Search Results (494)

Background and Objectives: Artificial intelligence (AI) is increasingly integrated into healthcare management and pharmaceutical marketing workflows, yet determinants of AI adoption intention among non-clinical professionals remain under-studied in Central and Eastern Europe. This cross-sectional study quantified AI adoption intention (AAI) across three professional groups and examined its organizational, cognitive, attitudinal, and regulatory correlates. Methods: We surveyed 127 Romanian professionals (43 hospital administrators, 42 pharmaceutical marketing professionals, 42 community pharmacy managers) using a 46-item structured instrument. The instrument combined items adapted from UTAUT/TAM and organizational-readiness measures with study-specific AI-marketing, AI-literacy, and regulatory-literacy items; Analyses included ANOVA with Tukey HSD, Spearman correlations, age-adjusted OLS regression with HC3 robust standard errors, bootstrap indirect-effect analysis, moderation, exploratory k-means clustering, and exploratory logistic/ROC analysis. Results: AAI differed across groups: pharmaceutical marketing 4.33 ± 0.50, hospital administrators 3.39 ± 0.47, and pharmacy managers 2.88 ± 0.54; all pairwise Tukey contrasts p < 0.001. In the multivariable model (R² = 0.833)—interpreted cautiously because conceptually related adoption constructs may overlap despite acceptable collinearity diagnostics—perceived usefulness, organizational readiness, and perceived ease of use were the strongest associated factors, while data governance concern was the main negative correlate. Perceived usefulness statistically accounted for 61.7% of the AI literacy–AAI indirect association, and regulatory literacy moderated the AI literacy–AAI association. An exploratory age-adjusted logistic model showed high within-sample discrimination for top-tertile AAI but should be interpreted as convergent validity among survey constructs rather than as a validated screening tool. Conclusions: AI adoption intention in Romanian medical management and pharmaceutical marketing is associated mainly with perceived usefulness and organizational readiness, tempered by data governance concern and regulatory knowledge. Longitudinal, multi-site, real-world implementation studies with external validation are needed. Full article

Background: In response to the World Health Organization’s Global Medication Safety Challenge, many countries, including Saudi Arabia, have launched implementation initiatives. This study examined how Saudi hospitals have addressed the WHO Global Medication Safety Challenge. Methods: A cross-sectional survey was conducted between January and June 2025 among medication safety officers at secondary and tertiary care hospitals in Saudi Arabia. Participants reported interventions implemented to enhance medication safety during or before 2025 using a self-administered survey adapted from a previously published tool. Interventions were categorized according to the domains, subdomains, and priority areas of the WHO Medication Safety Challenge framework. Descriptive statistics summarized responses, and thematic analysis was used to categorize interventions. Results: Twenty-eight hospitals reported 162 interventions. Most respondents were medication safety officers (75%). The most frequently reported domains were medication systems and practices (41.3%), followed by healthcare professionals (29%), medicines (22.5%), and patients/public (6.7%). Nearly 60% of interventions addressed WHO priority areas, primarily high-risk situations (81.4%), followed by transitions of care (11.3%) and polypharmacy (7.2%). Conclusions: The study findings suggest that selected hospitals in Saudi Arabia have primarily focused on medication systems, healthcare professionals, and high-risk situations. Expanding initiatives to address polypharmacy and patient/public engagement may further strengthen medication safety efforts. Full article

