Search Results (170)

Background/Objectives: Medication errors remain a patient safety concern in neonatal intensive care units (NICU), mainly due to multiple dilution steps, a lack of standardized preparation instructions, and the frequent use of high-alert medications. While standard concentrations (SCs) for intravenous (iv) medication are recommended internationally, a national standard is missing for NICUs in Germany. The aim of this study was to evaluate a proposal for a national list of standardized iv medication concentrations to be used in German NICUs. Methods: In collaboration with the German Society for Neonatology and Pediatric Intensive Care (GNPI) and the Federal Association of German Hospital Pharmacists (ADKA), a multiprofessional expert team, including experts from the medication safety initiatives TELE-KASPER and Kinderformularium.DE and affiliated with seven German university hospitals, evaluated SCs for infusion medication administered to infants weighing 500 g to 5 kg. The evaluation process was based on international SCs lists, clinical practice, stability data, and handling aspects. Medication used in at least four of the seven hospitals was shortlisted. In the first round of the consensus process, an online survey submitted to the German Level-1 NICUs (n = 165) and their affiliated hospital pharmacies identified preferred SCs. In the second round of the consensus process, the expert team further evaluated the results of the survey. Results: The survey response rate was 52%. The consensus process resulted in a list encompassing 50 iv medications and 80 appropriate SCs. Ancillary information on preparation, stability, osmolarity, pH, and practical administration was added. Conclusions: The proposed SCs for infusion medication used in NICUs have the potential to reduce medication errors, simplify electronic prescribing, and improve workflow efficiency. Implementation aligns with international patient safety initiatives to improve medication safety in pediatric patients. Full article

Background: Occupational exposure to cytotoxic drugs remains a major concern for pharmacy personnel, due to their well-established, carcinogenic, mutagenic and organ-specific effects. Despite the existence of robust international guidelines, evidence suggests substantial variability in compliance, training quality and operational conditions across healthcare settings. Objective: This study aimed to characterise current handling practices, assess working conditions, training, safety procedures, exposure patterns, and perceived risk factors among pharmacy technicians involved in the preparation of cytotoxic drugs in Portugal. Methods: A cross-sectional descriptive study was conducted using a structured questionnaire grounded in international standards (ISOPP, NIOSH, ASHP, USP <800>). The instrument was developed through literature review, expert panel validation (n = 42), and pre-testing. Data were collected electronically between April and May 2025 from pharmacy technicians actively handling cytotoxic drugs in Portugal. Results: A total of 124 valid responses were analysed. Most participants were female (78%) and under 50 years, with nearly one-third having less than one year of experience. Prolonged daily exposure (31.5% participants worked ≥ 5 h/day) extended uninterrupted handling periods (28.2% worked > 120 min), and high preparation workloads were common. While adherence to core protective measures—such as reinforced gowns, double gloves, and Class II B2 biological safety cabinets—was high, important gaps were identified, including incomplete use of closed system transfer devices, inconsistent respiratory and foot protection, limited automation, and insufficient environmental monitoring. Structured competency assessment, periodic training, and formal documentation were frequently absent. Institutional policies on reproductive risk showed strong protection for women but less clarity for male workers. Conclusions: Cytotoxic drug handling practices in Portugal demonstrate satisfactory adherence to fundamental protective measures but reveal significant structural and organisational gaps related to workload management, environmental monitoring, and continuous training. The absence of unified national guidance contributes to variability across institutions. These findings highlight the need for greater standardisation of occupational safety practices. Full article

Background: This scoping review aimed to identify gaps in the literature regarding medication therapy problems (MTPs) among hospitalized adults with decreased kidney function. Specifically, it aimed to answer the following questions: (1) What types of MTPs have been reported? (2) What is the reported prevalence of MTPs? (3) Do MTPs differ by type of kidney disease? (4) What gaps exist regarding MTPs and pharmacists’ involvement? Methods: Studies involving adult patients with decreased kidney function that investigated MTPs were included. Studies focused exclusively on post-transplant care, chemotherapy, or a single MTP type were excluded. Literature searches were conducted in PubMed, EMBASE, Cochrane Library, Web of Science, and International Pharmaceutical Abstracts. Two independent reviewers screened and extracted data, with a third reviewer resolving discrepancies. All identified MTPs were re-categorized using the Pharmacy Quality Alliance (PQA) framework and the Pharmaceutical Care Network Europe (PCNE) classification. Results: A total of 23 studies met the inclusion criteria, including two conference proceedings, encompassing 7151 patients. The most common MTP framework was the PCNE classification (13 studies, 57%). Reclassification using the PQA yielded 10,596 MTPs, most frequently “Safety—dosage too high” (n = 2464) and “Effectiveness—dosage too low” (n = 2262). Reclassification using the PCNE yielded 11,574 MTPs, most frequently “Drug selection” (n = 6974) and “Dose selection” (n = 2636). All studies involved patients with chronic kidney disease (CKD), and two also included acute kidney injury (AKI). Conclusions: Dosage-related MTPs were most prevalent among hospitalized patients with decreased kidney function. Variability in MTP definitions, limited representation of patients with AKI and AKD, and minimal reporting on pharmacists’ roles reveal important gaps. Addressing these gaps through standardized MTP classification and further research in understudied kidney disease populations may enhance patient safety and support clinical pharmacists’ contributions to optimizing medication safety across the kidney disease continuum. Full article

