Biological and Pharmaceutical Bulletin
Online ISSN : 1347-5215
Print ISSN : 0918-6158
ISSN-L : 0918-6158
Regular Article
Public Knowledge and Attitude of Caregivers Regarding Leftover Medications for Children under 6 Years of Age in Japan: A Descriptive Study on a Nationwide Exploratory Questionnaire Survey to Caregivers
Kenji Momo Kanae MoriyaAyaka ItohMami KobayashiNao TagawaRei EbataRemi KuchiraHironori TanakaYuka KashiwabaraHiroshi ShimamuraYoshifusa AbeTaro KamiyaTakanori Imai
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2024 年 47 巻 10 号 p. 1690-1698

詳細
Abstract

Leftover medications are a global concern for harm to health and inadequate medical care costs. However, information on leftover medicines and their inappropriate use in children in Japan is lacking. We aimed to clarify the proportion of leftover and re-use of children’s medications in Japan. We conducted a nationwide cross-sectional questionnaire survey using eight web-based domains, which covered parents’ demographics, children’s demographics, actual practices in handling about leftover (1) acute medication, (2) chronic medication, (3) short-term medicine, (4) antibiotic, and (5) topical medication, and attitudes towards leftover medicine. The questionnaire comprised 40 questions. We obtained responses from 3046 caregivers with children aged under 6 years before elementary school. Among these participants, 95% (2674/2809), 57% (147/256), and 69% (1687/2457) had experience with leftover acute medication use, medication for chronic disease, and short-term medication use, respectively. Instances of leftover antibiotics being given to the child’s brother/sister, parents, and child’s friends were 8.7, 7.9, and 3.2%, respectively. This trend was similar to other medication categories. In conclusion, most caregivers have experienced leftover medications; however, managing leftover medications depends on their beliefs and is influenced by inadequate knowledge about medications. Most of these cases lead to inadequate use of medications in children. Medical staff, especially pharmacists, need to educate and instruct caregivers on the appropriate use of children’s medications.

INTRODUCTION

Reducing leftover medications is a crucial challenge in healthcare safety, and aligning prescription optimization with appropriate knowledge about medications for patients is important.

Twenty percent of participants included in a web-based questionnaire survey reported having experience receiving medications from others in Saudi Arabia, with 73% of them receiving medications from family members and 14.3% involving antibiotics.1) In addition, face-to-face interviews in Ethiopia revealed that half of the participants had experienced leftover medications.2) The most common reason for leftover medications is that symptoms have improved (83.1%), followed by the intention to use them on another occasion (34.9%).2) These reasons are similarly observed in China and raise concerns regarding health issues for reusing leftover medications without professional guidance.3,4)

Approximately 40% of children have experienced receiving antibiotics at home before visiting hospitals for fever in Uganda.5) Leftover medications cause inappropriate use by caregivers. Forty percent of primary caregivers who visited with children at the U.S. emergency department do not know how to dispose of medications properly.6) Another study also revealed that half of the caregivers have experienced inappropriately administering non-prescribed antibiotics to their children in China.7) Inadequate use of non-prescribed, leftover medicine was based on the lack of knowledge, knowledge gaps, and unfavorable attitudes among caregivers.7,8) Clark in the U.S. has pointed out issues related to using leftover medications for children.9) Specifically, she highlighted that nearly half of caregivers store leftover medications at home. Regarding unused medications, caregivers tolerate actions such as allowing the administration of expired medications, with 15% of caregivers permitting this. She states, “We found that it is common for parents to keep medications long after they are expired or no longer needed, which creates an unnecessary health risk for children.”9) In Japan, a health care system named “kakaritsuke-yakuzaishi” (family pharmacist) allowed fees for having responsibility in reducing leftover medications in community pharmacists10,11) Kobayashi et al. reported that family pharmacists succeeded in a 15% reduction in prescribed medication cost via “Brown Bag Campaign.”12) However, information on leftover medicines and their inappropriate use in children in Japan is lacking.

Inappropriate medications, especially leftover medications, are global health issues that require up-to-date information, especially in children. Therefore, we aimed to clarify the proportion of leftover and reused medications in children’s care.

MATERIALS AND METHODS

Study Design and Participants

This study was a nation-wide cross-sectional exploratory survey targeted towards the demographic of primary caregivers for children under 6 years of age before elementary school in Japan. This study was adopted by anonymized web-based data collection, as this survey included questions about personalized information and considered a web-familiar population of parents of under-elementary-age children.

