INTRODUCTION: The use of three-compartment parenteral nutrition bags (3CPNBs) has widely expanded due to their potential time- and cost-saving advantages compared to hospital-compounded parenteral nutrition bags (HCPNBs)...INTRODUCTION: The use of three-compartment parenteral nutrition bags (3CPNBs) has widely expanded due to their potential time- and cost-saving advantages compared to hospital-compounded parenteral nutrition bags (HCPNBs). However, there is limited evidence of commercial 3CPNBs to adequately meet current nutritional guidelines. OBJECTIVES: This study assessed the nutritional adequacy of all commercial 3CPNBs available in Spain, according to current European guidelines, across four clinical scenarios for adult patients. METHODS: A simulation-based study was performed to evaluate the protein and caloric content of 3CPNBs commercially available in Spain. Four clinical scenarios were defined: early and late phases of intensive care (I1 and I2), surgical (Q), and medical (M) inpatients. Two sub-analyses were conducted: a 3CNPB-centered assessment of each formulation's theoretical adequacy for each scenario, and a patient-centered analysis involving 1000 simulated adult patients per scenario (total: 4000 simulations). Patients' weight was computer generated reflecting the published Spanish adult-population values (tested by the Anderson-Darling test and one-sample t-test). Nutritional requirements were calculated using ESPEN guidelines, and adequacy was defined as meeting protein and caloric targets within ±5% range. 3CPNBs were further screened for guideline-concordant composition. RESULTS: A total of 50 commercial 3CPNBs were identified, but 15 bags (30.0%) were excluded based on predefined criteria. Then, 35 were included in the study. While 51.4% formulations met adequacy criteria across all scenarios, 34.3% were suitable for only one, and 8.6% were unsuitable for any scenario. More than half (57.1%) failed to cover even 10% of patients in any scenario. ICU scenarios, I1 and I2, showed the lowest coverage, with only around 30% of patients with an appropriate 3CPNBs. Many weight strata showed less than 50% coverage depending on the scenario. In the 64-81,99 kg strata, around the population mean, 45.9% lacked an appropriate 3CPNBs across all scenarios. CONCLUSIONS: Substantial variability existed in the adequacy of commercial 3CPNBs to ESPEN guidelines. Many formulations failed to meet the criteria or were not usable across all scenarios. Many patients with body weight around population mean had no adequate 3CPNBs. These findings supported the need for critical evaluation of 3CPNBs and still place HCPNBs as a flexible alternative, especially in complex and critically ill populations.
INTRODUCTION: The automation of hazardous drug preparation in hospitals using robotic systems is an effective strategy to enhance safety, quality, and process efficiency. However, its implementation introduces a novel us...INTRODUCTION: The automation of hazardous drug preparation in hospitals using robotic systems is an effective strategy to enhance safety, quality, and process efficiency. However, its implementation introduces a novel user-robot interaction that transforms professional roles, tasks, and training needs. The acceptance of this technology depends on human, technical, and organizational factors. At present, no validated tool exists to specifically assess user-robot interaction in the preparation of hazardous drugs, whether in industrial or healthcare settings. Therefore, this study aims to develop and validate a questionnaire to evaluate such interaction in hospital settings. METHODS: This multicenter study will be conducted across five Spanish hospitals equipped with robotic systems for hazardous drugs compounding. The study population will include pharmacy technicians, nurses, and other healthcare professionals who operate these systems. The questionnaire will be developed using the Delphi method, a rigorous consensus process involving a panel of experts. Data collection will be conducted using the REDCap (Research Electronic Data Capture) platform. The validation process will assess: face validity (clarity and coherence of the questionnaire), content validity (relevance of the included items), criterion validity (correlation with an established external criterion), construct validity (consistency between the items and the construct under investigation), and internal consistency (measured using Cronbach's alpha). CONCLUSIONS: This study is the first initiative to develop and validate an instrument specifically designed to evaluate human-robot interaction in the preparation of hazardous drugs. Its implementation will support the identification of barriers and facilitators to the adoption of robotic systems in clinical practice, guide the design of specific training programs, and contribute to the optimization of medication preparation workflows in hospital settings.
