Revista de la OFIL

We make it to Volume 30 with the effort of many of us!

Looking back without anger

Outsourcing: yes, but...

Hospital Units of Research

Hacia una Farmacia Hospitalaria Digital

Combined therapy with bevacizumab and alteplasa for the treatment of submacular hemorrhages

RESUMEN Introducción: El uso combinado de bevacizumab y alteplasa intrarretiniano supone una alternativa de tratamiento de las hemorragias maculares que adquiere cada vez más relevancia. Además, su utilización en una única jeringa evita una inyección intrarretiniana reduciendo los posibles riesgos que conllevan. Objetivo: Confirmar la efectividad y seguridad de la combinación de bevacizumab y alteplasa in vivo para el tratamiento de hemorragias submaculares en pacientes con degeneración macular asociada a la edad y determinar si supone una alternativa de tratamiento válida. Metodología: Estudio retrospectivo observacional de pacientes tratados con bevacizumab y alteplasa para hemorragias submaculares desde febrero de 2017 a febrero de 2018. Se revisó la situación clínica pre-intervención y a los 3 meses. Las variables revisadas para determinar la efectividad del tratamiento fueron el tamaño de la superficie de la hemorragia, el grosor retiniano y la agudeza visual. La seguridad se evaluó con la aparición de reacciones adversas. Resultados: Fueron incluidos cinco pacientes, cuatro con un ojo afectado y uno con ambos, 60% hombres, con una mediana de edad de 78 años (68-89). Objetivamente se redujo el porcentaje de ocupación de la hemorragia de una media del 70% al 6% tras la intervención. El grosor retiniano disminuyó de 1.531 micras (1.891-1.195) a 516,8 micras (324-667). La agudeza visual mejoró en dos pacientes manteniéndose en el resto. Todos los pacientes refirieron subjetivamente mejoría tras la intervención. El tratamiento fue seguro por la ausencia de aparición de reacciones adversas. Conclusiones: El tratamiento estudiado ha demostrado ser efectivo y seguro clínicamente.

SUMMARY Introduction: The combined use of bevacizumab and intraretinal alteplase is an alternative treatment for macular hemorrhage that is becoming more and more relevant. In addition, its use in a single syringe prevents an intraretinal injection reducing the possible risks involved. Objective: To confirm the effectiveness and safety of the combination of bevacizumab and alteplase in vivo for submacular hemorrhage in patients with macular degeneration associated with age and to determine whether it is a valid treatment alternative. Material and methods: Observational retrospective study of patients treated with bevacizumab and alteplase for submacular hemorrhages from February 2017 to February 2018. The clinical situation was reviewed pre-intervention and at 3 months later. The variables reviewed to determine the effectiveness of the treatment were the size of the hemorrhage surface, the retinal thickness and the visual acuity. Safety was determined with the appearance of adverse reactions. Results: Six eyes of five patients were included, 60% men, with a median age of 78 years (68-89). Objectively the percentage of occupation of the hemorrhage was reduced from an average of 70% to 6% after the intervention. The retinal thickness decreased from 1,531 microns (1,891-1,195) to 516.8 microns (324-667). Visual acuity improved in two patients and remained in the rest. All patients reported subjectively improvement after the intervention. The treatment was safe due to the absence of adverse reactions. Conclusions: The reviewed treatment has shown to be clinically effective and safe.

Analysis and improvement of preparation and handling of hazardous oral drugs in a Hospital Pharmacy Department

RESUMEN Objetivos: Identificar de forma detallada las actividades en las cuales la exposición al riesgo es mayor por fallo en el manejo del medicamento peligroso (MP) o las medidas de autoprotección, y valorar su reducción tras llevar a la práctica una sesión formativa. Métodos: Estudio observacional y prospectivo, realizado en un hospital general de especialidades. Durante dos meses se lleva a cabo mediante el método de observación directa, un análisis de la manipulación y reenvasado de medicamentos peligrosos orales por personal técnico. Este periodo se dividió en dos etapas, tomando como punto de inflexión una sesión formativa al personal de farmacia al que se le explicaron los nuevos circuitos de trabajo para el manejo seguro de los medicamentos peligrosos, los protocolos elaborados, se informó sobre el manejo de los equipos de protección individual, y se entregó la documentación comentada. Posteriormente, las manipulaciones inseguras se categorizaron según la documentación de referencia: NIOSH y INSHT. Resultados: El número total de observaciones fue 181; 68 durante el primer periodo, de las cuales 11 (16,2%) correspondieron al reenvasado de MP orales. En todos los casos hubo una manipulación insegura. 113 observaciones en el segundo periodo, de ellas 16 (14,1%) fueron de reenvasado de MP. La probabilidad de error fue del 81,3%. En todos los casos la mayor probabilidad de error se asoció al empleo de los equipos de protección individual. Conclusiones: Mediante el método de la observación directa se han identificado los subprocesos donde es necesario incidir para disminuir el riesgo asociado al manejo de estos fármacos, que se han reducido parcialmente tras el empleo de una sesión formativa.

