Biological and Pharmaceutical Bulletin
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Regular Articles
Developing and Verifying the Efficacy of “Educational Program for Promoting Appropriate Self-medication via Pharmacies and Pharmacists”: A Randomized Controlled Trial
Tomoya Tachi Yoshihiro NoguchiHitomi Teramachi
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2020 Volume 43 Issue 1 Pages 77-86

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Abstract

Utilization of community pharmacies/pharmacists is important for promoting appropriate self-medication; however, appropriate self-medication via pharmacies/pharmacists has not been well-implemented in Japan. Based on the transtheoretical model of health behavior change, we constructed an Educational Program for Promoting Appropriate Self-medication via Pharmacies and Pharmacists to inform the public about the assistive services of pharmacies/pharmacists regarding self-medication and the use of medication notebooks for self-medications. We then tested the efficacy of the program through a randomized controlled trial. The subjects were residents living around Gifu City, aged 20 years and above, and recruited through posters and pamphlets. The subjects were randomly allocated to a group that received only a medication/health class (control group) or one that received the medication/health class, as well as the educational program (intervention group). A questionnaire was administered immediately before the medication/health class (T1) and 2 months afterwards (T2), which allowed us to evaluate and compare the changes in the two groups’ behavior regarding performing appropriate self-medication via pharmacies/pharmacists. The percentage of people who began consulting with pharmacists concerning self-medication was significantly higher among the intervention group (38.2%, 13/34) than the control group (14.3%, 4/28) (p = 0.047). The percentage of people who began recording details of self-medication in their medication notebooks was significantly higher among the intervention group (38.2%, 13/34) than the control group (10.7%, 3/28) (p = 0.019). The educational program effectively encouraged the public to adopt appropriate self-medication practices to avail the services provided by pharmacies/pharmacists.

INTRODUCTION

WHO has proposed self-medication as a method of empowering individuals to become responsible for their own health and develop the capability to independently treat mild physical disorders.1) Several governments worldwide recommend self-medication to the public2); consequently, self-medication is steadily becoming more prevalent.39) Specific examples of self-medication include the use of OTC medications and health products/supplements and self-administered health checks using measurement/testing devices. However, the use of OTCs, health foods/supplements can have complications including medication overlaps, drug interactions, and side-effects.912) Furthermore, the use of measurement/testing equipment can be difficult without consulting specialists.912) Hence, community pharmacies/pharmacists play a substantial role in self-medication1,9,1315); however, the public is largely unaware of the potential assistance these facilities and professionals can provide.16) In response to this lack of awareness, the Japanese government has begun promoting the use of pharmacies/pharmacists for self-medication in recent years, highlighting the possibility of receiving health consultations and advice regarding the proper usage of OTC medications.17) However, although Japan is beginning to establish self-medication-related service structures for pharmacies/pharmacists,18) self-medication for the public via pharmacies/pharmacists is advancing slowly.19)

To transform appropriate self-medication into an established method, self-medication education is crucial. Although education related to self-medication is provided at schools,2023) in reality, self-medication itself is not widely disseminated to the public, and appropriate self-medication is not being conducted.9,2427) Therefore, it seems clear that continuous, effective education regarding appropriate self-medication is necessary for adults. However, although there have been reports on the efficacy of self-medication education for patients with hypertension,28,29) few studies have examined the efficacy of self-medication education for adults in general.30)

In Japan, medication notebooks are used as a means of sharing information between medical institutions.31) Medication notebooks were initially proposed as a means of facilitating the uniform management of information related to patients’ pharmaceuticals.31) The notebook is used to record information such as drug-prescription history, purchases of OTC drugs and health foods, history of medication, side-effects, and allergies. The use of such books is based on the theory that side-effects, interactions, and overlapping use of pharmaceuticals can be prevented in advance by having patients present their medication notebooks to doctors and pharmacists at medical institutions.31) The notes written in the medication notebooks are mainly entered by pharmacists (at a pharmacy or hospital). Patients present their medication notebooks at pharmacies when collecting their prescription drugs; therefore, pharmacists can use the notebooks to manage patients’ medication and review their prescription history. However, at present, the management of OTC drugs and health foods via medication notebooks is somewhat rare, as such items can also be purchased outside of pharmacies and without a prescription.30,32) Consequently, information pertaining to the use of such items is not commonly shared correctly between medical institutions, which negatively affects the potential to conduct appropriate self-medication via pharmacies/pharmacists. In a previous study, the present authors examined the efficacy of patient education regarding the use of medication notebooks when purchasing OTC drugs and health foods.30) We found that, because of the education they received, patients changed their behavior, voluntarily using medication notebooks when purchasing OTC drugs or health foods.