Background/Objectives: Inappropriate antibiotic prescribing in primary healthcare (PHC) contributes to bacterial antimicrobial resistance (AMR). Antibiotic stewardship, including measuring the appropriateness of antibiotic prescribing using quality indicators, is a priority in PHC where most antibiotics are used. Using previously developed WHO AWaRe classification-based quality indicators, we aim to test the clinimetric properties of 13 acute respiratory tract infection (RTI) quality indicators and qualitatively explore factors influencing PHC antibiotic prescribing in South Africa. Methods: We conducted a mixed-methods exploratory feasibility study using point prevalence surveys (PPSs) with clinimetric assessment and prescriber interviews. PPSs were conducted at four PHC facilities in Gauteng province that had taken part in previous PPS studies, alongside face-to-face interviews with PHC personnel. Results: In total, 52/52 (100%) RTI patients received antibiotics. Four (30.8%) indicators achieved scores above 85%, while six (46.2%) scored below 50%. All indicators had applicability scores ≥10%. Twelve (92.3%) indicators had a measurability score of 100%, while one (7.7%) had a measurability score <75%. Twelve (92.3%) indicators met all predefined acceptable scores for applicability and measurability. No participant knew of the WHO’s AWaRe classification and none had specific training on antibiotic prescribing and AMR. They also had no antibiotic stewardship programmes (ASPs) or specific antibiotic-prescribing guidelines at their facilities. Key factors affecting antibiotic prescribing included shortages, patient expectations and fear of complications. Conclusions: The indicators demonstrated acceptable clinimetric properties in South Africa. Robust locally validated indicators, combined with ASPs promoting the AWaRe classification, are imperative for accurate assessment and improvement of antibiotic prescribing. Full article

Patients with ileostomy face unique pharmacotherapeutic challenges, including altered drug absorption, yet structured pharmaceutical care for this population is rarely integrated into routine clinical practice. This retrospective monocentric cohort study evaluated the reach, effectiveness, adoption, implementation, and maintenance of a structured ileostomy-specific clinical pharmacy service using the implementation science-based RE-AIM framework at a 1245-bed teaching hospital in Vienna, Austria. Sixty-two patients (54.8% male; median age of 65.5 years) were included, receiving a median of 11 medications. A total of 324 drug-related problems (DRPs) were identified, of which 202 (62.3%) were classified as stoma-specific drug-related problems (SDRPs), representing a predefined subgroup of DRPs associated with ileostomy-related pharmacotherapy challenges. This distinction enabled separate evaluation of the clinical relevance of stoma-specific pharmaceutical interventions. The implementation rate was significantly higher for SDRP-related interventions than for general DRP recommendations (92.0% vs. 63.9%; p < 0.001), with no significant interdepartmental differences observed in either DRPs (p = 0.137) or SDRPs (p = 0.071). Patients with high-output stoma (HOS) had significantly more SDRPs than those without (p < 0.001), while no differences were observed in general DRPs. The service demonstrated wide adoption, high interprofessional acceptance, full protocol fidelity, and continuous implementation over 30 months. The findings provide implementation evidence that may support healthcare decision-makers, hospital administrators, and policy stakeholders in establishing and sustaining structured clinical pharmacy services for ileostomy patients in Austria and similar healthcare settings. Full article

