Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre.

IF 4 2区医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-12-01 Epub Date: 2024-09-02 DOI:10.1007/s40264-024-01472-y

Annabelle S Chidiac, Nicholas A Buckley, Firouzeh Noghrehchi, Rose Cairns

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Abstract

Introduction: Paracetamol dosing errors can cause acute liver injury, with potentially toxic doses only slightly above the therapeutic range. This study aimed to characterise unintentional paracetamol overdose reported to an Australian poisons centre, including time trends, demographics, types of dosing errors, and outcomes.

Methods: Records regarding paracetamol dosing errors for individuals aged ≥12 years were extracted from the New South Wales Poisons Information Centre database, January 2017 to June 2023. Data from 2021 underwent an in-depth screening of free text case notes to examine: dose, duration, products involved, reasons for ingestion and outcomes including hospitalisation, treatment, liver transplantations and deaths. Where possible, complete outcome data were obtained from medical records of New South Wales hospitalised cases in 2021.

Results: There were 14,380 exposures due to paracetamol dosing errors (predominantly self-administered, median age 43 years, 62.6% female), with an average yearly increase of 2.5% (95% CI 1.6-3.8%; p < 0.0001). The in-depth analysis of exposures recorded during 2021 revealed 1899 exposures (median age 46 years, 63.4% female) with 26.8% requiring hospitalisation. Immediate- and modified-release formulations were highly implicated. Multiple paracetamol-containing products were ingested in approximately 20% of exposures. Hospitalised exposures were associated with paracetamol use for dental pain and ingested higher doses for longer durations. Over half of those hospitalised (52%) were treated with the antidote (N-acetylcysteine), and 6% of exposures developed hepatotoxicity.

Conclusion: Paracetamol dosing errors continue to occur, with relatively high rates of hospitalisation and liver injury. Many hospitalisations involved use for dental pain. Possible preventative measures include ingredient name prominence and increased education on appropriate dosing.

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12 岁及以上人群中的扑热息痛剂量错误：对澳大利亚毒药信息中心收到的 14,000 多例报告的分析。

简介扑热息痛用药错误可导致急性肝损伤，其潜在毒性剂量仅略高于治疗范围。本研究旨在了解澳大利亚毒物中心接报的扑热息痛意外过量的特点，包括时间趋势、人口统计学、给药错误类型和结果：从新南威尔士州毒药信息中心数据库中提取了2017年1月至2023年6月期间年龄≥12岁的人的扑热息痛用药错误记录。对 2021 年的数据进行了深入的自由文本病例记录筛选，以检查：剂量、持续时间、涉及的产品、摄入原因以及包括住院、治疗、肝移植和死亡在内的结果。在可能的情况下，从 2021 年新南威尔士州住院病例的医疗记录中获取了完整的结果数据：共有 14,380 例因扑热息痛剂量错误（主要为自行用药，中位年龄为 43 岁，62.6% 为女性）而导致的暴露，平均每年增加 2.5% (95% CI 1.6-3.8%; p < 0.0001)。对 2021 年期间记录的暴露情况进行的深入分析显示，共发生 1899 次暴露（中位年龄为 46 岁，63.4% 为女性），其中 26.8% 需要住院治疗。速释和改良释放制剂受到的影响较大。在约 20% 的暴露事件中，摄入了多种含扑热息痛的产品。住院患者多因牙痛而服用扑热息痛，且服用剂量较大、持续时间较长。超过一半的住院患者（52%）接受了解毒剂（N-乙酰半胱氨酸）治疗，6%的接触者出现了肝中毒：结论：扑热息痛用药错误仍时有发生，住院率和肝损伤率相对较高。许多住院治疗涉及牙痛。可能的预防措施包括突出成分名称和加强适当剂量的教育。

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来源期刊

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.