Biological and Pharmaceutical Bulletin
Online ISSN : 1347-5215
Print ISSN : 0918-6158
ISSN-L : 0918-6158
Regular Article
Development of a Remote Health Support Program by Pharmacists and Elucidation of Its Effectiveness: A Randomized Controlled Study
Tomoya Tachi Yoshihiro NoguchiHitomi Teramachi
Author information
JOURNAL FREE ACCESS FULL-TEXT HTML

2024 Volume 47 Issue 4 Pages 771-784

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Abstract

No progress has been made in using remote communication tools for less urgent but equally important health support services, such as preventive medicine and health education. In this study, we developed a remote health support program by pharmacists for community residents and conducted a randomized controlled study on its effectiveness in proper self-medication through pharmacists. People over the age of 20 years who lived in the vicinity of Gifu City, Japan were eligible to participate in this study. Participants were recruited using posters and brochures. This program comprised a lecture, based on the health belief model and behavioral economics, and access to remote health support. The participants were randomly assigned to two groups: the medicine/health class only (control) and the medicine/health class along with the program (intervention) groups. The participants were administered questionnaire surveys immediately before (the first survey) and 2 months after (the second survey) the medicine/health class, which allowed us to compare the changes in the two groups’ behavior regarding performing proper self-medication through pharmacists. The percentage of individuals who started consulting pharmacists about self-medication in the intervention group (63.9%, 23/36) was significantly higher than that in the control group (15.2%, 5/33; p < 0.001). The percentage of individuals who started recording information about their self-medication in their medication notebooks in the intervention group (16.7%, 6/36) was significantly higher than that in the control group (0%, 0/33; p = 0.026). We clarified the effectiveness of this program for behavioral changes toward proper self-medication using support from pharmacists.

INTRODUCTION

WHO describes self-medication as being responsible for one’s own health and self-treating mild physical disorders.1) Specific examples of self-medication include using OTC drugs, health food products, and dietary supplements as needed; daily health management, such as incorporating appropriate exercise, diet, and sleep; and self-health monitoring using measurement and testing devices. It is essential for community residents to perform proper self-medication; to have a correct understanding of health, to take appropriate behavior, and to self-treat mild physical disorders according to the symptoms and situation, through professionals. Community residents require information from professionals to practice proper self-medication by avoiding duplicate use, interactions, and side effects of OTC drugs, health food products, and dietary supplements26); by avoiding incorrect health information available through mass media and the Internet.7,8) Although it might be possible for community residents to carry out proper self-medication through self-judgment, proper self-medication is feasible through health consultation with, information provided by, and advice from professionals such as doctors and pharmacists. Self-medication does not include diagnosis and treatment but includes health consultation, information provision and advice except for diagnosis and treatment through doctors. Thus, pharmacies and pharmacists in the community play a major role in self-medication.1,2,911)

National governments worldwide also recommend self-medication; thus, self-medication is steadily becoming popular.2,1218) Recently, the Japanese government has also encouraged pharmacies and pharmacists to promote self-medication by providing advice on the proper use of OTC drugs and consultations or information on health-related matters.19) As a part of this policy, a certification system for pharmacies supporting community-initiated health maintenance and promotion activities (health support pharmacies) has been established in 2016.20) Although pharmacies and pharmacists have progressed in developing health support services,20) community residents are yet to progress in using pharmacists for proper self-medication.21)

Self-medication education is important to establish proper self-medication. School education programs include self-medication education2225); in reality, however, self-medication is not popular, and proper self-medication is not practiced.2,2628) Therefore, it is necessary to educate community residents continuously and effectively about proper self-medication. As a part of self-medication education by pharmacists, we have developed the “educational program for the use of medication notebooks at the time of purchasing OTC drugs and health food products29)” and “educational program for the promotion of self-medication using support from pharmacies30)” and demonstrated their effectiveness in terms of proper self-medication.

Meanwhile, because of the widespread use of remote communication devices, such as smartphones and feature phones, and the coronavirus disease 2019 pandemic, telemedicine and remote medication counseling have increasingly been adopted not only for people living in remote areas but also for people in need of medical care in general.31,32) However, no practical progress has been made in using remote communication tools for less urgent but equally important health support services, such as preventive medicine and health education.33) Community residents require information from professionals to practice proper self-medication as described above. However, there are problems in that it is troublesome and burdensome for community residents to visit hospitals, clinics, pharmacies, and drugstores for consulting doctors and pharmacists, resulting in the inhibition of their consultation. If community residents can consult with doctors and pharmacists remotely, the problems would be solved. Consultation with a doctor incurs a fee as part of medical examination, but consultation with a pharmacist is, in principle, free of charge. Thus, it is preferable to consult with a pharmacist from the perspectives of both reduction of medical costs and task shifting to lessen the burden on doctors. In addition, the Japanese government has encouraged pharmacies and pharmacists to promote self-medication of community residents by providing advice on the proper use of OTC drugs and consultations or information on health-related matters recently. However, there are no reports on developing effective remote health support programs on self-medication education and health counseling by pharmacists although the need for remote health support by pharmacists via remote support tools, such as telephone, e-mail, and social media, has been noted.34) If pharmacists can build an effective remote health support programs to remotely support local residents in proactively maintaining and improving their health, residents of all areas, including remote ones and isolated islands, will receive health support from pharmacists. We believe that this will lead to proper self-medication and eventually proactive maintenance and promotion of health.

Health literacy is defined as the ability and skills to obtain, understand, assess, and use health information to maintain and promote health status throughout the lifespan.35) Certain interventions, such as health education, are considered effective in improving health literacy36); health literacy has been reported to affect health outcomes and the use of health services.3739) Therefore, remote health support by pharmacists may influence health literacy, and health literacy may influence the efficacy of remote health support.

In this study, we developed a remote health support program by pharmacists for community residents and conducted a randomized controlled study on its effectiveness in proper self-medication thorough pharmacists. We also evaluated the association between the program’s effectiveness and health literacy.

MATERIALS AND METHODS

Program Description

The program comprised a lecture and access to remote health support for 2 months. The program also included a brochure sent as a reminder via mail 1 month later. The program was performed by the principal investigator.

The lecture comprised the definition of self-medication, importance of proper self-medication, support for proper self-medication by pharmacists, the importance of proper use of drugs and health food products in self-medication, and recording self-medication information such as drugs and health food products in medication notebooks and a check by a pharmacist. The lecture was provided to multiple individuals at once in a seminar format for approximately 20 min. Part of the diagrams of the lecture was shown in Fig. 1.

Fig. 1. Part of the Diagrams of the Lecture

The lecture was organized based on the health belief model and behavioral economics.40) The explanatory content was designed to increase perceived susceptibility, perceived severity, and perceived benefits and decrease perceived barriers in the health belief model. Specifically, participants received an explanation that some OTC drugs, health food products, and dietary supplements may have weaker effects or side effects when they are taken concomitantly with prescription drugs and they may exacerbate symptoms or have side effects when they are taken by people with certain diseases. Moreover, an explanation that these possibilities are not all slight and that symptoms are severe in some cases was provided to let the participants have perceived susceptibility and perceived severity, respectively. For having perceived benefits, participants were explained that consultation with pharmacists can facilitate the proper use of pharmaceutical products, health food products, and dietary supplements. To reduce perceived barriers, participants received the following information: consultation with pharmacists is free; consultation with pharmacists is available at any time via telephone, e-mail, or Line® (Line Corporation, Tokyo, Japan) in an informal manner. Line is a social networking service that can be used on various devices, including smartphones, tablets, and personal computers. It allows for voice calling and chatting. Furthermore, the lecture was also designed to induce behavioral changes intuitively using loss aversion and risk aversion in behavioral economics. Specifically, rather than conveying the benefits of involving pharmacists, we emphasized the health risks posed by improper use of drugs, health food products, and dietary supplements when pharmacists are not involved. We also emphasized the loss of not utilizing the free consultations and not using pharmacists who have a wealth of information in diseases, health, diet (nutrition), and other relevant information, rather than the benefits of using pharmacists.

The “access to remote health support” part of the program comprised introducing information to contact pharmacists via telephone call, e-mail, and Line and voluntary consultation for participants. After the lecture, each participant had an interview with the pharmacist who delivered the lecture, received a hardcopy of contact details for telephone, e-mail, and Line, and was told to feel free to consult with the pharmacist any time he/she wants to. For those who wanted to register the pharmacist as a Line friend on the spot, support for registration was provided.

As a reminder, a brochure summarizing the contents of the lecture and access to remote health support was sent to each participant’s home 1 month later.

The program and the preceding medicine/health class were held at multiple facilities of Gifu City Hall. Specific venues were: Ichihashi Community Center (western part of Gifu City) on October 29, 2021 and January 8, 2022; Nanbu Community Center (southern part of Gifu City) on November 12, 2021; Gifu Media Cosmos (central part of Gifu City) on December 3, 2021; and Nagamori Community Center (eastern part of Gifu City) on December 3, 2021.

Test of the Effectiveness of the Program

Study Design

A randomized controlled study was conducted from November 2021 to March 2022. The participants were randomly assigned to a group to attend the medicine/health class only (the control group) or a group to attend the medicine/health class along with the program (the intervention group). A simple randomization by an envelope method was used. The person, who was not involved in the program, other than principal investigator prepared the envelops using table of random numbers. The participants opened the envelope by themselves. The participants were given questionnaire surveys to evaluate behavioral changes toward proper self-medication using support from pharmacists in the two groups immediately before (the first survey) and 2 months after (the second survey) the medicine and health class.

The participants were randomized after they provided informed consent to participate in this study. For the first survey, the questionnaire forms were distributed and collected on-site; for the second survey, the questionnaire forms were distributed by postal mail and collected using return envelopes.

Participants

People aged ≥20 years who lived near Gifu City and could attend the medicine/health class and the program were eligible to participate in this study. People who had difficulty understanding the medicine/health class and the program (e.g., those with visual or hearing impairment) were excluded. When the principal investigator had a conversation with each participant, the investigator judged whether the participant corresponded with the exclusion criteria or not. To recruit participants, posters were put up; leaflets were distributed at multiple facilities of Gifu City Hall, where the medicine/health class was held; and leaflets were distributed to residents in the neighborhoods of these facilities. Among the people who gathered at the venues of the medicine/health class in response to the recruitment activities, those who consented were included in this study.

Survey Items

The questionnaire included the age, sex, marital status, cohabitation status, employment status, and medical status of participants. Further, questions about participants’ self-medication behaviors (Table 1 in the previous report of Tachi et al.30)), self-medication awareness (Table 1, questions a–k), and health literacy (European Health Literacy Survey Questionnaire Japanese Version; J-HLS-EU-Q4741)) were also included. Responses to the questions about self-medication awareness were based on a 5-point Likert scale (disagree: score 1, slightly agree: score 2, neither agree nor disagree: score 3, slightly disagree: score 4, and agree: score 5). Total and subscale scores of J-HLS-EU-Q47 were calculated using the following equation: (mean value of responses −1) × 50/3. The scores ranged from 0 to 50 points.

Table 1. Awareness of Self-medication

Questions
(a) I take care of my health and try not to get sick.
(b) I try to acquire information and knowledge about health and diseases.
(c) I can determine by myself whether my physical disorder/injury is mild.
(d) I want to consult a pharmacist about health and diseases.
(e) I am interested in reading any brochures and posters about health and diseases available at pharmacies.
(f) I am interested to participate in educational activities such as seminars, courses, and classes about health and diseases at pharmacies.
(g) I try to acquire information and knowledge about drugs.
(h) I try to take (use) drugs properly.
(i) I consider taking (using) OTC drugs when I have mild physical disorder/injury.*
(j) I am going to consult a pharmacist or a registered salesclerk when I take (use) OTC drugs.*
(k) When I take (use) an OTC drug, I try to read instructions before I take (use) the drug.*

* Questions (i) to (k) should only be answered by those who have been instructed by their doctor not to take (use) any OTC drugs.

