Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China

Yu, Yang; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yan-Ming; Feng, Yuji; Huang, Kui; Zhan, Siyan

doi:10.1007/s40264-017-0589-z

Cited by 46 publications

(46 citation statements)

References 26 publications

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“…This database has been used and described in a previous study. 25 – 27 This study was approved by the Peking University Health Science Center Ethics Committee.…”

Section: Methodsmentioning

confidence: 99%

Statins use and risk of new-onset diabetes in hypertensive patients: a population-based retrospective cohort study in Yinzhou district, Ningbo city, People’s Republic of China

Li¹,

Lin²,

Zhao³

et al. 2018

TCRM

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BackgroundReports have suggested that statin use is associated with an increased incidence of type 2 diabetes mellitus (T2DM). Guidelines suggested that statins should be prescribed in hypertensive patients for primary prevention. However, there were very few studies on the risk of T2DM associated with statin use among patients with hypertension in mainland People’s Republic of China.PurposeTo determine the association between statin use and new-onset diabetes mellitus among patients with hypertension in mainland People’s Republic of China.Patients and methodsWe performed a retrospective cohort study of hypertensive patients using the Yinzhou regional health care database from January 1, 2010, to August 31, 2016. Patients aged 30–90 years old without T2DM were eligible for inclusion. We identified new statin initiators and nonusers by using prescription records of inpatients and outpatients. Multivariate Cox model and propensity score methods were used to adjust potential confounders, including age, sex, body mass index, comorbidities, lifestyle characteristics, and baseline antihypertensive drug use. The risk of incident T2DM among statin initiators compared to nonusers was estimated by the Cox proportional hazards model. Propensity scores for statin use were then developed using logistic regression, statin initiators were matched 1:1 with nonusers according to propensity scores with the nearest neighbor matching method within 0.2 caliper width, and Cox regression was again conducted.ResultsAmong 67,993 patients (21,551 statin initiators; 46,442 nonusers), the unadjusted incidence rate of incident T2DM was higher in statin initiators than nonusers (25.68 versus 14.19 events/1,000 person-years; adjusted hazard ratio: 1.55; 95% confidence interval: 1.44–1.66). After propensity score 1:1 matching (19,818 statin initiators; 19,818 nonusers), baseline characteristics between 2 groups were balanced except that the nonusers group was 0.53 years older on average (P<0.001). Then statin use was still associated with a significant increased risk for T2DM in the matched cohort (adjusted hazard ratio: 1.54; 95% confidence interval: 1.41–1.67). Subgroup analyses also demonstrated similar findings.ConclusionOur study indicated an association between statin use and an increased risk of new-onset diabetes mellitus. It provides better understanding of statin and new-onset diabetes mellitus association among hypertensive patients in real-word setting. As an observational study, our findings were prone to unmeasured confounding and bias.

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“…This database has been used and described in a previous study. 25 – 27 This study was approved by the Peking University Health Science Center Ethics Committee.…”

Section: Methodsmentioning

confidence: 99%

Statins use and risk of new-onset diabetes in hypertensive patients: a population-based retrospective cohort study in Yinzhou district, Ningbo city, People’s Republic of China

Li¹,

Lin²,

Zhao³

et al. 2018

TCRM

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“…One subsystem of the Chinese Monitoring Network for the Rational Use of Drugs (CMNRUD) was the data source for model development. The CMNRUD was launched by the Chinese Ministry of Health in 2010, and it covers over 86% (30/35) of the provinces in China [ 38 ], including 60% of the nation’s tertiary hospitals (955 hospitals) and 6% of its secondary hospitals (375 hospitals) [ 39 ]. Each monitoring hospital must upload encrypted data every month.…”

Section: Methodsmentioning

confidence: 99%

A Multiview Model for Detecting the Inappropriate Use of Prescription Medication: Machine Learning Approach

et al. 2020

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Background The inappropriate use of prescription medication has recently garnered worldwide attention, but most national policies do not effectively provide for early detection or timely intervention. Objective This study aimed to develop and assess the validity of a model that can detect the inappropriate use of prescription medication. This effort combines a multiview and topic matching method. The study also assessed the validity of this approach. Methods A multiview extension of the latent Dirichlet allocation algorithm for topic modeling was chosen to generate diagnosis-medication topics, with data obtained from the Chinese Monitoring Network for Rational Use of Drugs (CMNRUD) database. Topic mapping allowed for calculating the degree to which diagnoses and medications were similarly distributed and, by setting a threshold, for identifying prescription misuse. The Beijing Regional Prescription Review Database (BRPRD) database was used as the gold standard to assess the model’s validity. We also conducted a sensitivity analysis using random samples of validated prescriptions and evaluated the model’s performance. Results A total of 44 million prescriptions were used to generate topics using the diagnoses and medications from the CMNRUD database. A random sample (15,000 prescriptions) from the BRPRD was used for validation, and it was found that the model had a sensitivity of 81.8%, specificity of 47.4%, positive-predictive value of 14.5%, and negative-predictive value of 96.0%. The model showed superior stability under different sampling proportions. Conclusions A method that combines multiview topic modeling and topic matching can detect the inappropriate use of prescription medication. This model, which has mediocre specificity and moderate sensitivity, can be used as a primary screening tool and will likely complement and improve the process of manually reviewing prescriptions.

