Abstract
The Bureau of Drugs and Narcotics, Department of Medical Sciences, conducted a five-year longitudinal
study that monitored the physical deterioration of drug products in 829 hospitals nationwide,
supervized or owned by the Ministry of Public Health, as well as some other hospitals in Bangkok,
between 2003 and 2008. The study encouraged healthcare professionals to voluntarily observe and report
defects or physical deterioration problems found in marketed drug products, available in government
hospitals. A total of 2,407 reports were gradually received. The results revealed the major problems: 37.1
percent of the total reports were related to container and packaging defects, 14.5 percent of which were
chipped, cracked, or splitting tablets, followed by discoloration or abnormal odor (11.5 percent) and suspected
product contamination and/or labeling concerns (6.2 percent). In terms of dosage forms, 47.4
percent were tablets, whose major issue was incomplete/missing amounts in original packages. The
percentages for other forms, including injections, solutions, capsules and inhalers, were also included.
Finally, the information regarding the physical deterioration of drug products obtained from this study is
helpful for healthcare providers in making decisions on product selections and for the quality assurance
of drug schemes, as well as for use in identifying standards in pharmaceutical development.
