Pharmaceutical Organizations Research Articles

АКТУАЛЬНЫЕ ВОПРОСЫ СИСТЕМЫ МЕНЕДЖМЕНТА КАЧЕСТВА В ФАРМАЦЕВТИЧЕСКОМ ПРОИЗВОДСТВЕ

The quality management system (QMS) is one of the prerequisites for successful production activities and serves as a basic mechanism to ensure strict compliance of medical and pharmaceutical organizations in the format of the requirements of applicable standards and regulations. The aim of the work was to analyze the quality management system of pharmaceutical production from the point of view of employees of the enterprise. As an information base the works of domestic and foreign scientists in the field of quality management system, as well as regulatory and organizational documentation on pharmaceutical activities were taken. The questionnaire method served as the main research method, as a result of which 96 employees of pharmaceutical production facilities in Orel, Kostroma, Moscow, Lipetsk and Leningrad regions were interviewed. It was found that from the documents of good manufacturing practices the respondents were most familiar with Good Manufacturing Practices, manufacturing (GMP). The provisions of other good manufacturing practices (GLP, GCP, GSP, GDP, GPP) are mostly unfamiliar to the employees. The majority of respondents believe that the quality of medicines has improved over the last five years, with 56.2% of respondents believing that not all manufacturers comply with good manufacturing practices, explaining that the rules are very complex and it is too expensive for a company to comply with them. The survey found that under the concept of "quality of medicines" employees of pharmaceutical companies mainly mean: safety when used (80.4%); efficacy (79.4%); compliance with the declared characteristics (78.4%). It was found that the specialists of pharmaceutical companies have a positive attitude to the processes of digitalization, but they note the high financial costs at the stages of its implementation and dependence on foreign-made equipment. Thus, we can conclude that the information base in the Russian pharmaceutical production is mainly focused on industry documentation and, to a lesser extent, on related areas; the current industry regulatory framework requires improvement in terms of formalizing processes and specifying requirements.

Новый методический подход к анализу состава и структуры товарного ассортимента фармацевтической организации

Новый методический подход к анализу состава и структуры товарного ассортимента фармацевтической организации

Investigating and Ranking of Barriers Affecting Development of Pharmaceutical Industry Exports in Iran: AHP Method

Background: The study aimed to investigate and rank the barriers affecting the development of pharmaceutical industry exports in Iran's AHP method.
 Methods: The research applied and descriptive method, a field documentary. The study's statistical population was all pharmaceutical organizations that operate in the direction of export to other countries; the study's statistical population consisted of business managers and professors working in the field of export and marketing managers of exporting pharmaceutical companies. The method of data collection was using a questionnaire. The data analysis method was a hierarchical analysis method using a decision tree.
 Results: Evaluation of the results obtained for the barrier of workforce and knowledge of indicators of access to specialized and skilled labor in the field of drug production, skills and technical knowledge in the company in innovative design and development of new products, existing knowledge infrastructure for clinical trial studies In the country of origin, access to a specialized and skilled workforce in the field of drug export, the number of academic and research centers in the field of medicine, the relationship of academic and research centers in the field of medicine with industry and access to cheap labor and the necessary knowledge in compiling and collecting documents Necessary for export to target countries were approved.
 Conclusion: For many firms, the most important external factors that prevent barriers to entering international markets include tariff and non-tariff barriers, foreign exchange rates, fluctuations, competition in foreign markets, government policies, foreign trade practices, and different product and consumption standards. [18] Similarly, operational barriers include the terms of receipt and payment from foreign buyers, establishing transport arrangements, customs clearance, representation, and managing international distribution channels through international markets.

Drug synergy model for malignant diseases using deep learning.

