Pharmacovigilance in Russia: current state of affairs, challenges, and prospects

Abstract

This review outlines current issues of the pharmacovigilance (PV) system in the Russian Federation, namely the present state of regulatory aspects, regulatory requirements in both Russia and the Eurasian Economic Union, and review of causes of under-reporting of adverse drug reactions. Specific attention will be focused on how the system is designed to monitor drug safety functions, reporting and accountability of pharmaceutical products, their manufacturers and medical staff, the role played by regional centers for drug-safety monitoring, and insufficient understanding of the part taken by patients in the system of PV. The prospects of the Russian PV system and its harmonization with global practice will also be discussed.

Biochemical parameters as a tool to assess the nutritional status of patients with amyotrophic lateral sclerosis

“…An important prognostic indicator of ALS is weight loss, primarily through muscle and adipose tissues (39). The percutaneous endoscopic gastrostomy is considered the safest nutritional method (40); however, since the main cause behind weight loss is malnutrition, further exploration of diet options is needed (41)(42)(43)(44)(45). While we acknowledge the availability of direct measures such as body mass index (BMI) for assessing the nutritional status of patients with ALS, the inclusion of biochemical parameters in our study serves a specific purpose.…”

Recent changes in the pharmacovigilance system in the Russian Federation and the EAEU

“…К аутсорсингу ФН целесообразно прибегать при небольшом количестве продуктов препаратов в портфеле компании, когда содержание собственной системы ФН становится необоснованно затратным. В таком в МФСФ должно содержаться детальное описание аутсорсинга, в т. ч. результаты аудитов организации, обеспечивающей систему ФН, со стороны держателя РУ [9].…”

The efficacy of L-carnitine in patients with nonalcoholic steatohepatitis and concomitant obesity

“…Although the mechanisms of L-carnitine’s effect on lipid and carbohydrate metabolism have been sufficiently studied, there is a need for a broader evidence base to introduce this compound into the diet. This study aims to supplement the existing information and provide more detailed research on the effects of taking L-carnitine compared with taking phospholipids on the activity of liver enzymes and carbohydrate metabolism [ 44 , 45 ]. The purpose of the current study is to assess the efficacy of L-carnitine and its effects on the functional state of the liver, as well as on lipid and carbohydrate metabolism in patients with NASH and concomitant obesity.…”