Evaluation of Compliance with the Guidelines for the Safe Use of Potassium Chloride

RESUMEN Objetivo: Analizar el grado de cumplimiento del “Protocolo de Utilización de Cloruro potásico” implantado en nuestro hospital, mediante la realización de auditorías periódicas presenciales, durante el periodo 2013-2016. Métodos: Estudio descriptivo de las auditorías realizadas a los 6 meses post-implantación (principios de 2013), y después cada año (2014-2016). Los indicadores de evaluación se establecen siguiendo las recomendaciones recogidas en el Protocolo y se refieren al almacenamiento, prescripción, preparación y administración de soluciones de potasio. Las unidades asistenciales evaluadas son: unidades autorizadas (almacenamiento y doble chequeo en la preparación y antes de la administración) y en todas las unidades de críticos y urgencias clínicas (prescripción y etiquetado correcto para su administración). Resultados: Se audita un total de 55 unidades asistenciales, que han mostrado un 100% de cumplimiento para los indicadores referentes a prescripción y etiquetado correcto. De dichas unidades, 12 (críticos y urgencias) están autorizadas para disponer de ampollas de cloruro potásico 1M. En estas 12, no se obtuvo un cumplimiento correcto de los otros dos indicadores, debido a que una no realizó su almacenamiento de forma adecuada (2014) y, en otras tampoco se cumplimentó el registro de doble chequeo (3 en 2013, 1 en 2014 y 2015). Conclusión: Las auditorías mostraron el correcto seguimiento de dicho Protocolo para la mayoría de los criterios evaluados, si bien, ponen de manifiesto la necesidad de realizar estrategias periódicas de intensificación y recuerdo para garantizar el adecuado cumplimiento de todas las recomendaciones establecidas.ABSTRACT Objective: To analyze the degree of compliance with the “Guidelines for the safe use of potassium chloride” implemented in our hospital, using periodic audits, during the period 2013-2016. Methods: Descriptive study of the audits carried out at 6 months post-implementation (beginning of 2013) and then every year (2014-2016). The evaluation indicators were developed following the recommendations included in the Guidelines and referred to storage, prescription, preparation and administration of potassium solutions. The patient care units evaluated are: critical care authorized units (storage and independent double checks during preparation of solutions and before its administration) and all patient care units (prescription and correct labeling for its correct administration). Results: There were audited 55 patient care units, which showed a compliance of 100% for the prescription and correct labeling indicators. Of those units, 12 (critical and emergency units) are authorized to have concentrated potassium chloride ampoules 1M. These 12 units did not have a correct compliance with the other two indicators, because one unit did not show a correct storage (in 2014) and the double check required was not verified by 3 units in 2013, one in 2014 and 2015. Conclusion: The audits showed the correct follow-up with the Guidelines for most of the evaluated criteria, however demonstrated the need to carry out periodic strategies of intensification and remembrance to guarantee the correct compliance of all the established recommendations

Evaluación del cumplimiento del protocolo de utilización de cloruro potásico

Objective: To analyze the degree of compliance with the “Guidelines for the safe use of potassium chloride” implemented in our hospital, using periodic audits, during the period 2013-2016. Methods: Descriptive study of the audits carried out at 6 months post-implementation (beginning of 2013) and then every year (2014-2016). The evaluation indicators were developed following the recommendations included in the Guidelines and referred to storage, prescription, preparation and administration of potassium solutions. The patient care units evaluated are: critical care authorized units (storage and independent double checks during preparation of solutions and before its administration) and all patient care units (prescription and correct labeling for its correct administration). Results: There were audited 55 patient care units, which showed a compliance of 100% for the prescription and correct labeling indicators. Of those units, 12 (critical and emergency units) are authorized to have concentrated potassium chloride ampoules 1M. These 12 units did not have a correct compliance with the other two indicators, because one unit did not show a correct storage (in 2014) and the double check required was not verified by 3 units in 2013, one in 2014 and 2015. Conclusion: The audits showed the correct follow-up with the Guidelines for most of the evaluated criteria, however demonstrated the need to carry out periodic strategies of intensification and remembrance to guarantee the correct compliance of all the established recommendations.Objetivo: Analizar el grado de cumplimiento del “Protocolo de Utilización de Cloruro potásico” implantado en nuestro hospital, mediante la realización de auditorías periódicas presenciales, durante el periodo 2013-2016. Métodos: Estudio descriptivo de las auditorías realizadas a los 6 meses post-implantación (principios de 2013), y después cada año (2014-2016). Los indicadores de evaluación se establecen siguiendo las recomendaciones recogidas en el Protocolo y se refieren al almacenamiento, prescripción, preparación y administración de soluciones de potasio. Las unidades asistenciales evaluadas son: unidades autorizadas (almacenamiento y doble chequeo en la preparación y antes de la administración) y en todas las unidades de críticos y urgencias clínicas (prescripción y etiquetado correcto para su administración). Resultados: Se audita un total de 55 unidades asistenciales, que han mostrado un 100% de cumplimiento para los indicadores referentes a prescripción y etiquetado correcto. De dichas unidades, 12 (críticos y urgencias) están autorizadas para disponer de ampollas de cloruro potásico 1M. En estas 12, no se obtuvo un cumplimiento correcto de los otros dos indicadores, debido a que una no realizó su almacenamiento de forma adecuada (2014) y, en otras tampoco se cumplimentó el registro de doble chequeo (3 en 2013, 1 en 2014 y 2015). Conclusión: Las auditorías mostraron el correcto seguimiento de dicho Protocolo para la mayoría de los criterios evaluados, si bien, ponen de manifiesto la necesidad de realizar estrategias periódicas de intensificación y recuerdo para garantizar el adecuado cumplimiento de todas las recomendaciones establecidas