SUMMARY Objective: Detect in detail the activities which the exposure is greater due to failure in the use of the hazardous drugs or self-protection measures and assess their reduction after carrying out a training session. Methods: Prospective and observational study in a general hospital of specialties. For two months to take place by direct observation, an analysis of handling and repackaging of hazardous oral drugs by a technical staff. This time was divided in two stages, taking a training session to pharmacy staff as a turning point, which explained the new system work, protocols developed, it was reported on the management of individual protection equipment and documentation was delivered. Later, the unsafe handling were categorised according the reference documentation: NIOSH and INSHT. Results: The total number of observation was 181; 68 for the first time, which 11 (16,2%) accounted for the repackaging of hazardous oral drugs. In all cases there was a unsafe handling. 113 observations in the second period, which 16 (14,1%) were repackaging of hazardous oral drugs. The probability of error was 81,3%. In all cases, the highest probability of error was associated with the use of personal protective equipment. Conclusions: Using the direct observation method, the sub-processes have been identified where it is necessary to reduce the risk associated with the management of these drugs, which have been partially reduced after the use of a formative session.

Real long-term data of dupilumab in atopic dermatitis

SUMMARY Objectives: Dupilumab is the first biological drug indicated in atopic dermatitis (AD). The aim of this study is to assess effectiveness and safety of dupilumab in moderate-severe AD in clinical practice, and the quality of life of treated patients. Methods: Descriptive retrospective study was conducted. Effectiveness was measured by SCORingAtopic Dermatitis (SCORAD). Primary endpoint was SCORAD-75; secondary endpoints were SCORAD-90 and “total clearance”, at week 4, 12, 24 and 48. Safety was evaluated according to adverse events profile. Quality of life was assessed by Dermatology Life Quality Index (DLQI) at week 0 and 48. Results: At week 4, 2 patients presented SCORAD-75, none presented SCORAD-90 or clearance. At week 12, 2 patients showed SCORAD-75, 2 SCORAD-90 and one clearance. At weeks 24 and 48, 3 patients presented SCORAD-90 and 3 clearance. All patients presented mild-moderate adverse events. DLQI at week 48 was 0.7. Conclusions: Dupilumab presented adequate effectiveness and safety, improving quality of life of treated patients.

RESUMEN Objetivos: Dupilumab es el primer fármaco biológico con indicación en dermatitis atópica. El objetivo es evaluar la efectividad y la seguridad de dupilumab en dermatitis atópica moderada-grave en la práctica clínica, así como la calidad de vida de los pacientes tratados. Métodos: Se realizó un estudio descriptivo retrospectivo. La efectividad se evaluó mediante el SCORingAtopic Dermatitis (SCORAD). La variable primaria fue SCORAD-75; las variables secundarias fueron SCORAD-90 y "aclaramiento total", en las semanas 4, 12, 24 y 48. La seguridad se evaluó mediante el perfil de eventos adversos. La calidad de vida se evaluó mediante el Dermatology Life Quality Index (DLQI) en las semanas 0 y 48. Resultados: En la semana 4, 2 pacientes presentaron SCORAD-75, ninguno presentó SCORAD-90 o aclaramiento. En la semana 12, 2 pacientes mostraron SCORAD-75, 2 SCORAD-90 y uno aclaramiento. En las semanas 24 y 48, 3 pacientes presentaron SCORAD-90 y 3 aclaramiento. Todos los pacientes presentaron efectos adversos leves-moderados. El DLQI en la semana 48 fue 0,7. Conclusiones: Dupilumab presentó una efectividad y seguridad adecuadas, mejorando la calidad de vida de los pacientes.

Evaluation of the safety and effectiveness of the exchange of tenofovir disoproxil to tenofovir alafenamide in real life

RESUMEN Objetivos: Evaluar la seguridad y efectividad en vida real del intercambio en el tratamiento antirretroviral de tenofovir disoproxilo (TDF) a tenofovir alafenamida (TAF) en pacientes VIH. Material y métodos: Estudio retrospectivo observacional durante 2017 en el que se incluyeron todos los pacientes del departamento de salud en tratamiento con TAF. Se evaluó la población obtenida y además se dividió en dos subgrupos no comparativos según el intercambio realizado: subgrupo 1, de elvitegravir/cobicistat/TDF/emtricitabina (EVG/c/TDF/FTC) a EVG/c/TAF/FTC; y subgrupo 2, de TDF/FTC a TAF/FTC. Para la seguridad se midió antes y después del intercambio: creatinina (Cr), urea y velocidad de filtrado glomerular (VFG). Para la efectividad carga viral (CV) y linfocitos CD4. La CV se tomó como variable binaria interpretándose como pacientes respondedores (<20 copias/mL) o no. Las variables numéricas se expresaron en medianas y las cualitativas en porcentaje e intervalo intercuartílico (IQR). Las pruebas utilizadas fueron W de Wilcoxon y chi cuadrado respectivamente. Resultados: Se obtuvo una muestra de 55 pacientes en los que hubo una variación antes y después del cambio de Cr=0,9 mg/dL (IQR=0,8-1) a Cr=0,8 mg/dL (IQR=0,7-0,9) (p<0,001), de urea=29 mg/dL (IQR=24-36) a urea=28 mg/dL (25-34,5) (p=0,06) y de VFG=92,8 mL/min (79,3-102,1) a VFG=103,6 (IQR=95,9-111,1) (p<0,001). En cuanto a efectividad hubo un incremento desde el 51% al 59,9% (p=0,821) y para CD4 de 668 CD4/mcL (IQR=496-824) a 684 CD4/mcL (IQR=611-807) (p=0,084). Los resultados por subgrupos fueron similares. Conclusiones: Este estudio muestra en una misma población en vida real, que tras el cambio en la sal de tenofovir se mantiene un buen perfil de seguridad con mejora de parámetros analíticos de la función renal sin perjuicio en la efectividad.

