Quality Assurance In Medicine Research Articles

Super-refractory status epilepticus, rhabdomyolysis, central hyperthermia and cardiomyopathy attributable to spinal anesthesia: a case report and review of literature

BackgroundThere are only six past reports of super-refractory status epilepticus induced by spinal anesthesia. None of those patients have died. Only < 15 mg of bupivacaine was administered to all six of them and to our case. Pathophysiology ensuing such cases remains unclear.Case presentationA 27 year old gravida 2, para 1, mother at 37 weeks of gestation came to the operating theater for an elective cesarean section. She had no significant medical history other than controlled hypothyroidism and one episode of food allergy. Her current pregnancy was uneventful. Her American Society of Anesthesiologists (ASA) grade was 2. She underwent spinal anesthesia and adequate anesthesia was achieved. After 5–7 min she developed a progressive myoclonus. After delivery of a healthy baby, she developed generalized tonic clonic seizures that continued despite the induction of general anesthesia. She had rhabdomyolysis, one brief cardiac arrest and resuscitation, followed by stress cardiomyopathy and central hyperthermia. She died on day four. There were no significant macroscopic or histopathological changes in her brain that explain her super refractory status epilepticus. Heavy bupivacaine samples of the same batch used for this patient were analyzed by two specialized laboratories. National Medicines Quality Assurance Laboratory of Sri Lanka reported that samples failed to confirm United States Pharmacopeia (USP) dextrose specifications and passed other tests. Subsequently, Therapeutic Goods Administration of Australia reported that the drug passed all standard USP quality tests applied to it. Nonetheless, they have detected an unidentified impurity in the medicine.ConclusionsAfter reviewing relevant literature, we believe that direct neurotoxicity by bupivacaine is the most probable cause of super-refractory status epilepticus. Super-refractory status epilepticus would have led to her other complications and death. We discuss probable patient factors that would have made her susceptible to neurotoxicity. The impurity in the drug detected by one laboratory also would have contributed to her status epilepticus. We propose several possible mechanisms that would have led to status epilepticus and her death. We discuss the factors that shall guide investigators on future such cases. We suggest ways to minimize similar future incidents. This is an idiosyncratic reaction as well.Graphical

Development and progress of the National Autopsy Network (NATON)

Autopsies have long been considered the gold standard for quality assurance in medicine, yet their significance in basic research has been relatively overlooked. The COVID-19 pandemic underscored the potential of autopsies in understanding pathophysiology, therapy, and disease management. In response, the German Registry for COVID-19 Autopsies (DeRegCOVID) was established in April 2020, followed by the DEFEAT PANDEMIcs consortium (2020-2021), which evolved into the National Autopsy Network (NATON). DeRegCOVID collected and analyzed autopsy data from COVID-19 deceased in Germany over three years, serving as the largest national multicenter autopsy study. Results identified crucial factors in severe/fatal cases, such as pulmonary vascular thromboemboli and the intricate virus-immune interplay. DeRegCOVID served as acentral hub for data analysis, research inquiries, and public communication, playing avital role in informing policy changes and responding to health authorities. Initiated by the Network University Medicine (NUM), NATON emerged as asustainable infrastructure for autopsy-based research. NATON aims to provide adata and method platform, fostering collaboration across pathology, neuropathology, and legal medicine. Its structure supports aswift feedback loop between research, patient care, and pandemic management. DeRegCOVID has significantly contributed to understanding COVID-19 pathophysiology, leading to the establishment of NATON. The National Autopsy Registry (NAREG), as its successor, embodies amodular and adaptable approach, aiming to enhance autopsy-based research collaboration nationally and, potentially, internationally.

Quality Assurance of Medicines: Main Scientific Approaches and Control Methods

The most important component of national health policy is the assurance of quality, efficacy, and safety of medicines entering the pharmaceutical market in the Russian Federation. In this interview, we have discussed the quality control of medicines; its interconnections with various branches of science, in particular, with analytical chemistry; and the matters of material and equipment supply with Elena L. Kovaleva (Doctor of Pharmaceutical Sciences, Deputy Director of the Centre for Medicinal Products Evaluation and Control of the Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation), Yuri A. Zolotov (Academician of the Russian Academy of Sciences, Full Professor, Doctor of Chemical Sciences), and Dmitry V. Somov (Candidate of Pharmaceutical Sciences, Acting Director General of the Information and Methodological Center for Expertise, Accounting, and Analysis of the Circulation of Medicinal Products of the Federal Service for Surveillance in Healthcare).

