Lack of essential information in spontaneous reports of adverse drug reactions in Catalonia—a restraint to the potentiality for signal detection

Plessis, Lorraine; Gómez, Ainhoa; García, Núria Fernández; Cereza, Glòria; Figueras, Albert

doi:10.1007/s00228-017-2223-5

Cited by 25 publications

(18 citation statements)

References 13 publications

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“…Table shows that age information was not available in 5.9% of the reports and that the sex of the patient was not included in 3.8% of the reports. Similar results were obtained in a previous study . Because patient information such as age or sex were not required to evaluate documentation grading, such missing information would not affect the quality evaluation of ADR reports by the WHO documentation grading scheme.…”

Section: Discussionsupporting

confidence: 84%

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: Discussionsupporting

confidence: 84%

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

Tsuchiya

Obara

Sakai

et al. 2019

Pharmacoepidemiology and Drug

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“…It is also important to note that improvements in the quality of ADR reports are also a critical measure, and unfortunately this was not investigated in any of the included studies. Studies have shown that the filling quality of ADR reports in national pharmacovigilance databases are extremely poor resulting in the inability to apply algorithms to determine any possible causal relationships between the medicine and ADR . This may be due to constraints within global pharmacovigilance legislations that mandate ADR reporting for pharmaceutical companies, who would focus on reporting ADRs just to comply with these regulations, even for cases with minimal information .…”

Section: Discussionmentioning

confidence: 99%

“…This may be due to constraints within global pharmacovigilance legislations that mandate ADR reporting for pharmaceutical companies, who would focus on reporting ADRs just to comply with these regulations, even for cases with minimal information . The same studies showed that the quality of ADR reports from HCPs are much higher than those received from the pharmaceutical companies indicating that those who choose to report are more motivated or had better knowledge of pharmacovigilance . Therefore, the focus of strategies should be to address the barriers associated with the voluntary nature of HCP reporting to increase the quantity of reports that are of high quality.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of interventions to improve adverse drug reaction reporting by healthcare professionals over the last decade: A systematic review

Zaidi

Chen

et al. 2019

Pharmacoepidemiology and Drug

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Background: Various strategies have been studied in the literature to address the significant underreporting of adverse drug reactions (ADRs) in healthcare systems worldwide. Objectives:We conducted a systematic review of the literature that assessed the impact of various strategies to improve ADR reporting published in the last decade and compared this with the strategies identified in a previous systematic review.Methods: MEDLINE and EMBASE databases were used to retrieve papers published from 01 July 2010 to 17 June 2019. We included papers in the English language that investigated the quantitative impact of strategies used to improve ADR reporting.Results: A total of 10,021 articles were retrieved using our search criteria, of which 13 met the inclusion criteria. Multifaceted strategies resulted in a point estimate increase in ADR reporting of 9.26-fold (−2.21-17.11, 95% CI) versus 7.19-fold (−5.29-32.68, 95% CI) for single interventions. Using electronic reporting tools was more commonly identified as an interventional strategy with a point estimate increase of 13.69-fold (−5.29-32.68, 95%CI) versus 4.42-fold (0.66-8.19, 95% CI) for traditional educational methods. The quality of the majority of publications included in this review was low. Conclusions:Developments in digital technology in the last decade has led to the increased use of electronic reporting tools to improve ADR reporting. Higher quality studies investigating the impact of these electronic methods are needed to fully explore its role in improving ADR reporting.

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“…Although the spontaneous reporting system is a keystone of pharmacovigilance, the incompleteness of data is a major concern for causality assessment [1, 2]. Since causal assessment of adverse events (AEs) cannot be made without demographic or clinical information, completeness in reporting is important for the early detection of adverse drug reactions.…”

Section: Introductionmentioning

confidence: 99%

Differential completeness of spontaneous adverse event reports among hospitals/clinics, pharmacies, consumers, and pharmaceutical companies in South Korea

Baek

Kim

et al. 2019

PLoS ONE

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The differential pattern and characteristics of completeness in adverse event (AE) reports generated by hospitals/clinics, pharmacies, consumer and pharmaceutical companies remain unknown. Thus, we identified the characteristics of complete AE reports, compared with those of incomplete AE reports, using a completeness score. We used Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) between January 1, 2016 and December 31, 2016. The completeness score was determined out of a total of 100 points, based on the presence of information on temporal relationships, age and sex of patients, AE progress, name of reported medication, reporting group by profession, causality assessment, and informational text. AE reports were organized into four groups based on affiliation: hospitals/clinics, pharmacies, consumers, and pharmaceutical companies. Affiliations that had median completeness scores greater than 80 points were classified as ‘well-documented’ and these reports were further analyzed by logistic regression to estimate the adjusted odds ratios and 95% confidence intervals. We examined 228,848 individual reports and 735,745 drug-AE combinations. The median values of the completeness scores were the highest for hospitals/clinics (95 points), followed by those for consumers (85), pharmacies (75), and manufacturers (72). Reports with causality assessment of ‘certain’, ‘probable’, or ‘possible’ were more likely to be ‘well-documented’ than reports that had causality assessments of ‘unlikely’. Serious reports of AEs were positively associated with ‘well-documented’ reports and negatively associated with hospitals/clinics.

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Lack of essential information in spontaneous reports of adverse drug reactions in Catalonia—a restraint to the potentiality for signal detection

Cited by 25 publications

References 13 publications

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

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

Effectiveness of interventions to improve adverse drug reaction reporting by healthcare professionals over the last decade: A systematic review

Differential completeness of spontaneous adverse event reports among hospitals/clinics, pharmacies, consumers, and pharmaceutical companies in South Korea

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