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Incidence of Idiosyncratic Drug-Induced Liver Injury Caused by Prescription Drugs. 处方药引起的偶发性药物性肝损伤的发生率。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-24 DOI: 10.1007/s40264-024-01486-6
Vincent L Chen, Don C Rockey, Einar S Bjornsson, Huiman Barnhart, Jay H Hoofnagle

Background: 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.

Methods: 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: EI ( drug A ) = EI AC × # DILIN cases of drug A # annual new prescriptions of drug A × # annual new prescriptions of AC # DILIN cases of AC 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.

Conclusions: 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.

背景:大多数处方药的药物性肝损伤(DILI)发生率尚不清楚。我们旨在估算门诊常用处方药的 DILI 发生率:为了确定 DILI 发生率的基线估计值,我们使用了之前在冰岛进行的一项基于人群的研究得出的阿莫西林/克拉维酸 DILI 估计发生率 (EI)。这与多中心前瞻性 DILI 网络 (DILIN) 队列和美国基于人口的医疗支出面板调查 (MEPS) 相结合。从 2005 年到 2019 年,至少有五例真正的 DILIN 病例的处方药以及该时间段内 MEPS 15 年中至少 10 年的数据都被纳入其中。药物 A "的 EI 计算如下:EI ( 药物 A ) = EI AC × # 药物 A 的 DILIN 病例数 # 药物 A 的年度新增处方数 × # AC 的年度新增处方数 # AC 的 DILIN 病例数 结果:共有 30 种药物符合纳入标准,其中 11 种为抗生素,4 种为抗癫痫药物 (AED),4 种为他汀类药物,11 种为其他类型药物。硫唑嘌呤和较老的 AEDs 的 EI 最高,每 349-2329 个新处方中就有一个 DILI 病例。抗生素的 EI 差别很大,米诺环素、阿莫西林/克拉维酸和硝基呋喃妥因的风险最高(约为新处方的 1:1000-2400 倍),而克林霉素、强力霉素、阿奇霉素和阿莫西林的风险最低(约为新处方的 1:40000-170000 倍)。常用他汀类药物的 EI 约为 1:10000-50000。从 2005 年到 2019 年,新处方超过 500 万张但 DILIN 病例少于 5 例的重要药物类别包括 β 受体阻滞剂、噻嗪类利尿剂、血管紧张素转换酶抑制剂、血管紧张素受体阻滞剂、选择性血清素再摄取抑制剂和二甲双胍,这些药物的 DILI 发生率可能非常低:硫唑嘌呤、较老的抗癫痫药和米诺环素的 EI 最高。相比之下,许多广泛使用的药物很少导致 DILI。这些发现有助于临床医生更好地权衡药物的潜在益处与肝毒性风险。
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引用次数: 0
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. 墨尔本东南部不同种族人群在怀孕期间使用多种药物的情况:探索潜在风险和并发症的回顾性分析。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-20 DOI: 10.1007/s40264-024-01482-w
Yitayeh Belsti, Aya Mousa, Hannah Jackson, Lisa J Moran, Kirsten R Palmer, Raja Ram Dhungana, Emily Callander, Daniel Lorber Rolnik, Helena Teede, Joanne Enticott

