ABSTRACT
Most of the medicines used to treat the novel coronavirus infection (COVID-19) are either approved under an accelerated procedure or not approved for the indication. Consequently, their safety requires special attention. The aim of the study was to review methodological approaches to collecting data on the safety of medicines, using COVID-19 treatment regimens involving azithromycin as a case study. Material(s) and Method(s): PubMed (MEDLINE), Scopus, eLIBRARY, and Cyberleninka databases were searched for publications on azithromycin as part of combination therapy for COVID-19 in 2020-2021. Search queries included names of the medicinal product or its pharmacotherapeutic group and words describing adverse drug reactions (ADRs) during treatment. Result(s): the analysis included 7 publications presenting the results of studies covering the use of azithromycin as part of COVID-19 combination therapy in more than 4000 patients. Most commonly, the patients receiving COVID-19 therapy including azithromycin developed cardiovascular ADRs (up to 30% of azithromycin prescription cases). In 3 of the analysed publications, safety information was collected through spontaneous reporting and active identification based on the findings of laboratory and instrumental investigations performed during the clinical studies;in other 3, only spontaneous reports were used;and in the last one, ADR database information was studied. Conclusion(s): currently, information on ADRs associated with the use of medicines is mainly gathered via spontaneous reporting. Direct sourcing of information on personal experiences with a certain product from patients, among other means through social media analysis, opens a promising direction towards the improvement of existing approaches to collecting safety data.Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.
ABSTRACT
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.
ABSTRACT
Most of the medicines used to treat the novel coronavirus infection (COVID-19) are either approved under an accelerated procedure or not approved for the indication. Consequently, their safety requires special attention. The aim of the study was to review methodological approaches to collecting data on the safety of medicines, using COVID-19 treatment regimens involving azithromycin as a case study. Material(s) and Method(s): PubMed (MEDLINE), Scopus, eLIBRARY, and Cyberleninka databases were searched for publications on azithromycin as part of combination therapy for COVID-19 in 2020-2021. Search queries included names of the medicinal product or its pharmacotherapeutic group and words describing adverse drug reactions (ADRs) during treatment. Result(s): the analysis included 7 publications presenting the results of studies covering the use of azithromycin as part of COVID-19 combination therapy in more than 4000 patients. Most commonly, the patients receiving COVID-19 therapy including azithromycin developed cardiovascular ADRs (up to 30% of azithromycin prescription cases). In 3 of the analysed publications, safety information was collected through spontaneous reporting and active identification based on the findings of laboratory and instrumental investigations performed during the clinical studies;in other 3, only spontaneous reports were used;and in the last one, ADR database information was studied. Conclusion(s): currently, information on ADRs associated with the use of medicines is mainly gathered via spontaneous reporting. Direct sourcing of information on personal experiences with a certain product from patients, among other means through social media analysis, opens a promising direction towards the improvement of existing approaches to collecting safety data. Copyright © 2022 Obstetrics, Gynecology and Reproduction. All rights reserved.
ABSTRACT
The COVID-19 pandemic has resulted in more than 6.2 million deaths worldwide. Despite advances in the treatment of this disease over the last 2 years, the only way out of the pandemic is vaccination against the SARS-CoV-2 virus, which is constantly confronted with considerable mistrust and fears of adverse reactions (ADRs) in Slovakia. The aim of this study is to analyse reported suspicions of ADRs of registered COVID-19 vaccines (Comirnaty, Vaxzevria, Spikevax), which the State Institute for Drug Control received from health care professionals and patients between 1 January and 31 May 2021. The program R (version 3.6.3), a language and environment for statistical calculations, GNU GPL license was used for data analysis. During the evaluation period, 5,763 reported suspicions of ADRs were analysed. Overall, there was a significant (p < .0001) fivefold increase in the number of reported ADRs. Ninety-three percent of ADRs (n = 5,346) were reported for COVID-19 vaccines. No statistically significant difference (p = .238) was identified between Spikevax and Comirnaty in the proportion of serious ADRs. However, a significantly higher (p = .00001) proportion of reported suspicions of severe ADRs was observed with Vaxzevria. There is a significant difference in the ratio of serious ADRs between the sexes for all COVID-19 vaccines (p < .00001);in women this ratio is in all cases significantly higher than in men (p < .0001). ADRs were most often reported by patients (p < .0001). In Slovakia, the rate of spontaneous reporting of suspected ADRs has been low for a long time;in the period between January and May 2021, however, the rate increased as a result of active calls for ADR reporting, most often from patients. According to European data, Vaxzevria has a significantly higher ratio of reported suspicions of serious ADRs. For all vaccines, the incidence of severe ADRs is significantly higher in women. [ FROM AUTHOR] Copyright of Acta Facultatis Pharmaceuticae Universitatis Comenianae is the property of Sciendo and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)