Pharmacovigilance

Pharmacovigilance in Ukraine is a state system aimed at collecting, scientifically evaluating, and controlling information about adverse reactions to medicinal products under normal conditions of their use. The purpose of this system is to ensure patient safety by making appropriate regulatory decisions regarding registered drugs.

Regulatory and Legal Framework:

Activities in the field of pharmacovigilance are regulated by the following documents:

The Law of Ukraine “On Medicinal Products” (1996) with amendments and additions.
Order of the Ministry of Health of Ukraine No. 898 dated 27.12.2006 “On Approval of the Procedure for Monitoring Adverse Reactions of Medicinal Products Authorized for Medical Use.”

Structure of the Pharmacovigilance System:

The responsibility for pharmacovigilance is assigned to the Ministry of Health of Ukraine, which has delegated these functions to the State Expert Center of the Ministry of Health of Ukraine (SEC). The SEC coordinates the work of the central office and regional branches in all regions of the country. In healthcare institutions, the process is supervised by responsible persons, usually deputy chief physicians for medical work or heads of departments.

Responsibilities of Healthcare Professionals and Manufacturers:

Healthcare professionals are required to report cases of adverse reactions by filling out relevant notification forms and sending them to the SEC. Manufacturers and applicants must ensure the functioning of a system for collecting, evaluating, and submitting information on adverse reactions, as well as other data necessary for assessing the risk-benefit ratio of a medicinal product.

Results of Activities:

Thanks to the effective operation of the pharmacovigilance system in Ukraine, decisions have been made to withdraw drugs from the market where the risks of their use outweighed the benefits. Such drugs include: Hemodes, eufillin (with ethylenediamine stabilizer), kava-kava, cimetidine, certain forms of furacilin, combined preparations of diclofenac and nimesulide, rimonabant, efalizumab, sibutramine, rosiglitazone, as well as calcitonin in the form of a nasal spray and ketoconazole.

The pharmacovigilance system in Ukraine is constantly being improved, harmonizing its approaches with international standards and European legislation, ensuring a high level of patient safety.

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