Enhanced Safety Surveillance of Influenza Vaccines in General Practice, Winter 2015-16: Feasibility Study.

ABSTRACT:

Background

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.

Objective

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.

Methods

A total of 9 GPs in E

SUBMITTER: de Lusignan S 

PROVIDER: S-EPMC6913774 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature