Drug Supply Research Articles

The Effect of Strategic Intelligence on Enhancing Customer Value: An Exploratory Study of the Opinions of a Sample of Employees at the State Company For Drug And Medical Supplies Manufacturing / Samarra - Iraq

The core objective of this research was to pinpoint the sources of strategic intelligence and their effect upon enhancing customer value, as well as to provide some suggestions that contribute to clarifying the effect between the research variables. Accordingly, the current problem was represented by the central question: (Is there a statistically significant effect of strategic intelligence on enhancing customer value?). To assess the opinions of the respondents, the research relied on the descriptive-analytical approach in dealing with the theoretical and field data of the studied company. Several research tools were used in the field aspect of the study to achieve the desired results, with the questionnaire being the main tool for data collection. A total of 130 forms were given to a random sample of employees in the studied company, of which 125 valid forms were returned for analysis, representing a rate of 96%. Several statistical methods and tools were used to handle the data, analyze the questionnaire items, and test its hypotheses based on the data processed through the (SPSS.V26) statistical program. The research concluded with several findings, including there is a statistically significant positive effect of strategic intelligence on enhancing customer value in the studied company.

DESIGNING AN E-KANBAN SYSTEM TO IMPROVE DRUG AVAILABILITY AND MINIMISE INVENTORY WASTE AT THE HOSPITAL PHARMACY INSTALLATION

In an effort to provide a high level of service to hospitals, pharmaceutical installations are often faced with problems in monitoring and determining adequate drug supply levels to respond to demand, both from outpatient and inpatient units. Inventory control by hospital pharmacies is often carried out without being supported by accurate information systems or control methods, resulting in excess inventory levels which leads to higher inventory costs. This study aims to identify and develop an e-kanban system suitable for the scope of hospital pharmacy. E-kanban as a method of controlling inventory through a simple reliable information system is expected to minimize inventory waste that occurs. The e-kanban system coupled with the use of barcodes and portable scanners is expected to provide more accurate information on drug availability. Inventory monitoring and control is expected to be much easier, both at the time of replenishment and during periodic stock-taking. The implementation of the e-kanban system is also able to eliminate waste, card use and manual recording activities, replaced by the use of simpler two-bin containers. The e-kanban system can also be integrated into the existing Hospital Information System, without disrupting the running system.

Blockchain-Based Drug Supply Chain Recommendation System (B-DSCRS) with Machine Learning for Supply Chain Management

The pharmaceutical industry has been struggling to keep tabs on its goods across the supply chain for the last decade, which has opened the door for counterfeiters to sell their phoney medications. Integrated product supply chain management mostly focuses on distribution. The pharmaceutical business places a premium on the drug distribution process because of the importance of ensuring the safe handling, storage, and distribution of medical items. The global pharmaceutical sector is facing a significant threat in the form of counterfeit pharmaceuticals. Blockchain technology can manage and monitor the supply chain process with remarkable efficiency when used to its maximum capacity.This paper proposed and implemented a Blockchain-based Drug Supply Chain Recommendation System (B-DSCRS). A pharmaceutical supply chain management system built on the blockchain and a consumer medication recommendation system powered by machine learning comprises our proposed system's two primary components. As a first step in the smart pharmaceutical industry's medication delivery process tracking and monitoring.Conversely, the machine learning module suggests the finest medications for pharmaceutical sector clients. Lastly, our suggested system goes through the testing process to ensure it is efficient and user-friendly.

Randomised clinical trial of a 16 mg vs 24 mg maintenance daily dose of buprenorphine to increase retention in treatment among people with an opioid use disorder in Rhode Island: study protocol paper

IntroductionBuprenorphine is a highly effective treatment for opioid use disorder (OUD). However, provider observations and preliminary research suggest that the current standard maintenance dose may be insufficient for suppressing withdrawal...

Rapid Assessment Amid an Injection Drug Use-Driven HIV Outbreak in Massachusetts' Merrimack Valley: Highlights from a Case Study.

