Pakistan journal of pharmaceutical sciencesRoberto Lozano, Aragn Health Service, Zaragoza Zaragoza, Spain Spain
BACKGROUND: Spinal muscular atrophy (SMA) is a rare neuromuscular disorder treated with disease-modifying therapies such as risdiplam. In Spain, its use is regulated by a national pharmacoclinical protocol that requires structured monitoring. OBJECTIVES: To evaluate real-world use, protocol adherence and registry completeness of risdiplam in routine clinical practice. METHODS: A retrospective registry-based case series was conducted including patients with spinal muscular atrophy treated with risdiplam.Variables included age, SMA subtype, SMN2 copy number, diagnostic confirmation, treatment sequence and persistence. Protocol adherence was assessed according to national criteria. RESULTS: Ten patients were included in the study. SMA types II and III predominated, with one presymptomatic case. SMN2 copy number ranged from three to four in documented cases. Protocol adherence was confirmed in 70% of patients, while 30% lacked key eligibility variables. No off-protocol prescribing was identified. Treatment persistence was 100% and 60% of patients had previously received nusinersen. CONCLUSION: Risdiplam was used appropriately in accordance with protocol criteria. Registry incompleteness, rather than clinical deviation, was the main limitation and standardized data capture is essential for real-world evaluation.
OBJECTIVES: Drug treatment for overactive bladder (OAB) is changing, with an increasing share of β3-adrenoceptor agonists relative to anticholinergics, but it is not known how far this change has progressed in older people, who are most vulnerable to the risks of anticholinergics. We examined the use of these drugs in Japan by age and sex, and analyzed changes in anticholinergic burden using a large database. METHODS: We analyzed outpatient prescriptions of two β3-adrenoceptor agonists and six anticholinergics from FY2017 to FY2024, using the sex- and age-stratified tables of the NDB Open Data of Japan. Dispensed tablets were converted into patient-days, and the β3-adrenoceptor agonist share was calculated. Anticholinergic burden was measured as ACB-weighted prescription volume (patient-days multiplied by the anticholinergic cognitive burden score). Because FY2021-FY2022 was a period of nationwide generic supply disruption, FY2018 and FY2024 were used as endpoints when estimating change over time. RESULTS: The β3-adrenoceptor agonist share rose from 36.2% to 64.9%, but anticholinergic use fell only slightly (3.10 × 108 to 2.94 × 108 tablets; -5.0%). In FY2024, the β3-adrenoceptor agonist share was higher in men than in women in every age group, and the difference widened with age (+1.2 percentage points at 50-54 years and +14.2 at ≥ 90 years). ACB-weighted prescription volume was higher in women than in men, and the female-to-male ratio rose with age (1.1 at 65-74 years, 1.6 at 75-84 years, and 2.8 at ≥ 85 years). Between FY2018 and FY2024, prescription volume fell by about 20% at 65-74 and 75-84 years, but the fall was smallest in women aged ≥ 85 years (-11.3%). CONCLUSIONS: The β3-adrenoceptor agonist share for OAB has continued to increase in Japan, but this change appears slower in older women, in whom anticholinergic exposure remains high.
Sexual healthDaniela Eassey, Jason J Ong, Ken Koh, David Nolan, David Baker, Mark O'Reilly, Beng Eu, Jillian Lau, Fiona Bisshop, Jessica Kent, Andrés Doblado-Maldonado, Dan…
BACKGROUND: Although clinical trials and real-world studies demonstrate the efficacy and tolerability of dolutegravir and lamivudine (DTG + 3TC), Australian real-world evidence remains limited despite differences in access to health care and prescribing context. Here, we present the motivations for switching to DTG/3TC (a fixed-dose, single-tablet regimen) and treatment outcomes. METHODS: We performed a retrospective, observational analysis of individuals with HIV with an undetectable viral load (VL; <50 copies/mL) who switched to DTG/3TC during a 24-month inclusion window from 1 December 2020 to 1 December 2022, in nine Australian clinics. Healthcare providers completed an electronic survey using baseline demographics of people with HIV and other clinical information gathered from participant medical records. Data were collected after December 2023 to allow a 12-month follow-up. Primary endpoints were baseline demographics, clinical characteristics, and motivations for switching to DTG/3TC. Secondary endpoints included virologic outcomes and rates and reasons for DTG/3TC discontinuation. RESULTS: Overall, 276 individuals with HIV who switched to DTG/3TC were included. Most were male (97%) and White (76%), with a median (interquartile range) age of 54 (45-61) years. The most common antiretroviral therapy before DTG/3TC switch was abacavir/dolutegravir/lamivudine (54%). The most common reason for switching to DTG/3TC was clinician preference for two-drug regimen (43%). Most individuals (98%) maintained virologic suppression (VL <50 copies/mL), and none experienced virologic failure. Through Month 12, one (<1%) individual discontinued DTG/3TC. CONCLUSIONS: These real-world data support the use of DTG/3TC as a viable treatment strategy in this Australian population of individuals with HIV.
BMJ open qualityPeter S Antkowiak, W Frank Peacock, Adam J Singer, Richard E Rothman, Gabriel A Bien-Willner
BACKGROUND: Differentiating bacterial from viral infections in acute care is challenging, often leading to inappropriate antibiotic use. MeMed BV (MMBV) is a host-protein test integrating TNF-related apoptosis-inducing ligand, induced protein-10 and C-reactive protein to distinguish infection aetiology. We evaluated whether alignment between MMBV results and antibiotic prescribing is associated with downstream clinical outcomes and costs. METHODS: Data were pooled from two prospective US studies (APOLLO and JUNO). Alignment was defined as: antibiotics prescribed for bacterial MMBV results or no antibiotics for viral results. The primary outcome was unplanned revisits and hospitalisations within 28 days. Exploratory analysis estimated healthcare costs using 2024 Healthcare Cost and Utilisation Project data. RESULTS: The cohort included 297 adults (median age 36.4 years). 20.5% had bacterial, 68.0% viral and 11.4% equivocal MMBV results. In patients with bacterial MMBV results, antibiotic prescription (alignment) was significantly associated with fewer revisits (5.0% vs 33.3%; p=0.003) and hospitalisations (2.5% vs 19.0%; p=0.026). For patients with viral results, outcomes were comparable regardless of antibiotic use. In the exploratory analysis, alignment with MMBV was associated with lower estimated costs (£101 vs £1175/patient; difference £1074), driven mainly by fewer hospital days in the aligned group. CONCLUSION: Misalignment between MMBV bacterial results and antibiotic prescribing in acute care settings was associated with higher revisit and hospitalisation rates. These findings identify a quality gap under diagnostic uncertainty and support a methodology which includes assessment of test versus clinical outcome alignment when evaluating new diagnostic tests.
Journal of medical Internet researchVerena Schneider, Akish Luintel, Bethan Balch, Shivani Gangadia, Grainne Brady, Emma McGuire, Gwenan M Knight, Laura Shallcross, Steve Harris, Cecilia Vindrola…
BACKGROUND: Prior microbiology results, resistance patterns, and antimicrobial exposure are central to safe and effective antimicrobial prescribing. Digital health fragmentation refers to the dispersal of patient data across multiple electronic systems and the associated challenge of accessing complete information at the point of care. Antimicrobial prescribing for infections represents a critical use case to investigate the impact of digital health fragmentation on patient care. While interoperability has been studied in the context of patient safety, no review has described digital health fragmentation within the United Kingdom and examined its impact on antimicrobial prescribing and antimicrobial stewardship (AMS). OBJECTIVE: This study aimed to (1) characterize the extent of digital health fragmentation in the United Kingdom, (2) summarize the available evidence on its impact on AMS and prescribing practices in high-income countries, and (3) identify potential solutions. METHODS: A rapid review of the peer-reviewed literature was conducted following published guidance for rapid reviews and the PRISMA (Preferred Reporting Items of Systematic Reviews and Meta-Analyses) statement. MEDLINE ALL and PsycInfo were searched on August 19, 2025, using search terms relating to digital health fragmentation or interoperability, patient safety, and antimicrobial use. Searches were limited to English-language publications from 2015 (for characterizing the recent trends or current state of digital health fragmentation in the United Kingdom) or 2010 onward (for AMS-related impacts and solutions). Screening was conducted by 4 researchers following predefined inclusion and exclusion criteria. Extracted data were synthesized narratively through framework analysis. Study quality was appraised using the Mixed Methods Appraisal Tool. RESULTS: Fourteen studies met the inclusion criteria. Ten studies described the extent and nature of digital health fragmentation in the United Kingdom. Digital health fragmentation affects a large number of patients and is linked to clinical care efficiency, quality, and safety risks, including limited access to external clinical records, missing or incomplete information, duplicate investigations, delays in decision‑making, and substantial time spent searching for data. Evidence specific to antimicrobial prescribing was limited (4 studies) but indicated that AMS relies on information spread across multiple systems, with poor interoperability disrupting workflows, hindering communication, and undermining stewardship activities. Only 1 study reported the development of a digital tool designed to address digital health fragmentation and support AMS. CONCLUSIONS: Digital health fragmentation negatively affects patient care across the United Kingdom, yet evidence on how it impacts AMS remains scarce. Given the urgency of the global antimicrobial resistance crisis, future research should therefore quantify the scale and impact of digital health fragmentation for AMS to inform investment and innovation in digital infrastructure and clinical-supportive solutions. TRIAL REGISTRATION: PROSPERO CRD420251126067; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251126067.
