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A Retrospective Study Of Physical Defects In Pharmaceuticals At Kenyatta National Hospital From January 2015 To December 2016

Author: Babra A. ,Tirop L. J. ,Aywak D. A.
Is Part Of: Pharmaceutical Journal of Kenya, Volume 23, No. 3 (2018)
The quality of pharmaceutical products is of utmost importance in the management of various life-threatening conditions. A retrospective study of physical quality defects in pharmaceuticals at Kenyatta National Hospital was carried out for the period January 2015 to December 2016. The aim of the study was to investigate the different types of physical quality defects encountered in pharmaceutical products. A total of 58 defects in 44 products were reported. Organoleptic changes, physicochemical changes of solids and physical package problems were the most frequently encountered defects (32%, 28% and 21% respectively). Oral dosage forms (39%) and parenteral preparations (36%) were the most common dosage forms with defects reported. Most (79%) defects occurred in less than a year after manufacture, suggesting inadequate preformulation studies. Imported products had the most (80%) defects. Majority (56%) of defects were reported by pharmacists. Apart from pessaries that required refrigeration (4-8°C), all other products with defects were stored at room temperature (20-25°C), as per the manufacturer’s recommendations. The classification system used by the researchers to study quality defects was clear and consistent. Methods should be created to sensitize health care providers as well as patients on how to detect and report physical defects in pharmaceutical products.
Keywords: Pharmaceutical product physical quality defect, pharmacovigilance, Kenyatta National Hospital
Publisher: The Pharmaceutical Society of Kenya
ISSN: 2411-6386