Assessment of Awareness and Experience of Using off-label Drugs by Doctors of Clinical Specialties.

Aim      To evaluate the frequency of off-label prescription of medicines in practice of clinical specialists and the awareness of respondents of the procedure of justified off-label prescription.Material and methods  The sample included 542 clinical specialists who worked in definite medical organizations in 26 entities of the Russian Federation. The respondents were proposed to fill in remotely an anonymous questionnaire to evaluate the experience of prescribing medicines off-label to adult patients.Results Prescribing medicines not in consistence with the officially approved instruction for medical use (off-label or "outside instruction") is a relevant issue of global medical care since convincing scientific evidence for safety of such use is scarce. Analysis of information about off-label prescription is one of current tasks of national medical research centers according to the Federal Project "Development of a network of national medical research centers and implementation of innovative medical technologies". According to the responses about the frequency of off-label prescriptions 67.5 % of respondents reported of no experience of off-label prescription, 27.7 % said "rarely" or "sometimes", and 4.8 % said "frequently" and "very frequently". Specialties of physicians who have more often used medicines off-label (50% and more) included obstetrics and gynecology, pediatrics, rheumatology, hematology, and pulmonology. Cardiologists, neurologists and clinical pharmacologists use medicines off-label relatively rarely (19.6%, 28.6 %, and 22.2 %, respectively). 40 % of medicines used off-label were those designed for the treatment of coronavirus infection SARS-CoV-2. The medicines most frequently used off-label included metformin, rituximab, and thioctic acid. 65 % of respondents assessed their knowledge of off-label prescription as insufficient. In addition, 75 % of respondents consider it useful to receive additional information about risks and benefits of off-label prescription in clinical practice.Conclusion      The survey revealed the need of physicians for information about risks of the off-label use of medicines in clinical practice.

[Assessment of Outcomes and Treatment Tactics in Patients With Non-ST-Elevation Acute Coronary Syndrome: Data of Five-Year Follow-up].

PURPOSE: to study the role of clinical factors and treatment tactics in the development of adverse outcomes in patients with non-STelevation acute coronary syndrome (NSTEACS) for five years follow up. MATERIALS AND METHODS: The study included 415 patients with NSTEACS observed for 60±4 months from the date of discharge. Adverse events (AE) were unstable angina (UA), myocardial infarction (MI), ischemic stroke or patient's death. The favorable 5-year outcome was identified in 200, adverse outcome - in 178 patients. Statistical processing was performed using STATISTICA 8.0 software package and MedCalc 11.0. RESULTS: Total mortality for 60 months was 16.1% (n=61). Highest mortality, maximal number of hospitalizations due to MI (41.1%) and UA (49.6%) were observed during first 12 months. Greatest impact on the development of AE produced: history of MI, higher GRACE score, age >54 years (p=0.0021), stenosis in brachiocephalic arteries, ischemic changes on admission ECG and reduced left ventricular ejection fraction (LVEF) ≤ 52% (p=0.0001). Five-year survival rate was influenced by coronary angiography (p=0.0001) and percutaneous coronary intervention (PCI) during index hospitalization (p=0.0039). DISCUSSION: Mortality and frequency of AE in this register were close to generally reported. The observed adverse impact on the long-term outcome of such risk factors such as age over 60 years, history of MI, ischemic ECG changes at admission, decreased LVEF corresponded to literature data. Our study proved the need for coronary imaging in patients with NSTEACS to determine treatment strategy in in hospital period as these factors affected the 5-year survival. CONCLUSION: During five-year follow-up AE occurred in 47.1% of patients with NSTEACS. Maximal number of patients with AE was registered during the first (24.7%) and fifth (13.8%) year of observation. The development of AE was associated with older age, history of MI and coronary artery bypass grafting, ischemic ECG changes, decreased LVEF, higher GRACE score, and brachiocephalic artery stenosis. Carrying out diagnostic coronary angiography and PCI with stenting during hospitalization in patients with NSTEACS was associated with favorable 5-year outcome.