Pharmaceutical Systems Research Articles

Evaluation of the Use of Information Systems Pharmacy Management Officer Pharmacy in RSU Royal Prima Medan Year 2020

Management information systems are urgently needed by hospital pharmacy installations to maintain the quality of the hospital, protect patient safety and support fast and precise decision making. The application of management information systems in the pharmaceutical installation of the Royal Prima Medan Hospital has been running. The pharmaceutical installation system that has been implemented is evaluating, repairing and improving to keep up with the times. The purpose of this study was to determine the effect of system quality, information quality, service quality on the use of pharmaceutical management information systems at Royal Prima Medan Hospital and the relationship between significant variables. This type of research is a mixed method with a sequential explanatory research strategy. This study uses the DeLone and Mclean information system success model. The research was conducted at the Royal Prima Medan Hospital with the research subjects being pharmaceutical officers at the Royal Prima Medan Hospital. Data analysis was performed by multiple linear regression analysis. The number of respondents used in this study were 30 respondents with the characteristics of all respondents being female (100%) and aged 25-29 years (43.33%). Based on the results of the T test, it can be concluded that system quality, information quality and service quality have no effect on system use. Simultaneously, system quality, information quality and service quality do not have a significant effect on the use of management information systems simultaneously. Keywords: Evaluation, Pharmaceutical Information Management System, D & M is Success Model, Royal Prima Medan Hospital.

Development of a pharmaceutical waste management system for medicines generated in the process of circulation among the population in the Republic of Tatarstan

Development of a pharmaceutical waste management system for medicines generated in the process of circulation among the population in the Republic of Tatarstan

Application of UV dissolution imaging to pharmaceutical systems.

UV-vis spectrometry is widely used in the pharmaceutical sciences for compound quantification, alone or in conjunction with separation techniques, due to most drug entities possessing a chromophore absorbing light in the range 190-800nm. UV dissolution imaging, the scope of this review, generates spatially and temporally resolved absorbance maps by exploiting the UV absorbance of the analyte. This review aims to give an introduction to UV dissolution imaging and its use in the determination of intrinsic dissolution rates and drug release from whole dosage forms. Applications of UV imaging to non-oral formulations have started to emerge and are reviewed together with the possibility of utilizing UV imaging for physical chemical characterisation of drug substances. The benefits of imaging drug diffusion and transport processes are also discussed.

ПРОБЛЕМЫ СОЗДАНИЯ ДОКУМЕНТАЦИИ СИСТЕМЫ ОБЕСПЕЧЕНИЯ КАЧЕСТВА

The article is devoted to the development of quality system documents for the pharmacy organization. The legislation of the Republic of Belarus, as well as the Eurasian Economic Union, requires the development and maintenance of the quality assurance system, the quality management system, the pharmaceutical quality system in a pharmacy organization, a distributor or manufacturer of medicinal products. The article presents the comparative analysis of regulatory requirements as well as approaches of the international standards ISO series to the construction of the quality systems and processes documentation. Such documents as the Quality Manual or its equivalent, Standard Operating Procedures (SOP) and Process Instructions are the most difficult to develop. The distribution of responsibility for processes within the organization is difficult to understand. On the example of RUE «BELPHARMATSIYA» it is shown how the processes in the pharmacy organization can be documented and responsibility for their implementation can be stated. The functioning of the quality system depends on the clarity of the documentation structure and its development and circulation organization. It is the responsibility of the organization authorities to maintain effective functioning of this system.

Peking Union Medical College Hospital and Its Training of Pharmaceutical Staff in the Republican Period

Several training programs for the pharmacy staff in the Pharmacy Department of Beijing Union Medical College Hospital were implemented over 1910's to 1942, such as apprenticeships, prior courses on pharmaceutical sciences,vocational training, study overseas, and developing the Beiping Pharmacy Evening School in collaboration with the North China Pharmaceutical Society around the 1930's. These programs explored training models for the hospital, developed practical talent with competence ensuring the needs and requirements within the hospital, established practical education on pharmacy in Beiping and therefore contributed to promoting future pharmaceutical training systems in China.

