Introduction: The COVID-19 pandemic determined a necessary reorganization of pharmacovigilance resources and strategies, particularly after vaccines authorization. Enhanced monitoring and quality of ICSRs is crucial for the causality assessment of the adverse events following immunization (AEFI) occurred in the COVID-19 vaccinated population [1]. Objective: To evaluate the effectiveness of enhanced Italian Pharmacovigilance activities during the first year of COVID-19 vaccination campaign on the quality of the ICSRs. Methods: The Italian PharmacoVigilance System is a network connecting the Italian Medicine Agency (AIFA) to local health authorities [2]. The collected ICRSs were prioritized by seriousness, special interest and disproportionality and harmonized for coding and key information requirements. Further follow up information were requested to reporters from Local/Regional PhV Representatives or AIFA. Targeted templates tailored on Brighton Collaboration Group case definitions were implemented for adverse events of special interest (AESI) [3]. The percentage of completed ICSRs by fields and the rate of evaluable causality assessments by WHO causality assessment tool for AEFI [4] were used as indicators for descriptive analysis of effectiveness. Completeness of ICSRs was evaluated for the following AESI: anaphylaxis, Guillain-Barre` syndrome, peripheral facial palsy, vaccine-induced thrombotic thrombocytopenia, myocarditis and pericarditis. Results: Between 26 December 2020 and 26 December 2021, 117.920 ICSRs were reported (98.717 not serious and 19.055 serious). Overall, patients’ demographic field were updated in 35% of ICSRs, with a total of 97,6% of cases with valid age and sex data. Suspected medicinal products section was modified in 11% of ICSRs with 91% of cases reporting batch number and administration date. Follow up was obtained in 26% of ICSRs (7% after AIFA request). Available information on seriousness and outcome was reported in 97,6% of cases. Time-to-onset was assessable in 95,2% of cases. Overall, causality assessment was applicable in 15.731/19055 (83%) of serious reports, only 751/15.731 (4,8%) of which was unclassifiable. Follow up information was not obtained in 831/3887 cases related to selected AESI (21%). Complete clinical data were available in the remaining 3056/3887 ICSRs (79%) and were used for BCG classification as cases (38%) or not cases (62%). Conclusion: A harmonized approach to ICSR enhanced surveillance and management through a structured Pharmacovigilance network was effective in improving the quality of AEFI reports related to COVID-19 vaccines, resulting in a high percentage of cases with complete information.
The Italian Approach to Improve Standard Quality of ICSRs for COVID 19 Vaccines: From Patient Data to Causality Assessment / Marchione, P.; Felicetti, P.; Petronzelli, F.; Marvulli, M.; Saccomandi, V.; Conte, M.; Guarducci, M.; Pimpinella, G.; Marra, A. R.. - In: DRUG SAFETY. - ISSN 0114-5916. - (2022).
The Italian Approach to Improve Standard Quality of ICSRs for COVID 19 Vaccines: From Patient Data to Causality Assessment
P. Marchione;P. Felicetti;M. Marvulli;G. Pimpinella;
2022
Abstract
Introduction: The COVID-19 pandemic determined a necessary reorganization of pharmacovigilance resources and strategies, particularly after vaccines authorization. Enhanced monitoring and quality of ICSRs is crucial for the causality assessment of the adverse events following immunization (AEFI) occurred in the COVID-19 vaccinated population [1]. Objective: To evaluate the effectiveness of enhanced Italian Pharmacovigilance activities during the first year of COVID-19 vaccination campaign on the quality of the ICSRs. Methods: The Italian PharmacoVigilance System is a network connecting the Italian Medicine Agency (AIFA) to local health authorities [2]. The collected ICRSs were prioritized by seriousness, special interest and disproportionality and harmonized for coding and key information requirements. Further follow up information were requested to reporters from Local/Regional PhV Representatives or AIFA. Targeted templates tailored on Brighton Collaboration Group case definitions were implemented for adverse events of special interest (AESI) [3]. The percentage of completed ICSRs by fields and the rate of evaluable causality assessments by WHO causality assessment tool for AEFI [4] were used as indicators for descriptive analysis of effectiveness. Completeness of ICSRs was evaluated for the following AESI: anaphylaxis, Guillain-Barre` syndrome, peripheral facial palsy, vaccine-induced thrombotic thrombocytopenia, myocarditis and pericarditis. Results: Between 26 December 2020 and 26 December 2021, 117.920 ICSRs were reported (98.717 not serious and 19.055 serious). Overall, patients’ demographic field were updated in 35% of ICSRs, with a total of 97,6% of cases with valid age and sex data. Suspected medicinal products section was modified in 11% of ICSRs with 91% of cases reporting batch number and administration date. Follow up was obtained in 26% of ICSRs (7% after AIFA request). Available information on seriousness and outcome was reported in 97,6% of cases. Time-to-onset was assessable in 95,2% of cases. Overall, causality assessment was applicable in 15.731/19055 (83%) of serious reports, only 751/15.731 (4,8%) of which was unclassifiable. Follow up information was not obtained in 831/3887 cases related to selected AESI (21%). Complete clinical data were available in the remaining 3056/3887 ICSRs (79%) and were used for BCG classification as cases (38%) or not cases (62%). Conclusion: A harmonized approach to ICSR enhanced surveillance and management through a structured Pharmacovigilance network was effective in improving the quality of AEFI reports related to COVID-19 vaccines, resulting in a high percentage of cases with complete information.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