Background and objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

背景和目的:越来越多的妇女使用药物来治疗原有的和与妊娠有关的疾病或并发症。本研究旨在调查与孕期多次用药相关的因素,以及服用多种药物的妇女发生妊娠并发症的风险是否会增加:方法:2016 年至 2021 年期间,在澳大利亚墨尔本东南部对常规收集的单胎孕妇医疗记录进行了回顾性分析。作为常规医疗护理的一部分,从首次产前预约开始,并在随后的每次产前预约中记录自我报告的药物使用情况,直至分娩。多病的定义是患有两种或两种以上的疾病。采用逻辑回归法评估多种药物使用的影响因素(定义为在妊娠的任何阶段服用两种或两种以上非补充性药物)以及与妊娠并发症的关系:在 48 502 名参与者中,34.9% 使用一种药物,11.7% 使用多种药物。年龄较大(30-34 岁、35-39 岁和≥40 岁)、体重指数较高(25.0-29.9 kg/m2 和≥30 kg/m2)、出生在澳大拉西亚和大洋洲、社会经济地位较高和患有多种疾病的妇女更有可能在怀孕期间使用多种药物。服用多种药物的妇女早产、剖腹产、胎儿死亡和新生儿入住重症监护室的风险较高。对不同发病率类别进行的敏感性分析没有改变研究结果:结论:孕期用药非常普遍,许多孕产妇服用多种药物。鉴于孕产妇年龄、体重指数和孕期发病率的上升,孕期用药量也在增加。孕期用药会增加不良妊娠结局的发生几率。在妊娠期用药安全性和有效性试验有限的情况下,及时利用常规医疗记录中的信息进行上市后监测非常重要。
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引用次数: 0
Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups. EudraVigilance 中用药错误的比例失调分析和特征描述:探讨性别和年龄组的调查结果。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-19 DOI: 10.1007/s40264-024-01478-6
Victor Pera, Jan A Kors, Erik M van Mulligen, Marcel de Wilde, Peter R Rijnbeek, Katia M C Verhamme
<p><strong>Background: </strong>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.</p><p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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<sup>®</sup> 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 >85 years. Heatmaps were utilised as a visual aid to identify striking SDRs.</p><p><strong>Results: </strong>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
背景:虽然欧洲药品管理局的 EudraVigilance 对用药错误(ME)进行了研究,但尚未尝试根据性别和年龄组进行广泛的特征描述和信号检测:本研究旨在描述 EudraVigilance 中所有与 ME 相关的个体病例安全报告的特征,并针对 30 种最常报告的药物,探讨不同性别和年龄组之间显著的报告比例失调(SDR)信号:方法:使用 EudraVigilance 在 2002 年至 2021 年间报告的单个病例安全报告。ME被定义为狭义的《监管活动标准化医学词典》(Standardised Medical Dictionary for Regulatory Activities® Query)中的任何首选术语。根据报告几率比的 95% 置信区间下限≥ 1 且至少有 3 份个体病例安全报告,选出报告比例失调的信号。分析的亚组包括女性个体、男性个体以及年龄组:0-1 个月、2 个月至 2 岁、3-11 岁、12-17 岁、18-64 岁、65-85 岁和大于 85 岁。利用热图作为视觉辅助工具来识别引人注目的特别提款权:在 9,662,345 份 EudraVigilance 报告中,267,262 份(2.8%)包含至少一个 ME,总共有 300,324 个 ME,涉及 429,554 种药物。报告最多的 ME 是 "产品给药时间不当"(52,646;17.5%),其次是 "给药剂量不正确"(32,379;10.8%)和 "产品使用过程中技术错误"(26,831;8.9%)。与 ME 有关的个体病例安全报告最常见于女性(148,009 份;55.4%),最常见于医护人员(155,711 份;58.3%),主要来自美国(98,716 份;36.9%),其次是法国(26,678 份;10.0%),报告的中位年龄为 50 岁(四分位间范围:26-68 岁)。大多数 ME 个案安全报告(158,991 份;59.5%)与严重健康后果有关。根据整个 EudraVigilance 数据库,共确定了 847 份严重健康后果报告;对于亚组,严重健康后果报告的数量从 0-1 个月年龄组的 84 份到女性个体的 749 份不等。女性和男性的报告比例失调信号非常相似。大多数 ME 报告的是人类乳头瘤病毒疫苗(解剖治疗化学[ATC]:J07BM01;11,086 个 ME,57% 为 "产品给药时间不当"),不同年龄组的报告几率比从 1.5 到 47.0 不等。带状疱疹减毒活疫苗(ATC:J07BK02)的 SDR 在所有亚组中的报告几率从 26.6 到 78.1 不等。羟考酮(ATC:N02AA05;847 例 "意外用药过量",35%)、利培酮(ATC:N05AX08;469 例 "产品给药时间不当",22.3%)和利伐沙班(ATC:B01AF01;1,377 例 "给药剂量不当",34.6%)的报告比例过高。6%)在 2 个月至 2 岁年龄组中的 SDR 值较高,报告几率范围在 8.2 至 10.7 之间,而在整个 EudraVigilance 中,相同药物的报告几率范围在 1.3 至 1.6 之间:这项探索性研究概述了 EudraVigilance 数据库中具有特征的 ME 个案安全性报告和 SDR。在特定年龄组中发现了最明显的 SDR。在疫苗、羟考酮、利伐沙班和利培酮中发现了文献中未描述过的过度报告信号,这可能会促使利益相关者进行进一步检查。报告率最高的 MEs("产品给药时间不当"、"给药剂量不正确 "和 "产品使用过程中的错误技术")成为一般优先重点,需要进一步开展由医疗服务提供者、制造商和监管机构参与的根本原因分析,以提高对 MEs 的理解和预防。
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引用次数: 0
Pharmacovigilance in the Age of Legalized Cannabis: Using Social Media to Monitor Drug–Drug Interactions Between Immunosuppressants and Cannabis-Derived Products 大麻合法化时代的药物警戒:利用社交媒体监测免疫抑制剂与大麻衍生产品之间的药物相互作用
IF 4.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-18 DOI: 10.1007/s40264-024-01481-x
Matthew R. Allen, Gwenyth Portillo Wightman, Zechariah Zhu, Adam Poliak, Davey M. Smith, Mark Dredze, John W. Ayers

Introduction

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.

