Search

Copyright of Humanities & Social Science (1407-9291) is the property of RTU Publishing House and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background and Objectives: Even though many industrially manufactured medicines are available, extemporaneous preparations still have their niche in dermatology. In several countries, dermatovenerologists are one of the specialists prescribing extemporaneous medicines the most. In order to increase the quality of compounded medications and minimize risks to patient safety, several countries, for example, Germany and the United States of America (USA), created standardized compounded preparation monographs. Latvia, unlike these countries, does not have any officially approved standardized compounded preparation monographs. The purpose of this survey is to analyze the extemporaneous prescriptions prescribed by Latvian dermatovenerologists to identify the active ingredients, combinations of active ingredients, and excipients prescribed by dermatovenerologists the most often, and to find out how many active ingredients are most often compounded in different dosage forms. To understand whether the extemporaneous formulations used in Latvia for dermatological indications are evidence-based, they were compared with German and USA formulations., Materials and Methods: A database was created entering data on all the prescriptions prepared in the selected pharmacies in 2017 to summarize information on extemporaneous prescriptions. The prescriptions prescribed by Latvian dermatovenerologists were selected and compared with German and USA formulations., Results: Data from 17 Latvian pharmacies were collected, and 2521 extemporaneous formulations were analyzed. In preparation of semi-solid dosage forms, 25 bulk drug substances and 37 industrially manufactured preparations were used; in preparation of suspensions, 25 bulk drug substances and 10 industrially manufactured preparations were used; in preparation of topical solutions, 23 bulk drug substances and two industrially manufactured preparations were used; in preparation of topical powders, nine bulk drug substances were used; in preparation of oral solutions, five bulk drug substances were used., Conclusions: The analyzed prescriptions contained active ingredients used in Germany and the USA, as well as active ingredients, the use of which is limited in Germany and the USA. In Latvia, topical dosage forms containing two or more active ingredients are widely prescribed.

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.