Post-marketing Quality Surveillance of Selected Antibacterial Agents Marketed in Setit Humera and west Gondar Zones, North West Ethiopia.
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Date
2023
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Addis Ababa University
Abstract
Background: The presence of low-quality medicines is becoming increasingly
problematic in many parts of the world, particularly in developing countries. Antibiotics
are among the most common anti-infective medicines that are falsified.
Objective: The purpose of this study was to assess the quality of selected antibacterials
that are marketed in Setit Humera and west Gondar Zones, North West Ethiopia.
Methods: Seventy-one samples of the antibacterials were collected from six sites in Setit
Humera and west Gondar Zones, North West Ethiopia. A mystery shopper collection
system was used for sample collection. Visual inspection and confirmation of the
registration status were carried out using the WHO/FIP/USP checklist and the EFDA's
MRIS database, respectively. Then Pharmacopeial methods (USP, BP) were employed to
assess the physicochemical parameters.
Results: From 71 samples, 25.35% (18/71) were not registered and 15.49% (11/71) were
registered but the license period was expired i.e not in line with the EFDA’s specification.
Some (74.65% (53/71) observed samples) did not meet the visual inspection criteria
outlined in the joint WHO/FIP/USP checklists. The physicochemical evaluation showed
that all the samples studied met the quality specification with respect to the identification
and hardness test. From 71 samples tested with regard to assay, dissolution, uniformity of
dosage units, disintegration and friability tests, 27.49% (23/71), 16.9%, and 14.08%
(10/71), 2.82% (2/71) and 8.57% (3/35) of samples were found to be substandard
respectively. Overall, 56.33 % (40/71) of the samples tested were of poor-quality.
Conclusion: The results indicated that some (56.33 %) antibacterial medicines circulating
in the market did not meet the required quality. Therefore, the regulatory body (EFDA)
should focus on enforcing the necessary measures to ensure that antibacterial drugs on the
market meet the required mandatory standards
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Keywords
Antibacterial, poor-quality medicine, Setit Humera, West Gondar, Post- marketing surveillance.