THE ORGANIZATIONAL AND LEGAL RESERVES FOR MODERNIZING A QUALITY ASSURANCE PROCESS IN THE PHARMACIES DISPENSING PARENTERAL DOSAGE FORMS

Introduction. Despite the risk of adverse reactions, many countries have reserved the right of a pharmacy to perform traditional functions in applying an individual approach to providing of the population with extemporaneous dosage forms. In the Russian Federation, the changes in the circulation of medicines have led to a sharp reduction in the volume of a pharmacy’s compounding due to the closure of drug manufacturing departments and pharmacies, which may destroy the drug manufacturing system in the pharmacy and reduce the availability of drug supply. Objective. To carry out a situational analysis of the intrapharmacy compounding of parenteral dosage forms and to identify reserves for improving the quality of prepared injectable and infusion formulations. Material and methods. The study objects were the legislative and normative-legal bases of the Russian Federation on drug circulation and the formula of manufacturing pharmacies in health care facilities. Retrospective, situational, graphical, and content analyses were used. Results. A list of parenteral (injectable and infusion) dosage forms manufactured in the pharmacies was made. The most common violations of license requirements and conditions in the pharmacy environment were structured. Conclusion. The reserves for modernizing a quality assurance process for parenteral formulations prepared in the pharmacy were identified and priority problems in the study area determined.