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. 2022 Aug;7(8):e008587.
doi: 10.1136/bmjgh-2022-008587.

Substandard and falsified antibiotics: neglected drivers of antimicrobial resistance?

Guillermo A Zabala  1   2   3   4 , Khonsavath Bellingham  1   2   4 , Vayouly Vidhamaly  1   2   4 , Phonepasith Boupha  1   2   4 , Kem Boutsamay  1   2   4 , Paul N Newton  1   2   4 , Céline Caillet  5   2   4
Affiliations

Substandard and falsified antibiotics: neglected drivers of antimicrobial resistance?

Guillermo A Zabala et al. BMJ Glob Health. 2022 Aug.

Abstract

Objectives: Antimicrobial resistance (AMR) is a significant global health threat with substandard and falsified (SF) antibiotics being neglected contributing factors. With their relationships poorly understood, more research is needed in order to determine how interventions to reduce SF antibiotics should be ranked as priorities in national AMR action plans. We assessed the evidence available on the global prevalence of SF antibiotics, examined the quality of the evidence and discussed public health impact.

Materials/methods: We searched PubMed, Embase, Google and Google Scholar for publications on antibiotic quality up to 31 December 2020. Publications reporting on the prevalence of SF antibiotics were evaluated for quantitative analysis and assessed using the Medicines Quality Assessment Reporting Guidelines.

Results: Of the 10 137 screened publications, 648 were relevant to antibiotic quality. One hundred and six (16.4%) surveys, published between 1992 and 2020 and conducted mainly in low-income and middle-income countries (LMICs) (89.9% (480/534) of the data points), qualified for quantitative analysis. The total number of samples tested for quality in prevalence surveys was 13 555, with a median (Q1-Q3) number of samples per survey of 47 (21-135). Of the 13 555 samples, 2357 (17.4%) failed at least one quality test and the median failure frequency (FF) per survey was 19.6% (7.6%-35.0%). Amoxicillin, sulfamethoxazole-trimethoprim and ciprofloxacin were the most surveyed antibiotics, with FF of 16.1% (355/2208), 26.2% (329/1255) and 10.4% (366/3511), respectively. We identified no SF survey data for antibiotics in the WHO 'Reserve' group. The mean Medicine Quality Assessment Reporting Guidelines score was 11 (95% CI 10.1 to 12.2) out of 26.

Conclusions: SF antibiotics are widely spread with higher prevalence in LMICs. The quality of the evidence is poor, and these data are not generalisable that 17.4% of global antibiotic supply is SF. However, the evidence we have suggests that interventions to enhance regulatory, purchasing and financial mechanisms to improve the global antibiotic supply are needed.

Prospero registration number: CRD42019124988.

Keywords: medical microbiology; pharmacology; public Health.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Number of prevalence surveys (y-axis) pertinent to antibiotic quality published per year (x-axis). A second-order polynomial trendline is represented as the blue dotted line.
Figure 2
Figure 2
Quality categories of samples from antibiotic quality prevalence studies. Samples are classed as of ‘good quality’ if they passed all the tests performed by the investigators of a given study, which often do not cover the full pharmacopoeial specifications. Substandard and falsified samples are those who have failed at least one of the tests performed by the investigators. SorF, substandard or falsified.
Figure 3
Figure 3
Global distribution of the evidence on antibiotics quality: total number of samples included in prevalence surveys (A) and failure frequency (B); countries with <15 samples have been greyed out. Caution must be exercised when drawing conclusions from these graphs. Samples from a given country may originate from a study sampling a single small urban or rural area, authorised or illicit outlets only (or a mix), etc and are not representative of medicine quality in the whole country. See online supplemental file 6 for further details.
Figure 4
Figure 4
Frequency and proportion of prevalence surveys (out of 82) by individual Medicine Quality Assessment Reporting Guidelines checklist items reported.
See this image and copyright information in PMC

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