SUMMARY Objective: To assess safety and effectiveness in real world of the switch in the antiretroviral treatment (ART) of tenofovir disoproxil (TDF) to tenofovir alafenamide (TAF) in HIV patients. Material and methods: Observational retrospective study during 2017 in which all the patients of the health department under treatment with TAF were included. The population obtained was evaluated and also divided into two non-comparative subgroups according to the switch performed: subgroup 1, from elvitegravir/cobicistat/TDF/emtricitabine (EVG/c/TDF/FTC) to EVG/c/TAF/FTC; and subgroup 2, from TDF/FTC to TAF/FTC. To evaluate safety, before and after the switch, was measured: creatinine (Cr), urea and glomerular filtration rate (GFR). To evaluate effectiveness was measured viral load (VL) and CD4 lymphocytes (CD4). VL was interpreted as binary variable: responder patients (<20 copies/mL) or non-responder patients. Numerical variables were expressed as medians (Md) and qualitative variables as percentage and interquartile interval (IQR). The statistical tests used were W of Wilcoxon and chi square respectively. Results: A sample of 55 patients was obtained. There was a variation, before and after the switch, of Cr=0.9 mg/dL (IQR=0.8-1) to Cr=0.8 mg/dL (IQR=0.7-0.9) (p<0.001), from urea=29 mg/dL (IQR=24-36) to urea=28 mg/dL (IQR=25-34.5) (p=0.06) and from GFR=92.8 mL/min (IQR=79.3-102.1) to GRT=103.6 (IQR=95.9-111.1) (p<0.001). In terms of effectiveness there was an increase from 51% to 59.9% (p=0.821) responding patients and for CD4 from 668 CD4/mcL (IQR=446-824) to 684 CD4/mcL (IQR=611-807) (p=0.058). The results by subgroups were similar. Conclusions: This study showed in real world after the change of tenofovir salt within the same population that a good safety profile is manteined with an improvement of analytical parameters of renal function without affecting its effectiveness.

Imunoprofilaxia do vírus sincicial respiratório com palivizumabe em crianças em hospital da zona sul de São Paulo

RESUMO As infecções agudas do trato respiratório inferior (IATRIs) são a primeiras causas de mortes nos países de baixa renda e a quarta nos países de média renda, que incluem o Brasil. O vírus sincicial respiratório (VSR) é o principal agente de infecções agudas do trato respiratório inferior, a causa mais conhecida bronquiolite, entre lactentes e jovens crianças. O palivizumabe é um anticorpo monoclonal imunoglobulina G subclasse 1 (IgG1) humanizado indicado para infecções do trato respiratório causado pelo VSR. Desenvolvimento de protocolo de imunização, e monitoramento do uso do palivizumabe em pacientes pediátricos de alto risco; verificando se a profilaxia com o palivizumabe reduz as taxas de internações e de mortalidade por VSR. O farmacêutico é parte fundamental no desenvolvimento dos protocolos clínicos, pois realiza um importante trabalho no seguimento farmacoterapêutico. Estudo observacional, prospectivo, em crianças com o risco de infecção grave por VSR que receberam palivizumabe de acordo com os critérios clínicos estabelecidos no Protocolo Federal da Portaria nº 522 de 13/05/2013. Os indivíduos foram seguidos por meio de visitas mensais. Implantação do protocolo de uso do palivizumabe dentro da instituição de saúde, nele foram estabelecidos, parâmetros e padrões, visando uma maior agilidade e eficiência dos processos. Foram acompanhados 14 neonatos e jovens crianças, 42,8% foram prematuros, 28,5% apresentavam displasia broncopulmonar e 28,5% cardiopatia congênita. Três óbitos (21,4%) foram registrados durante o acompanhamento. Os resultados mostraram que a imunização passiva com o palivizumabe é uma ferramenta importante na prevenção de infecções pelo VSR.

