Search Results (118)

This study describes the development and validation of a fully automated workflow for serum sample preparation, enabling the quantitative determination of cannabidiol (CBD) and its active metabolite, 7-hydroxy-CBD, via liquid chromatography coupled with tandem mass spectrometry (LC–MS/MS) analysis. Implemented on an automated platform, the workflow performs key steps such as solvent dispensing, mixing, centrifugation, filtration, and supernatant transfer, producing 96-well plates ready for analysis. Human serum samples were obtained from patients with epilepsy treated with CBD. All samples were processed using both manual and automated methods to evaluate method agreement. Quantification was performed by LC–MS/MS with CBD-d₃ as the internal standard (IS). Method validation was conducted in accordance with European Medicine Agency (EMA) guidelines, confirming that the automated protocol meets the recommended acceptance criteria for both intraday and interday precision and accuracy. Calibration curves demonstrated excellent linearity across the concentration ranges. Comparative analysis using Passing–Bablok regression and Bland–Altman plots demonstrated strong agreement between the methods. These findings support the clinical applicability of the automated method for the therapeutic drug monitoring (TDM) of CBD and 7-hydroxy-CBD, and its robust performance and scalability provide a solid foundation for the development of an expanded analytical panel covering a broader range of antiseizure medications (ASMs), enabling more standardized TDM protocols in clinical practice. Full article

Objectives: Scarce data are available regarding preventive medicine in forcibly displaced populations especially regarding non-communicable diseases like neoplasia, while even more limited data are available on Ukrainian refugees in Romania. To address this research gap, the present analysis was performed to investigate Ukrainian refugee women’s beliefs, attitudes, and opinions towards the Romanian and Ukrainian healthcare system in a comparison model while focusing on the HPV immunization rates and factors influencing the uptake for themselves and their children. Methods: Participants were recruited using the snowball sampling method through their General Practitioner (GP) and a health mediator. Results: In total, 105 women completed the online or physical survey. The mean age was 50 years. In total, 40% of women had not been to a gynecological check-up in 3 or more years, and more than 56% had never been screened. Only four were vaccinated against HPV, and none remembered which type of vaccine was dispensed or how many doses were utilized. The primary hindrances to accessing health services or immunization programs were language barriers, financial burdens, and a lack of information. Respondents’ general distrust of health systems and healthcare workforces were recurrent themes. Relationship status, living arrangements, and previous engagement in screening practices influenced immunization rates. Perceiving the healthcare officials as proactive concerning optional vaccination programs such as HPV immunization and actively receiving recommendations drove respondents to pursue vaccination. Conclusions: This analysis offers a foundational insight into the specific needs of refugee women. It can guide the development of effective public health interventions to improve health outcomes and vaccination rates among Ukrainian refugees in Romania. Tailored preventive campaigns with adequate native language information and prompts from medical experts in designated centers should be deployed to ensure inclusive tactics for vulnerable populations. Full article

First-line treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) is pharmacological but is associated with poor success rates in adults. The potential to discontinuously use stimulants may confound adherence assessment. Approximately 30–50% of adults with ADHD will experience depressive episodes, and associated treatment with antidepressants is generally recommended. It can therefore be expected that patients with a formal F90 diagnosis would show higher medication adherence than patients without a diagnosis and that the simultaneous use of antidepressants would increase adherence to ADHD medication. The primary aim was to explore the influence of factors of ADHD diagnosis and comorbid antidepressant use on stimulant adherence. A retrospective, longitudinal pharmacoepidemiological study was conducted on South African community pharmacy dispensing records for 2012–2016 for all patients aged between 18 and 40 years with any record of receiving a drug classified as “Central nervous system other” by the MIMS in 2015. Patients endorsed with an ADHD-linked diagnostic code (F90) were identified and contrasted with those receiving ADHD-indicated medication in the absence of a confirmatory diagnostic code. Two methods were applied to assess adherence to ADHD and/or depression treatment drugs: monthly medicine plotting and Proportion of Days Covered (PDC). Patients were classified as being more or less adherent based on monthly medicine plotting criteria. A study population of 89 patients was identified: 50 had F90 diagnostic codes and 39 were classified as “Non F90”. Adherence as measured based on PDC was generally higher for antidepressant use than for methylphenidate for patients classified as being more adherent. A trend towards higher consumption of antidepressants was shown for the treatment-adherent group. Diagnostic code distinction revealed significantly higher adherence rates to methylphenidate for F90 code patients. Adherence rates to antidepressants appeared to be generally higher for non-F90 patients. Many factors may influence adherence to ADHD-indicated drugs; however, the impact of a confirmed diagnosis may be a strong determinant of motivation to be adherent to ADHD pharmacotherapy. Full article

