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Vol 69, No 4 (2020)
- Year: 2020
- Articles: 7
- URL: https://journals.eco-vector.com/0367-3014/issue/view/5775
Articles
To the question of creating conditions for determining the sterility of drugs in the microbiological laboratory
Abstract
Correspondence of the quality of drugs in terms of «Sterility» guarantees the safety of the use of drugs for injection and infusion, eye drops and films, pharmaceutical substances and excipients, including biological drugs and their solvents, which must be sterile in accordance with regulatory documents and pharmacopeia articles. In the article, the authors consider the necessary conditions for the organization and conduct of the sterility test of drugs. The creation, operation and maintenance of the described conditions is in the area of responsibility of production, control and expert microbiological laboratories. Among the necessary conditions, the following are highlighted: a special aseptic room with a certain confirmed purity class; microbiological monitoring; proven sterility of all consumables, solutions and culture media used; test methods used with proven applicability. Actively discusses the issue that arises when a contaminated sample is detected. The revealed fact requires an investigation of the causes of the situation and a possible further recognition of the drug as poor in terms of «Sterility». The materials are included in the draft General Pharmacopoeia Monograph «Conditions for determining the sterility of drugs», which is currently under consideration and approval in the prescribed manner for further inclusion in the State Pharmacopoeia of the Russian Federation.
Farmaciya (Pharmacy). 2020;69(4):5-10
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Pharmacoeconomic studies of novel antibacterial drugs active against multidrug resistant pathogens
Abstract
The ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacterbaumannii, Pseudomonas aeruginosa, and some Enterobacter species) are a group of the most dangerous multiple antibacterial resistant infectious agents. The choice of effective antibiotic therapy becomes a difficult task for limited state budgets, whereas the discovery of new molecules that can act on resistant pathogens is extremely difficult and requires a lot of resources and time. Therefore, the role of pharmacoeconomic analysis in the rational use of antibacterial drugs is growing significantly in our time. The results of pharmacoeconomic studies of innovative antibacterial drugs are an important tool for determining the feasibility of introducing these drugs into routine clinical practice. The analysis of relevant publications has revealed that the experience of pharmacoeconomic studies of using antibacterial drugs is limited and unreasonably rarely used for economic evaluation of the feasibility for administering novel antibacterial drugs. This study makes it possible to evaluate the experience with pharmacoeconomically analyzing the novel antibacterial drugs that are active against multidrug-resistant pathogens and to identify opportunities for further pharmacoeconomic studies of novel antibacterial drugs.
Farmaciya (Pharmacy). 2020;69(4):10-17
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DIGITAL channels in the pharmaceutical promotion system in the Russian pharmaceutical market
Abstract
Introduction. The Internet takes leading positions in the ranking of information sources for physicians and pharmacy workers. This «dependence» of medical and pharmaceutical workers on the Internet creates new marketing opportunities for pharmaceutical companies. Digital marketing, a relatively new area, emerges in the pharmaceutical industry. Digital marketing is a powerful tool in informing medical and pharmaceutical workers about drugs, but it can also play a negative role when used for misinformation and misleading. Objective: to analyze the composition and contents of digital channels used to promote drugs in the Russian pharmaceutical market. Material and methods. The authors analyzed scientific publications and regulatory acts on the circulation of medicines, 13 specialized professional on-line resources, 50 websites of pharmaceutical manufacturers, 30 profiled specialized groups in the social networks, and 30 brand platforms. They used methods, such as content analysis, generalization, and systematization. Results. The authors compiled a list of 13 digital channels and described the features of using a certain category of digital promotion channels depending on the target audience and the degree of dispensing regulation. It was found that there were no clear and understandable mechanisms for verifying the information obtained through digital channels. This can contribute to irrational prescription and recommendation of drugs and increase treatment costs for patients or cause undesirable adverse reactions. Conclusion. During digital promotion, there is a risk of misinformation for ultimate drug users.
Farmaciya (Pharmacy). 2020;69(4):18-25
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Uncertainty analysis and risk assessment of the creation of a joint Russian-Nicaraguan biotechnology enterprise
Abstract
The authors have analyzed the current programs and projects of the World Health Organization and found that special attention is paid to immunization, vaccines, and biotechnological preparations. To date, global manufacturers of immunobiological preparations face a number of problems in continuing to design, manufacture, and supply innovative and high-quality vaccines that meet the needs of countries, as well as in creating new production capacities in the countries and regions where this potential was previously absent. Today, the Russian Federation has been established to be an active participant in the assistance and development of the resources of a number of countries in the field of immunobiotechnology. The project to create a joint Russian-Nicaraguan biotechnology enterprise will be able to introduce Russian immunobiological preparations and technologies for their production on the markets of Central and Latin America. The authors provide a rationale for selecting key parameters to assess project risks. A risk situations classification has been developed; approaches and measures to minimize risks have been substantiated.
