Descriptive Analysis of Carrier and Affected Hereditary Fructose Intolerance in Women during Pregnancy.

(1) Background: Hereditary fructose intolerance (HFI) is a rare autosomal recessive metabolic disorder resulting from aldolase B deficiency, requiring a fructose, sorbitol and sucrose (FSS)-free diet. Limited information exists on the relationship between pregnancy outcomes and HFI. This study aims to analyze pregnancy-related factors in a cohort of thirty Spanish women, with twenty-three being carriers and seven being HFI-affected (45 pregnancies). (2) Methods: A descriptive, cross-sectional and retrospective study utilized an anonymous questionnaire. (3) Results: Findings encompassed physical and emotional states, nutritional habits, pathology development and baby information. Notable results include improved physical and emotional states compared to the general population, with conventional analyses mostly within normal ranges. Persistent issues after pregnancy included hepatic steatosis, liver adenomas and hemangiomas. Carrier mothers' babies exhibited higher weight than those of patient mothers, while the weights of carrier children born with HFI were similar to disease-affected children. (4) Conclusions: Pregnant women with HFI did not significantly differ in physical and emotional states, except for nausea, vomiting, and cravings. Post-pregnancy, HFI patients and carriers exhibited persistent hepatic issues. Significantly, babies born to HFI-affected mothers had lower weights. This study sheds light on pregnancy outcomes in HFI, emphasizing potential complications and the need for ongoing monitoring and care.

Design of mobile and website health application devices for drug tolerability in hereditary fructose intolerance.

BACKGROUND: Hereditary fructose intolerance (HFI) is a rare metabolic disease caused by aldolase B deficiency. The aim of our study was to analyse excipient tolerability in patients with HFI and other related diseases and to design mobile and website health applications to facilitate the search for drugs according to their tolerance. RESULTS: A total of 555 excipients listed in the Spanish Medicines Agency database (July 2023) were classified as suitable for HFI patients, suitable with considerations ((glucose and glucose syrup, intravenous sucrose, oral mannitol, polydextrose, gums and carrageenans, ethanol, sulfite caramel and vanilla), not recommended (intravenous mannitol) and contraindicated (fructose, oral sucrose, invert sugar, sorbitol, maltitol, lactitol, isomaltitol, fruit syrups, honey, sucrose esters and sorbitol esters). Glucose and glucose syrup were classified as suitable with considerations due to its possible fructose content and their potential endogenous fructose production. For other related intolerances, wheat starch was contraindicated and oatmeal was not recommended in celiac disease; oral lactose and lactose-based coprocessed excipient (Cellactose®) were not recommended in lactose intolerance; and glucose, invert sugar and oral sucrose were not recommended in diabetes mellitus. The applications were named IntoMed®. Results are listed in order of tolerability (suitable drugs appear first and contraindicated drugs at the end), and they are accompanied by a note detailing their classified excipients. If a drug contains excipients within different categories, the overall classification will be the most restrictive. The apps are also able to classify substances with the same criteria if they act as active ingredients. The tools exhibited good usability (82.07 ± 13.46 points on the System Usability Scale [range: 0-100]) on a sample of HFI patients, their families and health care professionals. CONCLUSIONS: IntoMed® is a tool for finding information about the tolerability of drugs according to excipients for patients with HFI and other related intolerances, with good usability. It is a fast and reliable system that covers the current excipient legislation and expands on it with other specific information: HFI patients should be alert for excipients such as mannitol (especially in intravenous drugs), fruit syrups, honey, sulfite caramel or vanilla. Glucose might contain or produce fructose, and special precaution is needed because of potential errors in their composition.

Vitamin C and folate status in hereditary fructose intolerance.

