State Formulary Research Articles

The analysis of medical prescriptions for patients with duodenal ulcer in hospital setting

The analysis of medical prescriptions for patients with duodenal ulcer in hospital setting

Regulatory and legal regulation and monitoring of procurement of medicines and medical devices under a state of martial law

The national policy of public procurement in the health sector is based on its strategic importance in meeting urgent needs related to the safety of life and health of people. In the context of limited funding and growing needs of the healthcare system under martial law, it is extremely important to rationally use budget funds for the procurement of medicines with proven effectiveness and economic feasibility on the basis of HTA. The main problem of the medical procurement system is the imperfection of the regulatory framework and the lack of a clear and consistent position on the use of regulatory lists. The purpose of the study is to investigate the peculiarities of legal regulation and to monitor medical procurement under martial law. The research was based on the analysis of the legal framework, scientific and advisory publications, statistical and analytical data. According to the current legislation, medical procurement is carried out in the priority areas defined by the government, taking into account the estimated needs and allocated funding. One of the key problems is the formation and application of regulatory lists based on the results of the state HTA, and the regulation of procurement outside the National List is also relevant. An analysis of the structure and dynamics of centralized procurement for 2021–2023 was carried out. It was found that in terms of the number of ordered/purchased items and procurement amounts, adult oncology and cardiovascular diseases occupy leading positions. To ensure patients' access to high-cost innovative medicines, MEAs are used, and the current list contains 11 medicines that have passed the state HTA. Under martial law, decentralized medical procurement (at the regional level) is carried out using the procedure of requesting the price of proposals through Prozorro Market if the expected cost of procurement is more than UAH 50 thousand. The e-catalog includes 91 names of medical devices and 400 INN of medicinal products included in the National List, but not all of them are included in the State Formulary. Procurement under the price request procedure has proven to be effective by simplifying and shortening procedures, increasing competition and reducing prices. At the same time, the problem of harmonization of regulatory lists requires a systematic solution.

Analysis of the list of medicines for arterial hypertension therapy during pregnancy

Preserving the pregnant women health is one of the most important task in the health care system. In 2020, more than 21,000 cases of hypertensive disorders were diagnosed during pregnancy in Ukraine. Arterial hypertension during pregnancy is the main risk factor for negative consequences for the child and mother. During pregnancy, antihypertensive therapy reduces the risk of morbidity or premature birth, as well as adverse effects to the fetus/newborn.
 The purpose of the study was to analyze the list of registered antihypertensive medicines under the INN, which are presented on the domestic pharmaceutical market, and to analyze their socio-economic availability.
 Research materials and methods. Analysis of antihypertensive medicines in accordance with national recommendations for the arterial hypertension treatment during pregnancy in Ukraine; analysis of the State Register of Medicinal Products of Ukraine, the National List of Essential Medicines, the State Formulary of Medicines (15 issue). Data from the information resource «Tabletki.ua» were used to determine the pharmaceuticals prices. Methods – information search, analysis, generalization, marketing research, «minimization of cost» method, calculation of socio-economic affordability ratios – the liquidity ratio Cliq, the ratio of adequacy solvency Ca.s.
 The results of the analysis of antihypertensive medicines that are registered and have indications during pregnancy showed that the following medicines with INNs are available on the pharmaceutical market: methyldopa, nifedipine, metoprolol tartrate, esmolol, nicardipine, uradipyl, but the following INNs labetalol, hydralazine, acebutolol, mepindolol, oxprenolol are missing. It was established that the list of antihypertensive medicines used during pregnancy is represented by 33 trade names of various medicinal forms from 10 countries of the world, the specific weight of which is 69% of medicines of foreign production. There is an insufficient amount of methyldopa medicines on the domestic pharmaceutical market, as there is only one name of a foreign manufacturer.
 It was determined by the «cost minimization» method that the costs for one month of treatment when using nifedipine of a domestic manufacturer compared to a drug of a foreign manufacturer are lower by 90%. For metoprolol of the domestic manufacturer, the costs are 73% lower than for the imported drug.
 The socio-economic availability of medicines was determined using the price liquidity ratio and the solvency adequacy ratio, which indicated relatively adequate price competition and the high availability of most antihypertensive medicines for the population of Ukraine.