Role of Mechanochemistry in Solid Form Selection and Identification of the Drug Praziquantel

Identification of all possible polymorphs for a pharmaceutical compound is vital for the better formulation of medicine with desired properties. This study demonstrates the application of a mechanochemical approach to reveal new polymorphs of a drug and the potential of variable amounts of solvent in liquid-assisted grinding for solid form screening. Without solvent and by varying the amount of solvent added, we found two new polymorphs and an amorphous form, which were not reported previously. The finding portrays the advantage of the mechanochemical approach as a means of the polymorph screening strategy. While the focus here was on praziquantel, a similar approach is applicable to other pharmaceutical systems. This study also contributed to reinvestigate the solid-state behavior of the chiral praziquantel system, including the melt phase diagram and the role of experimental conditions on its phase behavior.

Accessing Affordable Medicines in a Post-TRIPS Environment: The Case of Bangladesh

The cost of medicines in Bangladesh is among the lowest in the world. Over the last forty years, Bangladesh, a Least Developed Country (LDC), has nurtured a local industry based on strong industrial policy and a pharmaceutical patent-free system. Of the 46 LDCs in the world, it is the only one to have a thriving industry of this kind. In this paper, we explore how a relatively poor LDC managed to take on the dominance of MNCs in the global production of pharmaceuticals. We focus on the 1982 National Drug Policy (NDP) which transformed the pharmaceutical sector in Bangladesh from one in which three-quarters of drugs were supplied by just eight MNCs to one where almost all domestic demand is met by local industry. The thriving local pharmaceutical industry also exports generic medicines to 147 different countries. In 2026, Bangladesh is due to graduate to ‘Developing Country’ status, at which time, as a member of the WTO, Bangladesh will have to abide by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. Under TRIPS it will have to change its patent regime to allow for the registration of pharmaceutical patents by 2029. Using interview data with key Bangladeshi experts, we argue that TRIPS compliance could potentially wipe out this flourishing local pharmaceutical industry, leading to steep increases in the cost of essential medicines, with dire implications for the right to health. We explore policy options open to the Bangladesh government to protect affordable drugs in the country, in particular protection for the production of domestic generics in a post-TRIPS environment. We also argue that there are ways in which Bangladesh and India could co-operate to protect the affordability of high-quality medicines for domestic and international markets.

Scenarios for 3D printing of personalized medicines - A case study

Background3D printing is a promising new technology for medicines' production. It employs additive manufacturing techniques, and is ideal for producing personalized medicines (e.g., patient-tailored dose, dosage form, drug release kinetics). ObjectiveTo investigate how 3D printing technologies can be implemented in a European pharmaceutical system, by suggesting different scenarios and assessing aspects that could affect its implementation. MethodQualitative, semi-structured interviews were conducted with key stakeholders (e.g., from ministry, authorities, research organizations, pharmacies) in the Netherlands to elicit perspectives on 3D printing of personalized medicines. The Netherlands were chosen since it has a strong tradition in compounding. Five general scenarios were investigated: placing the 3D printers in industry, community pharmacies, hospital pharmacies, compounding facilities, and in patients' homes. Content analysis was used, building on verbatim transcripts. ResultsFifteen stakeholders were interviewed. Regulatory, economic, ethical and organizational challenges were identified to varying degrees in the different scenarios. The industry and home scenarios were associated with the most challenges, hospital pharmacies and compounding facilities with the least. Other important aspects identified were the role of community pharmacies, and who should design the tablets to be printed. ConclusionAll potential scenarios for 3D printing of personalized medicines include challenges. These should be taken into account when pursuing the use of 3D printing of medicine.

Investigation on Formulation Strategies to Mitigate Compression-Induced Destabilization in Supersaturated Celecoxib Amorphous Solid Dispersions.

