MONITORING OF SUSPECTED ADVERSE REACTIONS FROM DRUGS AND VACCINES. DATA ANALYSIS COLLECTED AT THE UOS PHARMACOVIGILANCE DEPARTMENT OF ASP CALTANISSETTA

Abstract

Pharmacovigilance encompasses post-marketing surveillance activities on medications that aim to identify adverse effects, expanding the safety profile of the drug. All health professionals and citizens can report any suspected adverse reaction by filling out a specific reporting form. This study presents an exploratory analysis of suspected adverse reactions caused by drugs and vaccines reported to the Simple Operational Unit of Pharmacovigilance at the A.S.P. of Caltanissetta. Reports (spontaneous and not) collected from 2018 to 2022 relating to male and female patients aged 0 to 99 years were taken into account. In respect of the privacy of individual patients, data regarding the age and sex of the patient, the drug responsible for the reaction, symptoms, severity of the reaction and the indicator were extrapolated. The data processing was carried out thanks to the use of the RStudio Team software (2020). The main demographic and clinical variables were evaluated, highlighting the number of reports year by year, the sex of the patients, the median age, the type of reporter, the severity of the reactions and the five most frequent reactions. The study then focuses on the drugs most frequently reported by patients, analyzing the top ten drug classes and active ingredients most responsible for severe and non-severe reactions. Finally, the symptoms related to these drugs were evaluated. In the pharmacovigilance reports of the Sicily region for the period from 2018 to 2022, the total reports reported are 16,951, those recorded in the province of Caltanissetta are about 3.3%. The highest number of reactions (40%) was recorded in 2021 (the year of administration of the Covid-19 vaccines for which several reports were recorded). The percentage of men and women affected is the same. The median age of patients is around 56 years. More than half of the reporters are doctors (82%). 83% of reactions were classified as non-severe, with the most frequently reported reaction being "ineffective drug," primarily related to monoclonal antibodies (82%) and immunosuppressants (71%). Discrepancies between the period before the marketing authorization of the COVID-19 vaccines and the two years following (2021-2022) were also highlighted. Specifically, the percentage of patients reporting reactions rose to 26%, and the percentage of patients with severe or permanent disability increased from 5% to 20%. Monitoring of reactions revealed that among the drugs that have reported the highest number of reports were Covid-19 vaccines Comirnaty, Spikevax and Vaxzevria, it should be emphasized that, considering the administration of these vaccines on almost the entire population, it is credible that they are also the first in terms of side effects. The analysis based on the median age showed that, in both the over 56 and the under 56, the highest number of reports, in descending order, were for the COVID- 19 vaccines Comirnaty, Vaxzevria, Spikevax, and the monoclonal antibody Adalimumab. The top five drug classes associated with non-severe reactions were vaccines, monoclonal antibodies, immunosuppressors, statins, and antineoplastic drugs. More precisely, the year-by-year analysis showed that the difference between the number of vaccine reactions and that of other drug classes is only greater in 2021. As for the class of drugs that reported the highest number of serious reactions, it was always that of vaccines followed by antineoplastics, monoclonal antibodies, immunosuppressants and antithrombotics. Furthermore, the active ingredients and the most common severe and non-severe symptoms caused by these drug classes were identified. In particular, non-serious reactions caused by vaccines (excluding Covid-19 vaccines) mainly included hyperpyrexia and pain at the vaccination site (45%); while Covid-19 vaccines have, in most cases, caused fever and arthromyalgia (28%). Among the reports, there were