Drug Safety最新文献

{"title":"Incidence of Idiosyncratic Drug-Induced Liver Injury Caused by Prescription Drugs.","authors":"Vincent L Chen, Don C Rockey, Einar S Bjornsson, Huiman Barnhart, Jay H Hoofnagle","doi":"10.1007/s40264-024-01486-6","DOIUrl":"10.1007/s40264-024-01486-6","url":null,"abstract":"<p><strong>Background: </strong>The incidence of drug-induced liver injury (DILI) is not known for most prescription medications. We aimed to estimate the incidence of DILI for commonly prescribed outpatient drugs.</p><p><strong>Methods: </strong>To establish a baseline estimate of DILI incidence, we used the estimated incidence (EI) of amoxicillin/clavulanate DILI from a previous population-based study in Iceland. This was combined with the multicenter prospective DILI Network (DILIN) cohort and the US population-based Medical Expenditure Panel Survey (MEPS). From 2005 to 2019, prescription drugs with at least five bona fide DILIN cases and data from at least 10 of the 15 years from MEPS during that timeframe were included. The EI for 'drug A' was calculated as follows: <math><mrow><mtext>EI</mtext> <mrow><mo>(</mo> <mtext>drug A</mtext> <mo>)</mo></mrow> <mo>=</mo> <mtext>EI</mtext> <mfenced><mtext>AC</mtext></mfenced> <mo>×</mo> <mfrac><mrow><mo>#</mo> <mspace></mspace> <mtext>DILIN cases of drug A</mtext></mrow> <mrow><mo>#</mo> <mspace></mspace> <mtext>annual new prescriptions of drug A</mtext></mrow> </mfrac> <mo>×</mo> <mfrac><mrow><mo>#</mo> <mspace></mspace> <mtext>annual new prescriptions of AC</mtext></mrow> <mrow><mo>#</mo> <mspace></mspace> <mtext>DILIN cases of AC</mtext></mrow> </mfrac> </mrow> </math> RESULTS: In total, 30 drugs met the inclusion criteria, of which 11 were antibiotics, 4 were antiepileptic drugs (AEDs), 4 were statins, and 11 were other drug types. The highest EI was seen with azathioprine and older AEDs, with one DILI case per 349-2329 new prescriptions. The EI of antibiotics ranged greatly, with the highest risk seen for minocycline, amoxicillin/clavulanate, and nitrofurantoin (approximately 1:1000-2400 new prescriptions), and lowest risk for clindamycin, doxycycline, azithromycin, and amoxicillin (approximately 1:40,000-170,000 new prescriptions). The EI for commonly prescribed statins was approximately 1:10,000-50,000. Important medication classes with > 5 million new prescriptions from 2005 to 2019 but fewer than five DILIN cases included β-blockers, thiazide diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, selective serotonin reuptake inhibitors, and metformin, which presumably have very low DILI incidence.</p><p><strong>Conclusions: </strong>The highest EI was found for azathioprine, older antiepileptics, and minocycline. In contrast, many widely used drugs are rare causes of DILI. These findings may help clinicians better weigh potential benefits of medications against hepatotoxicity risk.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343748","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Use of Multiple Medications During Pregnancy Among an Ethnically Diverse Population in South-Eastern Melbourne: A Retrospective Analysis to Explore Potential Risks and Complications.","authors":"Yitayeh Belsti, Aya Mousa, Hannah Jackson, Lisa J Moran, Kirsten R Palmer, Raja Ram Dhungana, Emily Callander, Daniel Lorber Rolnik, Helena Teede, Joanne Enticott","doi":"10.1007/s40264-024-01482-w","DOIUrl":"https://doi.org/10.1007/s40264-024-01482-w","url":null,"abstract":"<p><strong>Background and objective: </strong>Medication use is increasing to treat both pre-existing and pregnancy-related medical conditions or complications. This study aims to investigate factors associated with multiple medication use during pregnancy, as well as any increased risk of pregnancy complications for women taking multiple medications.</p><p><strong>Methods: </strong>A retrospective analysis of routinely collected medical records of singleton pregnant women was conducted in Southeast Melbourne, Australia, between 2016 and 2021. Self-reported medication use was recorded as part of routine medical care, starting from the first antenatal booking appointment and continuing for every subsequent antenatal appointment until birth. Multimorbidity was defined as having two or more medical conditions. Logistic regression was used to assess factors influencing multiple medication use (defined as taking two or more non-supplemental medications at any stage of pregnancy) and associations with pregnancy complications.</p><p><strong>Results: </strong>Of 48,502 participants, 34.9% used one medication, while 11.7% used multiple medications. Women of older age (30-34, 35-39, and ≥  40 years), higher body mass index (25.0-29.9 kg/m² and ≥  30 kg/m²), born in Australasia and Oceania, higher socioeconomic status, and multimorbidity were more likely to use multiple medications during pregnancy. Women taking multiple medications had a higher risk of preterm and caesarean deliveries, fetal death, and neonatal admissions to intensive care. Sensitivity analyses exploring different morbidity categories produced no changes to findings.