Clinical experience with the integrase inhibitors Dolutegravir and Elvitegravir in HIV-infected patients: efficacy, safety and tolerance

[Abstract] Two integrase inhibitors (INSTIs), dolutegravir (DTG) and elvitegravir/cobicistat (EVG/COBI), have joined recently the pharmacotherapy arsenal against HIV. This study evaluated the efficacy and tolerability of these INSTIs in the last two years. A retrospective observational study in patients who started DTG or EVG/COBI from January 2015 to January 2017 at a reference hospital in north-western Spain was done. Epidemiological, clinical and immunovirological data were recorded. A statistical analysis was performed with SPSS software. A total of 542 DTG (n = 275)- or EVG/COBI (n = 267)-based therapies were initiated during the study period. Overall, more than 90% of naïve and pre-treated patients had virological suppression in both groups after 48 weeks of initiation of treatment per-protocol snapshot analysis. During follow-up, 10.2% of patients were treated with DTG and 4.5% of those treated with EVG discontinued due to adverse events (AE). In the case of DTG mainly related to neuropsychiatric disturbances (70.4%) and for EVG/COBI with gastrointestinal discomfort (50%). Female sex [HR 2.255 (95%CI 1.121–4.535), p = 0.023] and DTG treatment [HR 2.453 (95%CI 1.221–4.931), p = 0.012] were associated with AE discontinuations. Specifically for neuropsychiatric events, DTG treatment [HR 5.906 (95%CI 1.954–17.846), p = 0.002] and receiving abacavir/lamivudine/DTG [HR 4.380 (95%CI 1.348–14.233), p = 0.014] were identified as predictive risk factors for treatment discontinuations in two different multivariate analyses. A high percentage of AE discontinuations not previously described in clinical trials has been observed, especially with DTG. Female gender and DTG treatment were identified as risk factors for AE discontinuation. DTG-based therapies, especially in combination with abacavir/lamivudine, were associated with an increased risk of treatment discontinuation due to neuropsychiatric AE.Instituto de Salud Carlos III; CPII14/00014Instituto de Salud Carlos III; PI10/02166Instituto de Salud Carlos III; PI13/02266Instituto de Salud Carlos III; CM13/00328Instituto de Salud Carlos III; CM15/00233Instituto de Salud Carlos III; PI16/0215

Heavy metal in urban soils: Barrio Ramón Carrillo (CABA, Argentina)

Una de las etapas del estudio ambiental del Barrio Ramón Carrillo en CABA realizado por la FAUBA fue la determinación de los contenidos de metales pesados en muestras superficiales de suelos. Se determinaron en 21 sitios del barrio a los efectos de obtener el análisis más representativo del terreno. Se tomaron muestras por triplicado con barreno de los primeros 20 cm de profundidad y se determinaron los contenidos de metales según normas internacionales. Se compararon contra la legislación argentina y se calcularon los Igeos. Se encontraron valores de contaminación según Igeo especialmente en Cu y Zn. En el caso de Cr y Pb fue más aleatorio, característico de la presencia de materiales de relleno. Las correlaciones observadas sugieren un origen común para los contenidos de Cu, Zn y Pb, el Cr se relacionó en menor medida con Pb.Centro de Investigaciones Geológica

