Abstract
Background
Acetaminophen is a commonly used analgesic and antipyretic. In South Korea, a 2012 regulatory change allowed its over-the-counter sale in convenience stores, increasing public accessibility.
Objectives
We aimed to assess the impact of increased over-the-counter availability of acetaminophen on adolescent self-poisoning trends in South Korea.
Methods
This population-based observational study used the National Health Insurance Service customized database to analyze trends in acetaminophen-related poisoning among adolescents before and after the 2012 policy change. Age-specific trends were evaluated, and poisoning episodes were categorized by recurrence and severity.
Results
Following the policy change, the number of acetaminophen poisoning cases increased from 2.4 to 3.8 (during 2007–11 and 2013–17, respectively, per 100,000 adolescents). This increase was particularly significant among adolescents aged 16–18 years, rising from 10.7 to 23.8 per 100,000 (p < 0.05). While the total number of poisoning events increased, the number of affected individuals remained largely unchanged (86.4 vs 80.0), suggesting a more frequent recurrence. The proportion of acetaminophen poisonings among all drug poisoning cases increased from 5.2% to 9.7%, whereas the increase in the proportion of severe cases requiring hospitalization was relatively modest.
Conclusions
The findings suggest that increased over-the-counter availability of acetaminophen may be associated with a rise in misuse among older adolescents. Public health measures, including stricter over-the-counter regulation and targeted interventions, may be needed to mitigate the risk of self-harm in this population.
Supplementary Information
The online version contains supplementary material available at 10.1007/s40801-025-00521-x.
Key Points
| Increased over-the-counter availability of acetaminophen in South Korea was associated with a higher frequency of self-poisoning episodes among older adolescents. |
| The number of individuals affected remained stable, indicating a rise in repeated self-poisoning within the same population. |
| These findings highlight the potential risks of broad access to analgesics and underscore the need for targeted regulatory and preventive strategies to protect adolescents. |
Introduction
Acetaminophen (paracetamol) is one of the most widely used analgesics and antipyretics globally and is available both as a single-component medication and as an ingredient in numerous combination products. The accessibility of the drug has contributed to its extensive use in pain and fever management, with over 28 billion doses dispensed worldwide in 2005 [1]. Although acetaminophen is generally safe when used as directed, acetaminophen overdose remains a critical public health concern owing to its potential to cause severe hepatotoxicity and subsequent acute liver failure or death if left untreated [2].
Acetaminophen poisoning is caused by intentional self-poisoning or unintentional overdose, often due to repeated dosing to manage symptoms [3]. In the USA, more than 80,000 cases of acetaminophen poisoning were reported to poisoning control centers in 2021, thereby highlighting the need for careful monitoring and preventive measures [4]. Globally, acetaminophen overdose is one of the most common causes of drug-related poisoning and is a major contributor to acute liver disease and liver transplantation. In the UK, an estimated 150–200 fatalities occur annually due to paracetamol poisoning [5]. Notably, the incidence of acetaminophen poisoning has been linked to accessibility, with epidemiological data from Europe indicating an increase in poisoning cases following the expansion of sales outside pharmacies [6, 7]. Consequently, several countries, including Denmark and the UK, have introduced regulatory measures, such as age restrictions and limitations on package size, thereby monitoring subsequent trends to assess the effectiveness of these policies [8].
In Korea, accessibility to acetaminophen markedly increased following a policy change in November 2012 that permitted its over-the-counter (OTC) sale at convenience stores [9, 10]. Following the licensing of 17,851 OTC drug retailers in 2012, the number of retailers surpassed the total number of community pharmacies nationwide by 2013 and further increased to 34,206 by 2017. Although this policy aimed to enhance access to essential medications, it also raised concerns about potential misuse and overdose, particularly among vulnerable populations, such as adolescents [11]. Despite these concerns, the societal risks associated with OTC drug misuse are often underestimated owing to the challenges in tracking purchase and consumption behaviors [12]. Although acetaminophen availability has expanded in Korea, there is limited research on its usage patterns and the incidence of poisoning, particularly in the context of the 2012 policy changes.
