RESUMEN
There is considerable interest worldwide in developing safe and effective vaccines against COVID-19. Pharmacovigilance of adverse events following immunisation (AEFIs) is a key to making informed decisions regarding the global COVID-19 vaccination campaign. In the Kyrgyz Republic, there have been developed a national immunisation information system (IIS) for automated recording of vaccines, vaccinated persons, and AEFIs and a mobile application for AEFI reporting, called Den Sooluk. The aim of the study was to analyse the pattern of AEFIs against COVID-19 in the Kyrgyz Republic. Material(s) and Method(s): the study analysed the spontaneous safety reports submitted to the national IIS database through the Den Sooluk mobile application from 29.03.2021 to 25.09.2022. Result(s): according to the data available by 25.09.2022, the total number of vaccinated people in the country amounted to 2,940,082. At the time, the IIS database included 2111 AEFIs: 1 fatal (and coincidental), 3 severe and 2108 minor ones. AEFIs were more frequent in the young and middle-aged population (81.5%), than in the elderly (18.5%). The following AEFIs were reported: injection site pain (21.25%), fatigue (20.7%), headache (19.8%), body temperature above 38 C (10.10%), miscellaneous symptoms (5.12%), chills (4.41%), dizziness (4.32%), sore throat (3.36%), myalgia (2.9%), and nausea (2.2%). Conclusion(s): all COVID-19 vaccines used in the Kyrgyz Republic can be considered adequately safe. Pharmacovigilance of AEFIs is an integral part of the requirements to ensure the safe use of vaccines, and collecting of spontaneous reports on AEFIs supports adequate functioning of the post-marketing surveillance system. It is essential to provide access to electronic information platforms to health professionals and patients in order to ensure vaccination transparency and coordination and enable quick and safe reporting of AEFIs associated with the use of COVID-19 vaccines.Copyright © NEICON ISP LLC. All rights reserved.
RESUMEN
There is considerable interest worldwide in developing safe and effective vaccines against COVID-19. Pharmacovigilance of adverse events following immunisation (AEFIs) is a key to making informed decisions regarding the global COVID-19 vaccination campaign. In the Kyrgyz Republic, there have been developed a national immunisation information system (IIS) for automated recording of vaccines, vaccinated persons, and AEFIs and a mobile application for AEFI reporting, called Den Sooluk. The aim of the study was to analyse the pattern of AEFIs against COVID-19 in the Kyrgyz Republic. Material(s) and Method(s): the study analysed the spontaneous safety reports submitted to the national IIS database through the Den Sooluk mobile application from 29.03.2021 to 25.09.2022. Result(s): according to the data available by 25.09.2022, the total number of vaccinated people in the country amounted to 2,940,082. At the time, the IIS database included 2111 AEFIs: 1 fatal (and coincidental), 3 severe and 2108 minor ones. AEFIs were more frequent in the young and middle-aged population (81.5%), than in the elderly (18.5%). The following AEFIs were reported: injection site pain (21.25%), fatigue (20.7%), headache (19.8%), body temperature above 38 C (10.10%), miscellaneous symptoms (5.12%), chills (4.41%), dizziness (4.32%), sore throat (3.36%), myalgia (2.9%), and nausea (2.2%). Conclusion(s): all COVID-19 vaccines used in the Kyrgyz Republic can be considered adequately safe. Pharmacovigilance of AEFIs is an integral part of the requirements to ensure the safe use of vaccines, and collecting of spontaneous reports on AEFIs supports adequate functioning of the post-marketing surveillance system. It is essential to provide access to electronic information platforms to health professionals and patients in order to ensure vaccination transparency and coordination and enable quick and safe reporting of AEFIs associated with the use of COVID-19 vaccines.Copyright © NEICON ISP LLC. All rights reserved.
RESUMEN
There is considerable interest worldwide in developing safe and effective vaccines against COVID-19. Pharmacovigilance of adverse events following immunisation (AEFIs) is a key to making informed decisions regarding the global COVID-19 vaccination campaign. In the Kyrgyz Republic, there have been developed a national immunisation information system (IIS) for automated recording of vaccines, vaccinated persons, and AEFIs and a mobile application for AEFI reporting, called Den Sooluk. The aim of the study was to analyse the pattern of AEFIs against COVID-19 in the Kyrgyz Republic. Materials and methods: the study analysed the spontaneous safety reports submitted to the national IIS database through the Den Sooluk mobile application from 29.03.2021 to 25.09.2022. Results: according to the data available by 25.09.2022, the total number of vaccinated people in the country amounted to 2,940,082. At the time, the IIS database included 2111 AEFIs: 1 fatal (and coincidental), 3 severe and 2108 minor ones. AEFIs were more frequent in the young and middle-aged population (81.5%), than in the elderly (18.5%). The following AEFIs were reported: injection site pain (21.25%), fatigue (20.7%), headache (19.8%), body temperature above 38 ºC (10.10%), miscellaneous symptoms (5.12%), chills (4.41%), dizziness (4.32%), sore throat (3.36%), myalgia (2.9%), and nausea (2.2%). Conclusions: all COVID-19 vaccines used in the Kyrgyz Republic can be considered adequately safe. Pharmacovigilance of AEFIs is an integral part of the requirements to ensure the safe use of vaccines, and collecting of spontaneous reports on AEFIs supports adequate functioning of the post-marketing surveillance system. It is essential to provide access to electronic information platforms to health professionals and patients in order to ensure vaccination transparency and coordination and enable quick and safe reporting of AEFIs associated with the use of COVID-19 vaccines.
RESUMEN
The national clinical guidelines for the treatment of novel coronavirus infection (COVID-19) are the main source of information and the reference point for clinical decision-making by healthcare professionals in the Kyrgyz Republic. The recommendations presented in these documents are largely based on data from real clinical practice, but the efficacy and safety of a number of antiviral agents, the indications for which have been expanded to include COVID-19 treatment, remain unclear. The aim of the study was to conduct a retrospective pharmacoepidemiological analysis of lopinavir+ritonavir use in hospitals in the Kyrgyz Republic for the treatment of COVID-19 during the period from March until April 2020. Materials and methods: the paper describes a retrospective study of 145 medical records of patients with confirmed COVID-19 who were hospitalized in infectious disease departments/hospitals of the Kyrgyz Republic. Statistical processing was performed using Microsoft Excel 2017. Results: between 16 March 2020 and 25 April 2020, 145 patients were prescribed lopinavir+ritonavir at a dose of 200 mg + 50 mg, 2 tablets twice a day—in line with the dosage regimen recommended by the national guideline. The national guideline recommended the treatment duration of 10 days, while the actual treatment duration was 1–12 days (5.5 days on average) depending on the tolerability of the drug. The use of the drug was accompanied by adverse drug reactions (ADRs) in 78 patients (53.8%), and caused deterioration in the general condition of 73 of these patients (94.8%) which resulted in discontinuation of the drug. The most common ADRs were nausea, vomiting, diarrhoea, decreased appetite, yellowness of the skin, and, according to laboratory studies, an increase in serum levels of bilirubin, creatinine, glucose, aspartate aminotransferase and amylase activity. A retrospective assessment of the causal relationship probability according to the Naranjo scale showed an interrelation between the use of lopinavir+ritonavir and ADR development. Conclusions: the use of the lopinavir+ritonavir drug in COVID-19 patients led to deterioration of their general condition, which was severe in some cases. The data obtained indicate that the use of this drug for COVID-19 treatment is clinically unreasonable and irrational. Lopinavir+ritonavir was excluded from subsequent revisions of the clinical guidelines for the diagnosis and treatment of COVID-19 in the Kyrgyz Republic.