Impact of Penicillin Allergy Label on Length of Stay and Mortality in Hospitalized Patients through a Clinical Administrative National Dataset.

BACKGROUND: Penicillin allergy is a common problem in the management of infectious diseases. The aim of this study was to determine the impact of penicillin allergy on length of hospital stay (LOHS) among hospitalized adult patients and on in-hospital mortality at a national level. METHODS: A retrospective cohort study of adult patients discharged from the Spanish Hospital System between 2006 and 2015 was conducted using the Minimum Basic Data Set (MBDS). We compared LOHS and in-hospital mortality of adult patients whose records contained penicillin allergy code V14.0 (International Classification of Diseases, Ninth Revision, Clinical Modification) as a secondary diagnosis, with a random sample without such a code. RESULTS: We identified 981,291 admissions with code V14.0, which corresponded to 2.63% of all hospitalizations. Adults patients with a penicillin allergy label were significantly older than patients without such a label, with a median of 70 years (interquartile range [IQR]: 51-80) versus 63 years (IQR: 40-77). The proportion of women and the prevalence of infectious diseases were higher in the group with a penicillin allergy label (61.40% vs. 53.84%; 34.04% vs. 30.01%; respectively). We found a higher median Elixhauser-Van Walraven score in hospitalized patients with an allergy label. The median LOHS for hospitalizations with a penicillin allergy label (5 [IQR: 2-9]) was significantly longer than that in those without such a label (4 [IQR: 2-9]). Multivariate analysis showed an increase in LOHS due to the penicillin allergy label (odds ratio [OR] [95% confidence interval [CI]: 1.061 [1.057-1.065]) and a decrease in mortality in penicillin allergy records (OR [95% CI]: 0.834 [0.825-0.844]). CONCLUSION: In our study, the prevalence of a penicillin allergy label in hospitalized patients, using the MBDS, is low. Hospitalizations with an allergy label was associated with a longer LOHS. However, penicillin-allergic patients did not show higher mortality rates. Inaccurate reporting of penicillin allergies may have an impact on healthcare resources.

Coordinated assistance plan for the elimination of hepatitis C virus at the centro de ayuda integral al drogodependiente (CAID (Comprehensive Care Centre for Drug Addicts)). / Plan asistencial coordinado para la eliminación del virus de la hepatitis C en el centro de ayuda integral al drogodependiente (CAID).

INTRODUCTION: The drug-injecting population has a high prevalence of hepatitis C virus (HCV) and high risk of transmission. It is a priority to establish an agile diagnostic and treatment plan. OBJECTIVES: 1) Assess the effectiveness of a new coordinated care plan of referral from the Comprehensive Care Centre for Drug Addicts (CAID) to specialised care and 2) Determine the prevalence of HCV, clinical characteristics, effectiveness and safety of treatment in this population. METHODS: 1,300 serologies requested by the CAID between 1998 and 2018 were retrospectively analysed, the seroprevalence of HCV was calculated and the efficiency of the traditional CAID-specialised care referral system was evaluated. A care plan was designed and coordinated among specialists involved in diagnosis and treatment. Since October 2018, 11 patients have been included in the new plan and the performance of both referral systems was compared. RESULTS: With the traditional system, 48.2% (83/172) of the patients were lost. 14.5% (172/1,300) presented positive HCV serology, compared to the general population OR = 19; 95% CI 14.3-25. The prevalence of active infection was 80.3% (90/112). The prevalence of active infection was 80.3% (90/112). Of the 11 patients referred by the new plan, 76.9% (8/11) had active infection and 100% (8/8) were treated with Direct Antiviral Agents successfully. CONCLUSIONS: The new coordinated CAID-specialised care plan presents high effectiveness in comparison with the traditional referral system. The seroprevalence and prevalence of active infection in the CAID population is very high. Treatments with Direct Antiviral Agents are effective and safe.

Response to inhaled granulocyte-macrophage colony-stimulating factor in patient with mild-to-moderate autoimmune pulmonary alveolar proteinosis-24 months of follow-up.

INTRODUCTION: Autoimmune pulmonary alveolar proteinosis (aPAP) is a disease caused by IgG antibodies against granulocyte-macrophage colony-stimulating factor (GM-CSF). Whole lung lavage (WLL) allows to remove the lipo-proteinaceous material accumulated by the poor clearance of alveolar surfactant. However, it is a complex technique that is not exempt from complications, and in some cases, the patients are refractory, requiring the performance of several WLLs spaced apart in time. MATERIALS AND METHODS: We present the clinical, functional, and radiological evolution after 24 months of follow-up of a patient diagnosis of aPAP refractory to WLL, with performed three therapeutic WLLs spaced 16 and 36 months and serious potentially fatal complications in the last one. RESULTS AND DISSCUSION: After 24 months, no adverse effects have appeared and the great clinical, functional and radiological response is maintained. The patient has been successfully treated with inhaled recombinant human GM-CSF sargramostim.

[Translated article] Analysis of the degree of implementation of medication error prevention practices in Spanish hospitals (2022).

