2024 年 47 巻 10 号 p. 1690-1698
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.
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.
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 DevelopmentWe 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.
Domain | No. of items | Items | Scaling | |
---|---|---|---|---|
1 | Demographics (parents) | 11 | 1. 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 | ||||
2 | Demographics (children) | 11 | 1. Demographics (age, sex, disease) | Single and multiple answers, free description |
2. Primary care doctor/pharmacist | ||||
3. Hospital/clinic/pharmacy visit | ||||
3 | About acute use medicine (antipyretic medicine and vomiting etc.) | 1 | 1. About leftover | Single answer |
4 | About chronic use of medicine (including heart disease and psychiatric disease etc.) | 3 | 1. About leftover | Single and multiple answers |
2. Reason for leftover | ||||
5 | About short-term use medicine (influenza and hay fever medicine etc.) | 3 | 1. About leftover | Single and multiple answers |
2. Reason for leftover | ||||
6 | About antibiotics | 3 | 1. About leftover | Single and multiple answers |
2. Reason for leftover | ||||
7 | About topical medicine | 3 | 1. About leftover | Single and multiple answers |
2. Reason for leftover | ||||
8 | Attitude to leftover medicine | 5 | 1. Attitude toward leftover medicine | Single 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 DefinitionThe 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 AnalysisThe 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.
Domain | Measure | Denominator | N | |
---|---|---|---|---|
1 | Demographics (parents) | Demographics (area, age, income, education, work, marital status, family structure), knowledge of medicine prescribed to a child, parent's medication adherence | All participants | 3046 |
2 | Demographics (children) | Demographics (age, sex, disease), with or without a primary care doctor/pharmacist, the number of hospital/clinic/pharmacy visit | All participants | 3046 |
3 | About acute use medicine (antipyretic medicine, vomiting) | Handling leftover medication | With a prescribed history of acute use of medicine | 2809 |
4 | About chronic use medicine (heart disease, psychiatric disease) | Handling leftover medication | Participants prescribed chronic diseases medicine | 256 |
4 | About chronic use medicine (heart disease, psychiatric disease) | Handling leftover medication | Participants 1) with chronic diseases and 2) having leftover medicines | 147 |
5 | About short-term use medicine (influenza, hay fever medicine) | Handling leftover medication | Participants with prescribed history for short-term use medicine | 2457 |
5 | About short-term use medicine (influenza, hay fever medicine) | Handling of leftover medication | Participants with 1) prescribed history for short-term use medicine and 2) experienced leftover medications | 1687 |
6 | About antibiotics | Handling of leftover medication | Participants with a prescribed history of antibiotics | 1431 |
6 | About antibiotics | Handling of leftover medication | Participants with experience in the reuse of antibiotics | 380 |
7 | About topical medication | Handling of leftover medication | Participants with a prescribed history of topical medication | 2058 |
7 | About topical medication | Handling of leftover medication | Participants with experience in the reuse of topical medication | 1134 |
8 | Attitude toward leftover medication | Attitude toward leftover medication | All participants | 3046 |
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).
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.
