The quality of spontaneous adverse drug reaction reports from the pharmacovigilance centre in western China

Niu, Rui; Xiang, Yufang; Wang, Tingting; Zhi, Zhang; Chen, Yue; Feng, Bianling

doi:10.1080/14740338.2019.1559812

Cited by 15 publications

(20 citation statements)

References 18 publications

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“…In our study, the 2.9% of the ICSRs was excluded due to inconsistencies, which are a limiting factor for case evaluation and for the detection of safety signals in a spontaneous reporting system. In fact, a good report quality is fundamental for the risk management of marketed drugs and is the basis of an effective drug safety monitoring and data utilization in pharmacovigilance (Niu et al, 2019). Most of our pediatric cases were classified as non-off-label with a mean age of 9 years (IQR: 6-12) in accordance with data that showed a higher distribution of pediatric oncology patients ranged between 2 and 12 years (van den Berg and Tak, 2011).…”

Section: Discussionsupporting

confidence: 66%

Safety of Anticancer Agents Used in Children: A Focus on Their Off-Label Use Through Data From the Spontaneous Reporting System

et al. 2020

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Background: Among factors influencing the higher risk of developing unknown or rare adverse drug reactions (ADRs) among children and adolescents, there is the frequent offlabel use of drugs that seems to be very common in pediatric oncological patients. Our study aim to collect and evaluate data on the safety profile of antineoplastic drugs and their off-label use in the pediatrics population using real life data. Methods:We retrieved Individual Case Safety Reports (ICSRs) with an anticancer agent as suspected drug among those reported through the Campania spontaneous reporting system from 1 January 2013 to 30 September 2019. We classified ICSRs into four offlabel categories: "age," "route of administration," "weight," and "therapeutic indication." We defined an ICSR as an off-label case if it met at least one of the aforementioned categories for at least one of the reported suspected antineoplastic drugs.Results: A total of 18 ICSRs (7.6%) out of 236 were classified as off-label cases. The median age of patients was 13 years (interquartile range, IQR: 6-16), with 94.4% of cases occurring in male patients. In the classification of the off-label category, 16 ICSRs were categorized according to the "therapeutic indication" and two for the "age." No case was categorized for the off-label categories "route of administration" and "weight." The two offlabel cases categorized as "age" were both related to the use of brentuximab vedotin for Hodgkin's lymphoma in patients aged 16 years. Twenty-nine ADRs (1.6 suspected adverse drug reactions per ICSR) were identified among off-label cases. Among ADRs, those reported more than one were diarrhea (N = 3), neutropenia (N = 3), nausea (N = 2), pyrexia (N = 2), and vomit (N = 2). Conclusions: Our findings showed a low number of ICSRs classified as off-label. The majority of off-label ICSRs were categorized for the "therapeutic indication." This low number of off-label ICSRs might be largely due to the underreporting phenomenon, which

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Section: Discussionsupporting

confidence: 66%

Safety of Anticancer Agents Used in Children: A Focus on Their Off-Label Use Through Data From the Spontaneous Reporting System

et al. 2020

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“…The quality of ADR reports improved significantly during the three years studied, which is similar to results found in other studies. 17,20) This may be because of increasing awareness of the importance of ADR monitoring, perhaps linked to a series of policies in China to promote national food and drug safety. 9,21) Second, the provinces in eastern and central China showed better reporting quality.…”

Section: Discussionmentioning

confidence: 99%

“…Evaluation Criteria The sample reports were evaluated, assigned, sorted and counted using the items in the ADR report quality assessment system established by our research group. 17) The scores for the 65 items in the reports were summed to provide a total score for each report (maximum 1000). The specific evaluation criteria have been shown in our previous research.…”

Section: Sample Selectionmentioning

confidence: 99%

“…The specific evaluation criteria have been shown in our previous research. 17) The ADR reports were then separated into three quality classifications: high quality (score ≥800), medium quality (600≤ score <800) and poor quality (< 600). Statistical Analysis Each ADR report was classified in an Excel worksheet using the accuracy of each indicator.…”

