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Park, Gassert, Zoh, Lee, Sesana, Park, and Yoon: Lessons From the Household Humidifier Disinfectant Tragedy (HHDT) With Focus on the Chemical Poisoning Surveillance System: Review and Recommendation
Review Article
Humanities & Basic Medical Science

Journal of Korean Medical Science 2024; 39(21): e178.

Published online: 20 May 2024

DOI: https://doi.org/10.3346/jkms.2024.39.e178

Lessons From the Household Humidifier Disinfectant Tragedy (HHDT) With Focus on the Chemical Poisoning Surveillance System: Review and Recommendation

Dong-Uk Park1, Thomas H Gassert2, Kyung Ehi Zoh3, Dong Young Lee4, Fabrizio Sesana5, Soyoung Park6, Seong-Yong Yoon7

1Department of Environmental Health, Korea National Open University, Seoul, Korea.

2Department of Environmental Health, Harvard Chan School of Public Health, Boston, MA, USA.

3Department of Environmental Health, Graduate School of Public Health, Seoul National University, Seoul, Korea.

4Environment and Labor Division, National Assembly Research Service, Seoul, Korea.

5Milano Poison Center and Clinical Pharmacology, Milano, Italy.

6Department of Occupational and Environmental Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.

7Department of Occupational and Environmental Medicine, Soonchunhyang University Gumi Hospital, School of Medicine, Soonchunhyang University, Gumi, Korea.

Address for Correspondence: Dong-Uk Park, PhD. Department of Environmental Health, Korea National Open University, 86 Daehak-ro, Jongno-gu, Seoul 03087, Korea. pdw545@gmail.com

Received 20 March 2024       Accepted 7 May 2024

© 2024 The Korean Academy of Medical Sciences.

The Korean Academy of Medical Sciences

https://creativecommons.org/licenses/by-nc/4.0/
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Lessons learned from the Household Humidifier Disinfectant Tragedy (HHDT) in Korea, which poisoned thousands of citizens over a period of years, necessitated an examination of national poison prevention and surveillance systems. The objectives of this study are to identify essential changes needed in chemical poisoning prevention regulations and surveillance systems for effective poison control by comparing recent trends in international poison control center (PCC) operations, and to delineate the critical elements for establishing a state-of-the-art poison control surveillance system in Korea based on recent advances in PCCs with toxicovigilance.

Methods

A comprehensive review of Korea’s regulatory and surveillance systems for chemical health hazards, with a focus on household products under the HHDT, was conducted. A review of toxicovigilance systems in major countries shows that creating an effective national PCC requires key elements: a centralized database of toxic substances and poisoning cases, mandatory or voluntary reporting of poisoning cases, real-time alerts, collaboration among health organizations, and targeted follow-up of poisoned individuals.

Results

Significant deficiencies in Korea’s legislation, toxicological data management, and poisoning surveillance systems, explained the inadequate response of the Korean government to the HHDT for nearly 17 years until the end of 2011. Based on a review of PCC toxicovigilance systems in major countries, a national framework with five core components is recommended for establishing a modern comprehensive Korea PCC system with toxicovigilance capacity. The core components include establishment of a centralized database of toxic substances information and clinical poisoning cases, implementation of mandatory or permissive reporting of poisoning cases, real-time alert mechanisms, collaborative systems among health-related organizations, and clinical follow-up of poisoned sub-groups.

Conclusion

A rationale and framework for a state-of-the-art national Korean PCC with toxicovigilance is justified and offered. This proposed system could assist neighboring countries in establishing their own sophisticated, globally integrated PCC networks.

