National Center for Monitoring

Beijing, China

National Center for Monitoring

Beijing, China
SEARCH FILTERS
Time filter
Source Type

Hou Y.,National Center for Monitoring | Ye X.,Shanghai University | Wu G.,National Center for Monitoring | Cheng G.,National Center for Monitoring | And 2 more authors.
Expert Opinion on Drug Safety | Year: 2014

Objective: Several disproportionality analysis methods are widely used for signal detection. The goal of this study was to compare the concordance of the performance characteristics of these methods in spontaneous reporting system of China. Methods: Algorithms including reporting odds ratio (ROR), proportional reporting ratio (PRR) and information component (IC), a composite criterion previously used by Medicines and Healthcare Products Regulatory Agency (MHRA) were compared. Kappa coefficient was used as the gauge to test the concordance. Reports received in the year 2004 and 2005 were extracted for analysis in this study. Results: After data processing, 361,872 reports representing 52,769 combinations were analysed. The analysis generated 24,022, 22,646, 5637 and 5302 signals of disproportionality by PRR, ROR, MHRA and IC, respectively. The kappa coefficient increased with the threshold of number of drug-adverse drug reactions (ADR) combination, and the coefficient exceeded 0.7 when the number of suspected drug-ADR exceeded 2. Conclusion: This study shows that different measures used are broadly comparable in spontaneous reporting system in China when two or more cases per combination have been collected. © 2014 Informa UK, Ltd.


Wang J.,Shanghai University | Ye X.-F.,Shanghai University | Guo X.-J.,Shanghai University | Zhu T.-T.,Shanghai University | And 8 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2015

Purpose: Statistical shrinkage is a potential statistical method to improve the accuracy of signal detection results and avoid spurious associations detected by disproportionality analyses. In this study, we introduced statistical shrinkage influence on disproportionality methods in spontaneous reporting system in China. Methods: We added the shrinkage parameters in the numerator and denominator, denoted as in the formula of disproportionality analysis. The shrinkage parameters were subjectively set to between 0 and 5, with an interval of 0.1. Adverse drug reaction product label database was deemed as a proxy of golden standard to evaluate the effect of statistical shrinkage. Reports in the years of 2010-2011 were extracted from the national spontaneous reporting system database as the data source for analysis in this study. Results: When α was around 0.5, the Youden index reached the maximum for each disproportionality methods in this study. The value of 0.6 was suggested as the most appropriate statistical shrinkage parameter for reporting odds ratio and proportional reporting ratio and 0.2 for information component based on the spontaneous reporting system of China. © 2015 John Wiley & Sons, Ltd.


Hou Y.,National Center for Monitoring | Li X.,National Center for Monitoring | Wu G.,National Center for Monitoring | Ye X.,Shanghai University
Drug Safety | Year: 2016

It has been more than 25 years since an adverse drug reaction (ADR) monitoring agency was first established in China. In the past few years, the National ADR Monitoring System (NADRMS) has developed rapidly in the country. However, this system has not been reviewed in detail in the literature. Our aim was to demonstrate how individual case safety reports (ICSRs) are reported and evaluated and how data quality control is achieved in China. We also aimed to discuss the present status and future of NADRMS. We reviewed the relevant regulations and literature around ADR reporting in China. ADR report collection tools in China have gone through three phases, namely paper-based reporting, software-based reporting using standalone computers, and online reporting. Nowadays the online reporting system plays an important role in China and the number of ADR reports has rapidly increased. NADRMS is similar to most of the ADR reporting systems around the world, but also has its own unique characteristics such as four levels of monitoring agencies. In summary, there is still a long way to go for China to establish a high-level ADR monitoring system to ensure drug safety. © 2016, Springer International Publishing Switzerland.


PubMed | National Center for Monitoring and Shanghai University
Type: | Journal: Drug safety | Year: 2017

The method of time-to-onset (TTO) has been proposed to overcome the drawbacks of traditional disproportionality analyses (DPAs), and it has been used for detecting safety signals of vaccines and some non-vaccine products in spontaneous reporting systems (SRSs). However, there is no consensus on its superiority over DPAs. Further, it is still not clear whether this novel approach can be generalized to the entire national SRS database.The purpose of this study was to generalize the TTO method to the Chinese SRS and to identify suitable parameters for its optimal performance.Reports submitted to the national SRS of China in 2014 were used as the data source for analysis. We evaluated the performance of TTO by using product labels as proxies for the gold standard. A series of values of significance level and time windows were explored to identify the most suitable parameters for TTO based on Youdens index, a statistic that summarizes the performance of a diagnostic test. Additionally, we compared TTO with traditional DPAs and explored the characteristics of signals detected by these methods.Compared with DPAs, TTO had a lower sensitivity, buthigher specificity and positive predictive value. At a significance level of 0.2 and no restrictions on time windows, TTO had the highest Youdens index. The kappa coefficients between TTO and DPAs were rather low, indicating poor agreement between the two methods. More than 30% of the true signals detected by TTO were not identified by DPAs. Furthermore, TTO needed more number of reports to be able to detect signals.TTO can detect signals missed by traditional DPAs and could be an important complementary tool to the currently used DPAs in the SRS of China. We recommend a significance level of 0.2 and no restrictions on time windows for TTO.


