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An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014-2022) Following the Introduction of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older. 一项为期 8 年的前瞻性、观察性、多中心上市后安全性监测研究(2014-2022 年),在韩国针对 6 个月及以上年龄的受试者引入葛兰素史克四价季节性流感灭活疫苗(Fluarix Tetra)后进行。
IF 4.2 2区 医学
Drug Safety Pub Date : 2024-04-01 Epub Date: 2024-03-14 DOI: 10.1007/s40264-024-01395-8
Gaël Dos Santos, Raghavendra Devadiga, Chun Soo Kim, Joon Bang
{"title":"An 8-Year Prospective, Observational, Multi-centre Post-Marketing Safety Surveillance Study Conducted in South Korea (2014-2022) Following the Introduction of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) for Subjects Aged 6 Months and Older.","authors":"Gaël Dos Santos, Raghavendra Devadiga, Chun Soo Kim, Joon Bang","doi":"10.1007/s40264-024-01395-8","DOIUrl":"10.1007/s40264-024-01395-8","url":null,"abstract":"<p><strong>Introduction: </strong>Seasonal influenza is associated with substantial public health burden. The objective of this study was to assess the safety of inactivated quadrivalent seasonal influenza vaccine (IIV4, Fluarix Tetra, GSK, Belgium) in subjects aged ≥ 6 months in Korea.</p><p><strong>Methods: </strong>This prospective, observational, non-comparative, multi-centre post-marketing surveillance study was conducted in Korea in subjects aged ≥ 3 years for 6 years (2014-2020) and extended to subjects aged 6-35 months for 4 years (2018-2022). Subjects received IIV4 in routine clinical practice according to local prescribing information. Adverse events (AEs) were recorded over 21 days post-vaccination.</p><p><strong>Results: </strong>The group aged ≥ 3 years included 701 subjects (mean 31.97 years, range 3-86 years, 46.36% male), and the group aged 6-35 months included 687 subjects (mean 16.31 months, 47.02% male). In the group aged ≥ 3 years, 98 subjects (13.98%) reported 140 AEs, of which 42 events in 34 subjects (4.85%) were adverse reactions to vaccine (ARVs). Most of the ARVs were expected, mainly administration site reactions. There were seven mild unexpected ARVs. In the group aged 6-35 months, 248 AEs were reported in 149/687 subjects (21.69%). ARVs were reported in 25/687 subjects (3.64%, 29 events); one was considered unexpected. There were five serious AEs overall, none of which were considered related.</p><p><strong>Conclusion: </strong>No safety concerns were found during this surveillance study of IIV4 in subjects aged ≥ 6 months in Korea. The findings of this study suggest IIV4 is safe and well tolerated for use in all age groups with a vaccine indication.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10955014/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140131053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Authors' Response to Huang et al.'s Comment on "Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance". 作者对 Huang 等人关于 "连续组合流行病学设计并不能改善疫苗安全性监测的总体信号检测 "的评论的回应。
IF 4.2 2区 医学
Drug Safety Pub Date : 2024-04-01 Epub Date: 2024-03-05 DOI: 10.1007/s40264-024-01411-x
Fan Bu, Faaizah Arshad, George Hripcsak, Patrick B Ryan, Martijn J Schuemie, Marc A Suchard
{"title":"Authors' Response to Huang et al.'s Comment on \"Serially Combining Epidemiological Designs Does Not Improve Overall Signal Detection in Vaccine Safety Surveillance\".","authors":"Fan Bu, Faaizah Arshad, George Hripcsak, Patrick B Ryan, Martijn J Schuemie, Marc A Suchard","doi":"10.1007/s40264-024-01411-x","DOIUrl":"10.1007/s40264-024-01411-x","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140027706","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
Risk Factors Associated with Medication Administration Errors in Children: A Prospective Direct Observational Study of Paediatric Inpatients 与儿童用药错误相关的风险因素:儿科住院患者的前瞻性直接观察研究
IF 4.2 2区 医学
Drug Safety Pub Date : 2024-03-05 DOI: 10.1007/s40264-024-01408-6
Johanna I. Westbrook, Ling Li, Amanda Woods, Tim Badgery-Parker, Virginia Mumford, Alison Merchant, Erin Fitzpatrick, Magdalena Z. Raban
