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The objective of regulatory authorities is to ensure a favorable risk-benefit balance for medicines in their licensed indication, without seeking to establish their place in the therapeutic armamentarium beyond that. The licensed indication covers heterogeneous subpopulations and often does not sufficiently specify the characteristics of the patients who may benefit. The regulatory information does not always show the benefit over the standard treatments; moreover, it only reacts to the conditions specified in the developer's application, and lacks an assessment of the clinical relevance of the benefit and its uncertainties. Many cases highlight the need to establish a more specific therapeutic benefit scenario than the licensed indication. For example, abemaciclib was approved in the adjuvant setting for high-risk patients with early breast cancer, but the appropriate level of risk and how to assess it needs to be specified. Also, pembrolizumab is approved for neoadjuvant plus adjuvant treatment in lung cancer; but it remains to be analyzed whether it is superior to nivolumab in neoadjuvant treatment alone, which involves less treatment and economic burden. As therapeutic positioning is always a necessary decision, whether made at a national, regional, local or individual level, it must be made in the most appropriate way. The absence of a multidisciplinary discussion and consensus, relying only on individual decisions to determine positioning from the outset, underestimates information gaps, inter-individual variability and the influence of drug promotion. It can be harmful and costly. To properly manage the introduction of new medicines, it is essential to establish their benefit scenario in a multidisciplinary way. This, together with consideration of the clinical benefit provided versus the appropriate alternatives and the uncertainties of the benefit, constitutes the objective of the clinical assessment and the basis for designing a well-focused economic analysis. This allows policy makers to make the most appropriate decisions on pricing and funding new treatments. In an ideal situation, the benefit scenario considered for the new medicine would coincide with the one established for funding, but costs that are difficult to bear may lead to restrictions and affect the final positioning after the economic and budgetary impact assessment.
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OBJECTIVE: The primary objective is to describe the real-life effectiveness and safety of nivolumab treatment in patients with relapsed or refractory classical Hodgkin's lymphoma. The secondary objective is to describe the therapeutic management after nivolumab monotherapy. METHOD: Observational, retrospective, multidisciplinary study including all patients with relapsed or refractory classical Hodgkin's lymphoma treated with nivolumab monotherapy from November 2015 to March 2023. Patient and treatment-related variables were collected. Effectiveness was measured as overall response rate, progression-free survival and overall survival. Safety was measured as percentage of patients with adverse effects and severity. RESULTS: Thirteen patients were included, median age 37.5â¯years (RIQ: 25.3-54.7), 84.6% male. The median number of previous lines of therapy was 3 (RIQ: 2.0-4.5), including autologous hematopoietic stem cell transplantation (84.6%) and brentuximab vedotin (100%). All received nivolumab 3â¯mg/kg/14â¯days, with a median of 11â¯cycles (RIQ: 6.5-20.5) per patient. Median time on treatment was 4.9â¯months (RIQ: 3.0-9.6) and median follow-up time was 9.2â¯months (RIQ: 5.6-32.3). Complete response was achieved by 3 patients (23.1%), partial response by 3 (23.1%), stable disease by 3 (23.1%) and progression by 4 (30.8%). The objective response rate was 46.2%. Median progression-free survival was 23.9â¯months (95%CI: 0-49.1), median overall survival was not reached. At the study cutoff date, five patients had died (38.5%), four were in complete remission without active treatment (30.8%) and four were continuing treatment (30.8%). Adverse events occurred in 76.9% of patients, 44% of severity ≥3, the most frequent being hypothyroidism and hepatotoxicity. One patient discontinued treatment due to pneumonitis, two suffered treatment delays (thrombocytopenia and hypertransaminemia) and one changed the regimen to monthly (pulmonary toxicity). CONCLUSIONS: Nivolumab in the treatment of relapsed or refractory classical Hodgkin's lymphoma has confirmed in the study sample favorable effectiveness data, expressed as objective response rate of 46.2% and clinical benefit of 69.2%. Safety was acceptable, manageable, and consistent with that described in the literature.
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Onasemnogene abeparvovec (OA) is the approved intravenous gene therapy for the treatment of spinal muscular atrophy (SMA). A functional copy of the human SMN1 gene was inserted into the target motor neuron cells via a viral vector, AAV9. In clinical trials, OA was infused through a peripheral venous catheter, and no data are available on central catheter use. Recently, we had a case where OA was administered directly into the right atrium via a peripherally inserted central catheter (PICC) instead of a peripheral line, as recommended. The patient was a female child aged 4 months, diagnosed as SMA type I. For practical reasons, a dose of OA according to the weight of the patient (1.1 × 1014 vectorial genomes/kg) was administered via PICC in 1 h, as the product information recommends. The drug was well tolerated, with no hypersensitivity reactions or initial elevation of transaminases or other adverse effects. To our knowledge, this is the first case reported where OA was administered via a central line. This type of administration is not contraindicated, but it is not specifically contemplated or recommended. It is unknown whether central line administration could have any implications for transduction efficiency and immunogenicity. Future studies should clarify these aspects, as each gene therapy has a specific optimal dose recorded that depends on the site and route of administration of the drug, the AAV variant and the transgene.
