USAGE RATE OF THE UNLICENSED MEDICATIONS IN NEONATOLOGY: DATA OF THE PHARMACO EPIDEMIOLOGICAL RESEARCH

In recent years clinical pharmacologists working in the field of pediatrics all across the world scrutinize the application issues of unlicensed medications among children. Based on the example of a group of patients consisting of 449 premature infants and with the aid of the pharma coepidemiological research, the authors showed the usage rate of unlicensed anti infectious medications in neonatology. The analysis embraced the 9 year long period of work of the largest neonatal center in northwest. As a result they uncovered that the anti infectious medications which were prescribed most often were aminoglycoside and cephalosporin antibiotics. The applied medications were referred to the unlicensed in neonatology in 21% of cases, and in 8% of cases they were used off label. Further more, it was noted that there was a general trend towards the considerable increase of application of the banned medications for the analyzed period.Key words: very low birth infants, unlicensed drugs

PHARMACOEPIDEMIOLOGY OF CARBAPENEMS APPLICATION AMONG THE PREMATURE NEWBORNS IN SAINT PETERSBURG. WORLD EXPERIENCE IN NEONATOLOGY

Premature newborns are a high risk group in terms of the infection complications growth. therefore, it is highly urgent to choose the efficient and safe antibacterial medications for the given category of patients. The authors carried out a pharma coepidemiological study of the carbapenems application among 353 newborns with very low body weight at birth, as well as the literature analysis on the use of this medications group in compliance with the evidence based medicine. As a result, they showed that for the last 8 years the frequency of the carbapenems application in Saint-Petersburg among the newborns has grown from 10 to 52%. It is statistically accurate that imipenem/cilastatin was more often used to the amount of 25 mg/kg twice a day. In 71% of cases, carbapenems were applied in the form of the empiric therapy against the general bacterial infection in combination with vancomycin and/or metronidazole. Antibiotics proved to be safe. The literature analysis showed that there is no data, which would allow one to compare the efficiency of carbapenems with other antibiotics among the newborns based on the results of the meta analyses and randomized clinical studies. Nowadays, carbapenems demonstrated high efficiency and safety in the small clinical observations.Key words: carbapenems, imipenem, meropenem, newborns with very low body weight at birth

PHARMACOEPIDEMIOLOGY OF CARBAPENEMS APPLICATION AMONG THE PREMATURE NEWBORNS IN SAINT PETERSBURG. WORLD EXPERIENCE IN NEONATOLOGY

Premature newborns are a high risk group in terms of the infection complications growth. therefore, it is highly urgent to choose the efficient and safe antibacterial medications for the given category of patients. The authors carried out a pharma coepidemiological study of the carbapenems application among 353 newborns with very low body weight at birth, as well as the literature analysis on the use of this medications group in compliance with the evidence based medicine. As a result, they showed that for the last 8 years the frequency of the carbapenems application in Saint-Petersburg among the newborns has grown from 10 to 52%. It is statistically accurate that imipenem/cilastatin was more often used to the amount of 25 mg/kg twice a day. In 71% of cases, carbapenems were applied in the form of the empiric therapy against the general bacterial infection in combination with vancomycin and/or metronidazole. Antibiotics proved to be safe. The literature analysis showed that there is no data, which would allow one to compare the efficiency of carbapenems with other antibiotics among the newborns based on the results of the meta analyses and randomized clinical studies. Nowadays, carbapenems demonstrated high efficiency and safety in the small clinical observations.Key words: carbapenems, imipenem, meropenem, newborns with very low body weight at birth

ORGANIZATION OF EMERGENCY FOR NEWBORNS IN ST.-PETERSBURG

Authors present an experience of healthcare system of St.-Petersburg in organization of emergency to newborns. Staging of forming of neonatological emergency service and introduction of modern organizational and high-technology methods resulted in success in early neonatal and infant mortality.Key words: newborns, infant mortality, emergency, organization.(Voprosy sovremennoi pediatrii — Current Pediatrics. 2010;9(2):7-10

ФАРМАКОЭПИДЕМИОЛОГИЯ ПРИМЕНЕНИЯ КАРБАПЕНЕМОВ У НЕДОНОШЕННЫХ НОВОРОЖДЕННЫХ В САНКТ-ПЕТЕРБУРГЕ. МИРОВОЙ ОПЫТ В НЕОНАТОЛОГИИ

