Daniala L. Weir

Analysis of drug coverage before and after the implementation of Canada's Common Drug Review

Background: Canada’s Common Drug Review was implemented to provide publicly funded drug plans (provincial and federal) with a transparent, rigorous and consistent approach for assessing the clinical effectiveness and cost-effectiveness of new drugs. We compared uptake of drug coverage across jurisdictions before and after the implementation of the Common Drug Review. Methods: Using the IMS Brogan formulary acceptance: monitoring and evaluation database, we identified new drug products in Canada five years before and five years after the first recommendation was made by the Common Drug Review. For each jurisdiction, we compared the proportion of drugs listed, the median time-to-listing and the agreement between the listing decisions of the drug plans and the recommendations of the Common Drug Review. Results: We identified 198 new drugs approved for use in Canada between May 26, 1999, and May 27, 2009, of which 53 had a recommendation from the Common Drug Review. The proportion of drugs listed decreased after the introduction of the Common Drug Review for all participating drug plans (81.1% to 71.3% overall [p ≤ 0.01 for all plans, with the exceptions of Ontario and Quebec [p = 0.07]). The change in median time-to-listing between the periods before and after the Common Drug Review varied by jurisdiction, ranging from a decrease of 691 days to an increase of 250 days. The change in median time-to-listing was not statistically significant for most jurisdictions, with the exceptions of Saskatchewan (increased, Mann–Whitney U test p = 0.01) and New Brunswick, Prince Edward Island, and Newfoundland and Labrador (all decreased, Mann–Whitney U test p < 0.01). Interpretation: There was a decline in the proportion of new drugs listed after the introduction of the Common Drug Review for both participating and nonparticipating jurisdictions. The introduction of the review was associated with a decreased time-to-listing for certain smaller provinces.

The Interplay Between Continuity of Care, Multimorbidity, and Adverse Events in Patients With Diabetes.

Objectives:To evaluate the impact of continuity of care and multimorbidity on health outcomes in patients with diabetes. Research Design:Using a US claims database of insured patients, we identified those with incident diabetes between 2004 and 2008 and followed them until death, disenrollment, or December 31, 2010. Continuity of care was defined using Breslau’s Usual Provider of Continuity (UPC; proportion of visits to the usual or predominant provider within 2 y of diabetes diagnosis). Multivariable logistic regression was used to determine the association between UPC in the first 2 years after diabetes diagnosis and subsequent 1-year composite primary outcome of all-cause hospitalization or death in year 3 in patients with/without multimorbidity. Results:Of the 285,231 patients with incident diabetes, 74% had multimorbidity; their average age was 53 years (SD=10.5) and 49% were female. A total of 77,270 (27%) individuals had a mean UPC≥75% in the first 2 years. During year 3 of follow-up, 33,632 (12%) patients died or were hospitalized for any cause. Greater continuity of care (UPC≥75%) was associated with reduced risk of subsequent death or hospitalization [7.2% vs. 13.5%; adjusted odds ratio (aOR)=0.72; 95% CI, 0.70–0.75]. Although multimorbidity was independently associated with an increased risk of our primary composite endpoint (13.4% vs. 7.2%; aOR=1.26; 95% CI, 1.21–1.30), the association between greater continuity and better outcomes was similar in those with multimorbidity (aOR=0.71; 95% CI, 0.69–0.71) as in those without (aOR=0.75; 95% CI, 0.71–0.80). Conclusions:In patients with incident diabetes, greater continuity of care is associated with improved outcomes, irrespective of whether or not they have multimorbidity.

Risk of new-onset heart failure in patients using sitagliptin: a population-based cohort study

To examine whether patients using sitagliptin at the time of an acute coronary syndrome event are at increased risk of incident heart failure compared with those not exposed.

Acute vs cumulative benefits of metformin use in patients with type 2 diabetes and heart failure

To evaluate the association between metformin use and heart failure (HF) exacerbation in people with type 2 diabetes (T2D) and pre‐existing HF using alternative exposure models.

Usage and accuracy of medication data from nationwide health information exchange in Quebec, Canada

Objectiven(1) To describe the usage of medication data from the Health Information Exchange (HIE) at the health care system level in the province of Quebec; (2) To assess the accuracy of the medication list obtained from the HIE.nnnMethodsnA descriptive study was conducted utilizing usage data obtained from the Ministry of Health at the individual provider level from January 1 to December 31, 2015. Usage patterns by role, type of site, and tool used to access the HIE were investigated. The list of medications of 111 high risk patients arriving at the emergency department of an academic healthcare center was obtained from the HIE and compared with the list obtained through the medication reconciliation process.nnnResultsnThere were 31u2009022 distinct users accessing the HIE 11u2009085u2009653 times in 2015. The vast majority of pharmacists and general practitioners accessed it, compared to a minority of specialists and nurses. The top 1% of users was responsible of 19% of access. Also, 63% of the access was made using the Viewer application, while using a certified electronic medical record application seemed to facilitate usage. Among 111 patients, 71 (64%) had at least one discrepancy between the medication list obtained from the HIE and the reference list.nnnConclusionsnEarly adopters were mostly in primary care settings, and were accessing it more frequently when using a certified electronic medical record. Further work is needed to investigate how to resolve accuracy issues with the medication list and how certain tools provide different features.

Ability to Predict New-Onset Psychological Distress Using Routinely Collected Health Data: A Population-Based Cohort Study of Women Diagnosed With Breast Cancer

Objectives: The primary objective of this study was to identify the predictors of new-onset psychological distress available in routinely collected administrative health databases for women diagnosed with breast cancer. The secondary objective was to explore whether the predictors vary based on the period of cancer care. Methods: A population-based cohort study followed 16,495 female patients with newly diagnosed breast cancer who did not experience psychological distress during the 14 months before breast cancer surgery. The incidence of psychological distress was reported overall and by type of mental health problem. Time-varying Cox proportional hazards models were developed to identify predictors of new-onset psychological distress during 2 key periods of cancer care: (1) hospital-based treatment during which women undergo treatment with breast surgery, chemotherapy, and/or radiation, and (2) 1-year transitional survivorship when women begin follow-up care. Results: The incidence of psychological distress was 16% within each period. Anxiety was present in 85.1% and 65.5% of new cases during hospital-based treatment and transitional survivorship, respectively. Predictors during both periods were younger age, receipt of axillary lymph node dissection, rheumatologic disease, and baseline menopausal symptoms, as well as new opioid dispensations, emergency department visits, and hospital contacts that occurred during follow-up. Other predictors varied based on the period of cancer care. More advanced breast cancer and type of treatment were associated with onset of psychological distress during hospital-based treatment. Psychological distress during transitional survivorship was predicted by diagnosis of localized breast disease, shorter duration of hospital-based treatment, receipt of additional hospital-based treatment in survivorship, and newly diagnosed comorbidities or symptoms. Conclusions: This study identified the predictors of new-onset psychological distress available in routinely collected administrative health databases, and showed how predictors change between hospital-based treatment and transitional survivorship periods. The results highlight the importance of developing predictive models tailored to the period of cancer care.

Comparative Safety and Effectiveness of Metformin in Patients With Diabetes Mellitus and Heart FailureClinical Perspective

Background—There is an ongoing controversy regarding the safety and effectiveness of metformin in the setting of heart failure (HF). Therefore, we undertook a systematic review of the trial and nontrial evidence for metformin in patients with diabetes mellitus and HF. Methods and Results—We conducted a comprehensive search for controlled studies, evaluating the association between metformin and morbidity and mortality in people with diabetes mellitus and HF. Two reviewers independently identified citations, extracted data, and evaluated quality. Risk estimates were abstracted and pooled where appropriate. As measures of overall safety, we examined all-cause mortality and all-cause hospitalizations. Nine cohort studies were included; no randomized controlled trials were identified. Most (5 of 9) studies were published in 2010 and were of good quality. Metformin was associated with reduced mortality compared with controls (mostly sulfonylurea therapy): 23% versus 37% (pooled adjusted risk estimates: 0.80; 0.74–0.87; I2=15%; P<0.001). No increased risk was observed for metformin in those with reduced left ventricular ejection fraction (mortality pooled adjusted risk estimate: 0.91; 0.72–1.14; I2=0%; P=0.34), nor in those with HF and chronic kidney disease (pooled adjusted risk estimate: 0.81; 0.64–1.02; P=0.08). Metformin was associated with a small reduction in all-cause hospitalizations (pooled adjusted risk estimate: 0.93; 0.89–0.98; I2=0%; P=0.01). Metformin was not associated with increased risk of lactic acidosis. Conclusions—The totality of evidence indicates that metformin is at least as safe as other glucose-lowering treatments in patients with diabetes mellitus and HF and even in those with reduced left ventricular ejection fraction or concomitant chronic kidney disease. Until trial data become available, metformin should be considered the treatment of choice for patients with diabetes mellitus and HF.Background— There is an ongoing controversy regarding the safety and effectiveness of metformin in the setting of heart failure (HF). Therefore, we undertook a systematic review of the trial and nontrial evidence for metformin in patients with diabetes mellitus and HF.nnMethods and Results— We conducted a comprehensive search for controlled studies, evaluating the association between metformin and morbidity and mortality in people with diabetes mellitus and HF. Two reviewers independently identified citations, extracted data, and evaluated quality. Risk estimates were abstracted and pooled where appropriate. As measures of overall safety, we examined all-cause mortality and all-cause hospitalizations. Nine cohort studies were included; no randomized controlled trials were identified. Most (5 of 9) studies were published in 2010 and were of good quality. Metformin was associated with reduced mortality compared with controls (mostly sulfonylurea therapy): 23% versus 37% (pooled adjusted risk estimates: 0.80; 0.74–0.87; I 2=15%; P <0.001). No increased risk was observed for metformin in those with reduced left ventricular ejection fraction (mortality pooled adjusted risk estimate: 0.91; 0.72–1.14; I 2=0%; P =0.34), nor in those with HF and chronic kidney disease (pooled adjusted risk estimate: 0.81; 0.64–1.02; P =0.08). Metformin was associated with a small reduction in all-cause hospitalizations (pooled adjusted risk estimate: 0.93; 0.89–0.98; I 2=0%; P =0.01). Metformin was not associated with increased risk of lactic acidosis.nnConclusions— The totality of evidence indicates that metformin is at least as safe as other glucose-lowering treatments in patients with diabetes mellitus and HF and even in those with reduced left ventricular ejection fraction or concomitant chronic kidney disease. Until trial data become available, metformin should be considered the treatment of choice for patients with diabetes mellitus and HF.

Comparative Safety and Effectiveness of Metformin in Patients With Diabetes Mellitus and Heart FailureClinical Perspective: Systematic Review of Observational Studies Involving 34 000 Patients