SUMMARY Acute lower respiratory tract infections (IATRIs) are the main cause of death in low-income countries and the fourth in middle-income countries, which include Brazil. Respiratory syncytial virus (RSV) is the main agent of acute lower respiratory tract infections, the most well known cause of bronchiolitis, among infants and young children. Palivizumab is a humanized immunoglobulin G subclass 1 (IgG1) monoclonal antibody indicated for respiratory tract infections caused by RSV. The pharmacist is a fundamental part in the development of clinical protocols, as it performs an important work in the pharmacotherapeutic follow-up. Development of an immunization protocol and monitoring the use of palivizumab in high-risk pediatric patients; verifying whether prophylaxis with palivizumab reduces hospitalization rates and RSV mortality. Observational prospective study in children at risk of severe RSV infection who received palivizumab according to the clinical criteria established in the Federal Protocol of Administrative Rule nº 522 of 05/13/2013. Children were followed through monthly visits. Implementation of the protocol for the use of palivizumab on the health institution, in which parameters, standards and parameters were established, aim at greater agility and efficiency of the processes. 14 neonates and young children were followed, 42.8% were premature, 28.5% had bronchopulmonary dysplasia and 28.5% had congenital heart disease. Three deaths (21.4%) were recorded during follow-up. The results showed that passive immunization with palivizumab are an important tool in the prevention of RSV infections.

Desenvolvimento de uma ferramenta para avaliação do desempenho de fornecedores de medicamentos na divisão de farmácia de um hospital universitário brasileiro

RESUMO Objetivo: O presente estudo tem como objetivo desenvolver uma ferramenta para avaliação do desempenho dos fornecedores capaz de gerar indicadores que possam ser utilizados como critério de qualificação dos mesmos na divisão de farmácia de um hospital universitário brasileiro com intuito de garantir a aquisição de medicamentos seguros e eficazes, dentro dos prazos adequados e a custo reduzido, assegurando a prestação de um serviço de qualidade ao paciente. Métodos: O trabalho foi desenvolvido por meio das seguintes etapas: pesquisa bibliográfica, desenvolvimento da ferramenta por meio da elaboração de critérios e estabelecimento de um sistema de pontuação e avaliação do fornecedor mediante um score final. Em seguida foi realizado um estudo para validação e análise dos resultados e posterior definição de ações de melhoria. Resultado: O balanced scorecard (BSC) foi a ferramenta selecionada após levantamento bibliográfico por ter uma estrutura abrangente e simples na medição de desempenho. Em seguida foi elaborada a ferramenta a partir da seleção de quatro critérios alinhados com a visão da divisão de farmácia e baseados nas perspectivas financeiras, nos processos internos, no cliente e na inovação e aprendizagem do BSC. Para o estudo foi selecionado 10 fornecedores homologados em processos licitatórios no período de abril a junho de 2018 aos quais foi aplicada a ferramenta com objetivo de planejar ações futuras de melhoria. Conclusão: Pode-se observar ao final deste trabalho que o objetivo pretendido foi alcançado.

SUMMARY Objective: The objective of this study was to develop a tool for drug suppliers' performance evaluation that was able to generate indicators to be used as a qualification criterion in a pharmacy division of a Brazilian teaching hospital, ensuring the purchase of efficacious and safe drugs, within estimated delivery time and at reduced cost, thus providing a quality care for patients. Methods: The work was carried out in the following steps: bibliographical research on the theme, development of a tool based on criteria for supplier performance assessment and the establishment of a scoring system and the supplier evaluation trough a final score. A study was conducted for validation and analysis of the results for further definition of actions for improvement. Results: After the bibliographical survey, the Balanced Scorecard (BSC) was the chosen tool as it had a more comprehensive and simple structure for performance measuring. The tool was developed according to selected criteria compliant with the vision statement of the pharmacy division, based on: financial perspective, internal processes, costumer and innovation and BSC learning. For the study it was selected 10 of the approved suppliers in bidding processes from April to June 2018 to which was applied the tool in order to plan future actions of improvement. Conclusion: It can be observed at the end of this study that the intended objective was reached.

Antineoplastic medication pick-up rates in a Costa Rica national hospital

RESUMEN Objectivo: Analizar los porcentajes de dosis retiradas de medicamentos oncológicos no incluidos en la Lista Oficial de Medicamentos según el servicio médico prescriptor y la vía de administración del fármaco, en un hospital de tercer nivel de atención en Costa Rica. Métodología: Los datos fueron obtenidos de manera retrospectiva a partir de bases de datos desarrolladas a nivel hospitalario para el control de los medicamentos adquiridos y a partir de los registros de medicamentos despachados. Resultados: Las unidades aprobadas para compra en los Servicios de Oncología y Hematología no son retiradas en su totalidad por los pacientes en tratamiento oncológico. En general, el porcentaje de retiro fue de 90,3% para 98 solicitudes de compra. Existen diferencias estadísticamente significativas en los porcentajes de retiro según el servicio médico prescriptor (t=-2,68; p=0,01) y la vía de administración de los medicamentos (t=-2,61; p=0,01). Del análisis multivariado se desprende que en el Servicio de Oncología Médica el porcentaje de retiro de medicamentos es significativamente menor entre las personas divorciadas (ß=-4,7; p<0,01) y viudas (ß=-20,5; p=0,01) en comparación con las personas casadas. Conclusiones: El retiro de medicamentos, si bien no es una forma de medir la adherencia terapéutica, permite establecer una relación primaria entre el paciente y el tratamiento a administrar. El sub-retiro de medicamentos encontrado mediante este estudio evidencia la necesidad de ampliar la investigación con el fin de conocer los motivos por los que los pacientes no retiran sus tratamientos oncológicos de compra.