O024 Sodium oxybate for refractory narcolepsy and idiopathic hypersomnia: clinical and employment outcomes

Abstract Background Sodium oxybate (SOX) is an evidenced based treatment for narcolepsy. SOX is not available in Australia through the pharmaceutical benefits scheme. In 2018, Western Australia (WA) listed sodium oxybate on the state formulary for the treatment of refractory narcolepsy. We examine the demographics, clinical and employment outcomes of patients treated with SOX. Methods We undertook a retrospective study of patients treated with sodium oxybate in WA for refractory narcolepsy or idiopathic hypersomnia (IH). A database of SOX patients was cross checked with pharmacy prescribing data from across WA public hospitals. Electronic medical records were used to collect demographic, polysomnographic, prescribing and outcome data. Clinical outcomes were based on the Epworth sleepiness scale, clinical assessment and employment status. Patients that responded to SOX are to be compared to non-responders using appropriate statistical methodology. Progress to date The study has been registered as a hospital clinical audit (number 49852). A total of 50 patients prescribed SOX for the treatment of a central hypersomnia have been identified. A request for sodium oxybate dispensing data across WA has been made. Review of 10 patient’s records has been completed. Correspondence, sleep studies, MSLT, HLA testing and prescriptions are being reviewed for the remaining 40 patients. Intended outcome and impact Describe the characteristics of patients treated with SOX in WA. Explore whether clinical or sleep study characteristics predict response to SOX. Assess patient reported outcomes from treatment with SOX based on symptoms and changes in employment status.

Pharmaceutical providing of the treatment of children with epilepsy in Ukraine and abroad

The aim: to investigate the pharmaceutical providing for the treatment of epilepsy in children in Ukraine and abroad and to conduct a marketing analysis of the domestic market of antiepileptic drugs.
 Materials and methods: domestic and foreign Internet sources, medical and technological documents on a specific research topic, the regulatory and legal base of Ukraine, materials of the State Formulary of Medicines, the State Register of Medicines of Ukraine were the objects of the study. The methods of marketing analysis, graphic, documentary and analytical generalization were used.
 Results: a comparative analysis of clinical protocols (France, Great Britain and Ukraine) for the treatment of epilepsy in children showed that there are only 12 INNs out of 37 INNs in the country. The analysis of the formulary lists of drugs of Great Britain and Ukraine showed that the BNFC has 32 INNs, and the domestic - 10 INNs. As of October 2022, 287 names of antiepileptic drugs are registered in Ukraine, and 164 of them are allowed in children's practice. The main producers of antiepileptic drugs are India and Ukraine. Children's drugs forms are mainly represented by tablets and capsules - more than 90%. A comparison of the lists of drugs for the treatment of epilepsy from the National List of Essential Medicines of Ukraine, BNFC, WHO Model List of Essential Medicines and WHO Model List of Essential Medicines for Children showed that out of 37 INNs, only 11 INNs are listed in all documents.
 Conclusions: the results prove the need of improvement of pharmaceutical providing of epilepsy treatment in Ukraine. The nomenclature and variety of dosage forms for children's practice need to be expanded. In order to increase the economic availability of epilepsy treatment, it is advisable to update the National List of the main drugs of Ukraine and include new drugs in it, which will make it possible to purchase them at the expense of the State Budget of Ukraine

Analysis of pharmaceutical supply of breast cancer patients

The aim: to conduct a clinical and economic analysis of the state of pharmaceutical support for patients with breast cancer in women. Materials and methods. During the research, data from the National List of Essential Medicines, the 14th State Formulary of Medicines, the Ukrainian clinical protocol, the clinical protocols of Great Britain and the United States of America for the treatment of breast cancer, and a depersonalized database of drug prescriptions were used. The research used such methods as clinical-economic, organizational-economic, mathematical-statistical, graphic, grouping and generalization. Research results. It was established that 46 schemes of schemes for the treatment of breast cancer are presented in Ukrainian and international clinical protocols (Great Britain, USA). In all three protocols, there were 5 regimens for the treatment of breast cancer, such as CMF (Cyclophosphamide, Methotrexat, Fluorouracil), AC (Doxorubicin, Cyclophosphamide), DC (Docetaxel, Cyclophosphamide), TC (Trastuzumab, Capecitabin), EC (Epirubicin, Cyclophosphamide). Analysis of the pharmaceutical component in the protocols for individual drugs showed that they included 23 drugs according to the INN, which belong to the group of antineoplastic drugs. The Ukrainian clinical protocol includes 17 drugs, the British protocol – 14 drugs, and the American one – 15 drugs. The frequency analysis of antineoplastic drugs included in the Ukrainian clinical protocol revealed the TOP-3 in terms of drug prescription frequency: L01A A01 Cyclophosphamide (Ki=0.037), L01C D02 Docetaxel (Ki=0.029), L01D B01 Doxorubicin (Ki=0.026). The largest number of prescribed drugs are vital drugs – 61.96 %, the smallest share – essential drugs – 2.17 %, and the share of non-essential drugs is 35.87 %. The ABC analysis made it possible to determine the group of the most expensive drugs in the treatment of breast cancer - these are antineoplastic and immunomodulating agents. The total expenses for this group amounted to UAH 772,459.96, which according to the US dollar exchange rate of the National Bank of Ukraine at the end of August 2022 was USD 21,122.77. According to the analysis of the matrix of the integrated ABC-VEN-frequency analysis, it was established that the largest number of prescriptions belonged to the group of less expensive and vital drugs (B/V) – 7 drugs (48.73 % of the total amount. At the same time, the largest amount of expenses is observed in for the A/V group – UAH 772,459.96 (52.83 % of all costs directed to the pharmaceutical support of patients). The results of the structural analysis of the group of the most expensive drugs showed that the highest costs were characteristic of L01CD02 Docetaxel (UAH 1166,531.31; 39.81 % of the total cost in the group), and the lowest – for L01DB01 Doxorubicin – UAH 63,694.14 (5.46 %, respectively). Conclusions. According to the results of the conducted research, it was established that the largest costs fall on the group of essential drugs (1047735.07 UAH, 71.65 % of all costs). This determines the need for further pharmacoeconomic calculations of breast cancer treatment to optimize the costs of antineoplastic drugs