We believe that medication notebooks constitute an effective tool in ensuring appropriate self-medication via pharmacies/pharmacists and that medication notebooks can facilitate the sharing of information related to self-medication between medical institutions. Based on this, in the present study, we constructed an educational program aiming at appropriate self-medication for the public, the “Educational Program for Promoting Appropriate Self-medication via Pharmacists and Pharmacies,” which focused on encouraging people to consult pharmacists regarding their self-medication and use medication notebooks for self-medication purposes. Further, we sought to verify the efficacy of the program in a randomized controlled trial.

MATERIALS AND METHODS

Research Design

In this study, a randomized controlled trial was conducted to test the efficacy of the devised educational program between May and September 2019. Participants were randomly allocated to either a group that received the educational program and a medication/health class (intervention group) or one that received only the medication/health class (control group). A questionnaire survey was conducted immediately before the medication/health class (T1) and 2 months afterwards (T2), which allowed us to evaluate and compare the changes in the two groups’ behavior regarding performing appropriate self-medication via pharmacies/pharmacists.

Once participants had provided consent, they were randomly allocated to one of the two groups. For the first survey, the survey form was distributed onsite and retrieved directly. For the second survey, the survey form was distributed via mail and retrieved using a return envelope.

The Educational Program and Medication/Health Class

We set the objective of the educational program as promotion of the public’s behavior for appropriate self-medication via pharmacies/pharmacists. Concretely, the educational program involved encouraging the attendees to consult pharmacists regarding their self-medication. Additionally, the program involved encouraging the attendees to record details regarding self-medication in their medication notebooks for sharing information related to self-medication with the public and pharmacies/pharmacists because majority of the public had presented their medication notebooks to medical institutions such as pharmacies recently.31)

This educational program involved a 15-min educational class and, 1 month later, sending an informational pamphlet to participants’ homes. The educational session was in a lecture format, which allowed us to provide the information to multiple people at once. Further, the pamphlet provided a refresher of the content of the original lecture.

We developed the educational class based on the transtheoretical model of health behavior change by Prochaska and Velicer,33) and with reference to the patient education regarding the use of medication notebooks when purchasing OTC drugs and health foods, which we developed previously.30) In the model, the stages of behavior change were divided to “precontemplation,” “contemplation,” “preparation,” “action,” and “maintenance” and people needed to move from “precontemplation” to “action” or “maintenance” stage to behave and act by themselves. First, as the contents of the educational class, the definition of self-medication was explained. Second, the educational class informed attendees that appropriate health management and self-medication are important. Third, the educational class informed them that pharmacies/pharmacists provide health-support activities for appropriate self-medication to the public, and encouraged them to consult pharmacists regarding their self-medication. Fourth, the educational class informed them that appropriate checks on the interactions among OTC drugs, health foods/supplements and prescription drugs, and appropriate evaluations of measured values, test values, and health information are important in self-medication. Fifth, the educational class informed them that the information can be recorded in medication notebooks and evaluated by pharmacists, and the class encouraged the attendees to record OTC drugs, health foods/supplements, measured values, test values, and health information in their medication notebooks, in the corresponding columns. The first, second, and fourth explanations were intended to promote the cognitive process (experimental process)33) for change from “precontemplation” to “contemplation/preparation” stage. The third and fifth explanations were intended to promote the behavioral process for change from “contemplation/preparation” to “action/maintenance” stage.

In the medication/health class (about 45 min), which the control group also attended, general topics regarding medication and health were discussed.

The medication/health class, and the subsequent educational class were conducted at Ichihashi Community Center in the west of Gifu City (Japan) on May 31 and June 16, at Nanbu Community Center in the south of Gifu City on July 14, and at Gifu Media Cosmos in the east of Gifu City on June 4 and July 8.