Keywords: Poison Control Center (PCC), Chemical Poisoning, Toxicovigilance Systems, Household Humidifier Disinfectant Tragedy (HHDT)

INTRODUCTION

Approximately 41 household humidifier disinfectant (HD) products were marketed in the Republic of Korea (Korea) from 1994 to 2011.1 For 17 years, existing household chemical product regulations allowed over-the-counter disinfectants, or biocides, to be used in household humidifiers because toxicology testing or registration requirements for HD chemicals were inadequate.2 Between 1994 and 2011, Korean citizens sustained marked increase in HD-related respiratory disease and deaths (as of 2015, n = 530, including 221 fatal lung injuries) that had gone undetected by government surveillance. Cases increased significantly in 2006 (n = 41), 2009 (n = 51), and 2010 (n = 108), peaking in 2011 (n = 182).34
After becoming publicly known, the HD Victims Investigation and Decision Committee (HDVIDC) began its work in 2013 and until now continues its mission to evaluate medical records and HD use characteristics of the registered potential victims. As of February 2024, HDVIDC had determined that 5,667 of 7,901 reported HD poisoning cases, including 1,847 deaths, were caused by HD chemicals.5 Until 2018, the only recognized HD-associated disease was diffuse pulmonary fibrosis (elsewhere known as HD-associated lung injury67). Due to the increase in reported cases, additional diseases such as interstitial pneumonia (2014), fetal damage (2017), asthma (2017), toxic hepatitis (2019), childhood interstitial lung disease (2019), bronchitis and upper respiratory diseases (2020), eye diseases (2022), psychological disorders (2022), digestive diseases (2022), and lung cancer deaths (2023) have been added to the list of HD-associated diseases, with the number of victims per disease type varying widely.8 Collectively, all HD-related diagnostic types are now referred to as the Household Humidifier Disinfectant Tragedy (HHDT). Specific health problems reported by most patients are documented elsewhere.910 The HHDT sheds light on the challenges faced by several government agencies, including the Korea Disease Control and Prevention Agency (KDCA) and the Korea Ministry of Environment (KMOE), in their efforts to prevent, detect, and manage chemical poisonings.
This is the first study to evaluate Korea’s chemical poison prevention in relation to legislation and poison surveillance systems that address health risks associated with household products following the HHDT. This study identifies essential changes needed in chemical poisoning prevention regulations and surveillance systems for effective poison control by comparing recent trends in international poison control center (PCC) operations, and to delineate the critical elements for establishing a state-of-the-art poisoning surveillance system in Korea, drawing on recent advances in PCCs with toxicovigilance.

METHODS

Emergence and banning of home HD products in Korea

Both HD chemicals and brands associated with HHDT were reviewed and summarized according to the number, names and concentrations of HD products by manufacturers and suppliers. All official government reports, white papers, and journal literature in Korea related to chemical poisoning prevention regulations and monitoring systems were subjectively selected and reviewed, focusing on the examination of national chemical poisoning prevention and monitoring. Sales volume, chemical concentrations of disinfectant and scale of victims by type of HD and year were excluded due to lack of official data and being of low relevance. A review related to clinical features and type of diseases associated with HD was also not included due to lack of relevance of this study objectives.

Review of the regulatory framework and monitoring systems in Korea for the prevention of health hazards from household chemicals

The study examined legislative measures taken by the Korean government to reduce the health risks associated with chemicals in household products and compared key provisions of the legislation that were revised or enacted before 2011 the HHDT, and after the HHDT to the present. This included review of major revisions of chemical-related legislation from the KMOE, the Pharmaceutical Affairs Act from the Ministry of Food and Drug Safety, and the Quality Management and Product Safety Management Act from the Ministry of Trade, Industry and Energy. Government policies related to the national poisoning surveillance system that have been newly introduced or updated since the HHDT, focusing on the collection of data on chemical poisoning. Excluded was the lack of compliance by manufacturers, importers or distributors of HD to control the risk of HD to prevent consumer health risks.