American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System PharmacistsCristian R Villalva, Kelli Sims, Olivia Ramey, Sarah R Bermudez
PURPOSE: Studies indicate incretin mimetic utilization is relatively low, especially among patients of Hispanic/Latino ethnicity. The objective of this study was to evaluate the frequency of incretin mimetic prescribing and identify predictors of prescribing within a predominantly Hispanic/Latino population at a county-funded hospital system. METHODS: A retrospective chart review of patients living with type 2 diabetes was conducted. The primary endpoint evaluated percentage of patients prescribed an incretin mimetic during August 2023 to August 2024. The secondary endpoint evaluated predictors to prescribing such as prescriber specialty, visit(s) with an ambulatory care clinical pharmacist, insurance status, clinical laboratory values, comorbidities, and medications used for concomitant comorbidities. RESULTS: A total of 502 patients were randomly selected for review, of which 42.6% (n = 214) were prescribed an incretin mimetic. Key predictors of prescribing were: sex (OR = 0.62, 95% CI [0.41, 0.92], P = 0.019), obesity (OR = 2.65, 95% CI [1.84, 3.82], P < 0.001), hyperlipidemia (OR = 1.57, 95% CI [1.04, 2.38], P = 0.032), endocrinology clinic visit(s), (OR = 3.91, 95% CI [2.43, 6.27], P < 0.001), and visit(s) with an ambulatory care clinical pharmacist (OR = 1.72, 95% CI [1.06, 2.81], P = 0.030). There was no significant difference in prescribing for Hispanic/Latino vs non-Hispanic/Latino populations within this study. CONCLUSION: Incretin mimetics are historically underutilized among patients of Hispanic/Latino ethnicity despite their evidence-based benefits in patients with type 2 diabetes. Engagement with endocrinology and ambulatory care clinical pharmacy services may contribute to increased prescribing within clinical settings.
European journal of clinical pharmacologySoo Hyeon Lee, Seojun Lee, Sangyoon Chris Lee, Yeo Jin Choi
PURPOSE: This study aims to evaluate the comparative adverse drug event (ADE) reporting patterns associated with antidiabetic drugs and develop machine learning (ML)-based classification models for the seriousness of reported ADEs. METHODS: We performed a retrospective analysis of 28,633 antidiabetic-related ADEs reported to the Korea Institute of Drug Safety and Management- Korea Adverse Event Reporting System database (KAERS DB 2505A0010) from 2015 to 2024. Disproportionality analyses identified safety signals using reporting odds ratios (RORs) with 95% confidence intervals (CIs). Factors associated with serious adverse event (SAE) classification were assessed using multivariate logistic regression, and three ML-based classification models were developed. RESULTS: Older adults accounted for 64.1% of the reported ADEs, with 2.35% classified as SAEs. Sulfonylureas demonstrated the highest SAE reporting signal (ROR 2.60, 95% CI 2.22-3.05). Male sex, older age, and sulfonylurea exposure were associated with higher odds of reports being classified as serious. Across the ML models, diabetic neuropathy treatment consistently emerged as the most influential feature contributing to SAE classification. CONCLUSION: ML-based classification complemented disproportionality analyses by identifying features associated with classification of reported ADEs as serious. Further validation using integrated longitudinal real-world data is warranted to confirm the robustness of these findings.
Journal of paediatrics and child healthJasmine Ucas, Ian Hughes, Danielle J Borg, Olivia Holland, Karyn Reynolds, Angela Owens
BACKGROUND: Rising prevalence of neurodevelopmental disorders, including attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD), has increased demand for developmental paediatric services. Ongoing medication review requirements place increasing pressure on paediatrician-led models. Pharmacist-led shared care may improve capacity and access; however, evidence in paediatric outpatient settings remains limited. AIM: To evaluate the impact of a paediatric-pharmacy shared-care model on wait times, service capacity and efficiency compared with medical-only care. METHODS: We conducted a two-phase observational study. Phase 1 retrospectively analysed service activity from 2019 to 2024, including patient numbers, occasions of service, wait times, failure-to-attend rates, and financial outcomes. Phase 2 prospectively audited 100 pharmacist-led consultations to characterise clinical activities. RESULTS: Patient numbers increased by 87%, and the proportion receiving pharmacist-led shared care rose from 4.1% to 25.3%. Pharmacy clinics had shorter wait times than medical clinics (1.84 vs. 7.64 months; p < 0.001). Following transition to shared care, median medical occasions decreased from 3 to 2 while total occasions increased from 3 to 5 (both p < 0.001). Pharmacy clinics demonstrated greater revenue efficiency (revenue-to-cost ratio 2.97 vs. 1.73). Pharmacists conducted comprehensive medication reviews including medication counselling, adherence assessment, and non-pharmacological support within a supervised framework. CONCLUSION: The paediatric-pharmacy shared-care model was associated with shorter wait times, greater cost-efficiency, and redistribution of routine medication reviews to pharmacists, with increased overall review frequency despite fewer medical appointments per patient. Pharmacist reviews were comprehensive and delivered within a supervised framework. These findings support pharmacist-led shared care as a scalable strategy to improve access and workforce capacity in developmental paediatrics.
Gadoteridol, a gadolinium-based contrast agent used for magnetic resonance imaging, has been used in clinical settings since its approval in the United Kingdom in 1992. Although its efficacy in enhancing imaging results is well established, investigating its associated adverse reactions remains critically important. This study aimed to comprehensively assess the safety profile of gadoteridol-related adverse drug events (ADEs), as reported in the FDA Adverse Event Reporting System (FAERS) database. Adverse event reports on gadoteridol spanning from the first quarter of 2004 to the fourth quarter of 2024 were extracted from the FAERS database. The analysis employed 4 complementary signal-detection methods, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayes geometric mean (EBGM), and Bayesian confidence propagation neural network (BCPNN), to identify and evaluate adverse drug event signals. The data were processed and analyzed using R software. During the entire study period, a total of 1158 reports of ADEs related to gadoteridol were identified, with the highest number reported in 2021, accounting for 11.61% of the total reports. Most reports were from patients aged > 60 years, representing 32.36% of the total. Regarding sex distribution, a greater number of reports were filed for female patients (58.17%) than for male patients (37.31%). Geographically, the United States contributed 45.63% of all reports. Notably, adverse reaction outcomes indicated that "other serious" reactions were predominant, accounting for 50.91% of all cases. Signal analysis revealed that, among 19 system organ classes examined, neurological diseases were the most frequently reported (501 cases), followed by systemic diseases (411 cases) and respiratory diseases (376 cases). Specific analyses of adverse reaction signals demonstrated the strongest associations with respiratory illnesses, immune system disorders, and skin-related conditions. This study offers a systematic examination of adverse event signals associated with gadoteridol using data from the FAERS database. These findings highlight notable reporting signals involving neurological, systemic, and immune-related conditions. This information is crucial for clinical practitioners prescribing gadoteridol and may contribute to enhancing patient safety and informing future regulatory actions concerning contrast agents.
