tetano
Editor, Senior Moderator
JMIR Public Health Surveill. 2019 Nov 14;5(4):e12016. doi: 10.2196/12016. [h=1]Enhanced Safety Surveillance of Influenza Vaccines in General Practice, Winter 2015-16: Feasibility Study.[/h]
de Lusignan S[SUP]1[/SUP], Correa A[SUP]1[/SUP], Dos Santos G[SUP]2[/SUP], Meyer N[SUP]2[/SUP], Haguinet F[SUP]2[/SUP], Webb R[SUP]1[/SUP], McGee C[SUP]1,[/SUP][SUP]3[/SUP], Byford R[SUP]1[/SUP], Yonova I[SUP]1,[/SUP][SUP]3[/SUP], Pathirannehelage S[SUP]1[/SUP], Ferreira FM[SUP]1[/SUP], Jones S[SUP]1,[/SUP][SUP]4[/SUP].
[h=3]Author information[/h] 1 University of Surrey, Department of Clinical and Experimental Medicine, Guildford, United Kingdom. 2 GlaxoSmithKline, Wavre, Belgium. 3 Royal College of General Practitioners, London, United Kingdom. 4 NYU School of Medicine, Department of Population Health, New York, NY, United States.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] The 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.
[h=4]OBJECTIVE:[/h] This 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.
[h=4]METHODS:[/h] A 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.
[h=4]RESULTS:[/h] Our 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.
[h=4]CONCLUSIONS:[/h] Overall, 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.
[h=4]INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):[/h] RR2-10.1136/bmjopen-2016-015469.
?Simon de Lusignan, Ana Correa, Ga?l Dos Santos, Nadia Meyer, Fran?ois Haguinet, Rebecca Webb, Christopher McGee, Rachel Byford, Ivelina Yonova, Sameera Pathirannehelage, Filipa Matos Ferreira, Simon Jones. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 14.11.2019.
[h=4]KEYWORDS:[/h] England; drug-related side effects and adverse reactions; general practice; influenza vaccines; influenza, human; medical records systems, computerized; safety management; vaccines
PMID: 31724955 DOI: 10.2196/12016
de Lusignan S[SUP]1[/SUP], Correa A[SUP]1[/SUP], Dos Santos G[SUP]2[/SUP], Meyer N[SUP]2[/SUP], Haguinet F[SUP]2[/SUP], Webb R[SUP]1[/SUP], McGee C[SUP]1,[/SUP][SUP]3[/SUP], Byford R[SUP]1[/SUP], Yonova I[SUP]1,[/SUP][SUP]3[/SUP], Pathirannehelage S[SUP]1[/SUP], Ferreira FM[SUP]1[/SUP], Jones S[SUP]1,[/SUP][SUP]4[/SUP].
[h=3]Author information[/h] 1 University of Surrey, Department of Clinical and Experimental Medicine, Guildford, United Kingdom. 2 GlaxoSmithKline, Wavre, Belgium. 3 Royal College of General Practitioners, London, United Kingdom. 4 NYU School of Medicine, Department of Population Health, New York, NY, United States.
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] The 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.
[h=4]OBJECTIVE:[/h] This 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.
[h=4]METHODS:[/h] A 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.
[h=4]RESULTS:[/h] Our 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.
[h=4]CONCLUSIONS:[/h] Overall, 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.
[h=4]INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):[/h] RR2-10.1136/bmjopen-2016-015469.
?Simon de Lusignan, Ana Correa, Ga?l Dos Santos, Nadia Meyer, Fran?ois Haguinet, Rebecca Webb, Christopher McGee, Rachel Byford, Ivelina Yonova, Sameera Pathirannehelage, Filipa Matos Ferreira, Simon Jones. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 14.11.2019.
[h=4]KEYWORDS:[/h] England; drug-related side effects and adverse reactions; general practice; influenza vaccines; influenza, human; medical records systems, computerized; safety management; vaccines
PMID: 31724955 DOI: 10.2196/12016