Background—There is an ongoing controversy regarding the safety and effectiveness of metformin in the setting of heart failure (HF). Therefore, we undertook a systematic review of the trial and nontrial evidence for metformin in patients with diabetes mellitus and HF. Methods and Results—We conducted a comprehensive search for controlled studies, evaluating the association between metformin and morbidity and mortality in people with diabetes mellitus and HF. Two reviewers independently identified citations, extracted data, and evaluated quality. Risk estimates were abstracted and pooled where appropriate. As measures of overall safety, we examined all-cause mortality and all-cause hospitalizations. Nine cohort studies were included; no randomized controlled trials were identified. Most (5 of 9) studies were published in 2010 and were of good quality. Metformin was associated with reduced mortality compared with controls (mostly sulfonylurea therapy): 23% versus 37% (pooled adjusted risk estimates: 0.80; 0.74–0.87; I2=15%; P<0.001). No increased risk was observed for metformin in those with reduced left ventricular ejection fraction (mortality pooled adjusted risk estimate: 0.91; 0.72–1.14; I2=0%; P=0.34), nor in those with HF and chronic kidney disease (pooled adjusted risk estimate: 0.81; 0.64–1.02; P=0.08). Metformin was associated with a small reduction in all-cause hospitalizations (pooled adjusted risk estimate: 0.93; 0.89–0.98; I2=0%; P=0.01). Metformin was not associated with increased risk of lactic acidosis. Conclusions—The totality of evidence indicates that metformin is at least as safe as other glucose-lowering treatments in patients with diabetes mellitus and HF and even in those with reduced left ventricular ejection fraction or concomitant chronic kidney disease. Until trial data become available, metformin should be considered the treatment of choice for patients with diabetes mellitus and HF.Background— There is an ongoing controversy regarding the safety and effectiveness of metformin in the setting of heart failure (HF). Therefore, we undertook a systematic review of the trial and nontrial evidence for metformin in patients with diabetes mellitus and HF.nnMethods and Results— We conducted a comprehensive search for controlled studies, evaluating the association between metformin and morbidity and mortality in people with diabetes mellitus and HF. Two reviewers independently identified citations, extracted data, and evaluated quality. Risk estimates were abstracted and pooled where appropriate. As measures of overall safety, we examined all-cause mortality and all-cause hospitalizations. Nine cohort studies were included; no randomized controlled trials were identified. Most (5 of 9) studies were published in 2010 and were of good quality. Metformin was associated with reduced mortality compared with controls (mostly sulfonylurea therapy): 23% versus 37% (pooled adjusted risk estimates: 0.80; 0.74–0.87; I 2=15%; P <0.001). No increased risk was observed for metformin in those with reduced left ventricular ejection fraction (mortality pooled adjusted risk estimate: 0.91; 0.72–1.14; I 2=0%; P =0.34), nor in those with HF and chronic kidney disease (pooled adjusted risk estimate: 0.81; 0.64–1.02; P =0.08). Metformin was associated with a small reduction in all-cause hospitalizations (pooled adjusted risk estimate: 0.93; 0.89–0.98; I 2=0%; P =0.01). Metformin was not associated with increased risk of lactic acidosis.nnConclusions— The totality of evidence indicates that metformin is at least as safe as other glucose-lowering treatments in patients with diabetes mellitus and HF and even in those with reduced left ventricular ejection fraction or concomitant chronic kidney disease. Until trial data become available, metformin should be considered the treatment of choice for patients with diabetes mellitus and HF.

Comparative Safety and Effectiveness of Sitagliptin in Patients with Type 2 Diabetes and Heart Failure

s / Can J Diabetes 37 (2013) S13eS84 S45 Results: Similar proportions of DU and sitagliptin patients completed 104 weeks of treatment. Both once-weekly DU (1.5 mg, 0.75 mg) doses were superior to sitagliptin as measured by change in HbA1c at 104 weeks (e0.99%, e0.71% and e0.32%, respectively, adjusted p<0.001). Both DU doses were associated with a higher incidence of gastrointestinal (GI) treatment-emergent adverse events (AEs) than sitagliptin. The most common GI AEs for DU 1.5 mg, DU 0.75mg and sitagliptin, respectively, were nausea (17%,15%, 7%), vomiting (14%, 8%, 4%) and diarrhea (16%, 12%, 6%). The incidence of GI TEAEs peaked during the first 12 weeks, with no difference between groups after 26 weeks. Weight change was e2.88 kg in the DU 1.5 mg arm, e2.39 kg in the DU 0.75 mg and e1.75 kg for the sitagliptin arm (p<0.001 for DU 1.5 mg versus sitagliptin). Conclusion: Once-weekly DU AEs profile and superior HbA1c control versus sitagliptin after 104 weeks indicate an acceptable benefit/risk profile of DU over a longer time.