{"title":"Risk Factors Associated with Medication Administration Errors in Children: A Prospective Direct Observational Study of Paediatric Inpatients","authors":"Johanna I. Westbrook, Ling Li, Amanda Woods, Tim Badgery-Parker, Virginia Mumford, Alison Merchant, Erin Fitzpatrick, Magdalena Z. Raban","doi":"10.1007/s40264-024-01408-6","DOIUrl":"https://doi.org/10.1007/s40264-024-01408-6","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Limited evidence exists regarding medication administration errors (MAEs) on general paediatric wards or associated risk factors exists.</p><h3 data-test=\"abstract-sub-heading\">Objective</h3><p>The aim of this study was to identify nurse, medication, and work-environment factors associated with MAEs among paediatric inpatients.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>This was a prospective, direct observational study of 298 nurses in a paediatric referral hospital in Sydney, Australia. Trained observers recorded details of 5137 doses prepared and administered to 1530 children between 07:00 h and 22:00 h on weekdays and weekends. Observation data were compared with medication charts to identify errors. Clinical errors, potential severity and actual harm were assessed. Nurse characteristics (e.g. age, sex, experience), medication type (route, high-risk medications, use of solvent/diluent), and work variables (e.g. time of administration, weekday/weekend, use of an electronic medication management system [eMM], presence of a parent/carer) were collected. Multivariable models assessed MAE risk factors for any error, errors by route, potentially serious errors, and errors involving high-risk medication or causing actual harm.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Errors occurred in 37.0% (<i>n</i> = 1899; 95% confidence interval [CI] 35.7–38.3) of administrations, 25.8% (<i>n</i> = 489; 95% CI 23.8–27.9) of which were rated as potentially serious. Intravenous infusions and injections had high error rates (64.7% [<i>n</i> = 514], 95% CI 61.3–68.0; and 77.4% [<i>n</i> = 188], 95% CI 71.7–82.2, respectively). For intravenous injections, 59.7% (95% CI 53.4–65.6) had potentially serious errors. No nurse characteristics were associated with MAEs. Intravenous route, early morning and weekend administrations, patient age ≥ 11 years, oral medications requiring solvents/diluents and eMM use were all significant risk factors. MAEs causing actual harm were 45% lower using an eMM compared with paper charts.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>Medication error prevention strategies should target intravenous administrations and not neglect older children in hospital. Attention to nurses’ work environments, including improved design and integration of medication technologies, is warranted.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140036107","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 Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance). 摩洛哥实施大学草药药物警戒课程的经验(植物警戒)。
IF 4.2 2区 医学
Drug Safety Pub Date : 2024-03-01 Epub Date: 2023-11-15 DOI: 10.1007/s40264-023-01372-7
Souad Skalli
{"title":"The Moroccan Experience of Implementing a University Curriculum for the Pharmacovigilance of Herbal Medicines (Phytovigilance).","authors":"Souad Skalli","doi":"10.1007/s40264-023-01372-7","DOIUrl":"10.1007/s40264-023-01372-7","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"107590538","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
An Overview of Regression Models for Adverse Events Analysis. 不良事件分析的回归模型综述。
IF 4.2 2区 医学
Drug Safety Pub Date : 2024-03-01 Epub Date: 2023-11-25 DOI: 10.1007/s40264-023-01380-7
Elsa Coz, Mathieu Fauvernier, Delphine Maucort-Boulch
{"title":"An Overview of Regression Models for Adverse Events Analysis.","authors":"Elsa Coz, Mathieu Fauvernier, Delphine Maucort-Boulch","doi":"10.1007/s40264-023-01380-7","DOIUrl":"10.1007/s40264-023-01380-7","url":null,"abstract":"<p><p>Over the last few years, several review articles described the adverse events analysis as sub-optimal in clinical trials. Indeed, the context surrounding adverse events analyses often imply an overwhelming number of events, a lack of power to find associations, but also a lack of specific training regarding those complex data. In randomized controlled trials or in observational studies, comparing the occurrence of adverse events according to a covariable of interest (e.g., treatment) is a recurrent question in the analysis of drug safety data, and adjusting other important factors is often relevant. This article is an overview of the existing regression models that may be considered to compare adverse events and to discuss model