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Views on the Development and Use of a New Digital Adverse Drug Event Reporting Platform in Australia: A Qualitative Study. 关于澳大利亚新数字药物不良事件报告平台的开发和使用的观点:定性研究。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-02 DOI: 10.1007/s40264-024-01489-3
Eyob Alemayehu Gebreyohannes, Christopher Thornton, Myra Thiessen, Sieta T de Vries, Gretchen Coombs, Indae Hwang, Renly Lim

Background: Reporting of adverse drug events (ADEs) to regulatory authorities remains low, particularly among consumers.

Objectives: To explore stakeholders' views on the development and use of a digital platform to improve ADE reporting by consumers to the regulatory authority in Australia, i.e., the Therapeutic Goods Administration.

Methods: A qualitative study was conducted using semi-structured interviews, focus group discussions (FGDs), and co-design workshops with consumers, healthcare professionals (HCPs), and regulators. The interview recordings were transcribed verbatim, coded, and analysed thematically according to the Capability, Opportunity, Motivation, Behaviour model. Findings of the FGDs and co-design workshops were incorporated to enhance and complement the insights gathered from the interviews.

Results: A total of 39 participants took part in the study (54 % consumers, 41 % HCPs, and 5 % regulators). Uncovered themes related to ADE reporting in general were: difficulty recognizing ADEs and health literacy, awareness about reporting ADEs (Capability); visibility of ADE reporting, professionals' views on consumer ADE reporting, consumer education (Opportunity); the common good, benefit to the reporter, identifying ADEs worth reporting, and concern about reporting (Motivation). Additional identified themes specific to a new digital platform were: physical abilities (Capability); features that facilitate intuitive use, convenience and accessibility, user experience, integration with existing systems, trust, sharing experiences with others (Opportunity); and concern about using a reporting platform, and feedback loop (Motivation).

Conclusions: A cross-section of attitudes and values were obtained regarding ADE reporting in general and a new ADE reporting digital platform for consumers in Australia, which will inform its development, implementation and evaluation.

背景:向监管机构报告药物不良事件(ADE)的比例仍然很低,尤其是消费者:探讨利益相关者对开发和使用数字平台以改善消费者向澳大利亚监管机构(即治疗用品管理局)报告药物不良事件的看法:采用半结构化访谈、焦点小组讨论 (FGD) 以及与消费者、医疗保健专业人员 (HCP) 和监管机构共同设计研讨会的方式开展了一项定性研究。访谈记录被逐字转录、编码,并根据能力、机会、动机、行为模型进行主题分析。此外,还纳入了专题小组讨论和共同设计研讨会的结果,以加强和补充从访谈中收集到的见解:共有 39 人参加了研究(54 % 为消费者,41 % 为保健医生,5 % 为监管人员)。发现的与ADE报告相关的主题包括:ADE识别困难和健康知识普及、对ADE报告的认识(能力);ADE报告的可见性、专业人士对消费者ADE报告的看法、消费者教育(机会);共同利益、对报告者的益处、识别值得报告的ADE以及对报告的担忧(动机)。针对新数字平台确定的其他主题包括:身体能力(能力);便于直观使用的功能、便利性和可访问性、用户体验、与现有系统的整合、信任、与他人分享经验(机会);以及对使用报告平台和反馈回路的担忧(动机):我们获得了关于一般 ADE 报告和澳大利亚消费者新 ADE 报告数字平台的各种态度和价值观,这将为其开发、实施和评估提供参考。
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引用次数: 0
Identification of Pregnancy Adverse Drug Reactions in Pharmacovigilance Reporting Systems: A Novel Algorithm Developed in EudraVigilance. 识别药物警戒报告系统中的妊娠不良药物反应:在 EudraVigilance 中开发的新算法。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-06-19 DOI: 10.1007/s40264-024-01448-y
Cosimo Zaccaria, Loris Piccolo, María Gordillo-Marañón, Gilles Touraille, Corinne de Vries

Introduction: There is a need to strengthen the evidence base regarding medication use during pregnancy and to facilitate the early detection of safety signals. EudraVigilance (EV) serves as the primary system for managing and analysing information concerning suspected adverse drug reactions (ADRs) within the European Economic Area. Despite its various functionalities, the current format for electronic submissions of safety reports lacks a specific data element indicating medicine exposure during pregnancy.

