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 [...]
The transition of the Russian Federation to the implementation of a risk-based approach to control and supervisory activities in the field of pharmacovigilance from January 1, 2018 increased the number and significance of documentary checks, audits, inspections, examinations of the pharmacovigilance system, including quantitative and qualitative assessment of reporting, and minimizing risks in this part [...]
As you know, the organization, maintenance of the pharmacovigilance system, construction of the pharmacovigilance system is an important function of monitoring the safety of the use of any drug. Good pharmacovigilance practice, through the recording of incoming signals, allows for the collection of information on adverse events for time periods determined by the rules and, [...]
The basis of the pathogenetic therapy of multiple sclerosis (MS) are drugs that change the course of MS (MSITS). The dominant role among all MDDMS is currently occupied by four first-line drugs - three beta-interferon and glatiramer acetate. The therapeutic efficacy of PITRS has been confirmed by studies that meet the modern requirements of evidence-based [...]
Throughout the world, smoking remains one of the leading preventable causes of illness and premature death. Cigarette smoking is a risk factor for various diseases such as cancer (including lung cancer), chronic obstructive pulmonary disease (COPD), hypertension, coronary heart disease, and cerebrovascular disorders. Various treatments that help people successfully quit smoking have important effects on [...]
According to the World Health Organization, non-steroidal anti-inflammatory drugs (NSAIDs) are the second most used after antibiotics. More than 30 million people in the world take NSAIDs every day, with 40% of patients over the age of 60. Considering that large quantities of these drugs are taken without a prescription and due control by a [...]
The algorithm for the proper preparation of the PSA can be presented in the form of 17 recommendations as follows. It is necessary to track in advance the timing of the preparation of the PSAR and plan the work schedule in such a way that the compilers have enough time to collect the material, process [...]
The preparation of a PSAR, also referred to as a Periodic Safety Report, is an important part of the life cycle of any medicinal product. The periodic safety report is designed to minimize the risks of drug use and continually improve the benefit /safety ratio. PSAR are prepared either by special departments of pharmaceutical companies, [...]
