Medicines Management Research Articles

Implementation and operational management of marketed chimeric antigen receptor T cell (CAR-T Cell) therapy-a guidance by the GoCART Coalition Pharmacist Working Group.

Chimeric Antigen Receptor T cells (CAR-T cells) are a type of Advanced Therapy Medicinal Product (ATMP) classified as ex-vivo (cell-based) gene therapy. CAR-T cells constitute an immunotherapy that works by enabling T cells to specifically recognise cancer cells and destroy them [1]. CAR-T cells are currently licensed to treat certain blood cancers including relapsed or refractory lymphomas, B-cell acute lymphoblastic leukaemia or multiple myeloma [2]. The indications for their use are expanding and are expected to encompass other therapeutic areas. CAR-T cells are used both in children and adults [2]. CAR-T cells are biologic drugs and are therefore more complex than traditional medicinal products. T cells collected from the patient (or donor) are sent to a Good manufacturing Practice (GMP) manufacturing facility where they are genetically modified to contain a chimeric antigen receptor (CAR). This receptor is designed to recognise and target a specific protein on cancer cells. Once manufactured, they are delivered to the hospital where they are administered to the designated patient. Hospital pharmacies are central in the process of ensuring appropriate organisational governance, operational handling, clinical suitability, and pharmacovigilance [1, 3]. The GoCART Coalition Pharmacist working group's mission was to develop standards of care to advance the field of cellular therapies in Europe. The purpose of this document is to provide practical guidance on the implementation and safe operational use of marketed CAR-T cell products within hospital pharmacies primarily throughout Europe. This document outlines the key areas where pharmaceutical expertise should focus and the key considerations for the hospital pharmacy. Countries may have different requirements and there may be variation in practice between hospitals. This document is intended as a guide and the recommendations should be adapted to meet local requirements. This document does not provide clinical information relating to the use of CAR-T cell products. The Summary of medicinal Product Characteristics (SmPC) [4, 5], and national and international clinical guidelines (where in place) should be followed for the most up-to-date clinical management of CAR-T cell patients. An example is the UK "institutional readiness documents" for pharmacy which includes detailed checklists for each stage of the pathway [6]. Spain developed the Plan of Advanced Therapies in the National Health System: CAR medicines published in November 2018 [7], the CAR-T Medicines Management Procedure of the Spanish Society of Hospital Pharmacy [8] or the Hospital pharmacist's roles and responsibilities with CAR-T medicines article published also by the Spanish Oncology group of the Spanish Society of Pharmacy [9]. This guide has been designed to support the implementation of marketed CAR-T products; however, the principles may also be applicable to clinical trials. For CAR-T cell products being used in clinical trials, additional trial regulation and clinical trial protocols must be followed. This document is divided into two sections. Section 1 outlines considerations for hospital pharmacies during the implementation of a CAR-T cell service. Section 2 outlines the key operational considerations for hospital pharmacies in the patient and product pathway.

A case study of the impact of a dietitian in the multi-disciplinary team within primary care: a service evaluation.

Expanding the primary care workforce to alleviate general practitioner (GP) workload, improve access and improve quality of care is a current UK strategy. Evidence suggests dietitians can improve patient outcomes and make cost savings. The present study aimed to evaluate a dietitian working as an expert generalist and first contact practitioner (FCP) in a general practice multi-disciplinary team (MDT) to provide appropriate care to patients and reduce GP workload. A dietitian was employed for 6 months at 0.6 full-time equivalents in a group of general practices in Devon, UK. Data were collected on the referral source, patient satisfaction, health outcomes and changes in prescribing data for all patients seen by the dietitian. Focus groups and interviews provided data to understand the experience of introducing a dietitian into the team. This model of service delivery showed the dietitian acting as an expert generalist, a FCP and able to educate the MDT. A range of professionals within the MDT referred patients with a wide range of diagnoses (both paediatric and adults) and the dietitian acted as a FCP for 29% of patients. Saving were made for the optimisation of medicine management. The dietitian can improve patient-centred care for several patient groups; enhance learning for staff around nutrition and dietary issues; and contribute to more efficient working and cost savings around prescription of nutritional products. This was an evaluation of one service and further research is needed to understand the value dietitians can contribute and the factors supporting effective and efficient working in this context.

