The Quality of Medicines in Community Pharmacies in Riyadh, Saudi Arabia: A Lot Quality Assurance Sampling (LQAS)-Based Survey

作     者：Hani M. J. Khojah Henrik Pallos Naoko Yoshida Manabu Akazawa Hirohito Tsuboi Kazuko Kimura 

作者机构：Department of Drug Management and Policy Graduate School of Natural Science and Technology Kanazawa University Kana-zawa Japan Department of Drug Management and Policy Graduate School of Natural Science and Technology Kanazawa University Kana-zawa Japan Department of Drug Management and Policy Graduate School of Natural Science and Technology Kanazawa University Kana-zawa Japan Department of Clinical and Hospital Pharmacy College of Pharmacy Taibah University Madinah KSA Department of International Pharmaceutical Sciences Graduate School of Natural Science and Technology Kanazawa University Kanazawa Japan Department of Public Health and Epidemiology Meiji Pharmaceutical University Kiyose Japan 

出 版 物：《Pharmacology & Pharmacy》 (药理与制药（英文）)

年 卷 期：2013年第4卷第7期

页      面：511-519页

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

主　　题：Amoxicillin Antibiotic Quality of Medicines Lot Quality Assurance Sampling Saudi Arabia Community Pharmacy 

摘      要：Objectives: To classify community pharmacies (CPs) in Riyadh, Saudi Arabia, in terms of the quality of medicines sold by them, using?the lot quality assurance sampling (LQAS) technique with a predefined threshold. Methods: Riyadh CPs were divided into 2 categories (“lots for the purpose of LQAS), i.e., chain and independent CPs. Upper and lower rate thresholds for CPs that sell low-quality medicines were predefined as 20% and 5%, respectively. Consumer and provider risks were predefined as 0.05 and 0.10, respectively. The calculated number of randomly selected CPs required in each lot was 36;then, sale of low-quality medicines in 3 CPs implies a prevalence of 20% of such CPs according to LQAS. A randomly selected brand of amoxicillin (selected as a quality indicator of medicines because it is both widely counterfeited and heat-sensitive) was purchased from each pharmacy by a “mystery shopper, checked for authenticity, and analyzed for drug content and content uniformity using a validated HPLC method. Results: Substandard amoxicillin was purchased in 9 pharmacies (4 chains and 5 independent). Both lots were thus rejected as unacceptable, which may indicate that consumers in Riyadh are at risk of purchasing substandard medicines at CPs. Conclusions: The quality of medicines sold in CPs in Riyadh did not meet our acceptability criterion, and appropriate intervention by decision makers is recommended. LQAS proved to be a practical, economical, and statistically valid sampling method for surveying the quality of medicines. It should enable decision makers to allocate resources for improvement more efficiently.