INTRODUCTION: Bruton's tyrosine kinase inhibitors (BTKi) have replaced immunochemotherapy in patients with chronic lymphocytic leukemia (CLL). The safety profile, particularly in monotherapy indications under real-world...INTRODUCTION: Bruton's tyrosine kinase inhibitors (BTKi) have replaced immunochemotherapy in patients with chronic lymphocytic leukemia (CLL). The safety profile, particularly in monotherapy indications under real-world clinical practice conditions, is key to optimizing outcomes. OBJECTIVE: To describe the safety and tolerability of continuous/indefinite BTKi therapy in patients with CLL treated in the first line and relapse/refractory (R/R) conditions with BTKi monotherapy, within labeled indications, at a tertiary care hospital. METHODS: Observational, retrospective, single-centre study including patients with CLL treated with iBTK (2015-2024). Demographic data, previous lines of treatment, dose adjustments and suspensions, and adverse events (AEs) by system and severity were recorded. Proportions were compared using Fisher's exact test. Treatment continuation was analyzed using Kaplan-Meier curves, log-rank tests, and Cox regression. RESULTS: Eighty-three patients (50.6% male) were included, with a mean age at diagnosis of 67.2 years. Forty-eight (58%) received iBTK as first-line therapy and 35 (42%) in R/R. The most commonly used iBTK was ibrutinib (62.5% in first-line and 88.6% in R/R). Median follow-up was 20.8 months. Overall, 28,9% required dose adjustment, with no differences between the two groups (p = 0.158). Treatment discontinuation was more frequent in patients with R/R patients (74.3% vs 39.6%; RR 1.81; 95% CI: 1.23-2.66; p = 0.002). AE were the most common reason for treatment discontinuation (15.7%). A total of 161 AEs were recorded, with infectious AE being the most frequent category. Respiratory infections were significantly more incident in R/R patients (p = 0.046). Patients with prior exposure to immunochemotherapy had an increased risk of treatment discontinuation (HR = 2.15; 95% CI: 1.18-3.89; p = 0.012). CONCLUSIONS: BTKi showed a manageable safety profile, with infections as the most common toxicity and secondary malignancies occurring at rates comparable to those reported in the literature. Treatment discontinuation was less frequent in the frontline setting, underscoring the influence of clinical context and prior therapies. Despite the limitations of a retrospective, single-centre design, this study provides information applicable to daily practice and highlights the importance of close follow-up to optimize both safety and treatment continuity.
OBJECTIVES: New drugs such as faricimab have been developed to treat ophthalmic neovascular diseases. While these drugs increase treatment success, they also increase costs. Repackaging drugs strikes a balance between te...OBJECTIVES: New drugs such as faricimab have been developed to treat ophthalmic neovascular diseases. While these drugs increase treatment success, they also increase costs. Repackaging drugs strikes a balance between technical requirements and treatment flexibility. The aim of this study was to evaluate the microbiological stability of repackaged faricimab under controlled conditions in order its already demonstrated chemical, biological, and microbiological stability. METHODS: This was a prospective, controlled experimental study. The contents of four vials of faricimab were repackaged into 16 silicone oil-free syringes with a low dead space volume. A bubble adaptor was used to ensure the maximum efficiency from fractioning. All samples were stored at 2-8 °C. Four of the syringes were cultivated on blood and Sabouraud agar at set time points (9 days, 16 days, 23 days, and 30 days). The endpoint of the study was positive microbiological growth in any of the samples. Negative and positive controls were cultivated alongside the test samples. RESULTS: None of the 16 samples or the negative controls exhibited microbiological growth at any stage of the culturing process. All positive controls showed microbiological growth. CONCLUSIONS: When repackaged in silicone oil-free syringes, faricimab retains microbiological stability for up to 30 days when it is prepared and stored under controlled conditions.