Acute Coronary Syndrome in Patients > 80 Was Due to Slow Flow, Only Few Severe Lesions: An Angiographic Coronary Flow and Machine Learning Analysis for Personalized Medicine Management

Acute Coronary Syndrome in Patients > 80 Was Due to Slow Flow, Only Few Severe Lesions: An Angiographic Coronary Flow and Machine Learning Analysis for Personalized Medicine Management

Assessment of the magnitude and contributing factors of expired medicines in the public pharmaceutical supply chains of Western Ethiopia

BackgroundThe magnitude of expired medicines in supply chains are increasing globally due to lack of strict control of the supply chain, poor storage management and oversupply of medicines. This situation is very serious in resource-poor countries, including Ethiopia, where the supply of medicines is limited. Therefore, this study aimed to assess the magnitude and the contributing factors of expired medicines in the Public Pharmaceutical Supply Chains of Western Ethiopia.MethodsExplanatory sequential study design involving mixed quantitative and qualitative approach were employed among 62 public pharmaceutical supply chains of Western Ethiopia from July1 to August 30, 2021. An observational checklist and the self-administered questionnaire were used to review all records of the expired medicine file and to abstract secondary data on the extent, types of expired medicines and its contributing factors. The collected data was cleared, filtered, and coded using Microsoft Excel® 2010, and exported to SPSS version-23 (Amsterdam, Netherland) for statistical analysis. Bivariate logistic regression was used to check association between the outcome and independent variables. Multivariate logistic regression was analyzed when p-value is less than or equal to 0.25 in bivariate binary logistic regression, considering the statistical at p-value < 0.05. Moreover, audio recordings were transcribed and coded for emergent themes using thematic analysis.ResultsThe study revealed 5% expire rate over past two financial (2012 up to 2013) years and the total amount of expired drugs is estimated at 20 million Ethiopian Birr (ETB). Tetanus antitoxin (TAT), in terms of single drug value, had the highest drug expiry (4,110,426.43ETB: 20%), followed by liquid dosage forms (11,614,266.11 ETB: 57%). The Binary logistic regression result indicated that, poor store management were more likely associated with the magnitude of expired medicine than those with good store management (COR: 10.706, 95% CI: 2.148, 53.348). Multivariate logistic regression revealed that poor store management (AOR: 9.718, 95% CI: 1.474, 64.082) was a significant contributor to the expire rate at 5% (P < 0.05). Most facilities did not have a procedure, and programme for disposing of expired medicines. According to key informants, inadequate inventory management, lack of policy and implementation of standards are the main contributing factors of the medicine's expiration.Conclusion and recommendationsThe current study found that the overall rate of medication expiration is high, at a significant cost to the budget. Inadequate inventory management, lack of policy, and implementation of standards are the main contributing factors to the medicine's expiration, as cited by key informants. Further research is necessary to determine the quality and efficacy of these expired drugs to extend their shelf life to ensure adequate access to drugs in resource-limited settings.

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.

A systematic review of models of patient engagement in the development and life cycle management of medicines

There is currently no universally agreed code of practice for patient engagement (PE), and existing guidelines do not fully cover the scope across medicine development and subsequent life cycle management. This review conceptualises the meaning and summarises the current models of PE. A systematic literature review was conducted and analysed by thematic synthesis. Eight themes were identified as components of how to achieve meaningful PE, and five were identified for where to engage with patients in drug development. This review provides summative guidance for stakeholders intending to introduce PE and establishes a starting point for the development of a universal code of practice.

Pursuing precision in medicine and nutrition: the rise of electrochemical biosensing at the molecular level.