Premature newborns are a high risk group in terms of the infection complications growth. therefore, it is highly urgent to choose the efficient and safe antibacterial medications for the given category of patients. The authors carried out a pharma coepidemiological study of the carbapenems application among 353 newborns with very low body weight at birth, as well as the literature analysis on the use of this medications group in compliance with the evidence based medicine. As a result, they showed that for the last 8 years the frequency of the carbapenems application in Saint-Petersburg among the newborns has grown from 10 to 52%. It is statistically accurate that imipenem/cilastatin was more often used to the amount of 25 mg/kg twice a day. In 71% of cases, carbapenems were applied in the form of the empiric therapy against the general bacterial infection in combination with vancomycin and/or metronidazole. Antibiotics proved to be safe. The literature analysis showed that there is no data, which would allow one to compare the efficiency of carbapenems with other antibiotics among the newborns based on the results of the meta analyses and randomized clinical studies. Nowadays, carbapenems demonstrated high efficiency and safety in the small clinical observations.Key words: carbapenems, imipenem, meropenem, newborns with very low body weight at birth.Недоношенные новорожденные являются группой высокого риска по развитию инфекционных осложнений. Поэтому крайне актуален выбор эффективных и безопасных антибактериальных средств для данной категории пациентов. Авторы провели фармакоэпидемиологическое исследование применения карбапенемов у 353 новорожденных с очень низкой массой тела при рождении, а также анализ литературных данных по использованию этой группы лекарственных средств на основе принципов доказательной медицины. В результате было показано, что частота применения карбапенемов в Санкт-Петербурге у новорожденных за последние 8 лет увеличилась – с 10 до 52%. Статистически достоверно чаще применяли имипенем/циластатин (Тиенам) в дозе 25 мг/кг 2 раза в сутки. В 71% случаев карбапенемы применяли в виде эмпирической терапии генерализованной бактериальной инфекции в комбинации с ванкомицином и/или метронидазолом. Антибиотики были безопасны. Анализ литературы показал, что в настоящее время данных, позволяющих сравнить эффективность карбапенемов с другими антибиотиками у новорожденных и основанных на результатах метаанализов и рандомизированных клинических исследований, – нет. В то же время в небольших клинических наблюдениях карбапенемы показали высокую эффективность и безопасность. Ключевые слова: карбапенемы; имипенем; меропенем; новорожденные с очень низкой массой тела при рождении. (Педиатрическая фармакология. – 2008;5(4):58-64

Palivizumab: Four seasons in Russia

In 2010, the Russian Federation (RF) registered palivizumab - innovative drug, based on monoclonal antibodies for passive immunization of seasonal respiratory syncytial virus (RSV) infection in children of disease severe progress risk group, which include primarily premature infants, children with bronchopulmonary dysplasia and hemodynamically significant congenital heart disease. Currently, palivizumab is included in the list of recommended medicines and medical care standards of different countries, including Russia. In the review the results of Russian research on the progress of RSV infection, its epidemiology and immunization experience gained over the 2010-2014 period are summarized in relation to the foreign data. During the four epidemic seasons palivizumab immunization covered more than 3,200 children of severe RSV infection risk group with a progressive annual increase in the number of patients who received the drug. Geography of palivizumab immunization is also greatly expanded in our country during this time. If during the first two seasons measures of immunization were taken mainly in Moscow and St. Petersburg, at the present time, thirty one territorial entities of the Russian Federation have the experience in the drug application. Analysis of the results of RSV infection immunization (made in several regions) confirms the high clinical efficacy and palivizumab safety already demonstrated in international studies. In addition, the analysis presents the potential to improve the efficiency of the integrated RSV infection immunization programs, realizing in the establishment of high-risk child group register, adequate counseling for parents, as well as the development of the routing of patients and coordination of interaction between different health institutions during the immunization. © 2014, Izdatel'stvo Meditsina. All rights reserved

Palivizumab: Four seasons in Russia

In 2010, the Russian Federation (RF) registered palivizumab - innovative drug, based on monoclonal antibodies for passive immunization of seasonal respiratory syncytial virus (RSV) infection in children of disease severe progress risk group, which include primarily premature infants, children with bronchopulmonary dysplasia and hemodynamically significant congenital heart disease. Currently, palivizumab is included in the list of recommended medicines and medical care standards of different countries, including Russia. In the review the results of Russian research on the progress of RSV infection, its epidemiology and immunization experience gained over the 2010-2014 period are summarized in relation to the foreign data. During the four epidemic seasons palivizumab immunization covered more than 3,200 children of severe RSV infection risk group with a progressive annual increase in the number of patients who received the drug. Geography of palivizumab immunization is also greatly expanded in our country during this time. If during the first two seasons measures of immunization were taken mainly in Moscow and St. Petersburg, at the present time, thirty one territorial entities of the Russian Federation have the experience in the drug application. Analysis of the results of RSV infection immunization (made in several regions) confirms the high clinical efficacy and palivizumab safety already demonstrated in international studies. In addition, the analysis presents the potential to improve the efficiency of the integrated RSV infection immunization programs, realizing in the establishment of high-risk child group register, adequate counseling for parents, as well as the development of the routing of patients and coordination of interaction between different health institutions during the immunization. © 2014, Izdatel'stvo Meditsina. All rights reserved