INTRODUCTION: Since the post-antibiotic era, there has been significant difficulty in treating infectious diseases due to the increase in antimicrobial resistance, the scarcity of new antimicrobials, and the complexity o...INTRODUCTION: Since the post-antibiotic era, there has been significant difficulty in treating infectious diseases due to the increase in antimicrobial resistance, the scarcity of new antimicrobials, and the complexity of the healthcare system. The World Health Organization (WHO) recognized it as one of the main public health problems. To mitigate this issue, Antimicrobial Stewardship Programs (ASPs) have been established in hospital settings and in primary care, through multidisciplinary teams with specific objectives and measurable results. However, their implementation faces multiple challenges. Digital tools and artificial intelligence (AI) can enhance these ASPs, contributing to the discovery of new molecules, the identification of resistance patterns, and improvements in infection control and prevention. OBJECTIVE: To analyze the role of digital tools and AI in the interventions carried out by hospital-based ASP teams to improve established outcomes. MATERIAL AND METHODS: This protocol follows the PRISMA-P methodology and has been registered in PROSPERO (ID: CRD42024601221). A literature search will be conducted in PubMed, Scopus, and the Cochrane Library (2014-2024); gray literature will subsequently be reviewed in Google Scholar. Articles (clinical trials, interventional and observational) involving hospitalized adult patients requiring antimicrobial treatment will be included. The risk of bias will be assessed according to the study type, and methodological quality will be evaluated using the GRADE scale. Two independent researchers will perform study selection, quality assessment, and data extraction. Discrepancies will be resolved by consensus or through the intervention of a third researcher. DISCUSSION: Previous studies highlight the role of ASPs and digital tools in antimicrobial optimization. However, the difficulty and difference in the degree of implementation have also become apparent. The heterogeneity of interventions and indicators could be a limiting factor for conducting a meta-analysis. Despite these limitations, this systematic review will provide a better understanding of the potential use of digital tools and AI in hospital-based ASPs. PROTOCOL REGISTRATION: This protocol has been registered in PROSPERO with the ID: CRD42024601221.
OBJECTIVE: Pivotal study on perioperative toripalimab in resectable non-small-cell lung cancer showed population differences by histological subtype compared with other immunotherapy regimens, raising doubts about therap...OBJECTIVE: Pivotal study on perioperative toripalimab in resectable non-small-cell lung cancer showed population differences by histological subtype compared with other immunotherapy regimens, raising doubts about therapeutic positioning. The aim of this study was to interpret the methodological analysis by subgroups according to histological subtype of perioperative toripalimab in resectable non-small-cell lung cancer. METHODS: Validated subgroup analysis applicability tool was used. This tool had two parts: preliminary questions to directly rule out analysis without relevant minimum conditions, and checklist. This checklist assessed statistical association, biological plausibility and consistency of subgroup results, and related these criteria to recommendations on applicability. RESULTS: Preliminary question regarding differences in effect between subgroups p(i) < 0.1 was answered negatively, and checklist was not applied due to direct discard. Even if the checklist had been applied, statistical association criterion would have been rated 'null' due to absence of statistically significant differences. Biological plausibility would have been rated 'probable' due to non-squamous histology being a negative prognostic factor. Consistency would have been rated 'null' for absence of heterogeneity between subgroups in similar studies. CONCLUSIONS: This methodological interpretation recommended against applying histology-based subgroup results for perioperative toripalimab in resectable non-small-cell lung cancer, avoiding ruling out the use of toripalimab in the non-squamous subgroup.
OBJECTIVE: To evaluate the impact of an intervention algorithm on penicillin allergy label reassessment in emergency department patients, aiming to optimize antibiotic selection and improve patient safety. METHODS: A ret...OBJECTIVE: To evaluate the impact of an intervention algorithm on penicillin allergy label reassessment in emergency department patients, aiming to optimize antibiotic selection and improve patient safety. METHODS: A retrospective observational study was conducted in a 450-bed hospital, including adult patients with a penicillin allergy label admitted to the emergency department between November 2023 and August 2024. An algorithm developed by the pharmacy service in collaboration with the ASP team was applied, based on validated tools such as the Penicillin Allergy De-Labelling Toolkit, PEN-FAST, and Antibiotic Allergy Assessment Tool. Demographic data, allergy history, and clinical outcomes were collected. The acceptance of recommendations and the incidence of adverse reactions were analyzed. RESULTS: A total of 66 patients were evaluated. Delabeling was proposed in 35 (53.03%) patients, skin testing in 13 (19.69%), oral provocation testing in 9 (13.63%), and label maintenance in 9 (13.63%). A total of 89.39% of the recommendations were accepted, achieving effective delabeling in 42 patients. No adverse reactions were recorded. In 21 cases, antibiotic therapy was optimized following the intervention. CONCLUSIONS: The implementation of a structured algorithm for penicillin allergy reassessment in emergency settings is both effective and safe. Its application facilitates antibiotic optimization, improves patient safety, and reduces broad-spectrum antibiotic use. This study highlights the role of hospital pharmacists in drug allergy management and antimicrobial stewardship.
