ABSTRACT
Introducción: El fracaso de la terapia con biológicos en la enfermedad inflamatoria intestinal (EII) es un problema común. La monitorización farmacocinética es una herramienta que podría permitir optimizar estos tratamientos mediante la individualización de la posología en los diferentes escenarios clínicos. Objetivo: Describir las determinaciones de concentraciones séricas de infliximab y adalimumab en pacientes con EII y evaluar el impacto de las recomendaciones farmacocinéticas en la toma de decisiones clínicas y la evolución de los pacientes.Métodos: Estudio trasversal observacional retrospectivo de dos años de duración (2017-2018) de las determinaciones de inhibidores del factor de necrosis tumoral (anti-TNF) realizadas en pacientes del Servicio de Medicina Digestiva de un hospital general. Resultados: Se realizaron 133 determinaciones correspondientes a 66 sujetos (38% tratados con adalimumab; 62% infliximab). El principal motivo de monitorización (>55%) fue la presencia de enfermedad activa. Más de la mitad de los pacientes tenían concentraciones fuera del intervalo terapéutico (el 51% de adalimumab y 37% de infliximab presentaban una exposición subóptima). La recomendación de mantener la pauta posológica previa se propuso en <40% de los informes farmacocinéticos, siendo el grado de aceptación de la recomendación superior al 80% en todos los casos. Los datos analíticos de inflamación se redujeron tras la monitorización sin mostrar significación estadística en todos los casos.Conclusión: La mayoría de pacientes con EII tratados con anti-TNF presentan concentraciones de fármaco inadecuadas. La monitorización ha demostrado ser una herramienta útil para guiar la toma de decisiones terapéuticas y podría contribuir en la mejora de los parámetros clínicos de estos pacientes. (AU)
Introduction: The failure of biologic therapy in inflammatory bowel disease (IBD) is a common problem. The pharmacokinetic monitoring is a useful tool that allows to optimize these treatments.Objective: To describe the pharmacokinetic determinations of plasma concentrations of infliximab and adalimumab in patients with IBD and evaluate its impact on clinical decision.Method: Retrospective, observational study of two years duration (2017-2018) of the tumor necrosis factor (anti-TNF) inhibitor determinations performed in patients of the Digestive Service of a general hospital.Results: A total of 133 determinations were obtained about 66 subjects (38% adalimumab, 62% infliximab). The main reason (>55%) of the request for monitoring was the presence of active disease. More than half of the patients had concentrations outside the therapeutic range (51% of patients with adalimumab and 37% of those with infliximab had plasma levels below the lower range considered suboptimal). The maintenance of the previous dosage was recommended only in <40% of the monitoring and the degree of acceptance of the interventions were more than 80% in all cases. The analytical data of inflammation were reduced after monitoring without showing statistical significance in all cases.Conclusion: Standard anti-TNF regimen was not adequate to obtain range concentrations in more than half of analyzed cases. Monitoring has proven to be very useful in supporting clinical decision and it may promote an improvement in the clinical parameters of patients with IBD. (AU)
Subject(s)
Humans , Inflammatory Bowel Diseases , Drug Monitoring , Infliximab , Adalimumab , Antibodies, MonoclonalABSTRACT
Objective: To measure the indirect adherence of patients with multiple sclerosis (MS) to their pharmacological treatments, comparing medication for the disease itself with the other concomitant treatments that have been chronically prescribed.Methods: A cross-sectional, descriptive (November 2018) study at the Pharmacy Department of a spanish secondary hospital in Valencian Community. Study population is all those patients diagnosed with MS in its different variants, who are being treated with hospital dispensing drugs for a minimum of six months at the time of the study. The variable evaluated was the percentage of adherence of patients to their medication, which has been measured as the ratio between the doses of prescribed drugs and those dispensed; considering adherent to all patients with a percentage equal to or higher than 80%.Results: The study included 86 patients from the Pharmacy External Outpatient Unit. The average exposure time to drugs was 198.7±27.9 days, where the adherence to treatment of multiple sclerosis was 98.1±6.6% and that of the rest of the chronic medication concomitant 92.8±19.5%.Conclusions: Adherence to pharmacological treatments in this population has been very high. Patients have shown greater adherence to drugs dispensed at Pharmacy External Outpatient Unit, possibly because they consider the rest of medication less important and/or to treat milder comorbidities or pathologies. (AU)