OBJECTIVE: To assess the degree of implementation of medication error prevention practices in Spanish hospitals. METHOD: Descriptive multicenter study of the degree of implementation of the safety practices included in the "Medication use-system safety self-assessment for hospitals. Version. II". Spanish hospitals that completed the questionnaire between October, 2021 and September, 2022 participated. The survey contains 265 items for evaluation grouped into 10 key elements. Mean score and mean percentages based on the maximum possible values for the overall survey, for the key elements, and for each individual item of evaluation were calculated. The results were compared with those of the previous 2011 study. RESULTS: A total of 131 hospitals from 15 autonomous regions participated in the study. The mean score of the overall questionnaire in all hospitals was 898.2 (57.4% of the maximum possible score). No differences were found according to dependency, size, or type of hospital, either in the overall questionnaire or in the key elements. The lowest values were found for key elements VIII, I and VI, on competence and training of health professionals in safety practices (45.1%), availability and accessibility of essential information on patients (48%), and devices for administering drugs (52.3%). With respect to 2011, significant increases were found both in the overall questionnaire and in the key elements, except V and VII, referring to standardization, storage, and distribution of medications, and environmental factors and human resources. Several evaluation items on the safe management of high-risk drugs, medication reconciliation, incorporation of clinical pharmacists into the healthcare teams, and implementation of technologies that allow full traceability throughout the medication system, showed low percentages. CONCLUSIONS: There has been appreciable progress in the degree of implementation of some medication error prevention practices in Spanish hospitals, but many proven efficacy practices recommended by the World Health Organization and safety organizations are still poorly implemented. The information obtained can be useful for prioritizing the practices to be addressed and as a new baseline for monitoring progress.

Analysis of the degree of implementation of medication error prevention practices in Spanish hospitals (2022). / Análisis del grado de implantación de las prácticas de prevención de errores de medicación en los hospitales españoles (2022).

OBJECTIVE: To assess the degree of implementation of medication error prevention practices in Spanish hospitals. METHOD: Descriptive multicenter study of the degree of implementation of the safety practices included in the "Medication use-system safety self-assessment for hospitals. Version. II". Spanish hospitals that completed the questionnaire between October/2021 and September/2022 participated. The survey contains 265 items for evaluation grouped into 10 key elements. Mean score and mean percentages based on the maximum possible values for the overall survey, for the key elements and for each individual item of evaluation were calculated. The results were compared with those of the previous 2011 study. RESULTS: A total of 131 hospitals from 15 autonomous regions participated in the study. The mean score of the overall questionnaire in all hospitals was 898.2 (57.4% of the maximum possible score). No differences were found according to dependency, size or type of hospital, either in the overall questionnaire or in the key elements. The lowest values were found for key elements 8, 1 and 6, on competence and training of health professionals in safety practices (45.1%), availability and accessibility of essential information on patients (48%), and devices for administering drugs (52.3%). With respect to 2011, significant increases were found both in the overall questionnaire and in the key elements, except 5 and 7, referring to standardization, storage and distribution of medications, and environmental factors and human resources. Several evaluation items on the safe management of high-risk drugs, medication reconciliation, incorporation of clinical pharmacists into the healthcare teams and implementation of technologies that allow full traceability throughout the medication system, showed low percentages CONCLUSIONS: There has been appreciable progress in the degree of implementation of some medication error prevention practices in Spanish hospitals, but many proven efficacy practices recommended by the World Health Organization and safety organizations are still poorly implemented. The information obtained can be useful for prioritizing the practices to be addressed and as a new baseline for monitoring progress.

Comparison of Three Comorbidity Measures for Predicting In-Hospital Death through a Clinical Administrative Nacional Database.