BACKGROUND: Hereditary fructose intolerance (HFI) is a rare inborn error of fructose metabolism caused by the deficiency of aldolase B. Since treatment consists of a fructose-, sucrose- and sorbitol-restrictive diet for life, patients are at risk of presenting vitamin deficiencies. Although there is no published data on the status of these vitamins in HFI patients, supplementation with vitamin C and folic acid is common. Therefore, the aim of this study was to assess vitamin C and folate status and supplementation practices in a nationwide cohort of HFI patients. METHODS: Vitamin C and folic acid dietary intake, supplementation and circulating levels were assessed in 32 HFI patients and 32 age- and sex-matched healthy controls. RESULTS: Most of the HFI participants presented vitamin C (96.7%) and folate (90%) dietary intake below the recommended population reference intake. Up to 69% received vitamin C and 50% folic acid supplementation. Among HFI patients, 15.6% presented vitamin C and 3.1% folate deficiency. The amount of vitamin C supplementation and plasma levels correlated positively (R = 0.443; p = 0.011). Interestingly, a higher percentage of non-supplemented HFI patients were vitamin C deficient when compared to supplemented HFI patients (30% vs. 9.1%; p = 0.01) and to healthy controls (30% vs. 3.1%; p < 0.001). CONCLUSIONS: Our results provide evidence for the first time supporting vitamin C supplementation in HFI. There is great heterogeneity in vitamin supplementation practices and, despite follow-up at specialised centres, vitamin C deficiency is common. Further research is warranted to establish optimal doses of vitamin C and the need for folic acid supplementation in HFI.

Physicochemical and Microbiological Stability of Two Oral Solutions of Methadone Hydrochloride 10 mg/mL.

In this article, we studied physicochemical and microbiological stability and determined the beyond-use date of two oral solutions of methadone in three storage conditions. For this, two oral solutions of methadone (10 mg/mL) were prepared, with and without parabens, as preservatives. They were packed in amber glass vials kept unopened until the day of the test, and in a multi-dose umber glass bottle opened daily. They were stored at 5 ± 3 °C, 25 ± 2 °C and 40 ± 2 °C. pH, clarity, and organoleptic characteristics were obtained. A stability-indicating high-performance liquid chromatography method was used to determine methadone. Microbiological quality was studied and antimicrobial effectiveness testing was also determined following European Pharmacopoeia guidelines. Samples were analyzed at days 0, 7, 14, 21, 28, 42, 56, 70, and 91 in triplicate. After 91 days of storage, pH remained stable at about 6.5-7 in the two solutions, ensuring no risk of methadone precipitation. The organoleptic characteristics remained stable (colorless, odorless, and bitter taste). The absence of particles was confirmed. No differences were found with the use of preservatives. Methadone concentration remained within 95-105% in all samples. No microbial growth was observed. Hence, the two oral methadone solutions were physically and microbiologically stable at 5 ± 3 °C, 25 ± 2 °C, and 40 ± 2 °C for 91 days in closed and opened amber glass bottles.

Reply letter to the editor concerning the article 'Safety of Sars-Cov-2 vaccines administration for adult patients with hereditary fructose intolerance'.

According to the current European medicines legislation, on the labeling is mandatory a warning contraindicating for hereditary fructose intolerance (HFI) patients medicines with oral or parenteral fructose and sorbitol, and oral sucrose, invert sugar, isomaltitol, lactitol and maltitol, but parenteral sucrose is not mentioned. Intravenous administration of sucrose does not increase blood glucose concentrations, because sucrose is poorly oxidized to CO2 and mainly excreted in the urine as a disaccharide; absence of enzimatic activity outside the gut explains why there is not a warning for parenteral sucrose presentations. For this reason, parenteral drugs with sucrose are allowed in HFI patients. Nevertheless, due to interindividual variability and the fact that not all parenterally administered sucrose is recovered in urine, HFI patients need to be closely monitored after parenteral administration of sucrose-containing drugs, especially when the amount exceeds the maximum permissible thresholds.

Transferrin Isoforms, Old but New Biomarkers in Hereditary Fructose Intolerance.