Therefore, this study aimed to evaluate the effects of increased acetaminophen availability on adolescent self-poisoning in Korea, with a specific focus on the periods before and after the 2012 policy change. By analyzing national data on cases of acetaminophen poisoning, this study sought to provide insights into the trends and risk factors associated with adolescent self-poisoning. The study findings will contribute to a broader understanding of the public health implications of OTC medication policies.
Methods
Data Source and Study Design
We utilized the National Health Insurance Service customized database, which includes health information collected, managed, and maintained by the National Health Insurance Service for policy and academic research purposes, and provides comprehensive data on demographics, medical history, diagnoses, treatments, medication prescriptions, and reimbursement claims, covering approximately 50 million people in Korea. A retrospective analysis was conducted to assess the effects of the 2012 policy change on acetaminophen self-poisoning rates among adolescents in Korea. This policy change allowed for the OTC sale of acetaminophen in convenience stores. Institutional review board approval was obtained from Sungkyunkwan University (IRB No. SKKU2023-12-061), and informed consent was waived because all personal information was anonymized.
Study Population
Acetaminophen poisoning cases among adolescents were identified based on the International Classification of Diseases, 10th Revision codes for intentional self-poisoning (T36–T50), specifically those corresponding to acetaminophen-related diagnoses (T39.1). [13] Cases were included if patients were between 13 and 18 years of age at the time of poisoning, with data collected before (2007–11) and after (2013–17) the policy change. Individuals with repeated poisoning incidents were also recorded to assess the changes in recurrence rates.
Outcomes
The primary outcome was the frequency of acetaminophen poisoning cases among adolescents. We compared the periods before and after the 2012 policy change (2007–11 vs 2013–17) and also examined annual trends. Incidence rates per 100,000 population were calculated using annual live birth data from the Korean Statistical Information Service [14]. Adolescents were stratified into two age groups (13–15 and 16–18 years) for subgroup analyses. In addition, we analyzed the proportion of acetaminophen poisoning cases relative to all drug poisoning cases (diagnostic codes T36–T50). Severe cases requiring hospitalization were defined as those with the diagnostic code for acetaminophen poisoning (T39.1) accompanied by a medical inpatient admission code.
Statistical Analyses
All statistical analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC, USA). Descriptive statistics were presented as means (± standard deviation) for continuous variables and as counts and percentages for categorical variables. Chi-square tests were used to compare the proportion of poisoning cases across different time periods and age groups. Moreover, incidence rates per 100,000 individuals were calculated for both study periods, and differences in rates were assessed using t-tests. A p-value of < 0.05 was considered statistically significant for all analyses.
Results
Among 980 adolescents, the mean age was 16.08 years with females comprising 81.84% of the cohort, and the distribution of income quartiles was broadly similar between periods (Table 1). After the 2012 policy change, the total number of adolescent acetaminophen poisoning cases showed an overall upward trend. The average number of cases increased from 101.4 during 2007–11 to 135.6 during 2013–17 (Fig. 1A, Table 1 of the Electronic Supplementary Material [ESM]); however, because South Korea is a country experiencing a rapid decline in the number of live births, a simple comparison of crude case numbers did not yield statistically significant differences. After adjusting for the number of live births, the average number of cases per 100,000 people increased significantly from 2.40 ± 1.10 to 3.76 ± 1.13 (p = 0.045, Fig. 1B). When the number of poisoning cases per patient—an indicator of repeated overdose attempts—was analyzed, the average increased to 1.8 cases after the policy change, representing a 1.5-fold rise (Fig. 1C). This pattern was more evident in the trend-line analysis: the slope for 2013–17 was steeper than that for 2007–11 (0.16 vs 0.02), indicating a higher frequency of recurrent overdoses at the individual level (Fig. 1D). Similarly, when comparing cases and patients per 100,000 population, the incidence of poisoning cases per 100,000 increased, whereas the number of affected patients remained relatively stable (86.4 vs 80.0 per 100,000), again suggesting that repeated poisoning events within the same individuals had become more common (Fig. 1E). Notably, a marked increase was observed around 2016, suggesting that the rise in incidence did not occur immediately after the 2012 policy change but rather reflects a delayed or cumulative effect.
