Analysis of fall-related adverse events among older adults using the Japanese Adverse Drug Event Report (JADER) database

Hatahira, Haruna; Hasegawa, Shiori; Sasaoka, Sayaka; Kato, Yamato; Abe, Junko; Motooka, Yumi; Fukuda, Akiho; Naganuma, Misa; Nakao, Shin-ichi; Mukai, Ririka; Shimada, Kazuyo; Hirade, Kouseki; Kato, Takeshi; Nakamura, Mitsuhiro

doi:10.1186/s40780-018-0129-8

Cited by 16 publications

(15 citation statements)

References 63 publications

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“…Retrospective data analysis was performed using two different RWD in Japan. The Japanese Adverse Drug Event Report (JADER), a public spontaneous ADR database constructed by the Pharmaceuticals and Medical Devices Agency (PMDA), and a large prescription database constructed by a database vendor (Japan Medical Information Research Institute, Inc Japan [JMIRI]) database were analysed.…”

Section: Methodsmentioning

confidence: 99%

Polypharmacy in elderly patients in Japan: Analysis of Japanese real‐world databases

et al. 2020

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What is known and objective Polypharmacy is associated with an increased risk of adverse drug reactions (ADRs) and drug interactions, decreased adherence to medication and increased medical cost. Recently, polypharmacy has become a major problem in medical care in Japan as a result of the increase in the ageing population. The purpose of this study was to investigate the current situation of polypharmacy and the association between polypharmacy and adverse events. Methods A retrospective data analysis was performed using two different real‐world data from 2007 to 2015 in Japan. The Japanese Adverse Drug Event Report (JADER), a public spontaneous adverse drug reaction database constructed by the Pharmaceuticals and Medical Devices Agency (PMDA), and a large prescription database constructed by a database vendor (Japan Medical Information Research Institute, Inc Japan [JMIRI]) were analysed. Trends of polypharmacy during the study period were investigated. Results and discussion The mean number of drugs per report in the JADER database and per prescription in the JMIRI databases during the study period ranged from 4.8 to 5.6 and 3.5 to 3.7, respectively. The mean number of drugs increased with age in both the JADER and JMIRI databases, and the peak of the mean number of drugs was at 80‐89 years (5.74 drugs) in the JADER database and at 90‐99 years (4.97 drugs) in the JMIRI database. What is new and conclusions The number of drugs increased until age 90 years or more, even though adverse events are more likely to occur after the age of 80 in Japan. Therefore, polypharmacy in the elderly should be focused on the patients aged ≥80 years rather than patients aged ≥65 years from the viewpoint of the prevention of adverse events.

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Section: Methodsmentioning

confidence: 99%

Polypharmacy in elderly patients in Japan: Analysis of Japanese real‐world databases

et al. 2020

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“…Based on an SRS database, data mining algorithms have been developed to identify drug-associated adverse events (AEs) as signals using reporting odds ratio (ROR) by employing a stepwise method. We previously reported that the concomitant use of drugs might increase the risk of AEs using these approaches [21,22].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database

et al. 2020

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Clostridium difficile-associated colitis (CDAC) may cause gastrointestinal illness, ranging in severity from mild diarrhea to fulminant colitis and even mortality. The purpose of this study was to evaluate anti-infective-related CDAC profiles using the Japanese Adverse Drug Event Report (JADER) database. Methods: We selected case reports of adverse events of CDAC as specified in the Medical Dictionary for Regulatory Activities. The association between the number of administered anti-infectives and aging was evaluated using reporting odds ratio (ROR) and adjusted for covariates using multiple-logistic regression. We also evaluated anti-infective-related CDAC-onset profiles using Weibull shape parameter. Results: The JADER database contained 534 688 reports from April 2004 to June 2018. There were 1222 anti-infective related CDAC events. The top five anti-infectives were as follows: third-generation cephalosporins (Anatomical Therapeutic Chemical (ATC) code: J01DD, 313 cases), fluoroquinolones (ATC code: J01MA, 201 cases), macrolides (ATC code: J01FA, 146 cases), carbapenems (ATC code: J01DH, 143 cases), and penicillins with extended spectrum (ATC code: J01CA, 103 cases). The adjusted RORs (95% confidence interval) in individuals using 1, 2, and ≥ 3 anti-infectives were 8.88 (7.05−11.18), 9.77 (6.89−13.86), and 18.39 (11.85−28.54), respectively. Moreover, 47.2% of CDACs occurred within 7 days of anti-infective therapy initiation. The adjusted ROR of interaction terms of ≥ 70 years × 1 drug was 21.81 (14.56−32.68). Conclusion: Our results suggest that the number of administered anti-infectives and patient age are associated with CDAC. These data may be particularly beneficial to prescribers and would contribute to improving the management of CDAC.

