There is currently no established framework for conceptualizing or implementing drug use. These recommendations provide a framework that outlines considerations to be considered when developing definitions of drug use in real-world clinical practice. The structure is intended to aid researchers in understanding and contextualizing the findings of pharmacoepidemiological studies.

In 2021, the U.S. Food and Drug Administration (FDA) issued draft guidance on the use of electronic health records and medical claims data for regulatory decisions. The draft guidance provides recommendations for sponsors regarding the use of real-world data in conducting studies. It also addresses the challenges and limitations associated with the use of these data and provides recommendations to overcome them. The purpose of this article is to provide a brief overview of key aspects of the FDA's guidance on the use of electronic health record data in regulatory decision making.

The spread and consequences of the coronavirus disease 2019 (COVID-19) pandemic are currently one of the most pressing public health challenges in the world. Despite the fact that experience accumulates in the treatment and monitoring of COVID-19 patients, certain aspects are still a clinical dilemma. In particular, this regarded the use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the pandemic, both as a symptomatic treatment of infection, and in patients with comorbidities requiring NSAID. A series of studies did not establish evidence of the risk of infection and complications from NSAID therapy in COVID-19. At the same time, the practitioner should take into account the risk of specific NSAID-associated complications, which also remain relevant during the COVID-19 pandemic. This resolution focuses on the evolution of ideas about NSAID use and safety in COVID-19, and also emphasizes the particular relevance of their use for a number of clinical situations.

Pain is an important problem in oncology patients. Depending on its intensity, for pain treatment, analgesics of different pharmacological classes are used. According to WHO recommendations, for nociceptive pain treatment in oncology patients, non-steroidal antiinflammatory drugs (NSAIDs), mild and potent opioids are the essential medications. If in pain formation along with the nociceptive pain component, a neuropathic one is present, antiepilepsy drugs, tricyclic antidepressants, local anesthetics are added. Apart from these medicines, adjuvants are used. These agents potentiate the analgesic endpoint of NSAIDs and opioids, correct their adverse effects. Often, intensive pain development is driven by bone metastases, which form in oncologic processes of different primary localization. Herewith, patients could suffer from constant as well as from paroxysmal, “breakthrough” pain. The efficacy of NSAIDs in oncology patients is due not only to analgesic effect but also to their action on inflammatory processes in areas of tumor formation and growth as well as in metastatic foci. Dexketoprofen trometamol is an effective and safe NSAID, a water-soluble salt of a dexketoprofen dextrorotatory stereoisomer. The preparation has a good lipid and water solubility. Thus, dexketoprofen trometamol can rapidly absorb, create therapeutic concentrations in blood serum, and penetrate through brain-blood barrier. It produces a significant and fast analgesic action in different diseases, which is related both to central analgesic mechanisms and to anti-inflammatory effect in peripheral tissues. Dexketoprofen trometamol efficacy is proven in bone pain related to oncological disease. The availability of intravenous solution and the prompt action at oral administration allow using the medicine for “breakthrough” pain. The medication significantly potentiates the action of mild and potent opioids at combined therapy, which allows to use opioid analgesics in lower doses.

The personalization of therapy is one of the innovative approaches gaining an increasingly strong foothold in modern medicine, implying an individual approach to each patient, taking into account the individual characteristics of the patient and the specific clinical case. This same standpoint of personified therapy should be used to plan rational analgesic therapy, the most important component of managing patients with the most common and socially significant diseases, with conditions that have a significant impact on the patient’s quality of life and worsen the course of concomitant diseases. The Meeting of Experts of different specialties such as rheumatologists, neurologists, cardiologists and clinical pharmacologists considered the key aspects of the prescription of NSAIDs, the most widely used class of painkillers, including those used for the relief of musculoskeletal pain. It was noted that when choosing NSAIDs, the practitioner should take into account the diagnosis, the planned duration of analgesic therapy, the intensity of pain, medical history data, the presence of comorbid diseases and risk factors for drug complications. There are different types of NSAIDs, some of which are most useful for urgent acute pain therapy (eg, ketoprofen), while others are most suitable for long-term pain management in chronic diseases (eg, etoricoxib). In any case, the practitioner should take into account the priority of patient safety and pay the utmost attention to the prevention of NSAIDassociated complications, and also keep in mind the duration of the specific drug administration permitted by the patient information leaflet. It was also noted that the launch of a new generic etoricoxib (Kostarox®) expands the possibilities of analgesic therapy for the Russian practitioners.

The personalization of therapy is one of the innovative approaches gaining an increasingly strong foothold in modern medicine, implying an individual approach to each patient, taking into account the individual characteristics of the patient and the specific clinical case. This same standpoint of personified therapy should be used to plan rational analgesic therapy, the most important component of managing patients with the most common and socially significant diseases, with conditions that have a significant impact on the patient’s quality of life and worsen the course of concomitant diseases. The Meeting of Experts of different specialties such as rheumatologists, neurologists, cardiologists and clinical pharmacologists considered the key aspects of the prescription of NSAIDs, the most widely used class of painkillers, including those used for the relief of musculoskeletal pain. It was noted that when choosing NSAIDs, the practitioner should take into account the diagnosis, the planned duration of  analgesic therapy, the intensity of pain, medical history data, the presence of comorbid diseases and risk factors for drug complications. There are different types of NSAIDs, some of which are most useful for urgent acute pain therapy (eg, ketoprofen), while others are most suitable for long-term pain management in chronic diseases (eg, etoricoxib). In any case, the practitioner should take into account the priority of patient safety and pay the utmost attention to the prevention of NSAIDassociated complications, and also keep in mind the duration of the specific drug administration permitted by the patient information leaflet. It was also noted that the launch of a new generic etoricoxib (Kostarox®) expands the possibilities of analgesic therapy for the Russian practitioners.