title: Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety.
abstract: Post licensure surveillance of adverse events following immunization (AEFI) is a fundamental activity to improve safety and maintain public confidence in vaccines.   Since 2011, the Liguria Region has been involved in the inter-regional project of post-marketing surveillance of AEFI, coordinated by the Italian Medicine Agency and the Veneto region. The main objectives of the project are: (1) to coordinate the surveillance activities in the 8 Italian Regions included in the project; (2) to encourage the signal of AEFI by healthcare workers and patients; (3) to organize education activities addressed to health care workers, and, finally; (4) to establish vaccination counseling services in each Region. In particular, the Ligurian multidisciplinary team, composed by physicians expert in the field of vaccination and pharmacists, is involved in the causality assessment between vaccines and all adverse events signaled within the Liguria Region and in the analysis of all adverse events signaled in Italy as possibly related to influenza vaccines. During 2013, the team has organized 4 courses, addressed to healthcare personnel of vaccination outpatient clinics, focused on European and Italian legislation on pharmaco-vigilance and vaccine-vigilance and aimed at promoting signal of AEFI. Since October 2013, the Liguria Region has been participating to the inter-regional project of active surveillance of adverse events aimed at promoting the signal of AEFI by parents of vaccinated infants. After two years of implementation of the project both the number of reported AEFI and the reporting rate per 100 000 administered doses of vaccine increased. The activities need to be consolidated in the next years in order to guarantee high standard of vaccine safety, maintain the confidence in current immunization programs and reach optimal vaccination coverage rate.
authors.affiliation: a Department of Health Sciences, Vaccines and Clinical Trials Unit; University of Genoa; Italy and I.R.C.C.S. University Hospital San Martino; IST National Institute for Cancer Research; Genoa, Italy.
authors.forename: Cristiano
authors.initials: C
authors.lastname: Alicino
authors.forename: Caterina
authors.initials: C
authors.lastname: Merlano
authors.forename: Simona
authors.initials: S
authors.lastname: Zappettini
authors.forename: Sergio
authors.initials: S
authors.lastname: Schiaffino
authors.forename: Giovanni
authors.initials: G
authors.lastname: Della Luna
authors.forename: Cristina
authors.initials: C
authors.lastname: Accardo
authors.forename: Roberto
authors.initials: R
authors.lastname: Gasparini
authors.forename: Paolo
authors.initials: P
authors.lastname: Durando
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Icardi
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D007558:Italy; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000706:statistics & numerical data; D011635:Public Health Administration / Q000379:methods / Q000706:statistics & numerical data
chemical_list: D007252:Influenza Vaccines
keywords: AEFI; Vaccine-vigilance; adverse events following immunization; immunization; safety; surveillance