choice regarding the characteristics of the adverse events of interest. Many dimensions may be relevant to compare the adverse events between patients, (e.g., timing, recurrence, and severity). Recent efforts have been made to cover all of them. For chronic treatments, the occurrence of intercurrent events during the patient follow-up usually needs the modeling approach to be adapted (at least with regard to their interpretation). Moreover, analysis based on regression models should not be limited to the estimation of relative effects. Indeed, absolute risks stemming from the model should be presented systematically to help the interpretation, to validate the model, and to encourage comparison of studies.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10874334/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138440514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries. 2001 年至 2019 年与药物不良事件相关的死亡率的国际趋势:对世界卫生组织 54 个国家死亡率数据库的分析》(International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries)。
IF 4.2 2区 医学
Drug Safety Pub Date : 2024-03-01 Epub Date: 2023-12-22 DOI: 10.1007/s40264-023-01387-0
Toshihiro Koyama, Shunya Iinuma, Michio Yamamoto, Takahiro Niimura, Yuka Osaki, Sayoko Nishimura, Ko Harada, Yoshito Zamami, Hideharu Hagiya
{"title":"International Trends in Adverse Drug Event-Related Mortality from 2001 to 2019: An Analysis of the World Health Organization Mortality Database from 54 Countries.","authors":"Toshihiro Koyama, Shunya Iinuma, Michio Yamamoto, Takahiro Niimura, Yuka Osaki, Sayoko Nishimura, Ko Harada, Yoshito Zamami, Hideharu Hagiya","doi":"10.1007/s40264-023-01387-0","DOIUrl":"10.1007/s40264-023-01387-0","url":null,"abstract":"<p><strong>Background and objective: </strong>Adverse drug events (ADEs) are becoming a significant public health issue. However, reports on ADE-related mortality are limited to national-level evaluations. Therefore, we aimed to reveal overall trends in ADE-related mortality across the 21st century on an international level.</p><p><strong>Methods: </strong>This observational study analysed long-term trends in ADE-related mortality rates from 2001 to 2019 using the World Health Organization Mortality Database. The rates were analysed according to sex, age and region. North America, Latin America and the Caribbean, Western Europe, Eastern Europe and Western Pacific regions were assessed. Fifty-four countries were included with four-character International Statistical Classification of Disease and Related Health Problems, Tenth Revision codes in the database, population data in the World Population Prospects 2019 report, mortality data in more than half of the study period, and high-quality or medium-quality death registration data. A locally weighted regression curve was used to show international trends in age-standardised rates.</p><p><strong>Results: </strong>The global ADE-related mortality rate per 100,000 population increased from 2.05 (95% confidence interval 0.92-3.18) in 2001 to 6.86 (95% confidence interval 5.76-7.95) in 2019. Mortality rates were higher among men than among women, especially in those aged 20-50 years. The population aged ≥ 75 years had higher ADE-related mortality rates than the younger population. North America had the highest mortality rate among the five regions. The global ADE-related mortality rate increased by approximately 3.3-fold from 2001 to 2019.</p><p><strong>Conclusions: </strong>The burden of ADEs has increased internationally with rising mortality rates. Establishing pharmacovigilance systems can facilitate efforts to reduce ADE-related mortality rates globally.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138828687","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
Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS. 提高研究药物定义的透明度:用于规范 FAERS 中药物名称的开源 Living DiAna 字典。
IF 4.2 2区 医学
Drug Safety Pub Date : 2024-03-01 Epub Date: 2024-01-04 DOI: 10.1007/s40264-023-01391-4
Michele Fusaroli, Valentina Giunchi, Vera Battini, Stefano Puligheddu, Charles Khouri, Carla Carnovale, Emanuel Raschi, Elisabetta Poluzzi
