Abstract
Objective To determine the acceptability of providing free access to only a short list of medicines used in the Carefully seLected and Easily Accessible at No charge Medications (CLEAN Meds) trial.
Design A multimethod explanatory sequential design including interviews with trial participants and focus groups with prescribers.
Setting Ontario.
Participants Participants in the intervention arm of the CLEAN Meds trial and primary care providers who prescribed medicines to those in the intervention arm of the trial.
Main outcome measures The number of trial participants in each prescription category (ie, prescribed no off-list medicine, prescribed 1 off-list medicine, or prescribed 2 or more off-list medicines) and the acceptability of the list to both participants and prescribers.
Results There were 395 participants in the intervention group of the CLEAN Meds trial, but 16 participants withdrew consent or were not prescribed any medicines during the first 12 months of the trial, resulting in a total of 379 participants in the quantitative component of this study. Of the 2648 total prescriptions, 2349 (89%) were for medications that were on or had an equivalent covered by the list. Random sampling was used to select 5 participants to interview from each prescription category. A total of 19 prescribers participated in the focus groups. Themes from participant interviews included the following: having access to medicines on the list was a relief, participants trusted health care professionals to switch medicines and to decide which medicines should be on a publicly funded list, and a short list of essential medicines should be publicly funded. Major themes from the prescribers’ focus groups related to the process of developing the list, support for the list, and publicly funding a short list of essential medicines in Canada.
Conclusion The consensus among trial participants and prescribers is that the short list of medicines used in the trial is comprehensive and provides access to medicines commonly prescribed.
Since the 1960s, numerous commissions have recommended implementing a universal pharmacare program in Canada.1 Canada is currently the only country in the Organisation for Economic Co-operation and Development that offers a universal health insurance program without covering prescription medicines.2 Approximately 10% of Canadians do not take their medications as prescribed owing to cost and 1.45 million make sacrifices on food, heating, and other essentials to afford their medicines.3,4
The Carefully seLected and Easily Accessible at No charge Medications (CLEAN Meds) randomized controlled trial was conducted at 9 primary care sites in Ontario between 2016 and 2020 to investigate the effects of offering free and convenient access to a list of essential medicines on patient adherence to their prescribed medicines.5 The list used in this trial was created by adapting the World Health Organization’s 2013 list of essential medicines to reflect the range of illnesses and primary care prescribing patterns in Canada, which resulted in a total of 136 medicines (Appendix A, available from CFPlus*).6 It is worth noting that other high-income countries such as Sweden have lists of essential medicines, so it would not be unheard of for Canada to do the same.7 Moreover, publicly funding the medicines on this list was projected to reduce total spending by $7.3 billion annually.2
Although a short list of essential medicines can improve the appropriateness of physician prescribing, physicians and patients might feel that it is not comprehensive enough to meet their clinical needs (owing to the content and length of the list) and physicians might feel that it reduces their prescribing autonomy if they are restricted to prescribing from the list.6,8-10 Patients might dislike having to change from a medicine that is not on the list to one that is on the list in order to receive the medication at no cost.11 If physicians and patients do not feel that a short list of essential medicines meets their clinical needs, or if physicians feel that prescribing from a short list of medicines limits their autonomy, then publicly funding and implementing such a list may not be a viable approach to achieving universal pharmacare. Therefore, the purpose of this study was to understand CLEAN Meds participants’ and prescribers’ experiences with and acceptance of a short list of medications.
METHODS
Research design
This study used a multimethod explanatory sequential design and the results from the quantitative and qualitative components were integrated using the triangulation protocol method.12,13 We conceived of this study after the CLEAN Meds trial had been designed and had some preliminary findings available. We categorized trial participants according to the number of off-list medicines they had been prescribed. We then conducted interviews with trial participants and conducted focus groups with prescribers to assess the acceptability of the list. The interview and focus group guides were developed based on input from clinicians and governmental decision makers. We pretested the interview and focus group guides during several pilot interviews and focus groups. During the interviews and focus groups, we summarized discussions and asked participants to confirm accuracy to ensure that we correctly understood participants’ and prescribers’ opinions of the list.