OBJECTIVES: To characterize medication-related problems resulting in emergency department attendance involving high-alert medications, paying particular attention to sex-related differences in the type of the problem and...OBJECTIVES: To characterize medication-related problems resulting in emergency department attendance involving high-alert medications, paying particular attention to sex-related differences in the type of the problem and medication associated with it. METHODS: Retrospective observational study (2021-2022) based on the medical history at discharge, including adult patients seeking emergency department due to medication-related problems as a primary or secondary diagnosis. Patient grouping was performed according to the class of medication implicated in the event, as defined by the reference list of high-alert drugs for chronic patients (HAMC list). Sociodemographic and clinical baseline variables were collected. To explore gender differences in the type of problem and drug involved, statistical analysis included binomial tests and binary logistic regression with odds ratio estimation. RESULTS: Among the 1,611 adult patients admitted to the emergency department with adverse events associated with a medication problem, 1,028 (64%) involved a high-alert medication. Women with moderate- and high-risk comorbidity showed a significative greater incidence of medication-related problems. Gender differences were particularly notable for events associated with loop diuretics (136 women [70%] vs 57 men [30%], p = 0.000); antipsychotics (30 women [65%] vs 16 men [35%], p = 0.039); opioids (37 women [73%] vs 11 men [27%], p = 0.000] and digoxin (22 women [81%] vs 5 men [19%], p = 0.02). Women showed a trend toward higher odds of experiencing unintentional drug poisoning (OR = 2.5; 95% CI: 0.786-8.356; p = 0.119). In contrast, non-adherence to prescribed high-alert medications occurred with greater frequency in men (OR = 0.711, 95% CI: 0.473-1.070; p = 0.102). CONCLUSIONS: A considerable proportion of medication-related problems that lead to emergency room attendance involve high-risk medications, and the type of problem presented and the type of drug involved differ between sexes. Findings highlight that addressing gender differences, especially with regard to high-risk medicines, could be crucial in moving toward safer and more equitable healthcare.
BACKGROUND: On 11 March 2020, World Health Organisation declared COVID-19 a pandemic. During the early stages, treatments lacking scientific evidence, such as hydroxychloroquine and later remdesivir, were used; meanwhile...BACKGROUND: On 11 March 2020, World Health Organisation declared COVID-19 a pandemic. During the early stages, treatments lacking scientific evidence, such as hydroxychloroquine and later remdesivir, were used; meanwhile, clinical trials were being conducted in Spain to evaluate new therapies with greater scientific rigor. This article analyses the study profile, publication rate and completion of studies during the COVID-19 pandemic in Spain. METHODS: Meta-epidemiological, analytical, and retrospective study analyzing the characteristics and rate of completion of clinical trials with SARS-CoV-2-related drugs authorized in Spain between March 2020 and March 2021, focusing on treatment and prophylaxis. 179 clinical trials were reviewed using sources such as Registro Español de Estudios Clínicos, ClinicalTrials.gov, PubMed, Embase and TESEO. Statistical analysis was performed with SPSS v.26. RESULTS: 67.0% of the trials were national and 71.0% multicentre, with non-commercial sponsors (64.8%) and phase II (44.7%) and phase III (48.0%) studies being the most common. The majority employed a comparative design (93.9%), preferentially focused on treatment (91.1%) versus prophylaxis of SARS-CoV-2 disease, with a predominance of therapeutic repositioning (72.1%). Notably, studies initiated during the first wave of the pandemic (March-June 2020) were mostly non-international, non-commercial, non-placebo-controlled and aimed at drug repositioning. Some 21.2% of the clinical trials closed prematurely, mainly due to recruitment problems, involuntary discontinuation or failure to achieve expected efficacy. By the end of the study, 41.1% of the clinical trials had a final report and 31.3% published their results, most of them (71.9%) in first quartile journals. Statistically significant associations were found between the publication of results and variables such as multicentre, not having closed prematurely, having a final report, and phase III trials. The fact that a large number of clinical trials were not published (68.7%) represents a missed opportunity in terms of knowledge. CONCLUSION: We conclude that there is a need to improve transparency, record all results- including negative ones- and review key aspects of design and funding, as recommendations for future research, including in health emergencies.