Participants

The inclusion criteria comprised living in or close to Gifu City, being aged ≥20 years, and having the ability to attend the medication/health class and the educational program. The exclusion criteria comprised people inability to understand the medication/health class and the educational program, such as visual or hearing impairment. Recruitment was performed through posters and pamphlets, which were displayed and distributed in several institutes of the Gifu City Hall. All individuals who attended the medicine/health class and provided consent were treated as research participants. The target sample size was calculated as 27 in each group, using a power analysis (α = 0.05, β = 0.80) based on the results of a previous report.30)

Research Items

The research items captured participants’ background information, which included age, sex, marital status, cohabitation status, employment status, and whether they were healthcare professionals. Further, respondents’ behavior regarding self-medication, use of medication notebooks, and the consultations with pharmacists were also determined (Table 1).

Table 1. Question Items in the Questionnaire
SummaryQuestion detailsResponse details
1) Consultation with hospitals/clinicsAre you currently attending a hospital/clinic?No
Yes
2) Receipt of prescriptions at pharmaciesAre you currently receiving any prescription medicine from a pharmacy?No
Yes
3) Ownership of a medication notebookDo you own a medication notebook?No
Yes
3-1) Medication-notebook carrying statusDo you keep your medication notebook with you?I do not keep it with me
I only bring it with me when I need it
I always (or almost always) keep it with me
3-2) Presentation of medication notebooks at hospitals/clinicsDo you present your medication notebook when you attend hospitals/clinics?No
Only when necessary
Always (or almost always)
3-3) Presentation of medication notebooks at pharmacies when receiving prescribed medicinesDo you present your medication notebook when receiving prescribed medicine at a pharmacy?No
Only when necessary
Always (or almost always)
4) Treatment methods for mild illnesses/injuriesHow do you normally seek treatment for a mild illness/injury?I go to the hospital/clinic, without using any commercially available medicine
I initially use commercially available medicine and wait to determine whether it can cure the problem
I neither go to a hospital/clinic nor purchase any commercially available medicine
5) Mild illness/injury within the past 2 monthsHave you experienced any mild illness/injury within the past 2 months?No
Yes
6) Usage of OTC drugs (internal medicine) within the past 2 monthsHave you consumed any commercially available internal medicine (e.g., cold medicine, anti-diarrheic drugs, analgesics, or anti-nausea pills) within the past 2 months?No
Yes
6-1) Consultation with pharmacists regarding the abovementioned OTC drugs (internal medicine)Did you consult a pharmacist (or a registered seller) regarding the commercially available internal medicine you used?No
Yes
6-2) Recording details of the abovementioned OTC drugs (internal medicine) in the medication notebookDid you record the details of this commercially available internal medicine in your medication notebook?No
Yes
7) Usage of OTC drugs (external medicine) within the past 2 monthsHave you used any commercially available external medicine (e.g., ointments, mouthwashes, eye drops, or salves) within the past 2 months?No
Yes
7-1) Consultation with pharmacists regarding the abovementioned OTC drugs (external medicine)Did you consult a pharmacist (or a registered seller) regarding this commercially available external medicine?No
Yes
7-2) Recording details of the abovementioned OTC drugs (external medicine) in the medication notebookDid you record the details of this commercially available external medicine in your medication notebook?No
Yes
8) Engaging in measures for maintaining one’s health and preventing diseaseDo you regularly perform any of the listed actions with the aim of maintaining your health or preventing disease (multiple answers allowed)?Undergoing various medical check-ups, including comprehensive health screenings, health check-ups, and cancer screenings
Receiving vaccinations
Maintaining a regular, well-balanced diet
Performing moderate exercise and sports
Consuming orally-administered products other than medication (e.g., nutrition tablets, specific/specialized health foods, general health foods, and supplements)
Using external application products other than medication, including skin and hair treatment products
Ascertaining your own health using a sphygmomanometer, thermometer, scale, or body-fat calculator
Other
9) Consultation with pharmacists regarding health/diseases or lifestyle habits within the past 2 monthsHave you consulted a pharmacist regarding health/diseases or your lifestyle habits within the past 2 months?No
Yes
10) Recording health/diseases and lifestyle habits within the past 2 months in the medication notebookHave you recorded any details regarding your health/diseases and lifestyle habits in your medication notebook within the past 2 months?No
Yes
11) Usage of orally administered products (other than medication) within the past two monthsHave you consumed any orally administered products (other than medication) within the past 2 months (e.g., nutrition tablets, specific/specialized health foods, general/other health foods, or supplements)?No
Yes
11-1) Consultation with pharmacists on the abovementioned orally administered products (other than medication)Have you consulted a pharmacist regarding these orally administered products (other than medication)?No
Yes
11-2) Recording the abovementioned orally administered products (other than medication) in the medication notebookHave you recorded the details of these orally administered products (other than medication) in your medication notebook?No
Yes
12) Usage of externally applied products (other than medication) within the past 2 monthsHave you used any externally applied products (e.g., skin and hair treatment products) within the past 2 months?No
Yes
12-1) Consultation with pharmacists regarding the abovementioned externally applied products (other than medication)Have you consulted a pharmacist regarding these externally applied products?No
Yes
12-2) Recording the abovementioned externally applied products (other than medication) in the medication notebookHave you recorded details regarding the abovementioned externally applied products (other than medication) in your medication notebook?No
Yes
13) Usage of measuring/testing devices, other than in hospitals/clinics, within the past 2 monthsHave you used any measuring/testing device (e.g., sphygmomanometer, thermometer, scale, body-fat calculator), other than when at a hospital/clinic, within the past 2 months?No
Yes
13-1) Consultation with pharmacists regarding the abovementioned measuring/testing valuesHave you consulted a pharmacist regarding these measuring/testing values?No
Yes
13-2) Recording the abovementioned measuring/testing values in the medication notebookHave you recorded these measuring/testing values in your medication notebook?No
Yes