Review of toxicovigilance systems pertinent to building a modern Korea PCC

A literature scoping review focused on trends and advancements in PCCs incorporating toxicovigilance systems internationally. Search terms included ‘toxicovigilance,’ ‘toxicological surveillance,’ and ‘poison control center,’ used individually and in various combinations. From a total of 69 reports, we identified and summarized 19 peer-reviewed studies that specifically examined PCCs with toxicovigilance systems in different countries (Table 1). Our review incorporated stand-alone government and URLs111213 as well as national PCC reports1415 with toxicovigilance systems, along with others sourced from PubMed, Google, Medline, etc. Based on the definition and scope of a toxicovigilance system described elsewhere,16 the performance of toxicovigilance systems established in selected countries, including the United States, United Kingdom, Canada, and Germany, was reviewed. The review extended to PCCs with toxicovigilance systems in New Zealand, Sweden, and Italy ascertained through a combination of online and offline meetings and email exchanges, as these country systems have not been formally documented in academic publications. The key findings regarding toxicovigilance in selected countries in terms of performance, framework, management and governance were as follows:

  • • Collection and standardization of information on toxic substances and clinical poisoning exposures and cases

  • • Mandatory and voluntary reporting of safety data sheets (SDSs) and potential poisoning cases

  • • Nationwide poisoning case detection

  • • Risk assessment of unusual poisoning cases

  • • Real-time alert system involving both regional and central government health authorities

  • • Targeted clinical follow-up of poisoned subgroups

Table 1

Literature review procedures aimed at selecting literature related to frameworks for recommending chemical poisoning surveillance within a toxicovigilance system

jkms-39-e178-i001
Step-by-step inclusion criteria for manuscripts No. of studies included Exclusion criteria
Literature searched using the term “toxicovigilance.” 272
Literature searched using the term “toxicovigilance” and “poison control center” 69
Literature with at least an abstract 61 Literature with only titles without even an abstract was excluded.
Literature on surveillance of poisoning within a toxicovigilance systema 19a Specific poisoning cases report, analysis of poisoning cases, the role of poison control center, pharmacovigilance or drug vigilance
aInclude peer-reviewed literature on databases of toxic and poisoning information, mandatory and voluntary reporting of chemical poisoning cases, real-time alert systems and risk assessment for abnormal poisoning incidents, collaboration between health organizations, and clinical follow-up of poisoned subgroups.
Details of the inclusion and exclusion criteria for toxicovigilance system studies are not provided because of their low relevance to the overall literature review (Table 1). The aim of the review is only to identify the main frameworks of toxicovigilance systems for the implementation and improvement of PCC functions in Korea and other countries.

RESULTS

Emergence of home HDs, the epidemic they caused, and their eventual ban

Several major chemical disinfectant products associated with HHDT, including SKY BIO 1125, SKY BIO FG, AKACID and Preventol R80, were manufactured in Korea or imported due to several shortcomings in chemical legislation (Table 2). HD products with polyhexamethylene guanidine (PHMG) phosphate led in causing HHDT, followed by those with oligo(2-(2-ethoxy)ethoxyethyl guanidinium, a mixture of methylchloroisothiazolinone (CMIT) and methylisothiazolinone (MIT), and benzalkonium chloride (BKC).5 Unregulated chemical disinfectants used as biocides in HD products from 1994 to 2011 were eventually identified as the cause of numerous poisonings. This HHDT epidemic grew due to lack of detection by the chemical poisoning prevention related to regulation and public health surveillance system for almost 15 years. After the association between HD and many fatal lung injuries in patients, initially suspected at the private Seoul Asan University Hospital, causality was confirmed in November 2011 by both epidemiological studies and animal experiments conducted by the KDCA.1718 Many HD products were subsequently banned and recalls were initiated to remove them from circulation.
Table 2