Compression-induced destabilization was investigated in various celecoxib amorphous solid dispersions containing hydroxypropyl methylcellulose (HPMC), poly(vinylpyrrolidone)/vinyl acetate copolymer (PVP/VA), or poly(vinylpyrrolidone) (PVP) at a concentration range of 1-10% w/w. Pharmaceutically relevant (125 MPa pressure with a minimal dwell time) and extreme (500 MPa pressure with a 60 s dwell time) compression conditions were applied to these systems, and the changes in their physical stability were monitored retrospectively (i.e., in the supercooled state) using dynamic differential scanning calorimetry (DSC) and low-frequency Raman (LFR) measurements over a broad temperature range (-90 to 200 and -150 to 140 °C, respectively). Both techniques revealed similar changes in the crystallization behavior between samples, where the application of a higher compression force of 500 MPa resulted in a more pronounced destabilization effect that was progressively mitigated with increasing polymer content. However, other aspects such as more favorable intermolecular interactions did not appear to have any effect on reducing this undesirable effect. Additionally, for the first time, LFR spectroscopy was used as a viable technique to determine the secondary or local glass-transition temperature, Tg,β, a major indicator of the physical stability of neat amorphous pharmaceutical systems.

COVID-19 pandemic impact on the pharmaceutical sector in Bulgaria

In December, 2019 in Wuhan, Hubei Province, China, a new, unknown strain of coronavirus called SARS-CoV-2 was identified. The virus has spread rapidly to other countries around the world, among which the most affected were Italy, Spain and the United States. As a result, in March 2020 The WHO has declared the new coronavirus epidemic a global pandemic. Despite timely measures and efforts to reduce morbidity, up to date, confirmed cases are 119,452,269, while the number of deaths reached 2,647,662 people. The COVID-19 pandemic has affected all areas of human life – health, social, economic. In each of them, a number of restrictions and obligations were imposed, including wearing of masks, use of disinfectants, education in an online environment, limited work in restaurants and shops. The health sector was particularly affected, and all actors in the pharmaceutical system had to reorganize and adapt their activities in the name of a common goal – ending the COVID-19 pandemic.

Features of the development of the sphere of biomedical cell products in Russia

The successful development of the economy of a modern state is directly related to the entry into the market of new advanced therapy medicinal products. For Russia, the process of developing and implementing biomedical cell products will become the basis for the successful transformation of the pharmaceutical market into a knowledge-intensive market economy. Biomedical cell products can act as one of the main tools of such a promising and capital-intensive direction as regenerative medicine. The field of biomedical cell products therapy is developing rapidly, but there are still questions about the safe use of biomedical cell products therapy. The growing need for effective recommendations for the participants of the biomedical cell products market has determined the relevance of this study. Multivariate analysis of the prospects and barriers to the development of the biomedical cell products market to justify and develop recommendations for investors, pharmaceutical manufacturers and distributors for the production and sale of biomedical cell products in Russia. Materials and methods. The materials were regulatory legal documents of regulatory bodies: the USA, the EU, the Russian Federation, the EAEU, as well as analytical materials of open access. Results. A comparative analysis of the production features and the formation of the cost of autologous and allogeneic biomedical cell products revealed the ways of development of the biomedical cell products market. Further, the key directions of the prospective development of the biomedical cell products market were identified and characterized, risk factors, drivers and barriers were identified. Conclusion. In the direction of regulatory support: – create a general register for monitoring the results of research and the use of biomedical cell products. – to develop an information environment for comparing large sets of biomedical cell products life cycle data obtained from different sources; – to develop regulatory approaches to the circulation of biomedical cell products in the market. In the direction of technological support: – plan the implementation of automation of all stages of the production process; – to provide for the development of technology transfer methods; – to maintain the pharmaceutical quality system in an up-to-date functioning state; – implement a platform for training qualified personnel for this field. In the direction of marketing support: – to create logistics chain systems, with the help of integration technologies, capable of ensuring uninterrupted supply of biomedical cell products with minimal risks to the quality of the supply chain reliability; – supply planning should take into account the stability and storage conditions of the biomedical cell products; – scaling up production leads to a reduction in cost, and an increase in the use of biomedical cell products in routine medical practice leads to an increase in the present value; – conduct training of production employees, distributors and medical personnel. – develop a commercialization strategy for each biomedical cell products separately.

Evaluation of Iran's pharmaceutical policies in the import of drugs and determining the nature of imported drugs using the ABC-VED Method

Background: The supply of medicines in every country is vital in any country, and access to appropriate medicines ensures the health of that community by preventingthe spread of smuggling. The present study aimed to evaluate the current policies of Iran to supply medicines through importation and examine the application of the ABC-VED (Always, Better, Control-Vital, Essential, Desirable) method in assisting policymakers in making decisions on the medicine importation. Method: The present research study was conducted in qualitative and quantitative phases. In the qualitative phase, face-to-face interviews were conducted with 13 health experts in the field of production and import of medicine and their "content analysis" was done using MaxQDA 18 software.In the quantitative phase, to determine the nature of imported drug items, the ABC-VED analysis matrix and the information available in the pharmaceutical statistics of 2019 were used. Then, the distribution of drugs in each of the matrix categories was determined. Result: In the qualitative phase of the study, experts pointed to the impact of restrictive policies on importation of medicines, reducing access to medicines, increasing smuggling, reducing innovation, weakening marketing, and reducing the quality and increasing price of domestically produced medicines. In the quantitative phase, it was found that AV category consists of 36, AE 145, AD 85, BV 31, BE 240, CV 126, CE 970, and CD 672 type of medicines using the ABC-VED matrix. Finally, 21.5 % of medicines were categorized in group I belonging to vital and expensive medicines, 7.2 % in group II that are essential medicnies with moderate prices, and finaly 1 % were categorized in group III which are desirable medicines with lower prices. Conclusion: According to the opinions of experts in the country pharmaceutical industry, Iran's policy on drug importations has always been contractionary. Although it has led to lower prices and increased patients' access to medicines, it made side effects on the pharmaceutical system. Thses side effects includ sectional medical shortages over time. Policymakers can restrict the import of expensive and small quantities of drugs and allocate more funds to the supply of vital drugs. The analyses used cannot be the criterion for decision alone and can only indicate drug priorities in budget shortages and must make decisions within a multi-criteria decision framework.

"Ethical Issues in the Romanian Pharmaceutical System in the Context of Covid-19 Pandemic"

"COVID-19 infection is a disease caused by the new type Coronaviruses family strain, SARS-CoV-2. It was first identified in China’s Wuhan City in December 2019. On March 11, 2020, the World Health Organization officially declared the public health emergency with COVID-19 a pandemic. As in the other affected countries, Romania’s health care professionals are on the front line. Among them, community pharmacy and clinical pharmacy teams are facing special ethical situations related to issues as: the provision of protective equipment, sudden medicines price rises, a general increased need in pharmaceutical services of the population concerned about COVID-19, a possible shortage of drugs due to the cessation of their import, ensuring on-going provision of pharmaceutical services in the case of significant volumes of staff absences. Also, as our country goes through the four scenarios of fighting the new coronavirus based on number of declared positive patients, complex ethical issues could appear for the pharmacist. Thus, significant ethical problems can arise due to the conflict between the duty of care that the pharmacist has assumed by saying and taking the Hippocrates oath and the high exposure of infection that she/he and implicitly those close to her/him have in this situation. Critical situation that may occur in the last two scenarios could raise serious ethical problems related to the violation of fundamental rights for health care professionals and implicitly for pharmacists. The objective of this work is to assess the ethical issues related to the COVID-19 pandemic in the Romanian pharmaceutical system. "

Graph representation learning in bioinformatics: trends, methods and applications.

