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.

Keywords:

• drug retails
• regulatory compliance
• quality
• amoxicillin
• Ethiopia

Abbreviations

APIs, active pharmaceutical ingredients; WHO, World Health Organization; RS, reference standard; USP, United State Pharmacopeia.

Data Sharing Statement

The documents supporting this study will be available upon request from corresponding author.

Ethical Approval and Consent to Participate

The Declaration of Helsinki was followed in undertaking this study. It was approved by the Institutional review board of Jimma University (Reference no. JHRPGD/921/20). A letter of permission was received from the office of Jimma Regional Health Bureau. The informed consent of the study participants was taken prior to interviews for collection of data and evaluation of drug outlets. The withdrawal right of study participants from involvement of study at any time was assured.

Acknowledgments

The authors would like to extend their heartfelt gratitude to all dispensers and owners of drug retail outlets of Jimma Town for accepting invitation to be involved in this study and permit evaluation of retails. We would also like to thank Jimma University Laboratory of Drug Quality for permitting the laboratory facilities.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

The authors report no conflicts of interest in this work.