关于 COVID-19 腺病毒载体疫苗血栓形成伴血小板减少综合征的监管风险通报对欧洲医疗保健专业人员的影响。

IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Ella van Vliet, Nanča Čebron Lipovec, Marloes van der Goot, Shahab Abtahi, Inês Ribeiro-Vaz, Elita Poplavska, Foteini Dermiki-Gkana, Chara Oikonomou, Elena Deligianni, Christos Kontogiorgis, Ana Marta Silva, Paula Barão Sousa Ferreira, Mitja Kos, Anna Birna Almarsdóttir, Ramune Jacobsen, Caroline Buhl, Adrie de Bruijn, Ingrid Hegger, Teresa Leonardo Alves
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引用次数: 0

摘要

目的:欧洲药品管理局(EMA)于 2021 年发布了与腺病毒载体疫苗 Vaxzevria 或 Jcovden 相关的血栓与血小板减少综合征(TTS)的监管行动和通报。本研究旨在评估这些行动对医疗保健专业人员(HCP)的意识、知识和实践实施的影响:方法:我们对从事疫苗接种、监测或咨询工作的医护人员进行了网络横断面调查。我们测量了对 TTS 风险的认识和知识,以及他们在实践中对建议的执行情况。我们还进行了描述性分析和定性分析。这项研究在希腊、拉脱维亚、荷兰、葡萄牙和斯洛文尼亚进行:我们对 1659 名保健医生进行了调查。结果:我们对 1659 名保健医生进行了调查,其中 914 人被纳入分析范围。大多数人都知道与 COVID-19 腺病毒载体疫苗相关的 TTS 报告,各国报告的比例在 85% 到 97% 之间。主流媒体、卫生机构和同行是 TTS 风险信息的主要来源。大多数卫生保健人员能够识别 TTS 的主要症状,但对次要症状不太熟悉。卫生机构提供的 COVID-19 疫苗接种指南对 55%-77% 的保健医生的专业实践产生了影响。各国报告的产品信息使用情况一般,但也存在一些差异:结论:卫生保健人员对 COVID-19 腺病毒载体疫苗引发 TTS 风险的认识和了解程度较高。据报告,高级保健人员明显倾向于将国家指南作为风险信息的来源,而产品信息在各国的使用情况仍然一般。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID-19 Adenovirus Vector Vaccines on European Healthcare Professionals.

Purpose: The European Medicines Agency (EMA) issued regulatory actions and communications in 2021 on thrombosis with thrombocytopenia syndrome (TTS) associated with adenovirus vector vaccines Vaxzevria or Jcovden. This study aimed to evaluate the impact of these actions on awareness, knowledge and implementation in practises of healthcare professionals (HCP).

Methods: Web-based cross-sectional surveys were conducted on HCPs engaged in the vaccination, monitoring or counselling about the vaccines. We measured awareness and knowledge of the risk of TTS and their implementation of recommendations in practise. Descriptive and qualitative analyses were conducted. This study took place in Greece, Latvia, Netherlands, Portugal and Slovenia.

Results: We surveyed 1659 HCPs. From these, 914 were included in the analysis. Most were aware about the reports of TTS associated with COVID-19 adenovirus vector vaccines, with countries reporting percentages between 85% and 97%. Mainstream media, health authorities and peers were the main sources of TTS risk information. Most HCPs were able to identify key symptoms from TTS but were less familiar with minor symptoms. Guidelines from health authorities on COVID-19 vaccination impacted on professional practise of 55%-77% of HCPs. The reported use of product information across countries was moderate, with some variations.

Conclusions: Awareness about and knowledge of TTS risk from COVID-19 adenoviral vector vaccines were high among HCPs. HCPs reported a clear preference for national guidelines as source of risk information and the implementation of product information remained moderate across countries.

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来源期刊
CiteScore
4.80
自引率
7.70%
发文量
173
审稿时长
3 months
期刊介绍: The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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