SUMMARY Objective: To analyze the percentage of picked-up doses of oncologic drugs not included in the Essential Medicine List according to the medical prescribing service and the administration route of the drug in a third level hospital in Costa Rica. Method: Data was obtained by retrospective analysis from databases developed for the hospital's control of acquired drugs and from the dispatched drug registry. Results: Not all medications acquired through the special drug buying mechanism are picked-up by patients from the Oncology and Hematology Services. Overall, the pick-up rate was 90.3% for the 98 processes analyzed. Significant differences for the picking-up percentages were found for the medical prescribing service (t=-2.68; p=0.01) and the drug´s administration route (t=-2.61; p=0.01). Multivariate analysis shows that for the Medical Oncology Service, pick-up rate is significantly lower among divorced (ß=-4.7; p<0.01) and widowed (ß=-20.5; p=0.01) patients compared to married ones. Conclusions: Even when pick-up rates are not a way to measure therapeutic adherence, they allow to establish a primary relationship between the patient and its treatment. The underpicking of treatments found by this study shows the need to increase the research in order to understand patient´s reasons to abandon oncologic treatments that are not included in the Essential Medicine List.

Medicamentos isentos de prescrição (MIP): o farmacêutico pode prescrever, mas ele sabe o que são?

RESUMO Introdução: Medicamentos isentos de prescrição (MIP) representam expressiva parcela de comercialização no mercado farmacêutico mundial e brasileiro e possuem importância no manejo de problemas de saúde autolimitados e na automedicação responsável, por meio da atuação clínica do farmacêutico. Assim, o objetivo do trabalho foi identificar os MIP mais comumente dispensados em farmácias comunitárias da região metropolitana de Belo Horizonte, bem como o perfil de conhecimentos dos farmacêuticos em relação a categorização legal desta classe de medicamentos. Métodos: Trata-se de um estudo descritivo em que foram convidados a participar, via e-mail, todos os farmacêuticos responsáveis técnicos por farmácias comunitárias da região metropolitana de Belo Horizonte-MG (n=1.624; Outubro a Dezembro de 2017). A coleta de dados foi realizada por meio de questionário disponível na plataforma Google Docs®, onde requisitou-se aos farmacêuticos que listassem os cinco MIP mais dispensados por eles nos últimos 12 meses. Resultados: Foram obtidas respostas de 108 farmacêuticos. Os MIP mais dispensados constituem fármacos ou associações de fármacos com efeitos analgésico e/ou anti-inflamatório. Além disso 35,2% dos farmacêuticos listaram ao menos um medicamento não considerado isento de prescrição. Dentre 468 medicamentos citados, 54 representavam medicamentos sob prescrição médica. Conclusão: Os dados encontrados indicam uma lacuna no conhecimento desses farmacêuticos em relação à categorização legal de medicamentos, a qual pode acarretar em implicações legais e em resultados clínicos negativos. Neste sentido, torna-se essencial desenvolver estratégias, por meio de aprimoramentos e educação, visando suprir problemas de conhecimentos e condutas profissionais.

SUMMARY Introduction: Over the counter drugs (OTC) represent a significant market share in the global and Brazilian pharmaceutical market and are important in the management of minor ailments and to responsible self-medication through the pharmacist's clinical performance. Thus, the main of this research was to identify the OTC most commonly dispensed in community pharmacies in the metropolitan area of Belo Horizonte, as well as the knowledge profile of pharmacists regarding the legal categorization of this class of drugs. Methods: A descriptive study with pharmacists in charge of community pharmacies in the metropolitan region of Belo Horizonte-MG (n=1,624, October through December 2017) were realized. The invitations to participate were made via e-mail. Data collection was performed using a questionnaire available on the Google Docs® platform, where pharmacists were asked to list the five OTC most dispensed by them in the last 12 months. Results: Responses were obtained from 108 pharmacists. The most dispensed OCT are drugs or combinations of drugs with analgesic and/or anti-inflammatory effects. In addition, 35.2% of pharmacists listed at least one non-OTC drug. Of the 468 medicines mentioned, 54 represented medicines under medical prescription. Conclusion: The data indicate a gap in the knowledge of these pharmacists regarding the legal categorization of drugs, which may have legal implications and negative clinical results. In this sense, it is essential to develop strategies, through improvements and education, aiming to supply problems of knowledge and professional conduct.