Drug synergy has emerged as a viable treatment option for malignancy. Drug synergy reduces toxicity, improves therapeutic efficacy, and overcomes drug resistance when compared to single-drug doses. Thus, it has attained significant interest from academics and pharmaceutical organizations. Due to the enormous combinatorial search space, it is impossible to experimentally validate every conceivable combination for synergistic interaction. Due to advancement in artificial intelligence, the computational techniques are being utilized to identify synergistic drug combinations, whereas prior literature has focused on treating certain malignancies. As a result, high-order drug combinations have been given little consideration. Here, DrugSymby, a novel deep-learning model is proposed for predicting drug combinations. To achieve this objective, the data is collected from datasets that include information on anti-cancer drugs, gene expression profiles of malignant cell lines, and screening data against a wide range of malignant cell lines. The proposed model was developed using this data and achieved high performance with f1-score of 0.98, recall of 0.99, and precision of 0.98. The evaluation results of DrugSymby model utilizing drug combination screening data from the NCI-ALMANAC screening dataset indicate drug combination prediction is effective. The proposed model will be used to determine the most successful synergistic drug combinations, and also increase the possibilities of exploring new drug combinations.

Fake Drug Detection Using Blockchain Technology

Abstract: For a few decades, it is a getting challenging to keeptrack and monitor of non-counterfeit drugs in health care. Due to Lack a trust system and safe and secure monitoring, unauthorizerscan make fake drugs easily. Because fake drugs has a harmful effect on the human health and has deadly results. Fake medicinesare analyzed as a great challenge for the medical industry worldwide. As mentioned by statistics, due to these counterfeit drugs yearly business loss of around $200 billion is described by US pharmaceutical organizations. These fake medicines may not assist the patients to get well from health disorder but can have many other harmful ramifications. According to the World HealthOrganization (WHO) survey, in undeveloped nations each 10th medicine consumed by the patients is fake and has bad quality. To find the fake drugs, we are proposing a drug traceability system by using blockchain technology. Our system helps in detecting substandard and fake drugs from manufacturer to end user. Blockchain helps to make the system more reliable and transparent. Blockchain based system helps in detecting the fake drugs and ensures the transparency and security of e-health data. This paper aims to ensure transaction security, medicine quality, and data security by using blockchain technology.

THE CURRENT STATUS AND NEED OF PHARMACOVIGILANCE CENTERS IN THE HOSPITALS TO MINIMIZE THE DRUG PROBLEMS

The science and exercises identifying with the identification, appraisal, comprehension and counteractive action of antagonistic impacts or some other medication related issue”. It is a vital and indistinguishable piece of clinical research. Both clinical preliminaries safety and post-showcasing pharmacovigilance are essential all through the item life cycle. With a sensibly high number of late prominent medication withdrawals, both the pharmaceutical business and in addition different administrative offices over the globe have expanded the bar. Early flag identification from the post- advertising observation thinks about and clinical preliminaries in early stages have now been adjusted by significant pharmaceutical organizations so as to recognize the dangers related with their therapeutic item/s as right on time as could be expected under the circumstances. The indications of ADRs rely upon the age, sex, hereditary, poly pharmacy, portion exactness and ecological and other interior variables like illness conditions. ADRs ordinarily answered in because of known or obscure pharmacological highlights, poor item quality, prescription mistakes in recommending, getting ready, overseeing, or taking the medicine which requires hospitalization. ADRs in hospitalized patients can be partitioned into two classes: those that are the reason for clinic confirmation and those that happen amid hospitalization. A strengthening and commitment of network pharmacists to patient record check and electronic announcing may likewise lessen ADR related occasions. Without successful distinguishing proof and satisfaction of preparing needs of pharmacists and other medicinal services experts, the effectiveness of national pharmacovigilance frameworks is probably not going to enhance, which may bargain patient safety.

ВЛИЯНИЕ СТРАТЕГИЧЕСКОГО ЛИДЕРСТВА НА РАЗВИТИЕ ЭТИЧЕСКОЙ ПРАКТИКИ СРЕДИ ФАРМАЦЕВТИЧЕСКИХ ОРГАНИЗАЦИЙ В СИРИЙСКОЙ АРАБСКОЙ РЕСПУБЛИКЕ

The purpose of this study is to investigate the impact of strategic leadership on improving ethical practices in pharmaceutical organizations in Syria. Strategic leadership variables include the work environment, leadership traits, leadership style, and performance of strategic leaders. During the study, a questionnaire was compiled and sent to 83 managers and employees of pharmaceutical organizations in Syria. The results indicate that leadership effectiveness had the strongest influence on the ethical positions attributed to strategic leadership. Thus, strategic leadership has a greater influence on ethical practice and decision making in pharmaceutical organizations. According to the study, pharmaceutical organizations should pay special attention to the factors influencing the improvement of the morale of the staff and the promotion of ethical behavior in the workplace.

