Substandard and falsified antibiotics: neglected drivers of antimicrobial resistance?

Publication summary

Substandard and falsified (SF) antibiotics, identified as those antibiotics either fraudulently misrepresenting composition and source (falsified), or approved products failing to meet quality standards and/or specifications due to manufacturing, transport or storage issues. Active ingredients may be present at lower or higher levels or not be present at all. Treatments with SF antibiotics can prolong patients' illness, hospital stays, and lead to death and worse health outcomes. There are numerous documented examples of deaths caused by the use of substandard doses of antibiotics or falsified drugs. Substandard dose can also promote the spread of antimicrobial resistance (AMR). Data on the prevalence of SF antibiotics are unfortunately scarce and the impact that these drugs have on AMR is still poorly understood. In this study, the authors perform a systematic review of the literature to quantify the failure frequency of antibiotics and their global distribution.

Who this is for

• Policy-makers
• Governments
• Regulatory agencies

Key findings

• More than 13 500 samples from 67 countries were tested for quality (106 prevalence surveys considered). More than 17% failed at least one quality test and of those more than 14% were substandard and 8% falsified. Most samples were from Africa and Asia, however authors highlighted that survey methodology and reporting were of low quality and data should be interpreted  with caution.
• Sulfamethoxazole-trimethoprim was found to have the highest failure frequency, followed by ampicillin, amoxicillin, ciprofloxacin and tetracycline. Highest failure frequency were in Africa and Asia.
• Issues with API were the most frequent.
• Antimicrobial consumption data could be combined with prevalence of SF antibiotics to quantify population risk.
• Most of the antibiotics tested were found to be part of the Access List while no antibiotics from the Reserve List were found to have been screened. This is particularly worrying as use of SF antibiotics in these lists could dramatically impact patients outcomes especially in low and middle income countries.
• Concerning examples were found in Bangladesh where cephradine and ciprofloxacin samples contained only 1% and 1.5% of the stated amount, respectively. Additionally, samples of parental ampicillin tested in Kenya were found to contain 190% of the stated amount.
• Policy interventions should be directed towards ensuring access to quality antibiotics. This could be specifically addressed in AMR National Action Plans.