TY - JOUR
T1 - Adherence at 2 years with distribution of essential medicines at no charge
T2 - the CLEAN Meds randomized clinical trial
AU - for the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) Study Team
AU - Persaud, Nav
AU - Bedard, Michael
AU - Boozary, Andrew
AU - Glazier, Richard H.
AU - Gomes, Tara
AU - Hwang, Stephen W.
AU - Juni, Peter
AU - Law, Michael R.
AU - Mamdani, Muhammad
AU - Manns, Braden
AU - Martin, Danielle
AU - Morgan, Steven G.
AU - Oh, Paul
AU - Pinto, Andrew D.
AU - Shah, Baiju R.
AU - Sullivan, Frank
AU - Umali, Norman
AU - Thorpe, Kevin E.
AU - Tu, Karen
AU - Laupacis, Andreas
N1 - Funding: This work is supported by the Canadian Institutes for Health Research (NP, 381409, https://cihr-irsc.gc.ca/e/193.html), the Ontario SPOR Support Unit (NP, OSSU, https://ossu.ca/), and the St. Michael’s Hospital Foundation (NP, https://stmichaelsfoundation.com/). Funded by the Canadian Institutes of Health Research and the Ontario SPOR Support Unit.
PY - 2021/5/21
Y1 - 2021/5/21
N2 - 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.
AB - 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.
U2 - 10.1371/journal.pmed.1003590
DO - 10.1371/journal.pmed.1003590
M3 - Article
C2 - 34019540
SN - 1549-1277
VL - 18
JO - PLoS Medicine
JF - PLoS Medicine
IS - 5
M1 - e1003590
ER -