A QbD-led simple and sensitive RP-UHPLC method for simultaneous determination of moxifloxacin, voriconazole, and pirfenidone: An application to pharmaceutical analysis.

A novel, quick and precise RP-UHPLC analytical method for the simultaneous determination of moxifloxacin (MFX), voriconazole (VCZ) and pirfenidone (PIR) was developed and validated according to the International Conference on Harmonization guidelines using a QbD-driven response surface Box-Behnken design. The developed method was validated considering the selectivity, sensitivity, linearity, accuracy-precision, robustness, stability, limit of detection and limit of quantification, respectively. Resolution between MFX, VCZ and PIR was achieved using a gradient elution protocol against a Waters Symmetry Shield C18 column (150 × 4.6mm2 , 5μm) using an Agilent 1290, Infinity II series LC system. The method was applied to quantitatively estimate proprietary and in-house prepared pharmaceutical topical ophthalmic formulations containing MFX, VCZ and PIR at wavelength(λmax ) of 296, 260 and 316 nm. The method is sensitive enough to detect up to 0.1ppm of analytes in the formulation. The method was further exploited to study and identify the possible degradation products of the analytes. The proposed chromatographic method is simple, economical, reliable and reproducible. In conclusion, the developed method could be applicable for routine quality control analysis of single or combined MFX, VCZ and PIR-containing units or bulk dosage forms in pharmaceutical industries and research organizations working on drug discovery and development.

A Review on Introduction to Quality Assurance

Quality assurance (QA) is the management technique used to provide adequate confidence that a product, service, or result will satisfy requirements for quality and be fit for use. Each monitoring program or assessment must strive to generate data that is precise, dependable, and sufficient for the specified purpose. Data quality objectives are qualitative and quantitative standards that are used to create a system that will keep the level of uncertainty within permitted boundaries and at an acceptable level. Quality assurance will boost public and funding body confidence. Unconfirmed observations should not be used until they can be verified. Robust pharmaceutical quality assurance system ensures that products are effective and safe. Following good manufacturing practices (GMP) and enacting comprehensive inspection policies help drug manufacturers produce the highest quality products and avoid reputation-damaging incidents. Product Quality Review (PQR) is a mechanism to ensure that data captured by the Pharmaceutical Quality System (PQS) is reviewed for trends. This tool can support a continuous improvement environment. PQRs are designed for the purpose of identifying and implementing recommendations for required improvements. Quality control and quality assurance jobs are all about ensuring the medication has been manufactured correctly and is safe to use, as well as having its desired effect. Without these two functions of quality management, a pharmaceutical organisation would struggle to achieve consistency in its output. Quality assurance (QA) is any systematic process of determining whether a product or service meets specified requirements. QA establishes and maintains set requirements for developing or manufacturing reliable products.

The role and characteristics of emotional intelligence of pharmaceutical employees

Aim. To study and generalize the main provisions of emotional intelligence, the role of its basic components among professional competencies, features in performing the main functions of a pharmacist and the head of a pharmaceutical organization, as well as the specificity of the manifestation in a crisis situation, in particular, in the conditions of the Russian-Ukrainian war.
 Materials and methods. Data from scientific literature, legislative and regulatory acts, information sites on the Internet. Methods of content analysis, structural and logical analysis, generalization, comparison, grouping, and formalization of reasoning were used.
 Results. As a result of the study, the internal and external factors influencing on the emotional intelligence of a pharmaceutical worker have been identified. The features of the manifestation of the emotional state of a pharmacist and the head of the pharmaceutical organization in a crisis situation have been shown. The role of emotional intelligence in communication with stakeholders, in conflict situations, for the prevention of emotional burnout, etc., has been determined. The importance of emotional intelligence for the effectiveness of the individual and the pharmaceutical organization as a whole has been shown.
 Conclusions. The importance of emotional intelligence of pharmaceutical workers and managers in the performance of functional duties, including in communications with consumers of medicines and medical products, partners, employees of the organization, etc., has been shown when resolving conflicts, reducing the risk of emotional burnout, forming self-motivation and motivation, etc. Factors affecting emotional intelligence, including the crisis situation that the Russian-Ukrainian war has become, have been identified. The role of emotional intelligence for the individual and for the pharmaceutical organization has been differentiated.