BACKGROUND: Various authors have validated scales to measure comorbidity. However, the prognosis capacity variation according to the comorbidity measurement index used needs to be determined in order to identify which is the best predictor. AIMS: To quantify the differences between the Charlson (CCI), Elixhauser (ECI) and van Walraven (WCI) comorbidity indices as prognostic factors for in-hospital mortality and to identify the best comorbidity measure predictor. METHODS: A retrospective observational study that included all hospitalizations of patients over 18 years of age, discharged between 2017 and 2021 in the hospital, using the Minimum Basic Data Set (MBDS). We calculated CCI, ECI, WCI according to ICD-10 coding algorithms. The correlation and concordance between the three indices were evaluated by Spearman's rho and Intraclass Correlation Coefficient (ICC), respectively. The logistic regression model for each index was built for predicting in-hospital mortality. Finally, we used the receiver operating characteristic (ROC) curve for comparing the performance of each index in predicting in-hospital mortality, and the Delong method was employed to test the statistical significance of differences. RESULTS: We studied 79,425 admission episodes. The 54.29% were men. The median age was 72 years (interquartile range [IQR]: 56-80) and in-hospital mortality rate was 4.47%. The median of ECI was = 2 (IQR: 1-4), ICW was 4 (IQR: 0-12) and ICC was 1 (IQR: 0-3). The correlation was moderate: ECI vs. WCI rho = 0.645, p < 0.001; ECI vs. CCI rho = 0.721, p < 0.001; and CCI vs. WCI rho = 0.704, p < 0.001; and the concordance was fair to good: ECI vs. WCI Intraclass Correlation Coefficient type A (ICCA) = 0.675 (CI 95% 0.665-0.684) p < 0.001; ECI vs. CCI ICCA = 0.797 (CI 95% 0.780-0.812), p < 0.001; and CCI vs. WCI ICCA = 0.731 (CI 95% 0.667-0.779), p < 0.001. The multivariate regression analysis demonstrated that comorbidity increased the risk of in-hospital mortality, with differences depending on the comorbidity measurement scale: odds ratio [OR] = 2.10 (95% confidence interval [95% CI] 2.00-2.20) p > |z| < 0 using ECI; OR = 2.31 (CI 95% 2.21-2.41) p > |z| < 0 for WCI; and OR = 2.53 (CI 95% 2.40-2.67) p > |z| < 0 employing CCI. The area under the curve [AUC] = 0.714 (CI 95% 0.706-0.721) using as a predictor of in-hospital mortality CCI, AUC = 0.729 (CI 95% 0.721-0.737) for ECI and AUC = 0.750 (CI 95% 0.743-0.758) using WCI, with statistical significance (p < 0.001). CONCLUSION: Comorbidity plays an important role as a predictor of in-hospital mortality, with differences depending on the measurement scale used, the van Walraven comorbidity index being the best predictor of in-hospital mortality.

2019 SEFH National Survey: service portfolio, care activities, education and research in Spain's hospital pharmacy departments.

OBJECTIVE: To report on the results obtained from the 2019 SEFH National Survey regarding the service portfolio, care activities, training  programs and research work of Spanish hospital pharmacy departments. METHOD: In March 2019, SEFH designed and distributed a questionnaire containing 77 questions grouped into 8 domains to its 368  affiliated hospital pharmacy departments. The questionnaire included an  additional section on the activities carried out in 2017 and 2018. RESULTS: The overall response rate was 54.3%. Sixty-nine percent of hospitals were public and 75% were general hospitals. A total of 88.6% of hospital pharmacy departments provided pharmaceutical care to inpatients, whereas 77.5% and 65% treated outpatients and  ambulatory patients, respectively. Sterile formulations were prepared by  70.6% of pharmacy departments, while 12% measured drug levels in  bodily fluids; 76.9% of hospitals with more than 1,000 beds prepared  pharmacokinetic reports. In 2018, hospital pharmacies provided for a  mean of 929 patients a month and 2,680 a year. The amount of  formulations (sterile and non-sterile) prepared was 10,394,492, sterile  formulations accounting for 62.6%. The average amount of clinical trials  managed in hospitals with ≥ 500 and ≥ 1000 beds was of 186.2 and  421.8, respectively. The median of number of undergraduate tuition  agreements between pharmacy departments and universities was 1 (IQR:  0-2); 21.5% of pharmacy departments had no agreements with any  university. The mean number of undergraduate pharmacy students per  hospital pharmacy was 4.12 (SD: 8,26). A total of 290 pharmacists were  associate professors at some university. Fifteen percent of pharmacists  held a certification from the Board of Pharmacy Specialties, 55.3% of them in the specialty of oncology. Hospital pharmacy departments employed a  mean of 1.31(SD: 2,23) PhD holders. From those which reported the  impact factor of their publications, 60% had an impact factor of zero while  in 19.6% the impact factor was ≥ 10. CONCLUSIONS: Care of out-patients and medication compounding are increasingly the main activities performed in Spanish hospital  pharmacies, while there is still considerable room for improvement in the  area of clinical pharmacokinetics. Pharmacy departments are generally  committed to training as a key activity, while scientific output is still limited despite the increase in the number of PhD pharmacist.

