Journal of Pharmacovigilance

Suspected side effects in geriatric patients following vaccination with the vaccines indicated for SARS-CоV-2 on the territory of the EU-The role of the clinical pharmacist

16^th International Conference and Exhibition on Pharmacovigilance and Drug Safety

August 21, 2023 Webinar

Denitsa Panayotova, Alexina Parvanova, Maria Dimitrova, Maria Kamusheva and Ilko Getov

Medical University of Sofia, Bulgaria

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

Statement of the problem: Over the last years, the European regulator has incorporated all available mechanisms and also created new regulatory approaches with pharmacovigilance focus to provide European citizens with quality, safe and effective vaccines. The aim of this study was to analyze the Suspected Side Effects (SSI) in geriatric patients following vaccination with COVID-19 vaccines and the possibilities for their prevention through the inclusion of clinical pharmacists in the vaccination process. Methodology and Theoretical orientation: Scoping literature review was conducted on the information concerning safety of vaccines in the scientific databases using keywords search (COVID-19 vaccines, Pharmacovigilance, Safety of COVID-19 vaccines). A critical analysis was performed on the information in EudraVigilance System (EVS) for the vaccines indicated for SARS-CоV-2 on the territory of the EU. The analysis included the period from first marketing authorization for vaccine with indication SARS-CoV-2 infection and ended approximately two years later. Findings: From 21st December to 14th May 2022, the reported cases in the EVS for geriatric patients were 272 253 (26,8% of all reported cases), of which 61% affect women and respectively 38% men. The clinical pharmacist has a crucial role in discussing with geriatric patients any vaccine concerns emphasizing on the most prevalent side effects, importance of vaccination, managing drug-related problems and contraindications. Adding the peculiarities of elderly patients, exclusion from most clinical trials and the relatively lower rates of reporting for this age group, the clinical pharmacist should proactively monitor the course of vaccination, participate and encourage reporting of any relevant safety information. Conclusion: Considering the age-related changes in pharmacokinetics and pharmacodynamics and the increased risk of side effects among geriatrics, more attention should be paid to this vulnerable group and the clinical pharmacist’s potential to provide them with quality pharmaceutical care, corresponding to the constant changing COVID-19 situation.

Biography :

Denitsa Panayotova is a PhD student, Faculty of Pharmacy, Medical University of Sofia–Bulgaria. This study was conducted by a multidisciplinary team including leading scientists with long experience and interests in the field of drug safety and geriatrics, as well as PhD students from the Department of Pharmacy Organization and Economics at the Faculty of Pharmacy, Medical University-Sofia, Bulgaria. It is the integration of in-depth knowledge in both fields that makes possible the high level of expert assessment of suspected side effects in geriatric patients after vaccination and the definition of the pharmacist's role in preventing relevant ADRs after vaccination.