PubMed | National Center for Monitoring, Shanghai JiaoTong University and Shanghai University
Type: Journal Article | Journal: Pharmacoepidemiology and drug safety | Year: 2015

Statistical shrinkage is a potential statistical method to improve the accuracy of signal detection results and avoid spurious associations detected by disproportionality analyses. In this study, we introduced statistical shrinkage influence on disproportionality methods in spontaneous reporting system in China.We added the shrinkage parameters in the numerator and denominator, denoted as in the formula of disproportionality analysis. The shrinkage parameters were subjectively set to between 0 and 5, with an interval of 0.1. Adverse drug reaction product label database was deemed as a proxy of golden standard to evaluate the effect of statistical shrinkage. Reports in the years of 2010-2011 were extracted from the national spontaneous reporting system database as the data source for analysis in this study.When was around 0.5, the Youden index reached the maximum for each disproportionality methods in this study. The value of 0.6 was suggested as the most appropriate statistical shrinkage parameter for reporting odds ratio and proportional reporting ratio and 0.2 for information component based on the spontaneous reporting system of China.


PubMed | National Center for Monitoring, World Health Organization and Centers for Disease Control and Prevention
Type: Journal Article | Journal: Vaccine | Year: 2014

Japanese encephalitis (JE) is the most severe form of viral encephalitis in Asia and no specific treatment is available. Vaccination provides an effective intervention to prevent JE. In this paper, surveillance data for adverse events following immunization (AEFI) related to SA-14-14-2 live-attenuated Japanese encephalitis vaccine (Chengdu Institute of Biological Products) was presented. This information has been routinely generated by the Chinese national surveillance system for the period 2009-2012. There were 6024 AEFI cases (estimated reported rate 96.55 per million doses). Most common symptoms of adverse events were fever, redness, induration and skin rash. There were 70 serious AEFI cases (1.12 per million doses), including 9 cases of meningoencephalitis and 4 cases of death. The post-marketing surveillance data add the evidence that the Chengdu institute live attenutated vaccine has a reasonable safety profile. The relationship between encephalitis and SA-14-14-2 vaccination should be further studied.


Wang Y.,National Center for Monitoring | Dong D.,National Center for Monitoring | Cheng G.,National Center for Monitoring | Zuo S.,World Health Organization | And 2 more authors.
Vaccine | Year: 2014

Japanese encephalitis (JE) is the most severe form of viral encephalitis in Asia and no specific treatment is available. Vaccination provides an effective intervention to prevent JE. In this paper, surveillance data for adverse events following immunization (AEFI) related to SA-14-14-2 live-attenuated Japanese encephalitis vaccine (Chengdu Institute of Biological Products) was presented. This information has been routinely generated by the Chinese national surveillance system for the period 2009-2012. There were 6024 AEFI cases (estimated reported rate 96.55 per million doses). Most common symptoms of adverse events were fever, redness, induration and skin rash. There were 70 serious AEFI cases (1.12 per million doses), including 9 cases of meningoencephalitis and 4 cases of death. The post-marketing surveillance data add the evidence that the Chengdu institute live attenutated vaccine has a reasonable safety profile. The relationship between encephalitis and SA-14-14-2 vaccination should be further studied. © 2014 Elsevier Ltd.


Ma H.,Liaoning Adverse Drug Reaction Monitoring Center | Jin D.,Liaoning Adverse Drug Reaction Monitoring Center | Zhao P.,Shenyang Pharmaceutical University | Wang C.-T.,National Center for Monitoring | And 3 more authors.
Chinese Journal of New Drugs | Year: 2014

Through searching the websites of the State Food and Drug Administration (SFDA), the US FDA, EMEA, Japan's Ministry of Health, Labor and Welfare (MHLW) and WSMI, we introduced the types of children's expectorant medicines in our country and the management status of children's expectorant medicine home and abroad, and analyzed the risk source of children's medicine use. Moreover, we searched and summarized the risk control measures taken by Europe, the US and Japan on the use of children's expectorant chemical drugs. Based on these, we put forward relevant suggestions on regulating the use of children's expectorant chemical medicines in our country.


Wang L.,National Center for Monitoring | Zhou J.,National Center for Monitoring | Zhang X.,National Center for Monitoring | Lin X.,National Center for Monitoring
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation | Year: 2014

On the basis of real working practices in data normalization, the case reports from the monitoring system were studied, non-standard reports were summarized and the reasons were analyzed, the methods of data normalization and improving the reporting quality were discussed. The standard databases and the rule databases were created, they were capable of automatic completion of the standardization work of new cases.


PubMed | National Center for Monitoring
Type: Journal Article | Journal: Expert opinion on drug safety | Year: 2014

Several disproportionality analysis methods are widely used for signal detection. The goal of this study was to compare the concordance of the performance characteristics of these methods in spontaneous reporting system of China.Algorithms including reporting odds ratio (ROR), proportional reporting ratio (PRR) and information component (IC), a composite criterion previously used by Medicines and Healthcare Products Regulatory Agency (MHRA) were compared. Kappa coefficient was used as the gauge to test the concordance. Reports received in the year 2004 and 2005 were extracted for analysis in this study.After data processing, 361,872 reports representing 52,769 combinations were analysed. The analysis generated 24,022, 22,646, 5637 and 5302 signals of disproportionality by PRR, ROR, MHRA and IC, respectively. The kappa coefficient increased with the threshold of number of drug-adverse drug reactions (ADR) combination, and the coefficient exceeded 0.7 when the number of suspected drug-ADR exceeded 2.This study shows that different measures used are broadly comparable in spontaneous reporting system in China when two or more cases per combination have been collected.

Loading National Center for Monitoring collaborators
Loading National Center for Monitoring collaborators