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Clinical Pharmacy[JOURNAL]

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Optimising end-of-life geriatric pharmacotherapy: a hospital-based retrospective cohort study of deprescribing early in the care trajectory before hospice transition.

Alwidyan T, Parsons C, Alqudah A … +3 more , Al-Shudifat AE, Al-Lozi AN, Riziq Khader M

Int J Clin Pharm · 2025 Dec · PMID 40938542 · Publisher ↗

INTRODUCTION: Polypharmacy and potentially inappropriate medications (PIMs) are common among terminally ill older people and often persist until death, undermining comfort-focused care. While deprescribing is an effectiv... INTRODUCTION: Polypharmacy and potentially inappropriate medications (PIMs) are common among terminally ill older people and often persist until death, undermining comfort-focused care. While deprescribing is an effective strategy to optimise medicines use at the end of life, its timing is crucial. Delaying deprescribing until after hospice admission may diminish opportunities for comprehensive medication review during hospital-based care, when a full multidisciplinary team (MDT) and complete clinical records are available. Timely deprescribing during the final days of hospital-based care before hospice transition may better align pharmacotherapy with end-of-life goals and facilitate transition. AIM: This study aimed to evaluate the impact of an MDT-led intervention delivered during the final days of hospital-based care before hospice transition on medication burden, PIM use, and symptom control prescribing. METHOD: This retrospective cohort study was conducted at a Jordanian tertiary hospital. Patients aged ≥ 65 years with life-limiting illnesses who were transitioned to hospice care between January and December 2022 were included. Medication data were extracted at baseline (seven days before MDT review) and post-intervention (in the final 24 h of hospital-based care). Deprescribing was categorised as proactive (planned discontinuation to prevent future harm) or reactive (triggered by an immediate clinical issue). Medication appropriateness was assessed using STOPPFrail version 2. Regimen complexity was evaluated using the Medication Regimen Complexity Index (MRCI). RESULTS: Among 165 patients, polypharmacy (use of ≥ five medications) prevalence declined from 63.0% to 14.5% (P < 0.001), and the proportion receiving ≥ one PIM decreased from 91.6% to 34.0% (P < 0.001). The mean number of chronic medications declined by 4.5 (± 3.2), and MRCI scores decreased by 4.8 points (P < 0.001). Of 736 medications discontinued, 65.9% were proactively deprescribed. Use of symptom control medications, particularly opioids, increased significantly (from 5 to 64 prescriptions; P < 0.001). Regression analysis identified baseline polypharmacy, high MRCI, and dyslipidaemia as predictors of greater PIM reduction. CONCLUSION: MDT-led deprescribing, implemented during the final days of hospital-based care before hospice transition, was associated with reduced medication burden and PIM use, alongside increased symptom-focused prescribing. These findings support the integration of structured, proactive deprescribing into hospital-based care to improve medication safety, enhance patient comfort, and facilitate continuity across care settings.

Experiences and challenges of implementing clinical medication reviews in daily practice: a mixed-methods study.

Chau SH, Elders PJM, Domić J … +3 more , Nelissen-Vrancken HJMG, Schellevis FG, Hugtenburg JG

Int J Clin Pharm · 2026 Apr · PMID 40924284 · Full text

INTRODUCTION: Organisational problems still prevent widespread implementation of clinical medication reviews. The Opti-Med2 method was developed to facilitate the process of performing clinical medication reviews. The me... INTRODUCTION: Organisational problems still prevent widespread implementation of clinical medication reviews. The Opti-Med2 method was developed to facilitate the process of performing clinical medication reviews. The method includes patient involvement by means of a questionnaire and expert teams of community pharmacists and general practitioners (GPs) to perform pharmacotherapeutic analyses, providing the patients' own GP with pharmacotherapeutic advice. There is a supporting role of community pharmacy technicians and general practice nurses/assistants in the process. AIM: To gain insight into the implementation of the Opti-Med2 method within the framework of pharmacotherapeutic audit meeting groups in the Netherlands. METHOD: A mixed-methods implementation study in seven groups of primary care healthcare providers. Quantitative data were collected using study forms. Semi-structured interviews with 8 GPs, 5 community pharmacists and 2 community pharmacy technicians were held. Interviews were transcribed verbatim and were analysed using the extended Normalization Process Theory. RESULTS: Only one group provided sufficient quantitative data for analysis. Of the pharmacotherapeutic advice given by the expert team, 72% was adopted by the GPs of which 85% resulted in an intervention with the patient. In general, the healthcare providers were satisfied with using the Opti-Med2 method. The use of expert teams was appreciated by most GPs and community pharmacists. All healthcare providers were very satisfied with the use of the patient questionnaire. CONCLUSION: Although full implementation of Opti-Med2 method as a whole was not achieved, the structured organisation of conducting CMRs and the use of questionnaires was deemed successful.

Evaluating the quality, feasibility and patient satisfaction of medication history taking by telephone for patients with scheduled admissions: a pilot study.

Terstegen T, Bittmann JA, Kauk L … +7 more , Kirchner M, Krug S, Gauss A, Chiriac U, Morath B, Haefeli WE, Seidling HM

