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4. Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study

Author

Morrow, Richard L., Mintzes, Barbara, Souverein, Patrick C., Hallgreen, Christine E., Ahmed, Bilal, Roughead, Elizabeth E., De Bruin, Marie L., Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie-Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, and Dormuth, Colin R.

Published
2022
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6. Sodium glucose cotransporter 2 inhibitors and risk of major adverse cardiovascular events : multi-database retrospective cohort study

Author

CanadianNetworkforObservationalDrugEffectStudies(CNODES)Investigators, Filion, Kristian B, Lix, Lisa M, Yu, Oriana HY, Dell’Aniello, Sophie, Douros, Antonios, Shah, Baiju R, St-Jean, Audray, Fisher, Anat, Tremblay, Eric, Bugden, Shawn C, Alessi-Severini, Silvia, Ronksley, Paul E, Hu, Nianping, Dormuth, Colin R, Ernst, Pierre, and Suissa, Samy

Published
2020

7. Impact of using concomitant conventional DMARDs on adherence to biologic DMARD treatment in rheumatoid arthritis: Multi-centre, population-based cohort study

Author

Dormuth, Colin R., Fisher, Anat, Hudson, Marie, Austin, Peter C., Ernst, Pierre, Bresee, Lauren, Chateau, Dan, Tamim, Hala, Paterson, J. Michael, Lafrance, Jean Philippe, Taylor-Gjevre, Regina M., Platt, Robert W., and Canadian Network for Observational Drug Effect Studies (CNODES) Investigators

Published
2021
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20. Characteristics and incidence of opioid analgesic initiations to opioid na��ve patients in a Canadian primary care setting

Author

Klimas, Jan, Hamilton, Michee-Ana, Carney, Greg, Cooper, I. R. (Ian R.), Croteau, Nicole, Dong, Huiru, Dormuth, Colin, Maclure, Malcolm, Soc��as, Eugenia, Ti, Lianping, Wood, Evan, and McCracken, Rita

Abstract

Objective: To examine characteristics and incidence of opioid analgesic initiations to opioid na��ve patients in a Canadian primary care setting. Methods: This is a population-based cross-sectional study, outlining an analysis of health administrative data recorded in a centralized medication monitoring database (PharmaNet) covering 96% of population in British Columbia (BC), Canada. From the PharmaNet database, 5,657 doctors (87% of all practicing family physicians) were selected on the bases of (1) having been currently treating patients (defined as having written at least 25 prescriptions, for any drug, in preceding 12 months); and (2) having prescribed at least one opioid during study period. The primary outcome measure is incidence of new starts for opioid analgesics in opioid na��ve people, stratified by several important prescriber and regional characteristics (e.g., graduation year, geographical location). Results: Between December 1 st , 2018 and November 30th , 2019, there were 139,145 opioid initiations to opioid na��ve patients. The mean monthly initiation rate was 2.05 prescriptions per physician. Most initiations were in Lower Mainland regions of BC, also where the population is most concentrated (46,456, 33% in the Fraser region), by prescribers who graduated between 1986-1995 (39,601, 28%), and had less than 10 patient visits per day (72,506, 52%). Conclusions: From data presented in this study, it appears that the rate of opioid analgesic initiations in primary care remains unchanged. Individualized prescribing interventions targeted at physicians are urgently needed considering the current opioid epidemic and known links with opioid analgesics that raise concerns about the potential to cause harm.

Published
2023
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24. Influence of drug safety advisories on drug utilisation: an international interrupted time series and meta-analysis

