Introduction: The FARO project is an Italian multiregional project of active surveillance of drug safety in emergency department (ED). [1] Aim: We analyzed all the individual case safety reports (ICSRs) collected in the FARO database in the first three years of the project for the Tuscany region. We also analyzed the contribution of the project to the Tuscany reports. Methods: A total of 9 hospitals contributed to the FARO project in Tuscany. Dedicated monitors screened everyday ED visits using key words related to possible adverse drug reactions (ADR) (e.g., druginduced, reaction to drug). Then, all the selected ED visits were manually revised and only those caused by an ADR were reported as ICSRs first in the FARO database, and finally in the national pharmacovigilance network. Results: In the three-year period 2020-2022, in Tuscany we reported the following number of ICSRs: 5043, 9267 and 7133. In the same period, the ICSRs of the FARO which contributed to the total of yearly Tuscan reports were 1100 (22%), 474 (5%) and 1574 (22%) for 2020, 2021 and 2022, respectively. Most of the patients of the FARO project ICSRs were in the 18-65 years group. The seriousness of ICSRs were equally distributed between ‘‘not serious’’ (52%) and ‘‘serious’’ (48%). Among the ‘‘serious’’ ICSRs, 555 were classified as ‘‘other condition medically significant’’, 401 ‘‘hospitalization’’, 18 ‘‘life-threating’’, 6 ‘‘death’’ and 1 ‘‘permanent disability’’. The most reported outcome was ‘‘recovering’’ (58%). Acetylsalicylic acid was the most reported suspected active substance (50.3% ‘‘serious’’ and 49.7% ‘‘not serious’’), followed by warfarin (63.4% ‘‘serious’’ and 36.6% ‘‘not serious’’), and amoxicillin-clavulanate (43.9% ‘‘serious’’ and 56.2% ‘‘not serious’’). The three most reported System Organ Classes were ‘‘gastrointestinal disorders’’ (20%), ‘‘skin and subcutaneous tissue disorders’’ (14%), and ‘‘nervous system disorders’’ (10%). The three most reported Preferred Term were ‘‘anemia’’ (160), ‘‘epistaxis’’ (147), and ‘‘urticaria’’ (116). Conclusion: The ED is a privilege observatory for pharmacovigilance, offering the possibility to intercept ADRs in an outpatient setting that may result in hospitalization. The FARO project contributed for more than 20% of the regional ICSRs, with a noticeable reduction during 2021 due to the massive reporting storm of COVID- 19 vaccine ICSRs.
Analysis of the Drug Related Emergency Department Admissions in Tuscany: The FARO Project
G Valdiserra;E Cappello;M Bonaso;S Ferraro;I Convertino;M Tuccori
2023-01-01
Abstract
Introduction: The FARO project is an Italian multiregional project of active surveillance of drug safety in emergency department (ED). [1] Aim: We analyzed all the individual case safety reports (ICSRs) collected in the FARO database in the first three years of the project for the Tuscany region. We also analyzed the contribution of the project to the Tuscany reports. Methods: A total of 9 hospitals contributed to the FARO project in Tuscany. Dedicated monitors screened everyday ED visits using key words related to possible adverse drug reactions (ADR) (e.g., druginduced, reaction to drug). Then, all the selected ED visits were manually revised and only those caused by an ADR were reported as ICSRs first in the FARO database, and finally in the national pharmacovigilance network. Results: In the three-year period 2020-2022, in Tuscany we reported the following number of ICSRs: 5043, 9267 and 7133. In the same period, the ICSRs of the FARO which contributed to the total of yearly Tuscan reports were 1100 (22%), 474 (5%) and 1574 (22%) for 2020, 2021 and 2022, respectively. Most of the patients of the FARO project ICSRs were in the 18-65 years group. The seriousness of ICSRs were equally distributed between ‘‘not serious’’ (52%) and ‘‘serious’’ (48%). Among the ‘‘serious’’ ICSRs, 555 were classified as ‘‘other condition medically significant’’, 401 ‘‘hospitalization’’, 18 ‘‘life-threating’’, 6 ‘‘death’’ and 1 ‘‘permanent disability’’. The most reported outcome was ‘‘recovering’’ (58%). Acetylsalicylic acid was the most reported suspected active substance (50.3% ‘‘serious’’ and 49.7% ‘‘not serious’’), followed by warfarin (63.4% ‘‘serious’’ and 36.6% ‘‘not serious’’), and amoxicillin-clavulanate (43.9% ‘‘serious’’ and 56.2% ‘‘not serious’’). The three most reported System Organ Classes were ‘‘gastrointestinal disorders’’ (20%), ‘‘skin and subcutaneous tissue disorders’’ (14%), and ‘‘nervous system disorders’’ (10%). The three most reported Preferred Term were ‘‘anemia’’ (160), ‘‘epistaxis’’ (147), and ‘‘urticaria’’ (116). Conclusion: The ED is a privilege observatory for pharmacovigilance, offering the possibility to intercept ADRs in an outpatient setting that may result in hospitalization. The FARO project contributed for more than 20% of the regional ICSRs, with a noticeable reduction during 2021 due to the massive reporting storm of COVID- 19 vaccine ICSRs.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