Objective: This paper aims to address the limitations of existing approaches by developing a rule-based algorithm in EV that more reliably identifies cases that are truly representative of an ADR during pregnancy.

Methods: The study utilised the standardised MedDRA query (SMQ) 'Pregnancy and neonatal topics' (PNT) as a benchmark for comparison. Recognising that the SMQ PNT also retrieves healthy pregnancy outcomes, contraceptive failure, failed abortifacients as well as ADRs not associated with pregnancy, a novel algorithm was tailored to improve the accuracy of identifying suspected ADRs occurring during pregnancy.

Results: Upon testing, the algorithm demonstrated superior performance, correctly predicting 90% of cases reporting an ADR during pregnancy, compared to 54% achieved by the SMQ PNT. The implementation of the algorithm in EV led to the retrieval of 202,426 cases.

Conclusion: The development and successful testing of the novel algorithm represents a step forward in pregnancy-specific signal detection in EV. Because signals associated with pregnancy may be diluted in a large database such as EV, this study lays the groundwork for future research to evaluate the effectiveness of disproportionality methods on a more refined subset of pregnancy-related ADR reports.

导言:有必要加强有关孕期用药的证据基础,并促进安全信号的早期检测。EudraVigilance (EV) 是欧洲经济区内管理和分析可疑药物不良反应 (ADR) 信息的主要系统。尽管 EudraVigilance 具有多种功能,但其目前的安全报告电子提交格式中缺少表明孕期药物暴露的特定数据元素:本文旨在通过在 EV 中开发一种基于规则的算法来解决现有方法的局限性,从而更可靠地识别真正代表孕期 ADR 的病例:该研究利用标准化 MedDRA 查询 (SMQ) "妊娠和新生儿主题"(PNT) 作为比较基准。考虑到 SMQ PNT 还能检索健康妊娠结果、避孕失败、堕胎失败以及与妊娠无关的 ADR,研究人员定制了一种新算法,以提高识别妊娠期疑似 ADR 的准确性:结果:经测试,该算法表现出卓越的性能,能正确预测 90% 的妊娠期 ADR 报告病例,而 SMQ PNT 的准确率仅为 54%。在电动车中实施该算法后,共检索到 202426 个病例:新算法的开发和成功测试标志着在 EV 中进行妊娠特异性信号检测又向前迈进了一步。由于与妊娠相关的信号在 EV 这样的大型数据库中可能会被稀释,因此本研究为今后的研究奠定了基础,以便在更精细的妊娠相关 ADR 报告子集中评估比例失调方法的有效性。
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引用次数: 0
Adopting STOPP/START Criteria Version 3 in Clinical Practice: A Q&A Guide for Healthcare Professionals. 在临床实践中采用 STOPP/START 标准第 3 版:医护人员问答指南》。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-07-11 DOI: 10.1007/s40264-024-01453-1
Carlotta Lunghi, Marco Domenicali, Stefano Vertullo, Emanuel Raschi, Fabrizio De Ponti, Graziano Onder, Elisabetta Poluzzi

The growing complexity of geriatric pharmacotherapy necessitates effective tools for mitigating the risks associated with polypharmacy. The Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP)/Screening Tool to Alert doctors to Right Treatment (START) criteria have been instrumental in optimizing medication management among older adults. Despite their large adoption for improving the reduction of potentially inappropriate medications (PIM) and patient outcomes, the implementation of STOPP/START criteria faces notable challenges. The extensive number of criteria in the latest version and time constraints in primary care pose practical difficulties, particularly in settings with a high number of older patients. This paper critically evaluates the challenges and evolving implications of applying the third version of the STOPP/START criteria across various clinical settings, focusing on the European healthcare context. Utilizing a "Questions & Answers" format, it examines the criteria's implementation and discusses relevant suitability and potential adaptations to address the diverse needs of different clinical environments. By emphasizing these aspects, this paper aims to contribute to the ongoing discourse on enhancing medication safety and efficacy in the geriatric population, and to promote more person-centred care in an aging society.