Objective

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.

Methods

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?

Results

Of these, 66 posts (35%) expressed concern about a potential DDI, such as “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.” Four posts (2%) reported a unique DDI, such as “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.” 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.

Conclusion

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.

导言:Epidiolex® 是美国 FDA 批准的唯一一种大麻衍生消费品 (CDP),其临床试验发现它与一种免疫抑制剂(他克莫司)发生了相互作用,导致药物毒性,这凸显了处方药与通常不受监管的消费品之间的独特交叉。方法我们在 Reddit 上搜索了与 CDP 或健康相关的子论坛,共搜索到 63,561,233 个帖子。我们从中找出了 190 个讨论免疫抑制剂和 CDP 的帖子。两名盲人调查员对以下内容进行了评估。(1) 消费者是否担心 CDP 与免疫抑制剂之间可能存在 DDI?(2) 是否有独特的不良事件归因于消费者 CDP 与免疫抑制剂之间的 DDI?结果在这些帖子中,有 66 个帖子(35%)表达了对潜在 DDI 的担忧,例如 "嘿,我的伴侣想试试我的药剂......她正在服用 Prograf [他克莫司],想和一个做过心脏移植手术的石头人谈谈"。四个帖子(2%)报告了独特的 DDI,如 "我有半传闻的临床结果,显示了我停止使用药物的协调作用......是 CBD。我的 PROGRAF 在 4 毫克时就达到了 30 毫克"。在报告的四种 DDIs 中,有两种与首次报告的 Epidiolex 相似。其余两个报告的 DDI 包括潜在的大麻二酚 (CBD)/ 西罗莫司或δ-9-四氢大麻酚 (THC)/ 西罗莫司相互作用和 THC/ 他克莫司相互作用,两者均导致药物毒性。这表明了在使用处方药的同时使用消费类 CDPs 所带来的风险,同时强调了需要加强监测,以监控消费类 CDPs 的药物安全信号,并制定考虑到消费市场独特性的全面法规。
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引用次数: 0
23rd ISoP Annual Meeting "Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics" 1-5 October 2024 Montreal, Canada. 第 23 届 ISoP 年会 "数字时代药物警戒和先进疗法的全球视角",2024 年 10 月 1-5 日,加拿大蒙特利尔。
IF 4.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-17 DOI: 10.1007/s40264-024-01477-7
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引用次数: 0
Drug-Induced Hypouricemia 药物引起的高尿酸血症
IF 4.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-17 DOI: 10.1007/s40264-024-01485-7
Chaker Ben Salem, Myriam Agrebi, Dhouha Sahnoun, Neila Fathallah, Houssem Hmouda

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.

高尿酸血症是指血清尿酸浓度≤ 2.0 mg/dL 或 119 μmol/L。高尿酸血症可能继发于多种基础疾病,包括严重的肝细胞疾病、肿瘤、肾小管对尿酸的重吸收缺陷、遗传性嘌呤代谢缺陷和药物。药物是导致高尿酸血症的一个重要原因。药物可通过多种机制引起低尿酸血症。药物引起的高尿酸血症大多是由于降尿酸治疗(包括黄嘌呤氧化酶抑制剂、尿酸盐制剂和尿酸酶)过度治疗高尿酸血症所致。未用于治疗痛风的药物也可能导致尿酸水平下降。本文献综述总结了导致低尿酸血症的药物的作用机制和临床意义。
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引用次数: 0
Qualitative Interviews with Stakeholders in Herbal Pharmacovigilance and Recommendations for Best Practices to be Applied Worldwide 对草药药物警戒相关人员的定性访谈以及对全球适用的最佳做法的建议
IF 4.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-12 DOI: 10.1007/s40264-024-01480-y
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

Background and Objective

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.

Methods

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.

Results

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.

Conclusions

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.