Background: The 2-benzylbenzimidazoles or nitazenes are an evolving class of highly potent mu-opioid receptor agonists. Nitazenes were originally developed in the late 1950s for pharmaceutical use as analgesics; however, due to their extreme potency and the risk of adverse health outcomes, pharmaceutical research was discontinued. Since 2019, nitazenes have emerged as illicit drugs of abuse, causing significant concern. From 2021, they have been detected in both coronial and clinical casework in Victoria, Australia. This study examined nitazene-related coronial casework in Victoria from 2021 to 2025 to explore the trends and characteristics of nitazene-related deaths. Methods: Relevant cases were identified from the Victorian Institute of Forensic Medicine’s (VIFM’s) case management system. Data were collated and analysed from all coronial cases where a nitazene was detected by a toxicological analysis between 1 January 2021 and 31 December 2025. Trend comparisons were made with nitazene detections reported in other countries. Results: Nitazenes were detected in 23 deaths from a total of approximately 33,108 coronial cases admitted to the VIFM for investigation over the time period. The age range was 17–45 years, with a median of 32 and with 87% of the deaths being male. The nitazenes detected were protonitazene (n = 14), metonitazene (n = 5), isotonitazene (n = 2), N-pyrrolidino etonitazene (n = 2), N-desethyl isotonitazene (n = 1), methylenedioxynitazene (n = 1) and etodesnitazene (n = 1). Two cases contained more than one nitazene; both involved protonitazene, one involved metonitazene, and the other involved N-desethyl isotonitazene and methylenedioxynitazene. The timeline of detection of these nitazenes displays similarities with emergence trends in other countries. The nitazene concentrations ranged from 0.1 to 33 ng/mL. Broad polydrug usage was evident in all cases, with other drugs co-detected in the blood including stimulants (particularly, methylamphetamine (48%) and cocaine (44%)) as well as pharmaceutical benzodiazepines (43%) and pharmaceutical opioids (22%), and 13% had 6-monoacetylmorphine detected in either blood or urine. Novel benzodiazepines (39%) were also common, including bromazolam, which was co-detected in 35% of cases. Nineteen deaths were attributed solely to nitazene-related mixed-drug toxicity, while the remaining four cases were attributed to cardiac- and pulmonary-related disease, with polydrug use deemed a contributing factor. Conclusions: This novel case series adds comprehensive toxicological information to the body of evidence reinforcing the high risk of harm associated with the use of nitazenes. It is imperative that toxicology services continue to monitor for nitazenes to promote community awareness against nitazene-related harm. Full article

The roles of proline in stress tolerance, energy metabolism, immune function, and ecology across organisms suggest a broader relevance in orchard agroecosystems than is often recognized. In fruit trees, stress-induced proline accumulation reflects a complex regulatory network, while evidence also indicates that inter-organ transport contributes to protective responses under abiotic stress. In insects, proline functions as an oxidative substrate priming the rest-to-flight metabolic transition in pollinators and pests, a cryoprotective osmolyte and a structural element of conserved classes of antimicrobial peptides against microbial threats. These roles create paradoxical orchard-scale feedbacks while a stress-protective molecule both intensifies herbivore pressure and enhances pollination and biocontrol services. The orchard environment represents a meeting point of plant, environmental, animal and human health, reflecting the integrative logic of the One Health framework, where proline emerges as a highly water-soluble and bioactive compound. The functional homology between insect and human proline catabolism emerges governance-critical issues across tree physiology, insect immunity and human dietary exposure. The targeted application offers a unifying framework for farmers, scientists and policymakers to advance Sustainable Development Goal commitments across food security, human health, climate resilience and biodiversity. We conclude that proline supplementation in orchards requires regulatory monitoring across ecophysiological and pharmaceutical dimensions. Full article

Based on Social Learning Theory, the Health-oriented Leadership Model posits leaders as SelfCare role models. While this modeling influence is established for general SelfCare, its applicability to sensitive behaviors—such as disclosing mental health problems—remains unclear. Additionally, the role of interactional and contextual factors is insufficiently understood. The present paper investigates whether leaders’ role modeling extends to disclosure and whether communication aspects and Working from Home (WfH) intensity moderate these effects. Two cross-sectional studies were conducted among employees working partly from home. Employees rated their own and leaders’ SelfCare; Study 2 (pharmaceutical company; N = 198) additionally assessed disclosure. Both studies included communication frequency and WfH intensity; Study 1 (public service; N = 227) measured informal communication, and Study 2 assessed communication barriers. Results confirmed that leaders’ SelfCare and disclosure were related to employees’ corresponding behaviors. Communication frequency and WfH intensity showed no moderating effects. Informal communication was associated with a stronger leader SelfCare role model effect, whereas communication barriers were associated with weaker role model effects. Findings suggest an association between leaders’ and employees’ health behavior, consistent with role modeling processes. Based on these preliminary findings, organizations may raise leaders’ awareness of their impact, while leaders should hold informal check-ins and promote barrier-free communication. Future longitudinal and experimental research should validate these findings. Full article