Graph is a natural data structure for describing complex systems, which contains a set of objects and relationships. Ubiquitous real-life biomedical problems can be modeled as graph analytics tasks. Machine learning, especially deep learning, succeeds in vast bioinformatics scenarios with data represented in Euclidean domain. However, rich relational information between biological elements is retained in the non-Euclidean biomedical graphs, which is not learning friendly to classic machine learning methods. Graph representation learning aims to embed graph into a low-dimensional space while preserving graph topology and node properties. It bridges biomedical graphs and modern machine learning methods and has recently raised widespread interest in both machine learning and bioinformatics communities. In this work, we summarize the advances of graph representation learning and its representative applications in bioinformatics. To provide a comprehensive and structured analysis and perspective, we first categorize and analyze both graph embedding methods (homogeneous graph embedding, heterogeneous graph embedding, attribute graph embedding) and graph neural networks. Furthermore, we summarize their representative applications from molecular level to genomics, pharmaceutical and healthcare systems level. Moreover, we provide open resource platforms and libraries for implementing these graph representation learning methods and discuss the challenges and opportunities of graph representation learning in bioinformatics. This work provides a comprehensive survey of emerging graph representation learning algorithms and their applications in bioinformatics. It is anticipated that it could bring valuable insights for researchers to contribute their knowledge to graph representation learning and future-oriented bioinformatics studies.

Risk Management: How Not To Do It

Regulations worldwide tell us that a Pharmaceutical Quality System has to be risk-based. In reviewing best practices and ICH Q9 guidelines on QRM, the author shares insights on what not to do, using examples the author has come across over the more than 30 years in industry.

Native fluorescence detection with a laser driven light source for protein analysis in capillary electrophoresis

While ultraviolet light (UV) absorbance detection is the most widely used detection mode in capillary electrophoresis (CE), it can yield poor concentration sensitivity and has tendencies to exhibit baseline fluctuations. In order to overcome these challenges, alternative detection strategies, including the use of dedicated wavelength lasers, have been applied, resulting in enhancements of concentration sensitivity as well as decreased baseline disturbance. In this work, using a laser driven light source for excitation, we reported a native fluorescence detection (NFD) scheme for use in a commercial CE platform, PA 800 Plus Pharmaceutical Analysis System, for protein analysis. The CE-NFD system was characterized using tryptophan and a reduced IgG. We compared NFD with UV absorbance detection as applied to sodium dodecyl sulfate-capillary gel electrophoresis (SDS-CGE) and capillary isoelectric focusing (cIEF). In SDS-CGE, with the reported NFD a non-reduced IgG standard sample yielded a signal-to-noise ratio which was 14.6 times higher than with UV absorbance detection at 214 nm. In cIEF analysis of NISTmAb, Humanized IgG1k, with NFD ∼170 times less sample mass was needed to obtain similar profile quality to that with UV absorbance detection at 280 nm. NFD also eliminated baseline anomalies observed with UV absorbance detection and showed less interference by other absorbing species. These results suggest that CE-NFD is a practical and powerful tool for protein characterization in the biopharmaceutical industry.

Experience of EU countries in organizing of the circulation and availability of medicines for the population

Finland's health care system has evolved over the years, with its distinctive features being tax funding, the provision of the vast majority of medicines and medical services by public and municipal authorities. to study the experience of EU countries in the field of health care in the organization of circulation and availability of medicines. To achieve this goal used the methods of regulatory, documentary, comparative and graphical analysis. The increase in the cost of medical care leads to the fact that the state is increasingly thinking about containing costs. The level of co-financing by patients is growing, at the same time measures are being taken to limit the selling price of medicines. The existing system of reference prices promotes the entry of generics into the market and, apparently, this direction will develop. A characteristic feature of the health care and pharmaceutical supply system in the Nordic countries is coordination, which is implemented at different levels and in many forms. The organization of the circulation and accessibility of medicines for the population in Finland is based on covering the costs of medicines through the social insurance system, but with the participation of the state. The priority common aspects of the functioning of the national health care systems of the Scandinavian region remain: coordination between hospitals and definition of their areas of activity; coordination between general services and specialized assistance centers; coordination of the organization of drug circulation and medical care for certain categories of patients (privileged categories, patients with oncological diseases, etc.); coordination of pharmaceutical support and medical services for patients with chronic diseases (diabetes, etc.); coordination of long-term pharmaceutical provision and medical care for the elderly.

