High global consumption of potentially inappropriate fixed dose combination antibiotics: Analysis of data from 75 countries
Open accessAbstract
Antibiotic fixed dose combinations (FDCs) can have clinical advantages such as improving effectiveness and adherence to therapy. However, high use of potentially inappropriate FDCs has been reported, with implications for antimicrobial resistance (AMR) and toxicity. We used a pharmaceutical database, IQVIA-Multinational Integrated Data Analysis System (IQVIA-MIDAS®), to estimate sales of antibiotic FDCs from 75 countries in 2015. Antibiotic consumption was estimated using standard units (SU), defined by IQVIA as a single tablet, capsule, ampoule, vial or 5ml oral suspension. For each FDC antibiotic, the approval status was assessed by either registration with the United States Food and Drug Administration (US FDA) or inclusion on the World Health Organization (WHO) Essential Medicines List (EML). A total of 119 antibiotic FDCs were identified, contributing 16.7 x 109 SU, equalling 22% of total antibiotic consumption in 2015. The most sold antibiotic FDCs were amoxicillin-clavulanic acid followed by trimethoprim/sulfamethoxazole and ampicillin/cloxacillin. The category with the highest consumption volume was aminopenicillin/β-lactamase inhibitor +/- other agents. The majority of antibiotic FDCs (92%; 110/119) were not approved by the US FDA. Of these, the most sold were ampicillin/cloxacillin, cefixime/ofloxacin and metronidazole/spiramycin. More than 80% (98/119) of FDC antibiotics were not compatible with the 2017 WHO EML. The countries with the highest numbers of FDC antibiotics were India (80/119), China (25/119) and Vietnam (19/119). There is high consumption of FDC antibiotics globally, particularly in middle-income countries. The majority of FDC antibiotic were not approved by either US FDA or WHO EML. International initiatives such as clear guidance from the WHO EML on which FDCs are not appropriate may help to regulate the manufacturing and sales of these antibiotics.
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Pharmacologically incompatible combinations are widely used in India.
“Studies have also shown that pharmacologically incompatible combinations are widely used in India.29”
From Consumption of systemic antibiotics in India in 2019 (2022) · cites this paper as [29]
The Discussion’s “Country specific FDC antibiotic use” section reports substantial sales in India of antibiotic fixed-dose combinations not approved by the US FDA, accounting for about half of antibiotic FDC sales there. Its “Concerns regarding clinical efficacy” section describes problematic dosing in some Indian combinations. The paper does not establish that these widely sold combinations are pharmacologically incompatible; lack of approval or concerns about efficacy are not equivalent to pharmacological incompatibility. The indexed passages provide no page numbers. (LLM, conf=0.84)
Experimental — accuracy not yet measuredIn 2015, more than 80% of FDCs sold in India were not compatible with the 2017 WHO Essential Medicines List.
“This is an improvement compared to the findings by Barbara et al. that more than 80% of FDCs sold in 2015 were not compatible with the 2017 WHO Essential Medicines List.29”
From Consumption of systemic antibiotics in India in 2019 (2022) · cites this paper as [29]
The Results section ('Compatibility of antibiotic FDCs with the WHO EML'; page unavailable) reports that 98 of 119 antibiotic FDC types identified across 75 countries (82.3%) were incompatible with the 2017 WHO EML. The Abstract says India had 80 of those 119 types, but does not establish that more than 80% of FDCs sold in India were incompatible; the reported percentage is not an India-specific sales figure. (LLM, conf=0.90)
Experimental — accuracy not yet measuredIndia had the highest number of antibiotic FDCs (n = 80) in 2015, followed by China (n = 25) and Vietnam (n = 19).
“A recent analysis using data for the year 2015 from 75 countries showed that India had the highest number of antibiotic FDCs (n = 80), followed by China (n = 25) and Vietnam (n = 19).29”
From Consumption of systemic antibiotics in India in 2019 (2022) · cites this paper as [29]
The state government agencies that permit these products have limited technical capacity to decide on the merit of approval.
“These products are permitted by the state government agencies that have limited technical capacity to decide on the merit of approval.29”
From Consumption of systemic antibiotics in India in 2019 (2022) · cites this paper as [29]
The Discussion’s “Country specific FDC antibiotic use” section says many antibiotic fixed-dose combinations were historically sold in India without authorization from the national regulator. It does not say state government agencies permitted them or assess those agencies’ technical capacity. Searches for state regulatory authorities and approval expertise found no passage addressing that claim; page numbers were not available in our copy. (LLM, conf=0.73)
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- Authors
- Bortone, B., Jackson, C., Hsia, Y., Bielicki, J., Magrini, N., & Sharland, M.
- Affiliations
- Meyer Children's Hospital (IT)
- St George's, University of London (GB)
- Queen's University Belfast (GB)
- World Health Organization (CH)
- Corresponding author
- Hsia, Yingfen
- Venue
- PLoS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2021-01-20
- Volume
- 16
- Issue
- 1
- Pages
- e0241899
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC7817037
- OpenAlex
- W3123235992
- Cited by
- 54
- References
- 25
- Citations by year
- 2026: 9 · 2025: 10 · 2024: 6 · 2023: 10 · 2022: 16 · 2021: 3
- FWCI
- 5.27
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- journal article
- Language
- en
- Open access
- gold
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- Funders
- World Health Organization
- Topics
- Life Sciences › Immunology and Microbiology › Applied Microbiology and Biotechnology › Antibiotic Use and Resistance
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Pharmaceutical Economics and Policy
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Medicine › Antibiotic Resistance in Bacteria
- Keywords
- antibiotic use, antimicrobial resistance, WHO Model List of Essential Medicines, drug approval status, amoxicillin-clavulanic acid, trimethoprim-sulfamethoxazole, drug sales, middle-income countries, regulatory guidelines
- MeSH terms
- Anti-Bacterial Agents, Dose-Response Relationship, Drug, Drug Combinations, Drug Compounding, Humans, Physiological Phenomena, World Health Organization, Drugs, Essential, Amoxicillin-Potassium Clavulanate Combination, Cefixime, Inappropriate Prescribing
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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