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Adherence at 2 years with distribution of essential medicines at no charge: The CLEAN Meds randomized clinical trial

Author

Listed:
  • Nav Persaud
  • Michael Bedard
  • Andrew Boozary
  • Richard H Glazier
  • Tara Gomes
  • Stephen W Hwang
  • Peter Juni
  • Michael R Law
  • Muhammad Mamdani
  • Braden Manns
  • Danielle Martin
  • Steven G Morgan
  • Paul Oh
  • Andrew D Pinto
  • Baiju R Shah
  • Frank Sullivan
  • Norman Umali
  • Kevin E Thorpe
  • Karen Tu
  • Andreas Laupacis
  • for the Carefully seLected and Easily Accessible at No Charge Medications (CLEAN Meds) study team

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. Why was this study done?: What did the researchers do and find?: What do these findings mean?:

Suggested Citation

  • Nav Persaud & Michael Bedard & Andrew Boozary & Richard H Glazier & Tara Gomes & Stephen W Hwang & Peter Juni & Michael R Law & Muhammad Mamdani & Braden Manns & Danielle Martin & Steven G Morgan & Pa, 2021. "Adherence at 2 years with distribution of essential medicines at no charge: The CLEAN Meds randomized clinical trial," PLOS Medicine, Public Library of Science, vol. 18(5), pages 1-14, May.
    • Handle: RePEc:plo:pmed00:1003590
    DOI: 10.1371/journal.pmed.1003590
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    References listed on IDEAS

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    1. Kenneth F Schulz & Douglas G Altman & David Moher & for the CONSORT Group, 2010. "CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials," PLOS Medicine, Public Library of Science, vol. 7(3), pages 1-7, March.
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    1. Bailey Yee & Nisa Mohan & Fiona McKenzie & Mona Jeffreys, 2024. "What Interventions Work to Reduce Cost Barriers to Primary Healthcare in High-Income Countries? A Systematic Review," IJERPH, MDPI, vol. 21(8), pages 1-28, August.

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