Hereditary Fructose Intolerance (HFI) is an autosomal recessive inborn error of metabolism characterised by the deficiency of the hepatic enzyme aldolase B. Its treatment consists in adopting a fructose-, sucrose-, and sorbitol (FSS)-restrictive diet for life. Untreated HFI patients present an abnormal transferrin (Tf) glycosylation pattern due to the inhibition of mannose-6-phosphate isomerase by fructose-1-phosphate. Hence, elevated serum carbohydrate-deficient Tf (CDT) may allow the prompt detection of HFI. The CDT values improve when an FSS-restrictive diet is followed; however, previous data on CDT and fructose intake correlation are inconsistent. Therefore, we examined the complete serum sialoTf profile and correlated it with FSS dietary intake and with hepatic parameters in a cohort of paediatric and adult fructosemic patients. To do so, the profiles of serum sialoTf from genetically diagnosed HFI patients on an FSS-restricted diet (n = 37) and their age-, sex- and body mass index-paired controls (n = 32) were analysed by capillary zone electrophoresis. We found that in HFI patients, asialoTf correlated with dietary intake of sucrose (R = 0.575, p < 0.001) and FSS (R = 0.475, p = 0.008), and that pentasialoTf+hexasialoTf negatively correlated with dietary intake of fructose (R = -0.386, p = 0.024) and FSS (R = -0.400, p = 0.019). In addition, the tetrasialoTf/disialoTf ratio truthfully differentiated treated HFI patients from healthy controls, with an area under the ROC curve (AUROC) of 0.97, 92% sensitivity, 94% specificity and 93% accuracy.

Characteristics, complications and outcomes among 1549 patients hospitalised with COVID-19 in a secondary hospital in Madrid, Spain: a retrospective case series study.

OBJECTIVES: To describe demographic, clinical, radiological and laboratory characteristics, as well as outcomes, of patients admitted for COVID-19 in a secondary hospital. DESIGN AND SETTING: Retrospective case series of sequentially hospitalised patients with confirmed SARS-CoV-2, at Infanta Leonor University Hospital (ILUH) in Madrid, Spain. PARTICIPANTS: All patients attended at ILUH testing positive to reverse transcriptase-PCR on nasopharyngeal swabs and diagnosed with COVID-19 between 1 March 2020 and 28 May 2020. RESULTS: A total of 1549 COVID-19 cases were included (median age 69 years (IQR 55.0-81.0), 57.5% men). 78.2% had at least one underlying comorbidity, the most frequent was hypertension (55.8%). Most frequent symptoms at presentation were fever (75.3%), cough (65.7%) and dyspnoea (58.1%). 81 (5.8%) patients were admitted to the intensive care unit (ICU) (median age 62 years (IQR 51-71); 74.1% men; median length of stay 9 days (IQR 5-19)) 82.7% of them needed invasive ventilation support. 1393 patients had an outcome at the end of the study period (case fatality ratio: 21.2% (296/1393)). The independent factors associated with fatality (OR; 95% CI): age (1.07; 1.06 to 1.09), male sex (2.86; 1.85 to 4.50), neurological disease (1.93; 1.19 to 3.13), chronic kidney disease (2.83; 1.40 to 5.71) and neoplasia (4.29; 2.40 to 7.67). The percentage of hospital beds occupied with COVID-19 almost doubled (702/361), with the number of patients in ICU quadrupling its capacity (32/8). Median length of stay was 9 days (IQR 6-14). CONCLUSIONS: This study provides clinical characteristics, complications and outcomes of patients with COVID-19 admitted to a European secondary hospital. Fatal outcomes were similar to those reported by hospitals with a higher level of complexity.

The PANDEMYC Score. An Easily Applicable and Interpretable Model for Predicting Mortality Associated With COVID-19.

This study aimed to build an easily applicable prognostic model based on routine clinical, radiological, and laboratory data available at admission, to predict mortality in coronavirus 19 disease (COVID-19) hospitalized patients. METHODS: We retrospectively collected clinical information from 1968 patients admitted to a hospital. We built a predictive score based on a logistic regression model in which explicative variables were discretized using classification trees that facilitated the identification of the optimal sections in order to predict inpatient mortality in patients admitted with COVID-19. These sections were translated into a score indicating the probability of a patient's death, thus making the results easy to interpret. RESULTS: Median age was 67 years, 1104 patients (56.4%) were male, and 325 (16.5%) died during hospitalization. Our final model identified nine key features: age, oxygen saturation, smoking, serum creatinine, lymphocytes, hemoglobin, platelets, C-reactive protein, and sodium at admission. The discrimination of the model was excellent in the training, validation, and test samples (AUC: 0.865, 0.808, and 0.883, respectively). We constructed a prognostic scale to determine the probability of death associated with each score. CONCLUSIONS: We designed an easily applicable predictive model for early identification of patients at high risk of death due to COVID-19 during hospitalization.