Outcomes

As in the previous studies,30) the primary outcomes were the percentage of individuals who started consulting pharmacists about self-medication and the percentage of individuals who started recording information about their self-medication in their medication notebooks 2 months after the class/program. The medication notebooks42) were devised in Japan to consolidate patients’ medication-related information and record a history of drugs used, including prescription drugs, OTC drugs, and health food products. Each patient shows a medication notebook with drug-related information to doctors and pharmacists at medical institutions, and this is an effective way to prevent adverse drug reactions, drug interactions, duplicate use, and other medication-related problems from occurring.29,30) The percentage of individuals who started consulting pharmacists about self-medication was the percentage of respondents who answered “No,” which means that (I) did not consult, in the first survey and “Yes,” which means that (I) consulted, in the second survey to questions 6-1), 7-1), 9), 11-1), 12-1), or 13-1). The percentage of individuals who started recording information about their self-medication in their medication notebooks was the percentage of respondents who answered “No,” which means that (I) did not record, in the first survey and “Yes,” which means that (I) recorded, in the second survey to questions 6-2), 7-2), 10), 11-2), 12-2) or 13-2).

Secondary outcomes were the percentage of participants who showed score improvements in self-medication awareness (questions a–k) after 2 months and changes in the total and subscale health literacy scores after 2 months. Subscale scores for the three domains of health care, disease prevention, and health promotion; the four competencies to access, understand, appraise, and apply; and the combination scores of the three domains and the four competencies were evaluated.

Evaluation of the Association between Health Literacy and the Effectiveness of the Program (Sub-analysis)

As a sub-analysis, the participants in the intervention group were stratified into those who started consulting pharmacists about self-medication (the effective group) and those who did not (the ineffective group). Further, the health literacy subscale scores before they attended this program were compared between the two subgroups. The participants in the intervention group were also stratified into those who started recording information about their self-medication in their medication notebooks (the effective group) and those who did not (the ineffective group), and the health literacy subscale scores before they attended this program were compared between the two subgroups.

Statistical Analysis and Determination of a Sample Size

IBM SPSS Statistics (version 28; IBM Corporation, Armonk, NY, U.S.A.) was used for statistical analysis. Unpaired t-test, Fisher’s exact test, and χ2 test were used to compare between the two groups. Unpaired t-test was used in comparison of health literacy scores. Fisher’s exact test and χ2 test were used in comparison of rate of answers except for health literacy in the questionnaire. Mann–Whitney U test was used in comparison of age and health literacy scores in the sub-analysis rather than the unpaired t-test because the sample size was small. p < 0.05 was considered significant.

As a test of statistical power, the required total sample size was calculated as 66 (33 each in the control and intervention groups) under conditions of α = 0.05, β = 0.80, and two-tailed testing, with an assumption that the rates in the control and intervention groups were 0.05 and 0.34 based on the results of the two previous reports (mean values of the results of the two previous reports).29,30)

Ethics

This study was conducted with approval from the ethics committee of Gifu Pharmaceutical University (Approval Number: 2-4). The participants provided written informed consent after they received an adequate explanation using the informed consent document. After providing consent, the participants could withdraw from the study at any time. This study was registered with a public clinical trial system in Japan (UMIN-CTR ID: UMIN000041412) and conducted in accordance with the CONSORT statement.

RESULTS

All 69 eligible individuals consented to participate in this study (Fig. 2). None of them met the exclusion criteria. Of the 69 participants, 33 and 36 were assigned to the control and intervention groups, respectively. Responses to the first and second questionnaire surveys were collected from all 69 participants, and thus responses from all 69 participants were included in the analysis.

Fig. 2. Study Enrollment and Follow-Up

Table 2 summarizes the background variables of the participants. The participants in the control and intervention groups were aged 58.6 ± 15.3 years (mean ± standard deviation) and 54.4 ± 16.6 years, respectively, and 39.4 and 27.8%, respectively, were males.

Table 2. Analysis Subjects’ Background

Total (n = 69)
Control group (n = 33)Intervention group (n = 36)
Age (years, mean ± standard deviation)58.6 ± 15.354.4 ± 16.6
Gender
Male13 (39.4%)10 (27.8%)
Female20 (60.6%)26 (72.2%)
Marital status
Married25 (75.8%)26 (72.2%)
Unmarried8 (24.2%)10 (27.8%)
Cohabitants
Having cohabitants27 (81.8%)26 (72.2%)
Not having cohabitants6 (18.2%)10 (27.8%)
Employment status
Employed16 (48.5%)20 (55.6%)
Not Employed17 (51.5%)16 (44.4%)
Experience as a healthcare professional
Currently a healthcare professional2 (6.1%)2 (5.6%)
Was a healthcare professional in the past8 (24.2%)5 (13.9%)
Was not a healthcare professional in the past23 (69.7%)29 (80.6%)

Age, unpaired t test; gender, marital status, cohabitants and work, Fisher’s exact test; experience as a healthcare professional, χ2 test.

Table 3 summarizes the questionnaire results of the first survey. There were no significant differences in responses to all questions between the control and intervention groups.