Items for which the question numbers feature the appendix-1, -2, or -3 are questions that should only be answered by respondents who answered in the affirmative to the respective parent question. For example, questions 3-1), 3-2), and 3-3) should only be answered by those who answered in the affirmative to question 3). OTC = over the counter.

Outcomes

The main outcomes of our study involved the concrete objectives of the educational program, namely consultation with pharmacists about important items for self-medications, including health/diseases or lifestyle habits and the use of OTC drugs, health products and measuring/test devices, and recording these items in a medication notebook. The primary outcomes were the percentage of people who began consulting with pharmacists concerning self-medication 2 months after the program and the percentage of people who began recording details of self-medication in their medication notebooks 2 months after the program. The former was calculated by determining the proportion 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). The latter was calculated by determining the proportion 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).

Statistics

We performed an intention-to-treat analysis. In addition, we used the unpaired t-test, Fisher’s exact test, and χ2-test to compare the two groups. The significance threshold was set at p < 0.05. The analyses were performed using SPSS Statistics 24 (IBM, Armonk, NY, U.S.A.). The sample size was calculated using Power and Sample Size Calculation version 3.1.6 (Vanderbilt University, Nashville, TN, U.S.A.).

Ethical Considerations

The study was conducted in accordance with the Declaration of Helsinki and the Ethical Guidelines on Biomedical Research Involving Human Subjects and approved by the ethics committees of Gifu Pharmaceutical University (no. H29-17). Participants received a written briefing that fully explained the study, and all those whose data were analyzed provided written consent to participate. The trial was registered in a public trial registry (UMIN-CTR no. UMIN000028570), and conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT).

RESULTS

Sixty-five individuals attended the medicine/health class; however, we did not obtain consent from three of these individuals, and they were consequently excluded. Of the 62 remaining participants who consented to participate, 28 were allocated to the control group and 34 to the intervention group. We were unable to retrieve the second survey response from one participant from the control group and one from the intervention group. Participants’ background information is presented in Table 2. No significant differences in age or sex were found between the two groups for any items. The results of the T1 survey are presented in Table 3. No significant difference was found between the control and the intervention groups for any questionnaire items at T1.