National legislative frameworks governing prescribing, pricing, reimbursement, and dispensing play a decisive role in shaping access to medicines. This study examines the financial availability of medicines in Bulgaria and North Macedonia through a comparative review of national pharmaceutical legislation, pricing mechanisms, reimbursement models, and digitalisation policies, assessed in relation to European Union standards. The findings indicate that access to medicines in both countries is shaped by the combined effects of multiple regulatory and financial instruments rather than by individual policy measures. Both systems apply strict control of prescribing and dispensing, external reference pricing, and positive reimbursement lists, reflecting alignment with international recommendations. However, significant differences in policy design lead to divergent access outcomes. Bulgaria’s more advanced digitalisation of prescribing and reimbursement, including mandatory electronic prescribing for selected therapeutic groups, enhances regulatory oversight and expenditure control but is associated with higher patient out-of-pocket expenditure, partly due to the application of the standard value-added tax on medicines. In contrast, North Macedonia combines lower taxation with capped patient co-payments, higher regulated pharmacy margins, and fixed pharmacy remuneration per prescription, contributing to improved financial affordability for patients while supporting pharmacy sustainability. Additional instruments, such as the Generics without Co-Payment List, further strengthen patient financial protection. The study provides comparative evidence relevant to pharmaceutical policy reforms and highlights the importance of balanced regulatory approaches that promote affordability, system sustainability, and equitable access to medicines. Full article

Universities play a strategic role in advancing the Sustainable Development Goals (SDGs) through community engagement, particularly within medical education. This study examines medical students’ involvement in volunteering activities and evaluates how such engagement contributes to SDG 3 (Good Health and Well-being) and SDG 4 (Quality Education). A cross-sectional survey was conducted among 499 students from the Victor Babeș University of Medicine and Pharmacy in Timișoara, using a structured questionnaire assessing perceived community impact, soft skills development, motivation for volunteering, sustainability orientation, and institutional support. Results indicate a high level of availability and prior participation in volunteering, reflecting strong internalization of public health and social responsibility values. While no significant differences were observed between volunteers and non-volunteers regarding perceived community impact (SDG 3), volunteer experience was significantly associated with higher levels of soft skills development and motivation (SDG 4). Strong positive correlations were identified between perceived community impact and motivational, educational, and sustainability related dimensions. The intensity of involvement was modestly associated with sustainability orientation and institutional support. Despite high motivation, students reported limited structured institutional frameworks for sustained engagement. The findings suggest that medical volunteering functions as a dual mechanism, strengthening professional competencies while reinforcing community health orientation. Institutionalizing structured outreach programs, particularly in underserved areas, could enhance long-term impact and align medical education more effectively with the 2030 Sustainable Development Agenda. Full article

Background: Antineoplastic drugs are essential in the treatment of cancer; however, they are classified as hazardous due to their genotoxic, mutagenic, and carcinogenic properties. Healthcare professionals are at risk of exposure primarily through surface contamination. Despite international safety guidelines and technological innovations during the last decades, contamination remains a global occupational health challenge. Objective: This scoping review aims to identify and compare monitoring and detection methods, as well as cleaning and decontamination strategies, in relation to international occupational-safety standards. Methods: Following Arksey and O’Malley’s methodological framework and PRISMA-ScR reporting standards, the peer-reviewed literature and guidelines from 2000 to 2025 were reviewed. Studies were charted across three domains: contamination prevalence, monitoring/detection methods, and cleaning/decontamination effectiveness. Results: Evidence from twenty-two studies conducted in several countries worldwide demonstrated widespread surface contamination across hospital pharmacies, patient-care units, and outpatient facilities. Cyclophosphamide, ifosfamide, and methotrexate were the most frequently detected agents. LC—MS/MS wipe sampling remains the quantitative gold standard, while rapid immunoassay-based tools allow near real-time assessments but with reduced sensitivity. Cleaning protocols varied significantly: oxidizing and surfactant-based agents such as sodium hypochlorite and hydrogen peroxide achieved the highest removal rates (>90%) yet failed to eliminate residues completely. The included studies reported a wide range of monitoring, detection, and cleaning approaches used in healthcare settings. Conclusion: Surface contamination by antineoplastic drugs persists worldwide. Effective management requires harmonized contamination thresholds, validated cleaning strategies, adoption of rapid detection technologies, and continuous occupational surveillance. Full article