Disinfectant products as raw materials in HDs linked to health effects in Korea1

jkms-39-e178-i002
Name of disinfectant product Manufacturer Names and concentrations of disinfectant product Disinfectant level contained in HD product, % Disinfectant CAS number Usage period of HDa Total No. of HD products
SKY BIO 1125 SK Chemical PHMG phosphate 25% PHMG 0.5% 89697-78-9 1998–2011 8
SKYBIO FG SK Chemical A mixture of CMIT and MIT, 1% A mixture of CMIT (1–2.2%) and MIT (0.2–0.6 %) CMIT: 26172-55-4, MIT: 2682-20-4 1997–2011 14
AKACID Imported from Denmark PGH, 25% PGH 2% 374572-91-5 2009–2011 2
Peventol R80 Imported from Germany BKC 0.1% (1,000 ppm) BKC 0.08% (800 ppm) 8001-54-5 1996–2003 2
Key information in the table has been extracted and summarized from reference 1.
HD = humidifier disinfectants, PHMG = polyhexamethylene guanidine, CMIT = chloromethy isothiazolinone, MIT = methylisothiazolinone, PGH = oligo2-(2-ethoxy)ethoxyethyl guanidine chloride, BKC = benzalkonium chloride.
aBy the end of November 2011, the sale and marketing of HDs were legally prohibited and existing products were removed from the market due to the emergence of numerous humidifier disinfectant lung injury cases.

Legislative changes in Korea to prevent poisoning from household chemical products before and after HHDT

Korea’s Toxic Chemical Control Act (TCCA) of 1998 was the first legislation aimed at preventing poisoning from chemicals, including household chemicals. At the time, several HD products were already widely marketed from 1994 to 2011, when HHDT was discovered. Three major shortcomings of the TCCA with respect to managing health risks from chemicals used as disinfectants in HDs were identified by this study:

  • 1. It failed to require hazard assessments for certain chemicals, such as cationic PHMG, despite their potential inhalation risks;

  • 2. It allowed for adjustments in the application of disinfectants to humidifiers without the need for re-evaluation, despite in some cases the change in their earlier approved use as carpet disinfectants;

  • 3. It failed to require the registration of existing chemicals, such as CMIT, MIT and BKC.

The TCCA and the Pharmaceutical Affairs Act exempted HDs from both toxicity testing and product registration requirements.2 Industry was allowed to produce HD products without testing for toxicity, relying instead on industry to self-inspect in accordance with the Quality Management and Product Safety Management Act (Table 3). The KMOE failed to update key regulations for the control of hazardous chemicals, regulations that were fundamentally addressed in chemical-related legislation in the US and EU at the time.212223
Table 3

Overview of major acts enforced prior to the HD health tragedy in Korea for preventing health risks from household chemical products

jkms-39-e178-i003
Type of the regulations Competent authority The period of enforcement Critical shortcomings in mitigating health risks associated with HD usage
Toxic Chemical Control Acts19 Ministry of Environment 1991–2013a • PHMG and its categorization as a non-hazardous chemical due to its high molecular weight, which exempts it from hazard assessment
• No specific clauses to prevent the risk of PHMG and PGH with high cationic property
• CMIT, MIT, and BKC are not subject to hazard assessment because they are recognized as existing chemicals
• Permission is not required when the usage of products undergoes a change
Pharmaceutical Affairs Act20 Ministry of Food and Drug Safety 1996–presentb • HD products were not designated as a product other than medi-pharmacy items that require hazard assessment
Quality Management and Product Safety Management Act Ministry of Trade, Industry and Energy 1967–Jan, 2017b • Household chemical products including HD were designated as industrial products subject to pre-verification
HD = humidifier disinfectant, PHMG = polyhexamethylene guanidine, PGH = oligo2-(2-ethoxy)ethoxyethyl guanidine chloride, CMIT = chloromethyl isothiazolinone, MIT = methylisothiazolinone, BKC = Benzalkonium chloride.
aBolished in 2013 and transitioned to two enhanced chemical regulatory frameworks in Korea: The Consumer Chemical Products and Biocides Safety Control Act and the Act on Registration and Evaluation of Chemicals.
bFollowing the emergence of health effects associated with HDs, the prevention clauses for household chemical products were revised and consolidated into the Electrical Appliances and Consumer Products Safety Control Act.
Repeal of the TCCA in 201319 resulted in the integration of its regulatory framework and provisions into two separate laws: the Act on Registration and Evaluation of Chemicals (Korean REACH)24 in 2015 and the Consumer Chemical Products and Biocides Safety Control Act (CCPBSCA)25 in 2018. Korean REACH regulates chemical registration and risk assessment to protect public health and the environment, while the CCPBSCA aims to ensure public health and environmental protection by setting standards for chemicals with focus on biocides. This restructuring aimed to strengthen and refine oversight of chemicals and biocides, and to better align Korea’s regulations with international standards. The critical deficiencies in regulatory provisions to prevent and reduce health risks associated with chemicals, including disinfectants, prior to HHDT (Table 3), have all been revised in current or newly enacted regulations after HHDT. However, the KMOE still lacks a comprehensive centralized system for integrating and evaluating chemical exposure scenarios and SDSs, including toxicity information, provided by industry.