Int J Clin Pharm · 2026 Apr · PMID 40924283 · Full text

INTRODUCTION: Medication history taking at hospital admission is still prone to errors. Despite numerous quality improvement initiatives, new strategies to improve medication history taking are still sought and evaluated... INTRODUCTION: Medication history taking at hospital admission is still prone to errors. Despite numerous quality improvement initiatives, new strategies to improve medication history taking are still sought and evaluated. Unfortunately, the gold standard research methodology for evaluation is resource-intensive, as it requires each patient to complete two medication history interviews. Therefore, a new study design and quality parameter were developed. AIM: We aimed to pilot our newly developed study design and quality parameter in a study on medication history taking by telephone. METHOD: In this prospective interventional study, patients with scheduled admissions had their medication histories taken either by telephone before admission (intervention) by a pharmacist or in-person by physicians or medical interns upon admission (control). Following the newly developed design, we compared a patients' new medication histories to the respective pre-visit medication lists available in the medical records to calculate the new endpoint: the difference in the number of updates per patient. Further, we surveyed patients and staff on their satisfaction. RESULTS: We enrolled 76 intervention and 75 control patients. In the intervention group, a mean of 4.93 (± 4.45, 0-18) updates were found vs. 3.40 (± 3.75, 0-21) in the control group. Accordingly, the incident rate of number of updates per patient was 1.34 times higher in the intervention group (p = 0.044). The distribution of the types of updates was similar with the most common type of update being newly initiated medicines in both groups. Medication history taking by telephone took 15.7 ± 9.8 min (mean ± SD), including preparation, interview, and documentation. Survey results showed that intervention patients felt positive about the telephone interviews. Both groups were open to other digital approaches, e.g., online platforms. CONCLUSION: The new study design proved feasible to evaluate medication history taking by telephone with comprehensible results. The telephone approach delivered more updates compared to standard care, however, the proposed endpoint needs to be validated against the gold standard before widespread application Patient acceptance for this and other digital approaches was high in both groups.

A provincial survey of patient experiences while receiving care from pharmacists in team-based primary care in British Columbia, Canada.

Zed PJ, Kapanen AI, Nemir A … +2 more , Loewen PS, Salil A

Int J Clin Pharm · 2025 Dec · PMID 40911158 · Publisher ↗

INTRODUCTION: The Pharmacists in PCN Program integrated primary care clinical pharmacists as a core members of the interprofessional team in Primary Care Networks (PCNs) across British Columbia (BC), Canada. Patient expe... INTRODUCTION: The Pharmacists in PCN Program integrated primary care clinical pharmacists as a core members of the interprofessional team in Primary Care Networks (PCNs) across British Columbia (BC), Canada. Patient experiences after receiving care from pharmacists in a team-based primary care setting have not been extensively studied. AIM: To describe patient experiences while receiving care from a pharmacist as a member of the interprofessional team in PCNs across BC. METHOD: A survey was conducted over a 66-week period between May 30, 2022 and September 1, 2023, and was administered online through Qualtrics®. A questionnaire was distributed to 2714 patients who completed their initial patient appointment with a pharmacist and had a valid e-mail in their health record. RESULTS: We analyzed responses from 787 questionnaires (29.0% response) representing all 23 PCN communities (42 PCNs) active during the survey period. The mean (SD) age of respondents was 65.3 (14.7) years, 60.5% were female and 81.5% identified as White. Patients reported a high overall satisfaction (strongly agree/agree) with their experience of care provided by their pharmacist. Patients felt listened to during their appointment (93.2%, 703/754), that conditions, medications and their treatments were explained in a manner that was easy to understand (92.4%, 697/754), and that they were given an opportunity to ask questions (92.4%, 697/754). Pharmacists were highly acknowledged for showing sensitivity to patient values, needs and preferences (88.7%, 669/754), and that patients were treated with dignity and respect (94.6%, 713/754). Patients reported improved understanding of their medications and their health as well as increased confidence and motivation regarding their health and medication. Nearly all patients (95.3%, 714/749) wanted to see the same pharmacist again and 94.9% (711/749) would recommend their pharmacist to a friend/family member. Patients felt engaged with the decision-making process around their medications, and valued the process pharmacists used when helping them make decisions. CONCLUSION: Patients reported an overall high degree of satisfaction with their experiences of care provided by pharmacists in a team-based primary care model in BC. Patients reported improved understanding and confidence of the medications and their health and reported positive experiences with the shared decision-making process.

Impact of pharmacy clinical service redesign on quantity and quality of pharmacy interventions in a tertiary teaching hospital: a pre-post cohort study.

Chubaty AJ, Wills C, Yeung K … +4 more , Saran HK, Bordia AS, Widjaja G, Penm J

Int J Clin Pharm · 2025 Dec · PMID 40911157 · Publisher ↗

BACKGROUND: Pharmacists are integral to the multidisciplinary team; however, staffing and resource challenges limit pharmacists' impact. Aligning pharmacists by admission specialty teams, rather than traditional ward-bas... BACKGROUND: Pharmacists are integral to the multidisciplinary team; however, staffing and resource challenges limit pharmacists' impact. Aligning pharmacists by admission specialty teams, rather than traditional ward-based models, may address these challenges. AIM: This study aimed to evaluate whether a pharmacy redesign, which included aligning pharmacists to a specialty-based model from a ward-based model, increased the number and quality of interventions made per full-time equivalent pharmacist in hospitalised patients. METHOD: The pre-post observational cohort study was conducted at a 550-bed tertiary teaching hospital. The redesign of the clinical pharmacy service was conceived and implemented using redesign methodology. Implemented solutions involved alignment of pharmacists to a specialty team-based model, multidisciplinary teamwork, pharmacist clinical specialisation, an emphasis on clinical documentation, and prioritisation of patients requiring medication review. Pharmacist interventions documented pre- and post-clinical redesign were compared. Two independent reviewers classified the intervention type and determined the impact and significance. RESULTS: In total, 226 patients were included in the pre-cohort and 468 post. Age (mean 70 vs 69, p-value = 0.404) and other demographics were similar between the cohorts. Pharmacist interventions increased after the clinical pharmacy redesign (n = 310 vs n = 1,106). After the implementation of the clinical pharmacy redesign, there was a significant increase in the median number of clinical interventions per Full-time Equivalent pharmacist (13.5 [0-64] vs 81.5 [3-166], p = 0.004). The redesign showed a positive impact and increase in all interventions. CONCLUSION: The redesign of pharmacy services increased pharmacist impact without increasing resource requirements or using screening tools, resulting in improved prioritisation of patients, identifying drug-related problems and increased interventions.

Pharmacist-led anticoagulation model based on early active consultation optimizes perioperative venous thromboembolism management in orthopedic surgery: a retrospective cohort study.