Quantitative component
Participants. To be included in this study, participants had to have participated in the intervention arm of the CLEAN Meds trial (ie, participants must have reported cost-related nonadherence, thereby receiving free access to the list of 136 medicines) and had to have been prescribed at least 1 medicine during the first 12 months of the trial. This study population was selected as these individuals had reported cost-related nonadherence and would likely be most affected by policy change.
Data gathering procedures. We reviewed all medicines prescribed to participants in the intervention arm during the first 12 months of the trial to see whether medicines were on the list, had an equivalent to one on the list, or were not on the list or did not have an equivalent on the list.
Data analysis. We considered medicines equivalent if they were in the same chemical subgroup as a medicine on the list (as determined by their Anatomical Therapeutic Chemical codes). An exception was made in the case of codeine since it converts to morphine (a medicine on the list) in the body.14
For prescribed combination medications, each active ingredient was considered separately except in cases where the list contained a suitable combination medicine (eg, amoxicillin and clavulanic acid). We ensured that only unique medicines were listed for each participant. We then grouped participants according to the following prescription categories: those who had all their medicines covered (ie, no off-list medicine), those who had all but 1 medicine covered (ie, 1 off-list medicine), and those who had 2 or more medicines not covered by the list. We considered medicines to be covered if they were on or had an equivalent on the list.
Outcomes. We measured the number of participants who were part of the aforementioned prescription categories. These outcomes helped answer the question about acceptability of the short list by addressing the ability of the list to meet clinical needs.
Qualitative component: patient interviews
Participants. A subset of the participants in the quantitative component of the study were included in the qualitative component. We used purposeful random sampling to select 5 participants from each prescription category (ie, no off-list medicines, 1 off-list medicine, 2 or more off-list medicines) for a total of 15 participants.15
Data gathering procedures. We anticipated reaching data saturation after interviewing 15 participants because the interviews were semistructured and the questions were not overly deep or complex.16 We used random sampling since there were high numbers of participants in each category. Using purposeful random sampling generated a range of responses regarding the acceptability of the list.15 We contacted the selected participants by telephone and subsequently by e-mail or mail to invite them to participate. We explained that their participation was optional and that they could drop out of this study at any time without any consequence. We explained that we aimed to learn about their perceptions, attitudes, and knowledge related to the list of medicines used in the trial and that the information provided would help us better understand the perceived benefits and challenges of establishing and maintaining a national essential medicines list.
Trained research staff (M.Z.A., H.W., and I.A.) conducted one-on-one semistructured interviews with participants as we wanted a confidential environment to facilitate free expression of their opinions of and experiences with the list. These interviews took place over telephone or in person (in clinic or at the participant’s home) and were audiorecorded. The interviews were initiated using the interview guide (Supplementary file 1, available from CFPlus*) and lasted approximately 10 minutes. Member checks were employed and the interviewers took notes during the interviews. The participants had only ever interacted with the research team during the trial.
Data analysis. All interview responses were de-identified and all audiorecordings were transcribed. The transcripts were analyzed and coded iteratively by 2 authors (M.Z.A and H.W.) using inductive content analysis.17 We read each transcript twice to familiarize ourselves with the content and the transcripts were coded on the third reading. Each transcript was coded by 1 person and then coding was reviewed by another person. These codes were then grouped into categories, where major themes were identified.18
Outcome. The outcome of interest in conducting one-on-one interviews was to gauge the acceptability of the short list of essential medicines to participants.
Qualitative component: focus groups with prescribers
Participants. We conducted 3 focus groups with prescribers whose patients were in the intervention arm of the trial. We recruited only primary care providers as the list of essential medicines used in the trial was developed for primary care use.6
Data gathering procedures. We emailed prescribers to invite them to participate and informed them that they could drop out of this study at any time. We estimated that 3 focus groups would be sufficient to reach data saturation16 and that 3 focus groups would capture perspectives of prescribers from both urban and rural practice locations. We aimed to enrol approximately 15 to 20 prescribers or to cease enrolment when data saturation was reached (when new data collected were redundant).