In the era that we seek personalization in material things, it is becoming increasingly clear that the individualized management of medicine and nutrition plays a key role in life expectancy and quality of life, allowing participation to some extent in our welfare and the use of societal resources in a rationale and equitable way. The implementation of precision medicine and nutrition are highly complex challenges which depend on the development of new technologies able to meet important requirements in terms of cost, simplicity, and versatility, and to determine both individually and simultaneously, almost in real time and with the required sensitivity and reliability, molecular markers of different omics levels in biofluids extracted, secreted (either naturally or stimulated), or circulating in the body. Relying on representative and pioneering examples, this review article critically discusses recent advances driving the position of electrochemical bioplatforms as one of the winning horses for the implementation of suitable tools for advanced diagnostics, therapy, and precision nutrition. In addition to a critical overview of the state of the art, including groundbreaking applications and challenges ahead, the article concludes with a personal vision of the imminent roadmap.

Chronic pain management and a comprehensive approach for integration of Ayurveda with modern medicine

This paper aims to provide a comparative analysis of pain relief techniques for chronic pain management in Ayurveda and modern medicine. The analysis is based on available literature and evidence of efficacy. The paper also explores the commonalities between these disciplines and suggests methods for integrating both disciplines for effective pain management.

IKLAN OBAT KESEHATAN PADA SURAT KABAR LOKAL BINTANG BORNEO EDISI JANUARI-MARET 1929

Medicines are an important element in health services. In order to guarantee the availability of medicines, effective and efficient medicine management is needed which is supported by financial resources, human resources, information management, facilities and infrastructure. The health needs of the community are exploited by health service providers by advertising their health services in the mass media. Advertisements offering health services are increasingly widespread in print media, local radio and television. In print media, they generally advertise in the form of classified ads (small advertisements) whose rates are relatively different for each drug. There are quite a lot of advertisers every day in certain newspapers offering various medicines such as Sanatogen, Kalzan, Aspirin, Abdijsiroop, Purol and so on. This research, which uses a case study method with a qualitative approach, aims to find out regulations regarding health service advertising and health service practices that are advertised through advertisements in the local newspaper Bintang Borneo.

Physical Medicine and Rehabilitation Management in Patient with Loculated Empyema, Pleural Effusion et causa Chylothorax on WSD, Gastrointestinal Tuberculosis and History of Drop-Out Pulmonary Tuberculosis: A Case Report

Introduction: Tuberculosis (TB) is a lung disease caused by Mycobacterium tuberculosis (MTB), known for its high morbidity and mortality rate. When it infects organs outside the lungs, the condition is called extrapulmonary TB.&#x0D; Case report: A 52-year-old man who came to dr. Cipto Mangunkusumo hospital with worsening abdominal pain since a month ago. During the physical examination, tenderness in the right lower quadrant of the abdomen was felt. Furthermore, blood work showed leukocytosis and thrombocytosis. An X-ray examination revealed loculated pleural effusions. A WSD was placed, and pleural fluid analysis resulted in chylus. Sputum smears were negative. An abdominal CT scan revealed irregular thickening of the caecum wall extending to part of the large intestine and multiple surrounding lymphadenopathies. The patient was diagnosed with gastrointestinal TB and received category 1 anti-TB drugs.&#x0D; Conclusion: The patient also underwent pulmonary rehabilitation and had improvements at the end of the hospitalization period.&#x0D; Keywords: Extrapulmonary TB, Gastrointestinal TB, Loculated empyema, Pulmonary rehabilitation.

Non-Newtonian Slippery Nanofluid Flow Due to a Stretching Sheet Through a Porous Medium with Heat Generation and Thermal Slip