Wang Y, Du Q, Liu S … +9 more , Xiao J, Tang X, Feng J, Li D, Zhu J, Gou J, Zhang R, Wu F, Dong J

Int J Clin Pharm · 2025 Dec · PMID 40900289 · Publisher ↗

INTRODUCTION: Venous thromboembolism (VTE) is a common and preventable complication in orthopedic surgery, yet adherence to prophylaxis guidelines remains suboptimal. A pharmacist-led anticoagulation care model based on... INTRODUCTION: Venous thromboembolism (VTE) is a common and preventable complication in orthopedic surgery, yet adherence to prophylaxis guidelines remains suboptimal. A pharmacist-led anticoagulation care model based on the Pharmacist Early Active Consultation (PEAC) framework may enhance the quality and safety of VTE prevention in surgical patients. AIM: This study aimed to evaluate the impact of a pharmacist-led Venous Thromboembolism Clinical Pharmaceutical Care (VTE-CPC) model, derived from the PEAC framework, on VTE prevention and anticoagulation quality in orthopedic surgery patients. METHOD: A retrospective cohort study was conducted at a tertiary hospital in China. Patients admitted between December 2023 and May 2024 received routine care (no VTE-CPC group), while those admitted between June and November 2024 received additional pharmacist-led interventions (VTE-CPC group). Multivariate logistic regression was used to identify independent risk factors for VTE. Propensity score matching (PSM) was performed to control baseline differences, resulting in a balanced cohort of 812 patients. Outcomes included VTE incidence, pharmacological prophylaxis practices, and safety endpoints. RESULTS: A total of 959 patients were included (no VTE-CPC: n = 531; VTE-CPC: n = 428). The incidence of VTE was significantly lower in the VTE-CPC group (3.74%) compared to the no VTE-CPC group (7.53%, p = 0.020). VTE-CPC remained an independent protective factor in multivariate analysis (OR = 0.45; 95% CI 0.23-0.84; p = 0.015). In the PSM matched cohort, patients in the VTE-CPC group had higher rates of postoperative pharmacological prophylaxis (22.66% vs. 16.26%, p = 0.027) and improved dosage appropriateness across all perioperative phases (p < 0.05). No significant differences were observed between groups in rates of bleeding events, thrombocytopenia, or hepatic/renal dysfunction. CONCLUSION: A pharmacist-led anticoagulation management model based on the PEAC framework significantly reduced perioperative VTE incidence without increasing adverse events. These findings support broader implementation of proactive, pharmacist-driven strategies to improve thromboprophylaxis quality in orthopedic surgery.

Beyond black boxes: using explainable causal artificial intelligence to separate signal from noise in pharmacovigilance.

Ferreira-da-Silva R, Cruz-Correia R, Ribeiro I

Int J Clin Pharm · 2026 Apr · PMID 40889016 · Full text

Artificial intelligence (AI), particularly machine learning (ML), is increasingly influencing pharmacovigilance (PV) by improving case triage and signal detection. Several studies have reported encouraging performance, w... Artificial intelligence (AI), particularly machine learning (ML), is increasingly influencing pharmacovigilance (PV) by improving case triage and signal detection. Several studies have reported encouraging performance, with high F1 scores and alignment with expert assessments, suggesting that AI tools can help prioritize reports and identify potential safety issues faster than manual review. However, integrating these tools into PV raises concerns. Most models are designed for prediction, not explanation, and operate as "black boxes," offering limited insight into how decisions are made. This lack of transparency may undermine trust and clinical utility, especially in a domain where causality is central. Traditional ML relies on correlational patterns and may amplify biases inherent in spontaneous reporting systems, such as under-reporting, missing data, and confounding. Recent developments in explainable AI (XAI) and causal AI aim to address these issues by offering more interpretable and causally meaningful outputs, but their use in PV remains limited. These methods face challenges, including the need for robust data, the difficulty of defining ground truth for adverse drug reactions (ADRs), and the lack of standard validation frameworks. In this commentary, we explore the promise and pitfalls of AI in PV and argue for a shift toward causally informed, interpretable models grounded in epidemiological reasoning. We identify four priorities: incorporating causal inference into AI workflows; developing benchmark datasets to support transparent evaluation; ensuring model outputs align with clinical and regulatory logic; and upholding rigorous validation standards. The goal is not to replace expert judgment, but to enhance it with tools that are more transparent, reliable, and capable of separating true signals from noise. Moving toward explainable and causally robust AI is essential to ensure that its application in pharmacovigilance is both scientifically credible and ethically sound.

ADHD prescribing: national findings of children and adolescents attending mental health services in Ireland.

Cantwell E, Nelan I, Idid SZ … +2 more , McCarthy S, Driscoll DO

Int J Clin Pharm · 2026 Apr · PMID 40889015 · Full text

INTRODUCTION: Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental condition, which initially presents in childhood. While prescribing trends for treating ADHD have been previously examined in Ireland'... INTRODUCTION: Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental condition, which initially presents in childhood. While prescribing trends for treating ADHD have been previously examined in Ireland's paediatric population, off-label prescribing of ADHD medication has yet to be studied. AIM: We aimed to describe ADHD medication prescribing and off-label prescribing of ADHD medication in Ireland. METHOD: This cross-sectional study used a sample drawn from the population of children and adolescents who were attending mental health services in Ireland as of 31st December 2021. Participants were included based on predefined inclusion and exclusion criteria; those who were aged 17 years or younger and had been prescribed at least one psychotropic medication (n = 3,193). We described the frequency and population of those prescribed an ADHD stimulant or non-stimulant medication and the target condition or target symptom cluster for prescription. We reported the starting and maintenance doses of each medication. RESULTS: Fifty-three percentage (n = 1,687) of children and adolescents were prescribed an ADHD medication on 31st December 2021, with more boys being prescribed an ADHD medication compared to girls (n = 1,284 vs n = 395). The most common age category prescribed ADHD medication was 11-13 years of age. The most common indication for prescribing ADHD medication was the target condition ADHD (n = 1,661; 98.5%).Twenty-six patients (1.5%) were prescribed ADHD medication for target symptoms, most commonly depressive (n = 8) and behavioural disturbance symptoms (n = 8) (i.e., off-label prescribing of ADHD medication). CONCLUSION: More than half of young people attending specialist mental-health services in Ireland were receiving an ADHD-specific medicine, and almost all prescriptions were tied to a confirmed ADHD diagnosis. Off-label use for other symptom clusters was rare (< 2%), indicating strong adherence to licensed indications but also highlighting the importance of continued surveillance to detect emerging off-label trends and to ensure prescribing remains evidence-based and patient-centred.