Educational methods and technologies in pharmaceutical personnel training programs

The introduction of modern effective technologies and teaching methods is an urgent problem in the training of pharmaceutical personnel. Unfortunately, the main directions of the pharmaceutical industry, such as management, development and quality assurance of medicines, especially the development of technologies for industrial pharmaceutical production, are currently significantly ahead of the pace of development of pharmaceutical education. It should be noted that the purpose of higher and postgraduate education is not only the training of in-demand personnel, but also a look into the future, research and technology transfer, knowledge about the future. In order to bring together the content of the training program and the modern requirements of the pharmaceutical industry for graduates, it is necessary to search and implement effective approaches in training. To this end, in our work we present the experience of implementing project-oriented and dual training in different courses for students of the pharmaceutical training program. The discussion presents the results of the analysis of the implementation processes, the analysis of the problems encountered in the work.

An absence of evidence breeds contempt: A qualitative study of health system stakeholder perceptions of the quality of medicines available in Senegal.

Poor-quality medicines pose a significant challenge for health systems in low- to middle-income countries (LMICs),with recent deaths in multiple countries following ingestion of substandard cough syrups emphasising the need for quality-assurance of medicines in our increasingly interconnected global markets. Research also suggests that the source (country of manufacture) and type of medicine (generic/brand) are perceived to be associated with medicine quality. This study explores perceptions of medicines quality among national stakeholders of a medicines quality assurance system (MQAS) in sub-Saharan Africa. Through semi-structured interviews (n = 29) with managers from organisations responsible for the MQAS, public-sector doctors and nurses, and regulated private-sector pharmacists in three urban centres in Senegal in 2013. A thematic approach to analysis was undertaken with themes organised under three main categories, the source of drugs, the type of medicine, and medicines storage. A key emerging theme was the perception of the inferior quality of generic medicines, especially those produced in Asia and Africa, as they were lower in cost and thus believed to be less effective in alleviating symptoms than their brand versions. Medicines in Senegal's less regulated (informal) street markets were also thought to be of poor-quality as they were not subjected to national regulatory processes or stored appropriately, resulting in exposure to direct sunlight and high temperatures. In contrast, the interviewees expressed confidence in medicines quality within the regulated sectors (public and private retail pharmacies) attributed to stringent national medicines regulation, secure medicines supply chains and adequate technical capacity to survey and analyse for medicines quality. Also, the views expressed typically described a medicine's quality in terms of its effectiveness in alleviating the symptoms of ill health (efficacy of a medicine).These perceptions may have implications for developing national medicines policy, the procurement and supply of affordable medicines and consumers' decision-making when purchasing medicines. Indeed, a proclivity for supplying and purchasing more expensive brand medicines may act as a barrier to accessing essential medicines.

Phytopharmaceutical practices of traditional health practitioners in Burkina Faso: a cross-sectional study

BackgroundTraditional health practitioners constitute an important part of the health care system in Burkina Faso, particularly in the supply of traditional herbal medicines. Quality and safety of these medicines rely heavily on practices employed during their traditional development. However, traditional phytopharmaceutical practices are poorly described in Burkina Faso. This study aimed to describe the phytopharmaceutical practices of traditional medicine practitioners in Burkina Faso.MethodsThis was a cross-sectional descriptive ethno-pharmaceutical study, conducted from October 1 to November 30, 2020, among traditional practitioners in four randomly selected health districts: Nongr-Massom (Centre region), Tenkodogo (Centre-East region), Diapaga (East region) and Dafra (Hauts-Bassins region). An anonymous semi-structured face-to-face questionnaire was used to collect socio-demographic data and data on raw materials and finished products.ResultsSixty-seven (67) traditional health practitioners, aged 56 years on average, including a majority of men (72%), participated in the study. Gathering of wild medicinal plants was the main source of raw materials acquisition (51.5%), which were usually leaves (32.3%). These raw materials were usually sun-dried (43.9%) and packaged mostly in plastic bags (37.2%). They were derived from 60 plant species belonging to 33 botanical families. Fabaceae was the most represented family (18.7%) and Khaya senegalensis Juss. (Meliaceae) the most cited plant species (5.2%). The finished products had an average shelf life of 17 months and were usually prepared as a decoction (31.7%) and administered most often orally (71.4%). Gastrointestinal disorders were the main predictable adverse events of the finished products (54%).ConclusionThis study showed that THPs have important knowledge in the use of medicinal plants, but several shortcomings are observed in their phytopharmaceutical and plant protection practices. Continuous improvement of these practices, through education and training of traditional health practitioners, is essential for the conservation of plant biodiversity and quality assurance of traditional herbal medicines.