Garrido Quintero A, Cercas Lobo S, Ruiz Ramos J
… +6 more, Plaza Díaz A, González Díez A, Cañón Santos A, Villarejo Jiménez A, Pérez Méndez MC, Puig Campmany M
BACKGROUND: Gastrointestinal bleeding is a frequent cause of emergency department visits among anticoagulated patients. Antidepressants may potentiate bleeding risk by impairing platelet aggregation. The impact of concom...BACKGROUND: Gastrointestinal bleeding is a frequent cause of emergency department visits among anticoagulated patients. Antidepressants may potentiate bleeding risk by impairing platelet aggregation. The impact of concomitant antidepressant use on emergency room re-visits for gastrointestinal bleeding in anticoagulated elderly patients remains unclear. OBJECTIVE: This study aimed to assess the risk factors for Emergency Department (ED) re-visit within 90 days after an initial bleeding episode in elderly patients on oral anticoagulant (OAC) therapy. METHODS: A retrospective observational study was conducted at a hospital in Catalonia, including patients over 65 years treated with OACs who presented to the ED for gastrointestinal bleeding between 2018 and 2024. Data were obtained from electronic health records, including comorbidities, chronic medications, and discharge treatments. The primary outcome was ED revisit for bleeding within 90 days. Multivariate logistic regression was used to identify independent predictors. RESULTS: Of 143 patients included [mean age 82.4 years; 51.7% women], 26.7% were on antidepressants, 8.3% on antiplatelet agents, and 77.6% on proton pump inhibitors. Over a mean follow-up of 90 days, 23,1% patients re-visited the emergency room with bleeding. Univariate analysis identified chronic kidney disease, antidepressant therapy, and antiplatelet use as significant factors. In multivariate models, independent predictors were chronic kidney disease (OR 2.50; 95% CI 1.07-5.85; p = 0.034), antidepressant use (OR 2.56; 95% CI 1.07-6.14; p = 0.034), and concomitant antiplatelet therapy (OR 4.55; 95% CI 1.27-16.28; p = 0.020). CONCLUSIONS: In elderly patients anticoagulated, the addition of antidepressants significantly increases the risk of ED re-visit for gastrointestinal bleeding within 90 days. Chronic kidney disease and concomitant antiplatelet therapy also emerge as key risk factors.
Del Rosario García B, Ramos L, Ramos Díaz R
… +6 more, Salas Pérez A, Carrillo Palau M, Reygosa Castro C, Alonso Abreu I, Medina Chico S, Gutiérrez Nicolás F
OBJECTIVE: The individualization of treatments through pharmacokinetic monitoring is a therapeutic strategy aimed at improving both the effectiveness and safety of drug therapy. For tumor necrosis factor inhibitors used...OBJECTIVE: The individualization of treatments through pharmacokinetic monitoring is a therapeutic strategy aimed at improving both the effectiveness and safety of drug therapy. For tumor necrosis factor inhibitors used in Crohn's disease, a robust correlation has been demonstrated between drug exposure and clinical response. However, evidence regarding ustekinumab concentrations and their relationship with treatment effectiveness remains limited. The objective of this study was to analyze ustekinumab concentrations at week 8 of treatment for Crohn's disease and to evaluate their association with biochemical remission at week 24 and treatment persistence. METHODS: This prospective study included patients with Crohn's disease who initiated ustekinumab between 2020 and 2023. Ustekinumab trough plasma concentrations were measured at week 8. Quartile analysis and binary logistic regression were performed to assess the relationship between ustekinumab concentrations and biochemical remission rates at week 24. Treatment persistence across concentration quartiles was evaluated using Kaplan-Meier analysis. RESULTS: A total of 36 patients were included. Individuals achieving biochemical remission at week 24 had higher ustekinumab concentrations at week 8 compared with non-responders (10.64 vs. 5.83 μg/mL; p = 0.016). Patients within the quartile-4 (>13.29 μg/mL) at week 8 showed significantly higher biochemical remission rates at week 24 compared with the remaining quartiles (100% vs. 57.1%; p = 0.023); Odds Ratio = 1.20; 95%-Confidence Interval [1.02-1.42]; p = 0.027. The 2-year treatment persistence rate was significantly greater among patients in quartiles 3-4 (100%) compared with those in quartile-1 (55.6%) and quartile 2 (50%) (p = 0.014). CONCLUSION: This study confirms the association between ustekinumab concentrations at week 8 and treatment effectiveness in Crohn's disease. A concentration >13.29 μg/mL at week 8 was identified as a predictive marker of biochemical remission at week 24, which could serve as a basis for future therapeutic decision-making algorithms.
