ABSTRACT
Introduction: The literature shows that in Italy community pharmacists and patients are not active enough in reporting adverse drug reactions (ADRs) [1-3]. To improve these replies it has been set up VigiNetWork project (September 2020-September 2022): it is a multiregional (Emilia-Romagna and Veneto Region) pharmacovigilance (PV) project funded by the Italian Medicines Agency, joining pharmacists and citizens in pharmacovigilance activities within the community pharmacies. Objective(s): To develop a pharmacovigilance network among community pharmacies, to promote spontaneous ADRs reporting by pharmacists and patients and to improve pharmacists' knowledge on drug safety. Method(s): The project has been promoted through social networks, webinars, local newspapers, and the Category Professional Associations. An information leaflet explaining its characteristics, a free access to two e-learning courses and a personal access to a website (www.vigirete.it) have been made available to enrolled pharmacists. A similar leaflet has been developed for patients. To evaluate the effectiveness of VigiNetWork we assessed the number of enrolled community pharmacies/pharmacists and of ADR reports submitted by them, their participation to e-learning courses and their visits to the website. Result(s): From September 2020 to March 2022 a total of 669 and 371 community pharmacies were enrolled respectively in Emilia- Romagna and Veneto Region (Table 1). A total of 339 and 516 (about 90% of total reports from community pharmacists) ADR reports were submitted from the pharmacists of VigiNetWork respectively in Emilia-Romagna and Veneto Region and an increase in comparison to the previous 18 months was observed. The impact of the project in patient reporting was presumed, but not assessable. In our study period 40% and 58% of enrolled pharmacists registered for distance learning courses respectively in Emilia-Romagna and Veneto Region, even if only about 5% of them completed the training in both Regions. The website reached 2113 (86% of enrolled pharmacists) unique visitors. Conclusion(s): Our project showed a great attention of community pharmacists to PV, increased also due to COVID-19 pandemic. The total number of submitted reports, even if limited, represented almost the totality of all reports from community pharmacists in both Regions and their interest in our website contents was appreciable. More efforts could be done to continue these activities in daily practice. (Table Presented).
ABSTRACT
Introduction: Marketed COVID-19 vaccines showed an overall favourable safety profile in pivotal trials. However, those trials did not include high risk/fragile patient categories;hence, close monitoring of COVID-19 vaccine safety in those special cohorts in real-world setting is needed. The European Medicines Agency-funded "Covid- Vaccine-Monitor" project was set up to prospectively measure the incidence of solicited/unsolicited adverse events following COVID- 19 vaccination in several European Countries as reported by vaccinees through web-based questionnaires. Italy is one of the Countries participating in the project as a large network named "ilmiovaccinocovid19 collaborating group". Objective(s): To measure the incidence of vaccinee-reported adverse events following immunization (AEFIs) with marketed COVID-19 vaccines in pregnant and lactating women, pediatrics, immunocompromised, people with history of allergy and people with prior SARSCoV- 2 infection in Italy. Method(s): We performed a prospective cohort study of the abovementioned categories of vaccinees, who were recruited at multiple vaccination centers within 48 hours from either the first or booster COVID-19 vaccine dose administration. After providing informed consent and get registered into the web-app, vaccinees were asked to fill in an electronic baseline questionnaire and 6 follow-up questionnaires at different time points, within 6-month from vaccine administration, in which information on potential vaccine-related AEFIs were collected. We explored and compared the frequency of local and systemic solicited adverse events following first or booster dose for each special cohort and vaccine brands. Result(s): Overall, 1,331 vaccinees (40.4% first dose and 59.6% booster dose) were included in the analysis. Of these, 8.4% were immunocompromised, 32.0% had history of allergy, 25.5% had prior SARS-CoV-2 infection, 23.4% were children/adolescents, 6.2% were pregnant and 4.6% were lactating women (non-mutually exclusive cohorts). Of subjects belonging to at least one cohort, 52.3% reported at least one AEFI following either the first or booster dose. Among all special cohorts, injection site pain was the most frequently reported solicited local AEFI, after both the first (37.5%) and booster (39.5%) dose. As solicited systemic AEFIs, headache (19.0%) was the most frequently reported after the first dose, while malaise (23.7%) and fatigue (23.7%) after the booster dose. The frequency of severe AEFIs was very low following both first dose (0.8%) and booster dose (0.6%). Conclusion(s): Overall, this study confirmed the favourable safety profile of COVID-19 vaccines also in the above-mentioned special categories who have not (or marginally) been included in pivotal trials.