Author

Morrow, Richard L, Mintzes, Barbara, Souverein, Patrick C, De Bruin, Marie L, Roughead, Elizabeth Ellen, Lexchin, Joel, Kemp-Casey, Anna, Puil, Lorri, Sketris, Ingrid, Mangin, Dee, Hallgreen, Christine E, Pearson, Sallie-Anne, Lopert, Ruth, Bero, Lisa, Ofori-Asenso, Richard, Gnjidic, Danijela, Sarpatwari, Ameet, Perry, Lucy T, Dormuth, Colin R, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Morrow, Richard L, Mintzes, Barbara, Souverein, Patrick C, De Bruin, Marie L, Roughead, Elizabeth Ellen, Lexchin, Joel, Kemp-Casey, Anna, Puil, Lorri, Sketris, Ingrid, Mangin, Dee, Hallgreen, Christine E, Pearson, Sallie Anne, Lopert, Ruth, Bero, Lisa, Ofori-Asenso, Richard, Gnjidic, Danijela, Sarpatwari, Ameet, Perry, Lucy T, Dormuth, Colin R, Afd Pharmacoepi & Clinical Pharmacology, and Pharmacoepidemiology and Clinical Pharmacology

Subjects
Canada, pharmacoepidemiology, Health Policy, Humans, Interrupted Time Series Analysis, health policy, sense organs, medication safety, Drug Prescriptions, Drug Utilization, health services research
Abstract

ObjectiveTo evaluate the association between regulatory drug safety advisories and changes in drug utilisation.DesignWe conducted controlled, interrupted times series analyses with administrative prescription claims data to estimate changes in drug utilisation following advisories. We used random-effects meta-analysis with inverse-variance weighting to estimate the average postadvisory change in drug utilisation across advisories.Study populationWe included advisories issued in Canada, Denmark, the UK and the USA during 2009–2015, mainly concerning drugs in common use in primary care. We excluded advisories related to over-the-counter drugs, drug-drug interactions, vaccines, drugs used primarily in hospital and advisories with co-interventions within ±6 months.Main outcome measuresChange in drug utilisation, defined as actual versus predicted percentage change in the number of prescriptions (for advisories without dose-related advice), or in the number of defined daily doses (for dose-related advisories), per 100 000 population.ResultsAmong advisories without dose-related advice (n=20), the average change in drug utilisation was −5.83% (95% CI −10.93 to –0.73; p=0.03). Advisories with dose-related advice (n=4) were not associated with a statistically significant change in drug utilisation (−1.93%; 95% CI −17.10 to 13.23; p=0.80). In a post hoc subgroup analysis of advisories without dose-related advice, we observed no statistically significant difference between the change in drug utilisation following advisories with explicit prescribing advice, such as a recommendation to consider the risk of a drug when prescribing, and the change in drug utilisation following advisories without such advice.ConclusionsAmong safety advisories issued on a wide range of drugs during 2009–2015 in 4 countries (Canada, Denmark, the UK and the USA), the association of advisories with changes in drug utilisation was variable, and the average association was modest.

Published
2022
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29. The impact of online medication reviews and educational workshops on deprescribing during the COVID-19 pandemic: a controlled before-after study.

Author

Al-Sakran, Lina, Carney, Gregory, Maclure, Malcolm, Fisher, Anat, Perry, Thomas, and Dormuth, Colin

Subjects
MEDICATION reconciliation, COVID-19 pandemic, EDUCATION conferences, ODDS ratio, DEPRESCRIBING, CONSUMERS' reviews
Abstract

Objectives The South Peace Polypharmacy Reduction Project is a quality improvement project in three communities in rural Canada that aimed to reduce polypharmacy and inappropriate prescribing practices in older adults. This study aims to evaluate the impact of a multifaceted intervention consisting of online team-based medication reviews and educational workshops on the number of chronic medications. Methods A controlled before-after design was used to compare if a decrease in the number of chronic medications was associated with the intervention comprising of online team-based medication reviews and educational workshops, compared with two matched control groups that received either a standard medication review or no medication review. Logistic regression models fit with generalized estimated equations were used to identify the impact of the interventions on decreasing the number of chronic medications. Key findings Following a medication review, the percentage of individuals that had deprescribed at least one medication was highest in the intervention group (52%), followed by the medication review controls at 45%, and 36% in non-medication review controls. Individuals in the intervention group were 20% more likely to have at least one medication deprescribed than individuals in the medication review control group (adjusted odds ratio: 1.20; 95% CI: 1.03 to 1.39), whereas they were 42% more likely to deprescribe at least one medication compared with non-medication review controls (adjusted odds ratio: 1.42; 95% CI: 1.25 to 1.61). Conclusions Online team-based medication reviews had a significant impact on decreasing the number of chronic medications in older adults. Furthermore, providing healthcare providers with education can complement the role of other healthcare interventions. [ABSTRACT FROM AUTHOR]

