R-Pharm optimized the system of pharmacovigilance

R-Pharm achieved quality improvement of collecting and data processing about side effects of medicines. One of the first in the country R-Pharm implemented a specialized IT system on automation of accounting and the analysis of undesirable reactions. As provider the Russian company Flex Databases specializing in complete software solutions for development and testing of medicines was selected.

R-Pharm purposefully improves an internal system of pharmacovigilance and brings it into accord with requirements of the international regulators – FDA (Food and Drug Administration, USA) and EMA (European Medicines Agency) as prepares for entry into the western markets.

Security of medicines – one of key problems in the countries of advanced pharmaceutical industry. Inefficient accounting of side effects of medicines turns into serious financial losses for a health care system and, what is even more terrible, claims the lives of thousands of patients. According to the World Health Organization (WHO), undesirable reactions to medicines are among ten leading causes of death in many countries. Only in the European Union 197,000 people die every year of them according to the European agency of medicines (European Medicines Agency, EMA). The European Union spends the enormous amount in a year for overcoming effects of side effects – 79 billion euros. On average development of undesirable reactions leads to treatment value addition on 2.2 thousand dollars, and hospitalization term – for 1.91 days. In the different countries the percent of the hospitalization connected with side effect of drugs varies from 10 to 35%.

The system of pharmacovigilance is in Russia at a formation stage, but shows very high rates of development. In only 5 years the number of the registered messages about undesirable reactions to medicines in a subsystem Pharmacovigilance of the AIS of Roszdravnadzor grew by 159 times. 17,033 complaints in 2013 against 107 in 2008.

In Europe to secure lives of patients and to reduce finance costs, began to implement actively in the system of pharmacovigilance of IT technology. According to recent trends R-Pharm optimized the system on tracking of undesirable reactions. Key processes of pharmacovigilance at a stage of clinical trials and post-registration use of medicines in medical practice were automated. Among them: work with spontaneous messages about undesirable reactions, pregnancies, the serious undesirable phenomena in clinical trials, message handling about cases from literature and other significant information.

Implementation in R-Pharm company of the IT system of Flex Databases on automation of process of pharmacovigilance increased quality of registration and processing of undesirable reactions. All information is quickly entered in the register of the electronic database on uniform standards. As a result the quality and accuracy of the data improves.

Process automation leads to one of the most significant results of pharmacovigilance – risk minimization for patients and to increase in security of the produced medicines. Thanks to high quality of data they easily give in to the analysis, and it is possible to monitor without effort trends in development of undesirable reactions in each medicine.

"Implementation of the IT system of Flex Databases in R-Pharm company increased quality of registration and processing of undesirable reactions and other significant information on security. Process of monitoring of data on security in medical literature was transferred to paperless turnover, and process of unloading and compilation of information for creation of periodic reports on security of medicines significantly became simpler. But the most important – by means of a new automated system on pharmacovigilance we expect to achieve the maximum security of medicines for patients. Today it is one of the main calls of modern pharmaceutics", – the head of the safety department of R-Pharm medicines Sergey Grishin tells.

The system effectiveness of pharmacovigilance in the country in many respects depends on high activity of domestic manufacturers concerning identification, registration, the analysis and information transfer about undesirable reactions in regulatory bodies. What more Russian pharmaceutical companies will use the last IT achievements in this sphere, especially the high level of development of pharmacovigilance can be expected in general across Russia.