JSC Farmak pharmaceutical company (Kyiv) has launched the project “Electronic dossier of a series of medicinal products,” upon completion of which paper-based records of information on the production of a series of medicines will be completely replaced by electronic ones. According to the company’s press release, the project partner was Siemens, which introduced similar systems for the pharmaceutical companies Bayer, Johnson & Johnson, Takeda, etc.
The electronic dossier of a drug batch includes all the necessary protocols: from quality control of raw materials to information on all stages and parameters recorded during the manufacture of the drug.
The company clarifies that the introduction of an electronic dossier minimizes the risk of operator error, optimizes the technological process and allows real-time monitoring of the situation at the site, and also provides complete statistics for calculating the overall efficiency of the equipment
In addition, the electronic dossier allows an authorized person to analyze online all indicators of the drug for deviations and release a batch of the drug remotely, from anywhere in the world.
“Digitalization is a requirement of our time. As every citizen of Ukraine has an electronic passport, so each series of drugs should have its own electronic dossier. We are interested in the deep processes of digitalization, so we introduce electronic quality certificates, electronic research protocols, electronic dossiers of drug series and much more,” Executive Director of JSC Farmak Volodymyr Kostiuk said.
Farmak is the leader of the Ukrainian pharmaceutical market, produces medicines in all 14 therapeutic groups. Among the main directions are endocrinological, gastroenterological, cardiological, neurological, anti-cold and other drugs. Annually it introduces to the market about 20 new complex component modern drugs. Currently, the company’s product portfolio includes about 400 drugs.
Post-COVID rehabilitation is necessary for patients even at the time of stay in a medical facility, and 20-40% of patients who have recovered will suffer from post-COVID syndrome, a number of experts voiced this opinion during a press conference at Interfax-Ukraine. “Out of 100% of people who are sick with COVID-19, some 20% need hospitalization. Some of these patients need hospitalization in intensive care units, as well as mechanical ventilation. Rehabilitation for such patients is necessary even in the intensive care unit, especially for patients with artificial lung ventilation. Rehabilitation is also important for patients who move from the intensive care unit to the hospital,” Vadym Kerestey, the head of the rehabilitation department of the Adonis network of medical clinics, said.
At the same time, the expert emphasized that currently in Ukraine, very few rehabilitation measures are carried out in intensive care units, and rehabilitation centers do not cover all needs.
He noted that the majority of patients who had been ill in a mild form also need post-COVID rehabilitation, since patients have impairments from different systems. Patients often have tachycardia, lung problems, reduced ability to work, acute disorders of cerebral circulation, thrombosis, which increases the risk of strokes, disorders of the nervous system.
In addition, the country also has a demand for post-COVID rehabilitation among foreigners, the expert emphasized.
Physical therapy is especially important, he said.
“Physical therapy will accelerate the recovery of patients. Physical therapists teach patients to move, breathe correctly, determine the physical condition and the body’s ability to exercise,” Kerestey said.
The head of the department of inflammatory eye pathologies and microsurgical treatment of their consequences of the Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine, Oleksandra Zborovska, in turn, noted that patients after coronavirus also need to undergo rehabilitation with ophthalmologists.
“From the point of view of an ophthalmologist, everyone needs rehabilitation, even those who were not sick, since we were all on isolation, which significantly increased the time of contact with gadgets. There is evidence that an increase in myopia in children is recorded. Therefore, visual hygiene and a dosage visual load regimen are of great importance. Regarding post-COVID rehabilitation, patients come with different complaints and need to be observed by a doctor,” she said.
At the same time, Vitaliy Usenko, the medical adviser to Farmak, noted that, according to the latest data, 20-40% of patients who have recovered will suffer from post-COVID syndrome.
“Post-COVID syndrome has been included in the international classifier of diseases. The Ministry of Health of Ukraine has signed an order with a protocol for rehabilitation care for patients with coronavirus disease. It is impossible to implement the protocol with the help of one health system, and it is very good that rehabilitation services appear,” he added.
According to Usenko, during post-COVID rehabilitation, drugs that are used in the treatment of COVID-19 can be used, but only as directed by a doctor.
Farmak pharmaceutical company, within the framework of a strategic partnership with the Kyiv School of Economics (KSE), will allocate $ 500,000 for the development of KSE.
According to a press release from the pharmaceutical company, in particular, the funds will be used to equip a new campus, as well as to strengthen existing and launch new educational areas, including training bachelors.
“By supporting such projects, we are contributing to the achievement of the Global Sustainable Development Goals, one of the tasks of which is to improve the quality of higher education and ensure its close connection with science,” Executive Director of Farmak Volodymyr Kostiuk said.
The press release notes that Farmak supports not only KSE, but also other educational initiatives, including the Minor Academy of Sciences, publishes books about Ukrainian scientists. The company’s own scientific potential (150 scientists, 42 candidates of sciences, five doctors of sciences and an innovative R&D complex) allows providing a high level of academic expertise.
“The decision of Farmak company testifies that Ukrainian business is entering a new level of corporate social responsibility, and this should become an example for others. Thanks to the support of companies such as Farmak, we are preparing the ground for a strong and innovative Ukrainian economy,” President of KSE Tymofiy Mylovanov said.
Farmak is the leader of the Ukrainian pharmaceutical market, produces medicines in all 14 therapeutic groups. Annually it introduces to the market about 20 new complex component modern drugs. Currently, there are about 100 drugs in development. It exports products to more than 25 countries around the world.
The pharmaceutical company PJSC Farmak (Kyiv) has confirmed the compliance with the GMP of the Eurasian Economic Union (EAEU), which is a prerequisite for registration/re-registration and sale of drugs in the markets of the EAEU member countries, in particular in Belarus, Kazakhstan, Kyrgyzstan.
According to the company’s press release, the inspection of the pharmaceutical company at the beginning of 2021 was carried out by representatives of the Republic of Belarus, who checked production, warehouse, laboratory facilities and the functioning of the pharmaceutical quality system.
“The presence of the EAEU certificate becomes a prerequisite for the registration/re-registration and sale of drugs in the markets of the EAEU member states (Belarus, Kazakhstan, Kyrgyzstan, etc.) and will reduce the number of inspections carried out by local regulatory bodies of the EAEU member states,” a press release says.
The company is currently preparing to be tested for compliance with the FDA to enter the U.S. market, executive director of the Farmak company Volodymyr Kostiuk specified.
The company recalled that in 2020 the drug Dexamethasonum, which the company produces, successfully passed the WHO prequalification and is included in the list of drugs with confirmed quality and effectiveness in the treatment of HIV/AIDS and COVID-19.
As reported, Farmak at the end of 2020 increased the share of exports to 29.6% in total sales. Export deliveries by the end of the year increased by 40%.