Pine turpentine essential oil (PTEO) obtained from Pinus pinaster Ait. is known to be used in many fields such as medicine, cosmetics, agriculture, and art. The medicinal use of essential oils puts pressure on industry to produce high-quality products. Pure essential oils derived from natural sources are mistakenly recognized as safe on the grounds of their natural origin. Unless they meet international standards, their safety remains questionable. Therefore, in this study, it was aimed to evaluate the quality of 14 different pine turpentine essential oil samples purchased from various sources on the Turkish market, based on the legally recognized pharmacopoeia in Türkiye, the European Pharmacopoeia (EP). As stated in the “Turpentine Oil” monograph, appearance, relative density, refractive index, optical rotation, acid value, peroxide value, fatty oils, and resinified essential oils analyses were performed for each sample. Additionally, phytochemical profiles were analyzed by high performance thin-layer chromatography (HPTLC) and gas chromatography-mass spectrometry (GC-MS). The results revealed that none of the samples were compliant with EP standards. With this in mind, it is found necessary to impose strict regulations on the production of commercial essential oils. Nevertheless, pharmacies emerge as preferable options for obtaining such products. Full article

Background: Access to affordable essential medicines is critical for effective management of hypertension (HTN) and diabetes mellitus (DM). In Zimbabwe, frequent stock-outs in public facilities position private pharmacies as important alternative sources of these medicines. Aim: To assess availability, pricing, and stock-out levels of essential HTN and DM medicines in private retail pharmacies in Gweru Urban District, Zimbabwe. Methods: A cross-sectional survey was conducted in 40 registered private pharmacies. Data on medicine availability, retail prices, monthly stock-outs, and supply-chain factors were collected using a structured interviewer-administered questionnaire, stock cards, and observational checklists. Local prices were compared with international reference prices (IRPs). Chi-square analyses evaluated associations between pharmacy characteristics, medicine prices, availability, and stock-out durations. Results: Most tracer medicines for HTN and DM were available in ≥80% of pharmacies, with average stock-outs generally <3 days per month. Pharmacy characteristics were not significantly associated with availability or stock-outs. Medicines with <80% availability and those priced at ≥USD 5 were significantly associated with prolonged stock-outs of ≥7 days (p = 0.006 and p = 0.001, respectively). Local retail prices exceeded IRPs and public facility prices, suggesting potential affordability barriers in the context of an economic crisis, where most health expenditures are out-of-pocket. Key drivers of stock-outs included wholesaler shortages, delivery delays, limited procurement funds, and substitution with alternative medicines. Conclusions: While medicine availability and short-term stock-outs were generally favourable, high retail prices pose a major potential barrier to access. The cost burden is amplified by the common HTN-DM comorbidity, requiring multiple medications per person, thereby further increasing out-of-pocket expenses. High prices may limit adherence, reduce functional capacity, and negatively impact productivity. Policy interventions targeting pricing regulations and value-chain optimization are urgently needed to enhance equitable access to essential NCD medicines in urban Zimbabwe. Full article

Objectives: The study aims to assess the strategies used to estimate antimicrobial consumption (AMC) and the barriers encountered in data collection. It also addresses the perception about AMC based on the World Health Organization (WHO) definition. Methodology: The qualitative study adhered to the standard consolidated criteria for reporting qualitative studies (COREQ) guidelines. It involved stakeholders from diverse sectors, i.e., regulatory bodies, the pharmaceutical industry, international health organizations, policy experts, medical professionals, veterinary doctors, and academia (nursing, medicine, and pharmacy). A total of 37 in-depth interviews were conducted using a semi-structured interview schema. The interviews were recorded and transcribed verbatim. Codes were generated afterward and organized into themes. Results: Data analysis yielded five themes consisting of (i) Perception about Antimicrobial Consumption, AWaRe (Access, Watch, Reserve) classification and related terms, (ii) Antimicrobial Consumption: Policy Design, (iii) Data management and record keeping for the Estimation of Antimicrobial Consumption, (iv) Levels of Estimation for Antimicrobial consumption and Organizations, and (v) Challenges and suggested solutions in estimation of AMC: One health approach is the way forward. Conclusions: The study concluded that AMC and AMR are two sides of the same coin. The solution to AMR and excessive AMC is to re-evaluate the policy and implement legislation strictly. Efforts focused on irrational prescribing and unsupervised OTC sales of antimicrobials. This will help in reducing the consumption of broad-spectrum antimicrobials. Full article