Cold chain quality assurance in pharmaceutical distribution

RESUMEN Introducción: Una cadena de frío de calidad es aquella en la que se aseguran de manera integral todos los elementos necesarios para su adecuado desempeño. Objetivos: Diseñar un sistema de gestión integral de la cadena de frío de la Empresa Comercializadora y Distribuidora de Medicamentos EMCOMED, que permita garantizar la calidad de las operaciones de almacenamiento y transportación, y preservar la integridad de los productos farmacéuticos termosensibles durante su manipulación. Métodos: Se realizó una búsqueda bibliográfica para seleccionar bibliografía actualizada y de rigor científico aplicable a la gestión de calidad de la cadena de frío. Se aplicó la técnica del diagrama causa-efecto para establecer las variables requeridas para el manejo integral de la cadena de frío y elaborar el procedimiento normalizado de operación (PNO) aplicable a las diferentes operaciones de la empresa. Resultados: Se identificaron los cuatro elementos principales que permiten asegurar integralmente la calidad de la cadena de frío de EMCOMED. Se elaboró el PNO “Directrices para el manejo integral de la cadena de frío”. Conclusiones: El sistema de gestión de la cadena de frío de la empresa EMCOMED está basado en el aseguramiento de cuatro elementos principales. Las actividades necesarias para garantizar el manejo integral, están documentadas en un PNO. Su aplicación práctica reporta beneficios en los órdenes económico y social; y puede ser tomado como referente por empresas afines dedicadas a la distribución de productos termosensibles.

SUMMARY A solid cold chain is one that entirely assures all the necessary elements for an adequate performance. Objective: To design a cold chain management system for the Cuban Wholesale Distribution Company of Pharmaceuticals EMCOMED that guarantees the quality of warehousing and transportation operations and the preservation of product integrity during handling. Methods: A search was conducted to select updated bibliography with scientific rigor concerning the cold chain quality management system to be used as a reference. The cause-effect technique was applied to establish the necessary elements for the cold chain integral management and to draw up a standard operation procedure (SOP). Results: Four main elements were identified to be necessary for establishing the cold chain management system of the company. The SOP “Guidelines for the cold chain integral management” was drawn up. Conclusions: The cold chain management system of EMCOMED is based on four main elements. The SOP drawn up, sets out the necessary activities for the cold chain quality assurance. Its practical application brings economic and social benefits to the company and it could be an example to other distribution companies of temperature sensitive products.

Medication reconciliation in inpatient transfers

RESUMEN Objetivos: Valorar la efectividad de la intervención farmacéutica y caracterizar los tipos de discrepancias y errores de conciliación de la medicación, en el contexto de un programa de conciliación de la medicación durante el ingreso hospitalario de pacientes sometidos a una transición asistencial interna, cuya procedencia ha sido otro centro hospitalario o la unidad de cuidados intensivos. Métodos: Estudio prospectivo realizado en un hospital de especialidades. La población objeto de estudio han sido los pacientes que generaron estancia en nuestro centro durante un periodo de 8 meses, y cuya procedencia fue otro centro hospitalario o la unidad de cuidados intensivos (UCI). Diariamente se revisaron todos aquellos pacientes procedentes de una transición asistencial y posteriormente, se elaboró la mejor historia farmacoterapéutica posible revisando la información disponible sobre la medicación que podía estar recibiendo el paciente de forma previa a la transición asistencial y completando el proceso mediante una entrevista clínica. Las discrepancias que requerían aclaración fueron comunicadas al médico. Resultados: Se conciliaron un total de 350 medicamentos en 136 pacientes (una media de 2,6 fármacos por paciente). Se realizaron 139 actos de conciliación, de los cuales, en 68 se encontraron discrepancias justificadas, en 53 no se encontraron discrepancias y en los 18 restantes se encontraron discrepancias que requerían aclaración, siendo la más habitual entre ellas la omisión de un medicamento seguida de la prescripción incompleta y modificación de posología o vía sin justificación. De esas discrepancias, 15 fueron aceptadas por parte del médico prescriptor, modificando posteriormente la prescripción. La mayoría de los fármacos con esas discrepancias pertenecían a los grupos anatomoterapéuticos: tracto alimentario y metabolismo, sistema cardiovascular, sistema nervioso y sistema respiratorio. Conclusiones: La conciliación de la medicación durante las transiciones asistenciales llevada a cabo por un farmacéutico mostró ser útil en la identificación y prevención de errores de medicación con potenciales consecuencias clínicas para los pacientes.

SUMMARY Objetive: To assess the effectiveness of the pharmaceutical intervention and characterize the types of discrepancies and errors of medication reconciliation, in the context of a program of medication reconciliation during inpatient transfers, whose origin has been other hospital or the intensive care unit. Methods: An eight months prospective, observational study was carried out in a secondary hospital. Patients were selected when they were transferred to a medical unit of our hospital from an intensive care unit (ICU), a coronary intensive care unit (CICU) or other hospitals. Daily, in order to conduct the reconciliation process, the Pharmacist prepared the best pharmacotherapeutical history possible, reviewing all available information about the medication the patient could be taking before, and completing the process with a clinical interview. The discrepancies requiring clarification were reported to the physician. Results: 350 medications were reconciled in 136 patients, with a mean of 2,6 drugs per patient. 139 reconciliations were made: 68 were considered as justified discrepancies, 53 as no discrepancies and the remaining 18 as discrepancies that required clarification; the most frequent was the omission of a medication, followed by incomplete prescription and unjustified modification of dosing or way of administration. Among these 18 discrepancies, 15 were accepted by the hospital physician and prescriptions were modified. Most of the drugs with these discrepancies belonged to the anatomical-therapeutic groups: alimentary tract and metabolism, cardiovascular system, nervous system and respiratory system. Conclusions: The medication reconciliation process conducted by a pharmacist has proven to be useful in the identification and prevention of medication errors with potential clinical consequences for patients.