Treatment with tenofovir alafenamide fumarate worsens the lipid profile of HIV‐infected patients versus treatment with tenofovir disoproxil fumarate, each coformulated with elvitegravir, cobicistat, and emtricitabine

[Abstract] Two elvitegravir/cobicistat‐based therapies combined with emtricitabine/tenofovir disoproxil fumarate (EVG/c/FTC/TDF) or emtricitabine/tenofovir alafenamide fumarate (EVG/c/FTC/TAF) are currently available for HIV patients. This study evaluated the modifications in the lipid profile of patients who received these treatments in the last three years at our institution. A retrospective observational study in HIV‐infected patients who received EVG/c/FTC/TDF or EVG/c/FTC/TAF from January 2015 to January 2018 at a reference hospital in northwestern Spain was carried out. Epidemiological, clinical and immunovirological data were recorded. A statistical analysis was performed using SPSS software. A total of 384 EVG/c‐based therapies were initiated during the study period, 151 EVG/c/FTC/TDF and 233 EVG/c/FTC/TAF. A significantly negative influence in all the lipid profile parameters in experienced patients and total cholesterol (TC), and LDL‐C in naïve patients were observed after 48 weeks of treatment with EVG/c/FTC/TAF, while these parameters remained stable in the EVG/c/FTC/TDF group. During follow‐up, a greater proportion of patients had lipid levels above the normal range (63.1% TC, 56.2% LDL‐C) and new lipid‐modifying drugs were prescribed (11.9%) in the EVG/c/FTC/TAF group. The number of cardiovascular risk factors (OR 1.66 [95% CI 1.01‐2.72]; P = 0.043) was recognised as an independent predictor of lipid‐lowering prescription for patients treated with both EVG/c/FTC/TDF and EVG/c/FTC/TAF. For patients treated with EVG/c/FTC/TAF, the mean total cholesterol to HDL ratio in the first 48 weeks of the study treatment was associated with a higher likelihood of lipid‐lowering prescription in multivariate analysis (OR 1.6 [95% CI 1.12‐2.52]; P = 0.011). Significant changes in lipid profile have been observed in patients who have received EVG/c/FTC/TAF. It was necessary to prescribe almost twice the number of lipid‐lowering drugs to patients who received EVG/c/FTC/TAF (11.9%) vs EVG/c/FTC/TDF (4.7%)

Discontinuation due to neuropsychiatric adverse events with efavirenz- and dolutegravir-based antiretroviral therapy: a comparative real-life study

Obervational study[Abstract] Objectives: Despite the high efficacy of antiretroviral treatment, no drug is free from adverse events (AEs). Efavirenz (EFV) and dolutegravir (DTG) are antiretroviral drugs for which neuropsychiatric adverse events (NPAEs) have been described. This study evaluated the safety and tolerability of DTG-based and EFV-based antiretroviral regimens in HIV-infected patients. Methods: A retrospective observational study was carried out in HIV-infected patients who started DTG- or EFV-based antiretroviral treatment from January 2008 to December 2018 at a reference hospital in north-western Spain. Epidemiological, clinical and immunovirological data were recorded. A statistical analysis was performed with SPSS software. Results: A total of 282 DTG- and 148 EFV-based therapies were initiated. During follow-up, statistically significant differences have been found between the rate of patients who discontinued DTG and EFV due to AEs (12.1% vs 35.8%, p<0.001) and the main AEs in both groups, NPAEs (8.2% vs 25.0%, p<0.001). Female gender (OR 2.610 (95% CI 1.327 to 5.133), p=0.005) was associated with discontinuations due to AEs. Patients with documented psychiatric disorders were at higher risk of discontinuation due to NPAEs (OR 4.782 (95% CI 1.190 to 19.220), p=0.027). The multivariate analysis showed a 61.2% risk reduction in benzodiazepine prescriptions in patients treated with DTG. In both groups, patients needed consultation and follow-up in the psychiatry unit (16.9% in the EFV group and 8.9% in the DTG group, p=0.021). Conclusions: We found a high rate of discontinuations due to AEs and NPAEs, prescription of benzodiazepines and a requirement for consultation in a psychiatric unit in both treatment groups, especially with EFV

Cyclodextrin-polysaccharide-based, in situ-gelled system for ocular antifungal delivery