老年药物治疗日益复杂,因此需要有效的工具来降低与多种药物治疗相关的风险。老年人潜在不当处方筛查工具(STOPP)/提醒医生正确治疗筛查工具(START)标准在优化老年人用药管理方面发挥了重要作用。尽管 STOPP/START 标准在减少潜在用药不当(PIM)和改善患者治疗效果方面得到了广泛应用,但其实施仍面临着显著挑战。最新版本的标准数量繁多,而基层医疗机构的时间有限,这给实施带来了实际困难,尤其是在老年患者较多的情况下。本文以欧洲医疗环境为重点,批判性地评估了在各种临床环境中应用第三版 STOPP/START 标准所面临的挑战和不断发展的影响。本文采用 "问与答 "的形式,探讨了标准的实施情况,并讨论了相关的适用性和潜在的适应性,以满足不同临床环境的不同需求。通过强调这些方面,本文旨在为正在进行的关于提高老年用药安全和疗效的讨论做出贡献,并在老龄化社会中促进更加以人为本的护理。
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引用次数: 0
A Systematic Overview of Contraindications and Special Warnings for Biologic and Targeted Synthetic Disease Modifying Antirheumatic Drugs: Establishing a Framework to Create a "Safety Checklist". 生物制剂和靶向合成改变疾病抗风湿药物的禁忌症和特别警告系统概述:建立 "安全核对表 "框架。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-07-16 DOI: 10.1007/s40264-024-01461-1
Lykke Skaarup, Elvina Ingrid, Alexandre Sepriano, Elena Nikiphorou, René Østgård, Kim Lauper, Ilona Grosse-Michaelis, Margreet Kloppenburg, Bente Glintborg, David F L Liew, Tue W Kragstrup

Background/aim: The purpose of this review is to provide an overview of the contraindications, special warnings, and boxed warnings with the aim to establish a framework to create a prescription safety checklist for a class of drugs or disease indication. This study covers biologic disease modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs).

Methods: We identified contraindications, boxed warnings, and special warnings provided by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The study included b/tsDMARDs approved for treating rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (SpA), and juvenile idiopathic arthritis (JIA) within the drug-classes anti-CD20, tumor necrosis factor inhibitors (TNFi), interleukin-1 inhibitors (IL-1i), cytotoxic T-lymphocyte-associated protein (CTLA) 4, interleukin-12/23 inhibitors (IL-12/23i), interleukin 6 receptor inhibitors (IL-6Ri), Janus kinase inhibitors (JAKi), phosphodiesterase 4 inhibitors (PDE4i), interleukin-17 inhibitors (IL-17i), and interleukin-23 inhibitors (IL-23i).

Results: All drug classes, except PDE4i, had contraindications and/or warnings related to infections, including tuberculosis. A warning about herpes zoster was listed for anti-CD20, IL-1i, IL-6Ri, and JAKi, while a warning about hepatitis reactivation was listed for anti-CD20, TNFi, IL-1i, CTLA4-Ig, IL-6Ri, and JAKi. Malignancy risk was mentioned for all drug classes except PDE4i, IL-17i, and IL-23i. Other warnings included demyelinating disease (TNFi, CTLA4-Ig, and IL-6Ri), heart failure (anti-CD20 and TNFi), major adverse cardiac events (JAKi and IL-12/23) and venous thromboembolism (JAKi), hyperlipidemia (IL-6Ri and JAKi), liver impairment (TNFi, IL-1i, IL-6Ri, and JAKi), kidney impairment (IL-1i, JAKi, and PDE4i), inflammatory bowel disease (IL-17i), gastrointestinal perforation (IL-6Ri, JAKi), cytopenia (anti-CD20, TNFi, IL-1i, IL-6Ri, JAKi), and depression (PDE4i). Contraindications and warnings appeared to increase with the passage of time since the drug's approval.

Conclusion: This review provides an overview to establish the framework to create an easily accessible and actionable prescription safety checklist from individual medical product prescription information provided by regulatory medical authorities.

