Analysis of drug product defects in Srinagarind Hospital

Abstract

Background: Quality assurance of drug distribution, which covers the systems  of selection, purchasing and storage of is to assure that drug products distributed to patients have standard qualities. Department of Pharmacy service, Srinagarind Hospital, has established the self reporting system of drug product defects since 2004. However, data analysis regarding types of problems and possible measures to rectify problems has not yet been reported.

Objective: To study the incidence, types of problems of drug product and managements from the established self-reporting system in Srinagarind Hospital.

Materials and methods: Author had collected data from the self reporting forms since January, 2005 to July, 2006, calculated the incidence, analysed the kinds of problems and corrective measures.

Study design: Descriptive study

Affiliation: Drug Information Center, Department of Pharmacy Service, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University.

Results: The incidence of drug product defects found in Srinagarind Hospital was about 3 reports per month. There were 60 reports of drug product defects during 19 months of study. Types of them were 36 physical defects, 18 packaging defects, 2 associated device defects, 2 quality inconfidences defects, 1 labeling defect and 1 keeping process defect. Importantly, 41 defects could be classified into class 1, which is the most dangerous. The related managements were 1) reporting back to the manufacturers requesting for exchange (49 times), 2) requesting for explanations of the problems from the pharmaceutical company (8 items) and 3) survey and surviellance of the remain drug products that had defects’ history (10 items)

Conclusion: The established self reporting system had formed the clear analysing and management system of the problems. The hospital could decrease the expenses related to drug loss. In addition, the obtained information will be useful in the selection of drug items of the Srinagarind Hospital.

Keyword : dry product defects