Editorial du Professeur Serigne Omar Sarr

Dear readers, Dear authors ! The second publication of your quarterly journal is available on time thanks to the commitment of the peer reviewers, the publisher (Presses Universitaires de Dakar), the scientific and editorial committees and the Secretariat which made it possible to proceed within the planned deadlines and in scientific rigor, the evaluation and publication process. This volume 2, number 1 includes eight scientific articles submitted by young authors but also seasoned seniors which contributes to the transparent and equitable dissemination of science in open access. These original articles indexed in Scopus address medicinal and food plants, the optimization and validation of analytical methods for drug control, the quality of powdered milk sold in Dakar, the accessibility and quality of water in Mboro (Senegal), the quality of honeys from Casamance (Senegal), the continuing training of community pharmacists in particular. In the format of a Letter to the Editor, we are publishing a contribution from the American Pharmacopoeia through the PQM+ (Promoting the Quality of Medicines) team which sheds light on the problem of quality assurance of medicines in Africa South of the Sahara and the levels of performance/recognition of skills of official structures responsible for controlling the quality of medicines and other health products. The main results of this example of practical North-South cooperation are shared and bring a bit of hope in the fight against substandard/falsified medical products for better protection of population health through i) an efficient quality control infrastructure and ii) accessibility to quality, safe and effective medical products. This present issue pursues the objective of this journal which offers an opportunity to make Africa's scientific writing resonate more in a globalized world in which multidisciplinary and transversal analytical sciences are at the heart of any process of competitiveness, regulation and development. We thank the entire editorial team and peer reviewers for their collaboration. To your manuscripts and excellent reading!

Pregnancy Complications in Women With Pregestational and Gestational Diabetes Mellitus.

Diabetes mellitus (DM) is a major risk factor for complications of pregnancy. Based on information for all inpatient births in Germany, we assessed the risks for selected pregnancy complications in women with pregestational diabetes mellitus (preDM) or gestational diabetes mellitus (GDM). The underlying data comprised all singleton births contained in the inpatient perinatal medicine quality assurance statistics for the years 2013-2019. The frequencies of premature birth, elevated birth weight (large for gestational age, LGA), cesarean section, transfer of the newborn to the perinatal unit, and stillbirth were stratified by maternal age and diabetes status (preDM, GDM, no DM). Poisson regression was used to calculate the relative risks (RR) with 95% confidence intervals (95% CI) for the whole period and for each individual year in women with preDM or GDM relative to women without DM. Among the 4 991 275 singleton births included, GDM was documented in 283 210 (5.7%) and preDM in 46 605 (0.93%) cases. GDM was associated with higher RR for premature birth (1.13 [1.12; 1.15]), LGA (1.57 [1.55; 1.58]), cesarean section (1.26 [1.25; 1.27]), and transfer of the newborn (1.54 [1.52; 1.55]). These associations were even stronger in women with preDM: premature birth (2.13 [2.08; 2.18]), LGA (2.72 [2.67; 2.77]), cesarean section (1.62 [1.60; 1.64]), transfer of the newborn (2.61 [2.56; 2.66]). PreDM increased the risk of stillbirth (RR: 2.34 [2.11; 2.59]); GDM was associated with a lower risk (RR: 0.67 [0.62; 0.72]). For women with preDM, the risk of pregnancy complications increased over the study period. GDM and preDM are still associated with elevated risks of pregnancy complications. In the case of preDM, the risks may be attributable to the fact that the hyperglycemia is more severe and is already present before conception. Continuous monitoring should include risk factors in pregnant women and care-relevant aspects.

