Investigation of the Quality of the 12 Most-Used Antibiotics Available in Retail Private Pharmacies in Rwanda.

Thomas Bizimana,Marie Françoise Mukanyangezi,Védaste Kagisha,Egide Kayitare,Alain Katembezi Nyirimigabo,Raymond Muganga,Jean Baptiste Nyandwi

doi:10.3390/antibiotics11030329

Thomas Bizimana, Marie Françoise Mukanyangezi + Show 5 more

Open Access

https://doi.org/10.3390/antibiotics11030329

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Journal: Antibiotics	Publication Date: Mar 2, 2022
Citations: 3	License type: CC BY 4.0

Affiliation: University of Rwanda

Abstract

Using poor-quality antibiotics leads to increased risk of the development of microorganism-resistant strains, treatment failure, loss of confidence in health systems, and associated socio-economic impacts. The prevalence of poor-quality antibiotics has been found to be high in some of the Low and Middle-Income Countries (LMICs), but no data were available on the situation in Rwanda. This study was conducted to obtain data and inform health professionals on the quality of the 12 most-used selected antibiotics from private retail pharmacies in Rwanda. The investigation was conducted on 232 batches collected from randomly selected private retail pharmacies in all provinces of Rwanda, and concerned only with visual inspection and assay tests. Visual inspection was performed using a tool adopted by the International Pharmaceutical Federation (FIP) to identify manufacturing defects. An assay test quantified the Active Pharmaceutical Ingredient (API) in each collected batch using high-performance liquid chromatography (HPLC) coupled with an ultraviolet-visible (UV) detector, and the results were reported as the percentage content of the amount of APIs stated on the label. A total of 232 batches were analyzed, manufactured in 10 countries; the main country of manufacture was Kenya, with almost half of the batches (49.6%). The results of the visual inspection did not show the presence of counterfeit/ falsified antibiotics on the Rwandan market in this study but revealed weaknesses in labeling: more than 90% of the analyzed batches of the 12 antibiotics did not present the dosage statement on their label, and the complete list of excipients was missing in more than 20% of the analyzed batches. The assay test using HPLC confirmed the presence of APIs in 100% of the analyzed batches. However, moderate deviations from acceptable ranges of the API content defined by M. M. Nasr & C. M. Stanley in 2006 for erythromycin and the United States Pharmacopoeia 2018 for the other 11 molecules were found. The failure rate to meet the quality requirements in terms of the percentage content of active pharmaceutical ingredients declared on the labels was estimated at 8.2% in total, with 3.9% and 4.3% containing more and less than the amount of APIs stated on the labels respectively. The most-represented antibiotics on the Rwandan market were amoxicillin, co-trimoxazole and cloxacillin. No counterfeit antibiotics were found in this study. However, substandard batches with moderate deviations were found, suggesting that regular quality control of antibiotics is needed in Rwanda.

Highlights

Since the 1980s, there have been very few new antibiotics [1]
Few batches of the analyzed antibiotics were manufactured in European countries known as Stringent
Amoxicillin, co-trimoxazole and cloxacillin were the most-represented in the collected batches

Summary

Introduction

Since the 1980s, there have been very few new antibiotics [1]. If bacteria continue to develop resistance to existing antibiotics, there is a risk of losing stronger ones to treat serious infections. Factors including the use of substandard antibiotics and irrational use of antibiotics influence the development of resistant bacteria [3], and this has become a global health and development threat, hindering the achievement of Sustainable Development Goal 3.1 (SDG3.1) defined by the United Nations (UN) by 2030 [4]. The presence of substandard and counterfeit antibiotics on the global market constitutes a big concern to public health and socio-economic development [5]. The risks associated with the use of substandard antibiotics affect health, economy and socioeconomic aspects [6–8]. Do substandard antibiotics fail to treat an infection, the patients risk experiencing toxicity, serious side effects, the development of strains resistant to the antibiotic used, loss of productivity, unnecessary expenses to treat side effects, complication of the infection that can lead to death, and loss of confidence in the health system [7,9]

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