Published
2023
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30. Pioglitazone use in Australia and the United Kingdom following drug safety advisories on bladder cancer risk: An interrupted time series study

Author

Kemp-Casey, Anna, Mintzes, Barbara, Morrow, Richard L., Dormuth, Colin R., Souverein, Patrick C., Roughead, Elizabeth E., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Kemp-Casey, Anna, Mintzes, Barbara, Morrow, Richard L, Dormuth, Colin R, Souverein, Patrick C, and Roughead, Elizabeth E

Subjects
Male, Pioglitazone, adverse drug reaction reporting systems events, Epidemiology, Australia, Interrupted Time Series Analysis, United Kingdom, Diabetes Mellitus, Type 2, Urinary Bladder Neoplasms, pharmacovigilance, diabetes mellitus, patient safety, Humans, Hypoglycemic Agents, Female, Thiazolidinediones, Pharmacology (medical), Aged
Abstract

Purpose: National regulators in Australia and the United Kingdom issued safety advisories on the association between pioglitazone use and bladder cancer in July 2011. The Australian advisory noted that males were at higher risk of bladder cancer than females, while the UK advisory highlighted a new recommendation, suggest careful consideration in the elderly due to increasing risk with age. This study examined whether these differences in the advisories had different age- and sex-based impacts in each country. Methods: Interrupted time series analysis was used to compare pioglitazone use (prescriptions/100000 population) in Australia and the United Kingdom for the 24 months before and 11 months after the July 2011 safety advisories (study period July 2009–June 2012). Separate models were used to compare use by sex and age group (≥65 years vs.

Published
2022

33. Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study

Author

Morrow, Richard L, Mintzes, Barbara, Souverein, Patrick C, Hallgreen, Christine E, Ahmed, Bilal, Roughead, Elizabeth E, De Bruin, Marie L, Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie-Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, Dormuth, Colin R, Morrow, Richard L, Mintzes, Barbara, Souverein, Patrick C, Hallgreen, Christine E, Ahmed, Bilal, Roughead, Elizabeth E, De Bruin, Marie L, Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie-Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, and Dormuth, Colin R

Abstract

INTRODUCTION: Regulatory advisories on hydroxyzine and risk of QT prolongation and Torsade de pointes (TdP) were issued in the UK in April 2015 and Canada in June 2016. We hypothesized patients with risk factors for QT prolongation and TdP, compared with those without risk factors, would be less likely to initiate hydroxyzine in the UK and in British Columbia (BC), Canada, following advisories.METHODS: We conducted a longitudinal study with repeated measures, and evaluated hydroxyzine initiation in a UK cohort and a concurrent BC control cohort (April 2013-March 2016) as well as in a BC advisory cohort (June 2014-May 2017).RESULTS: This study included 247,665 patients in the UK cohort, 297,147 patients in the BC control cohort, and 303,653 patients in the BC advisory cohort. Over a 12-month post-advisory period, hydroxyzine initiation decreased by 21% in the UK (rate ratio 0.79, 95% confidence interval 0.66-0.96) relative to the expected level of initiation based on the pre-advisory trend. Hydroxyzine initiation did not change in the BC control cohort or following the Canadian advisory in the BC advisory cohort. The decrease in hydroxyzine initiation in the UK in the 12 months after the advisories was not significantly different for patients with risk factors compared with those without risk factors.CONCLUSION: Hydroxyzine initiation decreased in the UK, but not in BC, in the 12 months following safety advisories. The decrease in hydroxyzine initiation in the UK was not significantly different for patients with versus without risk factors for QT prolongation and TdP.