An Updated Review on Quality Aspects of Herbal Drug and its Formulation

Since a very long time ago, medicinal plants have been used to improve human health. Today, they are becoming more and more widely used as pharmaceuticals, supplementary and alternative therapies, food supplements, cosmetics, and, more surprising, medical gadgets. To assess a high-quality medicine, herbal formulations must be standardised. The total of all elements that directly or indirectly affect the safety, efficacy, and acceptability of the drug product makes up the quality of a herbal drug. The field of herbal drugs and formulations is developing quickly nowadays, and there is still much to learn about the standardisation of these products. However, the lack of a standardised parameter hurts herbal treatment. The major limitations are the lack of standardised raw materials, processing methods and of the final product , product formulation and lack of final products, product formulations, and lack of predetermined criteria for quality assurance. By applying current, suitable GMP standards, it is essential to evaluate the regulation of herbal medicine in order to ensure the quality, safety, and efficacy. The role of various spectroscopic, chromatographic, and electrophoretic methods in the standardisation and good quality assurance of herbal medicines and products was also discussed

The integrity of the antimicrobial supply chain in Bangladesh: assessing the regulatory environment and contextual challenges.

Most low- and middle-income countries lack theregulatory capacity to contain substandard and falsified (SF) medicines. Innovations for strengthening regulatory systems are needed to protect public health. We assessed the integrity of the antimicrobial supply chain in Bangladesh. We employed qualitative methods comprising policy content analysis, and literature and database reviews. Using a framework modified from the World Health Organization's and the United States Pharmacopoeia's, the Bangladesh National Drug Policy (BNDP), was evaluated forprovisions on medicinesquality assurance mechanisms. We used newspaper, peer-reviewed, and post-marketing surveillance reports to assess prevalence of SF antimicrobials. The BNDP contains provisions for quality assurance. Newspaper reports identified circulation of substandard antimicrobials. We identified only six peer-review studies testing antimicrobial product quality with three studies reporting out-of-specifications products. We suggest three strategies for strengthening the regulatory system: community-based surveillance, task shifting, and technology-enabled consumer participation.

Finding the optimal tube current and iterative reconstruction strength in liver imaging; two needles in one haystack.

ObjectivesThe aim of the study was to find the lowest possible tube current and the optimal iterative reconstruction (IR) strength in abdominal imaging.Material and methodsReconstruction software was used to insert noise, simulating the use of a lower tube current. A semi-anthropomorphic abdominal phantom (Quality Assurance in Radiology and Medicine, QSA-543, Moehrendorf, Germany) was used to validate the performance of the ReconCT software (S1 Appendix). Thirty abdominal CT scans performed with a standard protocol (120 kVref, 150 mAsref) scanned at 90 kV, with dedicated contrast media (CM) injection software were selected. There were no other in- or exclusion criteria. The software was used to insert noise as if the scans were performed with 90, 80, 70 and 60% of the full dose. Consequently, the different scans were reconstructed with filtered back projection (FBP) and IR strength 2, 3 and 4. Both objective (e.g. Hounsfield units [HU], signal to noise ratio [SNR] and contrast to noise ratio [CNR]) and subjective image quality were evaluated. In addition, lesion detection was graded by two radiologists in consensus in another 30 scans (identical scan protocol) with various liver lesions, reconstructed with IR 3, 4 and 5.ResultsA tube current of 60% still led to diagnostic objective image quality (e.g. SNR and CNR) when IR strength 3 or 4 were used. IR strength 4 was preferred for lesion detection. The subjective image quality was rated highest for the scans performed at 90% with IR 4.ConclusionA tube current reduction of 10–40% is possible in case IR 4 is used, leading to the highest image quality (10%) or still diagnostic image quality (40%), shown by a pairwise comparison in the same patients.

Point-of-care testing in primary healthcare: a scoring system to determine the frequency of performing internal quality control.

