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Substandard and falsified systemic anti-infectives in Peru
Carlos Huamaní-Pacsi1, Roberto Torres Olivera1
1Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Lima, Peru.
Abstract:
Substandard and falsified (SF) systemic anti-infective medications (SAMs) detected by the National Health Authority of Peru between 2015 and 2023 were quantified and characterized. An observational, descriptive, and retrospective design was applied, based on test reports issued by the National Quality Control Center on the quality of SAIs, complemented with national evidence of antimicrobial resistance (AMR). Of 9799 pharmaceutical products evaluated, 1247 (12.7%) were SF; of these, 189 (15.2%) corresponded to SF-SAM, with falsified ones predominating (11.0%). The main groups were β-lactams (27.5%), sulfonamides/tri-methoprim (26.5%), and quinolones (12.7%). 59.8% had informal origin, mostly from Lima (72%). The circulation of SF-SAM could promote selective pressure, the spread of AMR, and therapeutic failure.
Insights
Substandard and falsified systemic anti-infective medications (SAMs) are a significant issue in Peru. Their circulation may drive antimicrobial resistance (AMR) and treatment failures.
Area of Science:
- Pharmaceutical Sciences
- Public Health
- Infectious Diseases
Background:
- Substandard and falsified (SF) medications pose a global health threat.
- Systemic anti-infective medications (SAMs) are critical for treating infections.
- Antimicrobial resistance (AMR) is a growing concern linked to medication quality.
Purpose of the Study:
- To quantify and characterize SF-SAM detected in Peru from 2015 to 2023.
- To assess the prevalence and types of SF-SAM.
- To explore the potential impact of SF-SAM on AMR.
Main Methods:
- Observational, descriptive, and retrospective study design.
- Analysis of test reports from the National Quality Control Center (2015-2023).
- Inclusion of national AMR data.
Main Results:
- 12.7% of 9799 pharmaceutical products were SF, with 15.2% of these being SF-SAM.
- Falsified SF-SAM predominated (11.0%).
- Key SF-SAM groups included β-lactams, sulfonamides/tri-methoprim, and quinolones; 59.8% had informal origins, primarily from Lima.
Conclusions:
- The prevalence of SF-SAM in Peru is substantial.
- SF-SAM circulation may contribute to AMR development and therapeutic failures.
- Regulatory oversight and quality control are crucial to mitigate risks associated with SF-SAM.
