Pharmacovigilance

The system of pharmacovigilance is a system used by the State and the MAH for pharmacovigilance to monitor the safety and efficacy of medicines, vaccines, tuberculin and any changes in the benefit / risk balance. The approaches to pharmacovigilance providing are implemented by the World Health Organization (WHO). They are the same in all countries of the world.

Adverse reaction (AR) is any noxious and unintended reaction to a medicinal product. AR can occur due to many reasons.  This is facilitated by certain risk factors from medicines, the human body, the environment and society. There are different classifications of drugs’ adverse reactions, according to which they are distinguished by the pathogenesis of this occurrence, systemic manifestations and others.

The classification according to which the ARs are divided into 4 types - A, B, C, D - corresponds to the current level of knowledge about AR. It should be noted that the allocation of ARs in 4 types is conditional, because their pathogenesis can contemporary be associated with several mechanisms. However, today the WHO and the vast majority of countries, including Ukraine, adhere to the classification approaches, reflected in the table.

 Table. AR’s classification

  AR type         

            Effect                    

 Type А 

 Dose- related ARs

 Excessive therapeutic effect

 Pharmacological side effect

 Poisonous action(toxicity)

 Secondary effect

 Type В

 ARs not dose -related

 Immunoallergic

 Genetically determinated

 Unknown mechanism

 Type С   

 ARs resulted due to prolonged therapy

 Tolerance

 Addiction

 The abstinence syndroms

 Cumulative effects

 Effects of inhibiting the  hormones synthesis

 Type D

 Long-term ARs

 Mutageniciity

 Carcinogenicity

 Teratogenicity

 

Type A ARs occur in case of medical using of drugs most often (about 75%). Their emergence is due to the pharmacological properties or toxicity of the drug itself or its metabolites, therefore they are predictable, they are not characterized by high lethality. The ARs of type C and D occur in less than 5%.

According to the definition outlined in the order of the Ministry of Health of Ukraine dated 27.12.2006 No. 898 "About the approval of the procedure of pharmacovigilance for adverse reactions of medicines permitted for medical use", as amended by the order of the Ministry of Health of Ukraine dated September 26, 2016. No 996 (hereinafter - the order of the Ministry of Health No 996), pharmacovigilance is a process related to the collection, identification, evaluation, studying and prevention of the occurrence of adverse reactions (ARs), adverse events after immunization / tuberculin diagnostics, and any other problems related to the safety and efficacy of the use of drugs, vaccines, and tuberculins.

Supervision over the safety of drugs using in Ukraine on behalf of the Ministry of Health of Ukraine is carried out by the State Expert Center of the Ministry of Health of Ukraine. The Department of Pharmacovigilance (hereinafter - the Department) - the structural unit of the Center, is the central link of the system of pharmacovigilance of Ukraine and is directly involved in its implementation in Ukraine.

The usage of any medicinal product together with the therapeutic effect may cause adverse effects. Adverse reactions, occurring during the medical application of the drugs, may be due to their properties or features of the body response on the drug administration.
Absolutely safe medicines do not exist. This fact makes it necessary to permanent monitoring  the safety of medicines. Only if the benefit of the application prevails over the risk, the drug can be used, contrawise the drug should not be used.


Persistent monitoring of the drugs’ safety allows specialists to assess the risk / benefit ratio and make appropriate decisions on the further use of the drug. In case of insufficient quality of medicines, the control is carried out by the State Service of Ukraine on Medicines and Drugs Control. In case of ARs happened due to the characteristics of the drugs or organism’s response on their administration, the control is carried out by The State Expert Center of the Ministry of Health of Ukraine via the functioning of the system of the pharmacovigilance in Ukraine.

We will be grateful for the provision of any information on the detection of atypical manifestations or side effects, or lack of effectiveness in the use of medicines of our manufacture.
If you become aware of an adverse reaction associated with the drug company Mistral Capital Management Ltd, please find the opportunity to inform us.

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