Published
2022

34. Influence of drug safety advisories on drug utilisation: an international interrupted time series and meta-analysis

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Morrow, Richard L, Mintzes, Barbara, Souverein, Patrick C, De Bruin, Marie L, Roughead, Elizabeth Ellen, Lexchin, Joel, Kemp-Casey, Anna, Puil, Lorri, Sketris, Ingrid, Mangin, Dee, Hallgreen, Christine E, Pearson, Sallie-Anne, Lopert, Ruth, Bero, Lisa, Ofori-Asenso, Richard, Gnjidic, Danijela, Sarpatwari, Ameet, Perry, Lucy T, Dormuth, Colin R, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Morrow, Richard L, Mintzes, Barbara, Souverein, Patrick C, De Bruin, Marie L, Roughead, Elizabeth Ellen, Lexchin, Joel, Kemp-Casey, Anna, Puil, Lorri, Sketris, Ingrid, Mangin, Dee, Hallgreen, Christine E, Pearson, Sallie-Anne, Lopert, Ruth, Bero, Lisa, Ofori-Asenso, Richard, Gnjidic, Danijela, Sarpatwari, Ameet, Perry, Lucy T, and Dormuth, Colin R

Published
2022

35. Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Morrow, Richard L, Mintzes, Barbara, Souverein, Patrick C, Hallgreen, Christine E, Ahmed, Bilal, Roughead, Elizabeth E, De Bruin, Marie L, Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie-Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, Dormuth, Colin R, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Morrow, Richard L, Mintzes, Barbara, Souverein, Patrick C, Hallgreen, Christine E, Ahmed, Bilal, Roughead, Elizabeth E, De Bruin, Marie L, Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie-Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, and Dormuth, Colin R

Published
2022

36. Pioglitazone use in Australia and the United Kingdom following drug safety advisories on bladder cancer risk: An interrupted time series study

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Kemp-Casey, Anna, Mintzes, Barbara, Morrow, Richard L., Dormuth, Colin R., Souverein, Patrick C., Roughead, Elizabeth E., Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Kemp-Casey, Anna, Mintzes, Barbara, Morrow, Richard L., Dormuth, Colin R., Souverein, Patrick C., and Roughead, Elizabeth E.

Published
2022

37. Hydroxysine initiation following drug safety advisories on cardiac arrhythmias in the UK and Canada:A longitudinal cohort study

Author

Morrow, Richard, Mintzes, Barbara, Souverein, Patrick, Hallgreen, Christine, Ahmed, Bilal, Roughead, Elizabeth, De Bruin, Marie Louise, Kristiansen, Sarah, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie-Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, Dormuth, Colin, Morrow, Richard, Mintzes, Barbara, Souverein, Patrick, Hallgreen, Christine, Ahmed, Bilal, Roughead, Elizabeth, De Bruin, Marie Louise, Kristiansen, Sarah, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie-Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, and Dormuth, Colin

Published
2022

38. Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada:A Longitudinal Cohort Study

Author

Morrow, Richard L., Mintzes, Barbara, Souverein, Patrick C., Hallgreen, Christine E., Ahmed, Bilal, Roughead, Elizabeth E., De Bruin, Marie L., Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, Dormuth, Colin R., Morrow, Richard L., Mintzes, Barbara, Souverein, Patrick C., Hallgreen, Christine E., Ahmed, Bilal, Roughead, Elizabeth E., De Bruin, Marie L., Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, and Dormuth, Colin R.