Objetivo: Dar a conocer los resultados referentes a la cartera de servicios y actividad asistencial, docente e investigación de la encuesta nacional de la Sociedad de Farmacia Hospitalaria (SEFH) 2019 en los Servicios de Farmacia Hospitalaria españoles.Método: En marzo de 2019 se elaboró y envió un cuestionario con 77  preguntas agrupadas en ocho dimensiones a los 368 Servicios de Farmacia  Hospitalaria registrados en la SEFH, con un bloque adicional sobre actividad desarrollada en 2017 y 2018.Resultados: La tasa global de respuesta fue 54,3%. El 69% de los hospitales eran públicos y el 75% generales. El 88,6% de los Servicios de Farmacia Hospitalaria realizaban atención farmacéutica en  pacientes ingresados, y el 77,5% y el 65% en pacientes externos y  ambulantes, respectivamente. Se elaboraban preparados estériles en el  70,6% de los Servicios de Farmacia Hospitalaria. Se determinaban niveles  de medicamentos en el 12% y se efectuaban informes farmacocinéticos en el 76,9% de los hospitales con ≥ 1.000 camas. Los Servicios de Farmacia Hospitalaria atendieron en 2018 a una media de 929 pacientes al mes y 2.680 al año. El número de elaboraciones estériles y no estériles fue de 10.394.492, representando las estériles el 62,6%. La media de ensayos clínicos gestionados en los hospitales con más de 500 y 1.000 camas fue  de 186,2 y 421,8, respectivamente. La mediana de convenios docentes de  pregrado entre universidades y Servicios de Farmacia Hospitalaria era de 1 (rango intercuartílico: 0-2). El 21,5% de los Servicios de Farmacia Hospitalaria no tenía ningún convenio. La media de alumnos de grado de  farmacia en los Servicios de Farmacia Hospitalaria fue 4,12 (desviación  estándar: 8,26). Un total de 290 farmacéuticos eran profesores asociados  en la universidad. El 15% de los farmacéuticos disponía de una  certificación Board of Pharmacy Specialities, siendo el 55,3% de oncología. Los Servicios de Farmacia Hospitalaria contaban con una media de 1,31  (desviación estándar: 2,23) doctores. De los Servicios de Farmacia  Hospitalaria que refirieron el factor de impacto acumulado de sus  publicaciones, en un 60% era cero, y en el 19,6% ≥ 10.Conclusiones: La atención a pacientes no ingresados y la elaboración de  medicamentos continúan avanzando en los Servicios de Farmacia Hospitalaria españoles, mientras que existe un importante  margen de mejora en farmacocinética clínica. Se refleja un compromiso  con la docencia, mientras que la producción científica es todavía limitada,  a pesar del incremento de doctores en los servicios.

Factors associated with therapeutic inertia among pharmacists caring for people with multiple sclerosis.

INTRODUCTION: Pharmacists play a critical role on therapeutic decisions in multiple sclerosis (MS) care. Therapeutic inertia (TI) is defined as the lack of treatment initiation or escalation when there was evidence of clinical and radiological disease activity. The aim of this study was to assess factors associated with TI among pharmacists involved in MS care. METHODS: A multicenter, non-interventional, cross-sectional study involving hospital pharmacists in Spain was conducted. Participants answered questions regarding their standard practice, risk preferences, and management of nine simulated MS case-scenarios. We created a score defined as the number of case-scenarios that fit the TI criteria over the total number of presented cases (score range from 0-6). Similarly, an optimal treatment score (OTS) was created to determine the degree of appropriate pharmacological decisions (ranging from 0-lowest to 9-highest). Candidate predictors of TI included demographic data, practice setting, years of practice, MS expertise, number of MS patients managed at hospital/year, participation in MS clinical trials, and participants' risk preferences. RESULTS: Overall, 65 pharmacists initiated and completed the study (response rate: 45.5%). The mean age was 43.5 ± 7.8 years and 67.1% were female. Forty-two (64.6%) participants had specialization in MS management. Overall, the mean TI score was 3.4 ± 1.1. Of 390 individual responses, 224 (57.4%) met the TI criteria. All participants failed to recommend treatment escalation in at least one of the six case-scenarios. The mean OTS was 4.1 ± 1.4. Of 585 individual responses, 264 (45.1%) met the optimal choice criteria. Only 40% of participants (23/65) made five or more optimal treatment choices. Lower experience in dispensing MS drugs and lack of specialization in MS were the most common factors associated with TI and optimal management. The multivariable analysis revealed that more years of experience (p = 0.03), being a co-author of a peer-reviewed publication (p = 0.03), and specialization in MS (p = 0.017) were associated with lower TI scores (adjusted R2 = 0.23). CONCLUSION: Therapeutic inertia was observed in all pharmacist participants, affecting over fifty percent of MS treatment choices. Continuing education and specialization in MS may facilitate therapeutic decisions in MS care.

SEFH National Survey-2019: general characteristics, staffing, material resources and information systems in Spain's hospital pharmacy departments.

OBJECTIVE: To publicize the results regarding the general characteristics, human resources, materials and information systems of Spanish hospital pharmacy  departments arising from SEFH's 2019 Survey on the Situation of Spanish  Hospital Pharmacy Departments. METHOD: An online questionnaire was sent to the heads of the 368 hospital pharmacy departments affiliated to SEFH. The questionnaire included 77 questions grouped into 8 dimensions. The information was collected between  March and September 2019. RESULTS: The overall response rate was 54.3%. Sixty-nine percent of hospitals  were public and the most commonly reported hospital size was 101-250 beds.  Nine percent of responding hospitals remained open round the clock and 57.5%  did not offer a continued care service. A total of 41.9% of hospitals dispensed  medications to outpatients in the  afternoon and 52.7% of hospital pharmacy departments were accredited to some quality standard. The mean number of  specialist pharmacists per pharmacy Department was 5.34 (SD: 6.22); 47% of  pharmacists spent at least half their working day in a clinical unit. Hospital  pharmacy departments had a mean of 0.3 (SD: 0.7) or 0:9 (SD: 1.4) automated storage and dispensing carousels, depending on whether they were horizontal or vertical, respectively. A total of 16.1% of beds were assisted by automated  dispensing systems, a figure that reached 33.5% in hospitals with more than  1,000 beds. Three percent of hospital pharmacy departments had a robotized  system for compounding chemotherapy medications and 24.8% had a raceability and safety system. Smart infusion pumps were used by 21.4% of hospitals.  Electronic prescriptions were implemented in 98.8% of hospitals for inpatients  and in 62% for outpatients. CONCLUSIONS: Spanish hospital pharmacy departments face a shortage of  specialist pharmacists, although incorporation of such professionals to clinical  units has doubled in the last few years. There has been an increase in the level  of automation of the logistic processes involved in medication dispensing, but  there is still significant room for improvement in the area of robotized dispensing and compounding traceability systems. This data could play an invaluable role in the design of future action plans.