This study addresses the corrosion problem of refractory materials during high-temperature molten treatment of pharmaceutical waste salt, and systematically investigates the interface behavior and corrosion mechanism of MgO-based refractory materials in simulated pharmaceutical waste salt (65 wt% NaCl-30 wt% Na₂SO₄-5 wt% CaCO₃). Through sessile drop wetting infiltration experiments, static corrosion tests (950 °C and 1150 °C/48 h), combined with SEM-EDS, XRD characterization, and FactSage thermodynamic calculations, the corrosion resistance of high-purity MgO phase (HM-97) refractory materials and magnesium–aluminum spinel composite phase (MA-85) refractory materials was compared and analyzed. The results show that due to the fine periclase grains and rich grain boundaries, the molten salt infiltration rate of HM-97 material in the 644–800 °C range is significantly higher than that of MA-85. After corrosion at 950 °C, HM-97 and MA-85 formed 47 μm and 53 μm transition layers respectively, and the HM-97 surface generated Ca₃Mg(SiO₄)₂ phase leading to uneven corrosion morphology. At 1150 °C, HM-97 produced long cracks and the transition layer thickness remained almost unchanged due to dissolution, while MA-85 formed an approximately 72 μm transition layer and a dense metamorphic layer. Phase analysis and thermodynamic calculations suggest that the MgAl₂O₄ phase in MA-85 is likely stable at high temperatures, which appears to effectively prevent molten salt infiltration and contribute to forming a protective metamorphic layer, thereby potentially enhancing the material’s corrosion resistance. The MgAl₂O₄ phase is proposed to improve the service performance of MgO-based refractory materials in the molten pharmaceutical waste salt environment. Full article

Background/Objectives: Pharmacists play an essential role in healthcare delivery across Europe, yet growing professional demands, organisational constraints, and evolving practice models may negatively affect job satisfaction and professional fulfilment. This study aimed to evaluate job satisfaction and professional perception among pharmacists across multiple European countries and to identify sociodemographic and workplace-related factors associated with these outcomes. Methods: A cross-sectional, web-based survey was conducted between October 2023 and January 2024 among licensed pharmacists from 17 European countries. Eligible participants were pharmacists employed in community pharmacies, hospitals, clinical pharmacy services, or the pharmaceutical industry. The questionnaire, developed and administered in English, collected sociodemographic and professional data and included two composite measures: the Job Satisfaction Scale (12 items) and the Pharmacist Professional Perception Scale (6 items). Responses were recorded using 5-point Likert scales. Descriptive statistics and inferential analyses were performed using SPSS version 27.0. Results: A total of 789 pharmacists participated (median age 40 years; 80.1% female). The mean job satisfaction score was 3.26 (SD 0.88), with the lowest scores related to staffing adequacy and salary, and the highest to collegial relationships. The mean professional perception score was 3.08 (SD 0.81), indicating moderate perceived professional recognition. Significant associations were identified between both scales and workplace setting, income level, employment status, geographical region, education, and professional experience (p < 0.05). Conclusions: In this multi-country convenience sample, pharmacists reported moderate levels of job satisfaction and professional perception, with variation across workplace and sociodemographic factors. These findings should be interpreted cautiously, as the sample is not representative of all European pharmacists; however, they suggest that staffing conditions, remuneration, professional recognition, and career development opportunities may be relevant areas for further investigation and policy attention. Full article

