The quality assessment of the Japanese Adverse Drug Event Report database using vigiGrade

Tsuchiya, Masami; Obara, Taku; Miyazaki, Masaru; Noda, Aoi; Takamura, Chizuko; Mano, Nariyasu

doi:10.1007/s11096-020-00969-7

Cited by 17 publications

(13 citation statements)

References 14 publications

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“…Time-to-onset was calculated from the suspect drug start date and the ADR onset date and used in the vigiGrade completeness score calculation (Figure S1). As with our previous research (15), some of the assessed elements and penalties used in this study were modified from the original vigiGrade completeness score (Table S1). In previous research by the WHO Uppsala Monitoring Centre (9), a vigiGrade completeness score of >0.8 was defined as a 'well-documented report'.…”

Section: Methodsmentioning

confidence: 99%

“…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%

“…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. The vigiGrade completeness score was developed to measure the amount of clinically relevant information in a structured format without reflecting whether the information establishes causality between the drug and ADR (15). In this study, we compared and contrasted the characteristics of reports using the two schemes.…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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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“…There is much debate about the human papillomavirus vaccine in Japan. Thus, we contend that the JADER should be interpreted with caution because an event occurring after vaccination is not necessarily caused by the vaccination, and the quality of the ADR reports in the JADER has varied historically [ 22 , 23 ].…”

Section: Discussionmentioning

confidence: 99%

Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database

et al. 2020

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The present study aimed to describe the trends and characteristics of adverse events following immunization (AEFI) reporting for children in the Japanese Adverse Drug Event Report database (JADER). We used 6280 AEFI reports for children aged <19 years among 504,407 ADR reports included in the JADER from 2004 to 2017. The number of AEFI reports gradually increased among children aged <10 years and was the highest in 2011 among children aged 10–19 years. The number of suspected vaccines per AEFI report increased after 2011 among children aged <10 years. The percentage of “death” and “did not recover” as AEFI outcomes reported were 4.3% and 3.7% among children aged <10 years and 0.2% and 21.1% among children aged 10–19 years, respectively. The most frequently reported vaccine–reaction pair was Haemophilus influenzae type b conjugate vaccine and pyrexia among children aged <10 years and recombinant adsorbed bivalent human papillomavirus-like particle vaccine and a loss of consciousness among children aged 10–19 years. It is necessary to consider the Weber effects to understand the trend and characteristics of AEFI reporting because pharmacovigilance activity regarding vaccination is not sufficient in Japan.

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“…Similarly, another Spanish study showed overall completion rate of 88% on the vigiGrade score for spontaneous ADR reports [36]. A Japanese study, which evaluated over 8000 reports from medical institutions, found that 75.6% were 'well documented' on the vigiGrade criteria, but 'time-to-onset' of reactions could not be determined in 14.9% of cases [37].…”

Section: Quality Of Adr Reportsmentioning

confidence: 95%

Adverse drug reaction management in hospital settings: review on practice variations, quality indicators and education focus

Aung

Walker

Khu

et al. 2022

Eur J Clin Pharmacol

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Purpose Adverse drug reactions (ADRs) contribute significantly to healthcare burden. However, they are largely preventable through appropriate management processes. This narrative review aims to identify the quality indicators that should be considered for routine monitoring of processes within hospital ADR management systems. It also examines the potential reasons behind variation in ADR management practices amongst HCPs, and explores possible solutions, focusing on targeted education programmes, to improve both the quality and quantity indicators of ADR management processes. Methods A comprehensive literature review was conducted to explore relevant themes and topics concerning ADR management, quality indicators and educational interventions. Results Substantial variability exists in ADR management amongst healthcare professionals (HCPs) with regard to reporting rates, characteristics of ADRs reported, quality of assessment, completeness of reports and, most importantly, risk communication practices. These variable practices not only threaten patient safety but also undermine pharmacovigilance processes. To date, quality indicators to monitor ADR management practices within hospital settings remain ill-defined. Furthermore, evidence behind effective interventions, especially in the form of targeted education strategies, to improve the quality of ADR management remains limited. Conclusions The focus of ADR management in hospitals should be to promote patient safety through comprehensive assessment, risk communication and safe prescribing. There is a need to develop a system to define, measure and monitor the quality of ADR management. Educational strategies may help improve the quality of ADR management processes.

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The quality assessment of the Japanese Adverse Drug Event Report database using vigiGrade

Cited by 17 publications

References 14 publications

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

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

Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database

Adverse drug reaction management in hospital settings: review on practice variations, quality indicators and education focus

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