{"title":"Enhancing Transparency in Defining Studied Drugs: The Open-Source Living DiAna Dictionary for Standardizing Drug Names in the FAERS.","authors":"Michele Fusaroli, Valentina Giunchi, Vera Battini, Stefano Puligheddu, Charles Khouri, Carla Carnovale, Emanuel Raschi, Elisabetta Poluzzi","doi":"10.1007/s40264-023-01391-4","DOIUrl":"10.1007/s40264-023-01391-4","url":null,"abstract":"<p><strong>Introduction: </strong>In refining drug safety signals, defining the object of study is crucial. While research has explored the effect of different event definitions, drug definition is often overlooked. The US FDA Adverse Event Reporting System (FAERS) records drug names as free text, necessitating mapping to active ingredients. Although pre-mapped databases exist, the subjectivity and lack of transparency of the mapping process lead to a loss of control over the object of study.</p><p><strong>Objective: </strong>We implemented the DiAna dictionary, systematically mapping individual free-text instances to their corresponding active ingredients and linking them to the World Health Organization Anatomical Therapeutic Chemical (WHO-ATC) classification.</p><p><strong>Methods: </strong>We retrieved all drug names reported to the FAERS (2004-December 2022). Using existing vocabularies and string editing, we automatically mapped free text to ingredients. We manually revised the mapping and linked it to the ATC classification.</p><p><strong>Results: </strong>We retrieved 18,151,842 reports, with 74,143,411 drug entries. We manually checked the first 14,832 terms, up to terms occurring over 200 times (96.88% of total drug entries), to 6282 unique active ingredients. Automatic unchecked translations extend the standardization to 346,854 terms (98.94%). The DiAna dictionary showed a higher sensitivity compared with RxNorm alone, particularly for specific drugs (e.g., rimegepant, adapalene, drospirenone, umeclidinium). The most prominent drug classes in the FAERS were immunomodulating (37.40%) and neurologic drugs (29.19%).</p><p><strong>Conclusion: </strong>The DiAna dictionary, as a dynamic open-source tool, provides transparency and flexibility, enabling researchers to actively shape drug definitions during the mapping phase. This empowerment enhances accuracy, reproducibility, and interpretability of results.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10874306/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139086304","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project. 验证评估妊娠相关药物警戒病例报告中临床信息质量的新方法:ConcePTION 项目。
IF 4.2 2区 医学
Drug Safety Pub Date : 2024-03-01 Epub Date: 2024-01-06 DOI: 10.1007/s40264-023-01389-y
Yrea R J van Rijt-Weetink, Toine C G Egberts, Florence P A M van Hunsel, David J Lewis, Laura M Yates, Ursula Winterfeld, Eugène P van Puijenbroek
{"title":"Validation of a Novel Method to Assess the Clinical Quality of Information in Pregnancy-Related Pharmacovigilance Case Reports: A ConcePTION Project.","authors":"Yrea R J van Rijt-Weetink, Toine C G Egberts, Florence P A M van Hunsel, David J Lewis, Laura M Yates, Ursula Winterfeld, Eugène P van Puijenbroek","doi":"10.1007/s40264-023-01389-y","DOIUrl":"10.1007/s40264-023-01389-y","url":null,"abstract":"<p><strong>Background: </strong>To assess the causal relationship between a medicinal product and a reported event, relevant information needs to be present. Information elements for assessing cases of exposure to medicinal products during pregnancy were predefined and used in a new tool to assess the quality of information. However, the extent in which the presence or absence of these predefined information elements is associated with the overall clinical quality of these cases, as evaluated by pharmacovigilance experts, remains uncertain.</p><p><strong>Objective: </strong>We aimed to validate a novel method to assess the clinical quality of information in real-world pregnancy pharmacovigilance case reports.</p><p><strong>Methods: </strong>The clinical quality of case reports regarding medicinal product exposure and pregnancy-related outcomes was appraised from spontaneous reports, literature, Teratology Information Services (UK and Switzerland), The Dutch Pregnancy Drug Register, the Gilenya pregnancy registry and the Enhanced PV programme of Novartis. Assessment was done by means of the novel standardised tool based on the presence and relevance of information, and by expert judgement. The novel tool was validated compared to the expert assessment as the gold standard expressed as the area under the receiver operating characteristic curves, after which the sensitivity and specificity were calculated using cross-tabulations. Inter-rater variability was determined by means of weighted Cohen's kappa.