Maintaining Warp Speed: Policy Requirements for a Just-in-Time, Capability-Based, Scalable Medical Countermeasure Research and Development Enterprise.

Maintaining Warp Speed: Policy Requirements for a Just-in-Time, Capability-Based, Scalable Medical Countermeasure Research and Development Enterprise.

Analysis of the Availability of Medicinal Products Used in Virus Hepatitis in the Kyrgyz Republic

The article presents the results of the analysis of the availability of drugs used in the pharmacotherapy of viral hepatitis in the Kyrgyz Republic. The materials of the study were the pharmaceutical market for drugs used in viral hepatitis, data from the regulatory authority in the field of drug circulation and pharmaceutical organizations. Research results. In the Kyrgyz Republic, drugs used for viral hepatitis at the time of the study are represented by 6 international non-proprietary names and 19 trade names imported from 6 countries of the world. When analyzing the affordability of drugs used in viral hepatitis, it was found that the drugs of the tenofovir and Entecovir groups have the highest price liquidity, which indicates the greatest affordability of drugs in this group. In the analysis using the solvency adequacy ratio, drugs of the tenofovir and Entecovir groups also have greater availability for patients with an average income level. In the Kyrgyz Republic, drugs for the treatment of viral hepatitis are more expensive than in other countries, which reduces their affordability for citizens with an average income level. All investigational medicinal products present on the pharmaceutical market of the Kyrgyz Republic are imported into the country by foreign manufacturers.

On the conceptual project of an environmental management system at a pharmaceutical biotechnology enterprise

In our opinion, the ability to prevent or avoid negative impact on the environment by pharmaceutical industry organizations in normal situations fully depends on the environmental management system of the quality management system of the production enterprise. During the work, according to the set goals and objectives, an analysis of the accounting and reporting documentation of pharmaceutical manufacturers was carried out based on environmental international and domestic regulatory acts and documents in the paradigm of sustainable development. We have proposed a Conceptual project of an environmental management system in the form of a block diagram of nature conservation documentation for category II hazardous waste facilities of pharmaceutical biotechnology enterprises. Individual documents and document templates were developed in such a way as to cover the most common accounting and reporting documents filled out by a pharmaceutical industry production enterprise based on principles of social responsibility in environmental protection. It is necessary to note the relevance of introducing and balancing non-financial and financial reporting in the quality management system of pharmaceutical production enterprises, taking into account their social responsibility and personnel work. The results obtained can be used in the quality management system of pharmaceutical industry organizations - drug manufacturing enterprises using biological and chemical technologies when implementing projects during the development of nature conservation documentation for environmental management system projects with the aim of developing a project for social responsibility and non-financial reporting, not just for public joint-stock companies.

Diversity and uses of flowering plants distributed in both Vietnam and Malaysia

The paper assessed the diversity of species, genera, families and classes of the flowering plants (Magnoliophyta) distributed in both Vietnam and Malaysia. Main contents of the study are building a list of plant species and evaluation of the diversity of taxa of Magnoliophyta. The study has enumerated 1840 species, 876 genera, 162 families, 2 classes of Magnoliophyta, distributed in both Vietnam and Malaysia. Diversity of useful plants with 2 classes, 150 families, 689 genera, 1213 species. Medicinal plants with 869 species (2 classes, 133 families, 553 genera). Plants for timber with 127 species (1 class, 39 families, 87 genera). Ornamental plants with 156 species (2 classes, 31 families, 104 genera). Edible plants (edible fruits, seeds) with 103 species (2 classes, 37 families, 78 genera). Plants for essential oil with 13 species (2 classes, 8 families, 12 genera). Vegetables with 92 species (2 classes, 44 families, 76 genera). Dyed plants with 31 species (1 class, 12 families, 20 genera). Plants for fibre with 3 species (2 classes, 3 families, 3 genera). Plants for food of animal and human with 79 species (2 classes, 15 families, 56 genera). A model built for research and development of those species based on comprehensive cooperations and supports from agriculture, construction, cosmetic, fashion, forestry, food, ornamental and pharmaceutical organizations. The results provide a lot of valuable information, contributing to the development of cooperation of Vietnam and Malaysia on plant diversity research and orientation for application.

