Greg Powell, Vijay Kara, Daniel Naranjo, Mangesh Kulkarni, Kerri Best-Sule, Trinka Coster, Machaon Bonafede, Shruti Gangadhar, Lee Kallenbach, Andrew Bate
{"title":"Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event Information.","authors":"Greg Powell, Vijay Kara, Daniel Naranjo, Mangesh Kulkarni, Kerri Best-Sule, Trinka Coster, Machaon Bonafede, Shruti Gangadhar, Lee Kallenbach, Andrew Bate","doi":"10.1007/s43441-024-00711-9","DOIUrl":"https://doi.org/10.1007/s43441-024-00711-9","url":null,"abstract":"<p><p>A digital point-of-care solution was implemented to test the feasibility of near-real-time bi-directional communication between pharmacovigilance experts (PVEs) and healthcare professionals (HCPs) for exchanging unique and informative adverse event (AE) information. The solution was implemented in a commercially available electronic health record (EHR) system/platform, no direct contact between PVEs and the HCPs was possible. The Clinical Affairs team of the EHR vendor was used as an intermediary to ensure appropriate information was exchanged while protecting HCP and patient privacy. The study yielded 9 drug-event pairs of interest (AEI), 2 of which were confirmed as AEs by the HCP. On average it took 20.6 h to receive initial AEI information and 58.8 h to receive follow-up information, which represents a 96% reduction in time compared to current methods. Both interactions provided unique data that would not have been collected otherwise leading to the PVE being able to appropriately determine a potential causal association. This study successfully demonstrated the feasibility of using a compliant, bi-directional, digitally enabled clinical communication channel at the point of care to complement existing pharmacovigilance activities.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142648745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Solange Corriol-Rohou, Sabine Ingeborg Fürst-Recktenwald, Elin-Haf Davies, Martine Dehlinger-Kremer, Mark A Turner
{"title":"Better Medicines for Children: Lessons Learnt and Share Learnings at the EFGCP Annual Paediatric Conferences.","authors":"Solange Corriol-Rohou, Sabine Ingeborg Fürst-Recktenwald, Elin-Haf Davies, Martine Dehlinger-Kremer, Mark A Turner","doi":"10.1007/s43441-024-00710-w","DOIUrl":"https://doi.org/10.1007/s43441-024-00710-w","url":null,"abstract":"<p><p>For many years, the European Forum for Good Clinical Practice (EFGCP) Children Medicines Working Party has organised a Paediatric conference annually. In the past, this event was organised jointly with the European Medicines Agency who was used to host it, along with the Drug Information Association (DIA). This conference is the opportunity for all involved in paediatric drug development, i.e., regulators, HTA bodies, patients' representatives, academia and industry, to share learnings and raise awareness about new regulatory requirements of interest to optimise paediatric drug development. The theme of the 2021 conference was \"Challenges and Solutions - the path forward\" while in 2022 it focused on \"Progress made and Continuing Challenges\". Because of the COVID-19 pandemic these two conferences were organised virtually. However, this has not impacted the attendance and value of the conference, since because of a broad and attractive agenda there was a wide stakeholder participation, which provided a compendious overview of the leading issues to improve children's access to innovative medicines.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628584","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"An Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for MAGnetic Expansion Control Spinal Rods.","authors":"Jack Filan, Andrew Bowey, Thomas Joyce","doi":"10.1007/s43441-024-00724-4","DOIUrl":"https://doi.org/10.1007/s43441-024-00724-4","url":null,"abstract":"<p><strong>Background: </strong>MAGnetic Expansion Control (MAGEC) rods can prevent repeated lengthening operations for scoliosis patients. However, there have been several Field Safety Notices issued, including a worldwide product recall due to actuator endcap separation. We aimed to review adverse events reported to the Food and Drug Administration (FDA) regarding MAGEC rods, focusing on MAGEC X.</p><p><strong>Methods: </strong>Reports submitted to the Manufacturer and User Facility Device Experience database in relation to MAGEC devices were accessed and analysed using R Statistical Software. Exclusion criteria included duplicate and literature review reports (n = 54). Free-text data were analysed using inductive content analysis.</p><p><strong>Results: </strong>1016 adverse events were reported to 11/30/2023. 99.0% (1006) were submitted by the manufacturer. Reports primarily arose from the UK (465, 45.8%) or US (421, 41.4%). From free-text data the most frequent adverse events were distraction mechanism failure (573), device wear (272), and actuator seal damage (180). Rod fracture (n = 48) was not significantly associated with rod diameter (≤ 5.0 mm or > 5.0 mm), p = 0.736. 234 reports referenced MAGEC X devices; actuator endcap separation was identified in 41.9% (99). Other events include failure of distraction (63), surface damage (31), and rod fracture (15). On 06/30/2020 MAGEC X2 received FDA approval. Twenty reports reference devices manufactured after this date, seven describe distraction mechanism failure; notably there are no reports of endcap separation.</p><p><strong>Conclusion: </strong>These data represent the largest series of adverse events reported for MAGEC rods, including significant new data regarding MAGEC X. As well as endcap separation, failure of distraction, surface damage, and rod fracture were reported.</p>","PeriodicalId":23084,"journal":{"name":"Therapeutic innovation & regulatory science","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