Table 2. Participants’ Background Information
Total (n = 62)p
Control group (n = 28)Intervention group (n = 34)
Age (years, mean ± standard deviation)64.1 ± 13.465.6 ± 15.70.687
Sex0.438
Male12 (42.9%)11 (32.4%)
Female16 (57.1%)23 (67.6%)
Marital status0.521
Married24 (85.7%)26 (76.5%)
Unmarried4 (14.3%)8 (23.5%)
Cohabitants0.377
Having cohabitants23 (82.1%)24 (70.6%)
Not having cohabitants5 (17.9%)10 (29.4%)
Employment status0.599
Employed9 (32.1%)14 (41.2%)
Not employed19 (67.9%)20 (58.8%)
Experience as a healthcare professional0.538
Currently a healthcare professional3 (10.7%)4 (11.8%)
Was a healthcare professional in the past4 (14.3%)2 (5.9%)
Was not a healthcare professional in the past21 (75.0%)28 (82.4%)

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

Table 3. Results of the Questionnaire Survey (T1)
Total (n = 62)p
Control group (n = 28)Intervention group (n = 34)
1) Consultation with hospitals/clinics0.220
No8 (28.6%)5 (14.7%)
Yes20 (71.4%)29 (85.3%)
2) Receipt of prescriptions at pharmacies0.076
No10 (35.7%)5 (14.7%)
Yes18 (64.3%)29 (85.3%)
3) Ownership of a medication notebook0.650
No3 (10.7%)2 (5.9%)
Yes25 (89.3%)32 (94.1%)
3-1) Medication-notebook carrying status0.950
I do not keep it with me3 (12.0%)3 (9.4%)
I only bring it with me when I need it16 (64.0%)21 (65.6%)
I always (or almost always) keep it with me6 (24.0%)8 (25.0%)
3-2) Presentation of medication notebooks at hospitals/clinics0.885
No5 (20.0%)5 (15.6%)
Only when necessary14 (56.0%)18 (56.3%)
Always (or almost always)6 (24.0%)9 (28.1%)
3-3) Presentation of medication notebooks at pharmacies when receiving prescribed medicines0.537
No2 (8.0%)5 (15.6%)
Only when necessary8 (32.0%)12 (37.5%)
Always (or almost always)15 (60.0%)15 (46.9%)
4) Treatment methods for mild illnesses/injuries0.187
I go to the hospital/clinic, without using any commercially available medicine11 (39.3%)20 (58.8%)
I initially use commercially available medicine and wait to determine whether it can cure the problem12 (42.9%)12 (35.3%)
I neither go to a hospital/clinic nor purchase any commercially available medicine5 (17.9%)2 (5.9%)
5) Mild illness/injury within the past two months1.000
No19 (67.9%)22 (64.7%)
Yes9 (32.1%)12 (35.3%)
6) Usage of OTC drugs (internal medicine) within the past 2 months1.000
No16 (57.1%)19 (55.9%)
Yes12 (42.9%)15 (44.1%)
6-1) Consultation with pharmacists regarding the abovementioned OTC drugs (internal medicine)0.628
No9 (75.0%)13 (86.7%)
Yes3 (25.0%)2 (13.3%)
6-2) Recording details of the abovementioned OTC drugs (internal medicine) in the medication notebook1.000
No11 (91.7%)14 (93.3%)
Yes1 (8.3%)1 (6.7%)
7) Usage of OTC drugs (external medicine) within the past 2 months0.081
No10 (35.7%)20 (58.8%)
Yes18 (64.3%)14 (41.2%)
7-1) Consultation with pharmacists regarding the abovementioned OTC drugs (external medicine)1.000
No13 (72.2%)11 (78.6%)
Yes5 (27.8%)3 (21.4%)
7-2) Recording details of the abovementioned OTC drugs (external medicine) in the medication notebook0.613
No15 (83.3%)13 (92.9%)
Yes3 (16.7%)1 (7.1%)
8) Engaging in measures for maintaining one’s health and prevention of disease
Various medical checkups including comprehensive health screening, health checkups, and cancer screening18 (64.3%)24 (70.6%)
Vaccinations18 (64.3%)16 (47.1%)
Regular, well-balanced diet15 (53.6%)19 (55.9%)
Moderate exercise and sports19 (67.9%)19 (55.9%)
Enough sleep14 (50.0%)20 (58.8%)
Consuming orally-administered products other than medication (e.g., nutrition tablets, specific/specialized health foods, general health foods, and supplements)10 (35.7%)14 (41.2%)
Using of external application products, other than medication, including skin and hair treatment products4 (14.3%)9 (26.5%)
Ascertaining one’s own health using a sphygmomanometer, thermometer, scale, or body fat calculator19 (67.9%)21 (61.8%)
Other1 (3.6%)3 (8.8%)
9) Consultation with pharmacists regarding health/diseases or lifestyle habits within the past 2 months0.523
No22 (78.6%)29 (85.3%)
Yes6 (21.4%)5 (14.7%)
10) Recording health/diseases and lifestyle habits within the past 2 months in the medication notebook1.000
No26 (92.9%)32 (94.1%)
Yes2 (7.1%)2 (5.9%)
11) Usage of orally administered products (other than medication) within the past 2 months1.000
No11 (39.3%)13 (38.2%)
Yes17 (60.7%)21 (61.8%)
11-1) Consultation with pharmacists on the abovementioned orally administered products (other than medication)1.000
No16 (94.1%)19 (90.5%)
Yes1 (5.9%)2 (9.5%)
11-2) Recording the abovementioned orally administered products (other than medication) in the medication notebook1.000
No17 (100.0%)20 (95.2%)
Yes0 (0.0%)1 (4.8%)
12) Usage of externally applied products (other than medication) within the past 2 months0.795
No18 (64.3%)20 (58.8%)
Yes10 (35.7%)14 (41.2%)
12-1) Consultation with pharmacists regarding the abovementioned externally applied products (other than medication)0.615
No9 (90.0%)11 (78.6%)
Yes1 (10.0%)3 (21.4%)
12-2) Recording the abovementioned externally applied products (other than medication) in the medication notebook1.000
No10 (100.0%)13 (92.9%)
Yes0 (0.0%)1 (7.1%)
13) Usage of measuring/testing devices, other than in hospitals/clinics, within the past 2 months1.000
No12 (42.9%)14 (41.2%)
Yes16 (57.1%)20 (58.8%)
13-1) Consultation with pharmacists regarding the abovementioned measuring/testing values1.000
No13 (81.3%)17 (85.0%)
Yes3 (18.8%)3 (15.0%)
13-2) Recording the abovementioned measuring/testing values in the medication notebook0.574
No14 (87.5%)19 (95.0%)
Yes2 (12.5%)1 (5.0%)