Exploring the role of community pharmacists in perioperative management of antithrombotic agents: a qualitative study of barriers, facilitators, and future directions.

Capiau A, Kint I, Mehuys E … +3 more , De Backer T, Somers A, Boussery K

Int J Clin Pharm · 2025 Dec · PMID 40884687 · Publisher ↗

INTRODUCTION: Antithrombotic agents are considered as high-risk medications, particularly during the perioperative period, because of the increased risk of bleeding. Balancing bleeding and thrombosis risks is crucial in... INTRODUCTION: Antithrombotic agents are considered as high-risk medications, particularly during the perioperative period, because of the increased risk of bleeding. Balancing bleeding and thrombosis risks is crucial in the context of invasive procedures. The specific role of community pharmacists (CPs) in perioperative antithrombotic management remains unclear. AIM: This study aimed to explore the role of CPs in perioperative antithrombotic management, focusing on their experiences, and the barriers and facilitators to expand their involvement. METHOD: A qualitative study was conducted in Belgium between March and May 2024 using semi-structured, in-depth interviews with CPs. The Theoretical Domains Framework guided the development of the interview guide to ensure comprehensive coverage of relevant domains. Interviews were transcribed verbatim and analysed thematically using open and axial coding in NVivo 14 by two independent researchers. Participants were randomly sampled and recruited until no new themes were generated. RESULTS: A total of 13 CPs (7 female; median age 48 years, IQR 34-58) participated in the in-depth interviews. Four key themes emerged: (i) current involvement of CPs in perioperative antithrombotic management, (ii) factors influencing CPs' role, (iii) aspirations and perceived opportunities for role expansion, and (iv) proposed strategies to optimise CPs' contributions. CPs described their current role as limited and mainly reactive, with their involvement typically occurring postoperatively. Reported barriers included insufficient knowledge of antithrombotic protocols, time constraints, inconsistent and non-transparent hospital guidelines, lack of access to relevant medical records, and difficulty reaching hospital-based prescribers. Facilitators included CPs' unique position to oversee a patient's full medication regimen, strong and trusted patient relationships, early post-discharge contact, and intrinsic motivation to contribute more actively. Participants expressed a desire for more proactive and collaborative involvement, supported by structured training. They also stressed the importance of clear, well-accessible guidelines that are as uniform as possible across hospitals. Lastly, they emphasised the need for better accessibility to prescribers to facilitate more effective communication. CONCLUSION: CPs' role in perioperative antithrombotic management is currently limited, particularly preoperatively. Addressing identified barriers and implementing the suggested improvements could strengthen their role. Further research is needed to validate these findings and guide future interventions.

Incidence and risk factors of acute kidney injury in patients with polypharmacy: a systematic review and meta-analysis.

Yang F, Zhu L, Cao B … +5 more , Miao H, Zeng L, Yuan Z, Tian Y, Li Y

Int J Clin Pharm · 2025 Dec · PMID 40880032 · Publisher ↗

INTRODUCTION: Polypharmacy, typically defined as the use of five or more medications, has become increasingly common among older adults due to the rising prevalence of multimorbidity. While polypharmacy can be clinically... INTRODUCTION: Polypharmacy, typically defined as the use of five or more medications, has become increasingly common among older adults due to the rising prevalence of multimorbidity. While polypharmacy can be clinically necessary, it poses substantial risks for adverse drug events, including acute kidney injury (AKI). Drug-induced AKI accounts for a significant proportion of hospital-acquired cases and can result in prolonged hospitalization, increased healthcare costs, and higher mortality. Despite growing concern over these risks, the incidence of AKI associated with polypharmacy and the specific clinical and pharmacological factors contributing to this risk remain poorly quantified across different populations and setting. AIM: To estimate the incidence of AKI among adults exposed to polypharmacy and identify key drug-related and clinical risk factors. METHOD: A systematic review and meta-analysis were conducted and reported following PRISMA guidelines. We searched eight international and Chinese databases from inception to April 2025 for observational studies involving adults (≥ 18 years) receiving polypharmacy that reported AKI incidence or related risk factors. Eligible studies were assessed using the Newcastle-Ottawa Scale. Random-effects meta-analysis was used to calculate pooled AKI incidence. A narrative synthesis summarized the definitions of polypharmacy and identified associated risk factors. RESULTS: Ten studies comprising over 302,000 participants were included; six studies provided data suitable for meta-analysis. The pooled incidence of AKI among patients exposed to polypharmacy was 18% (95% CI 2%, 45%). Key risk factors included high medication burden (≥ 5 or ≥ 10 medications), cardiovascular drug combinations, use of nephrotoxic agents, pre-existing renal impairment, frailty, and exposure to intensive care. Definitions of polypharmacy varied substantially across studies, including count-based thresholds, class-specific definitions, and risk-based exposure models. CONCLUSION: Polypharmacy is significantly associated with an increased incidence of AKI, particularly among hospitalized and clinically vulnerable individuals. The lack of standardized definitions for polypharmacy complicates evidence synthesis and cross-study comparisons. Standardized terminology and risk-adjusted prescribing practices are essential to improve medication safety and renal outcomes in at-risk populations.