MedicineYanggang Dan, Guodong Xu, Hang Chen, Hongxiang Li, Bingchuan Hu
Ambrisentan is an endothelin receptor antagonist broadly used for the treatment of pulmonary arterial hypertension. However, multiple adverse events (AEs) were reported with its use, and we intended to evaluate potential ambrisentan-associated AE signals through the US Food and Drug Administration Adverse Event Reporting System. Reports from March 2019 to December 2022 were selected for disproportionality analysis. Four signal detection methods were applied, namely the reporting odds ratio, the proportional reporting ratio, the information component, and the empirical Bayes geometric mean, to assess ambrisentan-associated AE signals. Ambrisentan was identified as a suspected drug in 30,060 reports. AEs associated with ambrisentan covered 8 system organ classes and showed potential signals at the preferred-term level, such as peripheral edema and dyspnea, as well as cardiac AE signals including palpitations and cardiac failure. The median time to onset of ambrisentan-associated AEs was 240 days, and approximately half (49.66%) of the AEs with documented time to onset occurred after 1 year of use. Our research identifies potential safety signals of cardiac AEs associated with ambrisentan use. These signals are hypothesis-generating and warrant confirmation in prospective studies, as well as continued pharmacovigilance monitoring.
APMIS : acta pathologica, microbiologica, et immunologica ScandinavicaAditya K Gupta, Elizabeth M Teasell, Gregory Pellegrino, Vasiliki Economopoulos, Ditte M L Saunte
Fungal infections pose a significant health burden in Denmark. Increasing global antifungal use and emerging antifungal resistance underscore the need for ongoing characterization of national prescribing trends to inform antifungal stewardship. Danish Health Data Bank Medstat site was accessed to assess total antifungal dispensing in Denmark from 1996 to 2025 across primary care, secondary care (hospitals), and over-the-counter sectors for both topical and systemic antifungals. Over the 30-year period, national antifungal dispensing patterns shifted substantially, with increased dispensing of azole/corticosteroid combination products in primary care (mean annual change of 0.065 g or ml per 1000 inhabitants/day), and persistent predominance of miconazole in secondary care and over-the-counter settings. Systemic prescribing was dominated by oral terbinafine in primary care and fluconazole in secondary care. Oral terbinafine dispensing in primary care was highest in 2009, while fluconazole dispensing peaked in 2013 in secondary care. Following peaks between 2009 and 2013, dispensing of several systemic antifungals subsequently declined, suggesting evolving prescribing patterns over time. Continued increases in azole/corticosteroid dispensing raises concerns regarding antifungal stewardship. Shifts in systemic antifungal dispensing for terbinafine and fluconazole may reflect changes in demographics, disease incidence (e.g., cancer), treatment guidelines, and clinical practice.
Journal of the American Pharmacists Association : JAPhACarrie Yu, Christine Schumacher, Ana C Quiñones-Boex, Elizabeth Van Dril
BACKGROUND: The American Diabetes Association (ADA) recommends prescribing glucagon for people with diabetes (PWD) using insulin or at high risk of hypoglycemia; however, prescribing rates remain low. Few studies have examined practices and barriers to outpatient glucagon use from pharmacists' perspectives. OBJECTIVE: This study aimed to describe pharmacists' perspectives on current practices and barriers to outpatient glucagon use in PWD. METHODS: A voluntary, electronic survey questionnaire was distributed to 1,624 members of the American College of Clinical Pharmacy Ambulatory Care and Endocrine and Metabolism Practice and Research Networks. Categorical, Likert, and open-ended questions were used to evaluate practice scope, patient population, and knowledge and perceptions related to glucagon use. Statistical analyses were conducted using IBM SPSS Statistics and the Stats iQ function within the Qualtrics® platform. RESULTS: Of the 186 respondents included, most pharmacists practiced in urban areas (58.2%) and primary care (83.1%), with a mean of 10.6 years of experience managing PWD. Respondents estimated that 23.5% of their patients with diabetes have an active glucagon prescription, and 42.1% fill their prescription. In hypothetical patients, respondents were most likely to recommend or prescribe glucagon for PWD with a history of hypoglycemia requiring medical attention (95.7%), recurrent hypoglycemia (89.6%), or using intensive insulin regimens, including continuous subcutaneous insulin infusion (82.3-93.9%). Respondents were less likely to do so for people with type 2 diabetes using basal insulin only (38.4%) or secretagogues (17.1%), or PWD with a history of an isolated hypoglycemic event (17.7%). The most frequently identified barriers to outpatient glucagon use were cost (75.5%), patient health literacy regarding when to use glucagon (71.7%), and insurance coverage (68.2%). CONCLUSION: Current practices among pharmacists engaged in outpatient diabetes management may not fully align with recommendations for glucagon use, highlighting opportunities for pharmacists to support strategies that optimize appropriate glucagon prescribing for high-risk patients.
The clinical teacherLuciana Flavia de Almeida Romani, Marina Guimaraes Lima
INTRODUCTION: Entrustable Professional Activities (EPAs) have been adopted in community pharmacy practice experiences, but there are no studies describing the development and validation of EPAs in contexts before their implementation. This study aimed to develop and validate the content of EPAs for community pharmacy practice experiences in Brazil. METHODS: A multi-stage research approach based on established theoretical frameworks for EPA development was employed. Stages included: (1) team formation and preparation; (2) identification and adaptation of a validated quality assessment tool (Queen's EPA Quality-EQual) for the Brazilian context; (3) drafting EPAs by mapping Brazilian national competencies to established EPAs of the United States of America, and adapting them linguistically and contextually; (4) two rounds of expert content validation utilizing the EQual rubric in Portuguese. RESULTS: Seven experts participated in the first round of evaluation; six contributed to the second. Initial assessment of 11 EPAs revealed only two EPAs surpassing all domain-specific and overall quality cut-offs in the EQual tool. The initial list of EPAs was adjusted and sent back for a second round of evaluation. The final list comprised three required EPAs scoring above the EQual rubric's overall and domain-specific cut-offs. CONCLUSION: This research proposed a list of EPAs for community pharmacy practice experiences to be adopted for the first time, offering a framework to standardize teaching, inform preceptor training, and reliably assess student competency development.
Australian health review : a publication of the Australian Hospital AssociationKaren Lee, Champika Pattullo, Elizabeth Vujcich
OBJECTIVES: This study aimed to audit opioid prescribing practices at hospital discharge for elective surgical patients and assess alignment with contemporary best-practice recommendations. METHODS: A retrospective audit of adult elective surgical inpatients at a tertiary surgical and rehabilitation centre (1 October 2024-1 January 2025) examined discharge opioid prescribing, in oral morphine equivalent daily dose (oMEDD), against inpatient opioid use. A supplementary theatre register was used to compare patients discharged with and without an opioid. RESULTS: Of 580 patients screened, 576 were eligible; 47.6% (n = 274) were discharged with an opioid, most often oxycodone IR (54.8%) or tapentadol (41.2%), typically as a fixed quantity of 10 (52.2%) or five (27.4%) tablets. Discharge oMEDD (median 75 mg, interquartile range (IQR) 75-150) correlated moderately with inpatient oMEDD in the preceding 24 h (r = 0.57, P < 0.001); the estimated days-equivalent supply (median 3.1 days) matched recommended 3-5 day courses for most patients, though 13.8% received an opioid despite no recent inpatient use. Opioid recipients were significantly younger (48 vs 65 years, P < 0.001) and concentrated in higher-pain specialties such as orthopaedics, whereas opioids were rarely prescribed after ophthalmology; length of stay did not differ between groups. Only 17.8% of patients discharged with an opioid also received simple analgesia at discharge. CONCLUSIONS: Discharge opioid prescribing was reasonably individualised by patient and procedure, but quantity was frequently standardised rather than tailored, and a minority of patients received an opioid despite no recent inpatient need. Strengthening quantity individualisation, discharge simple analgesia, and patient education around cessation would further align prescribing with opioid stewardship principles.