Necesidades sociosanitarias en pacientes con intolerancia hereditaria a la fructosa en España / Social and health care needs in patients with hereditary fructose intolerance in Spain

INTRODUCCIÓN: La intolerancia hereditaria a la fructosa es una enfermedad metabólica debida a una deficiencia en la aldolasa B. Nuestro objetivo es conocer las necesidades sociosanitarias del colectivo. METODOLOGÍA: Estudio observacional prospectivo en el que se difundió una encuesta de necesidades sociosanitarias a pacientes con intolerancia hereditaria a la fructosa residentes en España. RESULTADOS: La mayoría disponían de diagnóstico, confirmado principalmente por análisis genético en menores y sobrecarga de fructosa en adultos, no padecían secuelas (72,34%) ni discapacidad (64%) y el 83,33% de niños tomaban medicamentos frente al 52,38% de adultos (p < 0,05) (2,06 medicamentos de media). La mayoría acudieron a consultas en los dos últimos años, principalmente unidades de enfermedades metabólicas (42,5%) y/o nutricionista (42,5%), aunque menos de la mitad eran atendidos en centros de referencia (mayoritariamente niños [p < 0,05]). El 48% estaban satisfechos con la atención sanitaria aunque se sintieron discriminados en actividades de ocio, escolares, sanitarias y/o cotidianas. Las fuentes más fiables de información fueron el médico de atención especializada (69,39%) y la asociación de pacientes (59,18%). El 54% no indicaron ningún problema en ninguna de las dimensiones de calidad de vida, aunque algunos tuvieron problemas en actividades cotidianas, dolor y ansiedad. CONCLUSIONES: Aunque su perfil no sea tan discapacitante como el de otras enfermedades raras, es importante conocer las necesidades del paciente con intolerancia hereditaria a la fructosa. Aunque se han reducido los tiempos en el diagnóstico, la menor atención y satisfacción sanitaria en adultos hace necesario incidir en las necesidades de esta población, siendo clave la formación e información de los profesionales sanitarios

INTRODUCTION: Hereditary fructose intolerance is a metabolic disease due to an aldolase B deficiency. Our objective was to ascertain the social and health care needs of those with this deficiency. MATERIAL AND METHODS: A prospective, observational study was performed. A survey of social and health care needs was conducted to hereditary fructose intolerance patients living in Spain. RESULTS: Most patients had been diagnosed, mainly by genetic analysis in children and based on fructose overload in adults. Population surveyed had no sequelae (72.34%) or disability (64%), and 83.33% of children and 52.38% of adults were taking drugs (p < .05) (2.06 drugs on average). Most patients had attended medical visits in the past two years, mainly in metabolic disease units (42.5%) and/or nutrition units (42.5%), but less than a half attended reference centers (mostly children [p < 0.05]). Although 48% were satisfied with health care, they felt discriminated in recreational activities, school, health and/or daily activities. The most reliable sources of information were the specialized care physician (69.39%) and patients' association (59.18%). Fifty-five percent reported no problem in any quality of life dimension, although some had problems in daily activities, pain, and anxiety. CONCLUSIONS: Although hereditary fructose intolerance is less disabling than other rare diseases, it is important to know the needs of those who suffer from it. Although time to diagnosis has shortened, the poorer health care and satisfaction with it perceived in adults makes it necessary to emphasize the needs of this population, and the critical need of training and information of health care professionals

Social and health care needs in patients with hereditary fructose intolerance in Spain. / Necesidades sociosanitarias en pacientes con intolerancia hereditaria a la fructosa en España.