Background: On-demand personalized drug production is currently not addressed with large-scale drug manufacturing. In our study, we focused primarily on identifying possible active pharmaceutical ingredients (APIs) for 3D Printing (3DP) in the current healthcare setting. Methods: We conducted a retrospective cross-sectional study in the Netherlands using three different sources; community pharmacies (n = 5), elderly care homes (n = 3), and the Erasmus MC Sophia Children’s Hospital. The primary endpoint was the percentage of prescriptions of medication manipulated before administration, thereby being a candidate for 3DP. Around a million prescriptions were analyzed in our study. Results: This study shows that around 3.0% of the prescribed drugs dispensed by Dutch community pharmacies were manipulated before administration, while around 10.5% of the prescribed drugs in the Erasmus MC Sophia Children’s Hospital were manipulated prior to administration. Conclusions: With our study, we show that the most manipulated drugs come from the groups of constipation, psychopharmaceutical, cardiovascular, and anti-infectant drugs. Successful introduction of a compounded API drug by 3DP does not only rely on the API, but it also comes with an optimal balance between technical, economic as well as societal impact factors. Our study gives direction for potential future research on the introduction of 3DP of medicine in the healthcare setting. Full article

Background/Objectives: Vulvovaginal candidiasis (VVC) is a common cause of vaginitis. Over-the-counter drugs are usually dispensed by pharmacy professionals to treat this condition without prior medical consultation. This study aimed at assessing the knowledge of Portuguese pharmacy professionals regarding VVC. Methods: An online questionnaire including questions about the symptoms and treatment of VVC was distributed between March and April of 2024. Results: A total of 376 professionals participated in this study. There was a significantly lower proportion of men (p = 0.007) and pharmacy technicians (p = 0.005) who correctly identified the main causative agent of VVC when compared to women and pharmacists. Only 30% of women correctly identified the number of VVC episodes in the same year they classified as complicated, but this was significantly higher (p = 0.038) than the proportion of men who identified complicated VVC (20%). Topical clotrimazole preparations were the more frequently identified medicines for the treatment of uncomplicated VVC, and fluconazole-containing medicines were the preferred choice for the treatment of complicated VVC. Conclusions: This study highlights the need to improve education and training for pharmacy professionals. By addressing these knowledge gaps, pharmacists and pharmacy technicians can provide more accurate and effective advice to patients. Full article