Objetivo: Dar a conocer los resultados referentes a características generales, recursos humanos, materiales y sistemas de información de la  encuesta nacional de la Sociedad Española de Farmacia Hospitalaria (SEFH)  2019 sobre la situación de los Servicios de Farmacia Hospitalaria españoles.Método: Se envió un cuestionario on line a los responsables de los 368  Servicios de Farmacia Hospitalaria españoles registrados en el directorio de  socios de la SEFH. El cuestionario incluía 77 preguntas agrupadas en ocho  dimensiones. La información se recogió entre marzo y septiembre de 2019.Resultados: La tasa global de respuesta fue del 54,3%. El 69% de los  hospitales eran de titularidad pública y el tamaño más representado de 101-250  camas. El 9% permanecía abierto durante las 24 horas y el 57,5% no disponía  de ninguna modalidad de atención continuada. La dispensación a pacientes  externos durante la tarde se realizaba en el 41,9% de los centros. El 52,7% de  los Servicios de Farmacia estaban acreditados por una norma de calidad. La  media de farmacéuticos especialistas por Servicio de Farmacia fue 5,34  (desviación estándar [DE]: 6,22). El 47% de los farmacéuticos trabajaban al  menos media jornada en las unidades clínicas. En cuanto a los sistemas  automatizados rotativos de almacenamiento y dispensación, de media los  Servicios de Farmacia disponían de 0,3 (DE: 0,7) y 0,9 (DE: 1,4) según fueran  de tipo horizontal o vertical, respectivamente. El 16,1% de las camas  hospitalarias estaban asistidas por sistemas automatizados de dispensación,  llegando al 33,5% en hospitales con > 1.000 camas. El 3% de los Servicios de  Farmacia Hospitalaria disponía de un sistema robotizado para la preparación de quimioterapia y el 24,8% de un sistema de trazabilidad y seguridad. Las bombas de infusión inteligentes se utilizaban en el 21,4% de los centros. La prescripción  electrónica estaba implantada en el 98,8% de los hospitales para pacientes  ingresados y en el 62% para pacientes ambulantes.Conclusiones: En los Servicios de Farmacia Hospitalaria españoles existe una  infradotación de farmacéuticos especialistas, a pesar de haberse duplicado su  incorporación a las unidades clínicas. Destaca un crecimiento en la  automatización de las actividades logísticas de dispensación, pero existe un  importante margen de mejora en sistemas robotizados y de trazabilidad de las  preparaciones. Conocer estos resultados puede resultar de gran utilidad para  establecer planes de actuación.

Assessing Pharmacists' Preferences towards Efficacy Attributes of Disease-Modifying Therapies in Relapsing-Remitting Multiple Sclerosis.

Introduction: Hospital pharmacists are increasingly playing a critical role in the care of patients with multiple sclerosis (MS). However, little is known about their preferences and perspectives towards different attributes of disease-modifying therapies (DMTs). The objective of this research was to assess pharmacists´ preferences for DMT efficacy attributes. Methods: A multicenter, non-interventional, cross-sectional, web-based study was conducted. Preventing relapses, delaying disease progression, controlling radiological activity, and preserving health-related quality of life (HRQoL) and cognition were the attributes selected based on a literature review and a focus group with six hospital pharmacists. Conjoint analysis was used to determine preferences in eight hypothetical treatment scenarios, combining different levels of each attribute and ranking them from most to least preferred. Results: Sixty-five hospital pharmacists completed the study (mean age: 43.5 ± 7.8 years, 63.1% female, mean years of professional experience: 16.1 ± 7.4 years). Participants placed the greatest preference on delaying disease progression (35.7%) and preserving HRQoL (21.6%) and cognition (21.6%). Importance was consistent in all groups of pharmacists stratified according to demographic characteristics, experience, research background, and volume of patients seen per year. Conclusions: Understanding which treatment characteristics are meaningful to hospital pharmacists may help to enhance their synergistic role in the multidisciplinary management of patients with MS.

Sclerotherapy and Topical Nasal Propranolol: An Effective and Safe Therapy for HHT-Epistaxis.