INTRODUCTION: Hereditary fructose intolerance is a metabolic disease due to an aldolase B deficiency. Our objective was to ascertain the social and health care needs of those with this deficiency. MATERIAL AND METHODS: A prospective, observational study was performed. A survey of social and health care needs was conducted to hereditary fructose intolerance patients living in Spain. RESULTS: Most patients had been diagnosed, mainly by genetic analysis in children and based on fructose overload in adults. Population surveyed had no sequelae (72.34%) or disability (64%), and 83.33% of children and 52.38% of adults were taking drugs (p <.05) (2.06 drugs on average). Most patients had attended medical visits in the past two years, mainly in metabolic disease units (42.5%) and/or nutrition units (42.5%), but less than a half attended reference centers (mostly children [p <0.05]). Although 48% were satisfied with health care, they felt discriminated in recreational activities, school, health and/or daily activities. The most reliable sources of information were the specialized care physician (69.39%) and patients' association (59.18%). Fifty-five percent reported no problem in any quality of life dimension, although some had problems in daily activities, pain, and anxiety. CONCLUSIONS: Although hereditary fructose intolerance is less disabling than other rare diseases, it is important to know the needs of those who suffer from it. Although time to diagnosis has shortened, the poorer health care and satisfaction with it perceived in adults makes it necessary to emphasize the needs of this population, and the critical need of training and information of health care professionals.

Jarabes de medicamentos: errores en ficha técnica con posibles consecuencias en pacientes con intolerancia hereditaria a la fructosa / Drug syrups: Errors in drug labels with possible consequences in patients with heritary fructose intolerance

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Experiencia autorreferida en pacientes tratados con antivirales directos frente al virus de la hepatitis C / Self-reported experience in patients treated with Hepatitis C direct acting antivirals

Introducción y objetivo: Conocer y analizar la experiencia autorreferida del tratamiento de los pacientes VHC que iniciaron tratamiento con agentes antivirales directos (AAD), a tiempo real, de forma proactiva e integrada en el proceso asistencial de atención farmacéutica. Material y métodos: Estudio observacional y transversal desarrollado entre abril (inicio del Plan Estratégico Nacional) y diciembre de 2015 en la Consulta Externa del Servicio de Farmacia. Se utilizó como herramienta un cuestionario prospectivo cumplimentado por los pacientes donde se recogieron variables relacionadas con la calidad de vida vinculadas con la salud (CVRS), adherencia, efectos adversos (EA), satisfacción con el tratamiento, y valoración y utilidad del programa formativo implementado por el Servicio de Farmacia. Se realizó un análisis descriptivo de todas las variables incluidas en el estudio y se analizó la influencia de las diferentes variables en el grado de adherencia y CVRS. El análisis de las diferencias entre los dos grupos se realizó mediante el test de chi cuadrado y el cálculo de las OR con un modelo de regresión logística simple. Se utilizó el programa SPSS® versión 20, y se estableció una significación estadística para valores de p < 0,05. Resultados: Se recogieron155 encuestas de las 226 enviadas, tasa de respuesta del 68,6%.En referencia a la CVRS (valoración del estado físico y emocional), un 38,7% de los pacientes refieren que su estado físico y emocional es mucho mejor desde el inicio del tratamiento. La presencia de EA y una peor información global de su enfermedad se asoció con un peor estado físico y emocional (p < 0,05). La adherencia reportada fue del 84,5% y el tratamiento fue valorado como muy bueno o bueno por el 87% de los pacientes. Un 52,9% de los pacientes no tuvieron efectos adversos relacionados con la medicación y el proceso formativo realizado por el farmacéutico especialista en la primera consulta fue valorado por el 96,7% de los pacientes como muy bueno o bueno. Conclusiones: La experiencia autorreferida obtenida a través de un contacto directo y permanente con los pacientes permite obtener información sobre aspectos importantes del tratamiento. Creemos que estas herramientas deben incorporarse a los procedimientos de atención farmacéutica como una forma de mantener la continuidad. Además, inducen al paciente a una autoevaluación de diversos aspectos de su propio tratamiento, que pueden ayudar a conseguir una mayor implicación en el mismo y contribuir a conseguir el máximo resultado en salud posible de la farmacoterapia (AU)