Whistleblowing as an anti-corruption strategy in health and pharmaceutical organizations: a scoping review

Whistleblowing as an anti-corruption strategy in health and pharmaceutical organizations: a scoping review

Audits and inspections of pharmacovigilance systems in Russia

The implementation of pharmacovigilance activities is impossible in isolation from compliance with the quality requirements of medicines and the activities of pharmaceutical and medical organizations throughout the pharmaceutical practice, as well as without access to sales plans, sales results and full relevance of information on drug conditions in all markets and in all cases of application. Properly conducted audit or inspection evaluation of the pharmacovigilance system makes it possible to identify and prevent drug safety problems at all stages of its life cycle.The aim. Development of a risk-based strategy for planning and passing audits and inspections of the pharmacovigilance system for the subsequent creation of effective programs for assessing the pharmacovigilance system on its basis.Material and methods. The study used structurallogical, empirical methods, general logical methods of scientific knowledge, methods of generalization and extrapolation.Results. The plans and results of audits and inspections of pharmacovigilance systems of Russian and foreign pharmaceutical organizations and their pharmacovigilance vendors were analyzed. A risk-based strategy and a checklist for planning internal and external audits of pharmacovigilance systems of Russian pharmaceutical organizations and their vendors for pharmacovigilance have been developed and recommendations for training internal auditors of pharmacovigilance systems and audit teams have been developed for them.Conclusion. Risk assessment indicators adapted for Russia have been developed, according to which Russian pharmaceutical organizations and their pharmacovigilance vendors can assess the likelihood of the risk of priority inclusion in the plan of Russian inspections of pharmacovigilance systems for compliance with the requirements of the good pharmacovigilance practice of the Eurasian Economic Union. Recommendations were prepared for the executive management and pharmacovigilance specialists of Russian pharmaceutical organizations in terms of assessing regulatory risks for the quality system of the pharmacovigilance system, planning and conducting audits; evaluating the relationship of pharmacovigilance with other good practices and with information from the plans and results of the organization as a whole. The indicators adapted for Russia for assessing the compliance of the pharmacovigilance system with the rules of the NPF EAEU are given.

Analysis of the Pharmaceutical Market of Drugs Used in the Pharmacotherapy of Bronchial Asthma in the Kyrgyz Republic

The article presents the results of the analysis of the pharmaceutical market of drugs used in the pharmacotherapy of bronchial asthma in the Kyrgyz Republic. The materials of the study were the pharmaceutical market of medicines used for the treatment of bronchial asthma in the Kyrgyz Republic, the data of the regulatory authority in the field of circulation of medicines and pharmaceutical organizations. Research results. It was established that in the Kyrgyz Republic the analyzed group of drugs included in the clinical protocol for the treatment of bronchial asthma is represented by 56 trade names. In the nomenclature of drugs for the treatment of bronchial asthma, the leading place belongs to single drugs — 87.5%, the share of combined drugs, respectively, is 12.5%. Of the total number of anti-asthma drugs in the pharmaceutical market, lecotriene receptor antagonists rank first with a share of 46.29%, β2-agonists — 37%, combined glucocorticosteroids — 17.83%, inhaled glucocorticosteroids — 29.62% and glucocorticosteroids for systemic use — 24%, methylxanines — 9.25%, anticholinergics — 7.4%. Conclusion. Drugs for the treatment of bronchial asthma, present on the pharmaceutical market of the Kyrgyz Republic, in general, comply with the recommendations of the experts of the Global Initiative for Asthma (GINA) (Global Initiative for Asthma). All medicines on the pharmaceutical market of the Kyrgyz Republic are represented exclusively by foreign manufacturers, among which Turkey is the leader.