Martín Cerezuela M, Domingo Chiva E, Betancor García T
… +10 more, Amor García MÁ, Aquerreta González I, Albanell-Fernández M, Doménech Moral L, Bastida Fernández C, Ortiz Pérez S, Cobo Sacristán S, Fernández Polo A, Egüés Lugea A, Becerril Moreno F
The management of pain, agitation/sedation and delirium is a fundamental part of the treatment received by patients admitted to Intensive Care Units (ICU). The use of different strategies for the prevention and treatment...The management of pain, agitation/sedation and delirium is a fundamental part of the treatment received by patients admitted to Intensive Care Units (ICU). The use of different strategies for the prevention and treatment of pain, agitation and delirium is one of the bases in the management of these patients. Knowledge of the different techniques for monitoring pain and delirium, pharmacokinetic behavior and the dosage used in this population, as well as the adverse effects and their management, is essential in order to provide optimal pharmacotherapeutic validation by the ICU clinical pharmacist.
OBJECTIVE: The presence of residual medications in blood donors can pose a risk to transfusion recipients, especially when drugs remain in plasma at clinically relevant levels. Current deferral recommendations for medica...OBJECTIVE: The presence of residual medications in blood donors can pose a risk to transfusion recipients, especially when drugs remain in plasma at clinically relevant levels. Current deferral recommendations for medicated donors are often generalized and lack pharmacokinetic rigor. This study aims to propose a pharmacologically and pharmacokinetically informed framework for assessing donor eligibility based on drug characteristics. METHOD: A structured literature review was conducted to evaluate key pharmacokinetic variables affecting drug persistence in blood, including half-life (t), time to maximum plasma concentration (t), maximum plasma concentration (C), and elimination pathways. Medications were stratified into five risk categories according to their pharmacological profile, systemic exposure, and clinical implications. Corresponding deferral periods were assigned to each category. The framework also considers the type of blood component being donated (e.g., plasma-rich vs. cellular products). RESULTS: Medications with long half-lives, genotoxic effects, or antiplatelet activity pose higher transfusion risks and require extended deferral periods. Conversely, drugs with minimal systemic absorption, low plasma bioavailability, or that serve as physiological replacements pose minimal risk and may not warrant deferral. The proposed model aligns deferral recommendations with drug clearance data and product-specific plasma exposure. CONCLUSIONS: A pharmacokinetic approach to donor eligibility enhances transfusion safety and supports evidence-based deferral guidelines. Pharmacists and clinicians can collaborate to assess medication risk profiles and optimize donor selection. This model can reduce unnecessary deferrals and maintain blood supply integrity while protecting recipients.
