Drug Quality Assurance under the National List of Essential Medicines - การประกันคุณภาพยาในบัญชียาหลักแห่งชาติ

Abstract

                       The monitoring and evaluation of products quality of drugs in stocks of 385 government hospitals after purchase and delivery was conducted. The quality assurance of drugs is crucial to the success of treatment programmes.  In this survey of drug quality, at least 3 production lots of each registered products selected by simple random sampling were sent from hospitals in each region of the country to a designated laboratory during fiscal years 2004-2007, covering 172 drugs in the National List of Essential Medicines, B.E. 2004. A total of 5,693 samples or 1,532 registered products, both locally manufactured and imported, were analyzed according to the official or current pharmacopeial requirements by the national laboratories, Department of Medical Sciences. The results revealed that 90.0 percent of the total samples or only 83.0 percent of registered products conformed to the pharmacopeial standards. Of the 10.0 percent of total samples or 261 registered products, only some batches were found to be substandard. The major problems were related substances, chromatographic purity and dissolution respectively. One important finding was that poor registered products were often associated with manufacturersี failure on quality control revision-under protective status of life-long registration- as legally specified in the improved official pharmacopeia because of life-long registration.  Finally, the information regarding the drugs quality obtained from this study would be helpful for healthcare providers in making decisions on product selection as well as for the Drug Committee for editing the National List of Essential Medicines and/or withdrawal of any drug products once scientifically proven to be substandard.

Key words:      National List of Essential Medicines, drug quality assurance