Background and objective: To learn about and analyze the self-reported treatment experience of HCV patients who started treatment with direct acting antivirals agents (DAA), at a real-time, proactive and integrated into the pharmaceutical care healthcare process, using a prospective questionnaire completed by patients as clinical tool. Material and methods: Observational and cross-sectional study conducted between April (start of the National Strategic Plan) and December 2015 in the Outpatient Pharmacy Service. The questionnaire includes variables related to health related quality of life (HRQOL), adherence, adverse effects (AEs), satisfaction, and usefulness of the Pharmacy Service implemented training program. A descriptive analysis of all variables included in the study was conducted and the influence of different variables analyzed in the degree of adherence and HRQOL. The analysis of the differences was performed using chi-square test and simple logistic regression model for calculation of OR. We use SPSS version 20 program and statistical significance for values of p < 0.05 was considered. Results: 155 of the 226 surveys returned, with a response rate of 68.6%. Referring to the HRQOL (evaluation of physical and emotional state), 38.7% of patients reports that their physical and emotional state is much better from the start of treatment. The presence of EA and worse global information of their disease was associated with worse physical and emotional state (p < 0.05). Reported adherence was 84.5% and the treatment was evaluated as very good or good by 87% of patients. 52.9% had no adverse effects related to the medication and the training process performed by the specialist pharmacist at the first visit 96.7% of patients assessed as very good or good. Conclusions: Self-reported experience acquired through direct and constant contact with patients provides information on important aspects of treatment. We believe that these tools should be incorporated into pharmaceutical care procedures as a way to maintain continuity in patients direct contact. They also induce patients to a self-assessment of various aspects of their own treatment, which can help achieve greater involvement in it and can contribute to achieve the maximum health outcome in pharmacotherapy (AU)

[Self-reported experience in patients treated with Hepatitis C direct acting antivirals]. / Experiencia autorreferida en pacientes tratados con antivirales directos frente al virus de la hepatitis C.

BACKGROUND AND OBJECTIVE: To learn about and analyze the self-reported treatment experience of HCV patients who started treatment with direct acting antivirals agents (DAA), at a real-time, proactive and integrated into the pharmaceutical care healthcare process, using a prospective questionnaire completed by patients as clinical tool. MATERIAL AND METHODS: Observational and cross-sectional study conducted between April (start of the National Strategic Plan) and December 2015 in the Outpatient Pharmacy Service. The questionnaire includes variables related to health related quality of life (HRQOL), adherence, adverse effects (AEs), satisfaction, and usefulness of the Pharmacy Service implemented training program. A descriptive analysis of all variables included in the study was conducted and the influence of different variables analyzed in the degree of adherence and HRQOL. The analysis of the differences was performed using chi-square test and simple logistic regression model for calculation of OR. We use SPSS version 20 program and statistical significance for values of p < 0.05 was considered. RESULTS: 155 of the 226 surveys returned, with a response rate of 68.6%. Referring to the HRQOL (evaluation of physical and emotional state), 38.7% of patients reports that their physical and emotional state is much better from the start of treatment. The presence of EA and worse global information of their disease was associated with worse physical and emotional state (p < 0.05). Reported adherence was 84.5% and the treatment was evaluated as very good or good by 87% of patients. 52.9% had no adverse effects related to the medication and the training process performed by the specialist pharmacist at the first visit 96.7% of patients assessed as very good or good. CONCLUSIONS: Self-reported experience acquired through direct and constant contact with patients provides information on important aspects of treatment. We believe that these tools should be incorporated into pharmaceutical care procedures as a way to maintain continuity in patients direct contact. They also induce patients to a self-assessment of various aspects of their own treatment, which can help achieve greater involvement in it and can contribute to achieve the maximum health outcome in pharmacotherapy.