Chemical poisoning surveillance system

Existing government organizations, even those partially responsible for chemical poisoning detection, showed no direct or indirect progress in identifying poisoning cases after HHDT. Park et al.26 analyzed the role of nine Korean government organizations with a partial role in detecting chemical poisoning during the widespread use of HD and concluded that they failed to contribute to the detection and prevention of the HHDT, which had been accumulating for over a decade.26 Indeed, no significant improvements have been made to the national chemical poisoning surveillance system since the HHDT emerged.
In 2021, the Seoul Metropolitan Government established a regional PCC to monitor household chemical poisoning, but it doesn’t have a nationwide focus and doesn’t provide real-time advice to hospitals treating poisoning cases.27 Korea does not have a national poison center with at least one unit that provides advice and assistance in the prevention, diagnosis, and treatment of poisoning as defined by World Health Organization (WHO),13 although the Seoul PCC was listed as a regional center in 2023 by the WHO.28 In January 2023, a bill was submitted to the National Assembly to establish a Health Hazard Control Center within the KDCA, similar to a PCC.29 This was done as a late response to the HHDT. It emphasizes need for active involvement of government health agencies and establishment of a surveillance system for non-infectious poisoning. Specific details of the bill, the timeframe, and the methodology for implementation are not in place.

Latest trends in PCC and toxicovigilance in leading countries

Several countries have established PCCs with toxicovigilance capacities. Components typically include mandated toxic substance information reporting by industries, clinical poisoning reports, a centralized toxic substance database, real-time clinical case surveillance, and national interagency collaboration (Table 4). This review of high-quality PCC toxicovigilance systems in major countries identified key framework components for establishing a comparable nationwide Korea system (Table 5). It suggests that PCCs should monitor and identify poisonings from a wide range of sources, not only household chemicals but also commercial chemicals, foods, and pharmaceuticals.
Table 4

Summary of key functional frameworks for monitoring and managing chemical poisoning