The domains of engineering, electrical, and medicine all have a significant demand for nanofluids. Applications for nanofluid flow include electronic device storage, industrial cooling and heating frameworks, and associated medicinal management information systems. Nanofluids are utilized generally as coolants in heat exchangers such as thermostats, electronic cooling systems, and radiators due to their enhanced thermal characteristics. This study aims to explain the mixed convection phenomenon’s applications on the thermal impact of Maxwell nanofluid. The mass diffusivity is supposed to be a function of concentration, whereas the thermal conductivity and viscosity of Maxwell nanofluid are assumed to be functions of temperature. It is recommended to consider the additional thermal effects of thermal slip, magnetic fields, and heat generation phenomena. The fluid flow motion was caused by the vertically stretched sheet. The dimensionless formulation of the suggested physical model is shown by the suitable variables interacting. The shooting approach is used in the numerical simulations, and it is based on lowering higher-order nonlinear differential equations to first-order. The slip velocity and the magnetic parameters have a direct impact on the local skin friction coefficient and velocity, as indicated by the research findings. Also, the increase in values of the Maxwell parameter, porous parameter, and viscosity parameter leads to the enhancement of temperature distribution, while the decline in velocity distribution can be attributed to the same factors. A comparison is also made with the results described in the literature that is currently available, and a superb agreement is discovered.

Evaluating the patient‐perceived impact of a neratinib special access program in an Australian community pharmacy

AbstractBackgroundIn Australia, breast cancer is the most commonly diagnosed cancer in women, and improved survival rates have placed an increased burden on the healthcare system. To better utilise community pharmacists in anticancer therapy, a medicine management service for neratinib was initiated in an Australian community pharmacy for patients with breast cancer.AimTo explore the experience and satisfaction of Australian breast cancer patients who received a pharmacist medicine management service for their neratinib treatment through a community pharmacy.MethodPatients enrolled in the neratinib special access program were invited to complete an electronic survey between February–September 2019. A mixed‐methods approach was utilised in data analysis. Ethics approval was granted by the University of Canberra Human Research Ethics Committee (Project No: 20181648).ResultsThirty‐three individuals completed the survey. A majority of participants (94%) were either ‘very satisfied’ or ‘satisfied’ with the time the pharmacist spent with them. As part of the service, 88% of participants viewed the first pharmacist session as ‘absolutely’ worthwhile and 79% believed that the pharmacist interaction increased their understanding of neratinib therapy. Many participants supported the continued provision and expansion of the service (88%).ConclusionThis pilot study provided valuable insights into participants' experiences of a pharmacist medicine management service for neratinib therapy. The unique preferences and health information needs of patients were highlighted. Further investigation is needed to explore how community pharmacists may be best utilised to improve breast cancer care and support patient needs.

Data on Mapping 444 Dairy Small Ruminant Farms during a Countrywide Investigation Performed in Greece.

The small ruminant industry is the most important branch of Greek agriculture. Nevertheless, despite the importance of small ruminant farming for Greece, no detailed mapping of the respective farms has been undertaken and published. The present work refers to mapping the dairy sheep and goat industry in Greece through an extensive, countrywide cross-sectional study, in which information was obtained from 325 sheep and 119 goat farms. The objectives were the collection, the classification and the presentation of data obtained from all these farms through interviews, using a questionnaire and through examination of samples collected during the visits. All the farms enrolled in the study were visited by the investigators. Initially, information was obtained by means of a detailed, structured questionnaire with 442 questions. Moreover, samples of milk were collected from the bulk-tank of each farm and faecal samples were collected from female animals in each farm. The milk samples were processed for cytological and microbiological examination. Staphylococcus spp. and Listeria spp. isolates were recovered and identified at a species level; furthermore, a full antibiotic sensitivity pattern assessment was conducted. Faecal samples were processed by standard parasitological tests for the identification of protozoan, trematode, cestode and gastrointestinal and respiratory nematode parasites. The paper presents the cumulative findings of the study, i.e., the answers to the questions during the interviews and the results of the laboratory examinations performed in the samples; the findings are presented separately for sheep and goat farms. The findings can be used as baseline measurements; individual farms and cohorts of farms can be compared against the current results to draw conclusions against the countrywide situation. Moreover, the current results can be used as reference points for the future, in order to assess changes that might have occurred in the meantime. The study also described the differences between farms with sheep or goats; in total, differences in 137 parameters were identified. Some of these can be attributed to the different management systems practiced; sheep flocks are managed mostly under the intensive or semi-intensive system, whilst goat herds are managed mostly under the semi-extensive or extensive system. These findings can be useful in the health management of small ruminants, in providing evidence-based support and within the scope of precise livestock medicine and health management.