Table 1.
Baseline characteristics of the cohort
| Characteristics | Total (n = 980) | Before 2012 (n = 564) | After 2012 (n = 416) |
|---|---|---|---|
| Mean age, years (SD) | 16.08 (1.36) | 15.79 (1.33) | 16.46 (1.32) |
| Sex | |||
| Male | 178 (18.16) | 97 (17.20) | 81 (19.47) |
| Female | 802 (81.84) | 467 (82.80) | 335 (80.53) |
| Income level, n (%) | |||
| First quartile | 224 (23.33) | 127 (23.18) | 97 (23.54) |
| Second quartile | 168 (17.50) | 102 (18.61) | 66 (16.02) |
| Third quartile | 209 (21.77) | 120 (21.90) | 89 (21.60) |
| Fourth quartile | 359 (37.40) | 199 (36.31) | 160 (38.83) |
SD standard deviation
Fig. 1.
Comparison of the number of acetaminophen poisoning cases before and after the 2012 policy change. A average number of cases, B average number of cases per 100,000 people, C average number of cases per patient, and D trends in the incidence of acetaminophen self-poisoning. The solid line indicates the annual incidence of acetaminophen poisoning cases per patient. The dotted line represents the trend for the pre-policy change (2007–11), and the dashed line represents the trend for the post-policy change (2013–17). E Number of acetaminophen poisoning cases and patients per 100,000 people by year. NS not significant; *p < 0.05
A subgroup analysis by age showed that the increase was more pronounced among adolescents aged 16–18 years, with incidence rising from 10.72 ± 6.79 to 23.82 ± 16.53 per 100,000 (p = 0.015), compared with those aged 13–15 years, who showed no significant difference (6.01 vs 5.22, Fig. 2). This age group exhibited a considerably higher rate of poisoning incidents, thereby indicating heightened vulnerability among older adolescents.
Fig. 2.
Number of acetaminophen poisoning cases by age. A Incidence per 100,000 people by year, B incidence per 100,000 people for ages 13–15 years before and after the 2012 policy change, and C incidence per 100,000 people for ages 16–18 years before and after the 2012 policy change. NS not significant; *p < 0.05
Moreover, the proportion of acetaminophen poisoning cases among all drug poisoning cases increased, from 5.17 ± 1.33% during 2007–11 to 9.74 ± 3.48% during 2013–17 (p = 0.020), highlighting the growing prominence of acetaminophen misuse within the broader context of drug poisoning (Fig. 3). The number of severe acetaminophen poisoning cases requiring hospitalization also showed an overall increasing trend; however, when comparing the 5 years before and after the 2012 policy change, the proportion of severe cases remained relatively stable in relation to the total number of cases (10.67 vs 13.29 per 100,000, Fig. 4, Table 2 of the ESM). This suggests that the severity of poisoning cases, as measured by hospitalization rates, has remained stable despite the increase in the frequency of poisoning cases.
Fig. 3.
Number of acetaminophen poisoning cases compared to the total number of drug poisoning cases. A Incidence per year and B incidence during 2007–11 (pre-policy change) and 2013–17 (post-policy change). *p < 0.05
Fig. 4.
