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Adverse Drug Reactions Resulting From the Use of Chiral Medicines Amoxicillin, Amoxicillin-Clavulanic Acid, and Ceftriaxone: A Mixed Prospective-Retrospective Cohort Study.

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Title: Adverse Drug Reactions Resulting From the Use of Chiral Medicines Amoxicillin, Amoxicillin-Clavulanic Acid, and Ceftriaxone: A Mixed Prospective-Retrospective Cohort Study.
Authors: Mwamwitwa, Kissa W.1,2 ki313ssa@yahoo.com, Bukundi, Elias M.1, Maganda, Betty A.1, Munishi, Castory1, Fimbo, Adam M.2, Buma, Deus3, Muro, Eva P.4, Sabiiti, Wilber5, Shewiyo, Danstan H.2, Shearer, Morven C.5, Smith, Andrew D.5, Kaale, Eliangiringa A.1
Source: Inquiry (00469580). 9/15/2024, p1-18. 18p.
Subject Terms: *Retrospective studies, *Longitudinal method, *Research methodology, Nausea -- Risk factors, Vomiting -- Risk factors, Risk assessment, Pearson correlation (Statistics), Diarrhea, Drug side effects, Patient safety, Receiver operating characteristic curves, Chest pain, Research funding, Clavulanic acid, Fisher exact test, Multiple regression analysis, Headache, Abdominal pain, Exanthema, Dizziness, Amoxicillin, Tertiary care, Descriptive statistics, Gastrointestinal system, Chi-squared test, Skin, Injections, Odds ratio, Itching, Causality (Physics), Medical records, Acquisition of data, Nervous system, Respiratory organs, Statistics, Public health, Data analysis software, Confidence intervals, Tachycardia, Ceftriaxone, Disease risk factors
Geographic Terms: Tanzania
Abstract: The use of chiral medicines (possessing center(s) of asymmetric carbon) may cause adverse drug reactions (ADRs). The safety assurance of these medicines is critical. We aimed to evaluate registered and commonly used anti-infective chiral medicines circulating in the Tanzanian market to establish their safety profile to protect public health. A mixed prospective-retrospective cohort study was conducted to assess the safety profile of amoxicillin, amoxicillin-clavulanic acid and ceftriaxone injection. ADRs causality assessment was conducted by using World Health Organization (WHO)-Algorithm criteria. Data were collected from 7 tertiary hospitals: Muhimbili National Hospital (MNH), Kilimanjaro Christian Medical Centre (KCMC), Bugando Medical Centre (BMC), Ligula Referral-Regional Hospital (LRRH), Kitete Referral-Regional Hospital (KRRH), Dodoma Referral-Regional Hospital (DRRH), and Mbeya Zonal-Referral Hospital (MZRH). Data were supplemented by those recorded in the WHO-Vigiflow/VigiLyze database within the same monitoring period. Data were analyzed using STATA version-15. The results were considered statistically significant when P <.05. A total of 2522 patients were enrolled in hospitals: MNH (499), KCMC (407), BMC (396), LRRH (387), KRRH (345), DRRH (249), and MZRH (239). Among those, 1197 (47.5%) were treated with ceftriaxone, 585 (23.2%) amoxicillin and 740(29.3%) amoxicillin-clavulanic acid. Out of those, 102 (4.5%) experienced adverse events (AEs), 49 (48%) were due to ceftriaxone, 37 (36.3%) amoxicillin-clavulanic acid and 16 (15.7%) amoxicillin (P -value.012). A total of 443 participants from the enrolled and WHO-Vigiflow/VigiLyze database were experienced with ADRs. The ADRs affected mainly gastro-intestinal system 234 (53%), skin and subcutaneous tissue 85 (19%), nervous system 49 (11%), respiratory thoracic 22 (5%), and general disorders 18(4%). In this study, approximately 90% of reported AEs were ADRs possible-related to the monitored medicines, with few plausible and certain. Ceftriaxone injection caused more ADRs. Amoxicillin-clavulanic acid was associated with more ADRs than amoxicillin alone. The safety profile of these medicines is still maintained; however, comprehensive monitoring of ADRs is recommended to improve patient safety and enhance overall treatment outcomes. [ABSTRACT FROM AUTHOR]
Copyright of Inquiry (00469580) is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract 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 abstract. (Copyright applies to all Abstracts.)
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  Data: Adverse Drug Reactions Resulting From the Use of Chiral Medicines Amoxicillin, Amoxicillin-Clavulanic Acid, and Ceftriaxone: A Mixed Prospective-Retrospective Cohort Study.
