Post Market Quality Surveillance (pms) Of Veterinary Anthelmintic Drugs (albendazole Ivermectin And Fenbendazole Tabletsboluses) Marketed In Gondar Zones North West Ethiopia.

Background: The presence of poor-quality veterinary drugs hampers the effectiveness of animalrnhealth systems. It may produce danger to human safety through animal-derived food productsrnconsumed by the people. Poor quality drugs include substandard medicines, caused by poorrnmanufacturing or distribution practices, and falsifications, prompted by a deliberate intent tornfraud. rnObjective: To assess the quality of veterinary albendazole, fenbendazole and ivermectin boluses rnmarketed in Gondar Zones, North West Ethiopia. rnMethods: 42 samples were collected from 11 sites of Gondar zones, Northwest Ethiopia.rnMystery shopping sampling technique was used. First, visual inspection was performed andrncompared with criteria given in the joint WHO/FIP/USP checklist. Finally, physicochemicalrnquality attributes were investigated using USP and manufacturer‟s methods. rnResults: All samples complied with criteria given in the joint WHO/FIP/USP checklists forrnvisual inspection and all samples passed for identification test. All brands of albendazole bolusesrnfailed to comply with the USP (2015) dissolution specification limit. Quantitative analysis forrnivermectin and fenbendazole drugs showed that all batches were within the limits of USP (2015)rnand manufacturer‟s specification respectively. However, 30% (9/30) of albendazole samples didrnnot meet USP specification for the assay (assay values for failed samples were ranged fromrn73.91 to 87.49% of label claim). Ivermectin and fenbendazole samples passed for uniformity ofrndosage units. However, 23.33% (7/30) of albendazole samples failed for uniformity of dosagernunits. Except three brands of albendazole, all samples had passed disintegration test. All batchesrnof ivermectin complied with pharmacopeial specification for friability. On the other hand, exceptrnone brand, all brands of albendazole and fenbendazole samples failed this test. Overall, 80.95%rn(34/42) of tested drug samples were substandard (do not meet the pharmacopoeial qualityrnSpecifications limits). rnConclusion The results of this study suggest that some veterinary anthelminthic medicinesrncirculating in the market did not meet the required quality. This could have risk of reducedrnefficacy due to wide distribution of poor quality drugs. Therefore, it is strongly recommended for veterinary drugs control authority to enforce the necessary regulatory measures that ensuresrndrugs circulating in the market fulfill the necessary mandatory standards.

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