Regulatory Compliance and Quality of Fixed-Dose Combination Amoxicillin–Clavulanic Acid Oral Suspensions:Evedence From Drug Retail Outlets In Sheger City, Oromia Regional State, Ethiopia

Abstract

Background: Fixed-dose combination amoxicillin-clavulanic acid oral suspensions are commonly used in pediatric care but are susceptible to degradation under inadequate storage conditions, especially in low-resource settings including Ethiopia. Objective: To assess regulatory compliance and the quality of Fixed-Dose Combination Amoxicillin–Clavulanic Acid Oral Suspensions:Evedences from Drug Retail Outlets of Sheger City, Oromia Regional State, Ethiopia. Methods: A cross-sectional study (May–July 2025) involving 200 drug retail outlets assessed product quality using 30 bottles from three brands collected via convenience sampling. Data were obtained through questionnaires, checklists, and laboratory testing, with counterfeit detection using the WHO visual inspection tool and quality evaluation per USP 40 standards. Analysis using SPSS v25 included descriptive statistics and logistic regression set at P < 0.05. Results: The study found that only 57% of drug retail outlets complied with national regulatory standards for pharmaceutical storage. While dispenser knowledge (88.9%) and attitudes (63%) toward proper storage were generally positive, practice gaps were evident. The multiple logistic regression indicates pharmacies with dispensers practicing over five years of experience were more than twice as likely to be compliant (AOR = 2.30, P = 0.028). Similarly, being a pharmacy owner (AOR = 1.86, p = 0.031) and having training in good storage practices (AOR = 1.72, p = 0.044) increased the odds of compliance. The licensed pharmacy outlets having a self-contained storage area and using a thermometer for monitoring (P<0.05) were also significantly linked to higher compliance levels. All samples met the WHO visual inspection and USP assay quality standards (amoxicillin 90–120%, clavulanic acid 90–125%). Samples from drug retail outlets that complied with national regulatory standards for pharmaceutical storage exhibited potency that is more consistent across brands. Conclusion: Despite the fact that every tested sample passed quality control testing, retail establishments continue to store pharmaceuticals in ways that do not comply with regulations, putting their long-term stability and effectiveness at risk. The study suggests that strengthened regulatory enforcement, improved storage infrastructure, and continuous dispenser training are essential to safeguard medicine quality and public health.