This study was outsourced to a company that provides web-based data collection and recruitment through e-mail to candidates that considered “entry criteria of the study” and “registered information.” All participants provided informed consent. Participants were recruited through the company from a panel of over 10 million members in Japan.

Questionnaire Development

We developed eight domains with 40 questions about 1) parents’ demographics, 2) children’s demographics, 3) actual practices in handling about leftover acute medicine use, 4) actual practices in handling about leftover chronic medication use, 5) actual practices in handling about leftover short-term medicine use, 6) actual practices in handling about leftover antibiotic use, 7) actual practices in handling about leftover topical medication use, and 8) attitudes towards leftover medications (Table 1). We modified the questionnaire after administering it in person to eight clinical pharmacists/investigators to test its comprehensiveness and clarity. We enhanced sentence fluency, chose words that were easily understood, and avoided expressions that could cause discomfort to the participants. The questionnaire was formatted as a question per web page. For data collection, we adopted adaptive questioning methods such as web page screen transitions that depend on each participant’s answer.

Table 1. Summary Information about Measurement Items

DomainNo. of itemsItemsScaling
1Demographics (parents)111. Demographics (area, age, income, education, work, marital status, family structure)Single, multiple-answer, free description, 5 scale
2. Knowledge of medicine prescribed to the child
3. Parent medication adherence
2Demographics (children)111. Demographics (age, sex, disease)Single and multiple answers, free description
2. Primary care doctor/pharmacist
3. Hospital/clinic/pharmacy visit
3About acute use medicine (antipyretic medicine and vomiting etc.)11. About leftoverSingle answer
4About chronic use of medicine (including heart disease and psychiatric disease etc.)31. About leftoverSingle and multiple answers
2. Reason for leftover
5About short-term use medicine (influenza and hay fever medicine etc.)31. About leftoverSingle and multiple answers
2. Reason for leftover
6About antibiotics31. About leftoverSingle and multiple answers
2. Reason for leftover
7About topical medicine31. About leftoverSingle and multiple answers
2. Reason for leftover
8Attitude to leftover medicine51. Attitude toward leftover medicineSingle answer
2. Storage condition for leftover medicine

Questionnaire formatting was checked and fully reviewed by the investigator and system engineer. The questionnaire included an introduction, a description of the study’s purpose, and informed consent. Participants started answering the questionnaire after filling out the informed consent. All participants were registered with an outsourcing company; therefore, duplicate answers were excluded from the study. Additionally, we obtained anonymized data. Participants were motivated by trying to maximize their reward points as an incentive, which was approximately under 100 Yen. The setup of these incentives was independent of the investigators.

We reported our findings using the Checklist for Reporting Results of Internet E-Surveys.13)

Study Procedure and Definition

The entry criteria included primary caregivers with children under 6 years of age before elementary school. Parents provided informed consent before entry to the study. The web survey was conducted between September 2, 2022, and September 5, 2022.

Study Endpoints and Statistical Analysis

The primary endpoint of this descriptive exploratory survey was the measurement of domains 3–7 for the proportion of leftover medicines in each medicine class. The secondary endpoints were 1) duration for storage in participants’ homes, 2) proportion for giving the medicine to another person, and 3) attitudes towards leftover medicine in domain 8.

Categorical variables are presented as frequencies (percentages), while quantitative variables are described as mean ± standard deviation. In our descriptive survey, all data are presented as simple tabulations. The proportion was calculated as a defined denominator in each question item (Table 2). The numerator is a measure in each question item (Table 2). JMP 16® (SAS Institute Inc., Cary, NC, U.S.A.) was used for data analysis.

