PHARMACEUTICAL AND LEGAL ISSUES OF PRODUCTION AND THE USE OF INFUSIONS IN ANESTHESIOLOGY (FOR EXAMPLE, CARDIOPLEGIC SOLUTIONS)

Abstract

The use of various infusion solutions in anesthesiology and intensive care involves certain risks due to the complexity of the supervised cases and the uniqueness of the interventions. Nevertheless, today reliable principles and approaches have been developed at the state level to minimize the threats associated with the quality of infusion solutions. These include the requirements for mandatory registration of all new combined solutions, including those made from already known components, as well as the rules for the production of sterile infusions according to the standard of good manufacturing practice (GMP – good manufacturing practice). Mandatory compliance with these requirements is a guarantee of the safety of infusion therapy from the standpoint of the quality of the infusion solution that is injected into the patient՚s body. On the example of cardioplegic solutions, the safety problems and contradictions in the existing system of providing high-tech field of medicine – cardiac surgery are shown.