OBJECTIVE: Pediatric palliative care aims to provide a professional, scientific, and compassionate response to the needs of terminally ill pediatric patients, with pain management being one of its fundamental pillars. Th...OBJECTIVE: Pediatric palliative care aims to provide a professional, scientific, and compassionate response to the needs of terminally ill pediatric patients, with pain management being one of its fundamental pillars. This systematic review analyzes the ethical aspects involved in the management of pain in pediatric patients at the end of life, using the core principles of clinical bioethics: autonomy, beneficence, non-maleficence, and justice as a framework. MATERIALS AND METHODS: A systematic review was conducted following the guidelines of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. Original qualitative or quantitative studies published between 2010 and 2024 in English or Spanish were included, provided they addressed pain management in pediatric palliative care from an ethical perspective. The databases consulted were PubMed, Scopus, and Web of Science. Methodological quality was assessed using the Mixed Methods Appraisal Tool (MMAT). RESULTS: A total of 18 studies met the inclusion criteria. Autonomy was addressed in a limited manner, often through indirect participation of the child via their caregivers. The principles of beneficence and non-maleficence were compromised by the underuse of analgesics due to fear of adverse effects, delays in referral to palliative care, and the continuation of futile treatments. The principle of justice was reflected in structural barriers, unequal access to opioids, and limited availability of specialized care, particularly in resource-limited settings. CONCLUSIONS: Bioethical principles are present in the management of terminal pediatric pain, but their application remains inconsistent. There is a clear need to enhance professional training, implement standardized clinical protocols, and promote effective communication with families.
de Dios Lopez A, Vicente Escrig E, Sempere Serrano P
… +3 more, Morillo-Verdugo R, En representación de MAPEX-SEFH, Grupo Cardio de la Sociedad Española de Farmacia Hospitalaria
OBJECTIVE: To develop a risk stratification tool for pharmaceutical care in patients with cardiovascular disease who require a comprehensive and personalized pharmaceutical approach. METHOD: The risk stratification model...OBJECTIVE: To develop a risk stratification tool for pharmaceutical care in patients with cardiovascular disease who require a comprehensive and personalized pharmaceutical approach. METHOD: The risk stratification model was collaboratively developed by hospital pharmacists specialized in managing cardiovascular risk patients, all members of the Spanish Society of Hospital Pharmacy. Through three workshops and a pilot study, relevant variables were identified, grouped into four dimensions, and assigned relative weights. In the pilot study, data from patients in the participating centers were collected and analyzed to determine priority levels and assess the contribution of each variable. The Kaiser Permanente pyramidal model was adopted, classifying patients into three priority levels: priority 1 (intensive pharmaceutical care, 90th percentile), priority 2 (60-90th percentiles), and priority 3 (below the 60th percentile). Cut-off points were established based on this stratification, and each center recorded variables in an Excel sheet to calculate mean weighted scores per priority level and total risk scores. RESULTS: Participants completed a questionnaire consisting of 20 variables grouped into four dimensions: demographic, socio-health and functional status, clinical and healthcare utilization, and treatment-related factors. Based on the tool application in a pretest study, the following cut-off points were established: 23 or more points for priority 1, 17-22 points for priority 2, and fewer than 16 points for priority 3. Over 80% of the total score was attributed to the dimensions of "clinical and healthcare utilization" and "treatment-related factors". Consequently, interventions based on the pharmaceutical care model were recommended for cardiovascular risk patients, tailored to their prioritization level. CONCLUSION: This stratification tool enables the identification of cardiovascular patients who require a higher level of pharmaceutical care, facilitating the adjustment of healthcare capacity. Validation of the model in a representative population is necessary to establish its broader applicability.