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Patient empowerment is one of the main pillars of humanisation. Therefore, consideration of patients' preferences and expectations should be taken into account during the practice of any healthcare professional. Improving overall survival and quality of life are the main wishes of patients. Indeed, the recent emergence of Patient Reported Outcomes has become an important focus for healthcare providers. The hospital pharmacist specialised in drug evaluation is a professional who evaluates the efficacy, safety, appropriateness and efficiency of treatments prescribed by physicians, and decision-making must be based on both technical factors and the four principles of bioethics. The correct application of evidence-based clinical practice allows to provide patients with increases in survival and/or quality of life, adapting the convenience and costs to the current situation. With this in mind, it could be said that the evaluation of medicines involves a strong commitment to humanisation. On the other hand, rganisations that promote the rigorous evaluation and selection of medicines stand as allies of patients, as they have a direct impact on them and an indirect impact on society. Regulatory agencies in charge of approving and financing medicines in healthcare systems play a key role in the process of humanising clinical decision-making and empowering patients. If these agencies approve the use of new medicines based on data that do not measure quality of life or survival of patients when there are already other therapeutic alternatives for these pathologies, they are indirectly failing to meet patients' expectations and are infringing bioethical principles. This can have a considerable influence on the benefit-risk ratio of drugs, and patients may be treated with regimens that do not provide benefit, or may even harm them. Therefore, where should the process of humanisation be oriented? It seems reasonable that the benefit of the patient should be the fundamental objective of the process of humanisation of healthcare, evidently.
El empoderamiento del paciente supone uno de los principales pilares de la humanización. Por ello, la consideración de las preferencias y expectativas de los pacientes debería ser tenida en cuenta durante el ejercicio de cualquiera de los profesionales de la salud. Mejorar la supervivencia global y la calidad de vida son los deseos principales de los pacientes. De hecho, la reciente aparición de los llamados Patient Reported Outcomes ha supuesto un importante foco para los agentes involucrados en la asistencia sanitaria. El farmacéutico hospitalario especializado en la evaluación de medicamentos es un profesional que evalúa la eficacia, seguridad, adecuación y eficiencia de los tratamientos prescritos por facultativos, y debe basar la toma de decisiones tanto en factores técnicos como en los cuatro principios bioéticos. La correcta aplicación de la práctica clínica basada en la evidencia permite proveer a los pacientes de incrementos de supervivencia y/o calidad de vida, adecuando la conveniencia y costes a la situación actual. Teniendo en cuenta esto, podría decirse que la evaluación de medicamentos supone un fuerte compromiso con la humanización. Por otra parte, las organizaciones que promueven la evaluación y selección de medicamentos rigurosamente se erigen como aliados de los pacientes, ya que repercuten de forma directa en éstos y de forma indirecta en la sociedad. Las agencias reguladoras encargadas de la aprobación y financiación de medicamentos en los sistemas sanitarios protagonizan un papel fundamental en el proceso de humanización de la toma de decisiones clínicas y empoderamiento de pacientes, ya que si aprueban el uso de nuevos medicamentos según datos que no miden la calidad de vida o supervivencia de los pacientes cuando ya existen otras alternativas terapéuticas para estas patologías, indirectamente no estarán dando respuesta a las expectativas de los pacientes y conculcarán los principios bioéticos. Esto puede tener una considerable influencia en la relación beneficio-riesgo de los fármacos, pudiendo tratar a pacientes con esquemas que no aportan beneficio, o incluso podrían perjudicarles. Por tanto, ¿hacia dónde debiera ir orientado el proceso de humanización? Parece razonable que el beneficio del paciente sea el objetivo fundamental del proceso de humanización de la asistencia sanitaria, evidentemente.
