Robyn Tamblyn1, Nadyne Girard2, William G Dixon3, Jennifer Haas4, David W Bates4, Thérèse Sheppard3, Tewodros Eguale5, David Buckeridge5, Michal Abrahamowicz5, Alan Forster6. 1. Department of Epidemiology, Biostatistics and Occupational Health, Purvis Hall, McGill University, 1020 Pine Avenue West, Montreal, Quebec H3A 1A2, Canada; Department of Medicine, McGill University Health Center, 1001 Decarie Boulevard, Montreal, Quebec H4A 3J1, Canada; Clinical and Health Informatics Research Group, McGill University, 1140 Pine Avenue, Montreal, Quebec H3A 1A3, Canada. Electronic address: robyn.tamblyn@mcgill.ca. 2. Clinical and Health Informatics Research Group, McGill University, 1140 Pine Avenue, Montreal, Quebec H3A 1A3, Canada. 3. Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, 2nd Floor, Stopford Building, Oxford Road, Manchester M13 9PT, UK. 4. Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA. 5. Department of Epidemiology, Biostatistics and Occupational Health, Purvis Hall, McGill University, 1020 Pine Avenue West, Montreal, Quebec H3A 1A2, Canada. 6. The Ottawa Hospital, 501 Smyth Road, Ottawa, Ontario K1H 8L6, Canada.
Abstract
OBJECTIVES: 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.
OBJECTIVES: 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.
Authors: D A Singleton; F Sánchez-Vizcaíno; E Arsevska; S Dawson; P H Jones; P J M Noble; G L Pinchbeck; N J Williams; A D Radford Journal: Prev Vet Med Date: 2018-09-08 Impact factor: 2.670
Authors: Robyn Tamblyn; David Westfall Bates; David L Buckeridge; Will Dixon; Alan J Forster; Nadyne Girard; Jennifer Haas; Bettina Habib; Siyana Kurteva; Jack Li; Therese Sheppard Journal: BMJ Open Date: 2019-05-14 Impact factor: 2.692
Authors: Meghna Jani; Nadyne Girard; David W Bates; David L Buckeridge; Therese Sheppard; Jack Li; Usman Iqbal; Shelly Vik; Colin Weaver; Judy Seidel; William G Dixon; Robyn Tamblyn Journal: PLoS Med Date: 2021-11-01 Impact factor: 11.069