Valdeolmillos Carbó LV, Esteban Gómez MJ, Ruiz-Jarabo Gómez I
… +7 more, Ribed Sánchez A, Vicente Oliveros N, Guisado Gil AB, Campino Villegas A, Campillos P, Olier Martínez P, de Pourcq JT
INTRODUCTION: In the perioperative setting, appropriate management of chronic medications is of great importance in determining which medications to discontinue and when to reintroduce them. Although individual decisions...INTRODUCTION: In the perioperative setting, appropriate management of chronic medications is of great importance in determining which medications to discontinue and when to reintroduce them. Although individual decisions based on patient and surgical risk are required, the need for national consensus has been identified. OBJECTIVE: To provide a set of specific recommendations for the perioperative management of chronic medication, based on recent scientific evidence and expert consensus, with the aim of improving the safety of surgical patient care. METHOD: A review of the available literature was conducted on perioperative recommendations for the drugs most commonly included in the chronic medication regimens of patients undergoing surgery. The review encompassed drug datasheets, literature from Medline and the Cochrane Library, as well as information from other databases such as UpToDate® and Micromedex®. RESULTS: Recommendations are summarized for various medications grouped by pharmacotherapeutic group, specific medications for the treatment of immune-mediated diseases, and finally natural supplements and herbal therapy. CONCLUSIONS: The information collected in this article can help the healthcare team to determine the approach to the patient's chronic medication.
Nogué-Xarau S, Martínez-Sánchez L, García-Peláez M
… +5 more, Fernández de Gamarra-Martínez E, Pi-Sala N, Gispert-Ametller À, Salgado-García E, Aguilar-Salmerón R
Acetaminophen is one of the most widely used drugs in clinical practice due to its analgesic and antipyretic properties. However, overdose is one of the leading causes of severe acute liver failure. N-acetylcysteine, int...Acetaminophen is one of the most widely used drugs in clinical practice due to its analgesic and antipyretic properties. However, overdose is one of the leading causes of severe acute liver failure. N-acetylcysteine, introduced as an antidote in 1974, has revolutionized the management of this intoxication by reducing hepatotoxicity and mortality associated with acetaminophen toxicity. At the end of the 19th century, acetaminophen was identified as the main active metabolite of phenacetin and acetanilide. Its therapeutic use began to gain popularity in the 1950s and later became one of the main drugs involved in suicide attempts, particularly among adolescents and young adults. Acetaminophen-induced hepatotoxicity was first described in 1966, establishing that an overdose could lead to fulminant hepatic necrosis. In 1975, Rumack and Matthew published a nomogram that allowed stratification of hepatic toxicity risk based on plasma drug levels. The mechanism of hepatotoxicity was elucidated in the early 1970s when it was discovered that acetaminophen is metabolized by cytochrome P450 into a highly reactive intermediate, N-acetyl-p-benzoquinoneimine, which is normally neutralized by hepatic glutathione. In overdose situations, glutathione depletion leads to hepatic necrosis. Based on these findings, sulfhydryl-containing agents such as cysteamine and methionine were introduced as antidotes, but N-acetylcysteine ultimately proved to be the most effective treatment. Since its introduction, N-acetylcysteine administration protocols have evolved to optimize efficacy and minimize adverse effects. Protocols such as the Scottish and Newcastle Acetylcysteine Protocol and the Two Bags regimen have simplified dosing and reduced the incidence of anaphylactoid reactions. Over the past 50 years, N-acetylcysteine has saved thousands of lives and remains the gold-standard antidotal treatment for acetaminophen poisoning.
