Nav Persaud1,2,3,4, Michael Bedard5, Andrew Boozary6, Richard H Glazier1,2,3,7,8, Tara Gomes1,2,9,10, Stephen W Hwang2,4,11, Peter Juni4,11, Michael R Law12, Muhammad Mamdani2,9,11,13, Braden Manns14,15,16,17, Danielle Martin1,18, Steven G Morgan19, Paul Oh11,20, Andrew D Pinto1,2,7, Baiju R Shah4,8,11, Frank Sullivan21,22, Norman Umali2, Kevin E Thorpe7,10, Karen Tu1,4,21, Andreas Laupacis2,4,11. 1. Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada. 2. Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada. 3. Department of Family and Community Medicine, St Michael's Hospital, Toronto, Ontario, Canada. 4. Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada. 5. Department of Family Medicine, Northern Ontario School of Medicine, Sudbury, Ontario, Canada. 6. Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, United States of America. 7. Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada. 8. Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada. 9. Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada. 10. Applied Health Research Centre, St. Michael's Hospital, Toronto, Ontario, Canada. 11. Department of Medicine, University of Toronto, Toronto, Ontario, Canada. 12. Centre for Health Services and Policy Research, School of Population and Public Health, The University of British Columbia, Vancouver, British Columbia, Canada. 13. Centre for Healthcare Analytics Research and Training at St Michael's Hospital and Vector Institute, Toronto, Ontario, Canada. 14. Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. 15. Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. 16. O'Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. 17. Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. 18. Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, Toronto, Ontario, Canada. 19. School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada. 20. Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada. 21. Department of Research and Innovation, North York General Hospital, Toronto, Ontario, Canada. 22. Division of Population and Behavioral Science, University of St Andrews, Scotland.
Abstract
BACKGROUND:Adherence to medicines is low for a variety of reasons, including the cost borne by patients. Some jurisdictions publicly fund medicines for the general population, but many jurisdictions do not, and such policies are contentious. To our knowledge, no trials studying free access to a wide range of medicines have been conducted. METHODS AND FINDINGS: We randomly assigned 786 primary care patients who reported not taking medicines due to cost between June 1, 2016 and April 28, 2017 to either free distribution of essential medicines (n = 395) or to usual medicine access (n = 391). The trial was conducted in Ontario, Canada, where hospital care and physician services are publicly funded for the general population but medicines are not. The trial population was mostly female (56%), younger than 65 years (83%), white (66%), and had a low income from wages as the primary source (56%). The primary outcome was medicine adherence after 2 years. Secondary outcomes included control of diabetes, blood pressure, and low-density lipoprotein (LDL) cholesterol in patients taking relevant treatments and healthcare costs over 2 years. Adherence to all appropriate prescribed medicines was 38.7% in the free distribution group and 28.6% in the usual access group after 2 years (absolute difference 10.1%; 95% confidence interval (CI) 3.3 to 16.9, p = 0.004). There were no statistically significant differences in control of diabetes (hemoglobin A1c 0.27; 95% CI -0.25 to 0.79, p = 0.302), systolic blood pressure (-3.9; 95% CI -9.9 to 2.2, p = 0.210), or LDL cholesterol (0.26; 95% CI -0.08 to 0.60, p = 0.130) based on available data. Total healthcare costs over 2 years were lower with free distribution (difference in median CAN$1,117; 95% CI CAN$445 to CAN$1,778, p = 0.006). In the free distribution group, 51 participants experienced a serious adverse event, while 68 participants in the usual access group experienced a serious adverse event (p = 0.091). Participants were not blinded, and some outcomes depended on participant reports. CONCLUSIONS: In this study, we observed that free distribution of essential medicines to patients with cost-related nonadherence substantially increased adherence, did not affect surrogate health outcomes, and reduced total healthcare costs over 2 years. TRIAL REGISTRATION: ClinicalTrials.gov NCT02744963.
RCT Entities:
BACKGROUND: Adherence to medicines is low for a variety of reasons, including the cost borne by patients. Some jurisdictions publicly fund medicines for the general population, but many jurisdictions do not, and such policies are contentious. To our knowledge, no trials studying free access to a wide range of medicines have been conducted. METHODS AND FINDINGS: We randomly assigned 786 primary care patients who reported not taking medicines due to cost between June 1, 2016 and April 28, 2017 to either free distribution of essential medicines (n = 395) or to usual medicine access (n = 391). The trial was conducted in Ontario, Canada, where hospital care and physician services are publicly funded for the general population but medicines are not. The trial population was mostly female (56%), younger than 65 years (83%), white (66%), and had a low income from wages as the primary source (56%). The primary outcome was medicine adherence after 2 years. Secondary outcomes included control of diabetes, blood pressure, and low-density lipoprotein (LDL) cholesterol in patients taking relevant treatments and healthcare costs over 2 years. Adherence to all appropriate prescribed medicines was 38.7% in the free distribution group and 28.6% in the usual access group after 2 years (absolute difference 10.1%; 95% confidence interval (CI) 3.3 to 16.9, p = 0.004). There were no statistically significant differences in control of diabetes (hemoglobin A1c 0.27; 95% CI -0.25 to 0.79, p = 0.302), systolic blood pressure (-3.9; 95% CI -9.9 to 2.2, p = 0.210), or LDL cholesterol (0.26; 95% CI -0.08 to 0.60, p = 0.130) based on available data. Total healthcare costs over 2 years were lower with free distribution (difference in median CAN$1,117; 95% CI CAN$445 to CAN$1,778, p = 0.006). In the free distribution group, 51 participants experienced a serious adverse event, while 68 participants in the usual access group experienced a serious adverse event (p = 0.091). Participants were not blinded, and some outcomes depended on participant reports. CONCLUSIONS: In this study, we observed that free distribution of essential medicines to patients with cost-related nonadherence substantially increased adherence, did not affect surrogate health outcomes, and reduced total healthcare costs over 2 years. TRIAL REGISTRATION: ClinicalTrials.gov NCT02744963.
Authors: Nav Persaud; Hannah Woods; Aine Workentin; Itunu Adekoya; James R Dunn; Stephen W Hwang; Jonathon Maguire; Andrew D Pinto; Patricia O'Campo; Sean B Rourke; Daniel Werb Journal: CMAJ Date: 2022-01-17 Impact factor: 8.262