Quality Assurance for Pharmaceutical Products Used in Public Hospitals - การประกันคุณภาพยาที่ใช้ในสถานพยาบาลรัฐ

Abstract

Drug supply management system has been reformed by the Ministry of Public Health, Thailand,
in order to ensure the quality, efficacy and rational use of drug, with affordable price. The Department
of Medical Sciences has conducted a program on quality assurance for pharmaceutical products. The
objective of this study was to assess the quality of pharmaceutical products used in public hospitals,
especially the quality of products in the Essential Drug List. The selection criteria of products were: high
consumption, wide range price variation for the same product, products in the Essential Drug List or life
threatening drugs. At least 3 production lots of each registered products selected by simple random
sampling were sent from 360 public hospitals to the designated laboratories during October 2007 –
September 2012, covering 184 products. Altogether 5,585 samples, both locally manufactured and
imported, were analyzed according to the official or current pharmacopeial requirements. The results
shown that 88.8 percent of the total samples conform to the pharmacopeial standards and 11.2 percent
of the total samples were substandard. The major problems were content of pharmaceutical active
ingredients, related substances and dissolution. One important finding was that the substandard products
were often associated with manufacturers’ failure on revised quality control part as legally specified in
the improved official pharmacopeial due to life-long drug registrations. In conclusion, the information
regarding the drug quality obtained from this study would be helpful for all the concerned parties in the
procurement process as well as improvement of drug registration process.
Key words: Drug Quality Assurance, Pharmaceutical Procurement, Drug Quality Information