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Motivação , Qualidade de Vida , Humanos , Objetivos , Pacientes , Pessoal de SaúdeRESUMO
Objective: To describe the admissions of patients diagnosed with severe mental illness (SMI) and anxiety disorder in a regional hospital; to explore factors related to the patient's referrer upon admission and prolonged stay. Materials and methods: Cross-sectional study of episodes of admission to the regional Psychiatric Hospitalization Unit over a period of 11 years with ICD-10 diagnostic codesF20-29, F30-39, F60-69 and F40-48. The data was extracted through the Admissions Unit and the information from the electronic medical record. For the statistical treatment, descriptive or inferential tests were used with a confidence level of 95%. Results: 961 patients were included (2,324 total discharges), aged 40.8±14.0 years. The most frequent reasons for admission were: positive symptoms (agitation, delusions and hallucinations), followed by suicidal ideation and attempt. The main remitting agent of the patients was the family itself. Approximately 1/5 of the cases were referred by the health system itself, and » of those admitted had self-excluded themselves from specialized supervision for more than a year. Conclusions: The problems that caused the admission and its origin, as well as its lack of follow-up, can be considered as a clear opportunity for improvement in the follow-up of patients with severe mental illness. An orientation towards proactivity, acting before the decompensation, would contribute to improving the care and quality of life of patients with severe mental illness and their environment.
Objetivo: Describir los ingresos de pacientes diagnosticados de enfermedad mental grave y trastorno de ansiedad en un hospital comarcal; explorar los factores relacionados con la derivación del paciente al ingreso y con estancia prolongada. Materiales y métodos: Estudio de corte transversal de los episodios de ingreso en la Unidad de Hospitalización Psiquiátrica comarcal en un periodo de 11 años con los códigos diagnósticos CIE-10 F20-29, F30-39, F60-69 y F40-48. Se extrajeron los datos a través de la Unidad de Admisión y la información de la historia clínica electrónica. Para el tratamiento estadístico se usaron pruebas descriptivas o inferenciales con nivel de confianza del 95%. Resultados: Se incluyeron 961 pacientes (2.324 altas totales), con edad de 40,8±14,0 años. Los motivos más frecuentes de ingreso fueron: síntomas positivos (agitación, delirios y alucinaciones), seguidos de ideación e intento de suicidio. El principal agente remisor de los pacientes fue la propia familia. Aproximadamente 1/5 de casos fue derivado por el propio sistema sanitario, y » de los ingresados se había autoexcluido de la supervisión especializada durante más de un año. Conclusiones: Los problemas causantes del ingreso y su procedencia, así como su falta de seguimiento, pueden considerarse como una oportunidad clara de mejora en el seguimiento del paciente con enfermedad mental grave. Una orientación hacia la proactividad, actuando antes de la descompensación, contribuiría a mejorar la asistencia y calidad de vida de los pacientes con enfermedad mental grave y su entorno.
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Hospitalização , Transtornos Mentais , Humanos , Estudos RetrospectivosRESUMO
BACKGROUND: Intermittent locking of central venous catheters (CVCs) is undertaken to help maintain their patency and performance. There are systematic variations in care: some practitioners use heparin (at different concentrations), whilst others use 0.9% sodium chloride (normal saline). This review looks at the effectiveness and safety of intermittent locking with heparin compared to normal saline, to see if the evidence establishes whether one is better than the other. This is an update of an earlier Cochrane Review. OBJECTIVES: To evaluate the benefits and harms of intermittent locking of CVCs with heparin versus normal saline in adults to prevent occlusion. SEARCH METHODS: We used standard, extensive Cochrane search methods. The latest search date was 20 October 2021. SELECTION CRITERIA: We included randomised controlled trials in adults ≥ 18 years of age with a CVC that compared intermittent locking with heparin at any concentration versus normal saline. We excluded studies on infants and children from this review. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were occlusion of CVCs and duration of catheter patency. Our secondary outcomes were CVC-related bloodstream infections and CVC-related colonisation, mortality, haemorrhage, heparin-induced thrombocytopaenia, CVC-related thrombosis, number of additional CVC insertions, abnormality of coagulation profile and allergic reactions to heparin. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: We identified one new RCT with 30 participants for this update. We included a total of 12 RCTs with 2422 participants. Data for meta-analysis were available from all RCTs. We noted differences in methods used by the included studies and variation in heparin concentrations (10 to 5000 IU/mL), time to follow-up (1 to 251.8 days), and the unit of analysis used (participant, catheter, line access). Five studies included ICU (intensive care unit) patients, two studies included oncology patients, and the remaining studies included miscellaneous patients (chronic kidney disease, haemodialysis, home care patients, etc.). Primary outcomes Overall, combined results may show fewer occlusions with heparin compared to normal saline but this is uncertain (risk ratio (RR) 0.70, 95% confidence interval (CI) 0.51 to 0.95; 10 studies; 1672 participants; low-certainty evidence). We pooled studies that used participant or catheter as the unit of analysis. We carried out subgroup analysis by unit of analysis. No clear differences were detected after testing for subgroup differences (P = 0.23). We found no clear evidence of a difference in the duration of catheter patency with heparin compared to normal saline (mean difference (MD) 0.44 days, 95% CI -0.10 to 0.99; 6 studies; 1788 participants; low-certainty evidence). Secondary outcomes We found no clear evidence of a difference in the following outcomes: CVC-related bloodstream infections (RR 0.66, 95% CI 0.08 to 5.80; 3 studies; 1127 participants; very low-certainty evidence); mortality (RR 0.76, 95% CI 0.44 to 1.31; 3 studies; 1100 participants; very low-certainty evidence); haemorrhage (RR 1.54, 95% CI 0.41 to 5.74; 3 studies; 1197 participants; very low-certainty evidence); or heparin-induced thrombocytopaenia (RR 0.21, 95% CI 0.01 to 4.27; 3 studies; 443 participants; very low-certainty evidence). The main reasons for downgrading the certainty of evidence for the primary and secondary outcomes were unclear allocation concealment, suspicion of publication bias, imprecision and inconsistency. AUTHORS' CONCLUSIONS: Given the low-certainty evidence, we are uncertain whether intermittent locking with heparin results in fewer central venous catheter occlusions than intermittent locking with normal saline in adults. Low-certainty evidence suggests that heparin may have little or no effect on catheter patency duration. Although we found no evidence of differences in safety (CVC-related bloodstream infections, mortality, or haemorrhage), the combined studies were not powered to detect rare adverse events such as heparin-induced thrombocytopaenia. Further research conducted over longer periods would reduce the current uncertainties.
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Cateteres Venosos Centrais , Heparina , Solução Salina , Adulto , Infecções Relacionadas a Cateter/epidemiologia , Hemorragia/induzido quimicamente , Heparina/efeitos adversos , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Solução Salina/efeitos adversos , Sepse , Trombocitopenia/induzido quimicamenteRESUMO
Oxidative stress plays a major role in the pathogenesis of retinitis pigmentosa (RP). The main goal of this study was to evaluate the effect of 2-year nutritional intervention with antioxidant nutraceuticals on the visual function of RP patients. Secondly, we assessed how nutritional intervention affected ocular and systemic redox status. We carried out a randomized, double-blind, placebo-controlled study. Thirty-one patients with RP participated in the study. RP patients randomly received either a mixture of nutraceuticals (NUT) containing folic acid, vitamin B6, vitamin A, zinc, copper, selenium, lutein, and zeaxanthin or placebo daily for 2 years. At baseline and after 2-year of the nutritional supplementation, visual function, dietetic-nutritional evaluations, serum concentration of nutraceuticals, plasma and aqueous humor concentration of several markers of redox status and inflammation were assessed. Retinal function and structure were assessed by multifocal electroretinogram (mfERG), spectral domain-optical coherence tomography (SD-OCT) and automated visual field (VF) tests. Nutritional status was estimated with validated questionnaires. Total antioxidant capacity, extracellular superoxide dismutase (SOD3), catalase (CAT), and glutathione peroxidase (GPx) activities, protein carbonyl adducts (CAR) content, thiobarbituric acid reactive substances (TBARS) formation (as indicator of lipid peroxidation), metabolites of the nitric oxide (NOX) and cytokine (interleukin 6 and tumor necrosis factor alpha) concentrations were assessed by biochemical and immunological techniques in aqueous humor or/and blood. Bayesian approach was performed to determine the probability of an effect. Region of practical equivalence (ROPE) was used. At baseline, Bayesian analysis revealed a high probability of an altered ocular redox status and to a lesser extent systemic redox status in RP patients compared to controls. Twenty-five patients (10 in the treated arm and 15 in the placebo arm) completed the nutritional intervention. After 2 years of supplementation, patients who received NUT presented better retinal responses (mfERG responses) compared to patients who received placebo. Besides, patients who received NUT showed better ocular antioxidant response (SOD3 activity) and lower oxidative damage (CAR) than those who received placebo. This study suggested that long-term NUT supplementation could slow down visual impairment and ameliorate ocular oxidative stress.
