Pharmacosurveillance without borders: electronic health records in different countries can be used to address important methodological issues in estimating the risk of adverse events
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 (Quebe...
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| Veröffentlicht in: | Journal of clinical epidemiology 2016-09, Vol.77, p.101-111 |
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| creator | Tamblyn, Robyn Girard, Nadyne Dixon, William G Haas, Jennifer Bates, David W Sheppard, Thérèse Eguale, Tewodros Buckeridge, David Abrahamowicz, Michal Forster, Alan |
| description | 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. |
| doi_str_mv | 10.1016/j.jclinepi.2016.03.033 |
| format | Article |
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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.</description><identifier>ISSN: 0895-4356</identifier><identifier>EISSN: 1878-5921</identifier><identifier>DOI: 10.1016/j.jclinepi.2016.03.033</identifier><identifier>PMID: 27212138</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Adverse outcome ; Aged ; Boston - epidemiology ; Cardiovascular Diseases - epidemiology ; Causality ; Cohort Studies ; Communication ; Comorbidity ; Confidence intervals ; Diabetes ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - epidemiology ; Drug-Related Side Effects and Adverse Reactions - epidemiology ; Electronic health record ; Electronic health records ; Electronic Health Records - statistics & numerical data ; Epidemiology ; Female ; Health informatics ; Health risks ; Humans ; Hypoglycemic Agents - adverse effects ; Internal Medicine ; Kidney diseases ; Lipids ; Male ; Medication adherence ; Middle Aged ; Obesity ; Patients ; Pharmacoepidemiology ; Pharmacosurveillance ; Population ; Prescription drugs ; Proportional Hazards Models ; Prospective Studies ; Quebec - epidemiology ; Risk ; Risk assessment ; Substance abuse treatment ; Surveillance ; United Kingdom - epidemiology ; Young Adult</subject><ispartof>Journal of clinical epidemiology, 2016-09, Vol.77, p.101-111</ispartof><rights>The Author(s)</rights><rights>2016 The Author(s)</rights><rights>Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.</rights><rights>Copyright Elsevier Limited Sep 01, 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c532t-4a4a4393624ac9aaa07edc6503089b98e0f4467bf59e14835562cb86e729e7da3</citedby><cites>FETCH-LOGICAL-c532t-4a4a4393624ac9aaa07edc6503089b98e0f4467bf59e14835562cb86e729e7da3</cites><orcidid>0000-0003-1817-5047 ; 0000-0002-3172-3952 ; 0000-0002-1550-6528</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1867999860?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27212138$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tamblyn, Robyn</creatorcontrib><creatorcontrib>Girard, Nadyne</creatorcontrib><creatorcontrib>Dixon, William G</creatorcontrib><creatorcontrib>Haas, Jennifer</creatorcontrib><creatorcontrib>Bates, David W</creatorcontrib><creatorcontrib>Sheppard, Thérèse</creatorcontrib><creatorcontrib>Eguale, Tewodros</creatorcontrib><creatorcontrib>Buckeridge, David</creatorcontrib><creatorcontrib>Abrahamowicz, Michal</creatorcontrib><creatorcontrib>Forster, Alan</creatorcontrib><title>Pharmacosurveillance without borders: electronic health records in different countries can be used to address important methodological issues in estimating the risk of adverse events</title><title>Journal of clinical epidemiology</title><addtitle>J Clin Epidemiol</addtitle><description>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.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Adverse outcome</subject><subject>Aged</subject><subject>Boston - epidemiology</subject><subject>Cardiovascular Diseases - epidemiology</subject><subject>Causality</subject><subject>Cohort Studies</subject><subject>Communication</subject><subject>Comorbidity</subject><subject>Confidence intervals</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - epidemiology</subject><subject>Drug-Related Side Effects and Adverse Reactions - epidemiology</subject><subject>Electronic health record</subject><subject>Electronic health records</subject><subject>Electronic Health Records - statistics & numerical data</subject><subject>Epidemiology</subject><subject>Female</subject><subject>Health informatics</subject><subject>Health risks</subject><subject>Humans</subject><subject>Hypoglycemic Agents - 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epidemiology</topic><topic>Cardiovascular Diseases - epidemiology</topic><topic>Causality</topic><topic>Cohort Studies</topic><topic>Communication</topic><topic>Comorbidity</topic><topic>Confidence intervals</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - epidemiology</topic><topic>Drug-Related Side Effects and Adverse Reactions - epidemiology</topic><topic>Electronic health record</topic><topic>Electronic health records</topic><topic>Electronic Health Records - statistics & numerical data</topic><topic>Epidemiology</topic><topic>Female</topic><topic>Health informatics</topic><topic>Health risks</topic><topic>Humans</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Internal Medicine</topic><topic>Kidney diseases</topic><topic>Lipids</topic><topic>Male</topic><topic>Medication adherence</topic><topic>Middle Aged</topic><topic>Obesity</topic><topic>Patients</topic><topic>Pharmacoepidemiology</topic><topic>Pharmacosurveillance</topic><topic>Population</topic><topic>Prescription drugs</topic><topic>Proportional Hazards Models</topic><topic>Prospective Studies</topic><topic>Quebec - 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Academic</collection><collection>Safety Science and Risk</collection><jtitle>Journal of clinical epidemiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tamblyn, Robyn</au><au>Girard, Nadyne</au><au>Dixon, William G</au><au>Haas, Jennifer</au><au>Bates, David W</au><au>Sheppard, Thérèse</au><au>Eguale, Tewodros</au><au>Buckeridge, David</au><au>Abrahamowicz, Michal</au><au>Forster, Alan</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacosurveillance without borders: electronic health records in different countries can be used to address important methodological issues in estimating the risk of adverse events</atitle><jtitle>Journal of clinical epidemiology</jtitle><addtitle>J Clin Epidemiol</addtitle><date>2016-09-01</date><risdate>2016</risdate><volume>77</volume><spage>101</spage><epage>111</epage><pages>101-111</pages><issn>0895-4356</issn><eissn>1878-5921</eissn><abstract>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.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>27212138</pmid><doi>10.1016/j.jclinepi.2016.03.033</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0003-1817-5047</orcidid><orcidid>https://orcid.org/0000-0002-3172-3952</orcidid><orcidid>https://orcid.org/0000-0002-1550-6528</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Adverse outcome Aged Boston - epidemiology Cardiovascular Diseases - epidemiology Causality Cohort Studies Communication Comorbidity Confidence intervals Diabetes Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - epidemiology Drug-Related Side Effects and Adverse Reactions - epidemiology Electronic health record Electronic health records Electronic Health Records - statistics & numerical data Epidemiology Female Health informatics Health risks Humans Hypoglycemic Agents - adverse effects Internal Medicine Kidney diseases Lipids Male Medication adherence Middle Aged Obesity Patients Pharmacoepidemiology Pharmacosurveillance Population Prescription drugs Proportional Hazards Models Prospective Studies Quebec - epidemiology Risk Risk assessment Substance abuse treatment Surveillance United Kingdom - epidemiology Young Adult |
| title | 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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