Objetivos: Evaluar la adherencia indirecta de los pacientes con esclerosis múltiple (EM) a sus tratamientos farmacológicos, comparando la medicación para esta enfermedad entre los diferentes fármacos, y con el resto de tratamientos concomitantes prescritos por el médico de manera crónica.Material y métodos: Estudio descriptivo transversal (noviembre 2018) en el Servicio de Farmacia de un hospital secundario español de la Comunidad Valenciana. La población de estudio son todos aquellos pacientes diagnosticados con EM en sus diferentes variantes, que están siendo tratados con medicamentos dispensados desde el hospital, durante un periodo mínimo de seis meses. La variable evaluada fue el porcentaje de adherencia de los pacientes a su medicación, que se midió como la relación entre las dosis de los medicamentos prescritos y aquellos dispensados; considerando adherente a todos los pacientes con un porcentaje igual o superior al 80%.Resultados: Se incluyó a 86 pacientes desde la Unidad de Pacientes Externos del Servicio de Farmacia. El tiempo promedio de exposición a los fármacos para la EM fue de 198,7±27,9 días, observando una adherencia al tratamiento de 98,1±6,6% y una adherencia al resto de la medicación crónica concomitante de 92,8±19,5%.Conclusiones: La adherencia a los tratamientos farmacológicos en esta población ha sido muy alta. Los pacientes han mostrado una mayor adherencia a los medicamentos dispensados en la Unidad de Pacientes Externos del Servicio de Farmacia, posiblemente porque consideran que el resto de la medicación es menos importante y/o para tratar comorbilidades o patologías más leves. (AU)
Subject(s)
Humans , Multiple Sclerosis , Treatment Adherence and Compliance , Primary Health Care , PharmacyABSTRACT
OBJECTIVE: A rapid, simple and sensitive high-performance liquid chromatography (HPLC) method with ultraviolet detection has been developed for quantification of darunavir and raltegravir in their pharmaceutical dosage form. METHODS: The assay enables the measurement of both drugs with a linear calibration curve (R2= 0.999) over the concentration range 5-100 mg/L. The determination was performed on an analytical Tracer Excel 120 ODSB (15x0.4.6 cm) column at 35ºC. The selected wavelength was 254 nm. The mobile phase was a mixture of 0.037 M sodium dihydrogen phosphate buffer, acetonitrile and methanol (40:50:10, v/v/v) at a flow rate of 2.0 mL/min Nevirapine (50 mg/L) was used as internal standard. RESULTS: Accuracy, intra-day repeatability (n = 5), and inter-day precision (n = 3) were found to be satisfactory, being the accuracy from -4.33 to 3.88% and precisions were intra-day and inter-day, 0.25% and 4.42% respectively in case of darunavir. Raltegravir intra-day and inter-day precisions lower of 1.01 and 2.36%, respectively and accuracy values bet from -4.02 to 1.06%. CONCLUSIONS: Determination of the darunavir and raltegravir in their dosage form was done with a maximum deviation of 4%. This analytical method is rapid, easily implantable and offers good results.
Subject(s)
Anti-HIV Agents/analysis , Darunavir/analysis , Raltegravir Potassium/analysis , Calibration , Chromatography, High Pressure Liquid , Dosage Forms , Drug Combinations , Limit of Detection , Reference Standards , Reproducibility of Results , Sensitivity and Specificity , Spectrophotometry, UltravioletABSTRACT
OBJECTIVE: To estimate the acceptance of the pharmaceutical intervention in controlling duration of antimicrobial therapy and to evaluate their impact on optimizing the treatment. METHODS: Prospective observational study for two years in a General University Hospital. For the patients record, we followed non critical adult patients with antibiotic treatment. When the duration of antimicrobial treatment not complied with established criteria for each antibiotic and pathology, there was a communication with the physician, at which is recommended to assess the need for continue treatment. The acceptance of pharmaceutical intervention was collected and afterwards we analyzed the impact of this work by antimicrobial consumption and incidence of Clostridium difficile. RESULTS: . In 122 patients the pharmacist made a pharmaceutical intervention due to prolonged antibiotic treatment. The most prevalent antibiotics were ß-lactams, specifically meropenem. The intravenous administration was more frequent. In 77 cases it was decided to recommend the suspension of treatment, we conducted an orally prospective intervention at 70.15 % and the rest of interventions were written. Acceptance was 65.95 % and 65.00%, respectively. During the study period, the DDD of the antimicrobials decreased by 8.89% and expenditure on antimicrobials one 40.12%. The incidence of C. difficile was stable. CONCLUSIONS: . In a hospital, a pharmaceutical counselling program on the duration of antimicrobial therapy is well accepted by the prescriber physician, but it must be improved. The route of information does not affect the degree of acceptance. These actions could involve a reduction of antimicrobial consumption.
