The extent of extemporaneous preparation and regulatory framework of extemporaneous compounding in Latvia

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dc.contributor.authorKiseļova, Olga
dc.contributor.authorMauriņa, Baiba
dc.contributor.authorŠidlovska, Venta
dc.contributor.authorZvejnieks, Jānis
dc.contributor.institutionDepartment of Applied Pharmacy
dc.date.accessioned2021-04-23T09:05:01Z
dc.date.available2021-04-23T09:05:01Z
dc.date.issued2019-09
dc.descriptionPublisher Copyright: © 2019 by the authors. Licensee MDPI, Basel, Switzerland.
dc.description.abstractBackground 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is to identify the sales volume of extemporaneous preparations in community pharmacies in Latvia in 2017 by analyzing unpublished data of the State Agency of Medicines (SAM), as well as comparing Latvian laws with the requirements of the resolution.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and Methods: A separate Microsoft Excel spreadsheet was prepared for each statistical region in order to summarize the unpublished information of SAM on the turnover of extemporaneous preparations in 2017 in all Latvian statistical regions.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.en
dc.description.statusPeer reviewed
dc.format.extent918550
dc.identifier.citationKiseļova, O, Mauriņa, B, Šidlovska, V & Zvejnieks, J 2019, 'The extent of extemporaneous preparation and regulatory framework of extemporaneous compounding in Latvia', Medicina (Lithuania), vol. 55, no. 9, 531. https://doi.org/10.3390/medicina55090531
dc.identifier.doi10.3390/medicina55090531
dc.identifier.issn1010-660X
dc.identifier.urihttps://dspace.rsu.lv/jspui/handle/123456789/3910
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85071752775&partnerID=8YFLogxK
dc.language.isoeng
dc.relation.ispartofMedicina (Lithuania)
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectCommunity pharmacy
dc.subjectExtemporaneous preparations
dc.subjectLatvia
dc.subjectLegislation
dc.subjectResolution
dc.subject3.1 Basic medicine
dc.subject1.1. Scientific article indexed in Web of Science and/or Scopus database
dc.subjectGeneral Medicine
dc.titleThe extent of extemporaneous preparation and regulatory framework of extemporaneous compounding in Latviaen
dc.type/dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article

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