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

Tsuchiya, Masami; Obara, Taku; Miyazaki, Masaru; Noda, Aoi; Sakai, Takamasa; Funakoshi, Ryohkan; Mano, Nariyasu

doi:10.18433/jpps31417

Cited by 4 publications

(3 citation statements)

References 7 publications

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“…In contrast, reports from PRHs and other HCPs (including regulatory affairs officers, clinical trial associates, nurses, and medical assistants) were flagged as the key features negatively associated with Malaysian report completeness ( Figure 2 B). These findings are consistent with the features observed in the United States [ 15 ], Brazil [ 16 ], Spain [ 17 ], South Korea [ 18 ], and Japan [ 19 , 20 ]. Of note, the NPRA classified the reports from PRHs as reported by other HCPs when the primary reporter was unknown.…”

Section: Discussionsupporting

confidence: 90%

Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST

Choo,

Sartori,

Lee

et al. 2024

JMIR Med Inform

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Background The completeness of adverse event (AE) reports, crucial for assessing putative causal relationships, is measured using the vigiGrade completeness score in VigiBase, the World Health Organization global database of reported potential AEs. Malaysian reports have surpassed the global average score (approximately 0.44), achieving a 5-year average of 0.79 (SD 0.23) as of 2019 and approaching the benchmark for well-documented reports (0.80). However, the contributing factors to this relatively high report completeness score remain unexplored. Objective This study aims to explore the main drivers influencing the completeness of Malaysian AE reports in VigiBase over a 15-year period using vigiGrade. A secondary objective was to understand the strategic measures taken by the Malaysian authorities leading to enhanced report completeness across different time frames. Methods We analyzed 132,738 Malaysian reports (2005-2019) recorded in VigiBase up to February 2021 split into historical International Drug Information System (INTDIS; n=63,943, 48.17% in 2005-2016) and newer E2B (n=68,795, 51.83% in 2015-2019) format subsets. For machine learning analyses, we performed a 2-stage feature selection followed by a random forest classifier to identify the top features predicting well-documented reports. We subsequently applied tree Shapley additive explanations to examine the magnitude, prevalence, and direction of feature effects. In addition, we conducted time-series analyses to evaluate chronological trends and potential influences of key interventions on reporting quality. Results Among the analyzed reports, 42.84% (56,877/132,738) were well documented, with an increase of 65.37% (53,929/82,497) since 2015. Over two-thirds (46,186/68,795, 67.14%) of the Malaysian E2B reports were well documented compared to INTDIS reports at 16.72% (10,691/63,943). For INTDIS reports, higher pharmacovigilance center staffing was the primary feature positively associated with being well documented. In recent E2B reports, the top positive features included reaction abated upon drug dechallenge, reaction onset or drug use duration of <1 week, dosing interval of <1 day, reports from public specialist hospitals, reports by pharmacists, and reaction duration between 1 and 6 days. In contrast, reports from product registration holders and other health care professionals and reactions involving product substitution issues negatively affected the quality of E2B reports. Multifaceted strategies and interventions comprising policy changes, continuity of education, and human resource development laid the groundwork for AE reporting in Malaysia, whereas advancements in technological infrastructure, pharmacovigilance databases, and reporting tools concurred with increases in both the quantity and quality of AE reports. Conclusions Through interpretable machine learning and time-series analyses, this study identified key features that positively or negatively influence the completeness of Malaysian AE reports and unveiled how Malaysia has developed its pharmacovigilance capacity via multifaceted strategies and interventions. These findings will guide future work in enhancing pharmacovigilance and public health.

