How Covid-19 Pandemic Affected the National Pharmacovigilance System in the Czech Republic

• Published in: Drug safety Vol. 45; no. 10; p. 1185
• Main Authors: Kopecká, J, Deščíková, V
• Format: Journal Article
• Language: English
• Published: Auckland Springer Nature B.V 01.10.2022
• Subjects: Case reports; Coronaviruses; COVID-19 vaccines; Health services; Medicine; Pandemics; Patients; Pharmacovigilance; Prevention; Public concern; Regulatory agencies; Safety; Side effects; Vaccines; Czech Republic
• ISSN: 0114-5916; 1179-1942

Introduction: Covid-19 pandemic has impacted all areas of human society worldwide, including drug regulatory authorities. Enormous public interest and seriousness of the disease resulted in boom of new medicines for treatment and prevention of Covid-19. Patients and healthcare professionals (HCP) concerns on safety of these new medicines resulted in the highest increase in the reporting rate of adverse drug reactions (ADRs) in the history of the Czech Republic (CZ). Objective: To present how the PV processes were affected by Covid- 19 pandemic. To present the impact of increased reporting rate and related workload on the national PV system in Czech regulatory authority (SUKL) and the influence on awareness of ADRs reporting in the Czech public. Methods: In 2020, the total number of ADRs (n = 2904) reported to SUKL was the lowest in the past 5 years (2016-2020). The probable cause may be the Covid-19 pandemic, including the lack of time for HCP to report ADRs. Results: On the contrary, in 2021 (1) with the entry of the treatment and prevention of Covid-19 into the clinical practice, there was a massive increase in reported ADRs in CZ. Of the total number of reported cases (n = 13 759), 81.10 % (n = 11 159) were vaccinerelated (all types of vaccines). Of these vaccine-related ADRs 95.27 % (n = 10 631) were reported for Covid-19 vaccines only. Considerable interest in vaccine safety in CZ is evident, resulting in high number of suspected ADRs reported following vaccine administration. Conclusion: Due to the significant increase in the ADRs reported, the national PV system had to be adapted. A system of triage of case reports was set including pre-assessment of seriousness by PV assessors. More staffhad to be hired and trained to assist with the case processing, including receipt of the report, HCP confirmation of patient reports, follow-up and hospital records requests. To satisfy an extensive media attention and to increase transparency of vaccine safety, SUKL published an overview of reported ADRs on weekly basis (2) and communicated the most serious concerns online, together with EMA recommendations. Czech PV assessors were deeply involved in all European procedures related to Covid-19 treatment (e.g., remdesivir) and prevention (vaccines). The Czech public became more aware of the possibility of reporting ADRs, the number of reports will be presented. Based on reporters suggestions the online reporting form for ADRs was re-designed. This experience has been challenging and brought new approaches and improvements to the national PV system.