Abstract
Substandard medicines have a great impact on health systems. For example, they can engender drug resistance, adverse effects, drug toxicity, increase mortality and morbidity, etc. As a result, a larger budget is needed for longer healthcare treatment, while health personnel lose confidence in drug qual-ity monitoring and generic drugs. This study employs a descriptive retrospective design. It aims to analyze the database of test results from the Quality Assurance of Medicines Program, which was operated by the Department of Medical Sciences between the fiscal years of 2002 to 2016. The international pharma-copoeia, for example, the United States Pharmacopeia (USP) or British Pharmacopoeia (BP), were used as reference standards. The findings revealed that 428 government hospitals voluntarily sent medicine samples to the Quality Assurance of Medicines Program. The total number of modern medicine samples was 572 items or 16,212 samples. The number of substandard samples decreased from 19.0% in 2002 to 0.8% in 2016. Based on the latest 3-year data, 2.9% of domestic generic drugs failed the standard specifications, whilst 0.9% of imported drugs failed. Dissolution and content of active ingredients were the most common issues found. The corresponding organizations in pharmacovigilance and pharmaceutical manufacturing, for ex¬ample, the Thai Food and Drug Administration (Thai FDA), the Department of Medical Sciences (DMSc), the Government Pharmaceutical Organization (GPO), and the Thai Pharmaceutical Manufacturers Associ¬ation (TPMA) should cooperate to monitor and improve the quality of domestic generic drugs in order to achieve greater confidence in using domestic generic drugs while also making budget savings. This could also strengthen the domestic pharmaceutical industry and enhance national drug security.
