 88.5%. For CAM, the RORs of infections and infestations, hepatobiliary system disorders, and immune system disorders were 4.13 (95% confidence interval [CI], 2.3–7.44), 2.61 (95% CI, 1.39–4.91), and 2.38 (95% CI, 1.04–5.44). For EB, the ROR of eye disorders was 215.79 (95% CI, 132.62–351.12). For RFP, the RORs of renal and urinary tract disorders and investigations were 7.03 (95% CI, 3.35–14.77) and 6.99 (95% CI, 3.22–15.18). The β value of EB was 2.07 (95% CI, 1.48–2.76), which was classified as a wear-out failure type. Conclusions For MAC-LD, the adverse event which has the highest ROR is infections and infestations in CAM, eye disorders in EB, renal and urinary tract disorders in RFP. Adverse events of EB occur after 180 days, whereas the adverse events of CAM and RFP occur early in the course of treatment.

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Quality evaluation of the Japanese Adverse Drug Event Report database (JADER)

Cited by 26 publications

References 17 publications

Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Disproportionality Analysis Using Japanese and US Spontaneous Reporting Databases

Pregnancy Loss Signal from Prostaglandin Eye Drop Use in Pregnancy: A Disproportionality Analysis Using Japanese and US Spontaneous Reporting Databases

High-quality reports and their characteristics in the Japanese Adverse Drug Event Report database (JADER)

Analysis of adverse drug events in pulmonary Mycobacterium avium complex disease using spontaneous reporting system

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