Introduction Cost-related non-adherence to medicines is common in low-income, middle-income and high-income countries such as Canada. Medicine non-adherence is associated with poor health outcomes and increased mortality. This randomised trial will test the impact of a carefully selected list of essential medicines at no charge (compared with usual medicine access) in primary care patients reporting cost-related non-adherence.
Methods and analysis This is an open-label, parallel two-arm, superiority, individually randomised controlled trial conducted in three primary care sites (one urban, two rural) in Ontario, Canada, that was codesigned by a community guidance panel. Adult patients (≥18 years) who report cost-related non-adherence to medicines are eligible to participate in the study. Participants will be randomised to receive free and convenient access to a carefully selected list of 125 essential medicines (based on the WHO’s Model List of Essential Medicines) or usual means of medicine access. Care for patients in both groups will otherwise be unchanged. The primary outcome of this trial is adherence to appropriately prescribed medicines. Secondary outcomes include medicine adherence, appropriate prescribing, blood pressure, haemoglobin A1c, low-density lipoprotein cholesterol, patient-oriented outcomes and healthcare costs. All participants will be followed for at least 12 months.
Ethics and dissemination Ethics approval was obtained in all three participating sites. Results of the main trial and secondary outcomes will be submitted for publication in a peer-reviewed journal and discussed with members of the public and decision makers.
Trial registration number NCT02744963.
- appropriate prescribing
- essential medicines
- medicine adherence
- medicine costs
- patient-oriented outcomes
- randomized controlled trial
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Contributors All authors contributed substantially to conception and the design of the protocol, all revised the manuscript critically for important intellectual content, all approved the final manuscript, and all are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding The trial is funded by the Ontario SPOR Support Unit and the Canadian Institutes of Health Research.
Competing interests None declared.
Patient consent The protocol does not contain personal medical information about an identifiable living individual and does not require patients' explicit consent.
Ethics approval Ethics approval for the conduct of this study was obtained from the St Michaels Research Ethics Board, the Huron Shores Family Health Team Research Ethics Committee and the Laurentian University Research Ethics Board.
Provenance and peer review Not commissioned; externally peer reviewed.
Correction notice This paper has been amended since it was published Online First. Owing to a scripting error, some of the publisher names in the references were replaced with 'BMJ Publishing Group'. This only affected the full text version, not the PDF. We have since corrected these errors and the correct publishers have been inserted into the references.
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