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    1 Comment for this article
    interesting research; wrong conclusion
    James Williams |
    How can the authors claim a positive study when 2 of 3 endpoints were not reached? And the third, reduction of blood pressure, was only  7mm Hg systolic blood pressure. If these secondary outcomes were not reached, it begs the questions of either: 1) Was the measurement of adherence adequate? or 2) What is the benefit of free distribution of medicines? In any case, I am concerned that the results were misrepresented.
    CONFLICT OF INTEREST: None Reported
    Original Investigation
    Health Care Policy and Law
    October 7, 2019

    Effect on Treatment Adherence of Distributing Essential Medicines at No Charge: The CLEAN Meds Randomized Clinical Trial

    Author Affiliations
    • 1Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada
    • 2Li Ka Shing Knowledge Institute, St Michael’s Hospital, Toronto, Ontario, Canada
    • 3Department of Family and Community Medicine, St Michael’s Hospital, Toronto, Ontario, Canada
    • 4Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada
    • 5Department of Family Medicine, Northern Ontario School of Medicine, Sudbury, Ontario, Canada
    • 6Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts
    • 7Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
    • 8Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada
    • 9Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada
    • 10Applied Health Research Centre, St Michael’s Hospital, Toronto, Ontario, Canada
    • 11Department of Medicine, University of Toronto, Toronto, Ontario, Canada
    • 12Centre for Health Services and Policy Research, School of Population and Public Health, The University of British Columbia, Vancouver, British Columbia, Canada
    • 13Centre for Healthcare Analytics Research and Training, St Michael’s Hospital, Toronto, Ontario, Canada
    • 14Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
    • 15Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
    • 16O’Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
    • 17Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
    • 18Women’s College Hospital Institute for Health Systems Solutions and Virtual Care, Women’s College Hospital, Toronto, Ontario, Canada
    • 19School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada
    • 20Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada
    • 21The Upstream Lab, MAP Centre for Urban Health Solutions, St Michael’s Hospital, Toronto, Ontario, Canada
    • 22Department of Research and Innovation, North York General Hospital, Toronto, Ontario, Canada
    • 23Division of Population and Behavioral Science, University of St Andrews, St Andrews, Scotland
    JAMA Intern Med. 2020;180(1):27-34. doi:10.1001/jamainternmed.2019.4472
    Key Points

    Question  Does providing a comprehensive set of essential medicines at no charge to primary care patients who have difficulty affording medicines improve treatment adherence?

    Findings  In this randomized clinical trial of 786 primary care patients, free distribution of essential medicines vs usual access resulted in greater adherence to treatment with medicines (absolute risk difference, 11.6%). Control of type 1 and 2 diabetes was not significantly improved by free distribution of essential medicines (hemoglobin A1c, −0.38%), systolic blood pressure was reduced (−7.2 mm Hg), and low-density lipoprotein cholesterol levels were not affected (−2.3 mg/dL).

    Meaning  Distributing essential medicines at no charge increased adherence to appropriately prescribed treatment with medicines and improved some disease-specific surrogate health outcomes.

    Abstract

    Importance  Nonadherence to treatment with medicines is common globally, even for life-saving treatments. Cost is one important barrier to access, and only some jurisdictions provide medicines at no charge to patients.

    Objective  To determine whether providing essential medicines at no charge to outpatients who reported not being able to afford medicines improves adherence.

    Design, Setting, and Participants  A multicenter, unblinded, parallel, 2-group, superiority, outcomes assessor–blinded, individually randomized clinical trial conducted at 9 primary care sites in Ontario, Canada, enrolled 786 patients between June 1, 2016, and April 28, 2017, who reported cost-related nonadherence. Follow-up occurred at 12 months. The primary analysis was performed using an intention-to-treat principle.

    Interventions  Patients were randomly allocated to receive free medicines on a list of essential medicines in addition to otherwise usual care (n = 395) or usual medicine access and usual care (n = 391).

    Main Outcomes and Measures  The primary outcome was adherence to treatment with all medicines that were appropriately prescribed for 1 year. Secondary outcomes were hemoglobin A1c level, blood pressure, and low-density lipoprotein cholesterol levels 1 year after randomization in participants taking corresponding medicines.

    Results  Among the 786 participants analyzed (439 women and 347 men; mean [SD] age, 51.7 [14.3] years), 764 completed the trial. Adherence to treatment with all medicines was higher in those randomized to receive free distribution (151 of 395 [38.2%]) compared with usual access (104 of 391 [26.6%]; difference, 11.6%; 95% CI, 4.9%-18.4%). Control of type 1 and 2 diabetes was not significantly improved by free distribution (hemoglobin A1c, −0.38%; 95% CI, −0.76% to 0.00%), systolic blood pressure was reduced (−7.2 mm Hg; 95% CI, −11.7 to −2.8 mm Hg), and low-density lipoprotein cholesterol levels were not affected (−2.3 mg/dL; 95% CI, −14.7 to 10.0 mg/dL).

    Conclusions and Relevance  The distribution of essential medicines at no charge for 1 year increased adherence to treatment with medicines and improved some, but not other, disease-specific surrogate health outcomes. These findings could help inform changes to medicine access policies such as publicly funding essential medicines.

    Trial Registration  ClinicalTrials.gov identifier: NCT02744963

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