Pakistan journal of pharmaceutical sciencesJieyuan Chen, Zhaojun Wang, Songsong Mao
BACKGROUND: Sevoflurane, an ether-derived inhalational anesthetic widely used for general anesthesia, requires comprehensive safety evaluation. OBJECTIVES: This study aimed to identify sevoflurane-associated adverse events and detect unexpected safety signals using data from the FDA Adverse Event Reporting System (FAERS). METHODS: We analyzed FAERS data from the first quarter of 2004 through the first quarter of 2024, applying four disproportionality analysis algorithms (ROR, PRR, BCPNN, MGPS) to reports designating sevoflurane as the "primary suspect" drug. RESULTS: Among 1,649 reports, we identified 27 significant preferred terms affecting four major organ systems. Notable unexpected safety signals included cardiac arrest, anesthesia awareness, delayed recovery, pulmonary alveolar hemorrhage, anaphylactic shock and seizures. CONCLUSION: These findings provide critical insights into sevoflurane's real-world safety profile, particularly revealing severe yet underrecognized risks that can inform enhanced clinical monitoring and safer anesthetic practice. However, it should be acknowledged that disproportionality analysis is a hypothesis-generating or refinement approach, and further confirmatory studies are warranted to establish causal relationships.
This study examined the perceived impacts of New South Wales' (NSW) statewide prescription drug monitoring program (PDMP; "SafeScript NSW") from the perspective of prescribers and pharmacists, using a qualitative descriptive design. Fourteen prescribers and pharmacists who were users of NSW's PDMP completed semi-structured interviews between May and August 2024. Thematic analysis was guided by the Quadruple Aim framework. Impacts were classified as those relating to (1) population health outcomes, (2) patients' care experience, (3) costs, (4) practitioners' work experience. PDMP's perceived impacts on population health included improved medication safety and reduced prescription shopping. Key patient impacts included risk of stigma and treatment interruption. Despite these, both prescribers and pharmacists reported improved therapeutic relationships with patients following SafeScript NSW use. Impacts on relationships between healthcare practitioners were mixed, with resistance encountered from those who do not use SafeScript NSW. No impacts of PDMP on healthcare delivery costs were reported. Participants discussed efficiency impacts relating to practitioners' work. Both practitioner groups reported PDMP use increased confidence and safer prescribing/dispensing practices. Workflow misalignment and workarounds were reported, predominantly by pharmacists. This study adds evidence on healthcare practitioners' perspectives on PDMP. To minimize negative impacts, we suggest further evaluation and strategies to address user-identified gaps, including workflow challenges. Collaborative development of system improvements and strategies with users can maximize continued user acceptance and uptake, benefits realization, and the system's long-term success.
Pharmacology research & perspectivesYulisna Mutia Sari, J Simon Bell, Surya Adhi, Uswa Alhamid, Esthika Dewiasty, Annisa Dhanira, Clara M Kusharto, Evi Dwi Novriany, Dion Notario, Imran Pambudi, …
Indonesia and other Southeast Asian nations are experiencing rapidly aging populations. The Indonesian Government recently announced a national initiative of aged care homes to support older people not able to live independently or receive family care. Medication-without-harm is the topic of the World Health Organization Third Global Patient Safety Challenge. The objective of this study was to prioritize research questions for improving medication management in public and private aged care homes in Indonesia. In April 2025, a 20-person expert consensus panel was convened comprising general practitioners, geriatricians, neurologists, nurses, pharmacists, physiotherapists, nutritionists, public health practitioners, aged care home managers, Ministry of Health representatives, ASEAN organization representatives, and a family caregiver. The panel used modified nominal group technique to identify and prioritize research for improving medication management in aged care homes in Indonesia. The panel identified 47 research priorities that were consolidated into 15 policy and 20 practice priorities for voting. The highest ranked policy priorities focused on necessary regulations and clinical guidelines; essential medication lists for older people; and policies to support development and use of drug formulations acceptable for residents of aged care homes. The highest ranked practice priorities emphasized digital health technologies; medication safety monitoring; and enhancing communication among families, aged care home staff, and prescribers. The findings lay the groundwork for a culturally- and context-specific research roadmap for improving medication management in Indonesian aged care homes. This will guide researchers and research funding organizations in aligning future studies with policy and practice priorities.
Australian health review : a publication of the Australian Hospital AssociationChampika Pattullo, William Dace, Anita Pelecanos, Gerben Keijzers, Peter Donovan
OBJECTIVE: Chronic opioid use can develop in previously opioid-naïve patients following an emergency department (ED) or hospital admission; however, most evidence is from North America. This study aims to assess the prevalence of persistent opioid use after an ED presentation in an Australian setting. METHODS: This was a population-based, retrospective cohort study using state-based linked data. Persistent opioid use was defined as continued use after 12 months, among previously opioid-naïve patients who filled an opioid prescription following discharge from any Queensland public hospital ED between 1 January 2011 and 31 December 2017. Descriptive statistics were used to summarise demographic characteristics of the study population and to outline primary outcome measures. RESULTS: There were 3,082,681 ED presentations during the study period, and 11,281,039 opioid prescriptions within 12 months of the ED presentations included in the study. A total of 186,545 opioid-naïve patients had an opioid prescription associated with their ED presentation, with more prescriptions in 2017 (34,273) compared with 2011 (14,896), driven predominantly by oxycodone prescription increases. However, of the total cohort, only 3539 (1.9%) were classified as persistent opioid users, with similar annual proportions seen throughout the study period. CONCLUSION: The proportion of patients progressing to persistent opioid use after ED presentation was low and remained relatively stable, despite a substantial increase in the number of patients receiving at least one opioid prescription after an ED presentation. These results highlight the need for continued focus on appropriate prescribing and patient safety.
Cancer medicineYuqing Feng, Martin Yi, Catherine C Aftandilian, Melissa P Beauchemin, Christine Cunningham, David DeStephano, Rhea K Khurana, Emily Larimer, Jennifer Oberg, B…
PURPOSE: Opioid use in pediatric oncology is poorly characterized. The primary objective was to describe opioid administration or prescription patterns in pediatric oncology patients. METHODS: In this multi-center retrospective study conducted across three sites, we included patients aged 0-19 years with a malignant neoplastic disease who received their first chemotherapy between January 2019 and March 2024. Data were extracted from each site's Observational Medical Outcomes Partnership Common Data Model. We described patient characteristics based on: (1) first opioid administration or prescription, overall and for each specific opioid; and (2) all opioid administrations or prescriptions, overall and for each specific opioid. We also evaluated variability in opioid and naloxone use. RESULTS: Of 2903 pediatric patients with cancer, 2707 (93.2%) were administered or prescribed at least one opioid. Among these patients, fentanyl was the most common (92.4%), followed by morphine (68.7%), hydromorphone (55.3%), and oxycodone (38.6%). Across centers, the proportion of patients receiving fentanyl ranged from 90.9% to 94.9%, morphine from 34.0% to 89.2%, oxycodone from 0.9% to 76.1%, and naloxone from 2.4% to 29.5%. Overall, 10.9% were administered or prescribed naloxone, but among 169 methadone patients, 43.5% were administered or prescribed it. Of the 153,849 total opioid administrations or prescriptions, 22.4% occurred more than 12 months after initiating chemotherapy. CONCLUSIONS: Among pediatric patients with cancer who receive chemotherapy, 93.2% were administered or prescribed at least one opioid; fentanyl was the most common. There was heterogeneity in opioid choice and naloxone use across sites. These findings lay preliminary groundwork for understanding opioid use patterns and identifying potential areas for practice improvement in pediatric oncology.