Background/Objectives: The use of nonsteroidal anti-inflammatory drugs (NSAIDs) is common in dentistry, mainly for pain and inflammation. However, their coadministration with warfarin may lead to serious potential drug-drug interactions (PDDIs), increasing the risk of bleeding. This study aimed to identify and describe the frequency of PDDIs between warfarin and NSAIDs prescribed by dentists and dispensed by the Unified Health System (SUS) in Minas Gerais, Brazil, from January 2011 to December 2021. Methods: A descriptive analysis was conducted using data from Integrated Pharmaceutical Services Management System (Sigaf), considering prescriptions of warfarin and NSAIDs issued during the same period. Results: The prescribed NSAIDs were diclofenac sodium 50 mg, diclofenac potassium 50 mg, ibuprofen 600 mg, nimesulide 100 mg, and nimesulide 50 mg/mL oral suspension. Warfarin sodium 5 mg is the prescribed oral anticoagulants. The results showed a marked increase in both warfarin (from 6017 to 59,945 prescriptions; +896%) and NSAID use (from 2644 to 84,408 prescriptions; +3093%), paralleling the rise in PDDIs, which grew from 2 in 2011 to 62 in 2021. Despite this 3000% relative increase, the absolute frequency of PDDIs remained low, corresponding to approximately 0.7 interactions per 1000 NSAID prescriptions in 2021. Conclusions: Although these PDDIs are low, they are clinically significant and may have important implications for patients and the healthcare system. In conclusion, PDDIs between NSAIDs and warfarin, though low in absolute numbers, have increased over the years, reinforcing the need for greater awareness among dental professionals and for the implementation of clinical decision support strategies to promote safe care. Full article

Nyaope is a highly addictive street drug that is widely used in South Africa, particularly in urban and peri-urban settings. Although it is traditionally consumed by smoking, increasing injection use has raised serious public health concerns due to an elevated risk of bloodborne viral infections and other drug-related health complications. The composition of nyaope is highly variable, frequently adulterated, and continually evolving, thus highlighting the need for detailed chemical characterization to support forensic investigations and public health interventions. An exploratory study design was conducted using eight nyaope samples seized from six sites within the City of Tshwane Metropolitan Municipality that were provided by the South African Police Service Forensic Science Chemistry Laboratory (SAPS-FSCL). Samples were analyzed using Ultra-High-Performance Liquid Chromatography coupled to Quadrupole-Time-of-Flight Mass Spectrometry (UHPLC-qTOF-MS) operated in data-dependent acquisition mode under positive ionization. Raw data from the methanolic extracts of nyaope was converted to mzML format and processed using SIRIUS software for compound annotation based on isotope pattern ranking and fragmentation analysis. Chemical profiling revealed multiple opiate-related compounds, including noscapine, heroin, papaverine, and codeine. Molecular networking revealed chemically diverse yet structurally related metabolites consistent with a poppy-derived botanical origin. In addition, multiple synthetic pharmaceutical adulterants were detected. Notably, one sample contained formaline, a toxic rodenticide structurally related to protopine, highlighting the risk of misidentification using less advanced analytical approaches. This study demonstrates the value of advanced computational metabolomics, including molecular networking and machine-learning-assisted mass spectrometry interpretation, for comprehensive characterization of complex illicit drug mixtures. These approaches enhance forensic accuracy and support informed public health and law-enforcement responses. Full article

In November 2024, a two-day meeting entitled “PBBM—Best Scientific Practices to Define Drug Product Performance: Latest Regulatory and Industry Perspectives” was organised by the Academy of Pharmaceutical Sciences Biopharmaceutics Focus group and hosted by MHRA in London, UK. Physiologically based biopharmaceutics modelling, referred to as PBBM, is used to inform drug product quality strategies and provide a more detailed understanding of how medicines can interact with the human body. Industrial, academic, regulatory, and software company scientists came together to discuss the latest developments in PBBM and to debate key topics relevant to the establishment of best practices and improved implementation. Case study presentations and breakout sessions highlighted how companies are using PBBM in their portfolio decision-making (early development through post-approval changes). Discussions highlighted how the exploration of drug product quality risks has evolved over time, moving from the more empirical BCS classification approach to a more detailed in vivo and mechanistic understanding, where sponsors have and continue to invest in building clinical drug product knowledge. Regulatory scientists shared how they are building experience in using PBBM to set clinically relevant drug product quality specifications, including how they would like to see the area grow in the future. Although significant progress has certainly been made in this field over the last 10 years, the need to continue to bring industry and regulators closer together in the future remains a key topic. Guideline evolution, training and continued dialogue will be essential in reaching a harmonised approach to the use of PBBM to develop drug product strategies and set quality specifications. Full article

