Relative Risk Assessment for Substandard Antibiotics Along the Manufacturing and Supply Chain: A Proof-of-Concept...

Ensuring good quality of antibiotics is essential for desired health outcomes. Risk assessment of products for quality issues arising along the manufacturing and supply chain can thus have an important role in surveillance and management of interventions designed to reduce the burden of substandard antibiotics. Demonstrated and validated risk assessments are currently limited.

The objective of this study was to investigate whether a comparative risk assessment framework, which adapts the WHO criteria for estimating risks for quality issues posed by individual medicines, is applicable and can identify antibiotics with a higher relative risk of substandard prevalence.

For a proof-of-concept study, a set of antibiotics from the WHO essential medicines list was selected. Quantitative and qualitative data were extracted for each risk assessment criteria pertaining to severity and probability. A final risk matrix was then compared to field data for validation.

Antibiotic products were classified by relative risk. Of all the antibiotic products assessed (n = 28), 32% were categorized as highest risk, 46% as high risk, 18% as medium risk, and 4% as lowest risk. The comparison of the risk scores and incidence of quality failure from the USP Medicines Quality Database showed significant correlation.

The framework and extracted data sets appear applicable to determine relative risk for substandard antibiotics. Results of the risk matrix may be valuable for guiding pharmacovigilance, surveillance strategies, standardizing risk-based approaches, and mitigation efforts. Refinement with increased data availability may improve results.