Pronounced State-Level Disparities in Prescription of Cannabinoids to Medicaid Patients

Introduction: Dronabinol is approved in the USA for chemotherapy-induced nausea as well as vomiting and HIV-induced anorexia, while cannabidiol is primarily approved for childhood epileptic disorders Lennox-Gastaut and Dravet syndrome. The use pattern for these prescription cannabinoids in the USA is unknown. This study examined Medicaid claims for two FDA-approved prescription cannabinoids, dronabinol and cannabidiol, approved in 1985 and 2018, respectively, from 2016–2020 to better understand the pharmacoepidemiologic trends and distribution of these drugs in US Medicaid amidst the increasing use of non-pharmaceutical formulations of cannabis. Methods: The longitudinal study analyzed Medicaid prescription claims that were calculated by extracting the prescriptions on a state level from 2016 to 2020 for two cannabinoids, dronabinol and cannabidiol, where outcomes over each year were calculated. Outcomes were (1) the number of prescriptions for each state corrected for the number of Medicaid enrollees and (2) dronabinol and cannabidiol spending. Spending refers to the amount reimbursed by the state Medicaid program. Results: Dronabinol prescriptions per state decreased by 25.3% from 2016 to 2020, while cannabidiol prescriptions increased by 16,272.99% from 2018 to 2020. The spending on these drugs parallels that of their prescription trend with a 66.3% decrease in reimbursement for dronabinol ($5.7 million in 2020), whereas cannabidiol increased by +26,582.0% ($233.3 million in 2020). Dronabinol prescriptions, when corrected for the number of enrollees, in Connecticut were 136.4 times larger than in New Mexico, and seventeen states had zero prescriptions. Idaho’s prescriptions of cannabidiol (27.8/10,000 enrollees) were significantly elevated relative to the national average and were 15.4-fold higher than Washington, DC (1.8/10K enrollees). Conclusions: The prescriptions of pharmaceutical-grade tetrahydrocannabinol decreased while those of cannabidiol increased. This study also identified pronounced state-level variation in cannabinoid prescribing to Medicaid patients. State formularies and prescription drug list variation may contribute to the drug reimbursements in Medicaid, though further research is needed to identify the health policy or pharmacoeconomic origins of these disparities.

Drugs for the treatment of ulcerative colitis on the pharmaceutical market of Ukraine

The prevalence of diseases of the digestive organs at the current stage of human development is extremely high, and their universally increasing incidence rate is estimated as an epidemic. In Ukraine, mortality from diseases of the digestive organs ranks fourth in the population mortality structure (after diseases of the circulatory system, neoplasms, and accidents). Among all diseases of digestive organs in the modern world, inflammatory bowel diseases are one of the most serious and unsolved problems in modern gastroenterology and coloproctology. In terms of morbidity, non-specific ulcerative colitis (UC) and Crohn's disease (CD) are inferior to other gastroenterological diseases, although in terms of the severity of the course, the frequency of complications and mortality, they occupy one of the leading places in the structure of diseases of the gastrointestinal tract. Therefore, the goal of our work was the marketing analysis of drugs for the treatment of non-specific ulcerative colitis containing mesalazine as an active component. Obtaining data on the demand on the pharmaceutical market for medicinal products with mesalazine, determining trends in the use of dosage forms with this substance will allow predicting approaches to the development of a domestic effective medicinal product containing mesalazine. The objects of the study were medicinal products of local and systemic action, containing mesalazine in their composition. To achieve the goal, generally accepted research methods were used, which contributed to the objective assessment of the analysis of the pharmaceutical market.
 The analysis of the assortment of medicines with mesalazine presented on the domestic pharmaceutical market was carried out according to the data of the classification system of the ATС, the State Formulary of Medicines, the State Register of Medicines of Ukraine. The presence on the pharmaceutical market of Ukraine of drugs of the group A07E Intestinal antiinflammatory agents indicates that the leader in terms of assortment offers is drugs with mesalazine (5-ASA). As of February 2023, Ukraine has registration certificates for 19 medicinal products of five brands with the active ingredient mesalazine. According to the received data, no medicinal product of domestic production containing mesalazine has been registered on the pharmaceutical market of Ukraine. Several types of dosage forms with mesalazine are available on the pharmaceutical market of Ukraine (coated tablets, long-acting granules, suppositories, and rectal suspension). It should be noted the absence of combined medicines with mesalazine. Also, there is no such medicinal form as enteric-dissolving hard gelatin capsules on the pharmaceutical market of Ukraine.
 Taking into account the obtained data, approaches to the introduction into production of a domestic medicinal product for the treatment of non-specific ulcerative colitis containing mesalazine and medicinal plant raw materials are in demand for pharmaceutical development.

