Effect on Treatment Adherence of Distributing Essential Medicines at No Charge

Abstract

; for the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team 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 A 1c 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 A 1c , −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

Trends in diabetes medication use in Australia, Canada, England, and Scotland: a repeated cross-sectional analysis in primary care

“…(50, 51) A recent study found that covering a set of essential medications at no charge to patients resulted in better adherence, with patients reporting improvements in their ability to make ends meet (buy food, pay rent). (52) Trade-offs in costs and outcomes, for patients and health systems, of the rapid uptake of these medications in broad populations of persons with diabetes should be studied further. (53) It would be helpful to continue to monitor the extent to which the opportunity to switch to medications with evidence of better outcomes is seized in primary care settings.…”

Cost-Related Medication Nonadherence in Canada: A Systematic Review of Prevalence, Predictors, and Clinical Impact

“…(46,57) The sole RCT in our SR found that the free provision and delivery of essential medications increased adherence by 10% and improved one of three clinical surrogates at 12 months follow-up, but did not improve clinical outcomes. (58) In summary, the relationship between medication costs, medication adherence and patient outcomes is more complex than originally thought.…”

“…(47) CRNA Association with Clinical Outcomes Only three studies measured clinical outcomes potentially related to CRNA (Table 1; n = 93,653). (52,53,58) The highest quality study was a recent randomized controlled trial involving patients in primary care in Ontario who reported that they did not fill a prescription or changed regimens to make their supply last longer because of the cost. The study found that the intervention group provided free, mailed prescriptions deemed essential, reported better adherence, improved perceived care, and less concern about making ends meet at 12 months follow-up.…”

The U.S. Health Care System on the Eve of the Covid-19 Epidemic: A Summary of Recent Evidence on Its Impaired Performance

“…Hemoglobin A 1c and LDL cholesterol levels also fell slightly, but nonsignificantly, in the free medications group. 14 A new study finds that Veterans Health Administration (VA) patients, relative to Americans with non-VA coverage, are only about half as likely to skip a prescribed medication because of costs (6.1% vs 10.9% of others), despite VA patients having lower average incomes. VA coverage especially improved drug adherence among people with chronic illnesses, while shrinking racial/ethnic and income-related disparities.…”