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

Both groups’ results for the questionnaire items relating to our two outcomes (for both the T1 and T2 surveys) are presented in Table 4. In the T1 survey, for all questions pertaining to whether the respondents consulted with pharmacists, the proportions who answered “yes” were low, at approximately 10 to 20% in both groups. Similarly, the proportions of respondents who stated that they had recorded details of their prescriptions in their medication notebooks were low, at 0 to 30% in both groups. After comparing the T1 and T2 surveys, we determined that the percentage of people who began consulting with pharmacists concerning self-medication in the intervention group (38.2%, 13/34) was significantly higher than that in the control group (14.3%, 4/28) (p = 0.047). Further, the percentage of people who began recording details of self-medication in their medication notebooks in the intervention group (38.2%, 13/34) was significantly higher than that in the control group (10.7%, 3/28) (p = 0.019).

Table 4. The Results of the Question Items Related to the Outcome in the Surveys (T1 and T2) and the Outcome
T1 (1st time survey)T2 (2nd time)
Control group (n = 28)Intervention group (n = 34)Control group (n = 28)Intervention group (n = 34)
6-1) Consultation with pharmacists regarding the abovementioned OTC drugs (internal medicine)
No9 (75.0%)13 (86.7%)6 (75.0%)10 (76.9%)
Yes3 (25.0%)2 (13.3%)2 (25.0%)3 (23.1%)
7-1) Consultation with pharmacists regarding the abovementioned OTC drugs (external medicine)
No13 (72.2%)11 (78.6%)7 (63.6%)11 (64.7%)
Yes5 (27.8%)3 (21.4%)4 (36.4%)6 (35.3%)
9) Consultation with pharmacists regarding health/diseases or lifestyle habits within the past 2 months
No22 (78.6%)29 (85.3%)21 (77.8%)23 (69.7%)
Yes6 (21.4%)5 (14.7%)6 (22.2%)10 (30.3%)
11-1) Consultation with pharmacists on the abovementioned orally administered products (other than medication)
No16 (94.1%)19 (90.5%)15 (83.3%)15 (71.4%)
Yes1 (5.9%)2 (9.5%)3 (16.7%)6 (28.6%)
12-1) Consultation with pharmacists regarding the abovementioned externally applied products (other than medication)
No9 (90.0%)11 (78.6%)4 (66.7%)7 (87.5%)
Yes1 (10.0%)3 (21.4%)2 (33.3%)1 (12.5%)
13-1) Consultation with pharmacists regarding the abovementioned measuring/testing values
No13 (81.3%)17 (85.0%)15 (78.9%)13 (65.0%)
Yes3 (18.8%)3 (15.0%)4 (21.1%)7 (35.0%)
“The percentage of people who began consulting with pharmacists concerning self-medication”4 (14.3%)13 (38.2%)
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 = 0.047*]
6-2) Recording details of the abovementioned OTC drugs (internal medicine) in the medication notebook
No11 (91.7%)14 (93.3%)5 (62.5%)12 (92.3%)
Yes1 (8.3%)1 (6.7%)3 (37.5%)1 (7.7%)
7-2) Recording details of the abovementioned OTC drugs (external medicine) in the medication notebook
No15 (83.3%)13 (92.9%)8 (72.7%)13 (76.5%)
Yes3 (16.7%)1 (7.1%)3 (27.3%)4 (23.5%)
10) Recording health/diseases and lifestyle habits within the past 2 months in the medication notebook
No26 (92.9%)32 (94.1%)24 (88.9%)24 (72.7%)
Yes2 (7.1%)2 (5.9%)3 (11.1%)9 (27.3%)
11-2) Recording the abovementioned orally administered products (other than medication) in the medication notebook
No17 (100.0%)20 (95.2%)17 (94.4%)16 (76.2%)
Yes0 (0.0%)1 (4.8%)1 (5.6%)5 (23.8%)
12-2) Recording the abovementioned externally applied products (other than medication) in the medication notebook
No10 (100.0%)13 (92.9%)5 (83.3%)6 (75.0%)