jkms-39-e178-i004
Countries National toxic information management system National management of cases of clinical poisoning
SDS provision by industry Harmonized/standardized documentation Accessibility for the general public including physicians and PCC Existence of mandatory and optional reporting Harmonized/standardized documentation of poisoning cases Giving advice regarding the diagnosis and treatment of poisoning cases Prompt activation of poisoning warning alerts Involvement of central and local public health agencies
US153031 Mandatory NPDS Yes Yes NPDS Yes Yes NPDS, CDC, regional PCC, state and local public health departments
France31 Mandatory BNPC Yes Yes BNCI Yes Yes ARS, InVs
Germany32 Mandatory Yes Yes Decentralized/non-harmonized Yes BfR, PCC
Canada, Quebec31 Mandatory MADO Yes Yes MSSS
New Zealand333435 Mandatory TOXINZ: comprehensive poisoning database for treatment with key chemical information Yes Yes TOXINZ Yes Yes Many stakeholders in multiple sectors (health, law enforcement, customs/border protection, community organizations)
UK113637 Spontaneous TOXBASE, NPIS: comprehensive poisoning database for treatment Yes Yes TOXBASE, NPIS Yes The UKHSA RCE and PHS, the DHSC and PHE
Sweden Spontaneous NPC & ECHA database for PCN Yes Yes NPC Yes Yes, if needed The Swedish Chemicals Agency, Swedish Defense Research Agency and Public Health Agency of Sweden. Regional public health departments
Italy Mandatory ISS Yes Yes Decentralized/non-harmonized Yes Yes ISS, Ministry of Health
PCC = poison control center, NPDS = National Poison Data System, CDC = Centers for Disease Control and Prevention, BNPC = French National Products and Composition, BNCI = The National Bank for Commerce and Industry, ARS = Agence Régionale de Santé (rmfRegional Health Agencies), InVs = Institut de veille sanitaire (French Institute for Public Health Surveillance), BfR = Bundesinstitut für Risikobewertung (German Federal Institute for Risk Assessment), MADO = Maladies à déclaration obligatoire (notifiable diseases), MSSS = Ministère de la Santé et des Services (Ministry of Health and Social Services), NPIS = The National Poisons Information Service, UKHSA = the UK Health Security Agency, RCE = Radiation, Chemicals and Environmental Hazards Directorate, PHS = Public Health Scotland, DHSC = Department of Health and Social Care, PHE = Public Health England, NPC = Swedish National Poison Centre, ECHA = the European Chemicals Agency, PCN = product change notifications, ISS = Istituto Superiore di Sanità (National Institute of Health).
Table 5

Recommendations of the essential components for selected toxicovigilance in the future PCCs in Korea

jkms-39-e178-i005
Recommended key components Specific considerations for establishing a toxicovigilance system within the KDCA
Repository for national toxic information database • Consolidation of toxic information and SDSs that industries are legally required to register or report
• Harmonization and standardization of toxic information accessible to PCC, physicians, and the public
Establishment of PCC with toxicovigilance system • The establishment of a central PCC under the KDCA with multiple local PCCs for nationwide coverage
• Providing guidance on the diagnosis and treatment of poisoned patients and individuals exhibiting poisoning symptoms
• Real-time issuance of poisoning warning signals to local and central public health units
• Clinical follow-up of subgroup poisoned cases
• Require clinical toxicologists and specialists to provide guidance on the management and follow-up of poisonings
Reporting of poisoning cases • Reporting poisoning cases to the PCC by health professionals: mandatory, spontaneous, or incentive-based
National repository for cases of clinical poisoning • Continuous real-time collection, analysis, and dissemination of poisoning cases
• Harmonization and standardization of clinical poisoning information accessible to physicians and the public
Collaboration between central and local public health units with central and regional PCC • Early detection of anomalous poisonings based on timely risk assessment and analysis of national repository database
• Rapid removal of products causing anomalous poisoning
PCC = poison control center, KDCA = Korea Disease Control and Prevention Agency, SDS = safety data sheet.

DISCUSSION

The HHDT prompted Korea to revise and create laws and policies to improve chemical safety and poison prevention. However, Korea still does not have a centralized system for systematically collecting and analyzing data on chemical toxicity and poisonings. A bill proposing to create PCCs within the DCA does not meet the standards of advanced PCC toxicovigilance systems or WHO recommendations.13 This study strongly recommends establishing a national PCC with toxicovigilance system framework capable of early detection, national coordination, and long-term surveillance (Table 5) based on successful sustainable PCCs internationally (Table 4) with five key components.