Abstract

Introduction: Regulatory advisories on hydroxyzine and risk of QT prolongation and Torsade de pointes (TdP) were issued in the UK in April 2015 and Canada in June 2016. We hypothesized patients with risk factors for QT prolongation and TdP, compared with those without risk factors, would be less likely to initiate hydroxyzine in the UK and in British Columbia (BC), Canada, following advisories. Methods: We conducted a longitudinal study with repeated measures, and evaluated hydroxyzine initiation in a UK cohort and a concurrent BC control cohort (April 2013–March 2016) as well as in a BC advisory cohort (June 2014–May 2017). Results: This study included 247,665 patients in the UK cohort, 297,147 patients in the BC control cohort, and 303,653 patients in the BC advisory cohort. Over a 12-month post-advisory period, hydroxyzine initiation decreased by 21% in the UK (rate ratio 0.79, 95% confidence interval 0.66–0.96) relative to the expected level of initiation based on the pre-advisory trend. Hydroxyzine initiation did not change in the BC control cohort or following the Canadian advisory in the BC advisory cohort. The decrease in hydroxyzine initiation in the UK in the 12 months after the advisories was not significantly different for patients with risk factors compared with those without risk factors. Conclusion: Hydroxyzine initiation decreased in the UK, but not in BC, in the 12 months following safety advisories. The decrease in hydroxyzine initiation in the UK was not significantly different for patients with versus without risk factors for QT prolongation and TdP.

Published
2022

39. Influence of drug safety advisories on drug utilisation:an international interrupted time series and meta-analysis

Author

Morrow, Richard L., Mintzes, Barbara, Souverein, Patrick C., De Bruin, Marie L., Roughead, Elizabeth Ellen, Lexchin, Joel, Kemp-Casey, Anna, Puil, Lorri, Sketris, Ingrid, Mangin, Dee, Hallgreen, Christine E., Pearson, Sallie-Anne, Lopert, Ruth, Bero, Lisa, Ofori-Asenso, Richard, Gnjidic, Danijela, Sarpatwari, Ameet, Perry, Lucy T., Dormuth, Colin R., Morrow, Richard L., Mintzes, Barbara, Souverein, Patrick C., De Bruin, Marie L., Roughead, Elizabeth Ellen, Lexchin, Joel, Kemp-Casey, Anna, Puil, Lorri, Sketris, Ingrid, Mangin, Dee, Hallgreen, Christine E., Pearson, Sallie-Anne, Lopert, Ruth, Bero, Lisa, Ofori-Asenso, Richard, Gnjidic, Danijela, Sarpatwari, Ameet, Perry, Lucy T., and Dormuth, Colin R.

Abstract

Objective To evaluate the association between regulatory drug safety advisories and changes in drug utilisation. Design We conducted controlled, interrupted times series analyses with administrative prescription claims data to estimate changes in drug utilisation following advisories. We used random-effects meta-analysis with inverse-variance weighting to estimate the average postadvisory change in drug utilisation across advisories. Study population We included advisories issued in Canada, Denmark, the UK and the USA during 2009-2015, mainly concerning drugs in common use in primary care. We excluded advisories related to over-the-counter drugs, drug-drug interactions, vaccines, drugs used primarily in hospital and advisories with co-interventions within +/- 6 months. Main outcome measures Change in drug utilisation, defined as actual versus predicted percentage change in the number of prescriptions (for advisories without dose-related advice), or in the number of defined daily doses (for dose-related advisories), per 100 000 population. Results Among advisories without dose-related advice (n=20), the average change in drug utilisation was -5.83% (95% CI -10.93 to -0.73; p=0.03). Advisories with dose-related advice (n=4) were not associated with a statistically significant change in drug utilisation (-1.93%; 95% CI -17.10 to 13.23; p=0.80). In a post hoc subgroup analysis of advisories without dose-related advice, we observed no statistically significant difference between the change in drug utilisation following advisories with explicit prescribing advice, such as a recommendation to consider the risk of a drug when prescribing, and the change in drug utilisation following advisories without such advice. Conclusions Among safety advisories issued on a wide range of drugs during 2009-2015 in 4 countries (Canada, Denmark, the UK and the USA), the association of advisories with changes in drug utilisation was variable, and the average association was modest.

Published
2022

40. Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy

Author

Henry, David, Dormuth, Colin, Winquist, Brandace, Carney, Greg, Bugden, Shawn, Teare, Gary, Levesque, Linda E., Berard, Anick, Paterson, J. Michael, and Platt, Robert W.