Table 3. Results of the Questionnaire Survey (the First Survey)

Total (n = 69)p
Control group (n = 33)Intervention group (n = 36)
1) Consultation with hospitals/clinics1.000
No13 (39.4%)14 (38.9%)
Yes20 (60.6%)22 (61.1%)
2) Receipt of prescriptions at pharmacies0.811
No15 (45.5%)15 (41.7%)
Yes18 (54.5%)21 (58.3%)
3) Ownership of a medication notebook0.348
No4 (12.1%)8 (22.2%)
Yes28 (87.9%)28 (77.8%)
3-1) Medication-notebook carrying status0.806
I do not keep it with me5 (16.7%)3 (10.7%)
I only bring it with me when I need it19 (63.3%)19 (67.9%)
I always (or almost always) keep it with me6 (20.0%)6 (21.4%)
3-2) Presentation of medication notebooks at hospitals/clinics0.587
No6 (20.0%)6 (21.4%)
Only when necessary14 (46.7%)16 (57.1%)
Always (or almost always)10 (33.3%)6 (21.4%)
3-3) Presentation of medication notebooks at pharmacies when receiving prescribed medicines0.535
No3 (10.0%)1 (3.6%)
Only when necessary11 (36.7%)9 (32.1%)
Always (or almost always)16 (53.3%)18 (64.3%)
4) Treatment methods for mild illnesses/injuries1.000
I go to the hospital/clinic, without using any commercially available medicine8 (24.2%)6 (16.7%)
I initially use commercially available medicine and wait to determine whether it can cure the problem20 (60.6%)24 (66.7%)
I neither go to a hospital/clinic nor purchase any commercially available medicine5 (15.2%)6 (16.7%)
5) Mild illness/injury within the past two months1.000
No17 (51.5%)19 (52.8%)
Yes16 (48.5%)17 (47.2%)
6) Usage of OTC drugs (internal medicine) within the past 2 months1.000
No24 (72.7%)22 (61.1%)
Yes9 (27.3%)14 (38.9%)
6-1) Consultation with pharmacists regarding the abovementioned OTC drugs (internal medicine)0.142
No7 (77.8%)14 (100%)
Yes2 (22.2%)0 (0%)
6-2) Recording details of the abovementioned OTC drugs (internal medicine) in the medication notebook0.391
No8 (88.9%)14 (100%)
Yes1 (11.1%)0 (0%)
7) Usage of OTC drugs (external medicine) within the past 2 months0.150
No20 (60.6%)15 (41.7%)
Yes13 (39.4%)21 (58.3%)
7-1) Consultation with pharmacists regarding the abovementioned OTC drugs (external medicine)1.000
No11 (84.6%)18 (85.7%)
Yes2 (15.4%)3 (14.3%)
7-2) Recording details of the abovementioned OTC drugs (external medicine) in the medication notebook1.000
No13 (100%)20 (95.2%)
Yes0 (0%)1 (4.8%)
8) Engaging in measures for maintaining one’s health and prevention of disease
Various medical checkups including comprehensive health screening, health checkups, and cancer screening23 (69.7%)29 (80.6%)
Vaccinations17 (51.5%)22 (61.1%)
Regular, well-balanced diet16 (48.5%)18 (50.0%)
Moderate exercise and sports24 (72.7%)21 (58.3%)
Enough sleep19 (57.6%)16 (44.4%)
Consuming orally-administered products other than medication (e.g., nutrition tablets, specific/specialized health food, general health foods, and supplements)9 (27.3%)17 (47.2%)
Using of external application products, other than medication, including skin and hair treatment products8 (24.2%)14 (38.9%)
Ascertaining one’s own health using a sphygmomanometer, thermometer, scale, or body fat calculator24 (72.7%)21 (58.3%)
Other0 (0%)1 (2.8%)
9) Consultation with pharmacists regarding health/diseases or lifestyle habits within the past 2 months0.415
No29 (87.9%)34 (94.4%)
Yes4 (12.1%)2 (5.6%)
10) Recording health/diseases and lifestyle habits within the past 2 months in the medication notebook1.000
No32 (97.0%)35 (97.2%)
Yes1 (3.0%)1 (2.8%)
11) Usage of orally administered products (other than medication) within the past 2 months0.633
No16 (48.5%)15 (41.7%)
Yes17 (51.5%)21 (58.3%)
11-1) Consultation with pharmacists on the abovementioned orally administered products (other than medication)0.672
No15 (88.2%)17 (81.0%)
Yes2 (11.8%)4 (19.0%)
11-2) Recording the abovementioned orally administered products (other than medication) in the medication notebook1.000
No16 (94.1%)20 (95.2%)
Yes1 (5.9%)1 (4.8%)
12) Usage of externally applied products (other than medication) within the past 2 months0.093
No18 (54.5%)12 (33.3%)
Yes15 (45.5%)24 (66.7%)
12-1) Consultation with pharmacists regarding the abovementioned externally applied products (other than medication)1.000
No15 (100%)23 (95.8%)
Yes0 (0%)1 (4.2%)
12-2) Recording the abovementioned externally applied products (other than medication) in the medication notebook1.000
No15 (100%)23 (95.8%)
Yes0 (0%)1 (4.2%)
13) Usage of measuring/testing devices, other than in hospitals/clinics, within the past 2 months1.000
No10 (30.3%)10 (27.8%)
Yes23 (69.7%)26 (72.2%)
13-1) Consultation with pharmacists regarding the abovementioned measuring/testing values1.000
No23 (100%)25 (96.2%)
Yes0 (0%)1 (3.8%)
13-2) Recording the abovementioned measuring/testing values in the medication notebook1.000
No23 (100%)25 (96.2%)
Yes0 (0%)1 (3.8%)

Questions 3-1), 3-2), 3-3), and 4), χ2 test; the other questions, Fisher’s exact test.

In the intervention group, 55.6% participants (20/36) accessed remote health support using the contact referred to in this study. In the intervention group, 5.6% (2/36), 5.6% (2/36), and 47.2% (17/36) accessed remote health support via telephone call, e-mail, and Line (chat), respectively, including those who used multiple means to access.