OBJECTIVE: The main objective is to describe the project and evaluate the impact of replacing repackaged medications with unit dose presentations in 15 public hospitals within a regional health system. Secondary objectiv...OBJECTIVE: The main objective is to describe the project and evaluate the impact of replacing repackaged medications with unit dose presentations in 15 public hospitals within a regional health system. Secondary objectives include identifying differences in the changes implemented across the 15 audited hospitals and conducting an exploratory analysis of the potential impact in other non-audited centers that requested participation in the project. METHOD: A database containing over 2,000 medications available in unit dose format was developed and is updated monthly. In parallel, an automated system based on decision-making algorithms was implemented to identify improvement opportunities in medication procurement. The system was adopted either individually by hospitals or through centralized structures at the regional or private level. The analysis included data from 15 public hospitals, where the reduction in repackaging and its environmental, economic, and operational impact were assessed by measuring material, time, and cost savings. The results were subsequently extrapolated to the 172 hospitals that applied. RESULTS: In the 15 monitored hospitals, repackaging of approximately 1.27 million tablets per year was avoided, resulting in estimated savings of 17,016 km of packaging material, 866 kg in weight, and 113,693 min of labor. The avoided costs in materials and machinery amounted to 36,274€ annually. No statistically significant differences were observed in project adoption across the hospitals (p = 0.234). The extrapolation to 172 hospitals suggests a potential impact of 16.67 million tablets no longer requiring repackaging per year, with an estimated savings of 2220.13 km of material, 24,723 h of labor, and 451,768€ annually. CONCLUSIONS: Replacing repackaged medications with commercially available unit dose formats significantly reduced material consumption, labor time, and repackaging-related costs in the evaluated hospitals. The implementation of the project was consistent across the 15 monitored hospitals. Furthermore, the model proved to be scalable. The main limitation identified was the limited availability of unit dose medications on the market; therefore, it is recommended to prioritize their inclusion in procurement processes and to promote their development by the pharmaceutical industry.
INTRODUCTION: The off-label use of drugs requires scientific support to balance risk/benefit, being limited to exceptional cases in which there are no therapeutic alternatives. METHODS: Retrospective descriptive study of...INTRODUCTION: The off-label use of drugs requires scientific support to balance risk/benefit, being limited to exceptional cases in which there are no therapeutic alternatives. METHODS: Retrospective descriptive study of the reports of the Pharmacy and Therapeutics Committee between 2018 and 2022 in a third level hospital; analyzing the requests, drugs, final opinion, reasons, level of evidence and economic impact. RESULTS: A total of 124 reports were analyzed, highlighting oncohematological (41.9%) and autoimmune (27.4%) diseases as main indications. Oncology (37.1%) and Pediatrics (18.5%) were the main applicants, with 87.9% for antineoplastic and immunomodulatory drugs. A total of 74.2% of the applications were approved due to lack of alternatives and solid evidence (phase II-III trials), while 25.8% were denied due to the availability of therapeutic options or insufficient evidence. In terms of cost, 53% of oncohematological drugs cost between €10,000-50,000/treatment and 62.1% of non-oncohematological drugs cost between €1,000-10,000/year. Approval of the rejected treatments would have generated an additional expenditure of €2,272,603. CONCLUSION: An increase of up to four times in the evaluation of off-label use drugs was evidenced, with a high approval rate.
Bastida C, Egües Lugea A, Fernández Polo A
… +10 more, Becerril Moreno F, Martín Cerezuela M, Domingo Chiva E, Betancor García T, Amor García MA, Aquerreta González I, Albanell-Fernández M, Doménech Moral L, Ortiz Pérez S, Cobo Sacristán S
Sepsis and septic shock are major global health issues, with significant morbidity and mortality. Early identification and appropriate management during the first few hours are crucial for improving clinical outcomes. Se...Sepsis and septic shock are major global health issues, with significant morbidity and mortality. Early identification and appropriate management during the first few hours are crucial for improving clinical outcomes. Sepsis treatment focuses on infection control, restoration of perfusion, and the implementation of adjunctive therapies. A thorough understanding of these approaches is essential for the clinical pharmacist in the intensive care unit to provide optimal pharmacotherapeutic validation.