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  Data: The use of chiral medicines (possessing center(s) of asymmetric carbon) may cause adverse drug reactions (ADRs). The safety assurance of these medicines is critical. We aimed to evaluate registered and commonly used anti-infective chiral medicines circulating in the Tanzanian market to establish their safety profile to protect public health. A mixed prospective-retrospective cohort study was conducted to assess the safety profile of amoxicillin, amoxicillin-clavulanic acid and ceftriaxone injection. ADRs causality assessment was conducted by using World Health Organization (WHO)-Algorithm criteria. Data were collected from 7 tertiary hospitals: Muhimbili National Hospital (MNH), Kilimanjaro Christian Medical Centre (KCMC), Bugando Medical Centre (BMC), Ligula Referral-Regional Hospital (LRRH), Kitete Referral-Regional Hospital (KRRH), Dodoma Referral-Regional Hospital (DRRH), and Mbeya Zonal-Referral Hospital (MZRH). Data were supplemented by those recorded in the WHO-Vigiflow/VigiLyze database within the same monitoring period. Data were analyzed using STATA version-15. The results were considered statistically significant when P &lt;.05. A total of 2522 patients were enrolled in hospitals: MNH (499), KCMC (407), BMC (396), LRRH (387), KRRH (345), DRRH (249), and MZRH (239). Among those, 1197 (47.5%) were treated with ceftriaxone, 585 (23.2%) amoxicillin and 740(29.3%) amoxicillin-clavulanic acid. Out of those, 102 (4.5%) experienced adverse events (AEs), 49 (48%) were due to ceftriaxone, 37 (36.3%) amoxicillin-clavulanic acid and 16 (15.7%) amoxicillin (P -value.012). A total of 443 participants from the enrolled and WHO-Vigiflow/VigiLyze database were experienced with ADRs. The ADRs affected mainly gastro-intestinal system 234 (53%), skin and subcutaneous tissue 85 (19%), nervous system 49 (11%), respiratory thoracic 22 (5%), and general disorders 18(4%). In this study, approximately 90% of reported AEs were ADRs possible-related to the monitored medicines, with few plausible and certain. Ceftriaxone injection caused more ADRs. Amoxicillin-clavulanic acid was associated with more ADRs than amoxicillin alone. The safety profile of these medicines is still maintained; however, comprehensive monitoring of ADRs is recommended to improve patient safety and enhance overall treatment outcomes. [ABSTRACT FROM AUTHOR]
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  Data: &lt;i&gt;Copyright of Inquiry (00469580) is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites without the copyright holder&#39;s express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract 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 abstract.&lt;/i&gt; (Copyright applies to all Abstracts.)
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      – Type: doi
        Value: 10.1177/00469580241273323
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      – Code: eng
        Text: English
    PhysicalDescription:
      Pagination:
        PageCount: 18
        StartPage: 1
    Subjects:
      – SubjectFull: Retrospective studies
        Type: general
      – SubjectFull: Longitudinal method
        Type: general
      – SubjectFull: Research methodology
        Type: general
      – SubjectFull: Nausea -- Risk factors
        Type: general
      – SubjectFull: Vomiting -- Risk factors
        Type: general
      – SubjectFull: Risk assessment
        Type: general
      – SubjectFull: Pearson correlation (Statistics)
        Type: general
      – SubjectFull: Diarrhea
        Type: general
      – SubjectFull: Drug side effects
        Type: general
      – SubjectFull: Patient safety
        Type: general
      – SubjectFull: Receiver operating characteristic curves
        Type: general
      – SubjectFull: Chest pain
        Type: general
      – SubjectFull: Research funding
        Type: general
      – SubjectFull: Clavulanic acid
        Type: general
      – SubjectFull: Fisher exact test
        Type: general
      – SubjectFull: Multiple regression analysis
        Type: general
      – SubjectFull: Headache
        Type: general
      – SubjectFull: Abdominal pain
        Type: general
      – SubjectFull: Exanthema
        Type: general
      – SubjectFull: Dizziness
        Type: general
      – SubjectFull: Amoxicillin
        Type: general
      – SubjectFull: Tertiary care
        Type: general
      – SubjectFull: Descriptive statistics
        Type: general
      – SubjectFull: Gastrointestinal system
        Type: general
      – SubjectFull: Chi-squared test
        Type: general
      – SubjectFull: Skin
        Type: general
      – SubjectFull: Injections
        Type: general
      – SubjectFull: Odds ratio
        Type: general
      – SubjectFull: Itching
        Type: general
      – SubjectFull: Causality (Physics)
        Type: general
      – SubjectFull: Medical records
        Type: general
      – SubjectFull: Acquisition of data
        Type: general
      – SubjectFull: Nervous system
        Type: general
      – SubjectFull: Respiratory organs
        Type: general
      – SubjectFull: Statistics
        Type: general
      – SubjectFull: Public health
        Type: general
      – SubjectFull: Data analysis software
        Type: general
      – SubjectFull: Confidence intervals
        Type: general
      – SubjectFull: Tachycardia
        Type: general
      – SubjectFull: Ceftriaxone
        Type: general
      – SubjectFull: Disease risk factors
        Type: general
      – SubjectFull: Tanzania
        Type: general
    Titles:
      – TitleFull: Adverse Drug Reactions Resulting From the Use of Chiral Medicines Amoxicillin, Amoxicillin-Clavulanic Acid, and Ceftriaxone: A Mixed Prospective-Retrospective Cohort Study.
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              Text: 9/15/2024
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