OBJECTIVES: To assess changes in quality of life in patients with rare disease hereditary transthyretin amyloidosis after initiating vutrisiran. Secondary objectives included evaluating effectiveness and safety. METHODS:...OBJECTIVES: To assess changes in quality of life in patients with rare disease hereditary transthyretin amyloidosis after initiating vutrisiran. Secondary objectives included evaluating effectiveness and safety. METHODS: Prospective, observational study, conducted in a real-world clinical setting between November 2023 and May 2024. Quality of life was assessed using Norfolk QOL-DN questionnaire at baseline and six months after treatment initiation. Statistical analysis was performed using SPSS Statistics®, and the Wilcoxon signed-rank test was applied to compare outcomes. RESULTS: Twenty-five patients were included. The median Norfolk QOL-DN score changed from 54 [40.5; 77.5] to 48 [32.0; 83.0] after six months (p = 0.935). NIS scores decreased from 41 [14.0; 70] to 22 [6.0; 66.5] (p = 0.177). Serum TTR levels were maintained or reduced to undetectable levels in all patients. NT-proBNP decreased from 464.0 [102.0; 827.0] to 345.0 pg/mL [146.0; 995.0] (p = 0.518). No treatment-related adverse events were reported. CONCLUSION: Although statistical significance was not reached, vutrisiran maintained or improved quality of life and clinical status in a real-world population that was more pretreated and had greater disease burden than the clinical trial. Combined with its favorable safety profile, subcutaneous administration, and extended dosing interval-preferred by patients-vutrisiran represents a promising therapeutic option for ATTRv amyloidosis. Long-term real-world studies are warranted to confirm these findings.
OBJECTIVE: The effectiveness of alemtuzumab in patients with relapsing-remitting multiple sclerosis (RRMS) have been demonstrated in clinical trials. The primary endpoint was to describe the annual effectiveness of alemt...OBJECTIVE: The effectiveness of alemtuzumab in patients with relapsing-remitting multiple sclerosis (RRMS) have been demonstrated in clinical trials. The primary endpoint was to describe the annual effectiveness of alemtuzumab over a 4-year period, according to the different parameters of the NEDA-3 concept (no evidence of disease activity) in clinical practice. METHODS: A retrospective, observational multicentric open study of patients with RRMS treated with alemtuzumab between 2015 and 2024. Effectiveness was assessed according to different parameters of the NEDA-3 concept (absence of relapses, stability in disability status according to the EDSS scale, and absence of new lesions and/or contrast enhancement in brain magnetic resonance imaging) with annual follow-up for up to four years. RESULTS: A cohort of 32 patients (71.9% women, mean age 40.3 ± 11 years) were included. The proportion of patients achieving NEDA-3 was 51.7% (15/29) in the first year, 56.2% (12/26) in the second year, 47.4% (9/19) in the third year, and 47.1% (8/17) in the fourth year. At the end of the study, 82% of patients remained relapse-free, 59% had stable disability according to the EDSS scale, and over 47% were free of radiological activity. CONCLUSIONS: Alemtuzumab has proven to be effective, over 4 years, in clinical practice in patients with RRMS according to the different parameters of the NEDA-3 concept.
