By order of the Ministry of Health of Ukraine of 02.04.2020 No. 762, the protocol “Provision of Medical Care for the Treatment of Coronavirus Disease (COVID-19)” was approved. This protocol contains information on medicinal products that are registered with other indications or are not registered in Ukraine, but are used for the treatment of certain groups of patients with coronavirus disease (COVID-19) in the countries defined by the Law of Ukraine of 30 March 2020 No. 539-IX “On Amendments to Certain Laws of Ukraine on Ensuring the Treatment of Coronavirus Disease (COVID-19)”.
The use of the above-mentioned medicinal products in the treatment of COVID-19 requires early and systematic detection, recording, and reporting of adverse reactions (ARs) and/or lack of efficacy (LE), unknown properties of medicinal products when used off-label, or the absence of safety data for medicinal products that have not undergone state registration.
This approach to pharmacovigilance is aimed at minimizing the risks to patients' health associated with the use of medicinal products in the treatment of COVID-19 and at standardizing the management of the data received.
Also, in such circumstances, the performance of pharmacovigilance involves clinical monitoring, registration, and reporting.
Clinical monitoring includes a systematic clinical and laboratory evaluation of the patient, in accordance with the requirements of the protocol “Provision of Medical Care for the Treatment of Coronavirus Disease (COVID-19)”.
Registration and reporting involve healthcare professionals completing and submitting to the State Expert Center of the MoH, within 48 hours, ADR and/or lack-of-efficacy report forms (form No. 137o) not only for medicinal products that are registered with other indications or are not registered in Ukraine, but also for medicinal products registered in Ukraine that were used for the symptomatic treatment of patients with coronavirus disease (COVID-19). ADR and/or lack-of-efficacy report forms (form No. 137o) should be sent via the Automated Pharmacovigilance Information System (AISF) at the link https://aisf.dec.gov.ua indicating in the report forms the laboratory and clinical examination findings of the patients.
