Abstract
Background and objectives: 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is to identify the sales volume of extemporaneous preparations in community pharmacies in Latvia in 2017 by analyzing unpublished data of the State Agency of Medicines (SAM), as well as comparing Latvian laws with the requirements of the resolution. Materials and Methods: A separate Microsoft Excel spreadsheet was prepared for each statistical region in order to summarize the unpublished information of SAM on the turnover of extemporaneous preparations in 2017 in all Latvian statistical regions.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. Results: 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. Conclusions: 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.
Highlights
According to European Pharmacopoeia, extemporaneous preparations are pharmaceutical preparations individually prepared for a specific patient or patient group, supplied after preparation [1].One of the main reasons for prescribing extemporaneous preparations is the non-existence of appropriate dosage forms of industrially manufactured medicines [2]
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, which was first adopted by the Committee of Ministers of the Council of Europe in 2011 [12]
An accurate number of extemporaneous medicinal products prepared in Latvian pharmacies based on prescriptions issued by medical practitioners in 2017 is unknown, data about the market share of extemporaneous preparations are available
Summary
According to European Pharmacopoeia, extemporaneous preparations are pharmaceutical preparations individually prepared for a specific patient or patient group, supplied after preparation [1].One of the main reasons for prescribing extemporaneous preparations is the non-existence of appropriate dosage forms of industrially manufactured medicines [2]. Researchers emphasize that all European patients are entitled to receive medicinal products of equivalent quality and it is not permissible to apply different quality standards to extemporaneous preparations compounded in different European countries [11] This problem is partially resolved by Resolution CM/Res(2016) on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients (hereinafter referred to as the resolution), which was first adopted by the Committee of Ministers of the Council of Europe in 2011 [12]. Legislation regulating the compounding of extemporaneous preparations is not harmonized among European countries This problem is partially resolved by Resolution CM/Res(2016) on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