Table 2. Definition for the Denominator of Each Measurement in the Study

DomainMeasureDenominatorN
1Demographics (parents)Demographics (area, age, income, education, work, marital status, family structure), knowledge of medicine prescribed to a child, parent's medication adherenceAll participants3046
2Demographics (children)Demographics (age, sex, disease), with or without a primary care doctor/pharmacist, the number of hospital/clinic/pharmacy visitAll participants3046
3About acute use medicine (antipyretic medicine, vomiting)Handling leftover medicationWith a prescribed history of acute use of medicine2809
4About chronic use medicine (heart disease, psychiatric disease)Handling leftover medicationParticipants prescribed chronic diseases medicine256
4About chronic use medicine (heart disease, psychiatric disease)Handling leftover medicationParticipants 1) with chronic diseases and 2) having leftover medicines147
5About short-term use medicine (influenza, hay fever medicine)Handling leftover medicationParticipants with prescribed history for short-term use medicine2457
5About short-term use medicine (influenza, hay fever medicine)Handling of leftover medicationParticipants with 1) prescribed history for short-term use medicine and 2) experienced leftover medications1687
6About antibioticsHandling of leftover medicationParticipants with a prescribed history of antibiotics1431
6About antibioticsHandling of leftover medicationParticipants with experience in the reuse of antibiotics380
7About topical medicationHandling of leftover medicationParticipants with a prescribed history of topical medication2058
7About topical medicationHandling of leftover medicationParticipants with experience in the reuse of topical medication1134
8Attitude toward leftover medicationAttitude toward leftover medicationAll participants3046

Ethics Approval, Consent to Participate, and Permission for Publication

The data collected were anonymized. We obtained informed consent from all participants using adequate methods on the web. The study protocol (“Questionnaire survey to parents with children under 6 years of age about leftover medication” as SAFFRON study) was approved by the institutional review board of Showa University (August 16, 2022, Approval No. 22-097-B).

RESULTS

Participants Identification Flow and Caregivers’ and Children’s Demographics (Domains 1 and 2)

A total of 5514 participants visited the website (Fig. 1). Among them, 3046 were recruited for this study. Fifty-six percent of the caregivers were dual-income earners, and 60% had university or more education levels. (Tables 2, 3; domain 2). Family income between 4000 and 6000 thousands yen was the most frequent. Approximately 5.2% of the children had asthma, and 1.5% had cardiovascular diseases (Tables 2, 4; domain 3). Children who have home doctors and pharmacists were 88.5 and 27.6%, respectively.

Fig. 1. Analyzed Participant Identification Flow in the Study Using a Web-Based Questionnaire Survey
Table 3. Parents’ Demographics (Domain 1)

Number of participants (male/female)3046 (1016/2030)
Age, year (standard deviation)37.0 ± 5.9
Marriage history
Unmarried35
With marriage history3011
Family structure
Child
Living with a child in elementary school2975
Living with a child of elementary school age and older71
Number of people in a family4.4 ± 2.0
Number of children
11445
21113
3351
491
≥546
Medication adherence in parents
Completely take medicine1368
Almost completely take medicine1050
Sometimes forgot to take472
Rarely take according to the indication156
Working
Dual-income family1699
Single-income family1225
Working as single (including divorced)94
Without working and as single (including divorced)28
Family income (thousand JPY/year)
0–2000144
2000–4000465
4000–6000949
6000–8000739
>8000749
Education level
Compulsory education52
High school575
Technical school579
University1624
Graduate school216
Table 4. Children’s Demographics (Domain 2)

Number of participants (male/female)3046 (1589/1457)
Age
0290
1–31354
4–61402
Chronic diseases
None2690
Cardiovascular disease45
Asthma158
Epilepsy32
Developmental disorders54
Cancer6
Mainly visiting medical facility
Hospital1190
Clinic1856
Number of visits to hospital/clinic during last 1-year1.9 ± 1.2
Have home doctor2695
Number of visits to the pharmacy for receiving medicine during last 1-year1.6 ± 1.0
Have home pharmacist842

Leftover Medications and Managing Medications Prescribed to Children at Home (Domains 3–7)

Approximately 92.2% (2809/3046) of participants were prescribed acute medications. Among them, 4.8% (135/2809) discarded the medication immediately, while 54.0% (1517/2809) reported “never discarding” medications (Tables 1, 2; Fig. 2).

Fig. 2. Storage Period for Leftover Medications Used Exclusively during the Acute Phase, Such as Antipyretics, Vomiting etc. (Domain 3)

Among caregivers of children with chronic diseases, 57.4% (147/256) of the children who were administered chronic medications reported having leftover medications. The most common duration for storing these leftover medications was within 1 week, accounting for 49.7% (73/147) of the cases (Tables 1, 2; Fig. 3). The primary reason for leftover medications was “withdrawal by caregiver’s decision” (53.1%), followed by “Medication therapy was changed” (23.8%) (Table 5).