Internal quality control (IQC) plays an important role in quality assurance in laboratory medicine. However, there is no universal consensus or guideline on when and how IQC should be analyzed on point-of-care testing (POCT) devices. The aim of this study was to develop a scoring system to determine how often IQC should be analyzed in primary healthcare on the various POCT devices. Based on a systematic literature review and a thorough process involving the whole Noklus, a nationwide POC organization, a scoring system for when to analyze IQC was developed. Four factors were considered to significantly impact IQC frequency: The importance of the analyte in diagnosing and monitoring patients, type of POCT device, user-friendliness, and number of patient samples. For each POCT device, the first three factors were given a score, and the sum of the scores determined the general recommended IQC frequency. The number of patient samples determined whether and how to adjust these frequencies in each individual general practice. The scoring system was applied to 17 analytes and 134 different POCT devices (153 analyte-device combinations). Most of the devices analyzing high-risk analytes (71 out of 74) obtained daily or weekly IQC frequency. For example, all blood-cell counters and all glucose meters should undergo IQC daily and weekly, respectively. This study presents a consensus-based scoring system for differentiated and device-specific recommendations for IQC frequency on POCT devices in primary healthcare. The scoring system can easily be adopted to other local environments and is easy to use.

Establishment of the German Burn Registry - five years of prospective data collection

BackgroundFrom 1991–2014, all major burn centers of the German-speaking countries participated in a multicenter study in which essentially demographic data were collected. Individual patient data was located at the particular burn centers and only cumulated data were summarized annually for presentation. Retrospective statistical analysis of the entire data collection and identification of subgroups was not possible. In 2015 the German Burn Registry was established for prospective collection of individual patient data as a tool for quality management (QM) and for scientific analyses. MethodsA working group was formed to ensure the development and administration of the registry. From the official start of the German Burn Registry at the beginning of the year 2015 prospective data collection was realized with an individualized, web-based data collection software in a pseudonymized way. Selected data analysis was performed for the first 5 years of data collection. Severely burned adults and all hospitalized children with burn injuries were documented in the registry. ResultsThe German Burn Registry was successfully established. 64 burn divisions have already been registered. 18,891 patients were documented over 5 years, of which 58% where children (<16 years). Mean ABSI Score was 4 (children: 3, adults: 6) with a mortality rate of 3.8.0% (children: 0.2%, adults: 9.3%). Children were hospitalized for an average of 7 days, whereas adults were discharged after 18 days. ConclusionA registry is mandatory for quality assurance in burn medicine, since realization of randomized studies is difficult due to the heterogeneity of burn injuries. The German Burn Registry already is one of the biggest burn registries in Europe. Several scientific projects, based on the registry database, are in working process or have already been published.

Study of the advantages and risks of electronic retail trade in medicines

One of the most important issues of interest to scientists and practitioners of pharmacy is medicines quality assurance at all stages of their life cycle. From 2021 in Ukraine, the retail trade of medicines via the Internet was allowed. The system of electronic (distance) retail trade (ERT) has its obvious advantages for consumers of pharmaceutical services, but also its potential risks for the medicines quality being sold.&#x0D; The aim of the study is analysis of legislative innovations on ERT in medicines, determination of advantages and possible problems of ERT in medicines, identification of potential risks to the medicines quality during ERT and determination of organizational and practical measures to prevent and minimize them.&#x0D; The research materials were scientific publications, legislative and regulatory acts of Ukraine and the EU, public information of public authorities and pharmaceutical enterprises, data from own observations. The following methods were used in the work: system and content analysis, generalization, systematization, structural-logical, visual-graphic.&#x0D; The analysis of sources of scientific and professional literature showed that domestic and foreign scientists have studied the legal, socio-economic and marketing aspects of ERT in medicines. We studied this issue from the standpoint of quality assurance and risk management for the medicines quality.&#x0D; The paper provides a system and content analysis of legislative innovations on ERT in medicines, summarizes and systematizes the general and special requirements for the procedure for ERT in medicines, identifies the advantages and possible problems of ERT in medicines. The structural and logical scheme of the ERT in medicines process is developed. It is proposed to use this scheme as a basis for the regulation and documentation of the ERT in medicines process by developing appropriate regulatory and instructional documents (regulations or techniques for performing the process, standard operating procedures, work instructions, etc.).&#x0D; According to the research results, the potential risks for the medicines quality in the conditions of ERT are identified and the complex of organizational and practical measures for their prevention and minimization is determined. It is proposed to implement this complex in the overall risk management process for the medicines quality and pharmaceutical services, which should be an integral part of the quality management system of the pharmaceutical enterprise that performs ERT in medicines. These measures should be taken into account when developing standard operating procedures for different stages of ERT in medicines and documentation on risk management for the medicines quality (passports of risk profiles, risk register, risk management plan, etc.).

