Main Article Content
Background: Drug quality problem is a global concern which affects both patients and societies. It yields to economic losses and lack of confidence in the quality of healthcare facilities. Hence, examing the factors that effect on drug quality problems is necessary for the further solutions.
Objectives: This study examined prevalence and severity of drug quality problems, identified factors affecting drug quality, and association between the therapeutic groups and drug quality problems at the Songklanagarind hospital.
Methods: All record forms of drug quality problems were collected between October 2017 and September 2019. Details of drugs, severity of problems, and factors affecting drug quality problems were studied. Descriptive statistics were used to assess drugs data and severity while the association between factors and drug quality problems were measured by using a logistic regression model.
Results: The results showed that 69 of 80 record forms during the study period met the inclusion criteria. Among the 69 records, only 44 items of drugs were found. The average drug quality problem per year was 1.4%. Most types of problems were packaging at 53.6% followed by physical appearance changes 27.5%, labeling 10.1%, and packing 8.7%. Most drug quality problems reported were at low to moderate level of seriousness. No serious drug quality problem was reported. Two significant factors affecting drug problems were found in therapeutic groups and primary packaging materials. Statistics by odds ratio showed as follow; nutrition and blood in the therapeutic group (OR=4.07, 95% CI, 1.90–8.71), primary packaging materials of bag (OR=3.93, 95% CI, 1.49–10.4) and primary packaging materials of bottle (OR=2.88, 95% CI, 1.46–5.70). Dosage forms and generic medicines were negatively correlated with drug problems.
Conclusions: The factors that affect on drug quality problems at our hospital were nutrition and blood in the therapeutic group, primary packaging materials of bag and bottle. As a result, we recommended that it should more further study comparing packaging materials of same drug especially in the therapeutic group of nutrition and blood which affecting drug quality problems.
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