Mini Cleanroom for the Manufacture of Advanced Therapy Medicinal Products (ATMP): Bioengineered Corneal Epithelium.

Among several requirements for the manufacture of Advanced Therapy Medicinal Products (ATMP) are: following the guidelines of a pharmaceutical quality system, complying with Good Manufacturing Practice (GMP) and access to a cleanroom fulfilling strict environmental conditions (Class A work area and Class B environment). This makes ATMP expensive. Moreover, the production of many of these therapeutic products may also be unprofitable, as in most cases their use is limited to a few patients and to a single batch per manufacturing unit. To reduce costs, ATMP may be produced in a scaled-down system isolated from the external environment (isolator), allowing for placement of this facility in a Class D environment, which is much more permissive and less costly. In this work, we confirm that it is possible to manufacture bioengineered corneal epithelium inside an isolator while fulfilling all the safety assurance standards at an affordable cost for patients. This small-scale ultra-clean working environment complies with GMP guidelines and could be a solution for the high costs associated with conventional cleanroom ATMP production.

Tailoring drug co-delivery nanosystem for mitigating U-87 stem cells drug resistance.

Glioblastoma multiforme (GBM) is the most prevalent form of brain tumor, which generally has a poor prognosis. According to consensus, recurrence of the tumor and chemotherapy resistance acquisition are the two distinguishing features of GBM originated from glioblastoma stem cells (GSCs). To eliminate these obstacles inherent in GBM chemotherapy, targeting GSCs through a smart drug delivery system has come to the front position of GBM therapeutics. In this study, B19 aptamer (Apt)-conjugated polyamidoamine (PAMAM) G4C12 dendrimer nanoparticles (NPs), called Apt-NPs, were formulated for the co-delivery of paclitaxel (PTX) and temozolomide (TMZ) to U-87 stem cells. These drugs were loaded using a double emulsification solvent evaporation method. As a result, drug-loaded Apt-NPs significantly inhibited the tumor growth of U-87 stem cells, by the initiation of apoptosis via the downregulation of autophagic and multidrug resistance (MDR) genes. Additionally, by their downregulation by qPCR of CD133, CD44, SOX2, and the canonical Wnt/β-catenin pathway, cell proliferation has substantially decreased. Altogether, the results demonstrate that this intelligent drug co-delivery system is capable of effectively transferring PTX and TMZ to U-87 stem cells and without any toxic effect on Apt-NPs alone to U-87 stem cells. Furthermore, the designed dendrimer-based pharmaceutical system along with single-stranded B19 aptamer might be utilized as a new therapeutic strategy for the treatment of U-87 stem cells drug resistance in the GBM.

Experimental Design: Approaches and Applications in Development of Pharmaceutical Drug Delivery System

Conventionally, all the delivery systems have been prepared by methodology of trial and error concept by manipulating one variable at a Time, but attainment of optimal formulation is not achievable. The systematic approach Design of Experiments (DoE) enables researchers to provide appropriate outline to develop a best optimized delivery system. Optimization techniques using DoE helps to provide effective and economical analytical tools to find the perfect solution for a particular problem. In screening designs, there is large number of screening factors in minimum number of experiments and beneficial to minimize the variables in a desired size therefore further experimentation may be performed easily by using these variables. Experimental designs and optimization techniques are the tools which are systematically used to categorize various types of problems that may influence development of pharmaceutical delivery system. Use of experimental design is the best approach to the screening and optimization of experimental factors. In the present review article we have focused on application of practically applicable experimental designs and optimization techniques for the development of quality and efficacious of pharmaceutical formulations such as, nanoparticles, Phytosomes, microspheres, liposomes, micells, films, nanostructured lipid carriers and tablets and which type of factors to be considered while optimization are also discussed.
 Keywords: Experimental design, Optimization, Applications, Drug delivery, Phytosomes, Nano delivery System.