</p><p><strong>Results: </strong>One hundred and eighty-six case reports were included. The clinical quality score as assessed by the novel method was divided into three categories with cut-off values of 45% (poor to intermediate) and 65% (intermediate to excellent). Sensitivity was 0.93 and 0.96 for poor to intermediate and intermediate to excellent, respectively. Specificity was respectively 0.52 and 0.73. Inter-rater variability was 0.65 (95% confidence interval 0.53-0.78) for the newly developed approach, and 0.40 (95% confidence interval 0.28-0.52) for the gold standard assessment.</p><p><strong>Conclusions: </strong>The tool described in this study using the presence and relevance of elements of information is the first designed, validated and standardised method for the assessment of the quality of information of case reports in pregnancy pharmacovigilance data. This method confers less inter-rater variability compared with a quality assessment by experts of pregnancy-related pharmacovigilance data.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10874330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139110890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations. COVID-19国际药物妊娠登记处(COVID-PR):方案考虑事项。
IF 4.2 2区 医学
Drug Safety Pub Date : 2024-03-01 Epub Date: 2023-11-16 DOI: 10.1007/s40264-023-01377-2
Diego F Wyszynski, Aris T Papageorghiou, Cheryl Renz, Torri D Metz, Sonia Hernández-Díaz
{"title":"The COVID-19 International Drug Pregnancy Registry (COVID-PR): Protocol Considerations.","authors":"Diego F Wyszynski, Aris T Papageorghiou, Cheryl Renz, Torri D Metz, Sonia Hernández-Díaz","doi":"10.1007/s40264-023-01377-2","DOIUrl":"10.1007/s40264-023-01377-2","url":null,"abstract":"<p><strong>Background and objective: </strong>Over the past 2 years, several drugs have been approved for coronavirus disease 2019 (COVID-19) treatment, but their safety during pregnancy remains poorly understood. This study aims to assess the relative risk of obstetric, neonatal, and infant outcomes associated with the use of drugs specifically indicated for the treatment of COVID-19 compared with other drug treatment strategies. The purpose of this article is to present elements of the study protocol.</p><p><strong>Methods: </strong>The COVID-19 International Drug Pregnancy Registry (COVID-PR) is a noninterventional, postmarketing cohort study. Pregnant women receiving treatment with monoclonal antibodies (mAbs) or antiviral drugs for mild, moderate, or severe COVID-19 are matched 1:1 with pregnant women not receiving these study-specific drugs, based on calendar time, country, gestational age at enrollment, and COVID-19 severity. Participants complete online questionnaires at enrollment, during pregnancy, and for 12 months after delivery of liveborn infants. The study began enrolling participants on 1 December 2021 and is set to span 5 years for each drug of interest.</p><p><strong>Discussion: </strong>The COVID-PR is designed to evaluate the safety profile of each studied drug. Additionally, it may allow for an analysis of the effects of COVID-19 drug exposure during relevant gestational periods on specific neonatal outcomes. Although the sample size will be too small to detect associations with rare outcomes, the study has the potential to generate hypotheses for future research. Ultimately, these data can provide valuable insights for evidence-based decisions about COVID-19 treatment during pregnancy.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT05013632. EU PAS EUPAS42517.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":null,"pages":null},"PeriodicalIF":4.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136396827","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
Risk of Major Bleeding Associated with Concomitant Direct-Acting Oral Anticoagulant and Clopidogrel Use: A Retrospective Cohort Study. 与同时使用直接作用口服抗凝剂和氯吡格雷有关的大出血风险:一项回顾性队列研究
IF 4.2 2区 医学
Drug Safety Pub Date : 2024-03-01 Epub Date: 2023-12-23 DOI: 10.1007/s40264-023-01388-z
Y Joseph Hwang, Hsien-Yen Chang, Thomas Metkus, Kathleen M Andersen, Sonal Singh, G Caleb Alexander, Hemalkumar B Mehta
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