According to the WHO rules, monitoring and transfer of information about AD drugs to the VigiBase database can only be carried out by National Pharmacovigilance Centers organized in different countries. Pharmacovigilance documents, pharmacovigilance standard operating procedures (SOPs), master file - all this should be formed according to the same rules. Each country wishing to become [...]
The use of drugs (MP) in practical medicine is inextricably linked with the risk of adverse reactions (AD), which in many cases is caused by an insufficiently established level of drug safety. Studying and ensuring the safety of medicinal products at different stages of the life cycle is an important element of the pharmacovigilance system. [...]
The identification and validation of signals in pediatric practice is very time consuming. The presence of certain problems, such as a shortage of drugs approved for use in pediatrics, a low percentage of reporting of AD messages in children and poor quality of filling in messages, increases the significance of the identified signal. Full-service pharmacovigilance [...]
The safety of using various drugs in children is one of the main requirements for pharmacotherapy. The study of the effect of drugs (drugs) on the child's body is extremely important, since they can have a negative impact on the growth and formation of a child and further affect the quality of life. Standard operating [...]
The emergence of new effective and safe medicines (drugs) for the prevention and treatment of many diseases and their complications contributes to an increase in life expectancy and, thereby, demographic aging of the world's population as a whole. But, like any drugs, new drugs can cause adverse reactions (AD). In this regard, literature monitoring and [...]
Non-prescription herbal preparations in Russia are traditionally in high demand among the population. In this regard, pharmacovigilance, the audit system, inspection and examination of the safety of medicinal products based on herbal raw materials are of great importance. Among the sedatives of natural origin, widely used in everyday life and in stressful situations, more than [...]
In persons 60 years and older, there is a decrease in the immune response compared to younger people due to the aging process of the immune system, mainly due to involution of the thymus. This is manifested by a decrease in the number of naive T cells produced by the body (CD4 and CD8), an [...]
Monitoring of the literature to identify the frequency of adverse events of drugs and vaccines is used not only within the framework of pharmacovigilance, the literature review of pharmacovigilance can be used in studies of the safety of drugs in fragile elderly and senile patients. Persons of the elderly and senile age are at an [...]
Cardiac arrhythmias are complications of many cardiovascular diseases. They quite often acquire an unpredictable course and can result in the death. According to epidemiology data, heart rhythm disorders lead to the sudden death of about 200 thousand people in the Russian Federation annually. Sudden cardiac death overtakes about 400 thousand outpatients and hospital patients in [...]
To assess the regulatory impact, an assessment was made of the results of a survey of 38 industry representatives and an analysis of 164 administrative decisions made as a result of an audit of the pharmacovigilance system, inspection and examination. It was found that in the first 9 months of 2018, the greatest difficulties arose [...]
