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JAMA Intern Med. 2019 Oct 7. doi: 10.1001/jamainternmed.2019.4472. [Epub ahead of print]

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

Author information

1
Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.
2
Li Ka Shing Knowledge Institute, St Michael's Hospital, 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.
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, St Michael's Hospital, 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
The Upstream Lab, MAP Centre for Urban Health Solutions, St Michael's Hospital, Toronto, Ontario, Canada.
22
Department of Research and Innovation, North York General Hospital, Toronto, Ontario, Canada.
23
Division of Population and Behavioral Science, University of St Andrews, St Andrews, Scotland.

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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