Pharmacovigilance in Hospital: Monitoring Reports of Adverse Drugs and Vaccines Reactions Collected in an Active Pharmacovigilance Project: An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Introduction: By using pharmacist monitors, active pharmacovigilance projects make possible to detect many adverse drugs and vaccines reactions (ADRs) that otherwise would go unreported and to improve the quality of the reports entered in the Italian National Pharmacovigilance Network [1]. In our healthcare facility, the pharmacist was responsible for catalysing the process of reporting suspected ADRs by doctors and healthcare workers operating in Emergency and Acceptance Department. Since such adverse drugs and vaccines reactions could potentially have caused the patient to access the emergency department, they were responsible for a part of the requests in charge of the emergency system. Objective: The aim of this paper is to analyse the reports of adverse drugs and vaccines reactions (ADRs) that caused patients to enter the emergency department of our facility during the last 10 months. Methods: Suspected ADRs were identified by the analysis of emergency room reports written by clinicians at Careggi University Hospital during the period from May 2021 to February 2022. ADRs reports were loaded into the Italian National Pharmacovigilance Network and were subsequently analysed according to the reported drug/vaccine, the Anatomical Therapeutic Chemical Classification System (ATC) class and the severity of the reaction, as well as stratified according to patients sex and age. Results: The total number of ADRs reports collected during the analysed period and entered in the Pharmacovigilance Network was 76, of which 38 (50%) related to drugs, 35 (46%) to vaccines used for immunisation against Sars-CoV-2, and 3 (4%) to contrast media for diagnostic use. In terms of severity, only 17 ADRs were classified as serious (22,4 %). Most ADRs were detected in female patients and in adults aged between 30 and 60 years. Conclusion: The active pharmacovigilance project called FARO enabled to intercept a good number of ADRs causing patients to access the emergency department, increasing the quantity and quality of reports entered into the Italian National Pharmacovigilance Network. In the period May 2021-February 2022, almost half of the intercepted ADRs concerned vaccines for immunisation against SARS-CoV-2. However, ADRs from drugs remained prevalent, and concerned molecules belonging to various ATC classes, in particular the class of drugs affecting the nervous and cardiovascular systems. The majority of ADRs were classified as non-serious (77.6%), indicating that many emergency room admissions were inappropriate. This highlights the need of strengthening territorial medicine and continuity of care services, which should ensure adequate care of patients with mild problems.