背景和目的草药产品在全球范围内的使用量很大,但不同的定义和监管框架导致草药产品的药用地位和安全性监测方法存在差异。本文通过对该领域全球专家的访谈,探讨了草药药物警戒的现状,并提出了最佳实践建议,以提高草药产品的安全性和效益与危害之间的平衡。方法这项研究包括对国际药物警戒学会-草药和传统药物特别兴趣小组和营养警戒信息交流网络成员的半结构式访谈,访谈采用有目的的抽样方式。采用 NVIVO® 对数据进行了存储和编码,并采用定性归纳法对数据进行了专题分析。结果 来自 11 个国家的 16 位参与者接受了访谈,揭示了草药药物警戒方面的不同监管方法和挑战。关键主题包括草药产品的法律地位、认识、识别和编码、上市前/后产品控制、药物不良反应报告、因果关系评估和信号。本研究提出了五项一般性建议,以进一步改善全球草药药物警戒工作。 结论 本研究概述了全球草药药物警戒工作的现状,强调了草药产品监测工作面临的挑战,并提出了普遍性建议。这些建议包括提高认识、加强教育和改进立法框架。鉴于草药产品的使用日益增多,实施强有力的药物警戒措施对确保消费者安全至关重要。
{"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<sup>®</sup> 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}
引用次数: 0
Emergency Department Use of Heart Failure-Exacerbating Medications in Patients with Chronic Heart Failure 慢性心力衰竭患者在急诊科使用加重心力衰竭药物的情况
IF 4.2 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-12 DOI: 10.1007/s40264-024-01479-5
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

Background

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).

Methods

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.

Results

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%).

Conclusion

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.

背景心衰加重药物(HFEMs)的使用可能会导致可预防的急性失代偿性心衰(HF)发作。我们对 2016 年 1 月 1 日至 2020 年 12 月 31 日期间在医疗系统内急诊科就诊的高血压患者进行了一项观察性研究。慢性心房颤动患者通过电子健康记录中的诊断代码进行识别。队列仅限于门诊(即出院回家)急诊室就诊患者。从用药记录中提取急诊室处方或急诊室出院时处方的药物,并根据 2016 年美国心脏协会科学声明将其识别为潜在的 HFEMs。描述性统计用于总结门诊急诊室就诊期间高频电磁干扰药物的使用率。研究队列包括 23907 次急诊室就诊。20%的非住院急诊就诊者在急诊室使用或开具了 HFEM。在急诊室使用 HFEM 的比例(17%)高于急诊室出院时开具 HFEM 处方的比例(6%)。在急诊室使用的最常见的高频电磁干扰药物包括非甾体抗炎药(11%)和阿布特罗(7%)。在急诊室就诊的高血压患者中,可能存在优化用药的机会。
{"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}
引用次数: 0
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. 绝经后骨质疏松症患者使用 Romosozumab 与常用抗骨质疏松症药物相比的心血管安全性:随机对照试验的系统回顾和网络 Meta 分析》。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-03 DOI: 10.1007/s40264-024-01475-9
Shih-Hao Cheng, William Chu, Wen-Hsiang Chou, Woei-Chyn Chu, Yi-No Kang

Introduction: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

简介本研究旨在调查罗莫司单抗对绝经后骨质疏松症妇女心血管的安全性。罗莫索单抗是一种靶向硬骨素的单克隆抗体,已被证明可增加骨矿密度并降低骨质疏松性骨折的风险。然而,在之前的研究中,罗莫索单抗疗法被认为是心血管事件的潜在风险因素,尤其是在易患心血管疾病的患者中:在Cochrane图书馆、Embase、PubMed和Web of Science数据库中进行了系统性文献检索,以确定在绝经后骨质疏松症女性患者中比较romosozumab与阿仑膦酸钠、特立帕肽、地诺单抗或安慰剂的安全性和有效性的随机对照试验(RCT)。采用随机效应模型进行了基于对比的网络荟萃分析。汇总的估计值以风险比和95%置信区间表示:在检索到的 5282 篇文章中,有 25 项随机对照试验(n = 24942)被纳入本综述,18 项随机对照试验(n = 16777)被纳入网络荟萃分析。结果表明,罗莫单抗与安慰剂在心血管死亡率方面无明显差异。关于主要心血管事件的风险,直接证据和以安慰剂为参照物的网络荟萃分析均未发现明显差异:结论:罗莫单抗可能是治疗绝经后妇女骨质疏松症的一种安全选择。结论:罗莫司单抗可能是治疗绝经后妇女骨质疏松症的安全选择,与这种治疗方法相关的心血管问题似乎没有以前认为的那么严重,尽管还需要更多的真实世界数据来证实这一结论。
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引用次数: 0
Paracetamol Dosing Errors in People Aged 12 Years and Over: An Analysis of Over 14,000 Cases Reported to an Australian Poisons Information Centre. 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。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-02 DOI: 10.1007/s40264-024-01472-y
Annabelle S Chidiac, Nicholas A Buckley, Firouzeh Noghrehchi, Rose Cairns

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.

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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引用次数: 0
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