FARMACIA HOSPITALARIA最新文献

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.

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.

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.

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.

Introduction: Inhaled antibiotics are used in the treatment of various respiratory diseases, including cystic fibrosis (CF), non-CF bronchiectasis, and ventilator-associated pneumonia. While some of these drugs are marketed as ready-to-use formulations, others require prior manipulation, such as dilution or reconstitution procedures that are often not standardized. Furthermore, certain antibiotics are only approved for intravenous administration, making it necessary to develop specific protocols for their preparation and use via the inhaled route. Their biochemical properties may also compromise patient safety and tolerability. The aim of this study was to assess how frequently preparation methods and biochemical parameters of inhaled antibiotic solutions are described in the scientific literature. Additionally, we explored their prevalence of use in our country and evaluated their biochemical characteristics to assess tolerability.

Methods: A literature review was conducted using the MEDLINE database to identify studies describing the dilutions used for the administration of inhaled antibiotics. In addition, a nationwide survey was carried out to assess the dilutions currently used in hospital clinical practice. Biochemical analyses were performed in parallel to determine the pH, osmolality, and sodium and chloride ion concentrations of the solutions employed. Excipients present in each formulation were recorded based on information from the product's summary of characteristics.

Results: The literature review identified 533 full-text publications describing 737 different inhaled antibiotic mixtures. Of these, 476 were not standardized. Only 190 mixtures included precise dilution instructions, while just 31 provided data on pH and 28 on osmolality. The national survey revealed a high prevalence of inhaled antibiotic use among participating hospitals, with 22 centres (64.7%) reporting the use of intravenous formulations administered via inhalation. Laboratory analyses showed that some of the evaluated dilutions fell outside the acceptable tolerability range, particularly those involving reconstitution of dry powders or dilution of concentrated intravenous solutions.

Conclusion: There is limited information in the scientific literature regarding preparation methods and the biochemical characteristics of inhaled antibiotic solutions. Off-label use of intravenous formulations for inhalation is widespread, and some of the dilutions used exhibit biochemical parameters outside the recommended tolerability range, which may compromise both the safety and effectiveness of treatment.

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: To compare radiographic progression-free survival in metastatic prostate cancer patients treated with low-dose abiraterone versus standard-dose abiraterone acetate (Abi-SD), and to evaluate prostate-specific antigen progression-free survival.

Methods: Retrospective cohort study of patients with metastatic prostate cancer, castration-sensitive or castration-resistant, treated with low or standard-dose abiraterone. All patients were followed until radiographic or prostate-specific antigen progression. Cox proportional hazards regression was used to assess radiographic progression-free survival and prostate-specific antigen progression-free survival according to abiraterone dose (low vs. standard-dose). The model was adjusted for Charlson Comorbidity Index, castration resistance status, disease volume based on CHAARTED criteria, and presence of de novo metastases.

Results: A total of 144 patients with metastatic prostate cancer were included in the study, with 28.4% (n = 41) receiving low-dose abiraterone. The median age was 79 years (IQR: 75-85) in the low-dose group and 75 years (IQR: 70-81) in the standard-dose group. For radiographic progression-free survival, the crude hazard ratio for the low-dose group compared with the standard-dose group was 0.49 (95% CI: 0.23-1.07). After adjusting for clinical variables, the adjusted hazard ratio was 0.65 (95% CI: 0.29-1.45). For prostate-specific antigen progression-free survival, the crude hazard ratio was 0.48 (95% CI: 0.24-0.90), and the adjusted hazard ratio was 0.58 (95% CI: 0.29-1.14).

Conclusion: This study provides evidence supporting the use of low-dose abiraterone in patients with metastatic prostate cancer, showing survival and progression outcomes comparable to those of the standard-dose. This approach may improve access to treatment; however, larger studies are needed to validate these findings.

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 analyzed 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.

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.