Number of severe acetaminophen poisoning cases requiring hospitalization
Discussion
This study assessed the potential effects of the 2012 policy change that permitted OTC sales of acetaminophen in convenience stores on the incidence of acetaminophen poisoning among Korean adolescents. The study findings revealed a notable increase in acetaminophen poisoning cases among adolescents following policy implementation compared with those during the pre-policy period. In the 1990s, the UK experienced a sharp increase in hospital admissions because of acetaminophen poisoning, accompanied by a substantial number of fatalities [15]. In response, the UK Paracetamol Information Centre identified the widespread availability of acetaminophen in large-bottle packages as a key factor contributing to unintentional overdoses and self-harm attempts during episodes of emotional distress. Ingestion of more than 15 g of acetaminophen is widely recognized as a critical threshold for severe hepatotoxicity, and treatment with acetylcysteine may be required in such cases [16]. Consequently, the UK government implemented regulations limiting pack sizes to a maximum of 8 g for non-pharmacy sales and 16 g for pharmacy sales. However, patients were able to circumvent these restrictions by visiting multiple pharmacies, highlighting the need for more comprehensive preventive measures.
In Korea, regulations mandate that convenience stores sell only one unit of OTC medication per transaction. However, in practice, compliance is inconsistent, with the proportion of stores selling more than one unit increasing from 46.5% in 2023 to 58.3% in 2024 [17]. Additionally, only approximately one fourth of part-time convenience store employees receive safety training on OTC medications from store owners, resulting in lower knowledge levels among vendors than those among consumers [10]. Furthermore, no training has been provided on inventory management or proper disposal of these medications, thus raising concerns regarding regulatory enforcement and public safety.
Notably, although the numbers of acetaminophen poisoning cases and severe cases requiring hospitalization showed a relatively steady increase, the overall incidence of acetaminophen poisoning continued to rise over time, and this trend was more pronounced among adolescents aged 16–18 years compared with those aged 13–15 years. An Australian study reported that only 0.02% of adolescent acetaminophen overdoses were due to unintentional supratherapeutic ingestion [18]. In our study as well, the disproportionate increase in cases relative to patient numbers suggests a higher likelihood of intentional self-poisoning attempts. Previous research has also shown that greater availability of OTC medications increases the risk of misuse, particularly for analgesics and sedatives [19]. Self-harm attempts using OTC medications occur especially frequently among adolescents and female individuals; similarly, in this study, female individuals accounted for a disproportionately high percentage (81.84%) of cases. Furthermore, prior studies of acetaminophen overdose in patients under 18 years of age reported that 89% required a psychiatric evaluation and 73% required psychiatric hospitalization, with depression being the most common comorbidity [20]. This suggests that adolescents in emotionally unstable states may be more likely to attempt acetaminophen overdose, and increased accessibility may further facilitate such attempts.
Importantly, a history of self-poisoning during adolescence can negatively impact long-term health and psychological outcomes. The risk of suicide within 1 year after an initial self-poisoning episode was markedly elevated, with a hazard ratio of 32.1, and self-poisoning in adolescence has been identified as a strong predictor of suicide and premature death in the subsequent decade [21]. Moreover, 15.8% experienced a recurrence of self-poisoning, and many reported persistent psychological distress, interpersonal difficulties, and reduced academic or occupational performance [22]. Because risky behaviors during adolescence can develop into substance abuse in adulthood, the Centers for Disease Control and Prevention also emphasizes the importance of recognizing early warning signs of adolescent crises and implementing timely intervention strategies [23, 24]. Therefore, preventive measures, such as strengthening sales regulations and expanding education for vulnerable populations, including adolescents, are of critical importance. Therefore, preventive measures, such as stricter regulations on sales and enhanced education for vulnerable populations, including adolescents, are of critical importance.
