Regulatory Compliance and Associated Quality of Amoxicillin in Drug Retail Outlets of Southwestern Ethiopia

Abstract

Background: While the research findings confirm the existence of private drug retail outlets that do not comply with regulatory standards in many low-income countries, there are a lack of reports that evaluate the quality of medicines obtained from these firms. Therefore, the aim of this study was to evaluate the regulatory compliance of the retails and associated quality of amoxicillin in Southwestern Ethiopia. Methodology: Forty-two drug retail outlets in Jimma town were evaluated using an inspection checklist developed by the Ethiopian regulatory authority, and dispensers from these retail outlets were interviewed using the pretested structured questionnaire. The drug outlets were coded and categorized into noncompliant and compliant drug retail outlets. The physicochemical quality of amoxicillin capsules obtained from these retail outlets were evaluated following methods described in the US Pharmacopoeia. Results: The present study revealed that about 54.76% drug retail outlets were compliant with the regulatory standard. Factors like income of retail outlet, experience of dispenser, and training regarding good storage practice were associated with status of regulatory compliance (p-value <0.05). The identification, dissolution, and assay results indicated that all amoxicillin samples obtained from both noncompliant and compliant drug retail outlets complied with pharmacopoeial specification limit. Besides, the independent unequal variance t-test revealed that there is no significant difference between mean dissolution and assay of API of the amoxicillin samples obtained these drug retail outlets (p-value >0.05). Conclusion:The regulatory compliance of private drug retail outlets in Jimma town is not satisfactory. Moreover, the laboratory findings revealed that all samples of amoxicillin capsules compiled with pharmacopoeial specifications acceptance for packaging and labeling information, identification, assay, and dissolution. However, despite the fact that assays of the amoxicillin from retail outlets are within the required specification, the assays of amoxicillin obtained from noncompliant retail outlets appears to be slightly degraded, which may potentially demonstrate the impact of noncompliance of the drug retail outlets on the quality of medicines.

Compliance of good storage practices of pharmacies and medicine outlets: a scoping review

“…A recent review of the current literature found that the antibiotic failure frequency (the proportion of samples in a prevalence study that failed at least one quality test) was 15.7% for private pharmacies 31 . In a demonstrated combined sampling and testing study included in this review, the assays of amoxicillin obtained from non‐compliant retail outlets appeared to be slightly degraded compared to compliant retail outlets, although still within pharmacopoeial limits 12 . Additionally, in another study included in this review in which the microbiological potency of sampled antibiotics were tested, pharmacy air conditioning was significantly associated with potency 15 .…”

“…Full study characteristics are provided in Table 1, and further details are provided within the quality assessment in Table S1. Of the 15 studies, publication dates ranged from 2007 to 2021, with the majority published in 2021 ( n = 6) 12,14–16,23,26 , and 10 countries were represented by those 15 studies, with the majority located in Asia and Africa. Five studies investigated outlets in Pakistan 17,21,23–25 .…”

“…As for the methodology in the 15 studies, 12 used participatory research (e.g. surveys, questionnaires, interviews), and of those, 12,[14][15][16][17][18][20][21][22][23][24][25] three also included observational inspections/visits. 14,18,24 In one study, Principal Investigator-administered inspections were used, 26 and in two, retroactive analyses of inspection data or a quantitative dataset were conducted.…”

“…31 In a demonstrated combined sampling and testing study included in this review, the assays of amoxicillin obtained from non-compliant retail outlets appeared to be slightly degraded compared to compliant retail outlets, although still within pharmacopoeial limits. 12 Additionally, in another study included in this review in which the microbiological potency of sampled antibiotics were tested, pharmacy air conditioning was significantly associated with potency. 15 Furthermore, only four of the 29 activities were above 80% compliance.…”