Background/Objectives: Medication incidents remain a significant concern in hospital settings. Integrated medication systems, regarding organized processes, policies, technologies and professional practices are designed to enhance patient safety; however, their safety performance is still suboptimal. The use of valid and reliable instruments to assess hospital medication system safety can be a valuable resource for health care management. The aim of this study was to describe the development and psychometric validation of the Hospital Medication System Safety Assessment Questionnaire (HMSSA-Q) for assessing the safety of hospital medication systems and its processes in Portugal. Methods: The HMSSA-Q was developed through a literature review and two rounds of expert panel consultation. Following consensus, a pilot methodological study was conducted in 95 Portuguese hospitals. Construct validity was assessed using principal component factor analysis, and reliability was evaluated through internal consistency (Cronbach’s alpha). Results: The instrument is theoretically structured into five predefined domains/subscales: Organizational Environment, Safe Medication Prescribing, Safe Medication in Hospital Pharmacy, Safe Medication Preparation and Administration, and Information and Patient Education. Principal component analyses performed separately for each domain supported their internal structure. The overall scale showed excellent internal consistency (Cronbach’s α = 0.97), with Cronbach’s alpha values for the domains ranging from 0.86 to 0.94. Conclusions: The HMSSA-Q is a valid and reliable instrument for assessing the safety of hospital medication systems and has the potential to serve as an innovative management tool for improving patient safety. Full article

Fluoxetine and carbamazepine are widely prescribed psychotropic drugs, yet few studies have quantified metal(loid) impurities in these medicines, which may pose health risks to patients. This study aimed to determine concentrations of As, Cd, Cr, Cu, Fe, K, Mg, Mn, P, Pb, Se, and Zn in brand, similar, and generic samples of fluoxetine and carbamazepine marketed in Campo Grande, Brazil. Drug samples were purchased from local pharmacies, digested with acid, and analyzed by Inductively Coupled Plasma Optical Emission Spectrometry (ICP OES). Results showed that arsenic was detected only in fluoxetine samples, with concentrations ranging from 0.068 to 0.217 mg/kg, all below national and international limits. Phosphorus presented the highest levels, especially in fluoxetine, reaching up to 14,000 mg/kg, and up to 93 mg/kg in carbamazepine. Other elements such as Fe (0.07–3.03 mg/kg), Mg (0.21–259 mg/kg), K (up to 45 mg/kg), Se (up to 1.5 mg/kg), and Zn (up to 4.2 mg/kg) were also quantified, while Cd, Cr, Cu, and Pb were below detection limits. The hazard index (HI) exceeded 1 for all carbamazepine samples and for one brand, two similar, and three generic fluoxetine samples, indicating that the intake of these medications may pose potential health concerns. These findings underscore the need for stricter monitoring of metal(loid) impurities in psychotropic drugs to protect patient safety and ensure regulatory compliance. Full article

Background and Objectives: Osteoporosis risk in real-world, outpatient settings is shaped by intersecting socio-demographic, environmental, and clinical factors. We evaluated predictors of fracture risk status among adults seeking care in community pharmacies in Lahore, Pakistan. Materials and Methods: We conducted a cross-sectional study across urban and suburban pharmacies using a validated questionnaire aligned with international guidelines. Participants were classified as lower risk (osteopenia/osteoporosis without fragility fracture) or high risk (≥1 fragility fracture with clinical osteoporosis). Associations between candidate factors and risk status were examined using univariate and multivariable logistic regression analyses. Results: Of 286 participants, 53.1% were classified as lower risk. After adjustment, most sociodemographic characteristics were not independently associated with fracture risk status, except monthly income. Strong associations were observed for diabetes (AOR = 0.005, 95% CI 0.0007–0.040; p < 0.001), short-term glucocorticoid use (AOR = 32.33; p = 0.004), current smoking (AOR = 14.23; p = 0.002), ex-smoking (AOR = 4.95; p = 0.042), and lack of sunlight exposure (AOR = 7.09; p = 0.019). CKD, rheumatoid arthritis, and vitamin D insufficiency demonstrated borderline non-significant trends. Multivariable modeling did not include “not tested” categories or sparse variables. Conclusions: In Lahore’s community pharmacies, diabetes, CKD, RA, glucocorticoid exposure, smoking, and sunlight/vitamin D-related factors were the dominant correlates of osteoporosis fracture risk status, whereas most socio-demographic factors exerted limited independent effects. Pharmacy-anchored screening and counseling focused on these high-yield clinical indicators alongside timely BMD referral and guideline-concordant therapy may help identify individuals at elevated fracture risk. Full article

