Ekstemporālo zāļu pieejamība Latvijas aptiekās: situācijas kvantitatīvs un kvalitatīvs novērtējums un nākotnes perspektīva. Promocijas darba kopsavilkums

The Doctoral Thesis was developed at Rīga Stradiņš University, Latvia. Defence: at the public session of the Council of the Basic Sciences of Medicine, including Pharmacy, on 8th April 2022 at 12.00 online via Zoom platform.Availability of extemporaneous preparations in pharmacies in Latvia: a quantitative and qualitative assessment of the situation and future perspectives According to the international scientific publications published in academic research databases over the last five years, extemporaneous preparations are still prescribed and compounded worldwide. In Europe, America and Australia compositions and compounding technologies of extemporaneous preparations continue to evolve, and new standardized formulations, as well as guidelines and recommendations on safe prescribing and compounding of extemporaneous preparations are being created. In Latvia the oldest pharmacy service, compounding of extemporaneous preparations, has also survived to the present day. However, Latvia has not established its own standardized formulations and official information resources in state language. Until now, it was not known what compositions of extemporaneous preparations are prescribed in Latvia, what specialties of physicians prescribe extemporaneous preparations and what is the sales volume of these medicines. In order to promote cross-border harmonization of processes related to extemporaneous preparations, the Committee of Ministers of the Council of Europe adopted in 2011 and updated in 2016 the document “Resolution on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients”. The member states of the Council of Europe are invited to implement this resolution in their national guidelines and legislation. After the adoption of the resolution several studies were carried out to determine how the resolution influenced national laws of several European countries, but there is a lack of such studies in the Baltic States. The study of the current situation in the Baltic States is needed to develop a shared vision across the European Union for processes related to the extemporaneous preparations. The aim of the study was to assess the regulatory framework of extemporaneous compounding and the extent of this service, as well as to collect and analyse the assortment of extemporaneous formulations in Latvian pharmacies, comparing them with German, USA and Australian standardized formulations, and to develop practical recommendations for improving the quality of extemporaneous preparations compounded in Latvian pharmacies and for progressing the field. For the first time information about Latvian extemporaneous formulations became available to the international scientific community. The main results of the dissertation are summarized in five international publications, which allows researchers from other countries to get to know traditions of extemporaneous formulations in Latvia. This thesis summarizes and analyses the assortment of extemporaneous formulations in pharmacies in Latvia and clarifies the sales volume of these medicines. Latvian legislation regulating the compounding of extemporaneous preparations was compared with the requirements of the resolution of the Committee of Ministers of the Council of Europe. This thesis revealed specialties of those physicians who prescribed extemporaneous prescriptions most often, the most popular dosage forms, as well as identified how many active ingredients most often were combined in different dosage forms. In order to compare the compliance of the extemporaneous preparations in Latvia with modern European and world practice, the active ingredients, their combinations and excipients identified in the prescriptions for the first time were compared with the professional literature of Germany, the USA and Australia. In order to promote safe and effective prescribing, compounding and dispensing of extemporaneous preparations, practical recommendations were provided to Latvian health care professionals. Before this thesis, even field experts lacked general information on how prescription of extemporaneous preparations has developed in Latvia over the past 30 years. This thesis shows that the compounding of extemporaneous preparations is still offered in all regions of Latvia. The analyzed prescriptions of Latvian physicians contained active ingredients and excipients used in other countries, as well as active ingredients, the use of which in Germany, the USA and Australia is limited and is permissible only in exceptional cases. The obtained results can be used in development of new, evidence-based instructional materials on extemporaneous preparations, as well as in education of health care professionals on safe prescribing, compounding, and dispensing of extemporaneous preparations, and in creation of Latvian standardized formulations.Project No. 8.2.2.0/20/I/004 “Support for involving doctoral students in scientific research and studies