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Advanced therapy drugs have emerged in recent years as new pharmacotherapeutic strategies. In this context, hospital pharmacy services have had to adapt to the new challenges posed by the inclusion of advanced therapies in their roster of services against the background of the complex pharmacotherapeutic process patients typically go through.All the activities carried out in the hospital pharmacy services must abide by the rules established in the Spanish legislation and ensure both the quality of the different drugs they manage and the safety of every single patient.Advanced therapy drugs are associated certain peculiarities, including the need to select and evaluate potential candidates to receive them; recourse to financing mechanisms based on risk sharing; and their extreme fragility, which means that the personnel in charge of handling them must be properly trained to maintain their viability and that special storage conditions, involving temperatures below 180 ºC in the case of chimeric antigen receptor T cell therapies, must be maintained. In addition, use of advanced therapy medications in the clinical setting has made it necessary for scientific societies to produce consensus documents recognizing the pivotal role of hospital pharmacists as indispensable members of the multidisciplinary healthcare team and ensuring the same traceability, conservation, custody and pharmacotherapeutical monitoring standards imposed on other drugs to provide for adequate pharmaceutical care. Scientific societies have also highlighted the importance of intensifying clinical research, an essential requirement for the safe incorporation of new therapeutic targets. The present document is intended to describe the challenges pharmacists may face when using advanced therapy drugs at the different stages or processes in the patient's clinical journey.
Los medicamentos de terapia avanzada han emergido en los últimos años como nuevas estrategias farmacoterapéuticas. En este contexto, los servicios de farmacia hospitalaria nos hemos tenido que adaptar al nuevo reto que ha supuesto su inclusión en nuestra cartera de servicios dentro del complejo proceso farmacoterapéutico en el que están inmersos los pacientes. Todas las actividades que se desarrollan en los servicios de farmacia hospitalaria cumplen con una base legal establecida en nuestra legislación y garantizan la calidad y seguridad tanto de los pacientes atendidos como de todos y cada uno de los medicamentos que se gestionan. Los medicamentos de terapia avanzada tienen unas características especiales a considerar que van desde las fases iniciales de selección y evaluación de los pacientes candidatos y su modelo de financiación, basado en riesgo compartido, hasta una fragilidad en su manipulación que requiere de una adecuada y adaptada formación del personal implicado en la logística para mantener su viabilidad, al necesitar unas condiciones de conservación, en ocasiones, a temperaturas de menos 180 ºC, en el caso de las células T con receptores quiméricos de antígenos. Además, la utilización clínica de los medicamentos de terapia avanzada ha necesitado de documentos de consenso de las sociedades científicas que pongan en valor el posicionamiento del farmacéutico hospitalario, como miembro indispensable dentro del equipo multidisciplinar asistencial, y que garanticen, como en cualquier otro medicamento, la trazabilidad, la correcta conservación y custodia y el seguimiento farmacoterapéutico asociado a una adecuada atención farmacéutica de nuestros pacientes, sin olvidar la importancia de la creciente investigación clínica, necesaria e imprescindible para una incorporación segura de nuevas dianas terapéuticas. Por todo ello, consideramos necesario el presente documento, en donde se ponen de manifiesto los retos o necesidades, desde el punto de vista farmacéutico, en cada una de las etapas o procesos a considerar en la utilización de los medicamentos de terapia avanzada dentro de nuestro amplio arsenal terapéutico.
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Antineoplásicos , Serviço de Farmácia Hospitalar , Consenso , Humanos , Conduta do Tratamento Medicamentoso , FarmacêuticosRESUMO
BACKGROUND: Information regarding the impact on healthcare systems of secondary acute myeloid leukemia (sAML) is scarce. METHODS: A retrospective review of medical charts identified patients aged 60-75 years with sAML between 2010 and 2019. Patient information was collected from diagnosis to death or last follow-up. Outpatient resource use, reimbursement, frequency and duration of hospitalization, and transfusion burden were assessed. Forty-six patients with a median age of 64 years were included. Anthracycline plus cytarabine regimens were the most common induction treatment (39 patients, 85%). The ratio of the total days hospitalized between the total follow-up was 29%, with a sum of 204 hospitalizations (average four/patient; average duration 21 days). The total average reimbursement was EUR 90,008 per patient, with the majority (EUR 77,827) related to hospital admissions (EUR 17,403/hospitalization). Most hospitalizations (163, mean 22 days) occurred in the period before the first allogeneic hematopoietic stem cell transplant (alloHSCT), costing EUR 59,698 per patient and EUR 15,857 per hospitalization. The period after alloHSCT (in only 10 patients) had 41 hospitalizations (mean 21 days), and a mean reimbursement cost of EUR 99,542 per patient and EUR 24,278 per hospitalization. In conclusion, there is a high consumption of economic and healthcare resources in elderly patients with sAML receiving active treatments in Spain.