INTRODUCTION: The standard first-line treatment for metastatic small-cell lung cancer (SCLC) is platinum-based chemotherapy in combination with etoposide. The aim of this study was to evaluate the real-world effectivenes...INTRODUCTION: The standard first-line treatment for metastatic small-cell lung cancer (SCLC) is platinum-based chemotherapy in combination with etoposide. The aim of this study was to evaluate the real-world effectiveness and safety of atezolizumab plus chemotherapy in SCLC and to explore factors associated with survival. METHODS: A retrospective, observational, multicenter study was conducted in patients diagnosed with SCLC who received first-line treatment with atezolizumab in combination with platinum-etoposide chemotherapy between November 2021 and March 2025. Treatment effectiveness was evaluated by assessing the objective response rate (ORR), treatment duration, progression-free survival (PFS) and overall survival (OS). Univariate and multivariate Cox models were used to explore associations between clinical variables and survival outcomes. RESULTS: A total of 76 patients with SCLC were included. Median age was 65 years, and 17.1% had an Eastern Cooperative Oncology Group performance status (ECOG PS) ≥2. The median duration of the treatment was 4.43 months (Interquartile range: 0.4-6.2). The ORR was 81.67% (95% CI: 70.08-89.44%). The median PFS was 7.2 months (95% CI: 6.5-8.6), and the median OS was 9.4 months (95% CI: 7.0-13.06). Patients with ECOG ≥2, hepatic metastases, and age ≥ 65 years were associated with a poor survival prognosis. Sex and the presence of brain metastases were not significantly associated with survival. Grade ≥ 3 treatment-related adverse events were observed in 44.7% patients, with no treatment-related deaths. CONCLUSIONS: In this real-world cohort, atezolizumab plus platinum-etoposide achieved high response rates and acceptable survival with a manageable safety profile in extensive-stage SCLC. Baseline ECOG performance status, hepatic metastases, and older age were associated with worse survival, underscoring the prognostic value of clinical factors. These observational data complement, but do not validate, the results of IMpower133, as no randomized control group or formal trial emulation methods were used.
BACKGROUND: The Pharmaceutical Care in Infectious Diseases Group (AFinf) is composed of a coordinating group of 11 pharmacists, 1 fellow, 1 resident pharmacist intern, 4 senior consultants and 221 associate members (July...BACKGROUND: The Pharmaceutical Care in Infectious Diseases Group (AFinf) is composed of a coordinating group of 11 pharmacists, 1 fellow, 1 resident pharmacist intern, 4 senior consultants and 221 associate members (July 2025). The aim is to understand and describe the profile of the members as a basis for defining future strategic lines to improve their participation. METHODS: An online survey was distributed to all AFinf group members, including questions about their professional activity, expectations and potential contributions to the group. RESULTS: The 41.7% of associated professionals participated in the survey. The median length of experience in the area of infectious diseases was 5 years (RIC 2-10). Antimicrobial stewardship programmes represented the main area of expertise (73.9%; 95% CI: 63.2-84.5), followed by pharmacokinetic monitoring (16.9%; 95% CI: 7.8-26.0). The priorities of the adherents were to receive training and education (52.3%; 95% CI: 40.2-64.5%) as well as the need to share doubts and experiences (27.7%; 95% CI: 16.8-38.6). Among the respondents, 50.0% (95% CI: 39.0-61.0) consider that they could contribute ideas and experiences, while 31.3% (95% CI: 21.1-41.4) research/collaborate on projects and 18.7% (95% CI: 10.2-27.3) participate in teaching and other group activities. CONCLUSION: This study has allowed us to better understand the professional profile of pharmacists who are members of the AFinf group and to analyze their concerns and possible contributions.
Aznar de la Riera MB, Valencia Soto CM, García-Avello Fernández-Cueto A
… +7 more, Villacañas Palomares MV, Muñoz Unceta N, Fernández Martínez V, Barbadillo Villanueva S, Rioja Carrera M, Valero Dominguez M, Martínez Callejo V
OBJECTIVE: The objective is to describe the real-world effectiveness and safety of atezolizumab in combination with carboplatin and etoposide as first-line treatment for patients with extensive-stage small-cell lung canc...OBJECTIVE: The objective is to describe the real-world effectiveness and safety of atezolizumab in combination with carboplatin and etoposide as first-line treatment for patients with extensive-stage small-cell lung cancer. METHODS: We conducted a retrospective observational study of 48 patients with extensive-stage small-cell lung cancer treated with atezolizumab, carboplatin, and etoposide between March 2022 and May 2024 at a tertiary care center. The primary endpoints were progression-free survival and overall survival, analyzed using the Kaplan-Meier method. Safety outcomes and clinical predictors of survival were also assessed using software SPSS v26. RESULTS: After a median follow-up of 7.6 months (range: 1.5-28.4), median progression-free survival was 5.8 months and median overall survival was 7.1 months. Baseline ECOG performance status (ECOG 1 and 2) and the presence of brain metastases were associated with reduced overall survival. Patients who received ≤2 cycles of maintenance atezolizumab showed inferior survival outcomes. Grade 3-4 treatment-related adverse events occurred in 60.4% (n = 29) of patients, with hematologic toxicity being the most frequent. CONCLUSIONS: In this real-world cohort, atezolizumab in combination with carboplatin and etoposide demonstrated feasibility and a manageable safety profile in first-line treatment of extensive-stage small-cell lung cancer. Longer follow-up and larger sample sizes are warranted to confirm these findings and further define prognostic markers in clinical practice.