Illicitly manufactured fentanyl within the drug supply has substantially increased opioid-related overdose deaths and driven infectious disease outbreaks among people who use drugs (PWUD). Local jurisdictions often lack the data and tools necessary to detect and translate such moments into actionable and effective responses. Informed by a risk environment framework, this case study adopted a mixed-methods design spanning two rapid assessment studies with PWUD in Lowell (n = 90) and Lawrence (n = 40), Massachusetts, during an HIV outbreak (2017, Study 1) and following the outbreak (2019, Study 2). Survey responses (n = 130) were summarized by computing descriptive statistics, ethnographic field notes were reviewed, and qualitative interviews (n = 34) were thematically analyzed to contextualize quantitative findings. Study 1 participants reported constrained syringe access, high injecting frequency, syringe reuse, and unsafe syringe disposal practices, and uncovered entrenched social and structural factors exacerbating existing substance use and HIV risks: housing instability, limited harm reduction supplies and services (e.g., MOUD access), and tensions between law enforcement and PWUD. Following the outbreak and substantial local investments in harm reduction and treatment infrastructures, Study 2 participants indicated lower injection risk reporting fewer syringe reuse episodes, improved syringe disposal practices, high frequency of naloxone administration at recent overdoses, frequent testing for HIV and HCV, and greater engagement with syringe services programs. A rapid assessment approach to fentanyl's emergence and a concomitant HIV outbreak provided time-sensitive, critical insights and identified needed and local response strategies. However, unless social and structural risk factors are also addressed, community vulnerability to future HIV outbreaks remains.

Assessment of the impact of procurement centralization on the drug provision for patients within the High-Cost Nosology Program in the Russian Federation

Background. In the Russian Federation, patients receive expensive drugs from the federal budget funds within High-Cost Nosology (HCN) Program.Objective: to assess the impact of drug procurement centralization on the weighted average price (WAP) per 1 unit of measurement (UM) of a drug, the procurement structure within HCN Program over 5 years (2019–2023), as well as the annual volume of procurements for each nosology and the additional annual growth compared to the previous year.Material and methods. The data on public procurement within HCN Program, regional and federal drug provision programs over the specified time period have been analyzed. During the analysis of individual nosologies, 22 drugs for the treatment of 12 HCN have been considered.Results. The median value of the change of WAP per 1 UM for all drugs within HCN Program was 6.01%. Aplastic anemia was characterized by the lowest volume of procurements over 5 years, while for malignant neoplasms was the largest. The growth in procurements from year to year within nosologies varied from +1% to +661%, while a decrease was from –97% to –1%.Conclusion. The results can be used as a basis for further research related to the process of implementation of preferential drug provision, and to development of additional tools to improve the efficacy of pharmacotherapy choice for included drugs and management decisions regarding the further expansion of HCN Program.

Addressing Racial and Ethnic Inequities in Opioid Overdose Mortality: Strategies for Equitable Interventions and Structural Change.

This review synthetizes findings reflecting the increasing racial and ethnic inequities in opioid overdose mortality and emphasizes the necessity for tailored interventions as well as other policy-level and structural strategies to stem this trend. Factors contributing to inequities in overdose mortality include changes in drug supply, persistent social-structural vulnerabilities stemming from structural racism, and inequities in access to medication for opioid use disorder and harm reduction services. Key strategies to address these inequities include the cultural adaptation of evidence-based interventions within an equity-based framework, integrating social determinants of health into addiction treatment, centering anti-racism praxis in addiction research, diversifying the addiction workforce, and integrating structural competency as a tool to restructure education and inform practice. Structural racism must be recognized as a key driver of inequities in substance use outcomes, and this understanding must be integrated into existing models of substance use disorder prevention, treatment, and research.