Section: Sample Selectionmentioning

confidence: 99%

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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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“…There are no globally accepted indicators which could demonstrate the functionality of an AEFI surveillance system. However, underreporting and incomplete reports are the most important limitations of spontaneous reporting 37 , 38 , so a high number of reports and a high good quality of the reported information are clearly related to the strength of the system. Moreover, a strong collaboration between the drug regulatory agency and the national immunization programme and the availability of reliable information on the actual number of immunizations have both been reported as essential components of an efficient surveillance system of AEFIs 39 .…”

Section: Discussionmentioning

confidence: 99%

Ten years of vaccinovigilance in Italy: an overview of the pharmacovigilance data from 2008 to 2017

Moretti

Gonella

Gironi

et al. 2020

Sci Rep

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Reporting and analysis of Adverse events following immunization (Aefis) are the cornerstones of vaccine safety surveillance prompting causality assessment and signal detection. this paper describes the impact of the Italian Pharmacovigilance System of vaccines over a 10-year period (2008-2017). The reporting rate (RR) per all distributed dose was calculated. Serious Aefis and causality assessments for fatal cases were described. the main results from signal detection were reported. During the study period, 46,430 AEFIs were reported with an overall RR of 17.2 per 100,000 distributed doses. Italy showed the highest number of reports among European countries. Only 4.4% of the reports came from citizens. Of the total, 12.7% were classified as serious with a RR over the study period of 2.20 per 100,000 distributed doses. They were mainly related to hyperpyrexia and usually had a positive outcome. Fatal outcomes were reported in 0.3% of the cases and were primarily associated with the influenza vaccine in elderly patients. None of these outcomes had a consistent causal association with the vaccination. febrile convulsions by the measles, mumps, rubella and varicella vaccines and intussusception by the rotavirus vaccine were among the highlighted signals. the reporting rate and the analysis of serious events from 10 years support the good risk/benefit profiles of vaccines. Vaccination is one of the most important achievements in public health. It prevented at least 10 million deaths between 2010 and 2015 1. Despite substantial evidence for the benefits of immunization, they may not be immediately perceived by the general population. Moreover, misconceptions about vaccine safety still influence public confidence and adherence to immunization programmes. In fact, safety concerns are the main reason for vaccination refusal in Western countries 2. Nevertheless, the risks of adverse events following immunization (AEFIs) are very low compared with those associated with the target diseases 3-6. Low public confidence in the safety of immunization programmes may impede vaccination coverage and compromise herd immunity protection. This effect has serious consequences for population 7,8. A dramatic recent example was the decline in measles vaccination coverage in Italy. It caused a large outbreak since January 2017 which accounted for 29% of all measles cases reported by EU countries in 2017-2018 9. At the same time, poliomyelitis vaccine coverage fell below the 95% threshold. Consequently, in June 2017, the Italian Ministry of Health increased the number of compulsory vaccinations from 4 to 10 (diphtheria, tetanus, hepatitis B, poliomyelitis, pertussis, Haemophilus influenzae type b, measles, mumps, rubella, and varicella) for children up to 16 years of age (Law no 119/2017). This policy had a positive impact on all vaccination coverage 10. The new legislation increased public awareness about the importance of vaccines and vaccination. However, parental adherence to vaccination programmes is complex and requires further evaluati...

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The quality of spontaneous adverse drug reaction reports from the pharmacovigilance centre in western China

Cited by 15 publications

References 18 publications

Safety of Anticancer Agents Used in Children: A Focus on Their Off-Label Use Through Data From the Spontaneous Reporting System

Safety of Anticancer Agents Used in Children: A Focus on Their Off-Label Use Through Data From the Spontaneous Reporting System

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

Ten years of vaccinovigilance in Italy: an overview of the pharmacovigilance data from 2008 to 2017

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