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Introduction: Introduction: amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease. Its symptoms include dysphagia that may make it necessary to place a percutaneous endoscopic gastrostomy (PEG) for feeding. The administration of drugs by PEG can obstruct it, decrease the effectiveness of treatment, and increase the risk of toxicity by altering the original pharmaceutical form. Objective: to describe and analyze the degree of adequacy of the prescription of drugs administered by PEG in patients with ALS and with enteral nutrition (EN). Material and methods: the prescription of pharmacological treatment for patients with ALS who were admitted for placement of a PEG was reviewed. The degree of adequacy of the prescribed drugs was analyzed according to criteria of loss of efficacy, toxicity, risk for handler, and compatibility with EN by consulting the available scientific evidence. Results: the medical prescriptions of the treatments of 34 patients were reviewed, with a total of 307 medications (median of 9 drugs per patient, range 2-17). Via PEG 267 oral medications (median 8 per patient, range 2-15) were prescribed; 81.65 % were solid forms, and the pharmaceutical form was modified in 43 %, due to the risk of catheter occlusion, toxicity or loss of efficacy, affecting 97 % of the patients. Conclusions: patients with ALS and PEG are at risk of presenting safety problems and loss of treatment efficacy related to alteration of the original pharmaceutical form and the interaction with EN.
Introducción: Introducción: la esclerosis lateral amiotrófica (ELA) es una enfermedad neurodegenerativa. Entre sus síntomas destaca la disfagia, que hace necesaria la colocación de una gastrostomía endoscópica percutánea (PEG) para alimentarse. La administración de fármacos por la PEG puede obstruirla, disminuir la eficacia del tratamiento y aumentar el riesgo de toxicidad, al alterar la forma farmacéutica original. Objetivo: describir y analizar el grado de adecuación de la prescripción de fármacos administrados por PEG en pacientes con ELA y con nutrición enteral (NE). Material y métodos: se revisó la prescripción del tratamiento farmacológico de los pacientes con ELA que ingresaban para la colocación de una PEG. Se analizó el grado de adecuación de los fármacos prescritos según los criterios de pérdida de eficacia, toxicidad, riesgo para el manipulador y compatibilidad con la NE, consultando la evidencia científica disponible. Resultados: se revisaron las prescripciones médicas de los tratamientos de 34 pacientes, con un total de 307 medicamentos (mediana de 9 fármacos por paciente; rango, 2-17). Se pautaron por la PEG 267 medicamentos de administración oral (mediana de 8 por paciente; rango, 2-15). El 81,65 % fueron formas sólidas y se modificó la forma farmacéutica en el 43 % por riesgo de oclusión de la sonda, toxicidad o pérdida de eficacia, afectando al 97 % de los pacientes. Conclusiones: los pacientes con ELA y con PEG tienen riesgo de presentar problemas de seguridad y de pérdida de eficacia del tratamiento relacionados con la alteración de la forma farmacéutica original y de la interacción con la NE.
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Esclerose Lateral Amiotrófica , Doenças Neurodegenerativas , Esclerose Lateral Amiotrófica/terapia , Nutrição Enteral , Gastrostomia , Humanos , Preparações FarmacêuticasRESUMO
OBJECTIVES: To analyse the effectiveness and safety of baricitinib for severe COVID-19 in cytokine storm syndrome based on its potential role as an anti-inflammatory immunomodulator and inhibitor of viral endocytosis. METHODS: This was an observational retrospective study of hospitalised patients treated with baricitinib for severe COVID-19. Outcomes were clinical improvement on an ordinal scale of 1-8 on day 1 of baricitinib compared with day 14 (where 8=death and 1=not hospitalised with no limitations of activities), overall survival, time to recovery since baricitinib treatment started (days until hospital discharge) and laboratory parameters related to COVID-19 poor prognosis. Adverse events related to baricitinib during the admission period were also reported. RESULTS: Forty-three patients (70% men, mean age 70 years (IQR 54-79)) treated with baricitinib daily for 6 days (IQR 5-7) were included. Thirty-six patients were treated with corticosteroids (84%). Clinical improvement was 3 points (IQR 1-4) in patients on an ordinal scale of 4-6, overall survival was 100% at day 30 and day 60 with a mean time to recovery of 12 days (IQR 9-25) from start of baricitinib treatment. No adverse events of interest were found and all poor prognosis risk factors improved at day 14: interleukin-6, C-reactive protein, ferritin, lymphocytes, platelets and D-dimers. CONCLUSIONS: Patients treated with baricitinib for severe COVID-19 showed improvements in clinical and analytical values without relevant adverse events and 100% overall survival. Clinical randomised trials are needed to confirm the clinical benefit of baricitinib.