Literature Review: Pengelolaan Manajemen Logistik Dalam Pengadaan Obat Di Rumah Sakit Di Jabodetabek

The background of this Literature Review is based on stagnant events and stockouts of certain drugs at health care facilities in Jabodetabek which have had a detrimental impact on the location concerned. This study is used to analyze the management of drug logistics management in health care facilities in Jabodetabek. The Literature Review method uses 7 article sources from Google Scholar using the keywords drug procurement, logistics management, and hospital. The results obtained were that in several research locations there were several problems such as drug reserves, drug distribution, to the withdrawal and destruction of drugs which were directly related to the implementation of logistics management. The conclusion that can be drawn is that the management of logistics management of medicines in health care facilities in Jabodetabek is one of the conditions that must be carried out by every health service and is useful in providing good quality health services. If logistics management is carried out properly, this can increase the effectiveness and efficiency of services in health facilities and special attention is needed from various sectors to carry out logistics management of medicines in health care facilities according to existing standards.

Medicine Management System: Its Design and Development

Medicine Management System: Its Design and Development

Analysis on Validity and Academic Competency of Mock Test for Korean Medicine National Licensing Examination Using Item Response Theory

The national licensing examination is used to evaluate the medical competency at the time of graduation, however no study has been performed on the validity of traditional Korean medicine license examination yet. The purpose of this study was to develop learning analytics using item response theory (IRT) to examine the validity and academic competency of the mock test of the national licensing exam. Classical test theory and IRT were used to evaluate the validity of test items, and IRT was used for test validity and competency analysis. The correlation between competency score of 12 subjects was analyzed using Pearson’s correlation. The distribution of students’ latent competencies was examined by gender and administrative group using a Kernel density map, Latent Profile Analysis, and χ&lt;sup&gt;2&lt;/sup&gt;. The guessing parameter of 340 items was relatively high, and the information level of 12 subjects were relatively low. Significant correlations (r = 0.49–0.83, &lt;i&gt;p&lt;/i&gt; &lt; 0.05) were observed between the competency scores of total and 12 subjects. Two (high and low) latent academic competency groups were identified based on the competency score of 12 subjects. The low academic competency group requiring intensive management has a significantly higher frequency of male students with the experience of academic fail in the seven-year course. This study presented the quantitative learning analytics for the national licensing exam of traditional Korean medicine. The multifaceted item and test validities of the mock license test were provided, and an evidence-based approach to competency-based student management and national licensing exam of traditional Korean medicine was suggested.

Editorial introductions.

Editorial introductions.

Whole-course management of traditional Chinese medicine in the treatment of EGFRIs related skin toxicity in lung cancer: A series of clinical studies.