An interrupted time series analysis of fentanyl, naloxone, and opioid-involved deaths in five counties in Eastern Missouri

IntroductionRates of opioid overdose deaths (OOD) have increased since the introduction of illicitly manufactured fentanyl in the U.S. drug supply. Though community-based naloxone distribution efforts have been found to effectively reduce OOD, no studies to date have examined their effects during the fentanyl era, nor in the epicenter of a state's overdose crisis. Thus, the current study assessed the impacts of both fentanyl and of subsequent grant-funded community-based naloxone distribution on OOD across Missouri's St. Louis region. MethodsMedical examiner data includes individuals who died within one of the five study counties (St. Louis City, St. Louis County, and Franklin, Jefferson, St. Charles counties [combined as “Collar Counties”]) between 2011 and 2022 due to an opioid overdose (N = 6799). Naloxone distribution date and location data came from Missouri's university-based naloxone distribution team. We conducted a controlled interrupted time series using an autoregressive model via proc. ARIMA to examine changes over time in the rate of OOD associated with the introduction of fentanyl (defined to be present in 25 % of opioid overdose deaths; June 2015) and the start of naloxone distribution for each location (August 2017, October 2017, and January 2018, respectively). ResultsThe introduction of fentanyl into the drug supply of St. Louis City was associated with an increased rate of OOD over time (p < .001). Naloxone distribution in the City was associated with an immediate decrease in OOD (p < .001) followed by a slowed increase in OOD (p < .001). These findings were not replicated in St. Louis County nor the Collar Counties. ConclusionsThe effects of fentanyl and naloxone on OOD varied by region in Eastern Missouri. Specifically, fentanyl and naloxone effects were only found in a high-need urban area with existing harm reduction and street outreach programs, but not in surrounding suburban or rural areas. State-level naloxone distribution decision-makers should prioritize funding harm reduction services in both urban and non-urban settings to help increase targeted naloxone distribution to those actively using drugs. Additionally, interventions tailored for people who engage in solitary drug use - such as safe consumption spaces and overdose detection technologies - should receive increased investment and implementation, particularly in rural areas where harm reduction infrastructure is more scarce.

Cross-sectional assessment of perception and attitude of pharmacy students towards pharmaceutical promotion: a study from developing country, Pakistan

BackgroundThe pharmaceutical promotion is “all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs. These promotional activities affect the dispensing behavior of physicians and pharmacists and influence begins from educational institutes.ObjectiveOur study’s main aim was to evaluate opinion and attitude of pharmacy students towards pharmaceutical promotion.Materials and methodsA cross-sectional online survey was conducted among 3rd, 4th and final year pharmacy students of 3 public and 3 private sector universities in Punjab Pakistan. A modified version of pre available questionnaire was used to collect data from students between June 2020 and December 2020. The tool was made available through a Google Form, assessable to students via provided link. We utilized the snowball sampling technique. Descriptive statistics were used to evaluate the demographics, while Chi-square and t-test were used to analyze associations between demographics and items. Data were analyzed using SPSS version 21.0.ResultsA total of 1,195 students participated in the survey with an average age of 22.2 ± 1.2 years. Nearly 2/3rd of the students were males (62.2%) and a significant proportion (87.3%) of pharmacy students had never taken part in any training provided by pharmaceutical company. Among all, 51.9% confirmed that pharmacists who frequently interact with medical representatives tend to dispense more antibiotics. Additionally, 42.1% indicated they may dispense antibiotics under the influence of promotion. Pharmacy students in senior college years and those with lower parental exhibited significantly more perception and attitude scores (p &amp;lt; 0.001).ConclusionA significant number of students concurred with the notion that promotional activities could impact dispensing practices and they also believed that such activities contribute to the growing issue of irrational antibiotic use. This study underscores the necessity for a heightened emphasis on the educational needs of pharmacy students.

Humanising and optimising HIV health care for refugees and asylum seekers.

Displaced populations living with HIV, including refugees and asylum seekers, face substantial challenges across various regions globally. The intersection of forced migration and HIV presents both shared challenges and region-specific differences. Key issues include little access to health care, pervasive stigma, discrimination, and disruptions in the continuity of HIV care. Refugees often encounter barriers such as legal, cultural, and economic disparities that impact their overall health outcomes. Although HIV prevalence differs across regions, displaced populations consistently face disproportionate challenges including high-risk environments and little health-care access. Addressing these challenges requires a focus on equitable health-care access, with both actionable local interventions and broader global policy changes and an emphasis on long-term sustainability. Reliable and continuous drug supplies, interagency collaboration, and holistic health-care approaches are essential. International collaboration, robust evidence generation, and comprehensive responses are urgently needed to address the complex interplay between forced migration and HIV among vulnerable populations.

