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. Met...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.展开更多
Exposure to excessive temperature during distribution or storage has unfavorable consequences on the quality of medicines, particularly in hot climates. This could be one of the possible reasons behind the existence o...Exposure to excessive temperature during distribution or storage has unfavorable consequences on the quality of medicines, particularly in hot climates. This could be one of the possible reasons behind the existence of substandard amoxicillin in community pharmacies in Riyadh, Saudi Arabia. This study explored the conditions under which medicines were kept in a random sample of 181 community pharmacies in Riyadh. The pharmacist in charge in each pharmacy was interviewed and our observations about the quality of storage were recorded. The inspection revealed that in 9% of the sample the readings of the existing room thermometers were >25℃, and that 13% of the sample lacked thermometers. Also in 33% of the sample the readings of the refrigerator thermometers were outside the accepted range, and 7% of the sample lacked refrigerator thermometers. About 15% of pharmacists were not informed about the local regulations of community pharmacy practice, neither before nor after taking up their current positions. Surprisingly, incorrect answers to simple questions about the system were frequently given by the informed pharmacists. Certain aspects of substandard storage conditions existed, in varying degrees, in significant percentages of pharmacies regardless of the pharmacists’ qualifications, experience, or awareness about the local regulations of community pharmacy practice. Stricter monitoring by the authorities regarding the adherence of community pharmacies to optimal conditions of storing medicines is recommended. Continuing education of community pharmacists must also be improved.展开更多
文摘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.
文摘Exposure to excessive temperature during distribution or storage has unfavorable consequences on the quality of medicines, particularly in hot climates. This could be one of the possible reasons behind the existence of substandard amoxicillin in community pharmacies in Riyadh, Saudi Arabia. This study explored the conditions under which medicines were kept in a random sample of 181 community pharmacies in Riyadh. The pharmacist in charge in each pharmacy was interviewed and our observations about the quality of storage were recorded. The inspection revealed that in 9% of the sample the readings of the existing room thermometers were >25℃, and that 13% of the sample lacked thermometers. Also in 33% of the sample the readings of the refrigerator thermometers were outside the accepted range, and 7% of the sample lacked refrigerator thermometers. About 15% of pharmacists were not informed about the local regulations of community pharmacy practice, neither before nor after taking up their current positions. Surprisingly, incorrect answers to simple questions about the system were frequently given by the informed pharmacists. Certain aspects of substandard storage conditions existed, in varying degrees, in significant percentages of pharmacies regardless of the pharmacists’ qualifications, experience, or awareness about the local regulations of community pharmacy practice. Stricter monitoring by the authorities regarding the adherence of community pharmacies to optimal conditions of storing medicines is recommended. Continuing education of community pharmacists must also be improved.