Experiences of people who inject drugs with hepatitis C testing and their perceptions of a pharmacy-based testing option: a qualitative study.

Balsom C, Bugden S, Jackson LA … +1 more , Kelly D

Int J Clin Pharm · 2026 Feb · PMID 40880031 · Full text

BACKGROUND: People who inject drugs (PWID) are at high risk of acquiring hepatitis C virus (HCV) infection, yet many remain undiagnosed due to testing barriers. Pharmacy-based point-of-care testing could improve access;... BACKGROUND: People who inject drugs (PWID) are at high risk of acquiring hepatitis C virus (HCV) infection, yet many remain undiagnosed due to testing barriers. Pharmacy-based point-of-care testing could improve access; however, little is known about its acceptability among PWID. AIM: To explore the experiences of PWID with HCV testing and their perceptions of a pharmacy-based HCV testing option. METHOD: A qualitative study involving interviews with eleven PWID between June and August 2022. Participants were asked about their perceptions and experiences about HCV testing as well as their views on a proposed pharmacy-based HCV testing model which was being proposed for a separate research study. Data were analyzed using reflexive thematic analysis. RESULTS: Regarding their experiences with HCV testing, participants recognized the importance of testing to know their status both for their health and that of others. Several challenges to testing were described, and participants described the impact of the primary care provider on testing. It was suggested that opioid agonist therapy programs were a missed opportunity for testing, and many potential advantages to pharmacy testing were described. Privacy and confidentiality within the pharmacy, as well as the impact of the relationship with pharmacists and staff were key factors influencing uptake. CONCLUSION: Pharmacy-based HCV testing is viewed by participants as a convenient and acceptable testing option. Addressing stigma, ensuring privacy, and building trust with pharmacy staff appear to be critical for uptake. This approach may help to engage PWID in HCV testing as part of HCV elimination efforts.

Real-world safety profile of mitomycin: signal detection and time-to-onset analysis from FDA adverse event reporting system and VigiAccess databases.

Hao Z, Yu L

Int J Clin Pharm · 2025 Dec · PMID 40875084 · Publisher ↗

INTRODUCTION: Mitomycin, a cytotoxic antitumor antibiotic, has been approved for the treatment of low-grade upper tract urothelial carcinoma (UTUC) and non-muscle invasive bladder cancer (NMIBC). It is also used off-labe... INTRODUCTION: Mitomycin, a cytotoxic antitumor antibiotic, has been approved for the treatment of low-grade upper tract urothelial carcinoma (UTUC) and non-muscle invasive bladder cancer (NMIBC). It is also used off-label in ophthalmic procedures and gastrointestinal malignancies. Although the efficacy of mitomycin is well recognized, its safety profile, particularly regarding rare or serious adverse events (AEs), remains insufficiently characterized in large real-world populations. AIM: This study aimed to evaluate mitomycin-associated AEs through comprehensive analysis of two major global pharmacovigilance databases, with the goal of identifying high-risk organ systems and specific AE signals requiring increased clinical awareness. METHOD: AE data were retrieved from the FDA Adverse Event Reporting System (FAERS) covering Q1 2004 to Q3 2024. Data were deduplicated and standardized according to MedDRA terminology. Complementary data were collected from the World Health Organization VigiAccess database. Disproportionality analysis was performed using four signal detection algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). The time-to-onset of adverse events was analyzed using non-parametric statistical methods. RESULTS: A total of 1461 mitomycin-related reports, comprising 3652 AEs, were identified in the FAERS database. Notably, strong safety signals have emerged at the system organ class (SOC) level for eye, renal and urinary, blood and lymphatic system, and skin and subcutaneous tissue disorders. At the preferred term (PT) level, high disproportionality values were observed for serious events, such as scleral thinning (OR = 7129.60, 95% CI 4576.64-11,106.7) and bladder perforation (OR = 1585.69, 95% CI 1111.91-2261.33). Over two-thirds of AEs occurred within 30 days of drug administration, although 68.93% of the reports lacked valid onset-time data. The VigiAccess findings corroborated the SOC trends observed in FAERS. CONCLUSION: Mitomycin is associated with a broad range of organ-specific toxicities, many of which occur early in the treatment course and may have serious clinical consequences. This study highlights the need for early risk identification, individualized monitoring strategies, and greater pharmacovigilance in populations treated with mitomycin. These findings provide an important foundation for optimizing the safe and effective use of mitomycin in oncology and in other therapeutic settings.

Evaluating medication discrepancies and harm: a matched cohort study of collaborative pharmacist prescribing in a statewide healthcare system using electronic prescribing.

Amer H, Marotti S, Inglis JM … +4 more , Widagdo I, Goldsworthy S, Johnson J, Kalisch Ellett L

Int J Clin Pharm · 2026 Feb · PMID 40875083 · Full text

INTRODUCTION: Collaborative pharmacist prescribing models involve pharmacists working with doctors and patients to develop medication plans and prescribe medications. Limited evidence exists on the impact of these models... INTRODUCTION: Collaborative pharmacist prescribing models involve pharmacists working with doctors and patients to develop medication plans and prescribe medications. Limited evidence exists on the impact of these models on medication discrepancies in hospitals using electronic prescribing systems (EPS). AIM: This study aimed to evaluate the impact of collaborative pharmacist prescribing on medication discrepancies and potential patient harm within a statewide healthcare system using EPS. METHOD: A multi-site matched cohort study involving 240 patients was conducted. EPS data for 120 patients aged ≥ 18 years who received collaborative pharmacist prescribing was matched 1:1 with 120 patients who received usual care of independent medical prescribing. Matching variables were hospital, clinical unit, sex, age, admission date, triage category and pre-admission medication count. The electronic medical record was reviewed to identify undocumented medication discrepancies, which were defined as any unexplained difference between the pharmacist-led medication history and medications prescribed on admission. The frequency of undocumented discrepancies was calculated. An independent multi-disciplinary clinician panel determined potential harm, using the Harm Associated with Medication Error Classification (HAMEC) tool. RESULTS: There were fewer undocumented discrepancies per medication prescribed in the collaborative pharmacist prescribing group compared to usual care (RR 0.04, 95% CI 0.03-0.06) and the relative risk of undocumented discrepancies per patient was lower (RR 0.23, 95% CI 0.13-0.39). The expert clinician panel found that undocumented discrepancies rarely posed serious or severe harm in either group (0 undocumented discrepancies with potential to cause serious or severe harm in the collaborative pharmacist prescribing group compared to 8 in the usual care group). CONCLUSION: The implementation of collaborative pharmacist prescribing within a statewide EPS significantly reduced undocumented discrepancies and lowered the potential for patient harm. As healthcare systems globally shift towards electronic prescribing, this study provides timely and actionable evidence to inform policy and support the adoption of collaborative prescribing models in hospitals using EPS. Such models offer a practical strategy to improve medication safety, reduce patient harm and strengthen interprofessional collaboration at the point of prescribing.