Marketing analysis of the use of drugs containing retinoids in the treatment of acne

Acne is a common skin disease, which is accompanied by a significant skin and psychological burden. Today in Ukraine, significant attention is paid to the issue of acne treatment – scientists from leading scientific, medical (pharmaceutical) and cosmetic institutions are engaged in the search for the most optimal means for the acne treatment. Retinoids are a group of substances that deserves thorough study in terms of production and sustainable introduction of drugs to the pharmaceutical market of Ukraine.
 Therefore, the goal of our work was the marketing analysis of drugs for the treatment of acne with the content of retinoids as active substances.
 Determining the main trends of foreign manufacturers in the use of retinoids in medicinal products for the acne treatment will allow to predict approaches to the development of domestic effective medicine containing retinoids. During the analysis, methods of logical and meaningful formulation of the problem, office marketing research, content analysis of publications in scientific and practically oriented medical and pharmaceutical publications, comparative analysis, tabular and graphic means of visual presentation of the obtained data were used.
 The analysis of the range of drugs containing retinoids, presented on the domestic pharmaceutical market, was carried out according to the data of the State Register of Medicinal Products of Ukraine, the classification system of the ATC, and the State Formulary of Medicinal Products.
 According to the results of the work, it was determined that 13 trade names of medicinal products containing retinoids for the acne treatment are registered on the pharmaceutical market of Ukraine. It was determined that there are no registered medicinal products for the acne treatment containing retinoids of domestic production. In Ukraine medicines containing retinoids are represented by six countries. Among the dosage forms used for the acne treatment, solid dosage forms (hard and soft capsules) and soft dosage forms (gels, creams, lotions) should be distinguished. Today, the pharmaceutical market of Ukraine presents drugs of the I, III and IV generation of retinoids. Most of the drugs for the acne treatment containing retinoids registered in Ukraine are monocomponent. The lack of combinations of retinoids with active components widely used for the acne treatment is related to the technological aspects of the production of drugs with retinoids. The volume of sales of drugs with retinoids for the treatment of acne has been increasing in recent years, despite the high cost of products, which indicates the demand for the development of these drugs of domestic production. The obtained data will make it possible to develop approaches to the introduction into the production of domestic drugs for the treatment of acne containing retinoids.

Infusion reaction incidence after switching all patients to an infliximab biosimilar in an Australian hospital

AbstractTo date, two infliximab biosimilar brands have been approved for use in Australia. In 2020, Queensland Health encouraged biosimilar use by removing the infliximab originator from their state formulary and left only one infliximab biosimilar (Renflexis®; Samsung Bioepis, Sydney, NSW, Australia). The aim was to conduct a quality assurance study examining the incidence of infusion reactions after switching all patients to the one approved biosimilar brand of infliximab. This was a retrospective study of medical charts of all patients who received an infliximab dose at a tertiary hospital between 10 June to 30 September 2020. The number of infusion reactions to the first dose of Renflexis® (Samsung Bioepis) was compared to the two doses immediately prior to the switch with an alternative brand. The study received ethics exemption (2020100904CM). A total of 370 doses of infliximab were dispensed to 139 patients, of which 320 doses (86.5%) were Renflexis® (Samsung Bioepis). There were three patients excluded from the study. A total of 119 patients (88%) were switched to the Renflexis® (Samsung Bioepis) brand and two of these patients (1.7%) experienced a true infusion reaction. When compared to doses prior to the switch, three of 116 patients (2.6%) with data available experienced an infusion reaction for the dose immediately prior, and one of 113 patients (0.9%) for two doses prior. No treatment‐naïve patients (n = 17) initiated on Renflexis® (Samsung Bioepis) experienced an infusion reaction. The use of a biosimilar infliximab, in both treatment‐naïve patients and those and switching from alternative brands, does not appear to have an increased incidence of infusion reactions.