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“…The UEBMI is one of the three main national health insurance schemes in China and is a mandatory program covering urban and retired employees . The UEBMI contains longitudinal patient data including demographics, clinical diagnoses, and prescriptions for drugs and procedures from all health care institutions in Beijing since 2008 . By the end of 2014, more than 98% of all active and retired urban employees in Beijing were covered by the UEBMI, equivalent to approximately 14 million people.…”

Section: Methodsmentioning

confidence: 99%

“…Beijing since 2008 22. By the end of 2014, more than 98% of all active and retired urban employees in Beijing were covered by the UEBMI, equivalent to approximately 14 million people.…”

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confidence: 99%

Treatment patterns of prostate cancer with bone metastasis in Beijing: A real‐world study using data from an administrative claims database

Cheng

Zhuo

Pan

et al. 2019

Pharmacoepidemiology and Drug

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PurposeTo explore treatment patterns among patients with prostate cancer and bone metastasis and to compare clinical outcomes following use of different hormone therapies including combined androgen blockade (CAB), nonsteroidal antiandrogen (NSAA) monotherapy, and castration monotherapy.MethodsWe conducted a population‐based cohort study using data from the Urban Employee Basic Medical Insurance database (2011‐2014) in Beijing. We identified 475 patients with newly diagnosed bone metastatic prostate cancer with at least one prescription for hormone therapy and described their treatment patterns over a median follow‐up of 20.7 months. Cox proportional hazards model was used to compare time to chemotherapy initiation between patients starting on different hormone therapies.ResultsHormone therapy and/or bisphosphonate therapy with zoledronic acid were the initial treatments in the majority of patients (87.8%); chemotherapy, radiotherapy, and surgery were usually given later in the treatment pathway. CAB was the most common hormone treatment (73.7%). For time to chemotherapy initiation, hazard ratios (95% confidence intervals) were 2.43 (1.08‐5.44) for NSAA alone vs CAB and 1.29 (0.78‐2.13) for castration alone vs CAB.ConclusionsOur findings show that while a wide range of therapies are used to treat patients with prostate cancer and bone metastasis in Beijing, hormone therapy and bisphosphonate therapy are the most commonly prescribed, and use of CAB was seen to be advantageous in delaying time to chemotherapy initiation over NSAA monotherapy. Future studies should explore longer‐term treatment patterns, including use of newly approved treatments.

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Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China

Abstract: These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

Cited by 46 publications

References 26 publications

Statins use and risk of new-onset diabetes in hypertensive patients: a population-based retrospective cohort study in Yinzhou district, Ningbo city, People’s Republic of China

Statins use and risk of new-onset diabetes in hypertensive patients: a population-based retrospective cohort study in Yinzhou district, Ningbo city, People’s Republic of China

A Multiview Model for Detecting the Inappropriate Use of Prescription Medication: Machine Learning Approach

Treatment patterns of prostate cancer with bone metastasis in Beijing: A real‐world study using data from an administrative claims database

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Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China

Abstract: These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

Cited by 46 publications

References 26 publications

Statins use and risk of new-onset diabetes in hypertensive patients: a population-based retrospective cohort study in Yinzhou district, Ningbo city, People&rsquo;s Republic of China

Statins use and risk of new-onset diabetes in hypertensive patients: a population-based retrospective cohort study in Yinzhou district, Ningbo city, People&rsquo;s Republic of China

A Multiview Model for Detecting the Inappropriate Use of Prescription Medication: Machine Learning Approach

Treatment patterns of prostate cancer with bone metastasis in Beijing: A real‐world study using data from an administrative claims database

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Statins use and risk of new-onset diabetes in hypertensive patients: a population-based retrospective cohort study in Yinzhou district, Ningbo city, People’s Republic of China

Statins use and risk of new-onset diabetes in hypertensive patients: a population-based retrospective cohort study in Yinzhou district, Ningbo city, People’s Republic of China