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“…The reporting odds ratio (ROR) has been used to derive an index for detecting drug-associated adverse events (AEs) [7,8]. We previously analyzed an SRS database and found that the combination of medications might increase the risk of AEs according to the index derived from the RORs [10][11][12]. In this study, we evaluated the anti-infectives-related AKI pro les using ROR.…”

Section: Introductionmentioning

confidence: 99%

“…By evaluating the adjusted RORs using a multivariate logistic regression analysis technique, Abe et al showed that polypharmacy and age might be more closely linked to an increased risk of kidney disorder than liver disorder [10]. Association rule mining in large databases is a new analytical approach for evaluating association rules between variables [11,17]. Hatahira et al applied this algorithm to assess the association rules among fall-related AEs, the number of administered drugs, and age in the JADER database [11].…”

Section: Introductionmentioning

confidence: 99%

“…Association rule mining in large databases is a new analytical approach for evaluating association rules between variables [11,17]. Hatahira et al applied this algorithm to assess the association rules among fall-related AEs, the number of administered drugs, and age in the JADER database [11]. Our study was focused on the association rules among anti-infectives-related AKI, the number of administered anti-infectives, and age.…”

Section: Introductionmentioning

confidence: 99%

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Risk Assessment for Anti-Infectives-Related Acute Kidney Injury Using the Japanese Adverse Drug Event Report Database

Nakao

Hasegawa

Umetsu

et al. 2020

Preprint

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Background: Acute kidney injury (AKI) is associated with significant increases in short- and long-term morbidity and mortality. Drug-induced AKI is a major concern in the present healthcare system. Our spontaneous reporting system (SRS) analysis assessed links between AKIs, along with patients’ age, as healthcare-associated risks and administered anti-infectives. We also generated anti-infectives-related AKI-onset profiles.Method: We calculated adjusted reporting odds ratios (RORs) for reports of anti-infectives-related AKIs (per Medical Dictionary for Regulatory Activities) in the Japanese Adverse Drug Event Report database and evaluated associations between anti-infectives and age by association rule mining. We evaluated time-to-onset data and hazard types using the Weibull parameter.Results: Among 534,688 reports (submission period: April 2004–June 2018), there were 21,727 AKI events. Anti-infective treatments including glycopeptide antibacterials, fluoroquinolones, third-generation cephalosporins, triazole derivatives, and carbapenems were associated with 596, 494, 341, 315, and 313 AKI incidences, respectively. Adjusted RORs of anti-infectives-related AKIs increased among older patients and were higher in anti-infective combination therapies [anti-infectives, ≥ 2; ROR, 2.75 (2.56–2.95)] than in monotherapies [ROR, 1.52 (1.45–1.61)]. In association rule mining, the number of anti-infectives and age were associated with anti-infectives-related AKI lift values (as consequent). Moreover, 48.1% of AKIs occurred within 5 days (median, 5.0 days) of anti-infective therapy initiation.Conclusion: Thus, adjusted RORs derived from our new SRS analysis indicate potential AKI risks linked to age and number of administered anti-infectives.

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Analysis of fall-related adverse events among older adults using the Japanese Adverse Drug Event Report (JADER) database

Cited by 16 publications

References 63 publications

Polypharmacy in elderly patients in Japan: Analysis of Japanese real‐world databases

Polypharmacy in elderly patients in Japan: Analysis of Japanese real‐world databases

Evaluation of anti-infective-related Clostridium difficile-associated colitis using the Japanese Adverse Drug Event Report database

Risk Assessment for Anti-Infectives-Related Acute Kidney Injury Using the Japanese Adverse Drug Event Report Database

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