Fig. 3. Storage Period for Leftover Medications for Chronic Use Medicines, Such as Heart Disease, Psychiatric Disease etc. (Domain 4)
Table 5. Reason for Leftover Medications for Chronic Medication Use (Domain 4)

Variablesn%
Withdrawal by parents7853.1
Medication therapy was changed3523.8
Adverse events138.8
Refused by child1711.6
Parent forgot to give the medications3221.8
Discomfort to give medicine, such as formula and preparation, by parents96.1
Could not give to a child owing to “sleep,” “kindergarten”1912.9
Stock up just in case you cannot visit the hospital/clinic3221.8

Regarding short-term medication use, such as those for hay fever and influenza, 68.7% (1687/2457) reported having leftover medications. The most frequent reasons for leftover of short-term medicines were “Withdrawal by parents” for 88.0% (1485/1687) (Table 6). Of these, 3.6% had stored the medication for >30 d (Tables 1, 2; Fig. 4).

Table 6. Reason for Leftover Medicines for Short-Term Use Medicine (Domain 5)

Variablesn%
Withdrawal by parents148588.0
Visit the hospital/clinic just in case to stock up on medicine1036.1
Adverse events472.8
Refused by child1418.4
Parent forgot to give the medications975.7
Discomfort to give medicine, such as formula and preparation, by parents523.1
Could not give to a child owing to “sleep,” “kindergarten”1126.6
Fig. 4. Storage Period for Leftover Medications for Short Term Use Medicines, Such as Influenza, Hay Fever Medicine etc. (Domain 5)

Forty-seven percent (1431/3046) had a history of being prescribed antibiotics (Tables 1, 2; Fig. 5). From these participants, 26.6% reported reuse for leftover antibiotics. Additionally, 8.7, 7.9, and 3.2% reported giving antibiotics to siblings, parents, and the child’s friends, respectively. The duration of antibiotic storage after prescription was “between 1 to 6 months” for 34.7% and “between 1 week to 1 month” for 27.9%. Furthermore, 6.8% reported reusing antibiotics that had been stored for >1 year.

Fig. 5. Re-Use Experience and Storage Period for Leftover Medications of Antibiotics (Domain 6)

Topical medication users in our study were 67.6% (2058/3046) of all participants (Tables 1, 2; Fig. 6). Among these participants, 23.9, 17.3, and 1.7% reported giving topical medications to siblings, parents, and the child’s friends, respectively. Additionally, 9.1% (103/1134) reported reusing topical medications stored for >1 year.

Fig. 6. Re-Use Experience and Storage Period for Leftover Medications of Topical Medicines (Domain 7)

Attitude toward Leftover Medicine (Domain 8)

The attitude for storing medicine at home was “not good but necessary to have in case of emergency for the child” was the most frequent answer for 44.1% (Tables 1, 2, 7). Approximately 26.8% considered it “essential for emergency use for the child.” However, 29.1% believed it was “inadequate for the caregiver to decide.”

Table 7. Attitude toward Stock for Prescribed Medication at Home (Domain 8)

Variablesn%
Essential for emergency use for child81726.8
Not good but need to stock just in case there is an emergency for the child134344.1
Inadequate use by parents’ decision88629.1

With respect to the attitude toward reusing stored medicine at home, 34.5% answered “reuse is inadequate” (Tables 1, 2, 8). Approximately 31.5% felt it was permissible for the caregiver to decide only for themselves if the symptoms were similar, and 9.1% permitted reuse for a sibling.

Table 8. Attitude toward Reuse of Stored Medications at Home (Domain 8)

Variablesn%
May be used only for the individual at the discretion of the parent/caregiver if similar symptoms are present.96131.5
If the symptoms are similar, the parent/caregiver may use it for the patient at his/her own discretion. The doctor has instructed me to use it; therefore, I may use it.66421.8
May be used for siblings with the patient at the discretion of the parent/caregiver if they have similar symptoms2779.1
May be used not only for the individual but also for acquaintances and caregivers if they have similar symptoms943.1
Reuse for the individual is also inappropriate, and the hospital/clinic should be consulted on a case-by-case basis105034.5

Regarding the expiratory period for powder formula dispensed by pharmacists, 5.2% believed there was “no expiratory period,” and 7.1% thought it was for “several years” (Tables 1, 2, 9). The attitude towards collecting stock medications at home from pharmacies were answered negatively for “troubling because I want to save it in case of emergency” for 39.4% (Tables 1, 2, 10).