Martínez-Barros H, Muñoz-García M, Antolín-Amérigo D
… +11 more, Sánchez-Cuéllar S, Morales-Tirado A, de-Andrés-Martín A, de-Los-Santos-Granados G, Yeguas-Ramírez L, Blitz-Castro E, Santamaría-Gadea A, de-la-Hoz-Caballer B, Martín-Aragón S, González-de-Olano D, Álvarez-Díaz AM
OBJETIVES: To design the patient onboarding in a multidisciplinary severe asthma unit, according to the needs identified by patients and professionals in the unit. METHODS: Qualitative study using the human-centred desig...OBJETIVES: To design the patient onboarding in a multidisciplinary severe asthma unit, according to the needs identified by patients and professionals in the unit. METHODS: Qualitative study using the human-centred design conducted between November 2022 and February 2023. Patients and professionals from the severe asthma unit and experts in the methodology participated. Three workshops were held. In the first, we elaborated the patient experience map, identifying positive aspects and needs. Possible solutions were devised. In the second, we selected the solutions described in a previous project applicable to onboarding and determined the key moments. In the third, we finalised the definition of the key moments, the professionals in charge in each step and the tools to be incorporated. Finally, in short sessions (sprints) we developed the necessary material and infographics. RESULTS: We identified the main needs of patients (better control of the disease and autonomy in care, two-way conversation with professionals and receiving coordinated and personalised care) and professionals (defining, structuring, unifying and adapting the information provided to patients and managing to maintain open conversations with them). We determined that onboarding should establish a controlled welcome to the severe asthma unit, which is identifiable by patients, promotes the patient-professional relationship and the learning, use and functioning of the severe asthma unit. Previously devised solutions applicable to onboarding, such as the landing kit or the patient diary, were selected. We established the key moments of onboarding (identification consultation, initial consultation, onboarding consultation and complementary consultations), the professionals involved and the necessary information, material and infographics. Finally, we developed the design, structure and final content of the necessary tools, such as the patient diary or the asthma infographic. CONCLUSIONS: This work has allowed us to design, structure and standardise the onboarding, providing an environment that facilitates self-care and open, empathetic, two-way conversation between patients and professionals, according with the key needs expressed by both. These findings may be useful for other multidisciplinary care units.
INTRODUCTION: Intensive Care Units (ICU) are recognized as high-risk settings for medication errors, primarily due to the complex pharmacological regimens and the critical condition of patients. It is estimated that the...INTRODUCTION: Intensive Care Units (ICU) are recognized as high-risk settings for medication errors, primarily due to the complex pharmacological regimens and the critical condition of patients. It is estimated that the probability of errors occurring in these units is two to three times higher than in general hospital patients, with prescribing and administration being the stages most frequently associated with such incidents. OBJECTIVE: To evaluate the applicability and satisfaction with electronic prescribing systems in Intensive Care Units of hospitals in Spain. METHODS: A nationwide survey was conducted targeting pharmacists to assess the functionalities of the electronic prescribing systems used in these units. The evaluation covered hospital characteristics, features of the prescribing software, and healthcare professionals' satisfaction, with the aim of understanding the current situation and proposing improvement strategies to enhance medication safety through prescribing systems in the context of critically ill patients. RESULTS: A total of 64 surveys were completed across 55 different hospitals. In 50.8% of cases, a prescribing system different from that used in general hospital wards was employed. In 84.4% of cases, the system had been developed by a commercial vendor. In 65.1% of hospitals, the system enabled communication with the pharmacy, and in 57.7% it allowed for pharmaceutical validation. However, 50.8% of the systems were not capable of interfacing with automated dispensing or administration systems. In 71.9% of cases, the system allowed for direct data extraction. Pharmacists reported satisfactory overall perceptions in only 43.8% of cases, while 42.9% identified unmet needs requiring improvement. CONCLUSIONS: Despite significant heterogeneity in the functionalities of electronic prescribing systems across Spanish ICUs, such systems are widely implemented nationwide and are regarded as a key element in ensuring medication safety within these units. Clinical pharmacists reported a generally acceptable level of satisfaction; however, there remains considerable scope for improvement.