Training via learning oriented assessment: an investigation of knowledge acquisition, skill application and job effectiveness

PurposeThe purpose of this paper is to explore more agile and effective learning processes that help identify potentially high-performing staff during workplace training.Design/methodology/approachTo test the efficacy of the learning-oriented assessment (LOA) process in workplace training, a pharmaceutical sales organization implemented an online training over three months that was modeled with the LOA process. During work hours, employees within the organization took two tests (one before and after training) as well as participated in training with essential work-related content, where they were given problem sets and scenarios to complete that would vary based on their responses. Their assessment scores, formative learning behaviors and quarterly revenue were recorded to determine the effects of the training.FindingsThe outcome of this study supported the theory that the LOA model would facilitate the acquisition and application of knowledge differentially between employees of the organization, and this knowledge would serve to improve the performance of the employees to the extent that it increased revenue.Research limitations/implicationsThis study was a field experiment that did not allow for the control of possible confounds. However, the real-world real people outcomes provide novel insights on best practices in workplace training.Practical implicationsThe findings of this study showed the short-term effectiveness of the LOA process in professional knowledge acquisition and application in relevant skills that increase organizational revenue.Originality/valueThis study provides an applied understanding on the applicability of the LOA process in workplace learning and training which has not been previously investigated.

АНАЛИЗ НОРМАТИВНО-ПРАВОВОГО РЕГУЛИРОВАНИЯ ХРАНЕНИЯ НЕЗАРЕГИСТРИРОВАННЫХ ЛЕКАРСТВЕННЫХ ПРЕПАРАТОВ В МЕДИЦИНСКИХ И ФАРМАЦЕВТИЧЕСКИХ ОРГАНИЗАЦИЯХ В РОССИЙСКОЙ ФЕДЕРАЦИИ

Compliance with the necessary storage conditions for unregistered medicines by health facilities and pharmacies is one of the most important aspects of medicine provision of patients. Currently, some aspects related to ensuring the storage conditions for unregistered medicines remain insufficiently regulated by the current legislation. The aim of the study is to analyze the legal regulation of the storage in health facilities and pharmacies of unregistered medicines in the Russian Federation which are imported for the purpose of providing medical care to specific patients. The texts of regulatory legal acts of the Russian Federation have been used in this study as well as grammatical and logical methods of their interpretation. It has been shown that at present unregistered medicines can be imported into the Russian Federation to provide medical care to patients for health reasons, including containing narcotic and psychotropic substances. It has been analyzed that this import into the country is provided by a legal entity entitled to it, after which at the regional level such medicines are transferred for storage either to an intermediary pharmaceutical organization or directly to a health facility in which the medicine will be administered to the patient or dispensed for use at home. It has been established that the current legislation of the Russian Federation does not regulate in detail the organization of storage of unregistered medicines. The necessity of developing legal norms regulating the storage of unregistered medicines in health facilities and pharmacies has been presented. The expediency of providing separate storage of unregistered medicines in in health facilities and pharmacies has been substantiated, which, depending on the available space and equipment, can be organized on four levels, which will reduce the likelihood of errors at this stage of their circulation.

Системи якості у фармації: мультидисциплінарний контекст державної фармакопеї України

The multidisciplinary context of the State Pharmacopoeia of Ukraine in drug quality systems was justified through an interdisciplinary study of pharmaceutical business organization, quality control, standardization, drug technology, management, marketing, forensic pharmacy, medical and pharmaceutical law in the system of legal relations "doctor-patient-pharmacist-lawyer" during state formation and implementation of Ukraine's integration processes into the WTO and the EU. Noted that the State Pharmacopoeia of Ukraine was from the first of the CIS countries, fully harmonized with the European Pharmacopoeia, takes into account national specificities, the Constitution of Ukraine, legislation on normative legal acts of Ukraine. Proven that, according to international assessments, the State Pharmacopoeia of Ukraine is the best National Pharmacopoeia in the post-Soviet space concerning the modern requirements of the WTO and WHO regarding quality and safety systems of medicines.