Journal of the American College of Clinical Pharmacy : JACCPMontserrat Viñas-Bastart, Maria-Estela Moreno-Martínez, Sònia Ruiz-Boy, Jan T De Pourcq, Cristina Martínez Roca, Maria Josep Carreras-Soler, Miguel Ángel Amor …
BACKGROUND: Board of Pharmacy Specialties certification has emerged internationally as a mechanism to support advanced pharmacy practice and professional differentiation. However, little is known about how BPS-certified pharmacists perceive its value within health care systems with specialist training pathways, such as in Spain. This study aimed to explore the perceived value, professional impact, and implementation barriers of BPS certification among hospital pharmacists in Spain. METHODS: A qualitative descriptive study used semi-structured interviews with BPS-certified hospital pharmacists practicing in Spain. Participants were purposively recruited to ensure diversity in certification specialty, geographical region, and profile. Interviews were conducted between April and June 2026, audio-recorded, transcribed, and analyzed using qualitative content analysis. Reporting followed Consolidated Criteria for Reporting Qualitative Research. RESULTS: Eleven hospital pharmacists representing multiple BPS specialties participated. Participants perceived BPS certification as strengthening clinical competence, improving confidence in pharmacotherapeutic decision-making, and supporting advanced clinical practice. Certification was perceived to enhance professional credibility within interprofessional clinical teams and among pharmacist colleagues. However, participants described limited institutional recognition, with little impact on salary, career progression, employment systems, or protected professional development time. Major barriers included time investment, economic costs, recertification requirements, and partial mismatch between the United States-oriented examination framework and the Spanish health care context. Participants viewed BPS certification as a complementary credential to the national hospital pharmacy residency system rather than a substitute for specialist training. Most anticipated demand for credentialing would continue to increase as hospital pharmacy practice becomes specialized and clinically complex. CONCLUSIONS: BPS certification is perceived as a valuable mechanism supporting advanced clinical competence, professional differentiation, and integration into interprofessional practice. Nevertheless, broader implementation remains limited by insufficient institutional recognition and structural support. Greater alignment between international credentialing systems and national professional development frameworks may facilitate integration of pharmacy practice credentials within the Spanish health care system.
Pharmacoepidemiology and drug safetyValcieny Sandes, Alice Ramos-Silva, Adriana Ivama-Brummell, Albert Figueras, Elisangela Costa Lima
PURPOSE: Appropriate antibiotic dosing is essential to minimise treatment failure and reduce selective pressure that may contribute to antimicrobial resistance. This study characterised antibiotic medication-error drug-event pairs (MEPs) reported to the medicines Individual Case Safety Reporting (ICSR) system, VigiMed and assessed the distribution of dosing-related error drug-event pairs (DEPs) across World Health Organization (WHO) AWaRe (Access, Watch, and Reserve) antibiotic classes. METHODS: We conducted an exploratory cross-sectional analysis of reports involving systemic antibiotics (Anatomical Therapeutic Chemical, ATC Classification System as J01 - antibacterials for systemic use) from Brazil's open-access pharmacovigilance database (VigiMed) from 2018 to 2025. MEPs were identified using the Standardised MedDRA Query for Medication Error; within this group, Preferred Terms (PTs) related to dose amount, timing, frequency, duration, or rate of administration were classified as DEPs (32 PTs). Descriptive analyses and modified Poisson regression were used to examine demographic and reporting characteristics associated with MEP classification and, among MEPs, the association between AWaRe class and DEP classification. RESULTS: The adjusted prevalence of MEP classification was higher among neonates (PR 3.90), infants (PR 1.78) and older adults (PR 1.70) than among adults. DEPs accounted for 31.7% of MEPs (n = 2587; 61 antibiotics), with dose omission (51.4%) and dosing regimen problems (16.7%) as the leading error subtypes. Among DEPs, 35.9% involved Access, 56.7% Watch and 7.1% Reserve antibiotics. In adjusted analyses, Watch (PR 1.14; 95% CI 1.07-1.22) and Reserve (PR 1.31; 95% CI 1.16-1.49) antibiotics showed a higher prevalence of DEPs than Access antibiotics. CONCLUSIONS: This study analyses pharmacovigilance data on antibiotic dosing-related medication errors, highlighting potential opportunities for antimicrobial stewardship.
Research in social & administrative pharmacy : RSAPYahia Gobran
BACKGROUND: Artificial intelligence (AI) is increasingly used across medication-use workflows, but discrimination alone does not establish safe or useful implementation. OBJECTIVE: To propose an evidence-informed framework for responsible implementation of AI across the medication-use process. METHODS: A targeted critical evidence scan through 28 July 2026, updated on 17 September 2026, charted 17 clinical studies. Domains were derived through inductive coding, comparison with clinical-AI and pharmacy guidance, and structured study-level appraisal. RESULTS: The Medication-Use AI Safety and Implementation Framework contains seven linked domains: clinically meaningful target and label; transportable validation; calibration and threshold justification; clinically actionable information and explanation; workflow integration and human oversight; prospective clinical evaluation; and lifecycle governance and resilience. Human factors and equity are cross-cutting. Medication-specific criteria emphasize severity-weighted false negatives, alert burden, pharmacy capacity, formulary and workflow dependence, safety nets for low-risk suppression, and contingency planning. CONCLUSIONS: The framework is a proposed implementation structure, not a validated minimum standard or readiness score. It is intended to help medication-use professionals judge whether AI systems have sufficient clinical, operational, and governance evidence to progress responsibly toward prospective use. Stakeholder consensus, reliability testing, and prospective validation are required.
Journal of pharmaceutical policy and practiceAthirah Bakhtiar, Angelina Lim, Li Ling Yeap, Daniel Malone, Han Yin Lim, Sunanthiny Krishnan
BACKGROUND: Experiential learning is central to pharmacy education, yet the translation of clinical skills from simulated examinations to actual practice remains under-researched. This study utilised mystery shopping to evaluate how well clinical competencies transfer when students move from university Objective Structured Clinical Examinations (OSCEs) to independent community pharmacy placements, shedding light on systemic barriers to clinical care integration. METHODS: Using a sequential explanatory mixed-methods design, 57 third-year undergraduate pharmacy students were covertly evaluated during their placements by mystery shoppers reenacting clinical scenarios identical to those used in the primary-care component of their university OSCEs. Scores were compared using Wilcoxon signed-rank tests and Spearman's correlation. Additionally, semi-structured interviews explored students' perspectives on the performance gap and the systemic obstacles that prevent successful skill transfer. RESULTS: Real-world performance was markedly lower than examination scores, with mystery shopping scores dropping to a median of 0% versus 91.67% in the OSCE (p < 0.001). No significant correlation existed between simulated success and independent execution (rs = 0.14, p = 0.2934). Qualitative analysis identified three main drivers for this mismatch: the disconnect between structured examinations and fluid retail practice; environmental distractions; and restrictive public expectations that actively discouraged thorough clinical counselling. CONCLUSION: Simulated clinical competence does not reliably translate to independent practice. This performance drop illustrates how national policy and retail realities constrain a student's actual clinical output. Integrating independent workplace assessments, such as mystery shopping, may provide a more direct, unsupervised measure of readiness. Bridging this gap will likely require coordinated efforts among academic institutions, practising pharmacists, and regulatory bodies. These findings may offer preliminary insights relevant to other developing health systems navigating similar transitions in clinical pharmacy practice, pending further research across diverse settings.
Recent advances in drug delivery and formulationSukanta Satapathy, Ganesh Patro, Santanu Shaw
Artificial Intelligence (AI) is revolutionizing the pharmaceutical industry by enhancing efficiency, precision, and personalization in drug discovery, development, and patient care. This review explores the diverse applications of AI in pharmacy, including drug discovery, formulation development, target identification, hit discovery, and lead optimization. The review explains the clinical trial design and predictive modeling in the crucial implementation of AI. Clinical care for diagnosis, medical image analysis, and early disease detection with sharp clinical decisions are the new directives of AI, as explained. Personalized medicine and pharmacovigilance also include AI to improve outcomes. Community and hospital pharmacies use AI to check treatment plans and drug interactions, as highlighted. Pharma manufacturing uses AI for process optimization, quality management, and supply chain management, resulting in better output. Pharma marketing also uses AI to predict trends and analyze the market. Sales forecasting and compliance monitoring are additional areas in which AI is increasingly being applied. Academic research has also benefited from AI applications. However, regulatory compliance and cultural barriers remain important challenges to AI adoption. Future research directions and emerging opportunities have the potential to further advance the pharmaceutical sector. The challenges associated with AI across these domains are discussed to provide a balanced perspective. This review provides an integrated overview of AI applications across the pharmaceutical sector and the associated challenges.
