Wijesinghe P R, Jayakody R L, De A Seneviratne R
Anti Leprosy Campaign, Ministry of Health, Sri Lanka.
Pharmacoepidemiol Drug Saf. 2007 Feb;16(2):197-206. doi: 10.1002/pds.1277.
To evaluate the compliance of private pharmacies to good pharmacy practice (GPP) in an urban and rural district in Sri Lanka and identify deficiencies with a view to improving supply of safe and effective drugs to consumers.
Lot quality assurance sampling (LQAS) method was used to determine the number of pharmacies that need to be studied and the threshold limit of defective elements. An inspection of 20 pharmacies in the urban and all 18 pharmacies in the rural district was carried out using a structured checklist. Compliance to seven subsystems of GPP was studied.
Storage of drugs, maintenance of cold chain, dispensing and documentation were comprehensively substandard in both districts. Individual items of supervision in registration, physical environment and order of the pharmacy were also found to be substandard in both districts.
This study shows that the LQAS method can be used to identify inadequate pharmacy services in the community as a whole. There was poor compliance to GPP by the private pharmacies in both districts. There are concerns about the quality of drugs and the safety of private pharmacy services to the community. Some of the deficiencies could be easily corrected by educating the pharmacists and authorised officers, and more effective and streamlined supervision.
评估斯里兰卡城乡地区私立药店对良好药房实践(GPP)的依从性,并找出不足之处,以期改善向消费者供应安全有效药品的情况。
采用批质量保证抽样(LQAS)方法来确定需要研究的药店数量以及缺陷项目的阈值。使用结构化检查表对城市地区的20家药店和农村地区的所有18家药店进行检查。研究了对GPP七个子系统的依从性。
两个地区的药品储存、冷链维护、调配和记录均全面不符合标准。两个地区在药店注册、物理环境和秩序方面的个别监督项目也被发现不符合标准。
本研究表明,LQAS方法可用于识别整个社区中不合格的药房服务。两个地区的私立药店对GPP的依从性都很差。人们对药品质量以及私立药房服务于社区的安全性表示担忧。通过对药剂师和授权官员进行培训以及更有效、简化的监督,一些不足之处可以很容易地得到纠正。