Desensitization protocol with levofloxacin in patient with osteoarticual infection. Report of clinical case

RESUMEN Las reacciones alérgicas y cutáneas para fluoroquinolonas las presentan entre el 0,4% y el 2,2% de los pacientes. Se presenta un protocolo de desensibilización por vía intravenosa que se desarrolla en 4 horas con dosis de 0,05 mg hasta una dosis acumulada de 750 mg.

SUMMARY Allergic and cutaneous reactions to fluoroquinolones are shown among 0.4% and 2.2% of the patients. A protocol of intravenous desensitization is presented, which develops in 4 hours with a dose of 0.05 mg to a cumulative dose of 750 mg.

Multiple fractures and unusual consumption of licorice pastillas Juanola®

RESUMEN El regaliz (Glycyrrhiza glabra) se ha considerado una planta medicinal desde hace miles de años, y actualmente se utiliza en multitud de preparados por su sabor, poder endulzante y efecto antiinflamatorio. No está exento de efectos secundarios, entre ellos, la hipertensión por su efecto mineralcorticoide. Además, los flavonoides presentes en el extracto de regaliz producen un aumento de la hormona paratiroidea (PTH) y de los niveles de calcio en la orina. Presentamos un caso de una mujer de 60 años con fracturas múltiples asociadas a un consumo inusual y exagerado de pastillas Juanola® (PJ®), producto a base de extracto de regaliz.

SUMMARY Licorice (Glycyrrhiza glabra) has been considered a medicinal plant for thousands of years, and it is included in several compounds for its flavor, sweetener and anti-inflammatory properties. It is not free of side effects, including high blood pressure due to its mineralocorticoid effect. In addition, there are flavonoids in licorice extract which increase serum parathyroid hormone (PTH) and urinary calcium levels. We report a case of a 60-year-old woman with multiple bone fractures associated with an unusual and exaggerate consumption of pastillas Juanola (PJ), product based on licorice extract.

Pustular psoriasis with BRAF inhibitors to treat metastatic melanoma

RESUMEN La inhibición dirigida de BRAF con vemurafenib y dabrafenib ha demostrado ser una opción de tratamiento del melanoma metastásico con mutación BRAF-V600E. Sin embargo, los eventos adversos cutáneos son frecuentes con los inhibidores de BRAF, siendo la psoriasis una complicación rara. Presentamos un caso de psoriasis pustulosa palmoplantar en un hombre adulto con melanoma metastásico tratado con ambos inhibidores de BRAF, de forma secuencial. Fue incluso necesario el tratamiento con corticoides sistémicos y apremilast para controlar la sintomatología. Hasta la fecha, sólo se ha descrito en la literatura un caso de psoriasis asociada a dabrafenib. Postulamos que la elevación del factor de necrosis tumoral alfa (TNF-a) y la activación paradójica de la vía de la proteína quinasa activada por mitógenos (MAPK) debido a la inhibición de BRAF pueden ser responsables de este caso. Se necesitan más estudios para dilucidar más a fondo los mecanismos inmunopatógenos detrás de este evento adverso.

SUMMARY Targeted BRAF inhibition with vemurafenib and dabrafenib has proven to be a useful tool in the treatment of metastatic melanoma with BRAF-V600E mutation. While cutaneous adverse events are prevalent with BRAF inhibition, psoriasis is a rare complication. We report a case of palmoplantar pustular psoriasis in an adult man with metastatic melanoma treated with both BRAF inhibitors, sequentially. Systemic corticosteroids and apremilast were required to control symptomatology. To date, a case has been described in the literature of psoriasis associated with dabrafenib. We postulate that the elevation of tumor necrosis factor-alpha (TNF-a) and the paradoxical activation of the mitogen-activated protein kinase (MAPK) pathway due to BRAF inhibition may be responsible for this case. More studies are needed to further elucidate the immunopathogenic mechanisms behind this adverse event.