Background: Prefilled syringes (PFSs) are increasingly used for self- and assisted administration of high-value parenterals, yet design verification (DV) planning remains challenging due to overlapping drug, device, and combination product expectations, as well as limited harmonization of device components. To the best of our knowledge, there is no publication providing an end-to-end DV approach for developers. This work aims to provide a best-practice template for structuring and justifying DV programs for PFSs, with the explicit intent of improving transparency and offering practical clarity to development teams navigating regulatory and technical complexity. Methods: A risk-based DV approach is presented for an exemplary 1 mL long staked needle glass PFS intended for subcutaneous administration of a surrogate solution representative of a high-concentration biologic. The approach starts with the design inputs which were derived from intended use, user requirements, and the drug’s quality target product profile (QTPP), then translated into design outputs including Essential Drug Delivery Outputs (EDDOs). These outputs were proven by executing drug-independent and simulated drug-dependent DV tests using ISO- and pharmacopeia-aligned methods, including defined sampling, and real-time/accelerated aging. Results: A best-practice DV approach is presented, including test results across the evaluated functional, mechanical, and integrity endpoints. Conclusions: The presented approach provides a transferable DV template linking intended use to acceptance criteria, sample size rationale, and test selection. As a best-practice contribution, it supports more consistent, defensible DV planning for PFSs and may reduce ambiguity in the interface between drug and device development expectations. Full article

Background: The implementation of pharmaceutical care (PC) in Primary Health Care (PHC) faces challenges related to interprofessional integration, management support, and infrastructure, despite its potential to improve patient-centered care. Objectives: To analyze, from the perspective of pharmacists working in PHC, the facilitating factors and barriers to the implementation of PC in the public health system in a post-implementation context. Methods: This is a qualitative, exploratory study, with eight individual semi-structured interviews conducted remotely between December 2024 and February 2025. The interviews were recorded, transcribed, and subjected to thematic content analysis by a trained team, with peer validation. Results: The main facilitators identified were: a solid relationship with the team, participation in continuing education, and a bond with patients. Barriers included a lack of adequate infrastructure, workload, staff turnover, and resistance from the health team. Management support, although frequently cited as a facilitator, did not always translate into concrete actions for service implementation. Even in the face of these barriers, the implementation of PC contributed to strengthening patient-centered care, the clinical protagonism of pharmacists, and improving health outcomes. Conclusions: The analysis highlighted that the sustainability of PC depends on structural and relational conditions that go beyond individual training. The study reveals that, after implementation and continuing education processes, organizational barriers persist that limit the consolidation of PC, highlighting the need for institutional policies and ongoing management support to effectively integrate pharmacists into healthcare. Full article

Adverse Drug Reactions (ADRs) represent a major public health concern due to their impact on patient safety. In Spain, the Spanish Agency of Medicines and Medical Devices, through the FEDRA database, coordinates the reporting of suspected ADRs under real-world conditions of use, contributing to the continuous updating of safety information. In this context, community pharmacist, through Professional Pharmaceutical Care Services, plays a key role in the early detection of ADRs and Drug-Related Problems (DRPs). This article describes the case of a 70-year-old polymedicated woman included in a Personalized Dosage System (PDS). Following the substitution of diazepam with clonazepam and an increase in the dose of semaglutide, the patient developed urinary incontinence, nausea and abdominal pain. Coordinated intervention between the community pharmacy and primary care enabled adjustment of the clonazepam dose, optimization of semaglutide administration and discontinuation of unnecessary naproxen use. These measures resulted in improved treatment tolerance and safety, as well as optimization of pharmacotherapy. Full article