Historical preconditions of the creation of pharmacovigilance system in

  • N. V. Sholoiko State Expert Center of the Ministry of Health of Ukraine
  • O. V. Matvieieva State Expert Center of the Ministry of Health of Ukraine
  • K. S. Haiduk State Expert Center of the Ministry of Health of Ukraine
Keywords: thalidomide tragedy, «sulfanilamide boom», diethylstilbestrol, side effects, pharmacovigilance, State expert center, regulatory framework, history of emergence, prospects for development


The system of pharmacovigilance in the world appeared in response to series of tragedies related to the use of medicines. The largest of these were «sulfanilamide boom», «thalidomide tragedy» and «bomb with time mechanism».

In Ukraine, the pharmacovigilance system has existed since 1996, and since 2002 Ukraine has been a member of the WHO international monitoring program for side effects. In 2000–2001 appeared the first orders of the Ministry of Health of Ukraine that regulated the implementation of pharmacovigilance in Ukraine, and in 2007, when the Order of the Ministry of Health of Ukraine № 898 came into force, the legislative framework in the pharmacovigilance system has been radically changed. This is connected with the reflection of the provisions of Directive 2001/83 / EC of the European Parliament and of the Council on the Community code relating to medicinal products in the order № 898.

Today, the development of pharmacovigilance in Ukraine is carried out through adaptation to European legislation, which is stipulated by the Law of Ukraine «On the National Program of Adaptation of Ukrainian Legislation to the Law of the European Union».

Among the prospects for the development of pharmacovigilance in Ukraine:

  • introduction of amendments and additions to the legislative base of Ukraine in the context of pharmacovigilance;
  • introduction of proactive management of the negative consequences of the use of drugs;
  • introduction of the Automated Information System with the Pharmacovigilance System (AISЗ) into the health care system of Ukraine;
  • dissemination of necessary knowledge about adverse reactions among the public, establishing the algorithm of action in case of an adverse reaction, the promotion of compliance and trust between the patient and the physician, reasoning of the rational, cautious and correct use of drugs and the prevention of self-treatment of serious conditions.


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How to Cite
Sholoiko, N. V., Matvieieva, O. V., & Haiduk, K. S. (2018). Historical preconditions of the creation of pharmacovigilance system in. Farmatsevtychnyi Zhurnal, (3-4), 3-17. https://doi.org/10.32352/0367-3057.3-4.17.01
Management of pharmacy