No abstract

Thus, replacement of the original preparation of valproic acid with generics should be considered as an independent risk factor for development of complications of drug therapy. In clinical practice, in case of successful seizure control substitutions of different preparations of valproic acid should be avoided.

Myopathy is a life-threatening disease that can be caused, among other things, by the intake of various medications. Despite the fact  that many drug-induced myopathies are well known, however, many  health professionals are not alert to myopathies caused by drug  interactions. Myopathy is a wellknown adverse reaction of statins,  and muscle damage can range from minor muscle pain and  weakness to life-threatening rhabdomyolysis. Colchicine can also  cause myopathy, including rhabdomyolysis. The combination of  colchicine and statins can significantly increase the risk of myopathy  compared with their intake separately. In cases of development of  myopathy in patients receiving colchicine and statins simultaneously, the most common manifestation of drug interaction was muscle  weakness, occurring in almost every case, and in some cases,  muscle weakness was so severe that the patient lost the ability to  move. In a third of cases, the development of muscle weakness was  accompanied by muscular pain, and darkening of urine to tea shade.  One study showed that 40 % of patients received concurrent combinations of drugs that increased the risk of muscle  damage. It is concluded that the simultaneous administration of  colchicine and statins requires an assessment of the “benefit-risk”  ratio, as well as the administration of drugs in minimally effective doses.

No abstract

The risk-based approach to pharmacovigilance control implemented in Russia since January 1, 2018 increases the responsibility of manufacturers and developers of medicines. The purpose of the work is to assess the system of Express reporting and Periodic reporting on the safety of drugs in accordance with the relevant requirements of the legislation of the Russian Federation and the Eurasian Economic Union. The article continues a series of publications on recommendations for the preparation of reporting forms on pharmacovigilance. The article presents the results of the assessment of the state of elements of the system of drug safety control in Russia in terms of the preparation of reporting forms in accordance with the current regulatory requirements of national and international legislation for holders of registration certificates of medicines for medical use and developers of medicines. Recommendations for proper preparation of periodic reporting are proposed. The range of problems requiring additional assessment, in particular, the state of the system of regional centers for monitoring the safety of medicines in Russia is highlighted. The article is addressed to clinical pharmacologists, pharmacovigil commissioners, pharmacovigilance specialists, heads of medical and pharmaceutical organizations and medical authors.