背景/目的:本综述旨在概述禁忌症、特别警告和盒装警告,目的是建立一个框架,为一类药物或疾病适应症创建一个处方安全核对表。本研究涵盖生物改良抗风湿药(bDMARDs)和靶向合成 DMARDs(tsDMARDs):我们确定了欧洲药品管理局(EMA)和美国食品药品管理局(FDA)提供的禁忌症、盒装警告和特别警告。研究包括抗 CD20、肿瘤坏死因子抑制剂 (TNFi)、白细胞介素-1 抑制剂 (IL-1i) 等药物类别中获准用于治疗类风湿性关节炎 (RA)、银屑病关节炎 (PsA)、轴性脊柱关节炎 (SpA) 和幼年特发性关节炎 (JIA) 的 b/tsDMARDs、细胞毒性 T 淋巴细胞相关蛋白 (CTLA) 4、白细胞介素-12/23 抑制剂 (IL-12/23i)、白细胞介素 6 受体抑制剂 (IL-6Ri)、Janus 激酶抑制剂 (JAKi)、磷酸二酯酶 4 抑制剂 (PDE4i)、白细胞介素-17 抑制剂 (IL-17i) 和白细胞介素-23 抑制剂 (IL-23i)。研究结果除 PDE4i 外,所有药物类别都有与感染(包括结核病)相关的禁忌和/或警告。抗CD20、IL-1i、IL-6Ri和JAKi列出了带状疱疹警告,而抗CD20、TNFi、IL-1i、CTLA4-Ig、IL-6Ri和JAKi则列出了肝炎再激活警告。除PDE4i、IL-17i和IL-23i外,所有药物类别都提到了恶性肿瘤风险。其他警告包括脱髓鞘疾病(TNFi、CTLA4-Ig和IL-6Ri)、心力衰竭(抗CD20和TNFi)、重大心脏不良事件(JAKi和IL-12/23)和静脉血栓栓塞(JAKi)、高脂血症(IL-6Ri和JAKi)、肝功能损害(TNFi、IL-1i、IL-6Ri 和 JAKi)、肾功能损害(IL-1i、JAKi 和 PDE4i)、炎症性肠病(IL-17i)、胃肠道穿孔(IL-6Ri、JAKi)、全血细胞减少(抗 CD20、TNFi、IL-1i、IL-6Ri、JAKi)和抑郁症(PDE4i)。禁忌症和警告似乎随着药物批准时间的推移而增加:本综述概述了如何建立一个框架,以便从医疗监管机构提供的单个医疗产品处方信息中创建一个易于访问和可操作的处方安全核对表。
{"title":"A Systematic Overview of Contraindications and Special Warnings for Biologic and Targeted Synthetic Disease Modifying Antirheumatic Drugs: Establishing a Framework to Create a \"Safety Checklist\".","authors":"Lykke Skaarup, Elvina Ingrid, Alexandre Sepriano, Elena Nikiphorou, René Østgård, Kim Lauper, Ilona Grosse-Michaelis, Margreet Kloppenburg, Bente Glintborg, David F L Liew, Tue W Kragstrup","doi":"10.1007/s40264-024-01461-1","DOIUrl":"10.1007/s40264-024-01461-1","url":null,"abstract":"<p><strong>Background/aim: </strong>The purpose of this review is to provide an overview of the contraindications, special warnings, and boxed warnings with the aim to establish a framework to create a prescription safety checklist for a class of drugs or disease indication. This study covers biologic disease modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs).</p><p><strong>Methods: </strong>We identified contraindications, boxed warnings, and special warnings provided by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The study included b/tsDMARDs approved for treating rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (SpA), and juvenile idiopathic arthritis (JIA) within the drug-classes anti-CD20, tumor necrosis factor inhibitors (TNFi), interleukin-1 inhibitors (IL-1i), cytotoxic T-lymphocyte-associated protein (CTLA) 4, interleukin-12/23 inhibitors (IL-12/23i), interleukin 6 receptor inhibitors (IL-6Ri), Janus kinase inhibitors (JAKi), phosphodiesterase 4 inhibitors (PDE4i), interleukin-17 inhibitors (IL-17i), and interleukin-23 inhibitors (IL-23i).</p><p><strong>Results: </strong>All drug classes, except PDE4i, had contraindications and/or warnings related to infections, including tuberculosis. A warning about herpes zoster was listed for anti-CD20, IL-1i, IL-6Ri, and JAKi, while a warning about hepatitis reactivation was listed for anti-CD20, TNFi, IL-1i, CTLA4-Ig, IL-6Ri, and JAKi. Malignancy risk was mentioned for all drug classes except PDE4i, IL-17i, and IL-23i. Other warnings included demyelinating disease (TNFi, CTLA4-Ig, and IL-6Ri), heart failure (anti-CD20 and TNFi), major adverse cardiac events (JAKi and IL-12/23) and venous thromboembolism (JAKi), hyperlipidemia (IL-6Ri and JAKi), liver impairment (TNFi, IL-1i, IL-6Ri, and JAKi), kidney impairment (IL-1i, JAKi, and PDE4i), inflammatory bowel disease (IL-17i), gastrointestinal perforation (IL-6Ri, JAKi), cytopenia (anti-CD20, TNFi, IL-1i, IL-6Ri, JAKi), and depression (PDE4i). Contraindications and warnings appeared to increase with the passage of time since the drug's approval.</p><p><strong>Conclusion: </strong>This review provides an overview to establish the framework to create an easily accessible and actionable prescription safety checklist from individual medical product prescription information provided by regulatory medical authorities.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619523","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
The Methodological Quality of Observational Studies Examining the Risk of Pregnancy Drug Use on Congenital Malformations Needs Substantial Improvement: A Cross-Sectional Survey. 妊娠用药对先天性畸形风险的观察性研究的方法学质量有待大幅提高:一项横断面调查。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-08-02 DOI: 10.1007/s40264-024-01465-x
Yulong Jia, Jing Wang, Chunrong Liu, Peng Zhao, Yan Ren, Yiquan Xiong, GuoWei Li, Meng Chen, Xin Sun, Jing Tan