OBJECTIVE: This study aims to evaluate the involvement of hospital pharmacists in the protocolization, management and clinical follow-up of non-cytotoxic drug extravasations in Spanish hospitals. METHODS: A survey was di...OBJECTIVE: This study aims to evaluate the involvement of hospital pharmacists in the protocolization, management and clinical follow-up of non-cytotoxic drug extravasations in Spanish hospitals. METHODS: A survey was distributed through the SEFH email list using the REDCap® web platform. The characteristics of the participating hospitals, the availability of a protocol for managing non-cytotoxic drug extravasations, the healthcare professionals involved in developing the protocol, and the pharmacists' involvement and clinical follow-up in response to these incidents were investigated. RESULTS: A total of 89 complete responses were obtained from hospitals across 14 Autonomous Communities. Only 12 centers (13.5%) had a protocol that included recommendations for the extravasation of non-cytotoxic drugs, and in 11 (91.7%) of these, the pharmacist had participated in its development. The recommendations for extravasation management were mainly based on intrinsic drug properties such as pH and osmolarity, specific properties like vasoconstrictor drugs, or the classification of drugs as vesicants, irritants, or non-irritants. Wide variability was observed in recommendations regarding the application of cold or heat and hyaluronidase dosage. The decision to consult with pharmacy service regarding the management of extravasation depended largely on the individual nurse or physician's judgment, but 20 centers (22.5%) reported that they never received such consultations. A large proportion of Pharmacy Services (73.0%) reported that they participate in extravasation management by providing information by telephone, but 21 centers (23.6%) indicated that the pharmacist never participates in these adverse events. Limited involvement was also noted in the clinical assessment of the patient, follow-up of the extravasation, and documentation in the patient's medical history. CONCLUSION: The results of this survey reflect the limited standardization in the management of non-cytotoxic drug extravasations, as well as significant heterogeneity in the level of involvement of hospital pharmacists in these adverse events across hospitals in our country. The need to establish a national guideline or document on the management of non-cytotoxic drug extravasations is highlighted, along with the importance of promoting interdisciplinary collaboration to improve patient safety.
OBJECTIVE: Immunotherapy has emerged as a therapeutic alternative to chemotherapy (CT) for perioperative treatment of resectable non-small cell lung cancer (NSCLC). The objective is to perform a network meta-analysis com...OBJECTIVE: Immunotherapy has emerged as a therapeutic alternative to chemotherapy (CT) for perioperative treatment of resectable non-small cell lung cancer (NSCLC). The objective is to perform a network meta-analysis comparing the perioperative efficacy of immunotherapies in resectable NSCLC taking into account tumor expression of programmed death ligand 1 (PD-L1). METHOD: A review was performed in Pubmed® and EMBASE® until September 17, 2024. Phase III clinical trials on perioperative immunotherapies (P-) for resectable NSCLC with ≥50 patients were included. The selected endpoint was progression-free survival (PFS) according to different levels of PD-L1 expression. The statistical analysis used Bayesian methods. Fixed- or random-effects models were assessed using deviance information criteria (DIC). A sensitivity analysis was developed to evaluate the influence of heterogeneous studies. RESULTS: Four trials were included. Immunotherapeutic schemes with P-toripalimab, P-nivolumab, P-pembrolizumab and P-durvalumab were selected. Only P-toripalimab included a cycle of adjuvant toripalimab + CT. The remaining perioperative combinations contained the neoadjuvant immunotherapeutic agent + CT (4 cycles) regimen followed by adjuvant immunotherapy. The common comparator was neoadjuvant placebo + CT with adjuvant placebo (P-placebo). P-toripalimab was evaluated in a population with heterogeneous characteristics. Fixed effects model was selected for DIC values with irrelevant differences. P-toripalimab obtained greater magnitude of effect in PFS for populations with PD-L1 < 1% and 1-49% (reference treatment). No benefit of any immunotherapeutic combination over P-placebo was observed in resectable NSCLC with PD-L1 expression <1%. P-toripalimab was statistically superior to the other regimens [except P-pembrolizumab, HR = 1.6 (95%CrI: 0.84-3.2)] for PD-L1 expression 1-49%. Immunotherapeutic schemes were superior to p-placebo for PD-L1 expression ≥50%. Sensitivity analysis showed results compatible with the primary analysis. CONCLUSIONS: Our network meta-analysis provides reliable evidence on the efficacy of perioperative immunotherapy in resectable NSCLC according to PD-L1 expression levels, and may favor competition between therapeutic alternatives. A sensitivity analysis supported these results.