Department of Dosage Form Technology, Riga Stradins University, Dzirciema Street 16, LV-1007 Riga, Latvia.
State Agency of Medicines, Jersikas Street 15, LV-1003 Riga, Latvia.
Medicina (Kaunas). 2019 Aug 26;55(9):531. doi: 10.3390/medicina55090531.
: Extemporaneous preparations are pharmaceutical preparations individually prepared for a specific patient or patient group, but also high-risk products accompanied by doubts regarding their safety and quality. Legislation regulating the compounding of extemporaneous preparations is not harmonized among European countries. This problem is partially resolved by Resolution CM/Res(2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. In order to understand the relevance of extemporaneous compounding in Latvia and the fulfillment of the abovementioned resolution's requirements, it is essential to get information about the volume and breakdown of sales of extemporaneous medicinal products in community pharmacies. The purpose of this survey is to identify the sales volume of extemporaneous preparations in community pharmacies in Latvia in 2017 by analyzing unpublished data of the State Agency of Medicines (SAM), as well as comparing Latvian laws with the requirements of the resolution. : A separate Microsoft Excel spreadsheet was prepared for each statistical region in order to summarize the unpublished information of SAM on the turnover of extemporaneous preparations in 2017 in all Latvian statistical regions. In order to compare the regulatory framework in Latvia with the resolution, the Latvian Pharmaceutical Law and the Cabinet of Ministers Regulations regulating prescription, compounding and control of extemporaneous preparations in community pharmacies were analyzed. : Only 280 of 384 pharmacies submitted a report of sales of extemporaneous preparations for 2017 to the SAM. These pharmacies represented all Latvian statistical regions. Extemporaneous preparations were mostly sold in Riga (78.93%). The Latvian regulation does not include all paragraphs of the resolution. Most of the paragraphs of the resolution are described in Latvian regulatory enactments only partially. : The total number of compounding pharmacies evidence that the service is needed. Latvian example highlights a necessity for European Union countries to compare their national legislation with the requirements of the resolution's last version and, if necessary, implement relevant amendments.
: 临时制剂是为特定患者或患者群体单独制备的药物制剂，但也包括安全性和质量存在疑问的高风险产品。欧洲各国的临时制剂配制法规并不统一。关于这一问题，部分通过关于为满足患者特殊需求而在药房配制的药品的质量和安全保证要求的第 CM/Res(2016)1 号决议得到解决。为了了解拉脱维亚临时配制的相关性以及是否满足上述决议的要求，了解社区药房中临时药品的销售数量和分类至关重要。本次调查的目的是通过分析国家药品管理局（SAM）未公布的数据，确定 2017 年拉脱维亚社区药房中临时制剂的销售量，并将拉脱维亚法律与决议的要求进行比较。 : 为每个统计地区分别准备了一个 Microsoft Excel 电子表格，以汇总 SAM 关于 2017 年所有拉脱维亚统计地区临时制剂营业额的未公布信息。为了将拉脱维亚的监管框架与决议进行比较，分析了拉脱维亚药品法和规范社区药房处方、配制和控制临时制剂的部长内阁条例。 : 只有 384 家药店中的 280 家向 SAM 报告了 2017 年临时制剂的销售情况。这些药店代表了所有拉脱维亚统计地区。临时制剂主要在里加销售（78.93%）。拉脱维亚的规定并未包含决议的所有段落。决议的大部分段落仅在拉脱维亚法规中部分描述。 : 参与报告的配药药店数量证明该服务是有必要的。拉脱维亚的例子突出表明，欧盟国家有必要将其国家立法与决议的最新版本的要求进行比较，并在必要时实施相关修正案。