OBJECTIVES: Epistaxis is the most frequent clinical manifestation of hereditary hemorrhagic telangiectasia (HHT). Several topical, systemic, and surgical treatments have been tried, but none have been completely effective. The aim of the present study is to evaluate whether a combined treatment sclerotherapy and topical therapy with propranolol 0.5% nasal formulation would reduce the epistaxis due to HHT and improve patient's quality of life. METHODS: An observational cross-sectional study was carried out. The primary outcome measure was frequency and severity of epistaxis as measured by the epistaxis severity score (ESS) at baseline (4 weeks before therapy) and at least 4 weeks after the treatment was implemented. Quality of life was analyzed using EuroQol-5D (EQ-5D) scale and visual analogue (VAS) scale before and after treatment. RESULTS: A total of 38 consecutive patients subjected to the combined treatment were evaluated (mean age: 57.2 years, standard deviation [SD] = 13.9; 60.5% women). The mean time of treatment was 37.1 weeks (SD = 14.9). Combined therapy significantly reduces frequency and severity of epistaxis, with an ESS improvement of 5 points from 6.9 ± 2.6 to 1.9 ± 1.3 (P < 0.05); however, the EQ-5D scale increased from 0.66 ± 0.27 to 0.93 ± 0.12 (P < 0.05). The difference in VAS means showed an increase from 44.6 ± 28.3 to 82.5 ± 12.5 (P < 0.05). The increases in quality of life are in line with the drop in ESS. CONCLUSION: The study demonstrated that combined therapy (sclerotherapy and topical nasal propranolol) significantly reduced the epistaxis due to HHT and increased patients' quality of life. LEVEL OF EVIDENCE: 2c Laryngoscope, 129:2216-2223, 2019.

[Update of the stability of drugs cytostatic drugs by applying the methodology of the matrix of risk for the manufacture of sterile drugs]. / Actualización de la estabilidad de los medicamentos citostáticos y otras mezclas intravenosas aplicando la metodología de la matriz de riesgo para la elaboración de medicamentos estériles.

OBJECTIVE: To establish limits of validity to opened or reconstituted vials and cytostatic mixtures according to their physico- chemical stability and the level of risk and preparation requirements. The level of risk and preparation requirements were assigned by the risk matrix the Guide of Good Practice of Preparation of Drugs in Hospital Pharmacy Services. METHOD: A table of stabilities of cytostatic drugs was developed. Physicochemical stability data were obtained from data sheets and literature reviews. The level of risk was assigned by the matrix of risk depending on the requirements of each preparation. When the physico-chemical stability was equal to or higher than indicated by the matrix, it is assumed the terms of validity of the matrix; otherwise, validity periods coincided with the peak period of physicochemical stability. RESULTS: 61 drugs were reviewed. It was assumed the chemical term of validity in 45.9% of opened/reconstituted vials and 50.8% of cytostatic mixtures, and indicated by the risk in the rest array, respectively. According to the matrix, the level of risk was medium in most of cytostatic drugs. Only one preparation was high risk. No preparation obtained low-risk. CONCLUSIONS: To assign the term of validity of opened/reconstituted vials and cytostatic mixtures not only it is necessary to consider physical and chemical stability. The level of risk and preparation requirements are also important, allowing more adequate validity periods.

Objetivo: Establecer unos plazos de validez de los viales abiertos y/o reconstituidos y de las mezclas citostáticas según su estabilidad fisicoquímica, el nivel de riesgo y los requisitos de preparación asignados por la matriz de riesgo de la Guía de Buenas Prácticas de Preparación de Medicamentos en los Servicios de Farmacia Hospitalaria. Método: Se elaboró una tabla de estabilidades con los medicamentos citostáticos. Los datos de estabilidad fisicoquímica se obtuvieron de fichas técnicas y revisiones bibliográficas. El nivel de riesgo fue asignado por la matriz de riesgo en función de los requisitos de cada preparación. Cuando la estabilidad fisicoquímica era igual o superior a la indicada por la matriz, se asumieron los plazos de validez de la matriz; en caso contrario, los plazos de validez coincidieron con el periodo máximo de estabilidad fisicoquímica. Resultados: Se revisaron 61 fármacos. Se asumió el plazo de validez físico-química en el 45,9% de los viales abiertos/ reconstituidos y en el 50,8% de las mezclas citostáticas, y el indicado por la matriz de riesgo en el resto, respectivamente. Según la matriz, el nivel de riesgo fue medio en todos los medicamentos citostáticos salvo en uno, que resultó de riesgo alto. Ningún medicamento resultó de riesgo bajo. Conclusiones: Para asignar el plazo de validez de los viales abiertos/reconstituidos y de las mezclas citostáticas no solo es necesario tener en cuenta los datos de estabilidad físico-química, sino también el nivel de riesgo y los requisitos de preparación, permitiendo unos plazos de validez más adecuados.

Comparison of the effectiveness and renal safety of tenofovir versus entecavir in patients with chronic hepatitis B.

