Objectives This study aimed to describe the actions taken to implement a telepharmacy programme with home medication dispensing and informed delivery in an outpatient pharmaceutical care unit of a tertiary hospital, where approximately 5000 patients are treated per year. It also aimed to substantiate the applicability and benefits of the programme through analysing the findings and measuring patient satisfaction. Methods We identified the operational, logistical, technological and legal needs, as well as the need for training, information and coordination with the care team and patient associations. A standard operating procedure was developed which described the home dispensing model and the profile of patients eligible for telepharmacy. Care activity was evaluated, between the months of July 2020 and January 2021; and a survey was conducted to measure patient satisfaction based on the Enopex project, a cross-sectional observational study of patients who used telepharmacy services during the COVID-19 lockdown period in Spain. Results A total of 2536 medication deliveries were made over 144 working days, with a mean of 18 (standard deviation (SD): 6) deliveries per day, and a total of 2854 dispensings (1.1 drugs per delivery). In total, 197 different types of pharmaceutical formulations were delivered, corresponding to 123 active ingredients. The distance and time avoided during the study period totalled 1 05 624 km and 1 09 452 min (76 days), whereby the median distance and time saved per patient were 66 (interquartile range (IQR):122 km and 90 (IQR:90) minutes, which represents an approximate carbon footprint reduction of 25 kg of CO₂ per patient and 16.5 tonnes in total. The satisfaction survey conducted, completed by 134 patients, revealed high satisfaction with the pharmacy service of 9.88 points out of 10. Conclusions The SARS-CoV-2 pandemic (COVID-19) has provided the pharmacy service with an opportunity to develop and implement a telepharmacy programme that benefits patients, which has enabled better organisation of the unit and greater accessibility for patients attending in person. It is a replicable method that is applicable in other pharmacy services with similar characteristics and requirements.

Inflammatory bowel diseases (IBDs) are chronic inflammatory disorders influenced by microbial, environmental, genetic, and immune factors. The introduction of biological agents has transformed IBD therapy, improving symptoms, reducing complications, and enhancing patients’ quality of life. However, approximately 30% of patients exhibit primary non-response, and 50% experience a loss of response over time. Genetic and non-genetic factors contribute to variability in treatment outcomes. This systematic review aims to thoroughly analyze and assess existing studies exploring the relationships between genetic variations and individual responses to biologic drugs, in order to identify genetic markers that are predictive of treatment efficacy, risk of adverse effects, or drug toxicity, thereby informing clinical practice and guiding future research. PubMed and EMBASE papers were reviewed by three independent reviewers according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA] guidelines. Of the 883 records screened, 99 met the inclusion criteria. The findings of this review represent an initial step toward personalized medicine in IBD, with the potential to improve clinical outcomes in biological therapy.

Purpose: Quizartinib pharmacokinetics in FLT3-ITD negative acute myeloid leukemia (AML) remain largely unexplored. This study aims to validate a population pharmacokinetics model (popPK) for quizartinib in plasma samples of FLT3-ITD negative AML patients. To do so, an ultra-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) method has been developed and validated for the quantification of quizartinib. Methods: Plasma samples were collected from FLT3-ITD negative newly diagnosed AML patients undergoing quizartinib therapy at induction in the QUIWI phase II clinical trial [NCT04107727, PETHEMA group] between March 2020 and February 2022. The UPLC-MS/MS method was developed and validated. A previously described popPK model was validated using external validation techniques and implemented using the software NONMEM v7.5. Results: The developed UPLC-MS/MS method demonstrated high accuracy and precision with a linear range of 6 to 200 ng/mL, with relative standard deviation between 3–11 and accuracy of 88–97% from nominal values. The external validation of the quizartinib popPK model showed minimal bias at the population level (MdPE: -9.86%; ME: 0.50 ng/mL, p = 0.964), but moderate imprecision (MdAPE: 32.28%) and suboptimal accuracy (F20: 24.5%; F30: 43.4%). Individual predictions improved performance, with negligible bias (MdPE: -0.50%), acceptable precision (MdAPE: 11.27%), and F20 (64.2%) and F30 (77.4%) exceeding predefined thresholds. Visual predictive checks confirmed adequate prediction of median concentrations, though some deviations occurred at extremes. Conclusion: This study presents a replicable UPLC-MS/MS method for the determination of quizartinib in plasma. The validated popPK model can be used to optimize dosing strategies in future clinical studies.

Introduction: previous studies have shown that higher infliximab trough levels are associated with favorable shortterm and long-term therapeutic outcomes in inflammatory bowel disease.There is a need to determine which patients could benefit from proactive therapeutic drug monitoring in the induction phase. The aim of this study was to evaluate the pharmacokinetic variability of infliximab, determine the factors associated with achieving target infliximab trough levels in the induction phase and analyze the clinical and biochemical response at week 26 of treatment. Patients and methods: a retrospective observational study was performed of patients with inflammatory bowel disease and data available on serum levels of infliximab during the induction period.The percentage of patients that achieved target infliximab trough levels at week 6 was determined. Clinical remission and response and biochemical remission were evaluated at week 26. Results: thirty patients were included and only 13 (43.3 %) had infliximab trough levels > 15 mu g/mL at week 6. A clinical response was observed during the maintenance period in 71.4 % of patients, their infliximab levels were significantly higher than in non-responders (6.3 mu g/mL [IQR: 6.7] vs 1.0 mu g/mL [IQR: 5.0], respectively; p = 0.016). Likewise, 53.6 % of patients achieved biochemical remission (responders 6.2 mu g/mL DOR: 5.2] vs non-responders 3.2 mu g/mL DOR: 5.0]; p = 0.031). Conclusion: less than half of patients had target infliximab levels during the induction period. Therapeutic drug monitoring during this period is related to the achievement of therapeutic levels of infliximab and may lead to a better clinical response in these patients.

The standard immunosuppressive treatments in heart transplantation are calcineurin inhibitors, corticosteroids, and antimetabolite agents or inhibitors of the mammalian target of rapamycin. Pharmacogenetic studies show the impact on clinical course of genetic variability in genes that encode transporters, metabolizers, or molecular targets of immunosuppressants. The aim of this systematic review is to elucidate the role that pharmacogenetics of immunosuppressant drugs plays in clinical outcomes upon heart transplantation. PubMed, EMBASE, the Cochrane Central Register, and the Database of Abstracts of Reviews of Effects were searched without restrictions. The 64 studies analyzed followed these criteria: (1) were based on clinical data on heart transplantation patients; (2) analyzed the associations between polymorphisms and clinical response; (3) analyzed the impact of polymorphisms on immunosuppressant safety. CYP3A4/5 variants were associated with higher doses of tacrolimus, whereas POR*28 variants with lower doses—ABCB1, ABCC2, SLCO1B1, and SLC13A1—contribute to interindividual variability in drug absorption, distribution, and toxicity. An ABCC2 polymorphism (rs717620) was related to higher risk of graft rejection in pediatrics. Variations in HLA-G, TNF-α and TGF-β genes influence transplant rejection risk and immune response. Implementing pharmacogenetic screening of polymorphisms could enhance therapeutic outcomes by improving drug efficacy, reducing toxicity, and ultimately increasing heart graft survival rates. Strong evidence supports genotyping for CYP3A5 and TPMT, but further research is required for transporter genes and cytokine polymorphisms.