Analysis of spontaneous reports of suspected adverse reactions after vaccination against COVID-19 in Slovakia.

Introduction: The COVID-19 pandemic has resulted in more than 6.5 million deaths worldwide yet. Vaccination against the SARS-CoV-2 virus is a reliable way out of the pandemic, however, vaccination rate reaches only 58% in the Slovak Republic. Concerns about the adverse reactions of vaccines are one of the reasons for the low vaccination rate. Objective: The aim of our analysis was to review reported suspicions of adverse reactions (ARs) of registered COVID-19 vaccines (Comirnaty, Vaxzevria, Spikevax), which State Institute for Drug Control received from healthcare professionals and patients in the period from 1 January 2021 to 31 May 2021. Methods: Data were collected from the State Institute for Drug Control database, a retrospective analysis was carried out focusing on trends in the number of all reports of suspicions of adverse reactions sent to the State Institute for Drug Control during the previously mentioned period. We analysed the Retrieved data were analysed with the usage of descriptive statistics and comparison to historical data on drug adverse reactions in Slovakia was performed. Results: During the evaluation period, 5,763 reported suspicions of adverse reactions were analysed, overall, there was a significant (p < 0.0001) increase in the number of reported adverse reactions fivefold. 93% of ARs (n = 5,346) were reported for COVID-19 vaccines. In comparison of the extentof all adverse reactions, there is clearly a statistically significant difference between all types of vaccines administered at that time (p ≤ 0.0001). No statistically significant difference (p ≤ 0.238) was identified between Spikevax and Comirnaty in the proportion of serious adverse reactions. However, a significantly higher (p ≤ 0.00001) proportion of reported suspicions of serious adverse reactions was observed after the administration of Vaxzevria. Conclusion: This is the first analysis conducted in Slovakia aimed to reported adverse reactions in relation to the administration of COVID-19 vaccines. The rate of spontaneously reported suspected adverse reactions has been insufficient in the past for a long time; during the period from January to May 2021 the reporting rate increased due active calls for adverse reactions reporting. In concordance with European data, Vaxzevria had a significantly higher ratio of reported suspicions of serious adverse reactions.

Consumption of Antibacterials for Systemic Use in Slovakia: A National Study and the Quality Indicators for Outpatient Antibiotic Use.

This paper aims to analyse the consumption of antibiotics in the Slovak health care system from 2011 to 2020. The data source on the consumption of antibiotics is sales data from SUKL and NCZI. The study employed the ATC/DDD Index and focused on the consumption of antibiotics in the primary care sector. Total antibiotic consumption decreased from 19.21 DID in 2011 to 13.16 DID in 2020. Consumption of beta-lactamase-sensitive penicillins, expressed as a percentage of the total consumption of antibiotics, decreased from 8.4% in 2011 to 4.2% in 2020. Consumption of the combination of penicillins, including beta-lactamase inhibitor, expressed as a percentage of the total consumption of antibiotics, increased from 16.2% in 2011 to 17.9% in 2020. Consumption of third- and fourth-generation cephalosporins, expressed as the percentage of the total consumption of antibiotics, increased from 2.0% in 2011 to 4.6% in 2020. Consumption of fluoroquinolones, expressed as the percentage of the total consumption of antibiotics, decreased from 10.7% in 2011 to 8.6% in 2020. Overall, antibiotic consumption significantly changed in Slovakia from 2011 to 2020. The ratio of the consumption of broad-spectrum to the consumption of narrow-spectrum penicillins, cephalosporins and macrolides decreased from 14.98 in 2011 to 13.38 in 2020.

Antibiotics and the quality indicators for outpatient antibiotic use in Slovakia.

The aims of this study was to compare the data on the consumption of antibiotics in the outpatient care sector for Slovakia from 2019 to 2020 and to calculate quality indicators for outpatient antibiotic use. The data source on the consumption of antibiotics (ATC group J01), is the sales data from the NCZI. The main indicator describing the consumption of antibacterials for systemic use is the number of DDDs per 1000 inhabitants per day (DID). The data released by the European Centre for Disease Protection were used as the source for antibiotic consumption for 2019. The most frequently consumed antibacterials for systemic use in the outpatient care sector in 2020 were other beta-lactam antibacterials (J01D); macrolides, lincosamides and streptogramins (J01); and betalactam antibacterials, penicillins (J01C), with the levels of 3.30 DID, 3.30 DID and 3.27 DID, respectively. Consumption levels of 1.66 DID for tetracyclines (J01A), 1.14 DID for quinolone antibacterials (J01M), 0.41 DID for sulfonamides and trimethoprim (J01E), 0.07 DID for other antibacterials (J01X), and 0.01 DID for other antibiotics (J01B, J01G and J01R combined) can be seen. Overall, antibiotic consumption in the outpatient care sector did significantly change in Slovakia from 2019 to 2020 as a result of the COVID-19 pandemic.