OBJECTIVE: To compare the effectiveness and renal safety of treatment with tenofovir versus entecavir in patients with chronic hepatitis-B. METHODS: Retrospective study in hepatitis-B patients who initiated treatment with tenofovir or entecavir since January 1998 until 2013. The primary effectiveness variable was defined as viral DNA < 20 UI/ml (HBV-DNA) and the variable for renal safety was variations in glomerular filtration rate (eGFR) after 48 weeks of treatment. RESULTS: The analysis was conducted in 64 patients (1:1), with similar characteristics except for the prevalence of naive patients (p=0.036), comorbidities (p=0.077) and nephrotoxic drugs (p=0.088) in the entecavi arm, while the tenofovir arm presented a prevalence of patients with HBV-DNA < 20 UI/ml (p=0.032) and HBeAg-positive (p=0.050). Statistical univariate analysis and adjustment for confounding variables was conducted through the Propensity Score (PS). The outcomes for the primary effectiveness variable showed tenofovir superiority after PS adjustment, with an ORadj=6.7 (95% CI:1.2-35.3; p=0.028). Three patients on tenofovir experienced seroconversion (p=0.148). The outcomes for the primary safety variable (eGFR < 60 ml/min/1.73m2) showed no difference between both arms after adjustment, achieving an ORadj=0.6 (95% CI:0.1-2.8; p=0.521). The tenofovir arm registered two cases of treatment interruption due to renal toxicity, with subsequent recovery, including one Fanconi Syndrome. CONCLUSIONS: In our study, there are significant differences between both treatments regarding effectiveness, with tenofovir demonstrating superiority. In terms of renal safety, we have not found any significant differences, but two cases of treatment interruption due to renal toxicity with tenofovir lead us to the conclusion that treatment decision in patients with renal function alteration should include an individualized assessment of each case.

Objetivo: Comparar la efectividad y seguridad renal del tratamiento con tenofovir frente al entecavir en pacientes con hepatitis B cronica. Métodos: Estudio retrospectivo en pacientes con hepatitis B que iniciaron tratamiento con tenofovir o entecavir entre enero 1998-2013. La variable principal de la efectividad fue definida como DNA viral < 20 UI/ml (HBV-DNA) y la de la seguridad renal como variaciones en el filtrado glomerular (eGFR) tras 48 semanas de tratamiento. Resultados: Se analizaron un total de 64 pacientes (1:1), con caracteristicas semejantes excepto por el predominio de pacientes sin tratamiento previo (p=0,036), comorbilidades (p=0,077) y farmacos nefrotoxicos (p=0,088) en el grupo-entecavir, y de pacientes con HBV-DNA < 20 UI/ml (p=0,032) y HBeAg-positivo (p=0,050) en el grupo-tenofovir. Se realizaron analisis estadisticos univariantes y se ajustaron las variables confusoras mediante Propensity score (PS). Los resultados para la variable principal de efectividad (HBV-DNA < 20 UI/ml) denotan una superioridad del tenofovir tras el ajuste por PS con una ORadj= 6,7 (IC95%: 1,2-35,3; p=0,028). Tres pacientes con tenofovir sufrieron seroconversion (p=0,148). Los resultados para la variable principal de seguridad (eGFR < 60ml/min/1.73m2) no mostraron diferencias entre ambas ramas tras el ajuste, obteniendo una ORadj= 0,6 (IC95%: 0,1-2,8; p=0,521). El grupo-tenofovir registro dos casos de suspension por toxicidad renal, con posterior recuperacion, entre ellos un sindrome de Fanconi. Conclusiones: En nuestro estudio existen diferencias significativas entre ambos tratamientos respecto a su efectividad, mostrandose el tenofovir superior. En cuanto a la seguridad renal, no hemos encontrado diferencias significativas, pero dos casos de suspension de tratamiento por toxicidad renal con tenofovir nos llevan a concluir que la decision de tratamiento en los pacientes con alteraciones en la funcion renal deberia incluir un analisis individualizado de cada caso.

[Analysis of the nutritional parameters and adjustment of the requirements of the initial parenteral nutrition in post surgical critically ill patients]. / Análisis de los parámetros nutricionales y ajuste de requerimientos de la nutrición parenteral de inicio en el paciente crítico postquirúrgico.

