Pharmacosurveillance without borders: electronic health records in different countries can be used to address important methodological issues in estimating the risk of adverse events

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• 作者：Robyn Tamblyn^a ; ^b ; ^c ; ^{robyn.tamblyn@mcgill.ca" class="auth_mail" title="E-mail the corresponding author} ; Nadyne Girard^c ; William G. Dixon^d ; Jennifer Haas^e ; David W. Bates^e ; Thé ; rè ; se Sheppard^d ; Tewodros Eguale^a ; David Buckeridge^a ; Michal Abrahamowicz^a ; Alan Forster^f
• 关键词：Pharmacosurveillance ; Medication adherence ; Electronic health record ; Adverse outcome ; ​Risk assessment ; Health informatics ; Pharmacoepidemiology
• 刊名：Journal of Clinical Epidemiology
• 出版年：2016
• 出版时间：September 2016
• 年：2016
• 卷：77
• 期：Complete
• 页码：101-111
• 全文大小：370 K

文摘

Evaluate methodological advantages and limitations of an international pharmacosurveillance system based on electronic health records (EHRs).

Study Design and Settings

Type 2 diabetes was used as an exemplar. Cohorts of newly treated diabetics were followed in each country (Quebec, Canada; Massachusetts, United States; Manchester, UK) from 2009 to 2012 using local EHR systems. Cox proportional hazards models were used to assess the risk of cardiovascular events.

Results

A total of 44,913 newly treated diabetics were identified; 82.6% (United States) to 93.1% (Canada) were started on biguanides; 13% of patients failed to fill initial prescriptions. An increased risk of cardiovascular events with sulfonylureas was observed when dispensing [hazard ratio (HR): 2.83] vs. EHR prescribing (HR: 2.47) data were used. The addition of clinical data produced a threefold to 10-fold increase in comorbidity for obesity and renal disease, but had no impact on the risk of different hypoglycemic therapies. The risk of cardiovascular events with sulfonylureas was higher in the United States [HR: 3.4; 95% confidence interval (CI): 2.1, 5.5] compared to England (HR: 1.3; 95% CI: 1.1, 1.6).

Conclusion

An international surveillance system based on EHRs may provide more timely information about drug safety and new opportunities to estimate potential sources of bias and health system effects on drug-related outcomes.