  • 1. Databases of toxic substances and poisoning cases. Given Korea’s geographic size, population density, capacity for effective rapid public health communication, and high-quality medical services, centralized standardized databases of toxicological information and clinical poisoning cases must be established. Currently, collection of toxicological data on chemicals and product ingredients legally-required by industry overseen by MOE38 and Ministry of Employment and Labor is fragmented, not standardized, and not publicly accessible. This information must become openly accessible. Lack of detailed health-related information on chemical-based consumer products, such as hazardous ingredients, warnings, and emergency guidelines, often leaves both consumers and medical professionals without essential data to quickly identify, treat and mitigate poisoning. Creation of a robust toxic substances database should be independently accessible not only to individual healthcare providers, hospitals and employers, but also to all citizens, regardless of the presence of a PCC. Databases in Korea of HD poisonings apparently still lack standardization regarding HD chemical use characteristics, demographics, and clinical features. For future poisonings, a centralized toxicology database offering real-time, 24/7 tele-consultation with toxicologists and clinicians would provide immediate, reliable guidance to health professionals and the public, improving medical management while alerting authorities to emerging threats. The US American Association of Poison Control Centers’ National Poison Data System (NPDS), central to their PCC network, catalogues more than 466,000 products and has recorded 77 million cases of human poisoning since 1985, including 2 million cases in 2022 from all 55 US PCCs.3940 The NPDS supports early hazard identification, safety adjustments and risk reduction by tracking data on poisoning cases, outcomes and interventions.1530 It uses real-time data analysis against a decades-long historical record.41 By comparison, the main objectives of the UK TOXBASE® and New Zealand TOXINZ are electronic textbooks on how to identify the main symptoms of patients with exposures/poisonings and how to treat them promptly, and provide basic toxicological information by chemical or product ingredient.35 Acceptance of UK’s TOXBASE has reduced need for telephone advice, allowing resources to be redirected to improve its electronic database.42 New Zealand’s National PCC team’s TOXINZ provides more than 120,000 documents offering a wide range of information on symptoms and treatment on many chemicals, pharmaceuticals, household products and plants. National databases on chemical exposure and poisoning can vary widely country to country, but essentially serve as emergency information services.

  • 2. Reporting of potential poisoning incidents. Mandatory and voluntary reporting systems must be established to effectively collect various suspected chemical poisoning cases. Korea lacks both reporting systems and a dedicated organization to collect data on poisoning cases involving substances, including chemicals. National surveillance practices for collecting poisoning cases vary, with some countries requiring health care professionals to report to PCCs or other authorities, and laws varying on which poisonings must be reported or permitted. Balancing the ethical health principles of beneficence, non-maleficence, justice and autonomy with an emphasis on shared decision-making is critical in these situations. 43 In places such as the EU,44 France,43 Canada and its French Quebec,43 and Australia,45 it is standard practice for health professionals to report suspected chemical poisonings to PCCs. German chemicals act requires physicians to share critical poisoning data with its Centre for Documentation and Evaluation of Poisonings at the Federal Institute for Risk Assessment.40 There are countries with legal requirements to report only high-risk “listed” poisonings. New Zealand requires reporting certain poisoning scenarios to the local health unit under the Health Ministry’s Notifiable Diseases Regulations, such as lead absorption and poisoning due to chemical contamination of the environment etc. where a common source is suspected or from a person in a high-risk category.43 US physicians are required to report some poisoning types, including lead, carbon monoxide, foodborne illnesses, and certain occupational exposures to hazardous substances and pesticide poisonings. These vary state-to-state.4346

  • 3. Real-time poisoning monitoring. Establishment of nationwide, real-time public health poisoning surveillance is essential for the rapid early detection and management of poisoning events. Toxicologic surveillance, critical for identifying hidden events and national trends, requires early detection of subtle population-level illnesses or deaths, and efficient interpretation for timely public health interventions.47 One challenge is to detect rare chemical or poison incidents amidst normal life without generating false alarms.48 In low- and middle-income countries, PCCs if they exist face big challenges in formal training, sampling and laboratory services, accessing toxicological information, and treatment capability. To better fulfil their public health mission, such centers need help to strengthen and expand key functions in population toxicological surveillance, environmental health monitoring, and rapid poison control capability, to address current and future toxicological concerns.49 If Korea has a national PCC with toxicovigilance, it can play a critical role in liaising with neighboring nations who have yet to improve their own toxicovigilance capabilities if there is potential for the same danger or epidemic to spread.

