Analysis of fatal outcomes associated with ceftriaxone treatment from the Russian database of spontaneous reports
Objective. To analyze spontaneous reports (SRs) from the Russian database of adverse reactions (Automated information system "Pharmacovigilance" of Roszdravnadzor), containing information on fatal outcomes during ceftriaxone treatment, and to identify factors associated with an increased...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | Russian |
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Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy
2023-06-01
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| Series: | Клиническая микробиология и антимикробная химиотерапия |
| Subjects: | |
| Online Access: | https://cmac-journal.ru/publication/2023/2/cmac-2023-t25-n2-p159/cmac-2023-t25-n2-p159.pdf |
| _version_ | 1797682241885700096 |
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| author | Klabukova D.L. Titova A.R. Krysanov I.S. Polivanov V.A. Krysanova V.S. Ermakova V.Yu. |
| author_facet | Klabukova D.L. Titova A.R. Krysanov I.S. Polivanov V.A. Krysanova V.S. Ermakova V.Yu. |
| author_sort | Klabukova D.L. |
| collection | DOAJ |
| description | Objective.
To analyze spontaneous reports (SRs) from the Russian database of adverse reactions (Automated information system "Pharmacovigilance" of Roszdravnadzor), containing information on fatal outcomes during ceftriaxone treatment, and to identify factors associated with an increased risk of death with ceftriaxone use.
Materials and Methods.
The study included 122 SRs concerning fatal cases during ceftriaxone therapy. All SRs were submitted to the Russian pharmacovigilance database from 06 May 2019 to 23 November 2022. A retrospective analysis of fatal adverse reactions cases in ceftriaxone treatment was carried out according to the following parameters: gender, age, drug intake and route of administration, clinical symptoms of anaphylaxis. Additionally, indications for the simultaneous use of drugs for local anesthesia as a solvent were evaluated.
Results.
A total of 86 SRs (70.5%) were primary and relevant for further analysis. 16 SRs (18.6%) were registered in the database for 8 months of 2019, 25 (29.1%) – for 2020, 15 (17.4%) – for 2021, for less than 11 months 2022 received 30 reports (34.9%). The number of adverse reactions reports in male and female patients was similar. Among the age groups, the largest number of SRs was observed in middleaged and elderly patients – 27 (31.4%) and 23 (26.7%) reports, respectively, 8 cases (9.3%) were registered in pediatric population. The development of fatal adverse reactions in the hospital was reported in 50 (58.1%) SRs, in outpatient setting – in 31 (36.1%) SRs. 18 SRs were identified with an indication of the patient’s self-treatment, which is 20.9% of all primary reports. Clinical symptoms of anaphylactic shock were noted in 63 reports (73.3%). Additional analysis of the combined use of ceftriaxone and local anesthetics cases revealed a range of medical errors.
Conclusions.
Ceftriaxone treatment was associated with a high risk of anaphylactic shock. The use of this antibiotic in outpatient setting, especially as self-treatment is an additional risk factor for death. Inappropriate use of local anesthetics in combination with ceftriaxone is an additional serious risk factor for fatal outcome. |
| first_indexed | 2024-03-11T23:56:44Z |
| format | Article |
| id | doaj.art-18409322205d434c8bdb7a0c699658c2 |
| institution | Directory Open Access Journal |
| issn | 1684-4386 2686-9586 |
| language | Russian |
| last_indexed | 2024-03-11T23:56:44Z |
| publishDate | 2023-06-01 |
| publisher | Interregional Association for Clinical Microbiology and Antimicrobial Chemotherapy |
| record_format | Article |
| series | Клиническая микробиология и антимикробная химиотерапия |
