Real-World Data & Evidence

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Vol 1, No 1 (2021)
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The modern request of the global healthcare system is the collection and analysis of the information obtained during the analysis of data collected in research of routine medical practice, namely real-world data (RWD), and the evidence based on it, real-world evidence (RWE).



The relevance of paracetamol safety assessment is associated with broad recommendations for its use as a symptomatic agent in COVID-19 and an agent for adverse events following vaccination to prevent COVID-19.

Objectives. Conducting a review of global paracetamol safety data during the initial period of COVID-19 pandemic (in 2020 and in the first half of 2021).

Materials and methods. 2,356 scientific articles and their abstracts on paracetamol safety in electronic libraries; data on 2,272 clinical trials of paracetamol in and the State Register of Medicines of the Ministry of Health of the Russian Federation; 173,707 individual reports of adverse drugs reactions of paracetamol in the international pharmacovigilance database VigiBase. The data were evaluated by statistical methods in the VigiLyze analytical system (authorized expert access).

Results. No publications and completed clinical trials were found on the safety issue of paracetamol use in COVID-19. During the initial period of COVID-19 pandemic (from January 1, 2020 to July 31, 2021), the number of reports of paracetamol safety issues included in VigiBase decreased by 22,1%, which may be due to a decrease in the number of specialists sending reports on safety, with an increase of their duties and with a switching attention of these specialists and patients to other problems associated with the COVID-19 pandemic. No changes have been identified in the sources of safety data and trade names for paracetamol medicinal products. It has been established that the main part (99,4% of cases) of side effects associated with paracetamol develops outside the use of vaccines for the prevention of COVID-19. Pre-COVID and COVID data include information on 2,692 and 2,527 names of various paracetamol safety concerns, respectively. These data overlap the list of side effects specified in instructions for medical use and include new symptoms not described in instructions for medical use.

Conclusions. The lack of safety signals may be due to the lack of alertness of specialists and marketing authorization holders regarding paracetamol. During the COVID period, the structure and frequency of paracetamol safety concerns codified in terms of MedDRA (version 24.0) have changed, which can be studied in future studies of paracetamol, ibuprofen and other medicinal products.



The development of medical science requires a constant increase in the effectiveness and safety of treatment. Collection of real-world data (RWD) is one way of solving these problems. Clinical registries are one of the most important parts of this process. Clinical registries allow collecting data on the use of medical technologies and monitoring the results of therapy in real clinical practice. The introduction of patient registers and the collection of RWD data into widespread medical practice can help to optimize costs in the treatment of high-cost diseases and to better plan the budget.



The article describes the approaches of law enforcement practice in relation to the regulatory limits within which a medical institution may exercise it's right to establish requirements for purchased drugs based on purchaser's clinical practice and its own clinical experience.



On September 16, 2021, the Association of Health Technology Assessment Professionals, the Association of Russian Clinical Pharmacologists, St. Petersburg Branch of ISPOR organized the II annual scientific and practical conference with international participation: "RWD/RWE – Research Tools of Real-World Clinical Practice Today and Tomorrow". The topic of the conference brought together leading Russian and world experts in the field of RWD/RWE. 

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ISSN 2782-3784 (Online)