</p><p><strong>Conclusions: </strong>Medication use during pregnancy is prevalent, with many pregnant mothers taking multiple medications. Given the rising maternal age, body mass index, and morbidities in pregnancy, the use of medications during pregnancy is increasing. Such use correlates with an increased chance of adverse pregnancy outcomes. In the context of limited trials on the safety and efficacy of medications in pregnancy, timely harnessing of the information available within routine medical records for post-marketing surveillance is important.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups.","authors":"Victor Pera, Jan A Kors, Erik M van Mulligen, Marcel de Wilde, Peter R Rijnbeek, Katia M C Verhamme","doi":"10.1007/s40264-024-01478-6","DOIUrl":"https://doi.org/10.1007/s40264-024-01478-6","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;While medication errors (MEs) have been studied in the European Medicines Agency's EudraVigilance, extensive characterisation and signal detection based on sexes and age groups have not been attempted.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;The aim of this study was to characterise all ME-related individual case safety reports in EudraVigilance and explore notable signals of disproportionate reporting (SDRs) among sexes and age groups for the 30 most frequently reported drugs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Individual case safety reports were used from EudraVigilance reported between 2002 and 2021. An ME was defined as any Preferred Term from the narrow Standardised Medical Dictionary for Regulatory Activities&lt;sup&gt;®&lt;/sup&gt; Query. Signals of disproportionate reporting were selected based on a lower boundary of the 95% confidence interval ≥ 1 of the reporting odds ratio, and at least 3 individual case safety reports. Analysed subgroups were female individuals, male individuals, and age groups 0-1 month, 2 months to 2 years, 3-11 years, 12-17 years, 18-64 years, 65-85 years, and &gt;85 years. Heatmaps were utilised as a visual aid to identify striking SDRs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of the 9,662,345 EudraVigilance reports, 267,262 (2.8%) contained at least one ME, with a total of 300,324 MEs, for 429,554 drugs. The most reported ME was \"Inappropriate schedule of product administration\" (52,646; 17.5%), followed by \"Incorrect dose administered\" (32,379; 10.8%) and \"Wrong technique in product usage process\" (26,831; 8.9%). Individual case safety reports with MEs were most frequently related to female individuals (148,009; 55.4%), most often submitted by healthcare professionals (155,711; 58.3%), originated predominantly from the USA (98,716; 36.9%), followed by France (26,678; 10.0%), and showed a median reported age of 50 years (interquartile range: 26-68). Most ME individual case safety reports (158,991; 59.5%) were associated with a serious health outcome. A total of 847 SDRs were identified, based on the entire EudraVigilance database; for subgroups, the number of SDRs ranged from 84 for the age group 0-1 month to 749 for female individuals. Signals of disproportionate reporting for female individuals and male individuals were very similar. Most MEs were reported for the vaccine against human papillomavirus (Anatomical Therapeutic Chemical [ATC]: J07BM01; 11,086 MEs, 57% being \"inappropriate schedule of product administration\"), with reporting odds ratios that range from 1.5 to 47.0 among age groups. The SDR for the live-attenuated vaccine against herpes zoster (ATC: J07BK02) had a reporting odds ratio that ranged from 26.6 to 78.1 among all subgroups. Signals of disproportionate reporting for oxycodone (ATC: N02AA05; 847 cases of \"Accidental overdose\", 35%), risperidone (ATC: N05AX08; 469 cases \"Inappropriate schedule of product administration\", 22.3%) and rivaroxaban (ATC: B01AF01; 1,377 cases of \"Incorrect dose ad","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacovigilance in the Age of Legalized Cannabis: Using Social Media to Monitor Drug–Drug Interactions Between Immunosuppressants and Cannabis-Derived Products","authors":"Matthew R. Allen, Gwenyth Portillo Wightman, Zechariah Zhu, Adam Poliak, Davey M. Smith, Mark Dredze, John W. Ayers","doi":"10.1007/s40264-024-01481-x","DOIUrl":"https://doi.org/10.1007/s40264-024-01481-x","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>A clinical trial of Epidiolex^®, the only US FDA-approved cannabis-derived consumer product (CDP), discovered an interaction with an immunosuppressant (tacrolimus) that led to drug toxicity, highlighting the unique intersection of prescription and commonly unregulated consumer products.</p><h3 data-test=\"abstract-sub-heading\">Objective</h3><p>We aimed to identify if similar drug–drug interactions (DDIs) are occurring among the consumer CDP market, even though they cannot be identified through trials.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>We searched Reddit for subreddits related to CDPs or health, resulting in 63,561,233 posts. From these, we identified 190 posts discussing both immunosuppressants and CDPs. Two blinded investigators evaluated the following. (1) Was there a concern about a potential DDI between consumer CDPs and immunosuppressants? (2) Was there a unique adverse event attributed to a DDI between consumer CDPs and immunosuppressants?