Repurposing prescribed hydromorphone: Alternative uses of safer supply and tablet-injectable opioid agonist treatment to meet unaddressed health needs

BackgroundIn response to the ongoing overdose crisis in Canada, a number of opioid agonist treatment and safer supply programs provide people at high overdose risk with daily-dispensed tablet hydromorphone, with some requiring witnessed ingestion and others providing take-away doses. While these programs are intended to reduce overdose events by limiting people's use of the contaminated drug supply, the experiences of people receiving hydromorphone vary. In this article we explore the ways people repurpose hydromorphone to address unmet needs. MethodsThis article draws on in-depth qualitative interviews from two studies evaluating hydromorphone tablet distribution programs in British Columbia, Canada. We used thematic analysis to identify themes related to repurposing hydromorphone. We compared themes across the two studies to identify any similarities or differences in relation to the ways study participants discussed repurposing hydromorphone tablets. We utilize vignettes – snapshots of participant experiences – to analyse and represent the data. ResultsFour vignettes demonstrate how hydromorphone tablets are often being used to address and resolve unmet needs of people who use drugs. While most participants reported reducing their use of illicit drugs, a variety of instrumental uses of tablet hydromorphone were also discussed, including reducing anxiety, addressing sleep issues, withdrawal management, and managing chronic pain. ConclusionOur findings demonstrate how people who use drugs are maximizing the benefits of tablet hydromorphone distribution to address unmet needs. Hydromorphone distribution programs represent a public health and harm reduction intervention that is usefully addressing experiences related to structural vulnerabilities (such as inadequate pain management), which are often overlooked amongst stigmatized groups.

Temporal and spatial trends of fentanyl co-occurrence in the illicit drug supply in the United States: a serial cross-sectional analysis

BackgroundFentanyl and its analogs contribute substantially to drug overdose deaths in the United States. There is concern that people using drugs are being unknowingly exposed to fentanyl, increasing their risk of overdose death. This study examines temporal trends and spatial variations in the co-occurrence of fentanyl with other seized drugs. MethodsWe identified fentanyl co-occurrence (the proportion of samples of non-fentanyl substances that also contain fentanyl) among 9 substances or substance classes of interest: methamphetamine, cannabis, cocaine, heroin, club drugs, hallucinogens, and prescription opioids, stimulants, and benzodiazepines. We used serial cross-sectional data on drug reports across 50 states and the District of Columbia from the National Forensic Laboratory Information System, the largest available database on the U.S. illicit drug supply, from January 2013 to December 2023. FindingsWe analyzed data from 11,940,207 samples. Fentanyl co-occurrence with all examined substances increased monotonically over time (Mann-Kendall p<0.0001). Nationally, fentanyl co-occurrence was highest among heroin samples (approx. 50%), but relatively low among methamphetamine (≤1%), cocaine (≤4%), and other drug samples. However, co-occurrence rates have grown to over 10% for cocaine and methamphetamine in several Northeast states in 2017-2023. InterpretationFentanyl co-occurs most commonly with heroin, but its presence in stimulant supplies is increasing in some areas, where it may pose a disproportionately high risk of overdose. FundingThis work was partly supported by FDA grant U01FD00745501. This article reflects the views of the authors and does not represent the views or policies of the FDA or US Department of Health and Human Services.

Profile of Trofinetide in the Treatment of Rett Syndrome: Design, Development and Potential Place in Therapy.