Fluconazole was studied with two different hydrophilic cyclodextrins (hydroxypropyl-β-cyclodextrin (HPBCD) and sulfobutyl ether-β-cyclodextrin (SBECD)) for the formation of inclusion complexes. HPBCD and SBECD showed low cell cytotoxicity in human keratocytes as assessed by the label-free xCELLigence system for real-time monitoring. The fluconazole–HPBCD complex was incorporated into an ion-sensitive ophthalmic gel composed of the natural polysaccharides gellan gum and κ-carrageenan. This system showed good bioadhesive properties and effective control of fluconazole release

Pharmaceutical care to hospital outpatients during the COVID-19 pandemic. Telepharmacy

Hospital Pharmacy Service (HPS) in Spain have been impacted by the health crisis caused by the COVID-19 pandemic. Thus, the outbreak has forced HPSs to adapt their outpatient consultation services to Telepharmacy to optimize clinical outcomes and reduce the risk of contagion. The purpose of this article is to describe and analyze the experience of HPSs with outpatient Telepharmacy during the COVID-19 pandemic and expose the lessons learned. Measures have been adopted in on-site outpatient pharmacy clinics to prevent exposure of patients and professionals to the virus. These measures are based on national and international recommendations on social distancing and hygiene. With regard to remote outpatient pharmacy services, teleconsultation with drug dispensing has been promoted based on five basic procedures, each with its advantages and limitations: home drug delivery from HPSs, with the advantage of universal access and the limitation of entailing a substantial investment in resources; HPS coordination with primary care pharmacists, which requires no investments but with limited access to some geographic areas; HPS coordination with community pharmacists based on a large network of pharmacies, which requires the patient to go to the pharmacy, without confidentiality being guaranteed for any patient; geolocation and hospital-based medication dispensing, which provides universal access and direct traceability, but entails investment in human resources; and HPS coordination with associations of patients, which does not entail any additional cost but limits the information available on the diseases of society members. Three main lessons have been learned during the pandemic: the satisfactory capacity of HPS to provide outpatient pharmacy consultation services in the setting of a public health crisis; the usefulness of Telepharmacy for the clinical follow-up, healthcare coordination, outpatient counseling, and informed dispensing and delivery of medication (with a high level of satisfaction among patients); and the need to foster Telepharmacy as a complementary tool through a mixed model of outpatient pharmacy consultation service that incorporates the advantages of each procedure and adapts to the individual needs of each patient in a context of humanized healthcare.YesLos servicios de farmacia hospitalaria (SFH) en España se han visto afectados por la crisis sanitaria provocada por SARS-CoV-2 y han tenido que adoptar sus procedimientos de atención farmacéutica (AF) al paciente externo (PE) mediante estrategias de Telefarmacia, con los objetivos de maximizar los resultados en salud y reducir el riesgo de contagio. El objetivo de ese artículo es describir y analizar los procedimientos AFPE durante la pandemia SARS-CoV-2 y comunicar las lecciones aprendidas en los SFH. En relación con las consultas externas de AF presenciales, se han adoptado medidas para minimizar el contagio viral de pacientes y profesionales, siguiendo las recomendaciones nacionales e internacionales de referencia de distanciamiento temporal, espacial y recomendaciones higiénicas. En cuanto a las consultas externas de AF no presenciales, se han potenciado las teleconsultas con dispensación del tratamiento en base a cinco procedimientos básicos, cada uno de ellos con sus ventajas y limitaciones: dispensación domiciliaria desde SFH que presenta las ventajas de la universalidad de acceso, pero requiere una elevada inversión en recursos; coordinación del SHF con farmacéuticos de atención primaria, que conlleva una nula inversión en recursos, pero limita el acceso a determinadas zonas geográficas; coordinación del SFH con farmacéuticos comunitarios, que utiliza una amplia red de oficinas de farmacia, pero exige el desplazamiento del paciente sin garantías de confidencialidad para todos los casos; geolocalización y dispensación hospitalaria, que permite un acceso universal y trazabilidad directa, pero requiere un incremento en recursos humanos; y coordinación del SFH con asociaciones de pacientes, que no requiere inversión económica, pero limita el acceso a las patologías de los asociados. Destacamos finalmente tres lecciones aprendidas: la capacidad de AFPE de SFH españoles ante una crisis sanitaria; la utilidad de la Telefarmacia para el seguimiento clínico, la coordinación asistencial, información al PE, dispensación y entrega informada (con elevada satisfacción de los pacientes); y la necesidad de potenciar la Telefarmacia como herramienta complementaria, en un modelo mixto de AFPE que incorpore las ventajas de cada uno de los procedimientos adaptándose a las necesidades individuales de los pacientes en un entorno de humanización de la asistencia sanitaria