Table 9. Recognition for Expiratory Periods for Powder Formula (Picture) Dispensed by Pharmacists (Domain 8)

VariablesN%
No expiratory period1585.2
Several years2157.1
Can be stored as long as it does not deteriorate in appearance or texture2327.6
Half year62520.5
3 months49216.2
1 month65621.5
2 weeks66821.9

Picture of Powder Formula

Table 10. How Do You Feel about Pharmacies Collecting Stock/Excess Medications at Home (Domain 8)

VariablesN%
This is troubling because I want to save it in case of emergency.120039.4
Medications prescribed after a visit to the hospital/clinic are parents/caregivers and are not comfortable with them being collected.58719.3
I would like to have them collected owing to the possibility to miss-use of medicines.60619.9
I would like to have my medications collected as they are difficult to dispose of at home.65321.4

DISCUSSION

We clarified the proportion of reuse or distribution of children’s medications to others by a caregiver’s decision, categorized by each formulation or pharmacological mechanism of action in Japan.

Generally, gathering information about leftover medications through patient or family interviews is challenging. Approximately 6.6% of patients with chronic kidney diseases (CKDs) and 21% of patients undergoing hemodialysis (HD) responded with “Never tell the doctor even if I have any leftover medications.”14) Owing to this, we conducted an anonymous web survey for caregivers.

In this study, approximately 65.5% of the caregivers believed that reusing leftover medications is permissible within certain limits (Table 8). This may be owing to the lack of widespread general and fundamental knowledge about the proper handling of medications. This tendency was a consistent concern globally. Adults in New Zealand believe it is safe to lend or borrow painkillers (60.7%), allergy medications (36.0%), asthma medications (36.0%), and contraceptive medications (19.9%).15) The U.S. reported inadequate use of leftover medications obtained through inappropriate channels among 11% of high school students.16) In Japan, we conducted this survey because of lack of baseline information on citizens’ leftover medications used for children. Our data revealed that Japanese children’s caregivers also require knowledge for adequate medication use.

The major reason for leftover medications at home was that most caregivers forgot to administer them, sometimes because the children were already asleep. Consequently, they stored the leftover medicine for emergencies for children (Tables 5, 6). Reasons for storing medications are also similar to those observed in EU countries, such as “for future use.”17,18) This is partially understandable based on caregiver attitudes; however, providing education to caregivers is necessary, particularly emphasizing that in emergencies, accurate diagnosis by physician is crucial. In addition, they need to understand that using leftover medications can mask symptoms, which can negatively impact the child’s health.

Approximately 60% of the caregivers have permittable attitude toward collecting leftover medications by pharmacists (Table 10). Several efforts to reduce inappropriate medication use, especially in leftover medications, include pharmacist interventions, the provision of drug disposal bags (brown bags), financial incentives, and other initiatives.1927) Leftover medications lead to inappropriate medication use, and efforts by pharmacists, especially regarding children’s medications, can partially reduce the harm caused by leftover medications.

This study had some limitations, one of which could have been participant bias. This may have been the case because our participants were motivated to maximize their reward points as an incentive. The study participants were included only under 6 years old children. This needs to consider the interpretation the study results from our study. Additionally, the proportion of reuse may vary depending on the education level or the family income of caregivers, which has not been thoroughly analyzed.

In conclusion, we clarified leftover medicine in children in each formula or drug class in Japan using an anonymized web-based questionnaire survey. Almost all the guardians have experienced leftover medications and reuse of it; however, managing leftover medications depends on their beliefs based on inadequate knowledge of medicine. Most of these cases involve inadequate use of medications in children. Medical staff, especially pharmacists, need to educate caregivers on the appropriate use of children’s medications.

Acknowledgments

This work was supported by a Grant from Showa University Translational Research, and JSPS KAKENHI Grant Numbers: 24K09920 and 24K18317.

Author Contributions

All authors meet the ICMJE recommendations. Especially, KeM and KaM contributed to the study conception and drafted the manuscript. NT and was responsible for ethics handling. KeM managed raw data. All authors built the questionnaire form. AI, MK, NT, RE, RK, HT, YK, HS, YA, and TK interpreted the results clinically. TI finally approve this study. All authors took part in the discussions during manuscript preparation. All authors have agreed to publish this manuscript.

Conflict of Interest

The authors declare no conflict of interest.

Supplementary Materials

This article contains supplementary materials.

REFERENCES
 
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Published by The Pharmaceutical Society of Japan

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