</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Of these, 66 posts (35%) expressed concern about a potential DDI, such as <i>“Hey, my partner wants to try my edibles … she’s on Prograf [tacrolimus] and wants to talk to a stoner who’s had a heart transplant.”</i> Four posts (2%) reported a unique DDI, such as <i>“I have clinical results that are semi-anecdotal, showing the coordination to my halting substance use … It's the CBD. Shot my prograf to 30 at like 4 mg.”</i> Two of the four reported DDIs are similar to those first reported for Epidiolex. The remaining two reported DDIs include a potential cannabidiol (CBD)/sirolimus or delta-9-tetrahydrocannabinol (THC)/sirolimus interaction and a THC/tacrolimus interaction, both resulting in drug toxicity.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>This case study is the first to report on DDIs involving consumer CDPs, including both CBD and THC products, as well as a broader class of immunosuppressants. This demonstrates the risks associated with using consumer CDPs alongside prescription medications while highlighting the need for development of increased surveillance to monitor consumer CDPs for drug safety signals, as well as comprehensive regulations that take into account the unique characteristics of the consumer marketplace.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142266374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"23rd ISoP Annual Meeting \"Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics\" 1-5 October 2024 Montreal, Canada.","authors":"","doi":"10.1007/s40264-024-01477-7","DOIUrl":"https://doi.org/10.1007/s40264-024-01477-7","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142266375","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug-Induced Hypouricemia","authors":"Chaker Ben Salem, Myriam Agrebi, Dhouha Sahnoun, Neila Fathallah, Houssem Hmouda","doi":"10.1007/s40264-024-01485-7","DOIUrl":"https://doi.org/10.1007/s40264-024-01485-7","url":null,"abstract":"<p>Hypouricemia is defined as a serum uric acid concentration of ≤ 2.0 mg/dL or 119 μmol/L. Hypouricemia may occur secondarily to a number of underlying conditions, including severe hepatocellular disease, neoplasia, defective renal tubular reabsorption of uric acid, inherited metabolic defect in purine metabolism, and drugs. Medications are an important cause of hypouricemia. They can cause hypouricemia by a variety of mechanisms. Drug-induced hypouricemia mostly occurs as overtreatment of hyperuricemia by urate-lowering therapies including xanthine oxidase inhibitors, uricosuric agents and uricases. Drugs not used in the treatment of gout may also lead to a decrease of uric acid levels. In this literature review, medications leading to hypouricemia are summarized with regard to their mechanism of action and clinical significance.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142266373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Qualitative Interviews with Stakeholders in Herbal Pharmacovigilance and Recommendations for Best Practices to be Applied Worldwide","authors":"Corine Ekhart, Sjoerd H. P. Wiarda, Sonja van de Koppel, Souad Skalli, Waad Alghamdi, Francesca Menniti-Ippolito, Kunwarang Tangchitkhachon, John Samson Mponda, Herman J. Woerdenbag, Florence van Hunsel","doi":"10.1007/s40264-024-01480-y","DOIUrl":"https://doi.org/10.1007/s40264-024-01480-y","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background and Objective</h3><p>The use of herbal products globally is substantial, but varying definitions and regulatory frameworks have led to differences in their status as medicinal products and in approaches to monitoring their safety. This article explores the current landscape of herbal pharmacovigilance, drawing insights from interviews with global experts in the field, and offers recommendations for best practices to enhance the safety and benefit-to-harm balance of herbal products.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>This study comprised semi-structured interviews with members of the International Society of Pharmacovigilance-Herbal and Traditional Medicines Special Interest Group and the Nutrivigilance Information Exchange Network, recruited using purposive sampling. Data were stored and coded using NVIVO^® and analysed thematically using a qualitative inductive approach.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Sixteen participants from 11 countries were interviewed, revealing diverse regulatory approaches and challenges in herbal pharmacovigilance. Key themes included legal status, awareness, identification and coding of herbal products, pre-/post-marketing product control, reporting of adverse drug reactions, causality assessment and signals of herbal products. This study yielded five general recommendations to further improve herbal pharmacovigilance worldwide.