Trofinetide is a first-in-class pharmacological treatment proposed for patients with Rett Syndrome. It is a long half-life derivative of glycine-proline-glutamate, the tripeptide normally excided from Insulin-like Growth Factor 1 upon degradation. Due to containing glutamate and glycine in its structure, trofinetide is thought to act through NMDA receptor modulation, thus providing a normalization of neuronal activity and survival. Trofinetide was tested in a series of short and long-term trials, showing good efficacy at improving scores on the Clinical Global Impression-Improvement scale and Rett Syndrome Behavior Questionnaire, with specific effect only on some subscales, ie General Mood subscale and Repetitive Face Movement subscale. No effects were documented on other subscales or on epilepsy, heart and bone -related symptoms. The main adverse effects of trofinetide, severe enough to determine discontinuation, include diarrhea, vomiting, and consequent weight loss. These may be scarcely avoidable, given the need to assume a very large amount of trofinetide per day. Other inherent limitations of use possibly regard the limited duration of drug supplies, as one bottle may last three days only, depending on weight, and the relatively high cost per bottle. Trofinetide has no direct competitors: single symptoms of the Rett Syndrome, for instance, seizures or aggressive behaviors, are currently treated with drugs that have been developed for patients without the Rett Syndrome. This leads to suboptimal efficacy and increased risk of adverse effects. The place in therapy of trofinetide is yet to be determined, based on the results of clinical trials, on its practical usability, and on the windows of opportunity for intervention. Moreover, trofinetide may be curative if given early enough during brain development, or merely symptomatic if given to young adults, and no data exist on this aspect. The place in therapy of trofinetide will require reassessment after competing treatments enter the market.

Differences in Drug Shortages in the US and Canada

Drug shortages are a persistent public health issue that increased during the COVID-19 pandemic. Both the US and Canada follow similar regulatory standards and require reporting of drug-related supply chain issues that may result in shortages. However, it is unknown what proportion are associated with meaningful shortages (defined by a significant decrease in drug supply) and whether differences exist between Canada and the US. To compare how frequently reports of drug-related supply chain issues in the US vs Canada were associated with drug shortages. Longitudinal cross-sectional study conducted from January 2023 to March 2024 using drug-related reports of supply chain issues from 2017 to 2021 that were less than 180 days apart in Canada and the US. Shortages were assessed using data from the IQVIA Multinational Integrated Data Analysis database, comprising 89% of US and 100% of Canadian drug purchases. Country (Canada vs US), timing of report issuance (before vs after the COVID-19 pandemic), and characteristics of the supply chain prior to the reports of drug-related supply chain issues (including World Health Organization essential medicine status, Health Canada tier 3 medicine [moderate risk classification], whether there was sole-source manufacturing of the drug, the formulation, the price per unit, ≥20 years since drug approval, and the number of therapeutic alternatives). A drug shortage (a decrease of ≥33% in monthly purchased standardized drug units) within 12 months, relative to the average units purchased during the 6 months prior to the report of supply chain issues to a US or Canadian reporting system. Among the 104 drug-related reports of supply chain issues in both countries, 49.0% (95% CI, 39.3%-59.7%) were associated with drug shortages in the US vs 34.0% (95% CI, 25.0%-45.0%) in Canada (adjusted hazard ratio [HR], 0.53 [95% CI, 0.36-0.79]). The lower risk of drug shortages in Canada vs the US was consistent before the COVID-19 pandemic (adjusted HR, 0.47 [95% CI, 0.30-0.75]) and after the pandemic (adjusted HR, 0.31 [95% CI, 0.15-0.66]). After combining reports of supply chain issues in both countries, the shortage risk was double for sole-sourced drugs (adjusted HR, 2.58 [95% CI, 1.57-4.24]) and nearly half for Canadian tier 3 medicines (moderate risk) (adjusted HR, 0.56 [95% CI, 0.32-0.98]). Drug-related reports of supply chain issues were 40% less likely to result in meaningful drug shortages in Canada compared with the US. These findings highlight the need for international cooperation between countries to curb the effects of drug shortages and improve resiliency of the supply chain for drugs.

