Completeness of Spontaneous Adverse Drug Reaction Reports Sent by General Practitioners to a Regional Pharmacovigilance Centre: A Descriptive Study

Durrieu, Geneviève; Jacquot, Julien; Mège, Mathilde; Bondon‐Guitton, Emmanuelle; Rousseau, Vanessa; Montastruc, François; Montastruc, Jean‐Louis

doi:10.1007/s40264-016-0463-4

Cited by 40 publications

(35 citation statements)

References 21 publications

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“…Contrary to a previous finding reporting an association between seriousness of event and increased completeness [5], our logistic regression results were statistically insignificant. Moreover, an inverse association between the two was observed for hospitals/clinics.…”

Section: Discussioncontrasting

confidence: 99%

“…The omission of key information in AE reports has been a critical hurdle for the quality management of signal detection [2, 5, 16, 17]. Our study was designed to identify factors associated with completeness in AE reports.…”

Section: Discussionmentioning

confidence: 99%

“…Identifying the factors associated with reporting completeness is critical for enhancing quality management systems—an essential component of good pharmacovigilance practices [3, 4]. Higher reporting completeness is associated with the seriousness of an AE [5].…”

Section: Introductionmentioning

confidence: 99%

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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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Section: Discussioncontrasting

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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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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“…Statistical Analysis Each ADR report was classified in an Excel worksheet using the accuracy of each indicator. The quality of reports was compared by province, type of reports, 18) reporting source and reporters' occupation. The chi-square test (IBM-SPSS software version 13.0) was used to verify whether the differences were statistically significant.…”

Section: Sample Selectionmentioning

confidence: 99%

The Quality of Spontaneous Adverse Drug Reaction Reports in China: A Descriptive Study

Chen

Niu

Xiang

et al. 2019

Biological & Pharmaceutical Bulletin

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Pharmacovigilance is important to monitor the safety of drugs. There are, however, problems with the quality of adverse drug reaction reports in China. This study aimed to analyze the quality of adverse drug reaction reports in China, identify the factors affecting it, and propose measures to improve it. In our study, the western province of Shaanxi, the central province of Hubei and the eastern province of Jiangsu were chosen as typical, and adverse drug reaction reports from these three provinces from 2015 to 2017 were systematically sampled. The sampling reports were scored and graded to assess their quality. The results showed that only 10.18% were considered high quality in a total of 3429 reports. There were statistically significant differences in quality by year, province, report type, report source, and occupation of the reporter (p < 0.001). Reports from Shaanxi were slightly poorer quality, and "new" and "serious" reports and those from pharmacists were higher quality. Five indicators were particularly poor quality: patient information, adverse drug reaction, reporter information, drug information and vigilance. In conclusion, the quality of adverse drug reaction reports in China still needs improvement. Factors affecting quality included timing, location, report type, report source, and reporter's occupation. It may be helpful to publicize the importance of monitoring adverse drug reactions and improve the knowledge of reporters.

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“…However, the studies have shown that the doctors and pharmacists provide incomplete ADR reports or do not provide at all (2). The failure to provide adequate ADR reports by doctors and pharmacists is attributed to a lack of time on their side (3).…”

Section: Introductionmentioning

confidence: 99%

Adverse Drug Reaction Reporting by Patients: Experience of 12 European Countries

Valinčiūtė-Jankauskienė

Kubilienė

2020

Preprint

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Background Spontaneous reporting of suspected adverse drug reactions (ADRs) by a patient is an important method in minimizing safety risks related to medicine use. Patients as reporters of suspected ADRs are valuable participants of pharmacovigilance system. The aim of this study to examine the contribution of the patients to pharmacovigilance in European countries that started patient reporting schemes in 2012-2013 and to compare different tools used by their authorities to promote patients’ reporting. Methods A web-based questionnaire was sent to the NCAs of the Europe countries. The received answers were systematized and compared with each other through meta-analysis. Pooled standardized mean difference (SMD) with 95% confidence interval (CI) was calculated in a random or fixed-effects model. Heterogeneity was determined using the Cochrane Q-Test. Results The performed meta-analysis demonstrates that the changes in the number of received ADR report over the analyzed period increased significantly in each country. The reported statistic from Ireland and Finland significantly differ from other reviewed countries. Personalized feedback is a part of the pharmacovigilance system in 5 (41,6%) countries. Only Finland and Ireland (16,6%) do not offer specific reporting forms to patients. The common source of information on direct patient reporting is the websites of NCAs. Other tools in use are information on social media pages, leaflets, posters, etc. Conclusions This is the first insight into patients reporting schemes implemented after the significant reform of the European regulatory system for pharmacovigilance. The statistical data received from the interviewed countries indicate that it is essential for countries with minimal experience in pharmacovigilance systems with direct patient reporting schemes to organize comprehensive campaigns on ADR reporting. However, some countries do not promote the patient’s reporting schemes actively, which implies that the patient reporting is considered as mandatory and not as a supporting tool for safer medicines to consumers.

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Completeness of Spontaneous Adverse Drug Reaction Reports Sent by General Practitioners to a Regional Pharmacovigilance Centre: A Descriptive Study

Abstract: The study shows that only one out of eight ADR reports from GPs was 'well-documented'. Therefore, it appears to be important to promote further information being available regarding the data required in ADR reports to optimise the evaluation of drug causality.

Cited by 40 publications

References 21 publications

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

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

The Quality of Spontaneous Adverse Drug Reaction Reports in China: A Descriptive Study

Adverse Drug Reaction Reporting by Patients: Experience of 12 European Countries

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