Subjects
Care and treatment, Research, Health aspects, Acne -- Research -- Care and treatment, Isotretinoin -- Research -- Health aspects, Pregnant women -- Research -- Health aspects
Abstract

Isotretinoin is used widely to treat severe and scarring cystic acne. The drug was first approved for use in Canada in 1983. It is a potent teratogen, (1, 2) and [...], Background: Isotretinoin, a teratogen, is widely used to treat cystic acne. Although the risks of pregnancy during isotretinoin therapy are well recognized, there are doubts about the level of adherence with the pregnancy prevention program in Canada. Our objective was to evaluate the effectiveness of the Canadian pregnancy prevention program in 4 provinces: British Columbia, Saskatchewan, Manitoba and Ontario. Methods: Using administrative data, we identified 4 historical cohorts of female users of isotretinoin (aged 12-48 yr) for the period 1996 to 2011. We defined pregnancy using International Statistical Classification of Diseases and billing codes. One definition included only cases with documented pregnancy outcomes (high-specificity definition); the other definition also included individuals recorded as receiving prenatal care (high-sensitivity definition). We studied new courses of isotretinoin and detected pregnancies in 2 time windows: during isotretinoin treatment only and up to 42 weeks after treatment. Live births were followed for 1 year to identify congenital malformations. Results: A total of 59 271 female patients received 102 308 courses of isotretinoin. Between 24.3% and 32.9% of participants received prescriptions for oral contraceptives while they were taking isotretinoin, compared with 28.3% to 35.9% in the 12 months before isotretinoin was started. According to the high-specificity definition of pregnancy, there were 186 pregnancies during isotretinoin treatment (3.1/1000 isotretinoin users), compared with 367 (6.2/1000 users) according to the high-sensitivity definition. By 42 weeks after treatment, there were 1473 pregnancies (24.9/1000 users), according to the high-specificity definition. Of these, 1331 (90.4%) terminated spontaneously or were terminated by medical intervention. Among the 118 live births were 11 (9.3%) cases of congenital malformation. Pregnancy rates during isotretinoin treatment remained constant between 1996 and 2011. Interpretation: Adherence to the isotretinoin pregnancy prevention program in Canada was poor during the 15-year period of this study.

Published
2016
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41. Additional file 1 of Rapid monitoring of health services use following a policy to switch patients from originator to biosimilar etanercept���a cohort study in British Columbia

Author

Fisher, Anat, Kim, Jason D., Carney, Greg, and Dormuth, Colin

Abstract

Additional file 1. Supplementary Table 1. Cohorts construction: exclusion criteria. Supplementary Table 2. Drugs by therapeutic group. Supplementary Figure 1. Cumulative quantity of etanercept (originator or biosimilar) dispensed (mg per patient) over the follow-up period, by cohort. Supplementary Figure 2. Cumulative number of days on conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) per patient, over the follow-up period, by cohort. Supplementary Figure 3. Cumulative number of days on oral steroids per patient, over the follow-up period, by cohort. Supplementary Figure 4. Cumulative number of days on nonsteroidal anti-inflammatory drugs (NSAIDs) per patient, over the follow-up period, by cohort.

Published
2022
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45. Factors relating to nonpublication and publication bias in clinical trials in Canada: A qualitative interview study.

Author

Morrow, Richard L., Mintzes, Barbara, Gray, Garry, Law, Michael R., Garrison, Scott, and Dormuth, Colin R.

Subjects
PUBLICATION bias, CLINICAL trials, INSTITUTIONAL review boards, QUALITATIVE research, TRIAL practice
Abstract