English

Many claims from herbal medicines have been developed to manage COVID-19. Tests for identity and purity are important parameters in the quality assurance of herbal medicines. The aim of this study is to confirm the presence of Artemisia annua as a component of COVID-ORGANICS, an acclaimed herbal product for the management of COVID-19 in comparism with A. annua cultivated at NIPRD, Abuja, Nigeria. Pharmacognostic and physicochemical investigations, thin layer and high-performance Liquid chromatography of Covid-Organics along with A. annua were carried out using standard procedures. Similar microscopic features viz T-shaped, glandular, unicellular and uniseriate trichomes, wavy epidermal cells with anomocytic stomata and prismatic calcium oxalate crystals characteristic of A. annua were observed. Moisture, total ash and sulphated ash contents ranged from 8.5 &plusmn; 0.0 to 10.4 &plusmn; 0.2%w/w; 7.8 &plusmn; 0.5 to 12.1 &plusmn; 0.1%w/w and 9.7 &plusmn; 0.3 to 15.9 &plusmn; 0.4%w/w, respectively while water and alcohol soluble extractive values ranged from 20.6 &plusmn; 0.5 to 33.7 &plusmn; 0.7%w/w; and 23.4 &plusmn; 0.6 to 38.2 &plusmn; 0.6%w/w respectively. TLC and HPLC profiles showed artemisinin in evaluated samples. The findings confirm that Covid-Organics contain A. annua. The domestication of A. annua in Nigeria along with studies carried out has shown the capacity and technical know-how to develop a phytomedicine from A. annua for management of COVID-19 associated symptoms. This is possible with the provision of the enabling environment in order to provide medicines&rsquo; security. Relevant policies are therefore needed to prioritise the development of the sector. Key words: Covid-Organics, Artemisia annua, pharmacognostic studies, chromatographic fingerprint

Problems of false medicines' distribution and prospects of combat: survey of specialists and consumers results

The aim: comparative analysis of the results of a questionnaire survey of pharmaceutical and medical professionals and consumers, conducted by the authors during 2019-2021 to identify opinions on which there are coincidences and differences, as well as an assessment of the problem of drug counterfeiting in Ukraine to develop approaches to prevent their spread.&#x0D; Materials and methods. The study used scientific publications, as well as the results of a survey of specialists of the State Service of Ukraine for Medicines and Drug Control (State Medical Service) and its territorial bodies, pharmaceutical and medical professionals of health care institutions and consumers on the fight against drug falsification. The research was conducted using the methods of questionnaires, systematization and generalization.&#x0D; Results. According to the results of a comprehensive questionnaire during 2019-2021, it was found that the share of CM in the Ukrainian pharmaceutical market is estimated at 5 % by a majority of respondents on average 58.5 %, including 59.7 % of experts of the State Medical Service, 42.3 % of pharmacy specialists, 11.4 % by doctors and 73.5 % by consumers. Respondents' answers about the signs of drug falsification differ significantly, so most experts believe that this is a change in the usual signs (taste, smell, color), while pharmacy specialists - labelling in a foreign language, doctors - no therapeutic effect, for consumers it is a change in packaging design (labels) and a significantly lower price. The main sales channels of CM for experts and pharmacy specialists are e-commerce (68.7 % and 75.7 %, respectively), while the majority of consumers could not determine.&#x0D; Many experts and pharmacy specialists pointed to the need to introduce special security features of packaging in the form of 2d barcodes as the main method for protection and detection of CM (79.1 % and 39.6 %, respectively). Most of the surveyed pharmacy workers and consumers believe that the risk of purchasing counterfeit drugs is higher in the pharmacies of individual entrepreneurs or small pharmacy chains.The main problem that hinders the effective fight against drug counterfeiting was the imperfect legislation (68.7 %). Regarding effective tools in the fight against counterfeit drugs, experts called a significant strengthening of the powers of the regulatory body - following the example of the FDA (70.1 %).&#x0D; Conclusions. It is established that the most important priorities of the state policy for combating CM in Ukraine are the improvement of the system of state control and quality assurance of medicines, in particular 2d coding, as well as the need to strengthen the responsibility for drug falsification. The results of research on the problem of drug falsification indicate the feasibility of introducing a systematic survey for a wider range of respondents - professionals and consumers

A conversation between hyphenated spectroscopic techniques and phytometabolites from medicinal plants.

