A Decade of Pharmaceutical Quality Assurance

Abstract

         Pharmaceutical quality assurance is one of the strategies to ensure both physicians and patients that the medicines used in the national health insurance system are of quality. This report aims to evaluate the quality of medicines used in public hospitals all over the country. The retrospective study is conducted by reviewing and evaluating the quality test reports obtained during fiscal years 2002 – 2011 under the Pharmaceutical Quality Assurance Program operated by the Department of Medical Sciences. Those drugs were analyzed in accordance with the methodology and criteria specified in the pharmacopoeias promulgated by the Minister of Public Health as official pharmacopoeias, or the newer editions of such pharmacopoeias. The data showed that 1,314 samples (10.9%) from a total number of 12,027 samples (3,755 registration numbers) of 258 drug items, as listed by their generic names, or 451 items, as further subdivided each item by their dosage forms, failed to meet the acceptance criteria. The items that passed the criteria were subsequently included into the Green Book established by the Bureau of Drug and Narcotic, Department of Medical Sciences. For a decade, the systematic drug quality surveillance has helped in assessment and evaluation of the quality of drugs used within the country, as well as reducing redundant tests and saving resources. It also eases the related public health agencies in procurement of medicinal products and urges the manufactures to keep improving the quality of their products to meet the international standards.