Analysis of the assortment of antibiotics in the State Medicines Formulary according to the WHO AWaRe classification with the purpose of their rational use and reducing the risk of antimicrobial resistance

Rational use of antimicrobials have been recognized as one of the strategies to fight AMR. In 2017 WHO proposed the classification of antibioticsAWaRe, dividing them into groups Access, Watch, Reserve, which takes into account the potential of AMR and emphasizes the importance of rational antibiotic therapy. In Ukraine, the State Formulary of Medicines (State Formulary of Ukraine) is the manual on the rational use of medicines.
 The aim of the work was to analyse the assortment of systemic antibiotics (J01) of the State Formulary of Ukraine, their compliance with the classification of antibiotics AWaRe according to the WHO database, which will contribute to rational antibiotic therapy.
 The objects of the study were antibiotics (J01), of the 13th version of the State Formulary of Ukraine, data on the belonging of antibiotics to the group Access, Observations, Reserve on WHO AWaRe antibiotic classification database.The following research methods were used in the work: system-review, analytical, method of comparison and generalization.
 According to the analysis, the group Access includes 23 INN antibiotics (J01) of the State Formulary of Ukraine. For 16 INNs of these antibioticsWHO provides recommendations for rational antibiotic therapy as the first choice for 31 infectious diseases and the second choice for 13 infectious diseases. The Observations group includes 31 INN antibiotics (J01) of the State Formulary of Ukraine. For 18 INNs of these antibiotics WHO provides recommendations for rational antibiotic therapy as the first choice for 21 infectious diseases and the second choice for 17 infectious diseases. The Reserve group includes 3 INN antibiotics (J01) of the State Formulary of Ukraine.
 The State Formulary of Ukraine includes 64 INN antibiotics of systemic action (J01), 23 INNs according to the WHO AWaRe antibiotic classification are assigned to the group Access, 31 ‒ Observations and 3 ‒ Reserve group. The analysis provides WHO recommendations for rational antibiotic therapy for the treatment of common infectious diseases, taking into account the degree of counteraction to the development of AMR. The results of the work can be used in the development of guidelines for the rational choice of antibiotics for the treatment of infectious diseases.

The assessment of the rationality of the pharmacotherapy of acute respiratory viral infection in the outpatient practice

Acute respiratory viral infections (ARI) and influenza occupy a leading place in the structure of the overall morbidity of the population in most countries.
 Aim. To assess the rational prescription of drugs for etiotropic therapy of ARI in the outpatient practice.
 Materials and methods. The following materials for research were used: case histories; treatment sheets; the Unified clinical protocol of primary care for adults and children “Acute respiratory infections”; data of the State Formulary of Medicines as of January 2021; the Register of wholesale prices; the weekly “Apteka” (Pharmacy). The methods of retrospective, descriptive, frequency, and VEN-analysis were applied.
 Results. According to the research results, using patient histories, it was found that family doctors prescribed 67 drugs by trade names. For etiotropic therapy, 24 drugs were used; it was 37 % of the total number, and 63 % – for symptomatic therapy. Such drugs as Amizon, Aflubin, Amixin, Resistol, Umkalor were for etiotropic therapy (more than 5 prescriptions). None of these drugs is included in the State Formulary of Medicines and the Unified clinical protocol for the treatment of influenza and SARS. Thus, these drugs are without the proven efficiency, safety and cost-effective use.
 Conclusions. The study conducted has shown that the drugs prescribed most often do not have an evidence base of efficacy and safety; none of the most frequently prescribed drugs is included in the State Formulary of Medicines and the Unified clinical protocol. A direct relationship between an increase in the number of prescriptions and an increase in price has been proven.
 Key words: acute respiratory viral infections; influenza; frequency analysis; VEN-analysis; family doctor.

Effect of a state hospital formulary on medicines utilisation in Australia.

Objective The provision of medicines through state public hospitals is comparatively restrictive compared with the federally funded Pharmaceutical Benefits Scheme (PBS). Individual states are progressively moving towards statewide medicines formularies. Although a statewide formulary has existed in Queensland for some time. The effects of hospital formularies on medicines utilisation and policy in Australia has not been quantified. Thus, the aim of the present study was to quantify the effects of the Queensland Health List of Approved Medicines (LAM) on medicines utilisation in Queensland at a state and PBS-purchasing level and describe the implications for medicines policy. Methods This study used a quasi-experimental design with an interrupted time series (with control for PBS) examining utilisation effects of medicines within the therapeutic classes of proton pump inhibitors and non-vitamin K oral anticoagulants with LAM listing or delisting. Results The LAM was demonstrated to be highly effective at controlling utilisation within Queensland Health purchasing. Effects on PBS utilisation were evident, resulting in increases in generic utilisation (where available) and associated reduced total costs both within Queensland Health and to the PBS. The full benefit is likely underestimated due to limitations in the PBS datasets. Conclusion The LAM is a highly effective state medicines policy tool with demonstrable effects on PBS utilisation. With increased use of statewide medicines formularies, this will be an increasingly relevant aspect of Australia's overall medicines policy. What is known about the topic? State medicines policy is comparatively restrictive compared with the federal PBS. Most Australian states have, or are developing, statewide medicines formularies. What does this paper add? By examining several classes of medicines, a substantial quantitative effect of the Queensland state formulary on both state and PBS medicines utilisation can be demonstrated. Increased use of generic medicines and reduced costs are seen. What are the implications for practitioners? With increased use of state medicines formularies, state medicines formularies will become increasingly relevant to medicines policy makers and advocates at both the state and federal level.