The Journal of dermatological treatmentShinwon Hwang, Yerim Kwak, Yeon Woo Jung, Se Yong Jung, Jae Il Shin, Tae-Gyun Kim
INTRODUCTION: Infection-related adverse events are an important safety concern in psoriasis therapy. OBJECTIVE: To compare infection-related adverse-event reporting across mechanism-based therapy groups. METHODS: We analyzed psoriasis-indicated US Food and Drug Administration Adverse Event Reporting System (FAERS) reports from 2014 Q3 through 2025 Q3. Sixteen therapies were grouped as TNF, IL-12/23, IL-17, and IL-23 inhibitors and immunosuppressive or non-immunosuppressive nonbiologics. Primary exposure was a primary- or secondary-suspect listing; sensitivity analysis required drug-sequence linkage to psoriatic disease. Reporting odds ratios (RORs) and information-component lower bounds (IC025) were calculated. RESULTS: Among 357,728 reports, 67,827 contained an infection term. Signals were strongest for immunosuppressive nonbiologics (ROR 2.51; IC025 0.88) and IL-12/23 inhibition (2.43; 0.83), followed by IL-17 inhibitors (1.82; 0.47). TNF inhibitors showed a modest signal (1.17; 0.11), whereas IL-23 inhibitors were near null (0.99; -0.04). Indication linkage attenuated the immunosuppressive-nonbiologic signal to ROR 1.14 (IC025 0.09), while IL-12/23 and IL-17 signals persisted. IL-17 inhibitors showed a Candida signal (ROR 8.67; IC025 1.55). CONCLUSION: Reporting estimates varied by mechanism, and exposure attribution materially influenced the immunosuppressive-nonbiologic result.
ChestSusan E Smith, Kelli R Henry, Mojdeh S Heavner, Zhetao Chen, Xianyan Chen, John W Devlin, David J Murphy, Greg S Martin, Marisha Burden, Brian Murray, Andrea S…
BACKGROUND: Medication-related morbidity due to inappropriate prescribing, delays in appropriate treatment, and adverse drug events contributes to ICU patient mortality. Comprehensive medication management (CMM) is a care standard provided by pharmacists in collaboration with the interprofessional team. Optimizing ICU pharmacist workload via the pharmacist-to-patient ratio while ensuring daily CMM may reduce mortality. RESEARCH QUESTION: Is ICU pharmacist staffing, measured by the pharmacist-to-patient ratio and absence of CMM, associated with in-hospital mortality among critically ill adults? STUDY DESIGN AND METHODS: Adults admitted to an ICU from 64 centers (in the United States, Jordan, and Saudi Arabia) were enrolled in a multicenter observational study that collected patient and team staffing data from August 2023-January 2025. The primary outcome was in-hospital mortality. The primary exposure was the pharmacist-to-patient ratio calculated per patient, averaged over the ICU stay. A secondary exposure was the absence of CMM for at least 1 day of the ICU stay. Multivariable generalized estimating equations (GEE) were used to estimate associations with in-hospital mortality, accounting for clustering by center and adjusting for patient-, ICU-, and hospital-level covariates. RESULTS: Among 28,795 patients enrolled, the median (IQR) pharmacist-to-patient ratio was 1:17 (13-23). Each one-patient increase in the pharmacist-to-patient ratio was associated with a 1% increase in the odds of in-hospital mortality (Odds Ratio [OR] 1.01, 95% Confidence Interval [CI] 1.00-1.01, p=0.04). Patients who did not receive pharmacist-delivered CMM for at least 1 day of the ICU stay had 20% higher odds of in-hospital mortality (OR 1.20, 95% CI 1.03-1.40, p=0.02). Patients cared for at a pharmacist-to-patient ratio of 1:15.1-46 had 10% higher odds of mortality compared to those cared for at a ratio of 1:7-15 (OR 1.10, 95% CI 1.00-1.22). INTERPRETATION: Increasing pharmacist-to-patient ratios and the absence of pharmacist CMM every day were both associated with increased in-hospital mortality.
The International journal of pharmacy practiceRabea Parveen, Saba Khan, Ashim Malhotra, Javed Ali
OBJECTIVES: Pharmacy plays a critical role in healthcare through medication management, patient counselling, pharmaceutical care, public health services, and pharmaceutical research. India possesses one of the largest pharmacy education systems and pharmaceutical workforces globally; however, the profession continues to face several educational, regulatory, and practice-related challenges. METHODS: This narrative review provides a comprehensive overview of pharmacy education, professional practice, regulatory frameworks, career pathways, research culture, and emerging trends in India. Relevant literature was identified from peer-reviewed publications, official reports, policy documents, and regulatory resources obtained through databases including PubMed, Scopus, Google Scholar, and official websites of the Pharmacy Council of India (PCI), Central Drugs Standard Control Organisation (CDSCO), and other governmental and professional organizations. KEY FINDINGS: The review highlights that India has a well-established pharmacy education infrastructure and a large pharmaceutical workforce. However, several challenges persist, including variability in experiential and clinical training, limited implementation of patient-oriented pharmacy services, underutilization of clinical pharmacists, gaps in regulatory enforcement, inconsistent continuing professional development (CPD) frameworks, and limited outcomes-based evidence supporting pharmacist-led interventions. Opportunities exist for expanding clinical pharmacy services, medication therapy management, antimicrobial stewardship programs, and pharmacist participation in multidisciplinary healthcare teams. CONCLUSIONS: Strengthening competency-based education, experiential learning, clinical pharmacy practice, regulatory oversight, CPD, and research capacity will be essential for advancing the profession. Addressing these priorities may improve medication safety, patient outcomes, and the overall contribution of pharmacists to healthcare delivery while aligning pharmacy education and practice in India with evolving global standards.
Human vaccines & immunotherapeuticsWenjun Fang, Ben Liu, Li Cai
Rituximab is widely used for B‑cell malignancies and autoimmune diseases, but its pediatric safety profile requires systematic real‑world evaluation. This research mined safety signals of adverse events (AEs) linked to rituximab in pediatric patients using U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) data from 2004 to 2025. A total of 2,231 pediatric AE reports involving rituximab were identified and analyzed using four disproportionality methods (ROR, PRR, BCPNN, and MGPS) for signal detection and Weibull distribution analysis for time-to-onset patterns. Results showed a balanced sex distribution in AE reports (47.7% male, 48.5% female). Most reports involved adolescents aged 12-17, with an overall increasing trend. A total of 149 positive safety signals were detected via disproportionality analysis. Several of these signals pertained to immune system - and infection‑related adverse events. Notably, the elevated signal magnitudes for certain signals were substantially confounded by indication bias, pre‑existing comorbidities, and reports associated with therapeutic failure. Stratified analyses revealed differences in the signal distribution of adverse‑event reports across age and sex subgroups. Time‑to‑onset analysis of adverse‑event reports indicated that most events documented in these reports occurred within 30 d of therapy initiation, with a median of 7 d. This study characterizes the reported safety profile of rituximab in pediatric patients based on FAERS spontaneous reports. Our findings represent exploratory signal hypotheses only and can serve as a reference for subsequent relevant investigations.
Annales pharmaceutiques francaisesJ Raymond, L Viault, M Laureau, C Chenailler, R Varin, E Barat
OBJECTIVES: The aim of this study is to map clinical pharmacy activities within the adult emergency care pathway in France. METHOD: An online survey was sent out between 26/02/2024 and 31/10/2024 to 1,240 hospital pharmacists. The survey consisted of 36 questions on the characteristics of clinical pharmacy activities deployed or not deployed in adult emergency departments. Only one response per establishment was requested. RESULTS: The response rate was 36,9 % (458). Off the 266 institutions with an adult emergency department, 55 (20.7 %) have implemented clinical pharmacy activities, and their geographical distribution is not uniform across the country. The main activities carried out are pharmaceutical prescription analysis and medication reconciliation, particularly in the short stay unit. The profiles of the pharmaceutical professionals involved vary from one institution to another depending on the resources available, and they are mainly funded by the pharmacy department. Of the 211 institutions without any activities in place, 82 (38.9 %) have plans to implement them, either in progress or under consideration, with a stronger dynamic for university hospital-type institutions. The main obstacle to implementing these activities in adult emergency departments is a lack of human resources and funding. DISCUSSION AND CONCLUSION: This mapping reflects a positive trend in the deployment of clinical pharmacy activities in adult emergency departments in France, involving all types of pharmacists, despite disparities depending on the type of establishment or geographical location. The main obstacle identified is the lack of human resources, with few pharmacists currently having a position dedicated entirely to activities in an adult emergency department.