Yes0 (0.0%)1 (7.1%)1 (16.7%)2 (25.0%)
13-2) Recording the abovementioned measuring/testing values in the medication notebook
No14 (87.5%)19 (95.0%)18 (94.7%)14 (70.0%)
Yes2 (12.5%)1 (5.0%)1 (5.3%)6 (30.0%)
“The percentage of people who began recording details regarding self-medication in their medication notebooks”3 (10.7%)13 (38.2%)
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 = 0.019*]

Fisher’s exact test, * p < 0.05 OTC = over the counter.

DISCUSSION

In the current study, we constructed the Educational Program for Promoting Appropriate Self-medication via Pharmacies and Pharmacists, which was designed to inform the public about the assistive services of pharmacies/pharmacists regarding self-medication and appropriate means of using medication notebooks for self-medication and encourage appropriate self-medication. We then determined the efficacy of the educational program in a randomized controlled trial.

Given that no significant differences in backgrounds or the results of the T1 survey were found between the control and intervention groups, we confirmed that we could evaluate the efficacy of this program by comparing the outcomes of the two groups after the T2 survey.

In the T1 survey, the proportions of respondents who stated that they “had consulted” pharmacists were low, at approximately 10 to 20%. Similarly, several previous Japanese studies have reported that <20% of the public had consulted pharmacists.34,35) Thus, clearly, consulting pharmacists is not currently a widespread practice among the general Japanese public.

Given that the percentage of people who began consulting pharmacists concerning self-medication was significantly higher in the intervention than the control group, we could confirm that the educational program motivated the attendees to avail pharmacists’ services to assist them with self-medication. As mentioned in the Introduction, pharmacists can perform an essential role in self-medication for the public1); further, previous studies have shown that pharmacists play a key role in the public’s use of OTC drugs.36) Based on our findings, we believe that our program could facilitate appropriate self-medication practice by motivating the public to consult pharmacists regarding their self-medication voluntarily.

We also found that the percentage of people who began recording details regarding self-medication in their medication notebooks in the intervention group was significantly higher than that in the control group. This showed that the educational program was also effective in this regard. A previous study reported that medical institutions were relatively unaware of patients’ use of OTC drugs and health foods.37) Furthermore, previous studies have also shown that patients tended to believe, without evidence, that doctors were somehow aware of their use of OTC drugs,38) and approximately 50% of patients did not even inform their doctors that they used OTC drugs.38) Through the current educational program, attendees began to record details regarding their use of OTC drugs and health foods for self-medication in their medication notebooks voluntarily. Furthermore, many attendees actually presented their medication notebooks to medical institutions, as 79.4% (27/34) and 85.2% (29/34) responded “Only when necessary” or “Always (or almost always)” to questions 3-2) and 3-3), respectively, at T2. We believe that this practice will lead to more accurate sharing of information among medical institutions in the future.