Community pharmacists' practices and clinical reasoning towards hospital discharge prescription: a study using simulations and retrospective think-aloud methodology.

Solh Dost L, Guignard B, Gastaldi G … +4 more , Hasan Hamzo A, Nendaz M, Audétat MC, Schneider MP

Int J Clin Pharm · 2026 Feb · PMID 40856961 · Full text

BACKGROUND: The roles of community pharmacists have evolved from dispensing medications to clinical decision makers. This shift requires a clearer understanding of pharmacists' clinical reasoning. Managing hospital disch... BACKGROUND: The roles of community pharmacists have evolved from dispensing medications to clinical decision makers. This shift requires a clearer understanding of pharmacists' clinical reasoning. Managing hospital discharge prescriptions requires analytical reasoning to ensure patient safety through medication reconciliation and patient education. AIM: This study assessed community pharmacists' practices and their clinical reasoning towards hospital discharge prescriptions. METHOD: This mixed-method study consisted of two phases. First, community pharmacists participated in a simulated encounter in their pharmacy, where a patient presented a discharge prescription. Their practices and the structure of the encounter were assessed using a structured checklist of practices adapted from the MEDICODE checklist. Following the simulation, participants verbalised their thought processes in a retrospective think-aloud session. These semi-structured interviews were transcribed and analysed using both inductive and deductive qualitative methods. Charlin et al.'s model was used to assess clinical reasoning, while the Calgary-Cambridge model evaluated communication structure. RESULTS: Among 14 participating pharmacists, 13 performed medication reconciliation, and 10 contacted the simulated prescriber to address discrepancies. While most provided adherence aids, only seven assessed non-adherence, and five actively collaborated with the patient. Pharmacists exhibited diverse interview structures, often revisiting previous discussion points. Clinical reasoning misconceptions, such as assumptions or premature closure, were observed at multiple stages of the clinical reasoning process. CONCLUSION: Community pharmacists demonstrate strong medication-related skills but face challenges in clinical reasoning for discharge prescriptions. Clinical reasoning training, semi-structured consultations, and greater patient engagement would help tailor and improve post-discharge care.

The Aged Care Onsite Pharmacist (ACOP) program in Australia: a qualitative study to examine key considerations for successful implementation in residential aged care homes.

Javanparast S, Gutteridge DS, Hibbert PD … +5 more , Manias E, Stafford AC, Peterson GM, Caughey GE, Sluggett JK

Int J Clin Pharm · 2026 Feb · PMID 40856960 · Full text

INTRODUCTION: The Aged Care Onsite Pharmacist (ACOP) program was recently launched in Australia to enable pharmacists to deliver clinical governance, clinical pharmacy and education services on the ground in residential... INTRODUCTION: The Aged Care Onsite Pharmacist (ACOP) program was recently launched in Australia to enable pharmacists to deliver clinical governance, clinical pharmacy and education services on the ground in residential aged care homes (RACHs). As the program is now being scaled up nationally, it is crucial to understand the complex interactions between various factors at the individual and organisational levels to ensure the program is successfully implemented and achieves its ultimate goal of improving the quality use of medicines in RACHs. AIM: This qualitative study aimed to explore stakeholders' perspectives on medication management, perceived value of onsite pharmacists, and key considerations for successful program implementation in RACHs. METHOD: We employed a qualitative approach and conducted semi-structured interviews (n = 61) with residents/families, pharmacists, medical practitioners, RACH staff, and individuals involved in policy and planning. Participants with experience working in both metropolitan and rural areas were included. The interviews were audio-recorded, transcribed, and thematically analysed, both inductively and deductively. The Consolidated Framework for Implementation Research informed the design of the study, developing interview schedules and data analysis. RESULTS: Factors influencing the program implementation were grouped into five themes: (1) Individuals: factors concerning individuals involved in the program; (2) Innovation: factors related to the program design; (3) Process: implementation process actions; (4) Inner setting: factors relating to the organisational context; and (5) Outer setting: factors pertaining to the policy context. Most participants valued the potential contribution of onsite pharmacists. Program flexibility was noted as essential to increase its acceptability, uptake and adoptability. A desire for implementation strategies was evident. Workforce, organisational leadership, infrastructure and resources, and broader policy support were noted as critical for the program's success. CONCLUSION: The ACOP program represents a promising strategy to enhance medication management in RACHs. However, implementation on a large scale necessitates a thoughtful consideration of various interconnected factors at the individual, organisation and policy levels that may affect its uptake, adoptability, and long-term sustainability. This has implications for policymakers and providers at the scale up phase to ensure the program achieves its ultimate goal of enhancing residents' health outcomes.

Development of a machine learning-based risk prediction model and analysis of risk factors for docetaxel-induced bone marrow suppression in breast cancer patients.