e21047 Background: Epidermal growth factor receptor inhibitors (EGFRIs) significantly prolong the survival of advanced lung cancer patients. Skin toxicities are the most common side effects caused by EGFRIs, which have the limited standard treatment, and seriously affect the long-term use of EGFRIs and the quality of life. Rash is the main type in the early stage of skin toxicity, and xerosis commonly complicated by pruritus usually occurs in the later stage regularly. Our team carried out a series of clinical studies, taking advantage of traditional Chinese medicine (TCM) in syndrome differentiation and treatment, to observe the efficacy and safety of TCM in the treatment of EGFRIs-related skin toxicity following in order. Methods: From September 2016 to September 2018, patients who occurred xerosis after using EGFRIs were enrolled and randomly divided into the treatment group and control group, respectively receiving Zizao Yangrong granules (ZYG) and placebo granules combined with vitamin E ointment. And then from August 2018 to September 2020, patients suffering from EGFRIs-related moderate to severe rash were enrolled and randomly divided into the treatment group and the control group, receiving Zhiyang Pingfu liquid and placebo liquid respectively, combined with minocycline and methylprednisolone for 14 days. Finally, based on the participants of the preliminary clinical trials, progression free survival (PFS) was determined by telephone follow-up every 3 months in patients with EGFRIs-related xerosis. Results: 66 patients finished the study of EGFRIs-related xerosis. The effective rates of xerosis among the treatment group and the control group were 84.8% and 69.7% (P &lt; 0.05). The patients in the experimental group had better quality of life than that in the control group (P = 0.045). 54 patients finished the topical TCM for moderate to severe rash study, which the effective rates among the treatment group and the control group were 81.48% and 55.56% (P = 0.040). The median total dose of oral minocycline administration in the treatment group was lower than that in the control group (1000mg vs. 1400mg). In the end, 54 patients who received ZYG were successfully followed up. The median PFS in the treatment group was 41.6 months, and 40.9 months in the control group (HR = 0.85, 95%CI 0.48~1.51, P = 0.586). The median DLQI score of the 19 patients who received ZYG more than 8 weeks was 6, significantly higher than 4 before treatment (P＜0. 001). Conclusions: TCM had the great efficacy and safety in the treatment of EGFRIs related dermal toxicity, significantly improving the quality of life for patients. Long-term application of TCM will not affect the PFS of EGFRIs. The series of clinical studies suggested that the whole-course management of TCM in the treatment of EGFRIs related skin toxicity can increase the overall benefit of advanced lung cancer patients. Clinical trial information: ChiCTR1800017053 .

롱코비드의 기능의학적 접근과 관리

Long COVID, also known as post-acute sequelae of SARS-CoV-2 infection or post-acute COVID-19 syndrome, refers to a range of symptoms and complications that persist more than 4 weeks after diagnosis. Common symptoms include fatigue, headache, anosmia, ageusia, chronic cough, shortness of breath, impaired concentration and memory, sleep disturbances, depression, anxiety, and hair loss. The incidence of long COVID varies according to the data, but it has been reported in 20% to 60% of acute COVID-19 patients. Despite its high incidence and significant medical and societal burden, there is currently no clear definition or objective diagnostic criteria for long COVID. Its diagnosis and treatment options are also limited due to insufficient evidence. Nevertheless, a functional medicine approach, through aspects such as adrenal fatigue, gut health, inflammation resolution, histamine imbalance, and vitamin D deficiency, can help long COVID patients. Blood tests, urinary organic acid profile, and food intolerance tests can be utilized, and lifestyle modification, oral or intravenous nutrition therapies can be implemented. In this article, we review the existing medical literature on long COVID and propose a functional medicine approach and management for long COVID.

Standing in the canine precision medicine knowledge gap: Improving annotation of canine cancer genomic biomarkers through systematic comparative analysis of human cancer mutations in COSMIC.

The accrual of cancer mutation data and related functional and clinical associations have revolutionised human oncology, enabling the advancement of precision medicine and biomarker-guided clinical management. The catalogue of cancer mutations is also growing in canine cancers. However, without direct high-powered functional data in dogs, it remains challenging to interpret and utilise them in research and clinical settings. It is well-recognised that canine and human cancers share genetic, molecular and phenotypic similarities. Therefore, leveraging the massive wealth of human mutation data may help advance canine oncology. Here, we present a structured analysis of sequence conservation and conversion of human mutations to the canine genome through a 'caninisation' process. We applied this analysis to COSMIC, the Catalogue of Somatic Mutations in Cancer, the most prominent human cancer mutation database. For the project's initial phase, we focused on the subset of the COSMIC data corresponding to Cancer Gene Census (CGC) genes. A total of 670 canine orthologs were found for 721 CGC genes. In these genes, 365 K unique mutations across 160 tumour types were converted successfully to canine coordinates. We identified shared putative cancer-driving mutations, including pathogenic and hotspot mutations and mutations bearing similar biomarker associations with diagnostic, prognostic and therapeutic utility. Thus, this structured caninisation of human cancer mutations facilitates the interpretation and annotation of canine mutations and helps bridge the knowledge gap to enable canine precision medicine.