Table 4 shows questions related to the primary outcomes of the first and second questionnaire surveys. For all queries regarding consultation with pharmacists in the first survey, the percentage of individuals who answered that they consulted pharmacists was 0–20% in both the control and intervention groups. Similarly, for the question asking whether they recorded information in their medication notebooks, the percentage of participants who answered that they recorded was 0–10%. The percentage of individuals who started consulting pharmacists about self-medication in the intervention group (63.9%, 23/36) was significantly higher than that in the control group (15.1%, 5/33) (p < 0.001). The percentage of individuals who started recording information about their self-medication in their medication notebooks in the intervention group (16.7%, 6/36) was significantly higher than that in the control group (0%, 0/33) (p = 0.026).

Table 4. The Results of the Question Items Related to the Outcome in the Surveys (the First and the Second Surveys) and the Primary Outcomes

The first surveyThe second survey
Control group (n = 33)Intervention group (n = 36)Control group (n = 33)Intervention group (n = 36)
6-1) Consultation with pharmacists regarding the abovementioned OTC drugs (internal medicine)
No7 (77.8%)15 (100.0%)9 (90.0%)11 (68.8%)
Yes2 (22.2%)0 (0.0%)1 (10.0%)5 (31.3%)
7-1) Consultation with pharmacists regarding the abovementioned OTC drugs (external medicine)
No11 (84.6%)18 (85.7%)15 (100.0%)13 (72.2%)
Yes2 (15.4%)3 (14.3%)0 (0.0%)5 (27.8%)
9) Consultation with pharmacists regarding health/diseases or lifestyle habits within the past 2 months
No29 (87.9%)34 (94.4%)28 (84.8%)14 (38.9%)
Yes4 (12.1%)2 (5.6%)5 (15.2%)22 (61.1%)
11-1) Consultation with pharmacists on the abovementioned orally administered products (other than medication)
No15 (88.2%)17 (81.0%)13 (76.5%)11 (52.4%)
Yes2 (13.3%)4 (19.0%)4 (23.5%)10 (47.6%)
12-1) Consultation with pharmacists regarding the abovementioned externally applied products (other than medication)
No15 (100.0%)23 (95.8%)12 (100.0%)18 (78.3%)
Yes0 (0.0%)1 (4.2%)0 (0.0%)5 (21.7%)
13-1) Consultation with pharmacists regarding the abovementioned measuring/testing values
No23 (100.0%)25 (96.2%)25 (89.3%)31 (100.0%)
Yes0 (0.0%)1 (3.8%)3 (10.7%)0 (0.0%)
“The percentage of individuals who started consulting pharmacists about self-medication”5 (15.1%)13 (63.9%)
the percentage of people who answered ‘no (have not consulted)’ during the first survey and ‘yes (have consulted)’ during the second survey to any one of questions 6-1), 7-1), 9), 11-1), 12-1), and 13-1)[p < 0.001*]
6-2) Recording details of the abovementioned OTC drugs (internal medicine) in the medication notebook
No8 (88.9%)15 (100.0%)10 (100.0%)13 (81.3%)
Yes1 (11.1%)0 (0.0%)0 (0.0%)3 (18.8%)
7-2) Recording details of the abovementioned OTC drugs (external medicine) in the medication notebook
No13 (100.0%)20 (95.2%)15 (100.0%)17 (94.4%)
Yes0 (0%)1 (4.8%)0 (0.0%)1 (5.6%)
10) Recording health/diseases and lifestyle habits within the past 2 months in the medication notebook
No32 (97.0%)35 (97.2%)33 (100.0%)33 (91.7%)
Yes1 (3.0%)1 (2.8%)0 (0.0%)3 (8.3%)
11-2) Recording the abovementioned orally administered products (other than medication) in the medication notebook
No16 (94.1%)20 (95.2%)17 (100.0%)17 (81.0%)
Yes1 (5.9%)1 (4.8%)0 (0.0%)4 (19.0%)
12-2) Recording the abovementioned externally applied products (other than medication) in the medication notebook
No15 (100.0%)23 (95.8%)12 (100.0%)23 (100.0%)
Yes0 (0.0%)1 (4.2%)0 (0.0%)0 (0.0%)
13-2) Recording the abovementioned measuring/testing values in the medication notebook
No23 (100.0%)25 (96.2%)27 (96.4%)29 (96.7%)
Yes0 (0.0%)1 (3.8%)1 (3.6%)1 (3.3%)
“The percentage of individuals who started recording information about their self-medication in their medication notebooks”0 (0%)6 (16.7%)
the percentage of people who answered ‘no (have not recorded)’ during the first survey and ‘yes (have recorded)’ during the second survey for any one of questions 6-2), 7-2), 10), 11-2), 12-2), and 13-2)[p = 0.026*]

Fisher’s exact test, * p < 0.05.

Table 5(A) shows the percentage of participants who showed score improvements in self-medication awareness 2 months after the class/program. The percentage of participants who showed score improvements for question (d) “I want to consult a pharmacist about health and diseases,” question (e) “I am interested to read any brochures and posters about health and diseases available at pharmacies,” and question (j) “I am going to consult a pharmacist or a registered salesclerk when I take (use) over-the-counter drugs” in the intervention group were significantly higher than those in the control group. Table 5(B) shows changes in the total and subscale health literacy scores 2 months after the class/program. No significant differences were found in changes in overall scores or subscale scores of health literacy between the control and intervention groups.