OBJECTIVES: To analyze nutritional parameters in critical post-surgical patients under stressful conditions, their evolution, and to assess the degree of adjustment of initial parenteral nutrition (PN) to the requirements set for in the recently published recommendations. MATERIAL AND METHODS: Observational, retrospective study including post-surgical critically ill patients admitted to the post-surgical reanimation unit (RU) in whom PN was prescribed, in 2011. Demographical, anthropometric, diagnosis, nutritional parameters, mortality, total duration of hospitalization and duration of hospitalization at the RU, and complications were gathered. The type of PN prescribed was compared, with individualization of the requirements by Kg of body weight, according to the latest recommendations published on nutrition of critically ill patients (ASPEN, ESPEN, SENPE): 18-30 kcal/kg, 0.8-1.5 g/kg/proteins, 4 mg/kg/min/glucose and 2-3 mg/kg/min/glucose in patients with stress-related hyperglycemia, and 0.5-1 g/kg/day of lipids. The variables analyzed were caloric, protein, and glucose adjustments in the initial PN, recovering of albumin > 3 g/dL at day 10, and likely association with the number of complications, mortality and hospital stay. RESULTS: 60 patients were analyzed. 23.3% (14/60) presented hyponutrition at admission, with significant weight loss before the intervention. Albumin, a negative acute phase reactant, was significantly low at baseline, on average 1.9 g/dL (95%CI 1.83-2.12), which indicates a high level of metabolic stress in post-surgical patients. Prescribed PNs were adjusted to the recommendations for kcal, proteins and lipids in 68.3%, 71.7%, and 80.4%, respectively. 57.1% were adjusted for glucose, although the intake from fluid therapy was not taken into account. In patients with a BMI < 22 kg/m2 (16/60), it was observed that 81.8% of the prescribed PNs had an excess in calories, 60% in proteins, and 43.8% in lipids (p < 0.05). 34% of all patients recovered their albumin levels > 3 g/dL at day 10, and the mortality, the duration of hospitalization at the RU, and the number of complications were significantly lower in these patients than in those not recuperating their albumin levels (p < 0.05). CONCLUSIONS: Nutritional support is essential, particularly in those patients with a significant level of hyponutrition before surgical intervention, low weighed patients, or in those submitted to gastrointestinal surgery. In our study, baseline PN prescriptions were adjusted to recent recommendations in more than half of the patients; however, in patients with low weight or low BMI we observed higher caloric-protein excess in the prescribed PN since the intake has not been reduced by individualizing it to the body weight. Standardization of PN formulations is a tool of quality and safety, although in these patients it should be individually assessed. More studies are needed to validate the clinical benefits of individualized nutritional intake in post-surgical critically ill patients.

Objetivos: Analizar los parámetros nutricionales en pacientes críticos postquirúrgicos en situación de estrés, su evolución y evaluar el grado de ajuste de la Nutrición Parenteral (NP) de inicio a los requerimientos de las recomendaciones recientemente publicadas. Material y métodos: Estudio observacional, retrospectivo incluyendo pacientes críticos postquirúrgicos ingresados en una unidad de reanimación postquirúrgica en 2011 con prescripción de NP. Se recogieron datos demográficos, antropométricos, diagnóstico, parámetros nutricionales, mortalidad, estancia total y en Reanimación (REA), y complicaciones. Se comparó el tipo de NP pautada, con la individualización de los requerimientos por kg según las últimas recomendaciones publicadas de nutrición en el paciente crítico (ASPEN, ESPEN, SENPE): 18-30 kcal/kg, 0,8-1,5 g/kg/proteínas, 4 mg/kg/min/glucosa y 2-3 mg/kg/min/glucosa en pacientes con hiperglucemia de estrés, y 0,5-1 g/kg/día lípidos. Las variables analizadas fueron ajuste calórico, proteico y de glucosa en la NP de inicio, recuperación de la albúmina > 3 g/dl a día 10º y la posible asociación clínica con el número de complicaciones, mortalidad y estancia. Resultados: Se analizaron 60 pacientes. El 23,3% (14/60) presentaban al ingreso desnutrición con una pérdida significativa de peso previa a la intervención. La albúmina, reactante de fase aguda negativo, fue significativamente baja al inicio, media 1,9 g/dl (IC95% 1,83-2,12) indicando un alto grado de estrés metabólico de los pacientes postquirúrgicos. Las NP pautadas se ajustaron a las recomendaciones en kcal, proteínas y lípidos en un 68,3%, 71,7%, 80,4% respectivamente. El 57,1% estaban ajustados en glucosa aunque no se tuvo en cuenta el posible aporte en sueroterapia. En pacientes con IMC < 22 kg/m2 (16/60) se observó que el 81,8% de las NP pautadas presentaban exceso calórico, 60% exceso proteico y 43,8% exceso de lípidos (p < 0,05). Un 34 % de todos los pacientes recuperaron la albúmina por encima de 3 g/dl en día 10º, la mortalidad, estancia en REA y nº complicaciones en estos pacientes fue significativamente menor que en los que no recuperaron albúmina (p < 0,05). Conclusiones: El soporte nutricional es fundamental, especialmente en aquellos pacientes con un significativo grado de desnutrición previo a la intervención, pacientes de bajo peso o en aquellos que son sometidos a cirugía gastrointestinal. En nuestro estudio las NP de inicio pautadas se han ajustado en más de la mitad de los pacientes a las nuevas recomendaciones, sin embargo en aquellos pacientes con bajo peso e IMC observamos un mayor exceso calórico-proteico de la NP pautada dado que no se ha reducido el aporte individualizando por kg de peso. La estandarización de las preparaciones de NP es una herramienta de calidad y seguridad, pero en este tipo de pacientes debe estar acompañada de una valoración individualizada. Se necesitan más estudios para validar los beneficios clínicos del aporte nutricional individualizado en el paciente crítico postquirúrgico.