Post marketing surveillance of selected veterinary medicines in Tanzania mainland

BMC Veterinary Research

卷:18

Betty A. Maganda¹  Seth Kisenge²  Itikija E. Mwanga²  Gerald S. Kulwa²  Engelbert B. Mbekenga²  Sophia A. Mziray²  Kissa W. Mwamwitwa²  Danstan H. Shewiyo²  Yonah H. Mwalwisi²  Adam M. Fimbo² 

[1] Department of Pharmaceutics and Pharmacy Practice, Muhimbili University of Health and Allied Sciences;

[2] Tanzania Medicines and Medical Devices Authority;

关键词: Falsified;    Post-marketing surveillance;    Product Information Review;    Substandard;    Screening;    Veterinary medicines;   

DOI  :  10.1186/s12917-022-03329-x

来源: DOAJ

【 摘 要 】

Abstract Background Veterinary medicines have been widely used for the prevention and treatment of animal diseases. Globally, the veterinary medicine industry is growing. However, there is a significant increase of concern on the quality of veterinary medicines in various developing countries’ legal markets. Poor-quality medicines are associated with treatment failure, development of drug resistance, increased healthcare cost, and death. These reasons warrant a need for monitoring the quality of the medicines circulating in the Tanzania Mainland. Methods This was a survey study and veterinary medicines samples were collected from 9 out of 26 regions of Tanzania mainland between 2014 and 2017. Veterinary medicines were sampled from wholesale pharmacies, retail pharmacies, veterinary clinics and Veterinary Accredited Drug Dispensing Outlets (ADDO-vet). All sampled medicines were subjected to product information review and full quality control testing at the Tanzania Medicines and Medical Devices Authority-World Health Organization prequalified laboratory. Results A total of 238 samples of veterinary medicines were collected. Out of these, 97.1% (231/238) were subjected to full quality control testing and product information review. All sampled veterinary medicines conformed to visual appearance, clarity, pH, solubility and sterility tests. Also, of the sampled veterinary medicines 97.8% (226/231) and 89.2% (206/231) passed identification and assay tests, respectively. As well as, the majority of the collected samples 92% (219/238) failed to comply with product information requirements. The most observed deficiencies on product information were inadequate information on the package insert 94.1% (224/238), inappropriate storage conditions 55.5% (132/238) and lack of Tanzania registration number 27% (64/238). Conclusion Veterinary medicines with poor quality were found circulating in the legal markets of Tanzania. This can potentiate treatment failure and the development of drug resistance in animals and humans. Post marketing surveillance program will continue to be implemented to ensure that only good quality, safe and efficacious medicines are circulating in the Tanzania Mainland market.

【 授权许可】

Unknown