The system of pharmacovigilance is a state system for the collection and scientific evaluation of information about adverse events during medicinal drug application for the adoption of appropriate regulatory decisions. 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 undesirable negative reaction, arising from drugs use at standard doses, recommended for the prevention, diagnosis and treatment of diseases or for the modification of the physiological functions of the body. 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
Dose- related ARs
|Excessive therapeutic effect|
|Pharmacological side effect|
ARs not dose -related
ARs resulted due to prolonged therapy
|The abstinence syndroms|
|Effects of inhibiting the hormones synthesis|
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 December 29, 2011. No 1005 (hereinafter - the order of the Ministry of Health No 898), pharmacovigilance is a kind of activity related to the collection, identification, evaluation, studying and prevention of the occurrence of adverse reactions (ARs) or problems associated with the drugs using.
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 Post-Registration Supervision (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 Inspection for Quality Control of Medicines. 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 L.A. TRADING S.L.U., please find the opportunity to inform us.
The contact person responsible for pharmacovigilance of L.A. TRADING S.L.U.:
Jorge Fernandez Tuda
Telephone (with 24 hour automatic reply): +376338898