Irish medical journalF McNicholas, R Parkin, L Bond, D Purper-Ouakil, J Hayden, J Walkup
Psychotropic prescribing in youth is increasingly debated through concerns regarding both overmedicalisation and unmet mental health need. Rising rates are often interpreted as evidence of overprescribing, yet clinicians often operate in under-resourced services, with long waiting lists and limited access to psychological therapies. This paper argues that the key issue is not whether prescribing rates are too high, but whether prescribing is proportionate to clinical need. Drawing on international and recent Irish CAMHS prescribing data, we propose a "Goldilocks model" of psychotropic prescribing in youth, in which optimal prescribing lies on a continuum between the extremes of under- and over-prescribing. This position is shaped by evidence, patient factors, and service context. While psychotropics have an important evidence-based role within child psychiatry, safe and effective use depends on accurate assessment, appropriate monitoring, and access to multidisciplinary and psychosocial supports. Achieving proportionate prescribing therefore requires systems capable of supporting evidence-informed, ethically grounded, and developmentally informed care, ensuring treatment is neither too much nor too little, but ultimately "just right."
American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System PharmacistsSophia C Brown, Brian C Lund, Qianyi Shi, Mary K Good, Megan E Dahlke, Heather A Christ, Diana I Jalal, Masaaki Yamada
PURPOSE: To compare clinical pharmacist practitioner (CPP) service receipt among Veterans with chronic kidney disease (CKD) by rural/urban residence and by primary care site, and to describe CPP telehealth use. METHODS: Using Veterans Health Administration data, we identified Veterans with CKD (N=699,273), defined by two eGFR values <60 mL/min/1.73 m2 (≥90 days apart) and ≥1 primary care visit in 2019. Rurality was based on Rural-Urban Commuting Area codes. The primary outcome was ≥1 outpatient CPP encounter; secondary outcomes were CPP encounter frequency and telehealth use. We used multivariable logistic regression with a random intercept for health system. FINDINGS: Overall, 18% of urban and 17% of rural Veterans had ≥1 CPP encounter. After adjustment, rural Veterans were slightly more likely to have a CPP encounter (adjusted odds ratio [aOR] 1.05; 95% confidence interval [CI] 1.03-1.07). Differences were larger by primary care site: 21% at medical centers, 16% at urban clinics (aOR 0.69; 95% CI 0.68-0.70) and 14% at rural clinics (aOR 0.61; 95% CI 0.59-0.62). Among Veterans with ≥1 CPP encounter (n=124,490, 17.8%), rural Veterans had slightly more CPP encounters than urban Veterans (4.6 vs 4.3). CPP telehealth comprised 53.7% of encounters and varied by primary care site (56.5% medical centers, 48.8% urban clinics, 62.8% rural clinics). CONCLUSIONS: Rural-urban differences in CPP receipt were small after adjustment, but Veterans receiving primary care in community clinics had lower CPP receipt than those at medical centers. Telehealth may support expanded CPP access for Veterans with CKD.
OBJECTIVES: Solid organ transplantation is a standard treatment for end-stage organ failure, which improves patient survival. The long-term success of the transplant depends in particular on the use of immunosuppressive treatments known as anti-rejection drugs, the dispensing of which requires rigorous pharmaceutical analysis due to their narrow therapeutic index. The detection of treatment-related issues during analysis leads to the formulation of pharmaceutical interventions. METHODS: This study, conducted as a review of pharmaceutical interventions, aims to describe the types of pharmaceutical interventions involving oral anti-rejection drugs, with a view to standardizing clinical practice and ensuring the safe management for transplant patients. Conducted in accordance with a local procedure by a pharmacy resident and two clinical pharmacists over a five-year period, this review compiled data on each intervention (121), their clinical impact according to the rating system of the French Society of Clinical Pharmacy, and their acceptance rate. RESULTS: The main issues related are inappropriate route and/or administration (37%), drug interactions (23%) and overdoses (19%). Two-thirds of issues were attributed to calcineurin inhibitors, primarily tacrolimus. Issues with moderate clinical impact were the most common, particularly those related to drug interactions involving cyclosporine. The acceptance rate (38%) found in the study was lower than the national average, regardless of the clinical impact of the adverse drug reaction. No overall association was found between the type of IP and its acceptance (p = 0.50). CONCLUSION: These findings confirm the value of a systematic pharmaceutical review of oral anti-rejection prescriptions and highlight the importance of improving communication with prescribers.
Expert review of clinical pharmacologyWajid Zaman, Asma Ayaz
INTRODUCTION: Digital therapeutics (DTx) are evidence-based software interventions that can function as therapeutic modalities, either independently or adjunctively, while artificial intelligence (AI) may support personalization, prediction, adaptive delivery, and safety monitoring. Pharmacy practice is directly affected because pharmacists manage medicines, adherence, counseling, pharmacovigilance, access, and longitudinal medication-related care. AREAS COVERED: This structured narrative review defines digital health, digital medicine, DTx, prescription DTx (PDT), software as a medical device (SaMD), and AI-enabled DTx; critically examines clinical evidence and its limitations; and evaluates pharmacist roles in product selection, onboarding, monitoring, medication optimization, safety surveillance, reimbursement, and governance. PubMed and targeted regulatory and professional sources were searched through July 2026, with priority given to randomized trials, systematic reviews, meta-analyses, real-world evidence frameworks, and official guidance. EXPERT OPINION: AI-enabled DTx should be regarded as therapeutic modalities whose role may be standalone or adjunctive according to intended use and evidence. They are distinct from pharmacological medicines, and they should not autonomously displace indicated drug therapy or professional judgment without comparative evidence. Pharmacist-supervised integration is proposed as a clinically accountable conceptual implementation model, but its effectiveness, cost-effectiveness, and workflow consequences require prospective validation.
American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System PharmacistsKimberly Schaffer, Anoli Patel, Cherie Andrews, Nikki Beck, Jenna Tatter, Michelle Agnew, Tiffany Nation, Jen Marin, Barbara Pressley, Janice Taylo
PURPOSE: This retrospective study evaluated the primary objective of whether centralizing prior authorization drug request (PADR) adjudication across 4 Veterans Integrated Service Network (VISN) 21 healthcare systems reduced local pharmacist workload while maintaining or improving timely prior authorization completion. The study was determined to be institutional review board exempt. SUMMARY: In 2019, VISN 21 piloted a centralized PADR program, funded by the Veterans Health Administration Pharmacy Benefit Management. The program aimed to standardize prior authorization processes, promote pharmacoequity, and reallocate healthcare system (HCS) clinical pharmacy specialists' time toward increasing patient access. A retrospective analysis compared prior authorizations processed 6 months before and 6 months after centralization. Before centralization, 10,922 prior authorizations were adjudicated by 161 clinical staff members (8 pharmacist full-time equivalents [FTEs]), with 95% of the prior authorizations completed within 96 hours. After centralization, 10,779 prior authorizations were handled by 6 VISN staff FTEs (4 pharmacists and 2 technicians), achieving a 98% completion rate within 96 hours. This HCS-to-VISN prior authorization workload shift enabled HCS clinical pharmacists to devote an additional 3,100 hours to patient care. CONCLUSION: The centralized PADR program in VISN 21 significantly reduced HCS-level administrative burden and improved patient access by increasing clinical pharmacist availability for clinical responsibilities. Centralization reduced the required number of FTEs for prior authorization adjudication by 25%, improved turnaround time by 3.6%, and ensured standardized adjudication practices. This initiative demonstrates an effective strategy to standardize prior authorization adjudication and improve care delivery efficiency within VISNs and across the national Veterans Affairs system.