ABSTRACT
Introduction: The literature shows that in Italy community pharmacists and patients are not active enough in reporting adverse drug reactions (ADRs) [1-3]. To improve these replies it has been set up VigiNetWork project (September 2020-September 2022): it is a multiregional (Emilia-Romagna and Veneto Region) pharmacovigilance (PV) project funded by the Italian Medicines Agency, joining pharmacists and citizens in pharmacovigilance activities within the community pharmacies. Objective: To develop a pharmacovigilance network among community pharmacies, to promote spontaneous ADRs reporting by pharmacists and patients and to improve pharmacists' knowledge on drug safety. Methods: The project has been promoted through social networks, webinars, local newspapers, and the Category Professional Associations. An information leaflet explaining its characteristics, a free access to two e-learning courses and a personal access to a website (www.vigirete.it) have been made available to enrolled pharmacists. A similar leaflet has been developed for patients. To evaluate the effectiveness of VigiNetWork we assessed the number of enrolled community pharmacies/pharmacists and of ADR reports submitted by them, their participation to e-learning courses and their visits to the website. Results: From September 2020 to March 2022 a total of 669 and 371 community pharmacies were enrolled respectively in Emilia-Romagna and Veneto Region (Table 1). A total of 339 and 516 (about 90% of total reports from community pharmacists) ADR reports were submitted from the pharmacists of VigiNetWork respectively in Emilia-Romagna and Veneto Region and an increase in comparison to the previous 18 months was observed. The impact of the project in patient reporting was presumed, but not assessable. In our study period 40% and 58% of enrolled pharmacists registered for distance learning courses respectively in Emilia-Romagna and Veneto Region, even if only about 5% of them completed the training in both Regions. The website reached 2113 (86% of enrolled pharmacists) unique visitors.Conclusion: Our project showed a great attention of community pharmacists to PV, increased also due to COVID-19 pandemic. The total number of submitted reports, even if limited, represented almost the totality of all reports from community pharmacists in both Regions and their interest in our website contents was appreciable. More efforts could be done to continue these activities in daily practice.
ABSTRACT
Introduction: Marketed COVID-19 vaccines showed an overall favourable safety profile in pivotal trials. However, those trials did not include high risk/fragile patient categories;hence, close monitoring of COVID-19 vaccine safety in those special cohorts in real-world setting is needed. The European Medicines Agency-funded "Covid-Vaccine-Monitor" project was set up to prospectively measure the incidence of solicited/unsolicited adverse events following COVID-19 vaccination in several European Countries as reported by vaccinees through web-based questionnaires. Italy is one of the Countries participating in the project as a large network named "ilmiovaccinocovid19 collaborating group". Objective: To measure the incidence of vaccinee-reported adverse events following immunization (AEFIs) with marketed COVID-19 vaccines in pregnant and lactating women, pediatrics, immunocompromised, people with history of allergy and people with prior SARS-CoV- 2 infection in Italy. Methods: We performed a prospective cohort study of the abovementioned categories of vaccinees, who were recruited at multiple vaccination centers within 48 hours from either the first or booster COVID-19 vaccine dose administration. After providing informed consent and get registered into the web-app, vaccinees were asked to fill in an electronic baseline questionnaire and 6 follow-up questionnaires at different time points, within 6-month from vaccine administration, in which information on potential vaccine-related AEFIs were collected. We explored and compared the frequency of local and systemic solicited adverse events following first or booster dose for each special cohort and vaccine brands. Results: Overall, 1,331 vaccinees (40.4% first dose and 59.6% booster dose) were included in the analysis. Of these, 8.4% were immunocompromised, 32.0% had history of allergy, 25.5% had prior SARS-CoV-2 infection, 23.4% were children/adolescents, 6.2% were pregnant and 4.6% were lactating women (non-mutually exclusive cohorts). Of subjects belonging to at least one cohort, 52.3% reported at least one AEFI following either the first or booster dose. Among all special cohorts, injection site pain was the most frequently reported solicited local AEFI, after both the first (37.5%) and booster (39.5%) dose. As solicited systemic AEFIs, headache (19.0%) was the most frequently reported after the first dose, while malaise (23.7%) and fatigue (23.7%) after the booster dose. The frequency of severe AEFIs was very low following both first dose (0.8%) and booster dose (0.6%). Conclusion: Overall, this study confirmed the favourable safety profile of COVID-19 vaccines also in the above-mentioned special categories who have not (or marginally) been included in pivotal trials.
ABSTRACT
Introduction: The Istituto Superiore di Sanita and the Agenzia Italiana del Farmaco coordinate the project TheShinISS-Vax, Flu, a post-marketing "active" surveillance of influenza vaccines. We report the results of the investigation using the Self- Controlled Case Series (SCCS) design on influenza vaccine and Guillain-Barre syndrome in vaccinated population aged over than 6 months, during the influenza vaccine campaign 2020-2021 in Italy. Materials and methods: A SCCS multi-regional study was carried out using linked data from Regional Health Care Registries of Valle d'Aosta, Friuli Venezia Giulia, Emilia-Romagna, Toscana, Lazio, Campania, and Puglia. Relative incidence of Guillain-Barre syndrome was estimated, comparing the exposure risk periods (0-41 days from the vaccination day, subdivided in six intervals) with the unexposed period.