Table 5. The Subsidiary Outcomes

(A) The percentage of participants who showed score improvements in self-medication awareness
Awareness of self-medicationTotal (n = 69)p
Control group (n = 33)Intervention group (n = 36)
a)18.8%22.2%0.772
b)15.6%30.6%0.166
c)18.8%19.4%1.000
d)15.6%52.8%0.002*
e)9.4%38.9%0.006*
f)21.9%41.7%0.119
g)21.9%33.3%0.418
h)18.9%19.4%1.000
i)13.8%34.3%0.079
j)27.6%62.9%0.006*
k)10.3%28.6%0.118
(B) Changes in the total and subscale health literacy scores
Health literacyTotal (n = 69)p
Control group (n = 33)Intervention group (n = 36)
Overall−0.98 ± 6.43−1.13 ± 5.510.918
Health care−1.64 ± 8.56−0.14 ± 7.080.433
Disease prevention+0.44 ± 6.62−1.54 ± 6.210.121
Health promotion−1.92 ± 8.29−2.15 ± 6.740.901
Access−2.66 ± 8.56−0.24 ± 6.970.204
Understand−1.00 ± 7.64−0.68 ± 5.840.852
Appraise+0.40 ± 7.65−2.03 ± 8.000.209
Apply−0.24 ± 6.78−1.39 ± 6.600.483
Health care—Access−1.93 ± 10.731.70 ± 11.420.187
Health care—Understand−3.13 ± 11.74−0.23 ± 7.460.236
Health care—appraise−0.36 ± 9.93−2.01 ± 11.790.541
Health care—apply+0.39 ± 11.73−0.15 ± 7.390.824
Disease prevention—access−0.82 ± 11.21−0.67 ± 9.540.956
Disease prevention—understand−0.90 ± 9.94−1.23 ± 7.640.873
Disease prevention—appraise+1.58 ± 9.95−2.92 ± 9.270.052
Disease prevention—apply+2.00 ± 6.62−1.98 ± 9.610.051
Health promotion—access−3.38 ± 9.23−2.05 ± 8.700.557
Health promotion—understand+0.65 ± 10.05−0.60 ± 9.310.601
Health promotion—appraise−1.25 ± 11.00−2.31 ± 10.040.684
Health promotion—apply−2.69 ± 9.01−3.88 ± 8.160.574

(A) Fisher’s exact test, * p < 0.05; (B) mean ± standard deviation. Unpaired t test.

Next, the background variables of subjects included in the sub-analysis on consultation with pharmacists about self-medication are shown in Table 6(A). No background variables differed significantly between the effective and ineffective groups. Table 6(B) shows health literacy scores for the effective and ineffective groups before the subjects attended the program. The health literacy subscale scores for “access” (p = 0.042) and “access/health promotion” (p = 0.030) in the ineffective group (n = 13) were significantly lower than those in the effective group (n = 23). The health literacy total score and other subscale scores did not differ significantly between the two groups.

Table 6. Sub-analysis on Consulting Pharmacists about Self-medication

(A) Subjects’ background
Total (n = 36)p
Effective group (n = 23)Ineffective group (n = 13)
Age (years, mean ± standard deviation)52 (41, 66.5)51 (40, 72)0.843
Gender0.716
Male7 (30.4%)3 (23.1%)
Female16 (69.6%)10 (76.9%)
Marital status0.716
Married16 (30.4%)10 (76.9%)
Unmarried7 (69.6%)3 (23.1%)
Cohabitants1.000
Having cohabitants17 (73.9%)9 (69.2%)
Not having cohabitants6 (26.1%)4 (30.8%)
Employment status1.000
Employed13 (56.5%)7 (53.8%)
Not Employed10 (43.5%)6 (46.2%)
Experience as a healthcare professional0.890
Currently a healthcare professional1 (4.3%)1 (7.7%)
Was a healthcare professional in the past3 (13.0%)2 (15.4%)
Was not a healthcare professional in the past19 (82.6%)19 (76.9%)
(B) Subjects’ health literacy
Total (n = 36)p
Effective group (n = 23)Ineffective group (n = 13)
Overall28.4 (22.3, 31.5)24.5 (20.5, 29.5)0.365
Health care26.2 (21.9, 31.8)24.4 (18.8, 26.2)0.339
Disease prevention31.1 (26.7, 37.3)29.2 (23.3, 38.9)0.767
Health promotion26.0 (22.9, 30.7)25.6 (16.7, 28.1)0.205
Access25.6 (23.7, 30.0)20.8 (16.7, 25.0)0.042*
Understand33.3 (28.0, 37.1)33.3 (28.0, 37.1)0.429
Appraise24.1 (19.4, 18.1)24.1 (19.4, 30.4)0.692
Apply27.3 (22.7, 30.0)27.3 (22.7, 30.0)0.741
Health care - Access20.8 (14.6, 29.2)16.7 (12.5, 22.2)0.583
Health care - Understand29.2 (20.8, 35.4)27.8 (20.8, 33.3)0.474
Health care - appraise20.8 (16.7, 27.1)20.8 (8.3, 25.0)0.727
Health care - apply33.3 (29.2, 35.4)29.2 (27.8, 33.3)0.281
Disease prevention - access33.3 (25.0, 33.3)25.0 (20.8, 37.5)0.426
Disease prevention - understand38.9 (33.3, 50.0)38.9 (33.3, 50.0)0.946
Disease prevention - appraise26.7 (23.3, 38.3)30.0 (20.0, 46.7)0.716
Disease prevention - apply27.8 (23.6, 33.3)30.6 (20.8, 38.9)0.791
Health promotion - access29.2 (23.3, 32.5)20.0 (13.3, 27.3)0.030*
Health promotion - understand29.2 (25.0, 33.0)27.1 (19.8, 33.3)0.381
Health promotion - appraise22.2 (16.7, 30.6)22.2 (16.7, 27.8)0.973
Health promotion - apply25.0 (20.8, 32.3)20.8 (16.7, 33.3)0.642

n (%) or median (25 percentile, 75 percentile). (A) Age, Mann–Whitney U test; gender, marital status, cohabitants and work, Fisher’s exact test; experience as a healthcare professional, χ2 test; (B) Mann–Whitney U test, * p < 0.05.