The focus groups were held at St Michael’s Hospital in Toronto, Ont. We chose a group setting to allow prescribers to build on each other’s ideas, resulting in information-rich data. A trained individual (H.W.) facilitated all 3 focus groups with guidance from the focus group question guide (Supplementary file 2, available from CFPlus*). Researchers I.A. and A.B. attended 2 focus groups and M.Z.A. attended 1 focus group. All observers took notes during the focus groups. The focus groups lasted about 30 minutes and were audiorecorded.
We explained to prescribers that we were aiming to learn about their perceptions, attitudes, and knowledge related to the list of medicines used in the trial and that the information provided would help us better understand the perceived benefits and challenges of establishing and maintaining a national essential medicines list. Some of the prescribers were clinical colleagues of 1 coauthor (N.P.), but others were not.
Data analysis. All focus group responses were de-identified and all audiorecordings were transcribed. The transcripts were analyzed and coded iteratively by 2 authors (M.Z.A. and H.W.) using inductive content analysis.17 We read each transcript twice to familiarize ourselves with the content and transcripts were coded on the third reading. Each transcript was coded by 1 person (M.Z.A.) and then coding was reviewed by another person (H.W.). These codes were then grouped into categories, where major themes were identified.18
Outcome. The outcome of interest in conducting focus groups was to gauge the acceptability of the short list of essential medicines to primary care prescribers.
Ethics approval
This study received ethics approval from St Michael’s Hospital’s Research Ethics Board.
RESULTS
Quantitative component
There were 395 participants in the CLEAN Meds intervention group. Participant characteristics are summarized in Table 1. Sixteen participants either withdrew consent or were not prescribed any medicines during the CLEAN Meds trial, resulting in 379 participants being included in this study.
Baseline CLEAN Meds intervention group participants’ demographic characteristics: N=395.
Overall, 328 unique medicines were prescribed a total of 2648 times. There were 129 unique on-list medicines (distributed for free as part of the trial intervention) that were prescribed 1952 times (74% of prescriptions), 101 unique medicines that were equivalent to an on-list medicine that were prescribed 397 times (15%), and 98 unique off-list medicines (that participants accessed in the usual fashion such as by paying out of pocket) that were prescribed 299 times (11%). The most commonly prescribed on- and off-list medicines are shown in Tables 2 and 3, respectively.
No. of participants who received each of the 20 most frequently prescribed on-list medicines: N=379.
No. of participants who received each of the 20 most frequently prescribed off-list medicines: N=379.
We found that 200 (53%) participants had all their medicines on the list, 111 (29%) were prescribed 1 off-list medicine, and 68 (18%) were prescribed 2 or more off-list medicines. Participants prescribed at least 1 off-list medicine were prescribed a median of 7 (interquartile range=5 to 10) on-list and 1 (interquartile range=1 to 2) off-list medicines.
Qualitative component: patient interviews
Participants found the short list of essential medicines to be acceptable and indicated it should be publicly funded, though it could be expanded to include more medicines.
We reached data saturation at 16 trial participants (5 participants with no off-list medicines, 6 participants with 1 off-list medicine, and 5 participants with 2 or more off-list medicines), all of whom were recruited by telephone. Five trial participants who were contacted by telephone and invited to participate were not interested (reasons not specified). Most participants (12 [75%]) were female and the mean (SD) age was 53 (10.5). Most participants (75%) were White. Participants’ main income sources were wages and salaries (9 [56.3%]), and other sources included social support, old age security, and “other”; some declined to answer. Most participants (9 [56.3%]) reported the range of their household income to be less than $20,000 and 6 (37.5%) reported it to be between $20,000 and $50,000. Half (8) were from urban sites and half were from rural sites.
Three main themes were identified from the interviews: having access to medicines on the list was a relief, there was great trust in health care professionals, and a short list of medicines should be publicly funded. Representative quotes are presented in Table 4.
Themes, key concepts, and representative quotes identified from patient interviews
Relief. All participants said they were happy when they learned they were getting free access to medicines on the list. They indicated the high cost of medicines meant they would not have been able to afford them otherwise. Having access to medicines on the list relieved stress. Most individuals did not express any concerns with the list and the 2 who did were concerned about the cost of medicines not covered by the list.