Aims: This study aims to understand factors contributing to nonpublication and publication bias in clinical trials in Canada. Methods: Qualitative interviews were conducted between March 2019 and April 2021 with 34 participants from the Canadian provinces of Alberta, British Columbia and Ontario, including 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators, 3 research ethics board members and 10 clinical trial participants. We conducted a thematic analysis involving coding of interview transcripts and memo‐writing to identify key themes. Results: Several factors contribute to nonpublication and publication bias in clinical trial research. A core theme was that reporting practices are shaped by incentives within the research system taht favour publication of positive over negative trials. Investigators are discouraged from reporting by experiences or perceptions of difficulty in publishing negative findings but rewarded for publishing positive findings in various ways. Trial investigators more strongly associated positive clinical trials than negative trials with opportunities for industry and nonindustry funding and with academic promotion, bonuses and recognition. Research institutions and ethics boards tended to lack well‐resourced, proactive policies and practices to ensure trial findings are reported in registries or journals. Conclusion: Clinical trial reporting practices in Canada are shaped by incentives favouring reporting of positive over negative trials, such as funding opportunities and academic promotion, bonuses and recognition. Research institutions could help change incentives by adopting performance metrics that emphasize full reporting of results in journals or registries. [ABSTRACT FROM AUTHOR]

Published
2023
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47. Seasonal effects on the occurrence of nocturnal leg cramps: a prospective cohort study

Author

Garrison, Scott R., Dormuth, Colin R., Morrow, Richard L., Carney, Greg A., and Khan, Karim M.

Subjects
United States. Food and Drug Administration -- Analysis, University of British Columbia, Analysis, Online searching -- Analysis, Pregnant women -- Analysis, Database searching -- Analysis, Internet/Web search services -- Analysis
Abstract

Nocturnal leg cramps, or rest cramps, are painful involuntary muscle contractions that typically occur in the legs or feet during prolonged periods of rest and often interrupt sleep. (1,2) Although [...], Background: It has been anecdotally reported that nocturnal leg cramps in pregnant women are worse in summer. We analyzed population-level data to determine whether the symptom burden of nocturnal leg cramps is seasonal in the general population. Methods: We examined time-series data for 2 independent measures of the symptom burden of leg cramps: (a) new quinine prescriptions (reflecting new or escalating treatment of leg cramps) from December 2001 to October 2007 among adults aged 50 years and older, which were obtained from linked health care databases that contain the prescribing information for the 4.2 million residents of British Columbia, Canada; and (b) the Internet search volume from February 2004 to March 2012 for the term 'leg cramps' (reflecting public interest), which we obtained from Google Trends data and geographically limited to the United States and Australia. We assessed seasonality by determining how well a least-squares sinusoidal model predicted variability in the outcomes. Results: New quinine prescriptions and Internet searches related to leg cramps were both seasonal, with highs in mid-summer and lows in mid-winter, and a peak-to-peak variability that was about two-thirds of the mean. Seasonality accounted for 88% of the observed monthly variability in new quinine prescriptions (p < 0.001) and 70% of the observed variability in Internet searches related to leg cramps (p < 0.001). Interpretation: New quinine prescriptions and Internet searches related to leg cramps were seasonal and roughly doubled between the winter lows and summer highs. Why a disorder of peripheral motor neurons displays such strong seasonality warrants exploration.

Published
2015
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48. Patterns of antiemetic medication use during pregnancy: A multi-country retrospective cohort study.

Author

Fisher, Anat, Paterson, J. Michael, Winquist, Brandace, Wu, Fangyun, Reynier, Pauline, Suissa, Samy, Dahl, Matthew, Ma, Zhihai, Lu, Xinya, Zhang, Jianguo, Raymond, Colette B., Filion, Kristian B., Platt, Robert W., Moriello, Carolina, and Dormuth, Colin R.

Subjects
MISCARRIAGE, ABORTION, PREGNANCY, ANTIEMETICS, PREGNANT women, COHORT analysis
Abstract

