Darnitsa Creates a Digital Platform for Collecting Data on Adverse Drug Reactions

Darnitsa Pharmaceutical Company has launched the project for digitalization of the drug use safety monitoring system. The collection and exchange of messages will be organized jointly with the State Expert Center of the Ministry of Health and will take place in the international E2B format.

Drug safety monitoring is carried out throughout their life cycle, from the moment of development and research to sale and use. It is aimed at identifying and analyzing adverse reactions during the use of drugs and covers all entities - regulatory bodies, pharmaceutical companies, physicians, patients, pharmacists. The responsibility for the pharmacovigilance is borne by the manufacturer, who informs the regulatory authorities about each case of adverse reactions.

According to Dmytro Shymkiv, Chairman of the Board of Directors of Darnitsa Group, the digitalization of pharmacovigilance draws the creation of a single database of applications on the use of medicinal products closer. He noted that the analysis of these data makes it possible to prevent the occurrence of adverse drug reactions.

“For Darnitsa, patient safety always comes first. The new cloud version of the digital platform has a high security level, it strengthens the focus on the safety of human treatment. Furthermore, the digitalization of pharmacovigilance increases the transparency of the monitoring process and increases the effectiveness of interaction with foreign regulators. Integration into the world pharmaceutical market is the only way of development of the Ukrainian pharmaceutical industry. Therefore, in order to speed up the process of entering the markets of countries with strict regulatory policies, we must become a part of the global system of pharmacovigilance. Currently, Darnitsa’s pharmacovigilance system includes monitoring of the use of drugs in organic markets and in some EU countries. This is a competitive advantage that will strengthen the company's export potential and accelerate its entry into the EU and the US markets," Shymkiv emphasized.

He also added that by the end of 2020 Darnitsa plans to digitize the pharmacovigilance communication system for foreign markets and to conduct training involving patients, physicians and medical representatives during the first half of 2021.