Prevention of recurrent pancreatitis in lipoprotein lipase deficiency with antioxidant therapy

RESUMEN La hipertrigliceridemia por deficiencia de lipoprotein lipasa (LPL) es una enfermedad rara que se asocia a pancreatitis recurrente. La evidencia sugiere que la inflamación del páncreas podría estar relacionada con el daño por radicales libres. Existe bibliografía que avala el uso de antioxidantes en su prevención, en concreto la combinación de selenio, L-metionina, ácido ascórbico y tocoferol. A continuación se presenta el caso de un paciente con hipertrigliceridemia asociada a baja actividad de LPL con pancreatitis recurrentes. A partir de los 23 años comienza a sufrir episodios de pancreatitis aguda de repetición (más de 14 ingresos). Destaca un periodo de 4 años y medio en los que no presenta ningún episodio coincidiendo con el cese del hábito tabáquico. A los 46 años inicia tratamiento antioxidante; para ello se elaboran como fórmula magistral cápsulas de L-metionina y ácido ascórbico 480/120 mg y por otra parte cápsulas de selenometionina 600 mg. A lo largo del tratamiento los valores de triglicéridos se mantienen estables. Desde entonces no ha vuelto a presentar ningún diagnóstico de pancreatitis aguda. La asociación entre hipertrigliceridemia y pancreatitis es bien conocida, siendo además ésta última potencialmente mortal. En nuestro caso, la combinación de antioxidantes se muestra como una opción segura y efectiva. A tenor de los resultados y estudios parece también fundamental evitar el hábito tabáquico. Además, es esencial destacar la importancia de la formulación magistral. Sin embargo, serían recomendables estudios de eficacia y seguridad con mayor número de pacientes y durante un periodo de tiempo más prolongado.

SUMMARY Hypertriglyceridemia due to lipoprotein lipase deficiency (LPL) is a rare disease associated with recurrent pancreatitis. Evidence suggests that inflammation of the pancreas could be related to damage by free radicals. Bibliography supports the use of antioxidants in its prevention, specifically the combination of selenium, L-methionine, ascorbic acid and tocopherol. The following is the case of a patient with hypertriglyceridemia associated with low LPL activity with recurrent pancreatitis. From the age of 23, he begins to suffer episodes of recurrent acute pancreatitis (more than 14 admissions). It highlights a period of 4 and a half years in which there is no episode coinciding with the cessation of smoking. At the age of 46, he starts antioxidants treatment. For this purpose, master formula L-methionine and ascorbic acid capsules 480/120 mg and selenomethionine capsules 600 mg were performed. Throughout the treatment the values of triglycerides remain stable. Since then he has not presented any diagnosis of acute pancreatitis.The association between hypertriglyceridemia and pancreatitis is well known, and the latter is potentially fatal. In our case, the combination of antioxidants is shown as a safe and effective option. In view of the results and studies, it also seems essential to avoid smoking. In addition, it is essential to highlight the importance of the master formula. However, efficacy and safety studies with a greater number of patients and for a longer period of time would be recommended.

Possible spontaneous tendon rupture related to the use of atorvastatin

RESUMEN La rotura espontánea del tendón cuadricipital (REC) es una lesión de escasa incidencia cuya etiología se ha relacionado con el uso de diferentes fármacos. Las estatinas son fármacos que se han asociado a la aparición de reacciones adversas que afectan al sistema músculo-esquelético, aunque la relación entre su uso y las roturas tendinosas es controvertida. Presentamos 2 casos de REC de pacientes en tratamiento con atorvastatina. Este trabajo contribuye a aumentar la literatura publicada sobre la posible asociación entre el uso de atorvastatina y la aparición de REC.

SUMMARY Spontaneous quadriceps tendon rupture (SQTR) is a lesion of low incidence whose etiology has been related to the use of different drugs. Statins have been associated with the appearance of adverse reactions that affect the musculoskeletal system. However, the relationship between their use and tendon rupture remains controversial. We present 2 cases of SQTR in patients taking atorvastatin. This work contributes to increase the published literature of the association between use of atorvastatin and appearance of SQTR.

Adverse psychiatric effects with lorlatinib, a medicine that has not been widely used

RESUMEN El cáncer de pulmón no microcítico (CPNM) es la causa más frecuente de neoplasia maligna mortal en todo el mundo. Los tratamientos selectivos moleculares han supuesto un avance importante en el tratamiento del CPNM en pacientes determinados cuyos tumores albergan diversas mutaciones tales como EGFR, BRAF, reordenamiento ALK o ROS. El lorlatinib es un TKI selectivo de ALK con capacidad para penetrar en el cerebro y con gran actividad contra las fusiones de ALK y ROS1, incluidas las mutaciones de resistencia. Se describe el caso de una mujer con cáncer de pulmón no microcítico que presenta efecto adverso psiquiátrico en relación a lorlatinib.

SUMMARY Non-small cell lung cancer (NSCLC) is the most common cause of death worldwide. Selective molecular treatments have been an important advance in the treatment of NSCLC in certain patients whose tumors have diverse mutations such as EGFR, BRAF, ALK rearrangement or ROS. Lorlatinib is an ALK-selective TKI that it is able to penetrate the brain and it has highly activity against ALK and ROS1 fusions, including resistance mutations. We describe the case of a woman with non-small cell lung cancer who has an adverse psychiatric effect in relation to lorlatinib.

Analysis of the use of biosimilar medicines

Pharmaceutical care to patients in a smoking cessation group at a Brazilian teaching hospital