Department of Pharmacy, Uppsala University, Sweden.
Res Social Adm Pharm. 2012 Nov-Dec;8(6):567-73. doi: 10.1016/j.sapharm.2011.12.003. Epub 2012 Feb 9.
Sales of nonprescription medicines (NPMs) in retail outlets in Sweden have been permitted since 2009. The conditions are that sales are reported to the Medicine Product Agency (MPA) and that the owners of the retail outlets fulfill legal requirements. The MPA has an overall supervisory function, whereas municipalities are responsible for the actual control. This is mainly executed through inspections.
The aim of the study was to explore some aspects of control performed by Swedish authorities of NPM sales in retail outlets.
Telephonic interviews were conducted with inspectors from a heterogenic sample of municipalities in Sweden during autumn of 2010. A semistructured interview guide was designed, which included questions on inspections and deviations found in inspections. Interviews were documented in writing, and a deductive content analysis was performed.
Inspectors in 15 municipalities participated. In 8 of the municipalities, at least 1 inspection had been conducted. Seven inspectors had used a checklist designed by the MPA, although a majority found it difficult to use. Deviations found were mainly minor; they included lack of signs regarding age limits and prohibition of illegal sales, unlocked/open drug cabinet doors, nonexistent self-inspection programs, erroneous display of NPMs, and broken drug packages. Two serious deviations were found and reported to the MPA; these were negligence in reporting of sales statistics of NPM and 1 case where the inspector had not been allowed to conduct any inspection.
The restructuring of the sale of NPMs in Sweden, permitting sale outside pharmacies, has not been accompanied by satisfactory control procedures from authorities according to our findings. Work is still needed to make sure that optimal drug use and patient safety issues are kept in focus.
自 2009 年以来，瑞典的零售药店已获准销售非处方药品（NPM）。条件是向药品管理局（MPA）报告销售情况，并且零售药店的所有者应符合法律要求。MPA 具有全面的监督职能，而市政府则负责实际控制。这主要是通过检查来执行的。
本研究旨在探讨瑞典当局对零售药店 NPM 销售进行控制的某些方面。
在 2010 年秋季，对来自瑞典不同类型的市政府的检查员进行了电话访谈。设计了一个半结构化的访谈指南，其中包括有关检查和在检查中发现的偏差的问题。访谈以书面形式记录，并进行了演绎内容分析。
有 15 个城市的检查员参加了调查。其中 8 个城市至少进行了一次检查。7 名检查员使用了 MPA 设计的检查表，尽管大多数检查员发现难以使用。发现的偏差主要是次要的；它们包括缺乏有关年龄限制和禁止非法销售的标志，药品柜门未上锁/未关闭，不存在自我检查计划，NPM 错误展示以及药品包装破损。发现了两个严重的偏差，并向 MPA 报告了这些偏差；这些偏差包括销售 NPM 统计数据的疏忽报告和 1 例检查员未被允许进行任何检查的情况。
根据我们的发现，瑞典对 NPM 销售的结构调整，允许在药店外销售，并未得到当局令人满意的控制程序的支持。仍需要做更多的工作以确保将优化药物使用和患者安全问题放在首位。