Introducción y objetivo: Conocer y analizar la experiencia autorreferida del tratamiento de los pacientes VHC que iniciaron tratamiento con agentes antivirales directos (AAD), a tiempo real, de forma proactiva e integrada en el proceso asistencial de atención farmacéutica. Material y métodos: Estudio observacional y transversal desarrollado entre abril (inicio del Plan Estratégico Nacional) y diciembre de 2015 en la Consulta Externa del Servicio de Farmacia. Se utilizó como herramienta un cuestionario prospectivo cumplimentado por los pacientes donde se recogieron variables relacionadas con la calidad de vida vinculadas con la salud (CVRS), adherencia, efectos adversos (EA), satisfacción con el tratamiento, y valoración y utilidad del programa formativo implementado por el Servicio de Farmacia. Se realizó un análisis descriptivo de todas las variables incluidas en el estudio y se analizó la influencia de las diferentes variables en el grado de adherencia y CVRS. El análisis de las diferencias entre los dos grupos se realizó mediante el test de chi cuadrado y el cálculo de las OR con un modelo de regresión logística simple. Se utilizó el programa SPSS® versión 20, y se estableció una significación estadística para valores de p < 0,05. Resultados: Se recogieron155 encuestas de las 226 enviadas, tasa de respuesta del 68,6%.En referencia a la CVRS (valoración del estado físico y emocional), un 38,7% de los pacientes refieren que su estado físico y emocional es mucho mejor desde el inicio del tratamiento. La presencia de EA y una peor información global de su enfermedad se asoció con un peor estado físico y emocional (p < 0,05). La adherencia reportada fue del 84,5% y el tratamiento fue valorado como muy bueno o bueno por el 87% de los pacientes. Un 52,9% de los pacientes no tuvieron efectos adversos relacionados con la medicación y el proceso formativo realizado por el farmacéutico especialista en la primera consulta fue valorado por el 96,7% de los pacientes como muy bueno o bueno. Conclusiones: La experiencia autorreferida obtenida a través de un contacto directo y permanente con los pacientes permite obtener información sobre aspectos importantes del tratamiento. Creemos que estas herramientas deben incorporarse a los procedimientos de atención farmacéutica como una forma de mantener la continuidad. Además, inducen al paciente a una autoevaluación de diversos aspectos de su propio tratamiento, que pueden ayudar a conseguir una mayor implicación en el mismo y contribuir a conseguir el máximo resultado en salud posible de la farmacoterapia.

Cross-cultural Adaptation and Validation of the Medication Regimen Complexity Index Adapted to Spanish.

BACKGROUND: The most widely used validated instrument to assess the complexity of medication regimens is the Medication Regimen Complexity Index (MRCI). OBJECTIVE: This study aimed to translate, adapt, and validate a reliable version of the MRCI adapted to Spanish (MRCI-E). METHODS: The cross-cultural adaptation process consisted of an independent translation by 3 clinical pharmacists and a backtranslation by 2 native English speakers. A reliability analysis was conducted on 20 elderly randomly selected patients. Two clinical pharmacists calculated the MRCI-E from discharge treatments and 2 months later. For the validity analysis, the sample was augmented to 60 patients. Convergent validity was assessed by analyzing the correlation between the number of medications; discriminant validity was stratified by gender; and predictive validity was determined by analyzing the ability to predict readmission and mortality at 3 and 6 months. RESULTS: The MRCI-E retained the original structure of 3 sections. The reliability analysis demonstrated an excellent internal consistency (Cronbach's α=0.83), and the intraclass correlation coefficient exceeded 0.9 in all cases. The correlation coefficient with the number of medications was 0.883 ( P<0.001). No significant differences were found when stratified by gender (3.6; 95%CI=-2.9 to 10.2; P=0.27). Patients who were readmitted at 3 months had a higher MRCI-E score (10.7; 95%CI=4.4 to 17.2; P=0.001). The differences remained significant in patients readmitted at 6 months, but differences in mortality were not detected. CONCLUSIONS: The MRCI-E retains the reliability and validity of the original index and provides a suitable tool to assess the complexity of medication regimens in Spanish.