Background and objective: An increasing number of observational studies have investigated the risk of using drugs during pregnancy on congenital malformations. However, the credibility of the causal relationships drawn from these studies remains uncertain. This study aims to evaluate the potential methodological issues in existing observational studies.

Methods: We used a stepwise approach to investigate this issue. First, we identified observational studies published in 2020 that examined the risk of congenital malformations associated with medication use during pregnancy. We assessed the methodological characteristics for establishing causality, including study design, confounding control, and sensitivity analysis, and compared them between "core clinical journals" and "general journals." For studies reporting an increased risk of congenital malformations in core clinical journals, we searched for subsequent studies addressing the same research question published between January 2021 and May 2023 to assess the consistency of the literature.

Results: A total of 40 eligible studies were published in 2020, primarily focused on the safety of vitamin B12 and folic acid (n = 4), antidepressants (n = 4), and others (n = 32). Our findings suggest that only two (5.00%) studies used causal models to guide the identification of confounding, and only eight (20.00%) studies assessed the potential dose-response relationship. In all, 15 (37.50%) studies used propensity score analysis strategy to achieve "mimic-randomization." In addition, 22 studies (55.00%) performed sensitivity analyses, while 10 (45.45%) showed inconsistency with the primary outcome. Furthermore, 5 studies reported positive outcomes, whereas only 1 out of 11 studies demonstrated a positive correlation between drug usage during pregnancy and major malformations in subsequent studies.

Conclusion: A significant portion of the studies has failed to sufficiently consider the essential methodological characteristics required to improve the credibility of causal inferences. The increased risk of congenital malformations documented in core clinical journal was not adequately replicated in subsequent studies.

背景和目的:越来越多的观察性研究调查了孕期用药对先天性畸形的风险。然而,这些研究得出的因果关系的可信度仍不确定。本研究旨在评估现有观察性研究中潜在的方法学问题:我们采用循序渐进的方法来研究这一问题。首先,我们确定了 2020 年发表的观察性研究,这些研究探讨了与孕期用药相关的先天性畸形风险。我们评估了确定因果关系的方法学特征,包括研究设计、混杂控制和敏感性分析,并在 "核心临床期刊 "和 "一般期刊 "之间进行了比较。对于核心临床期刊中报告先天性畸形风险增加的研究,我们检索了2021年1月至2023年5月期间发表的针对同一研究问题的后续研究,以评估文献的一致性:2020年共发表了40篇符合条件的研究,主要集中在维生素B12和叶酸(4篇)、抗抑郁药(4篇)和其他药物(32篇)的安全性方面。我们的研究结果表明,只有两项(5.00%)研究使用因果模型来指导混杂因素的识别,只有八项(20.00%)研究评估了潜在的剂量-反应关系。总共有 15 项(37.50%)研究使用倾向得分分析策略来实现 "模拟随机"。此外,22 项研究(55.00%)进行了敏感性分析,10 项研究(45.45%)的主要结果不一致。此外,有 5 项研究报告了积极的结果,而 11 项研究中只有 1 项在后续研究中证实了孕期用药与重大畸形之间的正相关性:结论:相当一部分研究没有充分考虑到提高因果推论可信度所需的基本方法学特征。核心临床期刊中记录的先天性畸形风险增加在后续研究中没有得到充分证实。
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引用次数: 0
Tardive Dyskinesia with Antipsychotic Medication in Children and Adolescents: A Systematic Literature Review. 儿童和青少年服用抗精神病药物引起的迟发性运动障碍:系统性文献综述。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-06-11 DOI: 10.1007/s40264-024-01446-0
Frank M C Besag, Michael J Vasey, Iffah Salim, Chris Hollis

Background: Tardive dyskinesia (TD) is a persisting, and potentially irreversible, movement disorder associated with treatment with dopamine receptor antagonists. Few data are available on the risk of TD in children and adolescents treated with antipsychotic medication.

Objective: To review the literature on incidence, risk factors, and treatment options for antipsychotic-associated TD in children and adolescents (aged < 18 years).

Methods: Relevant articles were identified through a systematic search of Embase and Medline performed in January 2024. Methodological quality was assessed using the Newcastle-Ottawa Scale and Joanna Briggs Institute Critical Appraisal tools.

Results: Thirteen studies were identified. The reported TD point prevalence was 5-20%, with higher rates in studies involving typical antipsychotics. Lower estimates (around 1%) emerged from analyses of clinical database data suggesting underdiagnosis in clinical practice. Risk factors included treatment with typical antipsychotics, higher doses, longer duration of exposure, older age, female gender, higher baseline Abnormal Involuntary Movements Scale (AIMS) scores, intellectual impairment, and perinatal complications.

Conclusion: Although relatively few cases have been reported in children and adolescents, TD remains a risk in this population. Individuals receiving antipsychotics should be monitored carefully for the emergence of abnormal movements. Other than dose reduction, discontinuation, or switch to a lower-risk antipsychotic, few interventions have demonstrated efficacy. The strongest evidence for pharmacological treatment is for VMAT-2 inhibitors (valbenazine and deutetrabenazine), but these drugs are not licensed for use in children. To reduce risk, antipsychotics should be prescribed only if necessary, at the minimum effective dose and for the minimum necessary duration.

背景:迟发性运动障碍(TD)是一种与多巴胺受体拮抗剂治疗相关的持续性、可能不可逆的运动障碍。有关接受抗精神病药物治疗的儿童和青少年患 TD 的风险的数据很少:回顾有关儿童和青少年(年龄小于 18 岁)抗精神病药物相关 TD 的发病率、风险因素和治疗方案的文献:方法:于2024年1月对Embase和Medline进行系统检索,确定相关文章。采用纽卡斯尔-渥太华量表(Newcastle-Ottawa Scale)和乔安娜-布里格斯研究所(Joanna Briggs Institute)批判性评估工具对方法学质量进行评估:结果:共发现 13 项研究。报告的 TD 点患病率为 5-20%,涉及典型抗精神病药物的研究中患病率较高。临床数据库数据分析得出的估计值较低(约为1%),表明临床实践中诊断不足。风险因素包括使用典型抗精神病药物治疗、剂量较大、接触时间较长、年龄较大、女性、异常不自主运动量表(AIMS)基线评分较高、智力障碍和围产期并发症:尽管儿童和青少年中的病例报道相对较少,但TD在这一人群中仍然存在风险。接受抗精神病药物治疗的患者应仔细观察是否出现异常运动。除了减少剂量、停药或改用风险较低的抗精神病药物外,很少有干预措施能证明其疗效。最有力的药物治疗证据是VMAT-2抑制剂(戊苯丙肼和去甲戊苯丙肼),但这类药物未获得儿童使用许可。为了降低风险,只有在必要时才应处方抗精神病药物,并且应使用最低有效剂量和持续最短必要时间。
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引用次数: 0
Optimal Significance Levels and Sample Sizes for Signal Detection Methods Based on Non-constant Hazards. 基于非恒定危害的信号检测方法的最佳显著性水平和样本量。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-07-09 DOI: 10.1007/s40264-024-01460-2
Odile Sauzet, Julia Dyck, Victoria Cornelius

Background and objectives: Statistical methods for signal detection of adverse drug reactions (ADRs) in electronic health records (EHRs) need information about optimal significance levels and sample sizes to achieve sufficient power. Sauzet and Cornelius proposed tests for signal detection based on the hazard functions of Weibull type distributions (WSP tests) which use the time-to-event information available in EHRs. Optimal significance levels and sample sizes for the application of the WPS tests are derived.

Method: A simulation study was performed with a range of scenarios for sample size, rate of event due (ADRs), and not due to the drug and random time to ADR occurrence. Based on the area under the curve of the receiver operating characteristic graph, we obtain optimal significance levels of the different WSP tests for the implementation in a hypothesis free signal detection setting and approximate sample sizes required to reach a power of 80% or 90%.