However, the observed increase in adolescent acetaminophen poisoning cannot be fully explained by the 2012 deregulation alone. A gradual rise had already been observed between 2007 and 2012, suggesting that various social and health-related factors were contributing. In particular, the deterioration of adolescent mental health has been documented in multiple studies: in the UK, antidepressant prescriptions among adolescents aged 12–17 years doubled between 2005 and 2017, while in the USA, suicide rates in the same age group increased by 70% [25]. Moreover, the proportion of individuals under 25 years of age reporting themselves to be in a state of despair rose substantially, from 2.50 among male individuals and 3.21 among female individuals in 1993 to 6.63 and 9.32, respectively, in 2023/24. In this context, the expanded accessibility of acetaminophen may have acted as an important trigger that accelerated the rise in poisoning cases, which is consistent with our finding that acetaminophen poisoning increased more rapidly than other types of drug poisoning.
Nevertheless, our study demonstrates temporal associations rather than direct causality, which is a key limitation. Future longitudinal studies are needed to elucidate the interactions among adolescent mental health trajectories, medication accessibility, and policy changes. Another limitation of this study is that it did not fully account for the time required for actual policy implementation. Although a 5-year follow-up period was used before and after the policy to minimize the confounding effects of coronavirus disease 2019, it took approximately 3 years for the number of convenience stores selling OTC medications to surpass the 23,000 community pharmacies nationwide, and about 2 years for the supply of acetaminophen through convenience stores to exceed that through pharmacies [9, 26]. This indicates that longer term follow-up studies are needed to capture the full impact of the policy, and that the relatively short 5-year observation period may not have been sufficient to fully reflect potential lag or cumulative effects. Future studies should employ longer observation periods and more advanced analytical methods, such as a segmented time-series analysis, to more clearly establish causality. Moreover, because it was based on administrative data, we could not distinguish the intent of acetaminophen poisoning episodes, namely, whether they represented suicide attempts or unintentional overdoses. We sought to infer the possibility of repeated poisoning attempts by the same individual using the increase in cases per patient as indirect evidence; however, the absence of intent classification limits our ability to more clearly determine the relationship between poisoning events and factors such as adolescent mental health or social context. Future studies should integrate clinical records and other detailed sources to better contextualize and differentiate poisoning episodes.
Conclusions
The study findings emphasize the urgent need for a multifaceted approach to mitigate the increasing incidence of acetaminophen poisoning among Korean adolescents. Key strategies include revisiting the regulations on acetaminophen sales and implementing educational programs targeting high-risk youth. Local pharmacies play a critical role in public health by operating a drug utilization review system that provides real-time drug safety information. Given the successful implementation of government-mandated distribution programs, such as the public mask distribution system during the coronavirus disease 2019 pandemic, leveraging the existing drug utilization review infrastructure may enable the development of an effective acetaminophen purchase restriction policy.
Supplementary Information
Below is the link to the electronic supplementary material.
Funding
No funds, grants, or other support were received during the preparation of this article.
Declarations
Conflict of Interest
Hee Yeon Kay is an employee of Hubase and Hyun Ik Kim has equity in the company. Young Hee Kwon serves as the president of the Korean Pharmacy Association. However, no financial or direct organizational influence was exerted on the research process, results, or conclusions of this article.
Ethics Approval
Research involving de-identified data does not qualify as human subjects research, as it does not involve interaction with individuals or the use of identifiable private information. Consequently, this project was granted an exemption from review by the Institutional Review Board of Sungkyunkwan University (IRB No. SKKU 2023-12-061), and the requirement for informed consent was waived. The study was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
Consent to Participate
As this study does not include any identifiable personal data or individual case details, informed consent was not required. The study findings are presented in an aggregated and anonymized manner, ensuring participant confidentiality.
Consent for Publication
Not applicable.
Availability of Data and Material
The data that support the findings of this study are available from the database of the National Health Insurance Sharing Service (available from https://nhiss.nhis.or.kr/bd/ay/bdaya001iv.do).
Code Availability
Not applicable.
Authors’ Contributions
Conceptualization and research question: HYK, YHK, HIK. Methodology, data extraction, data management, data synthesis, and data analysis: HYK, writing (original draft): HYK, writing (reviewing and editing): HYK, YHK, HIK. All authors read and approved the final version.
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