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Tratamento Farmacológico da COVID-19 , Idoso , Azetidinas , Feminino , Humanos , Masculino , Purinas , Pirazóis , Estudos Retrospectivos , SARS-CoV-2 , SulfonamidasRESUMO
AIM: This SR aims to assess the effectiveness of pregabalin and gabapentin on pain and disability caused by acute sciatica and the adverse events associated with their clinical use. DESIGN: Systematic review. DATABASES: Electronic databases of Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and Clinical Trials.gov were searched from their inception until March 1st of 2021. SELECTION CRITERIA: Randomized trials (RCT) with adults>18 years old with acute sciatica for a minimum of 1 week and a maximum of 1 year (at least moderate pain). DATA TREATMENT: The outcomes were pain, disability and adverse events. Data was summarized using odds ratio and mean difference. GRADE was used to calculate the level of evidence. RESULTS: Eight RCT involving 747 participants were included. The effect of pregabalin was assessed in 3 RCT and in one three-arm trial (pregabalin vs limaprost vs a combination of limaprost and pregabalin). Two trials assessed the effect of gabapentin compared with placebo and one compared with tramadol. One study assessed the effect of gabapentin vs pregabalin in a crossover head-to-head trial. A statistically significant improvement on leg pain at 2 weeks and leg pain with movement at 3 and 4 months was found in a RCT comparing gabapentin with placebo. There were no statistically differences on the remaining time periods assessed for leg pain, low back pain and functional disability. CONCLUSIONS: This SR provides clear evidence for lack of effectiveness of pregabalin and gabapentin for sciatica pain management. In view of this, its routine clinical use cannot be supported.
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Dor Lombar , Ciática , Adolescente , Adulto , Analgésicos/efeitos adversos , Gabapentina/efeitos adversos , Humanos , Pregabalina/efeitos adversos , Ciática/complicações , Ciática/tratamento farmacológicoRESUMO
The presence of contamination in the healthcare work environment by one of the types of hazardous drugs, cytostatics, has been found in multiple international studies. Recent studies and guidelines recommend surface monitoring for risk assessment of healthcare professionals' exposure. The availability of detection techniques is critical to successfully carry out this type of monitoring. The use of new semi-quantitative techniques allows quicker results. The main objective of this study was to determine the existence of hazardous drugs on the working surfaces in different locations of a tertiary hospital using the BD HD Check® semi-quantitative device. The presence of methotrexate, doxorubicin and cyclophosphamide was analysed at 80, 89 and 82 locations in 10, 13 and 11 clinical units, respectively. A total of 251 samples were analysed. The monitoring results were positive for 13.1% of the analysed samples, with 36.3% of the methotrexate samples, 0% of the doxorubicin samples and 4.9% of the cyclophosphamide samples. Mapping the presence of HD in our hospital has allowed us to evaluate the effectiveness of controls established in the hospital to minimise the exposure of healthcare professionals to hazardous drugs. The speed in obtaining results has enabled immediate corrective actions in cases where contaminated surfaces were detected.
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Antineoplásicos , Exposição Ocupacional , Antineoplásicos/efeitos adversos , Antineoplásicos/análise , Ciclofosfamida/análise , Doxorrubicina , Monitoramento Ambiental/métodos , Contaminação de Equipamentos , Humanos , Metotrexato/efeitos adversos , Metotrexato/análise , Exposição Ocupacional/análise , Centros de Atenção TerciáriaRESUMO
Type 2 coronavirus pandemics that is plaguing almost all the world has caused qualitative and quantitative strains in health systems that have had to be responded to. The lack of known vaccines and effective treatments has generated the need to use drugs with very little evidence for their incorporation into pharmacotherapeutic protocols agreed by the clinical team. The hospital pharmacist, within the multidisciplinary team, has been responsible for critically evaluating the alternatives and positioning them in these protocols. Finally, some ethical and legal questions that should be considered in this scenario are analyzed in this article.
La pandemia por coronavirus tipo 2 que está azotando prácticamente todo el mundo ha provocado en los sistemas sanitarios tensiones cualitativas y cuantitativas a las que ha habido que dar respuesta. La inexistencia de vacunas y de tratamientos eficaces conocidos ha generado la necesidad de utilizar fármacos con muy escasa evidencia para su incorporación en protocolos farmacoterapéuticos consensuados por el equipo clínico. El farmacéutico de hospital, dentro del equipo multidisciplinar, ha sido en muchas ocasiones el responsable de evaluar críticamente las alternativas para su posicionamiento en estos protocolos. Se analizan en el presente artículo algunas cuestiones éticas y legales que deben ser consideradas en este escenario.