Results: The dWSP-pPWSP (combination of double WSP and power WSP) test with a significance level of 0.004 was recommended. Sample sizes needed for a power of 80% were found to start at 60 events for an ADR rate equal to the background rate of 0.1. The number of events required for a background rate of 0.05 and an ADR rate equal to a 20% increase of the background rate was 900.

Conclusion: Based on this study, it is recommended to use the dWSP-pWSP test combination for signal detection with a significance level of 0.004 when the same test is applied to all adverse events not depending on rates.

背景和目标:用于检测电子健康记录(EHR)中药物不良反应(ADR)信号的统计方法需要关于最佳显著性水平和样本大小的信息,以达到足够的功率。Sauzet 和 Cornelius 提出了基于 Weibull 型分布危险函数的信号检测测试(WSP 测试),该测试使用了电子健康记录中的时间到事件信息。得出了应用 WPS 检验的最佳显著性水平和样本大小:方法:对样本量、药物所致(不良反应)和非药物所致事件发生率以及不良反应发生的随机时间进行了一系列模拟研究。根据接收者操作特征曲线图的曲线下面积,我们得出了在无假设信号检测环境下实施不同 WSP 检验的最佳显著性水平,以及达到 80% 或 90% 功率所需的近似样本量:结果:推荐使用显著性水平为 0.004 的 dWSP-pPWSP(双 WSP 和功率 WSP 的组合)检验。结果发现,在 ADR 率等于 0.1 的背景率时,功率达到 80% 所需的样本量从 60 个事件开始。背景率为 0.05,ADR 率相当于背景率增加 20% 时所需的事件数为 900:根据这项研究,建议使用 dWSP-pWSP 测试组合进行信号检测,当同一测试应用于所有不良事件时,显著性水平为 0.004,而不取决于不良反应率。
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引用次数: 0
Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season. 2022/2023 年流感季节期间在比利时、德国和西班牙加强对葛兰素史克四价灭活季节性流感疫苗的安全性监测。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 Epub Date: 2024-06-29 DOI: 10.1007/s40264-024-01456-y
Ignacio Salamanca de la Cueva, Jennifer E Gerber, Andrew Hastie, Carlos Brotons, Falko Panzer, Jean-Yves Pirçon, Paul Talsma, Tamara Eckermann, Vanja Nikic, Xavier Martinez Gomez, Hannah Alsdurf

Background: Seasonal influenza is prevented through annual vaccination, especially in children and older adults. These vaccines are annually updated based on World Health Organization recommendations and require continuous safety monitoring.

Objective: We assessed the frequency and severity of adverse events within 7 days of administering GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in Belgium, Germany, and Spain during the 2022/2023 influenza season.

Methods: In this enhanced safety surveillance study, adults who received GSK's IIV4 and parents/guardians/legally acceptable representatives of vaccinated children (aged 6 months-17 years) were invited to complete adverse drug reaction cards reporting adverse events within 7 days post-vaccination.

Results: In total, 1332 participants (53.6% female) received at least one dose of GSK's IIV4, including 43 children who received two doses. Overall, 97.8% of adverse drug reaction cards were completed and returned in the study. All participants in Belgium were adults, while 54.7% and 7.4% in Spain and Germany, respectively, were pediatric participants aged 6 months-17 years. After Dose 1, across all age groups, 49.8% of participants reported at least one adverse event. The most common adverse events (cumulative frequency >5%) following Dose 1 were injection-site pain (37.6%), fatigue (15.0%), headache (13.2%), injection-site swelling (9.3%), myalgia (7.6%), and injection-site erythema (7.4%). Across all countries, adverse events were most common in adults aged 18-65 years (59.7%), followed by those aged 3-17 years (47.0%), >65 years (35.7%), and 6-35 months (23.5%). After Dose 2, 18.6% of participants reported at least one adverse event, with general disorders and administration site conditions again being the most frequent.

Conclusions: Across all age and risk groups for serious disease, no serious adverse events related to GSK's IIV4 were reported within 7 days post-vaccination. This study supports and confirms the acceptable safety profile of GSK's IIV4 across all recommended age groups.

Clinical trial registration: ClinicalTrials.gov number: not applicable.