Trust in health care professionals. Participants trusted health care professionals to make changes to their prescribed medicines, such as switching from an off-list medicine to an on-list medicine, and they trusted health care professionals to decide which medicines should be on a publicly funded list. The few participants who reported switching medicines said they did not have any concerns since the switch was initiated by or was approved by the physician or pharmacist. The consensus was that clinicians should have the most say in deciding which medicines are on a publicly funded list as they are more knowledgeable about which medicines are most needed. Participants believed that government bodies should not decide which medicines are on the list and should provide access to the medicines only.
Publicly funding a list of essential medicines in Canada. When we directly asked what participants thought about a short list of frequently used medicines being publicly funded for everyone, most had an affirmative response. Only 2 participants were unsure if they believed a short list of medicines should be publicly funded for everyone.
Participants believed the only individuals who would oppose publicly funding a short list of medicines are those with higher incomes and those concerned about increased taxes and having to pay for others to get medicines for free. Many participants thought the list should be expanded, especially for use in the general population, but that a short list was better than nothing.
When asked if there are medicines that they thought should be added to the list, most participants did not make any suggestions. Five participants reported switching medicines from ones that were not on the list to ones that were, and most said they had no concerns. Some felt the medicines on the list were “stronger” or more effective. One participant using a medicine not on the list said they tried to switch to a medicine on the list but did not find an on-list medicine that worked well for them.
Qualitative component: focus groups with prescribers
Prescribers found the list of essential medicines acceptable and felt it should be publicly funded. However, they cautioned against industry influence in the process. Nineteen prescribers (15 from the urban site and 4 from the rural sites) participated in a total of 3 focus groups, where we reached data saturation. Most prescriber participants (14 [74%]) were female. Three of the prescriber participants were nurse practitioners. We identified themes related to the process of developing the list, support for the list, and support for publicly funding a list of essential medicines. Representative quotes are presented in Table 5.
Themes, key points, and representative quotes identified from prescriber focus groups
Process of developing the list. Prescribers felt that a combination of health care professionals (who are free of industry bias) should be involved in developing a publicly funded list of medicines and that the public should be able to provide input, as this would increase support for the list. They said the list should be targeted to family medicine and should be evidence based.
Support for the list. Most prescribers said they were happy when they learned that some of their patients would be receiving access to a short list of medicines, as even a short list is “better than nothing.” Most did not have concerns about the list and some liked that it covered products that were not usually covered by formularies. Some prescribers felt antidepressants and medicines for diabetes were underrepresented and would prefer to have the list expanded to allow more choice.
Support for publicly funding a list of essential medicines in Canada. All prescribers thought a list of essential medicines should be publicly funded for everyone in Canada and that it should happen immediately. They expressed that not having medicines publicly funded limits their ability to help their patients, as some patients do not fill their prescriptions owing to cost. Most prescribers believed that since most Canadians support universal health care, they would also support publicly funding a list of medicines. Prescribers thought the greatest opposition to publicly funding a list of medicines would be from businesses (such as insurance and pharmaceutical companies) and that governments should not decide which medicines are on the list, as they might be influenced by industry. Some prescribers also mentioned there might be some opposition from health care practitioners (such as physicians from other specialties and at sites with drug detailing) if a short list of medicines were publicly funded, as it may limit prescribing autonomy. They thought this could be addressed by educating those individuals on the principles of having only a short list of medicines.
DISCUSSION
Most (89%) prescribed medicines were covered or had an equivalent covered by the list and participants and prescribers felt the list of medicines was acceptable. This quantitative finding is aligned with the qualitative findings in that it matched recurring themes from the interviews and focus groups that the short list is better than nothing and that having access to at least some of the most common medicines is important. We found 8 of the 20 most frequently prescribed off-list medicines (87 participants) were either for depression or diabetes, and the qualitative findings indicated that participants and prescribers thought more of these medicines should be added to the list. Both prescribers and participants felt the list provides access to common medicines and that most people would support a publicly funded list of medicines.