Understanding Drug Supply Shortages in the US and Canada

Understanding Drug Supply Shortages in the US and Canada

Impacts of the COVID-19 pandemic on the availability and retail price of unregulated drugs in Vancouver, Canada: An interrupted time-series analysis, 2018-2022

BackgroundImpacts of the COVID-19 pandemic on unregulated drug markets in North America have not been well characterized. We sought to estimate potential changes in the availability and retail price of unregulated drugs in Vancouver, Canada pre- vs. post-emergence of the COVID-19 pandemic. MethodsWe used self-report data from two prospective cohorts of people who use drugs in Vancouver. We employed interrupted time series analyses to identify changes in the monthly prevalence of immediate availability (i.e., within 10 minutes vs. any longer) and median retail price of crystal methamphetamine, powder cocaine, crack cocaine, and ‘down’ (the local term for unregulated opioids, e.g., heroin, fentanyl, etc), post-pandemic emergence (i.e. post-July 2020). ResultsBetween 2018 and 2022 among 739 participants, the monthly prevalence of immediate availability significantly decreased for all drugs immediately post- emergence of the pandemic (all p<0.05). The monthly prevalence of immediate availability of cocaine declined most (-18.1%, 95% confidence interval [CI]: -25.9, -10.4) and the immediate availability of ‘down’ declined least (-13.0%, 95% CI:-18.8, -7.3). In analyses of median price, the only significant change was in the price of cocaine, which increased by $3.46 per 0.5 grams (95% CI:1.0, 5.9) immediately post-emergence of the pandemic. ConclusionWhile more research is needed to investigate reasons for the observed trends, the stagnant price amidst decreased availability for all drugs examined in this study (save cocaine) may reflect decreased purity/increased contamination of unregulated drugs following the beginning of the pandemic in our study setting. These findings may have implications for drug policy and practice approaches, particularly in regions where synthetic psychoactive substances are increasingly dominating the unregulated drug supply.

State importation programs are unrealistic: diverting prescription drugs to American consumers would rapidly deplete the Canadian drug supply

State importation programs are unrealistic: diverting prescription drugs to American consumers would rapidly deplete the Canadian drug supply

Psychosocial Impact of Suspected Xylazine-Associated Skin Wounds Among People Using Fentanyl, Philadelphia, 2022 to 2023.

The United States opioid crisis has been worsened by the emergence of fentanyl adulterated or associated with the veterinary sedative xylazine. Designated by the White House as an "emerging threat to the US" in 2023, xylazine use is associated with severe skin wounds. This research explored beliefs, concerns, and treatment behaviors for skin wounds among 93 participants recruited outside of a Philadelphia, Pennsylvania harm reduction agency who reported past-6-month history of a skin wound via a cross-sectional survey administered August-September 2022 (group 1; n = 33). Following a December 2022 Philadelphia Department of Public Health Report that indicated xylazine was becoming more prevalent in the Philadelphian drug supply, additional data was collected with new participants from February-March 2023 (group 2; n = 60) using the same survey. Participants were ≥18 years old, reported past-year fentanyl use, and spoke English. Our 17-item tool measured skin wound-related beliefs, concerns, treatment behaviors, and treatment sources. An open-response item explored why participants self-treat skin wounds. Participants averaged 41 years old (SD = 9), slightly more than half were men (n = 54, 58%), 31% (n = 29) were non-White, and most (n = 66, 71%) were unhoused. Overall, 79% of participants self-treated skin wounds. Participants endorsed worry about limb loss (n = 77; 83%), wound shame (n = 76; 82%), and appearance changes (n = 80; 86%). Sixty participants (65%) reported waiting to see wound severity before seeking care. Forty-one participants (44%) delayed wound care because of withdrawal fears. People with probable xylazine-associated skin wounds have psychosocial concerns about and self-treat these wounds. Findings may be a harbinger of skin wound harm in other regions of the United States and internationally where xylazine is increasing.

Blockchain Factors in the Design of Smart-Media for E-Healthcare Management.