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>This study offers an overview of the global landscape of herbal pharmacovigilance, highlighting challenges in monitoring herbal products and presenting universal recommendations. These recommendations encompass increasing awareness, enhancing education and improving legislative frameworks. Given the growing use of herbal products, the implementation of strong pharmacovigilance practices is crucial to ensure consumer safety.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142200715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure","authors":"Martin F. Casey, Joy Hallmark, Patricia P. Chang, Jo E. Rodgers, Aakash Mehta, Srihari V. Chari, Preston Skersick, Thomas Bohrmann, Parag Goyal, Michelle L. Meyer","doi":"10.1007/s40264-024-01479-5","DOIUrl":"https://doi.org/10.1007/s40264-024-01479-5","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background</h3><p>Use of heart failure-exacerbating medications (HFEMs) may lead to preventable episodes of acute decompensated heart failure (HF). HFEMs use is common in patients with HF, and there may be opportunities to reduce their use from the emergency department (ED).</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>We performed an observational study on patients with HF presenting to EDs within a healthcare system between 1 January 2016 and 31 December 2020. Patients with chronic HF were identified using diagnostic codes within the electronic health record. The cohort was restricted to ambulatory (i.e., discharged to home) ED encounters. Medications, either ordered in the ED or prescribed at ED discharge, were extracted from the medication administration record and identified as potential HFEMs based on the 2016 American Heart Association Scientific Statement. Descriptive statistics were used to summarize the prevalence of HFEM use during ambulatory ED encounters. Exploratory analyses to identify correlates of HFEM use were performed.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>The study cohort included 23,907 ED encounters. ED administration or prescription of HFEMs occurred during 20% of ambulatory ED encounters. HFEM administration in the ED (17%) was more common than HFEM prescription at ED discharge (6%). The most common HFEMs administered in the ED included nonsteroidal anti-inflammatory drugs (11%) and albuterol (7%).</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>HFEM use is common in patients with HF seeking ED care, occurring in roughly one-fifth of ambulatory ED encounters. There may be opportunities to optimize medication use among patients with HF in the ED.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142200716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiovascular Safety of Romosozumab Compared to Commonly Used Anti-osteoporosis Medications in Postmenopausal Osteoporosis: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials.","authors":"Shih-Hao Cheng, William Chu, Wen-Hsiang Chou, Woei-Chyn Chu, Yi-No Kang","doi":"10.1007/s40264-024-01475-9","DOIUrl":"https://doi.org/10.1007/s40264-024-01475-9","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this study was to investigate the cardiovascular safety of romosozumab in postmenopausal women with osteoporosis. Romosozumab, a monoclonal antibody targeting sclerostin, has been shown to increase bone mineral density and reduce the risk of osteoporotic fractures. However, in previous studies, romosozumab therapy was identified as a potential risk factor for cardiovascular events, particularly in patients with predisposing cardiovascular disease.</p><p><strong>Methods: </strong>A systematic literature search was performed in the Cochrane Library, Embase, PubMed, and Web of Science databases to identify randomized controlled trials (RCTs) comparing the safety and efficacy of romosozumab versus alendronate, teriparatide, denosumab, or placebo in postmenopausal women with osteoporosis. Contrast-based network meta-analysis was performed using a random-effects model. The pooled estimates are presented as risk ratios with 95% confidence intervals.</p><p><strong>Results: </strong>Of the 5282 articles retrieved, 25 RCTs were included in this review (n = 24,942), and 18 randomized controlled trials (n = 16,777) were included in the network meta-analysis. The results indicated no significant differences in cardiovascular mortality rate between romosozumab and placebo. Regarding the risk of major cardiovascular events, no significant differences were found in the direct evidence or the network meta-analysis with placebo as the reference.</p><p><strong>Conclusion: </strong>Romosozumab might be a safe option for treating postmenopausal women with osteoporosis. The cardiovascular concerns associated with this treatment seem less significant than previously suggested, although additional real-world data are required to confirm this conclusion.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125149","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre.","authors":"Annabelle S Chidiac, Nicholas A Buckley, Firouzeh Noghrehchi, Rose Cairns","doi":"10.1007/s40264-024-01472-y","DOIUrl":"https://doi.org/10.1007/s40264-024-01472-y","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}