Zavaleta-Monestel E, Villalobos-Madriz A, Fallas-Mora A
… +12 more, Martínez-Vargas E, Munich-Calvo A, Teixeira V, Dalmaso-Neto S, Sánchez C, Morales-Vallespín J, Milano-Gil A, Arroyo-Monterroza D, Delgado-Pérez G, Stepanovic M, Eckel S, Ivey M
UNLABELLED: The standardization of hospital pharmacy practice remains a challenge in Latin America due to the heterogeneity of healthcare systems. The Basel Statements, developed by the International Pharmaceutical Feder...UNLABELLED: The standardization of hospital pharmacy practice remains a challenge in Latin America due to the heterogeneity of healthcare systems. The Basel Statements, developed by the International Pharmaceutical Federation, provide guidelines aimed at improving patient safety and medication management; however, their implementation across the region is inconsistent. OBJECTIVE: To evaluate the application of the Basel Statements Self-Assessment Questionnaire in hospitals across Latin America and identify priority areas for improvement. METHOD: A multicenter study was conducted in eight hospitals from eight countries. A 33-item questionnaire based on the Basel Statements was electronically distributed to clinical and hospital pharmacists. A descriptive analysis was performed. RESULTS: Only 25% of hospitals reported effective integration of pharmacists into clinical decision-making. Fewer than one-third had adequate medication traceability systems. Additionally, only 37.5% reported having regulations for the use of dietary supplements. Lack of standardization in medication storage and administration was also observed, increasing the risk of medication errors. CONCLUSIONS: Implementation of the Basel Statements in Latin America is heterogeneous and requires targeted interventions. Strengthening pharmacists' involvement in multidisciplinary teams, improving traceability systems, and developing stronger regulations to support the safe use of medications are essential steps to enhance patient safety in the region.
OBJECTIVE: To evaluate treatment persistence and dosing interval extension with faricimab in neovascular age-related macular degeneration (nAMD) in real-world practice. METHODS: Retrospective observational study conducte...OBJECTIVE: To evaluate treatment persistence and dosing interval extension with faricimab in neovascular age-related macular degeneration (nAMD) in real-world practice. METHODS: Retrospective observational study conducted in a tertiary hospital (March 2024-March 2025). Patients receiving faricimab (treatment-naïve or pre-treated with anti-VEGF therapy), with ≥1 post-loading dose, were included. Dosing intervals were analyzed at baseline, 6 and 12 months, Adherence was assessed with the medication possession ratio (MPR), with >80% considered adherent. Persistence was defined as the time from treatment initiation to discontinuation or end of follow-up. Persistence was estimated using Kaplan-Meier survival analysis. RESULTS: We included 129 patients (148 eyes), mean age 74.5 ± 8.85 years; 55% were female. A total of 39 patients (30.2%) were treatment-naïve and 90 (69.8%) were pretreated. At 12 months, 48.8% of naïve and 55.5% of pretreated patients achieved 8-12 weeks intervals. Mean persistence was 12.2 months (SD 0.2; 95% CI: 11.8-12.6). The median was not reached by the end of the study. Persistence rate was 93% at 6 and 12 months. Only one patient discontinued due to inefficacy. No serious adverse events or endophthalmitis occurred. CONCLUSIONS: Faricimab showed excellent persistence and extended dosing intervals in real-world practice. This is the first study specifically evaluating faricimab real-world persistence in nAMD.