Safety of Medicinal Products in Ukraine: Assessment of the Pharmacovigilance System and its Performance
(2012; 122 pages)

Lebega O., J. Nwokike, and H. Walkowiak. 2012. Safety of Medicinal Products in Ukraine: Assessment of the Pharmacovigilance System and its Performance. Submitted to the U.S. Agency for International Development by the Strengthening Pharmaceutical Systems (SPS) Program. Arlington, VA: Management Sciences for Health.

Abstract

The SPS Program has received funding from the USAID Ukraine to assist the Ministry of Health (MoH) of Ukraine and other local partners to address pharmaceutical management issues related to the management of anti-TB and ART-related medicines. Objectives of technical assistance include supporting the development of appropriate pharmaceutical management policies to help assure the quality and safety of TB and HIV/AIDS medicines. In 2011, the SPS Program worked with the State Expert Center (SEC) of the Ukraine MoH to adapt the IPAT and, in 2012, to conduct a comprehensive assessment of the country’s pharmacovigilance and medicines safety system.

This assessment complements previous efforts and provides additional value in benchmarking Ukraine’s pharmacovigilance system capacity and performance at each level of the health care system. The assessment objectives were to -

  • Provide a comprehensive description and analysis of Ukraine’s pharmacovigilance system and document the current level of performance
  • Identify potential strategies for strengthening pharmacovigilance system capacity and performance
 
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