Assuntos
Betacoronavirus , Infecções por Coronavirus , Medicina Baseada em Evidências , Pandemias , Farmacêuticos , Serviço de Farmácia Hospitalar/organização & administração , Comitê de Farmácia e Terapêutica/organização & administração , Pneumonia Viral , COVID-19 , Protocolos Clínicos , Infecções por Coronavirus/tratamento farmacológico , Tratamento Farmacológico/normas , Humanos , Comunicação Interdisciplinar , Uso Off-Label/ética , Uso Off-Label/legislação & jurisprudência , Equipe de Assistência ao Paciente , Serviço de Farmácia Hospitalar/legislação & jurisprudência , Pneumonia Viral/tratamento farmacológico , Guias de Prática Clínica como Assunto , Propaganda , Papel (figurativo) , SARS-CoV-2 , Tratamento Farmacológico da COVID-19RESUMO
The aim of the study was to explore the involvement of interleukin 6 in SARS-CoV-2 infection, and to position the drug siltuximab in the management of severe forms of COVID-19. A bibliographic search was performed in Pubmed on the immune response to the disease, and in ClinicalTrials.gov on clinical trials with interleukin 6 blockers. Interleukin 6 is involved in the cytokine cascade, which originates as a consequence of an excessive immune response secondary to viral infection, aggravating lung affectation. Blockers of this cytokine (tocilizumab, sarilumab and siltuximab) are being studied as a strategy for treating the disease. Siltuximab is a monoclonal antibody indicated in Castleman's disease that could be administered in a single dose of 11 mg/kg in severe forms of COVID-19 that have increased interleukin 6.
Assuntos
Anticorpos Monoclonais/uso terapêutico , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/metabolismo , Interleucina-6/metabolismo , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/metabolismo , COVID-19 , Sistemas de Liberação de Medicamentos , Humanos , PandemiasRESUMO
The addition of a fourth year to the hospital pharmacy residency program has allowed trainees to rotate through various inpatient clinical units where they can, under the supervision of a specialist pharmacist, work shoulder to shoulder with other healthcare providers to ensure that patients receive the care they need. In addition to sharing their pharmacotherapeutic and pharmacokinetic knowledge (among others) with their colleagues, hospital pharmacists can and should contribute with their expertise in the areas of drug evaluation, selection and positioning. As no other healthcare professional masters like a pharmacist the intricacies of treatment efficacy or effectiveness, or of therapeutic safety, conveying this knowledge is yet another of the many clinical activities a hospital pharmacist must perform as a member of a multidisciplinary team, while assisting fellow-team members in deciding what medications are best suited to each patient. Both the public authorities and the pharmaceutical profession as a whole should make sure the pharmacist's role is rightfully valued and given the recognition it deserves.
La especialidad de Farmacia Hospitalaria incorporó con el cuarto año de su programa formativo una parte importante de rotación por unidades clínicas de hospitalización en las que el farmacéutico en formación, acompañado de farmacéuticos especialistas, tiene la oportunidad de trabajar conjuntamente con otros profesionales en la atención directa al paciente. Además de contribuir a esta atención con sus conocimientos de farmacoterapia y farmacocinética, el farmacéutico de hospital puede y debe aportar al equipo su liderazgo en evaluación, selección y posicionamiento de medicamentos. Ningún profesional conoce como él los aspectos relativos a la eficacia o efectividad, seguridad y eficiencia de los tratamientos, y estos conocimientos constituyen una actividad clínica más de las que debe desempeñar en los equipos multidisciplinares, ayudando a la toma de decisiones sobre medicamentos en cada paciente. Es necesario que tanto desde los organismos públicos como desde nuestra propia profesión se ponga en valor este papel y que se potencie de forma adecuada.
Assuntos
Serviço de Farmácia Hospitalar , Avaliação de Medicamentos , Humanos , Equipe de Assistência ao Paciente , Farmacêuticos , Papel ProfissionalRESUMO
OBJECTIVES: The recreational use of drugs of abuse associated to therapeutically used drugs in sexual contexts forces the health care professional to know the possibility of drug-drug interactions among them. The aim of this review is updating the available information on cardiovascular safety of recreational use of sildenafil and cannabis. MATERIALS AND METHODS: A systematic search in databases PubMed, PreMedline, Medline, Embase, ChemID, HSRPROJ, POPLINE and TOXLINE, from the start of the databases until to March 1, 2018 was made. Search terms were "sildenafil", "vardenafil", "tadalafil", "phosphodiesterase inhibitors" and "cannabis", combining and crossing them by means of Boolean operators with "adverse effects" and "cardiovascular". No restrictions for language or type of study were made. RESULTS: Thirteen papers were found, 5out of them analyzed cannabis and sildenafil combination as a new style of recreational non-medical use. Only 3papers related sildenafil-cannabis association with cardiovascular events: one posterior myocardial infarction without Q wave, one myocardial infarction without ST elevation and one acute coronary syndrome. CONCLUSIONS: Severity of sildenafil-cannabis-related cardiovascular events forces the healthcare professionals to take them into account and considering them in clinical pictures of an ischemic cardiomyopathy hard to classify.