Number of participants (male/female) | 3046 (1016/2030) |
---|---|
Age, year (standard deviation) | 37.0 ± 5.9 |
Marriage history | |
Unmarried | 35 |
With marriage history | 3011 |
Family structure | |
Child | |
Living with a child in elementary school | 2975 |
Living with a child of elementary school age and older | 71 |
Number of people in a family | 4.4 ± 2.0 |
Number of children | |
1 | 1445 |
2 | 1113 |
3 | 351 |
4 | 91 |
≥5 | 46 |
Medication adherence in parents | |
Completely take medicine | 1368 |
Almost completely take medicine | 1050 |
Sometimes forgot to take | 472 |
Rarely take according to the indication | 156 |
Working | |
Dual-income family | 1699 |
Single-income family | 1225 |
Working as single (including divorced) | 94 |
Without working and as single (including divorced) | 28 |
Family income (thousand JPY/year) | |
0–2000 | 144 |
2000–4000 | 465 |
4000–6000 | 949 |
6000–8000 | 739 |
>8000 | 749 |
Education level | |
Compulsory education | 52 |
High school | 575 |
Technical school | 579 |
University | 1624 |
Graduate school | 216 |
Number of participants (male/female) | 3046 (1589/1457) |
---|---|
Age | |
0 | 290 |
1–3 | 1354 |
4–6 | 1402 |
Chronic diseases | |
None | 2690 |
Cardiovascular disease | 45 |
Asthma | 158 |
Epilepsy | 32 |
Developmental disorders | 54 |
Cancer | 6 |
Mainly visiting medical facility | |
Hospital | 1190 |
Clinic | 1856 |
Number of visits to hospital/clinic during last 1-year | 1.9 ± 1.2 |
Have home doctor | 2695 |
Number of visits to the pharmacy for receiving medicine during last 1-year | 1.6 ± 1.0 |
Have home pharmacist | 842 |
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).
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).
Variables | n | % |
---|---|---|
Withdrawal by parents | 78 | 53.1 |
Medication therapy was changed | 35 | 23.8 |
Adverse events | 13 | 8.8 |
Refused by child | 17 | 11.6 |
Parent forgot to give the medications | 32 | 21.8 |
Discomfort to give medicine, such as formula and preparation, by parents | 9 | 6.1 |
Could not give to a child owing to “sleep,” “kindergarten” | 19 | 12.9 |
Stock up just in case you cannot visit the hospital/clinic | 32 | 21.8 |
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).
Variables | n | % |
---|---|---|
Withdrawal by parents | 1485 | 88.0 |
Visit the hospital/clinic just in case to stock up on medicine | 103 | 6.1 |
Adverse events | 47 | 2.8 |
Refused by child | 141 | 8.4 |
Parent forgot to give the medications | 97 | 5.7 |
Discomfort to give medicine, such as formula and preparation, by parents | 52 | 3.1 |
Could not give to a child owing to “sleep,” “kindergarten” | 112 | 6.6 |
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.
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.
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.”
Variables | n | % |
---|---|---|
Essential for emergency use for child | 817 | 26.8 |
Not good but need to stock just in case there is an emergency for the child | 1343 | 44.1 |
Inadequate use by parents’ decision | 886 | 29.1 |
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.
Variables | n | % |
---|---|---|
May be used only for the individual at the discretion of the parent/caregiver if similar symptoms are present. | 961 | 31.5 |
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. | 664 | 21.8 |
May be used for siblings with the patient at the discretion of the parent/caregiver if they have similar symptoms | 277 | 9.1 |
May be used not only for the individual but also for acquaintances and caregivers if they have similar symptoms | 94 | 3.1 |
Reuse for the individual is also inappropriate, and the hospital/clinic should be consulted on a case-by-case basis | 1050 | 34.5 |
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).
Variables | N | % |
---|---|---|
No expiratory period | 158 | 5.2 |
Several years | 215 | 7.1 |
Can be stored as long as it does not deteriorate in appearance or texture | 232 | 7.6 |
Half year | 625 | 20.5 |
3 months | 492 | 16.2 |
1 month | 656 | 21.5 |
2 weeks | 668 | 21.9 |
Picture of Powder Formula
Variables | N | % |
---|---|---|
This is troubling because I want to save it in case of emergency. | 1200 | 39.4 |
Medications prescribed after a visit to the hospital/clinic are parents/caregivers and are not comfortable with them being collected. | 587 | 19.3 |
I would like to have them collected owing to the possibility to miss-use of medicines. | 606 | 19.9 |
I would like to have my medications collected as they are difficult to dispose of at home. | 653 | 21.4 |
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.19–27) 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.
This work was supported by a Grant from Showa University Translational Research, and JSPS KAKENHI Grant Numbers: 24K09920 and 24K18317.
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.
The authors declare no conflict of interest.
This article contains supplementary materials.