Ou H, Tan Z, Shen A … +10 more , Yu L, He Y, Hong R, Lin X, Shi X, Xing K, Song X, Liu Y, Zou L, Li J

Int J Clin Pharm · 2025 Dec · PMID 40856959 · Publisher ↗

INTRODUCTION: Breast cancer is the most prevalent malignancy in women worldwide. Docetaxel-based chemotherapy is commonly used for treatment, but its clinical application is often constrained by hematologic toxicity, par... INTRODUCTION: Breast cancer is the most prevalent malignancy in women worldwide. Docetaxel-based chemotherapy is commonly used for treatment, but its clinical application is often constrained by hematologic toxicity, particularly severe bone marrow suppression. The early identification of high-risk patients is essential to prevent complications and optimize therapeutic outcomes. Machine learning offers advanced capabilities for risk prediction by capturing complex patterns beyond those of traditional statistical models. AIM: This study aimed to identify the risk factors associated with bone marrow suppression in breast cancer patients receiving docetaxel-based chemotherapy, and to develop and validate predictive models using machine learning algorithms. METHOD: This retrospective case-control study included 119 patients with breast cancer treated with docetaxel-based chemotherapy at the Hainan Hospital of Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine, from January 2020 to December 2024. Patients were divided into bone marrow suppression (n = 57; WHO grades II-IV) and non-suppression (n = 62; grades 0-I) groups based on WHO toxicity criteria. Multivariate logistic regression was used to identify independent risk factors. Three prediction models, logistic regression, random forest, and AdaBoost, were constructed and evaluated. A five-fold cross-validation with 50 repetitions was performed to ensure model stability and reliability. RESULTS: Multivariate analysis revealed that a low baseline lymphocyte count (OR = 4.95, 95% CI 1.62-17.0), decreased white blood cell (WBC) count (OR = 0.62, 95% CI 0.40-0.9), and reduced prealbumin level (OR = 0.98, 95% CI 0.97-0.99) were significantly associated with severe bone marrow suppression (all p < 0.05). Among the models, AdaBoost achieved the best overall performance (AUC = 0.81; specificity = 94%; accuracy = 77%). The random forest model showed the highest sensitivity (83%), while logistic regression was more interpretable but demonstrated a lower predictive ability (AUC = 0.69). CONCLUSION: Pretreatment lymphocyte count, WBC count, and prealbumin level are reliable predictors of docetaxel-induced bone marrow suppression. The AdaBoost model demonstrates high specificity (94%) in identifying low-risk patients, supporting accurate risk stratification and personalized care in breast cancer treatment.

Does direct oral anticoagulant lead-in dosing following initial parenteral therapy affect clinical outcomes in acute venous thromboembolism?: A retrospective cohort study.

Kim J, Heybati K, Thompson E … +7 more , Sharma S, Barron D, Reynolds H, Mirzakandov M, Norville K, Reynolds J, Shiue HJ

Int J Clin Pharm · 2025 Dec · PMID 40848117 · Publisher ↗

INTRODUCTION: Initiation of direct oral anticoagulants (DOAC) for the management of venous thromboembolism (VTE) typically includes a lead-in dosing phase. However, some patients may receive a shortened course due to com... INTRODUCTION: Initiation of direct oral anticoagulants (DOAC) for the management of venous thromboembolism (VTE) typically includes a lead-in dosing phase. However, some patients may receive a shortened course due to comorbid conditions and/or numerous days of parenteral therapy. Limited data exist on the outcomes of an abbreviated lead-in therapy regimen. AIM: To investigate the clinical outcomes of patients receiving abbreviated versus standard/non-abbreviated DOAC lead-in regimens following parenteral anticoagulation therapy for VTE. METHOD: We conducted a retrospective cohort study including adults (≥ 18 years of age) who were admitted for acute VTE between 04/01/2019 and 12/31/2023 and received ≥ 24 h of parenteral anticoagulation before being transitioned to a DOAC with abbreviated versus non-abbreviated DOAC lead-in dose. The primary outcome was death or readmission from a thrombotic event within 30 days of discharge. Data were presented using descriptive statistics, logistic regression, and time-to-event analysis. RESULTS: Across 590 patients, the median (IQR) age was 67 (58-76) years and 280 (47.5%) were female. Over half had a pulmonary embolism (54.9%; N = 324), 21.0% (N = 124) had a deep vein thrombosis, and the remainder experienced a combination. Most patients received the non-abbreviated lead-in dose (83.2%; N = 491). When compared to the non-abbreviated cohort, a higher proportion of those who received an abbreviated lead-in therapy had prior VTE and heart failure. There were no significant associations between an abbreviated lead-in dose and the primary outcome (aOR 0.44; 95% CI 0.13-1.52; P = 0.20). Bleeding events were also similar between the abbreviated and non-abbreviated dose cohorts at the longest follow-up (3.0%, N = 3 vs. 2.9%, N = 14; P = 0.92; aOR 0.82; 95% CI 0.22-3.1; P = 0.77) and within 30 days of DOAC initiation (HR 1.24; 95% CI 0.26-5.82; P = 0.79). CONCLUSION: An abbreviated DOAC lead-in therapy was not associated with short-term mortality, readmission due to recurrent thrombosis, or bleeding. Further prospective studies are needed to confirm these findings and provide insights into more personalized regimens.

Socioeconomic deprivation and its association with polypharmacy in England: results from a national cross-sectional survey.