Table 7(A) shows the background variables of subjects included in the sub-analysis on using medication notebooks to record self-medication-related information. No background variables differed significantly between the effective and ineffective groups. The health literacy scores for the effective and ineffective groups before the subjects attended the program are listed in Table 7(B). The health literacy subscale score for “access/health promotion” (p = 0.013) in the ineffective group (n = 30) was significantly lower than that in the effective group (n = 6). The health literacy total score and other subscale scores did not differ significantly between the two groups.

Table 7. Sub-analysis on Recording Information about Their Self-medication in Their Medication Notebooks

(A) Subjects’ background
Total (n = 36)p
Effective group (n = 6)Ineffective group (n = 30)
Age (years, mean ± standard deviation)55.5 (50.5, 66.5)50.5 (40.3, 71.3)0.510
Gender0.157
Male0 (0%)10 (33.3%)
Female6 (100%)20 (66.6%)
Marital status1.000
Married4 (66.7%)22 (73.3%)
Unmarried2 (33.3%)8 (26.7%)
Cohabitants1.000
Having cohabitants4 (66.7%)22 (73.3%)
Not having cohabitants2 (33.3%)8 (26.7%)
Employment status0.196
Employed5 (83.3%)15 (50.0%)
Not Employed1 (16.7%)15 (50.0%)
Experience as a healthcare professional0.404
Currently a healthcare professional1 (16.7%)1 (3.3%)
Was a healthcare professional in the past1 (16.7%)4 (13.3%)
Was not a healthcare professional in the past4 (66.7%)25 (83.3%)
(B) Subjects’ health literacy
Total (n = 36)p
Effective group (n = 6)Ineffective group (n = 30)
Overall28.1 (25.0, 34.9)25.6 (21.5, 31.5)0.610
Health care28.2 (26.1, 35.1)25.2 (20.8, 30.7)0.268
Disease prevention28.9 (28.8, 35.6)31.7 (25.6, 38.5)0.788
Health promotion29.0 (26.7, 34.8)25.3 (20.9, 28.2)0.146
Access29.3 (22.7, 34.5)24.7 (20.6, 28.2)0.327
Understand34.1 (30.8, 37.1)30.3 (25.8, 36.4)0.394
Appraise23.8 (22.6, 28.7)25.0 (18.4, 30.4)0.756
Apply26.8 (22.3, 39.4)27.3 (23.6, 31.7)0.951
Health care—Access30.6 (19.4, 33.3)18.8 (12.5, 29.2)0.186
Health care—Understand33.3 (29.2, 37.5)29.2 (20.8, 33.3)0.268
Health care—appraise19.4 (16.7, 24.3)20.8 (16.7, 28.1)0.820
Health care—apply33.3 (33.3, 45.8)33.3 (27.8, 33.3)0.307
Disease prevention—access26.4 (25.0, 31.9)33.3 (20.8, 37.5)0.685
Disease prevention—understand38.9 (34.7, 43.1)38.9 (33.3, 50.0)0.820
Disease prevention—appraise27.2 (25.4, 36.9)30.0 (23.3, 39.2)0.820
Disease prevention—apply30.6 (27.8, 37.5)27.8 (22.2, 33.3)0.334
Health promotion—access33.3 (30.8, 39.6)24.2 (16.7, 29.2)0.013*
Health promotion—understand33.3 (29.2, 36.5)29.2 (20.8, 33.3)0.134
Health promotion—appraise23.6 (22.2, 31.3)22.2 (16.7, 27.8)0.186
Health promotion—apply26.4 (18.8, 31.9)25.0 (20.8, 33.3)0.881

n (%) or median (25 percentile, 75 percentile). (A) Age, Mann–Whitney U test; gender, marital status, cohabitants and work, Fisher’s exact test; experience as a healthcare professional, χ2 test; (B) Mann–Whitney U test, * p < 0.05.

DISCUSSION

We developed a remote health support program by pharmacists and tested its effectiveness in a randomized controlled study. We also studied the effects of health literacy on the effectiveness of this program.

The absence of significant differences in participants’ background variables and results of the first questionnaire survey between the control and the intervention groups ensured the validity of evaluating the program’s effectiveness by comparing the outcomes between the two groups.

For questions regarding consultation with pharmacists, the percentage of participants who answered that they consulted pharmacists was 0–20%. The percentage of people who consulted pharmacists has generally been low (≤20%), as reported in Japanese reports in 2010 and 201143,44) and 10–20% in our previous report in 2020.30) The results of the present study indicate that consultation with pharmacists remains uncommon.

Approximately half of the participants used the contact information provided in this study to access remote health support. Because participants who contacted their family pharmacists, rather than pharmacists whose contact information was provided in this study, were not counted in this result, the actual percentage of the participants who used remote health support is presumably higher. The participants most commonly used Line (chat) to access remote health support using the contact information provided in this study. As of 2021, 97.3 and 88.6% of Japanese people owned mobile terminals and smartphones, respectively.45) As of 2021, Line users accounted for 92.5% of people in Japan across all age groups, 98.1% in their 20s, 96.0% in their 30s, 96.6% in their 40s, 90.2% in their 50s, and 82.6% in their 60s and older.46) Line (chat) was the most commonly used medium, rather than calls or e-mails, although most Japanese people have mobile devices, presumably because the chat application allowed people to consult pharmacists more conveniently and casually. In contrast, consultation with pharmacists via phone call or e-mail was perceived to be more formal and less comfortable.

For the percentage of individuals who started consulting pharmacists about self-medication, which was a primary outcome, the percentage in the intervention group as significantly higher, indicating that those who attended this program started using pharmacist consultation services for self-medication. In a previous report,30) the percentage in the intervention group was 38.2%, higher by 23.9 points than 14.3% in the control group. The difference was more prominent in the present study as the percentage in the intervention group was 63.9% and 48.8 points higher than 15.1% in the control group. More people voluntarily may have consulted pharmacists about self-medication and prescription drugs in the present study because people could consult pharmacists more easily, particularly via chat, in an environment where remote health support by pharmacists is accessible any time.