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Section: Discussionsupporting

confidence: 90%

Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST

Choo,

Sartori,

Lee

et al. 2024

JMIR Med Inform

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“…The number of reports on ADRs in the JADER has been increasing yearly; however, most reports are from companies, while those from medical institutions are few. Tsuchiya et al 24 . demonstrated that of 561 122 ADR reports in the JADER, 419 540 (98.1%) were reported by pharmaceutical companies and 8257 (1.9%) were reported by medical institutions.…”

Section: Discussionmentioning

confidence: 99%

Analysis of drug‐induced liver‐related adverse event trend reporting between 1997 and 2019

Kamimura

Setsu

Kimura

et al. 2023

Hepatology Research

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Aim This study aimed to analyze the current trends of drug‐induced liver‐related adverse events in the Food and Drug Administration Adverse Event Reporting System (FAERS) and Japanese Adverse Drug Event Report (JADER) databases. Methods The characteristics of implicated drugs were investigated by analyzing big data on drug‐induced liver‐related adverse events over the past 20 years in FAERS, comparing drug rankings between the JADER and FAERS databases, and calculating rankings of drugs inducing liver‐related adverse events using the Medical Dictionary for Regulatory Activities Terminology. Results In the 452 272 cases registered in FAERS from 1997 to 2019, warfarin, paracetamol, and adalimumab were the drugs most related to drug‐induced liver injury (DILI). In the 38 919 cases registered in JADER from 2004 to 2019, sorafenib, nivolumab, and herbal extracts were the drugs most related to DILI. No associations were found between the top 30 drugs in either of the two databases. Notably, the number of drug‐induced liver‐related adverse event reports and total adverse events has sharply increased in recent years. Conclusions Although liver‐related adverse events are largely caused by host immunity and other constitutional factors, differences in primary diseases, countries, and historical backgrounds lead to differences in the number of reports. Securing an appropriate database and a mechanism to collect real‐time information on the frequency of adverse drug reactions is warranted.

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“…Our previous study indicated that the number of ADR reports submitted by pharmacists significantly increased with an increase in the number of hospitals charging an additional fee for pharmacist-performed ward operations. [22][23][24] It was suggested that the implementation of ward-based clinical pharmacy services provides clinical pharmacists with opportunities to encounter more ADRs and enhances cooperation between pharmacists handling drug information services and those handling ward operation services. Thus, posting pharmacists at wards and providing drug-related information could be effective in promoting ADR reporting.…”

Section: Discussionmentioning

confidence: 99%

Characteristics of hospitals that report adverse drug reactions: Results of a nationwide survey in Japan

Tsuchiya

Kikuchi

Hatakeyama

et al. 2022

Clinical Pharmacy Therapeu

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What is known and Objective Adverse drug reactions (ADRs) are one of the primary reasons for hospitalization. The spontaneous reporting of ADRs by healthcare professionals is important for issuing post‐marketing drug safety measures. The Japanese Society of Hospital Pharmacists (JSHP) conducts a nationwide survey annually. Using data from this large‐scale survey, we identified the characteristics of hospitals that reported ADRs to regulatory authorities and pharmaceutical companies. Methods Data were obtained from annual surveys conducted by JSHP from 2015 to 2020. All variables were expressed as categorical variables and tabulated. The Chi‐square test was used to compare the categorical variables. The Cochran–Armitage trend test was used to identify significant trends in the proportion of hospitals reporting ADRs. Results and Discussion From 2015 to 2020, 22,362 responses were recorded. There was a significant increase in the proportion of hospitals that reported ADRs with an increase in number of beds and pharmacists (p < 0.0001). The proportion of hospitals reporting ADRs to regulatory authorities was also significantly higher in those charging an additional fee for pharmacist‐performed ward operations and in those with an ADR data management section than in hospitals without these attributes (p < 0.0001). What is new and Conclusion Hospitals that submitted ADR reports to the regulatory authorities and pharmaceutical companies charged an additional fee for pharmacist‐performed ward operations, had a central ADR data management section, and had fewer beds per pharmacist. This trend was similar, regardless of the size of the hospital.

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

Cited by 4 publications

References 7 publications

Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST

Data-Driven Identification of Factors That Influence the Quality of Adverse Event Reports: 15-Year Interpretable Machine Learning and Time-Series Analyses of VigiBase and QUEST

Analysis of drug‐induced liver‐related adverse event trend reporting between 1997 and 2019

Characteristics of hospitals that report adverse drug reactions: Results of a nationwide survey in Japan

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