Trends of ex tempore drug preparation in Ukraine. Ways of their introduction into the practice

  • V.A. Heorhiiants National Pharmaceutic University, Kharkiv, Ukraine


Background. Advantages of the ex tempore formulation include the ability to provide the drug in the form and dosage, not available on the pharmaceutical market, but necessary for a particular patient; the ability to include the required ingredient in any desired form; the option of combining drugs; the manufacture of drugs without flavorings, preservatives and stabilizers; the possibility of adjusting of the drug taste; the possibility of manufacturing drugs that are in short supply on the market; no possibility of counterfeiting; production of specific drugs.

Objective. Assess the current situation and trends in the preparation of oncological drugs ex tempore.

Materials and methods. Analysis of the literature on this topic.

Results and discussion. In oncology the possibilities of ex tempore preparation include the manufacture of chemotherapeutic agents with individual dosage, of any adjuvant agents without excipients, of radiopharmaceuticals, combined and orphan drugs. In Ukraine, ex tempore formulation is not widespread: as of 2017, the percentage of drugs prepared in such way was 1.7 %, in 2018 – 1.43 %, in 2019 – 1.41 %. The situation is different in the European Union. For instance, in Poland the pharmacy receives a license only after creating the conditions for the manufacture of drugs, in Estonia any pharmacy must be able to produce non-sterile drugs, in Latvia 50 % of pharmacies have a license to manufacture drugs. The popularity of ex tempore preparation is also growing in the other countries (Australia, USA, Brazil, Jordan). The main areas of application of ex tempore drugs include hormone replacement therapy, analgesia, dermatology, chemotherapy, ophthalmology, treatment of orphan diseases, parenteral nutrition. Civilized countries often choose to develop the hospital pharmacy. However, there are a number of problems, including the lack of well-trained staff, the high cost of equipment and maintenance of sterile facilities, the constant changes in regulatory requirements and the need to gain the consumers’ respect.

Conclusions. 1. Ex tempore drug preparation has a number of advantages, in particular, the ability to provide the drug in the individual form and dosage, the ability to combine drugs and the manufacture of specific drugs. 2. Extemporaneous preparation of drugs is especially important for oncology. 3. In contrast to European Union countries, ex tempore drug preparation is not widespread in Ukraine. 4. Problems of ex tempore drug preparation include lack of the staff, high equipment costs, and constant changes in regulatory requirements.

Keywords: ex tempore drug preparation, medications, oncology, orphan diseases.
How to Cite
Heorhiiants , V. (2020). Trends of ex tempore drug preparation in Ukraine. Ways of their introduction into the practice. Infusion & Chemotherapy, (3.2), 51-52.
Oral presentation materials of IV International Congress of infusion therapy