Objective: To compare patterns in use of different antiemetics during pregnancy in Canada, the United Kingdom, and the United States, between 2002 and 2014. Methods: We constructed population-based cohorts of pregnant women using administrative healthcare data from five Canadian provinces (Alberta, British Columbia, Manitoba, Ontario, and Saskatchewan), the Clinical Practice Research Datalink from the United Kingdom, and the IBM MarketScan Research Databases from the United States. We included pregnancies ending in live births, stillbirth, spontaneous abortion, or induced abortion. We determined maternal use of antiemetics from pharmacy claims in Canada and the United States and from prescriptions in the United Kingdom. Results: The most common outcome of 3 848 734 included pregnancies (started 2002–2014) was live birth (66.7% of all pregnancies) followed by spontaneous abortion (20.2%). Use of antiemetics during pregnancy increased over time in all three countries. Canada had the highest prevalence of use of prescription antiemetics during pregnancy (17.7% of pregnancies overall, 13.2% of pregnancies in 2002, and 18.9% in 2014), followed by the United States (14.0% overall, 8.9% in 2007, and 18.1% in 2014), and the United Kingdom (5.0% overall, 4.2% in 2002, and 6.5% in 2014). Besides use of antiemetic drugs being considerably lower in the United Kingdom, the increase in its use over time was more modest. The most commonly used antiemetic was combination doxylamine/pyridoxine in Canada (95.2% of pregnancies treated with antiemetics), ondansetron in the United States (72.2%), and prochlorperazine in the United Kingdom (63.5%). Conclusions: In this large cohort study, we observed an overall increase in antiemetic use during pregnancy, and patterns of use varied across jurisdictions. Continued monitoring of antiemetic use and further research are warranted to better understand the reasons for differences in use of these medications and to assess their benefit-risk profile in this population. [ABSTRACT FROM AUTHOR]

Published
2022
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49. Characteristics of new users of recent antidiabetic drugs in Canada and the United Kingdom.

Author

Brunetti, Vanessa C., St-Jean, Audray, Dell'Aniello, Sophie, Fisher, Anat, Yu, Oriana H. Y., Bugden, Shawn C., Daigle, Jean-Marc, Hu, Nianping, Alessi-Severini, Silvia, Shah, Baiju R., Ronksley, Paul E., Lix, Lisa M., Ernst, Pierre, Filion, Kristian B., for the Canadian Network for Observational Drug Effect Studies (CNODES) Investigators, Suissa, Samy, Dormuth, Colin R., Hemmelgarn, Brenda R., Quail, Jacqueline, and Chateau, Dan

Subjects
HYPOGLYCEMIC agents, DESCRIPTIVE statistics, DRUG utilization, GLUCAGON-like peptide-1 agonists, ENZYME inhibitors, LONGITUDINAL method
Abstract

Background: Characteristics of patients using newer 2nd and 3rd line antidiabetic drugs in a real-world setting are poorly understood. We described the characteristics of new users of sodium-glucose co-transporter-2 inhibitors (SGLT-2i), dipeptidyl peptidase-4 inhibitors (DPP-4i), and glucagon-like peptide-1 receptor agonists (GLP-1 RA) in Canada and the United Kingdom (UK) between 2016 and 2018. Methods: We conducted a multi-database cohort study using administrative health databases from 7 Canadian provinces and the UK Clinical Practice Research Datalink. We assembled a base cohort of antidiabetic drug users between 2006 and 2018, from which we constructed 3 cohorts of new users of SGLT-2i, DPP-4i, and GLP-1 RA between 2016 and 2018. Results: Our cohorts included 194,070 new users of DPP-4i, 166,722 new users of SGLT-2i, and 27,719 new users of GLP-1 RA. New users of GLP-1 RA were more likely to be younger (mean ± SD: 56.7 ± 12.2 years) than new users of DPP-4i (67.8 ± 12.3 years) or SGLT-2i (64.4 ± 11.1 years). In Canada, new users of DPP-4i were more likely to have a history of coronary artery disease (22%) than new users of SGLT-2i (20%) or GLP-1 RA (15%). Conclusion: Although SGLT-2i, DPP-4i, and GLP-1 RAs are recommended as 2nd or 3rd line therapy for type 2 diabetes, important differences exist in the characteristics of users of these drugs. Contrary to existing guidelines, new users of DPP-4i had a higher prevalence of cardiovascular disease at baseline than new users of SGLT2i or GLP-1RA. [ABSTRACT FROM AUTHOR]

Published
2022
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