The quality assessment of the pharmacotherapy of patients with tuberculosis / HIV / AIDS co-infection according to the results of ABC / VEN / frequency analysis (research fragment)

TB / HIV / AIDS co-infection is a long-term infectious disease of major medical and social importance associated with widespread, progressive damage to the immune system, risk of opportunistic infections, reduced quality of life for patients, high overall cost of treatment.Aim. To determine the quality of pharmacotherapy of patients with TB / HIV / AIDS co-infection treated at a health institution (HI) in Mykolayiv according to the results of ABC / VEN / frequency analysis in order to assess the drug therapy compliance with the current standards and optimize costs for the pharmacotherapy of patients.Materials and methods. The quality of the pharmacotherapy of patients was assessed using ABC, frequency and “formal” VEN-analyzes.Results. Using the “formal” VEN analysis it was determined that most of the drugs prescribed were classified as vital since they were present in both medical and technological documents: State Formulary of Ukraine (SFU) of the 8th and 9th editions (75-83.3 % of drugs) and the current clinical protocol “Tuberculosis/HIV/AIDS” (88.9 % of drugs). According to the results of frequency analysis, leaders by prescription correspond to the main directions of treatment of patients with TB/HIV/AIDS co-infection. According to the results of ABC analysis, correction of the pharmacotherapy of patients is needed: the replacement of the high-cost original drug Atripla, which cost was 45.1 % of all funds for the treatment of patients, with its cheap generic analog to save public funds for the pharmacotherapy of patients.Conclusions. The basic directions of the pharmacotherapy of patients with TB/HIV/AIDS co-infection in the HI of Mykolayiv correspond to the current clinical protocol for providing medical care to patients at the time of the study. The most prescriptions consist of drugs recommended by the clinical protocol and are available in the SPhU. In general, the pharmacotherapy of patients with TB / HIV / AIDS co-infection in the HI of Mykolayiv can be considered as rational from the clinical point of view. However, it has been also found that few patients (23 %) with co-morbidities received the appropriate treatment.

PHARMACOECONOMIC ANALYSIS OF MACROLIDES AND AZALIDE ANTIBIOTICS

The purpose of the work is to investigate the range of macrolides and azalide antibioticspresented on the domestic pharmaceutical market, their presence in normative documentsregulating the circulation of medicines in Ukraine and in the world. Determine thedistribution of drugs depending upon their use (vital or minor importance) and expensesfor treatment (low-, medium-, or expensive).Material and methods. According to the method of formal VEN analysis, a comparativeevaluation of preparations of macrolides antibiotics was carried out on the basis of theirpresence (vital) or absence (non-essential) in the State Formulary of Medicines of Ukraine, the National List of Essential Medicines, the renovated list of the basic medicinesof WHO and the British National Formulary. Preparations of macrolide and azalideantibiotics, recommended by the Unified Clinical Protocol for the medical care of thepatients with non-community pneumonia, have been identified. The assortment of macrolides and azalide preparations of different manufacturers, presented on the pharmaceutical market of Ukraine and their cost, have been analyzed.Results. The nomenclature of macrolides, presented in the domestic pharmaceutical market, includes 117 drugs, most of them are of foreign production - 75 preparations (64%).According to the results of the formal VEN analysis, it has been established that allmacrolides and azalid antibiotics (eryhromycin, spiramycin, midecamycin, roxithromycin,jozzamycin, clarithromycin, azithromycin), registered in Ukraine, were included to theState Formulary of Medicines of Ukraine. Only 3 drugs: erythromycin, azithromycin andclarithromycin are available in the National Service List of vital remidies. The renovatedWHO list of essential medicines contains 2 drugs: azithromycin and clarithromycin. Fourdrugs are included to the British National Formulary: erythromycin, azithromycin,claricide and telithromycin. Among them, only telithromycin is not registered in Ukraine.The Unified Clinical Protocol of the medical attendance to the patients with non-hospitalpneumonia provides 5 international non-proprietary medicines of macrolides and azolideantibiotics: erythromycin, clarithromycin, spiramycin, jazzamycin and azithromycin. Thegroup of low value preparations consists of: erythromycin, azithromycin, clarithromycinof the domestic manufacturers as well as aziklar (India), azitro Sandoz (Switzerland) andazithromycin Grindex (Portugal); clarithromycin (Darnytsia), clarithromycin Grindex(Portugal), azithroks (Czechia), azithromax and clarimax (Canada), clasid® (Italy),hemomycin (Serbia); macropen® and fromilid uno® (Slovenia) are of the middle value.Original preparations such as vilprafen® (Germany), rovamycin® (Italy), sumamed®,sumamed-forte® (Croatia) and fromilid® (Slovenia) are expensive. The most expensivedrugs are the original preparations in the form of tablets, which disperse - Sumamed®tablets dispersible (Croatia) and tablets-solutab - vilprofen-solutab® (France).Conclusions. The domestic pharmaceutical market has a significant assortment ofmacrolide and azalide trade names in different price categories, which allows to optimizethe choice of the preparation taking into account the spectrum of antimicrobial activity,sensitivity of the pathogenic microflora to it and financial competence of the patient. Erythromycin, azithromycin and clarithromycin are referred to the category of vital drugs.The presence of all macrolides, presented in the pharmacy network, in the State Formularyof Medicines of Ukraine confirms their therapeutic efficacy and expediency of includingthem to antibiotic therapy schemes of infectious diseases in adults and children.

