Adverse drug reactions resulting from the use of chiral medicines amoxicillin, amoxicillin-clavulanic acid, and ceftriaxone: a mixed prospective-retrospective cohort study

Kissa W. Mwamwitwa; Elias M. Bukundi; Betty A. Maganda; Castory Munishi; Adam M. Fimbo; Deus Buma; Eva P. Muro; Wilber Sabiiti; Danstan H. Shewiyo; Morven C. Shearer; Andrew D. Smith; Eliangiringa A. Kaale

doi:10.1177/00469580241273323

Adverse drug reactions resulting from the use of chiral medicines amoxicillin, amoxicillin-clavulanic acid, and ceftriaxone: a mixed prospective-retrospective cohort study

Kissa W. Mwamwitwa^*, Elias M. Bukundi, Betty A. Maganda, Castory Munishi, Adam M. Fimbo, Deus Buma, Eva P. Muro, Wilber Sabiiti, Danstan H. Shewiyo, Morven C. Shearer, Andrew D. Smith, Eliangiringa A. Kaale

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Number of pages	18
Journal	INQUIRY: The Journal of Health Care Organization, Provision, and Financing
Volume	61
Early online date	15 Sept 2024
DOIs	https://doi.org/10.1177/00469580241273323
Publication status	E-pub ahead of print - 15 Sept 2024

Keywords

Prospective-retrospective cohort study
Ceftriaxone injections
Adverse drug reactions
Amoxicillin
Amoxicillin-clavulanic acid
Chiral medicines

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1177/00469580241273323Licence: CC BY

Mwamwitwa-2024-Adverse-drug-reactions-INQUIRY-61-CCBY
Copyright © The Author(s) 2024. Creative Commons Non Commercial CC BY-NC: This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
Final published version, 503 KBLicence: CC BY

ASCEND: Moving Tanzania's Clinical Research Ethics and Medicines Regulatory Capacity to the next level: Fostering Medicines Quality, Safety and GCP Clinical Trials - ASCEND
Sabiiti, W. (PI) & Shearer, M. (CoI)
6/10/20 → 5/04/23
Project: Standard

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Mwamwitwa, K. W., Bukundi, E. M., Maganda, B. A., Munishi, C., Fimbo, A. M., Buma, D., Muro, E. P., Sabiiti, W., Shewiyo, D. H., Shearer, M. C., Smith, A. D., & Kaale, E. A. (2024). Adverse drug reactions resulting from the use of chiral medicines amoxicillin, amoxicillin-clavulanic acid, and ceftriaxone: a mixed prospective-retrospective cohort study. INQUIRY: The Journal of Health Care Organization, Provision, and Financing, 61. Advance online publication. https://doi.org/10.1177/00469580241273323

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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",

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.",

keywords = "Prospective-retrospective cohort study, Ceftriaxone injections, Adverse drug reactions, Amoxicillin, Amoxicillin-clavulanic acid, Chiral medicines",

author = "Mwamwitwa, {Kissa W.} and Bukundi, {Elias M.} and Maganda, {Betty A.} and Castory Munishi and Fimbo, {Adam M.} and Deus Buma and Muro, {Eva P.} and Wilber Sabiiti and Shewiyo, {Danstan H.} and Shearer, {Morven C.} and Smith, {Andrew D.} and Kaale, {Eliangiringa A.}",

note = "Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was part of the EDCTP2 Program supported by the European Union partly under the SMERT project (CSA2016ERC-1432) and ASCEND project (CSA2019ERC-2683); and partly under TMDA. ",

year = "2024",

month = sep,

day = "15",

doi = "10.1177/00469580241273323",

language = "English",

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Mwamwitwa, KW, Bukundi, EM, Maganda, BA, Munishi, C, Fimbo, AM, Buma, D, Muro, EP, Sabiiti, W, Shewiyo, DH, Shearer, MC , Smith, AD & Kaale, EA 2024, 'Adverse drug reactions resulting from the use of chiral medicines amoxicillin, amoxicillin-clavulanic acid, and ceftriaxone: a mixed prospective-retrospective cohort study', INQUIRY: The Journal of Health Care Organization, Provision, and Financing, vol. 61. https://doi.org/10.1177/00469580241273323

Adverse drug reactions resulting from the use of chiral medicines amoxicillin, amoxicillin-clavulanic acid, and ceftriaxone: a mixed prospective-retrospective cohort study. / Mwamwitwa, Kissa W.; Bukundi, Elias M.; Maganda, Betty A. et al.
In: INQUIRY: The Journal of Health Care Organization, Provision, and Financing, Vol. 61, 15.09.2024.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Adverse drug reactions resulting from the use of chiral medicines amoxicillin, amoxicillin-clavulanic acid, and ceftriaxone

T2 - a mixed prospective-retrospective cohort study

AU - Mwamwitwa, Kissa W.

AU - Bukundi, Elias M.

AU - Maganda, Betty A.

AU - Munishi, Castory

AU - Fimbo, Adam M.

AU - Buma, Deus

AU - Muro, Eva P.

AU - Sabiiti, Wilber

AU - Shewiyo, Danstan H.

AU - Shearer, Morven C.

AU - Smith, Andrew D.

AU - Kaale, Eliangiringa A.

N1 - Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was part of the EDCTP2 Program supported by the European Union partly under the SMERT project (CSA2016ERC-1432) and ASCEND project (CSA2019ERC-2683); and partly under TMDA.

PY - 2024/9/15

Y1 - 2024/9/15

N2 - 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.

AB - 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.

KW - Prospective-retrospective cohort study

KW - Ceftriaxone injections

KW - Adverse drug reactions

KW - Amoxicillin

KW - Amoxicillin-clavulanic acid

KW - Chiral medicines

U2 - 10.1177/00469580241273323

DO - 10.1177/00469580241273323

M3 - Article

SN - 0046-9580

VL - 61

JO - INQUIRY: The Journal of Health Care Organization, Provision, and Financing

JF - INQUIRY: The Journal of Health Care Organization, Provision, and Financing

ER -

Mwamwitwa KW, Bukundi EM, Maganda BA, Munishi C, Fimbo AM, Buma D et al. Adverse drug reactions resulting from the use of chiral medicines amoxicillin, amoxicillin-clavulanic acid, and ceftriaxone: a mixed prospective-retrospective cohort study. INQUIRY: The Journal of Health Care Organization, Provision, and Financing. 2024 Sept 15;61. Epub 2024 Sept 15. doi: 10.1177/00469580241273323

Adverse drug reactions resulting from the use of chiral medicines amoxicillin, amoxicillin-clavulanic acid, and ceftriaxone: a mixed prospective-retrospective cohort study

Abstract

Keywords

UN SDGs

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ASCEND: Moving Tanzania's Clinical Research Ethics and Medicines Regulatory Capacity to the next level: Fostering Medicines Quality, Safety and GCP Clinical Trials - ASCEND

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