For the percentage of participants who started recording information about their self-medication in their medication notebooks, which was another primary outcome, the percentage in the intervention group was significantly higher, indicating that those who attended this program started recording self-medication-related information in their medication notebooks. In a previous report,30) the percentage in the intervention group was 38.2%, higher by 27.5 points than 10.7% in the control group. In the present study, the percentage in the control and intervention groups were 0 and 16.7%, respectively, and the percentage in the latter group was higher by 16.7 points. The percentage in the present study were somewhat lower, possibly because a sense of ease from the availability of remote health support by pharmacists may have inhibited information recording in medication notebooks. Also, the lecture focused on consultation with pharmacists; therefore, the lecture did not leave much impression about using medication notebooks. Studies have shown that medical care providers do not have much information about patients’ self-medication, such as OTC drugs and health food products used.47,48) Many patients do not convey such information to medical care providers either.49) If community residents voluntarily use their medication notebooks to record self-medication-related information, such as OTC drugs and health food products, correct information can be shared among medical care providers by simply collecting information from medication notebooks presented by patients. The results of this study suggest that this program is an effective means to increase community residents who voluntarily consult pharmacists about self-medication and record self-medication-related information in medication notebooks, promoting proper self-medication.

For secondary outcomes, responses to questions (d), (e), and (j) revealed that the percentage of participants whose scores on self-medication awareness increased in the intervention group were higher than those in the control group. These results suggest that participants in this program became interested in consulting pharmacists about health and diseases, reading any brochures and posters about health and diseases available at pharmacies, and consulting pharmacists or registered salesclerks when they take (use) OTC drugs. Thus, this program induced changes in awareness, resulting in behavioral changes reflected in the primary outcomes. Meanwhile, the absence of significant changes in the total and subscale scores of health literacy between the control and intervention groups indicates that this program did not improve health literacy. Randomized controlled and quasi-experimental studies using health literacy scales have shown that interventions such as education, counseling, and training improve health literacy.50) In the interventions, various communication media are used, including telephone calls, social media, animation, and face-to-face communication.50)

In this study, it was not concluded that health literacy was improved by this program, which aimed to promote proper self-medication using support from pharmacists. In order to raise health literacy, we believe that it is important for pharmacists and others to educate local residents on a daily basis. Thus, the ability of pharmacists to educate local residents might have an impact on improvement of the health literacy of local residents.

The sub-analysis results revealed that participants who did not consult pharmacists about self-medication had lower levels of health literacy regarding their ability to access health information, particularly in the area of health promotion, than those who did. The sub-analysis results also showed that participants who did not record self-medication-related information in their medication notebooks had lower levels of health literacy regarding their ability to access health information in the area of health promotion than those who did. These findings suggest that this program is less effective for people with low competencies to access health information and low health literacy in health promotion. Health literacy has been reported to be associated with health status, QOL, health behavior, and other factors.3739) In this study, health literacy affected consultation with pharmacists and information recording in medication notebooks in remote health support by pharmacists. Thus, uniform and passive support may not effectively induce behavioral changes in some participants.

In the lecture of this program, participants were explained that improper use of OTC drugs, health food products, and dietary supplements is associated with problems, such as adverse interactions, side effects, and symptom exacerbation. It was stressed that these are not rare problems and the symptoms can be severe in some cases to let the participants have perceived susceptibility and perceived severity, respectively, of the health belief model. These explanations must be carefully provided. The extended parallel process model is a model to understand responses when risks are communicated.51) According to this model, when a risk is communicated, people engage in a recommended action to avoid the risk or do not engage in a recommended action because they are overwhelmed by fear and stop thinking about the risk. If the susceptibility and severity are overemphasized, people may choose the latter behavior; for example, not using OTC drugs, health food products, and dietary supplements when necessary; not consulting pharmacists; and not recording information in medication notebooks. To prevent these from occurring, an easy-to-understand and careful explanation of potential benefits and reduction of the perceived barriers should be provided. Thus, the lecture in this program included an easy-to-understand and careful explanation of potential benefits and reduction of the perceived barriers, which was combined with loss aversion and risk aversion of behavioral economics to facilitate behavioral changes. Moreover, the remote health support program by pharmacists based on the health belief model and behavioral economics was highly effective in promoting proper self-medication through pharmacists in this study.

The limitations of this study are that people of only a limited area in Japan were included; participants might have a relatively high awareness of medicine and health because they were voluntarily interested in participating in this study; and the study could not be blinded because the subjects underwent the educational intervention. Additionally, this study investigated short-term effects in 2 months; thus, long-term effects may differ from those seen in this study. The effectiveness limited to a particular population was not evaluated because target population was set to people aged ≥20 years. In this study, education skills of pharmacists were not taken into consideration. Not only pharmacists’ education and support for local residents but also education for improvement of pharmacists’ skills is important. The exclusion criteria were not based on objective indicators for evaluation of participant’s ability to communicate.

In this study, we developed the remote health support program by pharmacists, which effectively induced behavioral changes (consultation with pharmacists about self-medication and information recording in medication notebooks) toward proper self-medication using support from pharmacists in a randomized controlled study. The effects of the program on consultation with pharmacists about self-medication were particularly noticeable. Further, the results suggest that the program is less effective for people who have low health literacy in certain aspects. Therefore, uniform and passive support may not effectively induce behavioral changes in some participants. Moving forward, developing personalized programs effective even for people with low health literacy in certain aspects may be necessary. This program places little burden on participants and can be easily implemented by pharmacists at a low cost. However, an increase in pharmacists’ workload and support during off-duty hours in the remote support for a lot of people is a challenge of the future. It is important to spread the use of this program and promote proper self-medication using support from pharmacists.

Acknowledgments

This work was supported by JSPS KAKENHI [Grant Number: 19K10562].

Conflict of Interest

The authors declare no conflict of interest.

REFERENCES
 
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