Quality Evaluation of A Selection of Antibiotics Distributed in Accra (Ghana) And Lagos (Nigeria)

ABSTRACT

The persistent prevalence of Counterfeit and substandard drugs poses a clear and present danger globally. Its higher degree of occurrence and under-reporting in developing nations especially in Africa and Asia is of great concern. Antibiotics are amongst the most used and abused in developing countries and as such, the need for its constant surveillance cannot be over emphasised. This study involved the assessment of the quality of three commonly used therapeutic groups of antibiotics; the macrolides (Azithromycin and Erythromycin) and lincosamides (Clindamycin). This involved the identification and quantification of the active pharmaceutical ingredient (API), and in vitro dissolution test. HPLC and in vitro dissolution tester instruments were used. Based on the population density, level of industrialization and demand, past incidence of existence of poor quality drugs, and their socio-economic relationship, Accra (Ghana) and Lagos (Nigeria) were chosen for this survey. All the available brands of the three APIs making a total of 45 different brands of the antibiotics were sampled from the two countries. In Ghana, 31% of the drugs sampled were locally manufactured while 69% were imported. Nineteen (19%) of the drugs sampled in Nigeria were locally manufactured while most of the imported ones came from India with 53%. All the samples from Nigeria had their National Agency for Foods and Drugs Administration and Control (NAFDAC) registration number printed on their labels, while only one sample from Ghana had the registration number from Food and Drugs Authority (FDA) printed on its label. This study revealed that all the samples contained the requisite API. On analysis of the results however, 73% of the total drugs sampled did not comply with the required amount of API xii content in accordance with the US Pharmacopoeia standard, while 30% out of the 37 samples in vitro dissolution tested did not comply. Sixty-nine (69%) of drugs collected in Ghana and 75% of those collected in Nigeria did not comply with the API requisite pharmaceutical specification standard. Sixty eight (68%) of the Azithromycin, 67% of Clindamycin, and 86 % of Erythromycin failed the API quantitative test as specified by USP. Seventy-five (75%) of the paediatric dosage form of Azithromycin samples assayed did not comply with the USP standard. All the Azithromycin samples in vitro dissolution tested complied with the USP standard, while 36% of Erythromycin and 67% of Clindamycin complied with the in vitro test. Eighty (80%) of the Ghana samples complied with the in vitro dissolution test, while 67% of the Nigeria samples complied. These findings suggest the existence of substandard antibiotics in Accra and Lagos. It is therefore recommended that the production companies should be better monitored to ensure the strict adherence to Standard Operating Procedures (SOP) and compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Furthermore, the need for continuous and effective monitoring of the influx, distribution and quality of drugs in our society through pharmacovigilance cannot be overemphasised.