Bioprinting of Advanced Therapy Medicinal Products offers promising new strategies for personalized medicine, but it requires comprehensive, non-destructive characterization and quality monitoring. To support patients with tailor-made constructs composed of hydrogels and cells derived from allogeneic donors or autologous samples, several challenges must be addressed—such as on-demand production, robust manufacturing, appropriate storage and logistics, and destruction-free quality control—before successful translation into clinical applications or pharmacy is possible. Although experience in cryo-preservation, blood banking, and organ donation helps to identify critical process parameters, detecting variations in manufacturing and ensuring product stability remain essential. Quality monitoring of 3D-printed objects before and after storage by magnetic resonance imaging (MRI) is complemented here by measurements of total mass and volume. These established methods provide rapid, non-destructive feedback and have well-characterized statistical limitations. Total mass can be assessed quickly; however, such integral measurements do not reveal information about internal structures. MRI, in contrast, offers detailed, spatially resolved insights. By combining these analytical modalities, we quantitatively analyzed the storage stability of 3D-printed hydrogels—without living cells in this study—in order to demonstrate and validate the analytical approach. We describe a workflow for measuring mass and geometry of 3D-printed hydrogel lattices before and after storage under varying process parameters. Critical quality attributes (cQAs), including overall and internal structural fidelity as well as mass conservation, were monitored. The presented workflow supports the development of cryopreservation protocols and has potential applications in biomaterial development for bioprinting and in quality assessment of tailor-made artificial tissues. Full article

Standardized pharmacist intervention practices and documentation among health-system specialty pharmacies could improve understanding of the pharmacists’ role and value in this setting. This study describes current health-system specialty pharmacies’ intervention practices. A survey developed by a volunteer committee subgroup was distributed to two health-system specialty pharmacy group email distribution lists. The survey evaluated the types of tasks considered to be clinical or non-clinical interventions; who could perform interventions; where and how they were documented; data elements included in documentation; and how intervention data were classified, used, reviewed, and shared with internal or external stakeholders. Twenty-four institutions responded to the survey. Tasks within medication management, adverse drug events/monitoring, and education domains were more commonly considered clinical interventions; tasks in the health maintenance and coordination of care domains were more frequently considered non-clinical interventions or not considered to be interventions. Interventions were completed by pharmacists (at 100% of sites) and were mostly documented in the electronic health record (92%). Intervention data were primarily collected to meet accreditation purposes (96%) or for quality auditing and review (88%). No respondents shared intervention data with patients. Results demonstrate areas of alignment and variance in intervention definition and documentation among health-system specialty pharmacies. Full article

Increasing healthcare demands and physician shortages have prompted many countries to expand clinical responsibilities of pharmacists. Although Canada, the UK, and the US have implemented pharmacist prescribing, other nations lag behind. This review compares international roles, identifies inferred competencies, and explores implications for role expansion. A systematic search of MEDLINE, CINAHL, and the Cochrane Library was conducted using the PICO framework; studies were appraised with Critical Appraisal Skills Programme (CASP) checklists, and interrater reliability assessed via Cohen’s Kappa. Data from 23 studies were thematically synthesized following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guidelines. Four themes emerged: (1) expanding clinical and public health roles and pharmacists’ self-perceived readiness; (2) regulatory frameworks defining legal authority, qualifications, and temporary pandemic exemptions; (3) inferred competencies, including micro-skills (patient assessment, guideline application) and macro-capabilities (clinical judgment, accountability, reflective practice); and (4) contextual barriers such as training gaps, limited funding, unclear legal provisions, and workflow challenges. Implementation implications were synthesized and included training, funding, acceptance, and integration. Evidence indicates pharmacist prescribing is safe and patient-centered when supported by regulation, structured training, and systemic integration. Insights from established models can guide incremental implementation, optimizing medication management, enhancing healthcare access, and promoting equitable care. Full article