Background: Type 2 diabetes is a chronic disease with high global prevalence and significant social and economic burden. The pandemic affected patients’ diagnostics and medicines dispensing. Diabetes was among the most-affected conditions during lockdown due to the limited resources and unaffordable medicines. The impact of the pandemic on utilisation and cost has not been thoroughly studied, which inspired us to conduct the current study. Objectives: The study explored cost dynamics, changes in antidiabetic medicines utilisation, and public expenditure of pharmacotherapy in three periods: pre-pandemic (2018–2019), during the pandemic (2020–2021), and post-pandemic (2022–2023). Methods: It is a retrospective, observational, macroeconomic analysis. Reimbursed cost and utilisation were analysed as a crude sum and as indexes of the average value. Results: The result shows that five new INNs have been included in the Positive Medicines List (PML), two of these being fixed dose combinations (FDCs). During the pandemic, a slow tendency of increase of the crude sum of public expenditure was observed, followed by a sharp increase in the post-pandemic period. The public spending increased more than twice, and we found a 30,018,982 Euro growth. The highest public spending is found for dapagliflozine in post-pandemic vs. pandemic period (index = 1.67), as well as empagliflozin/metformin and dapagliflozine in pandemic vs. pre-pandemic period (index = 0.21). Total utilisation increases from 58.16 to 71.78 DDD/1000 inh/day during 2018–2023. The most significant rise of utilisation is found for canagliflozin (index = 0.68) pandemic vs. pre-pandemic and dapagliflozin (index = 3.66) post-pandemic vs. pandemic. Conclusions: Analysis of the antidiabetic medicines market reveals the rising of reimbursed cost and utilisation in pre-, post-, and during the pandemic. In conclusion, organisation of the supply and financing of antidiabetic medicines was not affected during the pandemic. Full article

Pholiota nameko (T. Ito) S. Ito and S. Imai is an emerging wild mushroom species belonging to the genus Pholiota. Its unique brown–yellow appearance and significant biological activity have garnered increasing attention in recent years. However, there is a relative lack of research on the biological characteristics and genetics of P. nameko, which greatly limits the potential for an in-depth exploration of this mushroom in the research fields of molecular breeding and evolutionary biology. This study aimed to address that gap by employing Illumina and Nanopore sequencing technologies to perform whole-genome sequencing, de novo assembly, and annotation analysis of the P. nameko ZZ1 strain. Utilizing bioinformatics methods, we conducted a comprehensive analysis of the genomic characteristics of this strain and successfully identified candidate genes associated with its mating type, carbohydrate-active enzymes, virulence factors, pan-genome, and drug resistance functions. The genome of P. nameko ZZ1 is 24.58 Mb in size and comprises 33 contigs, with a contig N50 of 2.11 Mb. A hylogenetic analysis further elucidated the genetic relationship between P. nameko and other Pholiota, revealing a high degree of collinearity between P. nameko and ZZ1. In our enzyme analysis, we identified 246 enzymes in the ZZ1 genome, including 68 key carbohydrate-active enzymes (CAZymes), and predicted the presence of 11 laccases, highlighting the strain’s strong potential for cellulose degradation. We conducted a pan-genomic analysis of five closely related strains of Pholiota, yielding extensive genomic information. Among these, there were 2608 core genes, accounting for 21.35% of the total genes, and 135 dispensable genes, highlighting significant genetic diversity among Pholiota and further confirming the value of pan-genomic analysis in uncovering species diversity. Notably, while we successfully identified the A-mating-type locus, composed of the homeodomain protein genes HD1 and HD2 in ZZ1, we were unable to obtain the B-mating-type locus due to technical limitations, preventing us from acquiring the pheromone receptor of the B-mating-type. We plan to supplement these data in future studies and explore the potential impact of the B-mating-type locus on the current findings. In summary, the genome data of ZZ1 presented in this study are not only valuable resources for understanding the genetic basis of this species, but also serve as a crucial foundation for subsequent genome-assisted breeding, research into cultivation technology, and the exploration of its nutritional and potential medicinal value. Full article

