ArticleJMIR public health and surveillance2019
Enhanced Safety Surveillance of Influenza Vaccines in General Practice, Winter 2015-16: Feasibility Study.
Article in JMIR public health and surveillance, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Safety monitoring of GSK's quadrivalent seasonal influenza vaccine in European countries during the 2023/24 flu season: A multicenter, non-interventional study.Human vaccines & immunotherapeutics · 2025Observational
- Enhanced Safety Surveillance of GSK's Inactivated Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain During the 2022/2023 Influenza Season.Drug safety · 2024Article
- Observational
- Arrhythmias after COVID-19 Vaccination: Have We Left All Stones Unturned?International journal of molecular sciences · 2023Review
- Enhanced safety surveillance of GSK's quadrivalent seasonal influenza vaccine in Germany and Spain (2021/2022 season) using an electronic patient-reported outcome system for vaccine safety remote monitoring.Influenza and other respiratory viruses · 2023Article
- Article
- Brand-Specific Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season.Drug safety · 2020Article
- Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany, and Spain for the 2018/19 Season: Interim Analysis.Advances in therapy · 2019Article
- Article
- Challenges in implementing yearly enhanced safety surveillance of influenza vaccination in Europe: lessons learned and future perspectives.Human vaccines & immunotherapeutics · 2019Review
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced real-time surveillance of seasonal influenza vaccination. The EMA has specified a list of adverse events of interest to be monitored. The EMA sets out 3 different ways to conduct such surveillance: (1) active surveillance, (2) enhanced passive surveillance, or (3) electronic health record data mining (EHR-DM). English general practice (GP) is a suitable setting to implement enhanced passive surveillance and EHR-DM.
objectiveThis study aimed to test the feasibility of conducting enhanced passive surveillance in GP using the yellow card scheme (adverse events of interest reporting cards) to determine if it has any advantages over EHR-DM alone.
methodsA total of 9 GPs in England participated, of which 3 tested the feasibility of enhanced passive surveillance and the other 6 EHR-DM alone. The 3 that tested EPS provided patients with yellow (adverse events) cards for patients to report any adverse events. Data were extracted from all 9 GPs' EHRs between weeks 35 and 49 (08/24/2015 to 12/06/2015), the main period of influenza vaccination. We conducted weekly analysis and end-of-study analyses.
resultsOur GPs were largely distributed across England with a registered population of 81,040. In the week 49 report, 15,863/81,040 people (19.57% of the registered practice population) were vaccinated. In the EPS practices, staff managed to hand out the cards to 61.25% (4150/6776) of the vaccinees, and of these cards, 1.98% (82/4150) were returned to the GP offices. Adverse events of interests were reported by 113 /7223 people (1.56%) in the enhanced passive surveillance practices, compared with 322/8640 people (3.73%) in the EHR-DM practices.
conclusionsOverall, we demonstrated that GPs EHR-DM was an appropriate method of enhanced surveillance. However, the use of yellow cards, in enhanced passive surveillance practices, did not enhance the collection of adverse events of interests as demonstrated in this study. Their return rate was poor, data entry from them was not straightforward, and there were issues with data reconciliation. We concluded that customized cards prespecifying the EMA's adverse events of interests, combined with EHR-DM, were needed to maximize data collection. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2016-015469.
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