背景:季节性流感可通过每年接种疫苗来预防,尤其是儿童和老年人。这些疫苗每年都会根据世界卫生组织的建议进行更新,需要持续进行安全性监测:我们评估了 2022/2023 年流感季节期间比利时、德国和西班牙接种葛兰素史克四价季节性流感灭活疫苗(IIV4)后 7 天内不良事件的发生频率和严重程度:在这项强化安全性监测研究中,我们邀请接种了葛兰素史克四价灭活疫苗的成年人和接种儿童(6 个月至 17 岁)的父母/监护人/合法代表填写药物不良反应卡,报告接种后 7 天内发生的不良事件:共有 1332 名参与者(53.6% 为女性)至少接种了一剂葛兰素史克的 IIV4 疫苗,其中 43 名儿童接种了两剂。总体而言,97.8%的药物不良反应卡在研究中完成并交回。比利时的所有参与者均为成年人,而西班牙和德国分别有 54.7% 和 7.4% 的参与者为 6 个月至 17 岁的儿童。第 1 剂后,在所有年龄组中,49.8% 的参与者报告了至少一种不良反应。第一剂后最常见的不良反应(累计频率>5%)为注射部位疼痛(37.6%)、疲劳(15.0%)、头痛(13.2%)、注射部位肿胀(9.3%)、肌痛(7.6%)和注射部位红斑(7.4%)。在所有国家中,不良事件最常见于 18-65 岁的成年人(59.7%),其次是 3-17 岁(47.0%)、65 岁以上(35.7%)和 6-35 个月(23.5%)的人群。在剂量 2 之后,18.6% 的参与者报告了至少一种不良事件,其中最常见的仍然是一般疾病和用药部位疾病:结论:在所有年龄组和严重疾病风险组中,接种后 7 天内未出现与葛兰素史克公司 IIV4 疫苗相关的严重不良事件。这项研究支持并证实了葛兰素史克公司的IIV4在所有推荐年龄组中均具有可接受的安全性:临床试验注册:ClinicalTrials.gov 编号:不适用。
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引用次数: 0
Acknowledgement to Referees. 鸣谢裁判员。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1007/s40264-024-01492-8
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引用次数: 0
Use of the Sentinel System to Examine Medical Product Use and Outcomes During Pregnancy. 使用哨兵系统检查孕期医疗产品的使用情况和结果。
IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-06-28 DOI: 10.1007/s40264-024-01447-z
Jennifer G Lyons, Mayura U Shinde, Judith C Maro, Andrew Petrone, Austin Cosgrove, Maria E Kempner, Susan E Andrade, Jamila Mwidau, Danijela Stojanovic, José J Hernández-Muñoz, Sengwee Toh

While many pregnant individuals use prescription medications, evidence supporting product safety during pregnancy is often inadequate. Existing electronic healthcare data sources provide large, diverse samples of health plan members to allow for the study of medical product utilization during pregnancy, as well as pregnancy, maternal, and infant outcomes. The Sentinel System is a national medical product surveillance system that includes administrative claims and electronic health record databases from large national and regional health insurers. In addition to these data sources, Sentinel develops and maintains a sizeable selection of analytic tools to facilitate epidemiologic analyses in a way that protects patient privacy and health system autonomy. In this article, we provide an overview of Sentinel System infrastructure, including the Mother-Infant Linkage Table, parameterizable analytic tools, and algorithms to estimate gestational age and identify pregnancy outcomes. We also describe past and future Sentinel work that contributes to our understanding of the way medical products are used and the safety of these products during pregnancy.

虽然许多孕妇会使用处方药,但支持孕期产品安全性的证据往往不足。现有的电子医疗保健数据源提供了大量不同的健康计划成员样本,可用于研究怀孕期间医疗产品的使用情况,以及怀孕、孕产妇和婴儿的结局。哨兵系统(Sentinel System)是一个全国性的医疗产品监测系统,包括来自全国性和地区性大型医疗保险公司的行政索赔和电子健康记录数据库。除这些数据源外,哨兵系统还开发并维护了大量分析工具,以保护患者隐私和医疗系统自主权的方式促进流行病学分析。在本文中,我们将概述哨兵系统的基础设施,包括母婴关联表、可参数化的分析工具以及估算孕龄和确定妊娠结局的算法。我们还介绍了哨兵系统过去和未来的工作,这些工作有助于我们了解医疗产品的使用方式以及这些产品在孕期的安全性。
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引用次数: 0
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