A comprehensive analysis of prescribing drugs for the treatment of cardiovascular diseases in a clinical setting

Aim. To assess comprehensively the actual use of drugs for the treatment of the cardiovascular system, which cost is subject to the state reimbursement in a clinical setting.Materials and methods. The list of medicines for the treatment of cardiovascular diseases, 100 medication administration records in a clinical setting, the National List of Essential Medicines, the Register of Medicines, which cost is subject to reimbursement, the State Formulary of Medicines were used in the study. The research methods were as follows: epidemiological, retrospective, statistical, expert assessments, as well as frequency, ABC-, VEN-analysis. A retrospective analysis was used for the analysis of case histories and outpatient cards. Using VEN-, ABC- and frequency analysis the distribution of drugs by certain categories and the degree of compliance of the actual clinical practice with the State Formulary of Ukraine and the Register of Medicines were determined; the drugs, which doctors preferred in the pharmacotherapy of cardiovascular diseases, were also analyzed. The epidemiological method was intended to assess the state of cardiovascular morbidity in Ukraine. The statistical analysis was used to process the results of the study.Results and discussion. According to the questionnaire on the gender distribution of patients the percentage of women exceeded the percentage of men (females – 56 %, males – 44 %); the average age was 32 years old. The total cost of therapy was 34796.59 UAH, the average course of treatment was 9.5 days. The average cost of treatment for the average course was 347.96 UAH. It was found that the National List included only 15 % of the drugs prescribed. 71 % of the prescriptions corresponded to the category V – vital and essential medicines, 29 % belonged to the category N – non-essential medicines. According to the results of the ABC analysis, 17 drugs were included in the category A, 16 were in the category B, others in the category C.Conclusions. The results obtained indicate maldistribution of funds in purchasing medicines for the treatment of cardiovascular diseases. A significant part of the drugs prescribed in the healthcare institution belongs to the high-cost ones. At the same time, there are no data on their proven effectiveness in the corresponding pathology of the cardiovascular system, and therefore, the feasibility of their prescription has not been substantiated.

Butler pharmacists help guide state's formulary reviews.

Butler pharmacists help guide state’s formulary reviews Kate Traynor Kate Traynor Search for other works by this author on: Oxford Academic Google Scholar American Journal of Health-System Pharmacy, Volume 76, Issue 17, 1 September 2019, Pages 1262–1264, https://doi.org/10.1093/ajhp/zxz141 Published: 19 July 2019

The frequency and VEN-analysis of pharmacotherapy in children with ARVI in the healthcare institution of the Poltava region

Acute respiratory viral infections (ARVI) are diseases that have important medico-social importance since they are associated with a wide distribution among the population, the risk of complications, reduced quality of life of patients, and high total cost of treatment. Aim. To assess the quality of pharmacotherapy: the frequency of prescribing drugs for children with ARVI in the health­care institution of the Poltava region and the correspondence of drug prescriptions to clinical protocols for providing medical care and the State Formulary of Medicines of Ukraine (SFMU). Materials and methods. The quality assessment of pharmacotherapy of children with ARVI was performed using auxiliary clinical and economic methods – the frequency and formal VEN-analyses. Results. The main directions of pharmacotherapy of children with ARVI in one of the healthcare institution of the Pol­tava region correspond to the unified clinical protocol of the primary care for adults and children with ARVI and clinical protocols for pharmacotherapy of concomitant diseases. Using the formal VEN-analysis it has been determined that the majority of INN drugs prescribed are recommended by clinical protocols for pharmacotherapy of the main (ARVI) and associated diseases registered in patients, and are available in the SFMU (87.50 and 54.69 %, respectively). Conclusions. The formal VEN analysis has shown that the ARVI pharmacotherapy correction is needed in the health­care institution of the Poltava region studied since a significant part of the INN drugs prescribed is absent in the SFMU (45.31 %) and in clinical protocols for the primary pharmacotherapy (ARVI) and associated diseases (17.19 %). In both medical and technological documents there are no 12.50 % of INNs prescribed. For them 11.74 % of funds (4808.81 UAH) were spent by parents of sick children; they were prescribed 8.74 % times (38 prescriptions) of the total number of prescriptions – 431.