In addition, given that pharmacists are generally the most likely parties to record notes in patients’ medication notebooks, promoting the use of medication notebooks for self-medication can lead people to consult pharmacists voluntarily and actively. Certainly, consulting pharmacists on self-medication and recording details related to self-medication in one’s medication notebook leads to appropriate self-medication synergistically.

In our previous study, patient education in a one-to-one format promoted their behavior change, encouraging them to voluntarily use medication notebooks when purchasing OTC drugs or health foods.30) In the previous study, reminder stickers were put on a patient’s notebook. On the other hand, in this study, education in a lecture format for the public was adopted because of its efficiency and cost-effectiveness. Instead of the sticker for the reminder, the pamphlet provided a refresher of the content of the original lecture by mail to participants’ homes 1 month later. This educational program in these formats also promoted change in behavior of the public, encouraging them to voluntarily consult pharmacists regarding their self-medication and record details related to self-medication in their medication notebook.

We propose a behavior change model through this educational program (Fig. 1), based on the transtheoretical model of health behavior change developed by Prochaska and Velicer.33) In the educational program, the attendees understood the importance of appropriate health management and self-medication. The cognitive (experimental) process (e.g., consciousness raising)33) induced by the increased understandings of the importance of appropriate health management and self-medication is assumed to lead to the shift from “precontemplation” to “contemplation/preparation” stage. Moreover, the attendees of the educational program understood that pharmacies/pharmacists can provide opportunities to engage in health-promoting activities to the public to encourage appropriate self-medication. The behavioral process (e.g., helping relationship)33) induced by the increased understanding of convenient consulting with pharmacies/pharmacists for appropriate self-medication is assumed to lead to the shift from ”contemplation/preparation” to “action/maintenance” stage. As a result, the attendees begin to consult pharmacists regarding their self-medication voluntarily. Likewise, in the cognitive (experimental) process,33) the attendees understood the importance of appropriate checks on the interactions among OTC drugs, health foods/supplements and prescription drugs, and appropriate evaluations of measured and test values and health information to self-medication. The process is assumed to lead to the shift from “precontemplation” to “contemplation/preparation” stage. In the behavioral process,33) the attendees understood that information could be recorded in medication notebooks and evaluated by pharmacists conveniently. The process is assumed to lead to the shift from “contemplation/preparation” to “action/maintenance” stage. Consequently, the attendees begin to record details related to self-medication in their medication notebooks voluntarily. According to this model, an explanation and subsequent understanding of the importance of appropriate self-medication is essential for the cognitive process in this educational program, while an explanation and subsequent understanding of the public availability of appropriate self-medication via pharmacists is essential for the process of behavioral change. The decisional balance and self-efficacy in the transtheoretical model of health behavior change33) can be consistent with and attributable to an understanding of the ease with which pharmacists can be consulted regarding self-medication behaviors and the recording of details related to self-medication in a medication notebook.

Fig. 1. A Behavior Change Model through This Educational Program

Despite the findings, the study had some limitations. For instance, all participants were recruited from one region in Japan; further, all were individuals who participated in a study that they knew focused on health management. In other words, it is possible that participants comprised mainly people who had relatively high levels of awareness of and interest in medication and health. In addition, we could not blind participants to the study purpose because the intervention comprised an educational program. Further, we investigated only the short-term effects of the program over a period of 2 months; a long-term analysis could have obtained different study results.

This study revealed that the Educational Program for Promoting Appropriate Self-medication via Pharmacies and Pharmacists was effective in motivating people to adopt appropriate self-medication practices that involved availing the services of pharmacies and pharmacists. The educational program does not burden attendees considerably and can be implemented easily at a low cost. Hence, community pharmacists should actively seek to provide this educational program to the public. Based on our findings, it is likely that the dissemination of this educational program would lead to the widespread adoption of appropriate self-medication practices under the advice of pharmacists.

Acknowledgments

This work was supported by JSPS KAKENHI [Grant Number: 15K16505, 19K10562].

Conflict of Interest

The authors declare no conflict of interest.

REFERENCES
 
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