Background/Objectives: Genetic polymorphism of the dihydropyrimidine dehydrogenase gene (DPYD) is responsible for the variability found in the metabolism of fluoropyrimidines such as 5-fluorouracil (5-FU), capecitabine, or tegafur. The DPYD genotype is linked to variability in enzyme activity, 5-FU elimination, and toxicity. Approximately 10–40% of patients treated with fluoropyrimidines develop severe toxicity. The interethnic variability of DPYD gene variants in Afro-Latin Americans is poorly studied, thereby establishing a barrier to the implementation of personalized medicine in these populations. Therefore, the present study aims to analyze the frequency of DPYD variants with clinical relevance in the Dominican population and their association with genomic ancestry components. Methods: For this study, 196 healthy volunteers from the Dominican Republic were genotyped for DPYD variants by qPCR, and individual genomic ancestry analysis was performed in 178 individuals using 90 informative ancestry markers. Data from the 1000 Genomes project were also retrieved for comparison and increased statistical power. Results and Conclusions: The c.557A>G variant (decreased dihydropyrimidine dehydrogenase function) presented a frequency of 2.6% in the Dominican population. Moreover, the frequency of this variant is positively associated with African ancestry (r² = 0.67, p = 1 × 10⁻⁷), which implies that individuals with high levels of African ancestry are more likely to present this variant. HapB3 is completely absent in Dominican, Mexican, Peruvian, Bangladeshi, and all East Asian and African populations, which probably makes its analysis dispensable in these populations. The implementation of pharmacogenetics in oncology, specifically DPYD, in populations of Afro-Latin American ancestry should include c.557A>G, to be able to carry out the safe and effective treatment of patients treated with fluoropyrimidines. Full article

Background: Valproates are recognized for their significant teratogenic risks, which can lead to physical defects and developmental disorders when used during pregnancy. To mitigate these risks, the Pregnancy Prevention Program (PPP) was developed by European regulators for patients and healthcare professionals (HCPs). Despite the crucial nature of this program, the implementation of the PPP does not appear to be fully effective. This situation highlights the need for a deeper understanding of HCPs’ knowledge, attitudes, and behaviors regarding the PPP. Methods: A cross-sectional study using anonymous electronic questionnaires was conducted. The questionnaires were developed by a board of experts from eight different EU countries and were distributed among prescribers (general practitioners (GPs), neurologists, and psychiatrists) and pharmacists. Descriptive statistics were used to analyze the obtained data on participants’ knowledge, attitudes, and behaviors regarding the prescribing and dispensing of valproate-containing medicines to women of reproductive age, as well as the impact of PPP materials on their work. Results: The study results indicate that while HCPs in Latvia are generally aware of valproate teratogenic risks, significant gaps remain in the implementation of the PPP. A considerable number of both prescribers and pharmacists expressed the belief that they are not responsible for educating patients about the PPP, attributing this responsibility to other specialists. Furthermore, barriers such as a lack of time and accessible materials were identified. Conclusions: The roles and responsibilities of HCPs should be clearly defined to improve adherence to the PPP. Further research is needed to assess prescription and dispensing strategies, as well as HCPs’ attitudes toward the PPP. Additionally, re-evaluating and enhancing the accessibility of PPP materials is essential in effective risk management and better patient care. Full article

Background/Objectives: An automated extrusion-based material deposition is a contemporary and rapid method for pharmaceutical dose-dispensing and preparing (printing) individualized solid dosage forms. The aim of this study was to investigate and gain knowledge of the feasibility of automated extrusion-based material deposition technology in preparing customized prednisolone (PRD)-loaded gel tablets for veterinary applications (primarily for dogs and cats). Methods: The PRD loads of the extrusion-based deposited gel tablets were 0.5% and 1.0%, and the target weights of tablets were 0.250 g, 0.500 g, and 1.000 g. The effects of the material deposition processes on the physical solid state, in vitro dissolution, and the physicochemical stability of PRD gel tablets were investigated. Results: The small-sized gel tablets presented a uniform round shape with an exceptionally smooth outer surface texture. The actual average weight of the tablets (n = 10) was very close to the target weight, showing the precision of the process. We found that PRD was in a pseudopolymorphic sesquihydrate form (instead of an initial PRD crystalline form II) in the gel tablets. In all the immediate-release gel tablets studied, more than 70% of the drug load was released within 30 min. The soft texture and dimensions of gel tablets affected the dissolution behaviour in vitro, suggesting the need for further development and standardization of a dissolution test method for such gel tablets. A short-term storage stability study revealed that the content of PRD did not decrease within 3 months. Conclusions: Automated extrusion-based material deposition is a feasible method for the rapid preparation of gel tablets intended for veterinary applications. In addition, the present technology and gel tablets could be used in pediatric and personalized medicine where precise dosing is crucial. Full article

Introduction: Antimicrobial resistance (AMR) is a global health threat requiring immediate attention as it is set to cause ten million deaths worldwide by 2050, overtaking that of cancer. Continuation of overuse and/or misuse of these crucial medicines will prevent future generations from reaping the benefits, as the pandemic of AMR spirals out of control. Aims: The primary aim of this study was to investigate antimicrobial prescribing patterns in General Practices throughout Northern Ireland. A secondary aim was to analyse the impact of the COVID-19 pandemic on antimicrobial prescribing and consumption patterns in GP practices in Northern Ireland. Methods: A retrospective, cross-sectional quantitative study was designed to measure, analyse, and evaluate the antimicrobial prescribing patterns within GP practices in Northern Ireland, using open access Business Services Organisation (BSO) data. Results: A total of 3,168.78 kg of antibacterial drugs were prescribed in primary care throughout the duration of the study. Penicillins were the most prescribed class (59.79%), followed by tetracyclines (10.68%) and macrolides (9.53%). Access group antibiotics were the most frequently prescribed (79.35%), followed by Watch group antibiotics (20.64%), with Reserve group antibiotics equating to nearly 0% despite being prescribed. The Derry GP Federation prescribed and dispensed the greatest amount of antibiotics overall in Northern Ireland (10.90%). Despite there being no significant difference in antibiotic prescribing amongst GP federations prior to and during the COVID-19 pandemic (unpaired t-test, p > 0.05), there were differences in prescribing of individual drug classes throughout this period. Conclusions: Despite meeting World Health Organisation (WHO) targets, GP practices within Northern Ireland must achieve more to further reduce antimicrobial consumption. Although antibiotic prescribing rates here are on the decline, there was no significant difference in prescribing amongst GP federations pre- and midst-COVID-19 pandemic, thus sufficient strategies such as increased communication between colleagues and supportive measures must be implemented within GP practices to enhance antimicrobial stewardship (AMS) across Northern Ireland. Full article

This study documents the experiences of health system personnel in the implementation of mass distribution campaigns for the control of lymphatic filariasis in rural Guinea. This was an exploratory qualitative study using data collected from implementing actors of mass distribution campaigns in the Boké health district. The results showed four main facilitators of mass distribution campaign rollout in the Boké health district: (i) support to the district teams in the organization of the campaigns; (ii) involvement of community-based associations in social mobilization; (iii) strong adherence of the communities to the different mass distribution campaigns, facilitated through the involvement of community relays, who are members of these communities, in the distribution of drugs; and (iv) transparency in the allocation of incentives to drug dispensers and supervisors. However, the frequent shortages of medicines, the difficulty of access to rural areas, and the lack of logistical means for the supervision of activities were the main obstacles to the success of the various mass distribution campaigns in Boké. The provision of buffer stocks for special areas such as Boké by national programme actors and partners, joint planning of campaign activities with local managers of health systems and services, and improvement of existing mechanisms for motivating health workers, including community health workers, during future campaigns should help to achieve national objectives in the fight against NTDs in Guinea. Full article

Background: Since 2008, several cases of pregabalin abuse have been reported to the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA). Despite this evidence, gabapentinoids are increasingly being prescribed. Moreover, pregabalin is being used in a recreational setting for its dissociative effects and euphoria. Objectives: To assess the characteristics of non-therapeutic users of pregabalin and to show behavioral trends associated with requests for the medicine at community pharmacies. Methods: The Medicine Abuse Observatory (MAO), an epidemiological surveillance system, was able to analyze trends about the most diverted drugs and the behavioral patterns of the population from community pharmacies. We have conducted an observational and cross-sectional study from January 2022 to April 2023, to determinate trends in the behavior of patients who have requested pregabalin in the Catalan Sephanet. Results: Behavior with respect to sex was similar in all health problems, although one difference was raised when considering neuropathic pain, in which the females were more involved (72.7%), especially around 2.5 times more than the males (27.3%, p < 0.05). The study showed a potential recreational use related to patients aged <25 years and patients aged 25–35 years (p < 0.05). Neuropathic pain was mainly identified in patients >65 years. In 75% of the cases, there was a preceding prescription. Conclusions: This study underlines the evidence of non-therapeutic use of pregabalin among the Catalan population and the need to take control measures. Actions should be promoted, both at the level of prescription and dispensing, and focusing on education and knowledge about the risks that may appear with the use of pregabalin. Full article

Background: Previous studies found that the coronavirus disease 2019 (COVID-19) pandemic had a variable impact on the consumption of antimicrobial drugs in human medicine, with trends in several European countries differing between community and inpatient prescribing. Aim: This study analysed changes in the volumes and use density of antibacterial and antifungal drugs dispensed in acute care hospitals in Germany between 2019 and 2022. Methods: Surveillance data for the four years available from 279 hospitals were expressed as the total volumes of daily doses or as use density (daily doses per 100 patient/occupied bed days) per year and analysed descriptively, using recommended hospital-adapted daily dose definitions (RDDs) and (as sensitivity analysis) WHO/ATC-defined daily dose definitions (DDD). Hospitals were stratified according to size (number of beds), university affiliation, and location (East, West, South). Results: There were significant decreases in both the total number of patient days and antibacterial drug volumes in 2020 through 2022 compared with 2019. The relative changes between 2019 and 2020, 2021, and 2022 were −12.8%, −13.5%, and −13.3% for patient days, and −9.7%, −11.0%, and −10.1% for antibacterial RDDs, respectively. Broad-spectrum betalactams, notably piperacillin–tazobactam and carbapenems, increased in volume, unlike most other drug classes. The resulting antibacterial drug use density was slightly but significantly increased, with pooled means (and medians) of 43.3 (40.0) RDD/100 in 2019 compared to 44.8 (41.7), 44.5 (40.80), and 44.9 (41.7) RDD/100 in the years 2020 through 2022, respectively. Antifungal drug volumes and use density increased after 2019 and peaked in 2021 (the difference between 2019 and 2021 for total volumes was +6.4%, and that for pooled mean use density values was +22.9%, respectively). These trends were similar in the different hospital strata and comparable when DDDs instead of RDDs were used. Conclusions: Similar to what has been observed in a majority of European countries, the total volume of antibacterial drug use in German acute care hospitals decreased with the pandemic, without a rebound phenomenon in 2022. In association with restricted hospital capacities and presumably more immunocompromised general medicine patients, however, inpatient prescribing of (primarily broad-spectrum) antibacterials and of antifungal drugs increased. Full article

Background: The role of community pharmacists has evolved beyond the dispensing of medicines. The aim of this scoping review was to describe the interventions that expand the pharmacist’s scope of practice within a community pharmacy setting and assess their effectiveness. Methods: We performed a scoping review to identify randomised controlled trials (RCTs), published worldwide from 2013 to 2024, which focused on interventions designed to expand pharmacists’ scope of practice in the community. The review was undertaken in accordance with the Joanna Briggs Institute methodology for scoping reviews. To address the aim of this scoping review, the included RCTs were mapped to themes influenced by the Professional Practice Standards 2023 as developed by the Pharmaceutical Society of Australia: medication management, collaborative care and medication adherence. Results: Twelve studies demonstrated the potential to expand community pharmacists’ scope of practice. Two RCTs resulted in no effect of the intervention. One RCT (conducted in Italy) led to an actual change to community pharmacists’ scope of practice, with a statistically significant improvement in the proportion of patients with controlled asthma. Conclusions: On the whole, this scoping review synthesised the findings of peer-reviewed RCT studies that revealed expanding community pharmacists’ scope of practice may result in improved patient outcomes, a reduced burden for the healthcare system, and greater productivity. Full article