Adebisi YA, Alshahrani NZ, Bafail DA

Int J Clin Pharm · 2026 Feb · PMID 40848116 · Full text

INTRODUCTION: Polypharmacy is a growing public health concern, yet its association with area-level socioeconomic deprivation in England has been under-explored. AIM: To investigate whether socioeconomic deprivation, meas... INTRODUCTION: Polypharmacy is a growing public health concern, yet its association with area-level socioeconomic deprivation in England has been under-explored. AIM: To investigate whether socioeconomic deprivation, measured by the Index of Multiple Deprivation (IMD), is associated with polypharmacy among adults. METHOD: We analysed cross-sectional data from the 2021 Health Survey for England, including 1705 adults aged 16+ who completed nurse visits and reported prescribed medication use in the past week. Polypharmacy was defined as the use of five or more prescribed medications. IMD scores were categorised into quintiles (least to most deprived). Multivariable logistic regression estimated adjusted odds ratios (ORs) with 95% confidence intervals (CIs), controlling for age, sex, ethnicity, multimorbidity, obesity, smoking, alcohol use, and GP visit frequency. A polynomial contrast test assessed linear trends, and adjusted predicted probabilities were calculated to illustrate the deprivation-polypharmacy gradient. RESULTS: In the fully adjusted model, adults residing in the most deprived IMD quintile had significantly higher odds of polypharmacy (OR 1.82; 95% CI 1.09-3.04; p = 0.022) compared to those living in the least deprived areas. No statistically significant associations were observed for intermediate quintiles. A polynomial contrast test confirmed a significant linear trend across IMD levels (p = 0.010), indicating that the odds of polypharmacy increased progressively with greater area-level deprivation. This gradient was further illustrated by adjusted predicted probabilities, which rose from 18.3% (95% CI 15.3-21.3%) in the least deprived quintile to 24.6% (95% CI 20.1-29.2%) in the most deprived (p < 0.001). CONCLUSION: Socioeconomic deprivation is independently associated with polypharmacy, even after adjusting for multimorbidity and other confounders, highlighting persistent health inequalities within England's healthcare system. Targeted strategies, including regular medication reviews and enhanced access to care in deprived communities, may help mitigate risks and promote equity in prescribing practices.

Colorectal cancer patients' experiences with antineoplastic agents from the perspective of their significant others: a longitudinal qualitative study.

Brincat A, Tonna A, Vella Bonanno P … +2 more , Stewart D, Weidmann AE

Int J Clin Pharm · 2026 Feb · PMID 40848115 · Full text

BACKGROUND: Colorectal cancer and its treatment deeply impact patients' lives. Significant others, often family members, play crucial pre-existing roles in patients' lives and are closely involved in their care. However,... BACKGROUND: Colorectal cancer and its treatment deeply impact patients' lives. Significant others, often family members, play crucial pre-existing roles in patients' lives and are closely involved in their care. However, there is limited understanding of the patients' treatment journey from the significant others' perspective. AIM: To explore colorectal cancer patients' experiences with antineoplastic agents from the perspective of significant others over 24 weeks. METHOD: This involved a longitudinal qualitative study with 16 significant others nominated by patients with colorectal cancer. Two in-depth interviews were conducted: one at start and another after 24 weeks of treatment. Interviews were audio-recorded, transcribed and thematically analysed by 2 researchers independently. RESULTS: Five themes were identified: Patients' perceptions and knowledge of the illness and treatment, the healthcare system in relation to the illness and treatment, patients' involvement in treatment decision-making and their experience of medicine-taking, medicine and illness-related impact on patients and others and personal support structures. Significant others observed that patients initially viewed treatment as curative but later perceived as means to extend life-expectancy. While significant others considered that concerns about aesthetics were initially prominent for the patient, fatigue and peripheral neuropathy became most impactful effects. They considered patients' experiences with cancer services to remain overall positive, particularly regarding personalised support from nurse navigators. Significant others noted that early establishment of support network was crucial for fostering resilience throughout the treatment journey. CONCLUSION: This study provides insights from significant others highlighting the complex evolution of patients' experiences and importance of establishing a personalised support network early in treatment journey.

Clinical risk assessment of serum creatinine abnormalities during vancomycin therapy: a retrospective study using machine learning models.

Yang Y, Yan H, Wang X … +6 more , Lao J, Zhang R, Chen Z, Ma S, Li Y, Li X

Int J Clin Pharm · 2025 Dec · PMID 40828437 · Publisher ↗

INTRODUCTION: Vancomycin is a widely used antibiotic for the treatment of serious Gram-positive bacterial infections. However, its clinical utility is often limited by the risk of nephrotoxicity, typically reflected by a... INTRODUCTION: Vancomycin is a widely used antibiotic for the treatment of serious Gram-positive bacterial infections. However, its clinical utility is often limited by the risk of nephrotoxicity, typically reflected by abnormalities in serum creatinine levels, which may indicate the occurrence of acute kidney injury (AKI). Timely identification of patients at increased risk is essential for early intervention and improved clinical outcomes. AIM: This study aimed to identify clinical risk factors associated with vancomycin-induced abnormalities in serum creatinine levels and to develop predictive models capable of identifying high-risk hospitalized patients during vancomycin therapy. METHOD: We conducted a retrospective cohort study including 1,008 hospitalized patients who received vancomycin treatment between January 2018 and June 2022 at the First Affiliated Hospital of Shandong First Medical University. Patients were grouped based on the presence or absence of serum creatinine abnormalities, defined as an increase of ≥ 26.5 μmol/L or ≥ 50% from baseline. Multivariate logistic regression was applied to identify independent risk factors. Five machine learning algorithms-logistic regression, random forest, support vector machine, extreme gradient boosting, and gradient boosting machine (GBM)-were trained and compared. Model performance was evaluated using the area under the receiver operating characteristic curve (AUC), accuracy, sensitivity, and specificity. RESULTS: The incidence of serum creatinine abnormalities was 9.22%. Chronic kidney disease, respiratory failure, pancreatitis, pneumonia, and mechanical ventilation were identified as significant risk factors (all p < 0.05). Among the models tested, the GBM algorithm showed the highest predictive performance with an AUC of 0.783, along with good balance between sensitivity and specificity. The final model was deployed as a freely accessible web-based prediction tool using the R Shiny framework. CONCLUSION: Abnormalities in serum creatinine levels during vancomycin therapy remain a clinically significant concern, especially in patients with comorbidities or critical illness. The machine learning-based predictive model developed in this study offers a practical tool for individualized risk assessment, enabling early risk stratification and proactive management. Incorporating such tools into clinical workflows may enhance patient safety and optimize antibiotic use.
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