  • 4. Inter-agency and public health event communication. Establishing a collaborative system between the KDCA and relevant central and local government agencies will help create a toxicovigilance system with real-time early detection and prompt containment of poisoning events. The system could, for example, adopt key features of the US Centers for Disease Control and Prevention’s NPDS for centralized data collection and New Zealand’s National Poisons Centre. Together they provide 24/7 services and engage in toxicovigilance with cross-sector collaboration (including health, law enforcement, and community organizations).50 This approach could effectively detect significant poisoning events and improves emergency response by facilitating communication with health authorities. 51

  • 5. PCC with toxicovigilance. Establishment of a PCC with toxicovigilance system is essential for Korea's national and international harmonization on toxic substances and poison prevention. Waring et al.52 and others highlighted the need for a global network of poison centers and an international toxicological surveillance program. The United Nations (UN) WHO has published recent baseline standards for member states to establish national PCCs.13 Korea can benefit by adopting and adapting experience and technologies from international partners, such as the European Association of Poison Centers and Clinical Toxicologists and the WHO’s INTOX, which links experts worldwide to improve public health responses to chemical hazards.53 The key to collecting toxic information and poisoning cases is to create a standardized database of them to improve networking among existing poison centers.48

This study reviewed the main frameworks of PCC toxicovigilance systems among countries, which exhibit variations across different timeframes and national priorities (Table 4). It did not review the additional components for a PCC system that should ideally also include regulations and policies, education for health workers and the public, physical centers with qualified staff, toxicology laboratory, public alert and risk communication capacity, and evaluation and quality improvement.13 In addition, the study acknowledges the limited research focused on the clinical care of vulnerable populations, such as children and pregnant women, and emphasizes that their specific needs cannot be adequately addressed by animal or epidemiological studies alone. The strengths of this study lie in identifying key components of toxicovigilance frameworks by analyzing HHDT incidents in Korea and reviewing toxicovigilance operations in selected countries, providing insights for the development and improvement of advanced PCC toxicovigilance systems.

CONCLUSIONS

The Korean people’s HHDT suffering and epidemic over the last 30 years revealed a critical need for Korea to strengthen its laws and policies on hazardous substance controls and to establish a national state-of-the-art PCC system with toxicovigilance capacity in line with the UN WHO basic recommendations and the practices of other high-quality international PCC systems. Five key components for a first-ever national Korean PCC system with toxicovigilance framework are recommended: centralized toxic information and clinical poisoning databases; mandatory and permissive reporting of potential poisoning cases; real-time poisoning monitoring; clinical follow-up tailored to specific poisoning groups; and a robust modern PCC system itself. A new national PCC system with toxicovigilance as recommended by this study would help neighboring countries seeking to establish their own state-of-the-art, internationally integrated PCC system, effectively building regional alliances.

ACKNOWLEDGMENTS

The authors express special thanks to Adam Pomerleau MD, National Poisons Centre (New Zealand) and Peter Hultén, Swedish Poisons Information Center (Sweden) for providing national information on the toxicovigilance system.

Notes

Disclosure: The authors have no potential conflicts of interest to disclose.

Author Contributions:

  • Conceptualization: Park DU.

  • Data curation: Park DU.

  • Formal analysis: Park DU, Gassert TH, Zoh KE.

  • Methodology: Park DU.

  • Resources: Park DU, Sesana FM, Lee DY, Park S.

  • Supervision: Park DU.

  • Validation: Park DU, Gassert TH, Zoh KE.

  • Visualization: Park DU.

  • Writing - original draft: Park DU.

  • Writing - review & editing: Park DU, Gassert TH, Zoh KE, Sesana FM, Lee DY, Park S, Yoon SY.

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