EDITORIAL
REVIEWS
Vaccine safety is an important aspect of mass immunization of the population. Adverse reactions that occur following vaccination result in a decrease in public confidence. The aim of this research was to identify information on the development of adverse events after immunization with vaccines included into the national vaccination calendars of the USA, European Union (EU), Japan, China, South Korea and India. Particular attention was paid to vaccines that are not included in the vaccination calendar, but are presented in the Russian Federation. During monitoring of vaccination against human papillomavirus information in the European Union, Japan and the United States, according the possible connection with development of autoimmune diseases was refuted. Monitoring of adverse events after vaccination with rotavirus vaccine I generation in the USA, EU and India, allowed to establish a link with the development of intestine invagination and limit the use of this medicinal product in favor of vaccine II generation. After starting vaccination against influenza was detected narcolepsy as a complication of this procedure; and when analyzing the complications of meningococcal vaccination Guillain — Barre syndrome was detected. We also analyzed information on various complications associated with vaccination against Japanese viral encephalitis, which was included into the national vaccination calendar of countries in Asia and the Pacifi c region — China, India, Japan, and South Korea. The main complications registered in the PRC after the introduction of Japanese encephalitis vaccine into the national vaccination calendar included: febrile seizures, thrombocytopenic purpura, encephalitis and meningitis. The main safety concerns about vaccines included into the national vaccination calendars of EU countries, the USA and the Asia-Pacific region concern vaccines that have recently appeared on the pharmaceutical market.
Efficacy, safety and biotransformation features of any drug are fully revealed during widely using. Therefore, postmarketing studies of the pharmacological properties of drugs are an integral component of pharmacovigilance. The aim of this study was to evaluate the nature and frequency of drugs adverse reactions that have been reported in the post-marketing period, as well as a review of measures taken by foreign regulatory authorities to ensure the safety of use of these drugs. The results of monitoring the drug safety in the post-marketing period used in clinical practice during various time intervals are presented: from several years (atelizumab, daclizumab) to several decades (valproate, retinoids). The review included data from decisions of regulatory authorities, published in 2018. Recommendations from foreign sources on the rational use of drugs, ways to increase the benefit/risk ratio of adverse reactions when using drugs from different therapeutic groups and/or the need for changes in the instructions on their medical use due to changes in the safety profile are considered. These recommendations will be helpful to healthcare professionals, as well as persons authorized for pharmacovigilance by pharmaceutical companies. Particularly, this information may be of interest to rheumatologists, oncologists, neurologists, psychiatrists, as well as other physicians who use atezolizumab, tocilisumab, daclizumab, pomalidomide, valproate sodium and valproic acid, retinoids, clarithromycin, cotrimaxozol, cefalexine, hydroxycarbamide, ritonavir.
Malnutrition is a patient’s condition with high relevance and importance for elderly patients (most often seen in very old patients >80 years old), since it is associated with a high risk of progressive worsening of their state, prolongation of hospitalization and death. Exposure to some drugs may increase the risk of malnutrition, especially in elderly patients. The purpose of this work is to provide an overview of the causes of malnutrition, focusing on the pharmacological risk factors, as well as to highlight the existing methods of correction of this condition. The authors show that one of the key reasons for developing drug-induced malnutrition is the patients exposure to drugs, that reduce appetite, cause nausea and vomiting, change taste and olfactory sensations, and have anticholinergic effects. Use of pharmacological (additional prescription of drugs for symptomatic therapy, changing the dose, deprescribing drugs, etc.), and nonpharmacological (diet therapy, adding artificial and natural identical flavors, etc.) treatment methods may help to improve state of patients with already developed pathological condition.
Literature monitoring is a complicated aspect of pharmacovigilance. The guidelines on good practice of pharmacovigilance of the Eurasian Economic Union recommend the using of a biomedical reference database containing the maximum number of sources for the monitored drugs, which necessitates the selection of such a database. The aim of the paper is to compare the coverage and functionality of international databases of medical publications recommended for monitoring literature within pharmacovigilance in terms of coverage and functionality. The paper analyzes the coverage and presents the comparison of the results of the search in the databases Embase®, MEDLINE® and eLibrary for 35 drugs. It have been shown that the search in the Embase® database provides the maximum number of sources. In addition, the paper shows the applicability special PV Wizard functionality which facilitate the building of search strategies with high recall, sensitivity and compliance.
ORIGINAL ARTICLES
Eurasian Economic Union claims single rules for pharmaceutical circulation it will the ground for organizing the single pharmaceutical market. Because of such changes all the specialist from pharmaceutical market have to know all the new legislations. For the purpose of raise the organization responsibilities for quality and safety pharmaceuticals. Market autorotation holder have to create pharmacovigilance system. In connection with it the framework of the social survey was to find out the educational needs in pharmacovigilance among the health experts. The results of polling showed that experts had diffi culties in preparing pharmacovigilance documents. Major of the pollees expressed a wish to complete educational training which will be dedicated to the system of pharmacovigilance. The social survey results shows: converts educational needs among the pollees from 23 to 65 %, it points that experts want to get more additional information and some practical cases for understanding some issues in pharmacovigilance system through workshops, educational programs.
ISSN 2619-1164 (Online)