According to the current situation of deep aging globally, how to provide low-cost and high-quality medical services has become a problem that the whole society needs to consider. To address these challenges, we propose an e-healthcare management system leveraging the integration of the Internet of Things (IoT) and blockchain technologies. Our system aims to provide comprehensive, reliable, and secure one-stop services for patients. Specifically, we introduce a blockchain-based searchable encryption scheme for decentralized storage and real-time updates of electronic health records (EHRs). This approach ensures secure and efficient data traceability across medical equipment, drug supply chains, patient health monitoring, and medical big data management. By improving information processing capabilities, our system aspires to advance the digital transformation of e-healthcare services.

Switching from interleukin-6 receptor inhibitors to the direct interleukin-6 inhibitor olokizumab in patients with rheumatoid arthritis: efficacy and safety during one year of therapy

Objective: to investigate the efficacy and safety of olokizumab (OKZ) in patients with rheumatoid arthritis (RA) over a 12-month period after switching from interleukin (IL)-6 receptor inhibitors (iIL6R) for non-medical reasons.Material and methods. A retrospective cohort study conducted in 11 centers in the Russian Federation included 110 patients with confirmed diagnosis of RA according to 2010 ACR/EULAR criteria. In all patients in early 2022 (due to problems with drug supply during the coronavirus pandemic) iIL6R were switched for non-medical reasons to OKZ at a dose of 64 mg once every 2 weeks or once every 4 weeks in accordance with the instructions for the medical use of OKZ.Data on clinical efficacy, safety and changes in the dosing regimen of the drugs over an observation period of one year are presented. We assessed the dynamics of the clinical indicators: number of painful and swollen joints, pain on a visual analogue scale and DAS28-ESR/CRP indices. Routine laboratory tests included assessment of red and white blood cells count, ESR, hemoglobin, CRP, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin and cholesterol. Adverse events (AEs) were recorded in accordance with standard practice.Results and discussion. After 6 months of therapy, the proportion of patients who achieved remission/low disease activity according to DAS28-ESR and DAS28-CRP decreased to 70.1% and 72.9%, respectively, and the proportion of patients with moderate and high activity according to DAS28-ESR increased to 26.1% and 3.7%, respectively, and according to DAS28-CRP to 21.5% and 5.6 %, respectively. After 12 months, remission/low disease activity according to DAS28-ESR and DAS28-CRP was achieved in 81.4% and 83.5% of patients, respectively, and 18.6% and 16.5% of patients had moderate activity.In the OKZ monotherapy group, after 6 months of treatment 22 (71.0%) patients were in remission/low disease activity according to DAS28-ESR and 23 (74.2%) patients according to DAS28-CRP. After one year of observation, remission/low disease activity according to DAS28-ESR and DAS28-CRP had 24 (88.9%) and 23 (85.2%) patients, respectively.In the combined therapy group of OKZ + disease-modifying antirheumatic drugs (DMARDs), remission/low disease activity according to DAS28-ESR was observed in 53 (70.7%) patients and according to DAS28-CRP – in 55 (73.3%) patients by the 6th month of therapy. After 12 months, in this group 55 (78.6%) patients showed remission/low disease activity according to DAS28-ESR and according to DAS28-CRP – 58 (82.9 %) patients.After 6 months, 107 (97.3 %) out of 110 patients included in the study continued treatment. In 1 (0.9%) case OKZ was discontinued due to insufficient effect, in 2 cases contact with the patients was lost. After 12 months, therapy was continued in 97 (88.2%) patients. In 5 (4.5%) cases treatment was discontinued due to insufficient efficacy, in 2 (1.8%) cases – due to increased AST/ALT levels, in another 2 (1.8 %) cases – for non-medical reasons, and in 1 case contact with the patient was lost.Conclusion. OKZ, a direct IL-6 inhibitor, provided effective control over RA symptoms after switching from iIL6R, which allowed to achieve the treatment goal of maintaining remission/low disease activity over 1 year in more than 80% of patients. OKZ has demonstrated a broad spectrum of capabilities in real-world clinical practice, even when used as monotherapy. In terms of safety profile, OKZ was comparable to other IL6 inhibitors.