Clinical and economic analysis of pharmacotherapy of patients with chronic pancreatitis in the Druzhkovka healthcare institution

Aim. To determine the pharmacotherapy compliance of patients with chronic pancreatitis (CP) to medical and technological documents using clinical and economic analysis.Materials and methods. 94 case histories of patients with CP from the age of 25 to 65 who were treated at the therapeutic department of one of the Druzhkovka healthcare institutions (HCI) were analyzed. The research period was within 2015-2017. The clinical and economic analysis of pharmacotherapy of these patients was performed using ABC, VEN and frequency analyses.Results and discussion. It was determined that the majority of prescribed medicines were recommended by clinical protocols for use in the pharmacotherapy of the main CP and concomitant diseases diagnosed in the patients studied. These medicines are present in the State Formulary of Ukraine (SFU) (80.25 % and 91.36 %, respectively). The medicines that were present in the above documents were prescribed in most cases of all medical indications (67.50 % and 94.72 %, respectively). Most of the costs related to pharmacotherapy of patients with CP were spent on these medicines (60.00 % and 87.17 %, respectively).Conclusions and prospects of further research. Comparison of the results of ABC-, VEN- and frequency analyses showed that the main directions of pharmacotherapy of patients with CP in the therapeutic department of one of the Druzhkovka HCI corresponded to the clinical protocols of medical care for patients with CP and concomitant diseases at the time of the study, and the choice of trademarks of medicines was carried out, preferably, in accordance with the SFU. However, a significant number of medical prescriptions and a considerable part of the costs were related to the secondary drugs, which were absent in clinical protocols (32.50 % of prescriptions and 40.00 % of costs, respectively). Therefore, in general, the real pharmacotherapy of patients with CP in the therapeutic department of one of the Druzhkovka HCI is not rational from the clinical and economical point of view and needs further correction in accordance with the given medicotechnological documents. Optimization of pharmacotherapy of patients with CP in this department and money for its implementation are possible due to the exclusion of Solcoseril, a drug affecting the digestive system and metabolic processes, which is expensive and absent in clinical protocols and the SFU, from the treatment regimens. It was prescribed in 0.83% of all cases, and 5.70% of the total cost of medicines was spent on it.

Analysis of the pharmaceutical supply system for assisted reproductive technologies in Ukraine and the world

Aim. To analyze the domestic pharmaceutical market of hormonal drugs for assisted reproductive technologies in accordance with the treatment protocols and with the comparison with the State Formulary of Medicines of Ukraine and the British National Formulary. Materials and methods . The study was conducted on the basis of data from the clinical protocols on Assisted Reproductive Technologies (ART), the State Register of Medicinal Products of Ukraine, electronic databases, the Weekly Pharmacy on June 30, 2018, the State Formulary of Ukraine and the British National Formulary. The system, marketing, analytical and comparative analysis methods were used in the research. Results. The system legal support of assisted reproductive technologies in Ukraine has been estab lished in accordance with the European conventions. It has been determined that the list of medicines for ART includes 14 trade names. The marketing analysis has shown that among 45 trade names registered there are single-source ones, such drugs as Puregon®, Pergoveris®, Ovitrel®, Klostilbegit®, Orlutran®, Tsetrotid®; therefore, the pharmaceutical development of these drugs is promising. Among the study list of INNs in the State Formulary of medicines of Ukraine there are no medicines, such as Choriogonadotropin alfa (Ovitrelle®), Corifollitropin alfa (Elonva®), fixed combination of Follitropin alfa / Lutropin alpha (Pergoveris 150/75®) with evidence based effectiveness; therefore, it is advisable to expand the list of hormonal drugs in the State Formulary of Ukraine. At the expense of budget funds in Ukraine it is financed in the range of 2.4-32.6 % of the need for reproductive health programs. It is necessary to increase funding to provide the need in hormonal drugs for ART. Conclusions. The results of marketing research can be used for reviewing the State Formulary of Ukraine, for practical measures on the effective implementation of public procurement to increase the availability of ART in Ukraine.