Farmaciya (Pharmacy). 2020;69(4):26-31
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Marketing analysis of the market of drugs used to treat uroandrological diseases in the Kyrgyz Republic
Abstract
Introduction. According to the latest data, in the Kyrgyz Republic, there is currently a high prevalence of male genital tract disease and a progressive increase in the number of its cases. At the same time, the availability of drugs recommended for the treatment of urological diseases in accordance with recognized international clinical guidelines and the extent of the provision of the population with the drugs have not been studied to date. Objective: to carry out a marketing analysis and to study the provision of the Kyrgyz Republic's population with the medicines proven to be efficient and safe for treating uroandrological diseases. Material and methods. The authors carried out a marketing analysis of data on the registration and import of pharmacotherapeutic agents using INN (international nonproprietary names) of drugs and group names, as well as the ATC (anatomical and therapeutic chemical) classification of the medicines GO4:GO4B Urological drugs and GO4C Prostatic drugs. They also performed an ABC/VEN analysis of uroandrological drugs purchased by healthcare facilities in the Kyrgyz Republic, by using the statistics from the National Urology Center, Ministry of Health of the Kyrgyz Republic. Results. The findings suggest that despite the large number of available drugs (51 molecules) recommended by the WHO for the prevention and treatment of diseases; in the Kyrgyz Republic there are 8 practically available molecules, while 12 are officially registered; 48 names of drugs are the extracts of medicinal plants and the prostate, questionably effective and safe drugs that are not recommended by EAU (2018). Moreover, andrological medicines are prescription (57.4%) and oral (87%) ones. The drugs are mainly delivered by manufacturers of Germany, India, and Russia. Conclusion. Based on the foregoing, it is necessary to conclude that despite the available large number of drugs (51 molecules) recommended by the WHO for the prevention and treatment of uroandrological diseases; in the Kyrgyz Republic, 8 molecules are physically available, while 12 molecules are officially registered. Forty-eight names of medicines are the extracts of medicinal plants and the prostate; questionably efficient and safe drugs that are not recommended by EAU (2018). According to the ABC/VEN analysis, ABC purchases made in the first half of 2019 at the Urology Hospital, National Urology Center, National Hospital of the Kyrgyz Republic, are not feasible and rational.
Farmaciya (Pharmacy). 2020;69(4):32-39
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The methodological basis for developing and implementing a pharmacoprophylactic component of specialized pharmaceutical care in occupational diseases
Abstract
Introduction. In modern conditions, the prevention of occupational diseases comes to the fore when developing effective models to improve specialized pharmaceutical care for the able-bodied population. The established negative changes in the professional health of coal mining workers in Russia confirm the scientific and practical significance and relevance of solving the denoted problem. In many respects, this problem is historically due to methodological errors in the creation and rather long-term functioning of an ineffective model of a professional health protection system aimed at developing a predominantly medical area, which has led to an imbalance between treatment and prevention of diseases. Objective: to form the structural elements of a procedure for the development and implementation of a pharmacoprophylactic component of specialized pharmaceutical care in occupational diseases. Materials and methods. Pharmacoprophylactic drugs for prevention and treatment were chosen on the basis of expert opinions. Expert evaluations were carried out using scores and a ranking method. The main principle in choosing a pharmacoprophylactic drug was its pharmacotherapeutic rationality. The direct assessment method was used, which was a procedure for assigning numerical values to the objects under study in the interval scale. Results. Pharmacoprophylactic agents were chosen to use for coal mining workers in order to prevent the most common occupational diseases (chronic sensorineural deafness, pneumatic hammer disease, and respiratory diseases). Their cost per patient per year was calculated. Conclusion. The working population can be provided with pharmacoprophylactic drugs within the framework of the current concept of specialized pharmaceutical assistance to coal mining workers when structurally and functionally modifying the pharmacies in order to emphasize their preventive role. The requirements are defined for the medicines used for pharmacoprophylaxis of the considered occupational diseases.
Farmaciya (Pharmacy). 2020;69(4):40-46
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Costs of type 2 diabetes mellitus from payers’ perspective: a study from real-world evidence of district hospital in Vietnam
Abstract
Objective. Estimate yearly treatment cost of type 2 diabetes mellitus (T2DM) from payers' perspective and its influencing factors. Method. A cross-sectional descriptive study has been conducted based on real-world evidence from Thu Duc district hospital from January 2017 to April 2018. Cost of T2DM was estimated based on payers' perspective and included direct medical, direct non-medical and indirect costs. Result: Analyzing the sample of 206 patients with men: women rate of 1: 2.81 and mean age of 61.76±9.74, it has been shown that the average costs of T2DM per patient was accounted for US $ 1,038.3 (95% CI 951.4-1,125.2) with high proportion for direct costs (93.7%) and drugs cost (68.4% of direct medical costs and 60.6% of total costs). Costs per patient with complication was accounted for US $ 1,677.2 (95% CI 1,541.3-1,813.1), which is higher than those without complications (US $ 306.3 (95% CI 295.7-316.9)). Patients with comorbidities incurred higher average cost than those without them (p<0.05). Patients with previous inpatient hospitalization for T2DM or longer number of years for treating T2DM incurred higher cost (p<0.05). Patients with more risk factors or high HbA1c level also incurred higher costs (p<0.05). Conclusion: The average cost of T2DM was reported an estimate of US $ 1,038.3; in which average cost for patients with complication was 5 times higher than those without complication. HbA1c level, comorbidities and complication were the first 3 factors influencing average cost of T2DM.
Farmaciya (Pharmacy). 2020;69(4):47-56
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