The New Zealand medical journalSteven Lillis, Lara Oertly, Belinda Wheaton, Byron Rangiwai, Nicholas Bowden, Stephanie D'Souza
AIM: From February 2026, vocationally trained general practitioners and nurse practitioners in Aotearoa New Zealand are authorised to initiate stimulant medication for adults with attention-deficit/hyperactivity disorder (ADHD), marking a shift from a predominantly secondary care model. This viewpoint article examines the clinical, ethical and service-level implications of this regulatory change, with particular attention to equity, diagnostic quality, cost and sustainability in primary care. METHODS: This viewpoint draws on Aotearoa New Zealand policy documents, international clinical guidance and selected peer-reviewed literature to inform a policy and equity-focussed analysis of expanded stimulant prescribing authority. RESULTS: The policy change has the potential to improve access to ADHD treatment; however, the absence of mandated training, competency standards or operational guidance raises concerns about diagnostic quality, management of comorbidity and prescribing safety. The time-intensive nature of adult ADHD assessment presents workload and resourcing challenges for primary care, and multiple service delivery models are likely to emerge with variable equity implications. CONCLUSION: Expanded prescribing authority may improve access, but without appropriate training, resourcing and implementation frameworks, benefits may be unevenly realised. Clear standards and equity-centred service design are essential.
Selective β1-blockers are fundamental in managing hypertension, coronary artery disease, and heart failure. Yet, despite their widespread use, practical guidance on safe and individualized prescribing remains limited. Existing evidence is largely derived from controlled clinical trials, which may not fully capture drug-specific adverse events, sex-related susceptibility, or early-onset risks observed in routine clinical practice. To generate real-world, evidence-based recommendations for the safe use of selective β1-blockers, we compared the adverse event profiles of metoprolol, bisoprolol, and atenolol using 2 large pharmacovigilance systems. Adverse drug events reported for the 3 agents between 2004 and Q2 2025 were retrieved from the US Food and Drug Administration Adverse Event Reporting System, a spontaneous-reporting system, and compared with reports from the Canadian Vigilance Adverse Reaction Online Database. Disproportionality analyses, preferred term mapping, exploratory sex-stratified comparisons, and time-to-onset modeling were conducted to characterize shared reporting patterns, drug-specific signals, and potential patient-level modifiers. Across all 3 agents, disproportionate reporting was observed for a common cardiovascular spectrum that included bradycardia, conduction abnormalities, heart failure, and blood pressure instability. Metoprolol showed prominent reporting signals for BRASH syndrome and neuropsychiatric and suicide-related events. Bisoprolol showed signals for bradyarrhythmia, hyperkalemia, and acute kidney injury. Atenolol showed reporting patterns involving blood pressure perturbations, electrolyte imbalance, and interaction-related events. Exploratory sex-stratified analyses identified differences in the reporting distributions of several PT = preferred terms for metoprolol and atenolol, whereas bisoprolol showed a more balanced distribution. All 3 agents displayed early-failure time-to-onset patterns, supporting closer monitoring after treatment initiation. This real-world pharmacovigilance assessment identifies drug-specific patterns of disproportionate reporting that may inform hypothesis generation and individualized monitoring. Because spontaneous-reporting data cannot establish incidence or causality, the findings should complement, rather than replace, clinical judgment and confirmation in controlled or longitudinal data sources.
British journal of clinical pharmacologyPhyllis Lensker, Lisa Cuba, Frank Dörje, Martin F Fromm, Markus Metzler
AIM: Increasing use of oral antitumour therapeutics (OAT) in paediatrics is associated with numerous advantages, but also with error-prone aspects. Based on the randomized AMBORA trial including adults treated with various OAT, we developed a tailored pharmacological/pharmaceutical care programme for children and their caregivers during OAT treatment (youngAMBORA). We now aimed to analyse the impact of the youngAMBORA care programme on medication safety by assessing (1) patient-reported outcomes (PROs) and (2) medication errors. METHODS: Depending on the intended OAT treatment duration, the youngAMBORA care programme included three or four consultation sessions starting at therapy initiation (Week 0) and using developed information material. Validated questionnaires were used to record PROs (e.g., knowledge [Satisfaction with Information about Medicines Scale, SIMS, primary outcome] and side effects [Ped-PRO-CTCAE®]). Advanced medication reviews were conducted in every consultation session, and medication errors were systematically categorized (e.g., PCNE V9.1). RESULTS: We counselled 54 patients treated with 61 OAT. The most frequently prescribed OAT was 6-mercaptopurine (14/61; 23%). Knowledge about the OAT improved significantly between Week 0 at OAT initiation and Week 1 (SIMS total score 8.1 ± 4.2 vs. 15.8 ± 1.6; p < .0001). On average, patients and caregivers reported 2.6 OAT-related side effects per patient, with gastrointestinal symptoms (i.e., 'nausea') being most frequent and severe. Fifty-six OAT-related medication errors were detected (mean 1.0 per patient), and of these, 84% (47/56) were completely resolved. CONCLUSION: The youngAMBORA care programme improved caregivers' knowledge about OAT, enabled structured monitoring of patient-reported side effects and facilitated the identification and resolution of medication errors during paediatric OAT treatment to optimize medication safety.
Tetrandrine, a bisbenzylisoquinoline alkaloid extracted from Stephania tetrandra S. Moore, is clinically used in the treatment of silicosis and rheumatoid arthritis. Despite its demonstrated efficacy, systematic safety evaluations remain limited. This study represents the first effort to identify adverse event (AE) signals associated with tetrandrine meglumine using the World Health Organization VigiAccess database. Global AE reports for tetrandrine were extracted up to July 6, 2025. The collected data included demographic variables such as age group and gender, as well as regional distribution. Additionally, data on adverse drug reaction-related disease systems and symptoms were compiled from adverse drug reaction annual reports and reports submitted to the World Health Organization. Disproportionality analyses were conducted using the reporting odds ratio (ROR) and the Bayesian confidence propagation neural network. A total of 265 reports were included, documenting 448 AEs. The most commonly affected systems were gastrointestinal disorders (38.39%), skin and subcutaneous tissue disorders (16.96%), and nervous system disorders (16.07%). Frequently reported adverse reactions included nausea, dizziness, pruritus, vomiting, rash, abdominal pain, diarrhea, and abnormal hepatic function. Strong association signals were observed for oral anesthesia (ROR 241.19, 95% confidence interval [CI] 79.74-729.58), abnormal hepatic function (ROR 20.31, 95% CI 12.27-33.63), hypoaesthesia (ROR 10.47, 95% CI 4.66-23.54), pollakiuria (ROR 9.53, 95% CI 3.04-29.83), and abdominal pain (ROR 8.94, 95% CI 5.96-13.41). Additionally, potential adverse reactions not listed in the product labeling, including pruritus, rash, abnormal hepatic function, chest pain, palpitations, hypoaesthesia, edema, pyrexia, insomnia, pollakiuria, and dyspnea, were identified. This study comprehensively characterized the AE profile of tetrandrine and identified novel adverse effects. These findings underscore the importance of ongoing drug safety monitoring and patient management, and highlight the need for clinicians to use this medication more appropriately, tailoring treatment regimens based on the identified adverse effect profiles.
Ensifentrine is a newly approved inhaled dual phosphodiesterase 3 and 4 inhibitor for the maintenance treatment of chronic obstructive pulmonary disease. Because post-marketing safety experience is still limited, this study evaluated adverse event reporting patterns for ensifentrine. Quarterly US Food and Drug Administration (FDA) Adverse Event Reporting System/Adverse Event Monitoring System files from 2024Q3 to 2026Q1 were analyzed. Duplicate reports were removed using Case Identification Number (CASEID), FDA receipt date (FDA_DT), and Primary Identification Number (PRIMARYID), and the primary analysis was restricted to reports in which ensifentrine was recorded as the primary suspect drug. Preferred Terms (PTs) were mapped to Medical Dictionary for Regulatory Activities primary System Organ Class categories, and report-level disproportionality was assessed using reporting odds ratio, proportional reporting ratio, an information component approximation, and an observed-to-expected approximation. After deduplication, 2,831,030 records were reduced to 2,500,712 unique reports. Ensifentrine was identified in 1137 reports across all drug roles and in 823 primary-suspect reports, which included 1817 PT records. At the System Organ Class level, Respiratory, thoracic and mediastinal disorders was the only category meeting all predefined robust signal criteria. At the PT level, respiratory, cardiovascular, psychiatric/neuropsychiatric, and product quality- or medication-use-related terms were notable. Time-to-onset could be calculated for 139 reports, with a median of 12 days. Respiratory reporting patterns predominated in early post-marketing reports for ensifentrine. These findings should be interpreted as hypothesis-generating pharmacovigilance signals rather than estimates of incidence or causality.