| spelling | doaj.art-18409322205d434c8bdb7a0c699658c22023-09-18T07:30:53ZrusInterregional Association for Clinical Microbiology and Antimicrobial ChemotherapyКлиническая микробиология и антимикробная химиотерапия1684-43862686-95862023-06-0125215916410.36488/cmac.2023.2.159-164cmac-2023-t25-n2-p159Analysis of fatal outcomes associated with ceftriaxone treatment from the Russian database of spontaneous reportsKlabukova D.L.0Titova A.R.1Krysanov I.S.2Polivanov V.A.3Krysanova V.S.4Ermakova V.Yu.5A.I. Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, RussiaInformation and Methodological Center for Evaluation, Accounting and Analysis of Circulation of Medicinal Products, Moscow, RussiaA.I. Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, RussiaInformation and Methodological Center for Evaluation, Accounting and Analysis of Circulation of Medicinal Products, Moscow, RussiaMedical Institute of Continuous Education at the “Russian Biotechnological University”, Moscow, RussiaLLC “Institute of Clinical and Economic Expertise and Pharmacoeconomics”, Mytishchi, RussiaObjective. To analyze spontaneous reports (SRs) from the Russian database of adverse reactions (Automated information system "Pharmacovigilance" of Roszdravnadzor), containing information on fatal outcomes during ceftriaxone treatment, and to identify factors associated with an increased risk of death with ceftriaxone use. Materials and Methods. The study included 122 SRs concerning fatal cases during ceftriaxone therapy. All SRs were submitted to the Russian pharmacovigilance database from 06 May 2019 to 23 November 2022. A retrospective analysis of fatal adverse reactions cases in ceftriaxone treatment was carried out according to the following parameters: gender, age, drug intake and route of administration, clinical symptoms of anaphylaxis. Additionally, indications for the simultaneous use of drugs for local anesthesia as a solvent were evaluated. Results. A total of 86 SRs (70.5%) were primary and relevant for further analysis. 16 SRs (18.6%) were registered in the database for 8 months of 2019, 25 (29.1%) – for 2020, 15 (17.4%) – for 2021, for less than 11 months 2022 received 30 reports (34.9%). The number of adverse reactions reports in male and female patients was similar. Among the age groups, the largest number of SRs was observed in middleaged and elderly patients – 27 (31.4%) and 23 (26.7%) reports, respectively, 8 cases (9.3%) were registered in pediatric population. The development of fatal adverse reactions in the hospital was reported in 50 (58.1%) SRs, in outpatient setting – in 31 (36.1%) SRs. 18 SRs were identified with an indication of the patient’s self-treatment, which is 20.9% of all primary reports. Clinical symptoms of anaphylactic shock were noted in 63 reports (73.3%). Additional analysis of the combined use of ceftriaxone and local anesthetics cases revealed a range of medical errors. Conclusions. Ceftriaxone treatment was associated with a high risk of anaphylactic shock. The use of this antibiotic in outpatient setting, especially as self-treatment is an additional risk factor for death. Inappropriate use of local anesthetics in combination with ceftriaxone is an additional serious risk factor for fatal outcome.https://cmac-journal.ru/publication/2023/2/cmac-2023-t25-n2-p159/cmac-2023-t25-n2-p159.pdfceftriaxonefatal outcomeanaphylactic shocklocal anestheticspharmacovigilancespontaneous reports |
| spellingShingle | Klabukova D.L. Titova A.R. Krysanov I.S. Polivanov V.A. Krysanova V.S. Ermakova V.Yu. Analysis of fatal outcomes associated with ceftriaxone treatment from the Russian database of spontaneous reports Клиническая микробиология и антимикробная химиотерапия ceftriaxone fatal outcome anaphylactic shock local anesthetics pharmacovigilance spontaneous reports |
| title | Analysis of fatal outcomes associated with ceftriaxone treatment from the Russian database of spontaneous reports |
| title_full | Analysis of fatal outcomes associated with ceftriaxone treatment from the Russian database of spontaneous reports |
| title_fullStr | Analysis of fatal outcomes associated with ceftriaxone treatment from the Russian database of spontaneous reports |
| title_full_unstemmed | Analysis of fatal outcomes associated with ceftriaxone treatment from the Russian database of spontaneous reports |
| title_short | Analysis of fatal outcomes associated with ceftriaxone treatment from the Russian database of spontaneous reports |
| title_sort | analysis of fatal outcomes associated with ceftriaxone treatment from the russian database of spontaneous reports |
| topic | ceftriaxone fatal outcome anaphylactic shock local anesthetics pharmacovigilance spontaneous reports |
| url | https://cmac-journal.ru/publication/2023/2/cmac-2023-t25-n2-p159/cmac-2023-t25-n2-p159.pdf |
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