Our finding that the list covers those medicines most frequently prescribed in primary care settings in Ontario is consistent with a study that found a preliminary version of the list (containing 125 medicines) covered 90.8% of all medicines prescribed at an inner-city site and 92.6% of those at a suburban site; another study found that the list covered 77% of all prescriptions filled nationally.2,6 A study that looked at China’s essential medicines list (307 medicines and 102 traditional Chinese medicines) also found that although some doctors complained of reduced prescribing autonomy, they supported the principle of an essential medicines list.10 A study done in England that implemented a short practice formulary consisting of 50 medicines found that patients were satisfied with the formulary and that doctors’ satisfaction and compliance with the formulary increased over time.11 Prescribers’ high adherence over a 15-year period to Stockholm’s Wise List,7 which contains about 200 core and 100 complementary medicines, suggests they are satisfied with the list, which further supports our findings.19
After this study had been completed, the Advisory Council on the Implementation of National Pharmacare issued a report in which it recommended using a short list of essential medicines (specifically, the CLEAN Meds list) as an approach to the implementation of national pharmacare.20 Our findings indicate this approach may be accepted by patients and prescribers in primary care settings, and they provide some insight into what patients and prescribers think the process should look like. The report recommends starting with the short list of essential medicines and eventually expanding the list to include more medicines. This is consistent with participants in this study suggesting the list could be expanded to suit the needs of the general population.
Limitations
The views expressed by participants in this study may not reflect those of the general population because all participants had trouble affording medicines; however, they represented situations similar to more than 1 million Canadians.4,21 People who experience cost-related nonadherence are those most likely to be affected by policy change. Trial participants also do not represent every possible medical condition and people taking specific medicines (eg, anti-rejection treatment) might have definite views about whether they should be included in the list. Since a component of this study is qualitative, our position and bias may have influenced the participants, prescribers, and results. When recruiting participants for the interviews, we called during regular working hours and this might have excluded some participants, including those without functional phones, but we also sent letters to those who did not initially answer the phone. This was a study in primary care that did not include those whose views may differ from primary care providers.
Conclusion
The general consensus among participants and prescribers in this study was that a list of 136 medicines covered most common prescriptions and that a short list of essential medicines was acceptable. Medicines for depression and diabetes were among the most frequently prescribed off-list medicines and those most frequently identified by participants and clinicians as candidates for addition to the list. Future work should verify the acceptability of such a list in a broader population, either before or after implementation of a policy that provides people with access to essential medicines.
Acknowledgments
This research received funding from the Canadian Institutes of Health Research and the Ontario SPOR SUPPORT Unit.
Notes
Editor’s key points
▸ Patients and prescribers who participated in the Carefully seLected and Easily Accessible at No charge Medications trial found the short list of essential medicines acceptable and indicated that the list should be publicly funded.
▸ Eight of the 20 most frequently prescribed off-list medications were either for depression or diabetes; some prescribers thought the list should be expanded to include these medicines.
▸ Both participants and prescribers thought that opposition to a publicly funded list would come from individuals with higher incomes, insurance companies, and pharmaceutical companies.
▸ Participants believed clinicians should decide which medicines are on the list, as clinicians know which medicines are most needed.
Points de repère du rédacteur
▸ Les patients et les prescripteurs qui ont participé à l’essai CLEAN Meds (Carefully seLected and Easily Accessible at No charge Medications) ont jugé acceptable la courte liste de médicaments essentiels et ont indiqué que les médicaments de la liste devraient être financés par le secteur public.
▸ Huit des 20 médicaments les plus souvent prescrits absents de la liste étaient pour la dépression ou encore le diabète; certains prescripteurs étaient d’avis que la liste devrait être élargie pour inclure ces médicaments.
▸ Les participants et les prescripteurs croyaient que l’opposition à une liste de médicaments financés par le secteur public viendrait des personnes à revenu plus élevé, des compagnies d’assurance et des sociétés pharmaceutiques.
▸ Les participants jugeaient que les cliniciens devraient décider des médicaments à inclure sur la liste, parce qu’ils connaissent les médicaments qui sont les plus nécessaires.
Footnotes
↵* Appendix A, supplementary files 1 and 2, and the consolidated criteria for REporting Qualitative research checklist are available from https://www.cfp.ca. Go to the full text of the article online and click on the CFPlus tab.
Contributors
All authors contributed to the concept and design of the study; to data gathering, analysis, and interpretation; and to preparing the manuscript for submission.
Competing interests
None declared
This article has been peer reviewed.
Cet article a fait l’objet d’une révision par des pairs.
- Copyright © 2022 the College of Family Physicians of Canada
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