Pharmacovigilance and Risk Management in Japan

Kubota, Kiyoshi; Koyama, Hiroko

doi:10.1002/9780470059210.ch31

Cited by 4 publications

(1 citation statement)

References 8 publications

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“…Regarding “company reports,” grade 2 was the most frequent, followed by grade 0. “Company reports” in the JADER, which were based on various sources, including spontaneous reports from medical institutions, early postmarketing phase surveillance, research, literature reports, conference presentation, Internet, and so forth, were likely to have differences in quality . In some cases, it would be difficult for pharmaceutical companies to obtain more detailed information regarding ADR cases from information sources that could not be untraceable, although detailed information regarding the sources of ADR reports was undisclosed in the JADER.…”

Section: Discussionmentioning

confidence: 99%

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

Tsuchiya

Obara

Sakai

et al. 2019

Pharmacoepidemiology and Drug

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Introduction: The spontaneous adverse drug reaction (ADR) reporting system plays an important role in pharmacovigilance by providing information from clinical settings in the postmarketing environment. The Japanese Adverse Drug Event Report (JADER) database contains a portion of Japanese ADR reports, and no previous study has described the quality or characteristics of ADR reports in the JADER.Objective: The aim of this study was to identify the characteristics of the JADER database and to evaluate the quality of ADR reports contained in the JADER using the documentation-grading scheme developed by the World Health Organization.Methods: Of 478 508 ADR reports in the JADER, the analysis set consisted of 395 091 reports meeting inclusion criteria. An analysis was carried out to evaluate the quality of the reports according to the type of report, the type of sender, and the qualification of the reporter. Annual changes in the number of reports from medical institutions submitted by pharmacists were compared with changes in the number submitted by physicians.Results: The distribution of documentation grade differed according to the type of report, the type of sender, and the qualification of the reporter. Regarding "medical institution reports", the quality of reports was similar among qualification types, while the quality of reports submitted by physicians was higher for "company reports" and "study reports" (P < .0001, respectively). Conclusion:Our study showed that the quality of the ADR reports in the JADER differed among the type of report, the sender of the report, and the qualification of the reporter.

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Section: Discussionmentioning

confidence: 99%

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

Tsuchiya

Obara

Sakai

et al. 2019

Pharmacoepidemiology and Drug

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Pharmacovigilance and Risk Management in Japan

Kubota¹,

Sato²

2014

Mann's Pharmacovigilance

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Polypharmacy and adverse drug reactions in Japanese elderly taking antihypertensives: a retrospective database study

Sato¹,

Akazawa²

2013

DHPS

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BackgroundThe concomitant use of multiple medications by elderly patients with hypertension is a relatively common and growing phenomenon in Japan. This has been attributed to several factors, including treatment guidelines recommending prescription of multiple medications and a continuing increase in the elderly population with multiple comorbidities.ObjectiveThis study was aimed at investigating the association between polypharmacy, defined as the concomitant use of five or more medications, and risk of adverse drug reaction (ADR) in elderly Japanese hypertensive patients to examine the hypothesis that risk of ADR increases with the administration of an increasing number of co-medications.MethodsUsing a retrospective cohort design, the data regarding all hypertensive patients aged 65 years or older were extracted from the Risk/Benefit Assessment of Drugs – Analysis and Response Council antihypertensive medication database. The data were reviewed for classification of patients into one of three groups according to drug use at the initiation of therapy – a monotherapy group composed of patients who had taken the investigated drug only, a co-medication group composed of patients who had taken the investigated drug and a maximum of three other medications, and a polypharmacy group composed of patients who had taken the investigated drug and four or more other medications – and determination of the number of ADR events experienced. Estimated rate ratios (RRs) and 95% confidence intervals (CIs) were calculated using a Poisson regression model adjusted for drug category and patient age and sex. Various sensitivity analyses were performed to confirm the robustness of the study findings.ResultsOf 61,661 elderly Japanese patients (men, 41.8%; 75 years or older, 35.1%) registered in the database, 2491 patients (4.0%) experienced a total of 3144 ADR events during the study period. The rate of ADR per 10,000 person-days was 2.0 for the monotherapy group, 5.1 for the co-medication group, and 8.6 for the polypharmacy group. After adjusting for age, sex, and initial antihypertensive therapy, the RR was estimated at 2.4 (95% CI, 2.2–2.6) for the co-medication group and 4.3 (95% CI, 3.8–4.8) for the polypharmacy group, when compared with the monotherapy group.ConclusionThe use of polypharmacy increases the risk of ADR among elderly Japanese patients with hypertension, calling for regular medication review to eliminate the administration of unnecessary co-medications.

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Pharmacovigilance and Risk Management in Japan

Cited by 4 publications

References 8 publications

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

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

Pharmacovigilance and Risk Management in Japan

Polypharmacy and adverse drug reactions in Japanese elderly taking antihypertensives: a retrospective database study

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