FROM EDITOR
HEALTH TECHNOLOGY ASSESSMENT
In 2022, ISPOR released an updated checklist on economic evaluation of health care, since the latter several years have passed, the circumstances have changed, and science has progressed that it demanded fresh relevant changes. To support decision-making in accordance with the principles of evidence-based medicine, expanding participants, the involvement of as many sides as possible for more coordinated and high-quality work. The paper contains the main principles included into the ISPOR CHEERS 2022 check-list.
PROVISION OF DRUGS
Evaluation of the effectiveness of Preferential Medicinal Providing is due to the need for rational pharmacotherapy for patients from certain categories of citizens. There are not enough technologies for such an assessment, which requires their creation and implementation.
The purpose of the study. To develop the Integrative Scale for Evaluating the Effectiveness of the Program for Providing Certain Categories of Citizens with the Necessary Medicines on the model of the Far Eastern Federal District as an informative way to establish the effectiveness of the preferential segment of medicinal providing, to show the advantages of this Scale compared to other methods and to propose a set of measures to improve the effectiveness of the Program.
Materials and methods. The results of the patient survey, compliance of the structure of purchased medicines with the regulatory framework and clinical recommendations of the Ministry of Health of the Russian Federation regulating Preferential Medicinal Providing were analyzed. The structure of the incidence of patients who were initially and repeatedly recognized as disabled.
Results. Based on the analysis of compliance with the most important principles of medicinal providing, a technology for evaluating the effectiveness of the Program has been created that allows the participants of the Preferential Medicinal Providing, doctors, Health care organizers, specialists in the field of medicinal procurement, to carry out rational prescribing and purchase of medicines and it is advisable to allocate financial resources taking into account the priority of vital medicines.
Conclusion. The Integrative Scale will contribute to improving the clinical and economic efficiency of the Program and will make a significant contribution to improving and maintenance the quality of life of patients receiving pharmacotherapy in the preferential segment, both at the level of the subject of the Russian Federation and at the level of the national system of Preferential Medicinal Providing.
DRUGS UTILIZATION RESEARCH
Relevance. Studies devoted to the assessment of consumption, as well as to the issues of pharmacosafety of nonsteroidal anti-inflammatory drugs, are limited at the national level in the Russian Federation. The study of these issues will determine the general trends of consumption and prescription of this group of drugs.
Aim. To assess the consumption pattern of NSAIDs in the Russian Federation in the period from 2010 to 2020.
Methods. Information was searched using data from the state register of drugs (GRLS) as well as national database downloads (automated information system of Roszdravnadzor; AIS RZN). To estimate the consumption of the main INN from the group of NSAIDs for the period 2010–2020 the information on the sales volume of all trade names, sold for sale in the Russian Federation was unloaded from the database of IQVIA Solutions Ltd. and analyzed.
Results. The analysis showed that the first place by total amount of consumption was occupied by acetylsalicylic acid (5 953 058 854); second place — paracetamol (4 635 122 085); third place — ibuprofen (3 230 415 088); fourth place — metamizole (4 172 344 008); fifth place — ketorolac (91 617 809,04); sixth — nimesulide (69 761 7481,8). The claimed INNs showed a slightly different distribution when calculating the DDDs/P (patient-year) totals, namely, in descending order, nimesulide, ketorolac, ibuprofen, acetylsalicylic acid, paracetamol, and methamisole.
Conclusion. The indicated levels of consumption do not correlate with the data of the national database “Pharmacovigilance”, which indicates insufficient post-marketing monitoring of the safety profiles of the indicated medicines.
EPIDEMIOLOGY
Relevance. Chronic lymphocytic leukemia (CLL) is one of the most common lymphoproliferative diseases of the European population with an increase in the elderly and senile age frequency. In this category of patients standard approaches to predicting overall survival do not take into account the presence of comorbid pathology and have low accuracy. In view of this, the search for parameters that affect the overall survival rate of patients with CLL is of particular relevance.
The aim of the study is to identify factors affecting the CLL patients overall survival at the stage of CLL diagnosis.
Materials and methods. The data of 132 CLL patients with stage A-C according to Binet with known overall survival were retrospectively analyzed. The problem was solved by data mining methods, namely using logical classification algorithms.
Results. The glomerular filtration rate is defined as a parameter that objectively justifies the real terms deviation of the patients overall survival from the calculated ones according to the standard Binet staging system. For this parameter, an if…then rule is formed, which makes it possible to predict the patient’s survival. If the GFR value at the time of diagnosis of CLL is more than 76 ml/min /1.73 m2, we can say that the patient will overcome the calculated median survival data for the corresponding stage of CLL according to Binet. Otherwise, the overall survival of the CLL patient will be less than the estimated median survival according to Binet.
Conclusion. The analysis of the study allows us to conclude that it is advisable to use data mining methods in predicting the patients overall survival with CLL. The clinical examples given in the article show their effectiveness. According to the study results, an application for invention No. 2022104419 was issued.
DRUG SAFETY
Molnupiravir is an antiviral drug with a broad spectrum of activity against RNA viruses. The safety of molnupiravir in clinical trials with COVID-19 was analyzed. In a Phase I study (NCT04392219), molnupiravir was well tolerated at doses of 50 to 800 mg twice daily for 5.5 days and at single doses up to 1600 mg. Common adverse events were headache (18.8 % placebo versus 12.5 % molnupiravir) with a single dose and diarrhea (7.1 % in both groups) with multiple doses. In a phase II study in the molnupiravir 800 mg group, adverse events were noted in the form of headache, insomnia, and an increase in the level of alanine aminotransferase. Serious adverse events leading to hospitalization occurred in the placebo group (1.6 %) due to hypoxia, in the molnupiravir 400 mg group in two (3.2 %) participants due to cerebrovascular accident and in one (1.8 %) of a participant at a dose of 800 mg due to acute respiratory failure. In the phase III MOVe-OUT study (NCT04575597), adverse events were reported in 30.4 % in the molnupiravir group and 33.0 % in the placebo group. In the phase III study CTRI/2021/06/033992, adverse events occurred in 6.5 % in the molnupiravir group versus 8.9 % in the placebo group. The results of the conducted studies demonstrate the safety, tolerability of molnupiravir in phase I, II and III clinical trials and the antiviral efficacy of the drug against COVID-19. Use of molnupiravir for mild to moderate (SpO2 > 93 %) COVID-19 within 5 days of symptom onset significantly reduces disease progression by reducing hospitalizations and/or deaths.
World statistics shows increasing numbers of aging population and increasing number of patients with multiple comorbidities, i. e. polymorbidity, which today is an urgent problem of modern clinical geriatric practice. During clinical examination of elderly and senile patients, at least 4-5 diseases and manifestations of pathological processes are diagnosed on the average. Because of this many medicines are prescribed to elderly patients at the same time, unfortunately, often unreasonably, which becomes a widespread phenomenon and is called polypharmacy. Polypharmacy is associated with an increased risk of adverse reactions that can lead to hospitalization or even death, as well as a significant increase in health care costs.
In this regard, an analysis of medication prescribing in elderly inpatients with cardiovascular disease using the Medication Rationality Index (MAI) was conducted. As a result, it was found that professionals who provide care to patients are not sufficiently aware of the peculiarities of the use of drugs in elderly patients and in our health care sector there are no regulatory documents on the care of elderly patients.
ISSN 2618-8473 (Online)