Medicinal plant metabolomics has emerged as a goldmine for the natural product chemists. It provides a pool of bioactive phytoconstituents leading to accelerated novel discoveries and the elucidation of a variety of biosynthetic pathways. Further, it also acts as an innovative tool for herbal medicine's scientific validation and quality assurance. This review highlights different strategies and analytical techniques employed in the practice of metabolomics. Further, it also discusses several other applications and advantages of metabolomics in the area of natural product chemistry. Additional examples of integrating metabolomics with multivariate data analysis techniques for some Indian medicinal plants are also reviewed. Recent technical advances in mass spectrometry-based hyphenated techniques, nuclear magnetic resonance-based techniques, and comprehensive hyphenated technologies for phytometabolite profiling studies have also been reviewed. Mass Spectral Imaging (MSI) has been presented as a highly promising method for high precision in situ spatiotemporal monitoring of phytometabolites. We conclude by introducing GNPS (Global Natural Products Social Molecular Networking) as an emerging platform to make social networks of related molecules, to explore data and to annotate more metabolites, and expand the networks to novel "predictive" metabolites that can be validated.

The current state of the pharmaceutical market of Ukraine, quality assurance and falfication of medicines

The aim of our article was the study of the current state of the pharmaceutical market of Ukraine in the context of the quality assurance of medicines and preventing the spread of falsified medicines (FM), the identification of the main problems in the field of circulation of medicines and the ways to solve them. It is established that the dynamic development of the pharmaceutical market and its high profitability cause problem of drug quality, increasing threats to the spread of FM in circulation and require the implementation of effective mechanisms for regulation of quality and safety of medicines. Analysis the annual official statistics of the State Service of Ukraine on Medicines and Drug Control for the period of 2008–2019 on the number of detected FM in circulation showed a steady trend of increasing FM and insufficient implementation of effective measures to combat them. The creation of effective quality assurance system of drugs and preventing the spread of FM need to improve the organization of state control of drug quality, strengthening criminal liability for falsification of drugs and optimization of the system of their detection.

QUALITY ASSURANCE OF MEDICINES: THE STATE AND TRENDS OF THE EUROPEAN UNION AND UKRAINE LEGISLATION DEVELOPMENT

The aim: Scientific substantiation of the state and tendencies of development at the present stage of the legislation of the European Union and Ukrainian legislation on quality assurance of medicines. Materials and methods: Using the biblio-semantic, systematic-review, analytical, formal-legal and comparative-law methods, the individual regulatory sources of pharmaceutical legislation of the EU and Ukraine were studied. Conclusions: The paper identifies that pharmaceutical legislation of the EU and Ukraine on quality assurance of medicines at the present stage of their development have common features, which include the number, disorder of existing legal acts, which creates conflicts between them and the potential for gaps in regulation. The main trend in the development of this legislation in the EU and Ukraine is the disparity of legal acts and the lack of significant legislative efforts to codify them.

The hospital as a sorting machine

Large hospitals sort patients into wards or clinics based on a number of factors. The information of a patient’s location is potentially useful in a number of medical contexts. By demonstrating and studying the sorting that occurs in a hospital, we show that each ward has characteristic signatures emergent from the blood test results associated with patients in those wards. We further demonstrate the utility of this information to fundamental research by evaluating the distribution of serum alanine aminotransferase, a liver enzyme hypothesised to be linked to heart disease. We demonstrate the creation of classifiers to determine to which ward a patient is assigned with greater than 60 % accuracy within the first three prioritised predictions across 28 wards. This study is extended to predict patients’ movements from intake wards through to destination wards as a proof-of-concept into patient routing. We propose that this study provides a basis for leveraging metadata in a number of fields, including: fundamental research, laboratory medicine quality assurance, hospital and admissions management, and patient triage.